Methods and devices for delivering dynamic gastric bypass devices

Abstract

A gastric bypass device includes an occlusion device adapted to be deployed relative to a patient's pyloric sphincter, an anastomosis anchor adapted to be deployed relative to an anastomosis between the patient's stomach and its small intestine, and a tether extending through the patient's small intestine between the occlusion device and the anastomosis anchor. The dynamic traction strap may be fixed relative to the occlusion device and may work with a tether to assist in holding the occlusion device in place. The gastric bypass device may be deployed using a variety of methods, including a push-pull wire method, an orbital method, a stowage chamber method, a two-piece method, and an integrated method.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 420,053, filed on October 27, 2022, the entire disclosure of which is incorporated herein by reference. Technical Field

[0002] 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 Art

[0003] A wide variety of in vivo medical devices for medical applications (e.g., surgical / intravascular applications) have been developed. Some of these devices include guidewires, catheters, medical device delivery systems (e.g., implantable devices for stents, grafts, replacement valves, etc.), etc. These devices are manufactured by any of a variety of manufacturing methods and can be used according to any of a variety of methods. There is a need to provide alternative medical devices and alternative methods for manufacturing and / or using medical devices. Summary of the Invention

[0004] The present disclosure relates to medical devices such as gastric bypass devices, and more specifically to methods for delivering dynamic gastric bypass devices. One example is a method for delivering a gastric bypass device, the gastric bypass device comprising an occluding device adapted to be fixed in an appropriate position within a patient's stomach relative to the patient's pylorus, an anastomotic anchor adapted to be fixed in an appropriate position 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, the tether being fixed to the occluding device at a first end. The method comprises establishing an anastomosis between the patient's stomach and the patient's small intestine, and delivering a guidewire in a circular path down the patient's esophagus, through the patient's pylorus, up through the anastomosis, and up along the patient's esophagus, such that both the distal and proximal ends of the guidewire are accessible outside the patient's mouth. The guidewire is utilized to advance the gastric bypass device to a desired delivery position and deploy the gastric bypass device.

[0005] Alternatively or additionally, creating the anastomosis may include creating the anastomosis surgically.

[0006] Alternatively or additionally, establishing the anastomosis may include establishing the anastomosis laparoscopically.

[0007] Alternatively or additionally, establishing the anastomosis may include establishing the anastomosis endoscopically.

[0008] Alternatively or additionally, establishing the anastomosis may also comprise subsequently securing the anastomotic structure inside the anastomosis.

[0009] Alternatively or additionally, the method may further comprise the subsequent steps of delivering a dynamic traction band adapted to extend through the patient's stomach and provide tension to the occlusion device opposite to the tension provided by the tether, and securing the dynamic traction band relative to the gastric bypass device.

[0010] Alternatively or additionally, utilizing a guidewire can 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 translate the guidewire, thereby moving the delivery shuttle and gastric bypass device to a desired delivery position, advancing an endoscope into the patient's stomach, and using an endoscopic tool to detach the delivery shuttle from the gastric bypass device, thereby causing the anchor to self-expand.

[0011] Alternatively or additionally, the gastric bypass device may be secured to the delivery shuttle via an anastomotic anchor of the gastric bypass device.

[0012] Alternatively or additionally, delivering the guidewires in the annular path may include delivering a first guidewire through the patient's pylorus and into the patient's small intestine such that the distal end of the first guidewire reaches a position proximate to the anastomosis, and delivering a second guidewire through the patient's stomach such that the distal end of the second guidewire reaches a position proximate to the anastomosis. The distal end of the first guidewire and the distal end of the second guidewire may be adapted to secure the first guidewire and the second guidewire together to form the guidewires in the annular path.

[0013] 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.

[0014] Alternatively or additionally, utilizing a guidewire can include advancing a delivery catheter over the guidewire, the delivery catheter including a gastric bypass device secured to the delivery catheter, wherein the delivery catheter is advanced until the gastric bypass device reaches a desired delivery position, advancing an endoscope into the patient's stomach, and using an endoscopic tool to detach the delivery shuttle from the gastric bypass device, thereby deploying the anchor.

[0015] Alternatively or additionally, the gastric bypass device may be secured to the delivery catheter via anastomotic anchors of the gastric bypass device.

[0016] Alternatively or additionally, utilizing a guidewire can include loading a delivery and pickup catheter onto the proximal end of the wire with the gastric bypass device positioned within the delivery and pickup catheter, advancing the delivery and pickup catheter over the guidewire until the distal tip of the delivery and pickup catheter has advanced to and slightly past the anastomosis, deploying an anastomotic anchor within the anastomosis, withdrawing the delivery and pickup catheter until the distal tip of the delivery and pickup catheter has moved proximally through the patient's pylorus, and deploying the occlusion device.

[0017] Alternatively or additionally, the method may further include utilizing a pusher when deploying the anastomotic anchors and / or deploying the occlusive device.

[0018] Alternatively or additionally, utilizing a guidewire can 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.

[0019] Alternatively or additionally, the method may further include removing the first delivery catheter and the second delivery catheter.

[0020] Another example is a method for delivering a gastric bypass device, the gastric bypass device comprising an occlusion device adapted to be secured in position within a patient's stomach relative to the patient's pylorus, an anastomotic anchor adapted to be secured in position 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 being secured at a first end to the occlusion device. The method comprises establishing the anastomosis between the patient's stomach and the patient's small intestine, delivering a guidewire in a circular path down the patient's esophagus, through the patient's pylorus, up through the anastomosis, and up the patient's esophagus, such that both distal and proximal ends of the guidewire are accessible outside the patient's oral cavity, providing a delivery device adapted to be advanced over the guidewire, the delivery device comprising the gastric bypass device secured to the delivery device, advancing the delivery device to a desired deployment position, and releasing the gastric bypass device from the delivery device to deploy the gastric bypass device.

[0021] Alternatively or additionally, the delivery device may be adapted to releasably secure the gastric bypass device to the gastric bypass device external to the delivery device.

[0022] Alternatively or additionally, the delivery device may be adapted to retain the gastric bypass device inside the delivery device.

[0023] Another example is a method for delivering a gastric bypass device, the gastric bypass device comprising an occluder device adapted to be secured in position within a patient's stomach relative to the patient's pylorus, an anastomotic anchor adapted to be secured in position 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 being secured at a first end to the occluder device, the anastomotic anchor comprising a first flange and a second flange. The method comprises 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 location for forming the anastomosis, the delivery catheter retaining the gastric bypass device within the delivery catheter, the delivery catheter comprising 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 the anastomotic anchor on a stomach side of the anastomosis, withdrawing the delivery catheter so that the electrocautery distal tip is positioned within the small intestine, deploying a second flange of the anastomotic anchor on a small intestine side of the anastomosis, withdrawing the delivery catheter to the patient's pylorus, and deploying the occluder device.

[0024] The foregoing description of some embodiments, aspects, and / or examples is not intended to describe every embodiment or every implementation of the present disclosure. The following figures and detailed description more particularly exemplify these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] A more complete understanding of the present disclosure may be obtained by considering the following detailed description of various embodiments in conjunction with the accompanying drawings, in which:

[0026] Figure 1 is a schematic diagram of a portion of the human gastrointestinal (GI) system;

[0027] Figure 2 It is arranged in Figure 1 A schematic diagram of an illustrative gastric bypass system shown within the GI system, including an occlusive device, anastomotic anchors, a tether, and a dynamic leash;

[0028] Figures 3 to 26 is available for Figure 2 Schematic diagram of an illustrative occlusion device in an illustrative gastric bypass system;

[0029] Figures 27 to 4 0, 31A to 31B and 32A to 32B are available for Figure 2 Schematic diagram of an illustrative anastomotic anchor and ring in an illustrative gastric bypass system;

[0030] Figure 33 、 34Ato 34E, 35A to 35F, 36A to 36D, 37, 38A to 38B, 39, 40A to 40B and 41 to 47 are available for Figure 2 Schematic diagrams of exemplary tethers in an exemplary gastric bypass system, some of which are shown in combination with an occluding device;

[0031] Figure 48 is a schematic diagram of a portion of the human gastrointestinal (GI) system;

[0032] Figure 49 、 50A to 50C, 51 to 52 and 53A to 53D are available for Figure 2 Schematic diagram of an exemplary tether protecting the Papilla of Vater in an exemplary gastric bypass system;

[0033] Figures 54 to 59 is available for Figure 2 Schematic diagram of an illustrative dynamic traction belt in an illustrative gastric bypass system;

[0034] Figure 60 and 61 is a schematic diagram of a secondary engagement device; and

[0035] Figure 62 is a schematic diagram of an illustrative apparatus for integrated anastomosis creation and gastric bypass system delivery;

[0036] Figure 63 is a schematic diagram of the resulting anastomosis and gastric bypass system;

[0037] Figures 64 to 69 is a schematic diagram showing an illustrative wire pull method for delivering a gastric bypass system;

[0038] Figures 70 to 74 is a schematic diagram illustrating an exemplary rail system approach for delivering a gastric bypass system;

[0039] Figures 75 to 79 is a schematic diagram illustrating an exemplary garage approach for delivering a gastric bypass system;

[0040] Figures 80 to 83 is a schematic diagram showing an illustrative two-piece approach for delivering a gastric bypass system;

[0041] Figures 84 to 89 is a schematic diagram illustrating an exemplary integrated method for delivering a gastric bypass system;

[0042] Figure 90is a schematic diagram showing an illustrative two-part guidewire;

[0043] Figure 91 is a schematic diagram showing an illustrative manner of locking the length of the device during delivery of a gastric bypass system;

[0044] Figure 92A and 92B is a schematic diagram showing features of an illustrative pusher arrangement;

[0045] Figure 93A and 93B is a schematic diagram showing an illustrative connection between a tether and an occluding device;

[0046] Figure 94A and 94B is a schematic diagram showing an illustrative connection between a tether and an occluding device;

[0047] Figure 95A 、 95B and 95C are schematic diagrams showing an illustrative pusher arrangement; and

[0048] Figure 96 is a schematic diagram showing an illustrative pusher arrangement.

[0049] Although various aspects of the present disclosure are susceptible to various modifications and alternative forms, details thereof have been shown by way of example in the drawings and will be described in detail. Nevertheless, it should be understood that the various aspects of the present disclosure are not limited to the specific embodiments described. On the contrary, it is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure. DETAILED DESCRIPTION

[0050] The following description should be read with reference to the accompanying drawings, which are not necessarily drawn to scale, wherein like reference numerals indicate like elements throughout the several views. The detailed description (specific embodiments) and the accompanying drawings are intended to illustrate but not limit the present invention. Those skilled in the art will recognize that the various elements described and / or shown may be arranged in various combinations and configurations without departing from the scope of the present disclosure. The detailed description (specific embodiments) and the accompanying drawings illustrate example embodiments of the present invention.

[0051] For the following defined terms, these definitions shall apply, unless a different definition is given in the claims or elsewhere in this specification.

[0052] Whether or not explicitly stated, all numerical values herein are considered to be modified by the term "approximately". In the context of numerical values, the term "approximately" generally refers to a range of numbers that one skilled in the art would consider equivalent to the value (e.g., having the same function or result). In many cases, the term "approximately" may include numbers rounded to the nearest significant figure. Unless otherwise specified, other uses of the term "approximately" or "around" or "around" (e.g., in contexts other than numerical values) may be assumed to have their ordinary and customary definitions, as understood from and consistent with the context of the specification.

[0053] 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).

[0054] Although some suitable sizes, ranges and / or values are disclosed in connection with various components, features and / or specifications, those skilled in the art will appreciate in light of this disclosure that the desired sizes, ranges, and / or values may deviate from those explicitly disclosed.

[0055] As used in this specification and the appended claims, the singular forms "a" and "the" and the absence of quantifiers include plural indicators, unless the content clearly indicates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its sense including "and / or", unless the content clearly states otherwise. It should be noted that, for ease of understanding, certain features of the present disclosure may be described in singular form, even if those features may be plural or repeated in the disclosed embodiments. Unless explicitly stated to the contrary, each instance of a feature may include a single disclosure and / or be covered by a single disclosure. For the purpose of simplicity and clarity, all elements of the invention of the present disclosure are not necessarily shown in each drawing or discussed in detail below. However, it will be understood that the following discussion may apply equally to any and / or all parts in which there is more than one part, unless explicitly stated to the contrary. In addition, for clarity, not all instances of some elements or features may be shown in each drawing.

[0056] Relative terms (such as "proximal," "distal," "advance," "retraction," and variations thereof) can generally be considered relative to the positioning, orientation, and / or operation of various elements relative to the user / operator / manipulator of the device, with "proximal" and "retraction" indicating or referring to closer to or toward the user, and "distal" and "advance" indicating or referring to away from or away from the user. In some cases, the term "distal" refers to moving farther into the gastrointestinal system, and the term "proximal" refers to moving out of the gastrointestinal system. In some cases, for ease of understanding the present disclosure, the terms "proximal" and "distal" may be arbitrarily designated, and such situations will be apparent to those skilled in the art. Other relative terms (such as "upstream," "downstream," "inflow," and "outflow") refer to the direction of fluid flow inside a lumen (such as a body lumen, a blood vessel) or inside a device.

[0057] The term "extent" may be understood to mean the maximum measurement of a stated or identified dimension. For example, "external extent" may be understood to mean the maximum external dimension, "radial extent" may be understood to mean the maximum radial dimension, "longitudinal extent" may be understood to mean the maximum longitudinal dimension, and so on. Each instance of "extent" may be different (e.g., axial, longitudinal, transverse, radial, circumferential, etc.) and will be apparent to one skilled in the art from the context of individual use. Generally, "extent" may be considered to be the maximum possible dimension measured according to the intended use. In some cases, "extent" may generally be measured orthogonally within a plane and / or cross-section, but as will be apparent from the particular context, it may be measured in different ways, such as, but not limited to, angularly, radially, circumferentially (e.g., along an arc), and the like.

[0058] Note that references in the specification to "one embodiment," "some embodiments," "other embodiments," etc. indicate that the described embodiments may include specific features, structures, characteristics, but not every embodiment may include the specific features, structures, and / or characteristics. Moreover, such phrases do not necessarily refer to the same embodiment. Further, unless explicitly stated to the contrary, when a specific feature, structure, or characteristic is described in conjunction with an embodiment, it would be within the knowledge of those skilled in the art to implement the specific feature, structure, or characteristic in conjunction with other embodiments, whether or not explicitly described. That is, as will be understood by those of ordinary skill in the art, the various individual elements described below are intended to be combinable with each other or to be arranged to form other additional embodiments or to supplement and / or enrich the described embodiments, even if not explicitly shown in a particular combination.

[0059] For the sake of clarity, certain identification numerical nomenclature (e.g., first, second, third, fourth, etc.) can be used throughout the specification and / or claims to name and / or distinguish various descriptions and / or claimed features. It should be understood that numerical nomenclature is not intended to be restrictive, and is merely exemplary. In some embodiments, for simplicity and clarity, the numerical nomenclature previously used can be changed and deviated from. That is, the feature identified as a "first" element can be referred to as a "second" element, a "third" element, etc., subsequently, or can be omitted completely, and / or another different feature can be referred to as a "first" element. Implication and / or name in each case will be apparent to those skilled in the art.

[0060] This document relates to devices and methods for medical treatment of conditions such as obesity and metabolic diseases. For example, the document provides methods and devices for bypassing portions of the gastrointestinal tract to reduce nutrient turnover, reduce weight, and / or improve diabetes control.

[0061] Figure 1 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 passes food to the stomach 14. The stomach 14 secretes digestive enzymes and gastric acid to help digest food. The small intestine 16 is an organ that absorbs most of the nutrients and minerals from food. The small intestine 16 includes the duodenum 18, the jejunum 24, and the ileum (not shown). The pyloric sphincter 20 controls a passage 22 for moving partially digested food from the stomach 14 to the duodenum 18, which can be approximately 25-38 centimeters (cm) long. The food then enters the jejunum 24, which can be approximately 2.25-2.75 meters (m) long. It should be understood that these dimensions (or sizes) are merely illustrative and may vary from patient to patient.

[0062] An anastomosis 26 can be established between the stomach 14 and the small intestine 16. In some cases, an anastomosis 26 can be established between the stomach 14 and the duodenum 18. In some cases, an anastomosis 26 can be established between the stomach 14 and the jejunum 24. As an example, anastomosis 26 can be established via a gastrojejunostomy. Anastomosis 26 can allow food to move 28 directly from the stomach 14 to the jejunum 24, bypassing the duodenum 18. In some cases, anastomosis 26 can include a stent, staples, magnets, a balloon, or other structure for maintaining an opening and connection between the stomach 14 and the small intestine 16. In some cases, anastomosis 26 can have a diameter of approximately 1-4 cm. In some cases, the stomach 14 can be considered to include a pylorus 30 located upstream of the pyloric sphincter 20. The diameter of the pylorus 30 can be considered to be larger than the diameter of the pyloric sphincter 20. The stomach 14 can be considered to include an antrum 32 located just upstream of the pylorus 30. The diameter of the antrum 32 can be considered to be larger than the diameter of the pyloric sphincter 20.

[0063] Figure 2 Schematically shown is an illustrative gastric bypass device 34 shown as being disposed within anatomical structure 10. Gastric bypass device 34 includes an occluding device 36 that can be adapted to be placed within pyloric sphincter 20, or within pylorus 30, or within antrum 32, depending on the desired degree of occlusion of stomach 14. In some cases, occluding device 36 can be adapted to be placed within antrum 32. Gastric bypass device 34 includes an anastomotic anchor 38 that can be adapted to be secured relative to anastomosis 26. In some cases, anastomotic anchor 38 can be adapted to be secured to anastomotic structure (not shown) that can be present within anastomosis 26 in order to preserve and hold anastomosis 26 together.

[0064] Because the occluding device 36 is a foreign object, the stomach 14 may attempt to push the occluding device 36 out of the pyloric sphincter 20 and down into the duodenum 18. The stomach 14 may attempt to push the occluding device 36 out of the pyloric sphincter 20 and back into the stomach 14 itself. A tether 40 extends through the duodenum 18 and is secured to the occluding device 36 at a first end 40a of the tether 40 and to the anastomotic anchor 38 at a second end 40b of the tether 40. The tether 40 may be adapted to help maintain the occluding device 36 in place at its desired implantation location to resist movement caused by the stomach 14 attempting to dislodge the occluding device 36. In some cases, a dynamic traction band 42 extends between the occluding device 36 and the anastomotic anchor 38 and may be adapted to help maintain the occluding device 36 in its desired location. In some cases, the dynamic traction band 42 may extend from the occluding device 36 to an anchored location within the wall of the stomach 14. In some cases, occluder device 36 may include one or more anti-migration features, such as hooks or tines, or possibly a high-friction coating over at least a portion of occluder device 36. In some cases, anastomotic anchor 38 may also include additional anti-migration features.

[0065] The gastric bypass device 34 is shown schematically because each component of the gastric bypass device 34, including the occlusive device 36, the anastomotic anchor 38, the tether 40, and the dynamic traction band 42, can take a variety of different forms. Figures 3 to 26 Illustrative but non-limiting examples of possible occluding devices 36 are provided. Figures 27 to 32B Illustrative but non-limiting examples of possible anastomotic anchors 38 are provided. Figures 33 to 53D Illustrative but non-limiting examples of possible tethers 40 are provided. Figures 54 to 59 Illustrative but non-limiting examples of possible dynamic traction bands 42 are provided. It should be understood that a gastric bypass device, such as gastric bypass device 34, can include any occlusive device 36, any anastomotic anchor 38, any tether 40, and any dynamic traction band 42.

[0066] In some cases, the occluding device can be placed within or upstream of the pyloric sphincter 20. In some cases, depending on how much of the stomach 14 the physician or other professional wishes to occlude, the occluding device can be placed within the pylorus 30. The occluding device 36 can be placed within the antrum 32 or can extend into the antrum 32. Figures 3 to 26 Examples of illustrative occlusive devices that may be used as occlusive device 36 as part of gastric bypass device 34 are provided.

[0067] Figure 3 is a schematic diagram of an illustrative occluding device 44 positioned adjacent to the antrum 32. The occluding device 44 includes an annular ring 46 sized to span the anatomical structure. It will be appreciated that the dimensions of the annular ring 46 can be designed to facilitate positioning the occluding device 44 at a desired location within the anatomical structure. For example, if it is desired to position the occluding device 44 within the pyloric sphincter 20, the annular ring 46 can have an overall diameter of 1 to 3 cm. If it is desired to position the occluding device 44 within the pyloric sphincter 20, the annular ring 46 can have an overall diameter of 2 to 8 cm. If it is desired to position the occluding device 44 within the antrum 32, the annular ring 44 can have an overall diameter of 4 to 12 cm.

[0068] In some cases, the occluding device 46 is adapted to effectively reduce the volume of the stomach 14 while not allowing gastric contents to pass through the pyloric sphincter 20 into the upper portion of the small intestine 16, including the duodenum 18. In some cases, the occluding device 46 can be adapted to fill a majority of the volume of the stomach 14, thereby allowing passage through the stomach 14 to the anastomosis 26. Filling a majority of the volume of the stomach 14 can help provide the patient with a feeling of fullness and can help the feeling of fullness last longer. Reducing the volume of the stomach 14 can increase the efficiency of the gastric bypass effect.

[0069] The occluding device 46 includes a tapered body 48 that tapers from an annular ring 46 (which can be considered to define the maximum outer diameter of the occluding device 44) to a minimum diameter endpoint 50. For example, the minimum diameter endpoint 50 can be adapted to be secured to a tether 52. The tapered body 48 can taper smoothly from its maximum outer diameter to its minimum outer diameter. The tapered body 48 can taper in a stepwise manner, with one or more abrupt changes in diameter. In some cases, the tapered body 48 can have a curved profile. The tapered body 48 can be adapted to prevent materials such as food, chyme, and other gastric contents from flowing through the tapered body 48. In some cases, the tapered body 48 can be constructed of an impermeable material, such as, but not limited to, a polymeric material. In some cases, the tapered body 48 can comprise a polymeric membrane disposed on some kind of support frame (not shown).

[0070] The thickness, hardness and lubricity of the polymer material used to form the obturator 54 can vary along the length of the obturator 44. The obturator 44 can have, for example, a funnel shape or a cyclone shape. The obturator 44 can have a hemispherical or even spherical shape. The obturator 44 can include a notch (not shown) to accommodate a support ring. In some cases, the obturator 44 can be collapsible to help deliverability. The obturator 44 can include a film or other covering that spans the opening defined by the annular ring 46 to prevent material from accumulating inside the obturator 44.

[0071] The occlusive device 44 can be formed from any suitable polymer or metal material, as long as the material is suitable for long-term survival in the gastric environment. In some cases, the occlusive device 44 can be formed from silicone or another polymer. The occlusive device 54 can be formed, for example, via 3D printing. In some cases, the occlusive device 54 can be molded or even electrospun (e-spun).

[0072] In some cases, the occluding device 44 may include additional metal supports (not shown) to help provide an outward radial force to better engage the anatomical structure. In some cases, the material used to form the occluding device 44 may be thicker near the annular ring 46. The occluding device 44 may be formed of a shape memory material that allows the occluding device 44 to have a memory structure for deployment and to be temporarily deformed from the memory structure during delivery. Although not shown, the occluding device 44 may include anchors such as outward forks, hooks, splines, or tines. The occluding device 44 may include a surface treatment that promotes endothelialization. These are just examples.

[0073] Figure 4 is a schematic diagram of an illustrative occlusive device 54 that may be considered an example of an occlusive device 44. The exemplary occlusive device 54 is formed from a single continuous polymeric body 56 that extends from an annular ring 58, representing the maximum outer diameter of the occlusive device 54, to a minimum diameter endpoint 60. The minimum diameter endpoint 60 may be adapted to be secured to a tether, such as the tether 40. The annular ring 58 may be sized to position the occlusive device 54 in a desired location, for example, relative to the pyloric sphincter 20, the pylorus 30, or the antrum 32.

[0074] The occluding device 54 can be considered deformable and endoscopically deliverable. The annular ring 58 is adapted to apply an outward radial force to engage anatomical structures. If the occluding device 54 is intended for deployment within the pyloric sphincter 20, the annular ring 58 can have an overall diameter of 1 to 3 cm. If the occluding device 54 is intended for deployment within the pyloric sphincter 20, the annular ring 58 can have an overall diameter of 2 to 8 cm. If the occluding device 54 is intended for deployment within the antrum 32, the annular ring 58 can have an overall diameter of 4 to 12 cm.

[0075] Figure 5 32 is a schematic diagram of an illustrative occluding device 62 provided near the sinus 32. The occluding device 62 has an expandable body 64 that can be filled with gas or other fluids (e.g., saline) to maintain its expanded shape (as shown). For example, the expandable body 64 can be an expandable balloon. In some cases, the occluding device 62 can be delivered with the expandable body 64 in a deflated configuration. Once the occluding device 62 reaches its desired deployment position, the expandable body 64 can be filled with gas or other fluids, or possibly 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 occluding device 62 relative to the anatomical structure. If the occluding device 62 is intended for deployment within the pyloric sphincter 20, the expandable body 64 can have a maximum diameter of 1 to 3 cm. If the occluding device 62 is intended for deployment within the pyloric sphincter 20, the expandable body 64 can have a maximum diameter of 2 to 8 cm. If the occlusive device 62 is intended for deployment within the sinus 32, the expandable body 64 may have a maximum diameter of 4 to 12 cm.

[0076] The occlusive device 62 can be formed from any material, such as a polymeric material that can withstand the highly acidic gastric environment. As an example, the occlusive device 62 can be formed from silicone, although the occlusive device 62 can include additional fiber reinforcements. The occlusive device 62 can be formed, for example, via 3D printing. The occlusive device 62 can be molded or electrospun. The occlusive device 62 can be formed via dip coating. As another example, the occlusive device 62 can 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.

[0077] In some cases, the expandable body 64 can have a stiffness profile that can be varied. The expandable balloon 64 can be relatively flexible, which allows the walls of the expandable body 64 to compress and expand with peristalsis. The expandable balloon 64 can be relatively rigid, thereby helping to anchor the occlusion device 62 in place relative to the sinus 32. In some cases, the occlusion device 62 can have a variety of different shapes. The occlusion device 62 can have a three-dimensional funnel shape. The occlusion device 62 can have a hemispherical top or no hemispherical top. The occlusion device 62 can have an undefined organic shape. The occlusion device 62 can include one or more protruding lips or rings that help to secure the occlusion device 62 in place relative to the anatomical structure. Although not shown, the occlusion device 62 can include anchors, such as outward forks, hooks, splines, or tines. The occlusion device 62 can include a surface treatment that promotes endothelialization.

[0078] Although shown as being deployed within the antrum 32, this is not necessary in all cases. For example, the occluding device 62 can extend through the antrum 32 and partially into the duodenum 18. In some cases, such as Figure 6 As shown, the occlusive device 62 can extend from the antrum 32, through the pyloric sphincter 20, through the entire duodenum 18, and up through the anastomosis 26. Thus, the occlusive device 62 can serve as an occlusive device, a tether, and an anastomotic anchor. Figure 6 An occluder device 70 is shown having a first end 72 positioned proximate the pyloric sphincter 20 and a second end 74 extending through the anastomosis 26. The occluder device 70 includes an elongated expandable body 76 that extends from the first end 72 of the occluder device 70 through the duodenum 18 to the second end 74 of the occluder device 70. As shown, a deployment structure 78 extends into the stomach 14 and to the second end 74 of the occluder device 70.

[0079] Figure 7 is a schematic diagram of an illustrative occluding device 80 that may be considered an example of an occluding device 44. The illustrative occluding device 80 is shown within the anatomy and is shown near the antrum 32. In some cases, the occluding device 80 may occlude 10% to 50% of the stomach 14 and may conform to the wall of the stomach 14. The occluding device 80 includes a thin film funnel 82 that is funnel-shaped or conical. The thin film funnel 82 may be formed of, for example, silicone or expanded polytetrafluoroethylene (e-PTFE). The thin film funnel 82 may be formed of a polyurethane that is highly acid and chemical resistant. In some cases, a low molecular weight resin, such as that available from Cray Valley in In some cases, this polybutadiene-urethane has rubbery properties, excellent hydrolytic and chemical resistance, good elasticity, and can be reinforced with common rubber fillers.

[0080] The occluding device 80 extends from an annular ring 84, which represents the maximum outer diameter of the occluding device 80, to a minimum diameter endpoint 86. The minimum diameter endpoint 86 can be considered suitable for securing to a tether 88. The large end of the occluding device 80 can be covered or uncovered. The annular ring 84 (which can be a support ring added to the occluding device 80) can be sized to position the occluding device 80 in a desired position, for example, relative to the pyloric sphincter 20, the pylorus 30, or the antrum 32. If the occluding device 80 is intended for deployment inside the pyloric sphincter 20, the annular ring 84 can have an overall diameter of 1 to 3 cm. If the occluding device 80 is intended for deployment inside the pyloric sphincter 30, the annular ring 84 can have an overall diameter of 2 to 8 cm. If the occluding device 80 is intended for deployment inside the antrum 32, the annular ring 84 can have an overall diameter of 4 to 12 cm.

[0081] The annular ring 84 can be adapted to exert an outward radial force to help maintain the occlusion device 80 in position relative to the anatomical structure. The occlusion device 80 can include partial or full fiber or metal reinforcements, such as ultra-high weight polyethylene (UHMWPE) or nitinol. The occlusion device 80 can be manufactured by attaching a film funnel 82 to the annular ring 84 (e.g., via sewing, suturing, thermal bonding, or chemical bonding).

[0082] In some cases, such as Figure 8 As shown, the occluding device 80 may include a second intermediate support ring 90 that helps support the thin film funnel 82. The occluding device 80 may include a third support ring, a fourth support ring, and so on. The intermediate support ring 90 (as well as support rings added to the annular ring 84) may be formed from a shape memory metal, such as a nickel titanium alloy, including Nitinol. Although not shown, the occluding device 80 may include anchors such as outwardly directed prongs, hooks, splines, or tines. The occluding device 80 may include a surface treatment that promotes endothelialization.

[0083] Figure 9 is a schematic diagram showing an illustrative occluder device 92. The illustrative occluder device 92 has a structural frame 94 extending from a maximum diameter opening 96 to a minimum diameter endpoint 98. The minimum diameter endpoint 98 is suitable for securing to a tether 100. In some cases, the maximum diameter opening 96 can include a cover (not shown) spanning the opening. If included, the cover can be concave or convex.

[0084] The size of the maximum diameter opening 96 can be designed to position the occluding device 92 at a desired location, for example, relative to the pyloric sphincter 20, the pylorus 30, or the antrum 32. If the occluding device 92 is intended for deployment within the pyloric sphincter 20, the maximum diameter opening 96 can have an overall diameter of 1 to 3 cm. If the occluding device 92 is intended for deployment within the pylorus 30, the maximum diameter opening 96 can have an overall diameter of 2 to 8 cm. If the occluding device 92 is intended for deployment within the antrum 32, the maximum diameter opening 96 can have an overall diameter of 4 to 12 cm.

[0085] The structural frame 94 can be woven or braided. In some cases, the structural frame 94 can be a laser cut structure. As shown, the structural frame 94 has a plurality of separate struts 102, which are connected to provide rigidity to the structural frame 94. The structural frame 94 is suitable for having shape retention so that the structural frame 94 returns to an expanded structure (as shown) after being compressed or otherwise compressed for delivery. The size of each strut 102 can be varied to provide specific characteristics to the structural frame 94. The structural frame 94 can be conical or funnel-shaped. The shape of the structural frame can be spherical or hemispherical. In some cases, the structural frame 94 can be formed by two or more different parts fixed together. In some cases, the structural frame 94 can be formed by an expandable tube cut by laser. The structural frame 94 can be a multi-fiber braided or woven structure. The structural frame 94 can be formed by welding, fusion welding or otherwise joining together to form discrete wires of the structural frame 94. For example, the structural frame 94 can be cast by molten metal.

[0086] The occlusive device 92 includes a covering or coating 104 (shown in dashed lines) covering at least a portion of the structural frame 94. The covering or coating 104 can be PTFE or e-PTFE. The covering or coating 104 can be silicone or another chemically resistant polymer. The covering or coating 104 can be applied by, for example, dip coating, spray coating, or electrospinning. Although not shown, the occlusive device 92 can include anchors such as outwardly directed prongs, hooks, splines, or tines. The occlusive device 92 can include a surface treatment that promotes endothelialization.

[0087] Figure 10 is a schematic diagram of an illustrative structural frame 106 that may be considered an example of the structural frame 94. The structural frame 106 includes a plurality of outwardly facing tines 108 that help anchor the structural frame 106 (and thus an occlusive device including the structural frame 106) in place within the anatomical structure. When included as part of an occlusive device, the structural frame 106 will include a coating or covering, such as Figure 9 The coating or covering 104 is shown in FIG.

[0088] Figure 11 is a schematic diagram of an illustrative structural frame 110 that can be considered an example of the structural frame 94. The structural frame 110 is an example of a braided structure. When included as part of an occlusive device, the structural frame 106 will include a coating or covering, such as Figure 9 The coating or covering 104 is shown in FIG.

[0089] Figure 12is a schematic diagram showing an illustrative occlusive device 112. The illustrative occlusive device 112 includes a coiled support wire 114 adapted to be secured to a tether 120, extending from a maximum diameter end 116 to a minimum diameter end 118. The coiled support wire 114 supports a membrane 122 covering the coiled support wire 114, thereby occluding gastric contents from passing through the occlusive device 112 into the duodenum 18. In some cases, the coiled support wire 114 is formed of a shape memory material, such as nitinol.

[0090] Figures 13 to 16 FIG2 is a schematic diagram of an illustrative occlusive device including radial support members supporting an occlusive cover. In some cases, the radial support members are incompressible to ensure engagement of the occlusive cover. The support members are adapted to achieve enhanced self-alignment and engagement of the occlusive cover. The occlusive device has an open structure that allows any chyme that escapes through the occlusive cover to pass through the pylorus. The occlusive cover exerts an outward radial force to help anchor the occlusive device relative to the anatomy.

[0091] Figure 13 is a schematic diagram showing an illustrative occluder device 124. The illustrative occluder device 124 includes a plurality of radial support members 126 extending from a starting point 128 to a terminal end 130, wherein the terminal end 130 defines a maximum outer diameter of the occluder device 124. In some cases, as shown, the occluder device 124 includes an occluder cover 132 located at the terminal end 130.

[0092] Radial support member 126 can be metal or polymer. In some cases, radial support member 126 is a shape memory metal, such as nitinol. Radial support member 126 can be wrapped or curved to achieve a reduced size for deliverability. Radial support member 126 can be located within pylorus 30 or even extend into duodenum 18 to reduce potential trauma to pyloric sphincter 20. Although not shown, radial support member 126 can be covered with a film or other material to form a cone. In some cases, the opening of the cone can also be covered with a film or other material.

[0093] The occluder disk 132 can be formed from a polymer (such as silicone, ePTFE, or fabric) or a metal mesh. In some cases, the occluder disk 132 can include a support ring 134. The support ring 134, if included, can be polymeric or metallic. In some cases, the support ring 134 can be formed from nitinol. Although not shown, the occluder disk 132 can include outwardly facing prongs, hooks, splines, or tines to help engage tissue and thereby help anchor the occluder device 124 in place.

[0094] Figure 14is a schematic diagram showing an illustrative occluder device 136. The illustrative occluder device 136 is similar to the occluder device 124, but includes a support ring 138 positioned intermediate between the starting point 128 and the terminal point 130. Figure 15 is a schematic diagram showing an illustrative occluder device 140. The illustrative occluder device 136 is similar to the occluder device 124, but includes both a first support ring 142 and a second support ring 144.

[0095] Figure 16 1 is a schematic diagram showing an illustrative occluder device 146. The illustrative occluder device 146 is similar to the occluder devices 124, 136, and 140, but shows some rearrangement. 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 occluder device 146 in place within the anatomical structure. The occluder device 146 includes an occluder disc 150 positioned intermediate the starting point 128 and the terminal end 130.

[0096] Figures 17 to 19 is a schematic diagram of an occlusive device made of or otherwise including bellows. The bellows may be formed of any suitable polymer or metal material, and the bellows may be collapsible such that the occlusive device including the bellows may be delivered endoscopically.

[0097] Figure 17 The occluding device 152 is shown in a collapsed configuration, while Figure 18 The occluding device 152 is shown in an expanded configuration. The occluding device 152 extends from a first end 154 to a second end 156. Figure 18 As shown, the first end 154 defines the largest outer diameter portion of the occluding device 152 , while the second end 156 defines the smallest outer diameter portion of the occluding device 152 and is adapted to extend through the pyloric sphincter 20 , with the second end 156 facing the interior of the stomach 14 .

[0098] The corrugations may extend the length of the occluding device 152. In some cases, such as Figure 19As shown, the corrugations may form only the second end 156, with the membrane filter 158 extending distally from the second end 156. The corrugations may be a solid material or a corrugated frame with an atraumatic covering. The corrugations may be a tube constrained at one end to form a funnel. The corrugations may be designed as a funnel, wherein the corrugation depth varies along the length of the funnel. The corrugations may be formed from 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 span the second end 156. The membrane may be a polymer, such as silicone, or even a fabric. Although not shown, the occluding device 152 may include outwardly facing forks, hooks, splines, or tines to help engage tissue and thereby help anchor the occluding device 152 in place.

[0099] Figures 20 to 23 is a schematic diagram of an occluding device comprising a frame and a membrane. Figure 20 An occluding device 160 is shown that includes a frame 162 and a membrane cap 164. A polymer membrane 166 extends distally from the frame 162 and the membrane cap 164 and extends to a tether 167. For example, the polymer membrane 162 can be PTFE, ePTFE, or silicone. For example, the frame 162 can be a laser-cut expandable tube, or the frame 162 can be a multi-fiber braided structure. The frame 162 can be formed from nitinol or stainless steel. In some cases, polymers or other metals can be used to form the frame 162. The frame 162 can include anchoring features such as outward-facing forks, hooks, splines, or tines. The occluding device 160 can include a coating that promotes endothelialization. The occluding device 160 has an overall funnel shape or a conical shape.

[0100] Figure 21 An occluder device 168 is shown, comprising 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 can include suture points 176. In some cases, the membrane 172 can be a one-piece member. The tubular member 174 is formed of a polymer material such as ePTFE. The frame 170 is spherical.

[0101] Figure 22 is a schematic diagram of an occluder device 178 including a frame 180 and a membrane 182. The membrane 182 surrounds the frame 180 and extends distally from a suture point 184. The membrane 182 extends to a tether (not shown). Figure 23 A device similar to the occluding device 160 ( Figure 20 ) of the embodiment of the present invention, but the polymeric membrane 166 includes an opening 188 that allows any otherwise trapped chyme to escape.

[0102] Figures 24 to 26is a schematic diagram of an occlusion device including a rigid structure as part of the occlusion device. The rigid structure can be adapted so that the rigid structure cannot traverse the tortuous curves typically found in the proximal duodenum 18a. The proximal duodenum 18a is the portion of the duodenum 18 proximal to the pyloric sphincter 20 and typically includes a tortuous curve. Figures 24 to 26 A rigidity feature 190 is shown that may be incorporated into any of the occlusive devices described herein. Figures 24 to 26 An exemplary gastric bypass device 192 is shown including an occluding device 194 , an anastomotic anchor 196 , and an intervening tether 198 .

[0103] exist Figure 24 In FIG, the rigid structure 190 includes a bumper 200, which in some cases can be considered an extension of the rigid structure 190. The bumper 200, in combination with the rigid structure 190, prevents the occluding device 194 from moving distally because the bumper 200 cannot fit through the tortuous curves in the proximal duodenum 18a. Figure 25 In FIG, the rigid structure 190 includes an expandable buffer 202 that prevents both proximal and distal movement of the occluding device 194. Figure 26 In FIG. 1 , the rigid structure 190 includes a frame bumper 204. The frame bumper 204 is a rigid, self-expanding frame that prevents both proximal and distal movement of the occluding device 194.

[0104] Figures 27 to 32B Examples of illustrative anastomotic anchors are provided that may be used as anastomotic anchors 38 as part of a gastric bypass device 34. In some cases, an anastomotic structure (such as an expandable stent, a pair of magnetic structures, etc.) may be implanted near the anastomosis 26 to help hold the anastomosis 26 together. The anastomotic structure also provides a structure (site) for the anastomotic anchor to be secured.

[0105] Figure 27 It can be relative to the anastomotic portion 26 ( Figure 1 ) Schematic diagram of an illustrative anastomotic anchor 206 being secured. Figure 27 , but it will be appreciated that one of the characteristics of the anastomotic anchor 206 is that its diameter is greater than the lumen diameter of the anastomotic structure. Thus, advancing the anastomotic anchor 206 proximally through the anastomotic portion 26 (and through the anastomotic structure) means that once the anastomotic anchor 206 has reached its expanded configuration (as shown), the anastomotic anchor 206 cannot be pulled through the anastomotic portion 26 (or the anastomotic structure), thereby anchoring the anastomotic anchor 206 relative to the anastomotic portion 26 (and the anastomotic structure).

[0106] like Figure 27As shown, the anastomotic anchor 206 includes a ring 208 having an outer dimension that is greater than the inner diameter of the lumen of the anastomotic portion 26 (or anastomotic structure). Although shown as a ring, the ring 208 can take any of a variety of different shapes, such as a circle or a polygon. The ring 208 can be concave or convex. The shape of the ring 208 can be regular or irregular. The ring 208 can be formed of a material that is resistant to the highly acidic gastric 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, which can be Ring 208 is commercially available under the name . Ring 208 can be a composite material formed from several different materials. Ring 208 can be a wire that is bonded to the coupler. Ring 208 can be a laser cut structure. In some cases, ring 208 can be a woven or braided structure. Ring 208 can include a lubricating and / or corrosion resistant coating or covering.

[0107] The anastomotic anchor 206 includes a plurality of attachment members 210 extending between the ring 208 and the tether 212. Although a total of three attachment members 210 are shown, it should be understood that this is merely illustrative, 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 anastomotic portion 26 (and the anastomotic structure). The attachment members 210 can be flexible and threaded. The attachment members 210 can be rigid. Although not shown, the ring 208 can alternatively be attached to the tether 212 via a polymer film that spans from the ring 208 to the tether 212.

[0108] Figure 28 2 is a schematic diagram of an illustrative anastomotic anchor 214, which is shown as being arranged relative to an illustrative anastomotic structure 216. The illustrative anastomotic anchor 214 can be considered as an opposing double-ring anchor. The illustrative anastomotic structure 216 includes a first annular segment 218 adapted to be positioned inside the stomach 14 and a second annular segment 220 adapted to be positioned inside the small intestine 16. In some cases, the second annular segment 220 can be adapted to be positioned inside the duodenum 18 or the jejunum 24. An intermediate portion 222 extends between the first annular segment 218 and the second annular segment 220. It should be understood that the intermediate portion 222 defines a lumen extending through the anastomotic structure 216. Therefore, the size of the intermediate portion 222 defines ( Figure 27 The minimum size of the ring 208 of the anastomotic anchor 206 shown. In some cases, the anastomotic structure 216 can be considered a woven or braided self-expanding stent. In some cases, the anastomotic structure 216 can be considered a commercially available stent from Boston Scientific. Example of a bracket.

[0109] 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. Herein, terms such as above or below refer only to the orientation depicted. The anastomotic structure 216 may be deployed in any orientation, including, for example, with Figure 28 The orientation shown in FIG is roughly reversed.

[0110] The anastomotic anchor 214 includes one or more members 228 and 230 extending between a first ring 224 and a second ring 226. The anastomotic anchor 214 also includes one or more connectors 232 and 234 extending downwardly from the first ring 224 to couple the anastomotic anchor 214 to a tether. In some instances, tension applied to the connectors 232 and 234 can cause the distance between the first ring 224 and the second ring 226 to decrease. As the first ring 224 and the second ring 226 decrease in size, the resulting force applied to the anastomotic structure 216 causes the length of the anastomotic structure 216 to decrease and to grow radially. As the first annular segment 218 and the second annular segment 220 of the anastomotic structure 216 grow radially, the first annular segment 218 and the second annular segment 220 of the anastomotic structure 216 provide enhanced engagement with tissue, thereby helping to prevent migration of the device.

[0111] In some cases, one or more members 228 and 230 and / or one or more connectors 232 and 234 may comprise one or more strings. One or more members 228 and 230 and / or one or more connectors 232 and 234 may be a braided or coiled structure, or may be a sheath. For example, one or more members 228 and 230 and / or one or more connectors 232 and 234 may be covered or uncovered. Each component of the anastomotic anchor 214 may be independently made of a material that is resistant to the harsh gastric environment. Metals such as Nitinol stainless steel may be used, as may polymers such as PTFE and ultra-high molecular weight polyethylene (UHMwPE) fibers, which may be used in the anastomotic anchor 214. Connectors 232 and 234 may have a single point of attachment to the tether, or may have multiple points of attachment.

[0112] In some cases, part or all of the anastomotic anchor 214 may be covered, provided that the lumen through the anastomotic anchor 214 remains open so that food and chyme can pass through. A covering can be used to help protect part or all of the anastomotic anchor 214 from the gastric environment. If included, the covering can reduce interaction with chyme or food particles. If included, the covering can reduce friction or interaction with the tissues of the gastric environment. The covering can be tight-fitting or loose-fitting and can be PTFE, ePTFE, or other polymers. If included, the covering can largely encapsulate the entire anastomotic anchor 214, or only encapsulate individual components thereof.

[0113] Figure 29 is relative to Figure 28 The depicted anastomotic structure 216 is shown as a schematic diagram of an illustrative anastomotic anchor 236. As shown, the first annular segment 218 is positioned adjacent to the stomach wall 238 and the second annular segment 220 is positioned adjacent to the small intestine wall 240. It should be understood that although the anastomotic anchor 236 is shown as being constructed adjacent to a braided anastomotic structure 216 (such as The anastomotic structure 216 may be a stent, but the anastomotic anchor 236 will perform equally well without a stent or with a different lumen insert within the anastomotic portion 26. For example, the anastomotic structure 216 may instead simply be a pair of magnetic rings, one proximal to the stomach wall 238 and one proximal to the small intestine wall 240. In some cases, the anastomotic portion 16 may simply be a surgically (or endoscopically) created structure held in place with sutures. The anastomotic portion 16 may be created in a manner that does not require additional structures (e.g., the anastomotic structure 216) to maintain the patency of the anastomotic portion 16.

[0114] The anastomotic anchor 236 is a self-expanding braided structure that includes a first expanded diameter portion 242 adapted to be secured above the first annular portion 218 of the anastomotic structure 216. The anastomotic anchor 236 includes a second expanded diameter portion 244 adapted to be secured below the second annular portion 220 of the anastomotic structure 216. The anastomotic anchor 236 also includes an intervening portion 246 that extends from the first expanded diameter portion 242 to the second expanded diameter portion 244 and is adapted to fit within the middle portion 222 of the anastomotic structure 216. Terms such as above or below refer only to the orientation depicted. The anastomotic structure 236 can be deployed in any orientation, including, for example, with Figure 29 Furthermore, the first expanded diameter portion 242 and the second expanded diameter portion 244 can be considered to be adapted to interact with any anastomotic structure used.

[0115] In some cases, the first expanded diameter portion 242 can be designed to be larger than the first annular segment 218 of the anastomotic structure 216. The first expanded diameter portion 242 can be large enough to directly engage the stomach wall 238, particularly when force is applied to the anastomotic anchor 236 via the tether 248. The anastomotic anchor 236 can be formed from a material that is resistant to the gastric environment. The anastomotic anchor 236 can be formed from a shape memory polymer or a shape memory metal. In some cases, the anastomotic anchor 236 can include a covering, such as silicone. In some cases, the anastomotic anchor 236 can include hooks or tines that facilitate anchoring to the stomach wall 238.

[0116] Figure 30 is relative to Figure 28 A schematic diagram of an illustrative anastomotic anchor 250 is shown with reference to the depicted anastomotic structure 216. The anastomotic anchor 250 includes an anchor feature 252 adapted to be secured relative to the first annular section 218 of the anastomotic structure 216. The anastomotic anchor 250 also includes a through portion 254 coupled to the anchor feature 252 and adapted to pass through the intervening portion 222 of the anastomotic structure 216. In some cases, the anchor feature 252 can have one of several different heights to enable clearance of various anastomotic structures. In some cases, the anchor feature 252 can have an annular outer profile. In some cases, the anchor feature 252 can have one, two, three, four, or more legs or pads extending radially outward from the anchor feature 252 to engage the stomach wall 238.

[0117] In some cases, the anastomotic anchor 250 is adapted to form a friction fit with the first annular section 218 of the anastomotic structure 216. In some cases, the anastomotic anchor 250 includes hooks or tines adapted to engage the stomach wall 238. In some cases, the anastomotic anchor 250 includes hooks or tines or other structures adapted to engage the stomach wall 238, and the through-portion 254 includes hooks or tines or other structures adapted to engage the jejunal wall 240. In some cases, the through-portion 254 may include hooks or tines adapted to engage the intervening portion 222 of the anastomotic structure 216.

[0118] Figure 31A and 31B 1 and 2 are side and top views, respectively, showing an illustrative anastomotic anchor 256 disposed within an anastomotic structure 216. Figure 31B, anastomotic anchor 256 is adapted to fit within intervening portion 222 of anastomotic structure 216. In some cases, anastomotic anchor 256 includes a cylindrical body 258 that optionally includes a plurality of axially extending members 260. In some cases, cylindrical body 258 includes one or more rings that engage the sides of anastomotic structure 216. For example, one or more rings can be telescoping to apply an outward force to help prevent migration of anastomotic structure 216. In some cases, a tether can be attached to anastomotic anchor 256. In some cases, a tether can alternatively or additionally be attached to anastomotic structure 216.

[0119] Figure 32A and 32B 1 and 2 are side and top views, respectively, showing an illustrative anastomotic anchor 262 disposed within an anastomotic structure 216. Figure 32B As best shown in FIG, the anastomotic anchor 262 is adapted to fit within the intervening portion 222 of the anastomotic structure 216. In some cases, the anastomotic anchor 262 is a central insert and can be any shape with four or more sides. Examples include, but are not limited to, cross-sectional profiles defining squares, rectangles, and other polygons. The anastomotic anchor 262 can have a circular shape. The anastomotic anchor 262 can be solid or can have cutouts to allow chyme to flow through. The anastomotic anchor 262 can have arms or lobes that extend outwardly to help engage the anastomotic structure 216. In some cases, a tether can be attached to the anastomotic anchor 262. In some cases, the tether can be attached to the anastomotic structure 216 instead or in addition.

[0120] Figures 33 to 53D Examples of illustrative tethers are provided that may be used as tether 40 as part of gastric bypass device 34 . Figure 33 is a schematic diagram of an illustrative gastric bypass device 270. Gastric bypass device 270 includes an occluder device 272 and an anastomotic anchor 274. A tether 276 extends between occluder device 272 and anastomotic anchor 274. Tether 276 includes a spring 278 adapted to provide an increased return spring force when spring 278 extends in response to movement of occluder device 272 and / or anastomotic anchor 274 caused by gastric movement. In some cases, with occluder device 272 and anastomotic anchor 274 properly positioned, spring 278 is under minimal tension. Spring 278 can be formed from any suitable polymeric or metallic material. In some cases, spring 278 can be formed from nitinol or stainless steel.

[0121] Spring 278 may take a variety of forms. Figure 34A A spring 278a is shown having varying diameters, with a smallest diameter at the midpoint and larger diameters at either end. Figure 34BSpring 278b is shown having a diameter that tapers from a maximum diameter at one end to a minimum diameter at the other end. Figure 34C Spring 278c is shown having a uniform diameter and pitch from one end to the other. Figure 34D A spring 278d is shown having a constant outer diameter but a varying pitch. Figure 34E Spring 278e is shown having a diameter that tapers from a maximum diameter in the middle to a minimum diameter at either end. These are examples only. Spring 280 can be formed from any suitable polymeric or metallic material. In some cases, spring 280 can be formed from nitinol or stainless steel.

[0122] Figures 35A to 35G Additional possible designs for spring 278 are shown. Figure 35A In FIG, spring 280a comprises a single wound wire. Figure 35B In FIG, spring 280b includes an engaged ring or hoop 282. Figure 35C In the embodiment, spring 280c comprises a zigzag design. Figure 35D In FIG, the spring 280d includes a first spring 284a having a first spring constant and a second spring 284b having a second spring constant. For example, the first spring 284a and the second spring 284b may also differ in other properties (such as length and diameter). Figure 35E In the embodiment, the spring 280e may include a string 286 extending from one end of the spring 280e to the other end of the spring 280e to provide a limit on the extent to which the spring 280e can extend. Figure 35F In the embodiment, the spring 280f can fit tightly over the inner tube 288 to prevent interaction with food and chyme. Figure 35G In the embodiment of the present invention, spring 280g can include a rigid tube 290 extending into the obturator cone 292 to achieve a greater spring length in a relatively short device. Spring 280 can be formed of any suitable polymer material or metal material. In some cases, spring 280 can be formed of nitinol or stainless steel.

[0123] In some cases, one or more springs may include a covering or coating. The covering or coating can reduce friction or other interactions with tissues within the gastric system. The covering or coating can reduce interaction between the spring and chyme and food, thereby preventing potential blockages. The covering or coating can act as a barrier to the harsh gastric environment. The covering or coating can reduce damage or inflammation to the bile duct and / or papilla. In some cases, the covering or coating can be ePTFE, PTFE, or other polymers. Figure 36ASpring 294a is shown with a cover 296 that encapsulates the spring 294a and expands and contracts with the spring 294a. FIG36b shows spring 294b with a cover 298 that allows the spring 294b to move independently of the cover 298. Figure 36C The spring 294c is shown with a covering 300 that is conformal to the wire 302 forming the spring 294c. Figure 36D Shown is a spring 294d having a covering 304 adjacent to a material 306 forming at least a portion of the occluding device. The spring 294 can be formed of any suitable polymeric or metallic material. In some cases, the spring 294 can be formed of nitinol or stainless steel.

[0124] Figure 37 Tether 308 is shown in position within duodenum 18, extending between occlusion device 310 and anastomotic anchor 312, shown positioned within anastomosis 26. Tether 308 includes inner tether 314 positioned within a corrosion-resistant, impermeable sleeve 316 that encloses inner tether 314. Sleeve 316 protects inner tether 314 from the gastric environment while providing tension. Sleeve 316 is sealed to inner tether 314 at a first sealing point 318 and a second sealing point 320. Between first and second sealing points 318, 320, inner tether 314 is protected from the gastric environment by sleeve 316. While first sealing point 318 is shown distal to occlusion device 310 and second sealing point 318 is shown proximal to anastomotic anchor 312, in some cases, sleeve 316 may extend the entire length of inner tether 314.

[0125] In some cases, having an inner tether 314 inside the sleeve 316 helps decouple mechanical and chemical properties. The inner tether 314 can be made of a specific material selected for its mechanical properties 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.

[0126] Figure 38A and Figure 38B A tether 322 is shown extending between an occluder device 324 and an anastomotic anchor 326. The tether 322 includes a spring 328 having a first end 330 closest to the occluder 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 occluder device 324. Thus, distal movement of the occluder device 324 and / or proximal movement of the anastomotic anchor 326 will result in compression of the spring 328, as shown. Figure 38B As shown. This provides a hard-stop on how far the occluder device 324 and anastomotic anchor 326 can move, because the spring 328 can only be compressed so far. The spring 328 can be formed of any suitable polymer material or metal material, including NiTi or stainless steel. The diameter of the spring 328 can vary along its length. The spring 328 can be a single spring, or the spring 328 can include two or more different spring segments.

[0127] Figure 39 Tether 338 is shown, comprising an elastic polymer tube 340 and a covering 342 covering the elastic polymer tube 340. Elongation of tether 338 due to gastric motility will cause elastic polymer tube 340 to exert a tensile force as it attempts to return to its native or biased configuration. The hardness of the polymer used to form elastic polymer tube 340 can be varied to adjust its memory stress. Various polymers can be used for elastic polymer tube 340. As an example, elastic polymer tube 340 can be formed from latex. Elastic polymer tube 340 can be a single polymer tube. In some cases, elastic polymer tube 340 can be a plurality of elastic polymer strands. Cover 342 can help act as a barrier to the harsh gastric environment. Cover 342 can reduce interaction with chyme and food particles, and can reduce friction or other interactions with tissues within the gastric system. Cover 342 can reduce damage or inflammation to the bile duct and / or papilla. In some cases, cover 342 can be formed from silicone. In some cases, covering 342 may be PTFE or ePTFE.

[0128] In some cases, a spring (such as a leaf spring) may not be part of the tether itself, but may be attached to an occlusive device or anastomotic anchor, with the tether extending from the leaf spring. Thus, tension within the tether will cause the leaf spring to move from its natural biased configuration. Figure 40A and 40B A leaf spring 344 is shown fixed relative to the occluding device 346. The leaf spring 344 can be flat, concave, or convex. The leaf spring 344 can be a flat or circular beam, or can have multiple stacked beams. The leaf spring 344 can be formed from any suitable metal or polymer material.

[0129] A tether 348 extends from the leaf spring 344 through the occluder device 346 and distally therefrom. Although the leaf spring 344 is shown attached to the occluder device 346, a similar result can be achieved by alternatively securing the leaf spring 344 to the anastomotic anchor. Figure 40A In FIG, the tether 348 is not under any tension and the leaf spring 344 maintains a linear configuration, representing the native biased configuration of the leaf spring 344. Figure 40BIn the embodiment shown in FIG5 , the tether 348 is under tension, as shown by arrow 350. As can be seen, the leaf spring 344 has been bent and moved out of its natural biased configuration. As a result, the leaf spring 344 will attempt to return to its natural configuration, thereby resisting the movement of the anastomotic anchor.

[0130] In some cases, a helical torsion spring can be used at the end of the tether in place of the leaf spring 344. The helical torsion spring can be secured between the occluding device 346 and the tether 348. In some cases, the helical torsion spring can alternatively be secured between the anastomotic anchor and the tether 348. As the occluding device 346 and / or the anastomotic anchor move due to gastric movement, the tether 348 provides tension to the helical torsion spring, which moves out of its natural biased configuration. As a result, the helical torsion spring exerts a force on the tether 348 as it attempts to return to its natural biased configuration.

[0131] Figure 41 35 is a schematic diagram of an illustrative tether 352 extending between an occluding device 354 and an anastomotic anchor 356. In some cases, the tether 352 can be formed as a braided stent. The tether 352 can act as a spring, providing a return stress in response to the elongation of the tether 352 due to gastric motility. The tether 352 can be formed from any suitable metallic or polymeric material. The material, size, spacing, etc. of the tether 352 can be varied to provide a desired return stress behavior. As an example, the tether 352 can be designed to provide a linear increase in return stress as the device elongates. For example, the tether 352 can be designed to provide an increase in return stress as the device elongates.

[0132] In some cases, tether 352 can include a coating or covering that helps protect tether 353 from the stomach environment. If included, the coating or covering can reduce interaction with chyme and food particles, can reduce friction and interaction with stomach tissue, and can reduce damage or inflammation at the bile duct and / or papilla. If included, the coating or covering can be any suitable material, such as, but not limited to, PTFE and ePTFE.

[0133] Figure 42360 is a schematic diagram of an exemplary tether 358 formed as or otherwise including a pneumatic cylinder 360. The tether 358 extends between an occluding device 362 and an anastomotic anchor 364. The pneumatic cylinder 360 provides a return stress in response to tension applied to the tether 358. In some cases, the pneumatic cylinder 360 can be a positive cylinder or a negative cylinder. The pneumatic cylinder 360 can be rigid or flexible and can be located anywhere along the length of the tether 358, from near the occluding device 362, near the anastomotic anchor 364, or anywhere in between. The pneumatic cylinder 360 can be metallic or polymeric and can be filled with a liquid or gaseous working fluid. Figure 43 An example of a negative cylinder 360a is shown, while Figure 44 An example of a positive cylinder 360b is shown.

[0134] Figure 45 FIG3 is a schematic diagram of an illustrative tether 366 extending between an occluder 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. In some cases, the tether 366 includes a PTFE tube 375. In some cases, the PTFE tube 375 allows the tether 366 to extend smoothly, moving in and out of the sliding joint 376. In some cases, a nitinol wire may be located within the PTFE tube 375 to prevent kinking. A suture may also be located within the PTFE tube 375, which is attached to the spring 374 and the anastomotic anchor 370 and holds the spring 374 in place. The suture may be formed from UHMWPE (ultra-high molecular weight polyethylene). Although the spring 374 is shown proximal to the occluder device 368, the spring 374 may alternatively be located proximal to the anastomotic anchor 370. The sliding joint 376 is low friction, thereby allowing movement with low applied force, while being a tight fit to minimize the possibility of chyme entering the protective sleeve 372. In some cases, the sliding joint 376 can be a small tube inside a larger tube. The sliding joint 376 can be a small tube that is pulled through the soft membrane. The sliding joint 370 can be one or more threads inside the tube. The threads can be polymeric or metallic. The threads can be single-stranded, multi-stranded, or braided together. The spring can be an elastic polymer or metal, such as nitinol or spring steel. The protective sleeve 372 can be formed from a flexible, durable, and corrosion-resistant polymer, such as ePTFE.

[0135] Figure 46FIG3 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 the tether 378 from traveling in the opposite direction. In some cases, the tether 378 can be pulled relative to 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 travel in one direction but not the opposite direction. The collet 380 can utilize friction to control travel. In some cases, the collet 380 can cooperate with an interlocking feature on the tether 378 to control travel. The collet 380 can be located near the occlusion device, near the anastomotic anchor, or anywhere in between. The collet 380 enables a physician to adjust the tether length in vivo to tailor the tether to a specific patient's anatomy. In some cases, the collet 380 can be adjusted on a workbench prior to implantation to adjust the effective length of the tether 378.

[0136] Figure 47 FIG2 is a schematic diagram of an illustrative tether 382 extending between an occluder device 384 and an anastomotic anchor 386. Tether 382 includes a threaded connector 388 between a threaded member 390 and a spring 392 that threadably engages threaded member 390. In some cases, threaded connector 388 can be adjusted on a workbench prior to implantation to adjust the effective length of tether 382. In some cases, threaded connector 388 can be adjusted in vivo using endoscopic tools. Tether 382 can be formed from any suitable material. Threaded connector 388 can be located near occluder device 384, near anastomotic anchor 386, or anywhere in between.

[0137] Figure 48 398 is a schematic diagram of a portion of the gastrointestinal system indicating the relative positions 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 partially protrude into the interior of the duodenum 18. One potential problem with placing a tether in the duodenum 18 is that the tether may irritate the papilla of Vater 398, which may lead to inflammation and, in turn, various possible complications. In some cases, it may be desirable to provide a tether that avoids irritating the papilla of Vater 398.

[0138] Figure 494 is a schematic diagram of an illustrative 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 and a second spring segment 408, with the first spring segment 406 being located proximal to the Vater's papilla 398 and the second spring segment 408 being located distal to the Vater's papilla 398. The tether 400 includes a member 410 that extends between the first and second spring segments 406, 408 and across the Vater's papilla 398. Because the first and second spring segments 406, 408 have larger diameters relative to the member 410 (although not necessarily the same diameter as one another), the member 410 is held away from the inner surface of the duodenum 18 and, therefore, away from the Vater's papilla 398.

[0139] Figure 50A 、 50B and 50C provide additional examples. Figure 50A In the embodiment shown, tether 412a includes a first spring segment 414 and a second spring segment 416, but does not include any metal structure therebetween. Instead, tether 412a includes an atraumatic covering 418 that encapsulates first and second spring segments 414, 416. Atraumatic covering 418 narrows between first and second spring segments 414, 416 via a pair of sutures 420 that secure atraumatic covering 418 to the ends of first and second spring segments 414, 416. Thus, no metal is present near Vater's papilla 398.

[0140] Figure 50B A tether 412b is shown that is similar to tether 400, but includes an atraumatic covering 422 that encapsulates first spring segment 406, second spring segment 408, and member 410 extending therebetween. In some cases, as shown, a soft pillow 424 is disposed between first spring segment 406 and second spring segment 408 and is held in place by atraumatic covering 422. Thus, no metal is placed near Vater's nipple 398. Figure 50C A tether 412c is shown that includes a spring 426 disposed inside an atraumatic covering 428. The spring 426 has a varying diameter, having a maximum diameter at either end of the spring 426 and tapering to a minimum diameter near the midpoint of the spring 426.

[0141] Figure 51A tether 430 is shown that includes a physical support 432 disposed above the tether 430, wherein the tether 430 extends through the physical support 432. In some cases, the physical support 432 is capable of sliding relative to the tether 430. In some cases, the physical support 432 is a braided structure formed from a metal (such as nitinol). In some cases, the physical support 432 can alternatively be expandable, such as an expandable balloon. As shown, the physical support 432 includes a first bulb region 434 and a second bulb region 436, wherein a narrowed diameter portion 438 extends between the first bulb region 434 and the second bulb region 436. In some cases, the physical support 432 may also include additional bulb regions.

[0142] Figure 52 A tether 440 is shown that includes a physical support 442 that forms a portion of the tether 440. The tether 440 includes a first spring segment 444 and a second spring segment 446, with the physical support 442 disposed between the first spring segment 444 and the second spring segment 446. For example, the physical support 442 can be welded, sewn, or bonded to each of the first and second spring segments 444, 446. The physical support 442 can include a first bulb region 444 and a second bulb region 446, with a rigid member 448 extending between the first bulb region 444 and the second bulb region 446.

[0143] Figure 53A is a schematic diagram showing an illustrative tether 450. The illustrative 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 A first view of the bow segment 456 is shown, and Figure 53C A second view of the bow segment 456 is shown. Figure 53D As shown, tension on the tether 450 will cause the arcuate segment 456 to rotate perpendicular to the nipple 398 of Vater.

[0144] In some cases, a dynamic traction belt may be used as part of a gastric bypass device. Figures 54 to 59 An example of an illustrative dynamic traction belt that may be used as a dynamic traction belt 42 as part of a gastric bypass device 34 is provided.

[0145] Figure 54FIG2 is a schematic diagram of an illustrative dynamic traction band 458 shown within the anatomy. The dynamic traction band 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 traction band 458 is secured to an annular ring 464 that forms part of the occlusion device 460. A tether 466 also extends between the occlusion device 460 and the anastomotic anchor 462 through the duodenum 18. It should be understood that the tether 466 and the dynamic traction band 458 can work together to help maintain the occlusion device 460 in place regardless of gastric motility attempting to dislodge the occlusion device 460. If gastric motility attempts to move the occlusion device 460 proximally into the stomach 14, the tether 466 will provide resistance to this movement. If gastric motility attempts to move the occlusion device 460 distally into the duodenum 18, the dynamic traction band 458 will provide resistance to this movement.

[0146] Figure 55 4 is a schematic diagram of an illustrative dynamic traction band 468 shown within an anatomical structure. Dynamic traction band 468 includes a spring 470. Tether 472 includes a 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 can be selected as a combination to ensure that the two springs 470 and 474 together provide a dynamic balanced stress to maintain the desired position of occluding device 460.

[0147] Figure 56 is a schematic diagram of an illustrative dynamic traction band 476 shown within an anatomical structure. The dynamic traction band 476 extends between an occlusion device 478 positioned proximal to the pyloric sphincter 20 and an anastomotic anchor 480 positioned proximal to the anastomosis 26. As shown, the dynamic traction band 476 is secured to a cover 482 that forms part of the occlusion device 478. In some cases, a central attachment point, such as to the cover 482, allows the occlusion device 478 to lie flat, while attachment to the side of the occlusion device 478 may cause the occlusion device 478 to tilt or pivot into position.

[0148] A tether 484 also extends through the duodenum 18 between the occlusion device 478 and the anastomotic anchor 480. It should be understood that the tether 484 and the dynamic traction band 476 can work together to help maintain the occlusion device 478 in place, regardless of gastric movements attempting to dislodge the occlusion device 478. If gastric movements attempt to move the occlusion device 478 proximally into the stomach 14, the tether 484 will provide resistance to this movement. If gastric movements attempt to move the occlusion device 478 distally into the duodenum 18, the dynamic traction band 476 will provide resistance to this movement. In some cases, the dynamic traction band 476 includes a spring 486. The tether 484 includes a spring 488. In some cases, the spring 486 has a first spring constant, and the spring 488 has a second spring constant. In some cases, the spring 486 and spring 488 can be selected in combination to ensure that the two springs 486 and 488 together provide a dynamic balanced stress to maintain the desired position of the occlusion device 478.

[0149] Figure 57 FIG2 is a schematic diagram of an illustrative dynamic traction band 490 shown within an anatomical structure. The dynamic traction band 490 extends between an obturator 478 positioned proximal to the pyloric sphincter 20 and an attachment point 492 within the stomach wall 494. As shown, the dynamic traction band 476 is secured to a covering 482 that forms part of the obturator 478. In some cases, a central attachment point, such as to the covering 482, allows the obturator 478 to lie flat, while attachment to the side of the obturator 478 may allow the obturator 478 to tilt or pivot into position.

[0150] The tether 484 extends through the duodenum 18 between the occlusion device 478 and the anastomotic anchor 480. It should be understood that the tether 484 and the dynamic traction band 490 can work together to help maintain the occlusion device 478 in place, regardless of gastric motility attempting to dislodge the occlusion device 478. If gastric motility attempts to move the occlusion device 478 proximally into the stomach 14, the tether 484 will provide resistance to this motion. If gastric motility attempts to move the occlusion device 478 distally into the duodenum 18, the dynamic traction band 490 will provide resistance to this motion. In some cases, the dynamic traction band 490 includes a spring 496. In some cases, the spring 496 has a first spring constant, and the spring 488 has a second spring constant. In some cases, the spring 496 and spring 488 can be selected in combination to ensure that the two springs 496 and 488 together provide a dynamic balanced stress to maintain the desired position of the occlusion device 478.

[0151] Figure 58FIG2 is a schematic diagram of an illustrative dynamic traction band 498 shown within an anatomical structure. The dynamic traction band 498 extends between the occlusion device 478 positioned proximal to the pyloric sphincter 20 and the anti-migration anchor 500 positioned proximal to the anastomosis 26. The anti-migration anchor 500 is an anchor that can be attached to the stomach 14 such that tension can be applied to the anchor in either direction without causing the anti-migration anchor to move. In some cases, the dynamic traction band 498 can be connected to the anti-migration anchor 500 such that tension from the dynamic traction band 498 can cause the diameter and / or shape of the anti-migration anchor 500 to change. As an example, the anti-migration anchor 500 can increase in diameter and decrease in length to provide additional radially outward force and prevent slippage through the anastomosis 16. As shown, the dynamic traction band 498 is secured to the covering 482 that forms part of the occlusion device 478. In some cases, a central attachment point, such as to the cover 482, results in allowing the occluder 478 to lie flat, while attachments to the sides of the occluder 478 may cause the occluder 478 to tilt or pivot into place.

[0152] The tether 484 extends through the duodenum 18 between the occluding device 478 and the anti-migration anchor 500. It should be understood that the tether 484 and the dynamic traction band 498 can work together to help maintain the occluding device 478 in place regardless of gastric motility attempting to dislodge the occluding device 478. If gastric motility attempts to move the occluding device 478 proximally into the stomach 14, the tether 484 will provide resistance to this motion. If gastric motility attempts to move the occluding device 478 distally into the duodenum 18, the dynamic traction band 498 will provide resistance to this motion. In some cases, the dynamic traction band 498 includes a spring 502. In some cases, the spring 502 has a first spring constant, and the spring 488 has a second spring constant. In some cases, the spring 502 and the spring 488 can be selected as a combination to ensure that the two springs 502 and 488 together provide a dynamic balanced stress to maintain the desired position of the occluding device 478.

[0153] Figure 59 is a schematic diagram of an illustrative dynamic traction band 498 shown within the anatomy. The dynamic traction band 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 should be understood that the tether 484 and the dynamic traction band 498 can work together to help hold the occlusion device 478 in place regardless of gastric motility attempting to dislodge the occlusion device 478. If gastric motility attempts to move the occlusion device 478 proximally into the stomach 14, the tether 484 will provide resistance to that movement. If gastric motility attempts to move the occlusion device 478 distally into the duodenum 18, the dynamic traction band 476 will provide resistance to that movement.

[0154] Figure 60 FIG2 is a schematic diagram illustrating a passive engagement device 504 positioned near the pyloric sphincter 20. The passive engagement device 504 includes a first gastric clamp 506 that can be secured to a first side 508 of the pyloric sphincter 20, pylorus 30, or antrum 32, and a second gastric clamp 510 that can be secured to a second side 512 of the pyloric sphincter 20, pylorus 30, or antrum 32. A first elastic band 514 extends between the first and second gastric clamps 506, 510. A second elastic band 516 extends between the first and second gastric clamps 506, 510. Together, the first and second elastic bands 514, 516 help prevent distal movement of an occluding device 518. When the pyloric sphincter 20 is dilated, the first and second elastic bands 514, 516 engage with the occluding device 518 and prevent distal movement. When the pyloric sphincter 20 is not dilated or relaxed, the first and second elastic bands 514, 516 do not contact the occluding device 518.

[0155] Figure 61 is a schematic diagram illustrating a passive engagement device 520 positioned proximal to the pyloric sphincter 20. The passive engagement device 520 includes a first gastric clip 506 that can be secured to a first side 508 of the pyloric sphincter 20, pylorus 30, or antrum 32, and a second gastric clip 510 that can be secured to 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 prevent distal movement of the occluding device 518. As the pyloric sphincter 20 expands and the occluding device 518 moves distally, the first hook or bumper 522 and the second hook or bumper 524 engage the occluding device 518 and prevent distal movement of the occluding 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 occluding device 518 .

[0156] Figure 62 is a schematic diagram of an illustrative device that integrates anastomosis creation and gastric bypass system delivery into a single step. The illustrative device 530 includes an electrocautery tip 532 for creating an anastomosis 534 and a collapsing anastomotic anchor 536 that is deployed after the anastomosis 534 has been created using the electrocautery tip 532. Once the anastomosis 534 has been created, the remainder of the gastric bypass device 538 can be delivered through a pullback process (duodenum 18 to pyloric sphincter 20). A sleeve (not shown) can hold the anastomotic anchor 536 in a collapsed configuration until the sleeve is removed. The gastric bypass device 538 is, for example, Figure 63 Shown in.

[0157] As described above, a gastric bypass device can have any of a variety of different occlusive devices, any of a variety of different anastomotic anchors, and any of a variety of different tethers. In some cases, a gastric bypass device can also have any of a variety of different dynamic traction bands. Regardless of which occlusive device, anastomotic anchor, or tether is included, a gastric bypass device needs to be delivered and deployed. The following figures illustrate a variety of different delivery methods that can be used to deliver any of a variety of different gastric bypass devices. Although Figures 64 to 89 Each shows the delivery of a similar gastric bypass device, but it should be understood that each of the methods shown can be used when delivering a gastric bypass device that includes any occlusive device described herein, any anastomotic anchor described herein, and any tether described herein. Once the gastric bypass device has been delivered, any of the various dynamic traction bands described herein can be used as described herein. Figures 54 to 59 Endoscopic delivery and connection are shown.

[0158] Figures 64 to 69 A pull-wire method for installing a gastric bypass device is shown. Figure 64 and Figures 70-74 The track method is shown. Figure 64 and Figures 75-79 The storage room method is shown. Figure 64 and Figures 80-83 A two-piece approach is shown. It will be appreciated that each of these approaches utilizes a guidewire positioned through the digestive system 10 with both proximal and distal free ends extending up the esophagus 12 and out of the patient's mouth. Figures 84-89 A comprehensive approach is shown.

[0159] In some cases, a gastric bypass device may be implanted in a patient for a specific length of time, such as one or two years, for example. In some cases, it may be desirable to remove the gastric bypass device for a period of time to allow the patient's gastrointestinal tract to function normally before implanting another gastric bypass device. In some cases, during the period when the patient does not have a gastric bypass device implanted, it may be desirable to implant a device within the anastomosis 26 to temporarily block the anastomosis 26, allowing all gastric contents to pass through the pyloric sphincter 20 and into and through the small intestine 16 without passing through the anastomosis 26. When the gastric bypass device is subsequently implanted again, the implanted device blocking the anastomosis 26 will need to be removed.

[0160] Figure 64A guidewire 540 is shown which has been 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 such that the guidewire includes a distal free end 542 and a proximal free end 544, both of which extend out of the patient's oral cavity (not shown). Thus, a device can be advanced over the guidewire 540 starting from either the distal free end 542 or the proximal free end 544. As noted, the guidewire 540 can be used in this manner to perform a pull-wire method, a track method, a chamber method, and a two-piece method.

[0161] Figure 65 Continuing to show the wire pulling method, Figure 65 540 so 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 can be considered to generally represent any of a variety of different gastric bypass devices 548 that can be assembled using any occlusion device described herein, any anastomotic anchor described herein, and any tether described herein. Any of a variety of different techniques for securing the delivery shuttle 546 to the guidewire 540 can be used. Any of a variety of different techniques for releasably securing the gastric bypass device 548 to the delivery shuttle 546 can be used. The gastric bypass device 548 includes an anastomotic anchor 550, an occlusion device 552, and an intermediate tether 554 by which the gastric bypass device 548 is releasably secured to the delivery shuttle 546.

[0162] While the delivery shuttle 546 is shown as being releasably secured to the anastomotic anchor 550, it should be understood that the delivery shuttle 546 can be releasably secured to any portion of the gastric bypass device 548. In some cases, the delivery shuttle 546 can be attached to two or more components of the gastric bypass device 548. In some cases, multiple shuttles can be used, each attached to a different component of the gastric bypass device 548, to facilitate staged deployment of the gastric bypass device 548. In some cases, the shuttle can be made of a thin-walled polymer. In some cases, the shuttle can be formed of a soluble material that will dissolve or otherwise weaken and break when exposed to body fluids during delivery.

[0163] In from Figure 65 Go to Figure 66 , it can be seen that the guidewire 540 has moved distally. This can be accomplished by pulling on the distal free end 542 and / or pushing / feeding in the proximal free end 544. It can be seen that the gastric bypass device 548 has been pulled through the duodenum 18 such that the occluding device 552 is positioned proximal to the pylorus 30. It should be understood that the expanded (as shown) configuration of the occluding device 552 can determine whether the occluding device 552 remains in the pylorus 30 or extends into the antrum 32 ( Figure 1).

[0164] Wire pulling method Figure 67 Continue, Figure 67 The introduction of endoscope 556 is shown. In some cases, endoscope 556 may be introduced early in the procedure. Figure 68 548, an endoscopic tool 558 (such as, but not limited to, scissors or other cutting device) has been extended down a working channel (not shown) of an endoscope 556 to detach a delivery shuttle 546 from an anastomotic anchor 550 that forms part of a gastric bypass device 548. In response to release from the delivery shuttle 546, it can be seen that the anastomotic anchor 550 has expanded to a deployed configuration in which the anastomotic anchor 550 has a larger diameter than the anastomosis 26. In some instances, although not shown, a dynamic traction band may then be delivered and connected to the gastric bypass device 548.

[0165] Track method from Figure 70 The delivery catheter 560 has been partially advanced over the proximal free wire end 544. In this case, the delivery shuttle 546 is fixed to the delivery catheter 560, rather than to the guide wire 540 (e.g., Figure 65 and 66 ). Gastric bypass device 548 is releasably secured to delivery shuttle 546. In some cases, delivery shuttle 546 can be eliminated, and instead gastric bypass device 548 can be releasably secured directly to delivery catheter 560 itself.

[0166] like Figure 71 As shown, the delivery catheter 560 has been advanced over the guidewire 540 until the gastric bypass device 548 has reached the desired delivery position. As can be seen, the desired delivery position corresponds to the occlusion device 552 being positioned proximal to the pylorus 30 and the anastomotic anchor 550 having been advanced through to the gastric side of the anastomosis 26. Next, as shown in FIG. Figure 72 and Figure 73 As shown, endoscope 556 is used to provide a path (such as through a not shown working channel of endoscope 556) for endoscopic tools 558. In some cases, endoscope 556 may be able to be introduced early in the procedure.

[0167] Go to Figure 74 , it can be seen that the endoscopic tool 558 has been used to release the gastric bypass device 548 from the delivery shuttle 546. The guidewire 540 and the delivery catheter 560 (with the accompanying delivery shuttle 546) are withdrawn, allowing the gastric bypass device 548 to be properly deployed. The endoscope 560 can then be removed. In response to the release from the delivery shuttle 546, it can be seen that the anastomotic anchor 550 has expanded into a deployed configuration, wherein the anastomotic anchor 550 has a larger diameter than the anastomotic portion 26. In some cases, although not shown, a dynamic traction band can then be delivered and connected to the gastric bypass device 548.

[0168] Storage room method from Figure 75 The receiving catheter 562 is shown loaded onto the guide wire 540 above the proximal free end 544. The gastric bypass device 548 is held within the receiving catheter 562. Figure 76 As shown, receiving catheter 562 has been advanced over (i.e., along) guidewire 540 until distal end 564 of receiving catheter 562 has reached the desired delivery location, wherein receiving catheter 562 extends through anastomosis 26, with distal end 564 of receiving catheter 562 just entering stomach 14. In some cases, endoscope 560 may be introduced at this point in the procedure.

[0169] like Figure 77 As shown, the anastomotic anchor 550 has been deployed. Figure 78 , the receiving catheter 562 has been withdrawn proximally to a point where the distal end 564 of the receiving catheter 562 is located near the pylorus 30. Figure 79 As shown, the receiving catheter 562 has been withdrawn further proximally, thereby deploying the occlusion device 552. With the gastric bypass device 548 now deployed, the receiving catheter 562 and the guidewire 540 can now be withdrawn. In some cases, a pusher can be deployed inside the receiving catheter 562 to assist in the deployment of the gastric bypass device 548. As an example, the pusher can preferentially interact with different parts of the gastric bypass device 548 so that one part of the gastric bypass device 548 is deployed first, and then another part of the gastric bypass device 548 is deployed. In some cases, the pusher can be operated externally by a physician or other medical personnel. For example, the pusher can be an attachment that docks with the distal end of the endoscope 560. In some cases, although not shown, a dynamic traction band can then be delivered and connected to the gastric bypass device 548.

[0170] Two-piece approach Figure 80 1. 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 onto 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 can be withdrawn and removed.

[0171] like Figure 81 As shown, the 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. Figure 82As shown, 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 occluder 552 can be coupled together or otherwise connected using a variety of different connection methods. For example, the tether 544 and the occluder 552 can include any number of hooks, clips, magnets, ties, or other interlocking components. In some cases, an interference fit between the tether 544 and the occluder 552 can be used. Figure 83 As shown, 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 can now be withdrawn and removed. In some cases, although not shown, a dynamic traction band can then be delivered and connected to the gastric bypass device 548.

[0172] Comprehensive approach from Figure 84 The 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 forming the anastomosis. A delivery catheter 572 is loaded onto the guidewire 570, with the gastric bypass device 548 loaded within the delivery catheter 572. The delivery catheter 572 has an electrocautery distal tip 574. Figure 85 As shown, the delivery catheter 572 has been advanced along the guidewire 570 to a position where the electrocautery distal tip 574 has reached the distal end 571 of the guidewire 570.

[0173] like Figure 86 As shown, the electrocautery distal tip 574 is used to pierce the walls of the small intestine 16 and stomach 14 to form anastomosis 26. In this particular case, given the location of anastomosis 26, it is appropriate to refer to anastomosis 26 as a gastrojejunostomy. Figure 87 As shown, the first flange 576 of the anastomotic anchor is deployed. Figure 88 As shown, the delivery catheter 572 is withdrawn proximally a short distance to deploy the second flange 578 of the anastomotic anchor 580. Although the anastomotic anchor 580 is shown as having two flanges in this case, this is not necessary in all cases. For example, the anastomotic anchor 580 can have two rings, one of which is suitable for placement on each side of the gastrojejunostomy. For example, the anastomotic anchor 580 can be a single structure that is fully deployed in one motion. Finally, as Figure 89 As shown, delivery catheter 572 can be withdrawn proximally until electrocautery distal tip 574 passes through pylorus 30, thereby delivering occlusion device 582 and tether 584, resulting in deployed gastric bypass device 586. In some instances, although not shown, a dynamic traction band can then be delivered and connected to gastric bypass device 548.

[0174] Figure 90is a schematic diagram showing an illustrative method for extending a guidewire in a loop through the esophagus 12, through the pylorus 30, through the anastomosis 26 and up through the esophagus 12. In some cases, rather than having to guide a long guidewire (such as guidewire 540) through the path, 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 can 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 at or near the anastomosis 26. The second guidewire 604 can be advanced down the esophagus 12 and through the stomach 14 to a point where the distal end 606 is at or near the anastomosis 26. In some cases, the distal end 602 can include a magnet, and the distal end 606 can include a second magnet having an opposite polarity to the magnet in the distal end 602. Thus, the distal ends 602 and 606 will be attracted to each other, allowing the first guidewire 600 and the second guidewire 604 to effectively join together and form a single guidewire loop through the delivery site.

[0175] The first guide wire 600 and the second guide wire 604 can each be formed of a metal such as stainless steel or nitinol. The first guide wire 600 and the second guide wire 604 can be solid or braided. In some cases, the distal end 602 and the distal end 606 can include additional mechanical fasteners to better secure the connection between the distal end 602 and the distal end 606. It should be understood that naturally occurring magnets have both a north pole and an south pole. Thus, in some cases, the distal end 602 can include a first magnet with its north pole facing distally (as an example), and the distal end 606 can include a second magnet with its south pole facing distally. Thus, when the first guide wire 600 and the second guide wire 604 are as shown in FIG. Figure 90 When positioned as shown, the north pole of the magnet in distal end 602 will be attracted to the south pole of the magnet in distal end 606. Similarly, two magnets with opposite polarity to this example can be used. In some cases, mechanical fasteners can be used without any magnets.

[0176] Figure 91 is a schematic diagram of an illustrative tether 610 for use as part of a gastric bypass device. The tether 610 includes a spring 612 extending through a tether housing 614. The tether housing 614 may be a polymer sheath that helps protect the spring 612 from the stomach environment. The tether housing 614 may help prevent the spring 612 from irritating the papilla 398 (e.g., Figure 48). The spring 612 can be held in place by a suture 616 that includes a knot 618 that limits movement of the spring 612 relative to the tether housing 614. In some cases, delivery of the gastric bypass device can be simplified by limiting changes in the length of the gastric bypass device that might otherwise occur during delivery. For example, the spring 612 can be easily stretched. Anchoring the spring 612 relative to the tether housing 614 helps limit changes in length. Although a single suture 616 is shown, it should be understood that the spring 612 can be held in place relative to the tether housing 614 at two or more locations. In some cases, other components of the gastric bypass device (e.g., an occlusion device and an anastomotic anchor) can be temporarily sutured to another component to limit changes in length. Once the gastric bypass device has been successfully delivered, the suture 616 can be removed and thus no longer constrains the gastric bypass device.

[0177] Figure 92A and 92B is a schematic diagram of an illustrative pusher assembly 630, wherein Figure 92B A cross-sectional view is provided. The pusher device 630 can have a male threaded feature 632 that can interact with a corresponding female threaded feature 634 formed as part of an occlusion device 636. In some cases, the pusher device 630 can be used to deploy the occlusion device 636 and then rotate the pusher device 630 relative to the occlusion device 636 to disengage the pusher device 630 from the occlusion device 636. In some cases, the threaded interaction between the pusher device 630 and the occlusion device 636 during delivery can be used to constrain expansion of a gastric bypass device including the occlusion device 636 during delivery.

[0178] Figure 93B and 94B is a schematic diagram of an exemplary pusher device 640. Exemplary pusher device 640 is rod-shaped and includes a threaded portion 642 having male threads. Pusher device 640 is adapted to engage with a tether 644. Tether 644 includes a corresponding threaded portion 646 having female threads. Pusher device 640 can be threadedly engaged with tether 644. Pusher device 640 can be disengaged from tether 644 by rotating pusher device 640 relative to tether 644. In some cases, pusher device 640 can also capture occlusion device 648 when engaged with tether 644. It should be understood that in this manner, pusher device 640 can be used not only to facilitate delivery of a gastric bypass device including tether 644 and occlusion device 648, but can also be used to maintain the gastric bypass device in a compact configuration during delivery.

[0179] Figure 94B and 94B6 is a schematic diagram of an exemplary pusher device 650. Exemplary pusher device 650 is rod-shaped and includes a threaded portion 652 having male threads. Pusher device 650 is adapted to engage with a tether 654. An occluder device 656 includes a male threaded portion 658 with which threaded portion 652 of pusher rod 650 can threadably engage. Although not shown, tether 654 can also be temporarily secured relative to pusher rod 650. It should be understood that in this manner, pusher device 650 can be used not only to facilitate delivery of a gastric bypass device including tether 654 and occluder device 656, but can also be used to maintain the gastric bypass device in a compact configuration during delivery.

[0180] Figure 95A 、 95B and 95C are schematic diagrams showing illustrative pusher arrangements. Figure 95A A pusher device 660 is shown including a shaft region 662 and an atraumatic tip 664. In some cases, the atraumatic tip 664 has a profile that is complementary to the profile of the occluding device 668. Thus, the atraumatic tip 664 can help support and maintain the shape of the occluding device 668, including the inner diameter of the occluding device 668. In some cases, the pusher device 660 can alternatively be used to deliver the anastomotic anchor portion of a gastric bypass device. Although not shown, in some cases, the pusher device 660 can also include an outer member that helps support and maintain the outer diameter of the occluding 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 occluding device 668. The atraumatic tip 664 can have a length that is shorter than or even longer than the length of the occluding device 668. In some cases, such as Figure 95B As shown, 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 alongside the endoscope, rather than through endoscope 670.

[0181] like Figure 95CAs shown, in some cases, the pusher device 680 can be adapted to be fixed relative to the distal end of the endoscope 670. As shown, the pusher device 680 includes an attachment area 682 adapted to form a friction fit over the distal end of the endoscope 670, a central shaft portion 684, and an anti-traumatic tip 686 having a shape complementary to that of the occlusion device 688. In some cases, the attachment area 682 can be connected to the endoscope 670 via one or more elastic members (not shown) (such as rubber bands). In some cases, the pusher device 680 can be rigid enough to allow advancement through the anatomical structure without kinking. Portions of the pusher device 680 can be made of a transparent or translucent material for better visualization during delivery. In some cases, the pusher device 680 can alternatively be used to deliver the anastomotic anchor portion of the gastric bypass device.

[0182] Figure 96 FIG2 is a schematic diagram of an illustrative two-stage pusher device 690 shown disposed within a receiving chamber 692. A gastric bypass device 694 is shown within the receiving chamber 692, including an anastomotic anchor 696, an occluding device 698, and a tether 700 extending between the anastomotic anchor 696 and the occluding device 698. The two-stage pusher device 690 includes a shaft 702 extending proximally from the receiving chamber 692 and can thus 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 causes the first-stage component 704 to move distally, thereby pushing the anastomotic anchor 696 out of the receiving chamber 692. Further distal movement of the shaft 702 (e.g., after the receiving chamber 692 has been moved into position) causes the second stage member 706, which interacts with the occluding device 698, to be pushed out of the receiving chamber 692. It will be appreciated that, in some circumstances, it may be preferable to deploy the gastric bypass device 694 in the reverse manner, deploying the occluding device 698 before deploying the anastomotic anchors 696.

[0183] The materials that can be used for the various components of the medical device systems described herein and the various elements thereof disclosed herein may include materials commonly associated with medical devices. In some embodiments, the medical device systems described herein can be made of metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, or 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; low carbon steels; nickel-titanium alloys, such as linear elastic and / or superelastic nitinol; other nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as 625, UNS: N06022, such as UNS: N10276, such as other alloys, etc.), nickel-copper alloys (such as UNS: N04400, such as 400, 400, 400, etc.), nickel-cobalt-chromium-molybdenum alloys (such as UNS: R44035, such as etc.), nickel-molybdenum alloys (such as UNS: 10665, such as ALLOY ), 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, e.g. etc.); platinum-rich stainless steel; titanium; combinations thereof; etc.; or any other suitable material.

[0184] As mentioned herein, within the family of commercially available nickel-titanium, or Nitinol, alloys, there is a category designated as "linear elastic" or "non-superelastic," which, while chemically similar to conventional shape memory and superelastic varieties, can exhibit different and useful mechanical properties. Linear elastic and / or non-superelastic Nitinol differs 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 superelastic Nitinol does. In fact, 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 completely, linear relationship until plastic deformation begins, or at least continues to increase in a more linear relationship than the superelastic plateau and / or flag region seen in superelastic Nitinol. Therefore, for the 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.

[0185] In some cases, linear elastic and / or non-superelastic nitinol can also be distinguished from superelastic nitinol in that linear elastic and / or non-superelastic nitinol can accept strains up to about 2-5% while remaining substantially elastic (e.g., before plastic deformation), whereas superelastic nitinol can accept strains up to about 8% before plastic deformation. Both of these materials can be distinguished from other linear elastic materials such as stainless steel (which can also be distinguished based on their composition), which can only accept strains of about 0.2% to 0.44% before plastic deformation.

[0186] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy is an alloy that does not exhibit any martensite / austenite phase transformation detectable by differential scanning calorimetry (DSC) and dynamic metallographic thermal analysis (DMTA) analysis over a wide temperature range. For example, in some embodiments, within the range of about -60 degrees Celsius (°C) to about 120°C, there may be no martensite / austenite phase transformation detectable by DSC and DMTA analysis in the linear elastic and / or non-superelastic nickel-titanium alloy. As a result, the mechanical bending properties of such materials may be generally inert to the effects of temperature over this very wide temperature range. In some embodiments, the mechanical bending properties of the linear elastic and / or non-superelastic nickel-titanium alloy at ambient or room temperature are substantially the same as their mechanical properties at body temperature, for example, as evidenced by the fact that they do not exhibit superelastic plateaus and / or flag regions. In other words, the linear elastic and / or non-superelastic nickel-titanium alloy maintains its linear elastic and / or non-superelastic characteristics and / or properties over the entire wide temperature range.

[0187] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy may be about 50 to about 60 weight percent nickel, with the remainder being essentially titanium. In some embodiments, the composition is about 54 to about 57 weight percent nickel. An example of a suitable nickel-titanium alloy is FHP-NT alloy, commercially available from Furukawa Techno Material Co., Kanagawa, Japan. Other suitable materials may include ULTANIUM TM (available from Neo-Metrics) and GUM METAL TM (Available from Toyota.) In some other embodiments, superelastic alloys (eg, superelastic Nitinol) may be used to achieve the desired properties.

[0188] In at least some embodiments, part or all of the medical device systems described herein may also be doped with, made of, or otherwise include radiopaque materials. Radiopaque materials should be understood to be materials that can produce a relatively bright image on a fluoroscopic screen or other imaging technology during medical surgery. This relatively bright image helps the user determine the position of the medical device system. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, barium sulfate, polymer materials loaded with radiopaque fillers, and the like. In addition, other radiopaque marker bands and / or coils may also be incorporated into the design of the medical device systems described herein.

[0189] 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 can be made of materials that do not substantially distort images and do not produce substantial artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may not be suitable because they may produce artifacts in MRI images. In some cases, the medical device system or portions thereof can also be made of materials that can be imaged by MRI machines. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R44003, such as etc.), nickel-cobalt-chromium-molybdenum alloys (e.g. UNS: R44035, such as etc.), Nitinol, etc., and other materials.

[0190] In some embodiments, the medical device systems described herein can be made of or include a polymer or other suitable material. Some examples of suitable polymers can include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, available from DuPont, for example). ), polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., available from DSM Engineering Plastics ), ether or ester based copolymers (e.g., butene / poly(alkylene ether) phthalate and / or other polyester elastomers, such as those available from DuPont ), polyamides (e.g., available from Bayer or available from Elf Atochem ), elastic polyamides, block polyamide / ether, polyether block amide (PEBA, for example available under the trade name obtained under the following conditions), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), High-density polyethylene, Low-density polyethylene, linear low-density polyethylene (e.g. ), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polyethylene trimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyethylene oxide (PPO), polyterephthalamide (e.g. ), polysulfone, nylon, nylon-12 (e.g. available from EMS American Grilon ), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, ionomer, biocompatible polymer, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites thereof, etc. 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.

[0191] In some embodiments, the medical device systems described herein and / or other elements disclosed herein may include a fabric material disposed above or inside the structure. The fabric material may be composed of a biocompatible material (e.g., a polymeric material or a biomaterial) suitable for promoting tissue ingrowth. In some embodiments, the fabric material may include a bioabsorbable material. Some examples of suitable fabric materials include, but are not limited to, polyethylene glycol (PEG), nylon, polytetrafluoroethylene (PTFE, ePTFE), polyolefin materials (e.g., polyethylene, polypropylene), polyester, polyurethane, and / or blends or combinations thereof.

[0192] It should be understood that the present disclosure is in many respects merely illustrative. Changes may be made in detail, particularly in shape, size, and arrangement of steps, without departing from the scope of the invention. To the extent appropriate, this may include employing any feature of an exemplary embodiment as employed in other embodiments. Of course, the scope of the invention is defined in the language of the appended claims.

Claims

1. A delivery system adapted for delivering a gastric bypass device, the gastric bypass device comprising an occluding device adapted to be secured in position within a patient's stomach relative to the patient's pylorus, an anastomotic anchor adapted to be secured in position 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, the tether being secured at a first end to the occluding device, the delivery system comprising: a guidewire adapted to be delivered in a circular path down the patient's esophagus, through the patient's pylorus, up through the anastomosis, and up the patient's esophagus such that both distal and proximal wire ends of the guidewire are accessible outside of the patient's oral cavity; a gastric bypass device adapted to be delivered by advancing the gastric bypass device relative to the guidewire; as well as 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 releasably couple 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 translation of the guidewire results in corresponding translation of the delivery shuttle.

5. The delivery system of claim 1, further comprising a delivery catheter adapted to be advanced over the guidewire, wherein the delivery device comprises a delivery shuttle coupled to the delivery catheter.

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

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

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

9. The delivery system of any one of claims 1 to 8, wherein the guidewire 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 member; Wherein, the second coupler is adapted to be fixed to the first coupler so as to couple the first guide wire component and the second guide wire component together.

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

11. The delivery system of any one of claims 1 to 10, further comprising a dynamic traction band adapted to be subsequently delivered and secured relative to the gastric bypass device.

12. A delivery system adapted for delivering a gastric bypass device, the gastric bypass device comprising an occlusion device adapted to be secured in position within a patient's stomach relative to the patient's pylorus, an anastomotic anchor adapted to be secured in position 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, the tether being secured at a first end to the occlusion device, the delivery system comprising: a guidewire adapted to be delivered in a circular path down the patient's esophagus, through the patient's pylorus, up through the anastomosis, and up the patient's esophagus such that both distal and proximal wire ends of the guidewire are accessible outside of the patient's oral cavity; 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 subsequently advanced over the guidewire, the second delivery catheter including the tether and the occlusion device of the gastric bypass device; The first delivery catheter is adapted for delivering the anastomotic anchor, and the second delivery catheter is adapted for subsequently delivering an occlusion device and the tether to be coupled to the anastomotic anchor to form the gastric bypass device.

13. A delivery system adapted for delivering a gastric bypass device, the gastric bypass device comprising an occlusion device adapted to be secured in position within a patient's stomach relative to the patient's pylorus, an anastomotic anchor adapted to be secured in position 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, the tether being secured at a first end to the occlusion device, the delivery system comprising: a guidewire adapted to be delivered in a circular path down the patient's esophagus, through the patient's pylorus, up through the anastomosis, and up the patient's esophagus such that both distal and proximal wire ends of the guidewire are accessible outside of the patient's oral cavity; a delivery catheter adapted to be advanced over the guidewire, the delivery catheter comprising an electrocautery distal tip adapted to form the anastomosis; and A gastric bypass device can be positioned within the delivery catheter.

14. The delivery system of claim 13, wherein the gastric bypass device comprises an anastomotic anchor having a first flange adapted for deployment on a first side of the anastomosis and a second flange adapted for deployment on a second side of the anastomosis.

15. The delivery system of any one of claims 13 or 14, further comprising a dynamic traction band adapted to be delivered after the gastric bypass device.

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