Systems and methods for anchoring and restraining a gastrointestinal prosthesis

Abstract

Systems and methods for anchoring and restraining a gastrointestinal prosthesis are disclosed. In various examples, the systems and methods include securing a gastrointestinal device within the anatomy of a patient by extending an anti-migration anchor through multiple portions of the gastrointestinal device to couple the multiple portions of the gastrointestinal device together. In some examples, the anti-migration anchor extends through tissue located between the multiple portions of the gastrointestinal device.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 650,923, filed on March 30, 2018, which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure relates generally to implants placed within the gastrointestinal tract, including the stomach and small intestine. More specifically, the present disclosure relates to devices and methods for implanting and removing systems having implantable and removable components using endoscopic techniques for treating obesity, diabetes, non-alcoholic fatty liver disease (NAFLD), gastroparesis, and other gastrointestinal conditions. Background Art

[0004] Bariatric surgical procedures, such as sleeve gastrectomy, Roux-en-Y gastric bypass (RYGB), and biliopancreatic diversion (BPD), alter food intake and / or absorption within the gastrointestinal system to achieve weight loss in obese patients. These procedures affect metabolic processes in the gastrointestinal system by short-circuiting certain natural pathways or establishing different interactions between consumed food, the digestive tract, its secretions, and the neurohormonal systems that regulate food intake and metabolism. Over the past few years, there has been a growing clinical consensus that obese patients who undergo bariatric surgery can see significant improvements in their type 2 diabetes mellitus (T2DM) shortly after the procedure. The significant improvements in diabetes after RYGB and BPD often occur too rapidly to be explained by weight loss alone, suggesting that a direct effect on glucose homeostasis may occur. The mechanisms of this improvement in T2DM are not well understood, and it is likely that multiple mechanisms are involved.

[0005] One of the shortcomings of obesity treatment surgical procedures is that they require quite invasive surgery, with potentially serious complications and long patient recovery periods. In recent years, people have increased efforts to develop minimally invasive surgery to mimic the effects of obesity treatment surgery. Many of these procedures involve the use of gastrointestinal implants in the stomach or small intestine, which change the transportation and absorption of food and organ secretions. One of the main challenges of this type of procedure includes being difficult to safely anchor implants in the dynamic environment of the gastrointestinal tract due to intermittent and complex peristalsis in the gastrointestinal tract. It has been attempted to fasten implants in the gastrointestinal tract with devices such as sutures, nails and barbs. For example, U.S. Patent No. 7,476,256 describes an implant with a tubular sleeve with anchoring barbs, which penetrates the wall of the small intestine. However, a stent with an active fixation device, such as the barbs that penetrate the wall of the stomach or small intestine described in U.S. Patent No. 7,476,256, into the surrounding tissue, can potentially cause tissue necrosis and implant erosion by tissue. These systems are also associated with penetrating the stomach or small intestinal wall to establish a pathway for bacteria to migrate from the non-sterile environment inside the gastrointestinal tract to the sterile environment of various organs in the abdominal cavity. This increases the risk of infection of surrounding organs such as the liver and pancreas and can pose very serious health risks and require aggressive treatment including surgery. Summary of the invention

[0006] According to one example ("Example 1"), a gastrointestinal implant system includes an implant configured to be implanted within a patient's pylorus, the implant having a proximal portion, a distal portion, and a neck portion located between the proximal and distal portions, the neck portion being configured to span a pyloric sphincter of the pylorus when implanted, an anti-migration anchor comprising an elongated element, a first retention feature coupled to the elongated element, and a second retention feature coupled to the elongated element, the anti-migration anchor being configured to enable the elongated element to be manipulated to span the neck portion of the implant, such that the first retention feature can be positioned proximally of the proximal portion of the implant, and such that the second retention feature can be positioned distally of the distal portion of the implant.

[0007] According to another example ("Example 2") related to Example 1, the first and second retention features are configured to transition between delivery and deployed configurations.

[0008] According to another example ("Example 3") related to Example 2, in the delivery configuration, the first and second retention features extend along the elongated element, and wherein in the deployed configuration, the first and second retention features extend transverse to the elongated element.

[0009] According to another example ("Example 4") related to either of Examples 2 or 3, the first retention feature includes a first end, a second end, and a middle portion between the first and second ends, and wherein the elongated element is coupled to the middle portion.

[0010] According to another example ("Example 5") relating to any of Examples 2 to 4, when unrestrained, one or more of the first and second retention features are biased to transition to the delivery configuration.

[0011] According to another example (Example 6) related to any of the preceding examples, the anti-migration anchor is configured to extend through tissue between the proximal and distal portions of the implant, thereby securing the implant to the tissue.

[0012] According to another example ("Example 7") with respect to Example 6, the proximal and distal portions and the neck of the implant form a primary anchor for anchoring the implant to tissue, and wherein the anti-migration anchor forms a secondary anchor for anchoring the implant to tissue.

[0013] According to another example ("Example 8") with respect to any of the preceding examples, an anti-migration anchor operates to help maintain the geometry of the implant.

[0014] According to another example ("Example 9") related to Example 8, the anti-movement anchor is operative to minimize the amount of relative rotation between the proximal and distal portions of the implant by limiting the length between the proximal and distal portions of the implant.

[0015] According to another example ("Example 10") related to either of Examples 8 or 9, the anti-movement anchor limits the amount of deformation of one or more of the proximal and distal portions of the implant.

[0016] According to another example ("Example 11") related to any of the aforementioned examples, the first and second retention features of the anti-migration anchor are configured such that they can only contact proximal and distal portions of the implant and cannot directly contact pyloric tissue.

[0017] According to another example ("Example 12") of any of the aforementioned examples, the anti-migration anchor operates to tether the implant to the pylorus when implanted.

[0018] According to another example ("Example 13") of any of the aforementioned examples, the anti-migration anchor operates to securely attach the implant to the pylorus when implanted.

[0019] According to another example of any of the foregoing examples ("Example 14"), after implanting the implant, an anti-migration anchor may be implanted.

[0020] According to another example ("Example 15") related to any of the preceding examples, the anti-migration anchor is removable from the implant.

[0021] According to another example (“Example 16”), an anti-mobile device for retaining an implanted gastrointestinal implant at the pylorus of a patient includes an elongated element, a plurality of retention tabs including a first retention feature coupled to the elongated element and a second retention feature coupled to the elongated element, the first retention feature being operable to transition between a delivery configuration and a deployed configuration, the elongated element being configured to span between a proximal portion of a gastrointestinal device such that the first retention feature can be positioned proximal to the proximal portion of the gastrointestinal device and such that the second retention feature can be positioned distal to a distal portion of the gastrointestinal device.

[0022] According to another example ("Example 17"), a method for securing a gastrointestinal implant within a patient's pylorus includes providing an implant having a proximal portion, a distal portion, and a neck portion located between the proximal and distal portions, deploying the implant within the pylorus so that the neck portion spans the pylorus, wherein the proximal portion of the implant is located proximal to the pylorus and the distal portion is located distal to the pylorus, providing an anti-movement anchor, the anti-movement anchor comprising an elongated element, a first retaining feature coupled to the elongated element, and a second retaining feature coupled to the elongated element, and after deploying the implant, deploying the anti-movement anchor so that the anti-movement anchor spans the neck portion of the implant and punctures the proximal and distal portions of the implant, and so that the first retaining feature is located proximal to the proximal portion of the implant, and so that the second retaining feature is located distal to the distal portion of the implant.

[0023] According to another example ("Example 18") related to Example 17, the method further includes deploying the implant within the pylorus such that tissue of the pylorus is located adjacent the neck portion and between proximal and distal portions of the implant.

[0024] According to another example ("Example 19") with respect to any of Examples 17-18, the method further includes deploying the anti-migration anchor such that the anti-migration anchor punctures tissue of the pylorus but does not penetrate the wall of the stomach or small intestine into the surrounding abdominal cavity.

[0025] According to another example ("Example 20") related to any of Examples 17-19, the method further includes deploying a plurality of anti-movement anchors.

[0026] According to another example ("Example 21") relating to any of Examples 17 to 20, the method further includes deploying a plurality of anti-migration anchors such that each anti-migration anchor penetrates tissue.

[0027] According to another example ("Example 22"), an anti-mobility anchor delivery system convertible between a delivery configuration and a deployment configuration includes a first catheter, a locator system connected to the first catheter, the locator system including a locator capsule and a first extendable arm configured to extend radially outward from the locator capsule, such that in the delivery configuration, the first extendable arm is retracted within the locator capsule, and such that in the deployment configuration, the first extendable arm protrudes radially outward from the locator capsule, a second catheter connected to the first extendable arm, the second catheter being configured for anti-mobility anchor delivery to an implant deployed within the patient's anatomical structure, wherein in the delivery configuration, the second catheter is located at a first radial position relative to the locator capsule, and wherein in the deployment configuration, the second catheter is located at a second radial position relative to the locator capsule.

[0028] According to another example ("Example 23") related to Example 22, a locator capsule is located at the distal tip of the first catheter.

[0029] According to another example ("Example 24") related to any of Examples 22-23, the second radial position is a radial position that is radially farther from the longitudinal axis of the locator capsule than the first radial position.

[0030] According to another example ("Example 25") regarding any one of Examples 22 to 24, the locator system further includes a second extendable arm distal to the first extendable arm, wherein the second extendable arm is configured to extend radially outward from the locator capsule such that in the delivery configuration, the second extendable arm is retracted within the locator capsule, and such that in the deployed configuration, the second extendable arm protrudes radially outward from the locator capsule.

[0031] According to another example ("Example 26") regarding Example 25, in the delivery configuration, the first and second extendable arms are located at a first longitudinal distance from each other, and in the deployed configuration, the first and second extendable arms are located at a second longitudinal distance from each other.

[0032] According to another example ("Example 27") related to Example 26, the second longitudinal distance is shorter than the first longitudinal distance.

[0033] According to another example ("Example 28"), an anti-mobilization anchor delivery system includes a first catheter, a locator system connected to a distal end of the first catheter, the locator system including a locator capsule and a cover extending radially outward from the first catheter locator capsule, the cover positioned proximal to the locator capsule, and configured to deliver an anti-mobilization anchor to a second catheter of an implant deployed within the patient's anatomy, wherein the second catheter is configured to be advanced through an endoscope and the cover of the locator system such that the cover constrains the second catheter to a specified radial position relative to a longitudinal axis of the locator capsule.

[0034] While multiple embodiments are disclosed, still other embodiments will become apparent to those skilled in the art from the following detailed description which shows and describes illustrative embodiments.Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] The accompanying drawings are included to provide a further understanding of the disclosure and are incorporated in and constitute a part of this specification and illustrate embodiments and together with the description serve to explain the principles of the disclosure.

[0036] Figure 1 is a cross-sectional view of a portion of a digestive tract in a human body with a gastrointestinal device positioned in the pylorus according to some embodiments;

[0037] Figure 2 is a schematic diagram of a gastrointestinal device according to some embodiments;

[0038] Figure 3 is a cross-sectional view of a portion of the digestive tract in a human body in which a gastrointestinal device is implanted in the pylorus according to some embodiments;

[0039] Figure 4A is a front perspective view of a suture tether according to some embodiments;

[0040] Figure 4B is a front perspective view of a suture tether according to some embodiments;

[0041] Figure 5 is a cross-sectional view of a portion of the digestive tract of a human body with a gastrointestinal device and a suture tether implanted in the pylorus according to some embodiments;

[0042] Figure 6 is a front perspective view of a delivery system according to some embodiments;

[0043] Figure 7 According to some embodiments Figure 6 A magnified view of the delivery system;

[0044] Figure 8 According to some embodiments, the Figure 6 a cross-sectional view of a portion of a delivery system;

[0045] Fig. 9 According to some embodiments Figure 6 A magnified view of the delivery system;

[0046] Fig.10 According to some embodiments Fig. 9 An enlarged view of circle 10;

[0047] Fig.11 According to some embodiments Figure 6 A magnified view of the delivery system;

[0048] Fig.12 According to some embodiments Figure 6 A magnified view of the delivery system;

[0049] Fig.13 According to some embodiments Fig.12 An enlarged view of circle 13;

[0050] Fig.14 According to some embodiments Figure 6 A magnified view of the delivery system;

[0051] Fig.15 According to some embodiments Figure 6 A magnified view of the delivery system;

[0052] Fig.16 According to some embodiments Fig.15 An enlarged view of circle 16;

[0053] Fig.17 is a cross-sectional view of a portion of a digestive tract in a human body in which a gastrointestinal device is positioned transpylorically according to some embodiments;

[0054] Fig.18 is a cross-sectional view of a portion of a digestive tract in a human body in which a gastrointestinal device is positioned transpylorically according to some embodiments;

[0055] Fig.19 is a cross-sectional view of a portion of a human digestive tract in which a gastrointestinal device is positioned transpylorically according to some embodiments; and

[0056] Fig. 20A Gastrointestinal implant delivery system according to some embodiments

[0057] Fig. 20B is a cross-sectional view of a gastrointestinal implant delivery system taken along its longitudinal axis according to some embodiments

[0058] Figures 21A-21E Gastrointestinal implant delivery system according to some embodiments

[0059] Fig. 22 Gastrointestinal implant delivery system according to some embodiments

[0060] Figures 23A-23B Gastrointestinal implant delivery system in combination with a gastrointestinal device according to some embodiments

[0061] Figures 24A-24BA cross-sectional view of a portion of the digestive tract in a human body in which a gastrointestinal implant delivery system is combined with a gastrointestinal device according to some embodiments

[0062] Fig.25 is a cross-sectional view of a portion of the digestive tract in a human body according to some embodiments wherein a gastrointestinal device according to some embodiments is positioned transpyloric. DETAILED DESCRIPTION

[0063] Those skilled in the art will readily appreciate that various aspects of the present disclosure may be implemented by any number of methods and devices configured to perform the intended functions. It should also be noted that the drawings referenced herein are not necessarily drawn to scale, but may be enlarged to illustrate various aspects of the present disclosure, and for this reason the drawings should not be understood as limiting.

[0064] The present disclosure relates to devices, systems and methods for placing and removing devices and systems within the anatomical structure of a patient. Using the devices, systems and methods disclosed herein, an implantable device can be placed (e.g., delivered and / or deployed) within the anatomical structure of a patient and / or removed therefrom. In various embodiments, such procedures are performed endoscopically through the mouth, throat, stomach and intestines. Some examples relate to devices, systems and methods for placing an implantable medical device within the gastrointestinal tract of a patient (e.g., within the pyloric antrum, pylorus, duodenum and / or jejunum of a patient) and / or removing therefrom. It should be appreciated that in various instances, such medical devices can be delivered via one or more catheters.

[0065] In some cases, the devices, systems, and methods disclosed herein can be used to secure the position of a medical device (e.g., a gastrointestinal device) within the patient's anatomical structure. For example, in some instances, one or more anchoring elements can be used to secure the gastrointestinal device to a specific portion of the patient's stomach and / or intestines, including the pyloric antrum, pylorus, duodenum, and / or jejunum. In various embodiments, these devices and systems can be removed. For example, the anchoring element(s) and the gastrointestinal device can be removed after a specified period of time or in response to the occurrence of one or more events.

[0066] As discussed in more detail below, in various embodiments, an anchoring member (e.g., one or more anchoring elements) is operated to tether the gastrointestinal implant to the pylorus at the fundus of the stomach. The pylorus is a muscular body that acts as a sphincter by opening and closing with the relaxation and contraction of circular muscles, thereby including a circular aperture at the fundus of the stomach that acts as a valve. When fully open, the pylorus generally exhibits a maximum diameter between twelve millimeters (12 mm) and thirty millimeters (30 mm).

[0067] Therefore, disclosed system, device and method do not penetrate into the abdominal cavity from the digestive tract, thereby minimizing the risk of bacterial migration and subsequent infection. In various instances, the delivery system can be operated to deliver the suture tether through the muscle portion of the pylorus contained in the non-sterile environment of the gastrointestinal tract. In some instances, the delivery system additionally includes one or more features and / or attributes, which are operated to minimize the risk of penetrating the sterile environment of the surrounding abdominal cavity. In some instances, the delivery system additionally includes one or more features, which operate to minimize or otherwise protect the pylorus from excessive forces that can cause tearing, pressure necrosis or ulcers.

[0068] Figure 1 A cross-sectional view of a portion of a human digestive tract 10 is shown, showing the stomach 16, intestine 18, pylorus 20, and duodenum 22. The pylorus generally includes the pyloric antrum 24 and the pyloric sphincter 26. Figure 1 As shown, gastrointestinal device 100 is positioned between stomach 16 and intestine 18. In some examples, gastrointestinal device 100 is positioned within pylorus 20 such that one or more portions of gastrointestinal device 100 are positioned within or adjacent to pyloric antrum 24. In some examples, gastrointestinal device 100 is additionally or alternatively positioned such that one or more portions of gastrointestinal device 100 are positioned within duodenum 22.

[0069] Figure 2 and 3 A gastrointestinal device 100 is shown according to various embodiments. Figure 2 is a perspective view of a gastrointestinal device 100 . Figure 3 1 is a simplified cross-sectional view of gastrointestinal device 100 within the anatomy of a patient, illustrated with proximal and distal structural elements 172 and 196 removed for clarity.

[0070] In various embodiments, the gastrointestinal device 100 is an expandable, endoscopically deliverable component that interfaces with natural anatomical structures within the gastrointestinal tract to help achieve weight loss. In some instances, the gastrointestinal device 100 is expandable, as will be appreciated by those skilled in the art. That is, in various embodiments, upon deployment, the gastrointestinal device 100 can be transformed from a compressed or folded delivery configuration to an expanded deployment configuration. Although in Figure 2 3, it should be understood that in various examples, the sleeve may be attached or may be capable of being attached to the gastrointestinal device 100, and when deployed, the sleeve 120 may be positioned or capable of being positioned within the patient's intestine 18, as will be understood by those skilled in the art. Thus, in various examples, the bypass sleeve may be an intestinal bypass sleeve, an intestinal liner, or a bypass liner.

[0071] Continue to refer Figure 2 and 3, the gastrointestinal device 100 has a generally cylindrical shape. In some embodiments, the gastrointestinal device 100 defines a central longitudinal axis along the length of the gastrointestinal device 100. The gastrointestinal device 100 generally also includes a proximal portion 130, a distal portion 132, and a neck portion 134. In various examples, the neck portion 134 is located between the proximal portion 130 and the distal portion 132. The neck portion 134 may be integral with the proximal and distal portions 130 and 132, or alternatively coupled to the proximal and distal portions 130 and 132. In various examples, the neck portion 134 fluidly connects the proximal and distal portions 130 and 132. In some examples, the neck portion 134 is tubular and includes an inner cavity therethrough. In some such examples, the cavity extends along the longitudinal axis of the gastrointestinal device 100.

[0072] In some examples, the proximal portion 130 includes a proximal end 140 and a distal end 142. In some examples, the proximal portion 130 is cylindrical or tubular. In some embodiments, a proximal wall flange 148 is located between the proximal portion 130 and the neck portion 134. In some examples, the diameter of the outer surface of the proximal portion 130 is greater than the diameter of the outer surface of the neck portion 134. Therefore, in various examples, the proximal wall flange 148 is generally disc-shaped and extends between the neck portion 134 and the proximal portion 130, as shown. In some examples, the proximal wall flange 148 is oriented transversely to the central longitudinal axis of the gastrointestinal device 100.

[0073] In various embodiments, one or more of the proximal portion 130 and the proximal wall flange 148 adopt a curved profile or otherwise tend to have a curved profile when deployed (e.g., when the gastrointestinal device 100 is expanded). For example, in some examples, one or more of the proximal portion 130 and the proximal wall flange 148 include a concave surface. For example, the proximal wall flange 148 can resemble a bowl. In some other examples, one or more of the proximal portion 130 and the proximal wall flange 148 additionally or alternatively include a convex surface.

[0074] In some embodiments, the distal portion 132 includes a proximal end 144, a distal end 146, and an outer wall extending between the proximal and distal ends 144 and 146. In some examples, the distal portion 132 is shaped as a flange. In some examples, the distal portion 132 is cylindrical. In some examples, a distal wall flange 150 is located between the distal portion 132 and the neck portion 134. In some examples, the diameter of the outer surface of the distal portion 132 is greater than the diameter of the outer surface of the neck portion 134. Therefore, in various examples, the distal wall flange 150 is generally disc-shaped and extends between the neck portion 134 and the distal portion 132, as shown. The distal wall flange 150 extends generally from the proximal end 144 of the distal portion 132. In some examples, the distal wall flange 150 extends transversely to the central longitudinal axis of the gastrointestinal device 100. As discussed in greater detail below, when positioned within a patient, in the expanded configuration, the distal portion 132 may be positioned within the duodenum and / or may define an opening at a distal end 146 that faces the intestine 18 .

[0075] The neck portion 134 includes a first end 160, a second end 162, and a wall extending between the first and second ends 160, 162. The neck portion 134 can be shaped as a cylinder extending between the proximal portion 130 and the distal portion 132, as mentioned above. In some examples, the neck portion 134 defines a through lumen 152 that allows the contents of the stomach 16 (e.g., gurgling) to pass into the intestine 18. The neck portion 134 can be rigid to keep the pylorus 20 open, or it can be compliant to allow the through lumen 152 to open and close with the pylorus 20.

[0076] In some embodiments, the length of the neck portion 134 may be about the width of the patient's pylorus. In some embodiments, the length of the neck portion 134 may be longer than the width of the patient's pylorus to provide clearance between the proximal wall flange 148, the distal wall flange 150, and the pylorus 20. In some embodiments, the size of the neck portion 134 may be set to allow the proximal wall flange 148 and the distal wall flange 150 to contact the pylorus 20.

[0077] In various embodiments, the gastrointestinal device 100 can be formed of a braided wire structure, as will be appreciated by those skilled in the art. Such a braided wire structure can help position the gastrointestinal device 100 within the patient. For example, the braided wire structure can provide structural support for the gastrointestinal device 100 and help maintain the shape of the gastrointestinal device 100.

[0078] In some embodiments, gastrointestinal device 100 includes structural elements contained within a braided wire structure. Figure 2As shown, in some embodiments, the gastrointestinal device 100 has a distal structural element 196. In some examples, the distal structural element 196 includes rings 193, 194 attached to the distal portion 132 and / or the neck portion 134. In some examples, the distal structural element 196 includes a metal, such as Nitinol (nickel-titanium alloy), a nickel-cobalt base alloy, such as those sold under the trade name Nitinol. Cobalt alloys, such as alloy L605, cobalt-chromium-nickel-molybdenum alloys, such as those sold under the trade names Sold in stainless steel, or plastics such as PET, PEEK, polyoxymethylene, such as under the trade name , or any other suitable material. In some instances, the distal structural element 196 comprises a superelastic nitinol wire formed into a suitable shape. In an exemplary embodiment, the distal structural element 196 is formed by three loops of nitinol wire. If it is desired that the distal structural element 196 has a certain rigidity or stiffness, the size and material of the distal structural element 196 can be used to control these characteristics. For example, nitinol wire can be used to form a reinforcing element with suitable compressive strength and expansion strength, and the strength varies with the diameter of the wire used to make the distal structural element 196.

[0079] like Figure 2 As shown, the loops 193, 194 of the distal structural element 196 are arranged around the distal portion 132 and attached to the distal portion 132, such as by being integrally woven into the flange material. The loops 193, 194 of the distal structural element 196 are attached by weaving the loops 193, 194 through the braided structure of the distal portion 132. In some examples, the wire ends may be inserted into the connecting sleeve and crimped, welded, and / or fastened by any other suitable known means.

[0080] like Figure 2 As shown, in some embodiments, the gastrointestinal device 100 additionally or alternatively includes a proximal structural element 172 attached to the proximal portion 130. In some examples, the proximal structural element 172 is a compression biasing element, such as a spring. The proximal structural element 172 can be constructed as a generally circular frame with a node 186. The proximal structural element 172 can be constructed of the same material that forms the distal structural element 196. The proximal structural element 172 can also provide structural support for the proximal portion 130. For example, the proximal structural element 172 generally has a compressible but still rigid overall frame. The proximal structural element 172 can give the proximal portion 130 additional radial strength and help keep the proximal end 140 of the proximal portion 130 open. The proximal structural element 172 can be shaped to bias the folding direction of the gastrointestinal device 100 for removal from the patient and for loading the device onto a delivery catheter for delivery in the patient.

[0081] like Figure 2As shown, in some embodiments, the gastrointestinal device 100 may include a drawstring 192. In some examples, the drawstring 192 is attached to the proximal portion 130. The drawstring 192 may be attached to the proximal portion 130 by weaving the drawstring 192 through the material of the proximal portion 130. In various examples, the drawstring may be woven through the material of the proximal portion and have a portion of the drawstring forming a loop 198. For example, the drawstring 192 may be constructed of a rope or suture woven through alternating units in the braided wire structure of the gastrointestinal device 100. The loop 198 allows the drawstring 192 to be attached to a retraction tool, such as a hook or clamp. In some embodiments, the drawstring 192 is a suture woven through the proximal portion 130. The drawstring 192 may be a structure that separates the proximal structural element 172. The drawstring 192 may be constructed of a suture material and may include a thin wire or cable.

[0082] Now turn back to Figure 3 , when deployed within the patient's anatomy, the proximal portion 130 is generally located on a side of the pylorus 20 adjacent to the stomach 16 , wherein the distal portion 132 is generally located on a side of the pylorus 20 adjacent to the duodenum 22 , and wherein the neck portion 134 spans the pyloric sphincter 26 .

[0083] As shown, the gastrointestinal device 100 is deployed such that the pyloric sphincter 26 and associated tissue clamps or otherwise are located between the proximal and distal portions 130 and 132 of the gastrointestinal device 100. Traditionally, conventional designs have relied on the integrity and geometry of the implant device to resist movement and / or rotation of the implant device relative to the pylorus 20 and surrounding tissue.

[0084] For example, some conventional devices attempt to resist or minimize rotation and movement after implantation by increasing the length and / or diameter of the device portion protruding into the duodenum. Such configuration provides that the device can contact the duodenum and prevent further rotation before deflection or displacement. For example, the length and diameter size of the portion of the device extending into the duodenum can be set to prevent tilting or tipping over in the duodenum. In certain embodiments, such configuration provides that when the device rotates or tilts away relative to the surrounding anatomical structure, the device will contact the intestinal wall, and therefore will resist further rotation or tilting of movement. Some other conventional designs have included active fixing devices, such as the barbs that penetrate deeply into the surrounding tissues. However, as mentioned above, such configuration has the risk of tissue necrosis and erosion, which can lead to complications, such as bacterial infection or systemic infection of mucosal tissue.

[0085] In some cases, the device has included additional structural components to assist in anchoring the device to the surrounding anatomical structure, such as those structural elements discussed above (e.g., proximal and distal structural elements 172 and 196). However, these structural elements do not penetrate the surrounding tissue and therefore rely on the geometry of the device and its interference with the surrounding tissue to maintain the alignment of the device within the anatomical structure.

[0086] In various embodiments, one or more suture tethers may be used in combination with the gastrointestinal device 100 to secure the gastrointestinal device 100 to the surrounding tissue. As explained in more detail below, the one or more suture tethers operate to secure the gastrointestinal device to the surrounding anatomical structure and, in some cases, operate to help maintain the geometry of the gastrointestinal device 100. In various examples, one or more of the suture tethers extend through one or more portions of the gastrointestinal device 100 and through one or more portions of the surrounding anatomical structure. Generally speaking, the suture tethers thereby operate as a second anchoring mechanism that helps maintain the position of the gastrointestinal device 100 relative to the surrounding anatomical structure.

[0087] Now go to Figure 4A and 4B In some embodiments, the suture tether 200 is an anti-movement device, which includes a body 202 having a first end 204, a second end 206 opposite to the first end 204, and an elongated middle portion 208 extending between the first end 204 and the second end 206. The body 202 may include one or more filamentary members, braided fibers, or may be a line or a braided line. That is, in some instances, the body 202 may be structurally compressible, while in other instances, the body 202 cannot independently support a compressive load without significant deformation (e.g., overlap or wrinkles). In various instances, the body 202 is elastic to tensile loads. In some instances, the body 202 is stretch-resistant. It should be understood that the body may be composed of a biocompatible non-absorbable suture material, such as polypropylene, PTFE, ePTFE or dPTFE, polyester, nylon, UHMWPE or stainless steel. In some instances, the body 202 is formed by a material configured to resist tissue ingrowth, such as polypropylene or nylon, dPTFE or stainless steel.

[0088] In various embodiments, the suture tether 200 includes one or more retaining tabs. Figure 4AAs shown, the suture tether 200 includes a first retaining tab 210 and a second retaining tab 212. The retaining tabs 210 and 212 are operated to maintain the position of the suture tether 200 relative to the gastrointestinal device 100. For example, in some cases, the retaining tabs 210 and 212 are operated to minimize the risk of the suture tether 200 being disconnected from the gastrointestinal device 100, as further discussed below. Although a variety of retaining tabs can be envisioned and can be used without departing from the spirit or scope of the present disclosure, in some examples, the retaining tabs are formed by one or more tubes. In some examples, as discussed in more detail below, the tube is configured so that the body 202 can be received within the tube and coupled to the tube. In some examples, the tube can be crimped to facilitate coupling between the retaining tab and the body 202. The retaining tabs can be formed from a variety of biocompatible materials, including but not limited to metal particles such as stainless steel and nitinol, and polymers such as polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyetheretherketone (PEEK), ultra-high molecular weight polyethylene (UHMWPE), polyurethane, polyester, polyimide, nylon and polypropylene.

[0089] In some instances, the retaining tabs are integral with the body 202. In some such instances, the retaining tabs and the body 202 are used as an integral unit. In some instances, one or more of the retaining tabs are coupled to the body 202. In some instances, the body 202 terminates at or within each of its respective ends at a retaining tab. It should be appreciated that any suitable method may be used to couple the retaining tabs to the body 202, including but not limited to clamping, gluing, pinning, tying, or utilizing one or more fastening devices, as will be appreciated by those skilled in the art. As shown, the retaining tabs 210 and 212 are crimped onto the body 202.

[0090] In various embodiments, the suture tether 200 is configured to transition from a delivery configuration to an expanded configuration so that the suture tether 200 can be delivered to a target area with a minimal profile and then deployed (e.g., coupled to the gastrointestinal device 100) in a manner that minimizes the likelihood of disconnection of the retention tabs from the gastrointestinal device 100. Generally, when transitioning to the expanded configuration, one or more of the retention tabs of the suture tether 200 changes shape and / or orientation relative to the body 202. In various examples, one or more of the retention tabs 210 and 212 are coupled to the suture tether 200 so that when unrestricted, the retention tabs are biased to adopt an expanded configuration. Such configurations provide that one or more of the first and second retention tabs 210 and 212 will adopt or otherwise naturally transition to an expanded configuration when deployed within an anatomical structure. In some examples, the natural transition to the expanded configuration when deployed can be achieved by creating a preformed bend in the body 202.

[0091] Figure 4BThe suture tether 200 is shown in a partially deployed configuration to illustrate a non-limiting example of the first and second retention tabs 210 and 212 in a delivery and deployed configuration. Figure 4B , the first retention tab 210 is oriented in the deployed configuration while the second retention tab 212 is oriented in the delivery configuration. As shown, the orientation of the first retention tab 210 is different from the orientation of the second retention tab 212. In some examples, in the deployed configuration, the retention tab is oriented transversely to the body 202 (or otherwise extends transversely to the body 202). For example, Figure 4B As shown, the first retention tab 210 (which is illustrated in the expanded configuration) extends transversely to the body 202. In some examples, in the delivery configuration, the retention tab extends generally along or in line with the body 202. For example, as in Figure 4B As shown in FIG. 2 , the second retention tab 212 (which is illustrated in the delivery configuration) extends generally along or in line with the body 202 .

[0092] In addition, if Figure 4A As shown, the body 202 terminates or is otherwise coupled to retaining tabs 210 and 212 at a mid-portion thereof. Figure 4A As shown, the body 202 terminates in a first retention tab 210 at an intermediate portion 218 between a first end 214 and a second end 216 of the first retention tab 210. Thus, in various examples, the retention tab is coupled to the body 202 such that two or more portions of the retention tab protrude away from the body 202. Figure 4A As shown, in the deployed configuration, the first end 214 and the second end 216 extend or protrude away from the body 202 .

[0093] As mentioned above, in the delivery configuration, the suture tether 200 maintains a minimal profile. In some examples, the retention tab includes one or more features to help facilitate a minimal delivery profile. For example, Figure 4A As shown, the first retaining tab 210 includes a protrusion 220 formed in the main body first retaining tab 210 configured to receive the suture tether 200 in the delivery configuration. Figure 4B As shown, in the delivery configuration, the body 202 is received by the protrusion 220 in the second retention tab 212.

[0094] It should be understood that, although the retaining tabs 210 and 212 are described as changing orientation relative to the body 202 in the embodiments and examples discussed above, in various embodiments, when the suture tether 200 is converted from the delivery configuration to the deployment configuration, the retaining tabs of the suture tether 200 may additionally or alternatively change size and / or shape. For example, in some cases, the retaining tabs are inflatable members. In some other examples, the retaining tabs are expandable members that expand from the delivery profile to the deployment profile. In some such examples, the retaining member is self-expanding. In some examples, the retaining tabs are disc-shaped. In a certain example, the retaining tabs include one or more flaps configured to protrude away from the body 202 in the deployment configuration. It should be understood that any suitable configuration for the retaining member can be utilized, provided that the retention member is converted to the deployment configuration to minimize the possibility of the retaining tabs being disconnected from the gastrointestinal device 100.

[0095] Figure 5 for Figure 3 2, illustrating the deployment of a suture tether 200. As shown, in various examples, the suture tether 200 is configured to extend from the proximal portion 130 of the gastrointestinal device 100 to the distal portion 132 of the gastrointestinal device 100. In some examples, the suture tether 200 is configured to penetrate one or more of the proximal and distal portions 130 and 132 of the gastrointestinal device 100, as well as one or more portions of the surrounding anatomical structure. As discussed in more detail below, the suture tether 200 is deployed within the anatomical structure such that it penetrates the pyloric sphincter 26 (e.g., a muscle associated with the pylorus 20).

[0096] like Figure 5 As shown, the suture tether 200 penetrates the proximal portion 130 of the gastrointestinal device 100. In some examples, the suture tether 200 penetrates the proximal wall flange 148 of the proximal portion 130. In some examples, the second retention tab 212 is positioned adjacent to the proximal wall flange 148 on the stomach side of the gastrointestinal device 100. That is, in various examples, the suture tether 200 is deployed so that the proximal wall flange 148 of the proximal portion 130 (or substantially the proximal portion 130) is located between the second retention tab 212 and the tissue of the pylorus 20 (e.g., the pyloric sphincter 26) sandwiched between the proximal and distal portions 130 and 132 of the gastrointestinal device 100.

[0097] Similarly, if Figure 5As shown, the suture tether 200 penetrates the distal portion 132 of the gastrointestinal device 100. In some examples, the suture tether 200 is passed through the distal wall flange 150 of the distal portion 132. In some examples, the first retention tab 210 is positioned adjacent to the distal wall flange 150 on the duodenal side of the gastrointestinal device 100. That is, in various examples, the suture tether 200 is deployed so that the distal wall flange 150 of the distal portion 132 (or substantially the distal portion 132) is located between the first retention tab 210 and the tissue of the pylorus 20 (e.g., the pyloric sphincter 26) sandwiched between the proximal and distal portions 130 and 132 of the gastrointestinal device 100.

[0098] In various examples, the suture tether 200 is deployed such that the suture tether 200 spans between the proximal and distal portions 130 and 132 without penetrating the neck portion 134 of the gastrointestinal device 100. For example, Figure 5 As shown, the suture tether 200 is deployed such that it penetrates each of the proximal and distal portions 130 and 132 to the gastrointestinal device 100 and spans therebetween without penetrating the neck portion 134 of the gastrointestinal device 100. In other words, in various examples, the suture tether 200 is deployed and penetrates the gastrointestinal device 100 at one or more locations radially outward from the neck portion 134.

[0099] It should be appreciated that one or more suture tethers 200 may be used to secure the gastrointestinal device 100 to the surrounding anatomical structure. For example, in some instances, three suture tethers 200 may be deployed to secure the gastrointestinal device 100 to the surrounding anatomical structure. In some such instances, the suture tethers 200 are generally evenly distributed around the gastrointestinal device 100. For example, where three suture tethers 200 are used to secure the gastrointestinal device 100 to the surrounding anatomical structure, each of the suture tethers 200 may be positioned 120 degrees apart.

[0100] It will also be appreciated that such a configuration provides for manipulation of the one or more suture tethers 200 to minimize rotation of the gastrointestinal device 100 in situ about the longitudinal axis of the gastrointestinal device 100 , as well as movement of the gastrointestinal device 100 relative to the pylorus 20 .

[0101] It has been discovered that one of the factors that contributes to the displacement and movement of gastrointestinal implants (and specifically those located in the pylorus) involves the relative rotation of the portions of the gastrointestinal implant on either side of the pyloric sphincter 26 due to the natural contraction and movement of the surrounding tissue. For example, as the rotation of the distal portion 132 and / or the neck portion 134 increases relative to the proximal portion 130, the gastrointestinal device 100 deforms and loses its ability to adequately conform to the anatomy of the pylorus 20. This conformation issue results in a reduction in the surface area of ​​the proximal portion 130, which reacts or otherwise engages with the anatomy of the pylorus 20 adjacent the proximal portion 130, thereby reducing the ability of the gastrointestinal device 100 to resist displacement and movement. Given a sufficient amount of rotation, combined with the natural contraction and movement of the surrounding anatomy, the effective surface area of ​​the gastrointestinal device 100 will be insufficient to maintain the gastrointestinal device 100 within the pylorus 20, and the gastrointestinal device 100 will displace.

[0102] Thus, the suture tether 200 operates as a second anchoring mechanism that serves to minimize relative rotation of the proximal and distal portions 130 and 132 (and / or the neck portion 134) relative to each other and / or relative to the surrounding anatomical structure. The suture tether 200 physically secures the gastrointestinal device 100 to the surrounding anatomical structure by penetrating the surrounding anatomical structure and one or more of the proximal and distal portions 130 and 132 of the gastrointestinal device 100. In some such instances, the suture tether 200 is operated to maintain relative alignment of the anatomical structure and the portion of the gastrointestinal device 100 to which the suture tether 200 is coupled. In some instances, such a configuration is operated to maximize and maintain the effective surface area of ​​the gastrointestinal device 100 available for reacting with the surrounding anatomical structure or otherwise engaging to prevent displacement and / or movement.

[0103] In those configurations in which the suture tether 200 extends through the surrounding anatomical structure and each of the proximal and distal portions 130 and 132 of the gastrointestinal device 100, the suture tether 200 is additionally manipulated to minimize the amount of relative swivel between the proximal and distal portions 130 and 132 of the gastrointestinal device 100, thereby minimizing the amount of deformation of the gastrointestinal device 100. By further minimizing the amount of deformation of the gastrointestinal device 100, the suture tether 200 is manipulated to maximize and maintain the effective surface area of ​​the gastrointestinal device 100 available for reacting or otherwise engaging with the surrounding anatomical structure to prevent displacement and / or movement.

[0104] In various examples, the amount of free rotation of the proximal and distal portions 130 and 132 relative to each other is based at least in part on the length of the suture tether 200 relative to the distance between the proximal and distal portions 130 and 132, as will be appreciated by those skilled in the art. In some examples, the length of the suture tether 200 (e.g., the distance between the first and second retention tabs 210 and 212) exceeds the distance between the proximal and distal wall flanges of a given gastrointestinal device, such that the first and second retention tabs 210 and 212 do not contact tissue when implanting or pinching the proximal and distal wall flanges of a given gastrointestinal device together. For example, in some non-limiting examples, the distance between the proximal and distal wall flanges of the gastrointestinal device may be eleven millimeters, while the distance between the first and second retention tabs 210 and 212 of the suture tether 200 may be between fifteen and thirty millimeters. In some examples, selecting or configuring the suture tether in this manner helps avoid pressure necrosis, ulcers, and other damage to anatomical structures. In addition, selecting or configuring a suture tether to have a length that exceeds the distance between the proximal and distal wall flanges of a given gastrointestinal device allows the gastrointestinal device to dynamically adjust to the anatomical structure as the surrounding anatomical structure moves in association with digestive activity. The longer a given suture tether 200 is relative to the distance between the proximal and distal portions 130 and 132, the greater the amount of possible swivel between the proximal and distal portions 130 and 132. A certain degree of swivel between the proximal and distal portions 130 and 132 may be desirable. For example, a certain degree of swivel between the proximal and distal portions 130 and 132 may provide a gastrointestinal device 100 that more appropriately fits the surrounding anatomical structure.

[0105] Examples of suitable configurations for the gastrointestinal device 100 are illustrated and described in U.S. Patent Application Nos. 15 / 060,418, 14 / 872,990, and 15 / 600,214, the contents of which are incorporated herein by reference. It should be appreciated that the gastrointestinal device 100 can be delivered according to methods known to those of ordinary skill in the art. Examples of suitable methods for delivering the gastrointestinal device 100 are illustrated and described in the above-mentioned U.S. Patent Application Nos. 15 / 060,418, 14 / 872,990, and 15 / 600,214.

[0106] In various examples, the gastrointestinal device 100 can include one or more anchoring components that operate independently or collectively to maintain the position of the gastrointestinal device 100 within the patient's anatomy. In some examples, a sleeve 120 can be attached to the anchor 110, as will be appreciated by one skilled in the art. It should also be appreciated that the gastrointestinal device 100 can be an implant, a gastrointestinal implant, or a pyloric implant.

[0107] In various embodiments, the gastrointestinal device 100 and suture tether 200 can be endoscopically implanted into and / or removed from the patient's anatomy in a delivery configuration as discussed above. Generally, in the delivery configuration, the gastrointestinal device 100 and / or suture tether 200 are in a closed, compressed, or folded configuration because they have a smaller profile than the deployed profile, as will be appreciated.

[0108] Figures 6 to 11 The delivery system 300 and associated operations for delivering and deploying one or more of the suture tethers 200 to secure the gastrointestinal device 100 within the anatomy of the patient are shown. Figure 6 and 7 As shown, the delivery system 300 includes a handle 302 having a needle push element 304 and a suture tether push element 306. In various examples, the delivery system further includes an elongated element 308 having a proximal end 310 and a distal end 312. In some examples, the elongated element 308 is a catheter. In various examples, the handle 302 is operably connected to the elongated element 308. In some examples, the handle 302 is connected to the proximal end 310 of the elongated element 308. It should be understood that the various delivery systems discussed herein (including the delivery system 300) can be delivered via one or more guidewires.

[0109] Figure 8 For along Figure 7 8-8 of the cross-sectional view of the distal end 312 of the elongated element 308. Figure 8 As shown, in various examples, the delivery system further includes a needle 314 and a suture tether pusher 316. In various examples, the suture tether pusher 316 and the needle 314 are each coaxially located within the elongated element 308. Therefore, in various examples, the elongated element 308 includes a lumen extending therethrough. In various examples, the needle 314 is coaxially received within the lumen of the elongated element 308. In some examples, the suture tether pusher 316 is coaxially received within the lumen of the needle 314.

[0110] As discussed in more detail below, in some examples, the suture tether 200 is additionally located within the lumen of the needle 314. In various examples, the needle 314 is operably coupled to the needle push element 304 of the handle 302. It should be appreciated that the needle 314 may be coupled to the needle push element 304 via any suitable member or mechanism, provided that actuation of the needle push element 304 causes a corresponding actuation of the needle 314. In some examples, the needle 314 may be formed by a hollow elongated element having a proximal end and a distal end, wherein the hollow elongated element forming the needle 314 extends through the lumen of the elongated element 308. In some such examples, the proximal end of the elongated element forming the needle 314 is coupled to the needle push element 304, and the distal end of the elongated element forming the needle 314 is configured as a sharp tip adapted to puncture and drive through tissue. In some other examples, the needle 314 may be coupled to a member extending through the elongated element 308. In various embodiments, the distal end of the needle 314 is rigid and long enough to keep the suture tether 200 in a folded configuration during its delivery. In some instances, the distal end of the needle 314 is connected to a flexible shaft extending back to the needle push element 304 in the handle. The characteristics of the needle 314 make the proximal portion flexible enough to bend during navigation through the anatomical structure, while the distal portion has sufficient rigidity to allow the user to push the distal end of the needle through the target tissue. In some instances, the proximal portion of the needle 314 can be made of a high hardness polymer, such as PEEK, nylon and polyurethane. The harder distal portion of the needle can be made of biocompatible stainless steel, nitinol or similar metals, and can be processed to include a sharp tip for piercing tissue. However, it should be understood that the full length of the needle 314 can be formed by a single piece of nitinol, or a length of a stainless steel tube modified in this way, so that its proximal portion is flexible enough to navigate the anatomical structure. In some such examples, the entire length of the needle may be formed from a stainless steel tube that has been laser cut in a helical configuration along a portion of its length (eg, along a proximal portion).

[0111] In various instances, actuation of the needle push element 304 causes corresponding actuation of the needle 314. When actuated, the needle 314 generally translates relative to the slender element 308 (e.g., proximally or distally), as discussed in more detail below. In some instances, the needle push element 304 can be actuated to convert the needle 314 between a retracted and deployed state. In the retracted state, the needle 314 is retracted or otherwise hidden within the slender element 308. That is, in the retracted state, the distal tip of the needle 314 is positioned proximal to the distal end 312 of the slender element 308. The retracted state generally corresponds to the proximal advancement of the needle push element 304 to the delivery position. The delivery system 300 is Figure 6 and 7 , where the needle push element 304 is positioned in the delivery position.

[0112] On the other hand, in the deployed state, the needle 314 extends from the distal end 312 of the elongated element 308 so that the distal tip of the needle is positioned distal to the distal end 312 of the elongated element 308. The deployed state generally corresponds to the needle pushing element 304 being advanced distally to the deployed position. When the needle pushing element 304 is converted from the delivery position to the deployed position (e.g., when the needle pushing element 304 is advanced distally), the needle 314 is translated distally relative to the elongated element 308. That is, in various examples, distal actuation of the needle pushing element 304 relative to the handle 302 and / or the elongated element 308 and / or the suture tether pushing element 306 causes the needle 314 to translate distally relative to the elongated element 308.

[0113] Delivery system 300 Fig. 9 and 10 , wherein the needle push element 304 is positioned in the deployed position. Fig. 9 As shown, the needle push element 304 has been advanced distally relative to the handle 302 and the suture tether push element 306. In addition, as shown, the needle 314 has been advanced distally relative to the elongated element 308, so that a portion of the needle 314 is exposed. Specifically, as shown, the distal tip or end 318 of the needle 314 is positioned distal to the distal end 312 of the elongated element 308.

[0114] In some examples, advancement of the needle push element 304 additionally causes advancement of the suture tether pusher 316. Such configurations are facilitated by a mechanism for deploying the delivery system 300. That is, in various examples, the delivery system 300 includes a deployment mechanism 320 operable to cause simultaneous movement of the suture tether pusher 316 and the needle 314. As discussed further below, the deployment mechanism 320 is further configured to facilitate independent actuation of the suture tether pusher 316 relative to the needle 314. Fig.11 300 is a front perspective view of the delivery system 300, wherein a portion of the handle 302 is removed to illustrate the deployment mechanism 320 and its various components. As shown, the deployment mechanism 320 includes a housing 322 and a sliding member 324. The sliding member 324 is configured to slide relative to the housing 322.

[0115] As shown, the proximal end of the needle 314 is coupled to the housing 322 of the deployment mechanism 320, while the proximal end of the suture tether pusher 316 is coupled to the sliding member 324. In addition, as shown, the needle push element 304 is operably coupled to the distal end of the housing 322. However, it should be understood that the needle push element 304 can be coupled to any portion of the housing 322 in any suitable manner without departing from the spirit or scope of the present application, provided that actuation of the needle push element 304 causes actuation of the housing 322, which in turn causes actuation of the needle 314 relative to the elongated element 308. Similarly, because the sliding member 324 is located within the housing 322, the sliding member 324 can be operated to translate with the housing 322. Therefore, actuation of the needle push element 304 causes the housing 322 and the sliding member 324 to translate. This translation of the sliding member 324 together with the housing 322 causes the needle 314 and the suture tether advancer 316 to translate simultaneously, as will be appreciated by one skilled in the art.

[0116] It should also be appreciated that because suture tether advancer 316 is coupled to sliding member 324 and because sliding member 324 is operable to translate relative to housing 322 and needle 314, sliding member 324 may be actuated to cause suture tether advancer 316 to translate relative to housing 322 and needle 314. Thus, in addition to being actuated in conjunction with actuation of housing 322, suture tether advancer 316 may be further or additionally actuated in conjunction with actuation of sliding member 324 relative to housing 322.

[0117] In various examples, the sliding member 324 can be operated to advance and retract relative to the housing 322. Therefore, in various examples, the suture tether pusher 316 can be operated to advance and retract relative to the needle 314. Specifically, the distal advancement or translation of the sliding member 324 relative to the housing 322 causes the suture tether pusher 316 to advance relative to the corresponding distal side of the needle 314. It should be understood that various other mechanisms can be used to cause the suture tether pusher to advance and retract relative to the needle 314. Therefore, the examples discussed above should not be understood as limiting. On the contrary, it should be understood that those mechanisms and their equivalents that can be configured to cause the needle 314 and the suture tether pusher 316 to operate simultaneously and the suture tether pusher to advance and retract independently relative to the needle 314 fall within the spirit and scope of the present application. For example, the configuration in which the sliding mechanism translates proximally relative to the housing 322 causes the suture tether pusher 316 to advance relative to the distal side of the needle 314 and falls within the spirit and scope of the present application.

[0118] In various examples, as mentioned above, the sliding member 324 can be advanced distally relative to the housing 322 to cause the suture tether pusher 316 to be advanced distally relative to the needle 314. In some examples, as mentioned above, such distal translation of the suture tether pusher 316 relative to the needle 314 can be operated to cause the suture tether 200 to be deployed or translated relative to the needle 314. Specifically, as discussed above, in various examples, the delivery system 300 can be operated to deliver one or more suture tethers 200 to a treatment site within an anatomical structure. In some such examples, the suture tether 200 is loaded into the delivery system, advanced to the treatment site, and deployed. In some such examples, the suture tether 200 is loaded into the lumen of the needle 314 so that the suture tether 200 is located distal to the distal end of the suture tether pusher 316. Therefore, when the suture tether pusher 316 is advanced distally relative to the needle 314, so is the suture tether 200.

[0119] In various examples, the suture tether pushing element 306 can be operated to cause a corresponding actuation of the suture tether pusher 316, as discussed above. Specifically, when the suture tether pushing element 306 is actuated, the suture tether pusher 316 is generally translated relative to the elongated element 308. In various examples, the proximal advancement or translation of the suture tether pushing element 306 corresponds to the proximal advancement or translation of the suture tether pusher 316. Similarly, in various examples, the distal retraction or translation of the suture tether pushing element 306 corresponds to the distal retraction or translation of the suture tether pusher 316. In some examples, similar to the needle pushing element 304, the suture tether pushing element 306 can be actuated thereby to convert the suture tether pusher 316 between the stowed and deployed states. In the stowed state, the suture tether pusher 316 is stowed or otherwise concealed within the lumen of the needle 314 so that the suture tether 200 can be placed within the needle 314 so that the first and second ends 204 and 206 are located proximal to the distal tip or end 318 of the needle 314. That is, in the stowed state, the distal tip of the needle 314 is positioned distal to the first and second ends 204 and 206 of the suture tether 200 and distal to the distal end of the suture tether pusher 316. The stowed state generally corresponds to the suture tether pushing element 306 being in the delivery position. This may include proximally advancing or retracting the suture tether pushing element 306 to the delivery position. The delivery system 300 is in the stowed state. Fig. 9 and 11 , where the suture tether pushing element 306 is in the delivery position.

[0120] On the other hand, in the deployed state, the suture tether pusher 316 is advanced distally so that the second end 206 of the suture tether 200 is forced or ejected from the lumen of the needle 314. That is, in various examples, when the suture tether pushing element 306 is advanced to the deployed position, the suture tether 200 is only partially ejected from the lumen of the needle 314. In some examples, when the needle pushing element 304 is converted from the delivery position to the deployed position (e.g., when the needle pushing element 304 is advanced distally), the suture tether pusher 316 is translated distally relative to the needle 314. This distal advancement or translation of the suture tether pusher 316 relative to the needle 314 causes the suture tether pusher 316 to engage the suture tether 200 retracted within the lumen of the needle 314 and causes the suture tether 200 to be advanced relative to the needle 314.

[0121] Delivery system 300 Fig.12 and 13 , wherein the suture tether push element 306 is positioned in the deployed position. Fig.12 As shown, the suture tether push element 306 and the sliding member 324 have been advanced distally relative to the handle 302 and the housing 322. As shown, the second end 206 of the suture tether 200 extends from the distal tip or end 318 of the needle 314. However, as shown, when the suture tether push element 306 is positioned in the deployed position and when the needle push element 304 is in the deployed position, a portion of the suture tether 200 (e.g., the first end 204) remains retracted within the cavity of the needle 314. As discussed in more detail below, this type of configuration provides that the needle 314 can be advanced through the tissue from the first side of the tissue to the second side of the tissue, and the second end 206 of the suture tether 200 is deployed on the second side of the tissue while maintaining the ability of the first end 204 of the suture tether deployed on the first side of the tissue.

[0122] In some examples, the delivery system 300 includes one or more features that operate to minimize the likelihood of undesired pre-deployment of the suture tether 200. Specifically, and with reference to Fig. 9 and 12 , the delivery system 300 is configured such that one or more tabs 326 of the suture tether pushing element 306 must be depressed before the suture tether pushing element 306 can be advanced distally relative to the handle 302 . Fig. 9 One or more tabs 326 of the suture tether pusher element 306 are shown in an undepressed configuration, while Fig.12 The one or more tabs 326 of the suture tether pushing element 306 are shown in a depressed configuration.

[0123] In addition, in some examples, the suture tether push element 306 cannot be depressed until the needle push element 304 is advanced or translated distally to the deployed position. In some such examples, the housing 322 includes one or more blocking features (not shown) that operate to prevent the one or more tabs 326 of the suture tether push element 306 from being depressed when the needle push element 304 is in the delivery position. However, when the needle push element 304 is advanced to the deployed position and thereby the housing 322 is advanced distally relative to the handle 302 and the suture tether push element 306, the one or more blocking features of the housing are advanced to a position in which they no longer operate to prevent the one or more tabs 326 of the suture tether push element 306 from being depressed. In some examples, the housing additionally or alternatively includes one or more features configured to receive one or more tabs 326 of the suture tether pushing element 306, such that when the housing 322 is advanced distally to the deployed position in response to the needle pushing element 304, the features of the housing 322 configured to receive the one or more tabs 326 of the suture tether pushing element 306 are properly positioned relative to the suture tether pushing element 306 so that the one or more tabs 326 of the suture tether pushing element 306 can be depressed. Non-limiting examples of such receiving features include one or more slots, apertures, or protrusions in the housing 332.

[0124] In some examples, after the suture tether 200 has been partially deployed from the distal end 318 of the needle 314, the suture tether pushing element 306 can be retracted or proximally advanced to the delivery position. When retracted to the delivery position, the suture tether pusher 316 is generally withdrawn proximally relative to the needle 314. Fig.14 The suture tether pusher element 306 is illustrated retracted to a delivery position wherein the second end 206 of the suture tether 200 is deployed from the distal end 318 of the needle 314. It should be appreciated that in various examples, the suture tether pusher element 306 need not be withdrawn proximally from deployment before the remainder of the suture tether 200 is deployed.

[0125] In various examples, after partially deploying the second end 206 of the suture tether 200, the needle push element 304 can be retracted or withdrawn proximally relative to the handle 302. In some examples, withdrawing the needle push element 304 proximally causes the needle 314 to withdraw proximally relative to the elongated element 308. In some examples, withdrawing the needle push element 304 proximally also causes the needle 314 to withdraw proximally relative to the suture tether 200, such that the suture tether 200 is completely removed from the lumen of the needle 314. In some examples, the second retaining tab 212 is operated to maintain the position of the suture tether 200 when the needle 314 is retracted or withdrawn proximally, as discussed in more detail below.

[0126] Delivery system 300 Fig.15 and16 314, wherein the needle push element 304 is retracted or withdrawn proximally to the delivery position, wherein the suture tether 200 is fully deployed from the distal end 318 of the needle 314. When fully deployed, the first and second ends 204 and 206 of the suture tether 200 are ejected from the cavity of the needle 314 and are no longer located therein. In various examples, when the distal end 318 of the needle 314 is withdrawn proximally or retracted to a position proximal to the first end 204 of the suture tether 200, the first retaining tab 210 is free to switch to the deployed configuration, as discussed above. As shown, the needle 314 has been withdrawn or retracted proximally relative to the elongated element 308, so that the distal end 318 of the needle 314 is located within the cavity of the elongated element 308 and proximal to the distal end 312 of the elongated element 308.

[0127] Figure 17 to 2 0 shows a procedure for delivering and attaching a suture tether 200 to a patient's anatomy and a gastrointestinal device 100 to secure the gastrointestinal device 100 from displacement and / or movement. It should be appreciated that in some embodiments, one or more components of the delivery system 300 are configured to fit within a working channel or lumen of a standard endoscope, as will be appreciated by those skilled in the art. For example, in some instances, the elongated element 308 is sized so that the elongated element can be inserted into and advanced through the lumen of an endoscope. It should be appreciated that in some instances, the elongated element 308 is inserted into and advanced through the working lumen of an endoscope after the endoscope has been navigated through the patient's anatomy to the treatment site.

[0128] Fig.17 Gastrointestinal device 100 is shown, with reference to Figures 1 to 3 1 and 12, and is positioned within the patient at the pylorus 20 between the stomach 16 and the intestine 18. For clarity, Figure 17 to 2 0, the patient's anatomical structure has been dissected. In some cases, the endoscope 600 can be used to view the position of the gastrointestinal device 100. Additionally or alternatively, the tube of the endoscope 600 can also be used to guide the elongated element 308 to the gastrointestinal device 100 and select a position for deploying the suture tether. In some instances, as discussed in more detail below, one or more locator aids can advance the treatment site and help guide the elongated element 308 to the gastrointestinal device 100 and select a position for deploying the suture tether, while helping to maintain the position of the elongated element 308 relative to the gastrointestinal device 100 when the distal end 312 of the elongated element 308 is advanced through the gastrointestinal device 100 and associated anatomical structures, and when the suture tether 200 is deployed. In addition, as further discussed below, the suture tether can be delivered via a delivery system that is completely independent of the endoscope. That is, although the endoscope can be used to observe the treatment area, the delivery of the suture tether 200 is achieved via a delivery system that is completely independent of the operation of the endoscope.

[0129] like Fig.17 As shown, the endoscope is positioned at approximately the twelve o'clock position with the distal tip 312 of the elongate member 308 positioned adjacent the proximal wall flange 148 of the proximal portion 130 . Fig.18 A needle 314 is shown extending from the distal tip 312 of the elongate member 308. The needle 314 has been advanced distally relative to the elongate member 308 such that the needle 314 extends through the proximal wall flange 148, through the pyloric sphincter 26, and through the distal wall flange 150. Fig.19 Suture tether 200 is shown delivered and deployed within an anatomical structure. It should be appreciated that suture tether 200 is delivered and deployed according to the description herein. Specifically, as shown, suture tether 200 extends through proximal wall flange 148 at the twelve o'clock position, through pyloric sphincter 26, and through distal wall flange 150, such that first retention tab 210 is located proximal to proximal wall flange 148, and second retention tab 212 is located distal to distal wall flange 150.

[0130] As mentioned above, one or more locator aids can be advanced to the treatment site and help guide the elongated element 308 toward the gastrointestinal device 100 and the location selected for deploying the suture tether, while helping to maintain the position of the elongated element 308 relative to the gastrointestinal device 100 as the distal tip 312 and / or needle 314 of the elongated element 308 are advanced through the gastrointestinal device 100 and associated anatomical structures, and as the suture tether 200 is deployed. Thus, while the tube of the endoscope can be used to guide the elongated element 308 toward the gastrointestinal device 100 and the location selected for deploying the suture tether, in some instances, one or more additional delivery aids can be used in combination with the endoscope to accomplish delivery of the suture tether 200.

[0131] Now go to Fig. 20A and 20B , the delivery system 400 includes a locator catheter 500 configured to operate with an endoscope 600 to help facilitate delivery of the suture tether 200 to the target treatment area. In various examples, the locator catheter 500 includes an elongated element 510, a locator capsule 520, and a cover 530. As shown, the locator capsule is located at or near the distal end 512 of the elongated element 510. As shown, the cover 530 is located proximal to the locator capsule 520. In some examples, as shown, the cover 530 is located between the endoscope 600 and the locator capsule 520.

[0132] In various examples, the delivery system 400 is configured to interface with the endoscope 600. For example, in some examples, as shown, the positioner catheter 500 includes one or more endoscope engagement features 540 that are configured to limit the radial position of the endoscope 600 relative to the positioner catheter 500. By limiting the radial position of the endoscope 600 relative to the positioner catheter 500, the delivery system 400 can help control or limit the position of the elongated element 308 relative to the gastrointestinal device as the distal tip 312 and / or needle 314 of the elongated element 308 are driven through the gastrointestinal device and adjacent anatomical structures during delivery of the suture tether 200.

[0133] Continue to refer Fig. 20A and 20B , the locator capsule 520 is configured to engage or otherwise dock with a gastrointestinal device that has been deployed within the anatomical structure. The engagement between the locator capsule 520 and the deployed gastrointestinal device helps maintain or limit the orientation of the delivery system 300 when the suture tether 200 is delivered and deployed. In some examples, the locator capsule 520 includes a body 522 that is shaped and sized to complement the shape and size of the deployed gastrointestinal device. For example, in some examples, the body 522 is cylindrical and is configured to be received within the through lumen of the deployed gastrointestinal device to cause engagement between the locator capsule 520 and the gastrointestinal device.

[0134] In some examples, the cover 530 is configured to receive the elongated member 308. For example, Fig. 20A As shown, during delivery of the suture tether 200, the cover 530 is positioned between the endoscope 600 and the localizer capsule 520 (and the gastrointestinal device deployed thereby) such that the elongated element 308 extends through the cover 530 as it is advanced from the endoscope 600 toward the deployed gastrointestinal device. In some examples, as shown, the cover 530 includes an aperture or channel 532 configured to receive and limit the radial position of the elongated element 308 as the elongated element 308 extends through the cover 530. It should be appreciated that limiting the radial position of the endoscope 600 and / or the elongated element 308 relative to the localizer capsule 520 (and the gastrointestinal device deployed thereby) helps limit the radial position of the suture tether 200 deployed. Thus, delivery system 400 can be used to help ensure that suture tether 200 is delivered through pyloric tissue and help minimize the risk of inadvertent puncture of the wall of the stomach or small intestine during the delivery procedure, and thereby help minimize the risk of suture tether 200 being delivered through the wall of the stomach or small intestine, as mentioned above.

[0135] Furthermore, as mentioned above, in various examples, a delivery system separate from the endoscope is configured to be advanced to the treatment area and is configured to deliver and deploy the suture tether 200. Figures 21A-21E, a delivery system 700 is shown and includes a catheter 710 and a locator system 720. In some examples, the catheter 710 is a catheter, and the locator system 720 is located at or near the distal end 712 of the catheter 710. In some examples, as shown, the catheter 710 includes a through lumen for receiving a guide wire (GW). It should be understood that the delivery system 700 is Figures 21A-21E 700 is illustrated without the corresponding gastrointestinal device or surrounding anatomical structures to more clearly depict the elements and features of the delivery system 700. Figures 23A-24B The operation of delivery system 700 is shown and described with a gastrointestinal device and / or within an anatomical structure.

[0136] In various examples, the locator system 720 is configured to engage or otherwise dock with a gastrointestinal device that has been deployed within an anatomical structure. The engagement between the locator system 720 and the deployed gastrointestinal device helps maintain or limit the orientation of the delivery system 700 when the suture tether 200 is delivered and deployed. In some examples, the locator system 720 includes a locator capsule 722, which has a body shaped and sized in a manner complementary to the shape and size of the deployed gastrointestinal device, which is similar to the locator capsule 520 mentioned above. Therefore, in some examples, the locator capsule 722 can be cylindrical and configured to be received in the through cavity of the deployed gastrointestinal device to cause engagement between the locator capsule 722 and the gastrointestinal device. However, it should be understood that the locator capsule 722 can be configured to dock or engage the deployed gastrointestinal device in many other suitable ways, provided that the engagement between the locator capsule 722 and the gastrointestinal device is operated to maintain or limit the orientation of the delivery system 700 when the suture tether 200 is delivered and deployed.

[0137] In some examples, the locator system 720 further includes a plurality of extendable arms, including a first extendable arm 724 and a second extendable arm 726, that can be selectively deployed to help facilitate delivery of the suture tether 200. In various examples, the first and second extendable arms 724 and 726 are longitudinally spaced apart from each other such that when the first and second extendable arms 724 and 726 are radially extended from the locator capsule 722, a gap is defined between the first and second extendable arms 724 and 726. For example, as shown, the first extendable arm 724 is positioned closer to the distal end 721 of the locator capsule 722 than the second extendable arm 726. Likewise, as shown, the second extendable arm 726 is positioned closer to the proximal end 723 of the locator capsule 722 than the first extendable arm 724. As discussed further below, the gap between the first and second extendable arms 724 and 726 is configured so that the first and second extendable arms 724 and 726 can span the neck portion of the gastrointestinal device so that the first extendable arm 724 is positioned distally of the distal wall flange of the gastrointestinal device while the first extendable arm 724 is positioned proximally of the proximal wall flange of the gastrointestinal device. As discussed further below, such a configuration helps maintain the longitudinal and radial position of the delivery system 700 during delivery and deployment of the suture tether 200.

[0138] Additionally, as shown, the positioner system 720 is configured such that the first and second extendable arms 724 and 726 can be operated to selectively extend radially from the positioner capsule 722. Thus, it should be appreciated that such a configuration provides the delivery system 700 to be convertible between a delivery configuration (e.g., wherein the first and second extendable arms 724 and 726 are stowed within the positioner capsule 722) and a deployed configuration (e.g., wherein the first and second extendable arms 724 and 726 protrude radially from the positioner capsule 722). The configuration including the first and second extendable arms 724 and 726 helps provide the delivery system 700 with a minimal delivery profile.

[0139] Figures 21A-21C The deployment sequence of the first and second extendable arms 724 and 726 is illustrated. Fig.21A The delivery system 700 is shown in a delivery configuration with the first and second extendable arms 724 and 726 stowed within the locator capsule 722 . Fig. 21B First and second extendable arms 724 and 726 are shown extending partially radially. Fig. 21C The delivery system 700 is shown in an expanded configuration, wherein the first and second extendable arms 724 and 726 are fully radially extended. In various examples, the delivery system 700 is configured to include the elongated element 308. For example, Figures 21A-21EAs shown, the elongated element 308 is coupled to the second extendable arm 726 of the locator system 720. This coupling between the elongated element 308 and the locator system 720 helps to limit the position of the elongated element 308 (and thus the needle 314) relative to the locator system 720 during delivery of the suture tether 200. Fig.21A In the delivery configuration shown, the elongated element 308 is in a first radial position relative to the locator capsule 722 (e.g., the longitudinal axis of the elongated element 308 at the second extendable arm 726 is in a first radial position relative to the longitudinal axis of the locator capsule 722). In this first radial position, the elongated element 308 is not aligned with the target location where the suture tether 200 is to be extended through the gastrointestinal implant. On the other hand, in Fig. 21C In the deployed configuration shown, the elongated element 308 is located at a second radial position relative to the positioner capsule 722 (e.g., the longitudinal axis of the elongated element 308 at the second extendable arm 726 is at a second radial position relative to the longitudinal axis of the positioner capsule 722). In some examples, the second radial position is a radial position that is radially farther from the longitudinal axis of the positioner capsule 722 than the first radial position. In this second radial position, the elongated element 308 is aligned with a target location where the suture tether 200 will extend through the gastrointestinal implant.

[0140] Additionally, as mentioned above, the locator capsule 722 is configured to engage the deployed gastrointestinal device to help limit the position of the locator system 720 relative to the gastrointestinal device during delivery and deployment of the suture tether 200. Thus, it should be appreciated that the coupling between the elongated element 308 and the locator system 720 helps limit the position of the needle 314 relative to the gastrointestinal device during delivery and deployment of the suture tether 200.

[0141] Figures 21D-21E Advancement of the needle 314 from the elongate member 308 and deployment of the suture tether therefrom are illustrated. Fig.21D The needle 314 is shown advanced from the elongated member 308 such that the needle 314 extends across the gap between the first and second extendable arms 724 and 726 . Fig.21E The needle 314 is shown partially retracted to reveal the suture tether 200 with the first retaining tab 210 of the suture tether 200 deployed. Fig.21D and 21E As shown, the delivery system 700 is configured such that the needle 314 (and thereby the suture tether 200) can be advanced across the gap between the first and second extendable arms 724 and 726, and is thereby configured such that the needle 314 (and thereby the suture tether 200) can be advanced from a proximal position of the proximal wall flange of the deployed gastrointestinal device to a distal position of the distal wall flange of the deployed gastrointestinal device.

[0142] In various examples, the first and second extendable arms 724 and 726 can be selectively driven by a user, such as by means of a delivery handle (e.g., handle 302) from outside the body. In some examples, as the first and second extendable arms 724 and 726 radially extend from the locator capsule 722, the relative distance between the first and second extendable arms 724 and 726 decreases. For example, as Fig. 21B and 21C As shown, the relative distance between the first and second extendable arms 724 and 726 is from Fig. 21B The positions of the first and second extendable arms 724 and 726 shown in FIG. 7 are reduced to Fig. 21C 726. Thus, in some instances, when the first and second extendable arms 724 and 726 are deployed, the gap between the first and second extendable arms 724 and 726 is reduced. In some instances, the first extendable arm 724 is configured to translate toward the second extendable arm 726 when the first and second extendable arms 724 and 726 are radially extended from the locator capsule 722. In some instances, the second extendable arm 726 is configured to translate toward the first extendable arm 724 when the first and second extendable arms 724 and 726 are radially extended from the locator capsule 722.

[0143] Now turn to Fig. 22 , a delivery system 700 is shown, wherein the locator capsule 722 is divided into two halves (722A and 722B) to show the non-limiting exemplary internal configuration of the locator capsule 722 and the first and second extendable arms 724 and 726. It should be understood that the elongated element 308 has been removed for clarity (and should be understood to be coupled to the second extendable arm 726). As shown, the first extendable arm 724 includes a body with a projection 728. Although not shown, it should be understood that the first extendable arm 724 may include similar projections on the opposite sides of its body. Similarly, as shown, the second extendable arm 726 includes a body with a projection 730, and may include similar projections (not shown) on the opposite sides of its body.

[0144] In addition, as shown, the first half 722A of the locator capsule 722 includes a plurality of grooves or channels, including a first channel 732 and a second channel 734. Although not shown (due to the presence of the first and second extendable arms 724 and 726), it should be understood that the second half 722B of the locator capsule 722 may include a plurality of grooves or channels of similar size, shape and position to the channels 732 and 734 of the first half 722A of the locator capsule 722. As shown, the first and second channels 732 and 734 are angled relative to the longitudinal axis of the locator capsule 722 (e.g., coaxial with the longitudinal axis of the deployed gastrointestinal implant when the locator capsule 722 is engaged with the gastrointestinal implant). In some examples, the longitudinal axis of the locator capsule 722 is parallel to the longitudinal axis of the catheter 710. Although shown at approximately forty-five degrees relative to the longitudinal axis of the locator capsule 722, it should be understood that at least one of the first and second channels 732 and 734 can be angled at virtually any angle between zero and ninety degrees. As discussed further below, the relative angle between the first and second channels 732 and 734 provides for the first and second extendable arms 724 and 726 to extend radially from the locator capsule 722 when translated relative to each other. Thus, the angle of the first and second channels 732 and 734 can be less than forty-five degrees or, alternatively, greater than forty-five degrees. As will be appreciated by those skilled in the art, the first of the extendable arms 724 and 726 can be angled at zero or ninety degrees, provided that the other of the extendable arms 724 and 726 is angled at an angle different from zero and ninety degrees.

[0145] In various examples, the first channel 732 is configured to receive the protrusion 728 of the first extendable arm 724, so that the protrusion 728 of the first extendable arm 724 travels within the channel 732 and is otherwise constrained by it. This relationship between the protrusion 728 and the first channel 732 provides that the first extendable arm 724 can be radially extended from the locator capsule 722 when the first and second extendable arms 724 and 726 are translated relative to each other. Similarly, the second channel 734 is configured to receive the protrusion 730 of the second extendable arm 726, so that the protrusion 730 of the second extendable arm 726 travels within the channel 734 and is otherwise constrained by it. This relationship between the protrusion 730 and the channel 734 provides that the second extendable arm 726 can be radially extended from the locator capsule 722 when the first and second extendable arms 724 and 726 are translated relative to each other.

[0146] As mentioned above, in various examples, the locator capsule 722 is coupled to the catheter 710. In some examples, the catheter 710 includes a first elongated element 711 and a second elongated element 713. In some examples, the first elongated element 711 extends through the lumen of the second elongated element 713, as shown, so that the first and second elongated elements 711 and 713 can move relative to each other. In some examples, the first elongated element 711 is coupled to the first extendable arm 724, and the second elongated element 713 is coupled to one or more of the second extendable arm 726 and the locator capsule 722. Therefore, it should be understood that the first and second elongated elements 711 and 713 can be actuated relative to each other (such as by means of the handle 302) to cause relative movement between the first and second extendable arms 724 and 726. For example, the first elongated element 711 can be withdrawn proximally while the second elongated element 713 remains stationary to cause the first and second extendable arms 724 and 726 to be pulled closer to each other. Alternatively, the first elongated element 711 can be withdrawn proximally while the second elongated element 713 is advanced distally to cause the first and second extendable arms 724 and 726 to be drawn closer to each other.

[0147] exist Fig.21A In the delivery configuration shown in , the first and second extendable arms 724 and 726 are shown at a first longitudinal distance from each other (e.g., a first distance between the first and second extendable arms 724 and 726 along the longitudinal axis of the locator capsule 722). Fig. 21C In the deployed configuration shown in , the first and second extendable arms 724 and 726 are shown at a second longitudinal distance from each other (e.g., a second distance between the first and second extendable arms 724 and 726 along the longitudinal axis of the locator capsule 722). As shown, the second longitudinal distance is less than the first longitudinal distance. A mechanism is provided to allow the first and second extendable arms 724 and 726 to be drawn closer to each other. The first and second extendable arms 724 and 726 can engage the gastrointestinal device to help limit the longitudinal position of the delivery system 700 relative to the gastrointestinal device during suture tether delivery and deployment. For example, as Fig.23A and 23B As shown, the first and second extendable arms 724 and 726 can engage the gastrointestinal device and pinch the proximal and distal wall flanges between the first and second extendable arms 724 and 726 to help limit the longitudinal position of the delivery system 700 relative to the gastrointestinal device during the delivery and deployment of the suture tether, as further shown and discussed below.

[0148] In some examples, the second extendable arm 726 includes an aperture sized to receive the first elongated element 711 that passes through the aperture and extends to the first extendable arm 724. For example, Fig. 22, the first elongated element 711 extends through an aperture in a portion of the body of the second extendable arm 726 and extends therefrom to the first extendable arm 724. It should be appreciated that although the first elongated element 711 extends through a portion of the body of the second extendable arm 726, the first elongated element 711 is not coupled to the second extendable arm 726 because the first elongated element 711 is operable to slide relative to the second extendable arm 726. Likewise, therefore, the second extendable arm 726 is operable to slide relative to the first elongated element 711.

[0149] In some examples, the locator system 720 further includes a biasing member 736. The biasing member 736 may include one or more elastic elements, such as one or more springs. In some examples, the biasing member 736 is configured to bias the first extendable arm 724 away from the second extendable arm 726 and / or bias the second extendable arm 726 away from the first extendable arm 724. In some examples, the biasing member 736 is alternatively configured to bias the first extendable arm 724 toward the second extendable arm 726 and / or bias the second extendable arm 726 toward the first extendable arm 724. When the delivery system 700 is in the delivery configuration, the biasing member 736 may bias the first and / or second extendable arms 724 and 726 (e.g., the first and second extendable arms 724 and 726 are retracted within the locator capsule 722). Alternatively, when the delivery system 700 is in the deployed configuration, the biasing member 736 can bias the first and / or second extendable arms 724 and 726 (eg, the first and second extendable arms 724 and 726 extend radially outward from the localizer capsule 722).

[0150] In some examples, the biasing member 736 is located between the first and second extendable arms 724 and 726. For example, Fig. 22 , the biasing member 736 extends between the first and second extendable arms 724 and 726. Fig. 22 700, when the delivery system is in the deployed configuration, the biasing member 736 is configured to bias the first and second extendable arms 724 and 726 away from each other (e.g., the first and second extendable arms 724 and 726 extend radially outward from the locator capsule 722). As shown, when the first elongated element 711 extends from the second extendable arm 726 to the first extendable arm 724, it extends through the biasing member 736.

[0151] In addition, despite the Fig. 22 , the delivery system 700 is depicted with the elongated element 308 removed, but it should be understood that the elongated element 308 can be coupled to the second extendable arm 726. Fig. 22 As shown, the second extendable arm 726 includes a channel 738 configured to receive the elongated member 308 (e.g., as shown in FIG. Figures 21A-21D 23A-24B). In some examples, the channel 738 can be configured such that the elongated member 308 is removably coupled to the locator system 720. In some other examples, the elongated member 308 is fixedly coupled to the locator system 720.

[0152] As discussed above and in Fig. 22 Consistent with the configuration of the locator capsule 722 shown in FIG. 1 , when the relative distance between the first and second extendable arms 724 and 726 decreases, the relationship between the protrusions 728 and 730 and the first and second channels 732 and 734 causes the first and second extendable arms 724 and 726 to extend radially outward from the locator capsule 722, as shown in FIG. Figures 21A-21C shown.

[0153] In some examples, the first and second extendable arms 724 and 726 can be actuated to stabilize the delivery system 700 by translating them closer to each other as they extend radially outward from the locator capsule 722 to hold the proximal and distal wall flanges of the gastrointestinal device during delivery and deployment of the suture tether 200. For example, once the first and second extendable arms 724 and 726 of the locator system 720 engage the gastrointestinal device, the needle 314 can be advanced from the elongated element 308 and reliably puncture the gastrointestinal device and anatomical structure at a known and controlled location. In some examples, the delivery system 700 thereby provides delivery and deployment of the needle 314 and suture tether 200 at a specified radial distance relative to the central longitudinal axis of the gastrointestinal device.

[0154] Now go to Figures 23A-24B , illustrating the operation of a delivery system 700 having a gastrointestinal device 100. Figures 23A-23B The delivery system 700 is illustrated in combination with the gastrointestinal device 100 outside of a biological anatomy to clearly depict the interaction between the delivery system 700 and the gastrointestinal device 100 . Figures 24A to 24B The delivery system 700 is illustrated in combination with the gastrointestinal device 100 within the anatomy of a patient as the suture tether 200 is delivered and deployed.

[0155] like Fig.23A As shown, the locator capsule 722 extends through the lumen of the gastrointestinal device 100, with the first and second extendable arms 724 and 726 extending radially outwardly so that the first extendable arm 724 engages the distal wall flange 150 of the gastrointestinal device 100 and the second extendable arm 726 engages the proximal wall flange 148. Fig. 23BAs shown, the needle 314 has been advanced from the elongate member 308 such that the needle extends between the first and second extendable arms 724 and 726 and such that the needle extends from the proximal wall flange 148 across the neck portion 134 of the gastrointestinal device 100 to the distal wall flange 150 .

[0156] Fig.24A The positioner capsule 722 is shown extending through the lumen of the gastrointestinal device 100 , wherein the gastrointestinal device 100 is deployed within the anatomy, and specifically across the pyloric sphincter 26 . Fig. 24B Suture tether 200 is shown having been delivered through gastrointestinal device 100 and pyloric sphincter 26, and deployed to help secure gastrointestinal device 100 to the anatomy and to help minimize the possibility of gastrointestinal device 100 being dislodged from the anatomy. Fig. 24B As shown, after delivery and deployment of the suture tether 200, the needle 314 can be retracted into the elongated element 308, and the first and second extendable arms 724 and 726 can be actuated so that they reside within the locator capsule 722 in the delivery configuration. Fig. 24B , the delivery system can be rotated about the longitudinal axis of the gastrointestinal device 100 (e.g., from the 12 o'clock position to the 4 o'clock position) so that another suture tether 200 can be delivered through the gastrointestinal device 100 and the anatomical structure and deployed to further help minimize the possibility of displacement of the gastrointestinal device 100 from the anatomical structure. Fig. 24B , the delivery system 700 can be withdrawn from the anatomical structure with the positioner system 720, catheter 710, and elongate member 308 removed from the anatomical structure, and with the gastrointestinal device 100 and suture tether 200 remaining within the anatomical structure.

[0157] It should be understood that although the delivery system 700 is depicted with two extendable arms across the neck portion of the gastrointestinal device, it is contemplated that a delivery system such as the delivery system 700 includes a second extendable arm 726 (e.g., an extendable arm positionable proximal to the proximal wall flange of the gastrointestinal device) without requiring a first extendable arm (e.g., an extendable arm positionable proximal to the proximal wall flange of the gastrointestinal device). In some such examples, the delivery system may rely in part on friction between the locator capsule extending through the lumen of the gastrointestinal device for maintaining the longitudinal position of the delivery system as the suture tether 200 is delivered and deployed.

[0158] Fig.25The gastrointestinal device 100 is shown being delivered within an anatomical structure having a plurality of suture tethers 200. Specifically, as shown in Fig. 20, the suture tethers 200 are located at each of the twelve o'clock position, the four o'clock position, and the eight o'clock position. Each suture tether 200 extends through the proximal wall flange 148, through the pyloric sphincter 26, and through the distal wall flange 150 at the twelve o'clock position such that the associated first retention tab 210 is located proximal to the proximal wall flange 148 and such that the associated second retention tab 212 is located distal to the distal wall flange 150.

[0159] Thus, it will be appreciated that using the methods described herein, a device (such as in Figure 1 ) is secured to the surrounding anatomical structures via a second anchoring mechanism to minimize the possibility of displacement and movement. In various embodiments, using the methods described herein, the suture tether 200 and the gastrointestinal device 100 can be removed from the patient without surgery, for example, without making an incision in the patient's body.

[0160] It should be understood that although the examples discussed above are illustrated and described with respect to gastrointestinal devices used in conjunction with the pylorus, the devices, systems and methods discussed herein may be used in other anatomical regions without departing from the spirit or scope of the present disclosure. Therefore, the examples illustrated and described above should not be interpreted as limiting.

[0161] Many features and advantages have been described in the foregoing description, including various alternatives and details of the structure and function of the device and / or method. In addition, the scope of the invention of the various concepts solved in the present disclosure has been described generally and with respect to specific examples. The present disclosure is intended to be illustrative only, and therefore, and is intended to be exhaustive. For example, various embodiments of the present disclosure are described in the context of medical applications, but can also be applied in non-medical applications. It will be apparent to those skilled in the art that various modifications can be made, especially in the arrangement of material structures, materials, elements, parts, shapes, sizes and parts within the principles of the present invention, including combinations, to the full extent indicated by the broad general meaning of the terms expressed in the appended claims. To the extent that these various modifications do not depart from the spirit and scope of the appended claims, they are intended to be included therein.

Claims

1. A gastrointestinal implant system, comprising: an implant configured to be implanted within a patient's pylorus, the implant having a proximal portion including a proximal wall flange, a distal portion including a distal wall flange, and a neck portion located between the proximal and distal portions, the neck portion being configured to span a pyloric sphincter of the pylorus when implanted; an anti-migration anchor comprising a body, an elongated element, a first retention feature coupled to the elongated element, and a second retention feature coupled to the elongated element, the anti-migration anchor being configured such that the elongated element can be manipulated to span the neck portion of the implant, such that the first retention feature can be positioned proximally of the proximal portion of the implant, and such that the second retention feature can be positioned distally of the distal portion of the implant, wherein the first retention feature and the second retention feature are configured to transition between a delivery configuration and a deployed configuration and to change orientation relative to the body when transitioning to the deployed configuration, in, The proximal wall flange of the proximal portion is located between the second retention feature and the pyloric sphincter of the pylorus sandwiched between the proximal and distal portions of the implant, Wherein, the distal wall flange of the distal portion is located between the first retention feature and the pyloric sphincter of the pylorus sandwiched between the proximal and distal portions of the implant.

2. The system of claim 1, wherein in the delivery configuration, the first and second retention features extend along the elongated element, and wherein in the deployed configuration, the first and second retention features extend transversely to the elongated element.

3. The system of claim 1, wherein the first retention feature comprises a first end, a second end, and a middle portion between the first end and the second end, and wherein the elongated member is coupled to the middle portion.

4. The system of claim 1, wherein when unrestrained, one or more of the first retention feature and the second retention feature are biased to transition to the delivery configuration.

5. The system of claim 1, wherein the anti-migration anchor is configured to extend through tissue between the proximal and distal portions of the implant, thereby securing the implant to the tissue.

6. A system according to claim 5, wherein the proximal and distal portions and the neck portion of the implant form a primary anchor for anchoring the implant to the tissue, and wherein the anti-movement anchor forms a secondary anchor for anchoring the implant to the tissue.

7. The system of claim 1, wherein the anti-migration anchor is operated to help maintain the geometry of the implant.

8. The system of claim 7, wherein the anti-migration anchor is operative to minimize the amount of relative rotation between the proximal and distal portions of the implant by limiting the length between the proximal and distal portions of the implant.

9. The system of claim 7, wherein the anti-movement anchor limits an amount of deformation of one or more of the proximal and distal portions of the implant.

10. The system of claim 1, wherein the first and second retention features of the anti-migration anchor are configured such that they can only contact the proximal and distal portions of the implant and cannot directly contact pyloric tissue.

11. The system of claim 1 , wherein the anti-migration anchor is operative to tether the implant to the pylorus when implanted.

12. The system of claim 1, wherein the anti-migration anchor is operative to securely attach the implant to the pylorus when implanted.

13. The system of claim 1, wherein the anti-migration anchor can be implanted after implanting the implant.

14. The system of claim 1, wherein the anti-migration anchor is removable from the implant.

15. An anti-mobility device for holding an implanted gastrointestinal implant at the pylorus of a patient, the device comprising: Slender elements; a plurality of retention tabs including a first retention feature coupled to the elongated element and a second retention feature coupled to the elongated element, the first retention feature being operable to transition between a delivery configuration and a deployed configuration, the elongated element being configured to span between a proximal portion and a distal portion of the gastrointestinal implant such that the first retention feature can be positioned proximal to the proximal portion of the gastrointestinal implant and such that the second retention feature can be positioned distal to the distal portion of the gastrointestinal implant, in, The gastrointestinal implant has a proximal portion including a proximal wall flange, a distal portion including a distal wall flange, and a neck portion located between the proximal portion and the distal portion, wherein the proximal wall flange of the proximal portion is located between the second retention feature and the pyloric sphincter of the pylorus sandwiched between the proximal and distal portions of the gastrointestinal implant, wherein the distal wall flange of the distal portion is located between the first retention feature and a pyloric sphincter of the pylorus sandwiched between the proximal and distal portions of the gastrointestinal implant.

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