Dynamic anchoring of small intestine liner

Abstract

A gastric bypass device includes an occlusion device adapted to be deployed relative to a pyloric sphincter of a patient and a liner extending distally from the occlusion device. A tether extends from the occlusion device. The dynamic traction cord may be fixed relative to the occlusion device and may interact with the tether to assist in holding the occlusion device in place.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims the benefit of priority of U.S. Provisional Application No. 63 / 420,049, filed Oct. 27, 2022, the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] The present disclosure relates to medical devices such as gastric bypass devices. More specifically, the present disclosure relates to gastric bypass devices that include a small intestine lining. Background Art

[0004] A variety of in vivo medical devices have been developed for medical use, such as surgical and / or endovascular use. Some of these devices include guidewires, catheters, medical device delivery systems (e.g., for stents, grafts, replacement valves, etc.). These devices are manufactured by any of a variety of different manufacturing methods and can be used by any of a variety of methods. There remains a need to provide alternative medical devices and alternative methods of manufacturing and / or using medical devices. Summary of the Invention

[0005] The present disclosure relates to medical devices such as gastric bypass devices, and more particularly to gastric bypass devices that include a small intestine lining. An example can be found in an implantable medical device. The implantable medical device includes an occlusion device that is adapted to be disposed within a patient's stomach relative to the patient's pylorus to prevent gastric contents from flowing past the occlusion device, the occlusion device including a distal outflow end. A lining extends distally from the occlusion device, the lining defining a lumen extending through the lining, the lining having a proximal end fluidly coupled to the distal outflow end and a distal end adapted to be disposed within the patient's jejunum such that gastric contents entering the occlusion device flow through the lining and out through the distal end. A tether is fixed relative to the occlusion device and is adapted to restrict proximal movement of the occlusion device.

[0006] Alternatively or additionally, the tether can be adapted to extend within the lumen of the lining.

[0007] Alternatively or additionally, the tether can be adapted to extend outside of the lining.

[0008] Alternatively or additionally, the tether can include a proximal end and a distal end, the tether being fixable relative to the occlusion device by the proximal end and fixable to an anchor by the distal end.

[0009] Alternatively or additionally, the anchor can be adapted to be fixed in place relative to the patient's small intestine or stomach wall.

[0010] Alternatively or additionally, the anchor can be adapted to pierce the tissue of the patient's small intestine or stomach wall.

[0011] Alternatively or additionally, the anchor may include a self-expanding element adapted to be disposed within the small intestine of a patient.

[0012] Alternatively or additionally, the tether may further include an elongate friction anchor adapted to extend within the small intestine of a patient.

[0013] Alternatively or additionally, the implantable medical device may further include a dynamic drawstring extending from the occluding device to an anchoring site within the patient's stomach.

[0014] Alternatively or additionally, the occluding device may be adapted to extend into the antrum of the patient's stomach.

[0015] Alternatively or additionally, the lining may include a polymeric tube.

[0016] Another example can be found in a gastric bypass device. The gastric bypass device includes a funnel device adapted to be disposed within the patient's stomach relative to the pylorus of the patient to direct gastric contents through the funnel device. A tubular extension is fluidly coupled to the funnel device and extends distally therefrom, the tubular extension being adapted to extend through an upper portion of the patient's small intestine to prevent gastric contents flowing through the funnel device and the tubular extension from contacting the upper portion of the patient's small intestine. A tether is fixed relative to the funnel device and is adapted to restrict proximal movement of the funnel device.

[0017] Alternatively or additionally, the tether may be adapted to extend within the tubular extension.

[0018] Alternatively or additionally, the tether may be adapted to extend outside of the tubular extension.

[0019] Alternatively or additionally, the tether may include a proximal end and a distal end, the tether being fixable relative to the funnel device by the proximal end and fixable to an anchor by the distal end.

[0020] Alternatively or additionally, the gastric bypass device may further include an anchor.

[0021] Alternatively or additionally, the anchor may include a self-expanding element adapted to be disposed within the small intestine of a patient.

[0022] Alternatively or additionally, the tether may further include an elongate friction anchor adapted to extend within the small intestine of a patient.

[0023] Alternatively or additionally, the gastric bypass device may further include a dynamic drawstring extending from the funnel device to an anchoring site within the patient's stomach.

[0024] Another example can be found in a gastric bypass device. The gastric bypass device includes a funnel device that is adapted to be disposed within a patient's stomach relative to the patient's pylorus to direct gastric contents to flow through the funnel device. A tubular extension is fluidly coupled to the funnel device and extends distally from the funnel device, and the tubular extension is adapted to extend through an upper portion of the patient's small intestine to prevent the gastric contents flowing through the funnel device and the tubular extension from contacting the upper portion of the patient's small intestine. A tether is fixed relative to the funnel device and is adapted to restrict proximal movement of the funnel device. A dynamic drawstring extends from the funnel device opposite the tether.

[0025] The foregoing summary of some embodiments, aspects, and / or examples is not intended to describe every embodiment or every implementation of the present disclosure. The following figures and detailed description more particularly illustrate such embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The present disclosure may be more fully understood in connection with the following detailed description of various embodiments, in which:

[0027] Figure 1 is a schematic view of a portion of a human gastrointestinal (GI) system;

[0028] Figure 2 is disposed within Figure 1 the GI system shown is a schematic view of an exemplary gastric bypass system;

[0029] Figures 3 to 8 is an exemplary occlusion device that can be used for Figure 2 the exemplary gastric bypass system is a schematic view;

[0030] Figures 9A to 9D is an exemplary tether that can be used for Figure 2 the exemplary gastric bypass system is a schematic view;

[0031] Figure 10 is a schematic view of a portion of a human gastrointestinal (GI) system;

[0032] Figures 11A to 11C 、 Figures 12 to 13 and Figures 14A to 14D is an exemplary tether that can be used for Figure 2 the exemplary gastric bypass system to protect the Vater papilla is a schematic view;

[0033] Figure 15 is disposed within Figure 1 the GI system shown is a schematic view of an exemplary gastric bypass system;

[0034] Figure 16 is disposed within Figure 1 the GI system shown is a schematic view of an exemplary gastric bypass system; and

[0035] Figure 17 is disposed within Figure 1 the GI system shown in the exemplary gastric bypass system schematic diagram.

[0036] Although various aspects of the present disclosure may be subject to various modifications and alternative forms, specific details thereof have been shown by way of example in the drawings and will be described in detail. However, it should be understood that the purpose is not to limit various aspects of the present disclosure to the specific embodiments described. On the contrary, the purpose is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.. Detailed Description

[0037] The following description should be read in conjunction with the drawings, which are not necessarily to scale, in which like reference numerals represent like elements in several views. The detailed description and the drawings are intended to illustrate rather than 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 drawings illustrate example embodiments of the claimed invention.

[0038] For the terms defined below, unless a different definition is given in the claims or elsewhere in this specification, these definitions shall apply.

[0039] All numerical values herein are assumed to be modified by the term "about" whether or not explicitly indicated. In the context of numerical values, the term "about" generally refers to a series of numbers that a person skilled in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the term "about" may include numbers rounded to the nearest significant digit. 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 the context of the specification and consistent therewith, unless otherwise specified.

[0040] A numerical range defined by endpoints includes all numbers within that range, including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0041] Although some suitable dimensions, ranges, and / or values related to various components, features, and / or specifications are disclosed, those skilled in the art will understand, in light of the present disclosure, that the desired dimensions, ranges, and / or values may deviate from those explicitly disclosed.

[0042] As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its inclusive sense of "and / or" unless the context clearly dictates otherwise. It should be noted that for ease of understanding, some features of the present disclosure may be described in the singular, even though such features may be plural or repeated in the disclosed embodiments. Examples of each feature may include the singular disclosure and / or be implemented thereby, unless clearly stated to the contrary. For purposes of simplicity and clarity, not all elements of the disclosed invention are necessarily shown in each figure or discussed in detail below. However, it should be understood that the following discussion may equally apply to any and / or all of the components having more than one, unless clearly stated to the contrary. Additionally, for clarity, not all instances of some elements or features are shown in each figure.

[0043] Relative terms such as "proximal", "distal", "advance", "retract", and their variants are generally considered relative to the position, orientation, and / or operation of the user / operator / handler of the device, where "proximal" and "retract" indicate or refer to closer to or toward the user, while "distal" and "advance" indicate or refer to farther from or away from the user. In some cases, the term "distal" refers to movement further into the gastrointestinal system, while the term "proximal" refers to movement away from the gastrointestinal system. In some cases, the terms "proximal" and "distal" may be arbitrarily assigned for ease of understanding the present disclosure, and these cases will be apparent to those skilled in the art. Other relative terms, such as "upstream", "downstream", "inflow", and "outflow", refer to the direction of fluid flow within a lumen, such as a body cavity, blood vessel, or device.

[0044] The term "range" can be understood to refer to the maximum measurement of the stated or determined dimension. For example, "outer range" can be understood to refer to the maximum outer dimension, "radial range" can be understood to refer to the maximum radial dimension, "longitudinal range" can be understood to refer to the maximum longitudinal dimension, and so on. Each instance of "range" can be different (e.g., axial, longitudinal, transverse, radial, circumferential, etc.), and will be apparent to those skilled in the art from the context in which each is used. Generally, a "range" can be considered the maximum possible dimension measured according to the intended use. In some cases, a "range" can generally be measured orthogonally within a plane and / or cross-section, but can be apparent from the particular context to be measured in a different manner, such as but not limited to angular, radial, circumferential (e.g., along an arc), etc.

[0045] Note that references in the specification to "one embodiment", "some embodiments", "other embodiments", etc., indicate that the described embodiments may include a particular feature, structure, or characteristic, but not every embodiment necessarily includes that particular feature, structure, or characteristic. Moreover, these phrases do not necessarily refer to the same embodiment. Additionally, when a particular feature, structure, or characteristic is described in connection with an embodiment, implementation of that particular feature, structure, or characteristic in connection with other embodiments, whether or not explicitly described, is within the knowledge of those skilled in the art, unless explicitly stated to the contrary. That is, the various individual elements described below, even if not explicitly shown in a particular combination, are still considered combinable or arrangeable with each other to form additional embodiments or to supplement and / or enrich the described embodiments, as understood by those of ordinary skill in the art.

[0046] For clarity, certain alphanumeric nomenclature (e.g., first, second, third, fourth, etc.) may be used throughout the description and / or claims to name and / or distinguish various described and / or claimed features. It should be understood that the nomenclature is not intended to be limiting, but is merely exemplary. In some embodiments, for simplicity and clarity, changes and departures from the previously used alphanumeric nomenclature may be made. That is, a feature identified as a "first" element may subsequently be referred to as a "second" element, a "third" element, etc., or may be omitted entirely, and / or different features may be referred to as the "first" element. The meaning and / or designation in each instance will be apparent to those skilled in the art.

[0047] This document relates to devices and methods for treating conditions such as obesity and metabolic diseases. For example, this document provides methods and devices for bypassing some portions of the gastrointestinal tract to reduce nutrient absorption, reduce body weight, and / or improve diabetes control.

[0048] Figure 1Is a schematic diagram of a part of the human digestive tract 10. The digestive tract 10 includes the esophagus 12, the stomach 14, and the small intestine 16. The esophagus 12 connects the mouth to the stomach 14 and transports food to the stomach 14. The stomach 14 secretes digestive enzymes and gastric acid to aid in food digestion. The small intestine 16 is the organ where most of the nutrients and minerals in 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 passage 22 of partially digested food from the stomach 14 into the duodenum 18, and the length of the duodenum 18 is approximately 25 - 38 centimeters (cm). The food then enters the jejunum 24, which has a length of approximately 2.25 - 2.75 meters (m). It should be understood that these dimensions are merely exemplary and may vary from patient to patient. In some cases, the stomach 14 may be considered to include the pylorus 30 located exactly upstream of the pyloric sphincter 20. The diameter of the pylorus 30 may be considered larger than the diameter of the pyloric sphincter 20. The stomach 14 may be considered to include the antrum 32 located exactly upstream of the pylorus 30. The diameter of the antrum 32 may be considered larger than the diameter of the pylorus 30.

[0049] Figure 2 Schematically shows an exemplary gastric bypass device 34 disposed within the anatomical structure 10. The gastric bypass device 34 includes an occlusion device 36, which may be adapted to be placed within the pyloric sphincter 20, within the pylorus 30, or even within the antrum 32, depending on the desired degree of occlusion of the stomach 14. In some cases, the occlusion device 36 may be referred to as a funnel device, for example. The gastric bypass device 34 includes a lining 38 that extends distally from the occlusion device 36. In some cases, the lining 38 may be a separately formed element that is fixed to the occlusion device 36 by an adhesive or other means. In some cases, the lining 38 may be integrally formed with the occlusion device 36. The lining 38 may be referred to as a tubular extension in some cases, and may be considered adapted to allow gastric contents entering the lining 38 to pass through the lining 38. The lining 38 defines a lumen 40 that extends through the lining 38. In some cases, the lumen 40 extends through the lining 38 and is in fluid communication with the interior of the occlusion device 36. The lining 38 extends from a proximal end 38a to a distal end 38b, where the lining 38 is coupled to the occlusion device 36 at the proximal end 38a.

[0050] In some cases, the lining 38 may terminate at the junction between the duodenum 18 and the jejunum 24. In some cases, the lining 38 may end at any desired location along the duodenum 18 or the jejunum 24. In some cases, the lining 38 may terminate at any desired location along the small intestine 16. The lining 38 may be a polymeric sleeve or tube without added reinforcing members. As a result, when nothing is flowing through the lining 38, the lining 38 may collapse on its own. In some cases, the lining 38 may include loops or other structures adapted to help the lining 38 maintain its shape, even when empty. The lining 38 may be selected from a variety of different lining sizes to achieve the desired effect. For example, selecting a smaller diameter lining 38 will slow gastric emptying, while selecting a larger diameter lining 38 will increase the rate of gastric emptying. The lining 38 may be formed from any suitable material.

[0051] Because the occlusion device 36 is a foreign object, the stomach 14 may attempt to push the occlusion device 36 out of the pyloric sphincter 20 and down into the duodenum 18. The stomach 14 may attempt to push the occlusion device 36 out of the pyloric sphincter 20 and back into the stomach 14 itself. The tether 42 extends through the duodenum 18, and a first end 42a of the tether 42 is fixed to the occlusion device 36, and a second end 42b of the tether 42 is fixed to the anchor 44. The anchor 44 may be adapted to anchor to the side wall of the small intestine 16. In some cases, the anchor 44 may be adapted to anchor to the side wall of the stomach 14. The anchor 44 may be adapted to penetrate into the tissue of the small intestine 16 or the stomach 14. Other versions of the anchor 44 will be described with respect to subsequent figures. The tether 42 may be adapted to help hold the occlusion device 36 in its desired implanted position against movement caused by the stomach 14 attempting to move the occlusion device 36 out. In some cases, the anchor 44 may be attached to the intestine, the stomach, or even nearby ligaments.

[0052] As shown, the occlusion device 36 includes an open proximal opening 36a and a distal region 36b of reduced diameter. Gastric contents within the stomach 14 will pass through the open proximal opening 36a and be directed toward and through the distal region 36b of reduced diameter. From there, the gastric contents will enter and pass through the lining 38. When the gastric contents exit the lining 38 at the distal end 46 of the lining 38, the gastric contents will bypass the site of contact with a portion of the small intestine 16, including a portion of the duodenum 18 and possibly a portion of the jejunum 24.

[0053] The occlusion device 36 may take a variety of forms. Figure 3FIG. 0 is a schematic view of an exemplary occlusion device 45 disposed near the gastric antrum 32. The occlusion device 45 includes an annular ring 47 sized to span an anatomical structure. It should be understood that the annular ring 47 can be sized to assist in positioning the occlusion device 45 at a desired location within the anatomical structure. For example, if it is desired to position the occlusion device 45 within the pyloric sphincter 20, the overall diameter of the annular ring 47 can be 1 to 3 centimeters. If it is desired to position the occlusion device 45 within the pylorus 30, the overall diameter of the annular ring 47 can be 2 to 8 centimeters. If it is desired to position the occlusion device 45 within the gastric antrum 32, the overall diameter of the annular ring 47 can be 4 to 12 centimeters.

[0054] The occlusion device 47 includes a tapered body 48 that tapers from the annular ring 47 (which can be considered to define the maximum outer diameter of the occlusion device 45) to a minimum diameter end point 50. In some cases, a liner 38 extends distally from the minimum diameter end point 50. In some cases, a tether can be coupled to the tapered body 48. In some cases, the tether can extend external to the liner 38 as shown by tether 52a. In some cases, the tether can extend internal to the liner 38, within the lumen 44 or even within the sidewall of the liner 38.

[0055] The tapered body 48 can taper smoothly from its maximum outer diameter to its minimum outer diameter. The tapered body 48 can taper in a stepped manner, having one or more abrupt diameter changes. In some cases, the tapered body 48 can have a curved profile. The tapered body 48 can be adapted to allow substances such as food, chyme, and other gastric contents to flow through the tapered body 48 without flowing around the exterior of the tapered body 48. In some cases, the tapered body 48 can be constructed of a water-impermeable material, such as but not limited to a polymeric material. In some cases, the tapered body 48 can include a polymeric membrane disposed on some support frame (not shown).

[0056] The thickness, hardness, and lubricity of the polymeric material used to form the occlusion device 45 can vary along the length of the occlusion device 44. The occlusion device 45 can have, for example, a funnel shape or a cyclone shape. The occlusion device 45 can have a hemispherical or even spherical shape. The occlusion device 45 can include indentations (not shown) to accommodate support rings. In some cases, the occlusion device 45 can be collapsible to facilitate delivery.

[0057] The occlusion device 45 can be formed from any suitable polymeric or metallic material, provided that the material is suitable for long-term presence in the gastric environment. In some cases, the occlusion device 45 can be formed from silicone or another polymer. The occlusion device 45 can be formed, for example, by 3D printing. In some cases, the occlusion device 45 can be formed by molding or even electrospinning.

[0058] In some cases, the occlusion device 45 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 occlusion device 45 may be thicker near the annular ring 47. The occlusion device 45 may be formed from a shape memory material that allows the occlusion device 45 to have a memory configuration for deployment and be capable of temporarily deforming from the memory configuration during delivery. Although not shown, the occlusion device 45 may include anchors such as outward tips, hooks, splines, or barbs. The occlusion device 45 may include a surface treatment to promote endothelialization. These are merely examples.

[0059] Figure 4 is a schematic view of an exemplary occlusion device 54, which may be considered an example of the occlusion device 45. The exemplary occlusion device 54 is formed from a single continuous polymer body 56 that extends from an annular ring 58 representative of the maximum outer diameter of the occlusion device 54 to a minimum diameter endpoint 60. The minimum diameter endpoint 60 may be considered adapted to be secured to a tether such as the tether 40. For example, the dimensions of the annular ring 58 may be designed to position the occlusion device 54 at a desired location relative to the pyloric sphincter 20, the pylorus 30, or the gastric antrum 32.

[0060] The occlusion device 54 may be considered deformable and deliverable via an endoscope. The annular ring 56 is adapted to apply an outward radial force to engage the anatomical structure. If the occlusion device 54 is intended to be deployed within the pyloric sphincter 20, the total diameter of the annular ring 58 may be 1 to 3 centimeters. If the occlusion device 54 is intended to be deployed within the pylorus 30, the total diameter of the annular ring 58 may be 2 to 8 centimeters. If the occlusion device 54 is intended to be deployed within the gastric antrum 32, the total diameter of the annular ring 58 may be 4 to 12 centimeters.

[0061] Figure 5 is a schematic view of an exemplary occlusion device 80, which may be considered an example of the occlusion device 45. The exemplary occlusion device 80 is shown within the anatomical structure and near the gastric antrum 32. In some cases, the occlusion device 80 may occlude 10% to 50% of the stomach 14 and may conform to the wall of the stomach 14. The occlusion device 80 includes a thin film funnel 82 that is funnel-shaped or conical. For example, the thin film funnel 82 may be formed from silicone or expanded polytetrafluoroethylene (e-PTFE). The thin film funnel 82 may be formed from a polyurethane that is highly resistant to acids and chemicals. In some cases, a low molecular weight resin (e.g., a resin available under the name) may be mixed into the highly chemical-resistant polyurethane elastomer. In some cases, this polybutadiene-polyurethane has rubber-like properties, excellent hydrolysis and chemical resistance, good elasticity, and may be reinforced using common rubber fillers.

[0062] The occlusion device 80 extends from an annular ring 84 representative of the maximum outer diameter of the occlusion device 80 to a minimum diameter end point 86. The minimum diameter end point 86 can be considered adapted to be fixed to a lining 38 (not shown). The minimum diameter end point 86 can also be considered adapted to be fixed to a tether such as tether 38 ( Figure 5 not shown in). For example, the dimensions of the annular ring 84 (which can be a support ring added to the occlusion device 80) can be designed to position the occlusion device 80 at a desired location relative to the pyloric sphincter 20, the pylorus 30, or the gastric antrum 32. If the occlusion device 80 is intended to be deployed within the pyloric sphincter 20, the total diameter of the annular ring 84 can be 1 to 3 centimeters. If the occlusion device 80 is intended to be deployed within the pylorus 30, the total diameter of the annular ring 84 can be 2 to 8 centimeters. If the occlusion device 80 is intended to be deployed within the gastric antrum 32, the total diameter of the annular ring 84 can be 4 to 12 centimeters.

[0063] The annular ring 84 can be adapted to exert an outward radial force to help hold the occlusion device 80 in place relative to the anatomy. The occlusion device 80 can include partial or full fiber or metal reinforcement, such as ultra-high molecular weight polyethylene (UHMWPE) or nitinol. For example, the occlusion device 80 can be manufactured by attaching a thin film funnel 82 to the annular ring 84 via sewing, suturing, heat bonding, or chemical bonding.

[0064] In some cases, as Figure 6 shown, the occlusion device 80 can include a second intermediate support ring 90 that helps support the thin film funnel 82. The occlusion device 80 can include a third support ring, a fourth support ring, etc. The intermediate support ring 90 (as well as the support ring added to the annular ring 84) can be formed of a shape memory metal, such as a nickel-titanium alloy, including nitinol. Although not shown, the occlusion device 80 can include anchors such as outward pointed tips, hooks, splines, or teeth. The occlusion device 80 can include a surface treatment to promote endothelialization.

[0065] Figure 7 is a schematic view of an exemplary occlusion device 92. The exemplary occlusion device 92 has a structured frame 94 that extends from a maximum diameter opening 96 to a minimum diameter end point 98. The minimum diameter end point 98 is adapted to be fixed to a lining such as lining 38 and / or a tether such as tether 42.

[0066] The dimensions of the maximum diameter opening 96 can be designed to position the occlusion device 92 at a desired location relative to the pyloric sphincter 20, the pylorus 30, or the gastric antrum 32. For example, if the occlusion 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 centimeters. If the occlusion 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 centimeters. If the occlusion 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 centimeters.

[0067] The structured frame 94 can be interwoven 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, and these struts are connected to provide rigidity to the structured frame 94. The structured frame 94 is adapted to have shape retention such that the structured frame 94 returns to its expanded configuration (as shown) after being compressed or otherwise constricted for delivery. The dimensions of the individual struts 102 can vary to provide specific properties to the structured frame 94. The structured frame 94 can be conical or funnel-shaped. The shape of the structured frame 94 can be spherical or hemispherical. In some cases, the structured frame 94 can be formed from two or more different parts that are fixed together. In some cases, the structured frame 94 can be formed from laser-cut expandable tubing. The structured frame 94 can be a multi-fiber braided or interwoven structure. The structured frame 94 can be formed from discrete wire strands that are soldered, welded, or otherwise joined together to form the structured frame 94. For example, the structured frame 94 can be formed by casting molten metal.

[0068] The occlusion device 92 includes a covering or coating 104 (shown in a stippled pattern) that covers at least a portion of the structured 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. For example, the covering or coating 104 can be applied by dip coating, spraying, or electrospinning. Although not shown, the occlusion device 92 can include anchors such as outward-pointing tips, hooks, splines, or barbs. The occlusion device 92 can include a surface treatment that promotes endothelialization.

[0069] Figure 8 is a schematic view of an exemplary structured frame 106, which can be considered an example of the structured frame 94. The structured frame 106 includes a plurality of outward-pointing barbs 108 that help anchor the structured frame 106 (and thus the occlusion device including the structured frame 106) in place within the anatomical structure. When included as part of an occlusion device, the structured frame 106 will include a coating or covering such as the covering or coating 104 shown in Figure 7 as shown.

[0070] Figures 9 to Figure 14D provides an example of an exemplary tether 42 that can be used as part of the gastric bypass device 34. In some cases, the tether 42 can simply be a spring that is adapted to provide increased resilience in response to elongation of the spring when movement of the stomach causes movement of the occlusion device 36. The spring can be formed from any suitable polymeric or metallic material. For example, in some cases, the spring can be formed from nitinol or stainless steel.

[0071] The spring can take various forms. In some cases, the spring can have a varying diameter, with a minimum diameter at the midpoint and larger diameters at either end. The spring can have a tapered diameter from a maximum diameter at one end to a minimum diameter at the other end. The spring can have a uniform diameter and pitch from one end to the other. The spring can have a constant outer diameter, but a varying pitch. The spring can have a tapered diameter from a maximum diameter at the middle to a minimum diameter at either end. These are only examples.

[0072] In some cases, the spring or springs can include a covering or coating, particularly where the tether 42 will be placed and where the tether 42 may be subject to fluids and other substances within the gastric system. The covering or coating can reduce friction or other interactions with the tissue within the gastric system. The covering or coating can reduce the interaction of the spring with chyme and food, thereby avoiding possible blockages. The covering or coating can act as a barrier to the harsh gastric environment. The covering or coating can reduce damage or inflammation at the bile duct and / or papilla. In some cases, the covering or coating can be ePTFE, PTFE, or other polymers.

[0073] Figure 9A A spring 294a with a covering 296 is shown, which encapsulates the spring 294a and expands and contracts with the spring 294a. Figure 9B A spring 294b with a covering 298 is shown, which allows the spring 294b to move independently of the covering 298. Figure 9C A spring 294c with a covering 300 is shown, which is conformal with the wire 302 forming the spring 294c. Figure 9D A spring 294d with a covering 304 is shown, which is continuous with the material 306 forming at least a part of the occlusion device. The spring 294 can be formed of any suitable polymeric or metallic material. For example, in some cases, the spring 294 can be formed of nitinol or stainless steel.

[0074] Figure 10 A schematic view of a part of the gastrointestinal system is shown, which indicates the relative positions of the patient's bile duct 394, the patient's pancreatic duct 396, and the patient's Vater papilla 398. The Vater papilla 398 is where the bile duct 394 and the pancreatic duct 396 are fluidly connected to the duodenum 18. The Vater papilla 398 is located at the medial bend of the duodenum 18 and, in some cases, may partially project into the interior of the duodenum 18. One possible problem with placing a tether in the duodenum 18 is that, particularly when the tether is disposed outside the lining 38, the tether may irritate the Vater papilla 398, which can lead to inflammation and in turn various possible complications. In some cases, it is desirable to provide a tether that avoids irritating the Vater papilla 398.

[0075] Figure 11A, 11B and 11C provides an example of a tether adapted to avoid irritating the Vater papilla 398. In Figure 11A , 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 a trauma cover 418 that encapsulates the first spring segment 414 and the second spring segment 416. The trauma cover 418 is narrowed between the first spring segment 414 and the second spring segment 416 by a pair of sutures 420 that secure the trauma cover 418 to the ends of the first spring segment 414 and the second spring segment 416. Thus, no metal is close to the Vater papilla 398.

[0076] Figure 11B Shows a tether 412b, which is similar to the tether 400, but includes a trauma cover 422 that encapsulates the first spring segment 406, the second spring segment 408, and a member 410 extending therebetween. In some cases, as shown, a soft pillow 424 is disposed between the first spring segment 406 and the second spring segment 408 and is held in place by the trauma cover 422. Thus, no metal is close to the Vater papilla 398. Figure 11C Shows a tether 412c, which includes a spring 426 disposed within a trauma cover 428. The spring 426 has a varying diameter, with a maximum diameter at either end of the spring 426 and tapering to a minimum diameter near the midpoint of the spring 426.

[0077] Figure 12 Shows a tether 430, which includes a physical support 432 disposed on the tether 430, wherein the tether 430 extends through the physical support 432. It should be understood that the inner lining 38 is not shown in this view. In some cases, the physical support 432 is capable of sliding relative to the tether 430. In some cases, the physical support 432 is a braided structure formed of a metal such as nitinol. In some cases, the physical support 432 is alternatively inflatable, such as an inflatable balloon. As shown, the physical support 432 includes a first bulbous region 434 and a second bulbous region 436, with a narrowed diameter portion 438 extending therebetween. In some cases, the physical support 432 may further include additional bulbous regions.

[0078] Figure 13The tether 440 is shown, which includes a physical support 442 that forms part of the tether 440. It should be understood that the inner lining 38 is not shown in this view. The tether 440 includes a first spring segment 444 and a second spring segment 446, with the physical support 442 disposed between the first spring segment 444 and the second spring segment 446. For example, the physical support 442 can be welded, stitched, or adhered to each of the first spring segment 444 and the second spring segment 446. The physical support 442 can include a first spherical region 444 and a second spherical region 446, with a rigid member 448 extending between the first spherical region 444 and the second spherical region 446.

[0079] Figure 14A is a schematic view of an exemplary tether 450. It should be understood that the inner lining 38 is not shown in this view. The exemplary tether 450 includes a first spring segment 452 and a second spring segment 454. The tether 450 includes an arcuate segment 456 that extends between the first spring segment 452 and the second spring segment 454. Figure 14B shows a first view of the arcuate segment 456, while Figure 14C shows a second view of the arcuate segment 456. Tension on the tether 450 will cause the arcuate segment 456 to rotate perpendicular to the Vater papilla 398, as Figure 14D shown.

[0080] Figure 15 An exemplary gastric bypass device 460 disposed within the anatomical structure 10 is schematically shown. The gastric bypass device 460 includes an occlusion device 462 that can be adapted to be placed within the pyloric sphincter 20, within the pylorus 30, or even within the gastric antrum 32, depending on the desired degree of occlusion of the stomach 14. In some cases, the occlusion device 462 can be referred to as a funnel device, for example. The gastric bypass device 460 includes an inner lining 464 that extends distally from the occlusion device 462. In some cases, the inner lining 464 can be a separately formed element that is fixed to the occlusion device 462 by an adhesive or other means. In some cases, the inner lining 464 can be integrally formed with the occlusion device 462. The inner lining 464, which can be referred to as a tubular extension in some cases, can be considered to be adapted to allow gastric contents entering the inner lining 464 to pass through the inner lining 464. The interior of the inner lining 464 is in fluid communication with the interior of the occlusion device 462.

[0081] In some cases, the liner 464 may terminate at the junction between the duodenum 18 and the jejunum 24. In some cases, the liner 464 may end at any desired location along the duodenum 18 or the jejunum 24. In some cases, the liner 464 may terminate at any desired location along the small intestine 16. The liner 464 may be a polymeric sleeve or tube without added reinforcing members. As a result, when nothing is flowing through the liner 464, the liner 464 may collapse on itself. In some cases, the liner 464 may include loops or other structures adapted to help the liner 464 maintain its shape, even when empty. The liner 464 may be selected from a variety of different liner sizes to achieve a desired effect. For example, selecting a smaller diameter liner 464 will slow gastric emptying, while selecting a larger diameter liner 464 will increase the rate of gastric emptying.

[0082] The tether 466 extends through the duodenum 18 and is fixed at one end to the occlusion device 462 and at a second end to the anchor 468. In some cases, as shown, the anchor 468 may be a self-expanding structure, such as a braided structure or a stent structure, that is adapted to engage the small intestine 16. The tether 466 may be adapted to help hold the occlusion device 462 in its desired implantation position against movement caused by the stomach 14 attempting to move the occlusion device 462 out.

[0083] Figure 16 An exemplary gastric bypass device 470 disposed within the anatomical structure 10 is schematically shown. The gastric bypass device 470 includes an occlusion device 472 that may be adapted to be placed within the pyloric sphincter 20, within the pylorus 30, or even within the gastric antrum 32, depending on the desired degree of occlusion of the stomach 14. In some cases, the occlusion device 472 may be referred to as a funnel device, for example. The gastric bypass device 470 includes a liner 464 that extends distally from the occlusion device 472. In some cases, the liner 474 may be a separately formed element that is fixed to the occlusion device 472 by an adhesive or other means. In some cases, the liner 474 may be formed integrally with the occlusion device 472. The liner 474 may be referred to as a tubular extension in some cases and may be considered adapted to allow gastric contents entering the liner 474 to pass through the liner 474. The interior of the liner 474 is in fluid communication with the interior of the occlusion device 472.

[0084] In some cases, the liner 474 may terminate at the junction between the duodenum 18 and the jejunum 24. In some cases, the liner 474 may end at any desired location along the duodenum 18 or the jejunum 24. In some cases, the liner 474 may terminate at any desired location along the small intestine 16. The liner 474 may be a polymeric sleeve or tube and may not have a reinforcing member added. Thus, the liner 474 may collapse on its own when no material is flowing through it. In some cases, the liner 474 may include a ring or other structure adapted to help the liner 474 maintain its shape, even when empty. The liner 474 may be selected from a variety of different liner sizes to achieve a desired effect. For example, selecting a smaller diameter liner 474 will slow gastric emptying, while selecting a larger diameter liner 474 will increase the gastric emptying rate.

[0085] The tether 476 extends through the duodenum 18 and is fixed at one end to the occluding device 462 and at a second end to the anchor 478. In some cases, as shown, the anchor 478 may be a friction feature that extends distally down the small intestine 16. In some cases, the anchor 478 may be long enough such that the natural twists and turns of the small intestine 16 cause the anchor 478 to interact sufficiently with the small intestine 16 to provide an anchoring feature. In some cases, the anchor 478 may include an enlargement 479, which may provide additional friction between the anchor 478 and the small intestine 16. The tether 476 may be adapted to help hold the occluding device 472 in its desired implanted position against movement caused by the stomach 14 attempting to move the occluding device 472 out.

[0086] Figure 17 An exemplary gastric bypass device 480 disposed within the anatomical structure 10 is schematically shown. The gastric bypass device 480 includes an occluding device 482, which may be adapted to be placed within the pyloric sphincter 20, within the pylorus 30, or even within the gastric antrum 32, depending on the desired degree of occlusion of the stomach 14. In some cases, the occluding device 482 may be referred to as a funnel device, for example. The gastric bypass device 480 includes a liner 484 that extends distally from the occluding device 482. In some cases, the liner 484 may be a separately formed element that is fixed to the occluding device 482 by an adhesive or other means. In some cases, the liner 484 may be formed integrally with the occluding device 482. The liner 484, which may be referred to as a tubular extension in some cases, may be considered adapted to allow gastric contents entering the liner 484 to pass through the liner 484. The interior of the liner 484 is in fluid communication with the interior of the occluding device 482.

[0087] In some cases, the liner 484 may terminate at the junction between the duodenum 18 and the jejunum 24. In some cases, the liner 484 may end at any desired location along the duodenum 18 or the jejunum 24. In some cases, the liner 484 may terminate at any desired location along the small intestine 16. The liner 484 may be a polymeric sleeve or tube and may not have a reinforcing member added. Thus, when no material is flowing through the liner 484, the liner 484 may collapse on itself. In some cases, the liner 484 may include a ring or other structure adapted to help the liner 484 maintain its shape, even when empty. The liner 484 may be selected from a variety of different liner sizes to achieve a desired effect. For example, selecting a smaller diameter liner 484 will slow gastric emptying, while selecting a larger diameter liner 484 will increase the gastric emptying rate.

[0088] The tether 486 extends through the duodenum 18 and is fixed at one end to the occluding device 462 and at a second end to the anchor 488. In some cases, as shown, the anchor 488 may be fixed to the tissue of the small intestine 16 or the stomach 14. In some cases, the anchor 488 may extend through the sidewall of the small intestine and the sidewall of the stomach 14. The tether 486 may be adapted to help hold the occluding device 482 in its desired implantation position against movement caused by the stomach 14 attempting to move the occluding device 482 out.

[0089] In some cases, as shown, the dynamic tether 490 extends between the occluding device 482 and the anchor 488. In some cases, the dynamic tether 490 may not be fixed to the anchor 488, but rather to an anchoring location within the wall of the stomach 14. In some cases, the dynamic tether 490 may be a spring or may provide a force that balances the force provided by the tether 486 in some way. In some cases, when the anatomy attempts to move the gastric bypass device 480 out as a foreign body, the tether 386 may resist proximal movement of the occluding device 462, while the dynamic tether 490 may resist distal movement of the occluding device 462. The anatomy may view the occluding device 462 as a large piece of undigested food and may attempt to push the occluding device 462 proximally to return it to the stomach for further digestion.

[0090] The materials for the various components of the medical device systems described herein and the various elements disclosed herein can include those materials commonly associated with medical devices. In some embodiments, the medical device systems described herein can be made of metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, etc., or other suitable materials. Some examples of suitable metals and metal alloys include stainless steels such as 444V, 444L, and 314LV stainless steels; low-carbon steels; nickel-titanium alloys such as linear elastic and / or superelastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as INCONEL 625, UNS: N06022, such as HASTELLOY C-22 , UNS: N10276, such as HASTELLOY C276 , other HASTELLOY alloys, etc.), nickel-copper alloys (e.g., UNS: N04400, such as MONEL 400, NICKELVAC 400, NICORROS 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035, such as MP35-N , etc.), nickel-molybdenum alloys (e.g., UNS:

[0091] N10665, such as HASTELLOY ALLOY B2 ), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R44003, such as ELGILOY , PHYNOX , etc.); platinum-rich stainless steels; titanium; combinations thereof, etc.; or any other suitable material.

[0092] As mentioned herein, within the commercially available family of nickel-titanium or nitinol alloys, there is a category known as "linear elastic" or "non-superelastic", which may exhibit different and useful mechanical properties even though its chemical properties may be similar to those of traditional shape memory and superelastic variants. Linear elastic and / or non-superelastic nitinol can be distinguished from superelastic nitinol because linear elastic and / or non-superelastic nitinol does not show a distinct "superelastic plateau" or "flag region" in its stress / strain curve as does superelastic nitinol. Instead, in linear elastic and / or non-superelastic nitinol, as the recoverable strain increases, the stress continues to increase in a substantially linear manner or in a somewhat, but not necessarily completely, linear relationship until plastic deformation begins, or at least in a more linear relationship than the superelastic plateau and / or flag region visible in superelastic nitinol. Thus, 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.

[0093] In some cases, linear elastic and / or non-superelastic nitinol can also be distinguished from superelastic nitinol because linear elastic and / or non-superelastic nitinol can withstand strains up to about 2 - 5% while remaining substantially elastic (e.g., prior to plastic deformation), whereas superelastic nitinol can withstand strains up to about 8% without plastic deformation. Both of these materials can be distinguished from other linear elastic materials (such as stainless steel, which can also be distinguished based on its composition), which can only withstand strains of about 0.2 to 0.44% prior to plastic deformation.

[0094] In some embodiments, linear elastic and / or non-superelastic nickel-titanium alloys are alloys in which no martensite / austenite phase transformation is detected by differential scanning calorimetry (DSC) and dynamic mechanical thermal analysis (DMTA) over a large temperature range. For example, in some embodiments, in linear elastic and / or non-superelastic nickel-titanium alloys, no martensite / austenite phase transformation is detected by DSC and DMTA analysis in the range of about -60 degrees Celsius (°C) to about 120 °C. Thus, the mechanical bending properties of this material are generally insensitive to temperature over this very wide temperature range. In some embodiments, the mechanical bending properties of linear elastic and / or non-superelastic nickel-titanium alloys at ambient temperature or room temperature are substantially the same as their mechanical properties at body temperature, e.g., they do not show a superelastic plateau and / or flag region. In other words, over a wide temperature range, linear elastic and / or non-superelastic nickel-titanium alloys retain their linear elastic and / or non-superelastic characteristics and / or properties.

[0095] In some embodiments, the nickel content of a linear elastic and / or non-superelastic nickel-titanium alloy can be in the range of about 50 to about 60 weight percent, with the balance being substantially titanium. In some embodiments, the nickel content of the composition is in the range of about 54 to about 57 weight percent. An example of a suitable nickel-titanium alloy is the FHP-NT alloy available from Furukawa Technical Materials Corporation in Kanagawa, Japan. Other suitable materials can include ULTANIUM TM (available from Neo-Metrics) and GUMMETAL TM (available from Toyota). In some other embodiments, a superelastic alloy, such as superelastic Nitinol, can be used to achieve the desired performance.

[0096] In at least some embodiments, part or all of the medical device systems described herein can also be doped with, made of, or otherwise include a radiopaque material. A radiopaque material is understood to be a material that can produce a relatively bright image on a fluoroscope or another imaging technique during a medical procedure. This relatively bright image helps the user determine the location of the medical device system. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, etc. Additionally, other radiopaque marker bands and / or coils can also be incorporated into the design of the medical device systems described herein.

[0097] In some embodiments, the medical device systems described herein have a degree of magnetic resonance imaging (MRI) compatibility. The medical device can be made of materials that substantially do not distort the image and produce a large number of artifacts (such as gaps in the image). For example, certain ferromagnetic materials may not be suitable because they may produce artifacts in the MRI image. In some cases, the medical device system or a part thereof can also be made of materials that can be imaged by an MRI machine. Some materials that exhibit these characteristics include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R44003, such as ELGILOY 、PHYNOX etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035, such as MP35-N etc.), Nitinol, etc., and other materials.

[0098] In some embodiments, the medical device systems described herein can be made of or include polymers or other suitable materials. Some examples of suitable polymers can include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN available from DuPont ) Polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether-esters (e.g., ARNITEL available from DSM Engineering Plastics) ) Ether or ester group copolymers (e.g., butene / poly(alkylene ether) phthalate and / or other polyester elastomers such as HYTREL available from DuPont) ) Polyamides (e.g., DURETHAN available from Bayer) or CRISTAMID available from Elf Atochem ) Elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA, e.g., available under the trade name PEBAX) ) Ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), MARLEX High density polyethylene, MARLEX Low density polyethylene, linear low density polyethylene (e.g., REXELL) ) Polyesters, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly(p-phenylene terephthalamide) (e.g., KEVLAR) ) Polysulfones, nylons, nylon-12 (e.g., GRILAMID available from EMS AmericanGrilon) ) Perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrenes, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, etc. In some embodiments, the sheath may be mixed with a liquid crystal polymer (LCP). For example, the mixture may contain up to about 6% LCP.

[0099] In some embodiments, the medical device systems and / or other disclosed elements described herein may include a fabric material disposed over or within a structure. The fabric material may be composed of a biocompatible material, such as a polymeric material or a biomaterial, which is adapted to promote tissue growth. 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 such as polyethylene, polypropylene, polyester, polyurethane, and / or mixtures or combinations thereof.

[0100] It should be understood that the present disclosure is merely exemplary in many respects. Changes may be made in details, especially in matters of shape, size, and arrangement of steps, without departing from the scope of the invention. This may include using any feature of one exemplary embodiment in other embodiments where appropriate. Of course, the scope of the invention is defined by the language expressed in the appended claims.

Claims

1. An implantable medical device, comprising: An occlusion device adapted to be disposed within a patient's stomach relative to the patient's pylorus to prevent gastric contents from flowing past the occlusion device, the occlusion device including a distal outflow end; A liner extending distally from the occlusion device, the liner defining a lumen extending therethrough, the liner having a proximal end fluidly coupled to the distal outflow end and a distal end adapted to be disposed within the patient's jejunum such that gastric contents entering the occlusion device flow through the liner and exit through the distal end; And A tether fixed relative to the occlusion device and adapted to restrict proximal movement of the occlusion device.

2. The implantable medical device according to claim 1, wherein the tether includes a proximal end and a distal end, the tether being fixable relative to the occlusion device by the proximal end and fixable to an anchor by the distal end.

3. The implantable medical device according to claim 2, wherein the anchor is adapted to be fixed in place relative to the patient's small intestine or gastric wall.

4. The implantable medical device according to claim 3, wherein the anchor is adapted to pierce tissue of the patient's small intestine or gastric wall.

5. The implantable medical device according to claim 2, wherein the anchor includes a self-expanding element adapted to be disposed within the patient's small intestine.

6. The implantable medical device according to claim 2, wherein the tether further includes an elongate friction anchor adapted to extend within the patient's small intestine.

7. The implantable medical device according to any one of claims 1 to 6, further comprising a dynamic drawstring extending from the occlusion device to an anchoring site within the patient's stomach.

8. The implantable medical device according to any one of claims 1 to 7, wherein the occlusion device is adapted to extend into the patient's gastric antrum.

9. The implantable medical device according to any one of claims 1 to 8, wherein the liner includes a polymer tube.

10. A gastric bypass device, comprising: A funnel device adapted to be disposed within a patient's stomach relative to the patient's pylorus to direct gastric contents through the funnel device; A tubular extension fluidly coupled to the funnel device and extending distally from the funnel device, the tubular extension adapted to extend through an upper portion of the patient's small intestine to prevent gastric contents flowing through the funnel device and the tubular extension from contacting the upper portion of the patient's small intestine; And A tether fixed relative to the funnel device and adapted to restrict proximal movement of the funnel device.

11. The gastric bypass device according to claim 10, wherein the tether includes a proximal end and a distal end, the tether being fixable relative to the funnel device by the proximal end and fixable to an anchor by the distal end.

12. The gastric bypass device according to claim 11, further comprising an anchor.

13. The gastric bypass device according to claim 12, wherein the anchor includes a self-expanding element adapted to be disposed within the patient's small intestine.

14. The gastric bypass device according to claim 12, wherein the tether further includes an elongate friction anchor adapted to extend within the patient's small intestine.

15. The gastric bypass device according to any one of claims 10 to 14, further comprising a dynamic traction cord extending from the funnel device to an anchoring site within the patient's stomach.

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