Apparatus for manipulating and securing tissue

• US 7,361,180 B2
• Filed: 09/29/2004
• Issued: 04/22/2008
• Est. Priority Date: 05/07/2004
• Status: Active Grant

• Current Assignee: USGI Medical, Inc.
• Original Assignee: USGI Medical, Inc.
• Inventors: Saadat, Vahid, Ewers, Richard C., Lam, Cang C., Michlitsch, Kenneth J., Rothe, Chris, Vaughan, Robert A.
• Primary Examiner(s): Nguyen; Anhtuan T.
• Assistant Examiner(s): Neal; Timothy J
• Application Number:
  US10/954,666
• Publication Number:
  US 20050251160A1
• Time in Patent Office: 1,301 Days
• Field of Search: 606/139, 606/142, 606/205, 606/207
• US Class Current: 606/139
• 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 17/0469 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 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/06 Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials puncturing needles A61B17/34; hypodermic needles A61M5/32 ; sewing needles D05B85/00
• CPC Class Codes: A61B 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• 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 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• 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 2017/00867 shape memory effect for prostheses A61F2210/0014
• 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 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0446 Means for attaching and blocking the suture in the suture anchor
• CPC Class Codes: A61B 2017/045 : snug fit within the anchor
• CPC Class Codes: A61B 2017/0451 : Cams or wedges holding the suture by friction
• CPC Class Codes: A61B 2017/0454 : the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0456 : Surface features on the anchor, e.g. ribs increasing friction between the suture and the anchor
• CPC Class Codes: A61B 2017/0458 : Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0459 : Multiple holes in the anchor through which the suture extends and locking the suture when tension is applied
• CPC Class Codes: A61B 2017/0461 : with features cooperating with special features on the suture, e.g. protrusions on the suture
• CPC Class Codes: A61B 2017/0462 : One way system, i.e. also tensioning the suture
• CPC Class Codes: A61B 2017/0464 : for soft tissue
• CPC Class Codes: A61B 2017/0475 : using sutures having a slip knot
• CPC Class Codes: A61B 2017/0488 : Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/06052 : Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle hollow suture needles A61B2017/061
• CPC Class Codes: A61B 2017/081 : Tissue approximator A61B2017/1103, A61B17/8866 take precedence
• CPC Class Codes: A61B 2017/3488 : Fixation to inner organ or inner body tissue
• CPC Class Codes: A61F 5/0086 : using clamps, folding means or the like

Abstract

Apparatus for manipulating and securing tissue are described herein. In creating tissue folds within the body of a patient, a tissue manipulation assembly may generally have an elongate tubular member, an engagement member slidably disposed through the tubular member and a distal end adapted to engage tissue via a helical member, tissue stabilizing members positioned at the tubular member distal end which are adapted to stabilize tissue therebetween, and a delivery tube pivotable about the tissue stabilizer. The stabilizing members can be adapted to become angled relative to a longitudinal axis of the elongate tubular member. Moreover, one or all the articulation controls and functions can be integrated into a singular handle assembly connectable to the tissue manipulation assembly via a rigid or flexible tubular body.

Claims

1. An apparatus for forming a tissue fold, comprising:

an elongate member having a proximal end, a distal end, and a length therebetween;

a first stabilizing member and a second stabilizing member pivotably attached near or at the distal end of the elongate member and adapted to stabilize tissue therebetween;

an engagement member movably positioned between the first and second stabilizing members and adapted to engage the tissue thereto; and

a delivery tube pivotably attached directly to a distal end of said first stabilizing member and adapted to be positioned transversely to the tissue.

2. The apparatus of claim 1 further comprising a needle assembly slidably disposed within the delivery tube.

3. The apparatus of claim 2 further comprising an elongate hollow member connected to the needle assembly and disposed within the delivery tube.

4. The apparatus of claim 3 further comprising an elongate pusher slid ably disposed within the elongate hollow member.

5. The apparatus of claim 2 further comprising at least one expandable anchor slidably disposed within the needle assembly for securement against the tissue fold.

6. The apparatus of claim 5 further comprising a length of suture attached to the anchor for securement through the tissue fold.

7. The apparatus of claim 2 wherein the needle assembly is adapted to be advanced from the delivery tube perpendicular to the first or second stabilizing member.

8. The apparatus of claim 2 wherein the needle assembly is adapted to be advanced from the delivery tube at an angle relative to the first or second stabilizing member.

9. The apparatus of claim 2 wherein the needle assembly comprises a needle body having a sharpened distal end.

10. The apparatus of claim 9 wherein the needle body is hollow.

11. The apparatus of claim 9 wherein the needle body is curved.

12. The apparatus of claim 10 wherein the needle body is comprised of a shape memory alloy.

13. The apparatus of claim 9 wherein the needle body is adapted to be torqued via a proximal end of the needle body.

14. The apparatus of claim 13 wherein the needle body is threaded over an outer surface.

15. The apparatus of claim 2 wherein the needle assembly further comprises a lubricious layer or coating disposed over an inner surface of the needle assembly.

16. The apparatus of claim 2 wherein the needle assembly defines an opening along an outer surface proximally of a distal end of the needle assembly through which at least one expandable anchor is slidably disposed for securement against the tissue fold.

17. The apparatus of claim 2 wherein the needle assembly comprises a needle body having a piercing tip and a grasping arm positioned proximally of the tip, the grasping arm being adapted to project from the needle body and releasably retain a length of suture.

18. The apparatus of claim 1 wherein the elongate member comprises a flexible length.

19. The apparatus of claim 18 wherein the flexible length is adapted to he advanced through an endoscopic device.

20. The apparatus of claim 19 wherein the endoscopic device comprises a shape-lockable endoscopic body.

21. The apparatus of claim 19 wherein the endoscopic device is steerable.

22. The apparatus of claim 1 wherein the elongate member comprises a rigid length.

23. The apparatus of claim 1 wherein the distal end of the engagement member comprises a helically-wound member configured to pierce the tissue when rotated about its longitudinal axis.

24. The apparatus of claim 1 further comprising a linear bearing slidably connected to the stabilizing member.

25. The apparatus of claim 24 wherein the linear bearing is slidably connected to the engagement member.

26. The apparatus of claim 25 wherein the linear bearing is adapted to slide along the first stabilizing member when the engagement member is advanced distally or proximally relative to the first stabilizing member.

27. The apparatus of claim 1 wherein the first and the second stabilizing members are positioned adjacent to one another such that a tissue receiving channel is defined therebetween.

28. The apparatus of claim 1 wherein the second stabilizing member is pivotable relative to the first stabilizing member.

29. The apparatus of claim 1 wherein the second stabilizing member is adapted to pivot into a closed configuration relative to the first stabilizing member upon a linear bearing being advanced proximally over the first stabilizing member.

30. The apparatus of claim 1 wherein the second stabilizing member defines a split opening therethrough.

31. The apparatus of claim 30 wherein the split opening is defined via two articulatable arms.

32. The apparatus of claim 1 wherein the delivery tube is articulatable between a low-profile configuration and a pivoted launch configuration.

33. The apparatus of claim 1 wherein a distal portion of the delivery tube is configured to rotate about a pivot.