Suturing apparatus and method

• US 6,059,800 A
• Filed: 11/19/1997
• Issued: 05/09/2000
• Est. Priority Date: 09/10/1997
• Status: Expired due to Term

• Current Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Original Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Inventors: Hilal, Nabil, Hart, Charles C.
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): TRINH, HOA B
• Application Number:
  US08/974,724
• Time in Patent Office: 902 Days
• Field of Search: 606/144, 606/139, 606/148, 606/147, 606/145, 606/146, 606/150, 606/210, 606/211, 606/205, 606/206, 606/207, 606/208, 112/169, 112/80.03
• US Class Current: 606/144
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0483 Hand-held instruments for holding sutures A61B17/0469 takes precedence; other holders for needles or sutures A61B17/06061; surgical forceps A61B17/28; surgical pincettes A61B17/30
• CPC Class Codes: A61B 17/0625 the needle being specially adapted to interact with the manipulator, e.g. being ridged to snap fit in a hole of the manipulator A61B17/06109 takes precedence
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments

Abstract

A suturing apparatus is adapted for joining two objects which define a near side and a far side. The apparatus includes an elongate support structure having a working channel and an axis extending between a proximal end and a distal end. The structural support is adapted to be positioned over a guidewire extending between the two objects, in an operative position wherein the proximal end is disposed on the near side and the distal end as disposed on the far side. Removal of the guidewire permits use of a stylet for positioning a suture to extend within the working channel from the proximal end to the distal end. A pair of hooks are movable from a proximal position at the proximal end of the support structure through the objects and a pair of slots in the support structure, to a distal position wherein the hooks engage the suture within the working channel at the distal end of the support structure. The actuator is then operable to move the hooks and the engaged suture from the distal position to the proximal position in order to facilitate tying of the suture and joining of the two objects. Alternatively, suture loops can be carried through the objects by unidirectional hooks and into the working channel. The hooks can then be withdrawn leaving the suture loops in the working channel where they can be engaged by a snare and withdrawn proximally between the two objects. Suturing pledgets can be added to the suturing apparatus prior to operative disposition, and a backing member can be provided to support at least the pledgets when the hook passes through the object.

Claims

1. A suturing device for closing a wound in body tissue having a near side and a far side, including:

a shaft having an axis extending between a proximal end and a hollow distal end, the distal end of the shaft being adapted for movement from the near side of the body tissue, through the wound, to the far side of the body tissue;

a suture;

a first stylet operable from the proximal end of the shaft for carrying the suture from the near side of the body tissue into the hollow distal end of the shaft;

a second stylet operable from the proximal end of the shaft for engaging the suture within the hollow distal end of the shaft and for moving the suture from the far side of the body tissue to the near side of the body tissue;

whereby

the suture can be tied on the near side of the body tissue to close the wound.

2. The suturing device recited in claim 1, wherein:

the shaft has an operative position wherein first portions of the shaft are disposed on the proximal side of the body tissue and second portions of the shaft are disposed on the distal side of the body tissue;

at least one of the first stylet and the second stylet has a generally straight configuration in proximity to the first portions of the shaft; and

at least one of the first stylet and the second stylet has a generally curved configuration in proximity to the second portions of the shaft.

3. The suturing device recited in claim 2 wherein:

the first stylet and the second stylet have a space relationship in proximity to the first portions of the shaft; and

the first stylet and the second stylet have an intersecting relationship in proximity to the second portions of the shaft.

4. The suturing device recited in claim 1, wherein:

the first stylet is movable along a first path to carry the suture from the near side of the body tissue to the far side of the body tissue;

the second stylet is movable along a second path to move the suture from the far side of the body tissue to the near side of the body tissue; and

at least one of the first path of the first stylet and the second path of the second stylet is curved on the far side of the body tissue.

5. The suturing device recited in claim 1, further comprising:

first portions of the shaft defining a first guide slot along the distal end of the shaft;

second portions of the shaft defining a second guide slot opposing the first guide slot along the distal end of the shaft;

the first stylet being operable to move the suture from outside the shaft, through the first guide slot, and into the hollow distal end of the shaft;

the second stylet being operable to move from outside of the shaft into the second guide slot to engage the suture inside the hollow distal end of the shaft; and

the first guide slot and the second guide slot being positioned along the distal end of the shaft to guide the first stylet and second stylet into an intersecting relationship.

6. A suturing device for closing a wound in body tissue having a near side and a far side, including:

a shaft having an axis extending between a proximal end and a distal end;

first and second stylet each extendable from a first position on the near side of the body tissue to a second position on the far side of the body tissue;

a suture;

the first stylet being operable from the proximal end of the shaft for carrying at least a portion of the suture between the first position and the second position;

the second stylet being operable from the proximal end of the shaft to engage the suture portion at the second position and to move the suture portion to the first position;

the first stylet and the second stylet having a generally spaced relationship in the first position on the near side of the body tissue; and

the first stylet and the second stylet have a generally intersecting relationship at the second position on the far side of the body tissue.

7. The suturing device recited in claim 6, wherein:

the second stylet is curved to intersect the first stylet in order to engage the suture portion at the second position.

8. The suturing device recited in claim 7, wherein:

the second stylet intersects the first stylet within the distal end of the shaft.

9. The suturing device recited in claim 6, wherein:

the first stylet is movable along a first path to carry the suture from the near side of the body tissue to the far side of the body tissue;

the second stylet is movable along a second path to engage the suture on the far side of the body tissue and to move the suture to the near side of the body tissue; and

at least one of the first path and the second path is curved on the far side of the body tissue.

10. The suturing device recited in claim 6, further comprising:

first portions of the shaft defining a first guide slot along the distal end of the shaft;

second portions of the shaft defining a second guide slot opposing the first guide slot along the distal end of the shaft;

the first stylet being movable from outside the shaft through the first guide slot to carry the suture portion to the second position; and

the second stylet being movable from outside the shaft through the second guide slot to engage the suture portion at the second position and to move the suture portion to the first position.

11. A suturing device for closing a wound in body tissue having a near side and a far side, comprising:

a suture;

a shaft having an axis extending between a proximal end and a distal end;

a first stylet including portions defining a hole sized and configured to receive the suture, the first stylet being operable from the proximal end of the shaft and movable relative to the shaft to carry the suture from a first position on the near side of the body wall to a second position on the far side of the body wall; and

a second stylet including portions defining a hook sized and configured to engage the suture on the far side of the body wall, the second stylet being operable from the proximal end of the shaft to engage the suture with the hook and to withdraw the suture from the far side of the body wall to the near side of the body wall.

12. The suturing device recited in claim 11 wherein the second stylet is adapted to intersect the first stylet in order to engage the suture with the hook and to withdraw the suture from the far side of the body wall to the near side of the body wall.

13. The suturing device recited in claim 12 wherein the second stylet intersects the first stylet within the distal end of the shaft.

14. The suturing device recited in claim 11, wherein:

the first stylet is movable along a first path to carry the suture from the near side of the body tissue to the far side of the body tissue;

the second stylet is movable along a second path to engage the suture on the far side of the body tissue and to move the suture to the near side of the body tissue; and

at least one of the first path and the second path is curved on the far side of the body tissue.

15. The suturing device recited in claim 11, further comprising:

first portions of the shaft defining a first guide slot;

second portions of the shaft defining a second guide slot;

the first stylet being movable from outside the shaft through the first guide slot to carry the suture into the distal end of the shaft; and

the second stylet being movable from outside the shaft through the second guide slot to engage the suture within the distal end of the shaft.

16. The suturing device recited in claim 15 wherein the first portions of the shaft define the first guide slot along a first side of the shaft;

the second portions of the shaft define the second guide slot along a second side of the shaft; and

the first side of the shaft is disposed opposite to the second side of the shaft.

17. A suturing device for closing a wound in a body wall having a near side and a far side, comprising:

a suture;

a shaft having an axis extending between a proximal end and a distal end;

a first stylet movable along a first path to carry the suture through the body wall from the near side of the body wall to the far side of the body wall;

a second stylet movable along a second path to engage the suture on the far side of the body wall and to move the suture through the body wall from the far side of the body wall to the near side of the body wall; and

at least one of the first path and second path being curved on the far side of the body wall.

18. The suturing device recited in claim 17 wherein both the first path and the second path are curved on the far side of the body wall.

19. The suturing device recited in claim 17 wherein at least one of the first path and the second path on the near side of the body wall is generally parallel to the axis of the shaft.

20. The suturing device recited in claim 17 wherein the first path and the second path on the near side of the body wall are disposed on opposing sides of the shaft.

21. The suturing device recited in claim 18 wherein the first path and the second path cross the axis of the shaft on the far side of the body wall.

22. The suturing device recited in claim 21 wherein the first path intersects the second path generally along the axis of the shaft on the far side of the body wall.

23. The suturing device recited in claim 22 wherein the first path and the second path intersect at a point disposed generally along the axis of the shaft.

24. The suturing device recited in claim 23 wherein the first path and second path are curved at the point of intersection.

25. A method for operating a suture device to close a wound in body tissue having a near side and a far side, comprising the steps of:

providing the suturing device with a shaft and first and second stylets movable relative to the shaft and through the far side and the near side of the body tissue;

attaching a suture to the first stylet;

moving the first stylet and a portion of the attached suture through the near side of the body tissue and through the far side of the body tissue;

moving the second stylet through the near side of the body tissue and through the far side of the body tissue;

coupling the suture portion on the far side of the body tissue to the second stylet;

moving the second stylet and the coupled suture portion through the far side of the body tissue and through the near side of the body tissue; and

tying the suture on the near side of the body tissue to close the wound.

26. The method recited in claim 25 wherein the attaching step includes the step of threading the suture through a hole in the first stylet.

27. The method recited in claim 25, wherein:

the first moving step includes the step of moving the first stylet through the body tissue adjacent to the wound from the near side of the body tissue to the far side of the body tissue; and

the second moving step includes the step of moving the second suture through the body tissue at a location proximal to the wound from the near side of the body tissue to the far side of the body tissue.

28. The method recited in claim 25, wherein:

the providing step includes the step of forming first and second guide slots at the hollow distal end of the shaft;

the first moving step includes the step of moving the first stylet through the first guide slot; and

the second moving step includes the step of moving the second stylet through the second guide slot.

29. The method recited in claim 25, wherein the engaging step includes the step of:

providing a suture-transfer mechanism;

operating the suture-transfer mechanism to couple the suture portion in proximity to the first stylet on the far side of the body tissue;

operating the tissue-transfer mechanism to move the suture portion into proximity with the second stylet on the far side of the body wall; and

coupling the suture portion to the second stylet on the far side of the body wall.

30. A suturing device for closing a wound in body tissue having a proximal side and a distal side, including:

a shaft having an axis extending between a proximal end and a hollow distal end, the distal end of the shaft being adapted for movement from the proximal side of the body tissue, through the wound, to the distal side of the body tissue;

a suture;

a first stylet operable from the proximal end of the shaft and having portions defining a hole sized and configured to receive the suture and to carry the suture from the proximal side of the body tissue into the hollow distal end of the shaft;

a second stylet operable from the proximal end of the shaft and having portions defining a hook sized and configured to engage the suture within the hollow distal end of the shaft and to move the suture from the distal side of the body tissue to the proximal side of the body tissue;

whereby

the suture can be tied on the proximal side of the body tissue to close the wound.

31. A suturing device for closing a wound in body tissue having a proximal side and a distal side, including:

a shaft having an axis extending between a proximal end and a distal end;

first and second stylet, each extendable from a first position on the proximal side of the body tissue to a second position on the distal side of the body tissue;

a suture;

the first stylet being operable from the proximal end of the shaft and having portions defining a hole sized and configured to receive the suture at the first position and to carry at least a portion of the suture between the first position and the second position;

the second stylet being operable from the proximal end of the shaft and having portions defining a hook sized and configured to engage the suture portion at the second position and to move the suture portion to the first position;

the first stylet and the second stylet having a generally spaced relationship in the first position on the proximal side of the body tissue; and

the first stylet and the second stylet have generally intersecting relationship at the second position on the distal side of the body tissue.

32. A method for operating a suture device to close a wound in body tissue having a proximal side and a distal side, comprising the steps of:

providing the suturing device with a shaft, first stylet, and a second stylet having hook-defining portions, the stylets being movable relative to the shaft between the distal side and the proximal side of the body tissue;

attaching a suture to the first stylet on the proximal side of the body tissue;

moving the first stylet and a portion of the attached suture from the proximal side of the body tissue to the distal side of the body tissue;

moving the second stylet from the proximal side of the body tissue to the distal side of the body tissue;

coupling the suture portion on the distal side of the body tissue to the second stylet;

during the coupling step, engaging the suture portion with the hook-defining portions of the second stylet;

moving the second stylet and the coupled suture portion from the distal side of the body tissue to the proximal side of the body tissue; and

tying the suture on the proximal side of the body tissue to close the wound.