Apparatus and methods for forming and securing gastrointestinal tissue folds

• US 8,343,175 B2
• Filed: 04/26/2010
• Issued: 01/01/2013
• Est. Priority Date: 06/25/1999
• Status: Active Grant

• Current Assignee: USGI Medical, Inc.
• Original Assignee: USGI Medical, Inc.
• Inventors: Ewers, Richard C., Saadat, Vahid, Michlitsch, Kenneth J., Rothe, Chris A., Lam, Cang C., Chen, Eugene G., Brenneman, Rodney C.
• Primary Examiner(s): Nguyen, Victor
• Application Number:
  US12/767,731
• Publication Number:
  US 20100211086A1
• Time in Patent Office: 981 Days
• Field of Search: 606/151, 606/153, 606/232, 606/144, 606/139, 606/213, 606/215, 606/216, 606/220, 606/142, 606/1, 227/175.1, 600/104, 600/141, 623/2.36, 623/2.37
• US Class Current: 606/151
• CPC Class Codes: A61B 1/00135 Oversleeves mounted on the endoscope prior to insertion
• CPC Class Codes: A61B 1/0055 Constructional details of insertion parts, e.g. vertebral elements
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 1/2736 Gastroscopes
• CPC Class Codes: A61B 1/31 for the rectum, e.g. proctoscopes, sigmoidoscopes , colonoscopes
• 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 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 17/062 Needle manipulators
• 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 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 17/295 combined with cutting implements
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00269 : endoscopic mucosal resection EMR
• CPC Class Codes: A61B 2017/003 : Steerable
• CPC Class Codes: A61B 2017/00353 : one mechanical instrument performing multiple functions, e.g. cutting and grasping channel for multiple instruments A61B2017/3445; instrument channel A61B2017/22072; replaceable heads A61B2017/2931; suction A61M1/00
• CPC Class Codes: A61B 2017/00827 : Treatment of gastro-esophageal reflux
• CPC Class Codes: A61B 2017/0404 : Buttons
• CPC Class Codes: A61B 2017/0417 : T-fasteners
• CPC Class Codes: A61B 2017/0419 : H-fasteners
• CPC Class Codes: A61B 2017/0443 : the shaft being resilient and having a coiled or helical shape in the released state
• 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 2017/0458 : Longitudinal through hole, e.g. suture blocked by a distal suture knot
• 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 2017/0488 : 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 2017/061 : hollow or tubular suture extending inside a hollow needle A61B2017/06052; hollow sutures A61B2017/06185
• CPC Class Codes: A61B 2017/06176 : with protrusions, e.g. barbs
• CPC Class Codes: A61B 2017/0649 : Coils or spirals
• CPC Class Codes: A61B 2017/2905 : flexible
• CPC Class Codes: A61B 2017/2927 : the angular position of the head being adjustable with respect to the shaft
• CPC Class Codes: A61B 2017/2943 : Toothed members, e.g. rack and pinion
• CPC Class Codes: A61B 2017/3445 : used as instrument channel for multiple instruments catheters A61B2017/22072
• CPC Class Codes: A61B 2017/3488 : Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2090/3614 : using optical fibre
• CPC Class Codes: A61F 5/0086 : using clamps, folding means or the like

Abstract

Apparatus and methods are provided for forming a gastrointestinal tissue fold by engaging tissue at a first tissue contact point and moving the first tissue contact point from a position initially distal to, or in line with, a second tissue contact point to a position proximal of the second contact point, thereby forming the tissue fold, and extending an anchor assembly through the tissue fold from a vicinity of the second tissue contact point. Adjustable anchor assemblies; as well as anchor delivery systems, shape-lockable guides and methods for endoluminally performing medical procedures, such as gastric reduction, treatment of gastroesophageal reflux disease, resection of lesions, and treatment of bleeding sites; are also provided.

Claims

1. An endoscopic apparatus, comprising:

an elongate endoscopic device having a lumen within an overtube;

an end effector at a distal end of the endoscopic device having at least one opening connecting into the lumen, whereby when a suction source is coupled to the endoscopic device a suction is created in the opening to draw a portion of tissue wall into the opening;

a needle slidable within the endoscopic device by pushing or pulling on a proximal end of the needle for moving the needle from a retracted position in which a distal end of the needle is withdrawn from the opening, to an extended position in which the distal end of the needle extends at least partway across the opening, whereby the needle can be extended into the portion of tissue wall drawn into the opening; and

an anchor assembly comprising a distal anchor, a proximal anchor, and a connector, with at least one of the proximal anchor and the distal anchor having a through-passage of a size to accommodate the needle such that the at least one of the proximal anchor and the distal anchor is disposed substantially concentrically on an exterior surface of the needle.

2. The apparatus of claim 1 wherein the lumen extends from a proximal end of the endoscopic device to the distal end of the end of the endoscopic device, and the needle is slidably positioned within the lumen.

3. The apparatus of claim 1 further comprising an endoscope slidably disposed in the lumen.

4. The apparatus of claim 1 further comprising an endoscopic visualization device slidably disposed in the lumen.

5. The apparatus of claim 1, wherein at least one of the proximal anchor and the distal anchor comprises a T-type anchor.

6. The apparatus of claim 1, wherein the connector comprises suture and the proximal and distal anchors are both fixed in place on the suture.

7. The apparatus of claim 1, wherein the connector has a length that is adjustable.

8. Apparatus for endoscopically reconfiguring tissue, comprising:

a flexible overtube having an elongated body with a proximal end and a distal end, with a lumen within the overtube, and an aperture located at or near the distal end of the overtube and providing access from the exterior of the overtube to the lumen;

a piercing element having a sharp distal tip, the piercing element being slidably disposed in the overtube and having a retracted position in which a distal end of the piercing element is located substantially proximal of the aperture and an extended position in which the distal end of the piercing element is located substantially distal of the aperture and remains within the lumen; and

an anchor assembly comprising a distal anchor, a proximal anchor, and a connector, with at least one of the proximal anchor and the distal anchor having a through-passage of a size to accommodate the piercing element such that the at least one of the proximal anchor and the distal anchor is disposed substantially concentrically on an exterior surface of the piercing element.

9. The apparatus of claim 8, wherein at least one of the proximal anchor and the distal anchor comprises a T-type anchor.

10. The apparatus of claim 8, wherein the connector comprises suture and the proximal and distal anchors are both fixed in place on the suture.

11. The apparatus of claim 8, wherein the connector has a length that is adjustable.

12. The apparatus of claim 8 further comprising an endoscope slidably disposed within the lumen.

13. The apparatus of claim 12, wherein the piercing element is slidably disposed within a working channel of the endoscope.

14. The apparatus of claim 8, wherein the aperture is located on the side of the overtube at or near the distal end of the overtube.

15. The apparatus of claim 8, wherein the aperture is located at the distal end of the overtube.

16. The apparatus of claim 8, wherein the lumen extends from the proximal end of the overtube to the distal end of the overtube.