Medical device introduction systems and methods

• US 20080058595A1
• Filed: 06/13/2007
• Published: 03/06/2008
• Est. Priority Date: 06/14/2006
• Status: Abandoned Application

• Current Assignee: OptiVia Medical LLC
• Original Assignee: OptiVia Medical LLC
• Inventors: Wilson, Jon, McMillan, John, Rothstein, Lawrence, Massey, Joe, Finch, Marcus, Snoke, Phillip, Allred, Philip, Martel, Mark, Cassidy, Kenneth
• Application Number:
  US11/811,957
• Publication Number:
  US 20080058595A1
• Time in Patent Office: Days
• US Class Current: 600/114
• CPC Class Codes: A61B 1/00135 Oversleeves mounted on the endoscope prior to insertion
• CPC Class Codes: A61B 1/0051 with controlled bending of insertion part
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 1/07 using light-conductive means, e.g. optical fibres
• CPC Class Codes: A61B 1/303 for the vagina, i.e. vaginoscopes
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 2017/003 Steerable

Abstract

A medical device introduction system and method can include a medical introducer, a separate imaging device, and/or a separate working channel device, each of which may be movable independent of the other. The medical introducer can include a handle and an elongate introducer tube extending from the handle and having a plurality of lumens, and may be inserted into an interior body region of a patient. The separate imaging device may be inserted through the handle and positioned in one of lumens. The separate working channel device can include an elongate working channel tube and a position controller. The working channel tube can include at least one lumen defining a working channel. The position controller can be configured to control positioning of the working channel tube. The working channel device may be removably connected to the handle and positioned in another lumen.

Claims

1. A medical device introduction system, comprising:

a medical introducer comprising a handle and an elongate introducer tube extending therefrom and having a plurality of lumens extending longitudinally therein, the medical introducer insertable into an interior body region of a patient;

a separate imaging device insertable through the handle and positionable in a predetermined one of the plurality of lumens, the imaging device having an interface with the handle such that each of the imaging device and the medical introducer is movable independent of the other; and

a separate working channel device comprising an elongate working channel tube having at least one lumen extending the length thereof defining a working channel and a position controller for controlling the position of the working channel tube, the working channel device removably connectable to the handle and positionable in another predetermined one of the plurality of lumens such that each of the medical introducer, the imaging device, and the working channel device is movable independent of the other.

2. The system of claim 1, wherein the medical introducer handle comprises an oval-shaped ring of material having an open interior, a proximal end configured to receive at least one fluid tube and the imaging device therethrough, and a distal end adapted to connect to the introducer tube.

3. The system of claim 1, wherein the plurality of lumens further comprises a scope lumen, at least one working lumen, and at least one fluid lumen separate from the scope lumen and the at least one working lumen.

4. The system of claim 3, wherein the medical introducer further comprises a fluid inflow tube routed through the proximal end of the handle and in fluid communication with one of the at least one fluid lumen and a fluid outflow tube routed through the proximal end of the handle and in fluid communication with another one of the at least one fluid lumen.

5. The system of claim 3, wherein the diameter of the working lumen is larger than the diameter of the other lumens.

6. The system of claim 1, wherein the medical introducer further comprises a modular manifold integrally formed on a proximal end of the introducer tube and having a corresponding plurality of lumens aligned with the plurality of lumens in the introducer tube, the manifold removably connectable to the introducer handle such that the manifold and introducer tube are interchangeable in the handle with other manifolds and introducer tubes.

7. The system of claim 1, wherein the medical introducer is disposable.

8. The system of claim 1, wherein the working channel device is disposable.

9. The system of claim 1, wherein at least a portion of the medical introducer is translucent such that passage of materials therethrough is viewable.

10. The system of claim 1, wherein at least a portion of the working channel device is translucent such that passage of materials therethrough is viewable.

11. The system of claim 1, the introducer tube further comprising a proximal portion having a first durometer and a distal portion having a second durometer, wherein the second durometer is lower than the first durometer so as to allow deflection of the distal portion for controllable access to a target area in the interior body region.

12. The system of claim 11, wherein the introducer tube distal portion further comprises a distal tip having a first diameter smaller than a second diameter of the remainder of the introducer tube, the smaller first diameter adapted to seal about a device extending beyond the distal tip.

13. The system of claim 11, wherein the introducer tube further comprises a fluid lumen comprising a wall having a third durometer that is higher than the second durometer of the distal portion so as to prevent collapsing of the fluid lumen when the distal portion of the introducer tube is deflected.

14. The system of claim 1, wherein the handle further comprises a plurality of raised grips on an outside surface of the handle.

15. The system of claim 1, wherein the working channel device further comprises a steerable working channel device, and wherein the working channel tube comprises a flexible distal portion adapted for steering to selected positions.

16. The system of claim 15, wherein the position controller is operably connected to the working channel tube distal portion and slidable within the introducer handle for moving the working channel tube distal portion in distal and proximal directions.

17. The system of claim 16, wherein the position controller is actuatable to steer the flexible distal portion of the working channel tube in predetermined directions and amounts.

18. The system of claim 17, wherein the predetermined direction of steering comprises a plane generally parallel to an upper surface of the position controller.

19. The system of claim 16, wherein the steerable working channel device further comprises at least two steering wires each having a distal end connected to a distal tip of the working channel tube, extending through the working channel tube, and having a proximal end operably connected to the position controller to manipulate the distal portions of the working channel tube.

20. The system of claim 19, wherein the position controller further comprises a circular, lower housing having an upwardly extending hollow hub and a cooperating circular, upper housing having a downwardly extending rotor rotatingly seated inside the hollow hub, wherein each of the steering wires is connected to an opposite side of the position controller rotor such that rotation of the upper housing causes rotation of the rotor inside the hub and the distal end of the steering wire on one side of the rotor to retract so as to deflect the distal tip at an angle laterally away from a longitudinal axis of the working channel tube.

21. The system of claim 20,

wherein the introducer handle further comprises an oval-shaped ring of material having an open interior and a plurality of detents on an inner surface of the handle from a proximal position to a distal position,

wherein the lower housing of the position controller further comprises a downwardly extending bracket adapted to friction fit in the inner surface of the handle and a securing flange extending outwardly from the bracket adapted to friction fit about a bottom of the handle,

wherein the position controller is slidingly engageable with the detents so as to secure the position of the working channel tube distal tip along a longitudinal axis of the working channel tube.

22. The system of claim 20, wherein the position controller further comprises an automatic braking mechanism comprising a soft material on the outer surface of at least one of the upper housing rotor and the lower housing hub so as to provide sufficient friction to hold the upper housing in position relative to the lower housing when released by a user.

23. The system of claim 1, the working channel tube further comprising a proximal portion having a first durometer and a distal portion having a second durometer, wherein the second durometer is lower than the first durometer so as to allow deflection of the distal portion for improved access to a target area in the interior body region.

24. The system of claim 23, wherein the working channel tube distal portion further comprises a distal tip having a first diameter smaller than a second diameter of the remainder of the working channel tube, the smaller first diameter adapted to seal about a device extending beyond the distal tip.

25. The system of claim 1, wherein the working channel device further comprises at least one access port having a seal and connected to a proximal end of the working channel tube for controllable access to the steerable working channel.

26. The system of claim 1, wherein the position controller further comprises a size adapted to be readily held in a hand of a user.

27. The system of claim 1, wherein the position controller further comprises a plurality of grips on lateral edges of the position controller to assist a user in manipulating the position controller.

28. The system of claim 1, wherein the imaging device further comprises an endoscopic cannula, a light delivery mechanism, and a imaging system.

29. The system of claim 28, wherein the imaging system comprises at least one of an optical scope, an ultrasound instrument, or a camera positioned on a distal portion of the endoscopic cannula.

30. The system of claim 1, wherein the introducer handle further comprises a scope connector located on an opposite side of the handle from the introducer tube and longitudinally aligned with the one of the plurality of lumens in the introducer tube, and wherein the imaging device is securely connectable to the scope connector.

31. The system of claim 30, wherein the imaging device is adapted to rotate independent of movement of the medical introducer when the imaging device is securely connected to the scope connector.

32. The system of claim 28, wherein the endoscopic cannula comprises a proximal portion having a first durometer and a distal portion having a second durometer, wherein the second durometer is lower than the first durometer so as to allow deflection of the distal portion for improved viewing of a target area in the interior body region.

33. The system of claim 28, the imaging device further comprising at least two steering wires each having a distal end connected to a distal tip of the endoscopic cannula, extending at least the length of the endoscopic cannula, and a having proximal end operably connected to a deflection control mechanism at a proximal end of the endoscopic cannula, wherein actuation of the deflection control mechanism causes the distal tip of the endoscopic cannula to deflect at an angle away from a longitudinal axis of the imaging device.

34. The system of claim 33, wherein the at least two steering wires further comprise each of a first pair of wires adjacent opposite points on a circumference of the endoscopic cannula to deflect the distal tip along a first axis, and each of a second pair of wires adjacent two other opposite points on the circumference of the endoscopic cannula, each of the second pair of wires positioned 90 degrees from each of the first pair of wires, to deflect the distal tip along a second axis perpendicular to the first axis.

35. The system of claim 28, wherein the light delivery mechanism comprises one or more light emitting diodes mounted at a distal tip of the endoscopic cannula.

36. The system of claim 28, wherein the light delivery mechanism comprises a plurality of light delivery fibers attached to the endoscopic cannula and extending from a proximal end to the distal tip of the endoscopic cannula.

37. The system of claim 36, the light delivery mechanism further comprising a light source comprising a light cable attached on one end to a power source and on the opposite end to the light delivery fibers at the proximal end of the endoscopic cannula.

38. The system of claim 37, the light delivery mechanism further comprising a light source comprising one or more light emitting diodes connected to the light delivery fibers at the proximal end of the endoscopic cannula.

39. The system of claim 28, wherein the light delivery mechanism comprises a plurality of light delivery fibers integrated into the endoscopic cannula and extending from a proximal end to the distal tip of the endoscopic cannula.

40. The system of claim 39, the light delivery mechanism further comprising a light source comprising a light cable attached on one end to a power source and on the opposite end to the light delivery fibers at the proximal end of the endoscopic cannula.

41. The system of claim 40, the light delivery mechanism further comprising a light source comprising light emitting diodes in the introducer handle connected to the light delivery fibers.

42. The system of claim 1, further comprising an accessory device support removably connectable to the introducer handle and comprising a carrier arm for supporting an upper part of a body of a separate medical device to be used with the medical introducer and a slide member for slidably supporting a lower part of the body of the separate medical device for stabilizing placement of the separate medical device in the interior body region.

43. The system of claim 42, wherein the accessory device support is removably connectable to an outside surface of a scope connector on a proximal end of the introducer handle.

44. A medical introducer device, comprising:

a handle comprising an oval-shaped ring of material having an open interior, a proximal end, and a distal end;

an elongate introducer tube extending from the distal end of the handle and having a plurality of lumens extending longitudinally therein;

the proximal end of the handle configured to receive at least one fluid tube and an imaging device therethrough; and

the distal end of the handle adapted to connect to the introducer tube,

wherein the device is insertable into an interior body region of a patient.

45. The device of claim 44, wherein the plurality of lumens further comprises a scope lumen, at least one working lumen, and at least one fluid lumen separate from the scope lumen and the at least one working lumen.

46. The device of claim 45, further comprising a fluid inflow tube routed through the proximal end of the handle and in fluid communication with one of the at least one fluid lumen and a fluid outflow tube routed through the proximal end of the handle and in fluid communication with another one of the at least one fluid lumen.

47. The device of claim 45, wherein the diameter of the working lumen is larger than the diameter of the other lumens.

48. The device of claim 44, further comprising a modular manifold integrally formed on a proximal end of the introducer tube and having a corresponding plurality of lumens aligned with the plurality of lumens in the introducer tube, the manifold removably connectable to the handle such that the manifold and introducer tube are interchangeable in the handle with other manifolds and introducer tubes.

49. The device of claim 44, wherein a separate imaging device is inserted through the handle and positioned in a predetermined one of the plurality of lumens, the imaging device having an interface with the handle such that each of the imaging device and the medical introducer is movable independent of the other.

50. The device of claim 44, wherein a separate working channel device, comprising an elongate working channel tube having at least one lumen extending the length thereof defining a working channel and a position controller for controlling the position of the working channel tube, is removably connected to the handle and positioned in another predetermined one of the plurality of lumens such that each of the medical introducer, the imaging device, and the working channel device is movable independent of the other.

51. The device of claim 44, wherein the device is disposable.

52. The device of claim 44, wherein at least a portion of the device is translucent such that passage of materials therethrough is viewable.

53. The device of claim 44, the introducer tube further comprising a proximal portion having a first durometer and a distal portion having a second durometer, wherein the second durometer is lower than the first durometer so as to allow deflection of the distal portion for controllable access to a target area in the interior body region.

54. The device of claim 53, wherein the introducer tube distal portion further comprises a distal tip having a first diameter smaller than a second diameter of the remainder of the introducer tube, the smaller first diameter adapted to seal about a device extending beyond the distal tip.

55. The device of claim 53, wherein the introducer tube further comprises a fluid lumen comprising a wall having a third durometer that is higher than the second durometer of the distal portion so as to prevent collapsing of the fluid lumen when the distal portion of the introducer tube is deflected.

56. The device of claim 44, wherein the handle further comprises a size adapted to be readily held in a hand of a user.

57. The device of claim 44, wherein the handle further comprises a plurality of raised grips on an outside surface of the handle.

58. A kit, comprising at least one of:

a medical introducer comprising a handle and an elongate introducer tube extending therefrom and having a plurality of lumens extending longitudinally therein, the medical introducer insertable into an interior body region of a patient;

a separate imaging device insertable through the handle and positionable in a predetermined one of the plurality of lumens, the imaging device having an interface with the handle such that each of the imaging device and the medical introducer is movable independent of the other; and

a separate working channel device comprising an elongate working channel tube having at least one lumen extending the length thereof defining a working channel and a position controller for controlling the position of the working channel tube, the working channel device removably connectable to the handle and positionable in another predetermined one of the plurality of lumens such that each of the medical introducer, the imaging device, and the working channel device is movable independent of the other.

59. The kit of claim 58 wherein the medical introducer handle comprises an oval-shaped ring of material having an open interior, a proximal end configured to receive at least one fluid tube and the imaging device therethrough, and a distal end adapted to connect to the introducer tube.

60. The kit of claim 58, wherein the plurality of lumens further comprises a scope lumen, at least one working lumen, and at least one fluid lumen separate from the scope lumen and the at least one working lumen.

61. The kit of claim 60, wherein the medical introducer further comprises a fluid inflow tube routed through the proximal end of the handle and in fluid communication with one of the at least one fluid lumen and a fluid outflow tube routed through the proximal end of the handle and in fluid communication with another one of the at least one fluid lumen.

62. The kit of claim 58, wherein the medical introducer further comprises a modular manifold integrally formed on a proximal end of the introducer tube and having a corresponding plurality of lumens aligned with the plurality of lumens in the introducer tube, the manifold removably connectable to the introducer handle such that the manifold and introducer tube are interchangeable in the handle with other manifolds and introducer tubes.

63. The kit of claim 62, further comprising a plurality of manifolds and introducer tubes.

64. The kit of claim 58, wherein at least the medical introducer and the working channel device are each disposable.

65. The kit of claim 58, wherein at least a portion of the medical introducer and at least a portion of the working channel device is translucent such that passage of materials therethrough is viewable.

66. The kit of claim 58, the introducer tube further comprising a proximal portion having a first durometer and a distal portion having a second durometer, wherein the second durometer is lower than the first durometer so as to allow deflection of the distal portion for controllable access to a target area in the interior body region.

67. The kit of claim 58, wherein the working channel device further comprises a steerable working channel device, and wherein the working channel tube comprises a flexible distal portion adapted for steering to selected positions.

68. The kit of claim 67,

wherein the position controller is operably connected to the working channel tube distal portion and slidable within the introducer handle for moving the working channel tube distal portion in distal and proximal directions, and

wherein the position controller is actuatable to steer the flexible distal portion of the working channel tube in predetermined directions and amounts.

69. The kit of claim 58, wherein the imaging device further comprises an endoscopic cannula, a light delivery mechanism, and a imaging system.

70. The kit of claim 58, wherein the light delivery mechanism further comprises light emitting diodes, light delivery fibers, or light emitting diodes and light delivery fibers.

71. The kit of claim 58, further comprising an accessory device support removably connectable to an outside surface of a scope connector on a proximal end of the introducer handle and comprising a carrier arm for supporting an upper part of a body of a separate medical device to be used with the medical introducer and a slide member for slidably supporting a lower part of the body of the separate medical device for stabilizing placement of the separate medical device in the interior body region.

72. The kit of claim 58 comprising the medical introducer and the working channel device.

73. The kit of claim 72 wherein the medical introducer comprises the working channel device inserted therein.

74. A method, comprising:

inserting into an interior body region of a patient a medical introducer comprising a handle and an elongate introducer tube extending therefrom and having a plurality of lumens extending longitudinally therein;

inserting a separate imaging device through the handle and positioning the imaging device in a predetermined one of the plurality of lumens;

positioning the imaging device in a selected position within the interior body region;

producing an image from within the interior body region;

removably connecting to the handle a separate working channel device comprising an elongate working channel tube having at least one lumen extending the length thereof defining a working channel and a position controller for controlling the position of the working channel tube, and positioning the working channel in another predetermined one of the plurality of lumens; and

moving one of the group of the medical introducer, the imaging device, and the working channel device independent of the others of the group.

75. The method of claim 74, the medical introducer handle further comprising an oval-shaped ring of material having an open interior, the method further comprising connecting a distal end of the handle to the introducer tube.

76. The method of claim 74, the medical introducer further comprising a modular manifold integrally formed on a proximal end of the introducer tube and having a corresponding plurality of lumens aligned with the plurality of lumens in the introducer tube, the method further comprising removably connectable the manifold to the introducer handle.

77. The method of claim 76, further comprising interchanging the manifold and introducer tube in the handle with other manifolds and introducer tubes.

78. The method of claim 74, further comprising supplying fluid to the interior body region through a fluid inflow tube and a first dedicated fluid lumen in the introducer tube and removing fluid from the interior body region through a second dedicated fluid lumen in the introducer tube and a fluid outflow tube.

79. The method of claim 74, wherein at least a portion of the medical introducer and at least a portion of the working channel device is translucent, the method further comprising viewing passage of materials through the medical introducer and the working channel device.

80. The method of claim 74, the introducer tube further comprising a proximal portion having a first durometer and a distal portion having a second durometer lower than the first durometer, the method further comprising deflecting the distal portion of the introducer tube for controlling access to a target area in the interior body region.

81. The method of claim 80, further comprising sealing a distal tip of the introducer tube about a device extending beyond the distal tip.

82. The method of claim 74, the working channel device further comprising a steerable working channel device, and the working channel tube further comprising a flexible distal portion, the method further comprising controlling the steering of the flexible distal portion of the working channel device in predetermined directions and amounts to selected positions in the interior body region independent of movement of the medical introducer and the imaging device.

83. The method of claim 82, wherein, the position controller is operably connected to the working channel tube distal portion, the method further comprising sliding the position controller within the introducer handle for moving the working channel tube distal portion in distal and proximal directions.

84. The method of claim 82, wherein the position controller further comprises a soft material on interfacing surfaces of rotatable portions of the position controller, the method further comprising automatically braking rotation of the rotatable portions so as to maintain a position of the working channel distal portion when the position controller is released by a user.

85. The method of claim 74, the working channel tube further comprising a proximal portion having a first durometer and a distal portion having a second durometer lower than the first durometer, the method further comprising deflecting the distal portion of the working channel tube for controlling access to a target area in the interior body region.

86. The method of claim 85, further comprising sealing a distal tip of the working channel tube about a device extending beyond the distal tip.

87. The method of claim 74, further comprising:

securely connecting the imaging device to a scope connector located on an opposite side of the handle from the introducer tube and longitudinally aligned with the one of the plurality of lumens in the introducer tube; and

rotating the imaging device independent of movement of the medical introducer.

88. The method of claim 74, wherein the imaging device further comprises a proximal portion having a first durometer and a distal portion having a second durometer lower than the first durometer, the method further comprising deflecting the distal portion of the introducer tube for controlling access to a target area in the interior body region.

89. The method of claim 74, further comprising delivering light to the interior body region with light emitting diodes, light delivery fibers, or light emitting diodes and light delivery fibers.

90. The method of claim 74, further comprising placing a separate medical device in the interior body region by using an accessory device support removably connected to the introducer handle and comprising a carrier arm for supporting an upper part of a body of the separate medical device and a slide of the body of the separate medical device.

91. The method of claim 74, further comprising performing a medical procedure in the interior body region through the working channel device.

92. The method of claim 91, wherein the performing a medical procedure further comprises performing a gynecological procedure.

93. The method of claim 91, wherein the performing a medical procedure further comprises performing a spinal procedure.

94. The method of claim 74, further comprising disposing of the medical introducer and the working channel device.