Apparatus and method for performing a bypass procedure in a digestive system

• US 20040087977A1
• Filed: 08/30/2002
• Published: 05/06/2004
• Est. Priority Date: 03/06/2000
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: United States Surgical Corporation (Medtronic Plc)
• Inventors: Robertson, John Charles, Klinger, John, Aranyi, Ernie, Nolan, Tim, Ratcliff, Keith
• Granted Patent: US 7,179,267 B2
• Time in Patent Office: Days
• US Class Current: 606/142
• CPC Class Codes: A61B 17/07207 the staples being applied sequentially
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 17/1155 Circular staplers comprising a plurality of staples
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/07214 Stapler heads
• CPC Class Codes: A61B 2017/07257 characterised by its anvil
• CPC Class Codes: A61B 2017/1125 Forceps, specially adapted for performing or assisting anastomosis
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections Y-shaped blood vessel prostheses A61F2002/065
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61B 2017/2927 the angular position of the head being adjustable with respect to the shaft

Abstract

Surgical instrumentation and methods for performing a bypass procedure in a digestive system incorporate laparoscopic techniques to minimize surgical trauma to the patient. The instrumentation includes an outer guide member dimensioned for insertion and passage through an esophagus of a patient and defining an opening therein extending at least along a portion of the length of the outer guide member, an elongate anvil delivery member at least partially disposed within the opening of the outer guide member and being adapted for longitudinal movement within the outer guide member between an initial position and an actuated position and an anvil operatively engageable with the delivery member. The anvil includes an anvil rod defining a longitudinal axis and an anvil head connected to the anvil rod. The anvil head is at least partially disposed within the opening of the outer guide member when in the initial position of the delivery member and is fully exposed from the distal end of the outer guide member upon movement of the delivery member to the actuated position.

Claims

1. An apparatus for facilitating performance of a gastroplasty procedure, which comprises:

an outer guide member dimensioned for insertion and passage through an esophagus of a patient, the outer guide member having proximal and distal ends and defining an opening therein extending at least along a portion of the length of the outer guide member;

an elongate anvil delivery member at least partially disposed within the opening of the outer guide member, the delivery member adapted for longitudinal movement within the outer guide member between an initial position and an actuated position; and

an anvil operatively engageable with the delivery member, the anvil including an anvil rod defining a longitudinal axis and an anvil head connected to the anvil rod, the anvil head being at least partially disposed within the opening of the outer guide member when in the initial position of the delivery member and being fully exposed from the distal end of the outer guide member upon movement of the delivery member to the actuated position.

2. The apparatus according to claim 1 wherein the anvil head of the anvil is pivotally mounted to the anvil rod, the anvil head pivotally movable between a non-operative position and an operative position.

3. The apparatus according to claim 2 further including a pivot member at least partially disposed within the outer guide member and operatively connected to the anvil head, the pivot member movable between first and second positions thereof to cause corresponding movement of the anvil head between the respective non-operative and operative positions.

4. The apparatus according to claim 3 wherein the pivot member is normally biased to the second position thereof.

5. The apparatus according to claim 4 including means for releasably locking the pivot member in the first position.

6. The apparatus according to claim 4 wherein the pivot member is releasably locked in the first position.

7. The apparatus according to claim 6 wherein the pivot member includes a locking surface engageable with a corresponding locking surface of one of the delivery member and outer guide member, the locking surfaces cooperating to releasably lock the pivot member in the first operative position.

8. The apparatus according to claim 7 wherein the pivot member includes a manually operable handle, the handle defining the locking surface of the pivot element.

9. The apparatus according to claim 3 wherein the pivot member is dimensioned to extend proximally beyond the insertion member to be grasped by the surgeon.

10. The apparatus according to claim 2 wherein the anvil is pivotally mounted to the delivery member.

11. The apparatus according to claim 10 further including an elongate pivot member at least partially disposed within the outer guide member, the pivot member operatively connected to the anvil and being movable to cause corresponding pivotal movement of the anvil through a pivotal range of motion.

12. The apparatus according to claim 1 wherein the outer guide member includes an internal annular groove, the annular groove dimensioned to accommodate peripheral portions of the anvil head to facilitate retention of the anvil within the guide member.

13. The apparatus according to claim 1 wherein the insertion member comprises a flexible material.

14. The apparatus according to claim 13 wherein the cross-sectional dimension of the anvil head is greater than the internal dimension of the distal end of the outer guide, the outer guide member adapted to deform to permit passage of the anvil head through the opening to permit the anvil to be expelled from the insertion member.

15. A method for performing a bypass procedure in a digestive system, comprising the steps of:

introducing an anvil through an esophagus of a patient and into a first digestive tissue portion;

inserting an anastomosis instrument into a second digestive tissue portion displaced from the first digestive tissue portion;

manipulating the anvil from a proximal location to position the anvil at a desired orientation with respect to the anastomosis instrument;

connecting the anvil to the anastomosis instrument; and

firing the anastomosis instrument to connect the first and second digestive tissue portions.

16. The method according to claim 15 wherein the anvil is at least partially disposed within an outer guide and wherein the step of introducing includes advancing the outer guide and anvil through the esophagus.

17. The method according to claim 16 further including the step of moving the anvil relative to the outer guide to fully expose the anvil from the outer guide.

18. The method according to claim 17 including a delivery member at least partially disposed within the outer guide and operatively engageable with the anvil and wherein the step of moving includes advancing the delivery member to expel the anvil from the outer guide.

19. The method according to claim 15 wherein the anvil head is pivotally mounted to the anvil rod and further including the step of pivoting the anvil head from a non-operative position to an operative position prior to the step of firing.

20. The method according to claim 19 further including a pivot member disposed with the outer guide and operatively engageable with the anvil head and wherein the step of pivoting includes moving the pivot member to cause the anvil head to pivot to the operative position.

21. The method according to claim 15 wherein the anvil is pivotally mounted to a support member and wherein the step of manipulating includes pivoting the anvil relative to the support member to orient the anvil to a desired position with respect to the anastomosis instrument.

22. The method according to claim 21 wherein the anvil is operatively connected to a movable pivot member and wherein the step of manipulating includes moving the pivot member thereby causing pivotal movement of the anvil relative to the support member.

23. The method according to claim 15 wherein the step of inserting is performed through a trocar.

29. The method according to claim 15, further including the step of disconnecting the anvil from the anastomosis instrument and withdrawing the anvil through the esophagus.

30. The method according to claim 15 wherein:

the step of introducing includes at least partially positioning the anvil into a stomach tissue portion, the stomach tissue portion being the first tissue portion;

the step of inserting includes at least partially positioning the anastoiimosis instrument into an intestinal tissue portion, the intestinal tissue portion being the second tissue portion; and

whereby the step of firing connects the stomach tissue portion and the intestinal tissue portion.

31. The method according to claim 30 including the step of isolating an upper stomach portion, the upper stomach portion being connected to the esophagus.

32. The method according to claim 31 further including the step of resecting the bowel to define a first bowel portion connected to the stomach and a second bowel portion separated from the first bowel portion.

33. The method according to claim 32 further including the step of approximating and connecting the second bowel portion and the upper stomach portion.

34. The method according to claim 15 wherein:

the step of introducing includes at least partially positioning the anvil into an esophageal tissue portion, the esophageal tissue portion being the first tissue portion;

the step of inserting includes at least partially positioning the anastomosis instrument into one of a stomach tissue portion and an intestinal tissue portion, the one being the second tissue portion; and

whereby the step of firing connects the esophageal tissue portion to the one of the stomach tissue portion and the intestinal tissue portion.

35. The method according to claim 15 wherein:

the step of introducing includes at least partially positioning the anvil into a first stomach tissue portion, the first stomach tissue portion being the first tissue portion;

the step of inserting includes at least partially positioning the anastomosis instrument into a second stomach tissue portion, the second stomach tissue portion being the second tissue portion; and

whereby the step of firing connects the first stomach tissue portion and the second stomach tissue portion.

44. The method according to claim 35 wherein each of the steps of isolating, resecting and connecting is performed laparoscopically.

24. The method according to 15 further including the step of positioning a linear stapler instrument adjacent the first digestive tissue portion, and further including the step of firing the linear stapler instrument to form a staple line adjacent the first digestive tissue portion.

25. The method according to claim 24 further including the step of positioning a linear stapler instrument adjacent the second digestive tissue portion, and further including the step of firing the linear stapler instrument to form a staple line adjacent the second digestive tissue portion.

26. The method according to claim 25 wherein the linear stapler instruments each include a cutting member associated therewith, and wherein the steps of firing include actuating the cutting member to sever tissue adjacent the staple lines to thereby resect the section digestive tissue between the staple lines.

27. The method according to claim 25 further including the step of forming access openings in each of the first and second digestive tissue portions and further including the step of passing an anvil rod of the anvil through the access opening of the first digestive tissue portion and through the access opening of the second digestive tissue portion to connect to the anastomosis instrument.

28. The method according to claim 27 wherein each of the steps of positioning is performed laparoscopically through a trocar.

36. A method for performing a bypass procedure in a digestive system, comprising the steps of:

isolating an upper stomach portion of the stomach of a patient;

resecting the bowel to define a bowel portion disconnected from the stomach; and

connecting the bowel portion and the upper stomach portion.

37. The method according to claim 36 wherein the step of connecting is performed with an end to end anastomosis instrument.

38. The method according to claim 37 further including the step of introducing an anvil adapted for use with the anastomosis instrument through an esophagus and into the upper stomach portion.

39. The method according to claim 38 further including the step of inserting an end to end anastomosis instrument into the bowel portion.

40. The method according to claim 39 further including the step of connecting the anvil and the end to end anastomosis instrument, and firing the end to end anastomosis instrument to connect the bowel portion and the upper stomach portion.

41. The method according to claim 40 wherein the step of isolating includes positioning a linear stapler instrument about the stomach and firing the linear stapler to isolate the upper stomach portion with resect to the remainder of the stomach.

42. The method according to claim 41 wherein the step of reseating includes positioning a linear stapler about the small bowel and firing the linear stapler.

43. The method according to claim 42 wherein the linear stapler has a knife blade associated therewith and wherein the step of firing actuates the knife blade to resect the bowel to define the bowel portion.

45. A method for performing a bypass procedure in a digestive system comprising the steps of:

accessing digestive tissue portions of a digestive system;

advancing an anvil through the esophagus and into the first digestive tissue portion;

inserting an anastomosis instrument into the second digestive tissue portion;

connecting the anvil with the anastomosis instrument and firing the anastomosis instrument to connect the first and second digestive tissue portions;

disconnecting the anvil from the anastomosis instrument; and

withdrawing the anvil through the esophagus.

46. The method according to claim 45, further including the step of manipulating the anvil from a proximal location outside the body to facilitate connecting of the anvil with the anastomosis instrument.

47. The method according to claim 46, wherein the anvil is mounted to a support member and wherein the step of advancing includes passing the support member though the esophagus toward the first tissue portion.

48. The method according to claim 47, wherein the step of withdrawing includes removing the support member and anvil through the esophagus.

49. The method according to claim 48, wherein the step of disconnecting includes manipulating the anvil to position the anvil for withdrawal through the esophagus.

50. A method for performing a surgical bypass procedure, comprising the steps of:

providing an anvil delivery mechanism including a support member, an anvil mounted to the support member, and an outer guide mounted with respect to the support member;

accessing first and second tissue portions of a digestive system;

at least partially introducing the anvil delivery mechanism through the esophagus and into the first digestive tissue portion whereby the outer guide is positioned to substantially enclose the anvil to protect the esophagus during introduction;

inserting an anastomosis instrument into the second digestive tissue portion;

at least partially exposing the anvil from the outer guide of the insertion member;

connecting the anvil to the anastomosis instrument; and

firing the anastomosis instrument to connect the first and second digestive tissue portions.

51. The method according to claim 50, wherein the step of at least partially exposing includes actuating a remote device connected to the anvil, the remote device extending to a proximal location outside the body.

52. The method according to claim 51, wherein the step of at least partially exposing includes advancing the remote device to advance the anvil within the outer guide.

53. An anvil delivery instrument which comprises:

an elongated outer member defining a general longitudinal axis and having proximal and distal ends, and defining a longitudinal bore;

is a pivot member at least partially disposed within the longitudinal bore of the outer member, the pivot member adapted for longitudinal movement within the outer member; and

an anvil mounted to the outer member and operatively connected to the pivot member, the anvil including an anvil rod and an anvil head pivotally mounted to the anvil rod, the anvil head pivotally movable from a non-operative position to an operative position upon longitudinal movement of the pivot member, the anvil rod being mountable with respect to an end to end anastomosis instrument.

54. The instrument according to claim 53 wherein the pivot member is normally biased to a first position corresponding to the operative position of the anvil head.

55. The instrument according to claim 54 wherein the pivot member is releasably locked in a second position corresponding to the non-operative position of the anvil head.

56. The instrument according to claim 55 including a manually operable handle connected to the pivot member, the handle being manipulable to release the pivot member to permit longitudinal movement of the pivot member to the first position.

57. The instrument according to claim 53 further including an elongated catheter guide operatively connectable to the distal end of the outer member, the catheter guide dimensioned for passage through a restricted passage.

58. The instrument according to claim 57 wherein the catheter guide is connected to the anvil.

59. The instrument according to claim 58 wherein the anvil includes a suture assembly mounted thereto, the suture assembly including a length of suture looped through an opening in the anvil.

60. The instrument according to claim 59 wherein the suture assembly includes a coupler connected to the length of suture and wherein the catheter guide includes a corresponding coupler, the couplers being engageable to connect the catheter guide and the anvil.

61. An anvil adapter for facilitating connection of a detachable anvil rod to a circular anastomosis instrument, comprising an anvil adapter member defining a longitudinal axis and having first and second ends, the first end configured for attachment to a circular anastomosis instrument, the second end having an interior surface portion defining a longitudinal bore for receiving an anvil rod, the interior surface portion being dimensioned to engage the anvil rod in locking arrangement therewith to connect the anvil adapter to the anvil rod.

62. The anvil adapter according to claim 61 wherein the second end of the anvil adapter member includes circumferentially arranged internal grooves dimensioned to receive external splines of the anvil rod to rotationally fix the anvil rod with respect to the anvil adapter.

63. The anvil adapter according to claim 61 wherein the interior surface portion of the second end has a predetermined degree of resiliency to thereby permit insertion of an enlarged mounting portion of the anvil rod within the longitudinal bore.

64. The anvil adapter according to claim 63 wherein the interior surface portion of the second end defines an abutment wall surface dimensioned to engage the enlarged mounting portion of the anvil rod.

65. An anvil adapter for facilitating connection of a detachable anvil rod to a circular anastomosis instrument, comprising an anvil adapter member defining a longitudinal axis and having first and second ends, the first end configured for attachment to a circular anastomosis instrument, the second end having a pair of jaws mounted for relative movement between an open position to receive the anvil rod and a closed position to engage the anvil rod in locking arrangement therewith to connect the anvil adapter to the anvil rod.

66. The anvil adapter according to claim 65 wherein the pair of jaws are pivotally mounted about a pivot pin.

67. The anvil adapter according to claim 66 wherein the pair of jaws are normally biased to the closed position.

68. The anvil adapter according to claim 67, including an ejector mechanism for at least partially ejecting the anvil rod from the anvil adapter member upon movement of the pair of jaws to the open position thereof.

69. The adapter according to claim 68 wherein the ejector mechanism includes spring means operatively engageable with the anvil rod upon mounting of the anvil rod to the anvil adapter member.

70. The adapter according to claim 69 wherein the ejector mechanism includes an ejector plate engageable with the spring means and the anvil rod.

71. An anvil assembly having a reduced profile, which comprises:

an elongated anvil rod defining a longitudinal axis and having a length along the longitudinal axis ranging from about 1.6 0 inches to about 2.00 inches; and

an anvil head mounted to the anvil rod.

72. The anvil assembly according to claim 71 wherein the anvil rod defines a maximum cross-sectional dimension transverse to the longitudinal axis ranging from about 0.17 inches to about 0.20 inches.

73. A method for facilitating an anastomosis procedure of tissue portions, comprising the steps of:

introducing an anvil assembly including an anvil rod and anvil head within a first tissue portion;

introducing a circular anastomosis instrument into a second tissue portion;

attaching an anvil adapter to the anvil rod; and

connecting the anvil adapter to the anastomosis instrument;

whereby upon completion of the steps of attaching and connecting the anvil assembly is operatively connected to the anastomosis instrument.

74. The method according to claim 73 wherein the step of attaching is performed prior to the step of connecting.

75. The method according to claim 73 wherein the step of attaching is performed subsequent to the step of connecting.

76. A surgical instrument which comprises:

a handle;

an elongated shaft member connected to the handle and extending therefrom, the shaft member defining a longitudinal axis and having proximal and distal ends,

an anvil mounted to the shaft member, the anvil including an anvil rod and an anvil head;

an anvil adapter having a first end configured for attachment to a circular anastomosis instrument and a second end releasably mounted to the anvil; and

a release member extending through the shaft member and being movable to release the anvil from the anvil adapter.

77. The instrument according to claim 76 wherein the second end of the anvil adapter includes at least one member mounted for movement between an open position whereby the anvil adapter can receive and release the anvil rod and a closed position to engage the anvil rod in locking arrangement therewith to connect the anvil adapter to the anvil rod.

78. The instrument according to claim 77 wherein the anvil includes a release collar mounted about the anvil rod and operatively connected to the release member, the release collar engaging the one member of the anvil adapter upon movement of the release member to move the anvil adapter to the open position.

79. The instrument according to claim 78 wherein the second end of the anvil adapter includes a pair of jaws, the jaws mounted for movement between the open and closed position, the release collar being adapted to engage the jaw members to move the anvil adapter to the open position.

80. The instrument according to claim 79, including a manually engageable release actuator mounted to the handle and operatively connected to the release member to move the release member.

81. The instrument according to claim 80 wherein the anvil adapter includes an ejector for at least partially ejecting the anvil rod from the anvil adapter upon movement of the jaws to the open position.