Method and devices for tissue reconfiguration

Information

  • Patent Grant
  • 6835200
  • Patent Number
    6,835,200
  • Date Filed
    Thursday, July 18, 2002
    22 years ago
  • Date Issued
    Tuesday, December 28, 2004
    19 years ago
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.
Description




BACKGROUND OF THE INVENTION




Brief Description of the Related Art




This invention relates to devices and methods for treating gastroesophageal reflux disease, and more particularly, the invention relates to a minimally invasive device and method for creating and fixating a fold of tissue at or near the junction of the esophagus and the stomach.




Gastroesophageal reflux disease (GERD) is a common upper-intestinal disorder in which contents of the stomach flow inappropriately from the stomach into the esophagus. Backflow of gastric contents into the esophagus results when gastric pressure is sufficient to overcome the resistance to flow that normally exists at the gastroesophageal junction (GEJ), or when gravity acting on the contents is sufficient to cause flow through the GEJ. Medication, open surgical procedures, laparoscopic surgical procedures, and endoscopic techniques are known for treating GERD.




SUMMARY OF THE INVENTION




According to one aspect of the invention, a medical instrument includes moveable arms configured for fixating the wall of the stomach to the wall of the esophagus for the treatment of GERD. In one embodiment, the instrument includes a proximal end, a shaft, a retroflexing portion, movable arms, a retractor, and an implant. The movable arms are oriented with respect to the retroflexing portion in a position that allows the stomach wall to be folded against the esophagus wall. In one such embodiment of this instrument the movable arms open and close in the same plane within which the retroflexing portion moves. This configuration is in contrast to certain embodiments of the medical instrument described in the U.S. patent application Ser. No. 09/859,579, entitled “TISSUE RECONFIGURATION,” filed May 18, 2001, in which the moveable arms are oriented in a plane rotated 90° from the plane in which the retroflexing portion moves. The mechanism of operation of the medical instrument of the current invention is as is disclosed in the patent applications incorporated by reference and listed above.




According to another aspect of the invention, a method of treatment includes fixating the wall of the stomach to the wall of the esophagus for the treatment of GERD.




According to another aspect of the invention, 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.




Embodiments of this aspect of the invention may include one or more of the following features. The method includes engaging tissue by moving the first and second members relatively toward one another generally in the first plane. Moving the first and second members engages a first tissue section with a first securing part of the fixation device and a second tissue section with a second securing part of the fixation device. The method includes piercing the tissue with a third member of the distal end effector prior to engaging the tissue with the first and second members.











BRIEF DESCRIPTION OF THE DRAWINGS




The invention will now be described in greater detail with reference to the preferred embodiment illustrated in the accompanying drawings, in which like elements bear like reference numerals, and wherein:





FIG. 1

is a side cross sectional view of a portion of an esophagus and a portion of a stomach, and a side view of an instrument in place in the esophagus and stomach;





FIG. 2

is a side cross sectional view of a portion of the esophagus and a portion of the stomach, and a side view of the instrument in place in the esophagus and stomach, showing the instrument in a retroflexed position;





FIG. 3

is a side cross sectional view of a portion of the esophagus and a portion of the stomach, and a side view of the instrument in place in the esophagus and stomach, showing the movable arms open;





FIG. 4

is a side cross sectional view of a portion of the esophagus and a portion of the stomach, and a side view of the instrument in place in the esophagus and stomach, showing a retractor engaging tissue;





FIG. 5

is a side cross sectional view of a portion of the esophagus and a portion of the stomach, and a side view of the instrument in place in the esophagus and stomach, showing the retractor retracting the tissue;





FIG. 6

is a side cross sectional view of a portion of the esophagus and a portion of the stomach, and a side view of the instrument in place in the esophagus and stomach, showing the movable arms closed, forming a tissue fold;





FIG. 7

is a side cross sectional view of a portion of the esophagus and a portion of the stomach, and a side view of the instrument in place in the esophagus and stomach, showing the movable arms open and an implant fixating the tissue fold;





FIG. 8

is a side cross sectional view of a portion of the esophagus and a portion of the stomach, and a side view of the instrument in place in the esophagus and stomach, showing the tissue fold, with the instrument in a straight configuration for removal from the patient.











DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT




The device consists of an instrument


10


with a proximal end (not shown), a shaft


12


, a retroflexing portion


14


, and a distal end effector


15


including movable arms


16


, a retractor


20


, and an implant


22


. The function of the instrument is controlled by the user by controls at the proximal end, as is disclosed in the referenced patent applications. The device and method of the present invention will be illustrated using the accompanying drawings.





FIG. 1

shows the instrument


10


in place in the esophagus


30


and the stomach


32


. The instrument is in a straight configuration, which is the configuration in which it is inserted into the esophagus and stomach





FIG. 2

shows the instrument


10


in place in the esophagus


30


and the stomach


32


, with the instrument


10


in a retroflexed position. Retroflexion of retroflexing portion


14


is accomplished as disclosed in the referenced patent applications. In this position, the distal end of the movable arms


16


of distal end effector


15


is located near the junction


34


of the esophagus


30


and the stomach


32


.





FIG. 3

shows the instrument


10


in place in the esophagus


30


and the stomach


32


, with the instrument


10


in a retroflexed position and the movable arms


16


in an open position revealing a portion


18


of an implant


22


(FIG.


7


). It is important to note that the moveable arms


16


are oriented relative to the retroflexing portion


14


to grasp the tissue at the junction


34


of the esophagus


30


and the stomach


32


. The movable arms


16


open and close in the same plane within which the retroflexing portion


14


moves. The actuating mechanism used to open movable arms


16


is substantially the same as the mechanisms used to actuate the medical instruments described in the U.S. patent application Ser. No. 09/859,579, entitled “TISSUE RECONFIGURATION,” filed May 18, 2001, with the movable arms rotated 90° with respect to the configuration of the published application such that the arms


16


open and close in the same plane within which the retroflexing portion


14


moves.





FIG. 4

shows the instrument


10


in place in the esophagus


30


and the stomach


32


, with the instrument


10


in a retroflexed position, the movable arms


16


in an open position, and the retractor


20


engaged with the tissue at or near the junction


34


of the esophagus


30


and the stomach


32


. Engagement of the retractor


20


with the tissue at or near the junction


34


is accomplished as is disclosed in the referenced patent applications.





FIG. 5

shows the instrument


10


in place in the esophagus


30


and the stomach


32


, with the instrument


10


in a retroflexed position, the movable arms


16


in an open position, and the retractor


20


retracting the tissue at or near the junction


34


of the esophagus


30


and the stomach


32


into the space between the movable arms


16


.





FIG. 6

shows the instrument


10


in place in the esophagus


30


and the stomach


32


, with the instrument


10


in a retroflexed position, and the movable arms


16


closed, to create a fold


36


of tissue at or near the junction


34


of the esophagus


30


and the stomach


32


. The mechanism to close movable arms is as is disclosed in the referenced patent applications.





FIG. 7

shows the instrument


10


in place in the esophagus


30


and the stomach


32


, with the instrument


10


in a retroflexed position, and the movable arms


16


opened. An implant


22


has been placed through the tissue to maintain fixation of the tissue fold


36


. Placement of the implant is accomplished as is disclosed in the referenced patent applications.





FIG. 8

shows the instrument


10


in place in the esophagus


30


and the stomach


32


, with the instrument


10


in a straight position, and the movable arms


16


closed. The tissue fold


36


is shown, fixated by implant


22


. The instrument


10


is in position for removal from the patient.




This invention provides a device and method which can be used to treat GERD by creating and fixating a fold of tissue at or near the junction of the esophagus and the stomach, thereby fixating the wall of the stomach to the wall of the esophagus. This invention allows this fold to be created and fixated via a completely endoluminal technique.




In another aspect of the invention, more than one fold is created in the tissue at or near the junction of the esophagus and the stomach.




In another aspect of the invention, the movable arms are attached to the retroflexing portion in a manner that allows the operator to rotate the position of the movable arms relative to the retroflexing portion about the center axis of the movable arms, thus allowing the operator to vary the orientation of the tissue fold.




While the invention has been described in detail with reference to the preferred embodiments thereof, it will be apparent to one skilled in the art that various changes and modifications can be made and equivalents employed, without departing from the present invention. For example, in the embodiment described above in conjunction with

FIGS. 1-8

, the moveable arms open and close in the same plane within which the retroflexing portion moves. However, it is appreciated that the plane in which the moveable arms open and close relative to the retroflexing portion can be at other orientations including angles between the same plane (i.e., 0°) and a plane transverse (i.e., 90°) to the plane within which the retroflexing portion moves. Indeed, in certain embodiments, the medical instrument can include a mechanism for allowing the user to adjust the angle of the moveable arms relative to the retroflexing portion.



Claims
  • 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 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 carrying a fixation device for securing engaged portions of tissue together.
  • 2. The method of claim 1 further comprising engaging tissue by moving the first and second members relatively toward one another generally in the first plane.
  • 3. The method of claim 2 wherein the moving of the first and second members engages a first tissue section with a first securing part of the fixation device and a second tissue section with a second securing part of the fixation device.
  • 4. The method of claim 1 further comprising piercing the tissue with a third member of the distal end effector prior to engaging the tissue with the first and second members.
  • 5. The method of claim 1 further comprising releasably mounting the first and second members to the distal end effector.
  • 6. The method of claim 1 further comprising removing the first and second members from the distal end effector.
  • 7. The method of claim 6 further comprising releasably mounting third and fourth members on the distal end effector, at least one of the third and fourth members carrying a fixation device for securing engaged portions of tissue together.
  • 8. The method of claim 1 wherein at least one of the first and second members pierces the tissue.
  • 9. The method of claim 1 further comprising separating a frangibly coupled part of the fixation device from at least one of the first and second members.
  • 10. The method of claim 9 wherein the first and second members interact to separate the frangibly coupled part.
  • 11. The method of claim 1 further comprising securing the engaged portions of tissue with the fixation device.
  • 12. The method of claim 1 further comprising providing the first member with a first distal tip releasably mounted to the first member, and the second member with a second distal tip releasably mounted to the second member, at least one of the first and second distal tips carrying the fixation device.
  • 13. The method of claim 12 further comprising releasably mounting the first distal tip on the first member and releasably mounting the second distal tip on the second member.
  • 14. The method of claim 12 further comprising removing the first distal tip from the first member and removing the second distal tip from the second member.
  • 15. The method of claim 14 further comprising releasably mounting a third distal tip on the first member and releasably mounting a fourth distal tip on the second member, at least one of the third and fourth distal tips carrying a fixation device for securing engaged portions of tissue together.
Parent Case Info

This 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, 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 is a continuation-in-part of U.S. Ser. No. 09/519,945, filed Mar. 7, 2000, now 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, this application Ser. No. 10/197,574 entitled STOMACH ELEVATOR METHOD AND DEVICE, all hereby incorporated by reference in their entirety.

US Referenced Citations (148)
Number Name Date Kind
3470875 Johnson Oct 1969 A
3551987 Wilkinson Jan 1971 A
3638653 Berry Feb 1972 A
3842840 Schweizer Oct 1974 A
3875648 Bone Apr 1975 A
3901244 Schweizer Aug 1975 A
3946740 Bassett Mar 1976 A
4006747 Kronenthal et al. Feb 1977 A
4164225 Johnson et al. Aug 1979 A
4235238 Ogiu et al. Nov 1980 A
4448194 DiGiovanni et al. May 1984 A
4471781 DiGiovanni et al. Sep 1984 A
4500024 DiGiovanni et al. Feb 1985 A
4506670 Crossley Mar 1985 A
4573469 Golden et al. Mar 1986 A
4585153 Failla et al. Apr 1986 A
4586502 Bedi et al. May 1986 A
4591085 Di Giovanni et al. May 1986 A
4605004 Di Giovanni et al. Aug 1986 A
4606345 Dorband et al. Aug 1986 A
4627437 Bedi et al. Dec 1986 A
4696300 Anderson Sep 1987 A
4705040 Mueller Nov 1987 A
4724840 McVay et al. Feb 1988 A
4736746 Anderson Apr 1988 A
4741336 Failla et al. May 1988 A
4753469 Hiscott Jun 1988 A
4809695 Gwathmey Mar 1989 A
4887612 Esser et al. Dec 1989 A
4890615 Caspari et al. Jan 1990 A
4935027 Yoon Jun 1990 A
5015249 Nakao May 1991 A
5037433 Wilk et al. Aug 1991 A
5088979 Filipi et al. Feb 1992 A
5147373 Ferzli Sep 1992 A
5222963 Brinkerhoff et al. Jun 1993 A
5254126 Filipi et al. Oct 1993 A
5336263 Ersek Aug 1994 A
5346504 Ortiz et al. Sep 1994 A
5356416 Chu et al. Oct 1994 A
5358508 Cobb Oct 1994 A
5364408 Gordon Nov 1994 A
5395030 Kuramoto et al. Mar 1995 A
5403326 Harrison et al. Apr 1995 A
5433721 Hooven et al. Jul 1995 A
5441507 Wilk Aug 1995 A
5447512 Wilson et al. Sep 1995 A
5451406 Lawin Sep 1995 A
5465894 Clark et al. Nov 1995 A
5486189 Mudry et al. Jan 1996 A
5496331 Xu et al. Mar 1996 A
5522820 Caspari et al. Jun 1996 A
5549618 Fleenor et al. Aug 1996 A
5558665 Kieturakis Sep 1996 A
5571090 Sherts Nov 1996 A
5571116 Bolanos Nov 1996 A
5573496 McPherson et al. Nov 1996 A
5624453 Ahmed Apr 1997 A
5626613 Schmieding May 1997 A
5645552 Shertz Jul 1997 A
5662683 Kay Sep 1997 A
5665096 Yoon Sep 1997 A
5674230 Tovey et al. Oct 1997 A
5676674 Bolanos et al. Oct 1997 A
5697940 Chu et al. Dec 1997 A
5722421 Francese et al. Mar 1998 A
5725524 Mulier et al. Mar 1998 A
5728109 Schulze et al. Mar 1998 A
5735861 Peifer et al. Apr 1998 A
5741280 Fleenor Apr 1998 A
5749898 Schulze et al. May 1998 A
5787897 Kieturakis Aug 1998 A
5792153 Swain Aug 1998 A
5794948 Swain Aug 1998 A
5797927 Yoon Aug 1998 A
5810855 Rayburn Sep 1998 A
5810882 Bolduc et al. Sep 1998 A
5814054 Kortenbach et al. Sep 1998 A
5826776 Schulze et al. Oct 1998 A
5846254 Schulze et al. Dec 1998 A
5853409 Swanson et al. Dec 1998 A
5855311 Hamblin et al. Jan 1999 A
5887594 LoCicero, III et al. Mar 1999 A
5893592 Schulze et al. Apr 1999 A
5897562 Bolanos et al. Apr 1999 A
5901895 Heaton et al. May 1999 A
5958444 Wallace Sep 1999 A
5984932 Yoon Nov 1999 A
5993466 Yoon Nov 1999 A
6009877 Edwards Jan 2000 A
6051003 Chu et al. Apr 2000 A
6059798 Tolkoff May 2000 A
6067990 Kieturakis May 2000 A
6083202 Smith Jul 2000 A
6086600 Kortenbach Jul 2000 A
6086603 Termin Jul 2000 A
6098629 Johnson Aug 2000 A
6113609 Adams Sep 2000 A
6129761 Hubbell Oct 2000 A
6152935 Kammerer Nov 2000 A
6159146 El Gazayerli Dec 2000 A
6179840 Bowman Jan 2001 B1
6221084 Fleenor Apr 2001 B1
6258064 Smith et al. Jul 2001 B1
6352503 Matsui et al. Mar 2002 B1
6387104 Pugsley, Jr. et al. May 2002 B1
6551315 Kortenbach et al. Apr 2003 B2
6569085 Kortenbach et al. May 2003 B2
6569105 Kortenbach et al. May 2003 B1
6579301 Bales et al. Jun 2003 B1
6632227 Adams Oct 2003 B2
6645201 Utley et al. Nov 2003 B1
6660301 Vogel et al. Dec 2003 B1
6663639 Laufer et al. Dec 2003 B1
6666848 Stone Dec 2003 B2
6669713 Adams Dec 2003 B2
20010049537 Kortenbach Dec 2001 A1
20010056282 Sonnenschein Dec 2001 A1
20020063143 Adams et al. May 2002 A1
20020068945 Sixto, Jr. et al. Jun 2002 A1
20020068946 Kortenbach Jun 2002 A1
20020078967 Sixto, Jr. et al. Jun 2002 A1
20020082621 Schurr Jun 2002 A1
20020138086 Sixto, Jr. et al. Sep 2002 A1
20020173786 Kortenbach et al. Nov 2002 A1
20020198537 Smith et al. Dec 2002 A1
20020198538 Kortenbach et al. Dec 2002 A1
20020198539 Sixto, Jr. et al. Dec 2002 A1
20020198540 Smith et al. Dec 2002 A1
20020198541 Smith et al. Dec 2002 A1
20020198549 Sixto, Jr. et al. Dec 2002 A1
20030019905 Adams et al. Jan 2003 A1
20030036679 Kortenbach et al. Feb 2003 A1
20030188755 Milbocker Oct 2003 A1
20030191478 Kortenbach et al. Oct 2003 A1
20030192558 Durgin Oct 2003 A1
20030192559 Durgin Oct 2003 A1
20030195387 Kortenbach et al. Oct 2003 A1
20030195509 Edwards et al. Oct 2003 A1
20030196670 Durgin Oct 2003 A1
20030199731 Silverman et al. Oct 2003 A1
20030208209 Gambale et al. Nov 2003 A1
20030208211 Kortenbach Nov 2003 A1
20030216754 Kraemer et al. Nov 2003 A1
20030220657 Adams Nov 2003 A1
20030220660 Kortenbach et al. Nov 2003 A1
20030236535 Onuki et al. Dec 2003 A1
20030236536 Grigoryants et al. Dec 2003 A1
Foreign Referenced Citations (31)
Number Date Country
0 480 428 Apr 1992 EP
0 576 265 Dec 1993 EP
0 646 356 Apr 1995 EP
0975263 Oct 2003 EP
2 768 324 Mar 1999 FR
WO 9922649 May 1999 WO
WO9960931 Dec 1999 WO
WO 0035529 Dec 2000 WO
WO 0078227 Dec 2000 WO
0078229 Dec 2000 WO
WO0078229 Dec 2000 WO
WO 0224080 Mar 2002 WO
WO 0240081 May 2002 WO
WO 0245603 Jun 2002 WO
WO02094341 Nov 2002 WO
WO 03000115 Jan 2003 WO
WO 03004087 Jan 2003 WO
WO 03007796 Jan 2003 WO
WO 03015604 Feb 2003 WO
WO 03082359 Oct 2003 WO
WO 03090633 Nov 2003 WO
WO 03092498 Nov 2003 WO
WO 03092509 Nov 2003 WO
WO 03094800 Nov 2003 WO
WO 03098885 Nov 2003 WO
WO 03099137 Dec 2003 WO
WO 03099139 Dec 2003 WO
WO 03099140 Dec 2003 WO
WO 03099376 Dec 2003 WO
WO03105917 Dec 2003 WO
WO2004000129 Dec 2003 WO
Non-Patent Literature Citations (64)
Entry
International Search Report dated Oct. 22, 2003.
Bancewicz et al., “Held pressure, anatomy of the cardia and gastro-o+A25esophageal reflux”, Journal of Surgery, 1995, vol. 82, p. 943-947.
The Americal journal of gastroenterology, vol. 91, no. 3, 1996, p. 616-617.
Donahue et al., “Endoscopic control of gastro-esophageal reflux11:14 AM status report”, World Journal of Surgery, 16: 343-346, 1992.
International Search Report dated Oct. 16, 2000.
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.
Contractor QQ et al., Endoscopic esphagitis and gastroesophageal flap valve. J Clin Gastroenterol Apr. 1999; 28 (3):233-7.
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 et al., The gastroesophageal flap valve: in vitro and in vivo observations. Gastrointest Endosc Nov. 1996;44(5):541-7.
Hill LD, Intraoperative measurement of lower esophageal sphincter pressure. J Thorac Cardiovasc Surg Mar. 1978;75(3):378-82.
Hill LD, Mythis of the esophagus. J Thorac Cardivasc Surg Jul. 1989;98(1):1-10.
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., An ambulant porcine model of acid reflux used to evaluate endoscopic gastroplasty. Gut Jun. 1999;44(6):782-8.
Kadirkamanathan SS et al., Antireflux operations at flexible endoscopy using endoluminal stitching techniques: an experimental study. Gastrointest Endosc Aug. 1996;44(2):133-43.
Mason RJ et al., A new intraluminal antigastroesophageal reflux procedure in baboons. Gastrointest Endosc Mar. 1997;45(3):283-90.
McGouran RC et al., Does measurement of yield pressure at the cardia during endoscopy provide information on the function of the lower oestophageal sphincter mechanism? Gut Mar. 1988;29(3):275-8.
McGouran RC et al., Is yield pressure at the cardia increased by effective fundoplication? Gut Oct. 1989;30(10):1309-12.
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.
Rupp TH and Lehman GA, Endoscopic antireflux techniques. Endoluminal and lapaoscopic. 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.
Slim K et al., Intraoperative esophageal manometry and fundoplications: prospective study. World J Surg Jan. 1996;20(1):55-9.
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.
Boerema, M.D. , “Hiatus hernia: Repair by right-sided, subhepatic, anterior gastropexy,” Surgery, 65:884-893 (1969).
Cecconello, “Esophagogastric Anastomosis with Valvuloplasty: An Experimental Study,” International Surgery, 67:121-124 (1982).
Collis, M.D., “Surgical Control of Reflux in Hiatus Hernia,” The American Journal of Surgery, 115:465-471 (1968).
Collis, M.D., “An Operation for Hiatus Hernia with Short Esophagus,” The Journal of Thoracic Surgery, 34:768-778 (1957).
Cuschieri, et al. , “Multicenter prospective evaluation of laparoscopic antireflux surgery,” Surgical Endoscopy, 7:505-510 (1993).
DeMeester, M.D. et al., “Nissen Fundoplication for Gastroesophageal Reflux Disease,” Annals of Surgery, 204:9-20 (1986).
Donahue, M.D., et al., “Endoscopic Control of Gastro-Esophageal Reflux: Status Report,” World Journal of Surgery, 16:343-346 (1992).
Donahue, M.D., et al., “Endoscopic sclerosis of the gastic cardia for prevention of experimental gastroesophageal reflux,” Gastrointestinal Endoscopy, 36:253-256 (1990).
Falk, et al., “Laparoscopic Fundoplication: A preliminary report of the technique and postoperative care,” Aust. N.Z. J. Surgery, 62:969-972 (1992).
Hill, et al., “Surgery for Peptic Esophageal Stricture,” 139-147.
Hill, M.D., “An Effective Operation for Hiatal Hernia: An Eight Year Appraisal,” Annals of Surgery, 166:681-692 (1967).
Hill, et al., “The Esophagus, Medical and Surgicial 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. , “The development of surgery for gastro-oesophageal reflux disease,” Surgery of the Oesophagus, 233-245 (1988).
Jamieson, et al., “Laparoscopic Nissen Fundoplication,” Annals of Surgery, 220:137-145 (1994).
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).
Kahrilas, “Gastroesophageal Reflux Disease,”JAMA, 276:983-988 (1996).
Kraemer, M.D., et al., “Laparoscopic Hill repair,” Gastrointestinal Endoscopy, 40:155-159 (1994).
Little, M.D., “Mechanisms of Action of Antireflux Surgery: Theory and Fact,” World Journal of Surgery, 16:320-325 (1992).
Mason, et al., “Nissen Fundoplication Prevents Shortening of the Sphincter During Gastric Distention,” Arch Surg., 132:719-726 (1997).
McGouran, M.D., et al., “A laser-induced scar at the cardia increases the yield pressure of the lower esophageal sphincter,” Gastrointestinal Endoscopy, 36:439-443 (1990).
McKernan, “Laparoscopic repair of gastroesophageal reflux disease,” Surgical Endoscopy, 8:851-856 (1994).
Nathanson, et al., “Laparoscopic Ligamentum teres (round ligament) cardiopexy,” Br. J. Surg., 78:947-951 (1991).
Nissen, “Eine einfache Operation zur Beeinflussung der Refluxoesophagitis,” Journal Suisee De Medecine, 590-592 (1956).
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,” 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.
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,” Journal of Thoracic and Cardiovascular Surgery, 53:33-54 (1967).
Starling, et al. Assessment of the Angelchik Prosthesis for Treatment of Symptomatic Esophageal Reflux, World J. Surg. 11, 350-355 (1987).
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).
U.S. patent application Publication US 2001/0056282 A1, Dec. 27, 2001.
U.S. patent application Publication US 2002/0068946 A1, Jun. 6, 2002.
U.S. patent application Publication US 2002/0082621 A1, Jun. 27, 2002.
Provisional Applications (2)
Number Date Country
60/306652 Jul 2001 US
60/140492 Jun 1999 US
Continuation in Parts (5)
Number Date Country
Parent 09/859579 May 2001 US
Child 10/197574 US
Parent 09/520273 Mar 2000 US
Child 09/859579 US
Parent 09/519945 Mar 2000 US
Child 09/520273 US
Parent 09/574424 May 2000 US
Child 09/519945 US
Parent 10/197574 US
Child 09/519945 US