WO2003007796A2 - Methods and devices for tissue reconfiguration - Google Patents

Methods and devices for tissue reconfiguration Download PDF

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Publication number
WO2003007796A2
WO2003007796A2 PCT/US2002/022842 US0222842W WO03007796A2 WO 2003007796 A2 WO2003007796 A2 WO 2003007796A2 US 0222842 W US0222842 W US 0222842W WO 03007796 A2 WO03007796 A2 WO 03007796A2
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WO
WIPO (PCT)
Prior art keywords
tissue
members
stomach
esophagus
distal end
Prior art date
Application number
PCT/US2002/022842
Other languages
French (fr)
Other versions
WO2003007796A3 (en
Inventor
Michael D. Laufer
Jeffrey C. Cerier
Amos Cruz
Jonathan O'keefe
Richard Andrews
Ram Chuttani
Vincent A. Piucci
Michael Barenboym
Neal H. Marshall
Randal B. Chinnock
Original Assignee
Ndo Surgical, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to US30665201P priority Critical
Priority to US60/306,652 priority
Application filed by Ndo Surgical, Inc. filed Critical Ndo Surgical, Inc.
Publication of WO2003007796A2 publication Critical patent/WO2003007796A2/en
Publication of WO2003007796A3 publication Critical patent/WO2003007796A3/en

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Classifications

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    • A61B17/0482Needle or suture guides
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    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • AHUMAN NECESSITIES
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Abstract

A method includes advancing an apparatus (10) including an elongated member (12) transorally into the stomach. The apparatus (10) includes a distal end effector (15) having first and second members (16) configured to engage tissue. The first and second members (16) are movable relatively toward one another generally in a first plane. The method includes moving the distal end effector relative to the elongated member (12) in the first plane such that the distal end effector is retroflexed out of alignment with the elongated member (16) to position the first and second members (16) for engagement with the tissue. At least one of the first and second members (16) carries a fixation device (22) for fixing engaged portions of tissue together.

Description

METHODS AND DEVICES FOR TISSUE RECONFIGURATION

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 medical instruments described in International Publication Number WO 00/78227 Al entitled "GERD TREATMENT APPARATUS AND METHOD," published December 28, 2000, and United States publication number 20020040226A1 entitled "TISSUE RECONFIGURATION," published April 4, 2002, in which moveable arms are oriented in a plane rotated 90° from the plane in which a

-l- retroflexing portion moves. The mechanism of operation of the medical instrument of the current invention is as is disclosed in the referenced International Publication Number WO 00/78227 Al and US publication number 20020040226A1.

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. The method includes moving the plane in which the first and second members are movable 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 publications. 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. Retro flexion of retroflexing portion 14 is accomplished as disclosed in the referenced publications. 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 US publication number 20020040226 Al, entitled "TISSUE RECONFIGURATION," 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 publications.

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 publications.

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 publications.

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

WHAT IS CLAIMED IS:
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 fixing 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 moving the plane in which the first and second members are movable.
PCT/US2002/022842 2001-07-18 2002-07-18 Methods and devices for tissue reconfiguration WO2003007796A2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US30665201P true 2001-07-18 2001-07-18
US60/306,652 2001-07-18

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
AU2002320614A AU2002320614A1 (en) 2001-07-18 2002-07-18 Methods and devices for tissue reconfiguration

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WO2003007796A2 true WO2003007796A2 (en) 2003-01-30
WO2003007796A3 WO2003007796A3 (en) 2004-01-15

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WO (1) WO2003007796A2 (en)

Cited By (42)

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US6746460B2 (en) 2002-08-07 2004-06-08 Satiety, Inc. Intra-gastric fastening devices
US6773441B1 (en) 1999-06-22 2004-08-10 Ndo Surgical, Inc. Methods and devices for tissue reconfiguration
US6773440B2 (en) 2002-07-02 2004-08-10 Satiety, Inc. Method and device for use in tissue approximation and fixation
US7033373B2 (en) 2000-11-03 2006-04-25 Satiety, Inc. Method and device for use in minimally invasive placement of space-occupying intragastric devices
US7083629B2 (en) 2001-05-30 2006-08-01 Satiety, Inc. Overtube apparatus for insertion into a body
WO2007005394A1 (en) * 2005-07-05 2007-01-11 Mitralign, Inc. Tissue anchor and methods of using the same
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