DETAILED DESCRIPTION OF THE INVENTION

[0087] With obesity becoming an increasing problem, various tools and methods of treatment are described herein which are less traumatic and less invasive than procedures currently available. As described in further detail below, a variety of methods for the treatment of obesity, as well as other gastric-related diseases, are disclosed. Generally, the size of the stomach pouch may be reduced to limit the caloric intake as well as to provide an earlier feeling of satiety. This may be accomplished by creating a smaller gastric pouch within the stomach by a variety of methods. This procedure optionally may be enhanced by performing a pyloroplasty prior to and/or in conjunction with the pouch size reduction, i.e., rendering the pyloric sphincter incompetent. Additionally, the food in the stomach may be made to also bypass a proximal portion of the bowel, i.e., a portion of the duodenum and jejunum, by creating a gastric anastomosis thereby creating a malabsorption of sugars and fats which are mostly absorbed in the bypassed portion of the duodenum and jejunum. Sugars and fats entering the bowel directly from the stomach rather than passing through the pylorus and proximal duodenum and jejunum may cause “dumping” syndrome and diarrhea. Moreover, rendering the pylorus incompetent may also lead to dumping syndrome partly because of the rapid gastric emptying which may occur. This in turn may create enforced behavioral modifications, thereby discouraging the patient from eating these types of high-caloric foods.

[0088] FIG. 1A shows an example of a modified stomach 10 which may be created, by any one of the methods described below, as part of the present invention. Greater curvature 12 and lesser curvature 14 is seen in modified stomach 10 , as well as the distal end of esophagus 16 and pylorus 18 . As part of the present invention, stomach 10 may be divided along junction 24 into modified pouch 22 , which is preferably less than about 1 ounce in volume, and main pouch 20 . FIG. 1B shows a partial superior view of the cross section of main pouch 20 and modified pouch 22 as viewed from cutting plane P from FIG. 1A . As seen, modified lumen 26 is preferably formed by junction 24 from main lumen 28 by joining a portion of stomach wall 30 . During ingestion of food, modified pouch 22 accepts food from esophagus 16 and preferably passes it directly through modified lumen 26 into pylorus 18 . Main pouch 20 may remain intact and function normally, but preferably sees little or no food. Acids and other fluids that may be generated in main lumen 28 may drain through the reduced outlet near pylorus 18 and may pass through the digestive system normally.

[0089] Marking Tools and Methods

[0090] As part of forming a modified pouch, a marking device may be used, preferably at the beginning of the procedure, to create a dye marker “road map” on the interior surface of the stomach from the pylorus to the esophagus. Once such dye marks are placed, they may be visualized, e.g., endoscopically, thereby giving the physician a clear reference point for staple or fixation element placement. An example of such a marking device is shown in FIG. 2 as marking device or bougie 40 . Bougie 40 is preferably an elongated device made from tubing member 44 which may have several channels defined within. Tubing 44 may be made from any variety of biocompatible materials, e.g., stainless steel, plastics, etc., and preferably has a diameter and cross section which is similar to that of the finished modified lesser pouch. Along the length may be defined a series of dye ports 46 through which the marking dye may be channeled through from the proximal end of bougie 40 . Any variety of biocompatible dyes which preferably enhance visualization may be used, e.g., methylene blue, thionine, acridine orange, acridine yellow, acriflavine, quinacrine and its derivatives, brilliant green, gentian violet, crystal violet, triphenyl methane, bis naphthalene, trypan blue, and trypan red. Also along the length and on either side of dye ports 46 may be a series of vacuum ports 48 , which are optional. A distal balloon 52 , which may be inserted into the pylorus to stabilize bougie 40 during the procedure, is preferably attached to inflation tip 50 at distal end 42 and may be inflated from the proximal end of tubing 44 by the physician.

[0091] FIGS. 3A to 3 C show bougie 40 during one method of use. FIG. 3A shows stomach 60 as bougie 40 is inserted down through esophagus 62 . As bougie 40 is advanced down to pylorus 76 , distal balloon 52 may be inflated through inflation tip 50 , thus securing the device. Bougie 40 preferably follows lesser curvature 64 and may alternatively be shaped to approximate lesser curvature 64 . Bougie 40 is also preferably rotated such that dye ports 46 face away from lesser curvature 64 and face towards greater curvature 66 . Then the air and fluids contained within stomach 60 are preferably removed, either through vacuum ports 48 , if they are included in bougie 40 , or through another vacuum port which may be introduced endoscopically through esophagus 62 . FIG. 3B shows cross section 3 B- 3 B from FIG. 3A as deflated stomach 60 . Once deflated, modified lumen 70 may take shape around bougie 40 , separate from deflated main lumen 68 . In this deflated state, the dye may be channeled through dye ports 46 , thereby leaving dye marks 72 on interior lining 74 . Once the staining has been performed, lumen 68 may be insufflated, as shown in FIG. 3 C, and bougie 40 may then be removed. As seen in FIG. 3 C, dye marks 72 mark or delineate the junction region where anchors or fasteners may be placed to draw interior lining 74 together to form the modified lumen.

[0092] Gastric Reduction Tools and Methods Using Fasteners

[0093] One variation of reducing the stomach size involves grasping the interior walls of the stomach, preferably via an endoscope advanced trans-esophageally, and placing one to several fixation elements on opposing interior walls and then bringing those fixation elements together.

[0094] Several examples of different possible variations on fasteners are shown and described below. These variations are not intended to be limiting but are merely given as illustrative examples.

[0095] FIG. 4A shows a view of the interior of the lesser curvature of stomach 60 with part of the greater curvature wall removed. As seen, individual anchors 80 may be secured to the interior surface along the junction 24 where modified pouch 22 from FIG. 1A would form. Anchors 80 may be of any biocompatible material, e.g., stainless steel, polymers, etc., which may be formed into a variety of fasteners, e.g., staples, ratcheted wires, zip ties, clips, tags, eyelets, crimps, and screws. Anchors 80 may be placed by estimating the junction boundary, but they are preferably located along dye mark 72 , which may be formed by methods and tools described above, prior to anchor 80 placement, as shown in FIG. 4 B, which is cross section 4 B- 4 B from FIG. 4A . After anchors 80 have been fastened, suture 82 may be drawn through each of the anchors 80 , preferably in a zig-zag manner, and then suture 82 may be drawn tight to bring the opposing surfaces of interior lining 74 together in apposition along dye marks 72 to form the modified lumen. Alternatively, individual anchors 80 may be preloaded or prefastened by suture 82 , and anchors 80 may be fastened to interior lining 74 in this manner.

[0096] FIG. 5A shows a side view of a variation on a fastening device in crimping member 90 . Crimping member 90 is preferably made from a biocompatible material, e.g., stainless steel, nitinol, etc., and may be formed to have elbow 92 extend into two opposing anchoring ends 94 . FIG. 5B shows a superior view of a created modified lumen 100 formed from main lumen 98 by any of the methods described herein. In this variation, several crimping members 90 may be attached or fastened to interior lining 96 by anchoring ends 94 . As they become attached, each of the members 90 are preferably configured to interlock with an adjacent crimping member 90 , much like a zipper. FIG. 5B shows the interlocked members 90 from the top to form lumen 100 and FIG. 5C shows the view from 5 C- 5 C from FIG. 5B where each of the crimping members 90 are shown interlocking at their elbows 92 like a zipper.

[0097] FIG. 6A shows an isometric view of another variation on a fastening device in ratcheted wire or zip tie 110 . This particular variation shows a distal tip or male end 112 and a corresponding proximal end or female end 114 , with ratcheted length 116 between those two ends. FIG. 6B shows a superior view of stomach wall 120 just prior to the formation of modified lumen 124 from main lumen 122 . As seen, male end 112 of first zip tie 110 ′ may be pierced through one side of interior lining 118 and second zip tie 110 ″ may be pierced through the opposing side of interior lining 118 such that the male ends 112 of each zip tie preferably correspond to the female ends 114 of the other zip tie. To then form the lumen 124 , each zip tie 110 ′, 110 ″ may be drawn together and tightened accordingly, as shown in FIG. 6D . A plurality of zip ties 110 are preferably used to form modified lumen 124 by aligning them by any of the methods described above.

[0098] An alternative zip tie device which may be used is a perpendicular type version of zip tie 110 . As shown in FIG. 6 E, first perpendicular zip tie 134 ′ and second perpendicular zip tie 134 ″ may be used in place of zip tie 110 and lumen 124 may be formed in much the same manner as described above to result in the modified stomach as shown in FIG. 6E . A further alternative is shown in FIG. 6C where male zip tie 126 preferably has dual piercing male ends with catcher tubes 128 . In this variation, a vacuum-type device, as described below in detail, or forceps may be used to draw portions of stomach wall 120 in apposition. As the apposed stomach walls 120 are positioned, needles 130 , which are preferably passed through a double female zip tip 132 , may be used to pierce through tissue 120 and lock into catcher tubes 128 . Needles 130 may then be drawn back through tissue 120 , while simultaneously pulling male ends/catcher tubes 128 back through tissue 120 and into the corresponding double female zip tie 132 . The locked zip tie 126 may then be drawn tight against female zip tie 132 , trimmed, and then released. This procedure may be repeated for any number of zip ties which may be used to draw the stomach lining together to form the smaller pouch and may also be used with the dye marking device 40 and procedure as described above.

[0099] A further variation on the individual anchoring fasteners is shown in FIG. 7A . This variation shows gasping device 140 with retaining tube 142 and extendable members 146 which may extend from distal opening 144 . Extendable members 146 are preferably made from a biocompatible material, e.g., superelastic or shape memory alloy such as nitinol, which may be biased to urge away from a longitudinal axis defined by tube 142 once extended beyond distal opening 144 . As members 146 extend, they may reach out to grasp apposed portions of interior lining 150 by hooks 148 . As above, the locations where hooks 148 grasp may be defined by the marking device as described above and viewed by the physician through, e.g., an endoscope. Once hooks 148 have grasped the appropriate portion of lining 150 , members 146 may then be drawn back through distal opening 144 , as shown in FIG. 7 B, and a retaining device, such as crimp 152 , may be slid over a distal section of members 146 , as shown in FIG. 7 C, to maintain the position of hooks 148 and apposed lining 150 to create the desired lumen.

[0100] Gastric Reduction Tools and Methods Using Stapling Devices

[0101] Aside from individual anchoring and fastening devices, the stomach pouch may be modified and/or created by a variety of other device variations utilizing other methods. FIG. 8A shows the cross sectioned superior view of FIG. 11B with the addition of staple 160 maintaining junction 24 . The figure shows an example of how, e.g., an endoscopically applied stapler, may be used to retain and hold junction 24 to form modified-lumen 26 . FIG. 8B shows a close-up view of the junction 24 and staple 160 which was applied from within lumen 26 .

[0102] To staple opposing sides of a stomach together to form two separate lumens from within the interior surface of the stomach, an endoscopic stapling device may be used to accomplish such a task. Such an endoscopic stapler preferably brings two regions, of tissue into apposition and may then apply a fastening element, e.g., staples, clips, tags, etc., into the two regions of tissue to affix them together. These stapling devices may optionally incorporate the use of the marking device or bougie 40 , as described above, as a preliminary step as a guide to vacuum placement and/or stapling to form the desired modified lumen. The fastening elements, e.g., staples, are preferably made of a biocompatible material such as stainless steel, titanium, polymers, sutures, nitinol, or any other similar metals and alloys, etc. and may be in any conventional shape such as C-shaped and U-shaped staples or any of the other shapes as described herein. The two regions of tissue may be adhered to the stapling device by a variety of attachment methods, e.g., tines, barbs, hooks, vacuum, or any combinations thereof. In an adhering device utilizing a vacuum to hold the apposing regions of tissue together, such a device may be a tubular or wand-shaped member and preferably has at least two windows which may be spaced about the circumference of the tube or wand. These windows may be separated by an arc in a range of about 20° to 180° about the longitudinal axis defined by the length of the tube or wand, and are preferably separated by an arc in a range of about 90° to 180°.

[0103] Several examples of different possible variations on the stapling device are shown and described below. These variations are not intended to be limiting but are merely given as illustrative examples.

[0104] FIG. 9A shows a variation of an endoscopic stapling device in the isometric view of anvil stapling device 170 . Stapling unit 172 is shown attached to the distal end of tube 174 . Within stapling unit 172 is staple enclosure 176 where staples may be loaded and vacuum ports 178 which are seen in an alternating fashion with staple slots 180 , through which the staples may be deployed. FIG. 9B shows a reverse isometric view of the device of FIG. 9A . As seen, stapling unit 172 may have septum 184 insertable into septum slot 186 , which is preferably midway between the sides of staple enclosure 176 and which may separate the interior of staple enclosure 176 into two separate chambers. Septum 184 may serve several functions, one of which may be to allow selective activation of opposing sides of vacuum ports 178 of unit 172 as tissue is selectively adhered to the device. Other functions of septum 184 are discussed below.

[0105] In operation, stapling unit 172 may be inserted trans-esophageally into a stomach and a first portion of the interior lining may be adhered to a single side of staple enclosure 176 through a vacuum created within vacuum ports 178 . The vacuum may be created in stapling unit 172 through tube 174 and activated from the proximal end of tube 174 from outside the patient's body. Once the first portion of the interior lining is adhered to one side of staple enclosure 176 , the opposite set of vacuum ports 178 may be activated and unit 172 may be used to draw the first portion to an opposing second portion of the interior lining, which may then be adhered to the device such that the first portion and the second portion are preferably in apposition to each other. This action preferably forms the modified lumen 26 of FIGS. 8A and 8B . As the tissue is held to unit 172 , septum 184 may be withdrawn from septum slot 186 by introduced forceps through, e.g., an endoscopic or through an integral actuator, to form a single chamber within staple enclosure 176 . Removal of septum 184 may then bring the first and second portions of tissue into contact apposition. The side surfaces 188 of septum 184 may incorporate a cutting, abrading, scoring, heating, freezing, chemically damaging, or some other damaging surface to tissue. Such a surface 188 may damage the interior lining contacting each other upon removal of septum 184 as surface 188 slides past. This damage may encourage a more vigorous healing response and a more permanent fixation between the damaged tissue once stapled or affixed together.

[0106] After removal of septum 184 , the staples loaded within staple enclosure 176 may be fired through staple slots 180 to affix the tissue. As the staples are fired, anvil 182 may be used as an anvil to secure the staples to the tissue, thereby resulting in the modified lumen 26 as shown in FIG. 8B . The length of stapling device 170 may be made according to the desired junction length and the size of the patient's stomach. This particular variation may be withdrawn from the area after the stapling procedure by first pushing the stapling device 170 past the resulting staple line.

[0107] FIG. 10 shows an isometric view of another variation in box stapling device 190 . Stapling unit 192 is shown as being attached in fluid communication to vacuum tube 193 . Stapling device 190 may be inserted and operated in the same manner as device 170 described above. Stapling unit 192 may have vacuum ports 194 activated selectively on either side of septum 196 as described above. The tips of staples 198 are shown partially deployed for illustration purposes, but are preferably not deployed until septum 196 is first retracted preferably in the direction as indicated. Septum 196 may also be configured to damage the contacting tissue upon septum 196 withdrawal in the same manner as described above. Stapling device 190 may be easily applied and removed after staples 198 have been deployed.

[0108] FIG. 11A shows an assembly isometric view of another variation in stapling device 200 . This variation 200 shows curved tube 202 which may have lumen 204 house staples 206 as well as act as a combination vacuum and staple slot 216 . Tube 202 may be shaped in a variety of ways but is shown here as a C-shaped or U-shaped tube with first channel 210 ′ and second channel 210 ″, for adhering the two apposed portions of tissue, preferably separated by removable septum 212 . With this variation 200 , tissue may be adhered within the channels 210 ′, 210 ″ through vacuum/staple slot 216 and once positioned, staples 206 may be deployed while septum 212 is removed simultaneously by the use of curved wedge 218 . In operation, curved wedge 218 may be drawn within lumen 204 from the tube 202 distal end to the proximal end by, e.g., a pull-wire attached to wedge 218 . As wedge 218 is advanced proximally, wedge 218 would preferably force pivot 208 of staple 206 against contact edge 214 of septum 212 . As wedge 218 is advanced further proximally, urging end 220 may then urge the curved ends of staple 206 to rotate about pivot 208 and deploy through slot 216 . While staple 206 is deploying, notch 222 , preferably located at a distal end of wedge 218 , may engage contact edge 214 and begin to slide septum 212 simultaneously towards the proximal end of tube 202 . FIG. 11B shows a side view of stapling device 200 of FIG. 11A . As seen, curved wedge 218 preferably contacts septum 212 via notch 222 and pushes while simultaneously urging staple 206 to deploy. The figures show a single staple 206 for illustrative purposes only and any plurality of staples 206 may be used in practice depending upon the desired results.

[0109] FIG. 12A shows an isometric view of yet another variation in stapling device 230 . This variation may omit a removable septum. Curved tube 232 is preferably curved in this variation in a crescent shape forming contact channel 234 . Within contact channel 234 , a number of vacuum ports 236 and staple slots 238 may be defined in an alternating pattern, as shown. A possible W-shaped staple 240 preferably having pivot 242 at the staple 240 midpoint is shown outside of tube 232 for illustrative purposes in a possible orientation for insertion within staple slots 238 . FIG. 12B shows cross section 12 B- 12 B from FIG. 12A . As seen, tube 232 defines lumen 244 , which preferably runs the length of tube 232 , and translating wedge 246 which is preferably slidingly disposed within lumen 244 . As seen in FIGS. 12B and 12C , which is a side view of the interior of tube 232 , wedge 246 may be translated by pull-wire 248 . Pull-wire 248 , which may be made of any high-strength material, e.g., stainless steel, nitinol, nylon, polymers, etc., may be manipulated by a physician from the proximal end of tube 232 from outside of the patient's body. Like the device 200 of FIGS. 11A and 11B , once vacuum ports 236 have acquired the interior tissue lining to be approximated, translating wedge 246 may be advanced proximally. Advancing wedge 246 may urge staples 240 to deploy through staple slots 238 sequentially as shown to hold the tissue and form the desired lumen.

[0110] An example of deployment for any of the stapling devices described above is shown in FIG. 13 . As shown, stomach 250 with the wall partially cut out is seen with stapling device 252 inserted within. Stapling device 252 is shown merely as-an example of insertion and could comprise any of the devices described herein. Device 252 , which is preferably advanced trans-orally into stomach 250 and through esophagus 256 , is preferably located at the distal end of delivery/vacuum tube 254 . Once inserted, device 252 may be located by the assistance of the lesser curvature 258 of stomach 250 . Also shown are vacuum/staple ports 260 , which may be any of the configurations as described herein. In a preferable variation, stapling device 252 may be configured to produce a staple line or junction following the lesser curvature beginning from cardiac notch 264 down towards pylorus 262 . Accordingly, device 252 may have the length and vacuum/staple ports 260 configured such that the distal end of device 252 points towards pylorus 262 .

[0111] FIG. 14 shows stapling device 270 in a slightly different configuration for the treatment of other gastro-intestinal diseases such as gastroesophageal reflux disease (GERD), as discussed above. The stomach 250 of FIG. 13 is shown, but for the treatment of GERD, stapling device 270 may be slightly modified such that the device 270 and vacuum/staple ports 272 may be straight or flared away from, rather than towards, lesser curvature 258 and pylorus 262 as described above. As such, vacuum/staple ports 272 would preferably produce a staple line or junction beginning from cardiac notch 264 and then flares away from lesser curvature 258 and pylorus 262 . Device 270 may be any of the devices described and operated herein, but for the flared modification. Likewise, any of the devices described herein may be used for the treatment of GERD by simply angling the device to produce a flared staple line. Alternatively, a simple non-flared staple line may also suffice for treating GERD. The staple line may act as a Heimlich valve which preferably closes down in response to pressure exerted from the greater or main lumen. Moreover, the smaller volume of the modified lumen in-line with esophagus 256 may provide a smaller volume of acid available for esophageal reflux.

[0112] An isometric view of a single channel vacuum device variation is shown in FIG. 15A in approximating device 280 . Tube 282 is preferably a tubular device which may be inserted into a stomach through the esophagus of a patient. A lumen 284 may run through tube 282 from a proximal end to the distal end of tube 282 . At the distal end, two or more windows or slots 286 are preferably defined opposite of one another, as shown. The lengths and widths of slots 286 may vary and is preferably long enough to approximate the desired length of the boundary or junction line of the modified lumen; likewise, the width is preferably wide enough to accommodate at least two layers of the stomach interior lining. Approximating clip 288 is shown having at least two piercing ends 290 and may be loaded into tube lumen 284 from either the proximal end or distal end of tube 282 preferably prior to inserting the device 280 into the patient. Clip 288 is preferably made of a biocompatible material as described above. Biodegradable plug 292 may be placed into the distal end of tube 282 prior to insertion into the patient and is preferably made of a biocompatible biodegradable material, e.g., biodegradable polymers such as polylactide, polyglycolide, and their copolymers. Plug 292 may be alternatively made from a non-biodegradable material and may simply pass after the procedure. Plug 292 may aid in maintaining a vacuum seal through slots 286 during the approximation procedure, as described below.

[0113] FIG. 15B shows an end view from section 15 B- 15 B from FIG. 15A of tube 282 in operation. As shown, opposing portions of stomach interior lining 294 may be drawn into lumen 284 through opposing slots 286 by creating a vacuum within lumen 284 . Approximating clip 288 may be urged distally through tube 282 such that each of ends 290 may be drawn through a corresponding slot 286 over and/or pierced through lining 294 within lumen 284 . As lining 294 is approximated within lumen 284 , biodegradable plug 292 may become invaginated within lining 294 . Accordingly, as clip 288 and ends 290 are positioned over lining 294 , tube 282 may be withdrawn from the area while clip 288 preferably slides through the distal end of tube 282 leaving the approximated interior lining 294 held in position by ends 290 , as seen in FIG. 15D . Removal of tube 282 may urge plug 292 to slide off the distal end of tube 282 and remain within the newly formed lumen to become degraded over time or to pass through the patient's system.

[0114] FIG. 15E shows the device of FIG. 15 A, but in this variation, clip 288 may be replaced by screw 289 , which is preferably in the shape of a helix or coil having a tapering width or diameter. The first few turns or coils of screw 289 may have the same or similar diameter than the remaining tapering coils; this may enable piercing end 291 to engage interior 294 and may also allow screw 289 to be advanced at the desired orientation through the tissue. Screw 289 preferably maintains a parallel orientation with tube 282 during delivery into the tissue, i.e., a longitudinal axis defined by screw 289 is preferably parallel, or close to parallel, with the longitudinal axis defined by tube 282 . Moreover, the outer diameter of the first few turns or coils are preferably the same diameter, or slightly less than, the inner diameter of tube 282 . This may further enable screw 289 to be advanced through lumen 284 at the proper orientation prior to engaging interior 294 .

[0115] As described above for the device of FIGS. 15A to 15 D, opposing portions of stomach interior lining 294 may be drawn into lumen 284 through opposing slots 286 by creating a vacuum within lumen 284 , as shown in FIG. 15F . Screw 289 may then be urged through lumen 284 and rotated in the direction of the arrow shown until piercing end 291 engages the invaginated lining 294 . Piercing end 291 preferably is sharp and needle-like to enable piercing through multiple layers of lining 294 . As screw 289 is further rotated, it may be further advanced distally through the remaining portion of invaginated lining 294 . The tapering diameter and decreasing width may also begin to further approximate the opposing edges of lining 294 towards one another, as shown in FIG. 15G . Finally, as seen in FIG. 15 H, further advancement of screw 289 preferably draws the opposing surfaces into contact with one another. Tube 282 may then be removed, as described above. Although the fixation of one screw 289 is described, multiple screws 289 may be fastened one after another to form a continuous fixation line.

[0116] Screw 289 may be made of a bioabsorbable or biocompatible material, as described herein such as a polymer or superelastic alloy, and may be integrally formed with barbs or whisker-like filaments protruding along its length to help prevent screw 289 from backing out once it has been engaged within the lining 294 . An example of a spiraling suturing needle or screw which may be used in this variation is shown and described in U.S. Pat. No. 5,330,503 to Yoon, which is incorporated herein by reference in its entirety. Another example of a helical fastener or screw and applicator which may be used in this or another variation is shown and described in U.S. Pat. No. 5,582,616 to Bolduc et al., which is also incorporated herein by reference in its entirety. Other examples of helical fasteners or screws and applicators are also shown in U.S. Pat. No. 5,810,882; U.S. Pat. No. 5,824,008; and U.S. Pat. No. 5,964,772; all to Bolduc et al., each of which is incorporated herein by reference in their entirety.

[0117] Gastric Reduction Tools and Methods Using Rotatable Devices

[0118] Aside from endoscopically applied stapling and clip devices, rotating and rotatable probes may also be used to form a modified smaller lumen within a main lumen. Such probes generally may be inserted into a stomach endoscopically and may engage a portion of the interior lining of the stomach and may then be rotated to roll the engaged portion of the stomach wall around the probe itself to bring the wall in apposition with another portion of the stomach wall. Such rotating probes may be used to create a blind-ended pouch of stomach within the main stomach lumen, or as with the other devices, may be used to create a smaller pouch exiting into the pylorus. Once the roll of stomach wall is brought into apposition, a row or a plurality of fasteners, e.g., staples, blind staples, clips, tags, adhesives, etc., may be used to maintain the stomach. The tubes themselves may be made of any variety of biocompatible materials which preferably have sufficient strength to undergo a torsional load, e.g., stainless steel, nickel, platinum, etc.

[0119] An example of a stomach modified by such a rotating probe or device is shown in FIG. 16A . Main pouch 300 is seen with modified pouch 302 formed along the lesser curvature of the stomach and delineated by junction 304 . This example shows modified pouch 302 extending from esophagus 306 and terminating in pouch opening 308 proximally of pylorus 310 . Pouch opening 308 may also be made to terminate at pylorus 310 .

[0120] FIG. 16B shows a superior view from cross section 16 B- 16 B from FIG. 16A of one variation on producing modified pouch 302 having modified lumen 314 from main pouch 300 having main lumen 312 where junction 304 may be formed by rotating the stomach upon itself. FIG. 16C shows an alternative superior view from cross section 16 B- 16 B from FIG. 16A where modified pouch 302 ′ having modified lumen 314 ′ may be formed from main pouch 300 ′ having main lumen 312 ′. In this particular variation, junction 304 ′ may be formed by taking apposed sides of the interior stomach lining near the lesser curvature and approximating them to form modified lumen 314 ′.

[0121] Several examples of different possible variations on the rotating probe or device are shown and described below. These variations are not intended to be limiting but are merely given as illustrative examples.

[0122] FIG. 17A shows vacuum tube 320 which may have an elongate tubular body. Tube 320 may be inserted into a patient's stomach trans-esophageally via, e.g., an endoscope. Accordingly, distal end 322 is preferably rounded or gently tapered to be atraumatic to the patient. An opening or window 324 may be defined in the wall of tube 320 near distal end 322 and as seen in FIG. 17 B, opening 324 is preferably in communication with lumen 326 , which may run throughout tube 320 . The geometry of opening 324 is preferably large enough to accommodate the invagination of tissue from the interior stomach lining by a vacuum created within lumen 326 and opening 324 . The vacuum may be activated by the physician from a proximal end of tube 320 from outside of the patient. Once tissue is invaginated within window 324 , a fastening member may be inserted and deployed to secure the interior stomach lining thereby reducing its overall volume, as described in further detail below. As shown in FIG. 17 B, which is cross section 17 B 1 - 17 B from FIG. 17 A, tube 320 preferably has a diameter and cross section which may approximate a final geometry of the newly created lumen within the stomach.

[0123] FIG. 18A shows an isometric view of another variation in counter-rotating tube 330 . Counter-rotating tube 330 may have a gently tapered distal end 332 with an opening 334 defined in the tube wall near distal end 332 . Preferably contained within tube 330 is an additional inner tube 336 , which may be geometrically similar to tube 330 but with a diameter small enough to allow free rotation about the longitudinal axis preferably shared by both tubes 330 and 336 . Inner tube 336 likewise may have inner opening 338 , which may allow communication between lumen 340 and openings 334 and 338 . As above, a vacuum may be activated from a proximal end of tube 330 to draw tissue from the interior stomach lining through lumen 340 and into openings 334 and 338 when they are aligned. As shown in FIG. 18 B, which is cross section 18 B- 18 B from FIG. 18 A, once the tissue has become invaginated within openings 334 , 338 , inner tube 336 may be rotated to effectively pinch and firmly hold the tissue in place, as shown in FIG. 18B . The addition of the pinching action in addition to the vacuum may aid in holding the tissue, thereby aiding in the rotation of both tube 330 and inner tube 336 when forming the modified lumen. Both tubes 330 and 336 may be manipulated and rotated from a proximal end of the tubes from outside of the patient.

[0124] FIG. 19A shows an isometric view of another variation in barbed tube 350 . Tube 350 may be similar to vacuum tube 320 described above. Distal end 352 is preferably tapered and opening 354 may be defined in the wall of tube 350 near distal end 352 . Additionally, at least one and preferably several attachment points 356 , e.g., tines, barbs, or hooks, may be defined along at least a single edge around opening 354 . Attachment points 356 are preferably defined along the leading edge of opening 354 for rotation of tube 350 . FIG. 19 B, which is cross section 19 B- 19 B from FIG. 19 A, shows opening 354 preferably in communication with lumen 358 and a preferred orientation of attachment point 356 .

[0125] FIG. 20A shows an isometric view of yet another variation in split tube 360 . Split tube 360 may be formed of at least two splittable halves, e.g., first half 364 and second half 366 , which may be joined together longitudinally along split 370 . When first half 364 and second half 366 are joined together, split tube 360 preferably forms a tapered distal end 362 . Split tube 360 may also define a lumen 372 which may run throughout the length of split tube 360 . This variation may also comprise at least one and preferably several attachment points 368 on each of first half 364 and second half 366 . As shown in the figure, first half 364 may have a row of attachment points 368 preferably aligned along a portion of split 370 and second half 366 may likewise have a row of attachment points 368 juxtaposed and preferably mirroring those located on first half 364 . Attachment points 368 may be of any type described above and the number and positioning of attachment points 368 may depend upon the desired length of the resulting junction formed upon rolling the stomach. FIG. 20 B, which is cross section 20 B- 20 B from FIG. 20 A, shows split 370 and an example of the juxtaposed relationship of attachment points 368 .

[0126] FIG. 21 shows an example of a rotatable probe device during insertion into stomach 380 . As seen, tube 384 may be inserted into stomach 380 via esophagus 382 , preferably endoscopically. Tube 384 may be any of the devices described above and is shown generally as an example of how such devices maybe inserted into an organ, e.g., stomach 380 . As tube 384 is inserted, it may engage a portion of the interior of stomach 380 , preferably along lesser curvature 386 . The engagement may be accomplished by any of the methods described herein, e.g., attachment points partially piercing the stomach lining, a vacuum adhering a portion of the lining, etc. Once engaged, tube 384 may then be rotated to roll the engaged portion of the stomach wall around the probe itself to bring the wall in apposition with another portion of the stomach wall.

[0127] FIG. 22A shows a variation on partial cross section 22 / 23 - 22 / 23 from FIG. 21 with tube 350 from FIGS. 19A and 19B in a preferred operation. As shown, interior lining 390 may be adhered to tube 350 via a vacuum created in opening 354 through lumen 358 and/or via attachment points 356 which may partially pierce lining 390 , as described above. The location for adhering tube 350 may also be determined or aided by the use of marking device 40 , as described above. Once the desired location of interior lining 390 has been established, tube 350 may be rotated about its longitudinal axis, following the arrow as shown, by at least about 180° and preferably at least about 360°. Lining 390 is preferably rotated until the adhered portion contacts a second portion of lining 390 to result in the modified lumen 314 of FIG. 22 B, also shown in FIG. 16B . Once modified lumen 314 has been formed, fasteners may be fired or deployed through opening 354 or via a separate endoscopic stapling device at location 392 to secure and maintain modified lumen 314 . Fasteners may comprise any of the fasteners as described herein, e.g., staples. Once modified lumen 314 has been secured, tube 350 may then be removed. FIG. 16B shows newly created modified pouch 302 with modified lumen 314 and, as seen, interior lining 390 also forms the interior surface defining modified lumen 314 .

[0128] FIGS. 23A to 23 D show another variation on partial cross section 22 / 23 - 22 / 23 from FIG. 21 with split tube 360 from FIGS. 20A and 20B . Split tube 360 may be inserted into the stomach either as separate halves 364 , 366 individually or as a whole tube which may then be split while in the stomach. Once separated, first half 364 and second half 366 may be engaged to interior lining 390 by attachment points 368 at a slight distance from one another. The separation distance may be determined by the desired resulting size of the lumen. Alternatively, the separation distance may be determined or aided by the use of marking device 40 , as described above.

[0129] Once first half 364 and second half 366 have engaged interior lining 390 , as shown in FIG. 23 A, each of free ends 394 of halves 364 , 366 may then be rotated in the direction of the arrow, as shown. Free ends 394 may be configured to simply contact each other or to interlock with each other and rotate about a hinge or pivot. As first half 364 and second half 366 continue to be rotated, FIGS. 23B and 23C show the progression of lumen formation as attachment points 368 draw around and towards one another. Finally in FIG. 23 D, as split tube 360 is preferably formed again, modified lumen 314 ′ may be formed, as also shown in FIG. 16 C, to then be secured or maintained preferably by fasteners, e.g., staples, which may be deployed through junction 304 ′.

[0130] A further variation on a rotating device is shown in the isometric view of dual tube device 400 shown in FIG. 24A . Dual tube device 400 may have at least two elongate members, first member 402 and second member 404 , which may be rotatingly attached to controlling device 406 and may be parallel to each other. The members 402 , 404 are preferably counter-rotating and may be rotated by a rotation control 408 , which is preferably located on controlling device 406 . First member 402 may have first distal end 410 offset slightly from the longitudinal axis of first member 402 by first bend 412 . First opening 414 is also preferably defined in the wall of first member 402 proximally of first distal end 410 . Second member 404 is preferably similar to first member 402 and may have second distal end 416 offset slightly from the longitudinal axis of second member 404 by second bend 418 . Near second distal end 416 , second opening 420 may be defined in the wall of second member 404 .

[0131] FIG. 24B shows end view 24 B- 24 B from FIG. 24A . Distal ends 410 , 416 are seen as preferably being parallel and mirror images of one another. Also, the preferable counter-rotating action may be seen by the directional arrows. FIG. 24C shows cross section 24 C- 24 C from FIG. 24A . As shown, the relationship between first and second opening 414 , 420 , respectively, and first and second lumen 422 , 424 , respectively, may be seen in the figure. Lumens 422 , 424 preferably run through the length of members 402 , 404 , respectively, and are in communication with openings 414 , 420 . A vacuum may be created in openings 414 , 420 through lumens 422 , 424 , respectively, from the controlling device 406 . In operation, members 402 , 404 may be inserted trans-esophageally into a patient's stomach. A vacuum may then be created in first and second openings 414 , 420 to engage a portion of the stomach interior lining. Once engaged, a modified pouch may be created from the interior lining in much the same manner as described for FIGS. 23A to 23 D, except the individual counter-rotating members 402 , 404 do not form a split tube. The operation of the vacuum application and counter-rotation may be controlled through controlling device 406 which is preferably located outside the patient's body.

[0132] FIG. 25A shows yet another variation in vacuum device 432 shown inserted into stomach 430 . Vacuum device 432 may be an endoscopic device inserted trans-esophageally into stomach 430 through esophagus 434 . Device 432 may have vacuum member 438 and at least two grasping members 440 , preferably disposed on either side of vacuum member 438 . Once device 432 has been introduced into stomach 430 , vacuum member 438 may be steered towards a desired area of interior lining 442 , as seen in FIG. 25B which is a cross section view of device 432 attached to stomach interior lining 442 . The desirable area of interior lining 442 may be located along greater curvature 436 or alternatively along lesser curvature 444 , depending upon the desired results. In position, a vacuum may be activated in member 438 to draw a portion of interior lining 442 preferably between grasping members 440 . As lining 442 is adhered to vacuum member 438 , grasping members 440 may be used to pinch and grasp the drawn portion of lining 442 . Then, device 432 may be rotated in the direction of the arrow indicated in FIG. 25C to result in the formation of a modified lumen. Afterwards, grasping members 440 may be locked in place, disengaged from device 432 , and left as an implant. Alternatively, lining 442 may be fastened to maintain the created lumen by any of the methods described herein and grasping members 440 , along with the rest of device 432 , may be removed from stomach 430 .

[0133] Gastric Reduction Tools and Methods Using Volume Reduction Devices

[0134] Aside from the use of rotating and rotatable probes, gastric volume reduction devices may also be used as part of the present invention. Such volume reduction devices generally may be inserted into a stomach trans-esophageally through the use, of, e.g., an endoscope. The reduction device may be used to draw or engage a portion of the interior lining of the stomach; the drawn or engaged portion may then be eventually removed, either actively or through natural processes.

[0135] Several examples of different possible variations on the gastric volume reduction devices are shown and described below. These variations are not intended to be limiting but are merely given as, illustrative examples.

[0136] FIG. 26 shows an isometric view of a variation on the gastric volume reduction device in concentric tube device 450 . Device 450 may have inner tube 452 defining lumen 454 , which preferably runs throughout inner tube 452 . Pusher sleeve 456 may be disposed concentrically over inner tube 452 such that pusher sleeve 456 may be allowed to slide freely along inner tube 452 . Pusher sleeve 456 is also preferably disposed over inner tube 452 such that the distal end of inner tube 452 is open to allow ring 458 to be rolled or stretched onto the distal end. Ring 458 is preferably made of an elastic type material which would allow ring 458 to elastically cinch onto inner tube 452 .

[0137] During use, FIG. 27A shows a view of concentric tube device 450 within stomach 460 preferably inserted through esophagus 462 . The distal end of device 450 , particularly inner tube 452 , may be brought into position near a location of interior surface 464 where tissue may be desirably removed. As shown in FIG. 27 B, once device 450 is in place, a vacuum may be actuated within lumen 454 . The vacuum may then draw a portion of withdrawn lining tissue 466 up into lumen 454 , as seen in the cross section of device 450 . While lining tissue 466 is held within lumen 454 , pusher sleeve 456 may be pushed or urged distally along inner tube 452 . As pusher sleeve 456 advances, it may also push or urge elastic r