Apparatus and methods for forming and securing gastrointestinal tissue folds

• US 7,704,264 B2
• Filed: 11/17/2004
• Issued: 04/27/2010
• Est. Priority Date: 06/25/1999
• Status: Active Grant

• Current Assignee: USGI Medical, Inc.
• Original Assignee: USGI Medical, Inc.
• Inventors: Brenneman, Rodney, Ewers, Richard C., Lam, Cang C., Michlitsch, Kenneth J., Chen, Eugene C., Rothe, Chris, Saadat, Vahid C.
• Primary Examiner(s): Nguyen; Anhtuan T
• Assistant Examiner(s): Lang; Amy T
• Application Number:
  US10/992,306
• Publication Number:
  US 20050245945A1
• Time in Patent Office: 1,987 Days
• Field of Search: 606/151, 606/144, 606/139, 606/153, 606/232, 606/213, 606/215, 606/216, 606/220, 606/142, 227/175.1, 600/104
• 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. A method of reconfiguring tissue, comprising:

advancing a distal end of an endoscopic member through an opening in the body of a patient until the distal end of the endoscopic member is located in the vicinity of a portion of tissue, said endoscopic member having an elongated body having a proximal end and a distal end;

drawing the portion of tissue via a suction force through an aperture into an internal passageway located at the distal end of the endoscopic member to form a tissue fold;

advancing a piercing element slidably disposed in the endoscopic member from a retracted position in which a distal end of the piercing element is located substantially proximal of the aperture to an extended position in which the distal end of the piercing element extends substantially distal of the aperture and remains within the internal passageway, whereby the piercing element extends into the tissue fold drawn into the internal passageway, wherein at least one anchor of an anchor assembly has a through-passage of a size to accommodate the piercing element such that the at least one anchor is disposed substantially concentrically on an exterior surface of the piercing element;

deploying the anchor assembly through said tissue fold using said piercing element such that a distal anchor is deployed on a first side of the tissue fold, a proximal anchor is deployed on a second side of the tissue fold, and a connector extends through the tissue fold to connect the distal anchor to the proximal anchor; and

decreasing the distance between the proximal and distal anchors to thereby secure the tissue fold.

2. The method of claim 1 wherein the opening in the body of the patient is a natural body opening comprising one of the following:

the patient'"'"'s mouth or the patient'"'"'s anus.

3. A method of reconfiguring tissue, comprising:

advancing a distal end of an endoscopic member through an opening in the body of a patient until the distal end of the endoscopic member is located in the vicinity of a portion of tissue, said endoscopic member having an elongated body having a proximal end and a distal end;

drawing the portion of tissue via a suction force through an aperture into an internal passageway located at the distal end of the endoscopic member to form a tissue fold;

advancing a piercing element slidably disposed in the endoscopic member from a retracted position in which a distal end of the piercing element is located substantially proximal of the aperture to an extended position in which the distal end of the piercing element extends substantially distal of the aperture but remains within the internal passageway, whereby the piercing element extends into the tissue fold drawn into the internal passageway, wherein at least one anchor of an anchor assembly has a through-passage of a size to accommodate the piercing element such that the at least one anchor is disposed substantially concentrically on an exterior surface of the piercing element;

deploying the anchor assembly through said tissue fold using said piercing element such that a distal anchor is deployed on a first side of the tissue fold, a proximal anchor is deployed on a second side of the tissue fold, and a connector extends through the tissue fold to connect the distal anchor to the proximal anchor, wherein at least one of said distal anchor and said proximal anchor comprises a T-type anchor having a first portion that extends in a first direction generally perpendicular to the connector after deployment and a second portion that extends in a second direction generally perpendicular to the connector after deployment.

4. The method of claim 3, further comprising the step of decreasing the distance between the proximal and distal anchors to thereby secure the tissue fold.

5. The method of claim 3 wherein the opening in the body of the patient is a natural body opening comprising one of the following:

the patient'"'"'s mouth or the patient'"'"'s anus.

6. The method of claim 3, wherein the first portion and the second portion of the T-anchor extend generally in a single plane that also contains the connector.

10. The method of claim 3, further comprising the step of maintaining the suction force on the portion of tissue during the advancing and deploying steps.

11. The method of claim 10, further comprising the step of releasing the suction force only after the distal anchor and proximal anchor have been deployed.

7. A method of reconfiguring tissue, comprising:

advancing a distal end of an endoscopic member through an opening in the body of a patient until the distal end of the endoscopic member is located in the vicinity of a portion of tissue, said endoscopic member having an elongated body having a proximal end and a distal end;

drawing the portion of tissue via a suction force through an aperture into an internal passageway located at the distal end of the endoscopic member to form a tissue fold;

advancing a piercing element slidably disposed in the endoscopic member from a retracted position in which a distal end of the piercing element is located substantially proximal of the aperture to an extended position in which the distal end of the piercing element extends substantially distal of the aperture but remains within the internal passageway, whereby the piercing element extends into the tissue fold drawn into the internal passageway, wherein at least one anchor of an anchor assembly has a through-passage of a size to accommodate the piercing element such that the at least one anchor is disposed substantially concentrically on an exterior surface of the piercing element;

deploying the anchor assembly through said tissue fold using said piercing element such that a distal anchor is deployed on a first side of the tissue fold, a proximal anchor is deployed on a second side of the tissue fold, and a connector extends through the tissue fold to connect the distal anchor to the proximal anchor.

8. The method of claim 7, further comprising the step of decreasing the distance between the proximal and distal anchors to thereby secure the tissue fold.

9. The method of claim 7 wherein the opening in the body of the patient is a natural body opening comprising one of the following:

the patient'"'"'s mouth or the patient'"'"'s anus.

12. The method of claim 7, further comprising the step of maintaining the suction force on the portion of tissue during the advancing and deploying steps.

13. The method of claim 12, further comprising the step of releasing the suction force only after the anchor assembly has been deployed.