Endoluminal gastric ring and method

[0001] This application claims priority to Provisional Patent Application No. 60,677,345, filed May 4, 2005; Provisional Patent Application No. 60/677,355, filed May 4, 2005; Provisional Patent Application No. 60/697,544, filed Jul. 11, 2005; Provisional Patent Application No. 60/698,941, filed Jul. 14, 2005; Non-provisional patent application Ser. No. 11/267,321, filed Nov. 7, 2005; Non-provisional patent application Ser. No. 11/267,266, filed Nov. 7, 2005; and Provisional Patent Application No. 60/748,148, filed Dec. 8, 2005, which are each are hereby incorporated by reference.

[0002] 1. Field of the Invention

[0003] This invention relates in general to an endoluminal surgical procedure for the treatment and control of obesity and, more particularly, to gastric rings and a novel method for the endoluminal implantation of the rings.

[0004] 2. Discussion of the Related Art

[0005] Methods used in the prior art to treat obesity include gastric bypass and small bowel bypass surgery. Stapling of portions of the stomach has also been used to treat morbid obesity. This includes both vertical and horizontal stapling and other variations which will reduce the size of the stomach and make a small stoma opening. Many problems have been associated with the use of staples. First, staples are undependable. Second, staples may cause perforations in the stomach wall. Finally, the pouch or the stoma formed by the staples may become enlarged over time, thereby making the procedure useless.

[0006] A promising method for weight control employs the placement of a band around a portion of the stomach by open or laparoscopic surgery, thereby compressing the stomach and creating a stoma that is less than the normal interior diameter of the stomach. The constricted stoma restricts food intake into the lower digestive portion of the stomach. Such a band has been described by Kuzmak et al in U.S. Pat. Nos. 4,592,339, 5,074,868, and 5,226,429, which are hereby incorporated by reference.

[0007] These devices, known as gastric bands, require a surgical procedure for their implantation, which includes accessing the patient's stomach and other internal organs via incisions. The invasiveness related to these surgical procedures can cause pain, prolonged recovery, complications, and great expense to the patient and to the healthcare system. Moreover, the procedure can also be technically challenging for the surgeon.

[0008] Suturing devices described by Bjerken in U.S. Pat. No. 6,464,707 and in U.S. patent application Ser. No. 11/267,266 enable an operator to remotely place suture material within a closed space such a hollow body organ. Such devices enable the endoluminal implantation of prostheses, correction of defects, and the reconfiguration of tissue without the need for surgical incisions. U.S. Pat. No. 6,464,707 and U.S. patent application Ser. No. 11/267,266 are hereby incorporated by reference in their entirety.

[0009] The present invention includes prostheses, such as a ring, or series of rings; a suturing device; and a method for suturing prostheses within a subject. The rings are adapted to hold tissue in place around their circumference to create a constriction within an organ. If the organ is a stomach, the constriction is positioned such that a pouch of a certain volume is created proximal to the constriction, leaving a narrow passage to the remainder of the stomach's volume distal to the constriction. The suturing device is adapted to be passed into a patient's digestive system via a natural orifice, such as the mouth or anus. The suturing device can be adapted to expand once inside an organ and place multiple sutures in tissue around the circumference of the suturing device. After deploying suture, the device can be adapted to collapse to its original size to enable the withdrawal of the device. The rings are adapted to be held in place within an organ by the sutures.

[0047] The present invention is more particularly described in the following examples with reference to the accompanying drawings that are intended as illustrative only since numerous modifications and variations therein will be apparent to those skilled in the art.

[0048] For the placement of gastric rings or other implants within a patient shown in the exemplary embodiment of FIG. 1, the suturing device of the present invention may include an enclosure 1 and sheath 44. The enclosure 1 and sheath 44 have flexibility to help facilitate insertion, internal navigation, and positioning within a patient's body. The enclosure 1 and sheath 44 can be transparent, translucent, or opaque. The enclosure 1 and sheath 44 have a diameter and flexibility that is amenable for insertion into a natural body orifice, such as the mouth or anus, or into a surgical incision or existing stoma. The diameter of the sheath 44, which receives the enclosure 1, can be, for example, about 10 mm to about 22 mm for oral insertion and about 10 mm to about 35 mm for anal insertion. For other applications such as cardiac and vascular, the diameter can range from about 3 mm to about 35 mm in diameter.

[0049] In one embodiment, the enclosure 1 has a length sufficient to span the distance from its place of insertion to the targeted surgical location. For example, in gastrointestinal (GI) uses, the enclosure 1 can be approximately 2 to 3 feet. The length of the enclosure 1 for this embodiment should enable the device to reach several organs within the GI tract or within the abdominal cavity while a proximal end of the enclosure remains outside the patient's body and accessible to the operator.

[0050] The enclosure 1 and sheath 44 can be circular in its cross-section or it may have a non-circular cross-section. Possible cross-sectional shapes are oval, rectangular, or irregular, such as the shape of a mitral valve annulus.

[0051] The enclosure 1 and sheath 44 can house an endoscope (not shown). The device may include and be connected to the endoscope, or the endoscope may work in concert with the device. The device may also work without an endoscope.

[0052] Generally, an operator manipulates the enclosure 1 and sheath 44 to place the device at a desired location. The endoscope contained within the enclosure 1 and sheath 44 of the device may assist in directing the device to the desired location by applying force to the wall of the sheath 44, to steer the device. Alternatively, the enclosure 1 and sheath 44 may have the ability to direct or steer itself by using various methods of steering. For example, a balloon catheter (not shown) can run parallel within or along a side of the enclosure 1. A catheter (not shown) may be endoscopically placed in a defect, annulus, valve, or outlet, and inflated to hold the device in place. The sheath 44 can then be slid down the catheter (not shown) to be positioned and maintained in the desired location. In vascular applications, the device can be directed in a similar fashion following a guide wire (not shown). The enclosure 1 or sheath 44 can incorporate radio opaque markers (not shown) to enable visualization using fluoroscopy. In yet another embodiment, wires or cables can be used by varying tensions to turn the device within the closed organ or space. Steering the device may not be necessary for the implantation of gastric rings within the stomach.

[0053] The enclosure 1 can be in fluid communication with a vacuum source and can include or define one or more suction ports 5. The port 5 is generally located near the distal end of the enclosure 1, although other locations are possible. The suction port 5 can completely or partially circumscribe a portion of the distal end of the enclosure 1. In one embodiment, the device has a series of suction ports spaced around its circumference. Generally, the area immediately distal and proximal to, and including, the suction port 5 is designed to expand and contract in diameter as shown in FIGS. 1 and 2, respectively, and described in further detail below. The suction port 5 can draw tissue into a bore of the enclosure 1 when a vacuum is applied to the enclosure 1.

[0054] One or more cannulas 2, 3 are arranged within the enclosure 1. In the illustrated embodiment, for example, in FIGS. 1 and 2, the cannulas include delivery cannulas 2 and corresponding receiving cannulas 3 arranged in series on opposite sides of the suction port 5.

[0055] Generally, a cannula is a tubular passageway though which material can travel in either a forward or backward direction. Each cannula has an internal diameter adequate to contain one or more needles and accompanying sutures.

[0056] The cannulas 2, 3 are utilized to direct needles 20 to an intended point of incorporation with tissue. The cannulas 2, 3 maintain the movement of the needles in a forward or backward direction and contain or prohibit lateral movement and bending of the needles. Although the cannulas 2, 3 are referred to as “delivery” and “receiving cannulas” herein, either set of cannulas can deliver or receive the needles. The delivery cannulas 2 loop at cannula loop 4 and extend up through the central portion of device via a central delivery cannula shaft 11. The central delivery cannula shaft 11 can be a single shaft through which the needles 20 extend, or a collection or bundle of individual cannulas. The receiving cannulas 3 can be bundled or formed together in a similar fashion proximal to the expandable area of the enclosure 1. The needles 20 can be manipulated via the portions of the needles extending out of the proximal end of the device, as shown in FIG. 18. The needles 20 proceed through the device via the delivery cannulas 2, cross the suction port 5, and extend back out of the device via the receiving cannulas 3, and out of the enclosure 1 and sheath 44, as shown in FIG. 19. The needles 20 leave the attached sutures 7 incorporated in the tissue. If the desired result is to attach two portions of tissue together to form an anastomosis, after the first portion of tissue has been penetrated by the needles, the needles can be reloaded by pushing them back into the delivery cannulas 2 after the device has been disengaged from the first portion of tissue. The device is then repositioned so that a second portion of tissue is drawn in to the suction opening and the needles penetrate the second portion to incorporate the sutures into the second portion of tissue. The sutures can then be secured, fastening the first portion to the second portion, as shown in FIGS. 25 and 26.

[0057] The cannulas 2, 3 can be formed, molded, and/or cast as part of the enclosure 1, or can be independent components inserted into the enclosure 1. The cannulas 2, 3 can be flexible, but may optionally have rigid sections as necessary to allow turning and targeting of the needles 20. The cannulas 2, 3 may be made of extruded plastic tubing reinforced with braided stainless wire.

[0058] The cannulas 2, 3 can be configured within the enclosure 1 in many ways. The cannulas 2, 3 may have flared or trumpet shaped openings (not shown) to assist in receiving the needles 20 once they have traversed the suction port 5.

[0059] The needles 20 completely traverse the tissue drawn within the suction port and may enter the receiving cannulas 3 at or near the upper side of the suction port 5. This creates a “bite” or suture of tissue.

[0060] The suturing device of the present invention generally utilizes long suture needles 20 made of a material that has the properties of shape memory, such as Nitinol. Nitinol is a nickel and titanium alloy that quickly returns to an original configuration after being flexed. Other materials can also be used, such as stainless steel. In one embodiment, the suture needles 20 can be of adequate length to reach a suturing site, via a natural body orifice such as the mouth or anus, or an incision or stoma, and return back out of the device. As such, the needles 20 are typically at least twice the length of the enclosure 1 of the device. As an example, a needle utilized for gastrointestinal applications can be approximately 6 feet long. The needles 20 can be attached to suture material to deliver and incorporate suture material 7 into tissue that the needles 20 traverse.

[0061] In one embodiment of the present invention, the needles are straight. The needles have a flexibility to follow the path within a cannula, 2, 3, which may include various turns and loops, without losing its original shape. The generally straight shape of the needles 20 allows them to exit the cannulas, 2, 3 transect a port or ports in the enclosure 1 such as a suction port 5, and proceed in the direction in which it has been directed.

[0062] The needles 20 can be longer or shorter depending on the desired application, such as cardiac, vascular, gynecological, proctological, pulmonary, and general surgical procedures, or depending on the embodiment of the present invention. The needles 20 may have a distal tip or end that is made of a material that is more rigid, such as steel or titanium. The needles 20 may have differing diameter or gauge depending upon the application. By way of example, vascular anastomosis generally requires relatively thin needles, for example, needles with a diameter of about 0.1 mm to about 0.5 mm. The needles 20 may also have an original configuration other than straight, such as having a bend, curve or coil.

[0063] In some embodiments, the suturing device does not use a vacuum source. The enclosure 1 may be of a size such that the tissue envelops or enters into a port 5 without the need of a vacuum. This embodiment can be useful, for example, in a tissue-to-tissue anastomosis or tissue defect closure application.

[0064] The circumferential suction port 5 illustrated in FIG. 1 may be used for incorporating sutures around an annulus or the circumference of a lumen or organ wall. The port 5 may be formed by two enclosure segments held together by one or more struts 10. The struts 10 hold the two segments defining the suction port at a predetermined distance. The struts 10 may have an inward curvature. As shown in FIG. 1, for example, concave suction port supports 10 can be provided. The curvature allows tissue to be drawn into the bore of the enclosure 1 about the entire circumference. When the expandable area of the device is in its collapsed configuration, the struts 10 can stack next to each other with members on either side of the central shaft 11.

[0065] Alternatively, the curvature or inward concavity of the strut may be formed by two or more straight members with a hinge in the middle, so that when the hinge is pulled inward a V shape is formed. Also alternatively, as illustrated in FIGS. 23 and 24, straight members may form a rectangular shape. As shown in FIGS. 23 and 24, the hinged suction port strut embodiment allows for further reduction in the diameter of the device when in the collapsed configuration. In this embodiment, the suction port 5 is formed by the cannulas 2, 3 and strut members 37 connected with hinges 38. As shown in FIG. 24, in the collapsed state the strut members 37 and cannulas 2, 3 lay flat against the central shaft 11. To expand the device, sliding umbrella fulcrums 40 are slid together such that the umbrella struts are pushed outward. A flexible string or wire connection 39 of the hinged members 37 enables the members to deploy in the proper configuration by restricting the distance the member can extend from the central shaft 11.

[0066] The circumferential suction opening 5 for a circumferential placement of suture enables anastomosis, connection of tissue to tissue, or connection of tissue to a prosthetic graft. Particularly, the circumferential suction port enables the placement of a gastric ring or rings. In the embodiment shown in FIGS. 1 and 2, the device includes an enclosure 1 with a suction port 5 completely or partially circumscribing a portion of the distal end.

[0067] In another exemplary embodiment, a flexible plastic, non-porous fabric, or cellophane material 8 forms the expandable area of the enclosure 1. The distal end of the cannulas can be straight and made of a material such as metal or plastic. As shown in FIGS. 1 and 2, the distal end of the cannulas 2, 3 can be attached to the struts 9 that extend and retract, similar to the struts of an umbrella, when the fulcrum points 40 of their attachments are slid towards each other on a shaft 11. In this embodiment, when the struts 9 of the umbrella are extended, the flexible plastic, fabric, or cellophane material 8 makes up the wall of the enclosure 1 and forms the proximal and distal boundaries of the suction port 5. When the struts 9 are collapsed, the flexible plastic, fabric, or cellophane material 8 accordions down to size as demonstrated in FIG. 2. The diameter of the enclosure 1 near the suction port 5 may have the ability to expand in a range from approximately 10 mm to 150 mm. The struts 9 and fulcrum attachments 40 may be manipulated using a cable system. The thin sheath 44 may be slid up and down over the expandable area of the device in order to i) cover the open suction port and/or to ii) further compress the area facilitating insertion and withdrawal of the device from the patient.

[0068] In alternative embodiments of the suturing device, illustrated in FIGS. 20, 20A, 20B, 21, and 21A, the device eliminates the use of the relatively long needles 20, as well as the relatively long delivery cannulas 2 and the accompanying cannula loop 4 at the distal end of the suturing device.

[0069] In the embodiment shown in FIGS. 20, 20A, and 21, relatively short pushrods 31 releasably hold a detachable needle tip 46 with attached suture 7. The pushrods 31 may be 3 to 6 inches long in the GI embodiment. The needle tip 46 has a recessed area or barb 33 near its sharpened point. The recessed area 33 on the needle tip 46 is adapted to receive a needle catch 34 within a receiving needle grasping rod 45. The distal ends of the pushrods 31 are mounted or held on a carriage or carousal 30 contained in the distal end of the enclosure 1. The carriage 31 is connected to a central shaft 32 that has the ability to lift the carriage 31 when actuated upward. The pushrods 31 are made of a flexible material, such as nitinol, that maintains its column strength when pushed in a forward or backward direction. The pushrods 31 extend upward and are directed through relatively short cannula segments 43 spaced around the circumference of the expandable region of the device. Generally, the cannula segments 43 do not extend down to the distal end of the enclosure 1. This allows the carriage 30 to move freely upward and downward within the distal portion of the enclosure 1. The distance between the carriage 30 in its most distal position and the distal end of the relatively short cannula segments 43 is the distance the pushrods 31 are able to be actuated up and down. The expandable area of the device at the suction port 5 has the ability to expand and contract as described above. In use, when the carriage 30 is actuated upward, the pushrods 31 will pass the detachably held needle tips 46 with an attached suture 7 across the suction opening 5. The needle tips 46 will enter the distal end of the receiving cannulas 3 and be engaged by the needle grasping receiving rods 45 contained therein. The needle grasping receiving rods 45 are then pulled upward within the receiving cannulas 3 contained within the enclosure 1. The configuration of the double-armed suture illustrated in FIG. 20A loaded into the device of FIG. 20 is described as follows: The needle tips 46 are passed through the material of the distal ring or prosthesis 6. The ring or prosthesis 6 is slid down the suture to the approximate midpoint. Each length of suture and the attached suture needle extending from the ring or prosthesis 6 can be described as a suture arm. The needle tips 46 are then backed into the relatively short cannula segments 43 in the device. The suture loop 7 extending from the back end of the needle tip and the ring or prosthesis is pulled through the relatively short cannula segment 43 for each needle 46. These suture loops 7 are gathered and maintained by looping a string 47 or similar length of material through the suture loops 7, and then this string is pulled up a central hollow shaft 42 running up the length of the enclosure 1. The string 47 maintains tension on the suture loops 7, enabling their management throughout the deployment of the needles 46 during the procedure. Releasing one end of the string 47 will release its hold on the suture loops 7.

[0070] In another embodiment illustrated in FIG. 20B, the detachably held needle tips 46 and the pushrods 31 are replaced with relatively short needles 48. The relatively short needles 48 are approximately 3 to 6 inches long. As illustrated in FIG. 20B, the needles 48 are backloaded through relatively short cannula sections 43 and releasably held by the movable carriage 30. As illustrated in FIG. 21A, the tip of the needle 48 has a recessed area or barb 33 near its sharpened point. The recessed area 33 on the needle tip 48 is adapted to receive a needle catch 34 within a receiving needle grasping rod 45. In use, when the relatively short needles 48 are raised within the enclosure 1 by the carriage 30, the needles 48 are directed by the relatively short cannula sections 43 so that the needles 48 traverse the suction port 5 and then enter into the receiving cannulas 3 to be engaged by the receiving needle grasping rod 45 and subsequently pulled up and through the length of the enclosure 1.

[0071] In each of the embodiments, the distal ends of the delivery cannulas 2, or alternatively, the relatively short cannula segments 43, may be spaced around the circumference of the suction port 5 in a variety of fashions. In an exemplary embodiment, the delivery cannulas 2 are spaced about the circumference of the suction port 5 such that they are spaced as pairs of cannulas. Each pair of cannula can contain the two suture needles 20, 46, 48 connected by the one suture length 7. The pair can be spaced approximately 1 cm apart from one another at their distal ends when the expandable area of the device is fully expanded. If the double-armed suture is back-loaded into each cannula pair, the loop of suture that bridges the two cannulas is incorporated with the intended distal prosthesis as described later.

[0072] The shape of the expandable area of the suturing device may be capsule, spherical, or football shaped with the cannulas 2, 3 distributed equidistant from the central shaft 11. Alternatively, the expandable area of the enclosure 1 may have an irregular shape that can be adapted to conform to the natural shape of the interior of the organ. The suction opening 5 may also be irregular or non-circular in circumference. The proximal section of the expandable area may have the approximate same surface area of interior of the created proximal organ pouch. In other words, the device can be useful to template the resulting gastric pouch.

[0073] FIGS. 5-11 illustrate the implantation of the ring 6 or rings 6, 12 and the creation of a gastric pouch 16. The size of the gastric pouch 16 may vary in size. Surgeons often cite 15 cc to 50 cc to be the target volume size of the pouch. The size of an outlet 14 created by the rings 6, 12 may also vary in size. Surgeons often cite a 10 mm to 15 mm diameter as the target size for the outlet 14.

[0074] The implantable gastric rings 6, 12 are used to hold or secure portions of the stomach wall around their circumference. Ring 6 is shown in FIG. 1. In one embodiment, two rings 6, 12 are used to create a restricted outlet 14 within an organ. In another embodiment, only one ring 6 is used and the suture loop on the opposite side of the tissue can be bolstered through the use of individual pledgets. The rings 6, 12 can serve as anchors for each other and for the sutures 7, which have been incorporated into the tissue wall 13, for example, as shown in FIGS. 5-8.

[0075] In the exemplary embodiment where two gastric rings 6,12 are employed, once implanted, the result is two rings 6, 12 held together with tissue sandwiched between them, as illustrated in FIG. 7. In the stomach, because the diameter of the organ's lumen can be substantially larger that the diameter of the gastric rings, the entire circumference of the organ may not be incorporated between the rings. Folds 15 from sections of the organ's circumference are held by the rings, similar to the configuration of a cinched sac or purse-string, as shown in FIG. 8. The pliability of the tissue folds can serve to create a competent or near competent proximal gastric pouch 16.

[0076] The tissue 15 held between the rings may protrude within the circumference of the rings, 6 12. This produces a small outlet 14 made up of the tissue 15 of the organ. The size of the resulting outlet 14 can be measured and altered as necessary for the particular patient at the time of implantation by varying the amount of tension between the rings and or by selecting a larger or smaller proximal gastric ring 12.

[0077] The rings 6, 12 are configured in a generally circular shape, although other configurations are possible, for example, an oval shape. The ring 6, 12 may contain holes or slots 27 through which suture can be passed. In another embodiment, the ring initially has no holes and the suture needles pierce the ring material 28 and are passed through. The rings 6, 12 can be made of a flexible material that can be temporarily held in any shape. Flexible rings 6, 12 can be made of biocompatible material such as plastic, silicone, polypropylene, Nitinol, stainless steel cable, Gortex, Nylon, Teflon, fabric, rubber, composites of material, or another like material that bends but does not necessarily stretch or have elastic properties.

[0078] The suturing device can be loaded with the double-armed sutures and the distal gastric ring 6 in the following manner. As illustrated in FIG. 17, each of the two needles 20 of the double-armed suture are passed through adjacent holes or areas 27, 28 in the distal gastric ring 6. Alternatively, the ring 6 may not have holes and therefore the needles 20 are passed directly through the ring material. The ring 6 is slid down both needles 20 and onto the suture material 7 to approximately the midpoint of the suture 7. The back ends of the needles, i.e. the end which connects to the suture, are pushed down adjacent delivery cannulas 2 until the sharpened points of the needles 20 are level or near level with the distal end of the delivery cannulas 2. The attached suture 7 rides along next to the needles 20 within the cannulas 2. This loading configuration is repeated for each double-armed suture to be loaded within delivery cannula 2 sets spaced around the circumference of the enclosure 1. The distal gastric ring 6 is mounted on the distal end of the enclosure 1 with the suture loops 7 incorporated. The ring 6 may be held in place at the distal end of the device by the tension applied by the sutures, or alternatively, there may be a cavity to house the distal ring 6. If double-armed sutures are employed, there will be an even number of cannulas 2, needles 20, and areas of incorporation 27 on the prosthesis.

[0079] As illustrated in FIG. 13, the flexible ring 6 can be held in a narrow sheath, defining constraint 18, during insertion and then deployed once inside the targeted organ. The ring 6 can be folded as demonstrated in FIGS. 12 and 12A. Flexible gastric rings 6, 12 may range in diameter size from 10 mm to 150 mm. The flexible rings 6, 12 have the ability to bend and give as the natural muscular contractions of the stomach moves the organ. The ability of the rings 6, 12 to bend and give can help keep the sutures from tearing out of the tissue. The flexibility or flaccidness of the flexible rings 6, 12 also allow the created outlet 14 to close or collapse the opening, similar to the function of a natural sphincter, further restricting the food consumption capability of the patient and increasing the procedure's effectiveness.

[0080] The flexible ring 6 may be a linear length of material that is implanted in a circular fashion, as illustrated in FIGS. 12A and 14-15A. The length of material can be incorporated with sutures and releasably held on the distal end of the suturing device, as shown in FIG. 14.

[0081] In use, the suturing device deploys the incorporated sutures about the circumference of the lumen of an organ such as the stomach with unsecured mattress suture bites. A secured mattress suture bite can be provided wherein the two arms of a suture enter the first side of an object and/or tissue, exit a second side of an object and/or tissue and are secured together, forming a closed circuit of suture material. The flexible length of material is now held by the sutures distal to the tissue incorporated with the sutures. The second or proximal ring may now be incorporated with the sutures and lowered into the stomach and positioned above the length of material. The second proximal ring may be formed as a ring or it may be a length of material similar to the distal ring. If the proximal ring is a linear length of material, it can be incorporated with the sutures and aligned such that, when formed as a circle, the break in the circumference 19 formed by the two endpoints of the length of material are not be aligned with the break in the circumference of the distal ring. In an exemplary embodiment, the breaks 19 in the circumference should be 180 degrees apposed, as illustrated in FIG. 15A. The circumferential attachment of the two lengths of material with their endpoints misaligned produces a circumferential fixation that possesses hoop strength.

[0082] Rigid gastric rings with a diameter that is amenable to be passed trans-orally or trans-anally (10 mm-33 mm) can be formed as a closed circle. In another embodiment, as illustrated in FIGS. 12A, 14, 15 and 15A, the ring could be configured as an open circle having a length of material having two ends formed to make a circular shape. This material could be made of a material that has shape memory, such that the material could be formed in a round shape and then be held in a straight configuration, such as in a straight sheath, as illustrated in FIG. 14. When released from constraint 18 such as shown in FIG. 14, the material 17 would return to its round or predetermined formed shape. When utilizing two gastric rings with openings 19, the proximal ring should be incorporated with the sutures such that its opening 19 is 180 degrees opposed to the opening 19 on the distal ring. The opposition of openings 19 will provide the ring 6 with hoop strength to maintain circumferential fixation of the gastric tissue.

[0083] The rings 6, 12 can have any cross-section, for example, flat, round, oval, or irregular. The rings 6, 12 can have a diameter of 10 mm to 50 mm for gastric reduction, but rings can also have a diameter from 3 mm to 150 mm.

[0084] Closed rigid rings 6, 12 could be made of plastic, stainless steel, Nitinol, titanium, carbon fiber, or another like material which is compatible with biologic tissue.

[0085] The suture can be made of any material, for example, a non-absorbable material such as polypropylene. The size of the diameter of the suture may vary, although a 3.0 or 2.0 size suture can be particularly useful. The length of the suture connecting the two suture needles needs to be of adequate length to span the length of the two suture needles, plus the slack needed to loop through the gastric ring or other prosthesis. For example, if the length of the needles 20 utilized is six feet, then the suture 7 connecting them would need to be approximately thirteen feet.

[0086] To implant the gastric rings 6, 12, the device, loaded with the distal gastric ring 6, is inserted in its collapsed configuration, as shown in FIG. 2, through the patient's mouth. Once in the stomach, in this embodiment, the expandable portion of the enclosure 1 is expanded to increase the diameter of the suture engagement area which includes the suction port 5 circumscribing, or partially circumscribing the enclosure 1, as shown in FIG. 9. The enclosure 1 is pulled towards the patient's head so that the expandable portion is situated in the top of the stomach. The vacuum is applied, drawing tissue into the suction port 5. In this embodiment, the cannulas 2, 3 are back-loaded with suture needles as described above. As illustrated in FIG. 18, the long Nitinol needles 20, which are back-loaded into the delivery cannulas 2 and extend out of the proximal end of the delivery cannulas 2 and the enclosure 1 and sheath 44, such that the needles 20 can be manipulated by an operator, are manually, or mechanically, pushed by the operator through the delivery cannulas 2. The needles 20 cross the suction port 5, penetrate the drawn in tissue, and extend up into the receiving cannulas 3. As illustrated in FIG. 19, the needles 20 are grasped and pulled completely through and out of the device, leaving the sutures 7 extending through the tissue. The vacuum is deactivated and the expandable area 23 of the device is collapsed. The releasably held distal gastric ring which had been held in place on the device by the suture loops is released. The device is withdrawn from the patient. The suture 7, now incorporated and anchored in the stomach wall tissue, stays in place as the suture arms flow out of the receiving cannulas 3 via the suction port 5 as the device is withdrawn. The tension of the sutures 7 can be manipulated to position the gastric ring 6. In this embodiment, the pre-loaded distal gastric ring 6 is a distal gastric ring implant. As illustrated in FIG. 22, a suture/needle organizer can be employed to maintain the order of the needles as they are situated about a circumference. If a proximal gastric ring 12 is to be utilized, the needles 20 are passed through and incorporated into the proximal gastric ring 12. The operator uses an endoscope or other mechanism to push or slide the proximal gastric ring 12 down the patient's esophagus and into the stomach as tension is maintained on the sutures 7, such that the proximal gastric ring 12 slides down the sutures 7. The proximal gastric ring 12 is lowered into its position with the incorporated tissue folds separating it from the distal gastric ring 6. Proper tension is applied to the proximal gastric ring 12 and to the sutures 7, approximating the proximal gastric ring 12 over the distal gastric ring 6 with the incorporated tissue folds 15 between them. The sutures 7 are then secured by using suture anchors or by tying the sutures. The suture 7 arms are cut and withdrawn from the patient. The rings are now implanted, creating a small pouch 16 at the top of the stomach with a narrow outlet 14 leading into the distal stomach 25.

[0087] Because the implantation of the rings 6, 12 involves multiple needles 20 and attached suture 7 arms, the needles and suture arms should be maintained in their proper configuration or order throughout the implantation procedure. Procedures and devices may be used to maintain suture arm order. Clamps can be used to grasp each suture arm and then maintain the order of the clamps until the proximal prosthesis is incorporated. Alternatively, a mechanism that has the ability to releasably hold needles or suture arms about its circumference may be used, as illustrated in FIG. 22. Each needle or suture arm can be placed in a corresponding port or slit 35, while a mechanism 36 to releasably hold them in place is either opened or closed around the port or slit 35.

[0088] As illustrated in FIG. 27, multiple sets of rings can be implanted within a single organ. Implanting additional sets of rings creates additional outlets 14 and additional organ pouches 16. Additional outlets and organ pouches may further restrict the capability of the patient to intake food and may slow the patient's gastric emptying time, thereby increasing the effectiveness of the procedure. In use, the implantation procedure of multiple sets of rings may be staged as follows; The first distal ring 6 of the first set of rings is a flexible length of material such as illustrated in FIGS. 12A, 14, and 15. Utilizing a first suturing device, the first distal ring 6 of the first set of rings is incorporated into the organ tissue with suture as described earlier. The first suturing device is withdrawn from the patient leaving the suture arms running up the esophagus and out of the mouth of the patient. The suture arms are maintained in an orderly fashion and set aside. A second or reloaded suturing device holding a second distal ring 6 of the second set of rings is subsequently introduced into the patient's organ and positioned such that the suction port 5 of the second suturing device is distal to the incorporation site of the first distal ring 6. The second distal ring 6 of the second set of rings may be configured as a length of material or as material formed as a circle with a closed circumference. The second distal ring 6 of the second set of rings is incorporated into the organ tissue with suture as described earlier. The second suturing device is withdrawn and the sutures from the second device are now incorporated with the second proximal ring 12. The second proximal ring 12 is positioned and secured to the second distal ring 6 as described earlier, creating a second or distal outlet 14. The suture arms from the first suturing device are now incorporated with the first proximal ring 12, positioned and secured to the first distal ring 6 as described earlier, creating a first or proximal outlet 14. The organ now has a proximal, intermediate, and distal pouch.

[0089] If necessary, the gastric ring implantation procedure can be easily reversed by simply cutting the sutures connecting the rings while using endoscopic instrumentation, and removing the rings.

[0090] The distal or proximal gastric ring can be replaced with an alternate prosthesis such as a valve, stent, or graft utilizing the present invention. One-way valves utilizing leaflets or floppy tubes can be used in the gastrointestinal tract to prevent backflow of contents such as with gastroesophageal reflux disease (GERD). Expandable stents can be utilized to maintain a level of patency within a lumen. The suturing device of the present invention enables a stent to be secured at a location within the lumen, thereby prohibiting migration or movement of the stent after its endoluminal placement. The suture loops, which pass through the prostheses, can incorporate material that secure themselves and eliminate the need for tying. Self-tying U-clips made of a shape memory material is one example.

[0091] In one embodiment, the gastric ring can be described as a series of pledgets 28 connected to one another by a length of material 29 in the form of a circle, providing hoop strength to the tissue folds drawn into its circumference. In one embodiment, the material making up the pledget portions of the ring may be made of a material with different properties from the material making up the remainder of the ring's circumference. The pledget 28 function of the ring maintains the ring-to-tissue-to-ring configuration and connection while it prevents or retards the suture from tearing through the tissue. The ring, or closed circuit, function of the ring holds and maintains the incorporated tissue in a circumferential fashion as illustrated in FIGS. 7, 8, 11 and 27.

[0092] In one embodiment, as an alternative to the expandable umbrella struts, the expandable area of the device could expand by means of an inflatable member such as a balloon or balloons. The balloon or balloons, when inflated, would force the cannula outward to a preset diameter. Flexible strings or wires connecting the concave suction port struts to the central shaft can enable a predetermined radius size of the expanded area.

[0093] As illustrated in FIGS. 25 and 26, the device is suited for connecting two tissue lumens together. As an example, the device could be passed, through an incision or defect in the stomach 25 and then proceed into an incision or defect in the bowel 24. The suction port 5 of the device is advanced past the incision and into the bowel lumen. The expandable region of the device could then be expanded to a degree such that when the device is pulled back or withdrawn from the bowel incision, the tissue making up the lumen of the incision envelopes into the circumferential suction opening 5. The device is pulled further, now maintaining the tissue lumen in the concavity of the suction opening, until the proximal portion of the expanded area completely enters the stomach 25. The lumen of the stomach incision or defect will now envelope into the concavity of the suction opening. Now that the two tissue lumens are enveloped into the suction opening, a vacuum may be a applied to draw the tissue in even further, if necessary. The long suture needles 20 are now advanced as described earlier. The expandable area of the device is collapsed and the device is withdrawn from the patient, leaving behind the sutures incorporated into the two tissues. The sutures are then secured as described earlier, establishing a stomach to intestine anastomosis, as shown in FIG. 26.

[0094] As illustrated in FIGS. 29 and 30, the rings can be used to connect two tissue lumens. The suturing device can incorporate the first or distal ring 6 into the first tissue lumen around its circumference. The suturing device can be reloaded with the incorporated sutures 7 as described earlier. The suturing device can subsequently incorporate a second tissue lumen with sutures 7 around its circumference. The device can be withdrawn leaving sutures 7 incorporated with the first or distal ring 6, the first tissue lumen, and the second tissue lumen. The second or proximal ring 12 is incorporated with the sutures, lowered into position proximal to the distal ring 6 and the tissue of the first and second tissue lumens. The suture is then secured, fixing the first or distal ring 6 to the second or proximal ring 12 with the tissue of the first and second tissue lumens held between them, thereby connecting the two lumens.

[0095] The expandable portions of the enclosure proximal and distal to the suction opening 5 may expand and collapse in concert with one another, or alternatively, they may expand and collapse independently from one another.

[0096] The suture 7 on the distal ring 6 may not loop through the material, but may in fact be connected to, or formed together with, the distal ring such that each suture arm connects to the ring directly.

[0097] As illustrated in FIGS. 28 and 28A, the rings 6, 12 may be formed such that they can fasten together to eliminate the need to tie or otherwise secure sutures. Needles and sutures are connected to, or run through male connection members 49 of the distal ring 6, enabling the incorporation with tissue and remote incorporation with the proximal ring 12. The male connection members 49 of the distal ring 6 have distal anchors 50 that are of a size small enough to be pulled through the female connection slot 51 of the proximal ring 12, yet large enough as to not allow the member to easily return back through the female connection slot 51. In use, the distal ring 6 is incorporated with the tissue as described earlier. The proximal ring 12 is slide down the sutures 7 and positioned above the incorporated tissue and the distal ring 6. Tension on the sutures 7 will provide upward force on the distal ring 6, while endoscopic instrumentation applies downward force on the proximal ring 12. The male connection members 49 of the distal ring 6 extend through the incorporated tissue. The upward force on the distal ring 6 combined with the downward force on the proximal ring 12 enables the male connection members 49 to snap through the female connection slots, thereby fastening the distal ring 6 to the proximal ring 12 with the tissue folds fixated between them. The sutures 7 are now cut using endoscopic instrumentation.

[0098] The ring material of the rings 6 and 12 may be made of, contain, or coated with a biodegradable substance, such as a drug, that eludes a steady dose of the drug over time. This substance could be an appetite suppressant, a proton pump inhibitor, an anti-inflammatory drug, or other medication. For example, the drug can be an appetite suppressant that is eluded for a discrete amount of time to assist a patient in assimilating to their new eating pattern.

[0099] Plastic, rubber or cellophane sheaths may be used to cover the proximal ends of the needles 20 and attached sutures 7 prior to their deployment. The sheaths help maintain sterility of the needles 20 and suture 7 and will reduce the possibility of the suture loops 7 from becoming entangled with each other prior to, and as the needles 20 are being deployed.

[0100] Although FIGS. 18 and 19 illustrate a manual manipulation of the needles, the needles can also be mechanically manipulated. The cannulas and/or needles can include a code or color for identification.