Viewing surgical scope for minimally invasive procedures

• US 6,174,307 B1
• Filed: 01/08/1999
• Issued: 01/16/2001
• Est. Priority Date: 03/29/1996
• Status: Expired due to Fees

• Current Assignee: Eclipse Surgical Technologies, Inc. (Cryolife Incorporated)
• Original Assignee: Eclipse Surgical Technologies, Inc. (Cryolife Incorporated)
• Inventors: Reynolds, Timothy C., Harman, Stuart D., Daniel, Steven A.
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): YARNELL, BRYAN KEITH
• Application Number:
  US09/227,458
• Time in Patent Office: 739 Days
• Field of Search: 606/2, 606/7, 606/13-16, 606/32, 606/41, 606/129, 606/167, 606/185, 600/114, 600/103, 600/127, 600/125, 600/121, 600/129, 600/153, 600/160, 604/264, 604/164, 604/272, 604/280
• US Class Current: 606/15
• CPC Class Codes: A61B 1/00098 Deflecting means for inserted tools
• CPC Class Codes: A61B 1/00154 using guiding arrangements for insertion
• CPC Class Codes: A61B 1/00179 for off-axis viewing
• CPC Class Codes: A61B 1/00183 for variable viewing angles
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 1/267 for the respiratory tract, e.g. laryngoscopes, bronchoscopes
• CPC Class Codes: A61B 1/3132 for laparoscopy
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/22075 with motorized advancing or retracting means
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2018/00166 Multiple lumina
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00982 combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2018/2238 with means for selectively laterally deflecting the tip of the fibre
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

A viewing and treatment apparatus for performing minimally invasive surgery through an opening in a patient'"'"'s chest, the apparatus includes a visualization scope with an elongated portion and a distal end, and a working device such as a tissue ablation energy delivery device. The working device is encompassed within a working channel that communicates with the distal end of the scope. In one embodiment, a bronchoscope is used whose catheter shafting includes an introducer sleeve at the distal section of the scope for providing stability during introduction to a patient'"'"'s chest while stabilizing the treatment and visualization distal ends of the scope at a treatment site. This embodiment can include a needle piercing assembly that cooperatively works with the work device such as for drug delivery. In a second embodiment a rigid endoscope with a viewing channel has an introducer member that is slidably disposed and detachable from the viewing channel and has a transparent convex distal tip which provides non-articulation at the distal end. This introducer member can also be used in conjunction with the first embodiment where the catheter shaft requires non-articulation. Both types of visualization scopes include a working channel in which the working device can translationally egress from the scope'"'"'s distal end. Additionally, the rigid introducer member can be modified to include a movable transparent rotatable member design for varying the direction which the working devices egresses the apparatus'"'"' distal end. The preferred surgical procedure is transmyocardial revascularization and the preferred working device is an optical fiber element that is translatable from the distal end of the apparatus during the procedure. The working device can optionally include a flexible piercing needle with an internal lumen which allows translation of a working device such as an optical fiber or act as a conduit for drug delivery.

Claims

1. A minimally invasive surgical apparatus comprising:

a rigid tubular introducer having a proximal portion, an essentially transparent distal portion comprising an end cap, and a lumen housing a distal portion of a visualization device; and

at least one working tube defining a working channel in combination with the introducer having proximal and distal portions and a terminus at the distal portion of the introducer, the working channel configured to house an egressible working device for effectuating a minimally invasive surgical procedure, whereby the distal portion of the at least one working tube and a target tissue site are viewable at a proximal end of the visualization device when the distal portion of the introducer engages the target tissue.

2. The apparatus of claim 1 wherein the distal portion of the introducer has a conical shape.

3. The apparatus of claim 1 wherein the introducer is essentially transparent.

4. The apparatus of claim 1 wherein at least the distal portion of the working channel is essentially transparent to enable visualization of the working device.

5. The apparatus of claim 4 wherein the working channel is essentially transparent.

6. The apparatus of claim 1 wherein the proximal portion of the working channel is attached to an external surface of the introducer and the distal portion of the working channel is within the rigid introducer.

7. The apparatus of claim 6 wherein the distal portion of the working channel is at an angle to the proximal portion of the working channel.

8. The apparatus of claim 1 wherein the proximal and distal portions of the working channel are within the rigid introducer.

9. The apparatus of claim 1 wherein the proximal portion of the working channel is within a wall of the rigid introducer.

10. The apparatus of claim 1 wherein the working channel is within the lumen of the rigid introducer.

11. The apparatus of claim 1 further comprising a second working channel configured to house an egressible working device.

12. The apparatus of claim 1 further comprising a shaft having proximal and distal portions and at least one working channel coupled to the proximal portion of the rigid introducer, a first of the at least one working channel of the rigid introducer being coupled to a first of the at least one working channel of the shaft.

13. The apparatus of the claim 12 further comprising a handpiece having a working device advancement mechanism and an actuation member, said handpiece coupled to the proximal portion of the shaft.

14. The apparatus of claim 12 wherein the shaft further comprises a second working channel and the rigid introducer further comprises a second working channel.

15. The apparatus of claim 12 wherein the shaft further comprises two or more working channels and the rigid introducer further comprises two or more working channels, each working channel of the shaft coupling to a corresponding working channel of the introducer.

16. The apparatus of claim 12 further comprising a body member operably attached to the proximal portion of the shaft.

17. The apparatus of claim 16 wherein the body member comprises an actuation device for controlling the operation of the working device.

18. The apparatus of claim 17 wherein the actuation device comprises a movement mechanism for moving the working device, whereby the distal portion of the working device moves with respect to the point of egression from the rigid introducer in response to movement of the movement mechanism.

19. The apparatus of claim 18 wherein the shaft is essentially flexible.

20. The apparatus of claim 18 wherein the shaft is essentially rigid.

21. The apparatus of claim 18 wherein the end cap is rotatable, the end cap comprises an internal channel which communicates with the at least one working tube, the body member further comprises a means for controlling the orientation of the rotatable end cap thereby variably controlling the point of egression of the working channel.

22. The apparatus of claim 17 wherein the first of at least one working tube comprises a concentric working tube having a proximal and a distal portion having a piercing needle assembly, the first of at least one working tube being independently slidably disposed within the concentric working tube, the movement mechanism comprising a triggering device for actuating the piercing needle assembly.

23. The apparatus of claim 22 wherein the working device is at least one fiber optic element.

24. The apparatus of claim 1 wherein the working device is a laser energy delivery device.

25. The apparatus of claim 24 wherein the laser energy delivery device is at least one fiber optic.

26. The apparatus of claim 25 further comprising a piercing needle assembly in combination with the laser energy delivery device.

27. The apparatus of claim 26 wherein the piercing needle assembly comprises a flexible portion.

28. The apparatus of claim 27 wherein the piercing needle assembly is a drug delivery device.

29. The apparatus of claim 1 wherein the working device is a piercing needle assembly.

30. The apparatus of claim 29 wherein the piercing needle assembly comprises a flexible portion.

31. The apparatus of claim 30 wherein the piercing needle assembly is a drug delivery device.

32. The apparatus of claim 1 wherein the working device is a coring device.

33. The apparatus of claim 1 wherein the working device is a drug delivery device.

34. The apparatus of claim 33 further comprising a piercing needle assembly in combination with the drug delivery device.

35. The apparatus of claim 1 wherein the visualization device is rigid.

36. The apparatus of claim 1 wherein the visualization device is essentially rigid.

37. The apparatus of claim 1 wherein the visualization device is flexible.

38. The apparatus of claim 1 wherein the longitudinal axis of the distal portion of the at least first working channel and the longitudinal axis of the introducer are the same.

39. The apparatus of claim 1 wherein the longitudinal axis of the distal portion of the at least first working channel and the longitudinal axis of the introducer define an angle therebetween.

40. The apparatus of claim 39 wherein the angle is 0°

.

41. The apparatus of claim 39 wherein the angle is greater than 0°

.

42. The apparatus of claim 1 wherein the proximal portion of the rigid introducer comprises a handle member having a locking means for mechanically securing the at least one working tube to the rigid introducer.

43. The apparatus of claim 1 wherein a distal end of the visualization device defines a planar surface, whereby a line normal to the planar surface and the longitudinal axis of the rigid introducer defines a first angle.

44. The apparatus of claim 43 wherein the longitudinal axis of the working channel at the point of egression and the longitudinal axis of the introducer defines a second angle.

45. The apparatus of claim 44 wherein the first angle is about 0°

and the second angle is equal to or greater than 0°

.

46. The apparatus of claim 44 wherein the first angle is greater than about 0°

and the second angle is equal to or greater than 0°

.

47. The apparatus of claim 44 wherein the first angle is equal to or greater than 0°

and the second angle about 0°

.

48. The apparatus of claim 44 wherein the first angle is equal to or greater than 0°

and the second angle is greater than 0°

.

49. The apparatus of claim 44 wherein the rigid introducer further comprises a connection means for mating the distal portion of the rigid introducer to the proximal portion of the rigid introducer, a first distal portion of the rigid introducer being able to be quickly disconnected and replaced with a second distal portion, the second angle of the second distal portion being different from the second angle of the first distal portion.

50. A surgical procedural apparatus for visualizing and treating tissue in a minimally invasive surgical procedure, the apparatus comprising:

a visualization scope having a proximal portion comprising a body member, and an elongated sleeve member configurably attached to the body member and having a distal portion housing a visualization device; and

a rigid introducer and viewing assembly comprising;

a tubular member, the distal portion of the elongated sleeve member being sidably disposed within the tubular member;

at least one working tube defining a working channel configured to house a working device; and

an inelastic and essentially transparent distal portion comprising an end cap which encloses a distal portion of the tubular member, a distal end of the working tube being operably attached to the end cap,

whereby the distal portion of the at least one working tube and a target tissue site are viewable at a proximal end of the visualization device when the distal portion of the introducer engages the target tissue.

51. The apparatus of claim 50 wherein the visualization scope and sleeve member are rigid and the distal portion of the working channel has a terminus at the tip member.

52. The apparatus of claim 50 wherein the visualization scope is a bronchoscope, the sleeve member is a flexible catheter shaft and the introducer and viewing assembly further includes an essentially rigid outer sleeve member attached to a distal portion of the catheter shaft with a handle member at a proximal portion of the outer sleeve member.

53. The apparatus of claim 50 wherein the tubular member and the tip member are a unitary member having a substantially uniform wall thickness.

54. The apparatus of claim 50 wherein the body member further comprises an actuation device operatively attached to the working device for controlling operation of the working device.

55. The apparatus of claim 54 wherein the actuation device further comprises a movement control, whereby advancement and retraction of the working device out from and into the end cap can be controlled.

56. The apparatus of claim 55 wherein the end cap is rotatable and the end cap comprises an internal channel which communicates with the at least one working tube, the body member further comprises a means for controlling the orientation of the rotatable end cap thereby variably controlling the point of egression of the working channel.

57. The apparatus of claim 55 wherein the at least one working tube further comprises an inner tube member slidably disposed therein defining an internal lumen, a distal end of the inner tube comprising a piercing needle member, the working device independently slidably disposed within the internal lumen of the inner tube member.

58. The apparatus of claim 57 wherein the actuation device further includes a triggering member operatively attached to the inner tube, whereby the piercing member is advanced upon activation of the triggering member.

59. The apparatus of claim 58 wherein the lumen of the piercing needle member contains at least one optical fiber element.

60. The apparatus of claim 59 wherein the working means is an optical fiber element.

61. The apparatus of claim 50 wherein an outer surface of the end cap is convex shaped thereby spreading and stabilizing a surface of target tissue when pressing the assembly against the target tissue and enhancing viewing thereof.

62. The apparatus of claim 50 wherein the longitudinal axis of the working channel at the point of egression and the longitudinal axis of the introducer are the same.

63. The apparatus of claim 50 wherein a distal end of the visualization device defines a planar surface, whereby a line normal to the planar surface and the longitudinal axis of the rigid introducer defines a first angle.

64. The apparatus of claim 63 wherein the longitudinal axis of the working channel at the point of egression and the longitudinal axis of the introducer defines a second angle.

65. The apparatus of claim 64 wherein the first angle is about 0°

and the second angle is equal to or greater than 0°

.

66. The apparatus of claim 64 wherein the first angle is greater than about 0°

and the second angle is equal to or greater than 0°

.

67. The apparatus of claim 64 wherein the first angle is equal to or greater than 0°

and the second angle about 0°

.

68. The apparatus of claim 64 wherein the first angle is equal to or greater than 0°

and the second angle is greater than 0°

.

69. A method of performing a minimally invasive surgical procedure in a body comprising the steps of:

a) providing an apparatus comprised of a rigid introducer having a transparent distal portion comprising an end cap and configured to house a distal portion of a visualization device, and at least a first working channel in combination with said introducer, said working channel configured to house an egressible working device for effectuating the procedure, wherein the distal portion of the introducer and a target tissue site are viewable when the distal portion of the introducer engages the target tissue;

b) introducing the apparatus through a minimally invasive formed penetration;

c) advancing the working device through the working channel; and

d) viewing while effectuating the procedure.

70. The method of claim 69 wherein the working device is a laser energy delivery device.

71. The method of claim 70 wherein the procedure is the formation of revascularization channels through at least a portion of the heart wall.

72. The method of claim 71 wherein the procedure is transmyocardial revascularization.

73. The method of claim 71 further comprising an arbitrary step of drug delivery.

74. The method of claim 69 wherein step b) further comprises viewing a treatment site.

75. The method of claim 69 wherein the apparatus further comprises a piercing needle assembly in combination with the working device and prior to step d) further comprising the step of piercing the epicardium.

76. The method of claim 75 wherein the working device is a drug delivery device.

77. The method of claim 69 further comprising the step e) rotating the apparatus and repeating steps c) through d).