Dynamic anchor structure for small bowel liners

Abstract

The gastric bypass device includes an obstruction device adapted to be positioned against the patient's pyloric sphincter and a liner extending distally from the obstruction device. A tether extends from the obstruction device. A dynamic leash can be secured to the obstruction device and can cooperate with the tether to help hold the obstruction device in place.

Description

[Technical Field]

[0001] The present disclosure relates to medical devices such as gastric bypass devices. More particularly, the present disclosure relates to gastric bypass devices that include a small intestinal liner. [Background technology]

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

[0003] The present disclosure relates to medical devices, such as gastric bypass devices, and more particularly to gastric bypass devices that include a small intestinal liner. One example of an implantable medical device includes an obstructing device adapted to be positioned within a patient's stomach against the patient's pylorus and configured to prevent gastric contents from flowing around the obstructing device. The obstructing device includes a distal outflow end. A liner extends distally from the obstructing device and defines a lumen extending therethrough. The liner has a proximal end fluidly coupled to the distal outflow end and a distal end adapted to be positioned within the patient's jejunum such that gastric contents entering the obstructing device flow through the liner and exit the distal end. A tether is secured to the obstructing device and configured to limit proximal movement of the obstructing device.

[0004] Alternatively or additionally, the tether may be adapted to extend within the lumen of the liner. Alternatively or additionally, the tether may be adapted to extend outside the liner. Alternatively or additionally, the tether may include a proximal end at which the tether may be secured to an occlusion device and a distal end at which the tether may be secured to an anchor.

[0005] Alternatively or additionally, the anchor may be adapted to be secured in place against the patient's small intestine or stomach wall. Alternatively or additionally, the anchor may be adapted to penetrate tissue of the patient's small intestine or stomach wall.

[0006] Alternatively or additionally, the anchor may include a self-expanding element adapted to be placed within the patient's small intestine. Alternatively or additionally, the tether may further include an elongated friction anchor adapted to extend into the small intestine of the patient.

[0007] Alternatively or additionally, the implantable medical device may further include a dynamic leash extending from the occlusion device to an anchor site within the patient's stomach. Alternatively or additionally, the occlusion device may be adapted to extend into the patient's antrum.

[0008] Alternatively or additionally, the liner may comprise a polymer tube. Another example is a gastric bypass device. The gastric bypass device includes a funnel device adapted to be positioned within a patient's stomach relative to the patient's pylorus to direct stomach contents to flow through the funnel device. A tubular extension is fluidly coupled to the funnel device and extends distally from the funnel device, the tubular extension being adapted to extend through an upper portion of the patient's small intestine to prevent the funnel device and stomach contents flowing through the tubular extension from contacting the upper portion of the patient's small intestine. A tether is secured to the funnel device and adapted to limit proximal movement of the funnel device.

[0009] Alternatively or additionally, the tether may be adapted to extend within the tubular extension. Alternatively or additionally, the tether may be adapted to extend outside the tubular extension.

[0010] Alternatively or additionally, the tether may include a proximal end at which the tether may be secured to a funnel device and a distal end at which the tether may be secured to an anchor. Alternatively or additionally, the gastric bypass device may further include an anchor.

[0011] Alternatively or additionally, the anchor may include a self-expanding element adapted to be placed within the patient's small intestine. Alternatively or additionally, the tether may further include an elongated friction anchor adapted to extend into the small intestine of the patient.

[0012] Alternatively or additionally, the gastric bypass device may further include a dynamic leash extending from the funnel device to an anchor site within the patient's stomach. Another example is a gastric bypass device. The gastric bypass device includes a funnel device adapted to be positioned within a patient's stomach relative to the patient's pylorus to direct stomach contents to flow through the funnel device. A tubular extension is fluidly coupled to the funnel device and extends distally from the funnel device, the tubular extension being adapted to extend through an upper portion of the patient's small intestine to prevent stomach 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 adapted to limit proximal movement of the funnel device. A dynamic leash extends from the funnel device in a direction opposite to the tether.

[0013] The above summary of some embodiments, aspects, and / or examples is not intended to describe each embodiment or every implementation of the present disclosure. The figures and the detailed description that follow more particularly exemplify these embodiments.

[0014] The present disclosure may be more fully understood from a consideration of the following detailed description of various embodiments in conjunction with the accompanying drawings, in which: [Brief explanation of the drawings]

[0015] [Figure 1] Schematic diagram of part of the human gastrointestinal (GI) system. [Figure 2] 2 is a schematic diagram of an exemplary gastric bypass system positioned within the digestive tract shown in FIG. 1. [Figure 3] 3 is a schematic diagram of an exemplary occlusion device that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 4] 3 is a schematic diagram of an exemplary occlusion device that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 5] 3 is a schematic diagram of an exemplary occlusion device that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 6] 3 is a schematic diagram of an exemplary occlusion device that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 7] 3 is a schematic diagram of an exemplary occlusion device that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 8] 3 is a schematic diagram of an exemplary occlusion device that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 9A] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 9B] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 9C] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 9D] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2. [Figure 10] Schematic diagram of part of the human gastrointestinal (GI) system. [Figure 11A] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2 to protect the papilla of Vater. [Figure 11B]3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2 to protect the papilla of Vater. [Figure 11C] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2 to protect the papilla of Vater. [Figure 12] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2 to protect the papilla of Vater. [Figure 13] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2 to protect the papilla of Vater. [Figure 14A] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2 to protect the papilla of Vater. [Figure 14B] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2 to protect the papilla of Vater. [Figure 14C] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2 to protect the papilla of Vater. [Figure 14D] 3 is a schematic diagram of an exemplary tether that can be used in the exemplary gastric bypass system of FIG. 2 to protect the papilla of Vater. [Figure 15] 2 is a schematic diagram of an exemplary gastric bypass system positioned within the GI system shown in FIG. 1. [Figure 16] 2 is a schematic diagram of an exemplary gastric bypass system positioned within the GI system shown in FIG. 1. [Figure 17] 2 is a schematic diagram of an exemplary gastric bypass system positioned within the GI system shown in FIG. 1. DETAILED DESCRIPTION OF THE INVENTION

[0016] While aspects of the present disclosure are amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit aspects of the present disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.

[0017] The following description should be read with reference to the drawings, which are not necessarily to scale, and in which like reference numerals indicate like elements throughout the several views. The detailed description and drawings are intended to illustrate, not limit, the scope of the claims. Those skilled in the art will recognize that the various elements described and / or illustrated can be arranged in various combinations and configurations without departing from the scope of the present disclosure. The detailed description and drawings depict exemplary embodiments of the claimed invention.

[0018] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.

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

[0019] The recitation of numerical ranges by endpoints includes all numbers within that range, inclusive of the endpoints (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). Although some suitable dimensions, ranges and / or values ​​for various components, features and / or specifications are disclosed, one skilled in the art inspired by this disclosure will understand that the desired dimensions, ranges and / or values ​​may deviate from those expressly disclosed.

[0020] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its sense to include "and / or" unless the content clearly dictates otherwise. For ease of understanding, it should be noted that some features of the present disclosure may be described in the singular even though those features may be multiple or repeated within a disclosed embodiment. Each instance of a feature may include and / or be encompassed by a singular disclosure unless expressly stated to the contrary. For simplicity and clarity, not all elements of the disclosed invention(s) are necessarily shown in every figure or described in detail below. However, it will be understood that the following description may apply equally to any and / or all components present in more than one instance unless expressly stated to the contrary. Moreover, for clarity, not all instances of some elements or features are shown in every figure.

[0021] Relative terms such as “proximal,” “distal,” “advancing,” “retracting,” and variations thereof may generally be considered with respect to the position, orientation, and / or movement of various elements relative to a user / operator / manipulator of the device, with “proximal” and “retracting” indicating or referring to being closer to or toward the user, and “distal” and “advancing” indicating or referring to being farther from or away from the user. In some cases, the term “distal” refers to moving further into the gastrointestinal system, and the term “proximal” refers to moving out of the gastrointestinal system. In some cases, the terms “proximal” and “distal” may be assigned arbitrarily to facilitate understanding of the present disclosure, and such instances will be readily apparent to one of ordinary skill in the art. Other relative terms such as “upstream,” “downstream,” “inflow,” and “outflow” refer to the direction of fluid flow within a body lumen, a lumen such as a blood vessel, or within a device.

[0022] The term "extent" may be understood to mean the maximum measurement of a stated or specified dimension. For example, an "outer extent" may be understood to mean the maximum outer dimension, a "radial extent" may be understood to mean the maximum radial dimension, and a "longitudinal extent" may be understood to mean the maximum longitudinal dimension. Each instance of "extent" may be different (e.g., axially, longitudinally, laterally, radially, circumferentially, etc.) and will be apparent to one of ordinary skill in the art from the context of a particular use. In general, "extent" may be considered the maximum possible dimension measured according to the intended use. In some cases, "extent" may generally be measured orthogonally in a plane and / or cross-section, but may also be measured differently, such as, but not limited to, angularly, radially, circumferentially (e.g., along an arc), etc., as will become apparent from the particular context.

[0023] It should be noted that references herein to "one embodiment," "some embodiments," "other embodiments," etc., indicate that the described embodiment may include a particular feature, structure, or characteristic, but that not all embodiments necessarily include the particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Furthermore, when a particular feature, structure, or characteristic is described in connection with an embodiment, it would be within the knowledge of one skilled in the art to use the particular feature, structure, or characteristic in connection with other embodiments, unless expressly stated to the contrary, whether or not explicitly described. That is, it is contemplated that various individual elements described below, even if not explicitly shown in specific combinations, can be combined or arranged with one another to form other or additional embodiments, or to complement and / or enhance the described embodiments, as would be understood by one skilled in the art.

[0024] For purposes of clarity, certain distinguishing numerical nomenclature (e.g., first, second, third, fourth, etc.) may be used throughout the specification and / or claims to name and / or distinguish various features of the specification and / or claims. It should be understood that the numerical nomenclature is not intended to be limiting, but is merely exemplary. In some embodiments, variations and departures from previously used numerical nomenclature may be made for brevity and clarity. That is, a feature identified as a "first" element may later be referred to as a "second," "third," etc., or may be omitted entirely, and / or a different feature may be referred to as the "first" element. The meaning and / or name in each instance will be apparent to one of ordinary skill in the art.

[0025] This document relates to devices and methods for the medical treatment of conditions such as obesity and metabolic disease. For example, this document provides methods and devices for bypassing a portion of the GI tract to reduce nutritional intake, reduce weight, and / or improve diabetes management.

[0026] FIG. 1 is a schematic diagram of a portion of a human digestive tract 10. The digestive tract 10 includes an esophagus 12, a stomach 14, and a small intestine 16. The esophagus 12 connects the mouth to the stomach 14 and delivers food to the stomach 14. The stomach 14 secretes digestive enzymes and gastric acid to aid in food digestion. The small intestine 16 is where most of the absorption of nutrients and minerals from food occurs. The small intestine 16 includes a duodenum 18, a jejunum 24, and an ileum (not shown). A pyloric sphincter 20 controls a passageway 22 for the passage of partially digested food from the stomach 14 to the duodenum 18, which may be approximately 25 to 38 centimeters (cm) long. The food then passes into the jejunum 24, which may be approximately 2.25 to 2.75 meters (m) long. It will 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 a pylorus 30 located immediately upstream of the pyloric sphincter 20. The pylorus 30 may be considered to have a diameter larger than the diameter of the pyloric sphincter 20. The stomach 14 may be considered to include a pyloric antrum 32 located immediately upstream of the pylorus 30. The antrum 32 may be considered to have a diameter larger than the diameter of the pylorus 30.

[0027] FIG. 2 schematically illustrates an exemplary gastric bypass device 34 positioned within the anatomical structure 10. The gastric bypass device 34 includes an occlusion device 36, which may be adapted to be positioned within the pyloric sphincter 20, the pylorus 30, or even 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 liner 38 extending distally from the occlusion device 36. In some cases, the liner 38 may be a separate component secured to the occlusion device 36, such as by adhesive or in other ways. In some cases, the liner 38 may be integrally formed with the occlusion device 36. The liner 38 may be referred to as a tubular extension and may be considered adapted to allow stomach contents to pass through and enter the liner 38. The liner 38 defines a lumen 40 extending therethrough. Optionally, lumen 40 extends through liner 38 and is fluidly coupled to the interior of occlusion device 36. Liner 38 extends from a proximal end 38a, which is connected to occlusion device 36, to a distal end 38b.

[0028] In some cases, the liner 38 may terminate at the junction of the duodenum 18 and the jejunum 24. In some cases, the liner 38 may terminate anywhere along the duodenum 18 or jejunum 24. In some cases, the liner 38 may terminate anywhere along the small intestine 16. The liner 38 may be a polymer sleeve or tube without additional reinforcing members. As a result, the liner 38 may collapse when nothing is passing through it. In some cases, the liner 38 may include rings or other structures adapted to assist the rings in maintaining its shape even when empty. The liner 38 may be selected from a variety of different liner sizes to achieve the desired effect. For example, selecting a smaller diameter liner 38 may slow gastric emptying, while selecting a larger diameter liner 38 may increase the rate of gastric emptying. The liner 38 may be formed from any suitable material.

[0029] Because the obstructing device 36 is a foreign body, the stomach 14 may attempt to push the obstructing device 36 through the pyloric sphincter 20 and into the duodenum 18. The stomach 14 may attempt to push the obstructing device 36 back through the pyloric sphincter 20 and into itself. A tether 42 extends through the duodenum 18 and is secured to the obstructing device 36 at a first end 42a of the tether 42 and to an anchor 44 at a second end 42b of the tether 42. The anchor 44 may be adapted to anchor to a side wall of the small intestine 16. In some cases, the anchor 44 may be adapted to anchor to a side wall of the stomach 14. The anchor 44 may be adapted to penetrate tissue of the small intestine 16 or stomach 14. Other forms of anchors 44 are described with reference to later figures. Tether 42 may be adapted to help hold occlusion device 36 in place at its desired implantation location against movements caused by stomach 14 that tend to displace occlusion device 36. In some cases, anchor 44 may be attached to the small intestine, stomach, or even an adjacent ligament.

[0030] As shown, the occlusion device 36 includes an open proximal mouth 36a and a reduced diameter distal region 36b. Gastric contents within the stomach 14 pass through the open proximal mouth 36a and are directed toward and through the reduced diameter distal region 36b. From there, the stomach contents enter and pass through the liner 38. By the time the stomach contents exit the distal end 46 of the liner 38, the stomach contents have bypassed contact with a portion of the small intestine 16, including the duodenum 18 and a portion of the jejunum 24.

[0031] The occlusion device 36 may take a variety of forms. FIG. 3 is a schematic diagram of an exemplary occlusion device 45 shown positioned near the pyloric antrum 32. The occlusion device 45 includes an annular ring 47 sized to span the anatomical structure. It will be appreciated that the annular ring 47 may be sized to aid 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 annular ring 47 may have an overall diameter of 1-3 cm. If it is desired to position the occlusion device 45 within the pylorus 30, the annular ring 47 may have an overall diameter of 2-8 cm. If it is desired to position the occlusion device 45 within the pyloric antrum 32, the annular ring 47 may have an overall diameter of 4-12 cm.

[0032] Occlusion device 47 includes a tapered body 48 that tapers from annular ring 47 (which may be considered to define the maximum outer diameter of occlusion device 45) to a smallest diameter end 50. In some cases, liner 38 may extend distally from smallest diameter end 50. In some cases, a tether may be connected to tapered body 48. In some cases, the tether may extend outside of liner 38, as shown, for example, as tether 52a. In some cases, the tether may extend inside liner 38, into lumen 40, or even into a sidewall of liner 38, as shown, for example, as tether 52b.

[0033] The tapered body 48 may taper smoothly from a maximum outer diameter to a minimum outer diameter. The tapered body 48 may taper stepwise with one or more abrupt diameter changes. In some cases, the tapered body 48 may have a curved profile. The tapered body 48 may be adapted to allow substances, such as food, kettle, and other stomach contents, to pass through the tapered body 48 while preventing them from flowing around the outside of the tapered body 48. In some cases, the tapered body 48 may be constructed of an impermeable material, such as, but not limited to, a polymeric material. In some cases, the tapered body 48 may include a polymeric membrane disposed on some type of support frame (not shown).

[0034] The thickness, durometer, and lubricity of the polymeric material used to form the occlusion device 45 can vary along the length of the occlusion device 45. 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 a recess (not shown) to accommodate a support ring. In some cases, the occlusion device 45 can be collapsible to aid in deliverability.

[0035] Occlusion device 45 can be formed of any suitable polymeric or metallic material, so long as the material is adapted for long-term survival in the gastric environment. In some cases, occlusion device 45 can be formed of silicone or another polymer. Occlusion device 45 can be formed, for example, by 3D printing. In some cases, occlusion device 45 can be molded or even electrospun.

[0036] In some cases, the occlusion device 45 may include additional metal support (not shown) to help provide an outward radial force to better engage the anatomy. In some cases, the material used to form the occlusion device 45 may be thicker near the annular ring 47. The occlusion device 45 may be formed of a shape-memory material, allowing the occlusion device 45 to have a memorized configuration for deployment and to be temporarily deformed from the memorized configuration during delivery. Although not shown, the occlusion device 45 may include anchors such as outward prongs, hooks, splines, or tines. The occlusion device 45 may include a surface treatment to promote endothelialization. These are merely examples.

[0037] 4 is a schematic diagram of an exemplary occlusion device 54, which may be considered one example of occlusion device 45. Exemplary occlusion device 54 is formed of a single, continuous polymer body 56 that extends from an annular ring 58, which represents the maximum outer diameter of occlusion device 54, to a minimum diameter end point 60. Minimum diameter end point 60 may be considered to be adapted to be secured to a tether, such as tether 42. Annular ring 58 may be sized to position occlusion device 54 in a desired location relative to, for example, pyloric sphincter 20, pylorus 30, or antrum 32.

[0038] The obstructing device 54 may be considered deformable and endoscopically deliverable. The annular ring 56 is adapted to exert an outward radial force to engage an anatomical structure. If the obstructing device 54 is intended for deployment within the pyloric sphincter 20, the annular ring 58 may have an overall diameter of 1-3 cm. If the obstructing device 54 is intended for deployment within the pylorus 30, the annular ring 58 may have an overall diameter of 2-8 cm. If the obstructing device 54 is intended for deployment within the pyloric antrum 32, the annular ring 58 may have an overall diameter of 4-12 cm.

[0039] FIG. 5 is a schematic diagram illustrating an exemplary occlusion device 80, which may be an embodiment of occlusion device 45. The exemplary occlusion device 80 is shown within the anatomy and near the pyloric antrum 32. In some cases, the occlusion device 80 may occlude 10 to 50 percent of the stomach 14 and conform to the wall of the stomach 14. The occlusion device 80 includes a funnel-shaped or conical membrane funnel 82. The membrane funnel 82 may be formed, for example, from silicone or expanded polytetrafluoroethylene (e-PTFE). The membrane funnel 82 may be formed from polyurethane, which has high resistance to acids and chemicals. In some cases, low molecular weight resins, such as those available from Cray Valley under the name KRASOL®, may be blended into a highly chemically resistant polyurethane elastomer. In some cases, such polybutadiene-urethanes have rubbery properties, exceptional resistance to hydrolysis and chemicals, good elasticity, and may be reinforced using common rubber fillers.

[0040] The occlusion device 80 extends from an annular ring 84, which represents the largest outer diameter of the occlusion device 80, to a smallest diameter end point 86. The smallest diameter end point 86 may be considered adapted to be secured to the liner 38 (not shown). The smallest diameter end point 86 may be considered adapted to be secured to a tether, such as the tether 38 (not shown in FIG. 5). The annular ring 84, which may be a support ring added to the occlusion device 80, may be sized to position the occlusion device 80 in a desired location, for example, relative to the pyloric sphincter 20, the pylorus 30, or the pyloric antrum 32. If the occlusion device 80 is intended for deployment within the pyloric sphincter 20, the annular ring 84 may have an overall diameter of 1-3 cm. If the occlusion device 80 is intended for deployment within the pylorus 30, the annular ring 84 may have an overall diameter of 2-8 cm. If the occlusion device 80 is intended for deployment within the pyloric antrum 32, the annular ring 84 may have an overall diameter of 4-12 cm.

[0041] The annular ring 84 may be adapted to exert an outward radial force to help hold the occlusion device 80 in place against the anatomy. The occlusion device 80 may include, in part or in whole, a fabric or metal reinforcement, such as ultra-high weight polyethylene (UHMWPE) or nitinol. The occlusion device 80 may be manufactured by attaching the thin film funnel 82 to the annular ring 84 via, for example, sewing, suturing, thermal bonding, or chemical bonding.

[0042] 6, the occlusion device 80 may include a second, intermediate support ring 90 to help support the membrane funnel 82. The occlusion device 80 may include a third support ring, a fourth support ring, etc. The intermediate support ring 90 (and any support rings in addition to the annular ring 84) may be formed of a shape memory metal, such as a nickel-titanium alloy, including Nitinol. Although not shown, the occlusion device 80 may include anchors, such as outward prongs, hooks, splines, or tines. The occlusion device 80 may include a surface treatment to promote endothelialization.

[0043] 7 is a schematic diagram 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 secured to a liner, such as liner 38, and / or a tether, such as tether 42.

[0044] Maximum diameter opening 96 may be sized to position occlusion device 92 in a desired location relative to, for example, pyloric sphincter 20, pylorus 30, or antrum 32. If occlusion device 92 is intended for deployment within pyloric sphincter 20, maximum diameter opening 96 may have an overall diameter of 1-3 cm. If occlusion device 92 is intended for deployment within pylorus 30, maximum diameter opening 96 may have an overall diameter of 2-8 cm. If occlusion device 92 is intended for deployment within antrum 32, maximum diameter opening 96 may have an overall diameter of 4-12 cm.

[0045] The structured frame 94 can be a woven or braided structure. In some cases, the structured frame 94 can be a laser-cut structure. As shown, the structured frame 94 has a plurality of individual struts 102 connected to provide rigidity to the structured frame 94. The structured frame 94 is adapted to be shape-retentive, so that the structured frame 94 returns to an expanded configuration (as shown) after being compressed or compressed for delivery. The dimensions of the individual struts 102 can be varied to provide specific properties to the structured frame 94. The structured frame 94 can have a conical or funnel shape. The structured frame 94 can be spherical or hemispherical in shape. In some cases, the structured frame 94 can be formed from two or more different pieces secured together. In some cases, the structured frame 94 can be formed from laser-cut expandable tubing. The structured frame 94 can be a multi-fiber braided or woven structure. The structured frame 94 may be formed from separate wires that are soldered, welded, or otherwise joined together to form the structured frame 94. For example, the structured frame 94 may be cast from molten metal.

[0046] The occlusion device 92 includes a cover or coating 104 (shown with a dot pattern) covering at least a portion of the structured frame 94. The cover or coating 104 may be PTFE or e-PTFE. The cover or coating 104 may be silicone or another chemically resistant polymer. The cover or coating 104 may be applied via dip coating, spray coating, or electrospinning, for example. Although not shown, the occlusion device 92 may include anchors, such as outward prongs, hooks, splines, or tines. The occlusion device 92 may include a surface treatment to promote endothelialization.

[0047] 8 is a schematic diagram of an exemplary structured frame 106, which may be considered an example of structured frame 94. Structured frame 106 includes a plurality of outwardly extending tines 108 that help secure structured frame 106 (and thus an occlusion device including structured frame 106) in place within the anatomy. When included as part of an occlusion device, structured frame 106 would include a coating or covering, such as coating or covering 104 shown in FIG. 7.

[0048] 9-14D show examples of exemplary tethers that may be used as tether 42 as part of gastric bypass device 34. In some cases, tether 42 may simply be a spring adapted to provide a restoring spring force that increases by stretching as stomach movement moves occlusion device 36. The spring may be formed from any suitable polymeric or metallic material. In some cases, the spring may be formed from, for example, nitinol or stainless steel.

[0049] Springs can take several forms. In some cases, springs can have a varying diameter, with a smallest diameter at the midpoint and larger diameters at both ends. Springs can have a tapered diameter, from a largest diameter at one end to a smallest diameter at the other. Springs can have a uniform diameter and pitch from one end to the other. Springs can have a constant outer diameter but a varying pitch. Springs can have a tapered diameter, with a largest diameter in the middle and smallest diameters at both ends. These are just examples.

[0050] In some cases, particularly when tether 42 is positioned in a location where it may be exposed to fluids or other substances in the gastric system, the spring(s) may include a covering or coating. The covering or coating may reduce friction or other interaction with tissue in the gastric system. The covering or coating may reduce spring interaction with chyme and food, thereby potentially avoiding blockage. The covering or coating may act as a barrier against the harsh gastric environment. The covering or coating may reduce damage or inflammation in the bile duct and / or papilla. In some cases, the covering or coating may be ePTFE, PTFE, or other polymer.

[0051] FIG. 9A shows spring 294a having a cover 296 that encapsulates spring 294a and expands and contracts with spring 294a. FIG. 9b shows spring 294b having a cover 298 that allows spring 294b to move independently of cover 298. FIG. 9C shows spring 294c having a cover 300 that conforms to threads 302 forming spring 294c. FIG. 9D shows spring 294d having a cover 304 that is continuous with material 306 that forms at least a portion of the occlusion device. Spring 294 can be formed of any suitable polymeric or metallic material. In some cases, spring 294 can be formed of, for example, nitinol or stainless steel.

[0052] 10 is a schematic diagram of a portion of the gastrointestinal system showing the relative locations of a patient's bile duct 394, a patient's pancreatic duct 396, and a patient's papilla of vater 398. The papilla of vater 398 is where the bile duct 394 and pancreatic duct 396 fluidly connect with the duodenum 18. The papilla of vater 398 is located on the inner curve of the duodenum 18 and, in some cases, may protrude partway into the interior of the duodenum 18. A potential problem with placing a tether within the duodenum 18, particularly one that is placed outside the liner 38, is that the tether may irritate the papilla of vater 398, which may cause inflammation and, in turn, lead to various complications. In some cases, it may be desirable to provide a tether that avoids irritating the papilla of vater 398.

[0053] 11A, 11B, and 11C provide an embodiment of a tether adapted to avoid irritating the papilla of vater 398. In FIG. 11A, tether 412a includes a first spring segment 414 and a second spring segment 416, but does not include any metal structure between them. Instead, tether 412a includes an atraumatic covering 418 that encapsulates first spring segment 414 and second spring segment 416. The atraumatic covering 418 is constricted between the first spring segment 414 and the second spring segment 416 via a pair of sutures 420 that secure the atraumatic covering 418 to the ends of the first spring segment 414 and the second spring segment 416. Therefore, no metal is brought near the papilla of vater 398.

[0054] FIG. 11B shows tether 412b, similar to tether 400, but including an atraumatic covering 422 that encapsulates first spring segment 406, second spring segment 408, and member 410 extending therebetween. Optionally, as shown, a soft pillow 424 is disposed between first spring segment 406 and second spring segment 408 and held in place by atraumatic covering 422. Thus, no metal is near papilla 398. FIG. 11C shows tether 412c, including a spring 426 disposed within atraumatic covering 428. Spring 426 has a varying diameter, having a maximum diameter at either end of spring 426 and tapering to a minimum diameter near the midpoint of spring 426.

[0055] FIG. 12 illustrates a tether 430 including a physical standoff 432 disposed thereon, through which the tether 430 extends. It will be understood that the liner 38 is not shown here. In some cases, the physical standoff 432 may slide relative to the tether 430. In some cases, the physical standoff 432 is a braided structure formed of a metal such as Nitinol. In some cases, the physical standoff 432 may instead be inflatable, such as an inflatable balloon. As shown, the physical standoff 432 includes a first valve region 434 and a second valve region 436, with a reduced diameter portion 438 extending between the first valve region 434 and the second valve region 436. In some cases, the physical standoff 432 may further include additional valve regions.

[0056] 13 shows a tether 440 including a physical standoff 442 forming part of the tether 440. It will be understood that the liner 38 is not shown here. The tether 440 includes a first spring segment 444 and a second spring segment 446, with the physical standoff 442 disposed between the first spring segment 444 and the second spring segment 446. The physical standoff 442 may be welded, sewn, or glued to each of the first spring segment 444 and the second spring segment 446, for example. The physical standoff 442 may include a first valve region 444 and a second valve region 446, with a rigid member 448 extending between the first valve region 444 and the second valve region 446.

[0057] FIG. 14A is a schematic diagram of an exemplary tether 450. It will be understood that the liner 38 is not shown here. 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. 14B shows a first view of the arcuate segment 456, while FIG. 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 papilla of vater 398, as shown in FIG. 14D.

[0058] FIG. 15 schematically illustrates an exemplary gastric bypass device 460 shown positioned within the anatomy 10. The gastric bypass device 460 includes an occlusion device 462, which may be adapted to be positioned within the pyloric sphincter 20, the pylorus 30, or even the antrum 32, depending on the desired degree of occlusion of the stomach 14. In some cases, the occlusion device 462 may be referred to as a funnel device, for example. The gastric bypass device 460 includes a liner 464 extending distally from the occlusion device 462. In some cases, the liner 464 may be a separate component secured to the occlusion device 462, such as by adhesive or by other methods. In some cases, the liner 464 may be integrally formed with the occlusion device 462. The liner 464 may be referred to as a tubular extension and may be considered adapted to allow stomach contents to pass through and into the liner 464. The interior of liner 464 is fluidly coupled to the interior of occlusion device 462 .

[0059] In some cases, the liner 464 may terminate at the junction of the duodenum 18 and the jejunum 24. In some cases, the liner 464 may terminate anywhere along the duodenum 18 or the jejunum 24. In some cases, the liner 464 may terminate anywhere along the small intestine 16. The liner 464 may be a polymer sleeve or tube without any additional reinforcing members. As a result, the liner 464 may collapse if nothing passes through it. In some cases, the liner 464 may include rings or other structures adapted to help maintain its shape even when empty. The liner 464 may be selected from a variety of different liner sizes to achieve the desired effect. For example, selecting a smaller diameter liner 464 may slow gastric emptying, while selecting a larger diameter liner 464 may increase the rate of gastric emptying.

[0060] Tether 466 extends through duodenum 18 and has one end secured to occlusion device 462 and the other end secured to anchor 468. In some cases, as shown, anchor 468 may be a self-expanding structure, such as a braided or stent structure, adapted to engage small intestine 16. Tether 466 may be adapted to help retain occlusion device 462 in a desired implanted position against movements of stomach 14 tending to expel occlusion device 462.

[0061] FIG. 16 schematically illustrates an exemplary gastric bypass device 470 shown positioned within the anatomy 10. The gastric bypass device 470 includes an occlusion device 472, which may be adapted to be positioned within the pyloric sphincter 20 or 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 472 may be referred to as a funnel device, for example. The gastric bypass device 470 includes a liner 474 extending distally from the occlusion device 472. In some cases, the liner 474 may be a separate component secured to the occlusion device 472, such as by adhesive or by other methods. In some cases, the liner 474 may be integrally formed with the occlusion device 472. The liner 474 may in some cases be referred to as a tubular extension and may be considered adapted to allow stomach contents to pass through and into the liner 474. The interior of liner 474 is fluidly coupled to the interior of occlusion device 472 .

[0062] In some cases, the liner 474 may terminate at the junction of the duodenum 18 and the jejunum 24. In some cases, the liner 474 may terminate anywhere along the duodenum 18 or the jejunum 24. In some cases, the liner 474 may terminate anywhere along the small intestine 16. The liner 474 may be a polymer sleeve or tube without any additional reinforcing members. As a result, the liner 474 may collapse if nothing passes through it. In some cases, the liner 474 may include rings or other structures adapted to help maintain its shape even when empty. The liner 474 may be selected from a variety of different liner sizes to achieve the desired effect. For example, selecting a smaller diameter liner 474 may slow gastric emptying, while selecting a larger diameter liner 474 may increase the rate of gastric emptying.

[0063] Tether 476 extends through duodenum 18 and has one end secured to occlusion device 472 and the other end secured to anchor 478. In some cases, anchor 478 may be a frictional structure that extends distally within small intestine 16, as shown. In some cases, anchor 478 may be sufficiently long to allow the natural bends and curvatures of small intestine 16 to allow anchor 478 to sufficiently interact with small intestine 16 to provide an anchoring function. In some cases, anchor 478 may include an enlarged portion 479 that may provide additional frictional force between anchor 478 and small intestine 16. Tether 476 may be adapted to help retain occlusion device 472 in the desired implanted position against movement of stomach 14 attempting to expel occlusion device 472.

[0064] FIG. 17 schematically illustrates an exemplary gastric bypass device 480 shown positioned within the anatomy 10. The gastric bypass device 480 includes an occlusion device 482, which may be adapted to be positioned within the pyloric sphincter 20 or 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 482 may be referred to as a funnel device, for example. The gastric bypass device 480 includes a liner 484 extending distally from the occlusion device 482. In some cases, the liner 484 may be a separate component secured to the occlusion device 482, such as by adhesive or by other methods. In some cases, the liner 484 may be integrally formed with the occlusion device 482. The liner 484 may be referred to as a tubular extension and may be considered adapted to allow stomach contents to pass through and into the liner 484. The interior of liner 484 is fluidly coupled to the interior of occlusion device 482 .

[0065] In some cases, the liner 484 may terminate at the junction of the duodenum 18 and the jejunum 24. In some cases, the liner 484 may terminate anywhere along the duodenum 18 or the jejunum 24. In some cases, the liner 484 may terminate anywhere along the small intestine 16. The liner 484 may be a polymer sleeve or tube without any additional reinforcing members. As a result, the liner 484 may collapse if nothing passes through it. In some cases, the liner 484 may include rings or other structures adapted to help maintain its shape even when empty. The liner 484 may be selected from a variety of different liner sizes to achieve the desired effect. For example, selecting a smaller diameter liner 484 may slow gastric emptying, while selecting a larger diameter liner 484 may increase the rate of gastric emptying.

[0066] Tether 486 extends through duodenum 18 and has one end secured to occlusion device 462 and the other end secured to anchor 488. In some cases, as shown, anchor 488 may be secured to tissue of small intestine 16 or stomach 14. In some cases, anchor 488 may be adapted to extend through the side wall of the small intestine and the side wall of stomach 14. Tether 486 may be adapted to help retain occlusion device 482 in a desired implanted position against movement of stomach 14 that would tend to dislodge occlusion device 482.

[0067] In some cases, as shown, dynamic leash 490 extends between occlusion device 482 and anchor 488. In some cases, dynamic leash 490 is not secured to anchor 488, but instead may be adapted to be secured to an anchor location within the wall of stomach 14. In some cases, dynamic leash 490 may be a spring or may be adapted in some manner to provide a counterbalance to the force provided by tether 486. In some cases, tether 486 may act against proximal movement of occlusion device 462, and dynamic leash 490 may be adapted to act against distal movement of occlusion device 462, as the anatomy attempts to dislodge gastric bypass device 480 as a foreign body. The anatomy may view occlusion device 462 as a large, undigested piece of food and attempt to push occlusion device 462 proximally, i.e., back into the stomach, for further digestion.

[0068] The various components of the medical device systems described herein and materials that may be used for the various elements disclosed herein may include those commonly associated with medical devices. In some embodiments, the medical device systems described herein may be made from metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, and the like, or other suitable materials. Some examples of suitable metals and metal alloys include stainless steels such as 444V, 444L, and 314LV stainless steels; mild steels; nickel-titanium alloys such as linear elastic and / or superelastic nitinol; other nickel alloys, e.g., nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as INCONEL® 625; UNS: N06022, such as HASTELLOY® C-22®; HASTELLOY® C27®); 6 (registered trademark), other HASTELLOY® alloys, etc.), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035 such as MP35-N®), nickel-molybdenum alloys (e.g., HASTELLOY® ALLOY B2®, etc.), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc., cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS:R44003, such as ELGILOY®, PHYNOX®, etc.), platinum-rich stainless steel, titanium, combinations thereof, etc., or any other suitable material.

[0069] As mentioned herein, within the family of commercially available nickel-titanium or nitinol alloys, there is a category referred to as “linear elastic” or “non-superelastic,” which may be chemically similar to traditional shape memory and superelastic varieties but may exhibit unique and useful mechanical properties. Linear elastic and / or non-superelastic nitinol may be distinguished from superelastic nitinol in that linear elastic and / or non-superelastic nitinol does not exhibit a substantial “superelastic plateau” or “flag region” in its stress / strain curve as does superelastic nitinol. Instead, in linear elastic and / or non-superelastic nitinol, as recoverable strain increases, stress continues to increase in a substantially linear or somewhat, but not necessarily entirely, linear relationship until plastic deformation begins, or at least in a more linear relationship than the superelastic plateau and / or flag region that may be seen in superelastic nitinol. Thus, for purposes of this disclosure, linear elastic and / or non-superelastic nitinol may also be referred to as “substantially” linear elastic and / or non-superelastic nitinol.

[0070] In some cases, linear elastic and / or non-superelastic nitinol may also be distinguishable from superelastic nitinol in that linear elastic and / or non-superelastic nitinol can tolerate a maximum of about 2-5% strain while remaining substantially elastic (e.g., before plastic deformation), whereas superelastic nitinol can tolerate a maximum of about 8% strain before plastic deformation. Both of these materials may be distinguishable from other linear elastic materials, such as stainless steel (which may also be distinguished based on its composition), which can only tolerate a maximum of about 0.2-0.44% strain before plastic deformation.

[0071] In some embodiments, linear elastic and / or non-superelastic nickel-titanium alloys are alloys that do not exhibit a martensite / austenite phase change detectable by differential scanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA) analysis over a large temperature range. For example, in some embodiments, linear elastic and / or non-superelastic nickel-titanium alloys may not exhibit a martensite / austenite phase change detectable by DSC and DMTA analysis within a range of about -60 degrees Celsius (°C) to about 120°C. Thus, the mechanical bending properties of such materials may be substantially inert to the effects of temperature over this very wide temperature range. In some embodiments, the mechanical bending properties of linear elastic and / or non-superelastic nickel-titanium alloys at ambient or room temperature are substantially the same as those at body temperature, e.g., in that they do not exhibit a superelastic plateau and / or flag region. In other words, over a wide temperature range, linear elastic and / or non-superelastic nickel-titanium alloys maintain their linear elastic and / or non-superelastic properties and / or characteristics.

[0072] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy may range from about 50 to about 60 weight percent nickel, with the remainder essentially titanium. In some embodiments, the composition ranges from about 54 to about 57 weight percent nickel. One example of a suitable nickel-titanium alloy is FHP-NT alloy, commercially available from Furukawa Techno Material, Kanagawa Prefecture, Japan. Other suitable materials may include ULTANIUM™ (available from Neo-Metrics) and GUM METAL™ (available from Toyota). In some other embodiments, a superelastic alloy, such as superelastic nitinol, may be used to achieve the desired properties.

[0073] In at least some embodiments, some or all of the medical device system may also be doped with, made of, or otherwise include a radiopaque material. A radiopaque material is understood to be a material capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image assists a user in determining the location of the medical device system. Some examples of radiopaque materials include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, and the like. Additionally, other radiopaque marker bands and / or coils may also be incorporated into the design of the medical device systems described herein.

[0074] In some embodiments, a degree of Magnetic Resonance Imaging (MRI) compatibility is imparted to the medical device systems described herein. The medical devices described herein may be made of materials that do not substantially distort images and do not introduce substantial artifacts (e.g., gaps in the images). For example, certain ferromagnetic materials may not be suitable because they may introduce artifacts into MRI images. In some cases, the medical device systems, or portions thereof, may also be made from materials that MRI machines can image. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS:R44003, such as ELGILOY®, PHYNOX®, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R44035, such as MP35-N®), nitinol, and the like, among others.

[0075] In some embodiments, the medical device systems described herein may be made from or include a polymer or other suitable material. Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethanes (e.g., Polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyetheresters (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers such as HYTREL® available from DuPont), polyamides (e.g., DURETHAN® or Elf® available from Bayer), and the like. CRISTAMID® available from Atochem), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA, e.g., available under the trade name PEBAX®), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), MARLEX® high density polyethylene, MARLEX® low density polyethylene, linear low density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (e.g., EMS AmericanExamples of suitable materials include GRILAMID® (available from Grillon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxies, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, and the like. In some embodiments, the sheath can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6% LCP.

[0076] In some embodiments, the medical device systems disclosed herein and / or other elements disclosed herein may include a woven material disposed on or within the structure. The woven material may be composed of a biocompatible material, such as a polymeric material or a biomaterial, adapted to promote tissue ingrowth. In some embodiments, the woven material may include a bioabsorbable material. Some examples of suitable woven materials include, but are not limited to, polyethylene glycol (PEG), nylon, polytetrafluoroethylene (PTFE), ePTFE, polyethylene, polyolefin-based materials such as polypropylene, polyester, polyurethane, and / or blends or combinations thereof.

[0077] It will be understood that this disclosure is, in many respects, merely illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps, without exceeding the scope of the invention. This may include, to the extent appropriate, using any of the features of one illustrative embodiment in other embodiments. The scope of the invention is, of course, defined in the language in which the appended claims are expressed.

Claims

1. 1. An implantable medical device, comprising: the implantable medical device comprises an occlusion device adapted to be positioned within a patient's stomach against the patient's pylorus to prevent stomach contents from flowing around the occlusion device, the occlusion device including a distal outflow end; the implantable medical device comprises 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, wherein the liner is configured to allow stomach contents to flow into the occlusion device, through the liner, and out the distal end; The implantable medical device comprises a tether secured relative to the occlusion device and adapted to limit proximal movement of the occlusion device.

2. 10. The implantable medical device of claim 1, wherein the tether includes a proximal end at which the tether can be secured to the occlusion device and a distal end at which the tether can be secured to an anchor.

3. 3. The implantable medical device of claim 2, wherein the anchor is adapted to be fixed in place against a wall of the patient's small intestine or stomach.

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

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

6. 3. The implantable medical device of claim 2, wherein the tether further comprises an elongated friction anchor adapted to extend into the patient's small intestine.

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

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

9. The implantable medical device of any one of claims 1 to 8, wherein the liner comprises a polymeric tube.

10. 1. A gastric bypass device comprising: the gastric bypass device comprises a funnel device adapted to be positioned within the patient's stomach against the patient's pylorus to direct stomach contents to flow through the funnel device; the gastric bypass device comprising a tubular extension fluidly coupled to 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 stomach contents flowing through the funnel device and the tubular extension from contacting the upper portion of the small intestine; The gastric bypass device includes a tether secured relative to the funnel device and adapted to limit proximal movement of the funnel device.

11. 11. The gastric bypass device of claim 10, wherein the tether includes a proximal end at which the tether can be secured to the funnel device and a distal end at which the tether can be secured to an anchor.

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

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

14. 13. The gastric bypass device of claim 12, wherein the tether further comprises an elongated friction anchor adapted to extend into the patient's small intestine.

15. The gastric bypass device of any one of claims 10 to 14, further comprising a dynamic leash extending from the funnel device to an anchor location within the patient's stomach.

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