Methods and devices for tissue reconfiguration

• US 20050033328A1
• Filed: 04/08/2004
• Published: 02/10/2005
• Est. Priority Date: 06/22/1999
• Status: Active Grant

• Current Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Original Assignee: NDO Surgical, Inc.
• Inventors: Cerier, Jeffrey C., Laufer, Michael D., Cruz, Amos G.
• Granted Patent: US 7,896,893 B2
• Time in Patent Office: Days
• US Class Current: 606/153
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• 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 17/0485 Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
• 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 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• 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 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00827 Treatment of gastro-esophageal reflux
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0474 Knot pushers
• CPC Class Codes: A61B 2017/0475 : using sutures having a slip knot
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/061 : hollow or tubular suture extending inside a hollow needle A61B2017/06052; hollow sutures A61B2017/06185
• CPC Class Codes: A61B 2017/0647 : having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0649 : Coils or spirals
• CPC Class Codes: A61B 2017/2905 : flexible
• CPC Class Codes: A61B 2017/2915 : arcuate shaped guiding means
• CPC Class Codes: A61B 2017/2916 : pins in guiding slots
• CPC Class Codes: A61B 2017/2917 : with flexible part
• CPC Class Codes: A61B 2017/2927 : the angular position of the head being adjustable with respect to the shaft
• CPC Class Codes: A61M 25/0133 : Tip steering devices

Abstract

Methods and devices are provided for reconfiguring a tissue within a hollow body organ using an entirely endoscopic approach in order to effectively reduce flow of fluid contents into a second hollow body organ in fluid communication with the first.

Claims

1. A tissue shaping instrument comprising

a proximal controlling end;

a distal effector end;

an elongated portion connecting the distal effector end to the proximal controlling end, the elongated portion being of sufficient length to enable an operator to access an interior of a hollow organ of a subject with the distal effector end while the proximal controlling end remains outside of the subject;

a first tissue engaging device disposed on the distal effector end and operably connected to the proximal controlling end, the first tissue engaging device being structured for releasably engaging at least the inner surface of the hollow organ and for manipulating tissue thus engaged;

a second tissue engaging device also disposed on the distal effector end and operably connected to the proximal controlling end, the second tissue engaging device being structured for

(a) releasably engaging the interior of the hollow organ, and

(b) moving relative to the first tissue engaging device,

wherein the controlling end of the instrument is structured to actuate the tissue engaging device.

2. The tissue shaping instrument of claim 1, wherein the instrument is an endoscopic instrument.

3. The tissue shaping instrument of claim 1, further comprising a tissue securing device disposed at the distal effector end and operably connected to the proximal controlling end.

4. The tissue shaping instrument of claim 3, wherein at least one tissue fixation device is configured to be loaded into the tissue securing device by a person using the device.

5. A tissue shaping instrument comprising

a proximal controlling end;

a distal effector end;

an elongated portion connecting the distal effector end to the proximal controlling end, the elongated portion being of sufficient length to enable an operator to access an interior of a hollow organ of a subject with the distal effector end while the proximal controlling end remains outside of the subject;

a first tissue engaging device disposed on the distal effector end and operably connected to the proximal controlling end, the first tissue engaging device being structured for releasably engaging at least the inner surface of the hollow organ and for manipulating tissue thus engaged so as to reconfigure a portion of at least the interior of the hollow organ;

a second tissue engaging device also disposed on the distal effector end and operably connected to the proximal controlling end, the second tissue engaging device being structured for

(a) releasably engaging the interior of the hollow organ and for manipulating tissue thus engaged so as to reconfigure a portion of the interior of at least the interior of the hollow organ,

(b) moving relative to the first tissue engaging device, and

(c) working cooperatively with a tissue securing device; and

a tissue securing device disposed at the distal effector end and operably connected to the proximal controlling end, wherein the tissue securing device is effective for fixing tissue of the hollow organ reconfigured by at least one of the first tissue engaging device and the second tissue engaging device,

wherein the controlling end of the instrument is structured to actuate the tissue engaging device and the tissue securing device.

6. The instrument of claim 5 wherein the instrument is an endoscopic instrument.

7. The tissue shaping instrument of claim 5 wherein either or both the first tissue engaging device and the second tissue engaging device comprises a jawed clamp.

8. The tissue shaping instrument of claim 5 wherein at least one of the first tissue engaging device and the second tissue engaging device comprises a corkscrew-like retractor.

9. The tissue shaping instrument of claim 5 wherein the tissue securing device comprises a stapler.

10. The tissue shaping instrument of claim 9 wherein the stapler comprises a one-sided stapler.

11. The tissue shaping instrument of claim 5 wherein the tissue securing device comprises a device structured for delivering at least one biocompatible tissue fixation device into a tissue.

12. The tissue shaping instrument of claim 11 wherein the at least one tissue fixation device is selected from the group consisting of a staple, a clip, a tack, a rivet, a two-part fastener, a helical fastener, a suture, and a T-bar suture.

13. The tissue shaping instrument of claim 11 wherein the at least one tissue fixation device is a staple.

14. The tissue shaping instrument of claim 11 wherein the at least one tissue fixation device is a two-part fastener.

15. The tissue shaping instrument of claim 11 wherein the at least one tissue fixation device is a suture.

16. The tissue shaping instrument of claim 11 wherein the at least one tissue fixation device is a T-bar suture.

17. The tissue shaping instrument of claim 5 wherein either or both the first tissue engaging device and the second tissue engaging device is non-piercing.

18. The tissue shaping instrument of claim 5 wherein at least part of the elongated portion is flexible.

19. The tissue shaping instrument of claim 5 further comprising a viewing endoscope.

20. The tissue shaping instrument of claim 5 further comprising at least one working channel.

21. The tissue shaping instrument of claim 5 wherein the instrument is sterilized.

22. A tissue engaging device comprising a proximal controlling end;

a distal effector end; and

an elongated portion connecting the distal effector end to the proximal controlling end, the elongated portion being of sufficient length to enable an operator to access an interior of a hollow organ of a subject with the distal effector end while the proximal controlling end remains outside of the subject;

wherein the distal effector end comprises a helix with a sharpened end structured to be reversibly screwed into and out of a tissue brought into in contact with the sharpened end, and

wherein the controlling end of the tissue engaging device is structured to actuate the tissue engaging device.

23. The tissue engaging device of claim 22 wherein the device is an endoscopic device.

24. Apparatus comprising:

means for transorally engaging a plurality of regions of stomach tissue with a plurality of members from within the stomach, at least one of the members configured to move toward another member to reconfigure tissue, and

means for pulling tissue located between the plurality of regions of tissue prior to engaging the plurality of regions of tissue.

25. The apparatus of claim 24 wherein the plurality of members include a first member having a first securing part configured to engage a first tissue section and a second member having a second securing part configured to engage a second tissue section.

26. The apparatus of claim 24 wherein the engaging means includes a corkscrew element.

27. The apparatus of claim 24 wherein the engaging means includes a clamping device.

28. The apparatus of claim 24 wherein the engaging means includes a suction device.

29. The apparatus of claim 24 wherein the engaging means includes a grasping device.

30. The apparatus of claim 24 further comprising a means for securing the reconfigured tissue.

31. The apparatus of claim 30 wherein the securing means includes one or more of:

a staple, a clip, a tack, a rivet, a two-part fastener, a helical fastener, a suture, a T-bar suture, and a tissue adhesive.

32. The apparatus of claim 30 wherein the securing means is biocompatible.

33. The apparatus of claim 30 wherein the securing means is non-resorbable.

34. Apparatus comprising:

an elongated member configured for transoral placement in the stomach and having a distal region including first and second movable members configured to be moved toward one another to reconfigure stomach tissue, the distal region being steerable as a unit, and

means for deploying an implant from at least one of the members to secure the reconfigured tissue.

35. The apparatus of claim 34 wherein the first movable member includes a first securing part configured to engage a first tissue section and the second movable member includes a second securing part configured to engage a second tissue section.

36. The apparatus of claim 34 wherein the elongated member includes a corkscrew element.

37. The apparatus of claim 34 wherein the elongated member includes a clamping device.

38. The apparatus of claim 34 wherein the elongated member includes a suction device.

39. The apparatus of claim 34 wherein the elongated member includes a grasping device.

40. The apparatus of claim 34 wherein the deploying means includes a distal end effector configured to contact the reconfigured stomach tissue.

41. The apparatus of claim 40 wherein the distal end effector includes at least one tissue fixation device.

42. The apparatus of claim 41 wherein the distal end effector is configured for application of the at least one tissue fixation device into the reconfigured stomach tissue.

43. The apparatus of claim 40 further comprising a means for controlling the distal end effector.

44. The apparatus of claim 43 wherein the controlling means is disposed at a proximal end of the apparatus and is operatively connected to the distal end effector.