Abstract:
A technique for deploying an intraluminal device, such as a bariatric device, in a mammalian lumen, such as the gastrointestinal tract, includes positioning a visualization device through an orifice, such as a natural orifice, into the mammalian lumen. A deployment device having the intraluminal device mounted thereto is guided to the mammalian lumen. The intraluminal device, which has a lumen wall that is configured to the size and shape of a portion of the mammalian lumen, is at least partially deployed from the deployment device in the mammalian lumen. The at least partially deployed intraluminal device is positioned with the deployment device while a position of said intraluminal device is visualized with the visualization device.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application claims the priority benefits of International Patent Application No. PCT/US2013/029055, filed on Mar. 5, 2013, which claims priority from U.S. patent application Ser. No. 61/607,338, filed on Mar. 6, 2012, and U.S. patent application Ser. No. 61/635,477, filed on Apr. 19, 2012, the disclosures of which are hereby incorporated herein by reference in their entirety. 
    
    
     BACKGROUND OF THE INVENTION 
     The present invention is directed to a method and apparatus for deploying a medical device and, in particular, to an intraluminal device. While the invention is illustrated with deployment of a bariatric device, it has application for other types of intraluminal devices. 
     Intraluminal devices are often deployed with a radiopaque marker that is impenetrable to x-rays or other forms of radiation used to ensure that the device is properly positioned. Such device is deployed to the lumen, such as over a guide wire that is first positioned in the lumen. Positioning of the device is effected by the use of fluoroscopy or other form of radiography that detects the radiopaque marker or other portion of the intraluminal device. 
     SUMMARY OF THE INVENTION 
     The present application provides a technique for deployment of intraluminal devices, such as bariatric devices, in a manner that is capable of rapid and secure positioning of the device and may be performed without the use of x-rays or other forms of radiation. 
     A method of deploying an intraluminal device in a mammalian lumen, with the intraluminal device having a device lumen wall that is configured to the size and shape of a portion of the mammalian lumen, according to an aspect of the invention, includes positioning a visualization device through an orifice into the mammalian lumen to a deployment site. A deployment device having the intraluminal device mounted thereto is guided to the deployment site in the mammalian lumen. The intraluminal device is at least partially deployed from the deployment device at the deployment site in the mammalian lumen. The at least partially deployed intraluminal device is positioned at the deployment site with said deployment device while visualizing a position of the intraluminal device with the visualization device. 
     The deployment device may be guided through the orifice into the mammalian lumen to the deployment site with the visualization device. The deployment device may include a guidance wall surrounding an opening wherein the deployment device is guided by positioning the opening over the visualization device. The intraluminal device may be compressed around the guidance wall. The intraluminal device may be at least partially deployed by unfurling a portion of the intraluminal device from the guidance wall. 
     The deployment device may further include a deployment sheath surrounding the guidance wall, with the intraluminal device compressed between the deployment sheath and the guidance wall. The intraluminal device may be at least partially deployed by retracting a portion of the deployment sheath overlying the portion of the intraluminal device to be deployed. Deploying of the intraluminal device may be completed by further retracting the deployment sheath overlying a remaining portion of the intraluminal device. 
     The deployment device may include an actuator attached to the deployment sheath and the deploying may include retracting the actuator with respect to a handle. A stop may be defined between the actuator and the handle, wherein the stop is engaged after the intraluminal device is partially deployed. The visualization device may be a steerable endoscope. The endoscope may be retroflexed at the deployment site. The method may be performed substantially without radiography. 
     A method of deploying a bariatric device in a mammal, according to another aspect of the invention, includes positioning a visualization device transorally in the stomach. A deployment device having the bariatric device mounted thereto is guided to the stomach. The bariatric device has an esophageal member with an esophageal wall defining an esophageal surface that is configured to generally conform to the shape and size of a portion of the esophagus. The bariatric device has a cardiac member having a cardiac wall defining a cardiac surface that is configured to generally conform to the shape and size of a portion of the cardiac region of the stomach. The bariatric device includes a connector connected with the esophageal member and the cardiac member. The cardiac member is deployed from said deployment device in the stomach and positioned with the deployment device while visualizing a position of the bariatric device with the visualization device. 
     The deployment device may be guided transorally into the stomach with the visualization device. The deployment device may include a guidance wall surrounding an opening with the deployment device guided by positioning the opening over the visualization device. The bariatric device may be compressed to the guidance wall and wherein the cardiac member deployed by unfurling the cardiac member from the guidance wall. The esophageal member may then be deployed in the esophagus. The esophageal member may be deployed by unfurling the esophageal member from the guidance wall. 
     The deployment device may include a deployment sheath surrounding the guidance wall, with the bariatric device compressed between the deployment sheath and the guidance wall. The esophageal member and the cardiac member may be positioned on opposite sides of a spacer on the guidance wall. The cardiac member may be deployed by retracting a portion of the deployment sheath overlying the cardiac member. The esophageal member may be deployed by further retracting of the portion of the deployment sheath overlying the esophageal member. The cardiac member may be positioned by rotating the guidance wall and deployment sheath. 
     The deployment device may include an actuator attached to the deployment sheath and wherein the cardiac member and the esophageal member may be deployed by retracting the actuator with respect to a handle. A stop may be defined between the actuator and the handle, wherein said stop is engaged by the actuator after deploying the cardiac member. The visualization device may be a steerable endoscope. The endoscope may be retroflexed in the stomach. The method may be performed substantially without radiography. 
     An intraluminal assembly for use with a visualization device, according to yet another aspect of the invention, includes a deployment device having a guidance wall defining a device supporting surface and an opening. The opening is configured to receive the visualization device through the opening. An intraluminal device mounted to the deployment device has a lumen wall that is configured to the size and shape of a portion of a mammalian lumen. The lumen wall is mounted to the guidance wall and the intraluminal device is adapted to be unfurled from said deployment wall in the mammalian lumen. The deployment device is adapted to be guided into the mammalian lumen with the visualization device. 
     The guidance wall may generally surround the opening. The intraluminal device may be positioned around the guidance wall. The intraluminal device may be compressed on the guidance wall. A deployment sheath may be over the intraluminal device compressed on the guidance wall. 
     An actuator may be provided that is connected with the deployment sheath. The actuator is adapted to retract the deployment sheath from the intraluminal device in order to deploy the intraluminal device. The opening may be configured to receive a steerable endoscope. 
     A bariatric assembly for use with a visualization device, according to yet another aspect of the invention, includes a deployment device having a guidance wall defining a device supporting surface and an opening. The opening is configured to receive the visualization device through the opening. A bariatric device is mounted to said deployment device. The bariatric device has an esophageal member with an esophageal wall defining an esophageal surface that is configured to generally conform to the shape and size of a portion of the esophagus, a cardiac member with a cardiac wall defining a cardiac surface that is configured to generally conform to the shape and size of a portion of the cardiac region of the stomach and a connector connected with the esophageal member and the cardiac member. The esophageal wall and the cardiac wall are mounted to the guidance wall. The cardiac member is adapted to be unfurled from the deployment wall in the stomach and the esophageal member is adapted to be unfurled from the deployment wall in the esophagus. The deployment device is adapted to be guided into the esophagus and stomach with the visualization device in the opening. 
     The deployment wall may generally surround the opening. The bariatric device may be positioned around the guidance wall and may be compressed on the guidance wall. A deployment sheath may be provided over the bariatric device compressed on the guidance wall. An actuator may be provided that is connected with the deployment sheath and adapted to retract the deployment sheath with respect to the bariatric device in order to deploy the bariatric device. The actuator may be adapted to be retracted with respect to a handle in order to deploy the bariatric device. A stop may be provided that inhibits further retraction of the actuator with respect to the handle after the cardiac member is deployed. The stop may be adapted to be selectively overcome and the actuator further retracted with respect to the handle in order to deploy the esophageal member. A spacer may be provided on the guidance wall separating the cardiac member from the esophageal member. The opening may be configured to receive a steerable endoscope. 
     A bariatric assembly, according to yet another aspect of the invention, includes a deployment device having a guidance wall defining a device supporting surface and a bariatric device mounted to the deployment device. The bariatric device has an esophageal member with an esophageal wall defining an esophageal surface that is configured to generally conform to the shape and size of a portion of the esophagus, a cardiac member with a cardiac wall defining a cardiac surface that is configured to generally conform to the shape and size of a portion of the cardiac region of the stomach and a connector connected with the esophageal member and the cardiac member. The esophageal wall and the cardiac wall are compressed to the guidance wall. The deployment device is adapted to selectively allow the cardiac member to be unfurled from the guidance wall in the stomach and is adapted to selectively allow the esophageal member to be unfurled from the guidance wall in the esophagus. 
     The deployment device may be adapted to be guided to the stomach with an endoscope and at least the cardiac member visualized by retroflexing the endoscope in the stomach. 
     Because embodiments of the invention allow an intraluminal device, such as a bariatric device, to be deployed in the lumen, such as the gastro-intestinal tract, with a visualization device guiding placement of the device in the lumen, the need for radiography may be avoided. This allows the method to be carried out without the bulky and expensive equipment associated with radiography, such as fluoroscopy. In this manner, the method may be carried out in a more common out-placement procedure room. This not only reduces risk to the patient and practitioners, but eliminates the need for shielding of the patient and practitioners. This allows the procedure to be carried out faster. 
     These and other objects, advantages and features of this invention will become apparent upon review of the following specification in conjunction with the drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a perspective view of an intraluminal assembly, such as a bariatric assembly, according to an embodiment of the invention; 
         FIG. 2  is a frontal view illustrating guidance of the intraluminal assembly toward the deployment site using an endoscope; 
         FIG. 3  is the same view as  FIG. 2  illustrating retro-flexing of the endoscope; 
         FIG. 4  is the same view as  FIG. 2  illustrating locating of the cardiac member in the stomach; 
         FIG. 5  is the same view as  FIG. 2  illustrating unfurling and positioning of the cardiac member at the cardiac region of the stomach; 
         FIG. 6  is a sectional view taken along the lines VI-VI in  FIG. 5 ; 
         FIG. 7  is a sectional view taken along the lines VII-VII in  FIG. 5 ; 
         FIG. 8  is the same view as  FIG. 2  illustrating unfurling and positioning of the esophageal member; 
         FIG. 9  is the same view as  FIG. 2  illustrating detachment of the esophageal member from the deployment device; 
         FIG. 10  is the same view as  FIG. 2  illustrating the bariatric device in position with the deployment device and endoscope removed; 
         FIG. 11  is the same view as  FIG. 2  illustrating seating of the esophageal member; 
         FIG. 12  is a perspective view of an intraluminal assembly, such as a bariatric assembly, according to an alternative embodiment of the invention; 
         FIG. 13  is a perspective view of the intraluminal assembly in  FIG. 12  at an orientation that is about 45 degrees offset from the view in  FIG. 12 ; 
         FIG. 14  is a perspective view of a bariatric device that can be deployed according to the various embodiments of the invention; 
         FIG. 15  is an enlarged perspective view of a proximal portion of the intraluminal assembly in  FIGS. 12 and 13 ; 
         FIG. 16  is an enlarged perspective view of a distal portion of the intraluminal assembly in  FIGS. 12 and 13 ; 
         FIG. 17  is the same view as  FIG. 16  with the deployment sheath retracted and bariatric device removed to reveal internal details of the deployment device thereof; and 
         FIG. 18  is the same view as  FIG. 16  with the cardiac member deployed and the esophageal member partially deployed. 
     
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Referring now to the drawings and the illustrative embodiments depicted therein, an intraluminal assembly, such as a bariatric assembly  10 , includes a deployment device  12  and an intraluminal device, such as a bariatric device  14  ( FIG. 1 ). Intraluminal assembly  10  is configured to be guided to a deployment site and visualized during deployment by a visualization instrument, such as an endoscope  16 . Such endoscope has a manipulating portion  16   b  and a slender elongated portion  16   a  that extends to the procedure site and is capable of being steered and manipulated from manipulating portion  16   b . Such endoscope is conventional and is commercially available from various sources. In the illustrated embodiment, a miniature endoscope is used that is capable of being retro-flexed using known techniques. Bariatric device  14  is of the type disclosed in commonly assigned U.S. Pat. Nos. 7,846,174 and 8,100,931; U.S. Patent Application Publication No. 2010/0030017 A1 entitled BARIATRIC DEVICE AND METHOD; International Patent Application Publication No. WO 2012/044917 A1 entitled INTRALUMINAL DEVICE AND METHOD; and International Patent Application Publication No. WO 2012/162114 entitled INTRALUMINAL DEVICE AND METHOD WITH ENHANCED ANTI-MIGRATION, the disclosures of which are hereby incorporated herein by reference in their entireties. 
     Deployment device  12  includes a flexible shaft  18  that has a length that is greater than the length of the esophagus with a through-opening  22  extending the length of the shaft. Opening  22  has a diameter that is large enough to accommodate the elongated portion  16   a  of endoscope  16 . Shaft  18  includes a deployment portion  30  that receives intraluminal device  14  in a compressed form, as will be described in more detail below. Shaft  18  further includes a proximal portion  24  that has a larger diameter than deployment portion  20  in order to provide ripcord openings  26  and plenum-space  28  for passage of wrapping filament  29 , both of which are used to removeably retain intraluminal device  14  in a compressed state as will be described below. Proximal portion  24  has a filler  25 , such as a polymer, to provide flexible structure to shaft  18 . 
     Intraluminal device  14 , which is illustrated as a bariatric device, has a cardiac member  40 , an esophageal member  46  and a connector  50  connecting the cardiac and esophageal members ( FIGS. 8-11 and 14 ). Cardiac member  40  is made up of a cardiac wall  42  that is configured to the size and shape of the cardiac portion of the stomach and has a cardiac surface  44  that contacts and stimulates receptors in the cardiac region of the stomach. A resilient mesh  43  in wall  42  provides structure to the wall while allowing it to be compressed for deployment and to be self-unfurling for use. Intraluminal device  14  further includes an esophageal member  46  having an esophageal wall  48  that is configured to the size and shape of the distal portion of the esophagus and has an esophageal surface  50  that contacts the esophageal wall. A resilient mesh  49  allows esophageal member  46  to be compressed for deployment and to be self-unfurling for use. 
     A connector  54  connects esophageal member  46  and cardiac member  40  in a manner that does not substantially interfere with the operation of the GE junction. In the illustrated embodiment, connector  54  is made up of two struts, or tension members,  56  that pass through the GE junction and transmit force from esophageal member  46  to keep cardiac surface  44  in contact with the cardiac portion of the stomach. Struts  56  may be oriented in various orientations, such as side-to-side in a frontal plane or anterior-posterior in a sagittal plane. If oriented in a frontal plane, one strut oriented at the greater curve may be longer in order to allow for the angled orientation of the cardiac member with respect to the esophageal member. Also, the strut  56  that is at the greater curve area of the stomach may be of a more flexible material than the other strut in order to conform to the curvature of the greater curve. The struts are illustrated as being of equal length. The cardiac member will easily orient itself with respect to the esophageal member about a pivot axis that passes through both of the struts. Thus, the physician can orient the intraluminal device while partially deployed, i.e., with the cardiac member unfurled, but the esophageal member still compressed on shaft  18 . With the physician visualizing the physiology, namely, arrangement of the esophagus to the stomach in the particular patient, shaft  18  can be rotated as shown in  FIG. 8  to orient the bariatric device to allow the cardiac member to pivot with respect to the esophageal member without twisting struts  56  about each other. 
     The method of deploying intraluminal device, such as bariatric device  14 , in a lumen, such as the gastro-intestinal tract, is as follows. A visualizing device, such as endoscope  16 , is inserted in opening  22  in deployment device  12 , such as through a port  38  that connects with opening  22 , as illustrated in  FIG. 1 . With a portion of endoscope  16  extending distally beyond the distal end of shaft  18 , deployment device with elongated portion  16   a  of the endoscope extending distally from the end of the device is inserted into the esophagus E with or without an overtube in place, as illustrated in  FIG. 2 . In the illustrated embodiment, no overtube is used. Once endoscope  16  is guided through the esophageal-gastric (EG) junction under direct visualization of the EG junction through the endoscope, endoscope  16  terminates in the stomach S. The endoscope is retroflexed to view the EG region, as illustrated in  FIG. 3 . Endoscope  16  provides a guide to guide bariatric assembly  10  past the EG junction into the GE region by the physician, or other medical person, manipulating a handle  32  at a proximal end of deployment device  12  while cardiac member  40  is visualized through retroflexed endoscope  16 . With cardiac member  40  positioned in the stomach, as seen in  FIGS. 3 and 4 , a ripcord actuator  34  associated with the cardiac member is pulled. This retracts a deployment sheath in the form of a ripcord  35  from wrapping filament  36  wound around the cardiac member, thus freeing the wrapping filament to fall away and the cardiac member to unfurl under its own outward bias. Ripcord  35  may be retracted into proximal portion  24  of flexible shaft  18  or fully retracted from shaft  18 . A proximal portion of wrapping filament  36  at handle  32  may be used to fully retract the wrapping filament through plenum  28 . 
     With cardiac member  40  unfurled, handle  32  may be manipulated by rotating shaft  18  and proximally translating the shaft in order to position cardiac member  40  in a desired orientation and tensioned against the cardiac region of stomach S, as illustrated in  FIG. 5 . Visual markings may be provided on cardiac member  40  to facilitate this alignment. However, fluoroscopy is not used. 
     With cardiac member  40  in position against the cardiac region of the stomach, the physician further retracts the deployment sheath by pulling the other ripcord actuator  34  (not seen, but positioned behind the ripcord actuator  34  in  FIG. 1 ), the ripcord  35  holding the wrapping filament  36  surrounding esophageal member  46  is pulled away allowing esophageal member  46  to unfurl under its own outward bias. Both the ripcord and wrapping filament are withdrawn in the manner previously described. However, esophageal member  46  remains attached proximally with an attachment filament  58  that is looped through holes (not shown) in deployment portion  20  and the esophageal member  46  in a weave or stitched pattern. This allows esophageal member  46  to be rotated, if necessary, or pulled in order to position the esophageal member and adjust the pressure on cardiac member  40  by way of connector  54 , as illustrated in  FIG. 8 . Attachment filament  58 , which is routed external of shaft  18 , is then detached by pulling on one end of the filament, as seen in  FIG. 9 . While attachment filament  58  is shown only for use in manipulating esophageal member  46 , another attachment filament may be used between cardiac member  40  and deployment portion  20  to assist manipulation of the cardiac member after it is unfurled. 
     With bariatric device  14  positioned in the GE region of the recipient, the esophageal member  46  is seated to the esophagus. Esophageal member  46  has one or more mucosal capture openings  52 . Openings  52 , in the illustrated embodiment, are made up of a series of contiguous cells of the mesh that are not covered by the outer silicone cover over mesh  49 . This allows the mucosal lining of the esophagus, along with its blood supply, to be pooched into the diamond-shaped openings in the mesh, under the outward pressure of esophageal wall  48  against the esophagus using the principles disclosed in commonly assigned International Patent Application Publication No. WO 2008/100984 A2, entitled Mucosal Capture Fixation of Medical Device, the disclosure of which is hereby incorporated herein by reference. Such captured mucosa will bridge and overgrow the mesh wires separating these open cells. In the illustrated embodiment, four (4) contiguous open cells are provided for each opening  52  formed as a diamond-shaped pattern of diamond-shaped cells. However, it should be understood that other patterns may be used. Openings  52  may be distributed about esophageal wall  48  in a manner that they are separated from each other according to the wavelength of peristaltic waves travelling along the esophagus using the principles disclosed in commonly owned pending International Patent Application Publication No. WO 2012/162114, entitled INTRALUMINAL DEVICE AND METHOD WITH ENHANCED ANTI-MIGRATION, the disclosure of which is hereby incorporated herein by reference in its entirety. This further resists distal migration of esophageal member  46  from the peristalsis of the esophagus. 
     Esophageal member  46  may be seated by applying a vacuum or suction source to a portion of the esophagus. This is accomplished by placing a vacuum or suction source  62  in the esophagus at approximately the proximal end of the esophageal member. A seal, such as an inflatable balloon  64 , may be provided to avoid air from being drawn through the esophagus. Vacuum source  62  may be routed via an open channel in endoscope  16  and may be applied as the endoscope is being withdrawn. Alternatively, a larger double-lumen endoscope may be used as a vacuum or suction source, in which case a separate seal  64  may not be needed. Alternatively, a separate vacuum tube may be used. 
     With a suction applied to the interior of esophageal member  46 , the GE junction (or EG junction) is drawn proximally into closer engagement with the distal end portion of esophageal member  46 , thus reducing the tendency for distal migration. Also, the suction tends further pull the mucosa into openings  52  along with the blood supply for the mucosa. This provides additional mechanical binding because more of the mucosa is drawn through the openings. Also, this tends to cause the mucosa to become irritated and swollen which speeds up the inflammatory process thereby encouraging the mucosa to grow over the exposed wire of mesh  49  according to the principles disclosed in commonly owned U.S. Patent Application Publication No. 2010/0198237 A1 entitled MUCOSAL CAPTURE FIXATION OF MEDICAL DEVICE, the disclosure of which is hereby incorporated herein by reference. 
     Thus, the seating process may serve either or both to draw the GE junction tighter to the distal end portion of esophageal member  46  and to enhance mucosal capture in openings  52 . The process of applying suction can be repeated until the desired result is achieved. The suction can also, or alternatively, be applied directly to the mucosa pooched into each opening  52 . Alternatively or additionally, other techniques may be used to promote inflammatory response in the pooched mucosa, such as roughening it with a wire brush or treating it with an agent, such as a sclerosant, all as described in the &#39;237 patent application publication. 
     In an alternative embodiment, an intraluminal assembly, such as a bariatric assembly  110 , includes a deployment device  112  having a flexible shaft  118  that has a length that is greater than the length of the esophagus with a through-opening  122  extending the length of the shaft ( FIGS. 12-18 ). In particular, flexible shaft  118  has a length extending from the teeth to the esophageal-gastric (EG) junction of a “typical”, or average, mammal, such as a human. Opening  122  has a diameter that is large enough to accommodate the elongated portion  16   a  of endoscope  16 . For example, in the illustrative embodiment, opening  122  has a diameter of about 6.5 millimeters to fit over an endoscope shaft having an outer diameter  18  of about 5.9 millimeters. Deployment device  112  includes a deployment portion  120  that receives intraluminal device  14  in a compressed form, as will be described in more detail below. Shaft  118  further includes a proximal portion  124  that is connected with an operator handle  132  with an actuator  134  both of which are used to removeably retain intraluminal device  14  in a compressed state, as will be described below. 
     Shaft  118  includes a guidance wall  170  which is formed as a cylinder and defines through-opening  122  down the center of the cylinder. Guidance wall  170  terminates distally in a round tip  131  in order to present a smooth surface when passing through the GE junction. Bariatric device  14  is compressed onto guidance wall  170  by a deployment sheath  172 . A spacer  180  separates esophageal member  46  from cardiac member  40  when they are compressed against guidance wall  170 . Deployment sheath  172  surrounds guidance wall  170  and is sufficiently larger in diameter than guidance wall  170  such that intraluminal device  14  can be compressed between the deployment sheath  172  and guidance wall  170 . Deployment device  112  further includes a handle  132  that is connected with guidance wall  170 , such as at proximal portion  124  of shaft  118 , and an actuator  134  that is moveable with respect to handle  132  and is connected with deployment sheath  172 . Deployment sheath  172  can be axially displaced with respect to guidance wall  170  so that movement of actuator  134  with respect to handle  132  causes deployment sheath  172  to be axially moved with respect to guidance wall  170 . In this manner, retraction of actuator  134  causes deployment sheath  172  to be retracted with respect to guidance wall  170 . Bariatric device  14  can be deployed in stages by retracting the actuator to retract a portion of said deployment sheath  172  overlying a portion of the bariatric device to device  14  be deployed. Deployment of the bariatric device  14  can be completed by further retracting deployment sheath  172  from overlying the remaining portion of bariatric device  14 . 
     As can be best seen in  FIG. 13 , actuator  134  is moveable within a channel  174  of handle  132 . Channel  174  has a abrupt offset at  176  which defines a stop defined between actuator  134  and handle  132 . Thus, with actuator  134  fully extended distally, as illustrated in  FIG. 13 , deployment sheath  172  fully extends over guidance wall  170  which compresses the entire bariatric device  14  between the deployment sheath and guidance wall, as best seen in  FIG. 16 . Upon retracting actuator  134  using the physician&#39;s fingers while grasping handle  132 , sheath  132  is retracted sufficiently to expose cardiac member  40 , as best seen in  FIG. 18 . Because actuator  134  will strike offset  76  and stop further movement, the esophageal member  46  will remain compressed between deployment sheath  172  and guidance wall  170 , as best seen in  FIG. 18 . 
     After the physician is satisfied that cardiac member  40  is properly positioned against the cardiac portion of the stomach, as viewed by endoscope  16  being retroflexed to view the cardiac member, actuator  134  is moved laterally to bypass offset, or stop,  176  which allows the actuator to continue to be proximally retracted after the bariatric device  14  has been partially deployed. This further retraction of actuator  134  with respect to handle  132  causes deployment sheath  172  to be further proximally retracted with respect to guidance wall  170 , as seen in  FIG. 17 , thus allowing esophageal member  46  to unfurl thus completing the deployment process. One or more attachments, such as loops of suture material (not shown), can extend proximally from the top of esophageal member  46  through the space between deployment sheath  172  and guidance wall  70  and out the proximal end of deployment device  12 . These attachments extend external the recipient and allow the physician to pull up on the esophageal member to snug the cardiac member against the cardiac region of the stomach or to temporarily restrain bariatric device  14  such as when reinserting the endoscope  16  to carry out suctioning of mucosa pooching through mucosal capture openings, or the like. Once it is determined that the attachments are no longer needed, the loop of suture material can be cut and the suture material withdrawn by tugging on one end thereof. 
     The method of deploying intraluminal device, such as bariatric device  14 , in a lumen, such as the gastro-intestinal tract, using deployment device  112  is as follows. A visualizing device, such as endoscope  16 , is inserted in opening  122  in deployment device  112 , such as through a port  138  that connects with opening  122 , as illustrated in  FIG. 15 . In order to allow deployment sheath  172  to be withdrawn proximally, a slit  178  is defined in deployment sheath  172  through which endoscope  16  can pass. Elongated portion  16   a  of the endoscope is inserted until a distal end thereof extends passed opening  122  at a distal end of shaft  118  and first the endoscope and then the deployment device passed into the esophagus E with or without an overtube in place. Once endoscope  16  approaches the EG junction, it can be used to visualize the distal EG junction to guide the endoscope as the endoscope passes through the EG junction, but before the distal end of shaft  118  passes through the EG junction. The endoscope  16  is used to guide shaft  118  of the deployment device through the EG junction. It may be desirable to extend a sufficient amount of endoscope  16  into the stomach and retroflex the endoscope in order to visualize shaft  118  passing through the EG junction with a sufficient length of shaft  118  in the stomach to deploy cardiac member  40 . Alternatively, the endoscope can be used to guide shaft  118  through the EG junction and retroflex the endoscope only after both are in the stomach. 
     Thus, it can be seen that endoscope  16  provides a guide to guide bariatric assembly  110  into the GE region by the physician, or other medical person, manipulating a handle  132  at a proximal end of deployment device  112  while cardiac member  40  is visualized through retroflexed endoscope  16 . With cardiac member  40  positioned in the stomach, actuator  134  is retracted until it reaches stop or offset  176 . This retracts deployment sheath  172  from around the compressed cardiac member  40 , thus freeing the cardiac member to unfurl under its own outward bias, as best seen in  FIG. 18 . Once it is visualized, thorough retroflexed endoscope  16 , that cardiac member  40  is adequately seated against the cardiac portion of the stomach by manipulating handle  132 , actuator  134  may then be retracted further along channel  174  beyond offset  176 . This causes deployment sheath  172  to retract further thus exposing the entire bariatric device including esophageal member  46 . 
     Since the seating of cardiac member  40  in the proper position in the stomach will also properly position esophageal member  46  in the esophagus, the further retraction of deployment sheath  172  will cause esophageal member  46  to unfurl under the internal outward bias of the esophageal wall. With the esophageal wall outward bias against the mucosa of the esophagus, mucosa pooching into mucosal capture openings will provide anchoring of the esophageal member in the esophagus which will cause cardiac member  40  to apply a stress to the cardiac portion of the stomach through connector  54 . Esophageal member  46  may be seated further by applying a vacuum or suction source to a portion of the esophagus as previously described. This is accomplished by placing a vacuum or suction source  62  in the esophagus at approximately the proximal end of the esophageal member. Likewise, a filler material, such as collagen or hyaluronic acid, may be injected into bulging mucosa to further increase the size of the bulging mucosa and provide additional mucosal capture to anchor esophageal member  46  in the esophagus. 
     The techniques disclosed herein can be used for deploying other types of intraluminal devices in a mammalian lumen. For example, a medical device fixation tool of the type disclosed in U.S. Pat. No. 8,372,087 B2, the disclosure of which is hereby incorporated herein by reference, can be guided using a visualization device, such as an endoscope, in order to avoid the need for fluoroscopy to fix a medical device according to the principles disclosed in the &#39;087 patent. Optionally, a balloon can be positioned around the shaft of the fixation tool in order to seal the esophagus when insufflating the stomach such as using an insufflating channel of the endoscope. Other applications will be apparent to the skilled artisan when apprised of the teachings herein. 
     While the foregoing description describes several embodiments of the present invention, it will be understood by those skilled in the art that variations and modifications to these embodiments may be made without departing from the spirit and scope of the invention, as defined in the claims below. The present invention encompasses all combinations of various embodiments or aspects of the invention described herein. It is understood that any and all embodiments of the present invention may be taken in conjunction with any other embodiment to describe additional embodiments of the present invention. Furthermore, any elements of an embodiment may be combined with any and all other elements of any of the embodiments to describe additional embodiments.