Methods and devices for delivering a dynamic gastric bypass device - Patents.com

Abstract

The gastric bypass device includes an occlusion device adapted to be deployed against the patient's pyloric sphincter, an anastomotic anchor adapted to be deployed against the anastomosis between the patient's stomach and the patient's small intestine, and a tether extending through the patient's small intestine between the occlusion device and the anastomotic anchor. A dynamic leash may be secured to the occlusion device and may function with the tether to help hold the occlusion device in place. The gastric bypass device may be deployed using a variety of methods, including a push-pull wire method, a rail method, a garage method, a two-piece method, and an all-inclusive method.

Description

[Technical Field]

[0001] The present disclosure relates to medical devices such as gastric bypass devices. More particularly, the present disclosure relates to methods and devices for delivering dynamic gastric bypass devices. [Background technology]

[0002] A wide variety of intracorporeal medical devices have been developed for medical applications, such as surgical and / or intravascular use. Some of these devices include guidewires, catheters, medical device delivery systems (e.g., stents, grafts, replacement valves, etc.), and the like. These devices can be manufactured by any one of a variety of different manufacturing methods and used according to any one of a variety of methods. There is a continuing need to provide alternative medical devices and alternative methods of manufacturing and / or using medical devices. Summary of the Invention

[0003] The present disclosure relates to medical devices, such as gastric bypass devices, and more particularly to methods for delivering dynamic gastric bypass devices. One example can be found in a method for delivering a gastric bypass device, the gastric bypass device including an occlusion device adapted to be anchored in place within a patient's stomach relative to the patient's pylorus, an anastomosis anchor adapted to be anchored in place relative to an anastomosis formed between the patient's stomach wall and the patient's small intestine, and a tether adapted to extend through the patient's small intestine and secured at a first end to the occlusion device. The method includes forming an anastomosis between the patient's stomach and the patient's small intestine, and delivering a guidewire in a looped path down the patient's esophagus, through the patient's pylorus, up through the anastomosis, and up the patient's esophagus, such that both a distal wire end and a proximal wire end of the guidewire are accessible outside the patient's mouth. The guidewire is utilized to advance the gastric bypass device to a desired delivery location and deploy the gastric bypass device.

[0004] Alternatively or additionally, creating the anastomosis may include surgically creating the anastomosis. Alternatively or additionally, forming the anastomosis may include forming the anastomosis laparoscopically.

[0005] Alternatively or additionally, forming the anastomosis may include forming the anastomosis endoscopically. Alternatively or additionally, forming the anastomosis may further include subsequently securing an anastomotic structure within the anastomosis.

[0006] Alternatively or additionally, the method may further include the subsequent steps of delivering a dynamic leash adapted to extend through the patient's stomach and provide an opposite pulling force to the occlusion device than that provided by the tether, and securing the dynamic leash to the gastric bypass device.

[0007] Alternatively or additionally, utilizing the guidewire may include attaching a delivery shuttle to the guidewire, the delivery shuttle including a gastric bypass device removably secured to the delivery shuttle; pulling and / or feeding the guidewire to move the guidewire, thereby moving the delivery shuttle and gastric bypass device to the desired delivery location; advancing an endoscope into the patient's stomach; and using an endoscopic tool to detach the delivery shuttle from the gastric bypass device and allow the anchors to self-expand.

[0008] Alternatively or additionally, the gastric bypass device may be secured to the delivery shuttle via an anastomotic anchor of the gastric bypass device. Alternatively or additionally, delivering the guidewires in a looped path may include delivering a first guidewire through the patient's pylorus into the patient's small intestine so that a distal end of the first guidewire reaches a location proximate the anastomosis, and delivering a second guidewire through the patient's stomach so that a distal end of the second guidewire reaches a location proximate the anastomosis. The distal ends of the first guidewire and the second guidewire may be adapted to secure the first guidewire and the second guidewire together to form the guidewires in a looped path.

[0009] Alternatively or additionally, the distal end of the first guidewire may include a first magnet and the distal end of the second guidewire may include a second magnet of opposite polarity. Alternatively or additionally, utilizing the guidewire may include advancing a delivery catheter over the guidewire, the delivery catheter including a gastric bypass device secured thereto, the delivery catheter being advanced until the gastric bypass device reaches a desired delivery location; advancing an endoscope into the patient's stomach; and using an endoscopic tool to detach a delivery shuttle from the gastric bypass device and deploy the anchor.

[0010] Alternatively or additionally, the gastric bypass device may be secured to the delivery catheter via an anastomotic anchor of the gastric bypass device. Alternatively or additionally, utilizing the guidewire may include loading a delivery garage catheter onto the proximal wire end, with the gastric bypass device being placed into the delivery garage catheter; advancing the delivery garage catheter over the guidewire until the distal tip of the delivery garage catheter is advanced into and slightly through the anastomosis; deploying an anastomotic anchor within the anastomosis; withdrawing the delivery garage catheter until the distal tip of the delivery garage catheter is moved proximally through the patient's pylorus; and deploying the occlusion device.

[0011] Alternatively or additionally, the method may further include utilizing a pusher in deploying the anastomotic anchor and / or in deploying the occlusion device. Alternatively or additionally, utilizing the guidewire may include loading a first delivery catheter onto the distal wire end, the first delivery catheter including an anastomotic anchor of a gastric bypass device disposed therein; advancing the first delivery catheter over the guidewire to a position proximate to the anastomosis; deploying the anastomotic anchor within the anastomosis; loading a second delivery catheter onto the proximal wire end, the second delivery catheter including an occlusion device and a tether of the gastric bypass device disposed therein; advancing the second delivery catheter over the guidewire to a position proximate to the anastomotic anchor; attaching the tether of the gastric bypass device to the deployed anastomotic anchor; and withdrawing the second delivery catheter to deploy the occlusion device of the gastric bypass device.

[0012] Alternatively or additionally, the method may further include removing the first delivery catheter and the second delivery catheter. Another example may be found in a method for delivering a gastric bypass device including an occlusion device adapted to be anchored in place in the patient's stomach relative to the patient's pylorus, an anastomosis anchor adapted to be anchored in place relative to an anastomosis formed between the patient's stomach wall and the patient's small intestine, and a tether adapted to extend through the patient's duodenum, the tether secured at a first end to the occlusion device. The method includes forming the anastomosis between the patient's stomach and the patient's small intestine, delivering a guidewire in a looped path down the patient's esophagus, through the patient's pylorus, up through the anastomosis, and up the patient's esophagus such that both a distal wire end and a proximal wire end of the guidewire are accessible outside the patient's mouth, providing a delivery device adapted to advance over the guidewire, the delivery device including a gastric bypass device secured to the delivery device, advancing the delivery device to a desired deployment location, and releasing the gastric bypass device from the delivery device to deploy the gastric bypass device.

[0013] Alternatively or additionally, the delivery device may be adapted to releasably secure the gastric bypass device to the gastric bypass device outside of the delivery device. Alternatively or additionally, the delivery device may be adapted to retain the gastric bypass device within the delivery device.

[0014] Another example may be found in a method for delivering a gastric bypass device including an obstruction device adapted to be secured in place within the patient's stomach relative to the patient's pylorus, an anastomotic anchor adapted to be secured in place relative to an anastomosis formed between the patient's stomach wall and the patient's small intestine, the anastomotic anchor including a first flange and a second flange, and a tether adapted to extend through the patient's duodenum, the tether secured at a first end to the obstruction device. The method includes advancing a guidewire through the patient's stomach, through the patient's pylorus, and into the patient's small intestine; advancing a delivery catheter over the guidewire to a desired site for forming an anastomosis, the delivery catheter carrying a gastric bypass device therein, the delivery catheter including an electrocautery distal tip; forming an anastomosis between the patient's stomach and the patient's small intestine using the electrocautery distal tip; deploying a first flange of an anastomotic anchor on the stomach side of the anastomosis; withdrawing the delivery catheter so that the electrocautery distal tip is positioned in the small intestine; deploying a second flange of the anastomotic anchor on the small intestine side of the anastomosis; withdrawing the delivery catheter to the patient's pylorus; and deploying an obstruction device.

[0015] The above summary of some embodiments, aspects, and / or examples is not intended to describe each embodiment or every implementation of the present disclosure. The figures and the detailed description that follow more particularly exemplify these embodiments.

[0016] The present disclosure may be more fully understood from a consideration of the following detailed description of various embodiments in conjunction with the accompanying drawings, in which: [Brief explanation of the drawings]

[0017] [Figure 1] Schematic diagram of part of the human gastrointestinal (GI) system. [Figure 2] 2 is a schematic diagram of an exemplary gastric bypass system including an occlusion device, an anastomotic anchor, a tether, and a dynamic leash positioned within the GI system shown in FIG. 1. [Figure 3] 3 is a schematic diagram of an exemplary occlusion device that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 4] 3 is a schematic diagram of an exemplary occlusion device that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 5] 3 is a schematic diagram of an exemplary occlusion device that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 6] 3 is a schematic diagram of an exemplary occlusion device that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 7] 3 is a schematic diagram of an exemplary occlusion device that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 8] 3 is a schematic diagram of an exemplary occlusion device that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 9] 3 is a schematic diagram of an exemplary occlusion device that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 10] 3 is a schematic diagram of an exemplary occlusion device that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 11] 3 is a schematic diagram of an exemplary occlusion device that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 12] 3 is a schematic diagram of an exemplary occlusion device that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 13] 3 is a schematic diagram of an exemplary occlusion device that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 14] 3 is a schematic diagram of an exemplary occlusion device that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 15] 3 is a schematic diagram of an exemplary occlusion device that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 16]3 is a schematic diagram of an exemplary occlusion device that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 17] 3 is a schematic diagram of an exemplary occlusion device that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 18] 3 is a schematic diagram of an exemplary occlusion device that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 19] 3 is a schematic diagram of an exemplary occlusion device that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 20] 3 is a schematic diagram of an exemplary occlusion device that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 21] 3 is a schematic diagram of an exemplary occlusion device that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 22] 3 is a schematic diagram of an exemplary occlusion device that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 23] 3 is a schematic diagram of an exemplary occlusion device that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 24] 3 is a schematic diagram of an exemplary occlusion device that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 25] 3 is a schematic diagram of an exemplary occlusion device that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 26] 3 is a schematic diagram of an exemplary occlusion device that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 27] 3 is a schematic diagram of an exemplary anastomotic anchor and ring that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 28] 3 is a schematic diagram of an exemplary anastomotic anchor and ring that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 29] 3 is a schematic diagram of an exemplary anastomotic anchor and ring that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 40] 3 is a schematic diagram of an exemplary anastomotic anchor and ring that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 31A]3 is a schematic diagram of an exemplary anastomotic anchor and ring that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 31B] 3 is a schematic diagram of an exemplary anastomotic anchor and ring that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 32A] 3 is a schematic diagram of an exemplary anastomotic anchor and ring that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 32B] 3 is a schematic diagram of an exemplary anastomotic anchor and ring that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 33] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2, a portion of which is shown in combination with an occlusion device. [Figure 34A] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2, a portion of which is shown in combination with an occlusion device. [Figure 34B] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2, a portion of which is shown in combination with an occlusion device. [Figure 34C] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2, a portion of which is shown in combination with an occlusion device. [Figure 34D] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2, a portion of which is shown in combination with an occlusion device. [Figure 34E] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2, a portion of which is shown in combination with an occlusion device. [Figure 35A] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2, a portion of which is shown in combination with an occlusion device. [Figure 35B] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2, a portion of which is shown in combination with an occlusion device. [Figure 35C]3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2, a portion of which is shown in combination with an occlusion device. [Figure 35D] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2, a portion of which is shown in combination with an occlusion device. [Figure 35E] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2, a portion of which is shown in combination with an occlusion device. [Figure 35F] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2, a portion of which is shown in combination with an occlusion device. [Figure 36A] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2, a portion of which is shown in combination with an occlusion device. [Figure 36B] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2, a portion of which is shown in combination with an occlusion device. [Figure 36C] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2, a portion of which is shown in combination with an occlusion device. [Figure 36D] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2, a portion of which is shown in combination with an occlusion device. [Figure 37] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2, a portion of which is shown in combination with an occlusion device. [Figure 38A] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2, a portion of which is shown in combination with an occlusion device. [Figure 38B] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2, a portion of which is shown in combination with an occlusion device. [Figure 39]3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2, a portion of which is shown in combination with an occlusion device. [Figure 40A] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2, a portion of which is shown in combination with an occlusion device. [Figure 40B] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2, a portion of which is shown in combination with an occlusion device. [Figure 41] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2, a portion of which is shown in combination with an occlusion device. [Figure 42] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2, a portion of which is shown in combination with an occlusion device. [Figure 43] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2, a portion of which is shown in combination with an occlusion device. [Figure 44] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2, a portion of which is shown in combination with an occlusion device. [Figure 45] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2, a portion of which is shown in combination with an occlusion device. [Figure 46] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2, a portion of which is shown in combination with an occlusion device. [Figure 47] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2, a portion of which is shown in combination with an occlusion device. [Figure 48] Schematic diagram of part of the human gastrointestinal (GI) system. [Figure 49] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2 to protect the papilla of Vater. [Figure 50A]3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2 to protect the papilla of Vater. [Figure 50B] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2 to protect the papilla of Vater. [Figure 50C] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2 to protect the papilla of Vater. [Figure 51] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2 to protect the papilla of Vater. [Figure 52] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2 to protect the papilla of Vater. [Figure 53A] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2 to protect the papilla of Vater. [Figure 53B] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2 to protect the papilla of Vater. [Figure 53C] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2 to protect the papilla of Vater. [Figure 53D] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2 to protect the papilla of Vater. [Figure 54] 3 is a schematic diagram of an exemplary dynamic leash that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 55] 3 is a schematic diagram of an exemplary dynamic leash that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 56] 3 is a schematic diagram of an exemplary dynamic leash that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 57] 3 is a schematic diagram of an exemplary dynamic leash that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 58] 3 is a schematic diagram of an exemplary dynamic leash that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 59] 3 is a schematic diagram of an exemplary dynamic leash that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 60] FIG. 4 is a schematic diagram of a secondary engagement device. [Figure 61] FIG. 4 is a schematic diagram of a secondary engagement device. [Figure 62] 1 is a schematic diagram of an exemplary device that integrates anastomosis formation and gastric bypass system delivery. [Figure 63] Schematic diagram of the resulting anastomosis and gastric bypass system. [Figure 64] Schematic diagram illustrating an exemplary wire-pulling method for delivering a gastric bypass system. [Figure 65] Schematic diagram illustrating an exemplary wire-pulling method for delivering a gastric bypass system. [Figure 66] Schematic diagram illustrating an exemplary wire-pulling method for delivering a gastric bypass system. [Figure 67] Schematic diagram illustrating an exemplary wire-pulling method for delivering a gastric bypass system. [Figure 68] Schematic diagram illustrating an exemplary wire-pulling method for delivering a gastric bypass system. [Figure 69] Schematic diagram illustrating an exemplary wire-pulling method for delivering a gastric bypass system. [Figure 70] Schematic diagram illustrating an exemplary rail system method for delivering a gastric bypass system. [Figure 71] Schematic diagram illustrating an exemplary rail system method for delivering a gastric bypass system. [Figure 72] Schematic diagram illustrating an exemplary rail system method for delivering a gastric bypass system. [Figure 73] Schematic diagram illustrating an exemplary rail system method for delivering a gastric bypass system. [Figure 74] Schematic diagram illustrating an exemplary rail system method for delivering a gastric bypass system. [Figure 75] Schematic diagram showing an exemplary garage method for delivering a gastric bypass system. [Figure 76]Schematic diagram showing an exemplary garage method for delivering a gastric bypass system. [Figure 77] Schematic diagram showing an exemplary garage method for delivering a gastric bypass system. [Figure 78] Schematic diagram showing an exemplary garage method for delivering a gastric bypass system. [Figure 79] Schematic diagram showing an exemplary garage method for delivering a gastric bypass system. [Figure 80] Schematic diagram illustrating an exemplary two-piece method for delivering a gastric bypass system. [Figure 81] Schematic diagram illustrating an exemplary two-piece method for delivering a gastric bypass system. [Figure 82] Schematic diagram illustrating an exemplary two-piece method for delivering a gastric bypass system. [Figure 83] Schematic diagram illustrating an exemplary two-piece method for delivering a gastric bypass system. [Figure 84] 1 is a schematic diagram illustrating an exemplary overall method for delivering a gastric bypass system. [Figure 85] 1 is a schematic diagram illustrating an exemplary overall method for delivering a gastric bypass system. [Figure 86] 1 is a schematic diagram illustrating an exemplary overall method for delivering a gastric bypass system. [Figure 87] 1 is a schematic diagram illustrating an exemplary overall method for delivering a gastric bypass system. [Figure 88] 1 is a schematic diagram illustrating an exemplary overall method for delivering a gastric bypass system. [Figure 89] 1 is a schematic diagram illustrating an exemplary overall method for delivering a gastric bypass system. [Figure 90] 1 is a schematic diagram illustrating an exemplary two-piece guidewire. [Figure 91] Schematic diagram illustrating an exemplary method for locking the length of the device during delivery of the gastric bypass system. [Figure 92A] 1 is a schematic diagram illustrating components of an exemplary pusher device. [Figure 92B]1 is a schematic diagram illustrating components of an exemplary pusher device. [Figure 93A] Schematic diagram illustrating an exemplary connection between a tether and an occlusion device. [Figure 93B] Schematic diagram illustrating an exemplary connection between a tether and an occlusion device. [Figure 94A] Schematic diagram illustrating an exemplary connection between a tether and an occlusion device. [Figure 94B] Schematic diagram illustrating an exemplary connection between a tether and an occlusion device. [Figure 95A] 1 is a schematic diagram illustrating an exemplary pusher device. [Figure 95B] 1 is a schematic diagram illustrating an exemplary pusher device. [Figure 95C] 1 is a schematic diagram illustrating an exemplary pusher device. [Figure 96] 1 is a schematic diagram illustrating an exemplary pusher device. DETAILED DESCRIPTION OF THE INVENTION

[0018] While aspects of the present disclosure are amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit aspects of the present disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.

[0019] The following description should be read with reference to the drawings, which are not necessarily to scale, and in which like reference numerals indicate like elements throughout the several views. The detailed description and drawings are intended to illustrate, not limit, the scope of the claims. Those skilled in the art will recognize that the various elements described and / or illustrated can be arranged in various combinations and configurations without departing from the scope of the present disclosure. The detailed description and drawings depict exemplary embodiments of the claimed invention.

[0020] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.

[0023] In this specification, all numerical values ​​are assumed to be modified by the term "about," whether explicitly stated or not. The term "about" in the context of numerical values ​​generally refers to a range of numbers that one of ordinary skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many cases, the term "about" may include numbers that are rounded to the nearest significant figure. Other uses of the term "about" (e.g., in contexts other than numerical values) can be assumed to have their ordinary and customary definition as understood from and consistent with the context of this specification, unless otherwise specified.

[0021] The recitation of numerical ranges by endpoints includes all numbers within that range, inclusive of the endpoints (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). Although some suitable dimensions, ranges and / or values ​​for various components, features and / or specifications are disclosed, one skilled in the art inspired by this disclosure will understand that the desired dimensions, ranges and / or values ​​may deviate from those expressly disclosed.

[0022] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its sense to include "and / or" unless the content clearly dictates otherwise. For ease of understanding, it should be noted that some features of the present disclosure may be described in the singular even though those features may be multiple or repeated within a disclosed embodiment. Each instance of a feature may include and / or be encompassed by a singular disclosure unless expressly stated to the contrary. For simplicity and clarity, not all elements of the disclosed invention(s) are necessarily shown in every figure or described in detail below. However, it will be understood that the following description may apply equally to any and / or all components present in more than one instance unless expressly stated to the contrary. Moreover, for clarity, not all instances of some elements or features are shown in every figure.

[0023] Relative terms such as “proximal,” “distal,” “advancing,” “retracting,” and variations thereof may generally be considered with respect to the position, orientation, and / or movement of various elements relative to a user / operator / manipulator of the device, with “proximal” and “retracting” indicating or referring to being closer to or toward the user, and “distal” and “advancing” indicating or referring to being farther from or away from the user. In some cases, the term “distal” refers to moving further into the gastrointestinal system, and the term “proximal” refers to moving out of the gastrointestinal system. In some cases, the terms “proximal” and “distal” may be assigned arbitrarily to facilitate understanding of the present disclosure, and such instances will be readily apparent to one of ordinary skill in the art. Other relative terms such as “upstream,” “downstream,” “inflow,” and “outflow” refer to the direction of fluid flow within a body lumen, a lumen such as a blood vessel, or within a device.

[0024] The term "extent" may be understood to mean the maximum measurement of a stated or specified dimension. For example, an "outer extent" may be understood to mean the maximum outer dimension, a "radial extent" may be understood to mean the maximum radial dimension, and a "longitudinal extent" may be understood to mean the maximum longitudinal dimension. Each instance of "extent" may be different (e.g., axially, longitudinally, laterally, radially, circumferentially, etc.) and will be apparent to one of ordinary skill in the art from the context of a particular use. In general, "extent" may be considered the maximum possible dimension measured according to the intended use. In some cases, "extent" may generally be measured orthogonally in a plane and / or cross-section, but may also be measured differently, such as, but not limited to, angularly, radially, circumferentially (e.g., along an arc), etc., as will become apparent from the particular context.

[0025] It should be noted that references herein to "one embodiment," "some embodiments," "other embodiments," etc., indicate that the described embodiment may include a particular feature, structure, or characteristic, but that not all embodiments necessarily include the particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Furthermore, when a particular feature, structure, or characteristic is described in connection with an embodiment, it would be within the knowledge of one skilled in the art to use the particular feature, structure, or characteristic in connection with other embodiments, unless expressly stated to the contrary, whether or not explicitly described. That is, it is contemplated that various individual elements described below, even if not explicitly shown in specific combinations, can be combined or arranged with one another to form other or additional embodiments, or to complement and / or enhance the described embodiments, as would be understood by one skilled in the art.

[0026] For purposes of clarity, certain distinguishing numerical nomenclature (e.g., first, second, third, fourth, etc.) may be used throughout the specification and / or claims to name and / or distinguish various features of the specification and / or claims. It should be understood that the numerical nomenclature is not intended to be limiting and is merely exemplary. In some embodiments, variations and departures from previously used numerical nomenclature may be made for brevity and clarity. That is, a feature identified as a "first" element may later be referred to as a "second," "third," etc., or may be omitted entirely, and / or a different feature may be referred to as the "first" element. The meaning and / or name in each instance will be apparent to one of ordinary skill in the art.

[0027] This document relates to devices and methods for the medical treatment of conditions such as obesity and metabolic disease. For example, this document provides methods and devices for bypassing a portion of the GI tract to reduce nutritional intake, reduce weight, and / or improve diabetes management.

[0028] FIG. 1 is a schematic diagram of a portion of a human digestive tract 10. The digestive tract 10 includes an esophagus 12, a stomach 14, and a small intestine 16. The esophagus 12 connects the mouth to the stomach 14 and delivers food to the stomach 14. The stomach 14 secretes digestive enzymes and gastric acid to aid in food digestion. The small intestine 16 is where most of the absorption of nutrients and minerals from food occurs. The small intestine 16 includes a duodenum 18, a jejunum 24, and an ileum (not shown). A pyloric sphincter 20 controls a passageway 22 for the passage of partially digested food from the stomach 14 to the duodenum 18, which may be approximately 25-38 centimeters (cm) in length. The food then passes into the jejunum 24, which may be approximately 2.25-2.75 meters (m) in length. It will be understood that these dimensions are merely exemplary and may vary from patient to patient.

[0029] An anastomosis 26 may be formed between the stomach 14 and the small intestine 16. In some cases, the anastomosis 26 may be formed between the stomach 14 and the duodenum 18. In some cases, the anastomosis 26 may be formed between the stomach 14 and the jejunum 24. As an example, the anastomosis 26 may be formed by a gastrojejunostomy. The anastomosis 26 may allow for direct movement of food (arrow) 28 from the stomach 14 to the jejunum 24 by bypassing the duodenum 18. In some cases, the anastomosis 26 may include a stent, staple, magnet, balloon, or other structure to maintain an opening and connection between the stomach 14 and the small intestine 16. In some cases, the anastomosis 26 may be approximately 1-4 cm in diameter. In some cases, the stomach 14 may be considered to include a pylorus 30 located immediately upstream of the pyloric sphincter 20. The pylorus 30 may be considered to have a diameter greater than the diameter of the pyloric sphincter 20. The stomach 14 may be considered to include an antrum 32 located immediately upstream of the pylorus 30. The antrum 32 may be considered to have a diameter greater than the diameter of the pylorus 30.

[0030] 2 schematically illustrates an exemplary gastric bypass device 34 shown positioned within the anatomy 10. The gastric bypass device 34 includes an occlusion device 36. The occlusion device 36 may be adapted to be positioned within the pyloric sphincter 20, the pylorus 30, or the pyloric antrum 32, depending on the desired degree of occlusion of the stomach 14. In some examples, the occlusion device 36 may be adapted to be positioned within the antrum 32. The gastric bypass device 34 includes an anastomotic anchor 38 that may be adapted to be secured relative to the anastomosis 26. In some cases, the anastomotic anchor 38 may be adapted to be secured to an anastomotic structure (not shown) that may be present within the anastomosis 26 to preserve and hold the anastomosis 26 together.

[0031] Because the obstructing device 36 is a foreign body, the stomach 14 may attempt to push the obstructing device 36 through the pyloric sphincter 20 and into the duodenum 18. The stomach 14 may attempt to push the obstructing device 36 back through the pyloric sphincter 20 and into itself. A tether 40 extends through the duodenum 18 and is secured to the obstructing device 36 at a first end 40a of the tether 40 and to an anastomotic anchor 38 at a second end 40b of the tether 40. The tether 40 may be adapted to help hold the obstructing device 36 in place at its desired implantation location against movements caused by the stomach 14 that would tend to displace the obstructing device 36. In some cases, a dynamic leash 42 may extend between the obstructing device 36 and the anastomotic anchor 38 and be adapted to help hold the obstructing device 36 in its desired position. In some cases, the dynamic leash 42 may extend from the obstructing device 36 to an anchor location within the wall of the stomach 14. In some cases, the occlusion device 36 may include one or more anti-migration features, such as hooks or tines, or perhaps a high-friction coating over at least a portion of the occlusion device 36. In some cases, the anastomotic anchor 38 may also include additional anti-migration features.

[0032] Gastric bypass device 34 is shown schematically because each component of gastric bypass device 34, including occlusion device 36, anastomotic anchor 38, tether 40, and dynamic leash 42, can take a variety of different forms. FIGS. 3-26 provide illustrative, but non-limiting examples of possible occlusion devices 36. FIGS. 27-32B provide illustrative, but non-limiting examples of possible anastomotic anchors 38. FIGS. 33-53D provide illustrative, but non-limiting examples of possible tethers 40. FIGS. 54-59 provide illustrative, but non-limiting examples of possible dynamic leashes 42. It will be understood that a gastric bypass device, such as gastric bypass device 34, can include any of occlusion devices 36, any of anastomotic anchors 38, any of tethers 40, and any of dynamic leashes 42.

[0033] In some cases, the obstructing device may be placed within or upstream of the pyloric sphincter 20. In some cases, the obstructing device may be placed within the pylorus 30, depending on how much of the stomach 14 the physician or other professional desires to obstruct. The obstructing device 36 may be placed within or extend to the pyloric antrum 32. Figures 3-26 provide examples of exemplary obstructing devices that may be used as the obstructing device 36 as part of the gastric bypass device 34.

[0034] FIG. 3 is a schematic diagram of an exemplary occlusion device 44 shown positioned near the pyloric antrum 32. The occlusion device 44 includes an annular ring 46 sized to span the anatomy. It will be appreciated that the annular ring 46 may be sized to aid in positioning the occlusion device 44 at a desired location within the anatomy. For example, if it is desired to position the occlusion device 44 within the pyloric sphincter 20, the annular ring 46 may have an overall diameter of 1-3 cm. If it is desired to position the occlusion device 44 within the pylorus 30, the annular ring 46 may have an overall diameter of 2-8 cm. If it is desired to position the occlusion device 44 within the pyloric antrum 32, the annular ring 46 may have an overall diameter of 4-12 cm.

[0035] In some cases, the obstructing device 46 is adapted to effectively reduce the volume of the stomach 14 while preventing stomach contents from passing through the pyloric sphincter 20 into the upper portion of the small intestine 16, including the duodenum 18. In some cases, the obstructing device 46 may be adapted to fill a substantial portion of the volume of the stomach 14, allowing contents to pass through the stomach 14 to the anastomosis 26. Filling a substantial portion of the volume of the stomach 14 may help provide a patient with a feeling of fullness that lasts longer. Reducing the volume of the stomach 14 may increase the efficiency of the gastric bypass effect.

[0036] The annular ring 46 includes a tapered body 48 that tapers from the annular ring 46 (which may be considered to define the maximum outer diameter of the occlusion device 44) to a minimum diameter end point 50. The minimum diameter end point 50 may be adapted to be secured to, for example, a tether 52. The tapered body 48 may taper smoothly from its maximum outer diameter to its minimum outer diameter. The tapered body 48 may taper stepwise, with one or more abrupt diameter changes. In some cases, the tapered body 48 may have a curved profile. The tapered body 48 may be adapted to prevent the passage of substances such as food, chyme, and other stomach contents through the tapered body 48. In some cases, the tapered body 48 may be constructed of an impermeable material, such as, but not limited to, a polymeric material. In some cases, the tapered body 48 may include a polymeric membrane disposed on some type of support frame (not shown).

[0037] The thickness, durometer, and lubricity of the polymeric material used to form the occlusion device 54 may vary along the length of the occlusion device 44. The occlusion device 44 may have, for example, a funnel or cyclone shape. The occlusion device 44 may have a hemispherical or even spherical shape. The occlusion device 44 may include a recess (not shown) to accommodate a support ring. In some cases, the occlusion device 44 may be compressible to aid in deliverability. The occlusion device 44 may include a membrane or other cover spanning the opening defined by the annular ring 46 to keep materials from accumulating within the occlusion device 44.

[0038] The occlusion device 44 can be formed of any suitable polymeric or metallic material, so long as the material is adapted for long-term survival in the gastric environment. In some cases, the occlusion device 44 can be formed of silicone or another polymer. The occlusion device 44 can be formed, for example, by 3D printing. In some cases, the occlusion device 44 can be molded or even electrospun.

[0039] In some cases, the occlusion device 44 may include additional metal support (not shown) to help provide an outward radial force to better engage the anatomy. In some cases, the material used to form the occlusion device 44 may be thicker near the annular ring 46. The occlusion device 44 may be formed of a shape-memory material, allowing the occlusion device 44 to have a memorized configuration for deployment and to be temporarily deformed from the memorized configuration during delivery. Although not shown, the occlusion device 44 may include anchors, such as outward prongs, hooks, splines, or tines. The occlusion device 44 may include a surface treatment to promote endothelialization. These are merely examples.

[0040] 4 is a schematic diagram of an exemplary occlusion device 54, which may be considered one example of occlusion device 44. Exemplary occlusion device 54 is formed of a single, continuous polymer body 56 that extends from an annular ring 58, which represents the maximum outer diameter of occlusion device 54, to a minimum diameter end point 60. Minimum diameter end point 60 may be considered to be adapted to be secured to a tether, such as tether 40. Annular ring 58 may be sized to position occlusion device 54 in a desired location relative to, for example, pyloric sphincter 20, pylorus 30, or antrum 32.

[0041] The obstructing device 54 may be considered deformable and endoscopically deliverable. The annular ring 56 is adapted to exert an outward radial force to engage an anatomical structure. If the obstructing device 54 is intended for deployment within the pyloric sphincter 20, the annular ring 58 may have an overall diameter of 1-3 cm. If the obstructing device 54 is intended for deployment within the pylorus 30, the annular ring 58 may have an overall diameter of 2-8 cm. If the obstructing device 54 is intended for deployment within the pyloric antrum 32, the annular ring 58 may have an overall diameter of 4-12 cm.

[0042] FIG. 5 is a schematic diagram of an exemplary occlusion device 62 shown positioned near the pyloric antrum 32. The occlusion device 62 has an expandable body 64 that can be filled with gas or other fluid (such as saline) to maintain its expanded shape (as shown). The expandable body 64 can be, for example, an inflatable balloon. In some cases, the occlusion device 62 can be delivered with the expandable body 64 in a deflated configuration. Once the occlusion device 62 reaches its desired deployed location, the expandable body 64 can be filled with gas or other fluid, or perhaps a gel, to expand to its expanded configuration (as shown). The expandable body 64 can have, for example, a spherical or hemispherical shape and can have a maximum outer diameter that helps position the occlusion device 62 relative to the anatomy. When the occlusion device 62 is intended for deployment within the pyloric sphincter 20, the expandable body 64 can have a maximum diameter of 1-3 cm. If the obstruction device 62 is intended for deployment within the pylorus 30, the expandable body 64 may have a maximum diameter of 2 to 8 cm. If the obstruction device 62 is intended for deployment within the antrum 32, the expandable body 64 may have a maximum diameter of 4 to 12 cm.

[0043] The occlusive device 62 may be formed of any material, such as a polymeric material, that can withstand the highly acidic stomach environment. As an example, the occlusive device 62 may be formed of silicone, but the occlusive device 62 may include additional fiber reinforcement. The occlusive device 62 may be formed, for example, via 3D printing. The occlusive device 62 may be molded or electrospun. The occlusive device 62 may be formed via dip coating. As another example, the occlusive device 62 may be formed by electrospinning two halves and then dip coating the two halves together to form the occlusive device 62. The occlusive device 62 includes an attachment point 66 adapted to be secured to a tether 68.

[0044] In some cases, the expandable body 64 may have a variable stiffness profile. The expandable balloon 64 may be relatively flexible, allowing the walls of the expandable balloon 64 to compress and expand through peristalsis. The expandable balloon 64 may be relatively rigid, thereby helping to secure the occlusion device 62 in place relative to the antrum 32. In some cases, the occlusion device 62 may have a variety of different shapes. The occlusion device 62 may have a three-dimensional funnel shape. The occlusion device 62 may or may not have a hemispherical apex. The occlusion device 62 may have an undefined organic shape. The occlusion device 62 may include one or more protruding lips or rings that help secure the occlusion device 62 in place relative to the anatomical structure. Although not shown, the occlusion device 62 may include anchors such as outward prongs, hooks, splines, or tines. The occlusion device 62 may include a surface treatment that promotes endothelialization.

[0045] While shown deployed within the pyloric antrum 32, this is not required in all cases. For example, the occluding device 62 may extend through the pyloric antrum 32 and partially into the duodenum 18. In some cases, as shown in FIG. 6 , the occluding device 62 may extend from the pyloric antrum 32, through the pyloric sphincter 20, throughout the duodenum 18, and up through the anastomosis 26. Thus, the occluding device 62 may function as an occluding device, a tether, and an anastomotic anchor. FIG. 6 illustrates an occluding device 70 having a first end 72 positioned near the pyloric sphincter 20 and a second end 74 extending through the anastomosis 26. The occluding device 70 includes an elongated, inflatable body 76 that extends through the duodenum 18 from the first end 72 of the occluding device 70 to the second end 74 of the occluding device 70. As shown, the deployment arrangement 78 extends into the stomach 14 and to the second end 74 of the occlusion device 70 .

[0046] FIG. 7 is a schematic diagram of an exemplary occlusion device 80, which may be considered an example of occlusion device 44. The exemplary occlusion device 80 is shown within the anatomy and near the pyloric antrum 32. In some cases, the occlusion device 80 may occlude 10 to 50 percent of the stomach 14 and conform to the wall of the stomach 14. The occlusion device 80 includes a funnel-shaped or conical membrane funnel 82. The membrane funnel 82 may be formed, for example, from silicone or expanded polytetrafluoroethylene (e-PTFE). The membrane funnel 82 may be formed from polyurethane, which has high resistance to acids and chemicals. In some cases, low molecular weight resins, such as those available from Cray Valley under the name KRASOL®, may be blended into a highly chemically resistant polyurethane elastomer. In some cases, such polybutadiene-urethanes have rubbery properties, exceptional resistance to hydrolysis and chemicals, good elasticity, and may be reinforced using common rubber fillers.

[0047] The occlusion device 80 extends from an annular ring 84, which represents the largest outer diameter of the occlusion device 80, to a minimum diameter end point 86. The minimum diameter end point 86 may be considered adapted to be secured to a tether 88. The majority of the end of the occlusion device 80 may be covered or uncovered. The annular ring 84, which may be a support ring added to the occlusion device 80, may be sized to position the occlusion device 80 in a desired location, for example, relative to the pyloric sphincter 20, the pylorus 30, or the pyloric antrum 32. If the occlusion device 80 is intended for deployment within the pyloric sphincter 20, the annular ring 84 may have an overall diameter of 1-3 cm. If the occlusion device 80 is intended for deployment within the pylorus 30, the annular ring 84 may have an overall diameter of 2-8 cm. If the occlusion device 80 is intended for deployment within the pyloric antrum 32, the annular ring 84 may have an overall diameter of 4-12 cm.

[0048] The annular ring 84 may be adapted to exert an outward radial force to help hold the occlusion device 80 in place against the anatomy. The occlusion device 80 may include, in part or in whole, a fabric or metal reinforcement, such as ultra-high weight polyethylene (UHMWPE) or nitinol. The occlusion device 80 may be manufactured by attaching the thin film funnel 82 to the annular ring 84 via, for example, sewing, suturing, thermal bonding, or chemical bonding.

[0049] 8, the occlusion device 80 may include a second, intermediate support ring 90 to help support the membrane funnel 82. The occlusion device 80 may include a third support ring, a fourth support ring, etc. The intermediate support ring 90 (and any support rings in addition to the annular ring 84) may be formed of a shape memory metal, such as a nickel-titanium alloy, including Nitinol. Although not shown, the occlusion device 80 may include anchors, such as outward prongs, hooks, splines, or tines. The occlusion device 80 may include a surface treatment to promote endothelialization.

[0050] 9 is a schematic diagram of an exemplary occlusion device 92. The exemplary occlusion device 92 has a structured frame 94 extending from a maximum diameter opening 96 to a minimum diameter end point 98. The minimum diameter end point 98 is adapted to be secured to a tether 100. In some cases, the maximum diameter opening 96 may include a cover (not shown) that spans the opening. If included, the cover may be concave or convex.

[0051] Maximum diameter opening 96 may be sized to position occlusion device 92 in a desired location relative to, for example, pyloric sphincter 20, pylorus 30, or antrum 32. If occlusion device 92 is intended for deployment within pyloric sphincter 20, maximum diameter opening 96 may have an overall diameter of 1-3 cm. If occlusion device 92 is intended for deployment within pylorus 30, maximum diameter opening 96 may have an overall diameter of 2-8 cm. If occlusion device 92 is intended for deployment within antrum 32, maximum diameter opening 96 may have an overall diameter of 4-12 cm.

[0052] The structured frame 94 can be a woven or braided structure. In some cases, the structured frame 94 can be a laser-cut structure. As shown, the structured frame 94 has a plurality of individual struts 102 connected to provide rigidity to the structured frame 94. The structured frame 94 is adapted to be shape-retentive, so that the structured frame 94 returns to an expanded configuration (as shown) after being compressed or compressed for delivery. The dimensions of the individual struts 102 can be varied to provide specific properties to the structured frame 94. The structured frame 94 can have a conical or funnel shape. The structured frame 94 can be spherical or hemispherical in shape. In some cases, the structured frame 94 can be formed from two or more different pieces secured together. In some cases, the structured frame 94 can be formed from laser-cut expandable tubing. The structured frame 94 can be a multi-fiber braided or woven structure. The structured frame 94 may be formed from separate wires that are soldered, welded, or otherwise joined together to form the structured frame 94. For example, the structured frame 94 may be cast from molten metal.

[0053] The occlusion device 92 includes a cover or coating 104 (shown with a dot pattern) covering at least a portion of the structured frame 94. The cover or coating 104 may be PTFE or e-PTFE. The cover or coating 104 may be silicone or another chemically resistant polymer. The cover or coating 104 may be applied via dip coating, spray coating, or electrospinning, for example. Although not shown, the occlusion device 92 may include anchors, such as outward prongs, hooks, splines, or tines. The occlusion device 92 may include a surface treatment to promote endothelialization.

[0054] 10 is a schematic diagram of an exemplary structured frame 106, which may be considered an example of structured frame 94. Structured frame 106 includes a plurality of outwardly extending tines 108 that help secure structured frame 106 (and thus an occlusion device including structured frame 106) in place within the anatomy. When included as part of an occlusion device, structured frame 106 would include a coating or covering, such as coating or covering 104 shown in FIG. 9.

[0055] 11 is a schematic diagram of an exemplary structured frame 110, which may be considered an example of structured frame 94. Structured frame 110 is an example of a braided structure. When included as part of an occlusion device, structured frame 106 would include a coating or covering, such as coating or covering 104 shown in FIG.

[0056] 12 is a schematic diagram of an exemplary occlusion device 112. The exemplary occlusion device 112 includes a coiled support wire 114 extending from a largest diameter end 116 to a smallest diameter termination 118 adapted to be secured to a tether 120. The coiled support wire 114 supports a membrane 122 that covers the coiled support wire 114, thereby occluding the passage of stomach contents from the occlusion device 112 into the duodenum 18. In some cases, the coiled support wire 114 is formed of a shape memory material, such as nitinol.

[0057] 13-16 are schematic diagrams of an exemplary occlusion device including radial support members that support the occlusion cover. In some cases, the radial support members are non-compressible to ensure occlusion cover engagement. The support members are adapted to allow for better self-alignment and engagement of the occlusion cover. The occlusion device has an open structure that allows any chyme that escapes through the occlusion cover to pass through the pylorus. The occlusion cover provides an outward radial force to help secure the occlusion device relative to the anatomy.

[0058] 13 is a schematic diagram of an exemplary occlusion device 124. The exemplary occlusion device 124 includes a plurality of radial support members 126 extending from a starting point 128 to a terminal end 130, which defines a maximum outer diameter of the occlusion device 124. In some cases, as shown, the occlusion device 124 includes an occluder cover 132 disposed at the terminal end 130.

[0059] The radial support member 126 can be metal or polymer. In some cases, the radial support member 126 is a shape-memory metal such as nitinol. The radial support member 126 can be wrapped or bent to allow for reduced size for deliverability. The radial support member 126 can be located within the pylorus 30 or even extend into the duodenum 18 to reduce the possibility of trauma to the pyloric sphincter 20. Although not shown, the radial support member 126 can be covered with a membrane or other material, thereby forming a conical shape. In some cases, the opening of the cone can also be covered with a membrane or other material.

[0060] The occlusion disc 132 may be formed of a polymer, such as silicone, ePTFE, or a woven fabric or metal mesh. Optionally, the occlusion disc 132 may include a support ring 134. The support ring 134, if included, may be polymeric or metallic. Optionally, the support ring 134 may be formed of nitinol. While not shown, the occlusion disc 132 may include outwardly facing prongs, hooks, splines, or tines to aid in engaging tissue and thus securing the occlusion device 124 in place.

[0061] Figure 14 is a schematic diagram of an exemplary occlusion device 136. Exemplary occlusion device 136 is similar to occlusion device 124, but includes a support ring 138 located midway between start point 128 and end point 130. Figure 15 is a schematic diagram of an exemplary occlusion device 140. Exemplary occlusion device 136 is similar to occlusion device 124, but includes both a first support ring 142 and a second support ring 144.

[0062] 16 is a schematic diagram of an exemplary occlusion device 146. The exemplary occlusion device 146 is similar to occlusion devices 124, 136, and 140, but represents a minor repositioning. The radial support member 126 extends to an anchoring ring 148 formed at the terminal end 130. The anchoring ring 148 is adapted to secure the occlusion device 146 in place within the anatomy. The occlusion device 146 includes an occlusion disk 150 located intermediate the starting point 128 and the terminal end 130.

[0063] 17-19 are schematic illustrations of occlusion devices made from or including corrugated tubing. The corrugated tubing can be formed of any suitable polymeric or metallic material, and the corrugations (grooves, waves, bellows, pleats) can be compressible so that occlusion devices including the corrugated tubing can be deliverable under an endoscope.

[0064] Figure 17 shows occlusion device 152 in a compressed configuration, while Figure 18 shows occlusion device 152 in an expanded configuration. Occlusion device 152 extends from a first end 154 to a second end 156. As shown in Figure 18, first end 154 defines the largest outer diameter portion of occlusion device 152, while second end 156 defines the smallest outer diameter portion of occlusion device 152 and is adapted to extend through pyloric sphincter 20 with second end 156 facing the interior of stomach 14.

[0065] The corrugations may extend the length of the occlusion device 152. In some cases, as shown in FIG. 19 , the corrugations may form only the second end 156, with a membrane filter 158 extending distally from the second end 156. The corrugations may be a solid material or a corrugated frame with an atraumatic cover. The corrugations may be a tube constrained at one end to form a funnel. The corrugations may be designed as a funnel, with the depth of the corrugations varying along the length of the funnel. The corrugations may be formed of a shape-memory metal or polymer. The corrugations may include additional metal or non-metallic supports. The corrugations may have a thicker section at the second end 156. In some cases, the membrane may extend to the second end 156. The membrane may be a polymer, such as silicone, or even a fabric. Although not shown, the occlusion device 152 may include outwardly facing prongs, hooks, splines, or tines to aid in engaging tissue and thus securing the occlusion device 152 in place.

[0066] 20-23 are schematic diagrams of an occlusion device including a frame and a membrane. FIG. 20 shows an occlusion device 160 including a frame 162 and a membrane cap 164. A polymer membrane 166 extends distally from the frame 162 and the membrane cap 164 and to a tether 167. The polymer membrane 162 can be, for example, PTFE, ePTFE, or silicone. The frame 162 can be, for example, a laser-cut expandable tube, or the frame 162 can be a multi-fiber braided structure. The frame 162 can be formed of nitinol or stainless steel. In some cases, polymers or other metals can be used to form the frame 162. The frame 162 can include fixation features such as outward prongs, hooks, splines, or tines. The occlusion device 160 can include a coating that promotes endothelialization. The occlusion device 160 has an overall funnel or cone shape.

[0067] 21 shows an occlusion device 168 including a frame 170 and a membrane 172 covering the frame 170. The membrane 172 extends distally to a tubular member 174. In some cases, the membrane 172 may include suture points 176. In some cases, the membrane 172 may be an integral member. The tubular member 174 is formed of a polymeric material, such as ePTFE. The frame 170 is spherical.

[0068] Figure 22 is a schematic diagram of an occlusive device 178, including a frame 180 and a membrane 182. The membrane 182 encases the frame 180 and extends distally from a suture point 184. The membrane 182 extends to a tether (not shown). Figure 23 shows an occlusive device 186, which is similar to occlusive device 160 (Figure 20), except that the polymeric membrane 166 includes openings 188 that allow any trapped chyme to escape.

[0069] 24-26 are schematic illustrations of an occlusion device that includes a rigid component as part of the occlusion device. The rigid component can be adapted to prevent the rigid component from passing through the tortuous bends typically found in the proximal duodenum 18a. The proximal duodenum 18a is the portion of the duodenum 18 immediately distal to the pyloric sphincter 20 and generally includes tortuous bends. FIGS. 24-26 illustrate a rigid component 190 that can be incorporated into any of the occlusion devices described herein. FIGS. 24-26 illustrate an exemplary gastric bypass device 192 that includes an occlusion device 194, an anastomotic anchor 196, and an intervening tether 198.

[0070] In FIG. 24 , rigid component 190 includes bumper 200, which in some instances may be considered an extension of rigid component 190. Bumper 200, in combination with rigid component 190, prevents distal migration of occlusion device 194 because bumper 200 cannot negotiate the tortuous bends of proximal duodenal portion 18 a. In FIG. 25 , rigid component 190 includes inflatable bumper 202, which prevents both proximal and distal migration of occlusion device 194. In FIG. 26 , rigid component 190 includes frame bumper 204. Frame bumper 204 is a rigid, self-expanding frame that prevents both proximal and distal migration of occlusion device 194.

[0071] 27-32B provide examples of exemplary anastomotic anchors that may be used as anastomotic anchors 38 as part of gastric bypass device 34. In some cases, an anastomotic structure, such as an expandable stent, a pair of magnetic structures, or the like, may be implanted adjacent to anastomosis 26 to help hold anastomosis 26 together. The anastomotic structure also provides something for the anastomotic anchor to be secured to.

[0072] Figure 27 is a schematic illustration of an exemplary anastomotic anchor 206 that may be secured relative to the anastomosis 26 (Figure 1). While the corresponding anastomotic structure is not shown in Figure 27, it will be understood that one of the components of the anastomotic anchor 206 has a diameter larger than the lumen diameter of the anastomotic structure. Thus, advancing the anastomotic anchor 206 proximally through the anastomosis 26 (and through the anastomotic structure) means that once the anastomotic anchor 206 reaches its expanded configuration (as shown), the anastomotic anchor 206 cannot be pulled through the anastomosis 26 (or anastomotic structure), thereby securing the anastomotic anchor 206 relative to the anastomosis 26 (and anastomotic structure).

[0073] As shown in FIG. 27 , the anastomotic anchor 206 includes a ring 208 having an outer dimension larger than the lumen diameter of the anastomosis 26 (or anastomotic structure). While the ring 208 is shown to be annular, it can take on any of a variety of different shapes, such as circular or polygonal. The ring 208 can be concave or convex. The ring 208 can be regular or irregular in shape. The ring 208 can be formed of a material that is resistant to the highly acidic stomach environment. The ring 208 can be formed of a metal, such as nitinol or stainless steel. The ring 208 can be formed of a polymer, such as PTFE or ultra-high molecular weight polyethylene (UHMwPE) fiber, commercially available under the name Dyneema®. The ring 208 can be a composite formed of several different materials. The ring 208 can be a wire joined with a coupler. The ring 208 can be a laser-cut structure. In some cases, the ring 208 may be of woven or braided construction. The ring 208 may include a lubricious and / or corrosion-resistant coating or covering.

[0074] The anastomotic anchor 206 includes multiple attachment members 210 extending between the ring 208 and the tether 212. While a total of three attachment members 210 are shown, it will be understood that this is merely exemplary, as the anastomotic anchor 206 may include any number of attachment members 210. In some cases, having at least three attachment members 210 helps stabilize the position of the ring 208 relative to the anastomosis 26 (and the anastomotic structure). The attachment members 210 may be flexible and filamentous. The attachment members 210 may be rigid. Although not shown, the ring 208 may alternatively be attached to the tether 212 via a polymer membrane extending from the ring 208 to the tether 212.

[0075] 28 is a schematic diagram of an exemplary anastomotic anchor 214 shown positioned relative to an exemplary anastomotic structure 216. The exemplary anastomotic anchor 214 may be considered an opposed double ring anchor. The exemplary anastomotic structure 216 includes a first annular section 218 adapted to be positioned within the stomach 14 and a second annular section 220 adapted to be positioned within the small intestine 16. In some examples, the second annular section 220 may be adapted to be positioned within the duodenum 18 or the jejunum 24. An intervening portion 222 extends between the first annular section 218 and the second annular section 220. It will be appreciated that the intervening portion 222 defines a lumen extending through the anastomotic structure 216. Thus, the dimensions of the intervening portion 222 define the minimum size of the ring 208 (of the anastomotic anchor 206 shown in FIG. 27 ). In some cases, the anastomotic structure 216 may be considered to be a woven or braided self-expanding stent. In some cases, the anastomotic structure 216 may be considered to be an example of an Axios® stent, which is commercially available from Boston Scientific.

[0076] The anastomotic anchor 214 may include a first ring 224 adapted to be secured above the first annular section 218 of the anastomotic structure 216. The anastomotic anchor 214 may include a second ring 226 adapted to be secured below the second annular section 220 of the anastomotic structure 216. In this case, terms such as above or below simply refer to the orientation shown. The anastomotic structure 216 may be deployed in any orientation, including, for example, an orientation significantly upside down from that shown in FIG.

[0077] Anastomotic anchor 214 includes one or more members 228 and 230 extending between first ring 224 and second ring 226. Anastomotic anchor 214 also includes one or more connectors 232 and 234 extending downward from first ring 224 for coupling anastomotic anchor 214 with a tether. In some cases, tensile forces acting on connectors 232 and 234 can cause the distance between first ring 224 and second ring 226 to be reduced. As first ring 224 and second ring 226 become smaller, the resulting forces acting on anastomotic structure 216 cause the length of anastomotic structure 216 to shorten and grow radially. As the first annular section 218 and the second annular section 220 of the anastomosis structure 216 grow radially, the first annular section 218 and the second annular section 220 of the anastomosis structure 216 provide enhanced engagement with the tissue, thereby helping to ensure no device migration.

[0078] In some cases, one or more of the members 228 and 230 and / or one or more of the connectors 232 and 234 may include one or more strings. One or more of the members 228 and 230 and / or one or more of the connectors 232 and 234 may be braided or coiled, or may be sheathed. One or more of the members 228 and 230 and / or one or more of the connectors 232 and 234 may be covered or uncovered, for example. Each of the components of the anastomotic anchor 214 may be independently constructed of a material that is resistant to the harsh gastric environment. Metals such as nitinol and stainless steel may be used, as may polymers such as PTFE and ultra-high molecular weight polyethylene (UHMwPE) fibers commercially available under the name Dyneema®. The connectors 232 and 234 may have a single attachment point to the tether or multiple attachment points.

[0079] In some cases, some or all of anastomotic anchor 214 may be covered, although the through lumen through anastomotic anchor 214 remains open to allow food and chyme to pass through. The covering may function to help protect some or all of anastomotic anchor 214 from the stomach environment. If included, the covering may reduce interaction with chyme or food particles. If included, the covering may reduce friction or interaction with the tissues of the stomach environment. The covering may be tight-fitting or loose-fitting and may be PTFE, ePTFE, or other polymers. If included, the covering may largely encapsulate the entire anastomotic anchor 214 or may encapsulate only individual components thereof.

[0080] 29 is a schematic diagram of an exemplary anastomotic anchor 236 shown relative to the anastomosis structure 216 described with respect to FIG. 28. As shown, a first annular section 218 is positioned adjacent a stomach wall 238, and a second annular section 220 is positioned adjacent a small intestinal wall 240. While the anastomotic anchor 236 is shown adjacent a braided anastomosis structure 216, such as an Axios® stent, it will be understood that the anastomosis anchor 236 will function equally well with a different lumen insert or without a stent within the anastomosis 26. For example, the anastomosis structure 216 could instead simply be a pair of magnetic rings, one adjacent the stomach wall 238 and one adjacent the small intestinal wall 240. In some cases, the anastomosis 216 may simply be a surgically (or endoscopically) created structure held in place with sutures. The anastomosis 16 may be created in a manner that does not require additional structures, such as the anastomotic structure 216, to maintain the patency of the anastomosis 16.

[0081] The anastomotic anchor 236 is a self-expanding braided structure including a first enlarged diameter portion 242 adapted to be secured above the first annular section 218 of the anastomotic structure 216. The anastomotic anchor 236 includes a second enlarged diameter portion 244 adapted to be secured below the second annular section 220 of the anastomotic structure 216. The anastomotic anchor 236 also includes an intervening portion 246 extending from the first enlarged diameter portion 242 to the second enlarged diameter portion 244 and adapted to fit within the intermediate portion 222 of the anastomotic structure 216. Terms such as "upper" and "lower" simply refer to the orientations shown. The anastomotic structure 236 can be deployed in any orientation, including, for example, an orientation significantly upside down from that shown in FIG. 29 . Furthermore, the first enlarged diameter portion 242 and the second enlarged diameter portion 244 can be considered adapted to interact with whatever anastomotic structure is used.

[0082] In some cases, first expanded diameter portion 242 may be designed to be larger than first annular section 218 of anastomotic structure 216. First expanded diameter portion 242 may be large enough to directly engage stomach wall 238, particularly when force is applied to anastomotic anchor 236 via tether 248. Anastomotic anchor 236 may be formed of a material that is resistant to the stomach environment. Anastomotic anchor 236 may be formed of a shape memory polymer or a shape memory metal. In some cases, anastomotic anchor 236 may include a covering such as silicone. In some cases, anastomotic anchor 236 may include hooks or tines to facilitate fixation to stomach wall 238.

[0083] FIG. 30 is a schematic diagram of an exemplary anastomotic anchor 250 shown for the anastomotic structure 216 described with respect to FIG. 28 . The anastomotic anchor 250 includes an anchor component 252 adapted to be secured to the first annular section 218 of the anastomotic structure 216. The anastomotic anchor 250 also includes a piercing portion 254 coupled with the anchor component 252 and adapted to fit through the intervening portion 222 of the anastomotic structure 216. In some cases, the anchor component 252 may have one of several different heights to enable it to clear various anastomotic structures. In some cases, the anchor component 252 may have an annular outer profile. In some cases, the anchor component 252 may have one, two, three, four, or more feet or pads extending radially outward from the anchor component 252 to engage the stomach wall 238.

[0084] In some cases, anastomotic anchor 250 is adapted to form a friction fit with first annular section 218 of anastomotic structure 216. In some cases, anastomotic anchor 250 includes hooks or tines adapted to engage stomach wall 238. In some cases, anastomotic anchor 250 includes hooks or tines, or other structure, adapted to engage stomach wall 238, and piercing portion 254 includes hooks or tines, or other structure, adapted to engage jejunal wall 240. In some cases, piercing portion 254 may include hooks or tines adapted to engage interstitial portion 222 of anastomotic structure 216.

[0085] 31A and 31B are side and top views, respectively, of an exemplary anastomotic anchor 256 shown disposed within an anastomotic structure 216. As best seen in FIG. 31B , anastomotic anchor 256 is adapted to fit within interstitial portion 222 of anastomotic structure 216. In some cases, anastomotic anchor 256 includes a cylindrical body 258 that optionally includes several axially extending members 260. In some cases, cylindrical body 258 includes one or more rings that engage the sides of anastomotic structure 216. One or more rings may be telescoping, for example, to provide an outward force to help keep anastomotic structure 216 from migrating. In some cases, a tether may be attached to anastomotic anchor 256. In some cases, a tether may alternatively or additionally be attached to anastomotic structure 216.

[0086] 32A and 32B are side and top views, respectively, of an exemplary anastomotic anchor 262 shown positioned within an anastomotic structure 216. As best seen in FIG. 32B , the anastomotic anchor 262 is adapted to fit within the interstitial portion 222 of the anastomotic structure 216. In some cases, the anastomotic anchor 262 is a central insert and can be any four-sided or more-than-four-sided shape. Examples include, but are not limited to, cross-sectional profiles defining squares, rectangles, and other polygons. The anastomotic anchor 262 can have a rounded shape. The anastomotic anchor 262 can be solid or can have notches to allow chyme flow. The anastomotic anchor 262 can have outwardly extending arms or leaves to aid in engagement with the anastomotic structure 216. In some cases, a tether can be attached to the anastomotic anchor 262. In some cases, the tether may alternatively or additionally be attached to the anastomosis structure 216 .

[0087] 33-53D provide examples of exemplary tethers that may be used as tether 40 as part of gastric bypass device 34. FIG. 33 is a schematic diagram of exemplary gastric bypass device 270. Gastric bypass device 270 includes occlusion device 272 and an anastomotic anchor 274. Tether 276 extends between occlusion device 272 and anastomotic anchor 274. Tether 276 includes spring 278 adapted to provide a return spring that increases as spring 278 expands when stomach movement causes movement of occlusion device 272 and / or anastomotic anchor 274. In some cases, spring 278 is under a small amount of tension when occlusion device 272 and anastomotic anchor 274 are properly positioned. Spring 278 may be formed of any suitable polymeric or metallic material. In some cases, spring 278 may be formed of, for example, nitinol or stainless steel.

[0088] The spring 278 can take several forms. FIG. 34A shows a spring 278a with a varying diameter, having a minimum diameter at the midpoint and larger diameters at both ends. FIG. 34B shows a spring 278b with a tapered diameter, from a maximum diameter at one end to a minimum diameter at the other end. FIG. 34C shows a spring 278c with a uniform diameter and pitch from one end to the other. FIG. 34D shows a spring 278d with a constant outer diameter but a varying pitch. FIG. 34E shows a spring 278e with a tapered diameter, from a maximum diameter in the center to a minimum diameter at both ends. These are merely examples. The spring 280 can be formed of any suitable polymeric or metallic material. In some cases, the spring 280 can be formed of, for example, nitinol or stainless steel.

[0089] 35A-35G show additional possible designs for spring 278. In FIG. 35A, spring 280a includes a single coiled wire. In FIG. 35B, spring 280b includes joined rings or hoops 282. In FIG. 35C, spring 280c includes a zigzag design. In FIG. 35D, spring 280d includes a first spring 284a having a first spring constant and a second spring 284b having a second spring constant. The first spring 284a and the second spring 284b may also have differences in other characteristics, such as length and diameter. In FIG. 35E, spring 280e may include a string 286 extending from one end of spring 280e to the other end of spring 280e, providing a limit to how far spring 280e can stretch. In Figure 35F, spring 280f can be tightly fitted onto inner tube 288 to prevent interaction with food and chyme. In Figure 35G, spring 280g can include a rigid tube 290 that extends into occluder cone 292 to provide more spring length in a relatively short device. Spring 280 can be formed of any suitable polymeric or metallic material. In some cases, spring 280 can be formed of nitinol or stainless steel, for example.

[0090] In some cases, the spring(s) may include a cover or coating. The cover or coating may reduce friction or other interaction with tissue within the gastric system. The cover or coating may reduce spring interaction with chyme and food, thereby potentially avoiding blockage. The cover or coating may act as a barrier against the harsh gastric environment. The cover or coating may reduce damage or inflammation in the bile duct and / or papilla. In some cases, the cover or coating may be ePTFE, PTFE, or other polymer. FIG. 36A shows spring 294a with cover 296 that encapsulates spring 294a and expands and contracts with spring 294a. FIG. 36b shows spring 294b with cover 298 that allows spring 294b to move independently of cover 298. FIG. 36C shows spring 294c with cover 300 that conforms to threads 302 forming spring 294c. 36D shows a spring 294d having a cover 304 that is continuous with material 306 that forms at least a portion of the occlusion device. The spring 294 may be formed of any suitable polymeric or metallic material. In some cases, the spring 294 may be formed of, for example, nitinol or stainless steel.

[0091] 37 shows a tether 308 in place within the duodenum 18 extending between an occlusion device 310 and an anastomotic anchor 312, which is shown disposed within the anastomosis 26. The tether 308 includes an inner tether 314 disposed within a corrosion-resistant, impermeable sleeve 316 that encases the inner tether 314. The sleeve 316 protects the inner tether 314 from the stomach environment while the inner tether 314 provides the pulling force. The sleeve 316 is sealed to the inner tether 314 at a first sealing point 318 and a second sealing point 320. Between the first sealing point 318 and the second sealing point 320, the inner tether 314 is protected from the stomach environment by the sleeve 316. Although a first sealing point 318 is shown distal to the occlusion device 310 and a second sealing point 318 is shown proximal to the anastomotic anchor 312, in some cases the sleeve 316 may extend the entire length of the inner tether 314.

[0092] In some cases, having the inner tether 314 within the sleeve 316 provides the advantage of being able to separate mechanical and chemical performance. The inner tether 314 can be made from a particular material selected for its mechanical performance without having to worry about whether the material can withstand the harsh gastric environment. This means that any material can be used to form the inner tether 314.

[0093] 38A and 38B show a tether 322 extending between an occlusion device 324 and an anastomotic anchor 326. The tether 322 includes a spring 328 having a first end 330 closest to the occlusion device 324 and a second end 332 closest to the anastomotic anchor 326. A first attachment member 334 extends from the first end 330 of the spring 328 to the anastomotic anchor 326. A second attachment member 336 extends from the second end 332 of the spring 328 to the occlusion device 324. As a result, distal movement of the occlusion device 324 and / or proximal movement of the anastomotic anchor 326 will cause compression of the spring 328, as shown in FIG. 38B. This provides a hard stop on how far the occlusion device 324 and the anastomotic anchor 326 can move, as the spring 328 can only compress so far. The spring 328 may be formed of any suitable polymeric or metallic material, including NiTi or stainless steel. The spring 328 may have a varying diameter along its length. The spring 328 may be a single spring, or the spring 328 may include two or more separate spring segments.

[0094] FIG. 39 illustrates a tether 338 including an elastic polymer tube 340 and a cover 342 that covers the elastic polymer tube 340. Stretching of the tether 338 as a result of stomach movement causes the elastic polymer tube 340 to exert a tensile force as it attempts to return to its natural or biased configuration. The durometer of the polymer used to form the elastic polymer tube 340 can be varied to adjust its memory strength. Various polymers can be used for the elastic polymer tube 340. By way of example, the elastic polymer tube 340 can be formed of latex. The elastic polymer tube 340 can be a single polymer tube. In some cases, the elastic polymer tube 340 can be multiple elastic polymer strands. The cover 342 can help act as a barrier against the corrosive gastric environment. The cover 342 can reduce interaction with chyme and food particles and reduce friction or other interaction with tissue within the gastric system. The cover 342 can reduce damage or inflammation in the bile duct and / or papilla. In some cases, the cover 342 may be formed of silicone. In some cases, the cover 342 may be PTFE or ePTFE.

[0095] In some cases, the spring, such as a leaf spring, may not be part of the tether itself, but may be attached to either the occlusion device or the anastomotic anchor with a tether extending from the leaf spring. As a result, tension in the tether will move the leaf spring from its original biased configuration. FIGS. 40A and 40B show a leaf spring 344 secured to an occlusion device 346. The leaf spring 344 may be flat, concave, or convex. The leaf spring 344 may be a flat or round beam, or may have multiple stacked beams. The leaf spring 344 may be formed of any suitable metal or polymer material.

[0096] A tether 348 extends from the leaf spring 344 through and distally from the occlusion device 346. Although the leaf spring 344 is shown attached to the occlusion device 346, a similar result can be achieved by securing the leaf spring 344 to the anastomotic anchor instead. In FIG. 40A , the tether 348 is not under any tension, and the leaf spring 344 remains in a linear configuration, representing the original biased configuration of the leaf spring 344. In FIG. 40B , the tether 348 is under tension, as indicated by arrow 350. As can be seen, the leaf spring 344 has been bent, moving from its original biased configuration. As a result, the leaf spring 344 attempts to return to its original configuration, thereby resisting movement of the anastomotic anchor.

[0097] In some cases, a helical torsion spring may be used at the end of the tether in place of leaf spring 344. The helical torsion spring may be secured between occlusion device 346 and tether 348. In some cases, the helical torsion spring may instead be secured between the anastomotic anchor and tether 348. When tether 348 provides a tension force to the helical torsion spring as a result of stomach movement that causes movement of occlusion device 346 and / or the anastomotic anchor, the helical torsion spring will move from its original biased configuration. As a result, the helical torsion spring will exert a force on tether 348 as it attempts to resume its original biased configuration.

[0098] 41 is a schematic diagram of an exemplary tether 352 extending between an occlusion device 354 and an anastomotic anchor 356. In some cases, the tether 352 may be formed as a braided stent. The tether 352 may act as a spring, providing a return force in response to elongation of the tether 352 as a result of stomach movement. The tether 352 may be formed of any suitable metallic or polymeric material. The material, dimensions, pitch, etc. of the tether 352 may be varied to provide a desired return force behavior. As an example, the tether 352 may be designed to provide a linear increase in return force as the device elongates. The tether 352 may be designed to provide an increase in return force as the device elongates, for example.

[0099] In some cases, tether 352 may include a coating or covering that helps protect tether 353 from the gastric environment. If included, the coating or covering may reduce interaction with chyme and food particles, reduce friction and interaction with gastric tissue, and reduce damage or inflammation in the bile duct and / or papilla. If included, the coating or covering may be any suitable material, such as, but not limited to, PTFE and ePTFE.

[0100] FIG. 42 is a schematic diagram of an exemplary tether 358 formed as or otherwise including a pneumatic cylinder 360. The tether 358 extends between an occlusion device 362 and an anastomotic anchor 364. The pneumatic cylinder 360 provides a return force in response to a pulling force acting on the tether 358. In some cases, the pneumatic cylinder 360 can be a positive pressure cylinder or a negative pressure cylinder. The pneumatic cylinder 360 can be rigid or flexible and can be positioned anywhere along the length of the tether 358, from near the occlusion device 362, near the anastomotic anchor 364, or anywhere in between. The pneumatic cylinder 360 can be metal or polymer and can be filled with a liquid or gas working fluid. FIG. 43 shows an example of a negative pressure cylinder 360a, while FIG. 44 shows an example of a positive pressure cylinder 360b.

[0101] 45 is a schematic diagram of an exemplary tether 366 extending between an occlusion device 368 and an anastomotic anchor 370. The tether 366 includes a protective sleeve 372, a spring 374, and a sliding joint 376 that allows the spring 374 to extend within but independently of the protective sleeve 372. Optionally, the tether 366 includes a PTFE tube 375. Optionally, the PTFE tube 375 allows the tether 366 to smoothly extend and move in and out of the sliding joint 376. Optionally, a nitinol wire may reside inside the PTFE tube 375 to prevent kinking. Also, inside the PTFE tube 375 may be a suture that attaches to the spring 374 and the anastomotic anchor 370 and holds the spring 374 in place. The suture may be formed of UHMWPE (ultra-high molecular weight polyethylene). Although the spring 374 is shown proximate the occlusion device 368, the spring 374 may alternatively be positioned proximate the anastomotic anchor 370. The sliding joint 376 has low friction, thus allowing movement with low applied forces, while providing a tight fit to minimize the possibility of chyme entering the protective sleeve 372. In some cases, the sliding joint 376 may be a small tube within a larger tube. The sliding joint 376 may be a small tube pulled through a soft membrane. The sliding joint 370 may be one or more threads within the tube. The threads may be polymeric or metallic. The threads may be single-stranded, multi-stranded, or braided together. The spring may be an elastic polymer or a metal, such as nitinol or spring steel. The protective sleeve 372 may be formed of a flexible, durable, and corrosion-resistant polymer, such as ePTFE.

[0102] FIG. 46 is a schematic diagram of an exemplary tether 378 including a collet 380. In some cases, the collet 380 is a one-way collet adapted to allow the tether 378 to be pulled in a first direction while preventing movement of the tether 378 in the opposite direction. In some cases, the tether 378 can be pulled against the collet 380 to shorten the tether 378. In some cases, the collet 380 can include teeth or barbs that allow the tether 378 to move in one direction but not the other. The collet 380 can utilize friction to control movement. In some cases, the collet 380 can mate with an interlocking feature on the tether 378 to control movement. The collet 380 can be positioned near the occlusion device, near the anastomotic anchor, or somewhere in between. The collet 380 allows for in-vivo tether length adjustment by the physician to adjust for a particular patient's anatomy. Optionally, collet 380 can be adjusted on the benchtop prior to implantation to adjust the effective length of tether 378.

[0103] 47 is a schematic diagram of an exemplary tether 382 extending between an occlusion device 384 and an anastomotic anchor 386. The tether 382 includes a threaded joint 388 between a threaded member 390 and a spring 392 that threadingly engages the threaded member 390. In some cases, the threaded joint 388 can be adjusted on a benchtop prior to implantation to adjust the effective length of the tether 382. In some cases, the threaded joint 388 can be adjusted in vivo using an endoscopic tool. The tether 382 can be formed of any suitable material. The threaded joint 388 can be located near the occlusion device 384, near the anastomotic anchor 386, or somewhere in between.

[0104] 48 is a schematic diagram of a portion of the gastrointestinal system showing the relative locations of a patient's bile duct 394, a patient's pancreatic duct 396, and a patient's papilla of vater 398. The papilla of vater 398 is where the bile duct 394 and pancreatic duct 396 fluidly connect with the duodenum 18. The papilla of vater 398 is located on the inner curve of the duodenum 18 and, in some cases, may protrude partway into the interior of the duodenum 18. A potential problem with placing a tether within the duodenum 18 is that the tether may irritate the papilla of vater 398, which may cause inflammation and, in turn, various complications. In some cases, it may be desirable to provide a tether that avoids irritating the papilla of vater 398.

[0105] 49 is a schematic diagram of an exemplary tether 400 extending through the duodenum 18 between an occlusion device 402 and an anastomotic anchor 404. As shown, the tether 400 includes a first spring segment 406 proximal to the papilla of vater 398 and a second spring segment 408 distal to the papilla of vater 398. The tether 400 includes a member 410 extending between the first spring segment 406 and the second spring segment 408 and passing through the papilla of vater 398. Because the first spring segment 406 and the second spring segment 408 have larger diameters (although not necessarily the same as each other) relative to the member 410, the member 410 is held away from the interior surface of the duodenum 18 and, therefore, away from the papilla of vater 398.

[0106] Figures 50A, 50B, and 50C provide additional examples. In Figure 50A, tether 412a includes a first spring segment 414 and a second spring segment 416, but does not include any metal structure between them. Instead, tether 412a includes an atraumatic covering 418 that encapsulates first spring segment 414 and second spring segment 416. Atraumatic covering 418 is constricted between first spring segment 414 and second spring segment 416 via a pair of sutures 420 that secure atraumatic covering 418 to the ends of first spring segment 414 and second spring segment 416. Thus, no metal is in proximity to papilla 398.

[0107] FIG. 50B shows tether 412b, similar to tether 400, but including an atraumatic covering 422 that encapsulates first spring segment 406, second spring segment 408, and member 410 extending therebetween. Optionally, as shown, a soft pillow 424 is disposed between first spring segment 406 and second spring segment 408 and held in place by atraumatic covering 422. Thus, no metal is near papilla 398. FIG. 50C shows tether 412c, including a spring 426 disposed within atraumatic covering 428. Spring 426 has a varying diameter, having a maximum diameter at either end of spring 426 and tapering to a minimum diameter near the midpoint of spring 426.

[0108] FIG. 51 illustrates a tether 430 including a physical standoff 432 disposed thereon, through which the tether 430 extends. In some cases, the physical standoff 432 can slide relative to the tether 430. In some cases, the physical standoff 432 is a braided structure formed of a metal, such as Nitinol. In some cases, the physical standoff 432 can instead be inflatable, such as an inflatable balloon. As shown, the physical standoff 432 includes a first valve region 434 and a second valve region 436, with a reduced diameter portion 438 extending between the first valve region 434 and the second valve region 436. In some cases, the physical standoff 432 can further include additional valve regions.

[0109] 52 shows a tether 440 including a physical standoff 442 forming a portion of the tether 440. The tether 440 includes a first spring segment 444 and a second spring segment 446, with the physical standoff 442 disposed between the first spring segment 444 and the second spring segment 446. The physical standoff 442 may be welded, sewn, or glued to each of the first spring segment 444 and the second spring segment 446, for example. The physical standoff 442 may include a first valve region 444 and a second valve region 446, with a rigid member 448 extending between the first valve region 444 and the second valve region 446.

[0110] Figure 53A is a schematic diagram of an exemplary tether 450. The exemplary tether 450 includes a first spring segment 452 and a second spring segment 454. The tether 450 includes an arcuate segment 456 extending between the first spring segment 452 and the second spring segment 454. Figure 53B shows a first view of the arcuate segment 456, while Figure 53C shows a second view of the arcuate segment 456. Tension on the tether 450 will cause the arcuate segment 456 to rotate perpendicular to the papilla of vater 398, as shown in Figure 53D.

[0111] In some cases, a dynamic leash may be used as part of a gastric bypass device. Figures 54-59 provide examples of exemplary dynamic leashes that may be used as dynamic leash 42 as part of gastric bypass device 34.

[0112] 54 is a schematic diagram of an exemplary dynamic leash 458 shown in the anatomy. The dynamic leash 458 extends between an occlusion device 460 positioned proximal to the pyloric sphincter 20 and an anastomotic anchor 462 positioned proximal to the anastomosis 26. As shown, the dynamic leash 458 is secured to an annular ring 464 that forms part of the occlusion device 460. A tether 466 also extends through the duodenum 18 between the occlusion device 460 and the anastomotic anchor 462. It will be appreciated that the tether 466 and the dynamic leash 458 can work together to help hold the occlusion device 460 in place, regardless of how stomach movement attempts to move the occlusion device 460. If stomach movement attempts to move the occlusion device 460 proximally into the stomach 14, the tether 466 will provide resistance to that movement. If stomach movement attempts to move the occlusion device 460 distally into the duodenum 18, the dynamic leash 458 will provide resistance to that movement.

[0113] 55 is a schematic diagram of an exemplary dynamic leash 468 shown in an anatomical structure. Dynamic leash 468 includes spring 470. Tether 472 includes spring 474. In some cases, spring 470 has a first spring constant and spring 474 has a second spring constant. In some cases, spring 470 and spring 474 may be selected in combination to ensure that the two springs 470 and 474 together provide a dynamic balancing force to maintain the desired position of occlusion device 460.

[0114] 56 is a schematic diagram of an exemplary dynamic leash 476 shown in the anatomy. The dynamic leash 476 extends between an occlusion device 478 positioned proximate the pyloric sphincter 20 and an anastomotic anchor 480 positioned proximate the anastomosis 26. As shown, the dynamic leash 476 is secured to a cover 482 that forms part of the occlusion device 478. In some cases, a central attachment point to the cover 482 or the like may provide for allowing the occlusion device 478 to lie flat, while attachment to the side of the occlusion device 478 may allow the occlusion device 478 to tilt or swing in place.

[0115] Tether 484 also extends through duodenum 18 between occlusion device 478 and anastomotic anchor 480. It will be appreciated that tether 484 and dynamic leash 476 may work together to help hold occlusion device 478 in place regardless of how stomach movement tends to move occlusion device 478. If stomach movement tends to move occlusion device 478 proximally into stomach 14, tether 484 will provide resistance to that movement. If stomach movement tends to move occlusion device 478 distally into duodenum 18, dynamic leash 476 will provide resistance to that movement. In some cases, dynamic leash 476 includes spring 486. Tether 484 includes spring 488. In some cases, spring 486 has a first spring constant and spring 488 has a second spring constant. In some cases, spring 486 and spring 488 may be selected in combination to ensure that the two springs 486 and 488 together provide a dynamic balancing force to maintain the desired position of occlusion device 478.

[0116] 57 is a schematic diagram of an exemplary dynamic leash 490 shown in the anatomy. The dynamic leash 490 extends between an occlusion device 478 positioned proximate the pyloric sphincter 20 and an attachment point 492 in the stomach wall 494. As shown, the dynamic leash 476 is secured to a cover 482 that forms part of the occlusion device 478. In some cases, a central attachment point to the cover 482 or the like may provide for allowing the occlusion device 478 to lie flat, while attachment to the side of the occlusion device 478 may allow the occlusion device 478 to tilt or swing in place.

[0117] Tether 484 extends through duodenum 18 between occlusion device 478 and anastomotic anchor 480. It will be appreciated that tether 484 and dynamic leash 490 may work together to help hold occlusion device 478 in place regardless of how stomach movement tends to move occlusion device 478. If stomach movement tends to move occlusion device 478 proximally into stomach 14, tether 484 will provide resistance to that movement. If stomach movement tends to move occlusion device 478 distally into duodenum 18, dynamic leash 490 will provide resistance to that movement. In some cases, dynamic leash 490 includes spring 496. In some cases, spring 496 has a first spring constant and spring 488 has a second spring constant. In some cases, spring 496 and spring 488 may be selected in combination to ensure that the two springs 496 and 488 together provide a dynamic balancing force to maintain the desired position of occlusion device 478.

[0118] 58 is a schematic diagram of an exemplary dynamic leash 498 shown in the anatomy. The dynamic leash 498 extends between an occlusion device 478 positioned proximate the pyloric sphincter 20 and an anti-migration anchor 500 positioned proximate the anastomosis 26. The anti-migration anchor 500 is an anchor that can be attached to the stomach 14 such that tension can act on the anchor in either direction without the anti-migration anchor migrating. In some cases, the dynamic leash 498 can be connected to the anti-migration anchor 500 such that tension from the dynamic leash 498 can change the diameter and / or shape of the anti-migration anchor 500. As an example, the anti-migration anchor 500 can increase in diameter and decrease in length to provide additional outward radial force and prevent slippage through the anastomosis 16. As shown, the dynamic leash 498 is secured to a cover 482 that forms part of the occlusion device 478. In some cases, a central attachment point to the cover 482 or the like may result in the occlusion device 478 being able to lie flat, while attachment to the side of the occlusion device 478 may allow the occlusion device 478 to tilt or rock in place.

[0119] Tether 484 extends through duodenum 18 between occlusion device 478 and anti-migration anchor 500. It will be appreciated that tether 484 and dynamic leash 498 may work together to help hold occlusion device 478 in place regardless of how stomach movement tends to move occlusion device 478. If stomach movement tends to move occlusion device 478 proximally into stomach 14, tether 484 will provide resistance to that movement. If stomach movement tends to move occlusion device 478 distally into duodenum 18, dynamic leash 498 will provide resistance to that movement. In some cases, dynamic leash 498 includes spring 502. In some cases, spring 502 has a first spring constant and spring 488 has a second spring constant. In some cases, spring 502 and spring 488 may be selected in combination to ensure that the two springs 502 and 488 together provide a dynamic balancing force to maintain the desired position of occlusion device 478.

[0120] 59 is a schematic diagram of an exemplary dynamic leash 498 shown in the anatomy. The dynamic leash 498 extends between the occlusion device 478, positioned proximal to the pyloric sphincter 20, and a pair of magnetic rings 506, positioned proximal to the anastomosis 26. A tether 484 extends through the duodenum 18 between the occlusion device 478 and the magnetic rings 506. It will be appreciated that the tether 484 and the dynamic leash 498 can work together to help hold the occlusion device 478 in place, regardless of how stomach movement attempts to move the occlusion device 478. If stomach movement attempts to move the occlusion device 478 proximally into the stomach 14, the tether 484 will provide resistance to that movement. If stomach movement attempts to move the occlusion device 478 distally into the duodenum 18, the dynamic leash 476 will provide resistance to that movement.

[0121] 60 is a schematic diagram of a passive engagement device 504 shown in proximity to the pyloric sphincter 20. The passive engagement device 504 includes a first gastric clip 506 securable on a first side 508 of the pyloric sphincter 20, pylorus 30, or antrum 32, and a second gastric clip 510 securable on a second side 512 of the pyloric sphincter 20, pylorus 30, or antrum 32. A first elastic band 514 extends between the first gastric clip 506 and the second gastric clip 510. A second elastic band 516 extends between the first gastric clip 506 and the second gastric clip 510. Together, the first elastic band 514 and the second elastic band 516 help prevent distal migration of the occlusion device 518. When the pyloric sphincter 20 is dilated, the first elastic band 514 and the second elastic band 516 engage the occlusion device 518 and prevent distal migration of the occlusion device 518. When the pyloric sphincter 20 is not dilated or relaxed, the first elastic band 514 and the second elastic band 516 do not contact the occlusion device 518.

[0122] 61 is a schematic diagram of a passive engagement device 520 shown in proximity to the pyloric sphincter 20. The passive engagement device 520 includes a first gastric clip 506 securable on a first side 508 of the pyloric sphincter 20, pylorus 30, or antrum 32, and a second gastric clip 510 securable on a second side 512 of the pyloric sphincter 20, pylorus 30, or antrum 32. A first hook or bumper 522 is attached to the first gastric clip 506, and a second hook or bumper 524 is attached to the second gastric clip 510. Together, the first hook or bumper 522 and the second hook or bumper 524 help to prevent the occlusion device 518 from migrating distally. When the pyloric sphincter 20 dilates and the obstruction device 518 moves distally, the first hook or bumper 522 and the second hook or bumper 524 engage the obstruction device 518 and prevent distal movement of the obstruction device 518. When the pyloric sphincter 20 is not dilated or relaxed, the first hook or bumper 522 and the second hook or bumper 524 do not contact the obstruction device 518.

[0123] FIG. 62 is a schematic diagram of an exemplary device 530 that integrates anastomosis formation and gastric bypass system delivery into a single step. The exemplary device 530 includes an electrocautery tip 532 that is used to form the anastomosis 534, as well as a compressed anastomotic anchor 536 that is deployed after the anastomosis 534 is formed using the electrocautery tip 532. Once the anastomosis 534 is formed, the remaining portion of the gastric bypass device 538 can be delivered through a pullback process (from the duodenum 18 to the pyloric sphincter 20). A sleeve (not shown) can hold the anastomotic anchor 536 in a compressed configuration before removing the sleeve. The gastric bypass device 538 is shown, for example, in FIG. 63.

[0124] As described above, a gastric bypass device may include any of a variety of different occlusion devices, any of a variety of different anastomotic anchors, and any of a variety of different tethers. In some cases, a gastric bypass device may also include any of a variety of different dynamic leashes. Regardless of which occlusion device, anastomotic anchor, or tether is included, it is necessary to deliver and deploy the gastric bypass device. The following figures illustrate several different delivery methods that may be used in delivering any of a variety of different gastric bypass devices. While FIGS. 64-89 each illustrate the delivery of a similar gastric bypass device, it will be understood that each of the illustrated methods may be utilized in delivering a gastric bypass device including any of the occlusion devices described herein, any of the anastomotic anchors described herein, and any of the tethers described herein. Once the gastric bypass device is delivered, any of the various different dynamic leashes described herein may be delivered and connected endoscopically, as shown in FIGS. 54-59.

[0125] Figures 64-69 illustrate a wire-pull method for placing a gastric bypass device. Figures 64 and 70-74 illustrate a rail method. Figures 64 and 75-79 illustrate a garage method. Figures 64 and 80-83 illustrate a two-piece method. It will be understood that each of these methods utilizes a guidewire that is placed through the digestive system 10 with both its proximal and distal free ends extending up the esophagus 12 and out the patient's mouth. Figures 84-89 illustrate the generic method.

[0126] In some cases, a gastric bypass device may be implanted in a patient for a specified period of time, such as one or two years. In some cases, it may be desirable to remove the gastric bypass device for a period of time after implantation to allow normal function of the patient's gastrointestinal tract before another gastric bypass device is implanted. In some cases, during periods when a gastric bypass device is not implanted in a patient, it may be desirable to implant a device within anastomosis 26 to temporarily block anastomosis 26 so that all stomach contents pass through pyloric sphincter 20 into small intestine 16 and pass through small intestine 16 without passing through anastomosis 26. When a subsequent gastric bypass device is subsequently implanted, the implanted device blocking anastomosis 26 will be removed.

[0127] 64 shows a guidewire 540 advanced down the esophagus 12, through the stomach 14, through the pylorus 30, through the duodenum 18, through the anastomosis 26, and back through the stomach 14 so that the guidewire includes a distal free end 542 and a proximal free end 544, both of which extend out of the patient's mouth (not shown). As a result, a device can be advanced over the guidewire 540, starting from either the distal free end 542 or the proximal free end 544. As described above, the guidewire 540 can be used in this manner when performing wire-pull, rail, garage, and two-piece procedures.

[0128] The wire pulling technique continues with FIG. 65 , which shows a delivery shuttle 546 attached to a guidewire 540 such that movement of the guidewire 540 causes corresponding movement in the delivery shuttle 546. The delivery shuttle 546 is coupled to a gastric bypass device 548, which may be considered to generally represent any of a variety of different gastric bypass devices 548 that may be assembled using any of the occlusion devices described herein, any of the anastomotic anchors described herein, and any of the tethers described herein. Any of a variety of different techniques may be used to secure the delivery shuttle 546 to the guidewire 540. Any of a variety of different techniques may be used to releasably secure the gastric bypass device 548 to the delivery shuttle 546. The gastric bypass device 548 includes an anastomotic anchor 550, through which the gastric bypass device 548 is releasably secured to the delivery shuttle 546, an occlusion device 552, and an intervening tether 554.

[0129] While the delivery shuttle 546 is shown as being releasably secured to the anastomotic anchor 550, it will be understood that the delivery shuttle 546 may be releasably secured to any portion of the gastric bypass device 548. In some cases, the delivery shuttle 546 may be attached to more than one component of the gastric bypass device 548. In some cases, multiple shuttles may be used, with each shuttle attached to a different component of the gastric bypass device 548 to facilitate gradual deployment of the gastric bypass device 548. In some cases, the shuttle may be made from a thin-walled polymer. In some cases, the shuttle may be formed of a soluble material that dissolves or otherwise weakens and breaks down when exposed to bodily fluids during delivery.

[0130] 65 to 66, it can be seen that the guidewire 540 has been moved distally. This can be accomplished by pulling on the distal free end 542 and / or pushing / advancing on the proximal free end 544. As can be seen, the gastric bypass device 548 has been pulled through the duodenum 18 such that the occluding device 552 is located near the pylorus 30. It will be appreciated that the expanded configuration of the occluding device 552 (as shown) can determine whether the occluding device 552 remains within the pylorus 30 or extends into the antrum 32 (FIG. 1).

[0131] The wire pulling technique continues in FIG. 67 , which shows the introduction of endoscope 556. Optionally, endoscope 556 can be introduced earlier in the process. In FIG. 68 , an endoscopic tool 558, such as, but not limited to, scissors or other cutting device, is extended down the working channel (not shown) of endoscope 556 to detach delivery shuttle 546 from anastomotic anchor 550, which forms part of gastric bypass device 548. In response to being released from delivery shuttle 546, anastomotic anchor 550 can be seen to expand to a deployed configuration in which anastomosis anchor 550 has a larger diameter than anastomosis 26. Although not shown, optionally, a dynamic leash can be subsequently delivered and connected to gastric bypass device 548.

[0132] The rail technique is shown beginning with FIG. 70. A delivery catheter 560 is advanced partially over the proximal free wire end 544. In this case, the delivery shuttle 546 is secured to the delivery catheter 560, rather than secured to the guidewire 540 (as shown in FIGS. 65 and 66). A gastric bypass device 548 is releasably secured to the delivery shuttle 546. In some cases, the delivery shuttle 546 can be omitted, and the gastric bypass device 548 can instead be releasably secured directly to the delivery catheter 560 itself.

[0133] As seen in FIG. 71 , delivery catheter 560 is pushed over guidewire 540 until gastric bypass device 548 reaches the desired delivery location. It can be seen that the desired delivery location corresponds to occlusion device 552 being positioned adjacent to pylorus 30, with anastomotic anchor 550 advanced to the stomach side of anastomosis 26. Next, as seen in FIGS. 72 and 73 , endoscope 556 is used to provide a pathway for endoscopic tool 558 (e.g., through the working channel (not shown) of endoscope 556). In some cases, endoscope 556 can be introduced earlier in the process.

[0134] 74 , it can be seen that an endoscopic tool 558 is used to release the gastric bypass device 548 from the delivery shuttle 546. The guidewire 540 and delivery catheter 560 (with associated delivery shuttle 546) are withdrawn, leaving the gastric bypass device 548 properly deployed. The endoscope 560 may then be removed. In response to being released from the delivery shuttle 546, the anastomotic anchor 550 can be seen to expand to a deployed configuration in which the anastomosis anchor 550 has a larger diameter than the anastomosis 26. Although not shown, optionally, a dynamic leash can be subsequently delivered and connected to the gastric bypass device 548.

[0135] The garage technique is shown beginning with FIG. 75. A garage catheter 562 is loaded over the guidewire 540 beyond the proximal free end 544. A gastric bypass device 548 is captured within the garage catheter 562. As shown in FIG. 76, the garage catheter 562 is advanced over the guidewire 540 until the distal end 564 of the garage catheter 562 reaches the desired delivery location where the garage catheter 562 extends through the anastomosis 26, with the distal end 564 of the garage catheter 562 just within the stomach 14. Optionally, an endoscope 560 may be introduced at this point in the process.

[0136] As seen in FIG. 77 , the anastomotic anchor 550 is deployed. Moving to FIG. 78 , the garage catheter 562 is withdrawn proximally to a point where the distal end 564 of the garage catheter 562 is located near the pylorus 30. As seen in FIG. 79 , the garage catheter 562 is withdrawn further proximally, thereby deploying the occlusion device 552. Once the gastric bypass device 548 is now deployed, the garage catheter 562 and guidewire 540 may now be withdrawn. In some cases, a pusher may be deployed within the garage catheter 562 to assist in the deployment of the gastric bypass device 548. By way of example, the pusher may preferentially interact with different portions of the gastric bypass device 548 to first deploy one portion of the gastric bypass device 548, followed by deployment of another portion of the gastric bypass device 548. In some cases, the pusher may be externally operated by a physician or other medical personnel. The pusher may be, for example, an attachment that interfaces with the distal end of the endoscope 560. Although not shown, optionally, a dynamic leash may be subsequently delivered and connected to the gastric bypass device 548 .

[0137] The two-piece method is shown starting with FIG. 80. In the two-piece method, the gastric bypass device 548 is delivered in two pieces that are secured together to form the gastric bypass device 548. A first delivery catheter 566 is loaded over the distal free end 542 of the guidewire 540. The anastomotic anchor 550 portion of the gastric bypass device 548 is loaded into the first delivery catheter 566. The anastomotic anchor 550 portion of the gastric bypass device 548 is delivered, and the first delivery catheter 566 may be withdrawn and removed.

[0138] As shown in FIG. 81 , a second delivery catheter 568 is loaded onto the proximal free end 544 of the guidewire 540. The occluding device 552 and the tether 554 portion of the gastric bypass device 548 are loaded into the second delivery catheter 568. As shown in FIG. 82 , the second delivery catheter 568 is advanced over the guidewire 540 until the second delivery catheter 568 is positioned so that the tether 544 can be secured to the anastomotic anchor 552. The tether 544 and the occluding device 552 may be able to be coupled or otherwise connected together using a variety of different connections. For example, the tether 544 and the occluding device 552 may include any number of hooks, clips, magnets, ties, or otherwise interlocking components. In some examples, an interference fit between the tether 544 and the occluding device 552 may be used. 83, the second delivery catheter 568 is further withdrawn proximally to deploy the occlusion device 552, thereby delivering the gastric bypass device 548. The second delivery catheter 568 may now be withdrawn and removed. Although not shown, optionally, a dynamic leash may be subsequently delivered and connected to the gastric bypass device 548.

[0139] The general method is shown beginning with FIG. 84 . A guidewire 570 is advanced through the esophagus 12, through the stomach 14, and into the small intestine 16. The distal end 571 of the guidewire 570 can be positioned at the desired location for creating the anastomosis. A delivery catheter 572 is loaded over the guidewire 570, and a gastric bypass device 548 is loaded into the delivery catheter 572. The delivery catheter 572 has an electrocautery distal tip 574. As shown in FIG. 85 , the delivery catheter 572 is advanced along the guidewire 570 until the electrocautery distal tip 574 reaches the distal end 571 of the guidewire 570.

[0140] As shown in FIG. 86 , the electrocautery distal tip 574 is used to pierce the walls of the small intestine 16 and the stomach 14 to create the anastomosis 26. In this particular case, given the location of the anastomosis 26, it is appropriate to refer to the anastomosis 26 as a gastrojejunostomy. Next, as shown in FIG. 87 , the first flange 576 of the anastomotic anchor is deployed. Next, as shown in FIG. 88 , the delivery catheter 572 is withdrawn proximally a short distance to deploy the second flange 578 of the anastomotic anchor 580. In this case, the anastomotic anchor 580 is shown as having two flanges, although this is not required in all cases. For example, the anastomotic anchor 580 could be adapted to have two rings, one ring positioned on each side of the gastrojejunostomy. The anastomotic anchor 580 could be, for example, a unitary structure that is fully deployed in one motion. 89, the delivery catheter 572 can be withdrawn proximally until the electrocautery distal tip 574 passes through the pylorus 30, thereby delivering the occlusion device 582 and tether 584, resulting in a deployed gastric bypass device 586. Although not shown, optionally, a dynamic leash can be subsequently delivered and connected to the gastric bypass device 548.

[0141] 90 is a schematic diagram illustrating an exemplary method for extending a guidewire in a loop through the esophagus 12, through the pylorus 30, through the anastomosis 26, and back through the esophagus 12. Rather than having to guide a long guidewire such as guidewire 540 through the path, in some cases a first guidewire 600 having a distal end 602 and a second guidewire 604 having a distal end 606 may be used instead. The first guidewire 600 may be advanced down the esophagus 12, through the stomach 14, through the pylorus 30, and into the duodenum 18 to a point where the distal end 602 is located at or near the anastomosis 26. The second guidewire 604 may be advanced down the esophagus 12 and through the stomach 14 to a point where the distal end 606 is located at or near the anastomosis 26. In some cases, distal end 602 may include a magnet and distal end 606 may include a second magnet having an opposite polarity to the magnet in distal end 602. As a result, distal ends 602 and 606 will attract each other, allowing first guidewire 600 and second guidewire 604 to effectively join together and form a single guidewire loop through the delivery site.

[0142] The first guidewire 600 and the second guidewire 604 may each be formed of a metal such as stainless steel or nitinol. The first guidewire 600 and the second guidewire 604 may be solid or braided. In some cases, the distal ends 602 and 606 may include additional mechanical fasteners to better secure the connection between the distal ends 602 and 606. Naturally occurring magnets have both a north and a south pole. Thus, in some cases, the distal end 602 may (by way of example) include a first magnet oriented with its north pole facing distally, and the distal end 606 may include a second magnet oriented with its south pole facing distally. As a result, when the first guidewire 600 and the second guidewire 604 are positioned as shown in FIG. 90 , the north pole of the magnet in the distal end 602 will be attracted to the south pole of the magnet in the distal end 606. Two magnets may equally be used with their respective polarities reversed from this example. In some cases, mechanical fasteners may be used without any magnets.

[0143] FIG. 91 is a schematic diagram of an exemplary tether 610 used as part of a gastric bypass device. The tether 610 includes a spring 612 extending through a tether enclosure 614. The tether enclosure 614 may be a polymer sheath that helps protect the spring 612 from the stomach environment. The tether enclosure 614 may help keep the spring 612 from irritating the papilla of Vater 398 (as shown in FIG. 48 ). The spring 612 may be held in place by a suture 616 including a knot 618 that limits movement of the spring 612 relative to the tether enclosure 614. In some cases, delivery of the gastric bypass device may be simplified by limiting changes in length of the gastric bypass device that may occur during delivery. For example, the spring 612 may easily stretch. Securing the spring 612 relative to the tether enclosure 614 helps limit changes in length. Although a single suture 616 is shown, it will be understood that the spring 612 may be held in place relative to the tether enclosure 614 in more than one location. In some cases, other components of the gastric bypass device, such as the occlusion device and anastomotic anchors, may be temporarily sutured to another component to limit changes in length. Once the gastric bypass device is successfully delivered, the suture 616 may be cut and therefore no longer constrain the gastric bypass device.

[0144] 92A and 92B are schematic illustrations of an exemplary pusher device 630, with FIG. 92B providing a cross-sectional view. Pusher device 630 can have an external threaded formation 632 that can interface with a corresponding internal threaded formation 634 formed as part of occlusion device 636. In some cases, pusher device 630 can be used to rotate pusher device 630 relative to occlusion device 636 to deploy occlusion device 636 and then remove pusher device 630 from occlusion device 636. In some cases, the threaded interaction between pusher device 630 and occlusion device 636 during delivery can be useful in restraining a gastric bypass device including occlusion device 636 from expanding during delivery.

[0145] 93A and 94B are schematic diagrams of an exemplary pusher device 640. The exemplary pusher device 640 is rod-shaped and includes a threaded portion 642 having external threads. The pusher device 640 is adapted to engage with a tether 644. The tether 644 includes a corresponding threaded portion 646 having internal threads. The pusher device 640 may be threadably engaged with the tether 644. The pusher device 640 may be disengaged from the tether 644 by rotating the pusher device 640 relative to the tether 644. In some cases, when the pusher device 640 is engaged with the tether 644, the pusher device 640 may also capture the occlusion device 648. In this manner, it will be appreciated that the pusher device 640 not only aids in delivering the gastric bypass device including the tether 644 and the occlusion device 648, but may also be used to hold the gastric bypass device in a compact configuration during delivery.

[0146] 94A and 94B are schematic diagrams of an exemplary pusher device 650. The exemplary pusher device 650 is rod-shaped and includes a threaded portion 652 having external threads. The pusher device 650 is adapted to engage a tether 654. The occlusion device 656 includes an internally threaded portion 658 with which the threaded portion 652 of the pusher rod 650 can be threadably engaged. Although not shown, the tether 654 can also be temporarily secured relative to the pusher rod 650. In this manner, it will be appreciated that the pusher device 650 not only aids in delivering a gastric bypass device including the tether 654 and the occlusion device 656, but can also be used to hold the gastric bypass device in a compact configuration during delivery.

[0147] 95A, 95B, and 95C are schematic diagrams of an exemplary pusher device. FIG. 95A illustrates a pusher device 660 including a shaft region 662 and an atraumatic tip 664. In some cases, the atraumatic tip 664 has a profile complementary to that of the occlusion device 668. Thus, the atraumatic tip 664 can help support and maintain the shape of the occlusion device 668, including the inner diameter of the occlusion device 668. In some cases, the pusher device 660 can instead be used to deliver the anastomotic anchor portion of a gastric bypass device. Although not shown, in some cases, the pusher device 660 can further include an outer member that helps support and maintain the outer diameter of the occlusion device 668. The atraumatic tip 664 can be formed from a variety of different materials and can take any of a variety of different shapes. The atraumatic tip 664 can have a length equal to the length of the occlusion device 668. Atraumatic tip 664 can have a length that is shorter or longer than the length of occlusion device 668. In some cases, as shown in FIG. 95B, pusher device 660 can be adapted to extend through a working channel of endoscope 670. In some cases, pusher device 660 can be adapted to work with, rather than through, endoscope 670.

[0148] As seen in FIG. 95C , in some cases, pusher device 680 may be adapted to be secured relative to the distal end of endoscope 670. As shown, pusher device 680 includes an attachment region 682 adapted to form a friction fit over the distal end of endoscope 670, a central shaft portion 684, and an atraumatic tip 686 having a shape complementary to that of occlusion device 688. In some cases, attachment region 682 may be connected to endoscope 670 via one or more elastic members (not shown), such as rubber bands. In some cases, pusher device 680 may be sufficiently rigid to allow it to move through the anatomy without kinking. Components of pusher device 680 may be made of transparent or translucent materials for better visualization during delivery. In some cases, pusher device 680 may instead be used to deliver the anastomotic anchor portion of a gastric bypass device.

[0149] 96 is a schematic diagram of an exemplary two-stage pusher device 690 shown disposed within a garage 692. A gastric bypass device 694 is shown within the garage 692 and includes an anastomotic anchor 696, an occlusion device 698, and a tether 700 extending between the anastomotic anchor 696 and the occlusion device 698. The two-stage pusher device 690 includes a shaft 702 extending proximally from the garage 692 and, therefore, can be actuated by pushing or pulling the shaft 702. The two-stage pusher device 690 includes a first stage component 704 adapted to interact with the anastomotic anchor 696. The first stage component 704 is coupled to the shaft 702 such that distal movement of the shaft 702 moves the first stage component 704 distally, thereby pushing the anastomotic anchor 696 out of the garage 692. Further distal movement of shaft 702, such as after garage 692 has been moved into position, will cause second stage component 706, which interacts with occlusion device 698, to be pushed out of garage 692. It will be appreciated that in some cases it may be preferable to deploy gastric bypass device 694 in the opposite manner, deploying occlusion device 698 before deploying anastomotic anchor 696.

[0150] The various components of the medical device systems described herein and materials that may be used for the various elements disclosed herein may include those commonly associated with medical devices. In some embodiments, the medical device systems described herein may be made from metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, and the like, or other suitable materials. Some examples of suitable metals and metal alloys include stainless steels such as 444V, 444L, and 314LV stainless steels; mild steels; nickel-titanium alloys such as linear elastic and / or superelastic nitinol; other nickel alloys, e.g., nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as INCONEL® 625; UNS: N06022, such as HASTELLOY® C-22®; HASTELLOY® C27®); 6 (registered trademark), other HASTELLOY® alloys, etc.), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035 such as MP35-N®), nickel-molybdenum alloys (e.g., HASTELLOY® ALLOY B2®, etc.), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc., cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS:R44003, such as ELGILOY®, PHYNOX®, etc.), platinum-rich stainless steel, titanium, combinations thereof, etc., or any other suitable material.

[0151] As mentioned herein, within the family of commercially available nickel-titanium or nitinol alloys, there is a category referred to as “linear elastic” or “non-superelastic,” which may be chemically similar to traditional shape memory and superelastic varieties but may exhibit unique and useful mechanical properties. Linear elastic and / or non-superelastic nitinol may be distinguished from superelastic nitinol in that linear elastic and / or non-superelastic nitinol does not exhibit a substantial “superelastic plateau” or “flag region” in its stress / strain curve as does superelastic nitinol. Instead, in linear elastic and / or non-superelastic nitinol, as recoverable strain increases, stress continues to increase in a substantially linear or somewhat, but not necessarily entirely, linear relationship until plastic deformation begins, or at least in a more linear relationship than the superelastic plateau and / or flag region that may be seen in superelastic nitinol. Thus, for purposes of this disclosure, linear elastic and / or non-superelastic nitinol may also be referred to as “substantially” linear elastic and / or non-superelastic nitinol.

[0152] In some cases, linear elastic and / or non-superelastic nitinol may also be distinguishable from superelastic nitinol in that linear elastic and / or non-superelastic nitinol can tolerate a maximum of about 2-5% strain while remaining substantially elastic (e.g., before plastic deformation), whereas superelastic nitinol can tolerate a maximum of about 8% strain before plastic deformation. Both of these materials may be distinguishable from other linear elastic materials, such as stainless steel (which may also be distinguished based on its composition), which can only tolerate a maximum of about 0.2-0.44% strain before plastic deformation.

[0153] In some embodiments, linear elastic and / or non-superelastic nickel-titanium alloys are alloys that do not exhibit a martensite / austenite phase change detectable by differential scanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA) analysis over a large temperature range. For example, in some embodiments, linear elastic and / or non-superelastic nickel-titanium alloys may not exhibit a martensite / austenite phase change detectable by DSC and DMTA analysis within a range of about -60 degrees Celsius (°C) to about 120°C. Thus, the mechanical bending properties of such materials may be substantially inert to the effects of temperature over this very wide temperature range. In some embodiments, the mechanical bending properties of linear elastic and / or non-superelastic nickel-titanium alloys at ambient or room temperature are substantially the same as those at body temperature, e.g., in that they do not exhibit a superelastic plateau and / or flag region. In other words, over a wide temperature range, linear elastic and / or non-superelastic nickel-titanium alloys maintain their linear elastic and / or non-superelastic properties and / or characteristics.

[0154] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy may range from about 50 to about 60 weight percent nickel, with the remainder essentially titanium. In some embodiments, the composition ranges from about 54 to about 57 weight percent nickel. One example of a suitable nickel-titanium alloy is FHP-NT alloy, commercially available from Furukawa Techno Material, Kanagawa Prefecture, Japan. Other suitable materials may include ULTANIUM™ (available from Neo-Metrics) and GUM METAL™ (available from Toyota). In some other embodiments, a superelastic alloy, such as superelastic nitinol, may be used to achieve the desired properties.

[0155] In at least some embodiments, some or all of the medical device system may also be doped with, made of, or otherwise include a radiopaque material. A radiopaque material is understood to be a material capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image assists a user in determining the location of the medical device system. Some examples of radiopaque materials include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, barium sulfate, polymeric materials loaded with radiopaque fillers, and the like. Additionally, other radiopaque marker bands and / or coils may also be incorporated into the design of the medical device systems described herein.

[0156] In some embodiments, a degree of Magnetic Resonance Imaging (MRI) compatibility is imparted to the medical device systems described herein. The medical devices described herein may be made of materials that do not substantially distort images and do not introduce substantial artifacts (e.g., gaps in the images). For example, certain ferromagnetic materials may not be suitable because they may introduce artifacts into MRI images. In some cases, the medical device systems, or portions thereof, may also be made from materials that MRI machines can image. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS:R44003, such as ELGILOY®, PHYNOX®, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R44035, such as MP35-N®), nitinol, and the like, among others.

[0157] In some embodiments, the medical device systems described herein may be made from or include a polymer or other suitable material. Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethanes (e.g., Polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyetheresters (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers such as HYTREL® available from DuPont), polyamides (e.g., DURETHAN® or Elf® available from Bayer), and the like. CRISTAMID® available from Atochem), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA, e.g., available under the trade name PEBAX®), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), MARLEX® high density polyethylene, MARLEX® low density polyethylene, linear low density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (e.g., EMS AmericanExamples of suitable materials include GRILAMID® (available from Grillon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxies, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, and the like. In some embodiments, the sheath can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6% LCP.

[0158] In some embodiments, the medical device systems disclosed herein and / or other elements disclosed herein may include a woven material disposed on or within the structure. The woven material may be composed of a biocompatible material, such as a polymeric material or a biomaterial, adapted to promote tissue ingrowth. In some embodiments, the woven material may include a bioabsorbable material. Some examples of suitable woven materials include, but are not limited to, polyethylene glycol (PEG), nylon, polytetrafluoroethylene (PTFE), ePTFE, polyethylene, polyolefin-based materials such as polypropylene, polyester, polyurethane, and / or blends or combinations thereof.

[0159] It will be understood that this disclosure is, in many respects, merely illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps, without exceeding the scope of the invention. This may include, to the extent appropriate, using any of the features of one illustrative embodiment in other embodiments. The scope of the invention is, of course, defined in the language in which the appended claims are expressed.

Claims

1. 1. A delivery system adapted to deliver a gastric bypass device, the gastric bypass device including: an occlusion device adapted to be anchored in place in the patient's stomach relative to the patient's pylorus; an anastomotic anchor adapted to be anchored in place relative to an anastomosis formed between the patient's stomach wall and the patient's small intestine; and a tether adapted to extend through the patient's small intestine and secured at a first end to the occlusion device, the delivery system comprising: a guidewire adapted to be delivered in a looped path down the patient's esophagus, through the patient's pylorus, up through the anastomosis, and back up the patient's esophagus such that both a distal wire end and a proximal wire end of the guidewire are accessible outside the patient's mouth; a gastric bypass device adapted to be delivered by advancing the gastric bypass device relative to the guidewire; A delivery system comprising a delivery device adapted to carry the gastric bypass device.

2. The delivery system of claim 1 , wherein the delivery device comprises a delivery shuttle, and the gastric bypass device is coupled to the delivery shuttle.

3. The delivery system of claim 2 , wherein the delivery shuttle is adapted to be releasably coupled to the anastomotic anchor of the gastric bypass device.

4. The delivery system of claim 2 , wherein the delivery shuttle is secured to the guidewire such that movement of the guidewire results in corresponding movement of the delivery shuttle.

5. The delivery system of claim 1 , further comprising a delivery catheter adapted for advancement over the guidewire, the delivery device including a delivery shuttle coupled to the delivery catheter.

6. The delivery system of claim 1 , wherein the delivery device comprises a garage catheter including a garage adapted to hold the gastric bypass device therein.

7. 7. The delivery system of claim 6, further comprising a pusher adapted to push the gastric bypass device out of the garage.

8. The delivery system of any one of claims 1 to 7, further comprising a cutting tool adapted to be advanced through an endoscope to release the gastric bypass device from the delivery shuttle.

9. The guide wire comprises: a first guidewire component having a distal end; a first coupler secured to the distal end of the first guidewire component; a second guidewire component having a distal end; a second coupler secured to the distal end of the second guidewire component; Equipped with 9. The delivery system of claim 1, wherein the second coupler is adapted to be secured to the first coupler to join the first and second guidewire components together.

10. the first guidewire component is adapted to be delivered through the patient's pylorus and into the patient's small intestine so that the distal end of the first guidewire component reaches a location proximate the anastomosis; the second guidewire component is adapted to be delivered through the patient's stomach such that the distal end of the second guidewire component reaches a location proximate the anastomosis; 10. The delivery system of claim 9.

11. 11. The delivery system of claim 1, further comprising a dynamic leash adapted to be subsequently delivered to and secured to the gastric bypass device.

12. 1. A delivery system adapted to deliver a gastric bypass device, the gastric bypass device including: an occlusion device adapted to be anchored in place in the patient's stomach relative to the patient's pylorus; an anastomotic anchor adapted to be anchored in place relative to an anastomosis formed between the patient's stomach wall and the patient's small intestine; and a tether adapted to extend through the patient's small intestine and secured at a first end to the occlusion device, the delivery system comprising: a guidewire adapted to be delivered in a looped path down the patient's esophagus, through the patient's pylorus, up through the anastomosis, and back up the patient's esophagus such that both a distal wire end and a proximal wire end of the guidewire are accessible outside the patient's mouth; a first delivery catheter adapted to be advanced over the guidewire, the first delivery catheter including the anastomotic anchor of the gastric bypass device; a second delivery catheter adapted to be advanced over and following the guidewire, the second delivery catheter including the occlusion device and the tether of the gastric bypass device; a first delivery catheter adapted to be used to deliver the anastomotic anchor, and a second delivery catheter adapted to be used to subsequently deliver an occlusion device and the tether that are joined to the anastomotic anchor to form the gastric bypass device.

13. 1. A delivery system adapted to deliver a gastric bypass device, the gastric bypass device including: an occlusion device adapted to be anchored in place in the patient's stomach relative to the patient's pylorus; an anastomotic anchor adapted to be anchored in place relative to an anastomosis formed between the patient's stomach wall and the patient's small intestine; and a tether adapted to extend through the patient's small intestine and secured at a first end to the occlusion device, the delivery system comprising: a guidewire adapted to be delivered in a looped path down the patient's esophagus, through the patient's pylorus, up through the anastomosis, and back up the patient's esophagus such that both a distal wire end and a proximal wire end of the guidewire are accessible outside the patient's mouth; a delivery catheter adapted to be advanced over the guidewire, the delivery catheter including an electrocautery distal tip adapted to form the anastomosis; A delivery system comprising a gastric bypass device positionable within the delivery catheter.

14. 14. The delivery system of claim 13, wherein the gastric bypass device comprises an anastomotic anchor having a first flange adapted to be deployed over a first side of the anastomosis and a second flange adapted to be deployed over a second side of the anastomosis.

15. 15. The delivery system of claim 13 or 14, further comprising a dynamic leash adapted for subsequent delivery to the gastric bypass device.

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