Dynamic rope of gastric bypass device

Abstract

A gastric bypass device includes an occlusion device adapted to be deployed relative to a pyloric sphincter of a patient, an anastomotic anchor adapted to be deployed relative to an anastomotic stoma between a stomach and a small intestine of the patient, and a tether extending through the small intestine of the patient between the occlusion device and the anastomotic anchor. The dynamic tether may be secured relative to the occlusion device and may cooperate with the tether to assist in securing the occlusion device in place.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 63 / 390,183, filed on July 18, 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 medical devices such as gastric bypass devices that include a dynamic tether. Background Art

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

[0004] The present disclosure relates to medical devices such as gastric bypass devices, and more particularly to medical devices such as gastric bypass devices including a dynamic cord.

[0005] One example may be found in an implantable medical device system. The implantable medical device system includes an occluding device adapted to be secured in place relative to the patient's pylorus, and an anastomotic anchor adapted to be secured in place relative to an anastomosis formed between the patient's stomach wall and the patient's small intestine. A tether is adapted to extend through the patient's duodenum, the tether being secured to the occluding device at a first end and to the anastomotic anchor at a second end, the tether being further adapted to provide tension to the occluding device. A dynamic tether is adapted to extend through the patient's stomach, the dynamic tether being further adapted to provide tension to the occluding device opposite to the tension provided by the tether.

[0006] Alternatively or additionally, the tether may include a first spring having a first spring constant and the dynamic rope may include a second spring having a second spring constant.

[0007] Alternatively or additionally, the second spring constant may be different from the first spring constant.

[0008] Alternatively or additionally, the first spring may be adapted to resist movements of the gastrointestinal system that may cause the occluding device to move into the patient's stomach.

[0009] Alternatively or additionally, the second spring may be adapted to resist movement of the gastrointestinal system that may cause the occluding device to move into the duodenum of the patient.

[0010] Alternatively or additionally, the first spring may be adapted to cooperate with the second spring to position the occluding device relative to the pylorus of the patient.

[0011] Alternatively or additionally, the dynamic tether may be adapted to be secured to the occlusive device at one end and to the anastomotic anchor at the other end.

[0012] Alternatively or additionally, the occlusive device may include a support frame and a water-impermeable membrane spanning the support frame.

[0013] Alternatively or additionally, the dynamic cord may be adapted to be secured at one end to a support frame of the occluding device.

[0014] Alternatively or additionally, the dynamic cord may be adapted to be secured at one end to a water-impermeable membrane of the occluding device.

[0015] Alternatively or additionally, the dynamic cord may be adapted to be secured to the occluding device at one end and to the stomach wall of the patient at another end.

[0016] Alternatively or additionally, the dynamic cord may be adapted to be secured to the occlusive device at one end and to the anti-displacement anchor at another end.

[0017] Another example may be found in a dynamic tether adapted for use in a gastric bypass system including an occluding device and a tether secured to the occluding device, the dynamic tether adapted to extend within a patient's stomach between the occluding device and a securing point, the occluding device adapted to be deployed relative to the patient's pylorus. The dynamic tether includes an elastic member having a first end adapted to be secured relative to the occluding device and a second end adapted to be secured to the securing point, wherein the elastic member dynamically resists a force exerted on the occluding device by the tether.

[0018] Alternatively or additionally, the fixation point may comprise an anastomotic anchor.

[0019] Alternatively or additionally, the fixation point may comprise the patient's stomach wall.

[0020] Alternatively or additionally, the resilient member may comprise a spring.

[0021] Alternatively or additionally, the resilient member may comprise a pneumatic tube.

[0022] Alternatively or additionally, the resilient member may be adapted to resist movement of the gastrointestinal system that may cause the occluding device to migrate into the duodenum of the patient.

[0023] Another example can be found in an assembly suitable for use in a gastric bypass system that includes an occlusion device. The assembly includes a first gastric clamp adapted to be secured to one side of a patient's stomach and a second gastric clamp adapted to be secured to the other side of the patient's stomach. A first securing member is adapted to be secured to the first gastric clamp. A second securing member is adapted to be secured to the second gastric clamp. The first securing member and the second securing member releasably engage the occlusion device to limit distal movement of the occlusion device when the patient's pyloric sphincter is dilated.

[0024] Alternatively or additionally, the first securing member may comprise a first elastic band adapted to also be secured to the second gastric clamp.

[0025] Alternatively or additionally, the second securing member may comprise a second elastic band adapted to also be secured to the first gastric clamp.

[0026] Alternatively or additionally, the first securing member may comprise a first hook or bumper.

[0027] Alternatively or additionally, the second securing member may comprise a second hook or bumper.

[0028] Another example is a device adapted to create a stoma and deliver a gastric bypass system in a single step. The device includes an electrocautery tip adapted to create a stoma, and a device segment adapted to releasably retain an anastomotic anchor in a contracted configuration. The device segment is adapted to deploy an anastomotic anchor within the stoma, the anastomotic anchor expanding to an expanded configuration after deployment.

[0029] Alternatively or additionally, a gastric bypass device may be delivered via a pullback procedure.

[0030] The above summary of some embodiments, aspects and / or examples is not intended to describe every embodiment or every implementation of the present disclosure. The figures and the following detailed description more particularly exemplify these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] The present disclosure may be more fully understood by considering the following detailed description of various embodiments in conjunction with the accompanying drawings, in which:

[0032] Figure 1 It is a schematic diagram of a part of the human gastrointestinal (GI) system;

[0033] Figure 2 is located in Figure 1 A schematic diagram of an exemplary gastric bypass system within a GI system is shown, the exemplary gastric bypass system including an occlusive device, an anastomotic anchor, a tether, and a dynamic tether;

[0034] Figures 3 to 26 It is available for Figure 2 A schematic diagram of an exemplary occlusion device of an exemplary gastric bypass system;

[0035] Figures 27 to 32B It is available for Figure 2 Schematic diagram of an exemplary anastomotic anchor and ring of an exemplary gastric bypass system;

[0036] Figures 33 to 47 is Figure 2 Schematic diagrams of exemplary tethers that may be used in exemplary gastric bypass systems of , some of which are shown in conjunction with occlusion devices;

[0037] Fig.48 It is a schematic diagram of a part of the human gastrointestinal (GI) system;

[0038] Figures 49 to 53D is Figure 2 Schematic diagram of an exemplary tether for protecting the papilla of Vater that may be used in an exemplary gastric bypass system of;

[0039] Figure 54 to Figure 59 is Figure 2 Schematic diagram of an exemplary dynamic cord that may be used in a gastric bypass system of;

[0040] Fig.60 and Fig.61 is a schematic diagram of a secondary engagement device; and

[0041] Fig.62 is a schematic diagram of a device integrating anastomosis creation and gastric bypass system delivery; and

[0042] Fig.63 is a schematic diagram of the final anastomosis and gastric bypass system.

[0043] Although aspects of the present disclosure may be subjected to various modifications and alternative forms, details thereof have been shown by way of example in the drawings and will be described in detail. However, it should be understood that it is not intended to limit aspects of the present disclosure to the specific embodiments described. On the contrary, it is intended to cover all modifications, equivalents, and alternatives that fall within the spirit and scope of the present disclosure. DETAILED DESCRIPTION

[0044] The following description should be read with reference to the accompanying drawings, which are not necessarily drawn to scale, in which the same reference numerals represent the same elements in the multiple views. The detailed description and the accompanying drawings are intended to illustrate but not limit the claimed 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 and the accompanying drawings illustrate example embodiments of the claimed invention.

[0045] For the following defined terms, these definitions shall apply, unless a different definition is given in the claims or elsewhere in this specification.

[0046] All numerical values ​​are modified by the term "about", whether or not explicitly stated. The term "about" in the context of numerical values ​​generally refers to a range of numbers that one skilled in the art considers to be equivalent to the value (e.g., having the same function or result). In many cases, the term "about" may include numbers rounded to the nearest significant figure. Unless otherwise indicated, other uses of the term "about" (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.

[0047] 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).

[0048] Although some suitable sizes, ranges and / or values ​​are disclosed in relation to various components, features and / or specifications, those skilled in the art, in light of this disclosure, will appreciate that the desired sizes, ranges and / or values ​​may deviate from the sizes, ranges and / or values ​​explicitly disclosed.

[0049] As used in this specification and the appended claims, the singular forms "a", "an" and "the" include plural referents unless the content clearly stipulates otherwise. As used in this specification and the appended claims, the term "or" is generally used in a sense that includes "and / or", unless the content clearly stipulates otherwise. It should be noted that, for ease of understanding, certain features of the present disclosure may be described in the singular, even if these features may be plural or repeated in the disclosed embodiments. Each instance of a feature may include and / or be covered by a singular disclosure, unless otherwise clearly stipulated. For simplicity and clarity, all elements of the disclosed invention are not necessarily shown in each figure or discussed in detail below. However, it should be understood that, unless otherwise clearly stipulated, the following discussion may also apply to any and / or all components in which there are multiple components. In addition, for clarity, all instances of certain elements or features may not be shown in each figure.

[0050] Relative terms, such as "proximal," "distal," "advanced," "retracted," and variations thereof, and the like, generally may consider the positioning, orientation, and / or operation of various elements relative to a user / operator / manipulator of the device, with "proximal" and "retracted" meaning or referring to closer to or toward a user and "distal" and "advanced" meaning or referring to away from or away from a user. In some cases, the term "distal" means deeper into the gastrointestinal system and the term "proximal" means moved out of the gastrointestinal system. In some cases, the terms "proximal" and "distal" may be arbitrarily assigned to facilitate understanding of the present disclosure, and such cases will be apparent to one skilled in the art. Other relative terms, such as "upstream," "downstream," "inflow," and "outflow" refer to the direction of fluid flow within a lumen (e.g., a body cavity, a blood vessel, or a device).

[0051] The term "range" may be understood to mean the maximum measured value of a described or determined dimension. For example, "external range" may be understood to mean the maximum external dimension, "radial range" may be understood to mean the maximum radial dimension, "longitudinal range" may be understood to mean the maximum longitudinal dimension, etc. Each instance of "range" may be different (e.g., axial, longitudinal, transverse, radial, circumferential, etc.), and it will be apparent to those skilled in the art based on the context of individual usage. Generally, "range" may be considered to be the maximum possible dimension measured based on the intended use. In some cases, "range" may generally be measured orthogonally in a plane and / or cross-section, but as is apparent from the particular context, may be measured in different ways - for example, but not limited to, angular, radial, circumferential (e.g., along an arc), etc.

[0052] References in the specification to "embodiments", "some embodiments", "other embodiments", etc. indicate that the embodiments may include specific features, structures, or characteristics, but each embodiment does not necessarily include specific features, structures, or characteristics. In addition, these phrases do not necessarily refer to the same embodiment. In addition, when a specific feature, structure, or characteristic is described in conjunction with an embodiment, those skilled in the art may implement the specific feature, structure, or characteristic in conjunction with other embodiments, whether or not explicitly described, unless otherwise explicitly stated. That is, as understood by those of ordinary skill in the art, the various individual elements described below, even if not explicitly shown as a specific combination, are considered to be combined or arranged with each other to form other additional embodiments or to supplement and / or enrich the embodiments.

[0053] For the sake of clarity, throughout the specification and / or claims, certain identifying digital nomenclatures (e.g., first, second, third, fourth, etc.) may be used to name and / or distinguish various described and / or claimed features. It should be understood that the digital nomenclature is not intended to be limiting, but is exemplary only. In some embodiments, for simplicity and clarity, the digital nomenclature previously used may be changed and deviated from. That is, the feature identified as a "first" element may be referred to as a "second" element, a "third" element, etc., later, or may be omitted completely, and / or different features may be referred to as a "first" element. The meaning and / or name in each case will be apparent to a skilled practitioner.

[0054] This document relates to devices and methods for treating diseases such as obesity and metabolic diseases. For example, this document provides methods and devices for bypassing some parts of the gastrointestinal tract to reduce nutrient turnover, reduce weight and / or improve diabetes control.

[0055] Figure 11 is a schematic diagram of a portion of a human digestive tract 10. The digestive tract 10 includes an esophagus 12, a stomach 14, and a small intestine 16. The esophagus 12 connects the mouth to the stomach 14 and delivers food to the stomach 14. The stomach 14 secretes digestive enzymes and gastric acid to help digest food. The small intestine 16 is the organ where most of the nutrients and minerals of food are absorbed. The small intestine 16 includes the duodenum 18, the jejunum 24, and the ileum (not shown). The pyloric sphincter 20 controls the movement of partially digested food from the stomach 14 into the duodenum 18. The passage may be about 25-38 centimeters (cm) long. The food then enters the jejunum 24, which is about 2.25-2.75 meters long. It should be understood that these dimensions are for reference only and may vary from patient to patient.

[0056] An anastomosis 26 may be established between the stomach 14 and the small intestine 16. In some cases, an anastomosis 26 may be established between the stomach 14 and the duodenum 18. In some cases, an anastomosis 26 may be established between the stomach 14 and the jejunum 24. For example, the anastomosis 26 may be established by a gastrojejunostomy. The anastomosis 26 allows food to move directly from the stomach 14 to the jejunum 24, bypassing the duodenum 18. In some cases, the anastomosis 26 may include a stent, staples, magnets, balloons, or other structures for maintaining an opening and connection between the stomach 14 and the small intestine 16. In some cases, the diameter of the anastomosis 26 may be about 1-4 centimeters. In some cases, the stomach 14 may be considered to include a pylorus 30 located just upstream of the pyloric sphincter 20. The diameter of the pylorus 30 may be considered to be greater than the diameter of the pyloric sphincter 20. The stomach 14 may be considered to include a gastric antrum 32 located just upstream of the pyloric 30. The diameter of the gastric antrum 32 may be considered to be greater than the diameter of the pyloric 30.

[0057] Figure 2 A gastric bypass device 34 is schematically shown positioned within the anatomical structure 10. The gastric bypass device 34 includes an occluding device 36 that may be adapted to be placed within the pyloric sphincter 20, within the pylorus 30, or within the gastric antrum 32, depending on the desired degree of occlusion of the stomach 14. In some cases, the occluding device 36 may be adapted to be placed within the gastric antrum 32. The gastric bypass device 34 includes an anastomotic anchor 38 that may be adapted to be secured relative to the anastomotic stoma 26. In some cases, the anastomotic anchor 38 may be adapted to be secured to an anastomotic structure (not shown) within the anastomotic stoma 26 to protect and maintain the anastomotic stoma 26.

[0058] Since the occluding device 36 is a foreign body, 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, is secured to the occluding device 36 at a first end 40a of the tether 40, and is secured to the anastomotic anchor 38 at a second end 40b of the tether 40. The tether 40 may be adapted to help secure the occluding device 36 to its desired implantation location to resist movement caused by the stomach 14 attempting to dislodge the occluding device 36. In some cases, a dynamic tether 42 extends between the occluding device 36 and the anastomotic anchor 38 and may be adapted to help secure the occluding device 36 to its desired location. In some cases, the dynamic tether 42 may extend from the occluding device 36 to an anchoring location within the wall of the stomach 14. In some cases, occluder device 36 may include one or more anti-displacement features, such as hooks or prongs, or perhaps a high friction coating on at least a portion of occluder device 36. In some cases, anastomotic anchor 38 may also include additional anti-displacement features.

[0059] The gastric bypass device 34 is shown in schematic form because each of the components of the gastric bypass device 34, including the occlusive device 36, the anastomotic anchors 38, the tethers 40, and the dynamic tethers 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. Figure 54 to Figure 59 Illustrative but non-limiting examples of possible dynamic tethers 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 tether 42.

[0060] In some cases, the occluding device may be disposed 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 may be disposed within the pylorus 30. The occluding device 36 may be disposed within the antrum 32 or may extend to the antrum 32. Figures 3 to 26 An illustration of an exemplary occlusive device that may be used as an occlusive device 36 as part of a gastric bypass device 34 is provided.

[0061] Figure 3is a schematic diagram of an exemplary occlusive device 44 positioned proximate to the gastric antrum 32. The occlusive device 44 includes an annular ring 46, which may be sized to span the anatomical structure. It should be appreciated that the size of the annular ring 46 may help position the occlusive device 44 at a desired location within the anatomical structure. For example, if it is desired to position the occlusive device 44 within the pyloric sphincter 20, the overall diameter of the annular ring 46 may be 1 to 3 centimeters. If it is desired to position the occlusive device 44 within the pylorus 30, the overall diameter of the annular ring 46 may be 2 to 8 centimeters. If it is desired to position the occlusive device 44 within the gastric antrum 32, the overall diameter of the annular ring 44 may be 4 to 12 centimeters.

[0062] The occluder 46 includes a cone 48 that tapers from an annular ring 46 (which can be considered to define the maximum outer diameter of the occluder 44) to a minimum diameter endpoint 50. The minimum diameter endpoint 50 can be adapted to be secured to a tether 52, for example. The cone 48 can taper smoothly from its maximum outer diameter to its minimum outer diameter. The cone 48 can taper with one or more abrupt diameter changes. In some cases, the cone 48 can have a curved profile. The cone 48 can be adapted to prevent materials such as food, chyme, and other gastric contents from flowing through the cone 48. In some cases, the cone 48 can be made of an impermeable material, such as, but not limited to, a polymer material. In some cases, the cone 48 can include a polymer membrane arranged on some kind of support frame (not shown).

[0063] The thickness, hardness and lubricity of the polymer material used to form the occluder 54 can vary along the length of the occluder 44. The occluder 44 can have a funnel shape, for example, or a cyclone shape. The occluder 44 can have a hemispherical or even spherical shape. The occluder 44 may include a notch (not shown) to accommodate a support ring. In some cases, the occluder 44 can be retracted to facilitate delivery. The occluder 44 may include a film or other covering across the opening defined by the annular ring 46 to prevent material from accumulating in the occluder 44.

[0064] The occlusive device 44 may be made of 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 may be made of silicone or other polymers. For example, the occlusive device 54 may be formed by 3D printing. In some cases, the occlusive device 54 may be molded or even electronically spun.

[0065] In some cases, the occluder 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 occluder 44 may be thicker near the annular ring 46. The occluder 44 can be formed of a shape memory material that allows the occluder 44 to have a memory configuration for deployment and to be temporarily deformed from the memory configuration during delivery. Although not shown, the occluder 44 may include an anchor, such as an outward spike, hook, spline, or tine. The occluder 44 may include a surface treatment that promotes endothelialization. These are just examples.

[0066] Figure 4 is a schematic diagram of an exemplary occlusive device 54, which may be considered an example of the occlusive device 44. The exemplary occlusive device 54 is formed of a single continuous polymer 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 considered suitable for securing to a tether (e.g., tether 40). The annular ring 58 may be sized to position the occlusive device 54 at a desired location relative to, for example, the pyloric sphincter 20, the pylorus 30, or the gastric antrum 32.

[0067] The occluding device 54 can be considered deformable and can be delivered endoscopically. The annular ring 56 is adapted to apply an outward radial force to engage the anatomical structure. If the occluding device 54 is intended to be deployed within the pyloric sphincter 20, the overall diameter of the annular ring 58 can be 1 to 3 centimeters. If the occluding device 54 is intended to be deployed within the pylorus 30, the overall diameter of the annular ring 58 can be 2 to 8 centimeters. If the occluding device 54 is intended to be deployed within the gastric antrum 32, the overall diameter of the annular ring 58 can be 4 to 12 centimeters.

[0068] Figure 5is a schematic diagram of an exemplary occluding device 62, which is shown in the figure near the gastric antrum 32. The occluding device 62 has an inflatable body 64, which can be filled with gas or other fluids (e.g., saline) to maintain its inflated configuration (as shown). For example, the inflatable body 64 can be an inflatable balloon. In some cases, the occluding device 62 can be delivered with the inflatable body 64 in a deflated configuration. Once the occluding device 62 reaches its desired deployment position, the inflatable body 64 can be filled with gas or other fluids, or may be a gel, so as to expand to its expanded configuration (as shown). For example, the inflatable body 64 can have a spherical or hemispherical shape and can have a maximum outer diameter, which helps to position the occluding device 62 relative to the anatomical structure. If the occluding device 62 is for deployment in the pyloric sphincter 20, the maximum diameter of the inflatable body 64 can be 1 to 3 centimeters. If the occluding device 62 is for deployment in the pylorus 30, the maximum diameter of the inflatable body 64 can be 2 to 8 centimeters. If the occlusive device 62 is intended for deployment within the gastric antrum 32, the maximum diameter of the inflatable body 64 may be between 4 and 12 centimeters.

[0069] The occlusive device 62 can be formed of any material, such as a polymer material that can withstand the highly acidic gastric environment. For example, the occlusive device 62 can be formed of silicone, although the occlusive device 62 can include additional fiber reinforcement materials. For example, the occlusive device 62 can be formed by 3D printing. The occlusive device 62 can be molded or electronically spun. The occlusive device 62 can be formed by dip coating. As another example, the occlusive device 62 can be formed by electronically spinning two halves and then dipping the two halves together to form the occlusive device 62. The occlusive device 62 includes an attachment point 66 suitable for fixing to a tether 68.

[0070] In some cases, the inflatable body 64 may have a variable stiffness profile. The inflatable balloon 64 may be relatively flexible, which allows the walls of the inflatable body 64 to compress and expand with peristalsis. The inflatable balloon 64 may be relatively stiff, thereby helping to anchor the occluding device 62 in place relative to the gastric antrum 32. In some cases, the occluding device 62 may have a variety of different shapes. The occluding device 62 may have a three-dimensional funnel shape. The occluding device 62 may have a hemispherical top, or may not have a hemispherical top. The occluding device 62 may have an undefined organic shape. The occluding device 62 may include one or more protruding lips or rings that help to fix the occluding device 62 in place relative to the anatomical structure. Although not shown, the occluding device 62 may include anchors, such as outward spikes, hooks, splines, or tines. The occluding device 62 may include a surface treatment that promotes endothelialization.

[0071] Although the occluding device 62 is shown as being deployed within the gastric antrum 32, this is not necessarily the case in all cases. For example, the occluding device 62 may extend through the gastric antrum 32 and partially into the duodenum 18. In some cases, such as Figure 6 As shown, the occluding 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 occluding device 62 can function as an occluding 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 inflatable body 76 extending 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 feature 78 extends into the stomach 14 and to the second end 74 of the occluder device 70.

[0072] Figure 7 is a schematic diagram of an exemplary occluding device 80, which can be considered an example of an occluding device 44. The exemplary occluding device 80 is shown within the anatomical structure and is shown near the gastric antrum 32. In some cases, the occluding device 80 can occlude 10% to 50% of the stomach 14 and can conform to the wall of the stomach 14. The occluding device 80 includes a funnel-shaped or conical film funnel 82. For example, the film funnel 82 can be made of silicone or expanded polytetrafluoroethylene (e-PTFE). The film funnel 82 can be made of polyurethane that is highly resistant to acids and chemicals. In some cases, a low molecular weight resin (such as a resin sold by CrayValley under the name Krasol) can be mixed into a polyurethane elastomer that is highly chemically resistant. In some cases, this polybutadiene polyurethane has rubber properties, excellent hydrolysis and chemical resistance, good elasticity, and can be reinforced using common rubber fillers.

[0073] The occluder 80 extends from an annular ring 84, which represents the maximum outer diameter of the occluder 80, to a minimum diameter endpoint 86. The minimum diameter endpoint 86 may be considered suitable for fixing to a tether 88. The large end of the occluder 80 may be covered or uncovered. The annular ring 84 may be a support ring added to the occluder 80, and its size may be designed to position the occluder 80 in a desired position relative to, for example, the pyloric sphincter 20, the pylorus 30, or the gastric antrum 32. If the occluder 80 is intended to be deployed within the pyloric sphincter 20, the total diameter of the annular ring 84 may be 1 to 3 cm. If the occluder 80 is intended to be deployed within the pylorus 30, the total diameter of the annular ring 84 may be 2 to 8 cm. If the occluder 80 is for placement within the gastric antrum 32, the total diameter of the annular ring 84 may be 4 to 12 cm.

[0074] The annular ring 84 may be adapted to exert an outward radial force to help maintain the occluding device 80 in position relative to the anatomical structure. The occluding device 80 may include some or all of a fiber or metal reinforcement material, such as ultra-high weight polyethylene (UHMWPE) or nickel titanium alloy. The occluding device 80 may be manufactured by attaching a film funnel 82 to the annular ring 84 via suturing, stitching, thermal bonding, or chemical bonding.

[0075] In some cases, such as Figure 8 As shown, the occluder 80 may include a second intermediate support ring 90 that helps support the film funnel 82. The occluder 80 may include a third support ring, a fourth support ring, etc. The intermediate support ring 90 (and the support rings added to the annular ring 84) may be formed of a shape memory metal, such as nickel titanium alloy, including nickel titanium alloy. Although not shown, the occluder 80 may include anchors, such as outward spikes, hooks, splines or tines. The occluder 80 may include a surface treatment that promotes endothelialization.

[0076] Fig. 9 is a schematic diagram of an exemplary occluder device 92. The exemplary 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 adapted to be secured to a tether 100. In some cases, the maximum diameter opening 96 may include a covering (not shown) across the opening. If a covering is included, the covering may be concave or convex.

[0077] The size of the maximum diameter opening 96 can be designed to position the occluding device 92 at a desired location relative to the pyloric sphincter 20, the pylorus 30, or the gastric antrum 32. If the occluding device 92 is intended to be deployed within the pyloric sphincter 20, the total diameter of the maximum diameter opening 96 can be 1 to 3 cm. If the occluding device 92 is intended to be deployed within the pylorus 30, the total diameter of the maximum diameter opening 96 can be 2 to 8 cm. If the occluding device 92 is intended to be deployed within the gastric antrum 32, the total diameter of the maximum diameter opening 96 can be 4 to 12 cm.

[0078] The structured frame 94 can be woven or braided. In some cases, the structured frame 94 can be a laser cut structure. As shown, the structured frame 94 has a plurality of individual struts 102, which are connected together to provide rigidity to the structured frame 94. The structured frame 94 is suitable for having shape retention so that the structured frame 94 is compressed or otherwise compressed for delivery and then returns to an expanded configuration (as shown). The size of a single strut 102 can be changed to provide specific properties to the structured frame 94. The structured frame 94 can have a cone or funnel shape. The shape of the structured frame 94 can be spherical or hemispherical. In some cases, the structured frame 94 can be formed by two or more different parts fixed together. In some cases, the structured frame 94 can be formed by a laser cut expandable tube. The structured frame 94 can be a multi-fiber braided or woven structure. The structured frame 94 can be formed by discrete wires, which are connected together to form the structured frame 94 by welding, welding or otherwise. For example, the structural frame 94 may be cast from molten metal.

[0079] The occluder 92 includes a covering or coating 104 (shown in a dotted pattern) 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 occluder 92 can include anchors, such as outward spikes, hooks, splines, or tines. The occluder 92 can include a surface treatment that promotes endothelialization.

[0080] Fig.10 is a schematic diagram of an exemplary structural frame 106, which may be considered an example of the structural frame 94. The structural frame 106 includes a plurality of outwardly pointed tines 108 that help secure the structural frame 106 (and an occlusive device including the structural frame 106) in position within the anatomical structure. When used as part of an occlusive device, the structural frame 106 will include a coating or covering, such as Fig. 9 The coating or covering 104 is shown in FIG.

[0081] Fig.11 is a schematic diagram of an exemplary structural frame 110, which may be considered an example of the structural frame 94. The structural frame 110 is an example of a braided structure. When used as part of an occlusive device, the structural frame 106 will include a coating or covering, such as Fig. 9 The coating or covering 104 is shown in FIG.

[0082] Fig.12is a schematic diagram of an exemplary occlusive device 112. The exemplary occlusive device 112 includes a coiled support wire 114 extending from a maximum diameter end 116 to a minimum diameter endpoint 118, which is adapted to be secured to a tether 120. The coiled support wire 114 supports a membrane 122 covering the coiled support wire 114, thereby preventing 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 (e.g., a nickel-titanium alloy).

[0083] Figures 13 to 16 is a schematic diagram of an exemplary occlusive device including a radial support member that supports an occlusive cover. In some cases, the radial support member is incompressible to ensure engagement of the occlusive cover. The support member is adjusted to enable better self-alignment and engagement of the occlusive cover. The occlusive device has an open structure that allows any chyme that leaks from the occlusive cover to pass through the pylorus. The occlusive cover applies an outward radial force to help secure the occlusive device relative to the anatomical structure.

[0084] Fig.13 is a schematic diagram of an exemplary occlusive device 124. The exemplary occlusive device 124 includes a plurality of radial support members 126 extending from a starting point 128 to a distal end 130, wherein the distal end 130 defines a maximum outer diameter of the occlusive device 124. In some cases, as shown, the occlusive device 124 includes an occlusive cover 132 located at the distal end 130.

[0085] The radial support member 126 can be a metal or a polymer. In some cases, the radial support member 126 is a shape memory metal, such as a nickel titanium alloy. The radial support member 126 can be wound or bent to reduce the size for easy delivery. The radial support member 126 can be located within the pylorus 30 and even extend into the duodenum 18 to reduce the trauma that the pyloric sphincter 20 may suffer. Although not shown, the radial support member 126 can be covered with a film or other material to form a cone shape. In some cases, the opening of the cone can also be covered with a film or other material.

[0086] The occluder disk 132 may be made of a polymer, such as silicone, ePTFE, or a fabric or metal mesh. In some cases, the occluder disk 132 may include a support ring 134. The support ring 134, if included, may be a polymer or a metal. In some cases, the support ring 134 may be made of a nickel-titanium alloy. Although not shown, the occluder disk 132 may include outwardly facing prongs, hooks, splines, or tines to help engage tissue and thereby help secure the occluder device 124 in place.

[0087] Fig.141 is a schematic diagram of an exemplary occluder device 136. The exemplary occluder device 136 is similar to the occluder device 124, but includes a support ring 138 located between the start point 128 and the end point 130. Fig.15 1 is a schematic diagram of an exemplary occluder device 140. The exemplary occluder device 136 is similar to the occluder device 124, but includes a first support ring 142 and a second support ring 144.

[0088] Fig.16 1 is a schematic diagram of an exemplary occluder device 146. The exemplary occluder device 146 is similar to the occluder devices 124, 136, and 140, but slightly rearranged. The radial support member 126 extends to an anchor ring 148 formed at the end 130. The anchor ring 148 is adapted to secure the occluder device 146 in position within the anatomical structure. The occluder device 146 includes an occluder disk 150 located intermediate the start point 128 and the end 130.

[0089] Figures 17 to 19 Schematic diagram of an occluding device made of or otherwise including a bellows. The bellows may be formed of any suitable polymer or metal material, and the bellows may be collapsible such that the occluding device including the bellows may be delivered through an endoscope.

[0090] Fig.17 The occluding device 152 is shown in a collapsed configuration, while Fig.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. Fig.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 .

[0091] The corrugations may extend the length of the occluding device 152. In some cases, such as Fig.19 As shown, the corrugation may form only the second end 156, and the membrane filter 158 extends distally from the second end 156. The corrugation may be a corrugated frame of solid material or with a non-traumatic covering. The corrugation may be a tube, one end of which is constrained to form a funnel. The corrugation may be designed as a funnel, wherein the corrugation depth varies along the length of the funnel. The corrugation may be formed by a shape memory metal or polymer. The corrugation may include additional metal or non-metal support. The corrugation may have a thicker portion 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 outward spikes, hooks, splines or tines to help engage tissue and thus help anchor the occluding device 152 in place.

[0092] Figure 20 to Figure 23 is a schematic diagram of an occlusion device including a frame and a membrane. Fig. 20 An occluding device 160 including a frame 162 and a membrane cap 164 is shown. A polymer membrane 166 extends distally from the frame 162 and the membrane cap 164 and extends to a tether 167. The polymer membrane 162 can be, for example, PTFE, ePTFE, or silicone. The frame 162 can be, for example, an expandable tube cut by a laser, or the frame 162 can be a multi-fiber braided structure. The frame 162 can be made of nitinol or stainless steel. In some cases, polymers or other metals can be used to form the frame 162. The frame 162 can include anchoring features, such as outward 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 cone shape.

[0093] Fig.21 An occluding device 168 is shown, which includes 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 made of a polymer material (e.g., ePTFE). The frame 170 is spherical.

[0094] Fig. 22 is a schematic diagram of an occluder device 178 including a frame 180 and a membrane 182. The membrane 182 wraps around the frame 180 and extends distally from suture points 184. The membrane 182 extends to a tether (not shown). Fig.23 The occluding device 160 ( Fig. 20 ) An occlusive device 186 is similar to that of FIG. 1 , but the polymer membrane 166 includes openings 188 that allow any otherwise trapped chyme to flow out.

[0095] Figure 24 to Figure 26 is a schematic diagram of an occlusion device including a rigid feature as part of the occlusion device. The rigid feature can be adjusted so that the rigid feature cannot pass through the bend that is typically present in the proximal duodenum 18a. The proximal duodenum 18a is the portion of the duodenum 18 just distal to the pyloric sphincter 20 and typically includes a bend. Figure 24 to Figure 26 A rigidity feature 190 is shown, which may be incorporated into any of the occlusive devices described herein. Figure 24 to Figure 26 An exemplary gastric bypass device 192 is shown including an occluding device 194 , anastomotic anchor 196 , and a central tether 198 .

[0096] exist Fig.24In the embodiment of the present invention, the rigid feature 190 includes a bumper 200, which in some cases can be considered an extension of the rigid feature 190. In combination with the rigid feature 190, the bumper 200 prevents the occluding device 194 from moving distally because the bumper 200 cannot pass through the bend in the proximal duodenum 18a. Fig.25 In FIG. 1 , the rigid feature 190 includes an expandable bumper 202 that prevents the occluding device 194 from moving proximally and distally. Fig.26 , the rigid feature 190 includes a frame bumper 204. The frame bumper 204 is a rigid, self-expanding frame that prevents the occluding device 194 from moving proximally and distally.

[0097] Figures 27 to 32B Examples of exemplary anastomotic anchors are provided that may be used as anastomotic anchors 38 that are part of a gastric bypass device 34. In some cases, anastomotic structures (e.g., an expandable stent, a pair of magnetic structures, etc.) may be implanted near the anastomosis 26 to help secure the anastomosis 26 together. The anastomotic structure also provides a fixation for the anastomotic anchor.

[0098] Fig. 27 is relative to the anastomotic opening 26 ( Figure 1 ) is a schematic diagram of an exemplary anastomotic anchor 206 fixed thereto. Fig. 27 2, the corresponding anastomotic structure is not shown, but it should be understood that one of the characteristics of the anastomotic anchor 206 is that its diameter is greater than the inner diameter of the lumen of the anastomotic structure. Therefore, advancing the anastomotic anchor 206 proximally through the anastomotic stoma 26 (and through the anastomotic structure) means that once the anastomotic anchor 206 reaches its expanded configuration (as shown in the figure), the anastomotic anchor 206 cannot be pulled through the anastomotic stoma 26 (or the anastomotic structure), thereby fixing the anastomotic anchor 206 relative to the anastomotic stoma 26 (and the anastomotic structure).

[0099] like Fig. 27 As shown, the anastomotic anchor 206 includes a ring 208, the outer dimensions of which are larger than the lumen diameter of the anastomotic opening 26 (or anastomotic structure). Although the ring 208 is shown as a ring, the ring 208 can take 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 (such as The ring 208 may be formed of a composite material formed of several different materials. The ring 208 may be a wire connected to the coupler. The ring 208 may be a laser cut structure. In some cases, the ring 208 may be a woven or braided structure. The ring 208 may include a lubricating and / or corrosion resistant coating or covering.

[0100] 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 in the figure, it should be understood that this is merely exemplary, as the anastomotic anchor 206 may include any number of attachment members 210. In some cases, having at least three attachment members 210 helps stabilize the position of the ring 208 relative to the anastomotic stoma 26 (and the anastomotic structure). The attachment members 210 may be flexible and linear. The attachment members 210 may be rigid. Although not shown, the ring 208 may be attached to the tether 212 by a polymer film extending from the ring 208 to the tether 212.

[0101] Fig.28 is a schematic diagram of an exemplary anastomotic anchor 214, which is shown as being arranged relative to an exemplary anastomotic structure 216. The exemplary anastomotic anchor 214 can be considered as a relative double-loop anchor. The exemplary anastomotic structure 216 includes a first annular portion 218 adapted to be arranged within the stomach 14 and a second annular portion 220 adapted to be arranged within the small intestine 16. In some cases, the second annular portion 220 can be adapted to be arranged within the duodenum 18 or the jejunum 24. The middle portion 222 extends between the first annular portion 218 and the second annular portion 220. It should be understood that the middle portion 222 defines a lumen extending through the anastomotic structure 216. Therefore, the size of the middle portion 222 defines ( Fig. 27 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 woven or braided self-expanding stent available from Boston Scientific. Example of a bracket.

[0102] The anastomotic anchor 214 may include a first ring 224 adapted to be fixed above the first annular portion 218 of the anastomotic structure 216. The anastomotic anchor 214 may include a second ring 226 adapted to be fixed below the second annular portion 220 of the anastomotic structure 216. Herein, terms such as above or below refer only to the direction shown. The anastomotic structure 216 may be deployed in any direction, including, for example, with Fig.28 The orientation shown in is generally the reverse orientation.

[0103] The anastomotic anchor 214 includes one or more members 228 and 230 extending between the first ring 224 and the 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 cases, the tension applied to the connectors 232 and 234 may 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 become smaller, the combined force applied to the anastomotic structure 216 causes the length of the anastomotic structure 216 to decrease and grow radially. As the first annular portion 218 and the second annular portion 220 of the anastomotic structure 216 grow radially, the first annular portion 218 and the second annular portion 220 of the anastomotic structure 216 provide enhanced engagement with tissue, thereby helping to ensure that the device will not be displaced.

[0104] In some cases, one or more members 228 and 230 and / or one or more connectors 232 and 234 may include one or more ropes. One or more members 228 and 230 and / or one or more connectors 232 and 234 may be a braided structure or a 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 and stainless steel may be used, as may polymers such as PTFE and ultra-high molecular weight polyethylene (UHMwPE) fibers, which are known to Connectors 232 and 234 may have a single point of attachment to the tether, or may have multiple points of attachment.

[0105] In some cases, part or all of the anastomotic anchor 214 may be covered, provided that the lumen of the anastomotic anchor 214 remains open so that food and chyme can pass through. A covering may be used to help protect part or all of the anastomotic anchor 214 from the stomach environment. If a covering is included, interaction with chyme or food particles may be reduced. If a covering is included, friction or interaction with the tissues of the stomach environment may be reduced. The covering may be tight fitting or loose fitting and may be PTFE, ePTFE, or other polymers. If a covering is included, a majority of the anastomotic anchor 214 may be encapsulated, or only individual components thereof may be encapsulated.

[0106] Fig.29 is relative to Fig.28 Schematic diagram of an exemplary anastomotic anchor 236 shown in the anastomotic structure 216 described in FIG. As shown, the first annular portion 218 is located near the stomach wall 238, while the second annular portion 220 is located near the small intestine wall 240. It should be understood that although the anastomotic anchor 236 is shown as being adjacent to the braided anastomotic structure 216 (e.g. The anastomotic structure 216 may be a structure that is created surgically (or endoscopically) and held in place with sutures. ...

[0107] The anastomotic anchor 236 is a self-expanding braided structure that includes a first expanded diameter portion 242 that is 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 that is adapted to be secured below the second annular portion 220 of the anastomotic structure 216. The anastomotic anchor 236 also includes a middle portion 246 that extends from the first expanded diameter portion 242 to the second expanded diameter portion 244 and is adapted to be mounted within the middle portion 222 of the anastomotic structure 216. Terms such as above or below refer only to the direction shown. The anastomotic structure 236 can be deployed in any direction, including, for example, with Fig.29 Furthermore, the first expanded diameter portion 242 and the second expanded diameter portion 244 may be considered to be adapted to interact with any anastomotic structure used.

[0108] In some cases, the first expanded diameter portion 242 can be designed to be larger than the first annular portion 218 of the anastomotic structure 216. The first expanded diameter portion 242 can be large enough to directly engage the stomach wall 238, especially when a force is applied to the anastomotic anchor 236 by the tether 248. The anastomotic anchor 236 can be formed of a material that is resistant to the stomach environment. The anastomotic anchor 236 can be formed of 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.

[0109] Fig.30 is relative to Fig.28Schematic diagram of an exemplary anastomotic anchor 250 shown in the anastomotic structure 216 described in . The anastomotic anchor 250 includes an anchoring feature 252, which is adapted to be fixed relative to the first annular portion 218 of the anastomotic structure 216. The anastomotic anchor 250 also includes a penetration portion 254, which is connected to the anchoring feature 252 and is adapted to pass through the middle portion 222 of the anastomotic structure 216. In some cases, the anchoring feature 252 can have one of several different heights so as to be able to avoid various anastomotic structures. In some cases, the anchoring feature 252 can have an annular outer profile. In some cases, the anchoring feature 252 can have one, two, three, four or more legs or pads that extend radially outward from the anchoring feature 252 to engage the stomach wall 238.

[0110] In some cases, the anastomotic anchor 250 is adapted to form a friction fit with the first annular portion 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 penetration portion 254 includes hooks or tines or other structures adapted to engage the jejunal wall 240. In some cases, the penetration portion 254 may include hooks or tines adapted to engage the intermediate portion 222 of the anastomotic structure 216.

[0111] Fig.31A and 31B 2 and 3 are side and top views, respectively, of an illustrative anastomotic anchor 256 shown disposed within an anastomotic structure 216. Fig.31B As shown, the anastomotic anchor 256 is adapted to be mounted within the middle portion 222 of the anastomotic structure 216. In some cases, the anastomotic anchor 256 includes a cylindrical body 258, which optionally includes a plurality of axially extending members 260. In some cases, the cylindrical body 258 includes one or more rings that engage the sides of the anastomotic structure 216. One or more rings can be telescopic, for example, so as to apply an outward force to help prevent the anastomotic structure 216 from being displaced. In some cases, a tether can be attached to the anastomotic anchor 256. In some cases, the tether can be attached to the anastomotic structure 216 instead of or in addition to the anastomotic structure 216.

[0112] Fig.32A and 32B 2 are side and top views, respectively, of an illustrative anastomotic anchor 262 shown positioned within an anastomotic structure 216. Fig.32BAs shown, the anastomotic anchor 262 is suitable for installation in the middle portion 222 of the anastomotic structure 216. In some cases, the anastomotic anchor 262 is a central insert and can be any quadrilateral or more than quadrilateral shape. Examples include, but are not limited to, cross-sectional profiles that define squares, rectangles, and other polygons. The anastomotic anchor 262 can have a circular shape. The anastomotic anchor 262 can be solid, or can have a cutout to allow chyme to flow through. The anastomotic anchor 262 can have arms or leaves extending outward 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 replaced or additionally attached to the anastomotic structure 216.

[0113] Figures 33 to 53D Examples of exemplary tethers that may be used as tether 40 (as part of gastric bypass device 34) are provided. Fig.33 2 is a schematic diagram of an exemplary gastric bypass device 270. Gastric bypass device 270 includes an occluding device 272 and an anastomotic anchor 274. A tether 276 extends between the occluding device 272 and the anastomotic anchor 274. Tether 276 includes a spring 278 adapted to provide an increased return spring in response to elongation of spring 278 when gastric movement causes movement of the occluding device 272 and / or the anastomotic anchor 274. In some cases, when the occluding device 272 and the anastomotic anchor 274 are properly positioned, the spring 278 is under less tension. The spring 278 may be made of any suitable polymer or metal material. In some cases, the spring 278 may be made of, for example, nickel-titanium alloy or stainless steel.

[0114] Spring 278 may take a variety of forms. Fig.34A A spring 278a is shown having varying diameters, with a smallest diameter at a midpoint and larger diameters at either end. Fig.34B A spring 278b is shown having a tapering diameter, from a largest diameter at one end to a smallest diameter at the other end. Fig.34C Spring 278c is shown having a uniform diameter and pitch from one end to the other. Fig.34D A spring 278d is shown having a constant outer diameter but a varying pitch. Fig.34E A spring 278e is shown having a tapering diameter, from a maximum diameter in the middle to a minimum diameter at either end. These are examples only. The spring 280 may be formed from any suitable polymer or metal material. In some cases, the spring 280 may be formed from, for example, a nickel titanium alloy or stainless steel.

[0115] Figures 35A to 35G Other possible designs for spring 278 are shown. Fig.35A In FIG. 2 , spring 280a comprises a single coiled wire. Fig.35B In FIG. 2 , spring 280 b includes linked rings or hoops 282. In FIG. Fig.35CIn, spring 280c includes a sawtooth design. Fig.35D In FIG. 1 , spring 280 d includes a first spring 284 a having a first spring constant and a second spring 284 b having a second spring constant. The first spring 284 a and the second spring 284 b may also have differences in other properties (eg, length and diameter). Fig.35E In the embodiment, the spring 280e may include a rope 286 extending from one end of the spring 280e to the other end of the spring 280e to limit the distance that the spring 280e can extend. Fig.35F In the embodiment, the spring 280f can be tightly mounted on the inner tube 288 to prevent interaction with food and chyme. Figure 35G In the embodiment, spring 280g can include a hard tube 290 that extends into the occluding device cone 292 to obtain a longer spring length in a relatively short device. Spring 280 can be formed of any suitable polymer or metal material. In some cases, spring 280 can be formed of, for example, nickel titanium alloy or stainless steel.

[0116] In some cases, the spring may include a covering or coating. The covering or coating may reduce friction or other interactions with tissues within the gastric system. The covering or coating may reduce interaction of the spring with chyme and food, thereby avoiding possible blockages. The covering or coating may act as a barrier to the harsh gastric environment. The covering or coating may reduce damage or inflammation at the bile duct and / or papilla. In some cases, the covering or coating may be ePTFE, PTFE, or other polymers. Fig.36A Spring 294a is shown with a cover 296 that encapsulates spring 294a and expands and contracts with spring 294a. FIG. 36b shows spring 294b with a cover 298 that allows spring 294b to move independently of cover 298. Fig.36C A spring 294c is shown having a covering 300 that conforms to the filaments 302 that form the spring 294c. Fig.36D Shown is a spring 294d having a covering layer 304 that continues from a material 306 that forms at least a portion of the occluding device. The spring 294 can be formed of any suitable polymer or metallic material. In some cases, the spring 294 can be formed of, for example, a nickel-titanium alloy or stainless steel.

[0117] Fig.37A tether 308 is shown positioned within the duodenum 18, extending between an occlusion device 310 and an anastomotic anchor 312, which is shown disposed within the anastomotic stoma 26. The tether 308 includes an inner tether 314 disposed within an antiseptic and impermeable sleeve 316 that encases the inner tether 314. The sleeve 316 protects the inner tether 314 from the gastric environment, while the inner tether 314 provides tension. The sleeve 316 seals to the inner tether 314 at a first sealing point 318 and a second sealing point 320. Between the first sealing point 318 and the second sealing point 320, the inner tether 314 is protected from the gastric environment by the sleeve 316. Although the first sealing point 318 is shown as the distal end of the occlusion device 310 and the second sealing point 318 is shown as the proximal end of the anastomotic anchor 312, in some cases, the sleeve 316 may extend the entire length of the inner tether 314.

[0118] In some cases, placing the inner tether 314 within the sleeve 316 provides the advantage of being able to separate 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.

[0119] Fig.38A and 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 cause the spring 328 to compress, as shown in FIG. Fig.38B 326 . This provides a hard limit to the distance of travel between the occluding device 324 and the anastomotic anchor 326, because the spring 328 can only be compressed to a certain extent. The spring 328 can be formed of any suitable polymer 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.

[0120] Fig.39A tether 338 is shown, which includes an elastic polymer tube 340 and a covering 342 covering the elastic polymer tube 340. When the elastic polymer tube 340 attempts to return to its original or biased configuration, the elongation of the tether 338 due to gastric movement will cause the elastic polymer tube 340 to apply tension. The hardness of the polymer used to form the elastic polymer tube 340 can be changed to adjust its memory. The elastic polymer tube 340 can use a variety of polymers. For example, the elastic polymer tube 340 can be formed of latex. The elastic polymer tube 340 can be a single polymer tube. In some cases, the elastic polymer tube 340 can be a plurality of elastic polymer strands. The covering 342 can help act as a barrier to the corrosive gastric environment. The covering 342 can reduce interaction with chyme and food particles, and can reduce friction or other interactions with tissues within the gastric system. The covering 342 can reduce damage or inflammation at the bile duct and / or papilla. In some cases, the covering 342 can be made of silicone. In some cases, the covering 342 can be PTFE or ePTFE.

[0121] In some cases, a spring (e.g., 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 original biased configuration. Fig.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 round beam, or can have multiple stacked beams. The leaf spring 344 can be formed from any suitable metal or polymer material.

[0122] The tether 348 extends from the leaf spring 344, through the occluder device 346, and extends distally therefrom. Although the leaf spring 344 is shown as being attached to the occluder device 346, a similar result can be achieved by securing the leaf spring 344 to the anastomotic anchor. Fig.40A , the tether 348 is not subjected to any tension and the leaf spring 344 remains in a linear configuration, representing the original biased configuration of the leaf spring 344. Fig.40B In the embodiment of the present invention, the tether 348 is subjected to tension, as shown by arrow 350. It can be seen that the leaf spring 344 has been bent out of its original biased configuration. Therefore, the leaf spring 344 will try to return to its original configuration, thereby preventing the movement of the anastomotic anchor.

[0123] In some cases, a helical torsion spring may be used at one end of the tether in place of the leaf spring 344. The helical torsion spring may be fixed between the occluding device 346 and the tether 348. In some cases, the helical torsion spring may be fixed between the anastomotic anchor and the tether 348. The tether 348 provides tension to the helical torsion spring due to the movement of the occluding device 346 and / or the anastomotic anchor caused by gastric movement, so that the helical torsion spring will be out of its original biased configuration. Therefore, when the helical torsion spring attempts to return to its original biased configuration, the helical torsion spring will exert a force on the tether 348.

[0124] Fig.41 354 and anastomotic anchor 356. In some cases, the tether 352 can be formed as a braided stent. The tether 352 can act as a spring to provide a restoring force in response to the elongation of the tether 352 due to gastric movement. The tether 352 can be formed of any suitable metal or polymer material. The material, size, spacing, etc. of the tether 352 can be varied to provide the desired restoring force behavior. As an example, the tether 352 can be designed to provide a linear increase in restoring force as the device is elongated. For example, the tether 352 can be designed to provide an increase in restoring force as the device is elongated.

[0125] In some cases, tether 352 may include a coating or covering to help protect tether 353 from the stomach environment. If a coating or covering is included, the coating or covering may reduce interaction with chyme and food particles, may reduce friction and interaction with stomach tissue, and may reduce damage or inflammation of the bile duct and / or papilla. If a coating or covering is included, the coating or covering may be any suitable material, such as, but not limited to, PTFE and ePTFE.

[0126] Fig.42 360 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 restoring force in response to a pulling force 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: 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 operating fluid. Fig.43 An example of a negative cylinder 360a is shown, while Fig.44 An example of a positive cylinder 360b is shown.

[0127] Fig.45370. The tether 366 includes a protective sleeve 372, a spring 374, and a sliding joint 376, which allows the spring 374 to extend within the protective sleeve 372, but is independent 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 and move into and out of the sliding joint 376. In some cases, there may be a nickel titanium alloy wire in the PTFE tube 375 to prevent kinking. There may also be a suture in the PTFE tube 375, which is attached to the spring 374 and the anastomotic anchor 370 and fixes the spring 374 in place. The suture can be formed of UHMWPE (ultra-high molecular weight polyethylene). Although the spring 374 is located near the occlusion device 368 in the figure, the spring 374 can also be located near the anastomotic anchor 370. The sliding joint 376 has low friction, thereby allowing movement with less applied force, while fitting tightly to minimize the possibility of chyme entering the protective sleeve 372. In some cases, the sliding joint 376 can be a small tube within a larger tube. The sliding joint 376 can be a small tube passing through a soft membrane. The sliding joint 370 can be one or more threads within the tube. The threads can be polymers or metals. 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 of a flexible, durable, and corrosion-resistant polymer (e.g., ePTFE).

[0128] Fig.46 380 is a schematic diagram of an exemplary tether 378 including a clamp 380. In some cases, the clamp 380 is a one-way clamp adapted to allow the tether 378 to be pulled through 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 clamp 380 to shorten the tether 378. In some cases, the clamp 380 can include teeth or barbs that allow the tether 378 to travel in one direction but not in the opposite direction. The clamp 380 can use friction to control travel. In some cases, the clamp 380 can cooperate with an interlocking feature on the tether 378 to control travel. The clamp 380 can be located near the occlusion device, near the anastomotic anchor, or anywhere in between. The clamp 380 allows the physician to adjust the length of the tether in vivo to accommodate the anatomy of a particular patient. In some cases, the clamp 380 can be adjusted on a workbench prior to implantation to adjust the effective length of the tether 378.

[0129] Fig.47386. The tether 382 includes a threaded connector 388 located between a threaded member 390 and a spring 392 threadedly engaged with the threaded member 390. In some cases, the threaded connector 388 can be adjusted on a workbench prior to implantation to adjust the effective length of the tether 382. In some cases, the threaded connector 388 can be adjusted in vivo using an endoscopic tool. The tether 382 can be made of any suitable material. The threaded connector 388 can be located near the occlusion device 384, near the anastomotic anchor 386, or anywhere therebetween.

[0130] Fig.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 are fluidly connected to the duodenum 18. The papilla of Vater 398 is located on the inner curve of the duodenum 18 and may partially protrude into the interior of the duodenum 18 in some cases. A possible 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 lead to a variety of possible complications. In some cases, it is desirable to provide a tether that avoids irritating the papilla 398.

[0131] Fig.49 4 is a schematic diagram of an exemplary tether 400 extending through the duodenum 18 between an occlusion device 402 and an anastomotic anchor 404. As shown, the tether 400 includes a first spring segment 406 located proximal to the papilla 398 of Vater and a second spring segment 408 located distal to the papilla 398 of Vater. The tether 400 includes a member 410 extending between the first spring segment 406 and the second spring segment 408 and over the papilla 398 of Vater. Because the first spring segment 406 and the second spring segment 408 have larger diameters relative to the member 410 (although not necessarily the same as each other), the member 410 is retained on the inner surface of the duodenum 18 away from the papilla 398 of Vater.

[0132] Fig.50A , 50B and 50C provide additional examples. Fig.50AIn the embodiment of the present invention, the tether 412a includes a first spring segment 414 and a second spring segment 416, but does not include any metal structure therebetween. Instead, the tether 412a includes an atraumatic covering 418 that encapsulates the first spring segment 414 and the second spring segment 416. The atraumatic covering 418 is narrowed between the first spring segment 414 and the second spring segment 416 by a pair of sutures 420 that secure the atraumatic covering 418 to the ends of the first spring segment 414 and the ends of the second spring segment 416. Therefore, no metal objects can approach the mastoid process 398 of Vater.

[0133] Fig.50B A tether 412b is shown that is similar to tether 400, but includes an atraumatic covering 422 that encloses 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 secured in place by atraumatic covering 422. Thus, no metal objects are placed close to Vater's mastoid 398. Fig.50C A tether 412c is shown that includes a spring 426 disposed within an atraumatic covering 428. The spring 426 has a varying diameter, with a maximum diameter at either end of the spring 426 and tapers to a minimum diameter near the midpoint of the spring 426.

[0134] Fig.51 A tether 430 is shown that includes a physical spacer 432 located above the tether 430, wherein the tether 430 extends through the physical spacer 432. In some cases, the physical spacer 432 is able to slide relative to the tether 430. In some cases, the physical spacer 432 is a braided structure formed of a metal (e.g., a nickel-titanium alloy). In some cases, the physical spacer 432 can be expandable, such as an expandable balloon. As shown, the physical spacer 432 includes a first bulbous region 434 and a second bulbous region 436, wherein a narrowed diameter portion 438 extends between the first bulbous region 434 and the second bulbous region 436. In some cases, the physical spacer 432 may also include additional bulbous regions.

[0135] Fig.52A tether 440 is shown that includes a physical spacer 442 that forms part of the tether 440. The tether 440 includes a first spring segment 444 and a second spring segment 446, wherein the physical spacer 442 is disposed between the first spring segment 444 and the second spring segment 446. The physical spacer 442 can be, for example, welded or sewn or bonded to each of the first spring segment 444 and the second spring segment 446. The physical spacer 442 can include a first bulbous region 444 and a second bulbous region 446, wherein a rigid member 448 extends between the first bulbous region 444 and the second bulbous region 446.

[0136] Fig.53A 450. The exemplary tether 450 includes a first spring segment 452 and a second spring segment 454. The tether 450 includes an arcuate segment 456 extending between the first spring segment 452 and the second spring segment 454. Fig.53B A first view of the arcuate segment 456 is shown, and Fig.53C A second view of the arcuate segment 456 is shown. The tension on the tether 450 will cause the arcuate segment 456 to rotate perpendicular to the mastoid process 398 of Vater, as shown in FIG. Fig.53D shown.

[0137] In some cases, a dynamic tether may be used as part of a gastric bypass device. Figure 54 to Figure 59 An example of an exemplary dynamic tether that may be used as a dynamic tether 42 as part of a gastric bypass device 34 is provided.

[0138] Fig.54 4 is a schematic diagram of an exemplary dynamic tether 458 displayed within an anatomical structure. The dynamic tether 458 extends between an occluding device 460 located near the pyloric sphincter 20 and an anastomotic anchor 462 located near the anastomosis 26. As shown, the dynamic tether 458 is fixed to an annular ring 464, which forms a part of the occluding device 460. The tether 466 also extends between the occluding device 460 and the anastomotic anchor 462 through the duodenum 18. It can be understood that the tether 466 and the dynamic tether 458 can work together to help fix the occluding device 460 in place, regardless of how the gastric movement attempts to move the occluding device 460 out. If the gastric movement attempts to move the occluding device 460 proximally into the stomach 14, the tether 466 will provide resistance. If the gastric movement attempts to move the occluding device 460 distally into the duodenum 18, the dynamic tether 458 will provide resistance to the movement.

[0139] Fig.554 is a schematic diagram of an exemplary dynamic tether 468 shown within an anatomical structure. The dynamic tether 468 includes a spring 470. The tether 472 includes a spring 474. In some cases, the spring 470 has a first spring constant and the spring 474 has a second spring constant. In some cases, the spring 470 and the spring 474 can be selected in combination to ensure that the two springs 470 and 474 together provide a dynamic balancing force to maintain the desired position of the occluding device 460.

[0140] Fig.56 is a schematic diagram of an exemplary dynamic tether 476 shown in anatomy. The dynamic tether 476 extends between an occluder device 478 located near the pyloric sphincter 20 and an anastomotic anchor 480 located near the anastomosis 26. As shown, the dynamic tether 476 is secured to a cover 482 that forms part of the occluder device 478. In some cases, a central attachment point (e.g., cover 482) allows the occluder device 478 to lie flat, while attachment to the sides of the occluder device 478 allows the occluder device 478 to be tilted or pivoted into position.

[0141] The tether 484 also extends through the duodenum 18 between the occlusion device 478 and the anastomotic anchor 480. It will be appreciated that the tether 484 and the dynamic tether 476 can work together to help secure the occlusion device 478 in place, regardless of how the stomach movement attempts to move the occlusion device 478 out. If the stomach movement attempts to move the occlusion device 478 proximally into the stomach 14, the tether 484 will provide resistance to the movement. If the stomach movement attempts to move the occlusion device 478 distally into the duodenum 18, the dynamic tether 476 will provide resistance to the movement. In some cases, the dynamic tether 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 the spring 488 can be selected in combination to ensure that the two springs 486 and 488 together provide a dynamic balancing force to maintain the desired position of the occlusion device 478.

[0142] Fig.57 is a schematic diagram of an exemplary dynamic tether 490 shown in the anatomy. The dynamic tether 490 extends between an occluding device 478 located near the pyloric sphincter 20 and an attachment point 492 within the stomach wall 494. As shown, the dynamic tether 476 is secured to a cover 482 that forms part of the occluding device 478. In some cases, a central attachment point (e.g., an attachment point on the cover 482) can allow the occluding device 478 to lie flat, while attachments to the sides of the occluding device 478 can allow the occluding device 478 to tilt or pivot in situ.

[0143] The tether 484 extends through the duodenum 18 between the occlusion device 478 and the anastomotic anchor 480. It will be appreciated that the tether 484 and the dynamic tether 490 can work in concert to help secure the occlusion device 478 in place, regardless of how gastric movement attempts to dislodge the occlusion device 478. If gastric movement attempts to move the occlusion device 478 proximally into the stomach 14, the tether 484 will provide resistance to that movement. If gastric movement attempts to move the occlusion device 478 distally into the duodenum 18, the dynamic tether 490 will provide resistance to that movement. In some cases, the dynamic tether 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 the spring 488 can be selected as a combination to ensure that the two springs 496 and 488 together provide a dynamic balancing force to maintain the desired position of the occlusion device 478.

[0144] Fig.58 4 is a schematic diagram of an exemplary dynamic tether 498 shown in an anatomical structure. The dynamic tether 498 extends between the occlusion device 478 located near the pyloric sphincter 20 and the anti-displacement anchor 500 located near the anastomosis 26. The anti-displacement anchor 500 is an anchor that can be attached to the stomach 14 so that tension can be applied to the anchor in either direction without the anti-displacement anchor moving. In some cases, the dynamic tether 498 can be connected to the anti-displacement anchor 500 so that the tension from the dynamic tether 498 can cause the diameter and / or shape of the anti-displacement anchor 500 to change. For example, the diameter of the anti-displacement anchor 500 can be increased and the length can be reduced to provide additional outward radial force and prevent slipping through the anastomosis 16. As shown, the dynamic tether 498 is fixed to a cover 482 that forms a part of the occlusion device 478. In some cases, a central attachment point (such as a central attachment point on the cover 482) may allow the occluder 478 to lie flat, while attachments to the sides of the occluder 478 may allow the occluder 478 to tilt or pivot in place.

[0145] The tether 484 extends through the duodenum 18 between the occlusion device 478 and the anti-displacement anchor 500. It will be appreciated that the tether 484 and the dynamic tether 498 can work together to help secure the occlusion device 478 in place, regardless of how gastric movement attempts to dislodge the occlusion device 478. If gastric movement attempts to move the occlusion device 478 proximally into the stomach 14, the tether 484 will provide resistance to the movement. If gastric movement attempts to move the occlusion device 478 distally into the duodenum 18, the dynamic tether 498 will provide resistance to the movement. In some cases, the dynamic tether 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 balancing force to maintain the desired position of the occlusion device 478.

[0146] Fig.59 is a schematic diagram of an exemplary dynamic tether 498 shown in anatomy. The dynamic tether 498 extends between the occlusion device 478 located near the pyloric sphincter 20 and a pair of magnetic rings 506 located near the anastomosis 26. The tether 484 extends between the occlusion device 478 and the magnetic rings 506 through the duodenum 18. It will be appreciated that the tether 484 and the dynamic tether 498 can work together to help secure the occlusion device 478 in place regardless of gastric movement attempting to dislodge the occlusion device 478. If gastric movement attempts to move the occlusion device 478 proximally into the stomach 14, the tether 484 will provide resistance to that movement. If gastric movement attempts to move the occlusion device 478 distally into the duodenum 18, the dynamic tether 476 will provide resistance to that movement.

[0147] Fig.60 is a schematic diagram showing a passive engagement device 504 located near the pyloric sphincter 20. The passive engagement device 504 includes a first gastric clamp 506, which can be fixed on a first side 508 of the pyloric sphincter 20, the pylorus 30, or the gastric antrum 32; and a second gastric clamp 510, which can be fixed on a second side 512 of the pyloric sphincter 20, the pylorus 30, or the gastric antrum 32. A first elastic band 514 extends between the first gastric clamp 506 and the second gastric clamp 510. A second elastic band 516 extends between the first gastric clamp 506 and the second gastric clamp 510. The first elastic band 514 and the second elastic band 516 together help prevent the occlusion device 518 from moving distally. When the pyloric sphincter 20 is dilated, the first elastic band 514 and the second elastic band 516 will engage with the occlusion device 518 and prevent the occlusion device 518 from moving distally. When the pyloric sphincter 20 is not dilated or relaxed, the first elastic band 514 and the second elastic band 516 are not in contact with the occluding device 518 .

[0148] Fig.61is a schematic diagram showing a passive engagement device 520 located near the pyloric sphincter 20. The passive engagement device 520 includes: a first gastric clip 506, which can be fixed on a first side 508 of the pyloric sphincter 20, the pylorus 30, or the gastric antrum 32; and a second gastric clip 510, which can be fixed on a second side 512 of the pyloric sphincter 20, the pylorus 30, or the gastric antrum 32. A first hook or buffer 522 is attached to the first gastric clip 506, and a second hook or buffer 524 is attached to the second gastric clip 510. The first hook or buffer 522 and the second hook or buffer 524 together help prevent the occlusion device 518 from moving distally. When the pyloric sphincter 20 is expanded and the occlusion device 518 moves distally, the first hook or buffer 522 and the second hook or buffer 524 will engage with the occlusion device 518 and prevent the occlusion device 518 from moving distally. When the pyloric sphincter 20 is not dilated or relaxed, the first hook or bumper 522 and the second hook or bumper 524 are not in contact with the occluding device 518 .

[0149] Fig.62 is a schematic diagram of an exemplary device 530 that integrates the creation of anastomosis and delivery of a gastric bypass system into a single step. The exemplary device 530 includes an electrocautery tip 532 for creating an anastomosis 534 and a collapsed anastomotic anchor 536 that is deployed after the anastomosis 534 is created using the electrocautery tip 532. Once the anastomosis 534 is created, the remainder of the gastric bypass device 538 can be delivered (duodenum 18 to pyloric sphincter 20) by a pullback process. A sleeve (not shown) can maintain the anastomotic anchor 536 in a collapsed configuration before the sleeve is removed. For example, the gastric bypass device 538 may be delivered as shown in FIG. Fig.63 shown.

[0150] Materials that can be used for the various components of the medical device systems described herein and their various elements may include materials commonly associated with medical devices. In some embodiments, the medical device systems described herein may be made of metals, metal alloys, polymers (some examples 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 nickel-titanium alloys; other nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., UNS 625: N06625, for example UNS: N06022, for example UNS:N10276, others alloys, etc.), nickel-copper alloys (such as UNS: N04400, 400, 400, 400, etc.), nickel-cobalt-chromium-molybdenum alloys (such as UNS: R44035, such as etc.), nickel-molybdenum alloys (e.g. UNS: N10665, e.g. ), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g. UNS: R44003, such as etc.); platinum-rich stainless steel; titanium; combinations thereof, etc.; or any other suitable material.

[0151] As described herein, within the commercially available nickel-titanium alloy or families of nickel-titanium alloys, there is a class referred to as "linear elastic" or "non-superelastic" that, although their chemical properties may be similar to those of conventional shape memory and superelastic varieties, may exhibit unique and useful mechanical properties. Linear elastic and / or non-superelastic nickel-titanium alloys are distinguished from superelastic nickel-titanium alloys in that linear elastic and / or non-superelastic nickel-titanium alloys do not exhibit a distinct "superelastic plateau" or "flag region" in their stress / strain curves as do superelastic nickel-titanium alloys. Instead, in linear elastic and / or non-superelastic nickel-titanium alloys, as recoverable strain increases, stress continues to increase in a substantially linear or slightly linear, but not necessarily completely linear, relationship until plastic deformation begins, or at least increases in a more linear relationship than the superelastic plateau and / or flag region that may occur in superelastic nickel-titanium alloys. 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.

[0152] In some cases, linear elastic and / or non-superelastic Nitinol can also be distinguished from superelastic Nitinol, as 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 (also based on their composition) from other linear elastic materials, such as stainless steel, which can only accept strains of about 0.2% to 0.44% before plastic deformation.

[0153] In some embodiments, a linear elastic and / or non-superelastic nickel-titanium alloy is an alloy that does not show 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, in a linear elastic and / or non-superelastic nickel-titanium alloy, DSC and DMTA analysis may not detect a martensite / austenite phase transformation over a range of about -60 degrees Celsius (°C) to about 120°C. Therefore, the mechanical bending properties of such a material are generally unaffected by temperature over this very wide temperature range. In some embodiments, the mechanical bending properties of a linear elastic and / or non-superelastic nickel-titanium alloy at ambient or room temperature are substantially the same as the mechanical properties at body temperature, for example, because they do not show a superelastic plateau and / or signature region. In other words, over a wide temperature range, a linear elastic and / or non-superelastic nickel-titanium alloy maintains its linear elastic and / or non-superelastic properties and / or performance.

[0154] In some embodiments, the nickel content of the linear elastic and / or non-superelastic nickel-titanium alloy may be in the range of about 50 to about 60 weight percent, with the remainder being essentially titanium. In some embodiments, the composition is in the range of about 54 to about 57 weight percent. An example of a suitable nickel-titanium alloy is FHP-NT alloy, available from Furukawa Techno Material Co., Kanagawa, Japan. Other suitable materials may include ULTANIUM TM (available from Neo-Metrics) and GUMMETAL TM (Available from Toyota.) In some other embodiments, superelastic alloys (eg, superelastic Nitinol) may be used to achieve the desired properties.

[0155] In at least some embodiments, part or all of the medical device systems described herein may also be doped, made of, or otherwise include radiopaque materials. Radiopaque materials are understood to be materials that are capable of producing a relatively bright image on a fluorescent screen or another imaging technique during a medical procedure. 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, polymer materials filled 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.

[0156] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to the medical device systems described herein. The medical devices described herein can be made of materials that do not significantly distort the image and produce a large number of 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 others.

[0157] 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, e.g., available from DuPont ), polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., available from DSMEngineeringPlastics ), ether or ester based copolymers (e.g., butene / poly(alkylene ether) phthalates and / or other polyester elastomers, such as those available from DuPont ), polyamides (e.g., available from Bayer or available from ElfAtochem ), elastic polyamides, block polyamide / ether, polyether block amide (PEBA, for example, available under the trade name obtained), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low-density polyethylene (e.g. ), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyethylene terephthalamide (e.g. ), polysulfone, nylon, nylon-12 (e.g. available from EMS American Grilon ), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS50A), polycarbonate, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites thereof, etc. In some embodiments, the sheath can be mixed with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6% LCP.

[0158] In some embodiments, medical device systems as described herein and / or other elements disclosed herein may include a fabric material arranged above or within the structure. The fabric material may be composed of a biocompatible material (e.g., polymeric material or biomaterial) suitable for promoting growth in the tissue. 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 mixtures or combinations thereof.

[0159] It should be understood that the present disclosure is in many respects merely exemplary. Details may be changed, particularly in shape, size, and arrangement of steps, without exceeding the scope of the present disclosure. This may include, within appropriate limits, using any feature of an example embodiment for other embodiments. Of course, the scope of the present disclosure is defined by the expressive language of the appended claims.

Claims

1. An implantable medical device system, comprising: an occluding device adapted to be fixed in position relative to the patient's pylorus; an anastomotic anchor adapted to be secured in place relative to a stoma formed between a stomach wall of the patient and a small intestine of the patient; a tether adapted to extend through the duodenum of the patient, the tether being secured at a first end to the occlusion device and at a second end to the anastomotic anchor, the tether being further adapted to provide tension to the occlusion device; as well as A dynamic tether is adapted to extend through the patient's stomach, the dynamic tether being further adapted to provide a tension to the occluding device opposite to the tension provided by the tether.

2. The implantable medical device system of claim 1, wherein the tether comprises a first spring having a first spring constant and the dynamic cord comprises a second spring having a second spring constant.

3. An implantable medical device system according to claim 2, wherein the first spring is adapted to resist movements of the gastrointestinal system that may cause the occlusion device to move into the patient's stomach, and / or the second spring is adapted to resist movements of the gastrointestinal system that may cause the occlusion device to move into the patient's duodenum.

4. The implantable medical device system according to any one of claims 1 to 3, wherein the dynamic tether is adapted to be secured to the occlusive device at one end and to the anastomotic anchor at another end.

5. The implantable medical device system of any one of claims 1 to 4, wherein the occlusive device comprises a support frame and a water-impermeable membrane spanning the support frame.

6. The implantable medical device system according to any one of claims 1 to 5, wherein the dynamic tether is adapted to be secured at one end to the support frame of the occlusive device.

7. The implantable medical device system according to any one of claims 1 to 5, wherein the dynamic tether is adapted to be fixed at one end to a water-impermeable membrane of the occlusive device.

8. The implantable medical device system according to any one of claims 1 to 5, wherein the dynamic tether is adapted to be fixed to the occlusive device at one end and to the stomach wall of the patient at the other end.

9. The implantable medical device system of any one of claims 1 to 5, wherein the dynamic tether is adapted to be secured to the occlusive device at one end and to an anti-displacement anchor at another end.

10. A dynamic tether for use in a gastric bypass system, the gastric bypass system comprising an occluding device and a tether secured to the occluding device, the dynamic tether being adapted to extend within a patient's stomach between the occluding device adapted to be deployed relative to the patient's pylorus and a securing point, the dynamic tether comprising: a resilient member having a first end adapted to be secured relative to the occluding device and a second end adapted to be secured to a securing point; Wherein the resilient member dynamically resists the force exerted on the occlusive device by the tether.

11. The dynamic rope of claim 10, wherein the fixation point comprises an anastomotic anchor.

12. The dynamic rope of claim 10, wherein the fixation point comprises a stomach wall of the patient.

13. The dynamic rope according to any one of claims 10 to 12, wherein the elastic member comprises a spring.

14. An apparatus for creating a stoma and delivering a gastric bypass system in a single step, the apparatus comprising: an electrocautery tip, which is suitable for establishing an anastomosis; as well as a device segment adapted to releasably retain the anastomotic anchor in a collapsed configuration; The device segment is adapted to deploy the anastomotic anchor within the anastomosis, the anastomotic anchor expanding to an expanded configuration after deployment.

15. The device of claim 14, wherein the gastric bypass device is deliverable via a pull-back procedure.

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