Tether for dynamic gastric bypass device

Abstract

A gastric bypass device includes an occlusion device adapted to be deployed relative to a pyloric sphincter of a patient; an anastomotic anchor adapted to be deployed relative to an anastomotic stoma between the patient's stomach and its small intestine; and a tether extending through the small intestine of the patient between the occlusion device and the anastomotic anchor. A dynamic cord may be fixed relative to the occlusion device and may cooperate with the tether to assist in holding the occlusion device in place.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 390,174, filed on July 18, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0002] The present invention relates to medical devices, such as gastric bypass devices. More particularly, the present invention relates to medical devices, such as dynamic gastric bypass devices, including a tether. Background Art

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

[0004] The present invention relates to medical devices, such as gastric bypass devices, and more particularly to medical devices, such as dynamic gastric bypass devices including a tether. An example can be found in an implantable medical device system. The implantable medical device system includes an occlusion device adapted to be fixed in position relative to a patient's pylorus; an anastomotic anchor adapted to be fixed in position relative to an anastomosis formed between a stomach wall of the patient and the patient's small intestine; and a tether adapted to extend through the patient's duodenum, the tether being fixed at a first end to the occlusion device and at a second end to the anastomotic anchor, the tether being adapted to resist degradation when exposed to gastric fluid.

[0005] Alternatively or additionally, the tether may include one or more springs adapted to extend from the first end of the tether to the second end of the tether.

[0006] Alternatively or additionally, the implantable medical device system may further include a covering disposed over at least a portion of the tether.

[0007] Alternatively or additionally, the cover may be adapted to move independently of the one or more springs.

[0008] Alternatively or additionally, the cover may be adapted to move with movement of one or more springs.

[0009] Alternatively or additionally, the tether may have a hard stop by virtue of threads extending through the one or more springs, thereby limiting extension of the one or more springs.

[0010] Alternatively or additionally, the tether may comprise an elastic material disposed within the cover.

[0011] Alternatively or additionally, the cover may comprise a permeable cover.

[0012] Alternatively or additionally, the cover may comprise an impermeable cover.

[0013] Alternatively or additionally, the tether may include a first attachment member adapted to be secured to the occlusive device; a second attachment member adapted to be secured to the anastomotic anchor; and a spring extending from a first end closer to the first attachment member to a second end closer to the second attachment member; wherein the first attachment member is secured to the second end of the spring and the second attachment member is secured to the first end of the spring, such that tension applied to the first attachment member or the second attachment member acts to compress the spring.

[0014] Alternatively or additionally, the tether may comprise a torsion spring or a leaf spring.

[0015] Alternatively or additionally, the tether may include a braided member.

[0016] Alternatively or additionally, the tether may further include a covering disposed over at least a portion of the braided member.

[0017] Alternatively or additionally, the tether may include a collet that allows the tether to move relative to the collet in a first direction but not in an opposite direction, such that the collet is adapted to provide unidirectional length adjustment of the tether.

[0018] Alternatively or additionally, the tether may comprise a pneumatic cylinder.

[0019] Alternatively or additionally, the tether may include a threaded connector.

[0020] Another example can be found in a tether adapted for use in a gastric bypass system, the tether adapted to extend within a patient's duodenum between an occluding device adapted to be deployed relative to the patient's pylorus and an anastomotic anchor adapted to be secured in position relative to an anastomosis formed between the patient's stomach wall and the patient's small intestine. The tether includes an elongated member extending from a first region adapted to be secured to the occluding device to a second region adapted to be secured to the anastomotic anchor. The elongated member includes an intermediate portion disposed between the first region and the second region, the intermediate portion adapted to avoid contact with the patient's papilla of Vaters so as to avoid irritation of the patient's papilla of Vaters.

[0021] Alternatively or additionally, the intermediate portion may have a reduced outer diameter relative to the outer diameter of the first region and the outer diameter of the second region.

[0022] Alternatively or additionally, the first region may include a first spring and the second region may include a second spring.

[0023] Alternatively or additionally, the tether may further include a physical abutment disposed on the tether, the physical abutment being adapted to space the tether away from the patient's Vater's nipple.

[0024] Alternatively or additionally, the intermediate portion of the elongate member may include an arcuate member adapted to fit around a patient's Vater's nipple.

[0025] Another example can be found in a tether adapted for use in a gastric bypass system, the tether adapted to extend within a patient's duodenum between an occluding device adapted to be deployed relative to the patient's pylorus and an anastomotic anchor adapted to be secured in position relative to an anastomosis formed between the patient's stomach wall and the patient's small intestine. The tether includes an elastic member adapted to extend from a first end of the tether to a second end of the tether; and an impermeable cover disposed on the elastic member.

[0026] Alternatively or additionally, the impermeable covering may be adapted to move independently of the elastic member.

[0027] Alternatively or additionally, the impermeable covering may be adapted to move with movement of the elastic member.

[0028] Alternatively or additionally, the resilient member may comprise one or more metal springs.

[0029] The above summary of some embodiments, aspects and / or examples is not intended to describe every embodiment or every implementation of the present invention. The following figures and detailed description more particularly exemplify these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The present invention may be more fully understood by considering the following detailed description of various embodiments in conjunction with the accompanying drawings, in which:

[0031] Figure 1 is a schematic diagram of a portion of the human gastrointestinal (GI) system;

[0032] Figure 2 Is set in Figure 1 A schematic diagram of an illustrative gastric bypass system within a GI system shown, the illustrative gastric bypass system including an occlusion device, an anastomotic anchor, a tether, and a dynamic tether;

[0033] Figures 3 to 26 It is available for Figure 2 A schematic diagram of an illustrative occlusion device of an illustrative gastric bypass system;

[0034] Figures 27 to 32BIt is available for Figure 2 Schematic diagram of an illustrative anastomotic anchor and ring of an illustrative gastric bypass system;

[0035] Figures 33 to 47 It is available for Figure 2 Schematic diagrams of illustrative tethers of illustrative gastric bypass systems, some of which are shown in conjunction with occlusion devices;

[0036] Fig.48 is a schematic diagram of a portion of the human gastrointestinal (GI) system;

[0037] Figures 49 to 53D It can be used to protect the Vater's nipple Figure 2 a schematic diagram of an illustrative tether of an illustrative gastric bypass system;

[0038] Figure 54 to Figure 59 It is available for Figure 2 Schematic diagram of the dynamic cord of an illustrative gastric bypass system;

[0039] Fig.60 and Fig.61 is a schematic diagram of the auxiliary engagement device; and

[0040] Fig.62 is a schematic diagram of a device that integrates stoma creation and gastric bypass system delivery; and

[0041] Fig.63 is a schematic diagram of the resulting anastomosis and gastric bypass system.

[0042] Although the various aspects of the present invention are suitable for various modifications and alternative forms, the specific details thereof have been shown in the accompanying drawings by way of example and will be described in more detail. However, it should be understood that the present invention is not intended to limit the various aspects of the present invention to the specific embodiments described. On the contrary, it is intended to cover all modifications, equivalents and substitutes that fall within the spirit and scope of the present invention. DETAILED DESCRIPTION

[0043] The following description should be read with reference to the accompanying drawings, which are not necessarily drawn to scale, in which the same reference numerals in the several views indicate the same elements. The detailed description and the accompanying drawings are intended to illustrate, but not to 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 invention. The detailed description and the accompanying drawings illustrate example embodiments of the claimed invention.

[0044] For the following defined terms, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0045] All numerical values ​​are assumed to be modified by the term "about" herein, whether or not explicitly indicated. In the context of numerical values, the term "about" generally refers to a numerical range that one skilled in the art considers to be equivalent to the quoted value (e.g., having the same function or result). In many cases, the term "about" may include numbers rounded to the nearest significant figure. Unless otherwise specified, 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 and consistent with the context of this specification.

[0046] 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).

[0047] Although some suitable sizes, ranges and / or values ​​are disclosed for various components, features and / or specifications, those skilled in the art to which the present invention relates will understand that the desired sizes, ranges and / or values ​​may be derived from those explicitly disclosed.

[0048] As used in this specification and the appended claims, the singular forms "a", "an" and "the" include plural referents unless the content clearly indicates otherwise. As used in this specification and the appended claims, the term "or" is generally used in a sense that includes "and / or" unless the content clearly indicates otherwise. It should be noted that, for ease of understanding, certain features of the present invention may be described in the singular, even if those features may be plural or repeated in the disclosed embodiments. Each instance in a feature may include and / or contain a singular disclosure unless explicitly indicated to the contrary. For simplicity and clarity, not all elements of the disclosed invention will necessarily be shown in each figure or discussed in detail below. However, it should be understood that, unless explicitly stated to the contrary, the following discussion may be equally applicable to any and / or all of the components where there is more than one. Additionally, for clarity, all instances of some elements or features may not be shown in each figure.

[0049] Relative terms, such as "proximal", "distal", "advance", "retraction", variations thereof, and the like, may generally be considered with respect to the positioning, orientation, and / or operation of various elements relative to a user / operator / manipulator of the device, wherein "proximal" and "retraction" represent or refer to being closer to or toward the user and "distal" and "advance" represent or refer to being farther from or away from the user. In some cases, the term "distal" refers to moving farther into the gastrointestinal system, and the term "proximal" refers to moving out of the gastrointestinal system. In some cases, the terms "proximal" and "distal" may be arbitrarily assigned to facilitate understanding of the present invention, and this will be apparent to the skilled person. Other relative terms, such as "upstream", "downstream", "inflow", and "outflow" refer to the direction of fluid flow in a cavity, such as a body cavity, a blood vessel, or within a device.

[0050] The term "range" may be understood as the maximum measurement of a described or identified dimension. For example, "external range" may be understood to mean the maximum external dimension, "radial range" may be understood to mean the maximum radial dimension, "longitudinal range" may be understood to mean the maximum longitudinal dimension, and so on. Each instance of "range" may be different (e.g., axial, longitudinal, transverse, radial, circumferential, etc.) and will become apparent to a skilled person based on the context of individual use. Typically, "range" may be viewed as the maximum possible dimension measured based on the intended use. In some cases, "range" may typically be measured orthogonally within a plane and / or cross section, but as will be apparent based on the particular context, it may also be measured differently, such as, but not limited to, angularly, radially, circumferentially (e.g., along an arc), and the like.

[0051] It should be noted that references to "one embodiment," "some embodiments," "other embodiments," etc. indicate that the described embodiments may include a particular feature, structure, or characteristic, but each embodiment may not necessarily include the particular feature, structure, or characteristic. Furthermore, these phrases do not necessarily refer to the same embodiment. Furthermore, when a particular feature, structure, or characteristic is described in conjunction with an embodiment, it is within the knowledge of those skilled in the art to use the particular feature, structure, or characteristic in conjunction with other embodiments, whether or not explicitly described, unless explicitly stated to the contrary. That is, the various individual elements described below, even if not explicitly shown in a particular combination, may still be considered to be combinable or arranged with each other to form other additional embodiments, or to supplement and / or enrich the described embodiments, as will be understood by those of ordinary skill in the art.

[0052] For the sake of clarity, various descriptions and / or claimed features may be named and / or distinguished using certain identifying digital nomenclature (e.g., first, second, third, fourth, etc.) throughout the specification and / or claims. It should be understood that the digital nomenclature is not intended to be limiting and is merely exemplary. In certain embodiments, for simplicity and clarity, the digital nomenclature previously used may be changed and deviated from. That is, the feature identified as a "first" element may be referred to as a "second" element, a "third" element, etc., later, or may be omitted completely, and / or different features may be referred to as a "first" element. The meaning and / or name in each case will be apparent to the technician.

[0053] The present invention relates to devices and methods for treating conditions such as obesity and metabolic diseases. For example, methods and devices are provided herein for bypassing portions of the GI tract to reduce nutrient turnover, reduce weight, and / or improve diabetes control.

[0054] Figure 1 1 is a schematic diagram of a portion of a human digestive tract 10. The digestive tract 10 includes an esophagus 12, a stomach 14, and a small intestine 16. The esophagus 12 connects the mouth to the stomach 14 and delivers food to the stomach 14. The stomach 14 secretes digestive enzymes and gastric acid to help digest food. The small intestine 16 is an organ where most nutrients and minerals are absorbed from food. The small intestine 16 includes the duodenum 18, the jejunum 24, and the ileum (not shown). The pyloric sphincter 20 controls the passage for the movement of partially digested food 22 from the stomach 14 to the duodenum 18, which can be about 25-38 centimeters (cm) long. The food is then delivered to the jejunum 24, which can be about 2.25-2.75 meters (m) long. It should be understood that these dimensions are illustrative only and may vary from patient to patient.

[0055] An anastomosis 26 may be created between the stomach 14 and the small intestine 16. In some cases, an anastomosis 26 may be created between the stomach 14 and the duodenum 18. In some cases, an anastomosis 26 may be created between the stomach 14 and the jejunum 24. As an example, the anastomosis 26 may be created by a gastrojejunostomy. The anastomosis 26 may allow food to bypass the duodenum 18 and move directly from the stomach 14 to the jejunum 24. In some cases, the anastomosis 26 may include a stent, staples, magnets, balloons, or other structures to maintain the opening and connection between the stomach 14 and the small intestine 16. In some cases, the diameter of the anastomosis 26 may be about 1-4 cm. In some cases, the stomach 14 may be considered to include a pylorus 30, which is positioned just upstream of the pyloric sphincter 20. The diameter of the pylorus 30 may be considered to be greater than the diameter of the pyloric sphincter 20. The stomach 14 may be considered to include a gastric antrum 32 positioned just upstream of the pylorus 30. The diameter of the gastric antrum 32 may be considered to be larger than the diameter of the pylorus 30 .

[0056] Figure 2 An illustrative gastric bypass device 34 is schematically shown, which is shown disposed within the anatomical structure 10. The gastric bypass device 34 includes an occluding device 36, which may be adapted to be placed within the pyloric sphincter 20, or within the pylorus 30, or within the gastric antrum 32, depending on the desired degree of occlusion of the stomach 14. In some cases, the occluding device 36 may be adapted to be placed within the gastric antrum 32. The gastric bypass device 34 includes an anastomotic anchor 38, which may be adapted to be secured relative to the anastomosis 26. In some cases, the anastomotic anchor 38 may be adapted to be secured to an anastomotic structure (not shown) that may be present within the anastomosis 26 in order to maintain the anastomosis 26 and secure the anastomosis 26 together.

[0057] Since the occluding device 36 is a foreign body, the stomach 14 may attempt to push the occluding device 36 out of the pyloric sphincter 20 and down into the duodenum 18. The stomach 14 may attempt to push the occluding device 36 out of the pyloric sphincter 20 and back into the stomach 14 itself. A tether 40 extends through the duodenum 18 and is secured to the occluding device 36 at a first end 40a of the tether 40 and to the anastomotic anchor 38 at a second end 40b of the tether 40. The tether 40 may be adapted to help maintain the occluding device 36 in its desired implanted position to prevent movement caused by the stomach 14 attempting to dislodge the occluding device 36. In some cases, a dynamic tether 42 extends between the occluding device 36 and the anastomotic anchor 38 and may be adapted to help maintain the occluding device 36 at its desired position. In some cases, the dynamic tether 42 may extend from the occluding device 36 to an anchoring position within the wall of the stomach 14. In some cases, the occluder device 36 can include one or more anti-migration features, such as hooks or tines or perhaps a high friction coating on at least a portion of the occluder device 36. In some cases, the anastomotic anchor 38 can also include additional anti-migration features.

[0058] The gastric bypass device 34 is shown schematically because each of the components of the gastric bypass device 34, including the occlusive device 36, the anastomotic anchors 38, the tethers 40, and the dynamic cords 42, may take a variety of different forms. Figures 3 to 26 Illustrative but non-limiting examples of possible occluding devices 36 are provided. Figures 27 to 32B Illustrative but non-limiting examples of possible anastomotic anchors 38 are provided. Figures 33 to 53D Illustrative but non-limiting examples of possible tethers 40 are provided. Figure 54 to Figure 59 Illustrative but non-limiting examples of possible dynamic tethers 42 are provided. It should be understood that a gastric bypass device, such as gastric bypass device 34, may include any of occlusion devices 36, any of anastomotic anchors 38, any of tethers 40, and any of dynamic tethers 42.

[0059] In some cases, the occluding device may be disposed within or upstream of the pyloric sphincter 20. In some cases, the occluding device may be disposed within the pylorus 30, depending on the degree to which the physician or other professional desires to occlude the stomach 14. The occluding device 36 may be disposed within the antrum 32 or may extend to the antrum 32. Figures 3 to 26 Examples of illustrative occlusive devices that may be used as occlusive device 36 as part of gastric bypass device 34 are provided.

[0060] Figure 3 is a schematic diagram of an illustrative occlusive device 44 shown disposed proximate to the gastric antrum 32. The occlusive device 44 includes an annular ring 46 that is sized to span the anatomical structure. It should be appreciated that the annular ring 46 can be sized to assist in positioning the occlusive device 44 at a desired location within the anatomical structure. For example, if it is desired to position the occlusive device 44 within the pyloric sphincter 20, the annular ring 46 can have an overall diameter of 1 to 3 cm. If it is desired to position the occlusive device 44 within the pylorus 30, the annular ring 46 can have an overall diameter of 2 to 8 cm. If it is desired to position the occlusive device 44 within the gastric antrum 32, the annular ring 44 can have an overall diameter of 4 to 12 cm.

[0061] The occluder 46 includes a cone 48 that tapers from the annular ring 46 (which can be considered to define the maximum outer diameter of the occluder 44) to a minimum diameter endpoint 50. For example, the minimum diameter endpoint 50 can be adapted to be fixed to a tether 52. The cone 48 can taper smoothly from its maximum outer diameter to its minimum outer diameter. The cone 48 can taper gradually, with one or more sudden diameter changes. In some cases, the cone 48 can have a curved profile. The cone 48 can be adapted to prevent substances, such as food, chyme, and other gastric contents from flowing through the cone 48. In some cases, the cone 48 can be made of an impermeable material, such as, but not limited to, a polymer material. In some cases, the cone 48 can include a polymer film that is disposed on some kind of support frame (not shown).

[0062] The thickness, hardness and lubricity of the polymer material used to form the occluder 54 can vary along the length of the occluder 44. For example, the occluder 44 can have a funnel shape or a cyclone shape. The occluder 44 can have a hemispherical or even spherical shape. The occluder 44 may include a notch (not shown) to accommodate the support ring. In some cases, the occluder 44 can collapse to help achieve deliverability. The occluder 44 may include a membrane or other covering that spans the opening defined by the annular ring 46 to prevent material from accumulating in the occluder 44.

[0063] The occlusive device 44 can be formed of any suitable polymer or metal material as long as the material is suitable for long-term survival in the gastric environment. In some cases, the occlusive device 44 can be formed of silicone or another polymer. For example, the occlusive device 54 can be formed via 3D printing. In some cases, the occlusive device 54 can be molded or even electrospun.

[0064] In some cases, the occluder 44 may include an additional metal stent (not shown) to help provide an outward radial force to better engage the anatomical structure. In some cases, the material used to form the occluder 44 may be thicker near the annular ring 46. The occluder 44 can be formed of a shape memory material that allows the occluder 44 to have a memory shape for deployment and to be temporarily deformed from the memory shape during delivery. Although not shown, the occluder 44 may include an anchor, such as an outward tine, hook, spline or tine. The occluder 44 may include a surface treatment that promotes endothelialization. These are just examples.

[0065] Figure 4 is a schematic diagram of an illustrative occlusive device 54 that may be considered an example of an occlusive device 44. The illustrative occlusive device 54 is formed of a single continuous polymeric body 56 that extends from an annular ring 58 representing the maximum outer diameter of the occlusive device 54 to a minimum diameter endpoint 60. The minimum diameter endpoint 60 may be considered suitable for securing to a tether, such as the tether 40. For example, the annular ring 58 may be sized to position the occlusive device 54 in a desired position relative to the pyloric sphincter 20, the pylorus 30, or the gastric antrum 32.

[0066] The occluding device 54 can be considered deformable and endoscopically deliverable. The annular ring 56 can be adapted to apply an outward radial force to engage the anatomical structure. If the occluding device 54 is intended to be deployed within the pyloric sphincter 20, the annular ring 58 can have an overall diameter of 1 to 3 cm. If the occluding device 54 is intended to be deployed within the pylorus 30, the annular ring 58 can have an overall diameter of 2 to 8 cm. If the occluding device 54 is intended to be deployed within the gastric antrum 32, the annular ring 44 can have an overall diameter of 4 to 12 cm.

[0067] Figure 532 is a schematic diagram of an illustrative occluding device 62 shown as being disposed near the gastric antrum 32. The occluding device 62 has an inflatable body 64 that can be filled with gas or other fluids, such as saline, to maintain its inflated shape (as shown). The inflatable body 64 can be, for example, an inflatable balloon. In some cases, the occluding device 62 can be delivered together with the inflatable body 64 in a contracted configuration. Once the occluding device 62 reaches its desired deployment position, the inflatable body 64 can be filled with gas or other fluids or can be a gel to expand to its expanded configuration (as shown). For example, the inflatable body 64 can have a spherical or hemispherical shape and can have a maximum outer diameter that helps position the occluding device 62 relative to the anatomical structure. If the occluding device 62 is intended to be deployed within the pyloric sphincter 20, the inflatable body 64 can have a maximum diameter of 1 to 3 cm. If the occluding device 62 is intended to be deployed within the pylorus 30, the inflatable body 64 can have a maximum diameter of 2 to 8 cm. If the occluding device 62 is intended to be deployed within the gastric antrum 32, the inflatable body 64 may have a maximum diameter of 4 to 12 cm.

[0068] The occlusive device 62 can be formed of any material, such as a polymer material that can withstand the highly acidic gastric environment. As an example, the occlusive device 62 can be formed of silicone, however the occlusive device 62 can also include additional fiber reinforcement. For example, the occlusive device 62 can be formed via 3D printing. The occlusive device 62 can be molded or electrospun. The occlusive device 62 can be formed via dip coating. As another example, the occlusive device 62 can be formed by electrospinning two halves and then dipping the two halves together to form the occlusive device 62. The occlusive device 62 includes an attachment point 66, which is suitable for fixing to a tether 68.

[0069] In some cases, the inflatable body 64 may have a stiffness profile that may vary. The inflatable balloon 64 may have relative flexibility, which allows the wall of the inflatable body 64 to compress and expand with peristalsis. The inflatable balloon 64 may have relative rigidity, thereby helping to fix the occlusion device 62 in a suitable position relative to the gastric antrum 32. In some cases, the occlusion device 62 may have a variety of different shapes. The occlusion device 62 may have a three-dimensional funnel shape. The occlusion device 62 may have a hemispherical top or may not have a hemispherical top. The occlusion device 62 may have an undefined organic shape. The occlusion device 62 may include one or more protruding lips or rings that help to fix the occlusion device 62 in a suitable position relative to the anatomical structure. Although not shown, the occlusion device 62 may include anchors, such as outward forks, hooks, splines or tines. The occlusion device 62 may include a surface treatment that promotes endothelialization.

[0070] Although shown as being deployed within the gastric antrum 32, this need not be done in all cases. For example, the occluding device 62 may extend through the gastric antrum 32 and partially into the duodenum 18. In some cases, such as Figure 6 As shown, the occlusive device 62 can extend from the antrum 32, through the pyloric sphincter 20, through the entire duodenum 18 and up through the anastomosis 26. Thus, the occlusive device 62 can act as an occlusive device, a tether, and an anastomotic anchor. Figure 6 An occluder device 70 is shown having a first end 22 positioned proximate the pyloric sphincter 20 and a second end 74 extending through the anastomosis 26. The occluder device 70 includes an elongated inflatable body 76 extending from the first end 72 of the occluder device 70 through the duodenum 18 to the second end 74 of the occluder device 70. As shown, a deployment feature 78 extends into the stomach 14 and reaches the second end 74 of the occluder device 70.

[0071] Figure 7 is a schematic diagram of an illustrative occlusive device 80 that can be considered as an example of an occlusive device 44. The illustrative occlusive device 80 is shown within the anatomical structure and is shown near the gastric antrum 32. In some cases, the occlusive device 80 can occlude 10% to 50% of the stomach 14 and can conform to the wall of the stomach 14. The occlusive device 80 includes a funnel-shaped or conical film funnel 82. For example, the film funnel 82 can be formed of silicone or expanded polytetrafluoroethylene (e-PTFE). The film funnel 82 can be formed of a polyurethane with high acid resistance and high chemical resistance. In some cases, a low molecular weight resin (such as that available from Cray Valley under the name Krasol) can be mixed into a polyurethane elastomer with high chemical resistance. In some cases, this polybutadiene-polyurethane has rubber properties, excellent hydrolysis resistance and chemical resistance, good elasticity, and can be reinforced using ordinary rubber fillers.

[0072] The occluding device 80 extends from an annular ring 84, which represents the maximum outer diameter of the occluding device 80, to a minimum diameter endpoint 86. The minimum diameter endpoint 86 can be considered suitable for fixing to a tether 88. The large end of the occluding device 80 can be covered or uncovered. For example, the annular ring 84, which can be a support ring added to the occluding device 80, can be sized to position the occluding device 80 in a desired position relative to the pyloric sphincter 20, the pylorus 30, or the gastric antrum 32. If the occluding device 80 is intended to be deployed within the pyloric sphincter 20, the annular ring 84 can have an overall diameter of 1 to 3 cm. If the occluding device 80 is intended to be deployed within the pylorus 30, the annular ring 84 can have an overall diameter of 2 to 8 cm. If the occluding device 80 is intended to be deployed within the gastric antrum 32, the annular ring 84 can have an overall diameter of 4 to 12 cm.

[0073] The annular ring 84 can be adapted to exert an outward radial force to help maintain the occluding device 80 in position relative to the anatomical structure. The occluding device 80 can include partial or full fiber or metal reinforcement, such as ultra-high molecular weight polyethylene (UHMWPE) or Nitinol. The occluding device 80 can be manufactured by attaching the film funnel 82 to the annular ring 84 via, for example, sewing, suturing, thermal bonding, or chemical bonding.

[0074] In some cases, such as Figure 8 As shown, the occluding device 80 may include a second intermediate support ring 90 that helps support the film funnel 82. The occluding device 80 may include a third support ring, a fourth support ring, etc. The intermediate support ring 90 (and the support rings added to the annular ring 84) may be formed of a shape memory metal, such as a nickel titanium alloy, including Nitinol. Although not shown, the occluding device 80 may include anchors, such as outward prongs, hooks, splines or tines. The occluding device 80 may include a surface treatment that promotes endothelialization.

[0075] Fig. 9 is a schematic diagram of an illustrative occluder device 92. The illustrative occluder device 92 has a structural frame 94 extending from a maximum diameter opening 96 to a minimum diameter endpoint 98. The minimum diameter endpoint 98 is adapted to be secured to a tether 100. In some cases, the maximum diameter opening 96 may include a cover (not shown) spanning the opening. If a cover is included, the cover may be concave or convex.

[0076] For example, the maximum diameter opening 96 can be sized to position the occluding device 92 in a desired location relative to the pyloric sphincter 20, the pylorus 30, or the gastric antrum 32. If the occluding device 92 is intended to be deployed within the pyloric sphincter 20, the maximum diameter opening 96 can have an overall diameter of 1 to 3 cm. If the occluding device 92 is intended to be deployed within the pylorus 30, the maximum diameter opening 96 can have an overall diameter of 2 to 8 cm. If the occluding device 92 is intended to be deployed within the gastric antrum 32, the maximum diameter opening 96 can have an overall diameter of 4 to 12 cm.

[0077] The structured frame 94 can be woven or braided. In some cases, the structured frame 94 can be a laser-cut structure. As shown, the structured frame 94 has many individual pillars 102, which are connected to provide rigidity to the structured frame 94. The structured frame 94 is suitable for having a shape retention so that the structured frame 94 is compressed or otherwise compressed for delivery and then returns to an expanded form (as shown). The size of the individual pillars 102 can be changed to provide specific properties for the structured frame 94. The structured frame 94 can have a cone or funnel shape. The shape of the structured frame 94 can be spherical or hemispherical. In some cases, the structured frame 94 can be formed by two or more different parts fixed together. In some cases, the structured frame 94 can be formed by an expandable tube cut by laser. The structured frame 94 can be a multi-fiber braid or woven structure. The structured frame 94 can be formed by welding, welding or otherwise combining together to form discrete lines of the structured frame 94. For example, the structured frame 94 can be cast by molten metal.

[0078] The occluder 92 includes a covering or coating 104 (shown in a dotted pattern) that covers at least a portion of the structural frame 94. The covering or coating 104 can be PTFE or e-PTFE. The covering or coating 104 can be silicone or another chemically resistant polymer. For example, the covering or coating 104 can be applied via dip coating, spray coating, or electrospinning. Although not shown, the occluder 92 can include anchors, such as outward tines, hooks, splines, or tines. The occluder 92 can include a surface treatment that promotes endothelialization.

[0079] Fig.10 is a schematic diagram of an illustrative structural frame 106 that may be considered an example of the structural frame 94. The structural frame 106 includes a plurality of outwardly facing tines 108 that assist in anchoring the structural frame 106 (and an occlusive device including the structural frame 106) in place within the anatomical structure. When included as part of an occlusive device, the structural frame 106 will include a coating or covering, such as Fig. 9 A coating or covering 104 is shown.

[0080] Fig.11 is a schematic diagram of an illustrative structural frame 110 that can be considered an example of the structural frame 94. The structural frame 110 is an example of a braided structure. When used as part of an occlusive device, the structural frame 106 will include a coating or covering, such as Fig. 9 A coating or covering 104 is shown.

[0081] Fig.12is a schematic diagram of an illustrative occlusive device 112. The illustrative occlusive device 112 includes a coiled support wire 114 extending from a maximum diameter end 116 to a minimum diameter end point 118 adapted to be secured to a tether 120. The coiled support wire 114 supports a membrane 122 covering the coiled support wire 114, thereby blocking gastric contents from passing through the occlusive device 112 and into the duodenum 18. In some cases, the coiled support wire 114 is formed of a shape memory material, such as nitinol.

[0082] Figures 13 to 16 is a schematic diagram of an illustrative occluder device including radial support members supporting an occluder cover. In some cases, the radial support members are incompressible to ensure engagement of the occluder cover. The support members are adapted to achieve better self-alignment and engagement of the occluder cover. The occluder device has an open structure that allows any chyme that escapes past the occluder cover to pass through the pylorus. The occluder cover exerts an outward radial force to help anchor the occluder device relative to the anatomical structure.

[0083] Fig.13 is a schematic diagram of an illustrative occluder device 124. The illustrative occluder device 124 includes a plurality of radial support members 126 extending from a starting point 128 to a terminal end 130, wherein the terminal end 130 defines a maximum outer diameter of the occluder device 124. In some cases, as shown, the occluder device 124 includes an occluder cover 132 located at the terminal end 130.

[0084] The radial support members 126 can be metal or polymer. In some cases, the radial support members 126 are shape memory metals, such as nitinol. The radial support members 126 can be wound or bent to enable a reduced size for transportability. The radial support members 126 can be located within the pylorus 30 or even extend into the duodenum 18 to reduce possible damage to the pyloric sphincter 20. Although not shown, the radial support members 126 can be covered with a film or other material to form a cone. In some cases, the opening of the cone can also be covered with a film or other material.

[0085] The occlusive disc 132 can be formed of a polymer, such as silicone, ePTFE, or a fabric or metal mesh. In some cases, the occlusive disc 132 can include a support ring 134. If included, the support ring 134 can be polymeric or metallic. In some cases, the support ring 134 can be formed of nitinol. Although not shown, the occlusive disc 132 can include outwardly facing tines, hooks, splines, or prongs to help engage tissue and thus help anchor the occlusive device 124 in place.

[0086] Fig.14is a schematic diagram of an illustrative occluder device 136. The illustrative occluder device 136 is similar to the occluder device 124, but includes a support ring 138 located midway between the start point 128 and the end point 130. Fig.15 is a schematic diagram of an illustrative occluder device 140. The illustrative occluder device 136 is similar to the occluder device 124, but includes a first support ring 142 and a second support ring 144.

[0087] Fig.16 1 is a schematic diagram of an illustrative occlusive device 146. The illustrative occlusive device 146 is similar to the occlusive devices 124, 136, and 140, but presents a slight rearrangement. The radial support member 126 extends to an anchoring ring 148 formed at the terminal end 130. The anchoring ring 148 is adapted to secure the occlusive device 146 in place within the anatomical structure. The occlusive device 146 includes an occlusive disk 150 positioned intermediate the starting point 128 and the terminal end 130.

[0088] Figures 17 to 19 is a schematic diagram of an occluding device made of or otherwise including a bellows. The bellows may be formed of any suitable polymer or metal material, and the bellows may be collapsed such that the occluding device including the bellows may be delivered endoscopically.

[0089] Fig.17 The occluding device 152 is shown in a collapsed configuration, and Fig.18 1 shows an occluding device 152 in an expanded configuration. The occluding device 152 extends from a first end 154 to a second end 156. Fig.18 As shown, the first end 154 defines the largest outer diameter portion of the occluding device 152 , while the second end 156 defines the smallest outer diameter portion of the occluding device 152 and is adapted to extend through the pyloric sphincter 20 , wherein the second end 156 faces the interior of the stomach 14 .

[0090] The corrugations may extend the length of the occluding device 152. In some cases, such as Fig.19 As shown, the corrugation may only form the second end 156, wherein the membrane filter 158 extends distally from the second end 156. The corrugation can be a corrugated frame of solid material or a non-traumatic covering. The corrugation can be a tube constrained at one end to form a funnel. The corrugation can be designed as a funnel, wherein the corrugation depth varies along the length of the funnel. The corrugation can be formed by a shape memory metal or polymer. The corrugation can include additional metal or non-metal support members. The corrugation can have a thicker section at the second end 156. In some cases, the membrane can span the second end 156. The membrane can be a polymer, such as silicone or even a fabric. Although not shown, the occluding device 152 may include outwardly facing tines, hooks, splines or sharp teeth to help engage tissue and thus help anchor the occluding device 152 in place.

[0091] Figure 20 to Figure 23 is a schematic diagram of an occlusion device including a frame and a membrane. Fig. 20 An occluding device 160 including a frame 162 and a membrane cap 164 is shown. A polymer membrane 166 extends distally from the frame 162 and the membrane cap 164 and extends to a tether 167. For example, the polymer membrane 162 can be PTFE, ePTFE, or silicone. For example, the frame 162 can be a laser-cut expandable tube, or the frame 162 can be a multi-fiber braided structure. The frame 162 can be formed of nitinol or stainless steel. In some cases, polymers or other metals can be used to form the frame 162. The frame 162 can include anchoring features, such as outward-facing tines, hooks, splines, or tines. The occluding device 160 can include a coating that promotes endothelialization. The occluding device 160 has an overall funnel or cone shape.

[0092] Fig.21 An occluder device 168 is shown that includes a frame 170 and a membrane 172 covering the frame 170. The membrane 172 extends distally to a tubular member 174. In some cases, the membrane 122 may include suture points 176. In some cases, the membrane 172 may be a unitary member. The tubular member 174 is formed of a polymer material, such as ePTFE. The frame 170 is spherical in shape.

[0093] Fig. 22 is a schematic diagram of an occluder device 178 including a frame 180 and a membrane 182. The membrane 182 encapsulates the frame 180 and extends distally from a suture point 184. The membrane 182 extends to a tether (not shown). Fig.23 A similar occluding device 160 ( Fig. 20 ) of the embodiment of the present invention, but the polymer membrane 166 includes an opening 188 that allows any otherwise occluded chyme to escape.

[0094] Figure 24 to Figure 26 is a schematic diagram of an occlusive device including a rigid feature as part of the occlusive device. The rigid feature can be modified so that the rigid feature cannot pass through the tortuous bends typically found in the proximal duodenum 18a. The proximal duodenum 18a is a portion of the duodenum 18 that is just distal to the pyloric sphincter 20 and typically includes a tortuous bend. Figure 24 to Figure 26 A rigidity feature 190 is shown that may be incorporated into any of the occluding devices described herein. Figure 24 to Figure 26 An illustrative gastric bypass device 192 is shown including an occluding device 194, anastomotic anchor 196, and an intervening tether 198.

[0095] exist Fig.24In the embodiment of the present invention, the rigid feature 190 includes a bumper 200, which in some cases can be considered an extension of the rigid feature 190. The bumper 200, in combination with the rigid feature 190, prevents distal movement of the occluding device 194 because the bumper 200 cannot fit through the tortuous bend in the proximal duodenum 18a. Fig.25 In FIG. 1 , the rigid feature 190 includes an inflatable bumper 202 that prevents proximal and distal movement of the occluding device 194. Fig.26 , the rigid feature 190 includes a frame bumper 204. The frame bumper 204 is a rigid, self-expanding frame that prevents proximal and distal movement of the occluding device 194.

[0096] Figures 27 to 32B An example of an illustrative anastomotic anchor is provided that may be used as an anastomotic anchor 38 as part of a gastric bypass device 34. In some cases, an anastomotic structure, such as an expandable stent, a pair of magnetic structures, etc., may be implanted proximate to the anastomosis 26 to help secure the anastomosis 26 together. The anastomotic structure also provides for the securement of the anastomotic anchor.

[0097] Fig. 27 It can be relative to the anastomotic opening 26 ( Figure 1 ) is a schematic diagram of an illustrative anastomotic anchor 206 secured thereto. Fig. 27 206, but it will be appreciated that one of the features of the anastomotic anchor 206 is that its diameter is greater than the lumen diameter of the anastomotic structure. Thus, advancing the anastomotic anchor 206 proximally through the stoma 26 (and through the anastomotic structure) means that once the anastomotic anchor 206 reaches its expanded configuration (as shown), the anastomotic anchor 206 cannot be pulled through the stoma 26 (or the anastomotic structure), thereby anchoring the anastomotic anchor 206 relative to the stoma 26 (and the anastomotic structure).

[0098] like Fig. 27 As shown, the anastomotic anchor 206 includes a ring 208 whose outer dimensions are larger than the lumen diameter of the anastomotic stoma 26 (or anastomotic structure). Although shown as a ring, the ring 208 can also take any of a variety of different shapes, such as a circle or a polygon. The ring 208 can be concave or convex. The shape of the ring 208 can be regular or irregular. The ring 208 can be formed of a material that is resistant to the high acid gastric environment. The ring 208 can be formed of a metal, such as nitinol or stainless steel. The ring 208 can be formed of a polymer, such as PTFE or can be The ring 208 may be formed of ultra high molecular weight polyethylene (UHMwPE) fibers available from the manufacturer. The ring 208 may be a composite material formed of several different materials. The ring 208 may be a wire combined with a coupler. The ring 208 may be a laser cut structure. In some cases, the ring 208 may be a woven or braided structure. The ring 208 may include a lubricating and / or anti-corrosion coating or covering.

[0099] The anastomotic anchor 206 includes a plurality of attachment members 210 extending between the ring 208 and the tether 212. Although a total of three attachment members 210 are shown, it should be understood that this is merely illustrative, as the anastomotic anchor 206 may include any number of attachment members 210. In some cases, having at least three attachment members 210 helps stabilize the position of the ring 208 relative to the stoma 26 (and the anastomotic structure). The attachment members 210 may be flexible and linear. The attachment members 210 may be rigid. Although not shown, the ring 208 may instead be attached to the tether 212 via a polymer film spanning from the ring 208 to the tether 212.

[0100] Fig.28 is a schematic diagram of an illustrative anastomotic anchor 214 shown disposed relative to an illustrative anastomotic structure 216. The illustrative anastomotic anchor 214 can be viewed as an opposed double-ring anchor. The illustrative anastomotic structure 216 includes a first annular segment 218 adapted to be disposed within the stomach 14 and a second annular segment 220 adapted to be disposed within the small intestine 16. In some instances, the second annular segment 220 can be adapted to be disposed within the duodenum 18 or the jejunum 24. An intervening portion 222 extends between the first annular segment 218 and the second annular segment 220. It should be understood that the intervening portion 222 defines a lumen extending through the anastomotic structure 216. Thus, the intervening portion 222 defines ( Fig. 27 In some cases, the anastomotic structure 216 can be considered a woven or braided self-expanding stent. In some cases, the anastomotic structure 216 can be considered a commercially available stent from Boston Scientific. Example of a bracket.

[0101] The anastomotic anchor 214 may include a first ring 224 adapted to be secured to the first annular segment 218 of the anastomotic structure 216. The anastomotic anchor 214 may include a second ring 226 adapted to be secured below the second annular segment 220 of the anastomotic structure 216. Herein, terms such as above or below refer only to the illustrated orientation. The anastomotic structure 216 may be deployed in any orientation, including with, for example, Fig.28 The substantially inverted orientation is shown.

[0102] The anastomotic anchor 214 includes one or more members 228 and 230 extending between the first ring 224 and the second ring 226. The anastomotic anchor 214 also includes one or more connectors 232 and 234 extending downwardly from the first ring 224 to couple the anastomotic anchor 214 with a tether. In some cases, tension applied to the connectors 232 and 234 may cause the distance between the first ring 224 and the second ring 226 to decrease. As the first ring 224 and the second ring 226 become smaller, the resulting force applied to the anastomotic structure 216 causes the length of the anastomotic structure 216 to decrease and grow radially. As the first annular segment 218 and the second annular segment 220 of the anastomotic structure 216 grow radially, the first annular segment 218 and the second annular segment 220 of the anastomotic structure 216 provide enhanced engagement with tissue, thereby helping to ensure that the device does not migrate.

[0103] In some cases, one or more members 228 and 230 and / or one or more connectors 232 and 234 can include one or more strings. One or more members 228 and 230 and / or one or more connectors 232 and 234 can be a braided or coiled structure, or can be a sheath. For example, one or more members 228 and 230 and / or one or more connectors 232 and 234 can be covered or uncovered. Each of the components of the anastomotic anchor 214 can be independently made of a material that is resistant to the harsh gastric environment. Metals such as nitinol and stainless steel can be used, and polymers such as PTFE and can be used. Ultra high molecular weight polyethylene (UHMwPE) fibers are commercially available under the name TUNA®. Connectors 232 and 234 may have a single point of attachment to the tether, or may have multiple points of attachment.

[0104] In some cases, part or all of the anastomotic anchor 214 may be covered, but the through lumen through the anastomotic anchor 214 must remain open so that food and chyme can pass through. The covering can be used to help protect part or all of the anastomotic anchor 214 from the stomach environment. The covering, if included, can reduce interaction with chyme or food particles. The covering, if included, can reduce friction or interaction with the stomach environment tissue. The covering can be snug or loose and can be PTFE, ePTFE or other polymers. The covering, if included, can largely encapsulate the entire anastomotic anchor 214, or only encapsulate a single component thereof.

[0105] Fig.29 is relative to Fig.28Schematic diagram of an illustrative anastomotic anchor 236 shown in the anastomotic structure 216. As shown, the first annular segment 218 is positioned adjacent to the stomach wall 238, and the second annular segment 220 is positioned adjacent to the small intestine wall 240. It should be understood that although the anastomotic anchor 236 is shown adjacent to the braided anastomotic structure 216, such as The stent may be used to create the anastomotic structure 16, but the anastomotic anchor 236 may also function equally well with a different lumen insert or without a stent within the stoma 26. For example, the anastomotic structure 216 may simply be changed to a pair of magnetic rings, one adjacent to the stomach wall 236 and one adjacent to the small intestine wall 240. In some cases, the stoma 16 may be a surgically (or endoscopically) created structure held in place by sutures only. The stoma 16 may be created in a manner that does not require an additional structure (such as the anastomotic structure 216) to maintain the patency of the stoma 16.

[0106] The anastomotic anchor 236 is a self-expanding braided structure that includes a first expanded diameter portion 242 adapted to be secured to the first annular segment 218 of the anastomotic structure 216. The anastomotic anchor 236 includes a second expanded diameter portion 244 adapted to be secured below the second annular segment 220 of the anastomotic structure 216. The anastomotic anchor 236 also includes an intervening portion 246 that extends from the first expanded diameter portion 242 to the second expanded diameter portion 244 and is adapted to fit within the intermediate portion 222 of the anastomotic structure 216. Terms such as upper or lower refer only to the illustrated orientation. The anastomotic structure 236 can be deployed in any orientation, including with, for example, Fig.29 The substantially inverted orientation is shown. Additionally, the first expanded diameter portion 242 and the second expanded diameter portion 244 may be viewed as being adapted to interact with any anastomotic structure used.

[0107] In some cases, the first expanded diameter portion 242 can be designed to be larger than the first annular segment 218 of the anastomotic structure 216. The first expanded diameter portion 242 can be large enough to directly engage the stomach wall 238, especially when a force is applied to the anastomotic anchor 236 via the tether 248. The anastomotic anchor 236 can be formed of a material resistant to the stomach environment. The anastomotic anchor 236 can be formed of a shape memory polymer or a shape memory metal. In some cases, the anastomotic anchor 236 can include a covering, such as silicone. In some cases, the anastomotic anchor 236 can include hooks or sharp teeth that promote anchoring to the stomach wall 238.

[0108] Fig.30 is relative to Fig.28Schematic diagram of an illustrative anastomotic anchor 250 shown in the anastomotic structure 216. The anastomotic anchor 250 includes an anchoring feature 252, which is adapted to be fixed relative to the first annular section 218 of the anastomotic structure 216. The anastomotic anchor 250 also includes a through portion 254, which is connected to the anchoring feature 252 and is adapted to be assembled through the intermediate portion 222 of the anastomotic structure 216. In some cases, the anchoring feature 252 can have one of several different heights to be able to pass through various anastomotic structures. In some cases, the anchoring feature 252 can have an annular outer profile. In some cases, the anchoring feature 252 can have one, two, three, four or more legs or pads extending radially outward from the anchoring feature 252 to engage the stomach wall 238.

[0109] In some cases, the anastomotic anchor 250 is adapted to form a friction fit with the first annular segment 218 of the anastomotic structure 216. In some cases, the anastomotic anchor 250 includes hooks or tines adapted to engage the stomach wall 238. In some cases, the anastomotic anchor 250 includes hooks or tines or other structures adapted to engage the stomach wall 238, and the through-portion 254 includes hooks or tines or other structures adapted to engage the jejunal wall 240. In some cases, the through-portion 254 may include hooks or tines adapted to engage the intervening portion 222 of the anastomotic structure 216.

[0110] Fig.31A and Fig.31B 2 are side and top views, respectively, of an illustrative anastomotic anchor 256 shown disposed within an anastomotic structure 216. Fig.31B 2, the anastomotic anchor 256 is adapted to fit within the intervening portion 222 of the anastomotic structure 216. In some cases, the anastomotic anchor 256 includes a cylindrical body 258, which optionally includes several axially extending members 260. In some cases, the cylindrical body 258 includes one or more rings that engage the sides of the anastomotic structure 216. For example, one or more rings can be retracted to apply an outward force to help prevent migration of the anastomotic structure 216. In some cases, a tether can be attached to the anastomotic anchor 256. In some cases, the tether can be attached to the anastomotic structure 216 instead or in addition.

[0111] Fig.32A and Fig.32B 2 are side and top views, respectively, of an illustrative anastomotic anchor 262 shown disposed within an anastomotic structure 216. Fig.32BAs best shown in , the anastomotic anchor 262 is adapted to fit within the intervening portion 222 of the anastomotic structure 216. In some cases, the anastomotic anchor 262 is a central insert and can be any four-sided or more than four-sided shape. Examples include, but are not limited to, cross-sectional profiles defining squares, rectangles, and other polygons. The anastomotic anchor 262 can have a circular shape. The anastomotic anchor 262 can be solid, or can have a cutout to allow chyme to flow through. The anastomotic anchor 262 can have arms or leaves extending outwardly to help engage the anastomotic structure 216. In some cases, a tether can be attached to the anastomotic anchor 262. In some cases, the tether can be attached to the anastomotic structure 216 instead or in addition.

[0112] Figures 33 to 53D Examples of illustrative tethers that may be used as tether 40 as part of gastric bypass device 34 are provided. Fig.33 2 is a schematic diagram of an illustrative gastric bypass device 270. Gastric bypass device 270 includes an occluding device 272 and an anastomotic anchor 274. A tether 276 extends between the occluding device 272 and the anastomotic anchor 274. Tether 276 includes a spring 278 adapted to provide an increased return spring in response to elongation of spring 278 when gastric motion causes movement of the occluding device 272 and / or the anastomotic anchor 274. In some cases, with the occluding device 272 and the anastomotic anchor 274 properly positioned, spring 278 is under less tension. Spring 278 can be formed of any suitable polymer or metal material. In some cases, spring 278 can be formed of, for example, nitinol or stainless steel.

[0113] Spring 278 may take a variety of forms. Fig.34A A spring 278a of varying diameters is shown, with a smallest diameter at the midpoint and larger diameters at either end. Fig.34B A spring 278b is shown having a gradually decreasing diameter from a maximum diameter at one end to a minimum diameter at the other end. Fig.34C Spring 278c is shown having a uniform diameter and spacing from one end to the other. Fig.34D A spring 278d is shown having a constant outer diameter, but a varying pitch. Fig.34E Spring 278e is shown having a gradually decreasing diameter from a maximum diameter in the middle to a minimum diameter at either end. These are examples only. Spring 280 can be formed from any suitable polymer or metal material. In some cases, spring 280 can be formed from, for example, nitinol or stainless steel.

[0114] FIG. 35A to FIG. 35G A possible design of spring 278 is shown. Fig.35A In FIG. 2 , spring 280a comprises a single coiled wire. Fig.35BIn FIG. 2 , spring 280 b includes an incorporated ring or hoop 282. In FIG. Fig.35C In, spring 280c includes a zigzag design. Fig.35D In FIG. 2 , spring 280 d includes a first spring 284 a having a first spring constant and a second spring 284 b having a second spring constant. For example, the first spring 284 a and the second spring 284 b may also have differences in other properties, such as length and diameter. Fig.35E In the embodiment, the spring 280e can include a string 286 extending from one end of the spring 280e to the other end of the spring 280e to provide a limit on how far the spring 280e can extend. Fig.35F In the embodiment, the spring 280f can be tightly fitted on the inner tube 288 to prevent interaction with food and chyme. Figure 35G In the embodiment, spring 280g can include a rigid tube 290 that extends into the obturator cone 292 to obtain a longer spring length in a relatively short device. Spring 280 can be formed of any suitable polymer or metal material. In some cases, spring 280 can be formed of, for example, nitinol or stainless steel.

[0115] In some cases, one or more springs may include a covering or coating. The covering or coating can reduce friction or other interactions with tissues in 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 serve 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. Fig.36A A spring 294a is shown having a cover 296 that encapsulates the spring 294a and expands and contracts with 294a. Fig.36B A spring 294b is shown having a cover 298 that allows the spring 294b to move independently of the cover 298. Fig.36C A spring 294c is shown with a covering 300 that conforms to a filament 302 forming the spring 294c. Fig.36D A spring 294d is shown having a cover 304 continuous with a material 306 forming at least a portion of the occluding device. The spring 294 can be formed of any suitable polymer or metal material. In some cases, the spring 294 can be formed of, for example, nitinol or stainless steel.

[0116] Fig.37The tether 308 is shown in a suitable position in the duodenum 18, extending between the occlusion device 310 and the anastomotic anchor 312 shown as being disposed in the anastomotic opening 26. The tether 308 includes an inner tether 314 disposed in an anticorrosive and impermeable sleeve 316 enclosing the inner tether 314. The sleeve 316 protects the inner tether 314 from the gastric environment, while the inner tether 314 provides tension. The sleeve 316 seals to the inner tether 314 at a first sealing point 318 and a second sealing point 320. Between the first sealing point 318 and the second sealing point 320, the sleeve 316 protects the inner tether 314 from the gastric environment. Although the first sealing point 318 is shown as being distal to the occlusion device 310 and the second sealing point 318 is shown as being proximal to the anastomotic anchor 312, in some cases, the sleeve 316 may extend the entire length of the inner tether 314.

[0117] In some cases, placing the inner tether 314 within the sleeve 316 provides the benefit of being able to separate mechanical and chemical properties. The inner tether 314 can be made of a specific material that is selected for its mechanical properties without having to worry about whether the material can withstand the harsh gastric environment. This means that any material can be used to form the inner tether 314.

[0118] Fig.38A and Fig.38B A tether 322 is shown extending between an occluder device 324 and an anastomotic anchor 326. The tether 322 includes a spring 328 having a first end 330 proximal to the occluder device 324 and a second end 332 proximal to the anastomotic anchor 326. A first attachment member 334 extends from the first end 330 of the spring 328 to the anastomotic anchor 326. A second attachment member 336 extends from the second end 332 of the spring 328 to the occluder device 324. Thus, distal movement of the occluder device 324 and / or proximal movement of the anastomotic anchor 326 will result in compression of the spring 328, as shown in FIG. Fig.38B 326 can be moved, since the spring 328 can only be compressed to this extent. The spring 328 can be formed of any suitable polymer or metal material, including nickel titanium or stainless steel. The diameter of the spring 328 can vary along its length. The spring 328 can be a single spring, or the spring 328 can include two or more different spring segments.

[0119] Fig.39A tether 338 is shown, which includes an elastic polymer tube 340 and a covering 342 covering the elastic polymer tube 340. The elongation of the tether 338 due to gastric movement will cause the elastic polymer tube 340 to exert tension when the elastic polymer tube 340 attempts to return to its native or biased form. The hardness of the polymer used to form the elastic polymer tube 340 can be changed to adjust its memory. Various polymers can be used for the elastic polymer tube 340. As an example, the elastic polymer tube 340 can be formed of latex. The elastic polymer tube 340 can be a single polymer tube. In some cases, the elastic polymer tube 340 can be a plurality of elastic polymer strands. The covering 342 can help act as a barrier to the corrosive gastric environment. The covering 342 can reduce interaction with chyme and food particles, and can reduce friction or other interactions with tissues within the gastric system. The covering 342 can reduce damage or inflammation at the bile duct and / or papilla. In some cases, the covering 342 can be formed of silicone. In some cases, covering 342 may be PTFE or ePTFE.

[0120] In some cases, a spring, such as a leaf spring, may not be part of the tether itself, but may be attached to an occlusive device or anastomotic anchor, with the tether extending from the leaf spring. As a result, tension within the tether may cause the leaf spring to move from its native biased configuration. Fig.40A and Fig.40B A leaf spring 344 is shown fixed relative to the occluding device 346. The leaf spring 344 can be flat, concave, or convex. The leaf spring 344 can be a flat beam or a round beam, or can have multiple stacked beams. The leaf spring 344 can be formed from any suitable metal or polymer material.

[0121] The tether 348 extends from the leaf spring 344, through the occluder device 346, and extends distally therefrom. Although the leaf spring 344 is shown as being attached to the occluder device 346, a similar result can be achieved by fixing the leaf spring 344 to the anastomotic anchor instead. Fig.40A , the tether 348 is not under any tension and the leaf spring 344 is maintained in a linear configuration representing the native biased configuration of the leaf spring 344. Fig.40B In the embodiment of the present invention, the tether 348 is under tension, as shown by arrow 350. As can be seen, the leaf spring 344 has been arched out of its original biased configuration. As a result, the leaf spring 344 will attempt to return to its original configuration, thereby resisting the movement of the anastomotic anchor.

[0122] In some cases, a helical torsion spring may be used at one end of the tether in place of the leaf spring 344. The helical torsion spring may be secured between the occluding device 346 and the tether 348. In some cases, the helical torsion spring may instead be secured between the anastomotic anchor and the tether 348. As the stomach moves causing movement of the occluding device 346 and / or the anastomotic anchor, the tether 348 will provide tension to the helical torsion spring, and the helical torsion spring will therefore be disengaged from its original biased configuration. Thus, the helical torsion spring will exert a force on the tether 348 as it attempts to return to its original biased configuration.

[0123] Fig.41 354 and anastomotic anchor 356. In some cases, the tether 352 can be formed as a braided stent. The tether 352 can act as a spring, thereby providing a restoring force in response to the elongation of the tether 352 due to gastric movement. The tether 352 can be formed of any suitable metal or polymer material. The material, size, spacing, etc. of the tether 352 can be changed to provide the desired restoring force behavior. As an example, the tether 352 can be designed to provide a restoring force that increases linearly with the elongation of the device. For example, the tether 352 can be designed to provide a restoring force that increases with the elongation of the device.

[0124] In some cases, tether 352 can include a coating or covering that helps protect tether 353 from the stomach environment. If included, the coating or covering can reduce interaction with chyme and food particles, can reduce friction and interaction with stomach tissue, and can reduce damage or inflammation at the bile duct and / or papilla. If included, the coating or covering can be any suitable material, such as, but not limited to, PTFE and ePTFE.

[0125] Fig.42 360 is a schematic diagram of an illustrative tether 358 formed as or otherwise including a pneumatic cylinder 360. The tether 358 extends between an occluding device 362 and an anastomotic anchor 364. The pneumatic cylinder 360 provides a restoring force in response to tension applied to the tether 358. In some cases, the pneumatic cylinder 360 can be a positive pneumatic cylinder or a negative pneumatic cylinder. The pneumatic cylinder 360 can be rigid or flexible and can be located anywhere along the length of the tether 358, from near the occluding device 362, to near the anastomotic anchor 364, or anywhere therebetween. The pneumatic cylinder 360 can be metallic or polymeric and can be filled with a liquid or gas working fluid. Fig.43 An example of negative cylinder 360a is shown, while Fig.44 An example of a positive cylinder 360b is shown.

[0126] Fig.45370. The tether 366 includes a protective sleeve 372, a spring 374, and a sliding joint 376 that allows the spring 374 to extend within the protective sleeve 372 but independently of the protective sleeve 372. In some cases, the tether 366 includes a PTFE tube 375. In some cases, the PTFE tube 375 allows the tether 366 to extend smoothly, moving in and out of the sliding joint 376. In some cases, there may be a nitinol wire within the PTFE tube 375 to prevent kinking. There may also be a suture within the PTFE tube 375 that is attached to the spring 374 and the anastomotic anchor 370 and holds the spring 374 in place. The suture can be formed of UHMWPE (ultra-high molecular weight polyethylene). Although spring 374 is shown as being adjacent to occlusion device 368, spring 374 may alternatively be located adjacent to anastomotic anchor 370. Sliding joint 376 has low friction and therefore allows travel under low force while fitting tightly to minimize the possibility of chyme entering protective sleeve 372. In some cases, sliding joint 376 may be a small tube within a large tube. Sliding joint 376 may be a small tube pulled through a soft membrane. Sliding joint 370 may be one or more threads within the tube. The threads may be polymeric or metallic. The threads may be single-stranded, multi-stranded, or braided together. The spring may be an elastic polymer or metal, such as nitinol or spring steel. Protective sleeve 372 may be formed of a flexible, durable, and corrosion-resistant polymer, such as ePTFE.

[0127] Fig.46 380 is a schematic diagram of an illustrative tether 378 including a clamp 380. In some cases, the clamp 380 is a one-way clamp that is adapted to allow the tether 378 to be pulled through in a first direction while preventing the tether 378 from traveling in the opposite direction. In some cases, the tether 378 can be pulled relative to the clamp 380 to shorten the tether 378. In some cases, the clamp 380 can include teeth or barbs that allow the tether 378 to travel in one direction, but not in the opposite direction. The clamp 380 can use friction to control the travel. In some cases, the clamp 380 can cooperate with an interlocking feature on the tether 378 to control the travel. The clamp 380 can be located near the occlusion device, near the anastomotic anchor, or anywhere in between. The clamp 380 allows the physician to adjust the length of the tether in vivo to accommodate the anatomical structure of a particular patient. In some cases, the clamp 380 can be adjusted on a work surface before implantation to adjust the effective length of the tether 378.

[0128] Fig.47386. The tether 382 includes a threaded joint 388 between a threaded member 390 and a spring 392 that threadably engages the threaded member 390. In some cases, the threaded clamp 388 can be adjusted on a work surface prior to implantation to adjust the effective length of the tether 382. In some cases, the threaded joint 388 can be adjusted in vivo using an endoscopic tool. The tether 382 can be formed of any suitable material. The threaded joint 388 can be located near the occlusion device 384, near the anastomotic anchor 386, or anywhere in between.

[0129] Fig.48 is a schematic diagram of a portion of the gastrointestinal system indicating the relative positions of a patient's bile duct 394, a patient's pancreatic duct 396, and a patient's papilla 398. The papilla 398 is where the bile duct 394 and pancreatic duct 396 are fluidly coupled to the duodenum 18. The papilla 398 is located on the medial curve of the duodenum 18 and may partially protrude into the interior of the duodenum 18 in some cases. A potential problem with placing a tether in the duodenum 18 is that the tether may irritate the papilla 398, which may lead to inflammation and, in turn, various possible complications. In some cases, it is desirable to provide a tether that avoids irritating the papilla 398.

[0130] Fig.49 4 is a schematic diagram of an illustrative tether 400 extending through the duodenum 18 between an occlusion device 402 and an anastomotic anchor 404. As shown, the tether 400 includes a first spring segment 406 located proximal to the Vater's papilla 398 and a second spring segment 408 located distal to the Vater's papilla 398. The tether 400 includes a member 410 that extends between the first spring segment 406 and the second spring segment 408 and passes over the Vater's papilla 398. Because the first spring segment 406 and the second spring segment 408 have a larger diameter relative to the member 410 (although not necessarily the same as each other), the member 410 is held outside the inner surface of the duodenum 18 and, therefore, away from the Vater's papilla 398.

[0131] Fig.50A , Fig.50B and Fig.50C Additional examples are provided. Fig.50AIn the embodiment of the present invention, the tether 412a includes a first spring segment 414 and a second spring segment 416, but does not include any metal structure therebetween. Instead, the tether 412a includes an atraumatic covering 418 that encapsulates the first spring segment 414 and the second spring segment 416. The atraumatic covering 418 is narrowed between the first spring segment 414 and the second spring segment 416 via a pair of sutures 420 that secure the atraumatic covering 418 to one end of the first spring segment 414 and one end of the second spring segment 416. Thus, no metal is close to the Vater's nipple 398.

[0132] Fig.50B A tether 412b is shown that is similar to tether 400, but includes an atraumatic covering 422 that encapsulates first spring segment 406, second spring segment 408, and member 410 extending therebetween. In some cases, as shown, a soft pillow 424 is disposed between first spring segment 406 and second spring segment 408 and is held in place by atraumatic covering 422. Thus, no metal is placed near Vater's nipple 398. Fig.50C A tether 412c is shown that includes a spring 426 disposed within an atraumatic covering 428. The spring 426 has a varying diameter, with a maximum diameter at either end of the spring 426 and tapering to a minimum diameter near the midpoint of the spring 426.

[0133] Fig.51 A tether 430 is shown that includes a physical support 432 disposed on the tether 430, wherein the tether 430 extends through the physical support 432. In some cases, the physical support 432 is capable of sliding relative to the tether 430. In some cases, the physical support 432 is a braided structure formed of a metal, such as nitinol. In some cases, the physical support 432 can instead be inflatable, such as an inflatable balloon. As shown, the physical support 432 includes a first bulbous region 434 and a second bulbous region 436, wherein a narrowed diameter portion 438 extends between the first bulbous region 434 and the second bulbous region 436. In some cases, the physical support 432 can also include additional bulbous regions.

[0134] Fig.52A tether 440 is shown that includes a physical mount 442 that forms a portion of the tether 440. The tether 440 includes a first spring segment 444 and a second spring segment 446, wherein the physical mount 442 is disposed between the first spring segment 444 and the second spring segment 446. For example, the physical mount 442 may be welded or sewn or bonded to each of the first spring segment 444 and the second spring segment 446. The physical mount 442 may include a first bulbous region 444 and a second bulbous region 446, wherein a rigid member 448 extends between the first bulbous region 444 and the second bulbous region 446.

[0135] Fig.53A 4 is a schematic diagram of an illustrative tether 450. The illustrative tether 450 includes a first spring segment 452 and a second spring segment 454. The tether 450 includes an arcuate segment 456 extending between the first spring segment 452 and the second spring segment 454. Fig.53B A first view of the arcuate segment 456 is shown, and Fig.53C A second view of the arcuate segment 456 is shown. Fig.53D As shown, tension on the tether 450 will cause the arcuate segment 456 to rotate perpendicular to the nipple 398 of Vater.

[0136] In some cases, a dynamic cord may be used as part of a gastric bypass device. Figure 54 to Figure 59 Examples of illustrative dynamic tethers that may be used as dynamic tethers 42 as part of gastric bypass device 34 are provided.

[0137] Fig.54 4 is a schematic diagram of an illustrative dynamic tether 458 shown within an anatomical structure. The dynamic tether 458 extends between an occluding device 460 disposed proximate to the pyloric sphincter 20 and an anastomotic anchor 462 disposed proximate to the anastomosis 26. As shown, the dynamic tether 458 is secured to an annular ring 464 that forms a portion of the occluding device 460. A tether 466 also extends through the duodenum 18 between the occluding device 460 and the anastomotic anchor 462. It should be understood that the tether 466 and the dynamic tether 458 can work together to help keep the occluding device 460 in place regardless of gastric motility attempting to dislodge the occluding device 460. If gastric motility attempts to move the occluding device 460 proximally into the stomach 14, the tether 466 will provide resistance to the motion. If gastric motility attempts to move the occluding device 460 distally into the duodenum 18, the dynamic tether 458 will provide resistance to the motion.

[0138] Fig.554 is a schematic diagram of an illustrative dynamic tether 468 shown within an anatomical structure. Dynamic tether 468 includes spring 470. Tether 472 includes spring 474. In some cases, spring 470 has a first spring constant and spring 474 has a second spring constant. In some cases, spring 470 and spring 474 can be selected as a combination to ensure that the two springs 470 and 474 together provide a dynamic balancing force to maintain a desired position of occluding device 460.

[0139] Fig.56 is a schematic diagram of an illustrative dynamic tether 476 shown within an anatomical structure. The dynamic tether 476 extends between an occluder device 478 disposed proximate to the pyloric sphincter 20 and an anastomotic anchor 480 disposed proximate to the anastomosis 26. As shown, the dynamic tether 476 is secured to a cover 482 that forms a portion of the occluder device 478. In some cases, a central attachment point, such as to the cover 482, allows the occluder device 478 to be laid flat, while attachment to the sides of the occluder device 478 may allow the occluder device 478 to be tilted or pivoted in place.

[0140] The tether 484 also extends through the duodenum 18 between the occluder 478 and the anastomotic anchor 480. It should be understood that the tether 484 and the dynamic tether 476 can work together to help keep the occluder 478 in place, regardless of how the gastric movement attempts to move the occluder 478 out. If the gastric movement attempts to move the occluder 478 proximally into the stomach 14, the tether 484 will provide resistance to the movement. If the gastric movement attempts to move the occluder 478 distally into the duodenum 18, the dynamic tether 476 will provide resistance to the movement. In some cases, the dynamic tether 476 includes a spring 486. The tether 484 includes a spring 488. In some cases, the spring 486 has a first spring constant and the spring 488 has a second spring constant. In some cases, the spring 486 and the spring 488 can be selected as a combination to ensure that the two springs 486 and 488 provide a dynamic balancing force together to maintain the desired position of the occluder 478.

[0141] Fig.57 4 is a schematic diagram of an illustrative dynamic tether 490 shown within the anatomy. The dynamic tether 490 extends between an occluding device 478 positioned proximate to the pyloric sphincter 20 and an attachment point 492 within the stomach wall 494. As shown, the dynamic tether 476 is secured to a cover 482 that forms a portion of the occluding device 478. In some cases, a central attachment point (such as to the cover 482) allows the occluding device 478 to be laid flat, while attachment to the sides of the occluding device 478 may allow the occluding device 478 to be tilted or pivoted in place.

[0142] The tether 484 extends through the duodenum 18 between the occluder 478 and the anastomotic anchor 480. It should be understood that the tether 484 and the dynamic tether 490 can work together to help keep the occluder 478 in place, regardless of how the gastric movement attempts to move the occluder 478 out. If the gastric movement attempts to move the occluder 478 proximally into the stomach 14, the tether 484 will provide resistance to the movement. If the gastric movement attempts to move the occluder 478 distally into the duodenum 18, the dynamic tether 490 will provide resistance to the movement. In some cases, the dynamic tether 490 includes a spring 496. In some cases, the spring 496 has a first spring constant and the spring 488 has a second spring constant. In some cases, the spring 496 and the spring 488 can be selected as a combination to ensure that the two springs 496 and 488 together provide a dynamic balancing force to maintain the desired position of the occluder 478.

[0143] Fig.58 is a schematic diagram of an illustrative dynamic tether 498 shown within an anatomical structure. The dynamic tether 498 extends between the occlusion device 478 disposed proximate to the pyloric sphincter 20 and the anti-migration anchor 500 disposed proximate to the anastomosis 26. The anti-migration anchor 500 is an anchor that can be attached to the stomach 14 so that tension can be applied to the anchor in either direction without causing the anti-migration anchor to move. In some cases, the dynamic tether 498 can be connected to the anti-migration anchor 500 so that the tension from the dynamic tether 498 can cause the diameter and / or shape of the anti-migration anchor 500 to change. As an example, the diameter of the anti-migration anchor 500 can be increased and the length can be decreased to provide additional outward radial force and prevent sliding through the anastomosis 16. As shown, the dynamic tether 498 is fixed to a cover 482 that forms a portion of the occlusion device 478. In some cases, a central attachment point (such as to cover 482) allows the occluder 478 to lay flat, while attachments to the sides of the occluder 478 may allow the occluder 478 to be tilted or pivoted in place.

[0144] The tether 484 extends through the duodenum 18 between the occluding device 478 and the anti-migration anchor 500. It should be understood that the tether 484 and the dynamic tether 498 can work together to help keep the occluding device 478 in place, regardless of how the gastric movement attempts to move the occluding device 478 out. If the gastric movement attempts to move the occluding device 478 proximally, into the stomach 14, the tether 484 will provide resistance to the movement. If the gastric movement attempts to move the occluding device 478 distally, into the duodenum 18, the dynamic tether 498 will provide resistance to the movement. In some cases, the dynamic tether 498 includes a spring 502. In some cases, the spring 502 has a first spring constant and the spring 488 has a second spring constant. In some cases, the spring 502 and the spring 488 can be selected as a combination to ensure that the two springs 502 and 488 provide a dynamic balancing force together to maintain the desired position of the occluding device 478.

[0145] Fig.59 4 is a schematic diagram of an illustrative dynamic tether 498 shown within an anatomical structure. The dynamic tether 498 extends between an occluding device 478 disposed proximate to the pyloric sphincter 20 and a pair of magnetic rings 506 disposed proximate to the anastomosis 26. A tether 484 extends through the duodenum 18 between the occluding device 478 and the magnetic rings 506. It should be understood that the tether 484 and the dynamic tether 498 can work together to help keep the occluding device 478 in place regardless of gastric motility attempting to dislodge the occluding device 478. If gastric motility attempts to move the occluding device 478 proximally into the stomach 14, the tether 484 will provide resistance to that motion. If gastric motility attempts to move the occluding device 478 distally into the duodenum 18, the dynamic tether 476 will provide resistance to that motion.

[0146] Fig.60 is a schematic diagram of a passive engagement device 504 shown proximate to the pyloric sphincter 20. The passive engagement device 504 includes a first gastric clamp 506 that can be fixed on a first side 508 of the pyloric sphincter 20, the pylorus 30, or the gastric antrum 32, and a second gastric clamp 510 that can be fixed on a second side 512 of the pyloric sphincter 20, the pylorus 30, or the gastric antrum 32. A first elastic band 514 extends between the first gastric clamp 506 and the second gastric clamp 510. A second elastic band 516 extends between the first gastric clamp 506 and the second gastric clamp 510. The first elastic band 514 and the second elastic band 516 together help prevent the occlusion device 518 from moving distally. When the pyloric sphincter 20 is dilated, the first elastic band 514 and the second elastic band 516 will engage with the occlusion device 518 and prevent the occlusion device 518 from moving distally. When the pyloric sphincter 20 is not dilated or relaxed, the first elastic band 514 and the second elastic band 516 do not contact the occluding device 518 .

[0147] Fig.61 is a schematic diagram of a passive engagement device 520 shown proximate to the pyloric sphincter 20. The passive engagement device 520 includes a first gastric clip 506 that can be fixed on a first side 508 of the pyloric sphincter 20, the pylorus 30, or the gastric antrum 32, and a second gastric clip 510 that can be fixed on a second side 512 of the pyloric sphincter 20, the pylorus 30, or the gastric antrum 32. A first hook or bumper 522 is attached to the first gastric clip 506, and a second hook or bumper 524 is attached to the second gastric clip 510. The first hook or bumper 522 and the second hook or bumper 524 together help prevent the occlusion device 518 from moving distally. When the pyloric sphincter 20 is dilated and the occlusion device 518 moves distally, the first hook or bumper 522 and the second hook or bumper 524 will engage with the occlusion device 518 and prevent the occlusion device 518 from moving distally. When the pyloric sphincter 20 is not dilated or relaxed, the first hook or bumper 522 and the second hook or bumper 524 do not contact the occluding device 518 .

[0148] Fig.62 is a schematic diagram of an illustrative device 530 that integrates the creation of anastomosis and delivery of a gastric bypass system into a single step. The illustrative device 530 includes an electrocautery tip 532 for creating an anastomosis 534, and a collapsed anastomotic anchor 536 that is deployed after the anastomosis 534 is created using the electrocautery tip 532. Once the anastomosis 534 has been created, the remainder of the gastric bypass device 538 can be delivered through a pullback process (duodenum 18 to pyloric sphincter 20). A cannula (not shown) can hold the anastomotic anchor 536 in a collapsed configuration before the cannula is removed. For example, in Fig.63 A gastric bypass device 538 is shown in FIG.

[0149] The materials that can be used for the various components of the medical device systems described herein and the various elements thereof disclosed herein may include those commonly associated with medical devices. In some embodiments, the medical device systems described herein may 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 steel; low carbon steel; nickel-titanium alloys, such as linear elastic and / or superelastic nitinol; other nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as 625, UNS:N06022, such as UNS:N10276, such as other alloys, etc.), nickel-copper alloys (e.g., UNS: N04400, such as 400, 400, 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035, such as etc.), nickel-molybdenum alloys (e.g., UNS: N10665, such as ALLOY ), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R44003, such as etc.); platinum-rich stainless steel; titanium; combinations thereof; etc.; or any other suitable material.

[0150] As mentioned herein, within the family of commercially available nickel-titanium or Nitinol alloys, there is a class designated as "linear elastic" or "non-superelastic," which, while chemically similar to traditional shape memory and superelastic classes, may also exhibit different 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 display a significant "superelastic plateau" or "flag region" in its stress / strain curve as superelastic Nitinol does. In contrast, in linear elastic and / or non-superelastic Nitinol, as recoverable strain increases, stress continues to increase in a substantially linear or somewhat, but not necessarily completely, linear relationship until plastic deformation begins or at least proceeds in a more linear relationship than the superelastic plateau and / or flag region that may be seen with superelastic Nitinol. Therefore, for purposes of the present invention, linear elastic and / or non-superelastic Nitinol may also be referred to as "substantially" linear elastic and / or non-superelastic Nitinol.

[0151] 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 accept strains up to about 2-5% while remaining substantially elastic (e.g., before plastic deformation), while superelastic Nitinol can accept strains up to about 8% before plastic deformation. Both of these materials can be distinguished from other linear elastic materials, such as stainless steel (which can also be distinguished based on its composition), which can accept only about 0.2 to 0.44% strain before plastic deformation.

[0152] In some embodiments, the linear elastic and / or non-superelastic Nitinol alloy is an alloy that does not show any martensite / austenite phase transformation detectable by differential scanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA) over a large temperature range. For example, in some embodiments, there may be no martensite / austenite phase transformation detectable by DSC and DMTA analysis in the range of about -60 degrees Celsius (°C) to about 120°C in the linear elastic and / or non-superelastic Nitinol alloy. Therefore, the mechanical bending properties of such materials are generally inert to temperature effects over this very wide temperature range. In some embodiments, the mechanical bending properties of the linear elastic and / or non-superelastic Nitinol alloy at ambient or room temperature are substantially the same as the mechanical properties at, for example, body temperature, because they do not show superelastic plateaus and / or flag regions. In other words, over a wide temperature range, the linear elastic and / or non-superelastic Nitinol alloy maintains its linear elastic and / or non-superelastic characteristics and / or properties.

[0153] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy may be in the range of about 50 to about 60 weight percent nickel, with the remainder being primarily titanium. In some embodiments, the composition contains nickel in the range of about 54 to about 57 weight percent. An example of a suitable nickel-titanium alloy is FHP-NT alloy commercially available from Furukawa TechnoMaterial Co. of Kanagawa, Japan. Other suitable materials may include ULTANIUM TM (available from Neo-Metrics) and GUMMETAL TM (Available from Toyota.) In some other embodiments, superelastic alloys, such as superelastic Nitinol, may be used to achieve the desired properties.

[0154] In at least some embodiments, part or all of the medical device systems described herein may also be doped with, made of, or otherwise include radiopaque materials. Radiopaque materials should be understood as materials that can produce relatively bright images on a fluorescent screen or with another imaging technique during a medical procedure. This relatively bright image helps the user determine the position of the medical device system. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymer materials 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.

[0155] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to the medical device systems described herein. The medical devices described herein can be made of materials that do not substantially distort the image and create a large number of artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may not be suitable because they may create artifacts in the MRI image. In some cases, the medical device system or portions thereof can also be made of materials that can be imaged by an MRI machine. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R44003, such as etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035, such as etc.), Nitinol, etc.

[0156] In some embodiments, the medical device systems described herein can be made of or include a polymer or other suitable material. Some examples of suitable polymers can include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxyethylene (POM, e.g., commercially available from DuPont), polyoxyethylene (POM ... ), polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., commercially available from DSM Engineering Plastics ), ether- or ester-based copolymers (e.g., butylene phthalate / poly(alkylene ether) and / or other polyester elastomers (such as commercially available from DuPont ), polyamide (for example, commercially available from Bayer or commercially available from Elf Atochem ), elastomeric polyamides, block polyamide / ether, polyether block amide (PEBA, for example, available under the trade name commercially available), ethylene-vinyl acetate copolymer (EVA), silicone resin, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low-density polyethylene (e.g., ), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly(p-phenylene terephthalamide) (e.g., ), polysulfone, nylon, nylon-12 (such as commercially available from EMS American Grilon ), perfluoro(propyl vinyl ether) (PFA), ethylene-vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites thereof, etc. In some embodiments, the sheath can be mixed with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6% LCP.

[0157] In some embodiments, medical device systems as described herein and / or other elements disclosed herein may include fabric materials arranged on or within the structure. The fabric material may be composed of biocompatible materials suitable for promoting growth in tissues, such as polymeric materials or biomaterials. In some embodiments, the fabric material may include bioabsorbable materials. 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.

[0158] It should be understood that the present invention is in many respects merely illustrative. Changes may be made in details, particularly in matters of arrangement of shape, size and steps, without exceeding the scope of the present invention. To the extent appropriate, this may include using any of the features of an example embodiment used in other embodiments. Of course, the scope of the present invention is defined by the language of the appended claims.

Claims

1. An implantable medical device system, comprising: an occlusive device adapted to be fixed in position relative to the patient's pylorus; an anastomotic anchor adapted to be secured in position relative to a stoma formed between a stomach wall of the patient and a small intestine of the patient; as well as A tether is adapted to extend through the patient's duodenum, the tether being secured to the occlusion device at a first end and to the anastomotic anchor at a second end, the tether being adapted to resist degradation when exposed to gastric fluid.

2. The implantable medical device system according to claim 1, wherein: The tether includes one or more springs adapted to extend from the first end of the tether to the second end of the tether.

3. The implantable medical device system of any one of claims 1 or 2, further comprising a covering disposed on at least a portion of the tether.

4. The implantable medical device system according to claim 3, wherein: The cover may be adapted to move independently of the one or more springs and / or the cover may be adapted to move with movement of the one or more springs.

5. The implantable medical device system according to any one of claims 1 to 4, wherein: The tether has a hard stop by virtue of threads extending through the one or more springs, thereby limiting extension of the one or more springs.

6. The implantable medical device system according to any one of claims 1 to 5, wherein: The tether comprises: a first attachment member adapted to be secured to the occluding device; a second attachment member adapted to be secured to the anastomotic anchor; a spring extending from a first end closer to the first attachment member to a second end closer to the second attachment member; Wherein the first attachment member is fixed to the second end of the spring, and the second attachment member is fixed to the first end of the spring, so that tension applied to the first attachment member or the second attachment member acts to compress the spring.

7. The implantable medical device system according to claim 1, wherein: The tether also includes a covering disposed over at least a portion of the braided member.

8. The implantable medical device system according to claim 1, wherein: The tether includes a clamp that allows the tether to move relative to the clamp in a first direction but not in an opposite direction, such that the clamp is adapted to provide unidirectional length adjustment of the tether.

9. A tether adapted for use in a gastric bypass system, the tether adapted to extend within the duodenum of a patient between an occluding device adapted to be deployed relative to the patient's pylorus and an anastomotic anchor adapted to be secured in position relative to an anastomosis formed between a stomach wall of the patient and the patient's small intestine, the tether comprising: an elongated member extending from a first region adapted to be secured to an occlusive device to a second region adapted to be secured to an anastomotic anchor; The elongated member includes an intermediate portion disposed between the first region and the second region, the intermediate portion adapted to avoid contact with a patient's nipple of Vater so as to avoid irritation of the patient's nipple of Vater.

10. The tether according to claim 9, wherein: The intermediate portion has a reduced outer diameter relative to an outer diameter of the first region and an outer diameter of the second region.

11. The tether of claim 9, further comprising a physical standoff disposed on the tether, the physical standoff adapted to space the tether away from the patient's Vater's nipple.

12. The tether according to claim 9, wherein: The intermediate portion of the elongated member includes an arcuate member adapted to fit around the patient's Vater's nipple.

13. A tether adapted for use in a gastric bypass system, the tether adapted to extend within the duodenum of a patient between an occluding device adapted to be deployed relative to the patient's pylorus and an anastomotic anchor adapted to be secured in position relative to an anastomosis formed between a stomach wall of the patient and the patient's small intestine, the tether comprising: an elastic member adapted to extend from the first end of the tether to the second end of the tether; as well as An impermeable cover is disposed over the resilient member.

14. The tether according to claim 13, wherein: The impermeable cover is adapted to move independently of the elastic member.

15. The tether of claim 13, wherein: The impermeable cover is adapted to move with movement of the elastic member.

Images