METHODS AND APPARATUS TO SHAPE FLEXIBLE ENTRY GUIDES FOR MINIMALLY INVASIVE SURGERY

• US 20080287963A1
• Filed: 06/30/2008
• Published: 11/20/2008
• Est. Priority Date: 12/30/2005
• Status: Active Grant

• Current Assignee: David Q. Larkin, Theodore W. Rogers
• Original Assignee: Intuitive Surgical Operations, Inc. (Intuitive Surgical Holdings, LLC)
• Inventors: Larkin, David Q., Rogers, Theodore W.
• Granted Patent: US 9,962,066 B2
• Time in Patent Office: Days
• US Class Current: 606/130
• CPC Class Codes: A61B 1/00042 for mechanical operation
• CPC Class Codes: A61B 1/00087 Tools A61B17/00234 takes precedence
• CPC Class Codes: A61B 1/00128 mechanical, e.g. for tubes or pipes
• CPC Class Codes: A61B 1/00133 Drive units for endoscopic tools inserted through or with the endoscope
• CPC Class Codes: A61B 1/00135 Oversleeves mounted on the endoscope prior to insertion
• CPC Class Codes: A61B 1/00193 adapted for stereoscopic vision
• CPC Class Codes: A61B 1/005 Flexible endoscopes
• CPC Class Codes: A61B 1/0051 with controlled bending of insertion part
• CPC Class Codes: A61B 1/0052 Constructional details of control elements, e.g. handles
• CPC Class Codes: A61B 1/0055 Constructional details of insertion parts, e.g. vertebral elements
• CPC Class Codes: A61B 1/0057 Constructional details of force transmission elements, e.g. control wires
• CPC Class Codes: A61B 1/0058 using shape-memory elements
• CPC Class Codes: A61B 1/008 Articulations
• CPC Class Codes: A61B 1/009 with bending or curvature detection of the insertion part
• CPC Class Codes: A61B 1/01 Guiding arrangements therefore
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00323 Cables or rods
• CPC Class Codes: A61B 2017/00327 with actuating members moving in opposite directions
• CPC Class Codes: A61B 2017/3445 : used as instrument channel for multiple instruments catheters A61B2017/22072
• CPC Class Codes: A61B 2017/3447 : Linked multiple cannulas
• CPC Class Codes: A61B 2017/347 : Locking means, e.g. for locking instrument in cannula
• CPC Class Codes: A61B 2034/2061 : using shape-sensors, e.g. fiber shape sensors with Bragg gratings
• 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 2034/306 : Wrists with multiple vertebrae
• CPC Class Codes: A61B 34/30 : Surgical robots
• CPC Class Codes: A61B 34/37 : Master-slave robots A61B34/35 takes precedence
• CPC Class Codes: A61B 34/71 : Manipulators operated by drive cable mechanisms
• CPC Class Codes: A61B 34/72 : Micromanipulators

Abstract

In one embodiment of the invention, an apparatus for performing surgical procedures is disclosed including a flexible entry guide tube, and a first steering device. The flexible entry guide tube has one or more lumens extending along its length from a proximal end to substantially at or near a distal end. At least one of the one or more lumens is an instrument lumen with open ends to receive a flexible shaft of a surgical tool to perform surgery near the distal end of the flexible entry guide tube. The first steering device is insertable into the instrument lumen to shape the flexible entry guide tube as it is inserted through an opening in a body and along a path towards a surgical site. The apparatus may further include a flexible locking device to couple to the flexible entry guide tube and selectively rigidize the flexible entry guide tube to hold its shape. The flexible entry guide tube may be steered by remote control with one or more actuators.

Claims

1. An apparatus for surgical procedures, the apparatus comprising:

a flexible entry guide tube having one or more lumens extending along its length from a proximal end to substantially at or near a distal end, wherein at least one of the one or more lumens is a first instrument lumen with open ends to receive a surgical tool with a flexible shaft to perform surgery near the distal end of the flexible entry guide tube; and

a first steering device insertable into the first instrument lumen, the first steering device to shape the flexible entry guide tube as the flexible entry guide tube is inserted through an opening in a body and guided towards a surgical site.

2. The apparatus of claim 1, wherein

the flexible entry guide tube includes

a flexible locking device to couple to the flexible entry guide, the flexible locking device to selectively rigidize the flexible entry guide tube to hold its shape.

3. The apparatus of claim 1, wherein

the first steering device is a first surgical tool with control cables to move a steerable portion of a flexible shaft to shape the flexible entry guide tube as it is inserted into the opening in the body.

4. The apparatus of claim 1, wherein

the first steering device is a first rigid rod to shape the flexible entry guide tube as it is inserted through the opening in the body.

5. The apparatus of claim 4, wherein

the first rigid rod is initially inserted into the body cavity and the first entry lumen of the flexible entry guide tube is inserted over the rigid rod to shape the flexible entry guide tube as it is inserted.

6. The apparatus of claim 4, wherein

the flexible entry guide tube is initially inserted into the body cavity and the first rigid rod is inserted into the first entry lumen of the flexible entry guide tube to shape the flexible entry guide tube as it is further inserted into the body cavity.

7. The apparatus of claim 3, further comprising:

a platform to couple to the proximal end of the flexible guide tube, the platform to support the proximal end of the flexible guide tube and to insert the flexible guide tube into the opening in the body, wherein the platform to further provide support for the surgical tool and its respective actuating devices to perform the surgical procedure.

8. The apparatus of claim 1, wherein

at least a second one of the plurality of lumens is a second instrument lumen with open ends to receive a surgical tool with a flexible shaft to perform surgery near the distal end of the flexible guide;

and

the apparatus further includes

a second steering device insertable into second first instrument lumen to further shape the flexible guide tube as it is inserted into the opening in the body.

9. The apparatus of claim 8, wherein

the first steering device is a first surgical tool and the second steering device is a second surgical tool, the first surgical tool with first control cables to move a first steerable portion of a first flexible shaft and the second surgical tool with second control cables to move a second steerable portion of a second flexible shaft to shape the flexible entry guide tube as it is inserted through the opening in the body.

10. The apparatus of claim 8, wherein

the first steering device is a first rigid rod and the second steering device is a second rigid rod to shape the flexible entry guide tube as it is inserted into the opening in the body.

11. The apparatus of claim 1, wherein

the flexible locking device is inserted into a lumen of the plurality of lumens of the flexible entry guide tube, the flexible locking device substantially extending the length of the flexible entry guide tube.

12. The apparatus of claim 11, wherein

with the flexible locking device inserted into the lumen to hold the shape of the flexible entry guide tube, the first steering device may be removed from the first instrument lumen to permit a surgical tool to be inserted into the first instrument lumen.

13. The apparatus of claim 1, wherein

at least one of the lumens is a closed lumen with a closed base near the distal end of the flexible entry guide tube to receive a device to influence the behavior of the flexible entry guide tube.

14. The apparatus of claim 1, wherein

the flexible entry guide tube is a steerable entry guide tube steered by remote control with one or more actuators coupled to a respective one or more steering cables coupled to steering points of the flexible entry guide tube.

15. A method for a surgical procedure, the method comprising:

inserting a first steering device into a first lumen at a first end of a flexible entry guide tube;

inserting the flexible entry guide tube into a body cavity through an opening;

steering a second end of the flexible entry guide tube towards a first surgical site within the body cavity using the first steering device; and

locking the shape of the flexible entry guide tube in place within the body cavity with the second end located near the surgical site to guide surgical tools into the surgical site.

16. The method of claim 15, further comprising:

inserting a second steering device into a second lumen at the first end of the flexible entry guide tube; and

steering the second end of the flexible entry guide tube towards the surgical site using the first and second steering devices.

17. The method of claim 16, wherein

at least one of the first and the second steering devices is a surgical tool to perform the surgical procedure.

18. The method of claim 15, further comprising:

withdrawing the first steering device from the first lumen of the flexible entry guide tube after locking the shape of the flexible entry guide tube; and

inserting a first surgical tool into the first lumen of the flexible entry guide tube to perform a surgical procedure in the surgical site.

19. The method of claim 15, wherein

locking the shape of the flexible entry guide tube includes

inserting a flexible locking device into a second lumen of the flexible entry guide tube;

and

making the flexible locking device rigid within the second lumen to lock the shape of the flexible entry guide tube.

20. The method of claim 15, wherein

locking the shape of the flexible entry guide tube includes

axially compressing the flexible entry guide tube along its length to increase friction between articulating elements to lock the shape of the flexible entry guide tube.

21. The method of claim 15, further comprising:

unlocking the shape of the flexible entry guide tube in response to completing the surgical procedure in the surgical site; and

withdrawing the flexible entry guide tube from the body through the body opening after completing the surgical procedure at the surgical site.

22. The method of claim 15, further comprising:

unlocking the shape of the flexible entry guide tube after completing the surgical procedure in a first surgical site; and

repeating the inserting of the first steering device, the steering of the second end to a second surgical site within the body cavity, and the locking of the shape of the flexible entry guide tube to perform another surgical procedure at the second surgical site within the body cavity.

23. An apparatus for surgical procedures, the apparatus comprising:

a flexible entry guide tube having one or more lumens extending along its length from a proximal end to substantially at or near a distal end, wherein at least one of the one or more lumens has a non-circular cross section portion; and

a tool insertable into the at least one instrument lumen with the non-circular cross section portion, the tool to key to the non-circular cross section to substantially prevent rotation of the tool within the lumen.

24. The apparatus of claim 23, wherein

the tool is a surgical tool with an extended portion extending beyond the distal end of the flexible entry guide tube to perform a surgical procedure, and

a rotational torque in the extended portion of the surgical tool generated by its manipulation during the surgical procedure is transferred to the flexible entry guide tube.

25. The apparatus of claim 23, wherein

the non-circular cross section portion of the at least one instrument lumen extends the length of the entry guide tube to substantially prevent rotation of the tool along its substantial length within the lumen.

26. The apparatus of claim 23, wherein

the tool is an endoscopic camera keyed to the lumen to maintain its orientation with the flexible entry guide.

27. An apparatus for surgical procedures, the apparatus comprising:

a flexible entry guide tube having one or more lumens extending along its length from a proximal end to substantially at or near a distal end;

a first tool insertable into a first instrument lumen; and

a first locking device adapted to couple a portion of the first tool to a portion of the flexible entry guide tube within the first instrument lumen to deter axial motion of the first tool along the length of the flexible entry guide tube.

28. The apparatus of claim 27, wherein

the first locking device is further adapted to couple a portion of the first tool to a portion of the flexible entry guide tube within the first instrument lumen to deter rotational motion of the first tool within the first instrument lumen.

29. The apparatus of claim 28, wherein

the first tool is a first surgical tool with an extended portion extending beyond the distal end of the flexible entry guide tube to perform a surgical procedure, and

a rotation torque in the extended portion of the first surgical tool generated by its manipulation during the surgical procedure is transferred to the flexible entry guide tube.

30. The apparatus of claim 28, wherein

the first tool is an endoscopic camera locked to the within the first instrument lumen by the first locking device to maintain its orientation with the flexible entry guide tube.

31. The apparatus of claim 27, wherein

the first locking device is a inflatable bladder to inflate between a wall of the first instrument lumen and an outside surface of the first tool.

32. The apparatus of claim 31, wherein

the inflatable bladder is an inflatable balloon part of the first tool.

33. The apparatus of claim 31, wherein

the inflatable bladder is an inflatable cylinder part of the flexible entry guide tube.

34. The apparatus of claim 27, wherein

the first locking device is a mechanically expandable collar to expand between a wall of the first instrument lumen and an outside surface of the first tool.

35. The apparatus of claim 27, further comprising:

a second tool insertable into a second instrument lumen;

a second locking device adapted to couple a portion of the second tool to a portion of the flexible entry guide tube within the second instrument lumen to deter axial motion of the second tool along the length of the flexible entry guide tube; and

wherein the first tool and the second tool are sufficiently stiff and a respective first and second force applied near a proximal end of the first and second tool alternatively pushes and pulls on the tools or conjunctively pushes or pulls on the tools to steer the flexible entry guide tube towards a surgical site.

36. The apparatus of claim 35, wherein

the first tool and the second tool are a first surgical tool and a second surgical tool with first and second extended portions extending beyond the distal end of the flexible entry guide tube to perform a surgical procedure, and

a rotation torque in the first and second extended portions of the respective first and second surgical tools generated by their manipulation during the surgical procedure is transferred to the flexible entry guide tube.

37. An apparatus for surgical procedures, the apparatus comprising:

a flexible entry guide tube having one or more lumens extending substantially along its length from a proximal end to substantially near a distal end, wherein at least one of the one or more lumens is a closed lumen with a proximal open end and a distal closed end near the distal end of the flexible entry guide tube, the flexible entry guide tube including a tool in the distal end of the flexible entry guide tube substantially aligned with the cross section of the closed lumen; and

a device insertable into the proximal open end of the closed lumen, the device to influence the behavior of the flexible entry guide tube as it is inserted through an opening of a body and along a path towards a surgical site.

38. The apparatus of claim 37, wherein

the device is a steering device to steer the flexible entry guide tube.

39. The apparatus of claim 37, wherein

the device is a stiffening device to stiffen a portion of the flexible entry guide tube.

40. The apparatus of claim 37, wherein

the tool is a camera to capture images near the distal end of the flexible entry guide tube.

41. A surgical apparatus comprising:

a flexible entry guide having a longitudinal axis defined between a proximal end and a distal end, the flexible entry guide having a plurality of lumens extending parallel to the longitudinal axis of the flexible entry guide; and

a plurality of substantially rigid stiffening rods removeably insertable into a respective plurality of the lumens to assist in steering the flexible entry guide.

42. The apparatus of claim 41 further comprising:

a minimally invasive surgical instrument configured to be inserted into one of the lumens after one of the plurality of substantially rigid stiffening rods is removed.

43. The apparatus of claim 41, wherein

the plurality of substantially rigid stiffening rods are inserted by one or more servo-actuators under remote control.

44. The apparatus of claim 41, wherein

each of the plurality of substantially rigid stiffening rods has a different shape.

45. A method for a surgical procedure, the method comprising:

inserting a first substantially rigid removable stiffening rod into a first lumen within a flexible entry guide;

stiffening a first portion of the entry guide with the first substantially rigid removable stiffening rod; and

steering the flexible entry guide towards a surgical site.

46. The method of claim 45, further comprising:

removing the first substantially rigid removable stiffening rod from the first lumen; and

inserting a first minimally invasive surgical instrument through the first lumen to extend from a distal end of the entry guide to the surgical site.

47. The method of claim 45, wherein

the first substantially rigid removable stiffening rod has a curved portion to shape a portion of the flexible entry guide.

48. The method of claim 45, further comprising:

stiffening the first portion of the entry guide with a second substantially rigid removable stiffening rod inserted into a second lumen within the flexible entry guide.

49. The method of claim 45, further comprising:

stiffening a second portion of the entry guide with a second substantially rigid removable stiffening rod inserted into a second lumen within the flexible entry guide.

50. The method of claim 49, further comprising:

removing the first substantially rigid removable stiffening rod from the first lumen and the second substantially rigid removable stiffening rod from the second lumen;

inserting a first minimally invasive surgical instrument through the first lumen to extend from a distal end of the entry guide to the surgical site; and

inserting a second minimally invasive surgical instrument through the second lumen to extend from the distal end of the entry guide to the surgical site.

51. A surgical apparatus comprising:

an entry guide tube having a plurality of lumens defined between a proximal end and a distal end; and

a first device configured to be inserted into a first lumens, wherein the first device comprises a first steerable flexible portion;

wherein if the first steerable flexible portion of the first device is within the first lumen, then the first steerable flexible portion shapes an adjacent portion of the entry guide tube; and

wherein if the first steerable flexible portion extends out of the first lumens beyond the distal end of the entry guide tube, then the first steerable flexible portion is used to conduct a surgical operation.

52. The surgical apparatus of claim 51, further comprising:

a second device configured to be inserted into a second one of the lumens, wherein the second device comprises a second steerable flexible portion;

wherein if the first and second steerable flexible portions are within the respective first and second lumens, then the first and second steerable flexible portions shape adjacent portions of the entry guide tube; and

wherein if the first and second steerable flexible portions extend out of the respective first and second lumens beyond the distal end of the entry guide tube, then the first and second steerable flexible portions are used to conduct a surgical operation.

53. The surgical apparatus of claim 51, further comprising:

a locking device coupled to the entry guide tube, the locking device actuated by an actuator under remote control to lock and stiffen a portion of the entry guide tube.

54. The surgical apparatus of claim 51, further comprising:

a flexible lockable sleeve around and coaxial to the entry guide tube, the flexible lockable sleeve actuated by one or more actuators under remote control to lock into a rigid position around the entry guide tube to constrain the shape of the entry guide tube.

55. The surgical apparatus of claim 51, wherein

the entry guide tube is a steerable entry guide tube steered by remote control with one or more actuators coupled to a respective one or more steering cables coupled to the entry guide tube at steering points.

56. A method for a surgical procedure, the method comprising:

inserting a distal end of a flexible entry guide through an opening of a body, the flexible entry guide including one or more lumens to receive tools;

operating controls at a console to remotely control one or more actuators; and

steering the flexible entry guide towards a surgical site in response to the remote control of the one or more actuators.

57. The method of claim 56, wherein

the flexible entry guide is a steerable flexible entry guide with one or more steering cables respectively coupled to the one or more actuators such that the flexible entry guide is steered by remote control.

58. The method of claim 56, wherein

the shape of the flexible entry guide is influenced by a steerable portion of one or more tools inserted into the respective one or more lumens, the steerable portion of the one or more tools is respectively actuated by the one or more actuators such that the flexible entry guide is steered by remote control.

59. The method of claim 56, further comprising

extending the steerable portions of a plurality of tools out of a respective pair of lumens beyond the distal end of the flexible entry guide;

sensing the shape of all or a portion of the plurality of tools; and

controlling the shape of the plurality of tools in response to their respective sensed shape.

60. The method of claim 59, wherein

the steerable portions of the plurality of tools are controlled to have substantially the same shape.

61. The method of claim 60, further comprising

pushing the flexible entry guide over the steerable portions of the plurality of tools to guide it along a path in a body.

62. The method of claim 56, further comprising:

locking a portion of the one or more tools within the respective one or more lumens to the flexible entry guide to influence the shape of the entry guide with the steerable portion of the one or more tools.

63. The method of claim 56, further comprising:

keying a non-circular portion of the one or more tools to a respective non-circular portion within the respective one or more lumens of the flexible entry guide to maintain orientation of the one or more tools with the flexible entry guide.

64. The method of claim 56, further comprising:

stiffening a first portion of the entry guide with a first removable stiffening element.

65. The method of claim 64, further comprising:

stiffening a second portion of the entry guide with a second removable stiffening element.

66. A flexible entry guide system for a surgical procedure, the system comprising:

a flexible entry guide having a proximal end and a distal end, the flexible entry guide including

a plurality of vertebrae pivotally coupled together to allow the entry guide to flex, each of the plurality of vertebrae having one or more lumen openings axially aligned together to form one or more lumens along the length of the flexible entry guide;

a plurality of steering cables routed from a proximal end of the entry guide through a plurality of axially aligned cable openings in the vertebrae to one or more steering points of the entry guide; and

a plurality of actuators coupled to ends of the plurality of steering cables, the plurality of actuators under remote control of a first control system to steer the flexible entry guide within a body.

67. The system of claim 66, further comprising:

one or more steering tools insertable into the respective one or more lumens to further steer the flexible entry guide within the body.

68. The system of claim 66, further comprising:

one or more stiffening tools insertable into the respective one or more lumens to stiffen one or more portions of the flexible entry guide as the flexible entry guide is inserted into the body.

69. The system of claim 66, further comprising:

a surgical tool insertable into one of the one or more lumens to perform a surgical procedure, and

wherein the flexible entry guide is lockable to substantially hold its shape and position during the surgical procedure performed with the surgical tool.

70. The system of claim 69, wherein

the surgical tool is coupled to one or more actuators under remote control of a second control system to control the surgical tool during the surgical procedure.

71. The system of claim 66, wherein

each of the plurality of vertebrae include a pair of gear segments to pivotally couple together.

72. The system of claim 71, wherein

one or more of the plurality of vertebrae include an alignment pin to engage an alignment opening of an adjacent vertebrae, the alignment pin to engage the alignment opening to substantially maintain adjacent vertebrae in alignment.

73. A surgical apparatus for a surgical procedure, the apparatus comprising:

a flexible entry guide tube having a plurality of lumens between a proximal end and a distal end;

a plurality of tools insertable into the plurality of lumens, each of the plurality of tools including

a steerable portion extendable beyond the distal end of the flexible entry guide tube, and

a sensor to sense a shape of all or a portion of the tool;

wherein the shape of each of the plurality of tools is controlled in response to the shape of each respective tool sensed by each sensor.

74. The surgical apparatus of claim 73, further comprising:

a controller to control the steerable portion of each of the plurality of tools.

75. The surgical apparatus of claim 74, wherein

the controller controls the steerable portion of each of the plurality of tools to have substantially the same shape during insertion of the flexible entry guide into a body.

76. The surgical apparatus of claim 73, further comprising:

a first actuator coupled to the flexible entry guide tube, the first actuator under remote control to push the flexible entry guide tube along a path in the body.

77. The surgical apparatus of claim 73, further comprising:

a plurality of actuators respectively coupled to the plurality of tools, the plurality of actuators under remote control to respectively actuate the steerable portions of the plurality of tools to provide the shape thereof.

78. The surgical apparatus of claim 73, wherein

the flexible entry guide tube includes

a flexible locking device to couple to the flexible entry guide tube, the flexible locking device to selectively rigidize the flexible entry guide tube to hold its shape.

79. A method for a surgical procedure, the method comprising:

inserting a plurality of instruments into a respective plurality of lumens in a flexible entry guide and coupling portions of the plurality of instruments to lumen walls in the respective plurality of lumens of the flexible entry guide;

pushing and/or pulling the plurality of instruments having portions coupled to the lumen walls to steer the flexible entry guide to a surgical site of a body; and

rigidizing the flexible entry guide to maintain its shape and position in the body near the surgical site to perform the surgical procedure.

80. The method of claim 79, further comprising

decoupling portions of the plurality of instruments from the lumen walls to deploy the plurality of instruments to the surgical site to perform the surgical procedure.

81. The method of claim 80, wherein

the deployment of the plurality of instruments includes

extending portions of the plurality of instruments out of the lumens towards the surgical site;

and

spreading out the plurality of instruments from each other to perform the surgical procedure.

82. The method of claim 80, further comprising

removing the plurality of instruments from the respective plurality of lumens in the flexible entry guide.

83. The method of claim 82, further comprising

de-regidizing the flexible entry guide to relax its shape and withdrawal it from the body.

84. The method of claim 82, wherein

the plurality of instruments are steering instruments, and

the method further includes

inserting a plurality of surgical tools into the lumens of the flexible entry guide to perform the surgery at the surgical site.

85. The method of claim 80, further comprising

re-coupling portions of the plurality of instruments to the lumen walls in the respective plurality of lumens of the flexible entry guide;

de-regidizing the flexible entry guide to relax its shape; and

pushing and/or pulling the plurality of instruments having portions coupled to the lumen walls to steer and shape the flexible entry guide as it is withdrawn from the body.

86. The method of claim 79, wherein

a first portion of a first instrument of the plurality of instruments is coupled to a first lumen wall at a first depth in a first lumen of the entry guide;

and

a second portion of a second instrument of the plurality of instruments is coupled to a second lumen wall at a second depth in a second lumen of the entry guide, wherein the second depth differs from the first depth.

87. The method of claim 79, wherein

a first portion of a first instrument of the plurality of instruments is coupled to a first lumen wall at a first depth in a first lumen of the entry guide;

and

a second portion of a second instrument of the plurality of instruments is coupled to the first lumen wall at a second depth in the first lumen of the entry guide, wherein the second depth differs from the first depth.

88. The method of claim 79, further comprising:

prior to pushing and/or pulling the plurality of instruments, rigidizing the plurality of instruments within the respective plurality of lumens in the flexible entry guide.

89. The method of claim 79, further comprising:

insufflating a cavity in the body with a gas to expand the cavity and ease steering of the flexible entry guide.

90. The method of claim 79, wherein

the portions of the plurality of instruments are coupled to the lumen walls so that end-effectors of each instrument are within the lumens of the entry guide.