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US7776057: Methods and devices for tissue reconfiguration

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Filing Information

Inventor(s) Michael D. Laufer · Jeffrey C. Cerier · Amos Cruz · Jonathan O'Keefe · Richard Andrews · Vincent A. Puicci, Jr. · Michael Barenboym · Neal H. Marshall · Randal B. Chinnock ·
Assignee(s) Ethicon Endo-Surgery, Inc. ·
Primary Examiner Kevin T Truong ·
Application Number US10992228
Filing date 11/19/2004
Issue date 08/17/2010
Prior Publication Data
Predicted expiration date 09/16/2023
Patent term adjustment 1288
U.S. Classifications 606/139  ·
International Classifications A61B1704  ·
Kind CodeB2
Related U.S. Application DataThis application claims the priority of U.S. provisional application Ser. No. 60/306,652, filed Jul. 18, 2001, which is hereby incorporated by reference in its entirety.
This application is a continuation-in-part of copending application U.S. Ser. No. 09/859,579, filed May 18, 2001 now U.S. Pat. No. 6,821,285, entitled TISSUE RECONFIGURATION, which is a continuation-in-part of application U.S. Ser. No. 09/574,424, filed May 19, 2000 now U.S. Pat. No. 6,494,888, entitled TISSUE RECONFIGURATION, which is a continuation-in-part of application U.S. Ser. No. 09/520,273, filed Mar. 7, 2000 now U.S. Pat. No. 6,663,639, entitled METHODS AND DEVICES FOR TISSUE RECONFIGURATION, and application U.S. Ser. No. 09/519,945, filed Mar. 7, 2000 U.S. Pat. No. 6,506,196, entitled DEVICE AND METHOD FOR CORRECTION OF A PAINFUL BODY DEFECT, which claim priority from provisional application. U.S. Ser. No. 60/140,492, filed Jun. 22, 1999, entitled STOMACH ELEVATOR METHOD AND DEVICE, all hereby incorporated by reference in their entirety.
20 Claims, 9 Drawings


Abstract

A method includes advancing an apparatus having an elongated member transorally into the stomach. The apparatus includes a distal end effector having first and second members configured to engage tissue. The first and second members are movable relatively toward one another generally in a first plane. The method includes moving the distal end effector relative to the elongated member in the first plane such that the distal end effector is retroflexed out of alignment with the elongated member to position the first and second members for engagement with the tissue. At least one of the first and second members carries a fixation device for fixing engaged portions of tissue together.

Independent Claims | See all claims (20)

  1. 1. A method comprising: advancing an apparatus including an elongated member transorally into the stomach, the apparatus including a distal end effector having first and second members configured to engage tissue, the first and second members being movable relatively toward one another generally in a first plane, and moving the distal end effector relative to the elongated member in a second plane that is substantially orthogonal to the first plane to position the first and second members for grasping tissue distal to a distal-most end of the distal end effector along a greater curvature of a stomach, at least one of the first and second members carrying a fixation device for fixing engaged portions of tissue together.
  2. 8. A method for approximating tissue, comprising: advancing an apparatus including an elongated flexible member into a body through a natural orifice, the apparatus including a distal end effector movable relative to the elongated flexible member and having first and second members configured to engage tissue, at least one of the first and second members being movable relative to the other generally in a first plane; orienting the flexible elongated member into a desired location near a desired surgical site; visualizing at least the first and second members as they are moved into position to engage tissue; grasping substantially concave tissue to be approximated distal to a distal-most end of the distal end effector using the first and second members; manipulating the grasped tissue into a desired configuration; and approximating the grasped tissue using a fixation device deployed from at least one of the first and second members.
  3. 15. A method comprising: advancing an apparatus including an elongated member transorally into the stomach, the apparatus including a distal end effector movable relative to the elongated member and having first and second members configured to engage tissue, the first and second members being movable relatively toward one another generally in a first plane, at least one of the first and second members carrying a fixation device for fixing engaged portions of tissue together; grasping tissue distal to a distal-most end of the distal end effector along a greater curvature of the stomach; and plicating the tissue of the stomach with the fixation device to reduce a volume of the stomach.

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Other Publications

Boerema, “Hiatus Hernia: Repair by right-sided, subhepatic, anterior gastropexy,” Surgery (1969) 65:884-893.
Carvalho et al., “Fibrosis of Gastric Cardia After Endoscopic Sclerosis: Mechanism for Control of Experimental Reflux?” The American Surgeon (1990) 56:163-166.
Cecconello et al., Esophagogastric Anastomosis with Valvuloplasty: An Experimental Study Int. Surg. (1982) 67:121-124.
Collis, “An Operation for Hiatus Hernia with Short Esophagus,” J. Thorac. Surg. (1957) 34:768-778.
Collis, “Surgical Control of Reflux in Hiatus Hernia,” Am. J. Surg. (1968) 115:465-471.
Contractor et al., “Endoscopic Esophagitis and Gastroesophageal Flap Valve,” J. Clin. Gastroenterol. (1999) 28:233-237.
Cuschieri et al., “Multicenter prospective evaluation of laparoscopic antireflux surgery,” Surg. Endosc. (1993) 7:505-510.
DeMeester et al., “Nissen Fundoplication for Gastroesophageal Reflux Disease,” Annals of Surgery (1986) 204:9-20.
Donahue et al., “Endoscopic sclerosis of the gastria cardia for prevention of experimental gastroesophageal reflux,” Gastrointest Endosc. (1990) 36:253-256.
Falk et al., “Laparoscopic Fundoplication: A Preliminary Report of the Technique and Postoperative Care,” Aust. N.Z. J. Surg. (1992) 62:969-972.
Hill et al., “The gastroesophageal flap valve: in vitro and in vivo observations,” Gastrointest Endosc. (1996) 44:541-547.
Hill, “An Effective Operation for Hiatal Hernia: An Eight Year Appraisal,” Annals of Surgery (1967) 166:681-692.
Hill, “Antireflux Surgery: A Surgeon's Look,” Gastroent. Clin. No. Amer. (1990) 19:745-775.
Hill, “Intraoperative measurement of lower esophageal sphincter pressure,” J. Thorac. Cardiovasc. Surg. (1978) 75:378-382.
Hill, “Myths of the esophagus,” J. Thorac. Cardiovasc. Surg. (1989) 98:1-10.
Hill, “The Gastroesophageal Flap Valve,” J. Clin. Gastroenterol (1999) 28:194-197.
Hill, “Surgery for Peptic Esophageal Stricture,” 139-147.
Hinder et al., “The Surgical Option for Gastroesophageal Reflux Disease,” Symposium on Gastroesophageal Reflux Disease Am. J. Med. (1997) 144S-148S.
Ismail et al., “Yield Pressure: A New Concept in the Evaluation of GERD?” Br. J. Surg. (1995) 82:943-947.
Jamieson et al., “Laparoscopic Nissen Fundoplication,” Annals of Surgery (1994) 220:137-145.
Janssen et al., “Prospective randomized comparison of teres cardiopexy and Nissen fundoplication in the surgical therapy of gastro-oesophageal reflux disease,” Br. J. Surg. (1993) 80:875-878.
Jennings et al., “A Novel Endoscopic Transgastric Fundoplication Procedure for Gastroesophageal Reflux: An Initial Animal Evaluation,” J. Laparoendosc. Surg. (1992) 2:207-213.
Kadirkamanathan et al., “An ambulant porcine model of acid reflux used to evaluate endoscopic gastroplasty,” Gut (1999) 44:782-788.
Kadirkamanathan et al., “Antireflux operations at flexible endoscopy using endoluminal stitching techniques: an experimental study,” Gastroint. Endosc. (1996) 44:133-143.
Kahrilas, “Gastroesophageal Reflux Disease,” JAMA (1996) 276:983-988.
Kraemer et al., “Laparoscopic Hill repair,” Gastrointestinal Endoscopy (1994) 40:155-159.
Little, “Mechanisms of Action of Antireflux Surgery: Theory and Fact,” World J. Surg. (1992) 16:320-325.
Mason et al., “A new intraluminal antigastroesophageal reflux procedure in baboons,” Gastroint. Endosc. (1997) 45:283-290.
Mason et al., “Nissen Fundoplication Prevents Shortening of the Sphincter During Gastric Distention,” Arch. Surg. (1997) 132:719-726.
McGouran et al., “A laser-induced scar at the cardia increases the yield pressure of the lower esophageal sphincter,” Gastrointest. Endosc. (1990) 36:439-443.
McGouran et al., “Does measurement of yield pressure at the cardia during endoscopy provide information on the function of the lower oesophageal sphincter mechanism?” Gut (1988) 29:275-278.
McGouran et al., “Is yield pressure at the cardia increased by effective fundoplication?” Gut (1989) 30:1309-1312.
McKernan, “Laparoscopic repair of gastroesophageal reflux disease,” Surg Endosc (1994) 8:851-856.
Nathanson et al., “Laparoscopic ligamentum teres (round ligament) cardiopexy,” Br. J. Surg. (1991) 78:947-951.
Nissen, “Eine einlache Operation zur Beeinflussung der Refluxoesophagitis,” Journal Suise de Medecine (1956) 590-592.
O'Connor et al.,“An experimental endoscopic technique for reversing gastroesophageal reflux in dogs by injecting inert material in the distal esophagus,” Gastro. Endosc. (1984) 30:275-280.
O'Connor et al., “Endoscopic placement of collagen at the lower esophageal sphincter to inhibit gastroesophageal reflux: a pilot study of 10 medically intractable patients,” Gastroent. Endosc. (1988) 34:106-112.
Pedinielli, “Traitement Chirurgical de la Hernie Hiatale par la Technique du Collet,” Ann. Chir. (1964) 18:1461-1474.
Polk et al., “Hiatal Hernia and Esophagitis: A Survey of Indications for Operation and Technic and Results of Fundoplication,” Ann. Surg. (1971) 173:775-781.
Rampal et al., “Traitement des hernies hiatales et du reflux oesophagieu pa la cardio-pexie avec le ligament rond du foie,” Le Presse Medicale (1967) 75:617-619.
Rich, “Simple GERD treatment offers new alternative,” (www.medicalpost.com website) (Mar. 1999).
Rupp et al., “Endoscopic Antireflux Techniques: Endoluminal and Laparoscopic,” Exper. & Invest. Endosc. (1994) 4:353-368.
Shafik, “Intraesophageal Polytef injection for the treatment of reflux esophagitis,” Surg. Endosc. (1996) 10:329-331.
Singh et al., “Evaluation of the Endoscopic Suturing System in the Treatment of GERD,” DDW (May 16-19, 1999).
Skinner et al., Surgical management of esophageal reflux and hiatus hernia, J. of Thoracic & Cardiovas. Surg. (1967) 53:33-54.
Slim et al., “Intraoperative Esophageal Manometry and Fundoplications: Prospective Study,” World J. Surg. (1996) 20:55-59.
Starling et al., “Assessment of the Angelchik Prosthesis for Treatment of Symptomatic Esophageal Reflux,” World J. Surg. (1987) 11:350-355.
Starling et al., “Treatment of Symptomatic Gastroesophageal Reflux Using the Angelchik™ Prosthesis,” Ann. Surg. (1982) 686:690.
Thor et al., “Reappraisal of the Flap Valve Mechanism in the Gastroesophageal Junction,” Acta Chir. Scand. (1987) 153:25-28.
Tocornal et al., “A mucosal flap valve mechanism to prevent gastroesophageal reflux and esophagitis,” Surgery (1968) 64:519-523.
Wang et al., “A new anti-reflux procedure: cardiac oblique invagination,” Chung Hua Wai Ko Tsa Chih (1995) 33 (2) 73-75 (English abstract).
Watson et al., “Comparison of anterior posterior and total fundoplication using a viscera model,” Diseases of the Esophagus (1997) 10:110-114.
Westbrook et al., “Posterior Surgical Approaches to the Rectum,” Annals of Surgery (1982) 195:677-691.
European Search Report dated Sep. 2, 2004 in EP 04076389.
Eurpoean Search Report mailed Jul. 10, 2007 in EP Application No. 07075291.
International Search Report dated Oct. 16, 2000.
International Search Report dated Oct. 22, 2003.
Boerema MD ‘Hiatus Hernia: Repair by right-sided, subhepatic, anterior gastropexy’ Surgery, 65:884-893 (1969).
Carvalho PJPC et al Fibrosis of gastric cardia after endoscopic sclerosis. Mechanism for control of experimental reflux? Am Surg Mar. 1990; 56(3):163-6.
DeMeester, MD et al ‘Nissen Fundoplication for Gastroesophageal Reflux Disease’ Annals of Surgery 204:9-20 (1986).
Hill et al ‘Surgery for Peptic Esophageal Stricture’ 139-147.
Hill et at ‘The Esophagus, Medical and Surgical Management’ WB Saunders Co. 135-8 (1988).
Hill LD ‘Myths of the esophagus’ J Thorac Cardiovasc Surg Jul. (1989)98(1):1-10.
Hill MD ‘An Effective Operation for Hiatal Hernia: An Eight Year Appraisal’ Annals of Surgery (1967) 166:681-692.
Kraemer, MD et al ‘Laparascopic Hill repair’ Gastrointestinal Endoscopy,vol. 40 No. 2 155-159 (1994).
Mason et al ‘Nissen Fundoplication Prevents Shortening of the Sphincter During Gastric Distention’ ARCH Surg., 132:719-726 (1997).
Skinner et al ‘Surgical management of esophageal reflux and hiatus hernia’ Journal of Thoracic and Cardiovascular Surgery (1967) vol. 53, No. 1 pp. 33-54.
Starling et al ‘Assessment of the Angelchik Prosthesis for Treatment of Symptonatic Esophageal Reflux’ World J. Surg. 11, 350-355 (1987).
Slim K et al., Intraoperative esophageal manometry and fundoplications: prospective study, World J Surg Jan. 1996;20(1):55-9.
Kahrilas, “Gastroesophageal Reflux Disease,”JAMA, 276:983-988 (1996).
Little, M.D., “Mechanisms of Action of Antireflux Surgery: Theory and Fact,” World Journal of Surgery, 16:320-325 (1992).
McKernan, “Laparoscopic repair of gastroesophageal reflux disease,” Surgical Endoscopy, 8:851-856 (1994).
Falk, et al., “Laparoscopic Fundoplication: A preliminary report of the technique and postoperative care,” Aust. N.Z. J. Surgery, 62:969-972 (1992).
Kadirkamanathan SS et al., An ambulant procine model of acid reflux used to evaluate endoscopic gastroplasty. Gut Jun. 1999;44(6):782-8.
Mason RJ et al., A new intraluminal antigastroesphageal reflux procedure in baboons. Gastrointest Endosc Mar. 1997;45(3):283-90.
Hill LD et al., The gastroesophageal flap valve: in vitro and vivo observations. Gastrointest Endosc Nov. 1996;44(5):541-7.
Cuschieri, et al., “Multicenter prospective evaluation of laparoscopic antireflux surgery,” Surgical Endoscopy, 7:505-510 (1993).
Hill LD, Intraoperative measurement of lower esophageal sphincter pressure. J. Thorac Cardiovasc Surg Mar. 1978;75(3):378-82.
Ismail T. et al., Yield pressure, anatomy of the cardia and gastro-oesophageal reflux. Br. J Surg Jul. 1995;82(7):943-7.
Kadirkamanathan SS et al., Antireflux operations at flexible endoscopy using enodluminal stitching techniques: an experimental study. Gastrointest Endosc Aug. 1996;44(2):133-43.
Digestive Disease Week, Orange County Convention Center, p. A-802; 314.
Contractor QQ et al., Endoscopic esphagitis and gastroesophageal flap valve. J Clin Gastroenterol Apr. 1999; 28 (3):233-7.
Cecconello, “Esophagogastric Anastomosis with Valvuloplasty: An Experimental Study,” International Surgery, 67:121-124 1982.
Collis, M.D., “An Operation for Hiatus Hernia with Short Esophagus,” The Journal of Thoracic Surgery, 34:768-778 (1957).
Collis, M.D., “Surgical Control of Reflux in Hiatus Hernia,” The American Journal of Surgery, 115:465-471 (1968).
Donahue PE et al., Endoscopic sclerosis of the gastric cardia for prevention of experimental gastroesophageal reflux, Gastrointest. Endosc. May-Jun. 1990 36(3):253-6.
Hill LD and Kozarek RA, The gastroesophageal flap valve, J. Clin. Gastroenterol Apr. 1999 28(3): 194-7.
Hill LD et al., Antireflux surgery. A surgeon's look, Gastroenterol Clin. North Am. , Sep. 1990 19(3):745-75.
Hill LD, Myths of the esophagus, J. Thorac Cardiovasc. Surg. Jul. 1989 9S(1):1-10.
Hill, et al., “The Esophagus. Medical and Surgical Management,” WB Saunders Co., 135-8 (1988).
Hinder, et al. “The Surgical Option for Gastroesophageal Reflux Disease,” Symposium on Gastroesophageal Reflux Disease, Am. J. Med. 103:144S-148S (1997).
Ismail, et al., “Yield Pressure: A New Concept in the Evaluation of Gerd?,” AJG, 91:616-617 (1996).
Jamieson, et al., “Laparoscopic Nissen Fundoplication,” Annals of Surgery, 220:137-145 (1994).
Jamieson, et al., “The development of surgery for gastro-oesophageal reflux disease.” Surgery of the Oesophagus, 233-245 (1988).
Janssen, et al., “Prospective randomized comparison of teres cardiopexy and Nissen fundoplication in the surgical therapy of gastro-oesophageal reflux disease.” Br. J. Surg., 80:875-878 (1993).
Jennings, et al., “A Novel Endoscopic Transgastric Fundoplication Procedure for Gastroesophageal Reflux: An Initial Animal Evaluation,” Journal of Laparoendoscopic Surgery, 2:207-213 (1992).
McGouran RC and Galloway JM, A laser-induced scar at the cardia increases the yield pressure of the lower esophageal sphicter, Gastrointest. Endosc. Sep.-Oct. 1990 36(5):439-43.
McGouran RC et al., Does measurement of yield pressure at the cardia during endoscopy provide information on the function of the lower oesophageal sphicter mechanism? Gut Mar. 1988 29(3):275-8.
Nathanson, et al., “Laparoscopic Ligamentum teres (round ligament) cardiopexy,” Br. J. Surg., 78:947-951 (1991).
Issen, “Eine einfache Operation zur Beeinflussung der Refluxoesophagitis,” Journal Suisee eMedecine, 590-592 (1956).
O'Connor KW and Lehman GA, Endoscopic placement of collagen at the lower esophageal sphicter to inhibit gastroesophageal reflux: a pilot study of 10 medically intractable patients. Gastrointest. Endosc. Mar.-Apr. 1988 34(2):106-12.
O'Connor KW et al., An experimental endoscopic technique for reversing gastroesophageal reflux in dogs by injecting inert material in the distal esophagus. Gastrointest. Endosc. Oct. 1984 30(5):275-80.
O'Connor, et al., “Endoscopic placement of collagen at the lower esophageal sphicter to inhibit gastroesophageal reflux: a pilot study of 10 medically intractable patients,” Gastrointestinal Endoscopy, 34:106-112 (1988).
Pedinielli, “Traitement Chirurgical de la Herinie Hiatale Par La Technique du Collet,” Ann. Chir., 18:1461-1474 (1964). (English Abstract).
Polk, et al., “Hiatol Hernia and Esophagitis: A survey of indications for operation and technic and results of fundoplication,” Ann. Surg., 173:775-781 (1971).
Rampal, et al., “Technique Chirurgicale, Traitement des hernies hiatales et du reflux aesophagien par la cardio-pexie avec le ligament round de foie,” La Presse Medicale, 75:617-619 (1967).
Rich, “Simple GERD Treatment Offers New Alternative” (www.medicalpost.com website), Mar. 1999.
Rupp TH and Lehman GA, Endoscopic antireflux techniques. Endoluminal and laparoscopic. Gastrointest. Endosc. Clin. N. Am. Apr. 1994 4(2):353-68.
Shafik A., Intraesophageal Polytef injection for the treatment of reflux esophagitis. Surg. Endosc. Mar. 1996 10(3):329-31.
Singh et al., “Evaluation of the Endoscopic Suturing System in the Treatment of the GERD,” Conference Abstract for Plenary Session for Digestive Disease Week, p. 314 & A-802, May 16-19, 1999.
The Americal journal of gastroenterology, vol. 91, No. 3, 1996, p. 616-617.
Thor KBA et al., Reappraisal of the flap valve mechanism in the gastroesophageal junction. A study of a new valvuloplasty procedure in cadavers. Acta Chir Scand Jan. 1987 153(1):25-8.
Tocornal, M.D., et al., A mucosol flap valve mechanism to prevent gastroesophageal reflux and esophagitis, Surgery, 64:519-523 (1968).
Wang, et al., “A new anti-flux procedure: cardiac oblique invagination,” Chung Hua Wai Ko Tsa Chih, Feb. 33 (2) 73-5 (1995). (English Abstract).
Watson, et al., “Comparison of anterior, posterior and total fundoplication using a viscera model,” Diseases of the Esophagus, 10:110-114 (1997).
Westbrook, et al., “Posterior Surgical Approaches to the Rectum,” Annals of Surgery, 195:677-691 (1982).
Bancewicz et al ‘Yield Pressure, Anatomy of the cervix and Gastrooesphageal Reflux’ The American Journal of Gastroenterology, vol. 91, No. 3, (1996) pp. 616-617.
Japanese Office Action for Application No. 2005-122394 dated May 12, 2009.
European Office Action dated Apr. 3, 2009 in EP07075291.0.

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