Surgical fastener aligning instrument particularly for transoral treatment of gastroesophageal reflux disease

• US 20080149685A1
• Filed: 05/13/2004
• Published: 06/26/2008
• Est. Priority Date: 09/20/2002
• Status: Active Grant

• Current Assignee: Syntheon LLC
• Original Assignee: ID Company Limited
• Inventors: Kortenbach, Juergen A., Sixto, Robert, Smith, Kevin W.
• Granted Patent: US 8,454,628 B2
• Time in Patent Office: Days
• US Class Current: 227/181.1
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00827 Treatment of gastro-esophageal reflux

Abstract

A surgical instrument includes an end effector having a clevis and first and second jaws mutually rotatable between open and closed positions. The jaws are proximally directed and laterally displaced relative to an axis of a control shaft of the instrument. The jaws hold first and second parts of a fastener, respectively. The first part includes a base having tissue-piercing posts, and the second part includes a second base defining apertures receiving the posts and a portion movable relative thereto between first and second orientations. When the posts are inserted into the apertures, the movable portion can be moved from the first unlocked orientation into the second configuration to lock the fastener parts together in an implanting position determined by various alignment measures, including markings or flags on the jaws or at the housing. The instrument is adapted to move the second part into the second configuration.

Claims

1. A surgical instrument, comprising:

a tubular control shaft having proximal and distal ends;

a first control element extending through said control shaft and having proximal and distal ends;

a distal end effector coupled to said distal ends of said control shaft and said first control element, said end effector having first and second arms, at least one of said arms being rotatable between open and closed positions;

an actuator independently connected to said proximal ends of said control shaft and said control element for effecting a relative movement between said control shaft and said control element and, thereby, effecting a corresponding rotation of said at least one arm between said open and closed positions; and

an alignment indicator disposed at said distal end effector and indicating a given alignment of said first and second arms with respect to one another.

2. The surgical instrument according to claim 1, wherein said alignment indicator is disposed at said first and second arms and is a plurality of alignment marks.

3. The surgical instrument according to claim 2, wherein said alignment marks are horizontal lines.

4. The surgical instrument according to claim 2, wherein said alignment marks are arrows.

5. The surgical instrument according to claim 2, wherein said alignment marks are selected from the group consisting of asymmetric indicators and symmetric indicators.

6. The surgical instrument according to claim 1, wherein:

said first and second arms have recesses; and

said alignment indicator is said recesses.

7. The surgical instrument according to claim 2, wherein said alignment indicator is a plurality of colored marks disposed on a surface of said first and second arms.

8. The surgical instrument according to claim 2, wherein:

said alignment marks are formed from a material disposed on a surface of said first and second arms; and

said material is selected from the group consisting of a fluorescent dye, a fluorescent ink, a reflective dye, and a reflective ink.

9. The surgical instrument according to claim 2, wherein:

said first arm has a first tang;

said second arm has a second tang; and

said alignment marks include a first alignment mark disposed on said first tang and a second alignment mark disposed on said second tang.

10. The surgical instrument according to claim 2, wherein:

said first arm has a first tang and a first jaw;

said second arm has a second tang and a second jaw; and

said alignment marks include at least one of;

a first alignment mark disposed on said first tang and a second alignment mark disposed on said second jaw; and

a first alignment mark disposed on said first jaw and a second alignment mark disposed on said second tang.

11. The surgical instrument according to claim 2, wherein:

said alignment marks approach each other as said first and second arms are closed; and

said alignment marks retreat from each other as said first and second arms are opened.

12. The surgical instrument according to claim 3, wherein said horizontal lines extend across said first and second arms.

13. The surgical instrument according to claim 2, wherein said alignment marks are visual indicators.

14. The surgical instrument according to claim 2, wherein said alignment marks provide a user with continuous visual feedback as to a relative position of said first and second arms.

15. The surgical instrument according to claim 2, wherein said alignment marks illuminate when said first and second arms are in an aligned position.

16. The surgical instrument according to claim 2, wherein said distal end effector has an illuminator illuminating said alignment marks when said first and second arms are in an aligned position.

17. The surgical instrument according to claim 2, wherein said alignment marks are scribe marks formed in said first and second arms.

18. The surgical instrument according to claim 1, wherein said alignment indicator is a flag.

19. The surgical instrument according to claim 18, wherein said flag is attached to said end effector and moves when said first and second arms are in a substantially aligned position.

20. The surgical instrument according to claim 19, wherein said flag is attached pivotally to said end effector.

21. The surgical instrument according to claim 19, wherein at least one of said first and second arms has an actuator moving said flag when said first and second arms are in a substantially aligned position.

22. The surgical instrument according to claim 18, wherein:

said flag is attached pivotally to said end effector;

one of said first and second arms has an actuator; and

said actuator pivots said flag when said first and second arms are in a substantially aligned position.

23. The surgical instrument according to claim 18, wherein said flag has a visual indicator visually differentiating said flag from said end effector.

24. The surgical instrument according to claim 1, wherein:

said end effector has an actuator coupling said distal ends of said control shaft and said first control element to said first and second arms to move said first and second arms on said end effector between said open and closed positions when at least one of said control shaft and said first control element is moved relative to the other of said control shaft and said first control element; and

at least a part of said alignment indicator is at said actuator.

25. The surgical instrument according to claim 24, wherein said alignment indicator has a first part at said actuator and a second part at said end effector.

26. The surgical instrument according to claim 25, wherein said first part is moveable and said second part is stationary.

27. The surgical instrument according to claim 25, wherein:

said first and second parts of said alignment indicator approach each other as said first and second arms are closed; and

said first and second parts of said alignment indicator marks retreat from each other as said first and second arms are opened.

28. The surgical instrument according to claim 25, wherein said first and second parts of said alignment indicator provide a user with continuous visual feedback as to a relative position of said first and second arms.

29. The surgical instrument according to claim 25, wherein:

said actuator is a rotatable bell crank;

said first part is an extension of said bell crank; and

said second part is an alignment mark.

30. The surgical instrument according to claim 1, further comprising a two-part fastener having first and second parts adapted to be locked together, said first part being coupled releasably to said first arm, and said second part being coupled releasably to said second arm.

31. The surgical instrument according to claim 30, further comprising:

means for locking said first and second parts together; and

means for releasing said locked fastener from said first and second arms.

32. The surgical instrument according to claim 30, further comprising:

a locking assembly for locking said first and second parts together; and

a releasing assembly for releasing said two-part fastener from said first and second arms after said first and second parts are locked together.

33. The surgical instrument according to claim 1, wherein said alignment indicator is disposed on at least one of the group consisting of said end effector, said first arm, and said second arm.

34. The surgical instrument according to claim 1, wherein:

said actuator has a stationary portion and a first movable portion movable relative to said stationary portion; and

one of said stationary portion and said first movable portion is coupled to said proximal end of said control shaft and the other of said stationary portion and said first movable portion coupled to said proximal end of said first control element.

35. The surgical instrument according to claim 1, wherein:

said end effector has a clevis; and

said first and second arms are mutually rotatable on said clevis between said open and closed positions.

36. The surgical instrument according to claim 1, wherein:

said control shaft has longitudinal axis; and

said first and second arms;

have terminal ends;

are substantially oriented to direct said terminal ends in a proximal direction away from said distal end of said control shaft; and

are laterally displaced relative to said longitudinal axis of said control shaft.

37. The surgical instrument according to claim 30, wherein:

said actuator has a stationary portion, a first movable portion movable relative to said stationary portion, and a second movable portion movable relative to said stationary portion;

one of said stationary portion and said first movable portion is coupled to said proximal end of said control shaft and the other of said stationary portion and said first movable portion is coupled to said proximal end of said first control element;

a second control element extends through said control shaft and has;

a proximal end coupled to said second movable portion; and

a distal end extending to said distal end effector and coupled to said two-part fastener.

38. The surgical instrument according to claim 37, wherein:

relative movement of said first control element and said control shaft in a first direction operates to move said first and second arms into said closed position; and

relative movement of said second control element and said control shaft in a second direction operates to reconfigure said first and second parts of said two-part fastener relative to one another to lock said first and second parts relative to one another.

39. The surgical instrument according to claim 38, wherein relative movement of said second control element and said control shaft in a third direction decouples said first and second parts of said fastener from said first and second arms.

40. The surgical instrument according to claim 38, wherein said second direction is opposite said first direction.

41. The surgical instrument according to claim 39, wherein said second direction and said third direction are the same.

42. The surgical instrument according to claim 9, wherein:

said end effector has a mechanical assembly including;

a first bell crank having first and second sides; and

at least one second control element;

said first side is coupled to said distal end of said first control element;

said second control element extends between said second side and said first and second tangs; and

relative movement of said first control element and said shaft causes said first control element to apply a force in a first direction to said first bell crank to rotate said first bell crank and to apply a force in an opposite second direction to said second control element to rotate said arms.

43. The surgical instrument according to claim 1, wherein said end effector has an integrated nosepiece defining a longitudinal passage for receiving therethrough a guidewire.

44. The surgical instrument according to claim 1, wherein said end effector has a connector adapted to couple said end effector to an endoscope at a working channel of the endoscope.

45. The surgical instrument according to claim 1, wherein said end effector is an endoscopic end effector.

46. The surgical instrument according to claim 1, wherein said control shaft is flexible.

53. A surgical kit, comprising

at least one fastener having first and second parts lockable relative to one another;

and

a surgical instrument according to claim 1, one of said parts being removably connected to a respective one of said arms for applying said fastener to tissue.

57. The kit according to claim 53, wherein;

said first part of said fastener is coupled removably to said first jaw;

said second part of said fastener is coupled removably to said second jaw; and

when said first and second jaws are in said closed position, said structure on said first part is in said opening in said second part.

61. The surgical instrument according to claim 37, wherein actuation of one of said first and second movable portions connected to said second control elements decouples the first and second parts of the fastener from said first and second jaws.

62. The surgical instrument according to claim 37, wherein:

said first and second jaws are respectively provided with first and second release elements respectively movable relative to said first and second jaws;

said end effector has a housing with a bell crank having first and second sides, said first side is coupled to said distal end of said second control element and said second side is decoupled from said first and second release elements;

when said first and second jaws are in said closed position and second control element is moved distally relative to said control shaft, said second side of said bell crank contacts and moves said first and second release elements.

47. A surgical instrument, comprising:

a tubular member having proximal and distal ends;

a control element having proximal and distal ends and extending through and longitudinally movable relative to said tubular member;

a distal end effector coupled to said distal ends of said tubular member and said control element, said end effector having first and second arms, at least one of said arms being rotatable between open and closed positions;

an actuator independently connected to said proximal ends of said control shaft and said control element for effecting a relative movement between said control shaft and said control element and, thereby, effecting a corresponding rotation of said at least one arm between said open and closed positions; and

a means for indicating a given alignment of said first and second arms with respect to one another.

48. The surgical instrument according to claim 47, wherein said indication means is disposed at said distal end effector.

49. The surgical instrument according to claim 47, wherein said indication means is disposed at said actuator.

50. The surgical instrument according to claim 47, wherein:

said tubular member defines a longitudinal axis; and

said first and second proximally directed jaws are disposed at said end effector and are laterally displaced relative to said longitudinal axis of said tubular member.

54. A surgical kit, comprising

at least one fastener having first and second parts lockable relative to one another;

and

a surgical instrument according to claim 47, one of said parts being removably connected to a respective one of said arms for applying said fastener to tissue.

58. The kit according to claim 54, wherein;

said first part of said fastener is coupled removably to said first jaw;

said second part of said fastener is coupled removably to said second jaw; and

when said first and second jaws are in said closed position, said structure on said first part is in said opening in said second part.

51. A surgical instrument for use in applying a fastener to tissue, the fastener having first and second parts lockable relative to one another, the surgical instrument comprising:

an end effector having;

first and second jaws, at least one of said jaws being movable relative to the other of said jaws, said first jaw being adapted to be coupled to the first part of the fastener and said second jaw being adapted to be coupled to the second part of the fastener;

a jaw moving device connected to said jaws and moving said jaws relative to one another and, thereby, moving the first and second parts of the fastener relative to each other at least into an implantation position;

a fastener reconfiguring device disposed at said jaws and to be removably connected to the first and second parts of the fastener, said fastener reconfiguring device adapted to reconfigure the first and second parts of the fastener relative to each other; and

an alignment device connected to at least one of said jaw moving device, said first jaw, and said second jaw for indicating whether or not the parts of the fastener are in the implantation position.

55. A surgical kit, comprising

at least one fastener having first and second parts lockable relative to one another;

and

a surgical instrument according to claim 51, one of said parts being removably connected to a respective one of said arms for applying said fastener to tissue.

59. The kit according to claim 55, wherein;

said first part of said fastener is coupled removably to said first jaw;

said second part of said fastener is coupled removably to said second jaw; and

when said first and second jaws are in said closed position, said structure on said first part is in said opening in said second part.

52. A surgical instrument for use in applying a fastener to tissue, the fastener having first and second parts lockable relative to one another, the surgical instrument comprising:

an end effector having;

first and second jaws, at least one of said jaws being movable relative to the other of said jaws, said first jaw being adapted to be coupled to the first part of the fastener and said second jaw being adapted to be coupled to the second part of the fastener;

first means for moving said first and second jaws relative to each other and, thereby, moving the first and second parts of the fastener relative to each other at least into an implantation position;

second means for reconfiguring the first and second parts of the fastener relative to each other, wherein said first and second means are distinct from one another; and

third means for aligning said jaws in the implantation position.

56. A surgical kit, comprising

at least one fastener having first and second parts lockable relative to one another;

and

a surgical instrument according to claim 52, one of said parts being removably connected to a respective one of said arms for applying said fastener to tissue.

60. The kit according to claim 56, wherein;

said first part of said fastener is coupled removably to said first jaw;

said second part of said fastener is coupled removably to said second jaw; and

when said first and second jaws are in said closed position, said structure on said first part is in said opening in said second part.