WO2015085010A1

WO2015085010A1 - Intragastric anchor devices and methods of delivery

Info

Publication number: WO2015085010A1
Application number: PCT/US2014/068457
Authority: WO
Inventors: Jaime S. Vargas
Original assignee: IBIS Medical, Inc.
Priority date: 2013-12-03
Filing date: 2014-12-03
Publication date: 2015-06-11

Abstract

An intragastric anchor implant that provide non-penetrating anchoring and methods for delivery are provided herein. Such anchor implants include an elongate element or rod extending between proximal and distal atraumatic features. The elongate member may be sufficiently stiff to resist bending and engage a tissue of the stomach or gastrointestinal tract to prevent passage therethrough and may include one or more bends or curved portions to improve conformance with the natural shape of the gastrointestinal tract. The anchor implant device is coupleable with a therapeutic device, such as an intestinal bypass sleeve with by a coupling structure, such as a sliding seal, disposed between the proximal and atraumatic ends that remains distal of the pyloric valve when deployed to secure the proximal opening of the sleeve within the duodenum to direct a flow of food particles from the stomach therethrough, for treatment of various disorders, including obesity and diabetes.

Description

INTRAGASTRIC ANCHOR DEVICES AND METHODS OF DELIVERY

CROSS-REFERENCES TO RELATED APPLICATIONS

[0001] The present application claims benefit of priority to U.S. Provisional Patent Application 61/911,443 filed on December 3, 2013 and U.S. Provisional Patent Application No. 61/911,435 filed on December 3, 2013; the entire contents of which are incorporated herein by reference.

[0002] This application is generally related to U.S. Patent Application No. 12/568,899 filed September 29, 2009 and entitled "Intragastric Implant Devices," U.S. Patent Application No. 13/073,762 filed on March 28, 2011 and entitled "Intragastric Implant Devices," and U.S. Patent Application No. 13/627,627 filed on September 26, 2012 and entitled "Intragastric Implant Devices;" the entire contents of which are incorporated herein by reference.

FIELD OF THE INVENTION

[0003] The present invention relates generally to medical devices, system and methods. Exemplary embodiments provide devices, systems, and methods for anchoring a treatment or diagnostic device in the stomach of a patient. Specific embodiments provide devices, systems, and methods for anchoring a therapeutic device in the stomach of a patient for the treatment of various metabolic related disorders, particularly diabetes, hypertension, and/or obesity.

BACKGROUND OF THE INVENTION

[0004] Metabolic related disorders, such as diabetes and obesity, affect millions of patients, and the number of patients suffering from such disorders has increased in recent years.

Diabetes and morbid obesity are considered serious and potentially life threatening disorders. Since all of these disorders relate to regulation of digestive processes, treatment methods often involve interrupting the normal digestive process to reduce the absorption of food particles passing from the stomach through the gastrointestinal system or continual monitoring of blood sugar and administration of insulin or other therapeutics in response. Studies have shown that reducing intestinal contact with gastric chyme, which may influence the secretion of certain hormones such as ghrelin which may stimulate hunger, may also be a viable treatment for obesity and its associated medical conditions. Although bariatric surgical procedures, such as the Roux-en-Y gastric bypass and gastric sleeve resection, have proven beneficial, these procedures are highly invasive and typically involve removal of portions of the stomach, stapling or suturing, which generally result in permanent irreversible changes to the patient's digestive tract and carry a substantial risk of surgical complications or death.

[0005] Although more recently, endoscopic procedures have been developed to deliver less invasive therapies, such as the gastric bypass sleeve, into the a patient's gastrointestinal system, anchoring of such devices has proven difficult as the stomach and gastrointestinal tract is fairly flexible and may contort significantly during digestion. Additionally, the harsh digestive environment within the stomach can tend to break down foreign objects, such as an anchoring device, when placed in the stomach for any length of time. The unique anatomy of the stomach also presents challenges in anchoring a treatment device as devices large enough to resist passage from the stomach through the gastrointestinal tract may block the passage of nutrients and food particles through the digestive system, while devices small enough to allow passage of food and nutrients are often passed through the digestive system. Due to these difficulties in anchoring treatment devices in the stomach, many procedures rely on invasive techniques, such as suturing or penetrating tissues or treatments that avoid use of such devices altogether by relying on monitoring and administration of therapeutics.

[0006] In light of the above, it would be beneficial to provide improved devices, systems and methods for anchoring treatment, sensing and/or monitoring devices, and in particular anchoring of such devices in a stomach of a patient for use in treatment of diabetes, obesity and other metabolic related disorders. It would be desirable to provide a device and method for anchoring a treatment and/or sensing device in a gastrointestinal tract or stomach of a patient that does not require suturing, stapling, or resection of tissue, while allowing the passage of nutrients and food particles through the digestive system. It would also be beneficial to provide systems and methods of treatment that allow for treatment of metabolic disorders by limiting intestinal contact with stomach chyme and stomach secretions thereby influencing secretion of certain hormones, both of which contribute to metabolic disorders including diabetes and obesity. It would be further beneficial to provide systems and methods that allow for passage of such devices through the gastrointestinal tract after treatment monitoring is complete. It is further desirable that such devices are robust enough to withstand the harsh environment of the stomach while providing adequate anchoring in the unique morphology of the gastrointestinal tract. BRIEF SUMMARY OF THE INVENTION

[0007] The present invention generally provides improved medical devices, systems and methods of treatment and methods of deploying such devices. Exemplary embodiments of these devices and techniques can be used to anchor a treatment device in a stomach of a patient, which is particularly useful in treating metabolic disorders such as obesity (and related disorders), diabetes, hypertensions, and the like. Such disorders may be treated by anchoring a sleeve within the gastrointestinal tract in the stomach so that the sleeve can reduce intestinal contact with and absorption of gastric chyme or stomach secretions, flowing from the stomach through the gastrointestinal tract. Advantageously, the present invention allows for anchoring of a treatment device, such as a bypass sleeve, in the gastrointestinal tract of a patient by engaging a wall of the stomach and/or the gastrointestinal tract at multiple locations with an intragastric anchor, without the need for stapling, suturing, resection, rigid attachment to tissue walls or other invasive modification of the

gastrointestinal system.

[0008] In one aspect, the invention comprises an anchor having an elongate element extending between a proximal end and a distal end and further having a proximal and distal atraumatic feature disposed at each end, wherein the anchor is attached to or supports a treatment or diagnostic device, such as an intestinal bypass sleeve. Each of the proximal and distal atraumatic features are configured to inhibit tissue trauma when urged against a tissue of the stomach or the gastrointestinal tract, while the elongate element is sufficiently rigid so as to resist bending between the proximal and distal ends and is sufficiently long to inhibit advancement of the anchor around a bend of a proximal intestine, such as the proximal portion of the duodenum, when under anchoring loads. In any of the embodiments described herein, the anchor may include one or more expandable structures which may be incorporated into or separate from the proximal and distal atraumatic features. For example, the anchor may include an expandable structure disposed between proximal and distal atraumatic features, the distal atraumatic feature optionally comprising another expandable structure.

The elongate element and one or more expandable structures, as well as any other components associated with the anchor, may be made from the same or differing materials, including but not limited to polymers and various metals, including stainless steel alloys and nickel-titanium. In one aspect, the intragastric anchor may include one or more anchoring features to improve anchoring within the gastrointestinal tract as well as to improve patient comfort, thereby facilitating favorable treatment outcomes. Such anchoring features may include any of a duodenal portion extension of the intragastric anchor that extends distal of a coupling structure through a portion of the duodenum, a pylorus hooking feature to inhibit rotation of the anchor and distribute anchoring forces, at least two expandable structures spaced apart by a distal portion of the anchor that both remain distal of the pylorus when deployed, a bent anchoring shape, such as a zig-zag shape, to more closely conform with the natural shape of the gastrointestinal tract on each side of the pylorus. Anchor shapes include but are not limited to angled, curved, and hooked anchor shapes. Such anchoring features allow for improved anchoring by providing sufficient length and dimension to limit pivoting movement of the deployed anchor around the pylorus and may allow hooking onto the pylorus. Examples of these features are described in further detail herein and it is understood that one or more of these anchoring features can be combined in an intragastric anchor in accordance with the principles of the present invention.

[0009] In another aspect, the treatment device comprises an intestinal bypass sleeve having a lumen extending between a proximal opening and a distal opening, wherein the sleeve comprises a material substantially impenetrable to a flow of ingested matter, such as ingested nutrients and food particles, the flow being in contact with the walls of the stomach before passing into the lumen. The proximal opening of the lumen is supported by the anchor distally of the proximal end of the anchor so as to direct the flow of ingested matter from the stomach into the lumen thereby reducing contact of the ingested matter with the walls of the gastrointestinal tract. In an embodiment particularly useful in treating diabetes, the sleeve may prevent ingested matter from contacting a portion of the duodenum, thereby influencing production of certain hormones that affect diabetes, such as ghrelin, a hormone that stimulates hunger. In some embodiments, the anchor includes a coupling structure between the proximal and distal atraumatic ends that supports a proximal opening of an intestinal bypass sleeve and maintains the proximal opening downstream of the pylorus near the first section of the duodenum. The coupling structure may include an expandable structure so as to define a sliding seal slidably disposed within the first and/or second section of the duodenum that slidably supports the proximal opening of the intestinal bypass sleeve. [0010] In many embodiments, the distal atraumatic feature is sized and configured to be advanced through a pyloric valve such that when implanted the distal feature is disposed distal of the pyloric valve and the proximal feature is disposed within the stomach. In other embodiments, the distal atraumatic feature may be disposed in a distal portion of the stomach and the proximal feature may also be disposed in the stomach albeit proximal of the distal feature. Typically, in embodiments where the treatment device includes a sleeve, the elongate element between the features at each end has a profile smaller than the sleeve, and optionally, the distal feature may radially support the proximal opening of the sleeve so that a majority of a flow of ingested food advancing around the anchor passes into the opening of the sleeve. In other embodiments, the anchor is attached to the treatment device, often a sleeve, by a tether or other such coupling structure and the proximal opening of the sleeve may be supported by a separate structure, such as a sliding seal, which supports the proximal opening of the seal, typically by exerting an outward radially force so as to seal the proximal end of the sleeve against a wall of the gastrointestinal tract or the stomach. Such seals and support members may include expandable rings or other expandable structures, such as those described herein. Preferably, the seal is slidable so as to allow atraumatic movement within the gastrointestinal tract or the stomach.

[0011] In some embodiments, one or both of the atraumatic features include expandable members having a collapsed configuration suitable for delivery through the stomach, such as in an endoscopic procedure, and an expanded configuration, so as to distribute anchoring loads to inhibit tissue damage by an end of the elongate element or member and may also prevent passage of the distal feature across the pyloric valve or to help maintain a position of the anchor. In some embodiments, the proximal atraumatic feature is a blunted tip, such as a bulbous feature, and the distal atraumatic feature is an expandable structure or member. The expandable members may include balloons, rigid, or non-rigid members, expandable wire loop structures, sinusoidal-type structures, or any structures that may expand when released from a collapsed configuration, may be expanded by inflation, or by movement of a drawstring, by retraction of a constraining outer sheath, or other expanding mechanism. The distal atraumatic feature may include an expandable structure sized so as to circumferentially engage a lumenal surface of the duodenum and support the proximal opening of the sleeve in a position nearest the pyloric valve. The coupling structure may be configured according to any of the aspects described herein relating to the distal atraumatic feature and may be sized so as to support the proximal opening of the sleeve in a position near the pyloric valve and circumferentially engage the lumenal wall in the duodenum so as to provide a sliding seal about the proximal opening of the sleeve.

[0012] In many embodiments, the elongate element is sufficiently long to prevent end-to- end rotation in the stomach so as to maintain a relatively stable position in the stomach for anchoring the treatment or diagnostic device. Typically, the elongate element is at least 10 cm in length, such as between 15 and 25 cm. In some embodiments, when the distal atraumatic feature is disposed in a proximal portion of the duodenum a proximal portion of the anchor engages a portion of the stomach wall such that engagement of a proximal and distal portion of the anchor with the tissues of the gastrointestinal tract prevent the anchor from passing from the stomach through the duodenum. In some embodiments, the length of the elongate element and the distal and proximal features are configured such that displacement of a longitudinal axis of the anchor is limited by the engagement of the proximal and distal portions of the anchor with tissues of the stomach and the gastrointestinal tract so as to substantially maintain a position of the anchor and to maintain a position of the sleeve by limiting movement of anchor, thereby maintaining the position of the anchor as well as the flow of ingested matter from the stomach through the sleeve. In embodiments having a duodenal extension extending between an expanding coupling structure and the distal atraumatic feature, the duodenal extension is at least 4 cm in length, such as between 5 cm and 15 cm, so as to extend from the duodenal bulb to near the junction between the second and third section of the duodenum so as to substantially maintain the coupling structure near the duodenal bulb and improve anchoring within the gastrointestinal tract.

[0013] In some embodiments, the elongate element includes one or more sensors so as to allow for diagnostic procedures and/or medical monitoring. The elongate element may be sized so that the proximal atraumatic tip passed beyond the pyloric valve and sized so as to anchor at a point in the gastrointestinal tract distal of the pyloric valve, such as at the duodenal-jejunal juncture where the Ligament of Treitz produces a sharp, relatively fixed turn in the small bowel. In other embodiments, the sleeve may be configured in sections that are sequentially release over time, such as by use of dissolvable retention members interconnecting the sections or by use of an actuation mechanism, such as an electrically activated coupling mechanism. This approach allows the sleeve to be passed in discrete sections that are more easily passed by the patient over the course of treatment. [0014] Methods for treating a patient having an obesity or diabetes related disorder using the claimed anchor implant and method of delivering and deploying such implants are also provided. An exemplary method includes advancing a guidewire through the intestinal tract, advancing a constraining sheath in which the intragastric anchor is constrained, advancing a distal end of an intestinal bypass sleeve attached to the intragastric anchor by use of one or more sleeve guides slidably engaged with the guidewire, withdrawing the constraining sheath so as to deploy the intragastric anchor by allowing expansion of one or more expandable structure and/or allowing resilient recoiling of the intragastric anchor body to a pre-formed anchoring shape; and removing the constraining sheath and guidewire. Such methods may also include use of a sleeve catheter extending distally from the constraining sheath, which may include a push tube for use in pushing the one or more sleeve guides along the guidewire to extend the bypass sleeve through the duodenum and may utilize a locking member extending through a locking channel in the intragastric anchor to facilitate positioning of the intragastric anchor during delivery and release of the anchor from the constraining sheath during deployment.

[0015] These and other embodiments are described in further detail in the following description related to the appended drawing figures.

BRIEF DESCRIPTION OF THE DRAWINGS

[0016] FIG. 1 A shows an intragastric implant in accordance with some embodiments of the invention.

[0017] FIGS. 1B-1C show a distal atraumatic tip of a duodenal portion of an intragastric anchor in accordance with some embodiments.

[0018] FIG. ID shows a prototype of an intragastric anchor in accordance with some embodiments.

[0019] FIG. 2A shows a constraining section of a delivery system for deployment of an intragastric anchor in accordance with some embodiments.

[0020] FIG. 2B shows a distal opening of the constraining section of a delivery system for deployment of an intragastric anchor in accordance with some embodiments. [0021] FIG. 2C shows an anchor rod locked by a guidewire to delivery system in accordance with some embodiments. [0022] FIG. 2D shows an anchor within a constraining section of a delivery system with a sliding seal and an intestinal bypass sleeve in accordance with some embodiments.

[0023] FIG. 2E shows a distal end of a sleeve catheter and the distal end of an intestinal bypass sleeve with sleeve guide beads in accordance with some embodiments. [0024] FIG. 2F shows sleeve guides gathering the distal portion of the sleeve towards the guidewire in accordance with some embodiments.

[0025] FIG. 2G shows a side view of a distal constraining section and offset sleeve catheter in accordance with some embodiments.

[0026] FIG. 2H shows a pushrod extending within a delivery catheter both over a guidewire in accordance with some embodiments.

[0027] FIG. 3 shows a stiffened guidewire for use in a delivery system in accordance with some embodiments.

[0028] FIG. 4 shows an alternate embodiment of an intragastric implant in accordance with some embodiments. [0029] FIG. 5 shows an intragastric implant having an anchor rod in accordance with some embodiments.

[0030] FIG. 6A shows an intragastric anchor engaging the tissue of the stomach in a relatively fixed position within the body in accordance with some embodiments.

[0031] FIG. 6B shows a hooking feature with a distal tip including looping struts in accordance with some embodiments.

[0032] FIG. 6C shows an intragastric anchor with a sliding seal connected to the anchor rod solely at one end of the sliding seal in accordance with some embodiments.

[0033] FIG. 6D shows an intragastric implant including an anchor rod anchor with a pylorus-hooking feature in the structure of the anchor rod itself in accordance with some embodiments.

[0034] FIG. 6E shows an intragastric implant with an anchor rod configured to flex elastically from a substantially straight configuration to a substantially curved configuration and includes a proximal atraumatic tip with an integrated pylorus hooking feature in accordance with some embodiments.

[0035] FIG. 7 shows an intragastric implant may include an intestinal bypass sleeve configure for controlled in situ disassembly may include a plurality of overlapping sections in accordance with some embodiments.

[0036] FIG. 8 shows a frangible intragastric anchor and intestinal bypass sleeve in accordance with some embodiments.

[0037] FIG. 9 shows an example delivery system for use in delivery of an anchor device with bypass sleeve in accordance with some embodiments. [0038] FIG. 10 shows an example delivery system tools for use in delivery of various implantable and anchor device, such as that shown in FIG. 9.

[0039] FIGS. 1 lA-1 IB show a gastro-duodenal anchor with distal and proximal atraumatic features connected by a rod or elongate element in accordance with some embodiments.

[0040] FIGS. 12A-12D show a sleeve guide with a longitudinally oriented guide channel affixed to the sleeve near a distal end in accordance with some embodiments.

[0041] FIGS. 13A-13C show a delivery system including a push catheter and at least one sleeve catheter fixedly attached to one another in accordance with some embodiments.

[0042] FIG. 14 shows example elements that include a distal extension biased laterally to engage a luminal surface of the duodenum to facilitate anchoring. [0043] FIGS. 15A-15E show a method of delivery of an intragastric anchor over the wire with a locking catheter in accordance with some embodiments.

[0044] FIGS. 16A-16C show a method of delivery of an intragastric anchor over the wire using a partially stiff guidewire in accordance with some embodiments.

[0045] FIG. 17A shows a guidewire having a linkage portion and FIG. 17B shows an alternate embodiment of a linked guidewire including a plurality of links surrounding a central wire in accordance with some embodiments. [0046] FIGS. 18A and 18B show an embodiment of an intestinal bypass sleeve supported by a gastro-duodenal anchor that includes a sleeve catheter with a distal portion fixed to the sleeve in accordance with some embodiments.

[0047] FIG. 18C shows an example delivery system with a push catheter with least one finger with a radially inwardly-extending protrusion in accordance with some embodiments.

[0048] FIG. 19 shows an alternate delivery system in accordance with some embodiments.

DETAILED DESCRIPTION OF THE INVENTION

[0049] The present invention generally provides improved medical devices, system and methods for treatment of patients. As described herein, the term "proximal" means nearest the point of origin, within the context of the flow of food particles through the digestive system, and "distal" means situated farthest from the point of origin. For example, in reference to the stomach, a "proximal" portion of the stomach refers to the portion nearest the esophagus where the flow of food into the stomach originates, whereas the "distal" portion of the stomach refers to the portion nearest the pyloric valve where the flow of food particles leaves the stomach. Similarly, the "proximal" portion of the duodenum refers to the portion nearest the pyloric valve, from which the flow of food particles entering the duodenum originates. The terms "upstream" and "downstream" are also in reference to the direction of the flow of food particles through the digestive system. [0050] Exemplary embodiments of the present invention can be used to anchor a treatment device in a stomach of a patient in treating metabolic related disorders such as diabetes, hypertension, and obesity (along with related disorders). Such treatments typically include anchoring a sleeve placed in the gastrointestinal tract in the stomach, such that the sleeve reduces the absorption of ingested matter flowing from the stomach through the

gastrointestinal tract. Advantageously, the present invention allow for anchoring of a treatment device, such as a sleeve, in the stomach of a patient while still allowing sufficient flow of food and nutrients through the gastrointestinal tract via the sleeve without requiring stapling, suturing, resection, or other such invasive modification of the gastrointestinal tissues. The invention described herein exploits the geometry of the gastric and intestinal anatomy to maintain an intragastric implant in a relatively fixed position within the gastrointestinal tract without attachment to the gastric wall. Specifically, the present invention is directed to a gastric implant that comprises an intragastric anchor and a therapeutic or diagnostic device coupled to the anchor. The intragastric anchor of the invention limits the movements of a device attached to it to the displacement available to the anchor within the stomach and/or the duodenum.

[0051] In one aspect, the invention comprises an anchor having an elongate element extending between a proximal end and a distal end and further having a proximal and distal atraumatic feature disposed at each end, wherein the anchor is attached to or supports a treatment or diagnostic device, such as an intestinal bypass sleeve. Each of the proximal and distal atraumatic features are configured to inhibit tissue trauma when urged against a tissue of the stomach or the gastrointestinal tract, while the elongate element is sufficiently rigid so as to resist bending between the proximal and distal ends and is sufficiently long to inhibit advancement of the anchor around a bend of a proximal intestine, such as the proximal portion of the duodenum, when under anchoring loads. In any of the embodiments described herein, the anchor may include one or more expandable structures which may be incorporated into or separate from the proximal and distal atraumatic features. For example, the anchor may include an expandable structure disposed between proximal and distal atraumatic features, the distal atraumatic feature optionally comprising another expandable structure. The elongate element and one or more expandable structures, as well as any other components associated with the anchor, may be made from the same or differing materials, including but not limited to polymers and various metals, including stainless steel alloys and nickel-titanium. In one aspect, the intragastric anchor may include one or more anchoring features to improve anchoring within the gastrointestinal tract as well as to improve patient comfort, thereby facilitating favorable treatment outcomes. Such anchoring features may include any of a duodenal portion extension of the intragastric anchor that extends distal of a coupling structure through a portion of the duodenum, a pylorus hooking feature to inhibit rotation of the anchor and distribute anchoring forces, at least two expandable structures spaced apart by a distal portion of the anchor that both remain distal of the pylorus when deployed, a bent anchoring shape, such as a zig-zag shape, to more closely conform with the natural shape of the gastrointestinal tract on each side of the pylorus. Anchor shapes include but are not limited to angled, curved, and hooked anchor shapes. Such anchoring features allow for improved anchoring by providing sufficient length and dimension to limit pivoting movement of the deployed anchor around the pylorus and may allow hooking onto the pylorus. Examples of these features are described in further detail herein and it is understood that one or more of these anchoring features can be combined in an intragastric anchor in accordance with the principles of the present invention.

[0052] In another aspect, the treatment device comprises an intestinal bypass sleeve having a lumen extending between a proximal opening and a distal opening, wherein the sleeve comprises a material substantially impenetrable to a flow of ingested matter, such as ingested nutrients and food particles, the flow being in contact with the walls of the stomach before passing into the lumen. The proximal opening of the lumen is supported by the anchor distally of the proximal end of the anchor so as to direct the flow of ingested matter from the stomach into the lumen thereby reducing contact of the ingested matter with the walls of the gastrointestinal tract. In an embodiment particularly useful in treating diabetes, the sleeve may prevent ingested matter from contacting a portion of the duodenum, thereby influencing production of certain hormones that affect diabetes, such as ghrelin, a hormone that stimulates hunger. In some embodiments, the anchor includes a coupling structure between proximal and distal atraumatic ends that supports a proximal opening of an intestinal bypass sleeve and maintains the proximal opening downstream of the pylorus near the first section of the duodenum. The coupling structure may include an expandable structure so as to define a sliding seal slidably disposed within the first and/or second section of the duodenum that slidably supports the proximal opening of the bypass sleeve.

[0053] Various aspects of intragastric anchors in accordance with the present invention are described in further detail in the example embodiments below. It is understood that any of the following aspects or various combinations thereof may be utilized in an intragastric anchor to obtain the benefits of the features described herein.

[0054] Bent anchor rod

[0055] In some embodiments, the intragastric anchor includes an elongated anchor rod. The elongated anchor rod may be bent or curved to better align with resting state anatomy such that stimulation of stretch receptors is minimized and the patient is less likely to feel the anchor's presence.

[0056] FIG. 1 A illustrates an intragastric implant including an elongated anchor rod extending from within the stomach and into the duodenum. The elongated anchor 110 can include a rod with one or more curves 120 along its length so as to better align with and minimize deformation of the native anatomy. Less deformation may reduce stimulation of stretch receptors, thus making the patient less likely to feel the implant's presence. As shown in FIG. IB, the rod may curve in different planes to better match the natural 3-dimensional shape of the human stomach and duodenum. In some embodiments, such as that shown in FIG. 1A, the anchor rod includes two curves, one distal to the sliding seal 130 to

accommodate the bend in the small intestine between the 1^st and 2^nd portions of the duodenum, and another curve proximal to the sliding seal to roughly follow the lesser curve of the stomach towards the gastroesophageal junction. The sliding seal 130 may be configured to rest within the duodenum distal to the pylorus 180, within the duodenal bulb, within the 2^nd portion of the duodenum, or to slide between the bulb and the 2^nd portion. Other embodiments may include only one curve. 2^nd Duodenal Portion Extension

[0057] As shown in FIG. 1 A, a duodenal portion extension 140 of the anchor rod distal to the sliding seal may include a distal atraumatic tip 150 configured to limit distal axial motion of the anchor 100 by colliding with the duodenal wall near the junction 160 between the 2^nd and 3^rd portions of the duodenum. The section of anchor rod 110 distal of the pylorus 180 may include distal portion 140, sliding seal 130, and distal atraumatic tip 150, and may be sized to allow limited axial movement between the pylorus 180 and the junction 160 between the 2^nd and 3^rd portions of the duodenum. This configuration ensures that no persistent mechanical pressure is applied to any particular portion of the pylorus or the wall of the duodenum. Axial motion is limited by the distance D, usually between 2 cm and 12 cm, between the proximal face of the sliding seal and the distal face of the distal atraumatic element. In some embodiments, the duodenal portion extension is configured such that axial motion is constrained by mechanical interference of the distal portion 140 with the duodenum and pylorus 180 such that the sliding seal never overlaps the Ampulla of Vater 170. Other embodiments may include a duodenal portion extension 140 sized to press the proximal face of the sliding seal 130 against the pylorus 180 and the distal atraumatic tip 150 against the duodenal lumen at the junction 160 between the 2nd and 3rd portions of the duodenum, further constraining motion of the anchor.

[0058] In some embodiments, the anchor rod includes a relatively straight section 190 between the proximal face of the sliding seal and a proximal curve 120 in the rod. This straight section may be configured to be at least as long as the axial thickness of the pylorus, typically 5 mm to 20 mm, and ideally is long enough to accommodate the limited axial motion allowed by the anchor. [0059] In some embodiments, the overall length, L, of the rod is at least 10 cm, typically a length between between about 15 to 25 cm in length. Ideally the rod should be sized such that the distal atraumatic feature reaches the junction 160 between the 2^nd and 3^rd portions of the duodenum while the proximal atraumatic element extends to the cardia near the gastroesophageal junction 195, as can be understood by reference to FIG. 1 A. Utilizing a rod sufficiently long to extend from the junction between the 2^nd and 3^rd portions of the duodenum to the gastroesophageal junction is advantageous in limiting the ability of the rod to rotate on the pitch axis (end over end) through mechanical interaction with the walls of the relatively fixed 2^nd portion of the duodenum and the gastric wall near the relatively fixed gastroesophageal junction 195.

[0060] As shown in FIG. IB, distal atraumatic tip 150 may include an expandable structure consisting of one or more struts 151 configured to broadly distribute both axial and lateral mechanical loads to the duodenal wall. Those struts may be configured to leave openings or gaps 152 such that any circumferential contact against the duodenal lumen is discontinuous, leaving spaces for pancreatic juices and bile to flow freely outside of the bypass sleeve around the distal atraumatic tip 150. It is appreciated also that a sliding seal, as referred to herein, does not require a perfect seal about the entire circumference so long as the seal is sufficient to direct a flow of ingested matter through the bypass flow sufficient to effect a therapeutic effect. [0061] In some embodiments, the intragastric anchor include an anchor rod having curves, such as curves 121 and 122 shown in FIG. IB, that may bend into non-parallel planes so as to conform to the natural shape of the stomach and duodenum. As shown in FIG. 1C, angle A, describes the angle by which the duodenal portion 140 deviates from the adjacent, more proximal section of anchor rod 110. Angle A may be relatively acute, less than 45 degrees in the embodiment shown in FIG. 1C, maintaining a relatively linear overall configuration for anchor 100 and minimizing mechanical stresses in the rod material when it is placed in the constraining catheter 210. Some embodiments may include no curves at all, with a relatively straight anchor rod extending from the junction 160 of the 2nd and 3rd portions of the duodenum into the cardia or fundus of the stomach. Alternately, as shown in FIG. 6A, in some embodiments angle A may be 90 degrees or greater, tracking natural anatomic angles more closely. [0062] The prototype shown in FIG. ID is made of injection-molded polypropylene and extruded polypropylene film tubing. Molded components are thermally fused together to form the anchor rod. The polypropylene sleeve is thermally fused to molded components. This method of assembly allows the anchor to withstand the considerable forces applied to the anchor and the sleeve by the peristaltic movements of the stomach. While injection molding and thermal fusing of polymer-based components are particularly useful in an intragastric anchor device that remains deployed within a patient over a long period of time (e.g. weeks, months and years), it is appreciated that various other methods of assembly and materials may be used. Alternate sleeve materials may include PTFE film which may be plasma treated and bonded to itself or to portions of the anchor.

Delivery System

[0063] The following describes embodiments in accordance with the invention relating to delivery systems. It is understood that various aspects of these embodiments may be applied to delivery of various implantable devices and anchor devices, including any of the anchor device embodiments described herein.

[0064] In certain embodiments, a delivery system may include a constraining section 210 to put the anchor 100 including expanding structures into a radially-compressed and relatively straightened configuration for per oral delivery through the esophagus, stomach, and at least partially into the duodenum. That constraining section should be small enough in diameter, preferably 20 mm or smaller, and sufficiently tapered to pass easily through the esophagus and pylorus. The constraining section should be long enough to accept substantially the entire length of the anchor rod and its atraumatic tips.

[0065] In some embodiments, the delivery system includes a flexible sleeve catheter 220 that is used to advance an intestinal bypass sleeve through relatively tortuous portions of the gastrointestinal tract such as the duodenum and jejunum. The sleeve catheter can be attached to a distal portion of the constraining section offset from its central axis such that the majority of the distal opening 230 of the constraining section remains open and unobstructed. The proximal opening 240 of the sleeve catheter can be tapered and blended with the constraining section wall so as to minimize mechanical resistance during anchor deployment. In other embodiments, the sleeve catheter may be integrally formed with the constraining sheath and still in other embodiments, the sleeve catheter may be an integral part of the sleeve itself. [0066] In some embodiments, the anchor rod 110 includes a locking channel 317 that can be placed within the constraining section substantially in-line with the sleeve catheter 220 lumen such that a locking catheter and/or guidewire 250 may extend through each lumen, thus locking the anchor to the delivery system. This configuration may be advantageous in allowing easy withdrawal of the intragastric implant after the anchor has been deployed out of the constraining catheter 210. This way, if the deployment was not satisfactory the implant may be removed, reconstrained in the constraining catheter, and redeployed to the target site.

[0067] In some embodiments, the delivery system includes a sleeve catheter that extends proximally throughout the length of the constraining catheter such that the guidewire 250 does not lock the anchor to the delivery system. This configuration is particularly

advantageous if a concentric delivery system is desired, with the sleeve catheter extending within the intestinal bypass sleeve. Additionally, a non-locking sleeve catheter's lumen may be configured to extend to the proximal end of the delivery system so as to maintain an ability to flush the channel.

[0068] As shown in FIG. 2D, an embodiment of the invention provides for an intestinal bypass sleeve 260 to extend distally from the constraining section alongside the sleeve catheter 220. This configuration enables the sliding seal 130 to which the intestinal bypass sleeve 260 is attached to be compressed within the constraining section while providing mechanical support for the sleeve catheter which extends to the distal end of the bypass sleeve. As shown in FIG. 2E, the sleeve catheter may support at least one sleeve guide 270 attached to a distal portion of the intestinal bypass sleeve 260. Each of the sleeve guides 270 include a channel 271 through with a locking catheter 304 (as shown in Fig. 12B) and/or a guidewire 250 may extend so as to couple the distal end of the flexible intestinal sleeve 260 to the distal end of the sleeve catheter 220. This way the sleeve catheter may support the bypass sleeve 260 axially such that it may be advanced through the gastrointestinal tract in an extended configuration. In one embodiment, at least one sleeve guide 270 may be affixed to an outer surface of the bypass sleeve 260 such that a sleeve catheter extending alongside the bypass sleeve may abut the guide when advanced over a guidewire 250. As shown in FIG. 2F, one embodiment including a plurality of sleeve guides, a sleeve guide may be affixed to an inner surface of the bypass sleeve such that the wall of the distal sleeve opening is gathered towards the guidewire reducing the frontal area of the sleeve for easier advancement through the gastrointestinal tract. Some embodiments may include sleeve guides molded integrally with the bypass sleeve rather than affixed to a surface. Some embodiments may include sleeve guides in the form of simple or reinforced perforations in the bypass sleeve material itself such that the guidewire channel crosses the bypass sleeve wall rather than being parallel to it. In FIG. 2D, the example anchor is shown within a constraining section 210 of delivery system, sliding seal and distal atraumatic tip 150 compressed and rod curves substantially straightened, intestinal bypass sleeve 260 extending distally from the anchor alongside sleeve catheter 220.

[0069] As shown in FIG. 2H, the delivery system may include a slidable pushrod 280 that extends through a lumen of the delivery catheter (shown, left side of Fig. 2H) to the constraining section. In some embodiments, the guidewire 250 and/or locking catheter may extend through a lumen in the pushrod 280.

[0070] In some embodiments, the guidewire 300 can include a stiffened section 310 configured to extend from the esophagus to the second portion of the duodenum, such as shown in FIG. 3. The stiffened section may be configured to be sufficiently stiff to support a stomach which has been deformed into a "short" or "straight" position by an endoscopist and temporarily maintained in that position. This is advantageous in that a flexible catheter such as a sleeve catheter 220 may traverse a relatively open space like the stomach over the stiffened section 310 without buckling or "looping" while remaining flexible enough to travel over a distal, flexible section of guidewire extending through more tortuous portions of the gastrointestinal tract such as the duodenum and jejunum.

Simple long rod

[0071] As shown in FIG. 4, some embodiments of an intragastric implant include a substantially straight elongate element or rod 410 extending from near the gastroesophageal junction 405 to near the junction 420 of the 2^nd and 3^rd portions of the duodenum. As would be understood by one of skill in the art, the duodenum is generally C-shaped and the first portion refers to the duodenal bulb, the second portion refers to the generally vertical portion downstream from the duodenal bulb and the third portion refers to the laterally extending portion downstream from the second portion. The anchor rod can be relatively stiff compared to the anatomy of the gastrointestinal tract such that it remains substantially straight after implantation, or the anchor rod may be configured to allow for substantial flexing in response to gastric and intestinal tissue recoiling to its natural shape and position. Some embodiments may include a proximal atraumatic tip 440 extending to the gastric fundus 445 where it may promote a feeling of satiety by stimulating stretch receptors in the gastric wall as well as limiting axial motion. When configured for bypassing a portion of the small intestine a sliding seal 430 supporting an intestinal bypass sleeve may be located approximately within the duodenal bulb. Alternate embodiments may include a sliding seal located within the antrum, body of the stomach, esophagus, duodenum, or anywhere in- between.

Rod into the esophagus

[0072] In some embodiments, the anchor may include a version of either the straight or bent rod that extends through the lower esophageal sphincter and into the esophagus to provide extra rotational anchoring.

[0073] As shown in FIG. 5, some embodiments of an intragastric implant 500 include an anchor rod 510 extending from the esophagus, through the lower esophageal sphincter 505, through the pylorus 515, and substantially to the junction 525 between the second and third portions of the duodenum. This configuration of the elongate element or rod may provide enhanced anchoring capacity by providing extensive lateral support between the relatively- fixed esophagus and gastroesophageal junction and the relatively- fixed second-portion of the duodenum. Embodiments of an intragastric implant may include an esophagus-to-duodenum anchor rod supporting a sliding seal 520 and bypass sleeve 530 within the esophagus. The bypass sleeve may extend from the esophagus to the small intestine, allowing nutrients to bypass the stomach as well as a portion of the small intestine such as the duodenum to enhance weight-loss as well as treating metabolic syndrome.

[0074] As shown in FIG. 5, a sliding seal 520 may be include a compliant loop 540 larger in diameter than the anatomical lumen to which it is to be inserted to form a circumferential sealing surface. The loop 540 may be affixed to an anchor rod 510 such that it

accommodates lumens smaller than it's own diameter by deflecting to an angle relative to the lumen's central axis. Stiffness of the elongate element or rod and the loop itself may maintain circumferential mechanical contact between the loop 540 and the lumen. As shown in FIG. 5, bypass sleeve 530 may be affixed to an outer surface of loop 540 and the anchor rod 510 may extend distally within the sleeve 530. Alternate embodiments may include a bypass sleeve affixed to an inner surface of the loop 540 and an anchor rod 510 extending distally alongside and external to the sleeve. Pylorus hooking

[0075] As shown in FIG. 6A, gastrointestinal motility including peristalsis acting on an intestinal bypass sleeve 660 may be resisted by an intragastric anchor which engages the tissue of the stomach surrounding the pylorus 630 which is relatively fixed in position within the body by ligaments and connective tissue. The elongate element or rod 610 extending across the pylorus and including a duodenal portion will tend to remain coaxial with the pyloric sphincter such that a hooking feature 620 extending from the anchor rod 610 axis will tend to maintain a relatively fixed radial distance from the gastric outlet. Generally, the pylorus hooking feature is adapted and positioned to engage the antrum along the greater curvature of the stomach. The distal portion 621 of the hooking feature 620 may be configured with a smooth surface and relatively large surface area so as to spread mechanical load over a relatively broad tissue area. Examples of such configurations include spheres, arcs, loops, expandable struts and the like. FIG. 6B shows a hooking feature 650 with a distal tip 651 including looping struts configured to fold and compress radially while providing a large distal surface area. A protruding hooking feature 620 might also help to roll-stabilize the anchor rod 610 by engaging gastric tissue at a point radially distant from the portion of the anchor rod crossing through the pylorus.

[0076] As shown in FIG. 6C, some embodiments of an intragastric anchor with a pylorus hooking feature 695 include proximal sections of the anchor rod 690 extending no further into the stomach than the pylorus and antrum. The hooking feature 695 may be configured to flex elastically from a position where it is substantially in-line with the main axis of the anchor rod 690 to a position where it's distal portion 696 is radially distant from the main axis of the anchor rod. In some embodiments, the intragastric anchor includes a sliding seal 691 connecting to the anchor rod 690 solely at one end of the sliding seal. Such a

configuration may enable a sliding seal 691 to pivot about a connecting point 693 on the anchor rod 690 such that the central axis of the sliding seal may rotate in pitch and yaw relative to the anchor rod 690 and maintain better apposition to the intestinal lumen. In some embodiments, the sliding seal 691 is connected via proximal-facing apices 692 such that connecting struts 694 act as ramps upon withdrawal of the implant through the pylorus and lower esophageal sphincter.

[0077] As shown in FIG. 6D, alternate embodiments of an intragastric implant 680 may include an anchor rod anchor 685 with a pylorus-hooking feature 681 in the structure of the anchor rod 685 itself. An anchor rod 685 may be configured to flex substantially elastically from a substantially straight configuration during delivery within a constraining catheter to a target site in the gastrointestinal tract to a configuration including significantly acute angles after implantation. Such an anchor rod 685 may include portions made of nickel titanium alloy, stainless steel, or other suitably elastic materials. In some embodiments all or most of the length of the anchor rod 685 may be made of nickel titanium alloy, stainless steel, or the like and may also include a sliding seal 684 as well as proximal 682 and distal 683 atraumatic tips molded from polymers such as polypropylene, polyethylene, or any suitable material. Alternate embodiments may include a sliding seal 684 including nickel titanium alloy or other non-polymeric materials.

[0078] As shown in FIG. 6E, an intragastric implant 670 may include an anchor rod 675 configured to flex elastically from a substantially straight configuration to a substantially curved configuration and include a proximal atraumatic tip 676 with an integrated pylorus hooking feature 677. The pylorus hooking feature 677 may be configured to be parallel to the anchor rod 675 when constrained to a substantially straight configuration and to extend radially away from the central axis of the anchor rod 675 when the anchor is unconstrained and assumes a curved configuration (as shown in FIG. 6E). The anchor rod may be made of nickel titanium alloy, stainless steel, or any suitable material.

[0079] As shown in FIG. 6E a sliding seal 671 configured to produce a circumferential seal within a lumen may include two loops 672 affixed to each other at two connecting points 678 on their diameters and affixed to an anchor rod 675 by struts 673 affixed to their proximal- facing apices. A bypass sleeve may be affixed to the section of each loop proximal to the connecting points 678 so as to form a continuous circumferential connection. This configuration may be compressed radially so as to fit into a constraining catheter for delivery. Implant Configured for in situ disassembly

[0080] As implants intended for temporary implantation typically require patient follow-up and cooperation for explantation it may be advantageous to configure a temporary intragastric implant for in situ disassembly after a given period of time has elapsed. In particular, an intragastric implant supporting a flexible intestinal bypass sleeve might be configured to shed relatively small distal portions of that sleeve sequentially after a period of time has elapsed so as to ensure that an uncontrolled and potentially hazardous detachment of the entire bypass sleeve does not occur due to mechanical degradation over time. While an entire intestinal bypass sleeve extending into the jejunum may be 45 cm or longer, the sleeve portions configured for individual controlled detachment may each be short enough in length to pass easily out of the gastrointestinal tract with a minimal risk of causing an intestinal obstruction.

[0081] As shown in FIG. 7, an intragastric implant 700 may include an intestinal bypass sleeve 705 configured for controlled in situ disassembly may include a plurality of overlapping sections 740. In some embodiments, more distal sections of the bypass sleeve circumferentially overlap more proximal sections such that nutrient particles travel distally tend to stay within the bypass sleeve 705. A frangible intestinal bypass sleeve may be held together with fastening elements that are electrically disengageable such as a partially electrically-insulated stainless steel retainer 715 which may be electro lyrically eroded to release sections of bypass sleeve sequentially. Some embodiments may include batteries 795 such as button cell batteries and a microcontroller programmed to supply direct current to one or more electrolytically erodible elements after a specific period of time has elapsed. In one embodiment batteries, a circuit board 780 including a microcontroller, and an electrode 790 may be located within a portion of anchor rod 710 such as the distal atraumatic tip 720. At least one electrical conductor 750 insulated with an acid-resistant material such as PTFE may connect to the circuit board and extend distally to each of the frangible junctions 730 between bypass sleeve sections 740. The electrical conductors 750 may be bundled as cables, flex circuits, or any suitable type of bundled electrical conductor. Each electrical conductor may connect electrically to an electrically insulated circumferential conductor 760 affixed near the distal end of one bypass sleeve section 740 to which at least one uninsulated erodible retainer 715 is affixed and is electrically connected. Erodable retainers 715 may pierce, pinch, bond with, or mechanically connect in any suitable way with the overlapping proximal end of the distally adjacent sleeve section 740 so as to mechanically affix it to a more proximal sleeve section. Conductors connecting to more distal sleeve sections may be mechanically but not electrically connected to each junction 730 that they pass and may include a small uninsulated section 770 at each junction 730 that they pass. The uninsulated section 770 may be made of stainless steel, nickel titanium alloy, or any other suitable material that sufficiently resists acid and mechanical cycling. Each uninsulated section 770 of conductor should be sized to erode later than the erodible retainers 715 to which it is connected. If a conductor 750 passes through more than one junction 730 and includes more than one uninsulated section 770 along its length, more distal uninsulated sections should be sized to fully erode earlier than more proximal uninsulated sections to insure that all uninsulated sections are fully eroded as a sleeve section 740 is detached.

[0082] In some embodiments, a frangible intestinal bypass sleeve may be configured to bypass a greater portion of the small intestine and have a greater malabsorptive effect to produce significant weight-loss for a period of time, and then shed the more distal portion of the sleeve to reduce malabsorption while retaining a bypass of the duodenum for the continued treatment of metabolic syndrome and type 2 diabetes. By way of example, an intestinal bypass sleeve supported by an intragastric anchor rod may be configured for a period of accelerated weight-loss therapy at it's full length of 50 cm to 100 cm and a period of therapy focused on treatment of metabolic syndrome at a shorter length such as 25 cm to 45 cm. After an accelerated weight-loss period is completed, the implant may be configured to shed a 15 cm segment from the distal end of the bypass sleeve each day until the remaining sleeve is 30 cm long and bypasses only the duodenum. Alternately, a frangible intestinal bypass sleeve may be configured for elective shortening once a patient has lost a given amount of weight or some other therapeutic or physiologic goal has been achieved. Elective shortening may be achieved with an external transmitter and inductive coupling, capacitive coupling, acoustic coupling, or any suitable means of communicating with an implant, and may rely on an external power source such as an inductively coupled power supply rather than internal batteries. [0083] As shown in FIG. 8, embodiments utilizing a frangible intragastric anchor and intestinal bypass sleeve may include a hypertonic salt solution 810 encapsulated in a membrane 820 permeable to water and configured to absorb water through osmosis at a predictable rate to power an osmotic actuator 850. Osmotic pressure may drive a piston 830 to disengage a pin 840. The membrane 820 may be affixed to one section 805 of bypass sleeve and the pin 840 may be affected to an adjacent section 806 of bypass sleeve.

[0084] In some embodiments, the anchor may be configured with an osmotic actuator 860 attached to a one section 861 of bypass sleeve may be configured transfer water to a hypertonic solution 867 to move a piston and withdraw a pin 866 from a locking hole 870 affixed to an adjacent section 862 bypass sleeve, severing the mechanical connection between bypass sleeve sections after a period of time has elapsed. The thickness of the semipermeable membrane or the permeability of the membrane material may be selected such that a longer or shorter period of time elapses before detachment occurs. In this way, an intragastric implant may be configured to detach more distal sections of a frangible intestinal bypass sleeve before more proximal sections of the sleeve.

[0085] In some embodiments, expansion of an osmotic capsule may fracture or open a membrane which is relatively impermeable to metal ions and upon fracture may expose a dissimilar metal electrode such that a connecting element is electrochemically eroded without a battery or external power source.

[0086] FIG. 9 illustrates an example delivery system for use in delivery of an example anchor device with bypass sleeve and FIG. 10 illustrates example delivery system tools for use in delivery of various implantable and anchor device, including that shown in FIG. 9. Gastro-Duodenal Anchor

[0087] In another aspect, embodiments of the invention relating to anchor devices and methods for delivery can include any of the following features described below and shown in the examples of FIGS. 11-19.

[0088] As shown in the example of FIG. 11A, embodiments of the gastro-duodenal anchor 100 may include a distal atraumatic tip 101 and a proximal atraumatic tip 102 connected by a rod 103. The anchor 100 may include a locking channel 104 extending through a portion of its structure. In some embodiments, the locking channel 104 is a hole extending from the proximal atraumatic tip 102 to the rod 103 and configured to slidably accept a locking catheter 304. The distal atraumatic tip 101 may include a plurality of radial struts 105, a plurality of axial struts 108, and a circumferentially compliant sealing section 109. In some embodiments, the expandable structure comprises a plurality of radial struts 105 biased proximally to facilitate atraumatic passage distally through the gastrointestinal tract. The radial struts 105 may include thinner sections 106 configured to flex and thicker sections 107 configured to remain substantially rigid. The axial struts 108 may be relatively thick and configured to remain substantially rigid. Anchor 100 may include one or more radiopaque markers 121 along its length to aid in fluoroscopic visualization. The radiopaque markers may be made of materials such as gold, tantalum, or stainless steel, or the anchor may include a radiopaque substance such as barium sulfate or metal particles throughout a portion of its structure. In some embodiments, the anchor 100 includes a radiopaque marker 121 near the distal atraumatic tip 101 and near the proximal atraumatic tip 102. [0089] As shown in FIG. 1 IB, in some embodiments, a gastro-duodenal anchor 110 can be configured for longitudinal symmetry with a distal support section 118 mirroring the proximal sealing section 109 in structure. Such a longitudinally symmetric structure may be advantageous in providing more consistent radial stiffness along the length of the distal atraumatic tip than a design employing longitudinally asymmetric support structures. Anchor 110 may include a distal atraumatic tip 111 and a proximal atraumatic tip 112 connected by a rod 113. Anchor 110 may include a locking channel 114 extending through a portion of its structure. Locking channel 114 may be a hole extending from the proximal atraumatic tip 112 to the rod 113 and configured to slidably accept a locking catheter 304. The distal atraumatic tip 111 may include a plurality of radial struts 115, a plurality of links 120, and circumferentially compliant sealing 119 and distal support 118 sections. In some such embodiments, the plurality of radial struts 115 are biased proximally to facilitate atraumatic passage distally through the gastrointestinal tract. The radial struts 115 may include thinner sections 116 configured to flex and thicker sections 117 configured to remain substantially rigid.

[0090] As shown in FIGS. 12A-12B, one or more sleeve guides 206, each with a longitudinally oriented guide channel 207, are affixed on or defined in an inner or outer surface near the distal end of the sleeve 205 via thermal bonding, gluing, staking, swaging, crimping, or any suitable attachment means. In some embodiments, multiple sleeve guides 206 are affixed to the inner surface of sleeve 205 at equally-spaced intervals around the sleeve circumference. Those sleeve guides 206 may be affixed in staggered positions along the longitudinal axis such that they do not interfere with each other when placed into axial alignment to accept the locking catheter 304. Guide channel 207 may be configured to slidably accept locking catheter 304 and constrain the distal sleeve tip to the axis of the locking catheter. The guide channel 207 may also be sized to prevent passage of sleeve catheter 302, thus keeping the distal sleeve tip distal to the sleeve catheter 302. This configuration enables the distal sleeve tip to be supported by the sleeve catheter 302 keeping the sleeve 205 substantially extended as the delivery system is advanced distally through the gastrointestinal tract. Some embodiments of sleeve 205 may include a friction-reducing coating such as a hydrophilic polymer or any other suitable friction-reducing material on the outer surface. Sleeve flaps 208 formed when multiple sleeve guides 206 are aligned may be beveled such that they taper proximally to reduce mechanical resistance as the sleeve is advanced. [0091] In some embodiments, the sleeve guides 206 are configured to be substantially radiopaque. The sleeve guides can be constructed of polymer with a radiopaque additive such as barium or they may be constructed of naturally radiopaque materials such as stainless steel or other metals. Some embodiments may include sleeve guides 206 that are configured to detach from the sleeve 205 after a period of time or to biodegrade. These embodiments may include bioerodible materials such as magnesium, hyaluronic acid or any other suitable bioerodible material.

[0092] In some embodiments, a single sleeve guide 206 configured to may be adhered to a multiple points of the sleeve's 205 circumference or to relatively larger portion of the sleeves entire circumference. Such a sleeve guide may be configured to erode and/or detach after a given period of time in the presence of water or upon contact with a specific ingested substance. In some embodiments, the delivery system may include multiple such sleeve guides that adhere to multiple points of the sleeve's circumference.

[0093] In some embodiments, the anchor 100 is configured to be inserted into the gastrointestinal tract without being radially constrained. In alternate embodiments the anchor's distal atraumatic tip 101 may be radially constrained by an external constraining catheter 210. Radial compression provided by the constraining catheter 210 may help the anchor's distal atraumatic tip 101 more easily cross the pyloric valve. The constraining catheter 210 is withdrawn proximally after the distal atraumatic tip 101 has passed into the duodenum.

Delivery System

[0094] As shown in FIGS. 13A-13C, a embodiments of a delivery system includes a push catheter 301 and at least one sleeve catheter 302 which may be fixedly attached to one another. The sleeve catheter 302 extends distally from the push catheter 301 sufficiently to maintain a sleeve 205 in a substantially longitudinally-extended configuration. This sleeve configuration during delivery is advantageous in that it may enable the delivery of a longer bypass sleeve 205 into the small bowel than might be possible if the sleeve were substantially axially compressed for delivery. The sleeve catheter 302 may be offset from the push catheter's central axis and may be fused to a wall of push catheter 301. In alternate embodiments the push catheter and sleeve catheter may be separate and independently moveable. Some embodiments may include a sleeve catheter 302 with a tapered, narrowed, or relatively more fiexible distal section 310 configured to be more flexible than a relatively stiff proximal section 311 of the sleeve catheter 302. The flexible distal section may be approximately 4 cm to 20 cm in length and may include materials different from the proximal section 311. A locking catheter 304 may extend through substantially the entire length of the lumens of the combined push 301 and sleeve 302 catheters as well as through the guide channel 207 of each sleeve guide 206. The sleeve catheter 302 may be positioned proximally to the sleeve guides 206 to act as a backstop and provide compressive longitudinal stiffness to enable the sleeve guides 206 to maintain tension in the sleeve 205 thus keeping it in a substantially longitudinally-extended configuration while it is advanced distally through the gastrointestinal tract. [0095] In some embodiments, the push catheter 301 includes an anchor locking section 303 which is configured to accept the anchor's proximal atraumatic tip 102. The sleeve catheter 302 may include a proximal lumen opening 305 located within the anchor locking section 303. The proximal end of anchor 100 may be placed within the locking section 303 such that a removable locking catheter 304 and/or a guidewire 307 may pass through sleeve catheter 302, through the anchor's locking channel 104, and through the push catheter's 301 central lumen. This configuration enables the anchor 100 to be locked into the delivery system when the locking catheter 304 and/or guidewire 307 are present and released from the delivery system by removal of locking catheter 304 and/or guidewire 307. The push catheter distal lumen opening 306 may extend longitudinally proximally of the sleeve catheter proximal opening 305 such that the implant's proximal atraumatic tip 102 may enter and exit the push catheter 301 substantially without mechanical interference with the push catheter 301 or sleeve catheter 302. The push catheter 301 may include a countersink or other recessed space 308 with a shoulder or other mechanical limit against which the implant proximal atraumatic tip 102 may rest. In some embodiments, the sleeve catheter 302 may extend through the implant distal atraumatic tip 101 and through the lumen of the sleeve 205. This embodiment may be advantageous because in helping keep the anchor substantially aligned with the delivery system. Some embodiments include a sleeve catheter 302 which extends distally through a lumen in the anchor rod 103. Some embodiments may include a sleeve catheter 302 extending distally alongside the sleeve 205 and the anchor's distal atraumatic tip 101 rather than extending through them.

Gastric Bridge [0096] In some embodiments, locking catheter 304 serves an additional function as a repositionable stiffening element which bridge the relatively large gastric space between the gastro-esophageal junction and the pylorus. For instance, the locking catheter 304 may be made of a relatively stiff but deflectable material such as stainless steel, nickel-titanium alloy, liquid crystal polymer, or any suitable material, and may support the relatively flexible sleeve catheter 302 as it transits the stomach over the guidewire 307. After the distal tip of the sleeve 205 passes through the pyloric valve the locking catheter 304 may be held in a relatively fixed longitudinal position bridging the esophagus and duodenum while the push catheter 301 and sleeve catheter 302 advance distally past it. This configuration enables the delivery system to be relatively stiff within the stomach while becoming relatively flexible to advance through the turns of the small bowel.

[0097] In some embodiments, a locking catheter 304 may include at least one limited- motion joint that may flex relatively freely until reaching hard stops. This arrangement enables the locking catheter to flex to a predetermined minimum radius of curvature and to substantially resist further flexing beyond that radius. This may be advantageous in forming a curved but relatively stiff bridge between the gastroesophageal junction and the pylorus that reflects the shape taken by an endoscope placed in a "straight" position across the stomach and that will hold the stomach substantially in that "straight" position in the absence of the endoscope. Keeping a substantially straight position is advantageous in that it prevents excessive bowing and buckling of the sleeve catheter.

[0098] In some aspects, the same bridging function that maintains the straight position of the stomach may also be achieved by employing a guidewire 607 that includes a relatively stiff portion 608 of sufficient length to the longitudinal distance between the

gastroesophageal junction and duodenum as shown in FIG. 16B and that also includes a relatively flexible portion 611 of the guidewire distal to the stiff portion that is sufficiently long to guide a bypass sleeve 205 fully into the small bowel. Such variation in longitudinal stiffness may be achieved by grinding portions of the guidewire 607 to smaller, more-flexible diameters and other portions to larger, less-flexible diameters. Alternately longitudinal stiffness may be varied by affixing a relatively stiff sheath made of stainless steel, nickel- titanium alloy, an over- wrap of helically wound wire, plastic tubing, heat- shrink tubing, or the like over a portion of the guidewire 's length via crimping, welding, soldering, gluing, heating, or any suitable fixation technique. A guidewire with a stiffened section 607 may be inserted through the working channel an endoscope which has been placed into the small bowel and manipulated into a "straight" position. The stiffened section 608 of the guidewire should extend at least to the first turn of the duodenum. The endoscope may then be removed while the stiff portion of the guidewire maintains the stomach in a relatively straightened position. An intestinal bypass sleeve supported by a relatively flexible sleeve catheter may then be advanced over the guidewire 607 and into the small intestine.

[0099] In some embodiments, such as that shown on FIG. 17A, the guidewire 700 includes a linkage portion 701. The linkage portion 701 may be configured to flex within a limited range and then become relatively stiff when a flexing limit has been reached. The linkage portion may include a plurality of slots 702 between joints 703 along its length. The joints may include connectors 704 configured to flex or pivot while retaining the ability to support tensile loads. The slots and connectors may be sized and positioned so as to enable the guidewire to flex with relative ease to a minimum radius of curvature limited by inter-joint contact 705 as shown in the magnified view in FIG. 17A. The linkage may be made of stainless steel, nickel-titanium alloy, or the like. The linkage portion may include a covering layer 706 made of polymer such as PET, PTFE, or any suitable material.

[0100] In some embodiments of a linked guidewire, such as that shown on FIG. 17B, the linkage portion 710 includes a plurality of tubular links 711 surrounding a central wire 712. The distal and proximal links may be fixed to the central wire. Some or all of the links can be spaced such that inter-joint contact 713 when the guidewire is flexed limits flexure to a specific radius of curvature. In addition, the links can be configured to provide different flexure limits along different directions of flexure based on the shape and spacing of interfacing portions of adjacent links.

[0101] In some embodiments, the linkage include at least one helically- wound coil whose proximal and distal ends are fixed to a central wire. The coil's windings can be spaced such that they interfere in compression when the guidewire is flexed to a specific radius of curvature while the central wire provides opposing tension.

Sleeve with attached Sleeve Catheter

[0102] As shown in FIGS. 18A and 18B, some embodiments of an intestinal bypass sleeve 805 supported by a gastro-duodenal anchor can include a sleeve catheter 802 with at least a relatively distal portion fixed to the bypass sleeve 805. The sleeve catheter may be affixed to the sleeve via melt bonding, gluing, heat staking, suturing, or any suitable fixation means. This configuration may be advantageous in that sleeve guides 206, as depicted in FIG. 12, are not needed and that the sleeve catheter 802, anchor 850, and push catheter 801 may be arranged and delivered coaxially over a guidewire 807. The bypass sleeve 805 may include a beveled sleeve flap 808 biased proximally from the distal end of the sleeve catheter 802. In this configuration the sleeve catheter 802 may include at least one discrete radiopaque marker 860 such as gold, tantalum, or stainless steel, or may include a radiopaque substance such as barium sulfate or metal particles throughout a portion of its structure. The delivery system 800 may be advanced over a partially-stiff guidewire 807 that has been placed in the gastrointestinal tract as shown previously in FIGS. 16A and 16B.

[0103] In some embodiments, such as that shown on FIG. 18C, the delivery system may include a push catheter 870 having at include least one finger 871 with a radially inwardly- extending protrusion 872. Typically, the inwardly extending protrusion protrudes to a radius smaller than that of the anchor's proximal atraumatic tip 873. In some embodiments, the delivery system includes a constraining catheter 874 that inhibits or prevents the fingers 871 from flexing radially outwards, thereby retaining or locking the anchor 850 within the push catheter 870. In some embodiments, when the constraining catheter 874 is withdrawn such that it no longer prevents the fingers 871 from flexing radially outward the push catheter can be removed from the anchor with minimal force. Delivery alongside Endoscope

[0104] In some embodiments, such as the delivery system 900 shown in FIG. 19, the system is configured for use alongside an endoscope. The delivery system may include a push catheter 901 and sleeve catheter 902 which may be fused together over their lengths. An opening 963 between the sleeve catheter 902 and push catheter 901 lumens allows the locking catheter 904 and guidewire 907 to travel through the sleeve catheter 902 through the anchor's locking port 954 and into the push catheter's 901 lumen. The sleeve catheter runs alongside intestinal bypass sleeve 905 and supports sleeve guides 906 attachable to an outer surface of the sleeve 905, the gastro-duodenal anchor 950 supporting intestinal bypass sleeve 905. [0105] In operation, an endoscope 909 may first be placed into the small intestine per standard endoscopic technique, a guidewire 907 is inserted through the endoscope's working channel, and the endoscope is removed leaving the guidewire in place. The delivery guide 960 may then be attached to the endoscope 907 proximally to the endoscope's steering tip by snapping clips 961 over the endoscope's body. The delivery system 900 may then be mated with the delivery guide 960 by inserting the sleeve catheter 902 into the delivery guide's C- channel 962 and advancing it to the distal end of the delivery guide 960. The proximal end of the guidewire 907 may then be inserted into the distal end of the locking catheter 904 and advanced until it exits the proximal end of the locking catheter. The endoscope with the delivery system attached may then be reintroduced into the small bowel and manipulated into a straight position. The delivery system 900 may then be advanced via push catheter 901 past the endoscope 909 through the delivery guide 960 until the anchor's 950 distal atraumatic tip 951 has passed fully through the pylorus and entered the duodenum. The endoscope 909 and delivery guide 960 may then be withdrawn from the duodenum, leaving the delivery system 900 and anchor 950 across the pylorus. The locking catheter 904 and guidewire 907 may then be withdrawn to release the sleeve guides 906 and gastro-duodenal anchor 950. The endoscope and delivery system may then be withdrawn from the gastrointestinal tract, leaving the anchor 950 and sleeve 905 in place.

Anti-Rotation anchor extension

[0106] In some embodiments, the anchor 400 may include elements configured to prevent rotation of the anchor about its longitudinal axis. As shown in FIG. 14, examples of these elements include a distal extension 401 which is biased laterally such that it may engage a luminal surface of the duodenum distal to the first turn to resist any torques applied to the anchor by muscular contraction of the stomach and/or duodenum or other movement. Some embodiments of the distal extension 401 may be sufficiently compliant to be delivered in a substantially straightened configuration and may include at least one alignment ring 402 including a passage through which a sleeve catheter 302 may extend to maintain substantial alignment of the extension with the longitudinal axis of the delivery system prior to deployment. Some embodiments of a distal extension may be configured to be relatively flexible in one plane that intersects the anchor's longitudinal axis but be substantially inflexible in an orthogonal plane that also intersects the anchor's longitudinal axis. This configuration is advantageous in that it may enable a distal extension to enter the

gastrointestinal tract in a configuration that is substantially aligned with the anchor's rod and subsequently conform to a turn in the duodenum within one plane while retaining substantial stiffness in an orthogonal plane. Deployment over the wire with locking catheter as stiffener

[0107] In accordance with some embodiments, a delivery system 500 for delivery of an intestinal bypass sleeve 505 with gastro-duodenal anchor 550 over-the-wire using a locking catheter as a stiffener is depicted on FIGS. 15 A, B, C, & D, & E. This approach enables the bypass sleeve to advance through the gastrointestinal tract while remaining in a substantially extended configuration. For example, such a delivery system may be employed through the following steps:

1) Place endoscope 509 per orally through the esophagus, stomach, through the pyloric sphincter, and advance through the duodenum and proximal jejunum.

2) Insert a stiff guidewire 507 into the endoscope's working channel and advance until a distal portion of the guidewire is visible through the endoscope as shown in FIG. 15A.

3) Withdraw the endoscope entirely from the gastrointestinal tract, maintaining the position of the guidewire in the small bowel as shown in FIG. 15B.

4) Lubricate the delivery system and sleeve 505 along its length with surgical jelly or similar medical lubricant.

5) Insert the proximal end of the guidewire into the distal tip of the locking catheter and advance it through the delivery system 500, through the flexible distal section 510 of the sleeve catheter 502, and through the sleeve guides 506 until it protrudes from the proximal end of the locking catheter 504.

6) As shown in FIG. 15C, advance the delivery system 500 distally over the guidewire such that the bypass sleeve 505 advances through the stomach and across the pyloric sphincter.

7) Continue advancing the delivery system 500 via the push catheter 501 while

maintaining locking catheter 504 in a substantially fixed position as shown in FIG. 15D until the anchor's distal atraumatic tip 551 reaches the pyloric sphincter. The sleeve catheter 502 will advance over and beyond the locking catheter 504, advancing the sleeve 505 in a substantially extended configuration until it is completely within the small intestine.

8) Gradually increase the force on push catheter 501 to advance the delivery system distally slowly over the guidewire continuing until the anchor's distal atraumatic tip 551 passes fully through the pyloric sphincter. 9) Confirm that the distal atraumatic tip 551 has fully entered the duodenal bulb fluoroscopically and/or by tugging slightly on the push catheter 501. If the cage reemerges from the pylorus, repeat step 9.

10) Withdraw the locking catheter 504 and guidewire 507 proximally from the push catheter 501 as shown in FIG. 15D such that the guidewire completely exits the sleeve guides 506 to release the distal portion of the sleeve 505 and completely exits the anchor's locking channel 554 to release anchor 550 from the delivery system 500.

11) Withdraw the delivery system 500 from the gastrointestinal tract. Deployment over-the-wire using partially stiff guidewire

[0108] In accordance with some embodiments, a delivery system 600 for delivery of an intestinal bypass sleeve 605 with gastro-duodenal anchor 650 over-the-wire using a partially stiff guidewire is depicted on FIG. 16 A, B, C, & D. This configuration allows the bypass sleeve 605 to advance through the gastrointestinal tract while remaining in a substantially extended configuration while also transiting the stomach in substantially straight position. For example, such a delivery system may be employed through the following steps:

1) Place endoscope 609 per orally through the esophagus, stomach, through the pyloric sphincter, advance through the duodenum and proximal jejunum.

2) Place the endoscope 609, stomach, and proximal duodenum into a "straight"

position.

3) Insert a partially-stiff guidewire 607 into the endoscope's working channel and advance until a portion of the stiff section 608 of the guidewire is present inside the duodenum, inside the esophagus, and inside the stomach as shown in FIG. 16 A.

4) Withdraw the endoscope entirely from the gastrointestinal tract, maintaining the position of the guidewire 607 in the small bowel as shown in FIG. 16B. The stiff section 608 of the guidewire may maintain the stomach and duodenum in a substantially straight position.

5) Lubricate the delivery system and sleeve 605 along its length with surgical jelly or similar medical lubricant.

6) Insert the proximal end of the guidewire 607 into the distal tip of the locking

catheter 604 and advance it through the delivery system 600 through the flexible distal section 610 of the sleeve catheter 602, and through the sleeve guides 606 until it protrudes from the proximal end of the locking catheter 604.

7) Remove the locking catheter 604 from the delivery system 600.

8) As shown in FIG. 16C, advance the delivery system 600 distally over the guidewire, advancing the bypass sleeve 605 through the stomach and across the pyloric sphincter, continuing until the anchor's distal atraumatic tip 651 reaches the pyloric sphincter. The sleeve catheter 602 will advance over and beyond the stiff section of the guidewire 607, advancing the sleeve 605 in a substantially extended

configuration until it is completely within the small intestine.

9) Gradually increase the force on push catheter 601 to advance the delivery system distally slowly over the guidewire continuing until the anchor's distal atraumatic tip 651 passes fully through the pyloric sphincter.

10) Confirm that the distal atraumatic tip 651 has fully entered the duodenal bulb

fluoroscopically and/or by tugging slightly on the push catheter 601. If the cage reemerges from the pylorus, repeat step 9.

11) Withdraw the locking catheter 604 and guidewire 607 proximally from the push catheter 601 as shown in FIG. 16D such that the guidewire completely exits the sleeve guides 606 to release the distal portion of the sleeve 605 and completely exits the anchor's locking channel 654 to release anchor 650 from the delivery system 600. The stomach and duodenum may also be released from the straight position as guidewire 607 is withdrawn.

12) Withdraw the delivery system 600 from the gastrointestinal tract.

[0109] While the above steps illustrate an example of such a delivery method, it is appreciated that variations of the above steps are well within the scope of this approach. [0110] It is understood that the examples and embodiments described herein are for illustrative purposes only and that various modifications or changes in light thereof will be suggested to persons skilled in the art and are to be included within the spirit and purview of this application and scope of the appended claims. All publications, patents, and patent applications cited herein are hereby incorporated by reference in their entirety for all purposes.

Claims

WHAT IS CLAIMED IS:

1. An intragastric implant for treating a patient having a metabolic related disorder, the implant comprising:

an intragastric anchor comprising:

a substantially rigid or semi-rigid elongate element extending between a proximal atraumatic feature and a distal atraumatic feature, wherein the intragastric anchor is dimensioned so as to provide non-penetrating anchoring without fixed attachment to the gastrointestinal tract; and

a coupling structure for connecting a therapeutic device to the anchor so as to anchor the therapeutic device within the gastrointestinal tract of the patient.

2. The intragastric implant of claim 1, wherein the elongate element is of sufficient length to prevent passage of the anchor through the bends of the duodenum when the distal atraumatic feature is disposed downstream of the pylorus.

3. The intragastric implant of claim 1, wherein the elongate element is formed of a rigid or semi-rigid material sufficiently stiff to maintain a pre-formed deployed configuration when unconstrained and to resiliently return to the pre-formed shape when flexed.

4. The intragastric implant of claim 1, wherein the elongate element is formed of a semi-rigid material sufficiently stiff to maintain a pre-formed deployed shape of the elongate element when unconstrained and sufficiently flexible to be constrained in a low- profile delivery configuration.

5. The intragastric implant of claim 1, wherein the rigid or semi-rigid material is a polymer-based material.

6. The intragastric implant of claim 1, wherein the elongate element comprises a proximal portion extending from near the pylorus and within the stomach towards the esophageal junction or fundus and a distal portion that extends from near the pylorus toward a junction between a second and third portion of the duodenum.

7. The intragastric implant of claim 6, wherein the coupling structure is an expandable structure disposed between the proximal and distal portions and adapted to remain distal of the pylorus after deployment.

8. The intragastric implant of claim 7, wherein one or both of the proximal and distal portions is substantially straight.

9. The intragastric implant of claim 7, wherein one or both of the proximal and distal portions includes one or more curved portions.

10. The intragastric implant of claim 4, wherein the pre-formed deployed configuration is a zig-zag or S-shape such that the elongate element includes at least two curved portions that curved in different directions.

11. The intragastric implant of claim 9, wherein one or both of the curved portions have an obtuse apex.

12. The intragastric implant of claim 1, wherein the elongate element comprises at least three substantially straight sections that include a proximal section, an intermediate section and distal section interconnected such that each extends along a different plane.

13. The intragastric implant of claim 12, wherein the intragastric anchor is configured such that, when deployed in the gastrointestinal tract, the proximal section remains within the gastrointestinal tract, the intermediate portion extends across a pyloric valve of the gastrointestinal tract, and the distal section remains within a duodenum of the gastrointestinal tract.

14. The intragastric implant of claim 1, wherein the coupling structure comprises an expandable structure adapted for supporting a proximal opening of an intestinal bypass sleeve when expanded.

15. The intragastric implant of claim 14, wherein the expandable structure comprises a plurality of struts that define an outward facing surface that circumferentially engages an inside lumenal surface of the duodenum sufficiently to define at least a partial seal while allowing sliding along the lumenal surface.

16. The intragastric implant of claim 15, wherein the plurality of struts further define a proximal facing surface of sufficient rigidity to engage the pylorus to prevent passage of the expandable structure upstream from the pylorus when expanded downstream of the pylorus.

17. The intragastric implant of claim 1 further comprising: an intestinal bypass sleeve having a lumen extending between a proximal and distal opening through which contents of the stomach pass when the sleeve is coupled with the anchor deployed within the gastrointestinal tract.

18. The intragastric implant of claim 17, wherein the coupling structure is attached to the elongate element between the proximal and distal atraumatic feature and adapted to couple with the proximal opening of the intestinal bypass sleeve such that when coupled with the intestinal bypass sleeve and deployed within the gastrointestinal attract, the proximal opening of the intestinal bypass sleeve remains between the pyloric valve and an Ampulla of Vater of the duodenum.

19. The intragastric implant of claim 1, wherein the coupling structure comprises an expandable structure that extends circumferentially about the elongate element when deployed so as to define a sliding seal supporting the proximal opening of the intestinal bypass sleeve.

20. The intragastric implant of claim 12, wherein the coupling structure is attached to the elongate element along an intermediate section thereof such that the distal atraumatic feature remains near a junction of a second and third section of the duodenum when the implant is deployed within the gastrointestinal tract.

21. The intragastric implant of claim 1 , wherein an overall length of the elongate element is at least 10 cm and a distance between the distal atraumatic feature and where the coupling feature is attached is at least 4 cm.

22. The intragastric implant of claim 21 , wherein the distance between the distal atraumatic feature and where the coupling feature attaches to the elongate element is sufficiently short so that the distal atraumatic feature does not extend beyond a junction between the second and third sections of the duodenum.

23. The intragastric implant of claim 21 , wherein the overall length of the elongate element is between 15 and 25 mm and a distance between the distal atraumatic feature and where the coupling feature attaches to the elongate element is between 5 and 15 cm.

24. The intragastric implant of claim 21, wherein each of the coupling structure and the distal atraumatic feature comprises a radially expandable structure so as to circumferentially engage a lumen of the duodenum to distribute anchoring forces and maintain the proximal opening of the intestinal bypass sleeve within the duodenum.

25. The intragastric implant of claim 1, wherein the intragastric anchor includes a pylorus hooking feature disposed or defined along a portion of the anchor remaining proximal of the pylorus after deployment, the pylorus hooking feature being adapted to engage the stomach anywhere radially outward from the pylorus so as to distribute anchoring loads and inhibit rotation of the anchor after deployment.

26. The intragastric implant of claim 25, wherein the pylorus hooking feature comprises a curved or angled portion of the elongate member having an acute apex.

27. The intragastric implant of claim 25, wherein the pylorus hooking feature comprises a laterally extending member attached to the elongate member that extends laterally from a longitudinal axis of the elongate to an atraumatic feature.

28. The intragastric implant of claim 27, wherein the atraumatic feature comprises a bulbous tip or an expandable structure.

29. The intragastric implant of claim 27, wherein the laterally extending member is angled or curved in a distal direction so as to further distribute anchoring loads exerted in opposition to downstream movement of the anchor after deployment.

30. A system for delivery of an intragastric implant within a gastrointestinal tract of a patient for treatment of a metabolic related disorder, the system comprising:

an intragastric implant comprising:

an intragastric anchor having a substantially rigid or semi-rigid elongate element extending between a proximal atraumatic feature and a distal atraumatic feature, wherein the intragastric anchor is configured to provide non- penetrating anchoring without rigid attachment to the gastrointestinal tract, and

a therapeutic device coupled with the intragastric anchor; and a constraining sheath having a lumen in which the intragastric anchor resides during delivery that extends to a distal opening through which the anchor is deployed, wherein the constraining sheath is dimensioned with a sufficiently small delivery profile to allow passage through the esophagus and pylorus during oral delivery of the intragastric anchor in a delivery configuration into the gastrointestinal tract.

31. The system of claim 30, wherein the constraining sheath is dimensioned with a diameter of about 20 mm or less, the constraining optionally being distally tapered to facilitate oral delivery of the intragastric implant.

32. The system of claim 30, wherein the intragastric anchor includes one or more radially expandable structures adapted to at least partly circumferentially engage a lumenal wall of the duodenum when released from the constraining sheath.

33. The system of claim 30, wherein the intragastric anchor includes one or more curved portions when unconstrained in the deployed configuration and the constraining sheath is adapted for compressing the one or more curved portions toward a longitudinal axis of the lumen of the sheath during delivery.

34. The system of claim 30, wherein the constraining sheath is of sufficient length to substantially cover the entire length of the anchor rod including the proximal and distal atraumatic features of the anchor during delivery.

35. The system of claim 30, wherein the therapeutic device comprises an intestinal bypass sleeve having a lumen extending between a proximal opening and a distal opening, wherein the sleeve comprises a material substantially impenetrable to a flow of nutrients and particles of food from the stomach when passed through the lumen.

36. The system of claim 35, wherein the intestinal bypass sleeve is attached to the intragastric anchor by a coupling structure, wherein the coupling structure includes a radially expandable structure constrained within the constraining sheath during delivery.

37. The system of claim 35, wherein the intestinal bypass sleeve extends distally of the anchor through the distal opening of the constraining sheath during delivery.

38. The system of claim 30, further comprising:

a guidewire extendable through the esophagus and stomach and into the duodenum along which the constraining sheath is advanceable to facilitate positioning of the intragastric anchor within the gastrointestinal tract, wherein the guidewire extends through the lumen of the constraining sheath in which the anchor resides or through a separate lumen or guide attached to the constraining sheath.

39. The system of claim 38, wherein a distal portion of the sleeve is slidably coupled with the guidewire so as to facilitate delivery of the bypass sleeve within the duodenum.

40. The system of claim 38, wherein the guidewire is configured with a flexible portion having sufficient flexibility to be advanced through the duodenum and a stiff portion having increased stiffness as compared to the flexible portion, the stiff portion being proximal of the flexible portion when the guidewire is positioned within the gastrointestinal tract during oral delivery of the intragastric implant.

41. The system of claim 40, wherein the stiff portion is of sufficient length and stiffness so as to extend through the esophagus and stomach and into the duodenum without buckling or looping of the guidewire to facilitate advancement of the bypass sleeve without buckling or looping of the bypass sleeve,

optionally, the stiff portion is of sufficient length and stiffness so as to maintain the stomach in a straight position or short position during delivery of the intragastric implant.

42. The system of claim 40, wherein the stiff portion comprises a material of increased stiffness securely attached to the guidewire.

43. The system of claim 40, wherein the stiff portion comprises a section of hypotube crimped to the guidewire.

44. The system of claim 40, wherein the flexible portion comprises flexibility of a commercial grade guidewire suitable for use in an endoscopic procedure.

45. The system of claim 35, wherein the intestinal bypass sleeve includes one or more sleeve guides disposed near the distal end of the bypass sleeve adapted to slidably engage the guidewire to allow advancement of the bypass sleeve over the guidewire, optionally, the one or more sleeve guides include a plurality of sleeve guides disposed circumferentially about a distal portion of the sleeve and distributed axially along the distal portion so as to draw a distal opening of the sleeve radially inward toward the guidewire during delivery.

46. The system of claim 45, wherein the one or more sleeve guides comprise one or more eyelets formed in a distal portion of the sleeve through which the guidewire extends during delivery.

47. The system of claim 45, wherein the one or more sleeve guides comprises one or more elements attached to the sleeve in the distal portion, each having a guide channel through which the guidewire extends,

optionally being formed of a bio-degradable material so as to dissolve after the intragastric implant is deployed.

48. The system of claim 30, further comprising:

a flexible sleeve catheter extending distally from the constraining sheath along which the intestinal bypass sleeve extends during delivery.

49. The system of claim 48, wherein the flexible sleeve catheter comprises a lumen through which the guidewire extends during delivery of the intragastric implant.

50. The system of claim 48, wherein the flexible sleeve catheter is disposed within the sleeve so as to facilitate delivery of the bypass sleeve by advancement of the flexible sleeve catheter over the guidewire.

51. The system of claim 50, wherein the flexible sleeve catheter includes a push tube or push catheter to facilitate delivery of the bypass sleeve by engagement of the one or more sleeve guides when the push tube is advanced over the guidewire, wherein the push tube is separate from or incorporated into the flexible sleeve catheter.

52. The system of claim 48, wherein the sleeve catheter is attached to a distal portion of the constraining sheath and offset from a central axis of a lumen of the constraining sheath in which the rod resides during delivery.

53. The system of claim 30, wherein the intragastric anchor comprises a locking channel extending through a portion of the intragastric anchor and through which a locking member extends such that engagement between the locking member and a locking portion of the constraining sheath and/or a distally extending sleeve catheter inhibits advancement of the anchor relative the constraining sheath.

54. The system of claim 53, wherein the locking member is slidably disposed within the locking channel such that release of the anchor from the locking portion can be effected by axial movement of the locking member from the locking portion, wherein the locking member comprises any of a tether, wire, or the guidewire.

55. The system of claim 53, wherein the locking channel is formed at or near the proximal atraumatic feature such as the proximal atraumatic feature comprising a bulbous tip and the locking channel comprises a hole extending through the bulbous tip.

56. A delivery system for delivery and deployment of an intragastric implant within a gastrointestinal tract of a patient for treatment of a metabolic related disorder, the delivery system comprising:

a constraining sheath having a lumen in which a compressible intragastric anchor resides during delivery, the lumen extending to a distal opening through which the anchor is deployed, wherein the constraining sheath is dimensioned with a sufficiently small delivery profile to allow passage through the esophagus and pylorus during oral delivery of the intragastric anchor in a delivery configuration into the gastrointestinal tract; and

a sleeve catheter extending distally from the constraining sheath, wherein the sleeve catheter comprises a lumen extending therethrough from a proximal opening to a distal opening.

57. The delivery system of claim 56, wherein the sleeve catheter is attached to the constraining sheath near a distal end thereof such that the proximal opening of the sleeve catheter is at or distal of the distal opening of the lumen of the constraining catheter.

58. The delivery system of claim 56, further comprising: a guidewire along which the sleeve catheter and constraining sheath can be advanced; and

a push tube axially movable over the guidewire for deploying a bypass sleeve extending distally from the anchor through a portion of the duodenum.

59. A method for delivering an intragastric implant within a gastrointestinal tract of patient for treating of a metabolic disorder, said method comprising:

providing an intragastric implant comprising:

an anchor adapted to provide non-penetrating anchoring within the gastro-intestinal tract, the anchor comprising a substantially rigid or semi-rigid element extending between a proximal and distal feature and including and a coupling structure between the proximal and distal feature, and

an intestinal bypass sleeve attached to the coupling structure;

providing a delivery system comprising a constraining sheath having a lumen in which the intragastric anchor resides while the intestinal bypass sleeve extends distally of the anchor through a distal opening of the lumen, a locking catheter or guidewire extending through a locking channel of the anchor and through one or more sleeve guides attached or defined in a distal portion of the bypass sleeve; positioning the intragastric implant into a desired location in the gastrointestinal tract in an endoscopic procedure by advancing the delivery system along a guidewire extending through the gastrointestinal tract;

advancing the distal portion of the bypass sleeve into the duodenum by advancing a push tube that engages the one or more sleeve guides;

advancing the delivery system while the anchor remains constrained within the constraining sheath until the coupling structure is disposed distal of the pylorus;

withdrawing the constraining sheath thereby expanding the coupling structure so that the distal atraumatic feature and the coupling structure remain distal of the pylorus; and

withdrawing the delivery system from the gastrointestinal tract.

60. A method of delivering an intragastric implant with a delivery system, said method comprising: providing a delivery system comprising a constraining sheath in which an intragastric anchor resides attached to a distally extending bypass sleeve, a locking catheter extending through a locking channel in the anchor, a push catheter and a guidewire;

placing an endoscope per orally through the esophagus, stomach, through the pyloric sphincter, and advance through the duodenum and proximal jejunum;

inserting the guidewire into a working channel of the endoscope and advancing until a distal portion of the guidewire is visible through the endoscope;

inserting the proximal end of the guidewire into a distal tip of the locking catheter and advance it through the delivery system, through a flexible distal section of the sleeve catheter, and through one or more sleeve guides attached to the distal section of the sleeve;

advancing the delivery system distally over the guidewire such that the bypass sleeve advances through the stomach and across the pyloric sphincter;

advancing the delivery system via the push catheter while maintaining the locking catheter in a substantially fixed position until a distal atraumatic tip of the anchor reaches the pyloric sphincter;

advancing the sleeve in a substantially extended configuration until it is completely within the small intestine;

advancing the delivery system distally slowly over the guidewire continuing until the anchor's distal atraumatic tip passes fully through the pyloric sphincter;

withdrawing the locking catheter and guidewire proximally from the push catheter such that the guidewire completely exits the one or more sleeve guides to release the distal portion of the sleeve and completely exits the anchor's locking channel to release anchor from the delivery system; and

withdrawing the locking catheter, guidewire, constraining sheath, and push tube from the gastrointestinal tract.