Devices, assemblies, and systems for delivering and deploying a gastric obstruction device and methods of operating the same

Abstract

Devices, assemblies, and systems for delivering and deploying a gastric obstruction device and methods of operation thereof are disclosed. A system for deploying a gastric obstruction device can include a housing comprising a gear mechanism; a control component connected to the gear mechanism; a delivery tube connected to the housing, wherein a distal end of the delivery tube is configured to be positioned in the gastric obstruction device; and a control tube connected to the gear mechanism within the housing, wherein the control tube extends through a lumen of the delivery tube and is configured to engage with the gastric obstruction device, wherein the control tube is configured to rotate in response to rotation of the control component, and wherein rotation of the control tube is configured to rotate the gastric obstruction device. The devices, assemblies, and systems can be introduced or implanted and removed through a safe and relatively simple medical procedure.

Description

Technical Field

[0001] This disclosure generally relates to the field of obesity; more specifically, it relates to devices, components, and systems for delivering and deploying gastric obstruction devices, and methods of operating thereof. Background Technology

[0002] Obesity is rampant in the United States. Recent government research indicates that up to 40% of Americans are obese, with nearly 20% of them suffering from morbid obesity. Obese individuals are often associated with cardiovascular disease, heart disease, stroke, diabetes, and obstructive sleep apnea. Recent studies suggest that obesity can shorten the lifespan of adults by an average of three years and that of children by an average of twenty years.

[0003] Numerous attempts have been made in the existing technology to provide drugs, devices, and surgical methods for treating obesity; however, all of these have serious side effects or are essentially ineffective. For example, various diets, supplements, and drugs have been developed and marketed, but to date, with the exception of some drugs that have unfortunately been found to cause many serious and life-threatening medical conditions, no drug has shown any significant effectiveness in treating obesity. To date, there are no commercially available supplements or drugs that have been proven to effectively promote significant weight loss without serious side effects.

[0004] Recognizing that no measure has yet been developed that is both effective and safe, the medical industry has introduced more extreme surgical methods, one example being the Roux-En-Y gastric bypass. This extensive invasive surgery is highly effective, but it also carries a potential fatality rate of 1%-2%, a recovery period of 6 months, and costs tens of thousands of dollars. However, it is becoming increasingly popular because other available treatments simply cannot produce the desired results. Gastric reduction surgery, or simply the removal of most of the stomach, is another procedure similar to gastric bypass, and like gastric bypass, it is associated with potentially fatal complications. Recent research data suggests that even in the lowest-risk population, obesity surgery results in an average annual mortality rate of nearly 5%.

[0005] In another attempt to treat obesity, devices designed to provide patients with a feeling of fullness have been developed in the existing technology. Such devices can be configured as stents to support the stomach or pyloric valve, or as permanent occluders. Unfortunately, these devices are essentially permanently implanted in the patient's body and typically include complex mechanical or electrical features that may cease to function properly over time or may require periodic maintenance. Examples of such devices in the prior art can be found in U.S. patents with patent numbers 5,509,888, 6,067,991, 6,527,701, 6,689,046, 7,011,621, 7,037,344, 7,120,498, 7,122,058, and 7,167,750, and in U.S. patent applications with publication numbers 2004 / 0172142, 2005 / 0273060, 2007 / 0016262, 2007 / 0027548, and 2007 / 0083224.

[0006] Mounting evidence suggests that reducing gastroduodenal flow can be beneficial. Unpublished but recently presented data from the American Society for Bariatric Surgery Conference in June 2003 showed that stimulating the gastric vagus nerve and reducing gastric motility resulted in a weight loss index of over 20% within nine months. Furthermore, data indicate that gastrovagus nerve resection is also an effective treatment for obesity through a similar mechanism. Unfortunately, these treatments require highly invasive, and sometimes irreversible, surgery, making them undesirable for most obese individuals. Summary of the Invention

[0007] Devices, components, and systems for delivering and deploying gastric obstruction devices are disclosed, as well as methods of operation thereof. In one variant, a system for deploying a gastric obstruction device is disclosed. The system may include a housing comprising a gear mechanism, a control component connected to the gear mechanism, a delivery tube connected to the housing, and a delivery tube having a distal end and a lumen extending through the delivery tube. The distal end of the delivery tube may be configured to be positioned within the gastric obstruction device. The system may further include a control tube connected to the gear mechanism within the housing. The control tube may extend through the lumen of the delivery tube and be configured to engage with the gastric obstruction device. The control tube may be configured to rotate in response to rotation of the control component. Rotation of the control tube may be configured to rotate the gastric obstruction device, including a device cover of the gastric obstruction device.

[0008] The distal end of the delivery tube may include a flange. The flange may be positioned within a cavity defined by a device cover to connect the device cover to the delivery tube. The flange is configured to seal an opening in the cover defined along the proximal end of the device cover. The outer surface of the flange, the inner surface of the device cover, or a combination thereof may be covered with a polymer coating to reduce friction between the outer surface of the flange and the inner surface of the device cover when the device cover rotates.

[0009] The control tube may include a proximal control tube segment and a distal control tube segment. The distal control tube segment may include a key portion that mates with a locking member located within the gastric obstruction device. Both the key portion of the control tube and the locking member of the distal bushing have similar cross-sectional shapes. In one variation, the cross-sectional shape may be generally rectangular. In other variations, the cross-sectional shape may be generally elliptical.

[0010] The gear mechanism may include a first gear component and a second gear component. A control component may be connected to the first gear component and a control tube may be connected to the second gear component. The first gear component may be configured to rotate about a first gear rotation axis, and the second gear component may be configured to rotate about a second gear rotation axis. The first gear rotation axis may be perpendicular to the second gear rotation axis.

[0011] As the control tube segment and the delivery tube surrounding it extend into the patient's body, the control tube segment can be configured to bend into a curved configuration. In the curved configuration, the control tube can be configured to rotate.

[0012] The housing may also include a spool, and a control component may be connected to the spool. The control tube may also include a control tube cavity and multiple tension lines extending through the control tube cavity. Rotation of the control component may be configured to wind up the tension lines extending through the control tube cavity. Furthermore, at least one anchor line may extend through the control tube cavity, and rotation of the control component may also wind up the anchor line extending through the control tube cavity.

[0013] In another variation, a gastric obstruction assembly is disclosed. The gastric obstruction assembly may include a control tube and a gastric obstruction device cooperating with the control tube. The control tube may include a proximal section and a distal section. The distal section may include a key portion.

[0014] A gastric obstruction device may include a device cover, a distal closure member, and a distal hub, the distal closure member being connected to the device cover via a tether extending from the device cover, the distal hub being positioned within an infillable lumen of the device cover. The device cover may also include a cover opening at the proximal end of the device cover.

[0015] The distal bushing can be attached to the device cover. The distal bushing may include a locking member. Before deploying the gastric obstruction device, a key portion of the distal segment of the control tube can engage with the locking member of the distal bushing.

[0016] The gastric obstruction device may also include multiple internal struts arranged within an infillable cavity. Each internal strut may be connected at one end to the inner surface of the device cover and at the other end to a distal bushing.

[0017] The system may also include a delivery tube having a delivery tube lumen. A section of a control tube may be positioned within the delivery tube lumen, and the control tube may rotate within the delivery tube lumen. The device cover may be configured to rotate in response to rotation of the control tube when a key portion of the distal section of the control tube engages with a locking member of the distal bushing.

[0018] The gastric obstruction device may also include a coil member comprising a proximal coil end and a distal coil end. The distal coil end may extend into the fillable lumen and may be detachably connected to a distal bushing. The coil member may be configured to rotate in response to rotation of a control tube.

[0019] A method for deploying a gastric obstruction device is disclosed. The method may include orally advancing a distal segment of a delivery tube connected to the gastric obstruction device into the vicinity of a patient's stomach. The proximal segment of the delivery tube may be connected to a housing. The method may further include driving or rotating a control member connected to the housing about a first rotational axis in a first rotational direction while the gastric obstruction device is in the patient's stomach. In response to rotation of the control member, the gastric obstruction device connected to the delivery tube may rotate about a second rotational axis in a second rotational direction. The first rotational axis may not be parallel to the second rotational axis.

[0020] A drive or rotation control component can rotate a control tube that extends through the lumen of the delivery tube. The control tube may include a proximal control tube section and a distal control tube section. The distal control tube section may engage with a gastric obstruction device. The distal control tube section may include a key portion. The gastric obstruction device may include a locking component. When the gastric obstruction device is rotated, the key portion of the distal control tube section may engage with the locking component of the gastric obstruction device.

[0021] The housing may include a gear mechanism comprising a first gear component and a second gear component. A control component may be connected to the first gear component, and a control tube may be connected to the second gear component. The method may also include a drive or rotation control component that rotates the gastric obstruction device, including the device cover, at least three full revolutions.

[0022] The housing may also include a spool connected to the first gear component. The control tube may also include a control tube cavity. A drive or rotation control component may wind multiple tension lines extending through the control tube cavity onto the spool.

[0023] The method may also include inflating the fillable cavity of the gastric obstruction device by delivering fluid through the lumen of the delivery tube into the fillable cavity.

[0024] The method may further include introducing a coil member into a fillable cavity of the device cover. At least a portion of the coil member may extend through the delivery tube lumen before the actuation or rotation control component. Introducing the coil member into the device cover may be performed simultaneously with rotation of both the device cover and the coil member. Both the device cover and the coil member may rotate in response to rotation of the control component. The method may further include removing the device cover from the distal section of the delivery tube when the coil member is introduced into the fillable cavity of the device cover and the coil member is configured in a contracted-widening shape.

[0025] A system for deploying a gastric obstruction device is also disclosed. The system may include: a housing including a worm gear; a control tube including a proximal control tube section and a distal control tube section; and a control component connected to the worm gear.

[0026] The worm gear may include a worm wheel and a worm sleeve, the worm sleeve being configured to rotate in response to rotation of the worm wheel. A proximal section of the control tube may be connected to the worm sleeve. A gastric obstruction device may be connected to a distal section of the control tube. The gastric obstruction device may be configured to rotate in response to rotation of a control component.

[0027] The system may include a delivery tube comprising a proximal end, a distal end, and a lumen between the proximal and distal ends. The delivery tube may be connected to a housing at the proximal end, and the distal end may be configured to connect to a gastric obstruction device.

[0028] At least one section of the control tube may be configured to extend through the lumen of the delivery tube. Each of the delivery tube and the control tube may be bent into a curved configuration. The control tube may be configured to rotate when in the curved configuration within the delivery tube.

[0029] The control tube may be made of a biocompatible polymeric material. The worm gear may include multiple blades extending radially outward from the circumferential surface of the worm disc. The worm barrel may include multiple grooves projecting radially inward from the transverse surface of the worm barrel to define multiple grooved surfaces. Rotation of the worm gear may cause at least one blade to translate toward at least one grooved surface, thereby rotating the worm barrel.

[0030] Each wheel blade may have a blade ridge, and the blade ridge may be aligned at an angle relative to the centerline that bisects the circumferential surface of the wheel. The length of each wheel blade may be less than the circumference of the wheel.

[0031] The worm gear can include a proximal portion and a distal portion. The worm gear can also include a plurality of grooves projecting radially inward from the transverse face of the worm gear. Each groove may be oriented substantially longitudinally such that each groove extends from the proximal portion to the distal portion.

[0032] The worm barrel may include a radially converging middle section. The worm barrel can be configured to rotate 360 ​​degrees in response to a worm wheel rotating 1080 degrees. The worm barrel may include an inner cavity, and a section of a control tube may extend into the worm barrel.

[0033] The housing may also include a spool, and a worm gear may be connected to the spool. The control tube may also include a control tube cavity and multiple tension lines extending through the control tube cavity. Rotation of the control component can be configured to wind into the tension lines extending through the control tube cavity.

[0034] A method for deploying a gastric obstruction device is disclosed. The method may include advancing the gastric obstruction device orally to the vicinity of the patient's stomach and driving or rotating a control component connected to a worm gear.

[0035] The gastric obstruction device can be connected to the distal end of a control tube. The proximal end of the control tube can be connected to the worm gear sleeve of a worm wheel. The worm wheel can rotate in response to rotation of the control component. The worm gear sleeve can rotate in response to rotation of the worm wheel. The gastric obstruction device can rotate within the patient's stomach in response to rotation of the worm wheel.

[0036] The worm gear can rotate about the axis of rotation of the first gear. The worm cylinder can rotate about the axis of rotation of the second gear. The axis of rotation of the first gear can be substantially perpendicular to the axis of rotation of the second gear.

[0037] The method may also include driving or rotating control components for at least nine full revolutions. In other variations, the method may include driving or rotating control components for six to nine full revolutions.

[0038] The method may also include bending the control tube into a curved configuration to advance the gastric obstruction device orally into the patient's stomach. The control tube can rotate in response to the rotation of the worm gear. The control tube can be in a curved configuration when rotating.

[0039] The method may further include connecting the control tube to the gastric obstruction device by engaging a key portion of the distal segment of the control tube with a locking member within the gastric obstruction device. The gastric obstruction device may also include a device cover connected to the locking member. The device cover is rotatable in response to rotation of the control member. The gastric obstruction device may also include a coil member detachably connected to the device cover. The coil member is rotatable in response to rotation of the control member. The method may further include retracting the control tube from the gastric obstruction device before removing the control tube from the patient's esophagus.

[0040] A method for preparing and / or operating a gastric obstruction device is disclosed. The method may include providing a delivery tube connected to a distal segment of the gastric obstruction device. The proximal segment of the delivery tube may be connected to a housing. The method may further include driving a control component connected to the housing in a first rotational direction about a first rotational axis. In response to rotation of the control component, the gastric obstruction device connected to the delivery tube may rotate in a second rotational direction about a second rotational axis. The first rotational axis may not be parallel to the second rotational axis.

[0041] Another method for preparing and / or operating a gastric obstruction device is also disclosed. This method may include providing the gastric obstruction device. The gastric obstruction device may be connected to the distal end of a control tube. The proximal end of the control tube may be connected to a worm barrel of a worm gear. The method may further include a control component that drives a worm wheel connected to the worm gear. The worm wheel may rotate in response to rotation of the control component. The worm barrel may rotate in response to rotation of the worm wheel. The gastric obstruction device may rotate in response to rotation of the worm wheel. Attached Figure Description

[0042] Figure 1 A perspective view of a variant of the system for deploying a gastric obstruction device is shown.

[0043] Figure 2A and Figure 2B A variation of the gastric obstruction device after it has been deployed in the patient's stomach is shown.

[0044] Figure 3 An exploded view of a variant of the gastric obstruction device and a portion of the system used to deploy the gastric obstruction device is shown.

[0045] Figure 4A and Figure 4B A perspective view and a side sectional view of a variant of the gastric obstruction device in its deployed state are shown, respectively.

[0046] Figure 4C A perspective cross-sectional view of a portion of a coil component locked into a contracted-widened configuration is shown.

[0047] Figure 5A The coil component in a relaxed state is shown.

[0048] Figure 5B The coil component in an elongated configuration is shown.

[0049] Figure 5C A coil component in a partially unwound configuration is shown.

[0050] Figure 6 It is a variant black-and-white image of a gastric obstruction device connected to a delivery tube and a slender, partially unwound coil component located within the delivery tube.

[0051] Figure 7 A perspective view of a variant of a system for deploying a gastric obstruction device is shown.

[0052] Figure 8A A perspective sectional view of the distal bushing positioned within the device cover is shown.

[0053] Figure 8B It shows Figure 8A The diagram shows a top view of the distal bushing positioned within the device cover.

[0054] Figure 9A A perspective view of the distal segment of a variant of the control tube is shown.

[0055] Figure 9B It shows Figure 9A The top view of the distal segment of the variant of the control tube shown.

[0056] Figure 10 A variation of the gear mechanism for deploying a gastric obstruction device is shown.

[0057] Figure 11A A front view of the first gear component is shown, which is related to... Figure 10 The second gear component shown, which is part of the gear mechanism, is operably engaged.

[0058] Figure 11B A side view of the first gear component is shown, which is related to... Figure 10 The second gear component shown, which is part of the gear mechanism, is operably engaged.

[0059] Figure 12A A side sectional view of a variant of the flange, separated from the device cover of the gastric obstruction device, is shown.

[0060] Figure 12B A side sectional view of the flange of the device cover connected to the gastric obstruction device is shown.

[0061] Figure 13 This is a black-and-white image of a variant of a gastric obstruction device, which includes a device cover, a tether, and a distal closure member.

[0062] Figure 14A It is a black and white image of a tension line that extends through the spirally wound coil of the coil assembly and into the distal bushing of the gastric obstruction device.

[0063] Figure 14B It is a black and white image of the tension line that passes through the distal bushing and enters the inner cavity of the control tube at the distal end of the control tube.

[0064] Figure 14CIt is a black-and-white image of the tension line that leaves the inner cavity of the control tube near the proximal end of the control tube.

[0065] Figure 15 A variation of a spool configured to rotate in response to rotation of a control component is shown.

[0066] Figure 16 It is a black-and-white image of multiple tension lines and anchor lines extending into the distal bushing of the gastric obstruction device.

[0067] Figure 17 It is a black and white image of a pair of tension lines connected to the locking line.

[0068] Figure 18A A variation of a plunger, which is part of the deployment of a gastric obstruction device, is shown, which is translated distally through the lumen of the delivery tube.

[0069] Figure 18B A coil member is shown that is locked into a contraction-widening configuration within the infillable cavity of the device cover of a gastric obstruction device.

[0070] Figure 18C The separation of the delivery tube from the deployed gastric obstruction device is shown.

[0071] Figure 19 A perspective view of another variant of the system for deploying a gastric obstruction device is shown. Detailed Implementation

[0072] This document provides a detailed description of embodiments of the invention. However, it should be understood that the invention can be embodied in various forms. Therefore, the specific details disclosed herein should not be construed as limiting, but rather as a representative basis to teach those skilled in the art how to use the invention in virtually any detailed system, structure, or manner.

[0073] The devices, components, systems, and methods disclosed herein are applicable not only to the treatment of obesity but also to the treatment of other conditions, such as glucose intolerance in subjects with diabetes or prediabetes and the progression of diabetes itself, by inhibiting fasting insulin secretion or glucose-stimulated insulin secretion. The devices disclosed herein are also applicable to the treatment of other obesity-related conditions, including hyperphagia, dyslipidemia, Prader-Willi syndrome, Froelich's syndrome, Cohen syndrome, Summit syndrome, Alstrom syndrome, Borjesen syndrome, Bardet-Biedl syndrome, or type I, II, III, and IV hyperlipoproteinemia. The stomach and, generally speaking, the gastrointestinal tract tolerate the devices, components, and systems disclosed herein very well. The devices, components, and systems disclosed herein can be introduced or implanted and removed through safe and relatively simple medical procedures.

[0074] The gastric obstruction devices disclosed herein may include sensors or transmitters to provide feedback and other data to an in vivo or external processor, or may carry one or more compounds stored in a reservoir within the device or coated on the device. In some variations, insulin is released into the gastrointestinal tract by providing an insulin reservoir in a distal closure member of the device. This insulin release may be controlled by the size of the orifice between the reservoir and the external environment, or by a time-controlled actuator, or by an actuator controlled by one or more sensors, such as sensors responsive to the detection of glucose in the gastrointestinal tract.

[0075] Furthermore, the apparatuses, components, systems, and methods disclosed herein are compatible with and / or can be superseded by any apparatuses, components, systems, and methods disclosed in U.S. Patent Application No. 12 / 205,403 (US Patent Publication No. 2009 / 0198210), filed September 5, 2008; U.S. Patent Application No. 12 / 352,497 (US Patent Publication No. 2009 / 0182357), filed January 12, 2009; U.S. Patent Application No. 12 / 352,508 (US Patent Publication No. 2009 / 0182358), filed January 12, 2009; and U.S. Patent Application No. 15 / 878,319, filed January 23, 2018. The entire contents of each of these applications are incorporated herein by reference for any purpose.

[0076] Figure 1 A perspective view of a variant of a system 100 for deploying a gastric obstruction device 102 is shown. The system 100 may include a delivery tube 104 connected to a housing 106. Although Figure 1 Housing 106 is depicted as part of a handle, but housing 106 may also refer to a fixed device, part of a tabletop or desktop device, a portable device including wheels, a winch housing, a gearbox, or a combination thereof. System 100 may also include a control component 108 connected to housing 106. Figure 1 The control component 108 may have a manual crank connected to or integrated with it. In some variations, the control component 108 may be a control knob, a push knob, a wing knob, a lobed knob, a grooved knob, a cross-shaped knob, a triangular knob, a ball knob, or a combination thereof. The control component 108 may be connected to the lateral or side surface of the housing 106.

[0077] The delivery tube 104 may include a proximal delivery tube 110, a distal delivery tube 112, and a lumen 114. The delivery tube 104 may be made of or composed of a biocompatible or medical-grade polymeric material. For example, the delivery tube 104 may be made of polytetrafluoroethylene (PTFE), silicone, medical-grade polyvinyl chloride, or a combination thereof, or composed of PTFE, silicone, medical-grade polyvinyl chloride, or a combination thereof. In other variations, the delivery tube 104 may be made of or composed of a thin-walled metallic material. In some variations, the wall of the delivery tube 104 may be translucent or transparent, allowing the contents within the lumen 114 to be seen from the outside of the delivery tube 104.

[0078] The delivery tube 104 may also include a flange 116 located at the distal end 112 of the delivery tube. The flange 116 may be used, along with other components, to secure a portion of the gastric obstruction device 102 to the delivery tube 104. The flange 116 will be discussed in more detail in the following sections.

[0079] The gastric obstruction device 102 may include a proximal closure member 118 connected to the distal closure member 120 via a tether 122. When the gastric obstruction device 102 is deployed in the patient's stomach, the shape and size of the distal closure member 120 may be configured to pass through the patient's pylorus. The deployment of the gastric obstruction device 102 will be discussed in more detail in the following sections.

[0080] The distal closure member 120 can be generally shaped as an ellipse, an oval, a combination thereof, or many other non-invasive shapes. The maximum cross-sectional diameter of the distal closure member 120 can be approximately between 14 mm and 18 mm. In some variations, the maximum cross-sectional diameter of the distal closure member 120 can be approximately between 15 mm and 16 mm.

[0081] The tie 122 may be made of or composed of silicone resin, silicone rubber, polyurethane, thermoplastic elastomer, copolymer thereof, or a combination thereof. The tie 122 may have elastic properties such that the length of the tie 122 may change as the tie 122 is stretched or contracted.

[0082] The proximal closure member 118 may include a device cover 124 that surrounds and encapsulates the fillable cavity 400 (see [link]). Figure 4B The proximal closure member 118 may also include a coil member 126. When the device cover 124 is secured to the distal end 112 of the delivery tube via the flange 116, a section of the coil member 126 may be located within the delivery tube 104.

[0083] like Figure 1 As shown, the coil member 126 can be extended into a long and narrow configuration 128, such that the entire coil member 126 is stretched in length and the cross-sectional dimensions of the coil member 126 are reduced. Figure 1 As shown, when in the elongated and narrow configuration 128, the coil component 126 can be assembled in a closed space such as the delivery tube cavity 114.

[0084] In some variations, the tether 122 may be integrated with the device cover 124, such that the tether 122 is an extension of the device cover 124. The device cover 124 and the coil member 126 will be discussed in more detail in the following sections.

[0085] System 100 may also include a fluid delivery port 130 or fluid delivery tube extending from housing 106. Gas or fluid may be introduced into fluid delivery port 130 to inflate a portion of gastric obstruction device 102 (e.g., device cover 124) and blow into the stomach of a patient receiving gastric obstruction device 102.

[0086] Figure 1It is also shown that the control component 108 can rotate in a first rotational direction 132. When at least a portion of the gastric obstruction device 102 is in the patient's stomach, the control component 108 can rotate about a first rotation axis 134 in the first rotational direction 132. In response to the rotation of the control component 108 in the first rotational direction 132, the gastric obstruction device 102, connected to the distal end 112 of the delivery tube, can rotate about a second rotation axis 138 in a second rotational direction 136. The first rotation axis 134 may not be parallel to the second rotation axis 138. The first rotation axis 134 may not be parallel to the second rotation axis 138 when it is perpendicular or inclined (e.g., at an obtuse or acute angle) relative to the second rotation axis 138. For example, when the delivery tube 104 is kept substantially straight, the first rotation axis 134 may be substantially perpendicular to the second rotation axis 138. As a more specific example, the first rotation axis 134 may be a lateral axis extending from one lateral side of the housing 106 to the other lateral side of the housing 106. In this example, when the delivery tube 104 remains straight, the second axis of rotation 138 can be a longitudinal axis extending along the length of the delivery tube 104. As will be discussed in the following sections, when the delivery tube 104 is in a bent configuration 1900 (see...), Figure 19 When the first axis of rotation 134 is tilted relative to the second axis of rotation 138 (e.g., at an obtuse or acute angle), or the first axis of rotation 134 may intersect the second axis of rotation 138 at an oblique angle (e.g., at an obtuse or acute angle). When at least a portion of the delivery tube 104 extends through the patient's oral cavity (or mouth) and pharynx (or throat) into the patient's esophagus, the delivery tube 104 may be bent into a curved configuration 1900.

[0087] Figure 2A and Figure 2B It shows the patient's stomach (in Figure 2A and Figure 2B A variation of the gastric obstruction device 102 within the stomach (denoted as ST). The patient's esophagus (denoted as ES), pylorus (denoted as PY), and duodenum (denoted as DU) are also depicted. Figure 2A and 2B For reference only. When the coil member 126 of the proximal closure member 118 (see...) Figure 1 From the slender and narrow configuration 128 (see Figure 1 ) is formed or constructed as a contraction-widening configuration 300 (see Figure 3 , Figure 4B and Figure 18C When the gastric obstruction device 102 is fully deployed within the patient's stomach, as will be discussed in the following sections, the coil member 126 can be locked into a contraction-widening configuration 300 within the device cover 124 of the proximal closure member 118.

[0088] Once the patient ingests food or liquid, the stomach can begin to repeatedly contract and relax, causing the distal closure member 120 to be propelled by peristaltic waves or otherwise moved through the stomach toward the pylorus. Figure 2B As shown, the shape and size of the distal closure member 120 can be configured to pass through the pylorus, and the distal closure member 120, the frenulum 122, or a combination thereof can be positioned within the patient's duodenum. Due to the size and substantially spherical shape of the proximal closure member 118, the proximal closure member 118 cannot pass through the pylorus and remains within the stomach.

[0089] like Figure 2A and Figure 2B As shown, the proximal closure member 118 may include a conical pyloric contact area 200 near the frenulum 122 of the gastric obstruction device 102. The conical pyloric contact area 200 may taper gradually from a larger cross-sectional diameter toward a smaller cross-sectional diameter towards the distal end of the proximal closure member 118. In some variations, the conical pyloric contact area 200 may refer to a segment or portion of the device cover 124 near the frenulum 122. In other variations, the conical pyloric contact area 200 may refer to a portion of the proximal closure member 118 connected to the device cover 124.

[0090] The cone-shaped pyloric contact area 200 can be generally conical or truncated conical. In some variations, the cone-shaped pyloric contact area 200 can have a cone angle of approximately 30 to 50 degrees relative to the longitudinal axis of the gastric obstruction device 102. The cone-shaped pyloric contact area 200 can be compliant or compressible.

[0091] The conical pyloric contact area 200 of the gastric obstruction device 102 can intermittently cover or obstruct the pylorus, such as... Figure 2B As shown. Furthermore, the conical pyloric contact area 200 can intermittently expose food or liquid to the pylorus and allow food or liquid to pass through the pylorus when the patient's stomach and other digestive organs are relaxed. This intermittent obstruction of the pylorus allows food and / or liquid to enter the duodenum at a slower rate from the stomach, thus allowing the patient to feel full more quickly and reducing the patient's craving for more food. Once the stomach has been completely emptied, the gastric obstruction device 102 can reposition itself within the patient's stomach.

[0092] Despite Figure 2A and Figure 2BAs not shown, this disclosure contemplates that the gastric obstruction device 102 can be removed from the patient. The gastric obstruction device 102 can be removed by contraction and retraction through the patient's esophagus. An access sheath, an outer tube, or a combination thereof can be positioned within the patient's esophagus, and a grasping tool and endoscope can pass through the access sheath to access the proximal closure member 118 of the gastric obstruction device 102. A release mechanism 316 (see [link to documentation]) can be used to release the grasping tool to the proximal closure member 118. Figure 3 The contact and release mechanism 316 can cause the coil member 126 to deform or reconfigure from the contracted-widened configuration 300 (see...) Figure 3 , Figure 4B and Figure 19 ) is a slender and narrow configuration 128 (see Figure 1 Because the coil member 126 is in an elongated and narrow configuration 128, the device cover 124 of the proximal closure member 118 can be retracted or compressed to fit through the passage sheath. The coil member 126, device cover 124, tether 122, and distal closure member 120 can be pulled through the passage sheath and removed from the stomach through the patient's esophagus, pharynx, and mouth.

[0093] Figure 3 An exploded view is shown of a variant of the gastric obstruction device 102 and a portion of the system 100 used to deploy the gastric obstruction device 102. (See attached image.) Figure 3 As shown, the coil member 126 can be compressed or otherwise formed into a contracted-widened configuration 300. The coil member 126 can be located in the fillable cavity 400 of the device cover 124 (see...). Figure 4B The internal structure is compressed or otherwise formed into a contraction-widening configuration 300.

[0094] The coil member 126 may include a distal coil end 302 and a proximal coil end 304. When the device cover 124 is detachably connected to the distal delivery tube 112 via flange 116, the distal coil end 302 may be initially positioned within the delivery tube 104. In some variations, when the device cover 124 is detachably connected to the distal delivery tube 112, the distal coil end 302 may be positioned within the fillable cavity 400 of the device cover 124 (see [link to relevant documentation]). Figure 4B In other variations, the distal end 302 of the coil may be initially positioned within the delivery tube cavity 114 and introduced into the fillable cavity 400 during deployment.

[0095] Figure 3The device cover 124 is also shown to include a distal end 306 and a proximal end 308. The device cover 124 may also have a cover opening 310 at the proximal end 308. The cover opening 310 may be a generally circular gap or hole at the proximal end 308. A coil member 126 can be introduced into the fillable cavity 400 of the device cover 124 through the cover opening 310 (see [reference]). Figure 4B The device cover 124 may be made of or composed of silicone resin, silicone rubber, polyurethane, thermoplastic elastomer, copolymer thereof, or a combination thereof.

[0096] like Figure 3 As shown, the coil member 126 may include a plurality of helical wound coils 312 or loops. When the coil member 126 is in the contracted-widened configuration 300, the helical wound coils 312 or loops may be physically pressed against each other. As will be discussed in the following sections, when the coil member 126 is in the contracted-widened configuration 300, a portion of each helical wound coil 312 or loop may be nested within at least one adjacent helical wound coil 312 or loop.

[0097] In one variation, coil member 126 may include six helically wound coils 312 or loops. In other variations, coil member 126 may include approximately five to eight helically wound coils 312 or loops. When coil member 126 is in a contracted-widening configuration 300, the cross-sectional diameter or coil diameter of the central or intermediate coil or loop may be the largest of all coils or loops.

[0098] Figure 3The gastric obstruction device 102 is also shown to include a proximal assembly 314 connected to the proximal end 304 of the coil member 126. In one variation, the proximal assembly 314 may be a generally cylindrical component including a release mechanism 316 and a proximal plug 318. The release mechanism 316 may extend partially into the proximal plug 318 and be connected to the proximal plug 318 by an interference fit. In this and other variations, the release mechanism 316 may also be connected to the proximal plug 318 by fasteners, adhesives, connecting members or ropes, or combinations thereof. In one variation, the proximal assembly 314 may be connected to the proximal end 304 of the coil member 126. In other variations, the proximal assembly 314 may be positioned within a loop at the proximal end 304 of the coil. When the coil member 126 is in a contracted-widening configuration 300, the proximal assembly 314 may be used as a cap or plug to partially block or restrict the opening at the proximal end 304 of the coil. For example, the proximal assembly 314 may partially block or constrain the opening at the proximal end 304 of the coil to prevent or impede fluid or particles from entering the coil cavity constructed by the wound coil member 126. As will be discussed in the following sections, the proximal assembly 314 may be used as part of a locking mechanism to lock the coil member 126 in the contracted-widening configuration 300.

[0099] Figure 3 The gastric obstruction device 102 is shown to further include a distal bushing 320. The distal bushing 320 may further include a locking member 322 and an attachment collar 324 connected to the locking member 322. In one variation, the locking member 322 may be fitted within the attachment collar 324 by an interference fit. In this and other variations, the locking member 322 may also be connected to the attachment collar 324 by an adhesive, fastener, or a combination thereof. The distal bushing 320 may be positioned within the fillable cavity 400 of the device cover 124 (see [reference]). Figure 4B As will be discussed in more detail in the following sections, the distal bushing 320 can be accessed via an internal strut 800 within the device cover 124 (see [link to device cover]). Figure 8A and Figure 8B It is connected to the device cover 124. The distal bushing 320 can also be used with the proximal assembly 314 to lock the gastric obstruction device 102 into the constricted and widened configuration 300.

[0100] In some variations, the distal end 302 of the coil member 126 can be initially positioned within the delivery tube cavity 114 and connected via tension line 1400 (see...). Figure 14A , Figure 14B and Figure 14C Pulling or otherwise advancing the distal end 302 of the coil into the fillable cavity 400 of the device cover 124 (see...) Figure 4BIn these and other variations, the distal end 302 of the coil may be positioned around a portion of the distal bushing 320 and abut or press against the inner surface of the distal end 306 of the cover. Furthermore, the distal end 302 of the coil member 126 may be fitted or otherwise connected to the distal bushing 320 such that any rotation of the distal bushing 320 causes or translates into rotation of the coil member 126. Rotation of the distal bushing 320 will be discussed in more detail in the following sections.

[0101] Figure 3 It is also shown that a flange 116 of the delivery tube 104 can extend through a cover opening 310 of the device cover 124 and detachably secure the device cover 124 to the distal end 112 of the delivery tube. For example, when the flange 116 enters through the cover opening 310, the flange 116 can be momentarily compressed or contracted, and then expand when at least a portion of the flange 116 is within the fillable cavity 400 (see...). Figure 12B As will be discussed in the following sections, the inwardly curved portion 1200 of the device cover 124 surrounding the cover opening 310 (see...) Figure 12A The flange 116 can also be biased outward, and the radially inward force applied to the flange 116 by the previously inwardly bent portion can facilitate the connection or attachment of the device cover 124 to the delivery tube 104. In addition, a portion of the flange 116 within the fillable cavity 400 can also apply an outward expansion force to the portion of the device cover 124 surrounding and near the cover opening 310.

[0102] Figure 4A and Figure 4B A perspective view and a side sectional view of a variant of the gastric obstruction device 102 in its deployed state are shown, respectively. Figure 4A and Figure 4B The diagram shows that a fillable cavity 400 within the device cover 124 can be filled by coil members 126 that are locked or otherwise formed into a contractile-widening configuration 300. (As shown) Figure 4B As shown, the coil member 126 may have a plurality of coil protrusions 402 and coil grooves 404 defined along the length of the coil member 126. The coil protrusions 402 may be fitted within the coil grooves 404 such that when the coil member 126 is formed in a contracted-widening configuration 300, each helical wound coil 312 may be partially physically nested within an adjacent helical wound coil 312. For example, when the coil member 126 is viewed from the distal end 302 to the proximal end 304 of the coil, the coil grooves 404 may be defined along the lower side of the coil member 126, and the coil protrusions 402 may be defined along the top side of the coil member 126. Figure 4AAs shown, when the coil member 126 in the contracted-widened configuration 300 is completely encapsulated or surrounded by the device cover 124, the device cover 124 may be bulbous, teardrop-shaped or generally spherical 124 with a tapered end.

[0103] Figure 4A and Figure 4B It is shown that the proximal component 314 can extend into the cover opening 310 and at least a portion of the proximal component 314 can be surrounded or encircled by a plurality of helically wound coils 312. Figure 4A and Figure 4B The proximal assembly 314 is shown to include a proximal assembly opening 406 and a proximal assembly cavity 408.

[0104] The proximal assembly opening 406 and the proximal assembly cavity 408 allow the control tube 700 (see...) Figure 7 It extends into the cavity constructed of the helically wound coil 312 and contacts the locking member 322 of the distal bushing 320. As will be discussed in more detail in the following sections, a section of the control tube 700 (see...) Figure 7 It can extend through the proximal component opening 406 and the proximal component cavity 408 and fit tightly with the locking member 322 of the distal bushing 320.

[0105] Figure 4B Multiple locking wires 410 are also shown that can extend or pass through the helically wound coil 312 of the coil member 126. For example, as Figure 4B As shown, multiple pairs of locking wires 410 may extend or pass through the helical wound coil 312 in a curved trajectory, a longitudinal trajectory, or a combination thereof. The locking wires 410 may extend or pass through holes, openings, or channels laterally defined through each helical wound coil 312. The locking wires 410, proximal assembly 314, and distal bushing 320 may be configured to lock the coil member 126 into a contraction-widening configuration 300. Tension may be applied to the locking wires 410 such that the locking wires 410 are taut when the coil member 126 is locked into the contraction-widening configuration 300. As will be discussed in the following sections, the locking wires 410 may consist of one or more tension wires 1400 (see...). Figure 14A , Figure 14B and Figure 14C ) Pull it into place. Although in Figure 4B Two pairs of locking wires 410 are shown, but this disclosure contemplates that when the coil member 126 is in the contracted and widened configuration 300, four to eight pairs of locking wires 410 can be arranged uniformly around the periphery of the coil member 126 (e.g., the four pairs of locking wires 410 can be positioned approximately 90 degrees to each other around the periphery of each spirally wound coil 312).

[0106] Figure 4BIt is also shown that the frenulum 122 may include a frenulum lumen 412. In one variation, a reinforcing member 414, such as a wire, suture, cord, or a combination thereof, may extend through the frenulum lumen 412. The reinforcing member 414 may be connected at one end to a component within the proximal closure member 118 (e.g., the distal bushing 320) and at the other end to the distal closure member 120. The reinforcing member 414 may be used to prevent overstretching of the frenulum 122 during deployment and use of the gastric obstruction device 102. Furthermore, in the unlikely event of frenulum 122 failure, the reinforcing member 414 may prevent the distal closure member 120 from detaching from the proximal closure member 118.

[0107] Figure 4B The distal closure member 120 is also shown to include a distal weight 416. The distal weight 416 may be a separate component encapsulated in or integrated with the distal closure member 120. The distal weight 416 may be made of or composed of metallic materials, polymeric materials, or combinations thereof. The distal weight 416 serves to depress the distal closure member 120 and facilitates the placement and retention of the distal closure member 120 within the duodenum.

[0108] Figure 4C A perspective cross-sectional view of a portion of the coil member 126 locked into a contracted-widened configuration 300 is shown. For example, the coil member 126 may be located within the fillable cavity 400 of the device cover 124 (see...). Figure 8A The internal configuration is locked into a contraction and widening configuration 300. Figure 4C It is also shown that the coil member 126 may have coil protrusions 402 and coil grooves 404 defined along the length of the coil member 126. The coil protrusions 402 may be fitted within the coil grooves 404 such that when the coil member 126 is formed in a contracted-widening configuration 300, each helical wound coil 312 may be partially nested within an adjacent helical wound coil 312. When the coil member 126 is viewed from the contracted distal end 302 to the proximal end 304 of the coil, the coil grooves 404 may be defined along the lower side of the coil member 126, and the coil protrusions 402 may be defined along the top side of the coil member 126.

[0109] Furthermore, multiple locking wires 410 may extend or pass through the helical wound coil 312 in a curved trajectory, a longitudinal trajectory, or a combination thereof. Locking wires 410 may extend or pass through holes, openings, or channels laterally defined by each helical wound coil 312. Locking wires 410 may facilitate locking of the coil member 126 in the contracted-widening configuration 300. As will be discussed in the following sections, locking wires 410 may be composed of one or more tension wires 1400 (see...). Figure 14A , Figure 14B and Figure 14CWhen the coil component 126 is in the contracted and widened configuration 300, the locking wire 410 can be evenly arranged around the periphery of the coil component 126.

[0110] Figure 5A A coil member 126 in a relaxed state is shown. The relaxed state can be the state of the coil member 126 when no compressive or tensile force is applied. The coil member 126 may be made of or composed of a biocompatible polymeric material. For example, the coil member 126 may be made of or composed of silicone resin, silicone rubber, thermoplastic elastomer (TPE), or combinations thereof. The coil member 126 may have some elastic or shape memory properties such that when the force (e.g., tensile or compressive force) previously applied to the coil member 126 ceases to act on it, the coil member 126 can return to its relaxed state or as-molded shape.

[0111] Figures 5A-5C A diagram is shown for preparing to insert or position the coil member 126 into the delivery tube lumen 114 (see [reference]). Figure 1 , Figure 7 and Figure 19 Certain steps of the process within the delivery tube. For example, the inner diameter of the delivery tube lumen 114 can be approximately 15.0 mm to 17.5 mm. As a more specific example, the inner diameter of the delivery tube lumen 114 can be approximately 16.5 mm. Given the small diameter of the delivery tube lumen 114, the coil member 126 is preferably formed in an elongated and narrow configuration 128 (see...). Figure 1 , Figure 5C , Figure 6 and Figure 7 This facilitates easier insertion or positioning of the coil member 126 into the delivery tube lumen 114. Furthermore, the coil member 126 is preferably shaped into an elongated, narrow configuration 128 to facilitate easier movement (e.g., push, pull, or a combination thereof) of the coil member 126 through the delivery tube lumen 114 and into the fillable cavity 400 of the device cover 124 (see [reference]). Figure 8A ).

[0112] Figure 5A It is shown that the coil member 126 (e.g., the distal end 302 of the coil, the proximal end 304 of the coil, or a combination thereof) can first be pulled in the longitudinal direction 500 to stretch or otherwise form the coil member 126 into an elongated configuration. Figure 5BThe diagram shows that coil member 126 can also be rotated multiple full rotations 502 or a number of turns to partially or completely unwind the helical coil 312. A full rotation 502 can refer to a rotation of approximately 360°. In some variations, coil member 126 can be partially unwinded by rotating coil member 126 approximately two to three full rotations 502. In other variations, coil member 126 can be partially unwinded by rotating coil member 126 approximately three to five full rotations 502. In still other variations, coil member 126 can be completely unwinded by rotating coil member 126 approximately five and a half to six full rotations 502. Figure 5C The coil member 126 is shown in a slender and narrow configuration 128 after being stretched and partially unfolded. Although Figure 5A and Figure 5B The diagram shows the coil member 126 being first stretched and then rotated; this disclosure envisions that the coil member 126 can be stretched and rotated simultaneously. Alternatively, the coil member 126 can also be rotated first and then stretched.

[0113] Figure 6 It is a black and white image of a modified gastric obstruction device 102 connected to a delivery tube 104 and a slender, partially extended coil member 126 located within the delivery tube 104. Figure 6 The delivery tube 104 is shown to be generally translucent or transparent, such that the coil member 126 located within the delivery tube cavity 114 is visible to the user or operator. Figure 6 It is also shown that the coil member 126 in an elongated and narrow configuration 128 can occupy or take up a significant amount of space within the delivery tube cavity 114. One advantage of elongating and unfolding the coil member 126 by approximately two to five full turns 502 before inserting or positioning it within the delivery tube 104 is that it improves the delivery or movement of the coil member 126 through and out of the delivery tube cavity 114. For example, when the coil member is partially unfolded and elongated, it is easier to move (e.g., pull, push, or a combination thereof) the coil member 126 through the delivery tube cavity 114. More specifically, when the coil member 126 moves through and out of the delivery tube 104, an unfolded or partially unfolded coil member 126 can result in less friction exerted on the coil member 126 by the inner wall of the delivery tube 104.

[0114] As will be discussed in the following sections, when the coil member 126 is delivered through and eventually exits the delivery tube cavity 114 into the fillable cavity 400 of the device cover 124 (see... Figure 8A When the coil member 126 is in a position to return to its original rotation, it will need to resume its rotation. The coil member 126 will need to resume its rotation so that it is within the fillable cavity 400 of the device cover 124 (see [reference]). Figure 8AThe coil member 126 will need to restore its rotation to allow the coil protrusion 402 of the spirally wound coil 312 to form a contraction-expansion configuration 300. For example, the coil member 126 will need to restore its rotation to allow the coil protrusion 402 of the spirally wound coil 312 to form a configuration 300. Figure 4B Nested into adjacent coil grooves 404 (see...) Figure 4B )middle.

[0115] Although not in Figure 6 As shown, but can be further inserted into the channel sheath, the segment of delivery tube 104 including the coil member 126 and the remainder of the gastric obstruction device 102 connected to the distal end 112 of delivery tube 104 can be inserted. The device cover 124 of gastric obstruction device 102 can be compressed to fit into the lumen of the channel sheath. The channel sheath including gastric obstruction device 102 and the segment of delivery tube 104 including the coil member 126 can be introduced orally through the patient's mouth, pharynx, and esophagus, and the distal segment of the channel sheath can be positioned in the patient's stomach. When at least a portion of gastric obstruction device 102 is in the patient's stomach, the channel sheath can be pulled back or removed, and the device cover 124, tether 122, and distal closure member 120 can be exposed in the patient's stomach. At this time, the coil member 126 within the lumen 114 of delivery tube 104 can be introduced into the fillable cavity 400 of device cover 124 (see [reference]). Figure 8A ).

[0116] Figure 7 A perspective view of a variant of a portion of a system 100 for deploying a gastric obstruction device 102 is shown. Figure 7 As shown, system 100 may include control tube 700, which is configured to extend through the lumen 114 of delivery tube and engage with a portion of gastric obstruction device 102.

[0117] The control tube 700 may be made of or composed of biocompatible polymeric materials, metallic materials or alloys, or combinations thereof. In one variation, the control tube 700 may be made of or composed of polyether ether ketone (PEEK). In other variations, the control tube 700 may be made of or composed of fluoropolymers, polycarbonate, stainless steel, or combinations thereof.

[0118] In some variations, the control tube 700 can be an elongated cylinder with a control tube cavity 702. Multiple tension lines 1400 (see [reference]) are also possible. Figure 14A , Figure 14B and Figure 14C It can extend or pass through the inner cavity of the control tube 702.

[0119] The cylindrical segment of the control tube 700 may have a control tube diameter 704. In some variations, the control tube diameter 704 may be approximately 2.50 mm to 3.50 mm. In other variations, the control tube 700 may have a control tube diameter 704 of approximately 3.25 mm to 3.50 mm. In still other variations, the control tube 700 may have a control tube diameter 704 of approximately 3.50 mm to 5.00 mm.

[0120] In some variations, the control tube 700 may have a length of approximately 700 mm to 950 mm. In other variations, the control tube 700 may have a length of approximately 950 mm to 1200 mm. The dimensional difference between the control tube length and the control tube diameter 704 allows the control tube 700 to be easily bent or curved.

[0121] The control tube 700 may include a proximal control tube segment 706 and a distal control tube segment 900 (see...) Figure 9A and Figure 9B ).like Figure 7 As shown, the entire coil member 126 in the elongated and narrow configuration 128 can be wound helically around the control tube 700. For example, the coil member 126 wound around the control tube 700 can be elongated and partially unwound (e.g., unwound approximately 2 to 3 full turns). In some variations, the length dimension of the control tube can be greater than the end-to-end length of the fully unwound and elongated coil member 126.

[0122] Control tube remote section 900 (see) Figure 9A and Figure 9B A portion of the device can extend into the device cover 124 and be detachably engaged or mated with a portion of the gastric obstruction device 102. As will be discussed in the following sections, the distal segment 900 of the control tube can be detachably engaged or mated with the locking member 322 of the distal bushing 320, which is connected to the device cover 124.

[0123] The proximal section 706 of the control tube can be housed within the housing 106 (see...). Figure 1 A portion of the control tube proximal section 706 can be connected to the gear mechanism 1000 (see...). Figure 10 Part of ). As will be discussed in the following sections, control component 108 (see Figure 1 and Figure 19 It can be connected to gear mechanism 1000 (see...) Figure 10 The first gear component (e.g., worm gear 1002) and a section of the proximal end segment 706 of the control tube can be connected to the second gear component of the gear mechanism 1000 (see...). Figure 10(e.g., worm gear 1004). The rotation control component 108 can cause the first gear component (e.g., Figure 10 , Figure 11A or Figure 11B The worm gear 1002 in the first gear component rotates. The first gear component (e.g., Figure 10 , Figure 11A or Figure 11B The rotation of the worm gear 1002 can cause the second gear component (e.g., worm cylinder 1004) to rotate. The rotation of the second gear component (e.g., worm cylinder 1004) can cause the entire control tube 700 to rotate.

[0124] like Figure 7 As shown, when a portion of the control tube distal section 900 is connected to the distal bushing 320 (see...) Figure 8A and Figure 8B When in operation, rotation of control tube 700 can cause the distal end section 900 of control tube (see...) Figure 9A and Figure 9B Rotation. Rotation of the distal bushing 320 causes the device cover 124 connected to the distal bushing 320 to rotate. Therefore, rotation of the control tube 700 causes the device cover 124 to rotate. In addition, rotation of the control tube 700 also causes the strap 122 and the distal closure member 120 to rotate.

[0125] The coil member 126, which is in an elongated and narrow configuration 128 within the delivery tube cavity 114, can be moved (e.g., pulled, pushed, or a combination thereof) through the delivery tube cavity 114 and into the fillable cavity 400 of the device cover 124 (see [link]). Figure 8A Rotation of the device cover 124 can cause the coil member 126 to rotate and resume rotations not completed during deployment (see [link]). Figure 5B ).

[0126] When the distal end 302 of the coil enters the fillable cavity 400 of the device cover 124, the coil member 126 can begin to rotate. In some variations, the coil member 126 can begin to rotate when a section of the coil member 126 near the distal end 302 is pulled onto and around the distal bushing 320. In these and other variations, a tension line 1400 (see [reference needed]) cuts through or extends through the coil member 126 and the distal bushing 320. Figure 14A , Figure 14B and Figure 14C This allows the coil member 126 to rotate in response to rotation of the distal bushing 320. In other variations, the coil member 126 can begin to rotate when the inner surface of the device cover 124 applies frictional force to the section of the coil member 126 that enters the fillable cavity 400.

[0127] Figure 7It is also shown that the proximal section 706 of the control tube can rotate about a proximal rotation axis 708 of the control tube. The proximal rotation axis 708 of the control tube can be formed by a second gear component (e.g., Figure 10 , Figure 11A and Figure 11B The rotation of the worm gear cylinder 1004 in the middle is controlled by the rotation. Figure 7 The device cover 124 is further shown to be able to surround (can be with) Figure 1 The device cover rotation axis 710 (the same as the second rotation axis 138 shown) rotates. The device cover rotation axis 710 can be determined by the rotation of the distal bushing 320. The rotation of the distal bushing 320 can in turn be determined by the control tube distal section 900 (see...). Figure 9A and Figure 9B The rotation of the tube is controlled by the delivery tube 104 and the control tube 700 when they are kept straight (e.g., when the delivery tube 104 and the control tube 700 are kept straight). Figure 7 As shown), the rotation axis 710 of the device cover can be the same as the rotation axis 708 of the proximal end of the control tube. However, when the delivery tube 104 and the control tube 700 are bent... Figure 19 In the curved configuration 1900 (e.g., for deployment within a patient's esophagus), the proximal rotation axis 708 of the control tube and the rotation axis 710 of the device cover may intersect and not be parallel. In some cases, when the delivery tube 104 and the control tube 700 are bent into the curved configuration 1900, the proximal rotation axis 708 of the control tube and the rotation axis 710 of the device cover may intersect at an oblique angle (e.g., an obtuse or acute angle) or substantially at a right angle.

[0128] Figure 7 It is also shown that the device cover 124 can rotate when connected to the distal end 112 of the delivery tube. The device cover 124 can rotate when the delivery tube 104 remains stationary. As will be discussed in the following sections, the device cover 124 can be rotated via a flange 116 connected to the distal end 112 of the delivery tube (see...). Figure 3 and Figure 12B It can be detachably connected to the distal end 112 of the delivery tube.

[0129] Figure 8A A perspective cross-sectional view of the distal bushing 320 positioned within the fillable cavity 400 of the device cover 124 is shown. Figure 8AAs shown, the distal bushing 320 can be connected to the device cover 124 via a plurality of internal struts 800 within the fillable cavity 400. The internal struts 800 can extend radially relative to the distal bushing 320. In some variations, one end of each internal strut 800 can be connected to an attachment collar 324 at the base of the distal bushing 320, and the other end of each internal strut 800 can be connected to an inner surface of the device cover 124. For example, one end of the internal strut 800 can be connected to the attachment collar 324, and the other end of the internal strut 800 can be connected to the inner surface of the device cover 124 along the conical pyloric contact area 200. In other variations, the internal struts 800 can be extensions of the device cover 124 or can be integrated with the device cover 124.

[0130] The internal strut 800 enables the distal bushing 320 to transmit rotational motion to the remainder of the device cover 124. In some variations, the internal strut 800 may be made of or comprised of the same material as the device cover 124. For example, the internal strut 800 may be made of or comprised of a biocompatible polymer material. As a more specific example, the internal strut 800 may be made of or comprised of silicone resin, silicone rubber, thermoplastic elastomer (TPE), or combinations thereof.

[0131] like Figure 8A As shown, the attachment collar 324 of the distal bushing 320 can also be connected to the interior of the distal end 306 of the cover by fasteners, adhesives, wires, cords, or combinations thereof. The locking member 322 of the distal bushing 320 can protrude or extend into the fillable cavity 400 of the device cover 124. The locking member 322 may include a mating cavity 802 at the center of the locking member 322. The mating cavity 802 may be designed to receive a key portion 908 of the control tube 700 (see [link to relevant documentation]). Figure 9A ( ) gaps or openings. For example... Figure 8A As shown, the mating cavity 802 can be generally elliptical, rectangular, stadium-shaped, obround-shaped, or a combination thereof. The unique shape of the mating cavity 802 (e.g., elliptical, rectangular, stadium-shaped, obround-shaped, or a combination thereof) allows the key portion 908 of the control tube 700 (see...) to... Figure 9A It facilitates mating with or entering the mating cavity 802, and also enables the control tube 700 to effectively transmit torque from one end of the control tube 700 (e.g., the proximal segment 706 of the control tube) to the other end of the control tube 700 (e.g., the distal segment 900 of the control tube). The unique shape of the mating cavity 802 (e.g., elliptical, rectangular, stadium-shaped, and / or oblong) also allows the control tube 700 to be in a bent configuration 1900 (see...). Figure 19When ), the key portion 908 of the control tube 700 (see) Figure 9A It can easily mate with or enter the mating cavity 802. Furthermore, when the control tube 700 is in the bent configuration 1900 (see...), Figure 19 When combined with the unique shape of the cavity 802, the control tube 700 can more effectively transmit torque from one end of the control tube 700 to the other end.

[0132] The distal bushing 320, including the attachment collar 324 and the locking member 322, may be made of or composed of biocompatible polymeric materials, metallic materials or alloys, or combinations thereof. In some variations, the distal bushing 320, including the attachment collar 324 and the locking member 322, may be made of or composed of polyetheretherketone (PEEK). In other variations, the distal bushing 320, including the attachment collar 324 and the locking member 322, may be made of or composed of fluoropolymers, polycarbonate, stainless steel, or combinations thereof.

[0133] Figure 8B A top view is shown of the distal bushing 320 positioned within the device cover 124. Figure 8B In a variation of the gastric obstruction device 102 shown, the distal bushing 320 can be connected to the inner surface of the device cover 124 via four internal struts 800 evenly arranged around the distal bushing 320. For example, the four internal struts 800 can be arranged in a cross or X shape, such that each of the four internal struts 800 is approximately 90 degrees apart from its adjacent internal strut 800.

[0134] In other variations, the distal bushing 320 may be connected to the device cover 124 by six to eight internal struts 800. In all these variations, the internal struts 800 may be evenly arranged around the distal bushing 320, and the internal struts 800 may be spaced substantially uniformly apart from each other.

[0135] Figure 8A and Figure 8B The locking member 322 is shown to be accessible through the cover opening 310 of the device cover 124. The control tube distal section 900 (see...) Figure 9A The device cover 124 can extend through the cover opening 310 and engage or be bonded to the locking member 322 within the fillable cavity 400 of the device cover 124. When the device cover 124 is secured to the distal end 112 of the delivery tube via the flange 116 of the delivery tube 104, the distal end section 900 of the control tube (see...) Figure 9A It can be engaged or keyed with locking component 322. Furthermore, when via gear mechanism 1000 (see...) Figure 10 When the control tube 700 is rotated, the distal section 900 of the control tube (see...) Figure 9AA portion of the coil assembly 126 may mate or bond with the locking component 322. When the entire coil assembly 126 is configured in a contracted-widening configuration 300 within the fillable cavity 400 of the device cover 124, the control tube 700 may be removed from the distal bushing 320.

[0136] Although coil component 126 is not in Figure 8A and Figure 8B As shown in the diagram, this disclosure envisions that the coil member 126 can be formed in a contracted-widening configuration 300 around the control tube 700. For example, when the coil member 126 is moved into the fillable cavity 400 of the device cover 124, the coil 312 (see [reference]) is spirally wound. Figure 3 and Figure 4B The control tube 700 can be wrapped around or encircled. When the device cover 124 is decoupled from the delivery tube 104 and the gastric obstruction device 102 moves freely within the patient's stomach, the control tube 700 can eventually detach from the distal bushing 320 and retract away from the infillable cavity 400 of the device cover 124.

[0137] Figure 9A and Figure 9B Perspective and top views of the control tube distal segment 900, which terminates at the distal end 902 of the control tube, are shown respectively. Figure 9A As shown, the control tube distal segment 900 may include the end of the cylindrical elongated portion 904 of the control tube 700, a transition portion 906, and a key portion 908 between the transition portion 906 and the control tube distal segment 902.

[0138] The cylindrical elongated portion 904 can be extended from the proximal section 706 of the control tube (see...) Figure 7 The cylindrical elongated portion 904 extends to the transition portion 906. The cylindrical elongated portion 904 can be approximately 90% to 99% of the length of the control tube 700. As previously mentioned, the cylindrical elongated portion 904 can have a control tube diameter 704 of approximately 2.50 mm to 3.50 mm. In other variations, the cylindrical elongated portion 904 can have a control tube diameter 704 of approximately 3.25 mm to 3.50 mm. In yet another variation, the cylindrical elongated portion 904 can have a control tube diameter 704 of approximately 3.50 mm to 5.00 mm.

[0139] The transition portion 906 may be the portion of the control tube 700 between the cylindrical elongated portion 904 and the key portion 908. The transition portion 906 may be a segment of the control tube 700 in which the control tube 700 changes shape and the diameter 704 of the control tube gradually tapers or decreases in size.

[0140] The key portion 908 of the control tube 700 may be a section of the control tube 700 between the transition portion 906 and the distal end 902 of the control tube. The key portion 908 may have a mating cavity 802 with the locking member 322 (see [link]). Figure 8A The cross-sectional shape matches the cross-sectional shape of the locking member 322, or has a mating cavity 802 that matches the locking member 322 (see...). Figure 8A The outline that matches the outline of ).

[0141] For example, the key portion 908 may have a cross-sectional shape similar to the cross-sectional shape of the mating cavity 802 of the locking member 322, or a profile similar to the profile of the mating cavity 802 of the locking member 322. The key portion 908 of the control tube 700 may have a cross-sectional shape or profile slightly smaller than the cross-sectional shape or profile of the mating cavity 802, such that the key portion 908 can be fitted into or enter the mating cavity 802 (see...). Figure 8A and Figure 8B ).

[0142] The key portion 908 may have a generally elliptical cross section, a rectangular cross section, a stadium-shaped cross section, an oblong cross section, or a combination thereof. Figure 9A and Figure 9B The key portion 908 is shown to have a key height dimension 910 and a key width dimension 912. In some variations, the key height dimension 910 can be approximately 3.50 mm to 4.50 mm. In other variations, the key height dimension 910 can be approximately 3.70 mm to 4.10 mm. In some variations, the key width dimension 912 can be approximately 2.50 mm to 3.50 mm. In other variations, the key width dimension 912 can be approximately 2.75 mm to 3.10 mm.

[0143] Furthermore, in some variations, the ratio of the key height dimension 910 to the key width dimension 912 can be approximately 1.1 to 1.5. In other variations, the ratio of the key height dimension 910 to the key width dimension 912 can be approximately 1.2 to 1.4. In other variations, the ratio of the key height dimension 910 to the key width dimension 912 can be approximately 1.4.

[0144] Device cover 124 (see) Figure 8A and Figure 8B The key portion 908 can be configured to rotate in response to rotation of the control tube 700 when it engages with the locking member 322 of the distal bushing 320. (See previously regarding the mating cavity 802). Figure 8A and Figure 8BAs discussed, the unique cross-sectional shape of the key portion 908 (e.g., elliptical, rectangular, stadium-shaped, oblong, or a combination thereof) allows the key portion 908 to easily mate with or enter the mating cavity 802, and also allows the control tube 700 to effectively transfer torque from one end of the control tube 700 (e.g., the proximal section 706 of the control tube, see...) Figure 7 The signal is transmitted to the other end of the control tube 700 (e.g., the distal segment 900 of the control tube). The unique cross-sectional shape of the key portion 908 (e.g., elliptical, rectangular, stadium-shaped, and / or oblong) also allows: when the control tube 700 is in a curved configuration 1900 (see...) Figure 19 When the key portion 908 is in the bend configuration 1900, it readily engages with or enters the mating cavity 802. Furthermore, when the control tube 700 is in the bend configuration 1900 (see...), Figure 19 When the key portion 908 has a unique cross-sectional shape, it also allows the control tube 700 to transmit torque more effectively from one end of the control tube 700 to the other end.

[0145] Similar to the rest of the control tube, the key portion 908 may be made of or composed of PEEK. In other variations, the key portion 908 may be made of or composed of fluoropolymers, polycarbonate, stainless steel, or combinations thereof. In these and other variations, the key portion 908 may be made of or composed of a material different from the rest of the control tube 700.

[0146] Figure 9A It is also shown that the control tube lumen 702 can extend from the proximal section 706 of the control tube through the control tube 700 to the distal section 900 of the control tube. As will be discussed in the following sections, multiple tension lines 1400 can extend and be pulled through the control tube lumen 702.

[0147] When the key portion 908 enters the mating cavity 802 and is fixed to the locking member 322 by interference fit or mechanical fit, the control tube 700 can be reversibly or detachably connected to the distal bushing 320. The key portion 908 can be engaged with the locking member 322 before and during the unfolding process (see...). Figure 8A and Figure 8B )Cooperate.

[0148] Before the device cover 124 is released or removed from the delivery tube 104, the key portion 908 can be removed or decoupled from the locking member 322. The control tube 700 can be disengaged or decoupled from the distal bushing 320 by retracting the key portion 908 from the mating cavity 802.

[0149] Figure 10A variation of the gear mechanism 1000 positioned within the housing 106 is shown. In some variations, the gear mechanism 1000 may be a worm gear or worm drive mechanism including a worm wheel 1002 and a worm cylinder 1004. In other variations, the gear mechanism 1000 may be a bevel gear mechanism including complementary bevel gears.

[0150] The gear mechanism 1000 may include a first gear component and a second gear component. In some variations, the first gear component may be or include a worm gear 1002. In these and other variations, the second gear component may be or include a worm cylinder 1004. Figure 10 As shown, the first gear component (e.g., worm gear 1002) can be operatively engaged or interlocked with the second gear component (e.g., worm cylinder 1004) such that rotation of the first gear component can cause rotation of the second gear component.

[0151] The first gear component (e.g., worm gear 1002) and the second gear component (e.g., worm cylinder 1004) may be made of or composed of durable polymeric materials, metallic materials or alloys, or combinations thereof. For example, the first gear component, the second gear component, or a combination thereof may be made of or composed of nylon, ultra-high molecular weight polyethylene (UHMWPE), acetal (e.g., It may be made of or composed of polyoxymethylene (POM), acrylonitrile butadiene styrene (ABS), PTFE, PEEK, phenolic materials, polyester, polycarbonate, or combinations thereof. In these and other variations, the first gear component, the second gear component, or combinations thereof may be made of or composed of stainless steel, aluminum, bronze, or combinations thereof.

[0152] A first gear component (e.g., worm gear 1002) may be connected to a portion of a control component 108. For example, a crankshaft or rod extending from the control component 108 may be operatively engaged, interlocked, or connected to a hub 1006 of the first gear component (e.g., worm gear 1002). The hub 1006 may include an opening or hole defined in the middle of the first gear component. The hub 1006 may be substantially polygonal, such as hexagonal, octagonal, decagonal, or combinations thereof. The control component 108 may include a component configured to key or mate with the hub 1006. The control component 108 may also be connected to the first gear component (e.g., worm gear 1002) by an interference fit. Furthermore, fasteners and adhesives may be used to facilitate the connection between the control component 108 and the first gear component (e.g., worm gear 1002).

[0153] The control tube 700 can be connected to a second gear component (e.g., a worm gear cylinder 1004). For example, a portion of the proximal section 706 of the control tube can extend through and be secured to the inner cavity of the worm gear cylinder 1004. Rotation of the second gear component (e.g., the worm gear cylinder 1004) can cause rotation of the control tube 700.

[0154] The first gear component can be configured to rotate about a first gear rotation axis 1010 in a first gear rotation direction 1008. For example, the first gear rotation axis 1010 can be substantially parallel to a directional axis or line extending from one side of the housing 106 to the other side of the housing 106. The first gear component can rotate in response to rotation of the control component 108. The control component 108 can rotate in a rotation direction similar to the first gear rotation direction 1008.

[0155] The second gear component can rotate in response to the rotation of the first gear component. For example, the worm gear cylinder 1004 can rotate in response to the rotation of the worm wheel 1002. The second gear component can be configured to rotate about the second gear rotation axis 1014 in the second gear rotation direction 1012. In some variations, the second gear rotation axis 1014 can be substantially aligned with a longitudinal axis extending through the control tube 700. The first gear rotation axis 1010 can be substantially perpendicular to the second gear rotation axis 1014.

[0156] As a more specific example, when viewed from the side of housing 106 connected to control component 108 to the other side of housing 106, worm gear 1002 can rotate in a clockwise direction. In response to the rotation of worm gear 1002, when viewed from the proximal section 706 of control tube to the distal section 900 of control tube (see...) Figure 9A During observation, the worm cylinder 1004 can also rotate in a clockwise direction.

[0157] As previously mentioned, the control tube distal segment 900 may include a key portion 908 (see [link]). Figure 9A The key portion 908 is configured to engage with the locking member 322 of the distal bushing 320 within the device cover 124 (see [link]). Figure 8A ) to be fitted or otherwise connected. Rotation of the control tube 700 can cause the device cover 124, strap 122, distal closure member 120 (see Figure 1 and Figure 19 The rotation of the gastric obstruction device 102, or a combination thereof, is caused by the rotation of the control component 108. Thus, the rotation of the gastric obstruction device 102 can be caused by the rotation of the first gear component (e.g., worm gear 1002) and the second gear component (e.g., worm cylinder 1004).

[0158] The gear ratio determines the rotation of the second gear component (e.g., worm barrel 1004) relative to the first gear component (e.g., worm wheel 1002). In some variations, the first gear component (e.g., worm wheel 1002) and the second gear component (e.g., worm barrel 1004) can be configured such that approximately three full revolutions (e.g., three 360° rotations or 1080°) of the first gear component (e.g., worm wheel 1002) can cause approximately one full revolution (e.g., one 360° rotation) of the second gear component (e.g., worm barrel 1004). In other variations, the first gear component (e.g., worm gear 1002) and the second gear component (e.g., worm barrel 1004) can be configured such that approximately three full rotations (e.g., three 360° rotations or 1080°) of the first gear component (e.g., worm gear 1002) can cause approximately two full rotations (e.g., two 360° rotations or 720°) of the second gear component (e.g., worm barrel 1004). In other variations, the first gear component (e.g., worm gear 1002) and the second gear component (e.g., worm barrel 1004) can be configured such that approximately three full rotations (e.g., three 360° rotations or 1080°) of the first gear component (e.g., worm gear 1002) can cause approximately 1.5 full rotations (e.g., two 360° rotations or 720°) of the second gear component (e.g., worm barrel 1004). The gear ratio between the first gear assembly and the second gear assembly can also be somewhere between approximately 3:1 and 3:2.

[0159] As previously described, the coil member 126 can be partially or fully extended to facilitate insertion and delivery of the coil member 126 through the delivery tube 104. The coil member 126 can be inserted and delivered by rotating approximately two to six full turns 502 (see [link to documentation]). Figure 5A , 5B The coil member 126 is unfolded by means of approximately two to three full turns 502. As a more specific example, the coil member 126 can be partially unfolded by means of approximately two to three full turns 502. When at least a portion of the coil member 126 enters the fillable cavity 400 of the device cover 124, the coil member 126 can resume or return to its rotation (see 5C). Figure 8A ).

[0160] Rotation of the control component 108 can cause rotation of the gastric obstruction device 102, including the device cover 124. In some variations, three rotations of the control component 108 (i.e., three full rotations of the worm gear 1002) can (via rotation of the worm cylinder 1004 and the control tube 700) cause one rotation of the gastric obstruction device 102 or one rotation of the device cover 124. Furthermore, when the coil member 126 is wound within the device cover 124 and forms a contraction-expansion configuration 300 (see...),... Figure 4BWhen the control component 108 rotates 3 times (i.e., 3 full rotations of the worm gear 1002), it can cause the coil component 126 to rotate 1 time.

[0161] Since the coil component 126 can initially be passed through 2 to 3 full turns 502 (e.g., 2.5 full turns 502, see...), Figure 5A , 5B To deploy the device cover 124 and coil member 126, the control component 108 (and thus the first gear component, such as worm gear 1002) needs to be rotated approximately 6 to 9 full revolutions, causing the device cover 124 and coil member 126 to rotate approximately 2 to 3 full revolutions. The number of revolutions of the control component 108 and the first gear component can vary with the gear ratio between the first gear component and the second gear component. For example, the control component 108 (and thus the first gear component, such as worm gear 1002) can rotate at least 9 full revolutions. In this example, the gastric obstruction device 102 including the device cover 124 can rotate at least 3 full revolutions to fully deploy the coil member 126 within the fillable cavity 400 of the device cover 124.

[0162] For example, a method of deploying the gastric obstruction device 102 may include advancing the gastric obstruction device 102 orally to the vicinity of the patient's stomach. The gastric obstruction device 102 may be connected to a distal segment 900 of a control tube (see...). Figure 9A The control tube proximal section 706 can be connected to the worm barrel 1004 of the worm gear. The method may further include a control component 108 rotatably connected to the worm gear 1002 (see...). Figure 1 and Figure 19 The worm gear 1002 can rotate in response to the rotation of the control member 108. The worm cylinder 1004 can rotate in response to the rotation of the worm gear 1002. Furthermore, the gastric obstruction device 102 can rotate within the patient's stomach in response to the rotation of the worm gear 1002. The method may also include rotating the control member 108 at least 6 to 9 full revolutions. In other variations, the control member 108 can be rotated such that the gastric obstruction device 102, including the device cover 124, rotates at least 3 full revolutions.

[0163] Figure 10 The gear mechanism 1000 is also shown to be connectable to a spool 1016. For example, the spool 1016 may be connected to or extend from a worm gear 1002. In one variation, the spool 1016 may be integrated with the worm gear 1002 and be part of a molded component. In other variations, the spool 1016 may be connected to the worm gear 1002 by fasteners, connecting rods, adhesives, shafts, or combinations thereof.

[0164] The spool 1016 can rotate in response to rotation of the first gear component (e.g., worm gear 1002) and the control component 108. The spool 1016 can rotate in the same direction of rotation as the first gear component. The spool 1016 can be used to extend through the inner cavity 702 of the control tube (see...). Figure 7 Some tension lines 1400 are wound onto spool 1016.

[0165] Figure 11A and Figure 11B They respectively showed the same as Figure 10 The front and side views show a second gear component (e.g., worm gear 1004) that is part of a gear mechanism 1000, and a first gear component (e.g., worm wheel 1002) that is operably engaged or interlocked with it.

[0166] Figure 11A The worm gear 1002 is shown to include a plurality of blades 1100. The blades 1100 may be circumferentially oriented gear teeth that extend or protrude radially outward from or to the outside of the circumferential surface 1102 of the disc 1104.

[0167] Each wheel blade 1100 may terminate at two blade tips 1106. The blade tips 1106 of adjacent or neighboring wheel blades 1100 may be laterally offset 1108 or laterally separated from each other, such that the blade tips 1106 do not touch or directly contact each other. Furthermore, the length dimension of each wheel blade 1100 (measured from one blade tip of the same wheel blade 1100 to another blade) may be smaller than the circumference of the wheel disk 1104. This means that each wheel blade 1100 extends only partially around the circumference of the wheel disk 1104.

[0168] Each wheel blade 1100 may also have a blade ridge 1110 (also referred to as a blade top-land) and a blade surface 1112. The blade ridge 1110 may extend obliquely relative to the centerline 1114 that bisects the circumferential surface 1102 of the wheel disk 1104, or be aligned with the centerline 1114 at an oblique angle. In other words, the blade ridge 1110 may be oblique relative to the centerline 1114. In some variations, the blade ridge 1110 may be curved or twisted. Since the blade tips 1106 of the wheel blade 1100 do not contact each other and the wheel blade 1100 is oblique, the wheel blade 1100 may be characterized as a discontinuous helical protrusion extending radially from the circumferential surface 1102 of the wheel disk 1104.

[0169] like Figure 11B As shown, a portion of the proximal section 706 of the control tube can be connected to the second gear component. For example, a portion of the proximal section 706 of the control tube can extend through and be secured to the inner cavity of the worm gear cylinder 1004.

[0170] The worm gear cylinder 1004 may include a plurality of grooves 1116 protruding radially inward from the transverse surface 1118 of the worm gear cylinder 1004. For example... Figure 11B As shown, each groove 1116 may have an arcuate or curved groove surface 1120. Grooves 1116 may also be separated by splines 1122. For example, two adjacent grooves 1116 may have a spline 1122 on one side or be separated by a spline 1122. Similar to grooves 1116, splines 1122 may also be curved or have an arcuate profile. In some variations, splines 1122 do not extend radially outward beyond the transverse surface 1118 of the worm gear cylinder 1004. In these variations, the edge of the spline 1122 is horizontal or flush with the transverse surface 1118 of the worm gear cylinder 1004. In other variations, splines 1122 may extend radially outward beyond the transverse surface 1118 of the worm gear cylinder 1004.

[0171] like Figure 10 and Figure 11B As shown, the curvature of the groove 1116 and the rack 1122 allows the worm barrel 1004 to have a radially converging middle section 1124. Due to the radially converging middle section 1124, the worm barrel 1004 can be generally hourglass-shaped. The radially converging middle section 1124 allows the worm wheel 1002 to engage and drive the worm barrel 1004 more effectively.

[0172] The worm gear cylinder 1004 may have a proximal portion 1126 and a distal portion 1128. Each groove 1116 and each rack 1122 may be oriented substantially longitudinally such that each groove 1116 and each rack 1122 extends from the proximal portion 1126 to the distal portion 1128.

[0173] Figure 11B It is also shown that the groove 1116 can be inclined relative to the longitudinal axis 1130 of the cylinder. For example, each groove 1116 can have a groove centerline 1132 that bisects the groove 1116. The groove centerline 1132 can extend obliquely relative to the longitudinal axis 1130 of the cylinder or intersect the longitudinal axis 1130 of the cylinder at an angle of inclination. The orientation of the groove 1116 can complement the orientation of the wheel blade 1100 and enable the worm cylinder 1004 to engage more effectively with the worm wheel 1002.

[0174] Rotation of the worm gear 1002 can cause at least one blade 1100 of the worm gear 1002 to translate towards at least one grooved surface 1120 and the rack 1122, thereby rotating the worm gear 1002. In some variations, the worm barrel 1004 can be configured to rotate 360° in response to a 1080° rotation of the worm gear 1002. In other variations, the worm barrel 1004 can be configured to rotate 720° in response to a 1080° rotation of the worm gear 1002.

[0175] Figure 11B It is also shown that the worm gear 1002 may have a generally hexagonal hub 1006 defined in the middle of the worm gear 1002. The hub 1006 may be configured to receive a shaft or drive gear connected to the control unit 108 for rotating the worm gear 1002.

[0176] The unique design of the gear mechanism 1000 disclosed herein (including a unique worm gear 1002 and a complementary worm cylinder 1004) provides previously undiscovered advantages related to the rotation of the elongated control tube 700, which in turn controls the rotation of the fillable device cover 124 disclosed herein (see [link to document]). Figure 4B and Figure 8A The unique gastric obstruction device 102 and the rotation are designed to wind and compress the elongated coil member 126 into a contracted-widening configuration 300 within the device cover 124. The unique design of the gear mechanism 1000 disclosed herein (including the unique worm gear 1002 and the complementary worm cylinder 1004) also provides additional benefits by enabling the control unit 108 to control or drive multiple components within the same housing 106. For example, the gear ratio provided by the unique gear mechanism 1000 disclosed herein allows the control unit 108 to control or drive the worm cylinder 1004 and the spool 1016 for winding the tension line 1400 (see [link to document]). Figure 10 and Figure 15 Because the spool 1016 requires more rotation to wind the tension line 1400 than the device cover 124 (and fundamentally, the coil member 126), the unique gear mechanism 1000 disclosed herein provides a gear ratio that allows a control component 108 to handle this difference in rotation. The unique design of the gear mechanism 1000 disclosed herein (including a unique worm gear 1002 and a complementary worm cylinder 1004) provides previously undiscovered advantages related to the safe deployment of the removable gastric obstruction device 102 within a patient's stomach, which is well tolerated by the patient's stomach and gastrointestinal tract. The unique gear mechanism 1000 disclosed herein allows the gastric obstruction device 102 to rotate smoothly and in a controlled manner within the patient's stomach without causing unnecessary trauma to the patient's gastrointestinal tract.

[0177] Figure 12AA side sectional view of a variant of the flange 116, separate from the device cover 124 of the gastric obstruction device 102, is shown. In some variants, the flange 116 may be connected to the distal end 112 of the delivery tube. In other variants, the flange 116 may be integrated with and be an extension of the delivery tube 104. The flange 116 may be generally funnel-shaped, truncated conical, or a combination thereof. The flange 116 may be flexible and compressible, such that the flange 116 may be radially compressed or reduced in size when pushed or pulled through an opening (e.g., cover opening 310) whose diameter is smaller than the maximum diameter of the flange 116.

[0178] Flange 116 can be detached from device cover 124 before it is inserted into the fillable cavity 400 of device cover 124, or when flange 116 has been retracted from fillable cavity 400 before gastric obstruction device 102 is released from delivery tube 104. Flange 116 can be inserted into and retracted from fillable cavity 400 through cover opening 310 of device cover 124.

[0179] like Figure 12A As shown, the cover opening 310 can be circumferentially surrounded by the inwardly curved portion 1200 of the device cover 124. The inwardly curved portion 1200 can be a part of the device cover 124 at the proximal end 308 of the cover. The inwardly curved portion 1200 can be configured to bend inward or achieve a partial funnel shape through heat treatment or other types of shape memory treatment. The curvature of the inwardly curved portion 1200 can also be a molded shape of this portion of the device cover 124. The inwardly curved portion 1200 can be configured to bend inward or achieve a partial funnel shape when no stress or force is applied to the proximal end 308 of the cover of the device cover 124.

[0180] Figure 12A It is also shown that the outer surface of flange 116 may be coated or covered with lubricating coating 1202 to reduce friction between the inner surfaces of flange 116 and device cover 124 when device cover 124 is connected to flange 116 while rotating. In some variations, lubricating coating 1202 may be a polymer coating or surface treatment. For example, lubricating coating 1202 may be or include a parylene N coating, a parylene C coating, a parylene D coating, or a combination thereof. In other variations, lubricating coating 1202 may be a dry lubricant, such as a dry film lubricant. In other variations, the inner surface of device cover 124 near cover opening 310 may also be coated with lubricating coating 1202.

[0181] Figure 12BA flange 116 is shown that can facilitate securing the device cover 124 to the delivery tube 104. The flange 116 can extend through a cover opening 310 of the device cover 124 and secure the device cover 124 by an interference fit. For example, when the flange 116 enters through the cover opening 310, the flange 116 can be momentarily compressed or contracted, and then expanded when at least a portion of the flange 116 is within the fillable cavity 400. The flange 116 entering the fillable cavity 400 through the cover opening 310 can also pull the inwardly bent portion 1200 out of the fillable cavity 400 or bias the inwardly bent portion 1200 away from the fillable cavity 400. For example, the inwardly bent portion 1200 can flip when pulled out or biased away from the fillable cavity 400.

[0182] The outwardly bent or biased portion 1200 can apply a radially inward force to the outer surface of the flange 116, while the compressed flange 116 can apply a radially outward force to the inner surface of the device cover 124. Although not in Figure 12B As shown, but control tube 700 (see...) Figure 7 The control tube 700 can extend through the delivery tube cavity 114 and mate with the distal bushing 320 within the device cover 124. For example, the key portion 908 of the control tube 700 can mate with the locking member 322 of the distal bushing 320 within the device cover 124. The control tube 700 can serve to maintain the axial distance between the device cover 124 and the flange 116, preventing the device cover 124 from unintentionally translating proximally relative to the flange 116.

[0183] The device cover 124 can rotate in response to the rotation of the control pipe 700. When the device cover 124 is connected to the flange 116, the device cover 124 can rotate. While the device cover 124 rotates in response to the rotation of the control pipe 700, the flange 116 can remain stationary. A lubricating coating 1202 on the outer surface of the flange 116 can reduce friction between the device cover 124 and the flange 116 during rotation of the device cover 124 relative to the flange 116. The lubricating coating 1202 can also improve the material durability of the flange 116.

[0184] Flange 116 can also be configured to substantially seal cover opening 310 when at least a portion of flange 116 extends through cover opening 310. By sealing cover opening 310, flange 116 can establish a fluid passage between delivery tube cavity 114 and fillable cavity 400 of device cover 124. A fluid passage can be established to allow fillable cavity 400 of device cover 124 to expand. Fluid can then pass through fluid delivery port 130 of housing 106 (see...). Figure 1The fluid is introduced and guided through the delivery tube lumen 114 into the fillable cavity 400. In some variations, the fluid may be or include an inert gas. In other variations, the fluid may be or include a liquid. The fillable cavity 400 of the device cover 124 can be inflated to a lower pressure of approximately 0.125 psi to 0.275 psi. As a more specific example, the fillable cavity 400 can be inflated to a pressure of approximately 0.250 psi. The inflation of the fillable cavity 400 of the device cover 124 can be performed before or during the deployment of the coil member 126 into the fillable cavity 400. Inflating the fillable cavity 400 ensures that the device cover 124 does not collapse or deform when the coil member 126 is introduced into the fillable cavity 400. Inflating the fillable cavity 400 also increases the torsional stiffness or rigidity of the device cover 124, allowing the device cover 124 to rotate without twisting.

[0185] Figure 13 This is a black-and-white image of a variant of a gastric obstruction device 102, which includes a device cover 124, a tether 122, and a distal closure member 120. The inwardly curved portion 1200 is not... Figure 13 As shown, because the delivery tube 104 and flange 116 are separated from the device cover 124 and the inwardly bent portion 1200 bends into the fillable cavity 400. Once the flange 116 is removed from the fillable cavity 400 of the device cover 124, the inwardly bent portion 1200 may exhibit a tendency to restore its inwardly bent shape.

[0186] Figure 14A It is a black and white image of tension line 1400, which extends through the spirally wound coil 312 of coil member 126 and enters the distal bushing 320 connected to device cover 124. Figure 14A and Figure 14C The device cover 124 shown has been flipped and pulled back to more clearly show the fillable cavity 400 that is normally located in the device cover 124 (see [reference]). Figure 8A The distal bushing 320 is located within the ) . Furthermore, in Figures 14A to 14C Delivery tube 104 is omitted to more clearly show the tension line 1400 extending through the coil member 126 of the spirally wound coil 312. When the coil member 126 is located within the delivery tube cavity 114 (see...), Figure 1 and Figure 19 When inside, coil component 126 will look more like Figure 6 The coil member 126 shown (i.e., in the elongated and narrow configuration 128) is not... Figures 14A to 14C The coil component 126 is shown in the figure.

[0187] The tension wire 1400 may be a metal wire, a cord, or other type of connecting member for pulling the coil member 126 through the delivery tube 104 and into the fillable cavity 400 of the device cover 124. In some variations, the tension wire 1400 may be made of or composed of biocompatible high-strength fibers, including any number of synthetic polymeric fibers. For example, the tension wire 1400 may be made of or composed of medical-grade nylon, polyester fibers, polyvinylidene fluoride (PVDF) fibers, ultra-high molecular weight polyethylene (UHMWPE) fibers, polypropylene fibers, or combinations thereof. In other variations, the tension wire 1400 may be made of or composed of stainless steel wire.

[0188] Tension wire 1400 may extend transversely through the helical wound coil 312 of coil member 126. Tension wire 1400 may extend or pass through a hole 1402 defined for passage through each helical wound coil 312. Hole 1402 may be an opening or channel defined for passage through each helical wound coil 312.

[0189] The tension line 1400 can enter one or more openings 1404 circumferentially arranged around the attachment collar 324 of the distal bushing 320, and the tension line 1400 wraps around the interior of the distal bushing 320 and travels in the opposite direction within the distal bushing 320. The tension line 1400 can enter the control tube cavity 702 of the control tube 700 (see...). Figure 14B The control tube 700 mates with or is otherwise connected to the remote bushing 320.

[0190] The tension line 1400 can be pulled in the direction indicated by the directional arrow 1406. For example, the tension line 1400 can first be pulled toward the distal end in the direction of the device cover 124, and then, once the tension line 1400 has been reversed within the distal bushing 320, pulled toward the proximal end toward the housing 106 (see [link]). Figure 1 and Figure 19 ).

[0191] Tension line 1400 can be connected to gear mechanism 1000 (see...) Figure 10 The spool 1016 is wound into the housing 106. For example, the rotation control component 108 (see...) Figure 1 and Figure 19 This allows the spool 1016 to rotate and be wound into the tension line 1400. In other variations, the tension line 1400 can also be pulled or translated in ways other than those involving the spool 1016.

[0192] Figure 14AIt is also shown that tension line 1400 can be connected to locking line 410 at its end. Locking line 410 can be a separate set of wires, cords, or connecting members configured such that when coil member 126 is formed in a contracted-widening configuration 300 (see...). Figure 3 , Figure 4B and Figure 18C The locking line 410 is held within the coil member 126 to lock or otherwise hold the coil member 126 in the contracted and widened configuration 300. The locking line 410 will be discussed in more detail in the following sections.

[0193] although Figure 14A The tension line 1400 is shown in a loose or relaxed configuration, but tension can be applied to the tension line 1400 during the deployment of the gastric obstruction device 102, such that the tension line 1400 is pulled distally through the lumen 114 of the delivery tube (see [link]). Figure 7 And when pulled proximally through the inner cavity 702 of the control tube, the tension line 1400 is taut or stretched. Furthermore, although in Figures 14A to 14C The diagram shows one pair of tension lines 1400. This disclosure envisions that four to eight pairs of tension lines 1400 can be arranged circumferentially and uniformly around the spirally wound coil 312 of the coil member 126, so that different circumferential segments of the coil member 126 advance uniformly through the delivery tube cavity.

[0194] Figure 14B This is a black and white image of tension line 1400, which extends into distal bushing 320 and exits from locking member 322 of distal bushing 320 into control tube cavity 702. Figure 14B In the middle, the control tube 700 separates from the distal bushing 320 to more clearly show the tension line 1400 entering the control tube lumen 702. As the gastric obstruction device 102 unfolds, the coil member 126 is translated through the delivery tube lumen 114, and the distal section 900 of the control tube (including...) Figure 9A The key portion 908 will engage with the locking member 322 of the distal bushing 320, and the tension line 1400 will enter the control tube cavity 702 without leaving the distal bushing 320.

[0195] Figure 14A and Figure 14BIt is also shown that the segment of coil member 126 at the distal end 302 of the coil is configured to fit around the distal bushing 320, such that when coil member 126 forms a contracted-widening configuration 300 within the fillable cavity 2400 of device cover 124, the segment of coil member 126 at the distal end 302 of the coil surrounds and encloses the distal bushing 320. For example, the segment of coil member 126 at the distal end 302 of the coil can be substantially shaped as a loop or circle, with a gap or break along the loop or circle, so as to facilitate fitting the loop or circle around the distal bushing 320.

[0196] Figure 14C This is a black and white image of the tension wire 1400 exiting the control tube cavity 702 at the proximal end of the control tube 700. The segment of the tension wire 1400 exiting the control tube cavity 702 can be wound onto a spool 1016 within the housing 106. Once the coil member 126 is locked into the contraction-expansion configuration 300 within the fillable cavity 400 of the device cover 124, the tension wire 1400 can be cut or severed, allowing it to be separated from the locking wire 410 and removed from the control tube cavity 702.

[0197] Figure 15 A variation of the spool 1016, configured to rotate in response to rotation of the control unit 108, is shown. The spool 1016 can be connected to... Figure 10 It is part of the gear mechanism 1000. For example, the spool 1016 may be connected to or extend from the worm gear 1002. The spool 1016 may rotate in response to rotation of the first gear component (e.g., the worm gear 1002) and the control component 108. The spool 1016 may rotate in the same direction of rotation as the first gear component.

[0198] In some variations, the spool 1016 may be made of or composed of: nylon, acrylonitrile butadiene styrene (ABS), ultra-high molecular weight polyethylene (UHMWPE), acetal (e.g., It may be made of or composed of polyoxymethylene (POM), PTFE, PEEK, phenolic materials, polyester, polycarbonate, or combinations thereof. In other variations, the spool 1016 may also be made of or composed of stainless steel, aluminum, bronze, or combinations thereof.

[0199] The spool 1016 can be used to extend through the delivery tube lumen 114 and the control tube lumen 702 (see...). Figure 7 Multiple tension lines 1400 are wound onto spool 1016. Spool 1016 can also be used to wind up one or more anchor lines 1600 (see...). Figure 16The anchor line 1600 is configured to secure or fasten the gastric obstruction device 102 to the system 100 during the deployment of the gastric obstruction device 102.

[0200] like Figure 15 As shown, the spool 1016 may include a first tension line separator 1500, a second tension line separator 1502, and an anchor line separator 1504. The first tension line separator 1500 and the second tension line separator 1502 can be used to wind different groups of tension lines 1400 onto different portions of the spool 1016. The first tension line separator 1500 and the second tension line separator 1502 ensure that the extension passes through the hole 1402 along the coil member 126 (see...). Figure 14A The different groups of tension lines 1400 in different channels, defined by the system, will not become tangled or intertwined when wound onto the spool 1016. Separating certain tension lines 1400 from others on the spool 1016 also allows the clinician or user of the system 100 to cut certain tension lines 1400 while keeping others in place. Furthermore, separating the anchor line 1600 from the tension lines 1400 reduces the likelihood of them becoming tangled or intertwined.

[0201] Although Figure 15 A single spool 1016 is shown, but it should be understood that multiple spools 1016 (e.g., two to six spools 1016) may be located within the housing 106. The multiple spools 1016 may be configured to extend through the delivery tube lumen 114 and the control tube lumen 702 (see [reference]). Figure 7 ) different groups of tension lines 1400 winding.

[0202] Figure 16 It is a black-and-white image of multiple tension lines 1400 and anchor lines 1600 extending into the distal bushing 3 of the gastric obstruction device 102. Similar to... Figures 14A to 14C , Figure 16 The device cover 124 shown has been flipped and pulled back to more clearly show the fillable cavity 400 that is normally located in the device cover 124 (see [reference]). Figure 8A The distal bushing 320 inside.

[0203] Anchor wire 1600 may be made of the same material as tension wire 1400. For example, anchor wire 1600 may be made of or composed of medical-grade nylon, polyester fiber, polyvinylidene fluoride (PVDF) fiber, UHMWPE fiber, polypropylene fiber, or combinations thereof. In other variations, anchor wire 1600 may be made of or composed of stainless steel wire.

[0204] Anchor wire 1600 can be configured to prevent the distal bushing 320 of the gastric obstruction device 102 from unintentionally separating from the control tube 700 during the deployment of the gastric obstruction device 102 (including the formation of the coil member 126 within the fillable cavity 400 of the device cover 124). Anchor wire 1600 can enter an anchor wire hole 1602 defined along the attachment collar 324 of the distal bushing 320. Anchor wire 1600 can wrap around inside the distal bushing 320 and travel in the opposite direction within the distal bushing 320. Similar to tension wire 1400, anchor wire 1600 can then enter the control tube cavity 702 of the control tube 700 (see...). Figure 14B The control tube 700 mates with or is otherwise connected to the remote bushing 320.

[0205] Anchor line 1600 can be used with Figures 14A to 14C The anchor line 1600 is pulled in a direction similar to that indicated by directional arrow 1406. For example, the anchor line 1600 can first be pulled toward the distal end in the direction of the device cover 124, and then, once the anchor line 1600 has been reversed within the distal bushing 320, pulled toward the proximal end toward the housing 106 (see [reference]). Figure 1 and Figure 19 ).

[0206] Anchor line 1600 can be connected to gear mechanism 1000 (see...) Figure 10 The spool 1016 is wound onto the housing 106. The anchor line 1600 can be wound onto the anchor line divider 1504 of the spool 1016. For example, the rotation control component 108 (see...) Figure 1 and Figure 19 This allows the spool 1016 to rotate and wind into the anchor line 1600. In other variations, the anchor line 1600 can also be pulled or translated in ways other than those involving the spool 1016. Once the coil member 126 is locked into the contracted-widening configuration 300 within the fillable cavity 400 of the device cover 124 (see...), the coil is then wound into the anchor line 1600. Figure 4B and Figure 18C The anchor line 1600 can be cut or otherwise severed and can be pulled proximally away from the control tube cavity 702.

[0207] Figure 17 This is a black-and-white image of a pair of tension wires 1400 connected to the locking wire 410. The locking wire 410 may be made of the same material as the tension wires 1400. The locking wire 410 may be made of or composed of biocompatible polymeric fibers. For example, the locking wire 410 may be made of or composed of medical-grade nylon, polyester fibers, polyvinylidene fluoride (PVDF) fibers, UHMWPE fibers, polypropylene fibers, or combinations thereof.

[0208] like Figure 17As shown, the locking line 410 may have multiple color-differentiated segments 1700 along its length. The color-differentiated segments 1700 may be segments of the locking line 410 that are a different color from the rest of the locking line 410 or the tension line 1400. For example, the color-differentiated segments 1700 may be red or alternate between red and white. The color-differentiated segments 1700 can be used to inform a clinician or user that a cord, wire, or connecting member currently under visual observation (e.g., seen under an endoscope) is actually a segment of the locking line 410. The color-differentiated segments 1700 can also be used to inform a clinician or user of the progress of deployment (e.g., whether the coil member 126 has been locked into the contracted-widening configuration 300).

[0209] Figures 18A-18B The system 100 is shown to include a plunger 1800 configured as part of an unfolding gastric obstruction device 102, translating through the lumen 114 of a delivery tube. For example, the plunger 1800 may be displaced from the proximal end 110 of the delivery tube (see [link to documentation]). Figure 1 and Figure 19 ) Move distally to the distal end 112 of the delivery tube to push the proximal assembly 314 (including release mechanism 316 and proximal plug 318, see device cover 124) toward the device cover 124 Figure 3 The plunger 1800 can be connected to the plunger rod 1802, which is configured to translate proximal and distally through the delivery tube lumen 114. The plunger rod 1802 can be connected to the coil proximal end 304, or biased to the proximal end assembly 314 and the coil proximal end 304. Figure 10 The gear mechanism 1000, ratchet mechanism, slide bar, or combination thereof translates and is connected to the proximal end of the plunger rod 1802 housed within the housing 106. In some variations, the plunger 1800 may be a substantially cylindrical block for pushing or otherwise advancing the proximal assembly 314 and the coil proximal end 304 distally through the delivery tube cavity 114. In other variations, the plunger 1800 may include a substantially funnel-shaped flange at the distal end of the plunger 1800.

[0210] Figure 18A It is also shown that the coil member 126 may include a proximal loop 1804 at the coil proximal end 304. The coil proximal loop 1804 may be a closed hole or opening defined at the coil proximal end 304. A portion of the proximal assembly 314 may extend through the proximal loop 1804 to lock the coil member 126 in a contracted-widening configuration 300. For example, when the proximal assembly 314 and the coil proximal end 304 pass through the cover opening 310 (see... Figure 18BWhen entering the fillable cavity 400 of the device cover 124, the distal portion of the proximal assembly 314 may extend through the proximal ring 1804 and enter the cavity defined by the wound coil member 126.

[0211] The plunger 1800 can be pushed distally or otherwise translated through the delivery tube lumen 114 to push the proximal assembly 314 and the coil proximal end 304 distally, while the remainder of the coil member 126 is also pulled through the delivery tube lumen 114 by the tension line 1400. Furthermore, the plunger 1800 can be pushed distally or otherwise translated through the delivery tube lumen 114 to push the proximal assembly 314 and the coil proximal end 304 distally, while the device cover 124 and the distal bushing 320 are rotated by the rotation of the control tube 700.

[0212] Figure 18C This illustrates that once the coil member 126 is locked into a contracted-widening configuration 300 within the device cover 124, the delivery tube 104 separates from the deployed gastric obstruction device 102. (As shown) Figure 18C As shown, the control tube 700 can be disengaged from the distal bushing 320 and retracted proximally out of the delivery tube lumen 114. Furthermore, once the coil member 126 is locked into the contracted-widening configuration 300, the flange 116 can be retracted from the fillable cavity 400 of the device cover 124. The flange 116 can be retracted by pushing or otherwise (e.g., by applying force to the device cover 124) to remove the device cover 124 from the flange 116. At this point, the anchor line 1600 (see...) Figure 16 And any tension wire 1400 can be cut or severed so that only the locking wire 410 remains within the winding coil member 126.

[0213] Furthermore, once the flange 116 is removed from the fillable cavity 400, the inwardly curved portion 1200 of the device cover 124 surrounding the cover opening 310 can return to its inwardly curved shape. The proximal assembly 314 can act as a cap or plug to partially block the cover opening 310.

[0214] At this point, the gastric obstruction device 102 can move freely within the patient's stomach. Once the patient has ingested food or liquid, the stomach can begin to repeatedly contract and relax, causing the distal closure member 120 to be propelled by peristaltic waves or otherwise moved through the stomach toward the pylorus. When at least a portion of the distal closure member 120 is within the patient's duodenum, the conical pyloric contact area 200 of the gastric obstruction device 102 can intermittently cover or block the pylorus. This intermittent obstruction of the pylorus allows food and / or liquid to enter the duodenum at a slower rate from the stomach, thus allowing the patient to feel full more quickly and reducing the patient's craving for more food.

[0215] Figure 19A perspective view of another variation of the system 100 for deploying the gastric obstruction device 102 is shown. To more clearly show the control tube 700 within the lumen 114 of the delivery tube, Figure 19 The elongated and narrow configuration 128 within the lumen 114 of the delivery tube is not depicted (see [reference]). Figure 1 and Figure 7 ) coil component 126.

[0216] like Figure 19 As shown, the delivery tube 104 and control tube 700 can be bent or otherwise formed into a curved configuration 1900. When extended orally through the mouth and pharynx into the patient's esophagus or stomach, the delivery tube 104 and control tube 700 can be bent or otherwise formed into a curved configuration 1900. The delivery tube 104 and control tube 700 can extend into the patient's esophagus and stomach to advance the gastric obstruction device 102 into the patient's stomach. The delivery tube 104 and control tube 700 need to be bent or flexed to accommodate the natural curvature or curvature of the aforementioned organs that serve as delivery pathways within the patient's body.

[0217] like Figure 19 As shown, when the delivery tube 104 and control tube 700 are in the bent configuration 1900, the control member 108 can rotate in the first rotation direction 132. The control member 108 can rotate about the first rotation axis 134 in the first rotation direction 132. The control member 108 can be rotated when at least a portion of the gastric obstruction device 102 is in the patient's stomach. Rotation of the control member 108 can cause the control tube 700 within the lumen 114 of the delivery tube to pass through the gear mechanism 1000 within the housing 106 (see...). Figure 10 Rotation. When in the bent configuration 190°, the control tube 70° can be rotated.

[0218] Rotation of control tube 700 can make the control tube distal segment 900 (see...) Figure 9A The key portion 908 of the distal bushing 320 is mated, attached, or otherwise connected (see...) Figure 8A Rotation. The distal bushing 320 can be rotated via multiple internal struts 800 (see...). Figure 8A and Figure 8B The device cover 124 is connected to the gastric obstruction device 102. The device cover 124 of the gastric obstruction device 102 can rotate in response to the rotation of the distal bushing 320.

[0219] Therefore, in response to the rotation of the control unit 108 in the first rotation direction 132, the gastric obstruction device 102 connected to the distal end 112 of the delivery tube can rotate in the second rotation direction 136. The gastric obstruction device 102 can rotate about the second rotation axis 138 in the second rotation direction 136.

[0220] When the delivery tube 104 and control tube 700 are in the bent configuration 1900, the first axis of rotation 134 may not be parallel to the second axis of rotation 138. For example, when the delivery tube 104 and control tube 700 are in the bent configuration 1900, the first axis of rotation 134 may be inclined relative to the second axis of rotation 138 (e.g., at an obtuse or acute angle). More specifically, the first axis of rotation 134 may intersect the second axis of rotation 138 at an oblique angle (e.g., at an obtuse or acute angle).

[0221] A method of operating, preparing, and / or examining a gastric obstruction device 102 may include providing a distal segment of a delivery tube 104 connected to the gastric obstruction device 102. The proximal segment of the delivery tube 104 may be connected to a housing 106. The method may further include driving a control member 108 connected to the housing 106 in a first rotational direction about a first axis of rotation. In response to rotation of the control member 108, the gastric obstruction device 102 connected to the distal end 104 of the delivery tube may rotate in a second rotational direction about a second axis of rotation. The first axis of rotation may not be parallel to the second axis of rotation.

[0222] Another method of operating, preparing, and / or inspecting the gastric obstruction device 102 may include providing the gastric obstruction device 102. The gastric obstruction device 102 may be connected to the distal end of a control tube 700. The proximal end of the control tube 700 may be connected to a worm barrel of a worm gear. The method may further include a control member 108 driving a worm wheel connected to the worm gear. The worm wheel may rotate in response to rotation of the control member. The worm barrel may rotate in response to rotation of the worm wheel. The gastric obstruction device 102 may rotate in response to rotation of the worm wheel.

[0223] Numerous embodiments have been described. However, those skilled in the art will understand that various changes and modifications can be made to this disclosure without departing from the spirit and scope of the embodiments. Elements of the systems, apparatuses, devices, and methods shown with any embodiment are exemplary for particular embodiments and can be used in conjunction with or otherwise in accordance with other embodiments of this disclosure. For example, steps of any method depicted in the drawings or described in this disclosure need not be in a specific order or sequence shown or described to achieve the desired result. Furthermore, other steps may be provided, or steps or operations may be eliminated or omitted from the described method or process to achieve the desired result. Additionally, any component or portion of any device or system described in this disclosure or depicted in the drawings may be removed, eliminated, or omitted to achieve the desired result. Furthermore, for the sake of brevity and clarity, certain components or portions of the systems, apparatuses, or devices shown or described herein have been omitted.

[0224] Therefore, other embodiments are within the scope of the appended claims, and the description and / or drawings may be considered illustrative rather than restrictive.

[0225] Each individual variant or embodiment described and illustrated herein has separate components and features that can be readily separated from or combined with features of any other variant or embodiment. Modifications may be made to adapt particular circumstances, materials, composition, processes, process actions, or steps to the objectives, spirit, or scope of the invention.

[0226] The methods described herein can be performed in any logically possible order of the listed events, as well as in the listed order of events. Furthermore, additional steps or operations may be provided, or steps or operations may be eliminated to achieve the desired result.

[0227] Furthermore, where a numerical range is provided, every intermediate value between the upper and lower limits of that range, as well as any other specified or intermediate values ​​within that range, are included within the scope of this invention. Additionally, any optional features of the described variations of the invention may be set forth and claimed independently or in combination with any one or more features described herein. For example, a description of a range from 1 to 5 should be considered as having disclosed subranges (e.g., from 1 to 3, from 1 to 4, from 2 to 4, from 2 to 5, from 3 to 5, etc.) and individual digits within that range (e.g., 1.5, 2.5, etc.) and any overall or partial increments between them.

[0228] All existing subjects mentioned herein (e.g., publications, patents, patent applications) are incorporated herein in their entirety by reference, unless such subject matter may conflict with the subject matter of this invention (in which case the content herein shall prevail). References are provided solely for purposes prior to the filing date of this application. Nothing herein should be construed as an admission that this invention is not entitled to precedence over such material by virtue of prior invention.

[0229] References to singular items include the possibility that multiple identical items exist. More specifically, the singular forms “a,” “an,” “the,” and “the” as used herein and in the appended claims, unless the context clearly specifies otherwise, include plural references. It should also be noted that claims may be drafted to exclude any optional elements. Therefore, this statement is intended as a priori basis for the use of exclusive terms such as “unique,” ​​“only,” etc., when referencing claim elements or using the “negative” limitation. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0230] When referring to the phrase "at least one," when the phrase modifies multiple items or components (or an enumerated list of items or components), it means any combination of one or more of those items or components. For example, the phrase "at least one of A, B, and C" means: (i) A; (ii) B; (iii) C; (iv) A, B, and C; (v) A and B; (vi) B and C; (vii) A and C.

[0231] In understanding the scope of this disclosure, the term "comprising" and its derivatives as used herein are intended to be open-ended terms specifying the presence of the stated features, elements, components, groups, integers, and / or steps, but do not exclude the presence of other unstated features, elements, components, groups, integers, and / or steps. The foregoing also applies to words with similar meanings, such as the terms "comprising," "having," and their derivatives. Furthermore, when used in the singular, the terms "part," "section," "component," "element," or "part" may have a dual meaning of a single part or multiple parts. As used herein, the following directional terms "forward, backward, above, downward, vertical, horizontal, below, lateral, sideways, and perpendicular," and any other similar directional terms, refer to those positions of components of a device or equipment or those directions in which components of a device or equipment are being translated or moved.

[0232] Finally, as used herein, degree terms such as “basically,” “approximately,” and “roughly” refer to a specified or given value and a reasonable amount of deviation from that value (e.g., a deviation of up to ±0.1%, ±1%, ±5%, or ±10%, as such variation is appropriate) such that the final result will not be significantly or substantially changed. For example, “approximately / roughly 1.0m” can be interpreted as meaning “1.0m” or “between 0.9m and 1.1m.” When degree terms such as “approximately” or “roughly” are used to refer to numbers or values ​​that are part of a range, the term can be used to modify the minimum and maximum numbers or values.

[0233] This disclosure is not intended to limit the scope to the particular forms set forth herein, but rather to cover alternatives, modifications, and equivalents to the variations or embodiments described herein. Furthermore, the scope of this disclosure fully includes other variations or embodiments that may become apparent to those skilled in the art in light of this disclosure.

Claims

1. A system for deploying a gastric obstruction device, comprising: A housing, which includes a gear mechanism; A control component connected to the gear mechanism; A delivery tube connected to the housing, wherein the delivery tube has a distal end and a delivery lumen extending through the delivery tube, wherein the distal end of the delivery tube is configured to be positioned within the gastric obstruction device; and A control tube connected to the gear mechanism within the housing, wherein the control tube extends through the lumen of the delivery tube and is configured to engage with the gastric obstruction device, wherein the control tube is configured to rotate in response to rotation of the control member, and wherein rotation of the control tube is configured to rotate the gastric obstruction device. The control tube includes a proximal section and a distal section. The gastric obstruction device includes a coil member, a device cover, and a distal bushing. The device cover defines an infillable cavity, and the distal bushing is positioned within the cavity and connected to the device cover. Before the gastric obstruction device is deployed, the distal segment of the control tube is configured to engage with the distal bushing of the gastric obstruction device. The rotation of the control tube is configured to rotate the distal bushing, the rotation of the distal bushing is configured to rotate the device cover, and the rotation of the device cover is configured to cause the coil member to rotate to form a contraction-expansion configuration when the coil member enters the cavity of the device cover.

2. The system of claim 1, wherein the distal end of the delivery tube includes a flange, wherein the flange is configured to be positioned within a cavity defined by the device cover to connect the device cover to the delivery tube, wherein the flange is configured to seal a cover opening defined along the proximal end of the device cover.

3. The system according to claim 2, wherein, The outer surface of the flange, the inner surface of the device cover, or a combination thereof, are covered with a polymer coating to reduce friction between the outer surface of the flange and the inner surface of the device cover when the device cover rotates.

4. The system according to claim 1, wherein, The distal section of the control tube includes a key portion that mates with a locking member of the distal bushing located within the gastric obstruction device.

5. The system of claim 4, wherein the key portion of the control tube and the locking member of the distal bushing both have matching cross-sectional shapes.

6. The system according to claim 5, wherein the cross-sectional shape is rectangular.

7. The system according to claim 5, wherein the cross-sectional shape is elliptical.

8. The system of claim 1, wherein the gear mechanism includes a first gear component and a second gear component, wherein the control component is connected to the first gear component, the control tube is connected to the second gear component, wherein the first gear component is configured to rotate about a first gear rotation axis, and the second gear component is configured to rotate about a second gear rotation axis, wherein the first gear rotation axis is perpendicular to the second gear rotation axis.

9. The system of claim 1, wherein when a portion of the control tube and the delivery tube surrounding the portion of the control tube extend into the patient's body, the portion of the control tube is configured to bend into a curved configuration, and wherein the control tube is configured to rotate within the delivery tube when in the curved configuration.

10. The system of claim 1, wherein the housing further includes a spool, and the control member is connected to the spool, wherein the control tube further includes a control tube cavity, and a plurality of tension lines extend through the control tube cavity, and wherein rotation of the control member is configured to wind into the tension lines extending through the control tube cavity.

11. The system of claim 1, wherein the housing further includes a spool, and the control member is connected to the spool, wherein the control tube further includes a control tube cavity, and at least one anchor line extends through the control tube cavity, and wherein rotation of the control member is configured to wind up the anchor line extending through the control tube cavity.

12. A gastric obstruction component, comprising: A control tube, comprising a proximal section and a distal section, wherein the distal section includes a key portion; A delivery tube, the delivery tube including a delivery tube lumen, wherein a portion of a control tube is positioned within the delivery tube lumen and the control tube is rotatable within the delivery tube lumen; as well as A gastric obstruction device comprising: A device cover, comprising a cavity and a cover opening at a proximal end of the device cover; A distal closure member, which is connected to the device cover by a strap extending from the device cover; and A distal bushing, positioned within the cavity and connected to the device cover. The distal bushing includes a locking component. Prior to deploying the gastric obstruction device, the key portion of the distal segment of the control tube engages with the locking component of the distal bushing. The gastric obstruction device further includes a coil component comprising a proximal coil end and a distal coil end, wherein the distal coil end extends into the cavity and is connected to the distal bushing. The distal bushing is configured to rotate in response to the rotation of the control tube; The device cover is configured to rotate in response to rotation of the distal bushing; wherein the device cover is configured to rotate in response to rotation of the control tube when the key portion of the distal segment of the control tube engages with the locking member of the distal bushing; and The coil member is configured to rotate in response to the rotation of the device cover when the coil member enters the cavity of the device cover, forming a contraction-expansion configuration.

13. The gastric obstruction assembly according to claim 12, wherein, The gastric obstruction device also includes multiple internal struts arranged within the cavity.

14. The gastric obstruction assembly of claim 13, wherein one end of each of the internal struts is connected to the inner surface of the device cover, and the other end of the internal strut is connected to the distal bushing.

15. A system for deploying a gastric obstruction device, comprising: A housing comprising a worm gear, wherein the worm gear includes a worm wheel and a worm sleeve, the worm sleeve being configured to rotate in response to rotation of the worm wheel; A delivery tube, the delivery tube including a proximal delivery tube, a distal delivery tube, and a delivery tube lumen between the proximal delivery tube and the distal delivery tube, wherein the delivery tube is connected to a housing at the proximal delivery tube, and the distal delivery tube is configured to be connected to the gastric obstruction device; Control components, which are connected to the worm gear; and A control tube, comprising a proximal control tube segment and a distal control tube segment, the control tube being configured to extend through the lumen of the delivery tube; The proximal section of the control tube is connected to the worm gear cylinder. The gastric obstruction device is connected to the distal segment of the control tube, and The gastric obstruction device is configured to rotate in response to rotation of the control component; The gastric obstruction device includes a coil member, a device cover, and a distal bushing. The device cover defines an infillable cavity, and the distal bushing is positioned within the cavity and connected to the device cover. Before the gastric obstruction device is deployed, the distal segment of the control tube is configured to engage with the distal bushing of the gastric obstruction device. The gastric obstruction device is configured to rotate in response to the rotation of the control component, including: rotating the distal bushing in response to the rotation of the control component, rotating the device cover in response to the rotation of the distal bushing, and rotating the coil member in response to the rotation of the device cover to form a contraction-expansion configuration when the coil member enters the cavity of the device cover.

16. The system of claim 15, wherein each of the delivery tube and the control tube is bendable into a bent configuration, and wherein the control tube is configured to rotate when in the bent configuration within the delivery tube.

17. The system of claim 15, wherein the control tube is made of a biocompatible polymeric material.

18. The system of claim 15, wherein the worm gear includes a plurality of blades extending radially outward from the circumferential surface of the disc, wherein the worm barrel includes a plurality of grooves projecting radially inward from a transverse surface of the worm barrel to define a plurality of recessed surfaces, and wherein rotation of the worm gear causes at least one of the blades to apply a translational motion toward at least one of the recessed surfaces to rotate the worm barrel.

19. The system of claim 15, wherein the worm gear includes a plurality of blades projecting radially from the circumferential surface of the disk, wherein each of the blades has a blade ridge and the blade ridge is aligned at an angle with respect to a centerline that bisects the circumferential surface of the disk, and wherein the length dimension of each of the blades is smaller than the circumference of the disk.

20. The system of claim 15, wherein the worm barrel includes a proximal portion and a distal portion, wherein the worm barrel further includes a plurality of grooves that project radially inward from a transverse surface of the worm barrel, wherein each groove is oriented substantially longitudinally such that each groove extends from the proximal portion to the distal portion.

21. The system of claim 15, wherein the worm gear includes a radially converging middle section.

22. The system of claim 15, wherein the worm cylinder is configured to rotate 360 ​​degrees in response to the worm wheel rotating 1080 degrees.

23. The system of claim 15, wherein the worm gear cylinder includes an inner cavity, and a portion of the control tube extends into the worm gear cylinder.

24. The system of claim 15, wherein the housing further includes a spool, and the worm gear is connected to the spool, wherein the control tube further includes a control tube cavity, and a plurality of tension lines extend through the control tube cavity, and wherein rotation of the control member is configured to wind into the tension lines extending through the control tube cavity.

25. A method of operating a gastric obstruction device, comprising: A delivery tube is provided, the distal end of which is connected to the gastric obstruction device. A control tube is provided, extending through the lumen of the delivery tube and configured to engage with the gastric obstruction device. The proximal section of the delivery tube is connected to the housing; and A control component connected to the housing is driven about a first rotation axis in a first rotational direction, wherein the control tube is configured to rotate in response to the rotation of the control component; In response to the rotation of the control component, the gastric obstruction device connected to the delivery tube rotates about a second rotation axis in a second rotation direction, and Wherein the first axis of rotation is not parallel to the second axis of rotation; The gastric obstruction device includes a coil member, a device cover, and a distal bushing. The device cover defines an infillable cavity, and the distal bushing is positioned within the cavity and connected to the device cover. Before the gastric obstruction device is deployed, a distal segment of a control tube is configured to engage with the distal bushing of the gastric obstruction device. Rotation of the control tube is configured to rotate the distal bushing, and rotation of the distal bushing is configured to rotate the device cover. The rotation of the gastric obstruction device about the second rotation axis in the second rotation direction includes: rotating the device cover and the distal bushing about the second rotation axis in the second rotation direction, and rotating the coil member about the second rotation axis in the second rotation direction to form a contraction-widening configuration when the coil member enters the cavity of the device cover.

26. A method of operating a gastric obstruction device, comprising: Provide the gastric obstruction device, A delivery tube is provided, the distal end of which is connected to the gastric obstruction device. The gastric obstruction device is connected to the distal end of a control tube that extends through the lumen of the delivery tube. The proximal end of the control tube is connected to the worm barrel of the worm gear; and A control component that drives the worm gear connected to the worm. The worm gear rotates in response to the rotation of the control component. The worm cylinder rotates in response to the rotation of the worm wheel, and The gastric obstruction device rotates in response to the rotation of the worm gear; The gastric obstruction device includes a coil member, a device cover, and a distal bushing. The device cover defines an infillable cavity, and the distal bushing is positioned within the cavity and connected to the device cover. Before the gastric obstruction device is deployed, the distal end of the control tube is configured to engage with the distal bushing of the gastric obstruction device. The gastric obstruction device rotating in response to the rotation of the worm gear includes: rotating the distal bushing in response to the rotation of the worm gear, rotating the device cover in response to the rotation of the distal bushing, and rotating the coil member in response to the rotation of the device cover to form a contraction-expansion configuration when the coil member enters the cavity of the device cover.

Images