AU2016328478B2

AU2016328478B2 - Intragastric device for treating obesity

Info

Publication number: AU2016328478B2
Application number: AU2016328478A
Authority: AU
Inventors: Raghuveer Basude; Virender K. Sharma
Original assignee: SYNERZ MEDICAL Inc
Current assignee: SYNERZ MEDICAL Inc
Priority date: 2015-09-23
Filing date: 2016-04-20
Publication date: 2018-09-27
Anticipated expiration: 2036-04-20
Also published as: AU2018282461A1; JP6574313B2; HK1257683A1; AU2020207787A1; EP3352712A1; AU2020207787B2; CA2997727C; WO2017052694A1; CN108135719A; EP3352712A4; AU2016328478A1; CN108135719B; CA2997727A1; JP2018534093A

Abstract

An intragastric device configured for catheter deployment in a stomach comprises first and second wire mesh structures having a pre-deployment shape that is compressed within the lumen of the catheter, a post-deployment shape that is expanded within the stomach of the person, openings on an upper portion of the first mesh, and openings on a lower portion of the second mesh. The device also includes a connection to flexibly couple a lower portion of the first structure to an upper portion of the second structure such that the two structures are in fluid communication. Food enters the upper portion of the first wire mesh structure, passes through both wire mesh structures, and then exits the lower portion of the second wire mesh structure. Optionally, a sleeve is coupled to the lower portion of the second wire mesh structure and extends into a duodenum of a person.

Description

The present invention is directed towards multiple embodiments. The following disclosure is provided in order to enable a person having ordinary skill in the art to practice the invention. Language used in this specification should not be interpreted as a general disavowal of any one specific embodiment or used to limit the claims beyond the meaning of the terms used therein. The general principles defined herein may be applied to other embodiments and applications without departing from the spirit and scope of the invention. Also, the terminology and phraseology used is for the purpose of describing exemplary embodiments and should not be considered limiting. Thus, the present invention is to be accorded the widest scope encompassing numerous alternatives, modifications and equivalents consistent with the principles and features disclosed. For purpose of clarity, details relating to technical material

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2016328478 30 Aug 2018 that is known in the technical fields related to the invention have not been described in detail so as not to unnecessarily obscure the present invention.

Figure 1 is an illustration of an upper gastrointestinal system. After swallowing, food passes rapidly through the esophagus 111 into the stomach 112. There, it is digested for a period of time and undergoes the process of dilution to an iso-osmotic concentration by grinding and mixing with gastric juices. The stomach 112 relaxes to accommodate the volume of ingested food. As the stomach 112 gets filled with food the sensation of fullness or satiety is generated by stretch receptors in the gastric wall and the person stops eating. The iso-osmotic food, known as chyme, then passes through the pylorus 113 into the duodenum 114. Passage of chyme into the duodenum 114 results in the release of enzyme rich pancreatic secretions from the pancreas 115 and bile salt rich biliary secretions from the liver 116. The biliary secretions travel through the common bile duct 117 where they combine with the pancreatic secretions arriving through the pancreatic duct 118 and the two ducts combine to form the ampulla of vater 119. The ampulla of vater 119 serves as the entry point for the secretions to be deposited into the duodenum 114. In the jejunum 120, the mixing of pancreatic and biliary secretions with the chyme results in the digestion of proteins, fats, and carbohydrates, which are then absorbed into the blood stream.

Figure 2A is an illustration of a wire mesh structure 201 of an intragastric device in a post-deployment configuration with a proximally sloping anti-migration disc or collar 204 extending from or attached to its distal end, in accordance with one embodiment of the present specification. The wire mesh structure 201 comprises a three dimensional porous structure having an internal volume. The wire mesh structure 201 has an oval shape and includes a retrieval mechanism 203. In one embodiment, the retrieval mechanism is a silk suture loop. In one embodiment, the retrieval mechanism is an 80 lb. retrieval suture. The anti-migration collar

204 is proximally sloping in that it comprises a distal portion of the wire mesh structure 201 that is folded such that the distally directed end of the wire mesh structure 201 is made to point toward the proximal end of the wire mesh structure 201. In other embodiments, the collar 204 comprises any curved/atraumatic structure positioned circumferentially around the distal end of the wire mesh structure 201. The collar 204 helps prevent the wire mesh structure 201 from entering and passing through the pylorus. In one embodiment, the wire mesh structure 201 includes a bulbous, predominantly spherical or ovoid proximal end and an expanded distal end. In one embodiment, the distal half of the structure is covered with a membrane to impede the passage of food out of the structure 201, directing the food through a distal opening. In one embodiment, the structure 201 has an optional anti-reflux valve at the proximal end and another

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2016328478 30 Aug 2018 optional valve at the distal end. The valve at the distal end acts to control the flow of chyme or partially digested food from the inside of the structure 201 to the outside of the structure 201.

Figure 2B is an illustration of a wire mesh structure 210 in a post-deployment configuration with a proximally curving anti-migration collar 214 formed at its distal end, in accordance with one embodiment of the present specification. The wire mesh structure 210 has an oval shape with a proximal end and a distal end. The wire mesh structure 210 includes a first opening 211 at its proximal end and a second opening 219 at its distal end. The wire mesh structure 210 includes staggered nodes 216, 218 within its body to facilitate compression for delivery and removal. The wire mesh structure 210 also includes a set of staggered nodes 217 at its proximal end. The staggered nodes 217 at the proximal end provide a location for grasping, thereby enhancing ease of retrieval. The anti-migration collar 214 is formed from a continuation of the wire of the wire mesh structure 210 at its distal end. The anti-migration collar 214 bends proximally, toward the body of the wire mesh structure 210, and its ends 215 are formed in a rounded fashion to be atraumatic to body tissues. In various embodiments, the wire mesh structure 210 has no sharp edges, preventing the occurrence of abrasions, and a radial force high enough to prevent any significant or permanent deformation by gastric contractions and passage through the pylorus, but low enough such that the wire mesh structure 210 is not too rigid, allowing it to be affected by gastric contractions enough to facilitate movement of food through the wire mesh structure 210. In some embodiments, the wire mesh structure can withstand a contractile force up to 200 mm Hg without being completely compressed. The antimigration collar 214 is defined by a surface of revolution generated by revolving a semicircle in three-dimensional space about an axis extending through a center of the second opening 219 of the lower portion of the wire mesh device. The collar 214 is also defined by a diameter equal to or greater than 25 mm.

FIG. 2C is another illustration of a wire mesh structure, in accordance with one embodiment of the present specification. In various embodiments, the length of the wire mesh structure measured from a proximal end 222 to a distal end 224 of anti-migration collar 214 ranges from 169 mm to 180 mm. In some embodiments, the length measured from the proximal end 222 to a distal end 226 of the oval structure is approximately 141 mm and the length of the anti-migration collar 214 measured from a proximal end 228 to a distal end 224 of the antimigration collar 214 ranges from 31 mm to 36 mm. In an embodiment, a length of a middle portion 230 of the oval structure is approximately 109 mm measured from a distal end of a proximal set of nodes 233 to a proximal end of a distal set of nodes 239, while that of portion 232 is 117 mm measured from a proximal end of the proximal set of nodes 233 to a distal end of a distal set of nodes 239. Also, in an embodiment, lengths of a proximal portion 234

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2016328478 30 Aug 2018 extending from said proximal end 222 to said proximal end of said proximal set of nodes and a distal portion 236 extending from said distal end of said distal set of nodes 239 to said distal end 226 of the oval structure are 12 mm. In other embodiments, length of portion 232 ranges between 114 mm and 129 mm, while the lengths of proximal and distal portions 234, 236 of the oval structure ranges from 8 mm to 12 mm and 7 mm to 14 mm respectively. In embodiments, an inner diameter 238 of anti-migration collar 214, defining an opening at the distal end 224 of the device, ranges from 27 mm to 35 mm while an outer diameter 240, defining the outer limit of the anti-migration collar 214, ranges from 58 mm to 77 mm. Further, in some embodiments, the diameter of the wire mesh structure at a center widest part of the oval structure ranges from 116 mm to 123 mm. In embodiments, a diameter of a circular opening 250 at the proximal end 222 ranges from 17 mm to 20 mm.

As explained with reference to FIGS. 2A and 2B, the wire mesh structure comprises a plurality of openings or gaps 242 forming the mesh. In some embodiments, the gaps 242 are diamond shaped as a result of the criss-crossing pattern of the wire of the wire mesh structure.

In an embodiment, a width 244 of the gaps 242 in the middle portion 230 of the mesh ranges from 9.6 mm to 9.7 mm while a length 246 is 16 mm. In various embodiments, individual pieces of wire, such as wire piece 248, are joined together using processes such as riveting or crimping to form the wire mesh structure. In some embodiments, the length of wire piece 248 ranges from 5 mm to 5.5 mm and its diameter is approximately 1 mm.

In embodiments, as explained with reference to FIG. 3D and 3E, the wire mesh structure comprises a plurality of loops formed in the wires of the mesh proximal end 222, distal end 224 of anti-migration collar 214, and distal end 236 of the oval structure. In some embodiments, a thickness of the wire forming the loops, such as wire loop 252 shown in FIG. 2C, is approximately 0.4 mm, the diameter of the circular portion 254 of wire loop 252 is approximately 2 mm, and a thickness 256 of the loop 252 is approximately 1 mm. In an embodiment, the distal end 224 of anti-migration collar 214 comprises 9 loops such as the wire loop 252 shown in FIG. 2C.

Figure 3A is an illustration depicting a plurality of free ends or nodes 301, 302 positioned at a proximal end and a distal end of a wire mesh structure, in accordance with one embodiment of the present specification. Nodes 301 are positioned at the proximal end of a wire mesh structure and nodes 302 are positioned at a distal end of a wire mesh structure. The nodes comprise bends or curves in the wires of the wire mesh structure which are unsupported or not connected to other portions of the wire mesh. In other words, the nodes are the loops or bends comprising the free ends at each end of the wire mesh structure. Each wire mesh structure comprises at least two pluralities of nodes, one plurality of nodes 301 at its proximal end and

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2016328478 30 Aug 2018 at least one plurality of nodes 302 at its distal end. Other wire mesh structure embodiments, for example, those discussed with reference to Figures 3B and 3C below, comprise more than two pluralities of nodes which imparts greater compressibility to the wire mesh structures. Such wire mesh structures include free ends or nodes at each end of the structure plus free ends or nodes positioned at lateral locations along the body length of the structure.

Figure 3B is an illustration depicting a plurality of overlapping nodes 303 positioned at one end of a wire mesh structure, in accordance with one embodiment of the present specification. As depicted in Figure 3B, the nodes 303 are all positioned at the same lateral location. This creates a bulge in said lateral location when the wire mesh structure is compressed into its pre-deployment configuration. The bulge creates drag force on a delivery device or catheter during delivery of the wire mesh structure. Figure 3C is an illustration depicting a first plurality of nodes 304 positioned at one end of a wire mesh structure and a second plurality of nodes 305 positioned proximal to the first plurality of nodes 304, in accordance with one embodiment of the present specification. The two pluralities of nodes 304,

305 are staggered across two different lateral locations in Figure 3C. The staggering of nodes results in a smaller bulge when the wire mesh structure is compressed into its pre-deployment shape, resulting in less drag force applied to a delivery device or catheter and therefore easier delivery and retrieval of the wire mesh structure.

Figure 3D is an illustration of first and second pluralities of nodes 306, 307 at an end of a wire mesh structure, depicting loops 308 formed in the wires of the first plurality 306 in accordance with one embodiment of the present specification. Referring to Figure 3D, the loops 308 extend in a direction toward the center of the wire mesh structure. In other embodiments, the loops extend outward in a direction away from the center of the wire mesh structure. In some embodiments, the loops 308 serve as attachment points for other device components, for example, a sleeve component, as further discussed with reference to Figures 4B and 4C.

Figure 3E is an illustration of first and second pluralities of nodes 316, 317 at an end of a wire mesh structure, depicting loops 318 formed in the wires of the second plurality 317 in accordance with one embodiment of the present specification. Figure 3F is an illustration of first and second pluralities of nodes 310, 319 at an end of a wire mesh structure, depicting loops

313, 314 formed in alternating wires of both the first 310 and second 319 pluralities, in accordance with one embodiment of the present specification. The wire loop embodiments depicted in Figures 3D through 3F only disclose various options for node looping and are not intended to be limiting. In various embodiments, any number or percentage of the wires of a first plurality of nodes, a second plurality of nodes, or both a first and second plurality of nodes, may be looped. For example, in one embodiment, only the outermost nodes, with respect to a

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2016328478 30 Aug 2018 center of the wire mesh structure, are looped. In another embodiment, only the nodes just proximal to the outermost nodes are looped. In some embodiments, a percentage between 0 and 100% of the nodes are looped. In one embodiment, 50% of the nodes are looped. In another embodiment, 30% of the nodes are looped.

Figure 3G is an illustration depicting a wire mesh structure 315 having a first plurality of nodes 311 at its proximal end and a second plurality of nodes 312 at its distal end, in accordance with one embodiment of the present specification. The wire mesh structure 315 of Figure 3G includes the fewest plurality of nodes possible (two) and will have the largest bulges at its proximal and distal ends when compressed into its pre-deployment configuration. Figure

3H is an illustration depicting a wire mesh structure 320 having first and second pluralities of nodes 321, 322 at its proximal and distal ends respectively, and third 323 and fourth 324 pluralities of nodes distributed along its surface, in accordance with one embodiment of the present specification. The increased number of pluralities of nodes allows for fewer individual nodes to be positioned at the lateral location of each plurality. As such, when compressed, the wire mesh structure will comprise a bulge at each lateral location of each plurality of nodes but each bulge will be smaller in diameter than the bulges at the proximal and distal ends created when the wire mesh structure seen in Figure 3G is compressed. Therefore, the compressed predeployment configuration of the wire mesh structure of Figure 3H will create less drag force on a delivery device or catheter and will be easier to deploy. Although four pluralities of nodes

321, 322, 323, 324 are depicted in the wire mesh structure 320 of Figure 3H, a wire mesh structure can have three or more than four pluralities of nodes. In various embodiments, the wire mesh structure includes 2 to 60 pluralities of nodes positioned at different lateral locations.

Figure 31 is an illustration depicting various possible node shapes in accordance with multiple embodiments of the present specification. Possible node shapes include, but are not limited to, a sharp bend 331, a shallow bend 332, a pointed bend 333, a circular bend 334, and a shape similar to an end of a safety pin 335, including a wire loop 345 at the end of the node.

Figure 4A is a close-up illustration of an atraumatic anti-migration collar 414 of a wire mesh structure 410 of an intragastric device 400, in accordance with one embodiment of the present specification. The anti-migration collar 414 has a toroid bulb shape and comprises rounded ends 415 which extend proximally toward the wire mesh structure 410. The rounded ends 415 are designed to be atraumatic to body tissues. As discussed above, in some embodiments, the ends 415 are separated into various nodes to prevent bunching of the wires when compressed, which could lead to erosions. The long axis of the collar 412 is curved at an angle 413 greater than 90° compared to the long axis of the mesh 411 such that the rounded ends 415 are pointing in the direction toward the wire mesh structure 410.

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Figure 4B is a close-up illustration of an atraumatic anti-migration collar 424 of a wire mesh structure 421 of an intragastric device 420, in accordance with another embodiment of the present specification. The anti-migration collar 424 has a toroid bulb shape and comprises rounded ends 425 which extend proximally toward the wire mesh structure 421. The rounded ends 425 are designed to be atraumatic to body tissues. In some embodiments, the ends 425 are separated into various nodes 4271, 427s to prevent bunching of the wires when compressed, which could lead to erosions. The nodes include long nodes 4271 and short nodes 427s, wherein the long nodes 4271 extend further in a proximal direction back toward the top of the wire mesh structure 421 than the short nodes 427s. In some embodiments, the collar 424 includes 9 long nodes 4271 and 9 short nodes 427s. The free ends of the long nodes 4271 include hoops 428 for suturing a proximal end of a sleeve component. The hoops 428 extend outward away from the free ends of the long nodes 4271. In one embodiment, hoops 428a are formed from twisting the free ends of the long nodes 4271 into a hoop shape. In another embodiment, hoops 428b comprise separate wire hoops that are sutured to the free ends of the long nodes 4271. In some embodiments, once the sleeve is attached, additional suture knots are placed at the junction of the twist or separate wire hoop to prevent sliding of the sleeve attachment.

Figure 4C is a close-up illustration of an atraumatic anti-migration collar 434 of a wire mesh structure 431 of an intragastric device 430, in accordance with yet another embodiment of the present specification. The anti-migration collar 434 has a toroid bulb shape and comprises rounded ends 435 which extend proximally toward the wire mesh structure 431. The rounded ends 435 are designed to be atraumatic to body tissues. In some embodiments, the ends 435 are separated into various nodes 4371, 437s to prevent bunching of the wires when compressed, which could lead to erosions. The nodes include long nodes 4371 and short nodes 437s, wherein the long nodes 4371 extend further in a proximal direction back toward the top of the wire mesh structure 431 than the short nodes 717s. In some embodiments, the collar 434 includes 9 long nodes 4371 and 9 short nodes 437s. The free ends of the long nodes 4371 include hoops 439 for suturing a proximal end of a sleeve component. The hoops 439 extend inward toward the curve at the distal end of the wire mesh structure 431. In one embodiment, hoops 439a are formed from looping the free ends of the long nodes 4371 into a hoop shape. In another embodiment, hoops 439b comprise separate wire hoops that are sutured to the free ends of the long nodes 4371. In some embodiments, once the sleeve is attached, additional suture knots are placed at the junction of the loop or separate wire hoop to prevent sliding of the sleeve attachment.

In some embodiments, a sleeve component is attached to the distal end of the wire mesh structure or the collar of the intragastric device. In various embodiments, the sleeve component

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2016328478 30 Aug 2018 of the present specification is made of polytetrafluoroethylene (PTFE) or polyethylene or cast

PTFE (e.g., Teflon), PTFE with fluorinated ethylene propylene (FEP) or perfluoroalkoxy (PFA) coating, PFA, extruded FEP and extruded PFA or extruded PTFE or a fluoropolymer or silicone. In one embodiment, a silicone sleeve is manufactured by hand pouring and braiding.

In another embodiment, a silicone sleeve is manufactured by machine braiding. In various embodiments, the sleeve component has a length in a range of 6 inches to 6 feet or longer. In one embodiment, the sleeve component has a length of 24 inches. In another embodiment, the sleeve component has a length of 30 inches. In various embodiments, the sleeve component has a diameter in a range of 1 cm to 10 cm. In one embodiment, the sleeve component has a diameter of 3 cm.

Figure 5A is an illustration of a portion of a sleeve component 500 of an intragastric device in a post-deployment configuration in accordance with one embodiment of the present specification, depicting a single wire support 501 spiraling along the body of the sleeve 500. The metal wire needs to have a tight enough spiral to provide support but must not be too tight such that, once the sleeve in compressed for delivery, it becomes kinked and cannot regain its full shape. Referring to Figure 5A, the spiral metal wire 501 has a pitch depicted by length I which is equal to 60 mm. With a wire thickness of 0.1 to 1 mm, this pitch gives the spiral metal wire a strain percentage that will be no more than 20 %, and preferably less than 8 %.

Figure 5B is an illustration of a portion of a sleeve component 505 of an intragastric device in a post-deployment configuration in accordance with one embodiment of the present specification, depicting multiple wire supports 506, 507, 508 spiraling along the body of the sleeve 505. The sleeve includes more than one spiral metal wire to provide greater support while still preventing permanent kinking. Referring to Figure 5B, each individual wire 506, 507, 508 has a pitch depicted by length li which is equal to 60 mm. The wires 506, 507, 508 are spaced such that the pitch between two separate wires, depicted by length h, is equal to 20 mm.

Figure 5C is an illustration of a funnel shaped sleeve component 510 of an intragastric device in a post-deployment configuration in accordance with one embodiment of the present specification, depicting spiral wire loop supports 511, 513 on the sleeve 510. In the embodiment depicted in Figure 5C, the sleeve 510 includes two sets of wire loop supports 511, 513. Each set of wire loop supports 511,513 includes a loop comprising two individual wires, for a total of four wires on the sleeve 510. Each wire loop support 511, 513 is finished with blunted ends 515 to be atraumatic to body tissues. The wire loop supports 511, 513 are twisted into a spiral configuration and looped along the length of the sleeve 510. In one embodiment,

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2016328478 30 Aug 2018 the pitch, or distance between each loop 511, 513 (and between each wire of each loop 511,

513) is defined by length I and is approximately 15 mm.

Figure 5D is an illustration of a sleeve component 520 of an intragastric device in a post-deployment configuration in accordance with one embodiment of the present specification, depicting a funnel shaped opening 521 at the proximal end of the sleeve. The funnel shaped opening 521 is well suited for attachment to the nodes of the collar positioned at the distal end of the wire mesh structure of some embodiments of the intragastric device of the present specification, as discussed in detail with references to Figures 11C and 1 ID below.

Figure 5E is an illustration of a funnel shaped sleeve component 525 of an intragastric 10 device in a post-deployment configuration in accordance with one embodiment of the present specification, depicting a plurality of markings 527 on an outer surface of the sleeve body. The markings 527 are radiopaque and their radiographic visualization assists proper placement of the sleeve during device delivery.

Figure 5F is an illustration of a funnel shaped sleeve component 530 of an intragastric 15 device in a post-deployment configuration in accordance with one embodiment of the present specification, depicting a marking line 533 extending along the length of the sleeve 530 on an outer surface of the sleeve body. The line 533 is radiopaque and its radiographic visualization assists proper placement of the sleeve during device delivery. In addition, spiraling or rotation of the line about a center axis of the sleeve can indicate twisting of the sleeve.

Figure 5G is an illustration of a funnel shaped sleeve component 535 of an intragastric device in a post-deployment configuration in accordance with one embodiment of the present specification, depicting a plurality of markings 537 and a marking line 538 extending along the length of the sleeve 535 on an outer surface of the sleeve body. The markings 537 and the line 538 are radiopaque and their radiographic visualization assists proper placement of the sleeve during device delivery and help to detect twisting of the sleeve 535.

Figure 6A is a cross-sectional illustration of a funnel shaped sleeve component 600 of an intragastric device in a post-deployment configuration in accordance with one embodiment of the present specification, depicting a plurality of sleeve layers 606, 607, 608, 609. In one embodiment, the sleeve layers 606, 607, 608, 609 are comprised of PTFE. The sleeve 600 includes an innermost first layer 606 which is approximately 0.06 mm thick and extends in a configuration along the length of the sleeve. The first layer 606 extends along the entire length of the sleeve 600. The sleeve 600 includes a second layer 607, overlaying said first layer 606, which is approximately 0.06 mm thick and extends only along a proximal portion 616 of the sleeve 600 and a distal portion 618 of the sleeve 600. In one embodiment, the proximal portion

616 includes a funnel portion 601 and an additional portion having a length h which extends

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2016328478 30 Aug 2018 approximately 30-40 mm distally beyond said funnel portion 601. In one embodiment, the sleeve 600 includes a distal end having a length h of approximately 20 - 30 mm. The distal portion 618 comprises approximately only the most proximal 10 mm of length I2. In one embodiment, the second layer 607 extends in a configuration along the width of the sleeve 600.

The sleeve 600 includes a third layer 608, overlaying said second layer 607 and a center portion 617 of said first layer 606. The third layer 608 is approximately 0.06 mm thick and extends in a configuration along the width of the sleeve 600. The sleeve 600 includes a fourth layer 609, overlaying said third layer 608, which is approximately 0.06 mm thick and extends in a configuration along the length of the sleeve 600. Therefore, in the embodiment depicted in

Figure 6A, the sleeve 600 comprises four layers at its proximal section 616, three layers at its center section 617, and four layers at its distal section 618. The layers 606, 607, 608, 609 are cross-layered bonded, or applied in different configurations (along the length versus along the width of the sleeve 600), to give the sleeve added durability. In one embodiment, the sleeve 600 further includes metal wire supports 605 between the second layer 607 and the third layer

608 (or between the first layer 606 and the third layer 608 in the center portion 617 of the sleeve

600) to provide structural support. In one embodiment, the sleeve includes suture points 619 for connection to a wire mesh structure.

Figure 6B is a cross-sectional illustration of a funnel shaped sleeve component 620 of an intragastric device in a post-deployment configuration in accordance with another embodiment of the present specification, depicting a plurality of sleeve layers 626, 627, 628, 629, 630. In various embodiments, the sleeve layers 626, 627, 628, 629, 630 are comprised of any one or combination of polytetrafluoroethylene (PTFE), low-density polyethylene (LDPE), high-density polyethylene (HDPE), and ultra-high-molecular-weight polyethylene (UHMWPE). In one embodiment, the sleeve 620 includes an innermost first PTFE layer 626 which is approximately 0.06 mm thick and extends in a configuration along the length of the sleeve. The first PTFE layer 626 extends along the entire length of the sleeve 620. The sleeve 620 includes a second PTFE layer 627, overlaying said first PTFE layer 626, which is approximately 0.06 mm thick and extends only along a proximal portion 636 of the sleeve 620 and a distal portion 638 of the sleeve 620. In one embodiment, the proximal portion 636 includes a funnel portion 621 and an additional portion having a length h which extends approximately 30-40 mm distally beyond said funnel portion 621. In one embodiment, the sleeve 620 includes a distal end having a length I2 of approximately 20 - 30 mm. The distal portion 638 comprises approximately only the most proximal 10 mm of length I2. In one embodiment, the second PTFE layer 627 extends in a configuration along the width of the sleeve 620. The sleeve 620 includes a PTFE third layer 628, overlaying said second PTFE layer

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627 and a center portion 637 of said first PTFE layer 626. The third PTFE layer 628 is approximately 0.06 mm thick and extends in a configuration along the width of the sleeve 620.

The sleeve 620 includes a fourth PTFE layer 629, overlaying said third PTFE layer 628, which is approximately 0.06 mm thick and extends in a configuration along the length of the sleeve

620. In one embodiment, the sleeve further includes a fifth PFTE layer 630 sandwiched between the third PTFE layer 628 and the fourth PTFE layer 629. In one embodiment, the fifth PTFE layer 630 is approximately 0.06 mm thick and extends in a configuration along the length of the sleeve 620. Therefore, in the embodiment depicted in Figure 6B, the sleeve 620 comprises five total layers at its proximal section 636, four total layers at its center section 637, and five total layers at its distal section 638. In various embodiments, the layers 626, 627, 628, 629, 630 are cross-layered bonded, or applied in different configurations (along the length versus along the width of the sleeve 620), to give the sleeve added durability. In one embodiment, the sleeve 620 further includes metal wire supports 625 between the second PTFE layer 627 and the third PTFE layer 628 (or between the first PTFE layer 626 and the third PTFE layer 628 in the center portion 637 of the sleeve 620) to provide structural support. In one embodiment, the sleeve includes suture points 639 for connection to a wire mesh structure.

Figure 6C is a cross-sectional illustration of a funnel shaped sleeve component 640 of an intragastric device in a post-deployment configuration in accordance with one embodiment of the present specification, depicting a plurality of sleeve layers 643, 644, 646, 647, 648, 649,

650. In various embodiments, the sleeve layers 643, 644, 646, 647, 648, 649, 650 are comprised of any one or combination of polytetrafluoroethylene (PTFE), low-density polyethylene (LDPE), high-density polyethylene (HDPE), and ultra-high-molecular-weight polyethylene (UHMWPE). In one embodiment, the sleeve 640 includes an innermost first PTFE layer 643 which is approximately 0.06 mm thick and extends in a configuration along the length of the sleeve. The first PTFE layer 643 extends along the entire length of the sleeve 640. The sleeve 640 includes a second PTFE layer 644, overlaying said first PTFE layer 643, which is approximately 0.06 mm thick and extends only along a proximal portion 656 of the sleeve 640 and a distal portion 658 of the sleeve 640. In one embodiment, the proximal portion 656 includes a funnel portion 641 and an additional portion having a length h which extends approximately 30 - 40 mm distally beyond said funnel portion 641. In one embodiment, the sleeve 640 includes a distal end having a length h of approximately 20 - 30 mm. The distal portion 658 comprises approximately only the most proximal 10 mm of length I2. In one embodiment, the second PTFE layer 644 extends in a configuration along the width of the sleeve 640. The sleeve 640 includes a third PTFE layer 646, overlaying said second PTFE layer

644 and a center portion 657 of said first PTFE layer 643. The third PTFE layer 646 is

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2016328478 30 Aug 2018 approximately 0.06 mm thick and extends in a configuration along the width of the sleeve 640.

The sleeve further includes a first intermediate PFTE layer 648 and a second intermediate PFTE layer 649 sandwiched between the second PTFE layer 644 and the third PTFE layer 646. In one embodiment, the first intermediate PFTE layer 648 and second intermediate PFTE layer

649 are both approximately 0.06 mm thick. In one embodiment, the first intermediate PFTE layer 648 and second intermediate PFTE layer 649 both extend in a configuration along the length of the sleeve 640. In another embodiment, the first intermediate PFTE layer 648 and second intermediate PFTE layer 649 both extend in a configuration along the width of the sleeve 640. In another embodiment, the first intermediate PFTE layer 648 extends in a configuration along the length of the sleeve 640 and the second intermediate PFTE layer 649 extends in a configuration along the width of the sleeve 640. In yet another embodiment, the first intermediate PFTE layer 648 extends in a configuration along the width of the sleeve 640 and the second intermediate PFTE layer 649 extends in a configuration along the length of the sleeve 640. The sleeve 640 includes a fourth PTFE layer 647, overlaying said third PTFE layer

646, which is approximately 0.06 mm thick and extends in a configuration along the length of the sleeve 640. The sleeve further includes a third intermediate PFTE layer 650 sandwiched between the third PTFE layer 646 and the fourth PTFE layer 647. In one embodiment, the third intermediate PFTE layer 650 is approximately 0.06 mm thick and extends in a configuration along the length of the sleeve 640. Therefore, in the embodiment depicted in Figure 6C, the sleeve 640 comprises seven total layers at its proximal section 656, six total layers at its center section 657, and seven total layers at its distal section 658. In various embodiments, the layers 643, 644, 646, 647, 648, 649, 650 are cross-layered bonded, or applied in different configurations (along the length versus along the width of the sleeve 640), to give the sleeve added durability. In one embodiment, the sleeve 640 further includes metal wire supports 645 between the first intermediate PFTE layer 648 and the second intermediate PFTE layer 649 to provide structural support. In one embodiment, the sleeve includes suture points 659 for connection to a wire mesh structure.

While Figures 6A through 6C depict sleeves having multiple PTFE layers, these configurations are not intended to be limiting and other sleeve embodiments are envisioned having more or fewer PTFE layers or layers comprising other materials with varied stacking of the individual layers.

Figure 6D is a cross-sectional illustration of a funnel shaped sleeve component 660 of an intragastric device in a post-deployment configuration in accordance with yet another embodiment of the present specification, depicting a plurality of sleeve layers. The sleeve includes a cylindrical portion 660c and a funnel shaped portion 660f. In some embodiments,

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2016328478 30 Aug 2018 the cylindrical portion 660c has a length l_c of approximately 500 mm and the funnel portion has a length If of approximately 100 mm. The sleeve component 660 of Figure 6D is comprised of a single machine braided wire 661 sandwiched between multiple sleeve layers. In one embodiment, the single machine braided wire 661 is in an axially stretched configuration. The single machine braided wire 661 extends along only a proximal portion of the cylindrical portion 660c of the sleeve 660. In one embodiment, approximately 450 mm of the proximal portion of the cylindrical portion 660c of the sleeve 660 includes the single machine braided wire 661 while at least 50 mm at the distal end of the sleeve 660 contains no wire. In one embodiment, the distal end of the sleeve 660 includes a distal opening 682 having a diameter of approximately 24.5 mm. The funnel portion 660f includes a wire support 671 ending proximally in a plurality of nodes 672. In one embodiment, the sleeve 660 includes a total of 18 nodes equidistant from one another and comprising alternating long and short nodes as described above. In some embodiments, the sleeve layers extend proximally beyond the long nodes a distance of at least 5 mm. In one embodiment, the proximal end of the sleeve 660 includes a proximal opening 681 having a diameter of approximately 63 mm. In various embodiments, the single machine braided wire 661 and wire support 671 each comprise a wire having a diameter in a range of 0.100 to 0.150 mm. In one embodiment, the single machine braided wire 661 and wire support 671 each comprise a wire having a diameter of 0.127 mm. In another embodiment, the single machine braided wire 661 and wire support 671 each comprise a wire having a diameter of 0.140 mm.

The sleeve 660 includes an innermost first PTFE layer 662 which extends in a configuration along the width of the sleeve 660. The first PTFE layer 662 extends along the entire length of the sleeve 660. In one embodiment, the first PTFE layer 662 has a thickness of approximately 0.06 mm. The single machine braided wire 661 overlays said first PTFE layer

662 along the proximal portion of said cylindrical portion 660c and the wire support 671 overlays the first PTFE layer 662 along the funnel portion 660f of the sleeve 660. A proximal intermediate PFTE layer 663p overlays the wire support 671 along the funnel portion 660f and extends distally approximately 5 to 7 mm over the single machine braided wire 661 of the cylindrical portion 660c of the sleeve 660. A distal intermediate PFTE layer 663 d overlays the first PFTE layer 662 at the distal end of the sleeve and extends proximally approximately 5 to 7 mm over the single machine braided wire 1601 of the cylindrical portion 660c of the sleeve 660. A plurality of cylindrical intermediate PFTE layers 663c overlay the single machine braided wire 661 along sections of the cylindrical portion of the sleeve 660. In some embodiments, the sleeve 660 includes three cylindrical intermediate PFTE layers 663c, each having a length of approximately 3 to 5 mm and spaced 70 to 80 mm from one another and

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2016328478 30 Aug 2018 from the proximal intermediate PFTE layer 663p and distal intermediate PFTE layer 663d at the proximal and distal ends of the sleeve respectively. The sleeve 660 includes an outermost second PTFE layer 664 which is approximately 0.06 mm thick and extends in a configuration along the length of the sleeve 660.

In some embodiments, the sleeve 660 further includes at least one marker for visualization upon radiographic inspection to determine proper placement after delivery. Referring to Figure 6D, the sleeve includes three markers 665 positioned proximate a proximal end of the single machine braided wire 661, proximate a center of the single machine braided wire 661, and proximate a distal end of the single machine braided wire. In one embodiment, each marker 665 is covered and held in place by a patch of PTFE 666 having a length of approximately 5 mm, a width of approximately 5 mm, and a thickness of approximately 0.06 mm. In one embodiment, the markers 665 are separated from one another by a distance of approximately 145 mm to 155 mm. In one embodiment, the markers 665 are positioned at every alternate cylindrical intermediate PFTE layer 663 c. In one embodiment, the markers 665 are positioned on one side of the sleeve 660. In one embodiment, the markers 665 are tantalum markers.

Referring to Figures 6A through 6D, in various embodiments, the sleeve layers comprised of PTFE can also be comprised of polyethylene (PE), low-density polyethylene (LDPE), high-density polyethylene (HDPE), and ultra-high-molecular-weight polyethylene (UHMWPE). As an alternate to being bonded, the sleeve layers may be sutured.

Figure 6E is a cross-sectional illustration of a funnel shaped sleeve component 690 of an intragastric device in a post-deployment configuration in accordance with yet another embodiment of the present specification. Referring to Figure 6E, the sleeve 690 includes a proximal funnel shaped portion 690p and a distal cylindrically shaped portion 690d. The proximal portion 690p comprises a hand-braided Nitinol wire mesh 691 covered with PTFE. The distal portion 690d comprises a machine-braided Nitinol wire mesh 692 covered with PTFE. The distal portion 690d also includes at least one fluoropolymer band 695 overlaid for improved bonding of the Nitinol wire mesh with the PTFE. At least one radiopaque marker band 693 is also included in the distal portion 690d.

Figure 6F is an illustration of a stent support 680 for a sleeve component of an intragastric device, in accordance with one embodiment of the present specification. In the pictured embodiment, the stent support 680 includes a plurality of rings 683 formed from ‘Z’ shape segments of wire. In another embodiment, the stent support comprises a continuous spiral wire support wherein wires of the spiral are configured into ‘Z’ shapes. In one embodiment, the stent support 680 has a shape similar to the pattern 2033 depicted in Figure 20F. Referring

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2016328478 30 Aug 2018 again to Figure 6F, in one embodiment, each ring 683 is connected by a straight wire 684, such that a space 685 exists between each ring 683 which will comprise only the remaining layers of the sleeve component. In some embodiments, each ring 683 has length in a range of 1-2 cm.

In some embodiments, each connecting straight wire 684 has a length in a range of 1 -2 inches and each space 685 also has a length in a range of 1-2 inches. In one embodiment, the proximal end of the stent support 680 includes a funnel shaped ring segment 686. In one embodiment, the funnel shaped ring segment 686 includes a sutured connection 687 to the first distal ring 683a. In various embodiments, the funnel shaped ring segment 686 has a diameter sized to match the diameter of an anti-migration component at the distal end of a wire mesh structure to which it will be attached.

Figure 6G is an illustration of a sleeve component 688 of an intragastric device having the stent support 680 of Figure 6F. The stent support 680 includes rings 683 connected by straight wires 684. The other layers 689, such as PTFE, of the sleeve component 688 are depicted between each set of rings 683. The ‘Z’ shaped stent support 680 provides the sleeve component 688 with structural integrity such that it will not collapse as a result of intestinal contractions while still allowing the sleeve component 688 to be flexible enough to conform to the curves of the gastrointestinal tract.

In an embodiment, the sleeve and wire mesh of the present gastric wire mesh device may be covered with a web in order to make the sleeve portion flexible and kink resistant, while at the same time controlling the porosity of the device. In an embodiment, the web is produced through electrospinning PTFE into polymeric fibers with extremely small thickness ranging from 0.10 nanometers to 100 microns. Electrospinning allows materials to possess high surfaceto-weight and volume ratios while still maintaining excellent mechanical properties. It is similar in nature to expanded PTFE, but with a lower basis weight and has comparable chemical and temperature resistance. If a strand of the web breaks, it can be easily repaired. In an embodiment, a first web layer is webbed over a sleeve of an intragastric device. Then, a scaffolding followed by a second web layer is placed over the first web layer to form an outer layer, thus encapsulating the nitinol or polymer scaffold.

In an embodiment, the mesh device of the present specification may comprise a braided sleeve or over-braid that is both expandable and flexible for aerospace, automotive and medical markets created by using drawn fibers. The woven braiding guards against chaffing and provides additional chemical wear resistance and flexibility to a sleeve of the present wire mesh device. In embodiments, the drawn fiber may be a perfluoroalkoxy (PFA) drawn fiber, fluorinated ethylene propylene (FEP) drawn fiber, Ethylenetetrafluoroethylene (ETFE) drawn fiber, polyetheretherketone (PEEK) drawn fiber, polyvinylidene fluoride (PVDF) drawn fiber

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2016328478 30 Aug 2018 or Ethylene Chlorotrifluoroethylene (ECTFE) drawn fiber. In an embodiment, a high temperature resistant nano-fiber membrane, which has the ability to capture greater than 0.1 micron-sized particles, may be used to cover the wire mesh device of the present specification.

FIG. 6H illustrates a portion 603 of a sleeve of a wire mesh device covered with a nano-fiber membrane 605, in accordance with an embodiment of the present specification.

Figure 7 is an illustration of a funnel shape sleeve 700 for an intragastric device, in accordance with one embodiment of the present specification. The sleeve 700 has a funnel shape with a diameter that decreases as the sleeve extends from a first opening 713 at its proximal end to a second opening 719 at its distal end. The sleeve 700 comprises at least one wire 702 folded about itself to create the funnel shape with a crisscross weave pattern. As the sleeve 700 extends distally, its diameter decreases and the intersections of the wire of the crisscross weave become positioned closer together. The sleeve 700 includes curves, or free ends, at its proximal end and distal end. The free ends are designed to be atraumatic to body tissues. In some embodiments, the first opening 713 has a diameter that is substantially equal to or slightly greater than a diameter of an anti-migration collar of a wire mesh structure. The sleeve 700 is slid over an anti-migration collar and then secured in place by suturing free ends 714 at the proximal end of the sleeve to nodes comprising the anti-migration collar. The free ends 718 at the distal end of the sleeve 700 circumscribe the second opening 719. In various embodiments, the sleeve 700 is a short sleeve having a total length in a range of 1 cm - 120 cm.

In one embodiment, the sleeve 700 is a short sleeve having a total length of 10 cm. In the pictured embodiment, the conical funnel section comprises 100% of the sleeve length.

Figure 8 is an illustration of a funnel shape sleeve 800 for an intragastric device, in accordance with another embodiment of the present specification. The sleeve includes a proximal end with a first opening 813 and a distal end with a second opening 819. The sleeve

800 further includes a proximal portion 811 and a distal portion 816. Both the proximal portion

811 and the distal portion 816 of the sleeve 800 are funnel shaped, each having a diameter that decreases as the portions 811,816 extend distally. The diameter of the proximal portion 811 is greatest at the proximal end of the sleeve 800, at the position of the first opening 813, and decreases as the proximal portion 811 extends distally until the sleeve 800 transitions into its distal portion 816 at a transition point 803. At the transition point 803, the diameters of the proximal portion 811 and the distal portion 816 are equal. The diameter of the distal portion 816 then decreases as said distal portion 816 extends distally. In another embodiment, the diameter of the distal portion remains the same along its length. In yet another embodiment, the diameter of the distal portion increases as it extends distally. The distal portion 816 of the sleeve 800 ends in a second opening 819 at a distal end of the intragastric device 800. The

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2016328478 30 Aug 2018 proximal portion comprises a first wire 802 folded upon itself to create a funnel shape with a first crisscross weave pattern. The distal portion comprises a second wire 812 folded upon itself to create a funnel shape with a second crisscross weave pattern. In some embodiments, the second wire 812 is an extension of the first wire 802. In other embodiments, the first wire 802 and second wire 812 are separate wires which are joined together at the transition point 803. In one embodiment, the separate wires are spot welded together. In both the proximal 811 and distal portions 816, the intersecting sections of the wires come closer to one another as the portions 811, 816 extend distally and the funnel shape narrows, such that the weave pattern becomes tighter at the distal ends of each portion 811,816. In one embodiment, the proximal portion 811 has the same weave pattern as the distal portion 816. In another embodiment, the weave pattern of the proximal portion 811 is tighter than the weave pattern of the distal portion 816. In another embodiment, the weave pattern of the distal portion 816 is tighter than the weave pattern of the proximal portion 811.

In one embodiment, the proximal portion 811 has a length equal to a length of the distal portion 816. In another embodiment, the proximal portion 811 has a length that is less than a length of the distal portion 816. In another embodiment, the proximal portion 811 has a length that is greater than the length of the distal portion 816. The sleeve 800 includes curves, or free ends, at its proximal end and distal end. The free ends are designed to be atraumatic to body tissues. In some embodiments, the first opening 813 has a diameter that is substantially equal to or slightly less than a diameter of a neck of an anti-migration collar of a wire mesh structure. The sleeve 800 is slid into the neck an anti-migration collar and then secured in place by suturing free ends 814 at the proximal end of the sleeve to wire intersections in the neck of the anti-migration collar. The free ends 818 at the distal end of the sleeve 800 circumscribe the second opening 819. In various embodiments, the sleeve 800 is a short sleeve having a total length in a range of 1 cm - 120 cm. In one embodiment, the sleeve 800 is a short sleeve having a total length of 10 cm. In the pictured embodiment, the conical funnel section comprises 100% of the sleeve length.

Figure 9A is an illustration of a wire mesh structure 930 with attached sleeve component 944 in a post-deployment configuration in accordance with one embodiment of the present specification, depicting a blunt end 952 of a wire mesh support toward the proximal end of the sleeve 944. The sleeve 944 is connected to a proximally curving, atraumatic anti-migration collar 942 at the distal end of the wire mesh structure 930 and includes a proximal section 945 having four layers and a center section 955 having three layers.

Figure 9B is an illustration of a wire mesh structure 957 with a proximal portion of an attached sleeve component 959 in a post deployment configuration in accordance with one

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2016328478 30 Aug 2018 embodiment of the present specification, depicting a delivery catheter 969 positioned within the wire mesh structure 957. The sleeve 959 is attached to a proximally curving anti-migration component 958.

Figure 10A is an illustration of a funnel shaped braided short sleeve component 1000 in 5 a post-deployment configuration, in accordance with one embodiment of the present specification. The sleeve 1000 comprises a wire shape braided structure having a plurality of nodes 1001 at the proximal and distal ends of the sleeve 1000. The nodes 1001 are similar in structure to those described with reference to Figure 3A above and comprise unsupported free bends in the wire of the braided structure. In one embodiment, the number of nodes is uniform such that the number of nodes at the proximal end of the sleeve 1000 equals the number of nodes at the distal end of the sleeve 1000. In one embodiment, the number of uniform nodes is 24 at both ends. In other embodiments, the number of nodes is variable such that the number of nodes at the proximal end of the sleeve 1000 is different than the number of nodes at the distal end of the sleeve 1000. Any nodes not present at the distal end of the sleeve are staggered within the body of the sleeve. For example, in one embodiment, the sleeve includes 24 nodes at its proximal end and 18 nodes at its distal end. The remaining 6 nodes are staggered in the body of the sleeve. In another embodiment, the sleeve includes 24 nodes at its proximal end and 12 nodes at its distal end. The remaining 12 nodes are staggered in the body of the sleeve. Different embodiments include different staggering of nodes. In one embodiment, a distal portion of the sleeve includes a coating 1002. In various embodiments, approximately 30 - 60 mm of the distal end is covered with the coating 1002. In one embodiment, the coating 1002 is silicone. In one embodiment, staggered nodes are positioned in the distal portion with the coating 1002 and are covered to eliminate traumatic surfaces.

The sleeve 1000 depicted in Figure 10A includes a funnel shaped portion 1005 at its proximal end and a cylindrically shaped portion 1006 at its distal end. In one embodiment, the funnel portion 1005 includes a proximal section having a length h and a distal section. In one embodiment, the length h is approximately 30 mm. The entire funnel portion has a length h which, in one embodiment, is approximately 60 mm. The cylindrical portion 1006 has a length 13 which, in one embodiment, is approximately 60 mm. Therefore, in one embodiment, the sleeve 1000 has a total length l_t of approximately 120 mm. The sleeve 1000 has a first opening 1003 at its proximal end with a diameter di. In one embodiment, the diameter di is approximately 75 mm. The sleeve has a second opening 1004 at its distal end. In various embodiments, the diameter d2 of the second opening 1004 is 1 - 30 mm.

Figure 10B is an illustration of a funnel shaped braided short sleeve component 1010 having a cone shaped distal end 1017 in a post-deployment configuration, in accordance with

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2016328478 30 Aug 2018 one embodiment of the present specification. In various embodiments, the sleeve 1010 is comprised of a wire braid structure having a plurality of nodes 1011 wherein said plurality of nodes is uniform or variable as described with reference to Figure 10A. In one embodiment, a distal portion of the sleeve includes a coating 1012. In various embodiments, approximately

30-60 mm of the distal end is covered with the coating 1012. In one embodiment, the coating

1012 is silicone. In one embodiment, staggered nodes are positioned in the distal portion with the coating 1012 and are covered to eliminate traumatic surfaces.

The sleeve 1010 depicted in Figure 10B includes a funnel shaped portion 1015 at its proximal end and a cone shaped portion 1017 at its distal end. In one embodiment, the funnel portion 1015 includes a proximal section having a length li and a distal section. In one embodiment, the length h is approximately 30 mm. The entire funnel portion has a length h which, in one embodiment, is approximately 60 mm. The cone portion 1787 has a length I3 which, in one embodiment, is approximately 55 mm. In one embodiment, a short straight section 1016 of sleeve is positioned between the funnel portion 1015 and the cone portion 1017.

In one embodiment, the short straight section 1016 has a length of 5 mm. Therefore, in one embodiment, the sleeve 1010 has a total length l_t of approximately 120 mm. The sleeve 1010 has a first opening 1013 at its proximal end with a diameter di. In one embodiment, the diameter di is approximately 75 mm. The sleeve has a second opening 1014 at its distal end with a diameter d2. In one embodiment, the diameter d2 is approximately 10 mm.

Figure 10C is an illustration of a cone shape braided short sleeve component 1020 in a post-deployment configuration, in accordance with one embodiment of the present specification. In various embodiments, the sleeve 1020 is comprised of a wire braid structure having a plurality of nodes 1021 wherein said plurality of nodes is uniform or variable as described with reference to Figure 10A. In one embodiment, a distal portion of the sleeve includes a coating 1022. In various embodiments, approximately 30 - 60 mm of the distal end is covered with the coating 1022. In one embodiment, the coating 1022 is silicone. In one embodiment, staggered nodes are positioned in the distal portion with the coating 1022 and are covered to eliminate traumatic surfaces. In one embodiment, the sleeve 1020 has a total length I of approximately 120 mm. The sleeve 1020 has a first opening 1023 at its proximal end with a diameter di. In one embodiment, the diameter di is approximately 75 mm. The sleeve has a second opening 1024 at its distal end with a diameter d2. In one embodiment, the diameter d2 is approximately 10 mm.

Figure 10D is an illustration of the cone shape braided short sleeve component 1020 of Figure 10C attached to a wire mesh structure 1030 in accordance with one embodiment of the present specification. Referring to Figures 10C and 10D simultaneously, the diameter di of the

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2016328478 30 Aug 2018 first opening 1023 of the sleeve 1020 is sized similarly to the diameter of an anti-migration collar 1034 of the wire mesh structure 1030. To attach the wire mesh structure 1030 and sleeve

1020, the sleeve 1020 is slipped over the anti-migration collar 1034 and is attached thereto, as denoted by dashed lines 1035. Since they include first openings with similarly sized diameters, sleeve 1000 and sleeve 1010 of Figures 10A and 10B respectively, are attached to a wire mesh structure is the same manner as sleeve 1020 of Figure 10C. In other words, the sleeves 1000, 1010 are slid over an anti-migration collar of a wire mesh structure.

Figure 10E is an illustration of a cone shape braided short sleeve component 1040 in a post-deployment configuration, in accordance with another embodiment of the present specification. The sleeve 1040 is similar to sleeve 1020 of Figure 10C, with the exception that sleeve 1040 has a smaller first opening 1043. Referring to Figure 10E, in various embodiments, the sleeve 1040 is comprised of a wire braid structure having a plurality of nodes 1041 wherein said plurality of nodes is uniform or variable as described with reference to Figure 10A. In one embodiment, a distal portion of the sleeve includes a coating 1042. In various embodiments, approximately 30 - 60 mm of the distal end is covered with the coating 1042. In one embodiment, the coating 1042 is silicone. In one embodiment, staggered nodes are positioned in the distal portion with the coating 1042 and are covered to eliminate traumatic surfaces. In one embodiment, the sleeve 1040has a total length I of approximately 120 mm. The sleeve 1040 has a first opening 1043 at its proximal end with a diameter di. In one embodiment, the diameter di is approximately 30 mm. The sleeve has a second opening 1044 at its distal end with a diameter </?. In one embodiment, the diameter d2 is approximately 10 mm.

Figure 10F is an illustration of the cone shape braided short sleeve component 1040 of Figure 10E attached to a wire mesh structure 1050 in accordance with one embodiment of the present specification. Referring to Figures 10E and 10F simultaneously, the diameter di of the first opening 1043 of the sleeve 1040 is sized similarly to the diameter of the neck 1052 of an anti-migration collar 1054 of the wire mesh structure 1050. An outer diameter of the antimigration collar 1054 itself is greater than diameter di. Therefore, to attach the wire mesh structure 1050 and sleeve 1040, the sleeve 1040 is slid into the anti-migration collar 1054 and is attached to the collar neck 1052, as denoted by dashed lines 1055.

Figures 10G and 10H are illustrations of cone shape braided short sleeve components

1060, 1065 having an atraumatic distal tip 1062, 1067 and in a post-deployment configuration, in accordance with embodiments of the present specification. Referring to Figures 10G and

10H simultaneously, the wires 1061, 1066 of the sleeve components 1060, 1065 do not extend into the distal tips 1062, 1067. The distal tips 1062, 1067 only include the more flexible sleeve layers, such as PTFE, and, as such, are atraumatic to the gastrointestinal mucosa. In some

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2016328478 30 Aug 2018 embodiments, the distal tips 1062, 1067 have a diameter di of approximately 10 cm and a length in a range of 5-15 cm. In some embodiments, the sleeve components depicted in Figures 10A through 10F each include an atraumatic distal tip similar to those discussed with reference to

Figures 10G and 10H.

Figure 11A is a cross-sectional illustration depicting one embodiment of an intragastric device 1100 with an attached sleeve 1102 in a post-deployment configuration. The device 1100 includes a wire mesh structure 1101 having a collar 1103 positioned at its distal end. The sleeve 1102 has a cylindrically shaped body with a proximal end that is attached to the bottom surface of the collar 1103. Figure 1 IB is a cross-sectional illustration depicting the intragastric device

1100 of Figure 11A in a pre-deployment configuration. As the device 1100 is compressed into its pre-deployment configuration, the body of the sleeve 1102 is pulled upon to assist in folding out the collar 1103 of the wire mesh structure 1101. The collar 1103 must be folded out so that the device 1100 will have a small enough diameter to fit through a delivery device or catheter. Referring to Figure 1 IB, because the proximal end of the sleeve 1102 is attached to the bottom surface of the collar 1103, when the collar 1103 is folded out it creates a bulge comprising the thickness 1103’ of the collar and twice the thickness 1102’, 1102” of the sleeve.

Figure 11C is a cross-sectional illustration depicting another embodiment of an intragastric device 1110 with an attached sleeve 1112 in a post-deployment configuration. The device 1110 includes a wire mesh structure 1111 having a collar 1113 positioned at its distal end. The sleeve 1112 has a cylindrically shaped body with a funnel shaped proximal end that is attached to the nodes or free ends at the distal end of the collar 1113. The sleeve 1112 is attached to the collar 1113 via a plurality of sutures 1117. Figure 1 ID is a cross-sectional illustration depicting the intragastric device of Figure 11C in a pre-deployment configuration. As the device 1110 is compressed into its pre-deployment configuration, the body of the sleeve

1112 is pulled upon to assist in folding out the collar 1113 of the wire mesh structure 1111.

The sutures 1117 joining the sleeve 1112 to the collar 1113 are secured loosely to allow for some minimal movement between the sleeve 1112 and the collar 1113. Therefore, as seen in Figure 1 ID, when the collar 1113 is folded out, the funnel portion of the sleeve 1112 and the collar 1113 move relative to one another such that the resultant bulge in the compressed device comprises only the thickness 1113’ of the collar. This creates a lower cross-sectional area or diameter in the compressed device and allows for easier deployment through a delivery device or catheter.

In addition, the collar 1113 depicted in Figure 11C has less of a sharp bend (is more rounded) than the collar 1103 depicted in Figure 11A. A less sharp bend in the collar will make

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2016328478 30 Aug 2018 the collar less traumatic to body tissues and will allow it to retain its shape since it will have a lower strain percentage.

Figure 12A is an illustration of a plurality of nodes 1205 positioned at the distal end of a wire mesh structure connected to the proximal end of a funnel shaped sleeve 1202, in accordance with one embodiment of the present specification. The nodes 1205 are positioned at the distal end of the wire mesh structure or at the distal end of a collar, as seen in Figures 11C and 11D. Referring to Figure 12A, each node 1205 is attached to the sleeve 1202 by a suture 1208. As described with reference to Figures 11C and 11D, the sutures are secured loosely to allow some movement of the sleeve 1202 relative to the wire mesh structure.

Figure 12B is an illustration of a plurality of nodes 1215 positioned at the distal end of a wire mesh structure connected to the proximal end of a funnel shaped sleeve 1212, in accordance with another embodiment of the present specification. As depicted in Figure 12B, only every other node 1215 is attached to the sleeve via a suture 1218. While still fixedly attaching the wire mesh structure to the sleeve 1212, the reduction in the number of sutures

1218, when compared with the embodiment shown in Figure 12A, creates a device in the compressed pre-deployment configuration having a bulge with a smaller diameter. Such a compressed device will pass more easily through a delivery device or catheter.

Securing the sutures directly to the most distal end of the nodes can result in too much movement of the sleeve relative to the wire mesh structure as the sutures slide along the wires of each node. Figure 12C is an illustration of a plurality of nodes 1225 positioned at the distal end of a wire mesh structure connected to the proximal end of a funnel shaped sleeve 1222, in accordance with another embodiment of the present specification. Rather than placing the suture on the most distal end of each node 1225, the sutures 1228 are placed about the intersections 1229 of the wires of two adjacent nodes 1225. This prevents sliding of the sutures too far along any one wire while still allowing for the minimum movement of the sleeve 1222 relative to the wire mesh structure during compression.

Figure 12D is an illustration of a plurality of nodes 1235 positioned at the distal end of a wire mesh structure connected to the proximal end of a funnel shaped sleeve 1232, in accordance with another embodiment of the present specification. As depicted in Figure 12D, only every other intersection 1239 of wires of adjacent nodes 1235 is attached to the sleeve via a suture 1238. While still fixedly attaching the wire mesh structure to the sleeve 1232, the reduction in the number of sutures 1238, when compared with the embodiment shown in Figure 12C, creates a device in the compressed pre-deployment configuration having a bulge with a smaller diameter. Such a compressed device will pass more easily through a delivery device or catheter.

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2016328478 30 Aug 2018

Figure 12E is an illustration of a plurality of nodes 1245 positioned at the distal end of a wire mesh structure connected to the proximal end of a funnel shaped sleeve 1242, in accordance with another embodiment of the present specification. The nodes 1245 are positioned at the distal end of the wire mesh structure or at the distal end of an anti-migration collar and include loops 1246 formed from the wire of the nodes 1245 and extending in a direction toward the center of the wire mesh structure. Each loop 1246 of each node 1205 is attached to the sleeve 1242 by a suture 1248.

Figure 12F is an illustration of a plurality of nodes 1255 positioned at the distal end of a wire mesh structure connected to the proximal end of a funnel shaped sleeve 1252, in accordance with yet another embodiment of the present specification. The nodes 1255 are positioned at the distal end of the wire mesh structure or at the distal end of an anti-migration collar and include loops 1256 formed from the wire of the nodes 1255 and extending in a direction toward the center of the wire mesh structure. Each loop 1256 of each node 1255 is attached to the sleeve 1252 by a suture 1258. As depicted in Figure 12F, only every other node

1255 is attached to the sleeve via a suture 1258. While still fixedly attaching the wire mesh structure to the sleeve 1252, the reduction in the number of sutures 1258, when compared with the embodiment shown in Figure 12E, creates a device in the compressed pre-deployment configuration having a bulge with a smaller diameter. Such a compressed device will pass more easily through a delivery device or catheter.

Figure 13A is an illustration of a plurality of nodes 1305 positioned at the distal end of a wire mesh structure connected to the proximal end of a funnel shaped sleeve 1302, in accordance with an embodiment of the present specification. As depicted in Figure 13A, both the intersections 1309 between some adjacent nodes 1305 and the ends 1304 of some nodes 1305 are sutured to the sleeve 1302 with knots 1308.

In one embodiment, the distal end of a wire mesh structure is connected to the proximal end of a sleeve at 9 standalone connection points. Each connection point comprises a figure eight knot additionally secured with glue and a heat shrink tube. In one embodiment, each knot comprises 30 lb. break-strength ultra-high-molecular-weight-polyethylene (UHMWPE) braided suture line to provide a reliable connection between wire mesh and sleeve. Figure 13B is an illustration of a distal end of a wire mesh structure 1320 and connected proximal end of a funnel shaped sleeve covered with a heat shrink tube 1326, in accordance with one embodiment of the present specification.

Figure 14 is an illustration of an intragastric device 1400 with a funnel shaped sleeve 1410 in a post-deployment configuration, in accordance with one embodiment of the present specification. The intragastric device 1400 includes a wire mesh structure 1405 having a

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2016328478 30 Aug 2018 proximal end and a distal end with an anti-migration collar 1420 formed at said distal end. The sleeve 1410 includes a proximal end and a distal end and is attached via its proximal end to the anti-migration collar 1420.

The wire mesh structure 1405 comprises at least one metal wire folded about itself to 5 create a crisscross weave pattern with a plurality of free curved ends, or nodes, along the structure. In its expanded, post-deployment configuration, the wire mesh structure 1405 has an oval shape. To facilitate optimal expansion and compression for easier delivery and removal, the wire mesh structure 1405 includes a plurality of staggered nodes 1406, 1407, 1408, 1409 along its length. A first set of staggered nodes 1406 is positioned at the proximal end of the wire mesh structure 1405 and circumscribes a first opening 1401. In one embodiment, each node in said first set of staggered nodes 1406 is bent upwards to extend in a direction opposite from an interior of the wire mesh structure 1405. The nodes in said first set of staggered nodes 1406 are used as grasping points for a retrieval device during removal of the intragastric device 1400. The wire mesh structure 1405 includes a second set of staggered nodes 1407 distal to said first set 1406 and proximal to a midpoint of said wire mesh structure 1405. A third set of staggered nodes 1408 is positioned distal to said midpoint and proximal to the distal end of the wire mesh structure 1405. A fourth set of staggered nodes 1409 is positioned at the distal end of the wire mesh structure 1405 and comprises the free end of the anti-migration component 1420. All of the curves comprising the nodes in each set of staggered nodes 1406, 1407, 1408,

1409 are designed to have a bend that is atraumatic to body tissues. The nodes are staggered to prevent bunching of the bending points of the wire and bulking of the wire mesh structure as it is compressed to its pre-deployment configuration. Spreading the nodes along the length of the wire mesh structure allows for an overall smaller diameter of the device once it is compressed.

The sleeve 1410 includes a proximal portion 1411 and a distal portion 1416 which join at a transition point 1415 along the sleeve 1410 body. Both the proximal portion 1411 and the distal portion 1416 of the sleeve 1410 are funnel shaped, each having a diameter that decreases as the portions 1411, 1416 extend distally. In one embodiment, the diameter of the proximal portion 1411 is substantially the same as the diameter of the anti-migration collar 1420 at a proximal end of said proximal portion 1411. The diameter of the proximal portion 1411 decreases as the proximal portion 1411 extends distally until the sleeve 1410 transitions into its distal portion 1416, at which point the diameters of the proximal portion 1411 and the distal portion 1416 are equal. The diameter of the distal portion 1416 then decreases as said distal portion 1416 extends distally. The distal portion 1416 of the sleeve 1410 ends in a second opening 1419 at a distal end of the intragastric device 1400. In one embodiment, the proximal portion 1411 has a length that is less than a length of the distal portion 1416. In various

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2016328478 30 Aug 2018 embodiments, the funnel shaped sleeve 1410 comprises at least one wire support. In some embodiments, the at least one wire support comprises the same wire(s) in both the proximal portion 1411 and distal portion 1416. In other embodiments, the proximal portion 1411 and distal portion 1416 comprise separate wire supports and the wires are joined together at a distal end of the proximal portion 1411 and a proximal end of the distal portion 1416. In one embodiment, the separate wires are spot welded together. The wire is folded upon itself to create a crisscross weave pattern in the sleeve 1410. In both the proximal 1411 and distal portions 1416, the intersecting sections of the wire come closer to one another as the portions 1411, 1416 extend distally and the funnel shape narrows, such that the weave pattern becomes tighter at the distal ends of each portion 1411, 1416. The sleeve 1410 includes curves or free ends, similar to the nodes of the wire mesh structure 1405, at its proximal end and distal end. The free ends are designed to be atraumatic to body tissues. The free ends at the proximal end of the sleeve 1410 are attached to the nodes of the fourth set of staggered nodes 1409 of the wire mesh structure 1405 via one or more sutures 1422. The free ends at the distal end of the sleeve 1410 circumscribe the second opening 1419. In various embodiments, the sleeve 1410 is a short sleeve having a total length in a range of 5 cm - 120 cm. In one embodiment, the sleeve 1410 is a short sleeve having a total length of 60 cm. In one embodiment, the sleeve 1410 includes a soft atraumatic tip 1430 at its distal end. The tip 1430 contains no wires and is included to prevent injury to the intestinal mucosa from the sleeve tip.

When the sleeve 1410 is attached to the wire mesh structure 1405, the proximal end of the proximal portion 1411 of the sleeve 1410 is slid over and covers at least a portion of the anti-migration component 1420 such that the proximal portion 1411 of the sleeve 1410 covers an opening at the distal end of the wire mesh structure. This positioning enables fluid communication between the interior of the wire mesh structure 1405 and an interior of the sleeve 1410 and establishes a pathway for food from said first opening 1401, into said interior of said wire mesh structure 1405, through said interior of said sleeve 1410, and out said second opening 1419.

Figure 15 is an illustration of an intragastric device 1500 with a cylindrically shaped sleeve 1510 in a post-deployment configuration, in accordance with one embodiment of the present specification. The intragastric device 1500 includes a wire mesh structure 1505 having a proximal end and a distal end with an anti-migration collar 1520 formed at said distal end. The sleeve 1510 includes a proximal end and a distal end and is attached via its proximal end to the anti-migration collar 1520. In one embodiment, the sleeve 1510 includes a soft atraumatic tip 1530 at its distal end. The tip 1530 contains no wires and is included to prevent injury to the intestinal mucosa from the sleeve tip.

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The wire mesh structure 1505 is similar to the structure 1405 discussed with reference to Figure 14 and includes an oval shape with a crisscross weave pattern, a plurality of staggered nodes 1506, 1507, 1508, 1509, and a first opening 1501 at its proximal end. All of the curves comprising the nodes in each set of staggered nodes 1506, 1507, 1508, 1509 are designed to have a bend that is atraumatic to body tissues.

The sleeve 1510 includes a proximal portion 1511 and a distal portion 1516 which join at a transition point 1515 along the sleeve 1510 body. The proximal portion 1511 of the sleeve

1510 is funnel shaped and includes a diameter that decreases as the portion 1511 extends distally. In one embodiment, the diameter of the proximal portion 1511 is substantially the same as the diameter of the anti-migration collar 1520 at a proximal end of said proximal portion 1511. The diameter of the proximal portion 1511 decreases as the proximal portion

1511 extends distally until the sleeve 1510 transitions into its distal portion 1516, at which point the diameters of the proximal portion 1511 and the distal portion 1516 are equal. The diameter of the distal portion 1516 then continues at the same size as said distal portion 1516 extends distally, giving the distal portion 1516a substantially cylindrical shape. The distal portion 1516 of the sleeve 1510 ends in a second opening 1519 at a distal end of the intragastric device 1500. In one embodiment, the proximal portion 1511 has a length that is less than a length of the distal portion 1516.

In various embodiments, the funnel shaped proximal portion 1511 of the sleeve 1510 comprises at least one wire support. The wire is folded upon itself to create a crisscross weave pattern in the sleeve 1510. The intersecting sections of the wire come closer to one another as the portion 1511 extends distally and the funnel shape narrows, such that the weave pattern becomes tighter at the distal end of the proximal portion 1511. In various embodiments, the distal portion 1516 includes at least one helical wire support extending along its cylindrical length. The helical wire support has a consistent pitch such that a resultant helical weave structure has the same pattern along the length of the distal portion 1516 of the sleeve 1510. In some embodiments, the helical wire support of the distal portion 1516 is an extension of the at least one wire support of the proximal portion 1511. In other embodiments, the proximal portion 1511 and distal portion 1516 comprise separate wire supports and the wires are joined together at a distal end of the proximal portion 1511 and a proximal end of the distal portion 1516. In one embodiment, the separate wires are spot welded together. The sleeve 1510 includes curves or free ends, similar to the nodes of the wire mesh structure 1505, at its proximal end and distal end. The free ends are designed to be atraumatic to body tissues. The free ends at the proximal end of the sleeve 1510 are attached to the nodes of the fourth set of staggered nodes 1509 of the wire mesh structure 1505 via one or more sutures 1522. The free ends at the

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2016328478 30 Aug 2018 distal end of the sleeve 1510 circumscribe the second opening 1519. In various embodiments, the sleeve 1510 is a short sleeve having a total length in a range of 5 cm - 120 cm. In one embodiment, the sleeve 1510 is a short sleeve having a total length of 60 cm. The funnel shaped conical section can vary from being 1% of the total sleeve length to being 100% of the total sleeve length.

When the sleeve 1510 is attached to the wire mesh structure 1505, the proximal end of the proximal portion 1511 of the sleeve 1510 is slid over the anti-migration component 1520 such that the proximal portion 1511 of the sleeve 1510 covers an opening at the distal end of the wire mesh structure. This positioning enables fluid communication between the interior of the wire mesh structure 1505 and an interior of the sleeve 1510 and establishes a pathway for food from said first opening 1501, into said interior of said wire mesh structure 1505, through said interior of said sleeve 1510, and out said second opening 1519.

Figure 16A is a close-up illustration of a funnel shaped sleeve 1602 attached to an antimigration collar 1604 of a wire mesh structure 1605 of an intragastric device 1600, in accordance with one embodiment of the present specification. The sleeve 1602 is attached to the anti-migration collar 1604 via a plurality of sutures 1608.

Figure 16B is a close-up illustration of a funnel shaped sleeve 1612 attached to an antimigration collar 1614 of a wire mesh structure 1615 of an intragastric device 1610, in accordance with another embodiment of the present specification. The sleeve 1612, attached to the anti-migration collar 1614 via a plurality of sutures 1618, includes a plurality of frayed edges 1611 at its proximal end to make said edges less traumatic to body tissues.

Figure 16C is an illustration of an intragastric device 1620 comprising a wire mesh structure 1625 and attached sleeve 1622, in accordance with one embodiment of the present specification. The wire mesh structure 1625 is anchorless and includes atraumatic wire ends.

In one embodiment, the wire mesh structure 1625 is composed of Nitinol. The wire mesh structure 1625 includes an anti-migration collar 1624 to which the sleeve 1622 is attached. In some embodiments, the wire mesh structure 1625 includes retrieval drawstrings positioned proximate its proximal end, as depicted with reference to Figure 16E. The sleeve 1622 comprises an anchorless, impermeable, fluoropolymer liner designed to extend into the proximal portion of the small bowel, particularly the mid-duodenum. In various embodiments, the sleeve 1622 includes an embedded Nitinol stent structure within polymer layers such that the sleeve 1622 is atraumatic and no portion of the Nitinol comes into contact with the small intestine. In one embodiment, the sleeve 1622 includes radiopaque markers for assistance with proper delivery and placement.

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The wire mesh structure 1625 is anchorless and occupies a space within the stomach.

The wire mesh structure 1625 is free to float within the stomach and intermittently exerts gentle, atraumatic stretching forces on a portion of the stomach as it comes into contact with the inner stomach wall. The stretching forces induce the sensation of satiety in the patient. The anti5 migration collar 1624 is appropriately shaped to receive the attached sleeve 1622. Gastric contents enter the wire mesh structure 1625 through a first opening 1621 at the proximal end of the wire mesh structure 1625 or through openings 1629 between the wires of the wire mesh structure 1625 and are directed into the attached sleeve 1622. The gastric contents then pass through the sleeve 1622 and empty out a second opening 1623 at the distal end of the sleeve

1622, either into the duodenum or jejunum, depending on the length of the sleeve 1622. The sleeve 1622 is pre-attached to the anti-migration collar 1624 of the wire mesh structure 1625. The Nitinol stent structure embedded in the sleeve 1622 provides support to the sleeve 1622 and prevents it from torsion or being kinked by actions of the intestinal musculature. Additionally, the Nitinol stent structure provides a gentle, radial stretching force on the small intestinal wall, inducing a sensation of satiety in the patient and preventing the passage of chyme around the sleeve 1622.

Figure 16D is an illustration of the intragastric device 1620 of Figure 16C with the sleeve 1622 straightened to depict the device 1620 dimensions relative to the surrounding anatomy. The sleeve 1622 includes a proximal, funnel or cone shaped portion 1622p attached to the anti-migration collar of the wire mesh structure 1625 and a distal, cylindrically shaped portion 1622d extending distally from said proximal portion 1622p. The wire mesh structure 1625 and proximal portion 1622p of the sleeve 1622 are configured to reside in the stomach of the patient and together have a maximum outer diameter of approximately 8 inches and a length li. In some embodiments, length li is approximately 10 inches. In some embodiments, the volume of a fully deployed wire mesh structure 1625 is approximately 1 liter. The proximal portion 1622p of the sleeve 1622 and the distal portion 1622d of the sleeve 1620 meet at a junction point 1622j which is configured to sit at the patient’s pylorus. The distal portion 1622d of the sleeve 1620 is configured to reside in the small intestine of the patient, particularly the duodenum, and has a maximum outer diameter of approximately 1.0 inches and a length h. In some embodiments, length /2 is approximately 10 to 25 inches. In some embodiments, the length I2 of the distal portion 1622d is such that the distal end of the sleeve 1622 is positioned in the duodenum so gastric contents pass from the stomach, through the device 1620, and directly into the duodenum, bypassing the pylorus. In other embodiments, the length /2 is such that the distal end of the sleeve 1622 is positioned in the jejunum so gastric contents pass from the stomach, through the device 1620, and directly into the jejunum, bypassing the pylorus and

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2016328478 30 Aug 2018 duodenum. In other embodiments, the wire mesh structure has a maximum diameter of 18 inches, a maximum length of 24 inches, and a maximum volume of 2.5 liters.

Figure 16E is an illustration of a wire mesh structure 1635 and sleeve 1632 of an intragastric device 1630, depicting retrieval drawstrings 1637, 1638 on said wire mesh structure

1635, in accordance with one embodiment of the present specification. The sleeve 1632 is attached to an anti-migration collar 1634 at the distal end of the wire mesh structure 1635. In some embodiments, the anti-migration collar 1634 includes loops in the wires of the nodes at the distal end of the nodes, as seen with reference to Figure 4C, and the sleeve 1632 is sutured to the anti-migration collar 1634 at these loops. In the pictured embodiment, a pair of retrieval drawstrings 1637, 1638 are located on the wire mesh structure 1635 proximate its proximal end. A first drawstring 1637 is positioned at the proximal end of the wire mesh structure 1635 and the second drawstring 1638 is positioned distal to the first drawstring 1637 but still proximate the proximal end of the wire mesh structure 1635. The retrieval drawstrings 1637, 1638 pass through the openings between the wires of the wire mesh structure 1635. During retrieval, free ends of the retrieval drawstrings 1637, 1638 are pulled on using a grasper to constrict the wire mesh structure 1635 to a smaller outer diameter so it may be removed from the patient through an endoscope. In one embodiment, the two drawstrings 1637, 1638 are interconnected operably such that constricting one drawstring results in the other drawstring constricting simultaneously.

Figure 16F is an illustration of a wire mesh structure 1645 and sleeve 1642 of an intragastric device 1640, depicting a single retrieval drawstring 1648 on said wire mesh structure 1645, in accordance with one embodiment of the present specification. The sleeve 1642 is attached to an anti-migration collar 1644 at the distal end of the wire mesh structure 1645. In some embodiments, the anti-migration collar 1644 includes loops in the wires of the nodes at the distal end of the nodes, as seen with reference to Figure 4C, and the sleeve 1642 is sutured to the anti-migration collar 1644 at these loops. In the pictured embodiment, a single retrieval drawstring 1648 is located on the wire mesh structure 1645 proximate its proximal end. The retrieval drawstrings 1648 passes through the openings between the wires of the wire mesh structure 1645. During retrieval, free ends of the retrieval drawstring 1648 are pulled on using a grasper to constrict the wire mesh structure 1645 to a smaller outer diameter so it may be removed from the patient through an endoscope. In the pictured embodiment, the single drawstring 1648 is sufficient to constrict two pluralities of nodes 1647, 1649 on the wire mesh structure 1645, a first plurality 1647 at the proximal end of the wire mesh structure 1645 and a second plurality 1649 at the level of the drawstring 1648. In other embodiments, a single

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2016328478 30 Aug 2018 drawstring is sufficient for constricting one or more than two pluralities of nodes on the wire mesh structure.

In some embodiments, wherein the sleeve includes metal wire supports, the ends of the wire or wires are designed to be atraumatic to body tissues. In various embodiments, the wire ends are blunted, folded upon the wire, or welded to other wire ends. In other embodiments, the distal end of the sleeve includes a component designed to make said distal end atraumatic to body tissues. Figure 17A is a cross-sectional illustration of a distal end of a sleeve 1705, depicting one embodiment of a component 1710 designed to configure said distal end to be atraumatic to body tissues. The component 1710 has a cylindrical shape with a proximal end

1711, a distal end 1719, and a lumen 1716 within. The component 1710 is open at both ends

1711, 1719. The lumen 1716 of the component 1710 is in fluid communication with a lumen 1706 of the sleeve 1705 to allow for food to pass through the wire mesh of the device, the sleeve 1705, and the component 1710. The distal end 1719 is rounded into a blunt shape that is atraumatic to body tissues. An outer surface of the component 1710 includes a groove 1713 configured to receive a circular member or O-ring 1714. To attach the component 1710 to the sleeve 1705, the distal end of the sleeve 1705 is coaxially slid onto the proximal end 1711 of the component 1710 such that a portion of the sleeve 1705 is positioned over said groove 1713. The O-ring 1714 is then placed over the sleeve 1705 and into the groove 1713, providing a robust connection of the sleeve 1705 to the component 1710. The distal sleeve end 1707 is then folded in a proximal direction back toward the sleeve 1705 body. In one embodiment, the component 1710 includes a circular flange 1712 which extends outwardly from the outer surface of the component 1710 and then in a proximal direction. The flange 1712 serves to cover any sharp ends present in the folded distal sleeve end 1707 and further protect body tissues from trauma. In various embodiments, the component 1710 has a length in a range of 5 mm to 500 mm, an outside diameter in a range of 3 mm to 30 mm, and an inside diameter in a range of 0.5 to 50 mm.

Figure 17B is a cross-sectional illustration of a distal end of a sleeve 1705, depicting another embodiment of a component 1720 designed to configure said distal end to be atraumatic to body tissues. The component 1720 has a cylindrical shape with a proximal end 1721, a distal end 1729, and a lumen 1726 within. The component 1720 is open at both ends 1721, 1729. The lumen 1726 of the component 1720 is in fluid communication with a lumen 1706 of the sleeve 1705 to allow for food to pass through the wire mesh of the device, the sleeve 1705, and the component 1720. The distal end 1729 is rounded into a blunt shape that is atraumatic to body tissues. An outer surface of the component 1720 includes a groove 1723 configured to receive a circular member or O-ring 1724. To attach the component 1720 to the sleeve 1705,

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2016328478 30 Aug 2018 the distal end of the sleeve 1705 is coaxially slid onto the proximal end 1721 of the component

1720 such that a portion of the sleeve 1705 is positioned over said groove 1723. The O-ring

1724 is placed over the sleeve 1705 and into the groove 1723. The distal sleeve end is then folded in a proximal direction back toward the sleeve 1705 body. A heat shrink tube 1725 is then placed over said distal sleeve end and said O-ring 1724. Heat is applied to the heat shrink tube 1725 to shrink the tube 1725 such that it securely connects the sleeve 1705 to the component 1720. Any sharp ends in the distal sleeve end are contained under the heat shrink tube 1725 and are not exposed to body tissues.

Figure 17C is a cross-sectional illustration of a distal end of a sleeve 1705, depicting 10 another embodiment of a component 1730 designed to configure said distal end to be atraumatic to body tissues. The component 1730 has a cylindrical shape with a proximal end 1731, a distal end 1739, and a lumen 1736 within. The component 1730 is open at both ends 1731, 1739. The lumen 1736 of the component 1730 is in fluid communication with a lumen 1706 of the sleeve 1705 to allow for food to pass through the wire mesh of the device, the sleeve 1705, and the component 1730. The distal end 1739 is rounded into a blunt shape that is atraumatic to body tissues. An outer surface of the component 1730 includes a groove 1733 configured to receive a circular member or O-ring 1734. To attach the component 1730 to the sleeve 1705, the sleeve 1705 is first everted to be inside out. The distal end of the sleeve 1705 is then coaxially slid onto the distal end 1739 of the component 1730 such that a portion of the sleeve

1705 is positioned over said groove 1733. The O-ring 1734 is placed over the sleeve 1705 and into the groove 1733. The sleeve 1705 is then folded in a proximal direction back over the Oring 1734 and proximal end 1731 of the component 1730, providing a robust connection of the sleeve 1705 to the component 1730. This process of connecting the sleeve 1705 to the component 1730 ensures that the distal sleeve end 1707 will become positioned within the sleeve lumen 1706. Any sharp ends in the distal sleeve end 1707 are contained within the sleeve lumen 1706 and are not exposed to body tissues.

Figure 18 is an illustration of a distal end of a sleeve 1805 with a positioning tail 1810 attached thereto, in accordance with one embodiment of the present specification. The positioning tail 1810 is attached to the distal end of a short sleeve 1805 having a length of 5 mm to 500 mm. The positioning tail 1810 comprises a ribbon of material extending from the distal end of the sleeve 1805 into a patient’s duodenum and is used to help maintain proper implant orientation of the sleeve 1805 relative to a patient’s pylorus. In various embodiments, the positioning tail 1810 has a length I in a range of 5 mm to 500 mm. In one embodiment, the positioning tail 1810 has a length I of 25 mm. In one embodiment, the distal end of the positioning tail 1810 includes a bead 1815 for weighing down said distal end. In another

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2016328478 30 Aug 2018 embodiment, the distal end of the positioning tail includes a plurality of separate free ends similar to a horse tail. In other embodiments, the distal end of the positioning tail includes any mechanism or component designed to provide additional weight or tugging upon said distal end to allow for pulling on said tail to ensure proper sleeve orientation. In one embodiment, the distal end of the positioning tail does not include any additional components.

Figure 19A is an illustration of a distal end of a sleeve 1905 comprising a plurality of fringes 1907 joined to a ring 1908, in accordance with one embodiment of the present specification. In various embodiments, the distal end of the sleeve 1905 comprises two or more fringes 1907. In one embodiment, the distal end of the sleeve 1905 comprises four fringes

1907. Each fringe 1907 comprises a portion of sleeve material which is separate from adjacent fringes 1907. The fringes 1907 are separated from one another by a space 1906 which allows food passing through the intragastric device to exit from the sleeve 1905. In various embodiments, each fringe 1907 has a length in a range of 5 mm to 500 mm and a width in a range of 1 mm to 15 mm. In some embodiments, the width of each fringe 1907 decreases as the fringe 1907 extends distally. The fringes 1907 are connected to a ring 1908 at the most distal end of the sleeve 1905. The ring 1908 includes a center opening 1909 for passage of food. In some embodiments, the ring 1908 is semi-rigid. In various embodiments, the ring 1908 has an outer diameter in a range of 1 mm to 30 mm and an inner diameter in a range of 1 mm to 30 mm. In various embodiments, the ring 1908 is attached to each fringe 1907 via suturing, gluing, bonding or any other method of attachment. The ring 1908 serves to join the fringes 1907 together and to weigh down the distal end of the sleeve 1905 to assist with proper device orientation. The surfaces of the ring 1908 are blunted to be atraumatic to body tissues. In some embodiments, the fringes 1907 and ring 1908 are parachute shaped.

Figure 19B is an illustration of a distal end of a sleeve 1910 comprising a plurality of fringes 1912 joined to a ball 1913, in accordance with one embodiment of the present specification. In various embodiments, the distal end of the sleeve 1910 comprises two or more fringes 1912. In one embodiment, the distal end of the sleeve 1910 comprises four fringes 1912. Each fringe 1912 comprises a portion of sleeve material which is separate from adjacent fringes 1912. The fringes 1912 are separated from one another by a space 1911 which allows food passing through the intragastric device to exit from the sleeve 1910. In various embodiments, each fringe 1912 has a length in a range of 5 mm to 500 mm and a width in a range of 1 mm to 15 mm. In some embodiments, the width of each fringe 1912 decreases as the fringe 1912 extends distally. The fringes 1912 are connected to a ball 1913 at the most distal end of the sleeve 1910. In various embodiments, the ball 1913 has a diameter in a range of 2 mm to 30 mm. In various embodiments, the ball 1913 is glued or bonded to each fringe

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1907. The ball 1913 serves to join the fringes 1912 together and to weigh down the distal end of the sleeve 1910 to assist with proper device orientation. Since the ball 1913 has a spherical shape, it has no sharp edges and is atraumatic to body tissues. In another embodiment, the most distal ends of the fringes 1912 are tied together into a knot to form the ball 1913 and no additional ball component is required. In some embodiments, the fringes 1912 and ball 1913 are parachute shaped.

In one embodiment, as seen in Figure 19C, the ball 1913 includes a lumen 1933 to allow for passage of a guide wire. In another embodiment, the ball 1913 has a groove or depression 1932 to receive an inner pusher catheter or plunger of a delivery device. In one embodiment, the circumference of the ball is designed to sit inside an outer catheter of a delivery device.

Figure 19D is an illustration of a distal end of a sleeve 1915 having a plurality of sutures 1917 extending therefrom and joined to aball 1918, in accordance with one embodiment of the present specification. In various embodiments, the sleeve 1915 includes two or more sutures 1917. In one embodiment, the sleeve 1915 includes six sutures 1917. In various embodiments, the sutures 1917 have a length in a range of 5 mm to 500 mm. In one embodiment, the sutures 1917 are composed of nylon. A proximal end of each suture 1917 is attached to the distal end of the sleeve 1915 and a distal end of each suture 1917 is attached to a ball 1918. In various embodiments, the ball 1918 is glued to each suture 1917. In various embodiments, the ball has a diameter in a range of 3 mm to 30 mm. The ball 1918 is designed to add weight to the distal end of the sleeve 1915 to pull the sleeve 1915 into the proper implant orientation. Since the ball 1918 has a spherical shape, it has no sharp edges and is atraumatic to body tissues. Food exits the distal end of the sleeve 1915 and passes through the spaces 1916 between the sutures 1917. In one embodiment, the ball 1918 includes a center opening 1919 for the passage of guidewire there through. In various embodiments, the ball 1918 is replaced by a ring or similarly designed component to weigh down the sleeve 1915 and ensure proper device orientation. In some embodiments, the sutures 1917 and ball 1918 are parachute shaped.

Figure 19E is an illustration of a distal end of a sleeve 1920 having at least one suture 1922 with attached suture loop or bead 1923 extending therefrom, in accordance with one embodiment of the present specification. In one embodiment, the sleeve 1920 includes six sutures 1922. In various embodiments, the sutures 1922 have a length in a range of 5 mm to 500 mm. In one embodiment, the sutures 1922 are composed of UHMWPE. A proximal end of each suture 1922 is attached to the distal end of the sleeve 1920 and a distal end of each suture 1922 includes an attached suture loop or bead 1923. The suture loops or beads 1923 are designed to add weight to the distal end of the sleeve 1920 to pull the sleeve 1920 into the

100

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2016328478 30 Aug 2018 proper implant orientation. Since the suture loops or beads 1923 each have a spherical shape, they have no sharp edges and are atraumatic to body tissues.

Figure 20A is an illustration of a distal end of a sleeve 2005 depicting at least one fold

2007 in the sleeve wall 2006, in accordance with one embodiment of the present specification.

In one embodiment, the sleeve 2005 includes three folds 2007 in its wall 2006. The folds 2007 are created along a longitudinal axis of the sleeve 2005. In various embodiments, the folds 2007 are positioned equidistant from one another. Referring to Figure 20A, the sleeve 2005 is folded over itself twice resulting in three layers of sleeve wall 2006 at each fold 2007. The sleeve layers are bonded to each other at each fold 2007. In one embodiment, the sleeve layers are thermally fused together. The folding of the sleeve wall 2006 produces a pleated effect which adds structure and stability to the sleeve 2005. The added structure helps maintain the sleeve 2005 in the proper orientation relative to a patient’s pylorus and assists in preventing deformation of the sleeve 2005 by actions of the patient’s gastrointestinal tract.

Figure 20B is an illustration of a distal end of a sleeve 2010 depicting at least one channel 2012 and support structure 2013 within the sleeve wall 2011, in accordance with one embodiment of the present specification. In one embodiment, the sleeve 2010 includes four channels 2012 in its wall 2011 and each channel 2012 includes a support structure 2013 within. In various embodiments, the support structures 2013 comprise tubes or beads. In various embodiments, the support structures 2013 are sized to fit snugly within the channels 2012. The channels 2012 extend along a longitudinal axis of the sleeve 2010. In one embodiment, the channels 2012 extend the entire length of the sleeve 2010. In other embodiments, the channels extend only along a portion of the distal end of the sleeve 2010. In various embodiments, the channels 2012 are positioned equidistant from one another. The inclusion of the channels 2012 and support structures 2013 adds structure and stability to the sleeve 2010. The added structure helps maintain the sleeve 2010 in the proper orientation relative to a patient’s pylorus and assists in preventing deformation of the sleeve 2010 by actions of the patient’s gastrointestinal tract. In one embodiment, the channel 2012 is a hollow channel which can be filled or inflated with a fluid, such as water or air, to provide rigidity and/or structure to the sleeve 2010.

Figure 20C is an illustration of a portion of a sleeve 2015 depicting a corrugated sleeve wall in accordance with one embodiment of the present specification. The sleeve 2015 includes a plurality of alternating annular grooves 2016 and ridges 2017 extending along its length. In one embodiment, the entire sleeve 2015 is corrugated. In other embodiments, only a portion of the distal end of the sleeve 2015 is corrugated. In various embodiments, the corrugated portion of the sleeve 2015 is composed of fluoropolymer or polyethylene (PE). Referring to Figure

20C, in one embodiment, the corrugated portion of the sleeve 2015 is cylindrical and includes

101

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2016328478 30 Aug 2018 a consistent diameter along its entire length. In another embodiment, the corrugated portion of the sleeve is funnel shaped and includes a diameter that decreases as the sleeve extends distally.

In various embodiments, the distal end of the corrugated sleeve 2015 is configured to be soft, rounded, and atraumatic to body tissues. The corrugated structure helps maintain the sleeve

2015 in the proper orientation relative to a patient’s pylorus and assists in preventing deformation of the sleeve 2015 by actions of the patient’s gastrointestinal tract.

Figure 20D is an illustration of portion of a sleeve 2020 depicting a knitted sleeve wall in accordance with one embodiment of the present specification. The sleeve 2020 includes a knitted wire pattern 2021 extending along its length. In one embodiment, the entire sleeve 2020 is knitted. In other embodiments, only specific portions, such as the distal end, of the sleeve 2020 are knitted. Referring to Figure 20D, in one embodiment, the knitted portion of the sleeve 2020 is cylindrical and includes a consistent diameter along its entire length. In various embodiments, the diameter of the sleeve 2020 ranges from 1 cm - 10 cm. In one embodiment, the diameter of the sleeve is 25 mm and the length is 500 mm. In another embodiment, the knitted portion of the sleeve is funnel shaped and includes a diameter that decreases as the sleeve extends distally. In various embodiments, the distal end of the knitted sleeve 2020 is configured to be soft, rounded, and atraumatic to body tissues. The knitted structure helps maintain the sleeve 2020 in the proper orientation relative to a patient’s pylorus and assists in preventing deformation of the sleeve 2020 by actions of the patient’s gastrointestinal tract. The knitted structure provides the sleeve 2020 with structural integrity and prevents the sleeve 2020 from becoming kinked, twisted, or obstructed. In various embodiments, the sleeve 2020 has a radial force high enough to prevent deformation by the peristaltic actions of the gastrointestinal tract but low enough such that the sleeve 2020 can be compressed to allow food to propagate through the sleeve 2020. In addition, the radial force is low enough such that the sleeve is not too rigid which can result in trauma to the gastrointestinal tract, including abrasions. In one embodiment, the knitted structure of the sleeve 2020 functions similarly to a stent, keeping the sleeve 2020 properly positioned within the patient’s small intestine.

Figure 20E is an illustration of portion of a sleeve 2025 depicting a knitted sleeve wall and a distal sleeve end having frayed edges 2028, in accordance with one embodiment of the present specification. The sleeve 2025 includes a knitted wire pattern 2026 extending along its length. The frayed edges 2028 at the distal end of the sleeve 2025 are less traumatic to body tissues.

Figure 20F is an illustration of exemplary sleeve knit patterns 2031, 2032, 2033, 2034, 2035, 2036, 2037 in accordance with various embodiments of the present specification.

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Figure 21A is an illustration of an intragastric device 2130 having an oval shaped wire mesh structure 2131 deployed in the gastrointestinal tract of a patient, in accordance with one embodiment of the present specification. In the pictured embodiment, the device 2130 includes a wire mesh structure 2131 having an anti-migration collar 2134 and attached sleeve 2132. The device 2130 is deployed such that the wire mesh structure 2131 resides in the stomach 2160 with the anti-migration collar 2134 positioned just proximal to the pylorus 2161 and the sleeve 2132 extending through the pylorus 2161 and into the duodenum 2170. The distal end of the sleeve 2132 resides in the duodenum 2170. The anti-migration collar prevents migration of the totality of the device 2130 through the pylorus 2161 and into the duodenum 2170. The device

2130 occupies a volume of the stomach 2160, does not move entirely past the pylorus 2161, and provides a bypass for food past the pylorus 2161 and a portion of the duodenum 2170. In various embodiments, the sleeve 2132 is a short sleeve having a length in a range of 5 cm - 120 cm. In one embodiment, the sleeve 2132 is a short sleeve having a total length of 60 cm. In some embodiments, the short sleeve 2132 functions to weigh down wire mesh structure 2131 and orient the wire mesh structure 2131 in the correct direction toward the pylorus 2161. In addition, in one embodiment, the device 2130 having a short sleeve 2132 is capable of moving freely within the patient’s stomach 2160 after deployment. The short sleeve 2132 is capable of passing back and forth through the pylorus 2161 atraumatically. During situations when the device 2130 has moved such that the short sleeve 2132 is not positioned within the pylorus

2161 and duodenum 2170 but is rather in the stomach 2160 with the remainder of the device

2130, the short sleeve also functions to impede and regulate the flow of food into the pylorus 2161. This occurs as food enters the device 2130 at the proximal end of the wire mesh structure 2131 and travels through the wire mesh structure 2131 and sleeve 2132, where its progress is slowed as it passes through the funnel shaped sleeve 2132. At no time during its proper function is the device fixedly or permanently anchored to the wall of the gastrointestinal tract. After deployment, for a majority of its functional time, at least a portion of the device or the entire device is free to move relative to the stomach or small intestine. As a result of its included lumen, at no time during its normal function does the device completely or permanently block the passage of gastric contents into the small intestine for any clinically meaningful duration of time. Based on the shape of the sleeve, in various embodiments, the device can increase, decrease, or have no effect on, gastric emptying.

Figure 2IB is an illustration of an intragastric device 2140 having an oval shaped wire mesh structure 2141 deployed in the gastrointestinal tract of a patient, in accordance with another embodiment of the present specification. The wire mesh structure 2141 is positioned in the patient’s stomach 2160 and includes an anti-migration collar 2144 to which is attached a

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2016328478 30 Aug 2018 sleeve 2142. The sleeve 2142 includes a proximal, funnel shaped portion 2142p which resides in the stomach, just proximal to the pylorus 2161. The sleeve 2142 also includes a distal, cylindrically shaped portion 2142d which passes through the pylorus 2161 and the duodenum

2170 and ends in the jejunum 2172, where it releases the gastric contents passing through the intragastric device 2140, effectively bypassing the pylorus 2161 and duodenum 2170. In another embodiment, the sleeve has a shorter length and ends in the duodenum such that gastric contents passing through the intragastric device bypass only the pylorus and a proximal portion of the duodenum. At no time during its proper function is the device fixedly or permanently anchored to the wall of the gastrointestinal tract. After deployment, for a majority of its functional time, at least a portion of the device or the entire device is free to move relative to the stomach or small intestine. As a result of its included lumen, at no time during its normal function does the device completely or permanently block the passage of gastric contents into the small intestine for any clinically meaningful duration of time. Based on the shape of the sleeve, in various embodiments, the device can increase, decrease, or have no effect on, gastric emptying.

Figure 21C is an illustration of several views 2121, 2122, 2123, 2124 of a pylorus 2125 of a patient in an open state and a closed state with and without a sleeve 2126 of an intragastric device passing therethrough, in accordance with some embodiments of the present specification. In view 2121, the pylorus 2125 is closed and there is no sleeve extending therethrough. View 2122 shows a closed pylorus 2125 with a sleeve 2126 extending therethrough. Views 2123 and 2124 show partially open and fully open pylorus 2125 respectively, both with a sleeve 2126 extending therethrough. In various embodiments, the sleeve 2126 comprises a collapsible tubular reinforced membrane that opposes the pyloric orifice inner diameter wall. In various embodiments, the maximum inner diameter of the sleeve

2126 ranges from 25 mm to 40 mm with a wall thickness of approximately 0.2 mm. Any membrane, such as sleeve 2126, passing through the pylorus will have a negligible but finite cross-sectional area. In various embodiments, the cross-sectional area of the sleeve 2126 is approximately 15 mm², which is equivalent to a plug approximately 4.4 mm in diameter. In other words, the dynamic cross-sectional area of the pyloric orifice will always be reduced by approximately 15 mm² when a sleeve 2126 is passing therethrough.

Figure 22 is an illustration of an expanded wire mesh structure 2201 of a first intragastric device 2200 in a post-deployment configuration and a constricted wire mesh structure 2221 of a second intragastric device 2220 coupled to the distal end of an implantation catheter 2250, in accordance with one embodiment of the present specification. Second intragastric device 2220 also includes a sleeve 2222 coupled to the distal end of the wire mesh structure 2221. The wire

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2016328478 30 Aug 2018 mesh structure 2221 and sleeve 2222 of the second intragastric device 2220 have been compressed and slid coaxially onto the distal end of the implantation catheter 2250. In the pictured embodiment, the wire mesh structure 2221 and sleeve 2222 are maintained in their compressed configuration by a suture line or thread 2225 that has been wrapped about both the wire mesh structure 2221 and sleeve. Once the device 2220 has been positioned in the stomach and duodenum of a patient, the suture line or thread 2225 is unwound and the wire mesh structure 2221 and sleeve 2222 expand to their deployed configuration. As the device 2220 expands, it is released from the catheter 2250. The catheter 2250 is then removed from the patient. In another embodiment, the compressed wire mesh structure and sleeve are held in place over the implantation catheter via an overlaying coaxial sheath. Upon deployment, the sheath is unzipped, pulled away, or tom in a vertical direction to release the device.

Figure 23 is an illustration of an intragastric device 2300 with a partially constrained wire mesh structure 2301 on a delivery catheter 2350, in accordance with one embodiment of the present specification. The device 2300 also includes a coupled sleeve 2302 and anti15 migration component 2304. In the pictured embodiment, the proximal end of the wire mesh structure 2301 is still constricted by a suture or thread 2340. The sleeve 2302, anti-migration component 2304, and a portion of the wire mesh structure 2301 have begun to expand as the constricting suture or thread has already been removed from these components.

Figure 24A is an illustration of a first exemplary delivery device 2450 for an intragastric device 2400, in accordance with one embodiment of the present specification. An intragastric device 2400, comprising a compressed wire mesh structure 2401 and sleeve 2402, is positioned coaxially about the distal end of the delivery device or catheter 2450. A suture or thread 2440 is wrapped about the intragastric device 2400, maintaining the intragastric device 2400 in its compressed configuration. The catheter 2450 further includes a thread port 2458 from which the suture or thread 2440 used to compress the intragastric device 2400 exits the proximal end of the catheter 2450. A physician pulls on the free end 2459 of the suture or thread 2440 to release the intragastric device 2400. In one embodiment, the catheter 2450 also includes a locking mechanism 2455 for locking the device 2450 in position.

Figure 24B is a flow chart illustrating the steps involved in delivering an intragastric device using the delivery device of Figure 24A, in accordance with one embodiment of the present specification. At step 2410, a compressed intragastric device is placed coaxially over the distal end of the delivery device or catheter. The catheter is then inserted endoscopically into the patient and its distal end is advanced to the duodenum at step 2412. Then, at step 2414, the distal end of the catheter is positioned such that the wire mesh structure of the intragastric device is in the stomach just proximal to the pylorus and the sleeve of the device passes through

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2016328478 30 Aug 2018 the pylorus and into the duodenum. At step 2416, the physician pulls on the free end of the thread to remove the constricting thread from about the intragastric device, allowing the intragastric device to expand automatically. Finally, at step 2418, the catheter is slid coaxially away from the intragastric device and removed from the patient.

Figure 25A is an illustration of a second exemplary delivery device 2550 for an intragastric device 2500, in accordance with one embodiment of the present specification. An intragastric device 2500, comprising a compressed wire mesh structure 2501 and sleeve 2502, is positioned coaxially about the distal end of the delivery device or catheter 2550. A zippered constraining sheath 2541 is coaxially positioned over the intragastric device 2500, maintaining the intragastric device 2500 in its compressed configuration.

Figure 25B is a flow chart illustrating the steps involved in delivering an intragastric device using the delivery device of Figure 25A, in accordance with one embodiment of the present specification. At step 2510, a compressed intragastric device is placed coaxially over the distal end of the delivery device or catheter. The catheter is then inserted endoscopically into the patient and its distal end is advanced to the duodenum at step 2512. Then, at step 2514, the distal end of the catheter is positioned such that the wire mesh structure of the intragastric device is in the stomach just proximal to the pylorus and the sleeve of the device passes through the pylorus and into the duodenum. At step 2516, a working tool is used to unzip the compressing sheath from about the intragastric device, allowing the intragastric device to expand automatically. Finally, at step 2518, the catheter is slid coaxially away from the intragastric device and removed from the patient.

Alternatively, the sheath 2541 is a standard tubular sheath that is pulled off the intragastric device to release the intragastric device in the desired position. Figure 25C is a flow chart illustrating the steps involved in delivering an intragastric device using a delivery device comprising a pull away sheath, in accordance with one embodiment of the present specification. At step 2550, a compressed intragastric device is placed coaxially over the distal end of the delivery device or catheter. The catheter is then inserted endoscopically into the patient and its distal end is advanced to the duodenum at step 2552. Then, at step 2554, the distal end of the catheter is positioned such that the wire mesh structure of the intragastric device is in the stomach just proximal to the pylorus and the sleeve of the device passes through the pylorus and into the duodenum. At step 2556, a working tool is used to pull the compressing sheath coaxially away from about the intragastric device, allowing the intragastric device to expand automatically. Finally, at step 2558, the catheter is slid coaxially away from the intragastric device and removed from the patient.

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Figure 26A is an illustration of a third exemplary delivery device 2650 for an intragastric device 2600, in accordance with one embodiment of the present specification. An intragastric device 2600, comprising a compressed wire mesh structure 2601 and sleeve 2602, is positioned coaxially about the distal end of the delivery device or catheter 2650. A tear-away constraining sheath 2642 is coaxially positioned over the intragastric device 2600, maintaining the intragastric device 2600 in its compressed configuration.

Figure 26B is a flow chart illustrating the steps involved in delivering an intragastric device using the delivery device of Figure 26A, in accordance with one embodiment of the present specification. At step 2610, a compressed intragastric device is placed coaxially over the distal end of the delivery device or catheter. The catheter is then inserted endoscopically into the patient and its distal end is advanced to the duodenum at step 2612. Then, at step 2614, the distal end of the catheter is positioned such that the wire mesh structure of the intragastric device is in the stomach just proximal to the pylorus and the sleeve of the device passes through the pylorus and into the duodenum. At step 2616, a working tool is used to tear away a compressing sheath from about the intragastric device, allowing the intragastric device to expand automatically. Finally, at step 2618, the catheter is slid coaxially away from the intragastric device and removed from the patient.

Figure 26C is a flow chart illustrating the steps involved in delivering an intragastric device using the delivery device of Figure 26A, in accordance with another embodiment of the present specification. At step 2620, a compressed intragastric device is placed coaxially over the distal end of the delivery device or catheter. The catheter is then inserted endoscopically into the patient and its distal end is advanced to the stomach at step 2622. Then, at step 2624, the distal end of the catheter is positioned such that the wire mesh structure and the sleeve of the intragastric device are both positioned proximal to the pylorus. At step 2626, a working tool is used to tear away a compressing sheath from about the intragastric device, allowing the intragastric device to expand automatically. At step 2628, the catheter is slid coaxially away from the intragastric device and removed from the patient. Finally, at step 2630, gastric peristalsis pushes the sleeve of the intragastric device through the pylorus and into the duodenum.

Figure 26D is a flow chart illustrating the steps involved in delivering a wire mesh structure and sleeve separately and assembling an intragastric device within a patient’s gastrointestinal tract. At step 2660, the wire mesh structure is delivered into the stomach of a patient by a first catheter. Then, at step 2662, the sleeve is delivered into the wire mesh structure by a second catheter. The distal end of the sleeve is then extended through the distal opening

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2016328478 30 Aug 2018 in the wire mesh structure at step 2664. Finally, at step 2666, the proximal end of the sleeve is coupled to the distal end of the wire mesh structure.

Figures 27A and 27B are illustrations of a fourth exemplary delivery device 2700 for an intragastric device, in accordance with one embodiment of the present specification. The delivery device 2700 includes a flexible elongate device body, or outer catheter 2704 with a proximal end, a distal end, and a lumen within. The distal end includes an opening 2703 and the proximal end is attached to a first handle 2705. The first handle 2705 is used for positioning the delivery device 2700 in the gastrointestinal tract of a patient. A flexible plunger component 2716 is positioned coaxially, and movable longitudinally, within the lumen of the device body

2704. The plunger 2716 includes a proximal end, a distal end, and also includes a lumen within.

The distal tip 2714 of the plunger 2716 includes a mesh retention component 2719 comprising a plurality of fins 2715. The fins 2715 serve to securely hold the wire mesh structure 2701 of an intragastric device and push and pull the wire mesh structure 2701 as the plunger 2716 is moved back and forth within the device body 2704. A second handle 2706 is positioned at the proximal end of the plunger 2716 for moving the plunger 2716 longitudinally within the lumen of the device body 2704. Optionally, in one embodiment, the plunger 2716 includes a stopper 2718 which prevents the plunger 2716 from moving too far in a distal direction. A flexible elongate rod, or inner catheter 2717 is positioned coaxially, and movable longitudinally, within the lumen of the plunger 2716. The rod 2717 includes a proximal end and a distal end.

Positioned proximal the distal end of the rod 2717 is a first spherical component or olive 2708 and positioned at the distal end of the rod 2717 is a second spherical component or olive 2709. The first spherical component or olive 2708 has a diameter similar to or greater than that of the second spherical component or olive 2709. Attached to the proximal end of the rod 2717 is a third handle 2707 which is used for moving the rod 2717 longitudinally within the lumen of the plunger 2716. An intragastric device, comprising a wire mesh structure 2701 and a sleeve 2702, is positioned within the delivery device 2700 prior to deployment. The wire mesh structure 2701 is placed with a side loop about the rod 2717 and distal to the tip 2714 of the plunger 2716, with a portion of the wire mesh structure 2701 hooked on the fins 2715 of the tip 2714. In some embodiments, the rod 2717 passes through at least two openings in the wire mesh structure 2701 wherein the openings do not lie along a center longitudinal axis of the wire mesh structure 2701. In one embodiment, the wire mesh structure 2701 is compressed for positioning within the delivery device 2700 such that it has a compressed length of approximately 20 cm. The sleeve 2702, which is attached to the wire mesh structure 2701, is positioned distal to the wire mesh structure 2701 and proximal to the first spherical component or olive 2708. The sleeve 2702 is folded upon itself 2 to 10 times and then wrapped around the rod 2717. In one

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2016328478 30 Aug 2018 embodiment, the sleeve 2702 has a length of 80 cm and is folded upon itself 3 times resulting in a compressed length of approximately 30 cm. The sleeve 2702 is not passed coaxially over the rod 2717. Attached to the sleeve 2702 and looped on the rod 2717 in a position distal to the first spherical component or olive 2708 are first and second ends, respectively, of a suture loop

2713. The diameter of the suture loop 2713 about the rod is smaller than the diameter of the first spherical component or olive 2708 but greater than the diameter of the second spherical component or olive 2709. When the rod 2717 is pushed out of the device body 2704, the first spherical component or olive 2708 pushes the suture loop 2713 which pulls the attached sleeve 2702 out of the device body 2704. When the delivery device 2700, along with the rod 2717, are removed from the patient’s gastrointestinal tract, the suture loop 2713 slips over the smaller diameter second spherical component or olive 2709, allowing the intragastric device to remain in the patient. In one embodiment, the suture loop 2713 is biodegradable and dissolves over time. In another embodiment, the suture loop 2713 is non-biodegradable. In other embodiments, the suture loop 2713 is a biodegradable hook, ring, cone, or umbrella.

Optionally, in one embodiment, the delivery device 2700 further includes a balloon

2710 at the distal end of the device body 2704. A channel 2711 extends along the length of the device body 2704 and includes an input port 2712 at the proximal end of the device body 2704. The balloon 2710 is inflated using the input port 2712 and channel 2711 to anchor the delivery device within the patient’s gastrointestinal tract. Anchoring provides greater traction to the delivery device to allow for pushing and pulling during delivery of the intragastric device.

In some embodiments, the delivery device 2700 further includes a flushing or irrigation mechanism to reduce deployment forces during delivery.

In various embodiments, the delivery device or catheter has variable stiffness along its length. The delivery device is more flexible at its distal end and becomes less flexible along its length toward its proximal end. In some embodiments, the delivery device has three zones of flexibility: a proximal zone, a center zone, and a distal zone. In one embodiment, the proximal zone has a length of 100 cm and a flexibility of 55D, the center zone has a length of 20 cm and a flexibility of 40D, and the distal zone has a length of 30 cm and flexibility of 35D. Optionally, in one embodiment, the distal zone is split into two additional zones, comprising a more distal zone and a less distal zone. Both zones are 15 cm in length and the less distal zone has a flexibility of 35D while the more distal zone has a flexibility of 25D. In one embodiment, the proximal zone is braided and the center and distal zones are coiled.

The delivery device includes atraumatic distal ends and the three handle system of the delivery device allows for a shorter overall device body length. In various embodiments, referring to Figure 27B, the delivery device has the following dimensions: overall length

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2016328478 30 Aug 2018 ranging from 275 cm - 320 cm; length of said device body or outer catheter 2704 ranging from

100 cm - 150 cm; length of said plunger 2716 ranging from 120 cm - 150 cm; length of said rod or inner catheter 2717 ranging from 275 cm - 320 cm; length of each handle 2705, 2706,

2707 equal to 10 cm; distance between said second spherical component or olive 2709 and said first spherical component or olive 2708 ranging from 15 cm - 30 cm; distance between said first handle 2705 and said second handle 2706 when in an initial configuration before delivery equal to 60 cm; and, distance between said second handle 2706 and said third handle 2707 when in an initial configuration before delivery equal to 50 cm. In some embodiments, the outer diameter of the device body or outer catheter 2704 is 10 mm or less. In one embodiment, the delivery device is deployable over a 0.035 inch guidewire. In various embodiments, the plunger 2716 and rod 2717 are sufficiently flexible to allow for atraumatic intestinal navigation. In some embodiments, a solid outer catheter can bend up to 80 degrees and is capable of navigating curves having a radius 30 mm - 50 mm. In an embodiment, if a solid outer catheter is coiled into a radius of approximately 50 mm, the sleeve and mesh will kink or cinch in place and not deploy. Therefore, as depicted in Figure 27C, in some embodiments, the device body or outer catheter 2704 comprises a flexible braided catheter. The flexible braided catheter is capable of bending and coiling beyond the limits described above without causing failure of deployment of the sleeve and wire mesh.

Figure 27C is an illustration of a distal end of a delivery device 2700 depicting a pilot olive, or first spherical component 2709 for navigation, in accordance with one embodiment of the present specification. The pilot olive 2709 comprises a small sphere with a blunt outer surface attached to the distal end of the rod, or inner catheter 2717 of the delivery device 2700. The pilot olive 2709 guides the device 2700 during delivery and prevents kinking of the device 2700 and trauma to surrounding body tissues. Referring to Figure 27C, the portion of the inner catheter 2717 extending from the outer catheter 2704 comprises a pilot component. The stiffness of the pilot component is less than the stiffness of the distal portion of the outer catheter 2704. In some embodiments, the pilot component has a variable stiffness with a stiffness close to the stiffness of the distal end of the outer catheter 2704 at its proximal end and a stiffness close to that of a 0.035” guidewire at its distal end.

Figure 27D is an illustration of a portion of a delivery device 2700 depicting a mesh retention component 2719, in accordance with one embodiment of the present specification. The mesh retention component 2719 comprises a plurality of fins 2715. The fins 2715 serve to securely hold the wire mesh structure of an intragastric device and push and pull the wire mesh structure as the plunger 2716 is moved back and forth within the device body 2704.

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In one embodiment, the sleeve is only partially deployed during delivery. The wire mesh structure functions as an anchor to keep the device positioned. As the patient eats, the sleeve unfurls and becomes fully deployed due to the movements of the gastrointestinal tract.

Figure 27E is a flow chart illustrating the steps involved in delivering an intragastric 5 device using the delivery device of Figure 27A, in accordance with one embodiment of the present specification. At step 2720, the delivery device is slid over a guidewire into position within a patient’s gastrointestinal tract. At step 2721, a physician uses the first handle to position the distal end of the delivery device body in a duodenum of the patient. Optionally, at step 2722, the physician inflates a balloon at the distal end of the device body to anchor the delivery device in the patient’s gastrointestinal tract. The physician then pushes the second handle, pushing in the plunger component, until the sleeve is pushed out of the device body at step 2723. Optionally, the plunger includes a stopper so the physician knows when to stop pushing the second handle. At this point, the sleeve has been advanced approximately 20 cm, past the first spherical component and is positioned just proximal to the second spherical component. The wire mesh structure is positioned just proximal to the first spherical component and the opening at the distal end of the device body. Then, at step 2724, the physician pushes the third handle to advance the rod within the lumen of the plunger approximately 60 cm until the sleeve is fully deployed and is fully stretched or uncompressed. At step 2725, the physician repositions the device by pulling it back approximately 5 to 10 cm so that the distal end of the funnel section of the sleeve is within the stomach. Then, at step 2726, the physician pulls back on the first handle while holding the second handle steady to deploy the funnel section of the sleeve and the wire mesh structure in the stomach. This pulls the device body back while keeping the plunger in place, thus releasing the wire mesh structure. The delivery device is then removed from the patient at step 2727, leaving the intragastric device deployed in the patient’s gastrointestinal tract.

Figure 28A is an illustration of a fifth exemplary delivery device 2830 for an intragastric device, in accordance with one embodiment of the present specification. The delivery device 2830 includes a flexible elongate device body, or outer catheter 2834 with a proximal end, a distal end, and a lumen within. The distal end includes an opening 2833 and the proximal end is attached to an actuating mechanism 2835. The actuating mechanism 2835 includes an actuator handle 2849 and an actuator trigger 2848 and is used to move the components of the delivery device relative to one another. The actuating mechanism is also used for positioning the delivery device 2830 in the gastrointestinal tract of a patient. A flexible plunger component 2846 is positioned coaxially, and movable longitudinally, within the lumen of the device body

2834. The plunger 2846 includes a proximal end, a distal end, and also includes a lumen within.

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The distal tip 2844 of the plunger 2846 includes a mesh retention component 2819 comprising a plurality of fins 2845. The fins 2845 serve to securely hold the wire mesh structure 2831 of an intragastric device and push and pull the wire mesh structure 2831 as the plunger 2846 is moved back and forth within the device body 2834. The proximal end of the plunger 2846 is positioned within the actuating mechanism wherein pulling the actuation trigger 2848 causes the plunger 2846 to move back and forth longitudinally within the lumen of the device body 2834. A flexible elongate rod, or inner catheter 2847 is positioned within the lumen of the plunger 2846. The rod 2847 includes a proximal end and a distal end. Positioned proximal the distal end of the rod 2847 is a first spherical component or olive 2838 and positioned at the distal end of the rod 2847 is a second spherical component or olive 2839. The olives 2838, 2839 comprise spherical attachments which assist in guiding delivery of the intragastric device. The first spherical component or olive 2838 has a diameter greater than that of the second spherical component or olive 2839. Attached to the proximal end of the rod 2847 is a rod handle 2837 which is used for moving the rod 2847 longitudinally within the lumen of the plunger

2846. An intragastric device, comprising a wire mesh structure 2831 and a sleeve 2832 is positioned within the delivery device 2830 prior to deployment. In various embodiments, the sleeve is compressed axially. In other embodiments, the sleeve is not compressed coaxially. The wire mesh structure 2831 is placed with a side loop about the rod 2847 and distal to the tip 2844 of the plunger 2846, with a portion of the wire mesh structure 2831 hooked on the fins

2845 of the tip 2844. The sleeve 2832, which is attached to the wire mesh structure 2831, is positioned distal to the wire mesh structure 2831 and proximal to the first spherical component or olive 2838. The sleeve 2832 is folded upon itself 2 to 10 times and then wrapped around the rod 2847. The sleeve 2832 is not passed coaxially over the rod 2847. Attached to the sleeve 2832 and looped on the rod 2847 in a position distal to the first spherical component or olive

2838 is a suture loop 2843. The diameter of the suture loop 2843 about the rod 2847 is smaller than the diameter of the first spherical component or olive 2838 but greater than the diameter of the second spherical component or olive 2839. When the rod 2847 is pushed out of the device body 2834, the first spherical component or olive 2838 pushes the suture loop 2843 which pulls the attached sleeve 2832 out of the device body 2834. When the delivery device

2830, along with the rod 2847, are removed from the patient’s gastrointestinal tract, the suture loop 2843 slips over the smaller diameter second spherical component or olive 2839, allowing the intragastric device to remain in the patient. In one embodiment, the suture loop 2843 is biodegradable and dissolves over time. In other embodiments, the suture loop 2843 is a biodegradable hook, ring, cone, or umbrella.

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Optionally, in one embodiment, the delivery device 2830 further includes a balloon

2840 at the distal end of the device body 2834. A channel 2841 extends along the length of the device body 2834 and includes an input port 2842 at the proximal end of the device body 2834.

The balloon 2840 is inflated using the input port 2842 and channel 2841 to anchor the delivery device within the patient’s gastrointestinal tract. Anchoring provides greater traction to the delivery device to allow for pushing and pulling during delivery of the intragastric device.

Figure 28B is a flow chart illustrating the steps involved in delivering an intragastric device using the delivery device of Figure 28A, in accordance with one embodiment of the present specification. At step 2850, the delivery device is slid over a guidewire into position within a patient’s gastrointestinal tract. At step 2851, a physician uses the actuating mechanism to position the distal end of the delivery device body in a duodenum of the patient. Optionally, at step 2852, the physician inflates a balloon at the distal end of the device body to anchor the delivery device in the patient’s gastrointestinal tract. The physician then pulls on the actuation trigger until it locks a first time, pushing in rod handle, until the sleeve is pushed out of the device body at step 2853. Optionally, the plunger includes a stopper so the physician knows when to stop pushing the second handle. At this point, the sleeve has been advanced approximately 20 cm, past the first spherical component and is positioned just proximal to the second spherical component. The wire mesh structure is positioned just proximal to the first spherical component and the opening at the distal end of the device body. Optionally, at step

2854, the physician pulls on the trigger to advance the plunger approximately 60 cm until the sleeve is fully deployed and is fully stretched or uncompressed. At step 2855, the physician repositions the device by pulling it back approximately 5 to 10 cm so that the distal end of the funnel section of the sleeve is within the stomach. Then, at step 2856, the physician pulls on the actuation trigger again until it locks a second time. This pulls the device body back while keeping the plunger in place, thus releasing the funnel section of the sleeve and the wire mesh structure. The delivery device is then removed from the patient at step 2857, leaving the intragastric device deployed in the patient’s gastrointestinal tract.

Figure 29A is an illustration of yet another exemplary delivery device 2900 for an intragastric device, in accordance with one embodiment of the present specification. The delivery device 2900 of Figure 29A differs from the delivery device 2700 depicted in Figure 27A in that it includes only two handles 2905, 2906 and a device body or outer catheter 2904 and rod or inner catheter 2917. The delivery device 2900 of Figure 29A does not include a separate plunger with its own handle. Instead, a plunger 2916 is integrated with the second handle 2906 and coaxially envelopes a proximal portion of the inner catheter 2917. The delivery device 2900 includes a flexible elongate device body, or outer catheter 2904 with a

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2016328478 30 Aug 2018 proximal end, a distal end, and a lumen within. The distal end includes an opening 2903 and the proximal end is attached to a first handle 2905. The first handle 2905 is used for positioning the delivery device 2900 in the gastrointestinal tract of a patient. In one embodiment, the first handle 2905 includes a Y-connector. A flexible elongate rod, or inner catheter 2917 is positioned coaxially, and movable longitudinally, within the lumen of the outer catheter 2904. The rod 2917 includes a proximal end attached to a second handle 2906 and a distal end. A flexible plunger component 2916 is positioned coaxially over a proximal portion of, and moves longitudinally with, the inner catheter 2917. The plunger 2916 includes a proximal end also attached to second handle 2906 and a distal end. The distal tip of the plunger 2916 includes a mesh retention component 2919 comprising a plurality of fins 2915. The fins 2915 serve to securely hold the wire mesh structure 2901 of an intragastric device and push and pull the wire mesh structure 2901 as the plunger 2916 and inner catheter 2917 are moved back and forth within the outer catheter 2904. The second handle 2906 is positioned at the proximal end of the plunger 2916 and inner catheter 2917 for moving the plunger 2916 and inner catheter 2917 longitudinally within the lumen of the outer catheter 2904. Optionally, in one embodiment, the plunger includes a stopper which prevents the plunger and inner catheter from moving too far in a distal direction. Positioned proximal the distal end of the inner catheter 2917 is a first spherical component or olive 2908 and positioned at the distal end of the inner catheter 2917 is a second spherical component or olive 2909. The first spherical component or olive 2908 has a diameter greater than that of the second spherical component or olive 2909. An intragastric device, comprising a wire mesh structure 2901 and a sleeve 2902, is positioned within the delivery device 2900 prior to deployment. The wire mesh structure 2901 is placed with a side loop about the rod 2917 and distal to the tip of the plunger 2916, with a portion of the wire mesh structure 2901 hooked on the fins 2915 of the retention component 2919. In some embodiments, the rod 2917 passes through at least two openings in the wire mesh structure

2901 wherein the openings do not lie along a center longitudinal axis of the wire mesh structure 2901. In one embodiment, the wire mesh structure 2901 is compressed for positioning within the delivery device 2900 such that it has a compressed length of approximately 30 cm. The sleeve 2902, which is attached to the wire mesh structure 2901, is positioned distal to the wire mesh structure 2901 and proximal to the first spherical component or olive 2908. The sleeve

2902 is folded upon itself 2 to 10 times and then wrapped around the inner catheter 2917. In one embodiment, the sleeve 2902 has a length of 80 cm and is folded upon itself 3 times resulting in a compressed length of approximately 30 cm. The sleeve 2902 is not passed coaxially over the inner catheter 2917. Attached to the sleeve 2902 and looped on the inner catheter 2917 in a position distal to the first spherical component or olive 2908 are first and

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2016328478 30 Aug 2018 second ends, respectively, of a suture loop 2913. The diameter of the suture loop 2913 about the rod is smaller than the diameter of the first spherical component or olive 2908 but greater than the diameter of the second spherical component or olive 2909. When the inner catheter

2917 is pushed out of the outer catheter 2904, the first spherical component or olive 2908 pushes the suture loop 2913 which pulls the attached sleeve 2902 out of the outer catheter 2904. When the delivery device 2900, along with the inner catheter 2917, are removed from the patient’s gastrointestinal tract, the suture loop 2913 slips over the smaller diameter second spherical component or olive 2909, allowing the intragastric device to remain in the patient. In one embodiment, the suture loop 2913 is biodegradable and dissolves over time. In other embodiments, the suture loop 2913 is a biodegradable hook, ring, cone, or umbrella.

Optionally, in one embodiment, the delivery device 2900 further includes a balloon at the distal end of the device body. A channel extends along the length of the device body and includes an input port at the proximal end of the device body. The balloon is inflated using the input port and channel to anchor the delivery device within the patient’s gastrointestinal tract.

Anchoring provides greater traction to the delivery device to allow for pushing and pulling during delivery of the intragastric device.

In some embodiments, the delivery device 2900 further includes a flushing or irrigation mechanism to reduce deployment forces during delivery.

In various embodiments, the delivery device or catheter has variable stiffness along its 20 length. The delivery device is more flexible at its distal end and becomes less flexible along its length toward its proximal end. In some embodiments, the delivery device has three zones of flexibility: a proximal zone, a center zone, and a distal zone. In one embodiment, the proximal zone has a length of 100 cm and a flexibility of 55D, the center zone has a length of 20 cm and a flexibility of 40D, and the distal zone has a length of 30 cm and flexibility of 35D.

Optionally, in one embodiment, the distal zone is split into two additional zones, comprising a more distal zone and a less distal zone. Both zones are 15 cm in length and the less distal zone has a flexibility of 35D while the more distal zone has a flexibility of 25D. In one embodiment, the proximal zone is braided and the center and distal zones are coiled.

The delivery device includes atraumatic distal ends and the two handle system of the delivery device allows for a shorter overall device body length. In various embodiments, the delivery device has the following dimensions: overall length ranging from 265 cm - 310 cm; length of said device body or outer catheter 2904 ranging from 100 cm - 150 cm; length of said plunger 2916 ranging from 120 cm - 150 cm; length of said rod or inner catheter 2917 ranging from 265 cm - 310 cm; length of each handle 2905, 2906, 2907 equal to 10 cm; distance between said second spherical component or olive 2909 and said first spherical component or

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2016328478 30 Aug 2018 olive 2908 ranging from 15 cm - 30 cm; and, distance between said first handle 2905 and said second handle 2906 when in an initial configuration before delivery equal to 110 cm. In some embodiments, the outer diameter of the device body or outer catheter 2904 is 10 mm or less. In one embodiment, the delivery device is deployable over a 0.035 inch guidewire. In various embodiments, the plunger 2916 and inner catheter 2917 are sufficiently flexible to allow for atraumatic intestinal navigation. In some embodiments, a solid outer catheter can bend up to 80 degrees and is capable of navigating curves having a radius 30 mm - 50 mm. In an embodiment, if a solid outer catheter is coiled into a radius of approximately 50 mm, the sleeve and mesh will kink or cinch in place and not deploy. Therefore, in some embodiments, the outer catheter 2904 comprises a flexible braided catheter. The flexible braided catheter is capable of bending and coiling beyond the limits described above without causing failure of deployment of the sleeve and wire mesh.

In some embodiments, the outer catheter has a variable stiffness along its length and the inner catheter, coaxially positioned inside the outer catheter, includes an atraumatic distal end and a lumen for receiving a guiding device. Prior to delivery, an intragastric device is positioned in a space between the inner catheter and the outer catheter. The inner catheter further includes a flexible extension having a length of at least 5 cm at its distal end which extends beyond a distal end of the outer catheter. In some embodiments, the guiding device is a guidewire. In other embodiments, the guiding device is an endoscope for over the scope delivery. In some embodiments, the atraumatic distal end of the inner catheter is a ball-tip. In some embodiments, the inner catheter has a variable stiffness along its length. In some embodiments, said flexible extension includes a proximal end and a distal end and has a variable stiffness along its length wherein the stiffness varies between a stiffness of a guidewire at said distal end to a stiffness of said inner catheter at said proximal end. In other embodiments, the stiffness of the flexible extension is constant along its length.

Figure 29B is a cross sectional illustration of a pre-deployment coaxial arrangement of a sleeve 2935 of an intragastric device within a delivery device 2930, in accordance with one embodiment of the present specification. The delivery device 2930 comprises an inner catheter 2933 positioned coaxially within a lumen 2936 of an outer catheter 2937. The inner catheter

2933 includes a guide wire port 2932 for insertion of a guide wire to assist in guiding delivery.

In various embodiments, the guide wire is a super stiff guide wire having a diameter in a range of 0.035 to 0.038 inches. In the arrangement depicted in Figure 29B, the sleeve 2935 is depicted

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2016328478 30 Aug 2018 around the inner catheter 2933 such that the inner catheter 2933 is positioned within a lumen

2934 of the sleeve 2935.

Figure 29C is a cross sectional illustration of a pre-deployment coaxial arrangement of a sleeve of 2935 an intragastric device within a delivery device 2930, in accordance with another embodiment of the present specification. The delivery device 2930 comprises an inner catheter 2933 positioned coaxially within a lumen 2936 of an outer catheter 2937. The inner catheter 2933 includes a guide wire port 2932 for insertion of a guide wire to assist in guiding delivery. In the arrangement depicted in Figure 29C, the sleeve 2935 is depicted adjacent the inner catheter 2933 such that the inner catheter 2933 is positioned outside of a lumen 2934 of the sleeve 2935.

Figure 29D is a cross sectional illustration of a pre-deployment coaxial arrangement of a sleeve 2933 of an intragastric device within a delivery device 2930 depicted over an endoscope 2939, in accordance with one embodiment of the present specification. The delivery device 2930 comprises an inner catheter 2933 positioned coaxially within a lumen 2936 of an outer catheter 2937. The inner catheter 2933 includes an endoscope port 2938, within which is positioned an endoscope 2939, to assist in guiding delivery. In the arrangement depicted in Figure 29D, the sleeve 2935 is depicted around the inner catheter 2933 such that the inner catheter 2933 is positioned within a lumen 2934 of the sleeve 2935.

In some embodiments, a system for delivering an intragastric device to a gastrointestinal tract of a patient comprises: a porous mesh structure having a first lumen; a sleeve attached to said porous mesh structure and having a second lumen; and, a coaxial catheter system comprising an outer catheter and an inner catheter, wherein, prior to delivery, said porous mesh structure and said sleeve are constrained into a space between said outer and inner catheters wherein the outer catheter covers a substantial portion of the intragastric device and the inner catheter passes within a majority of the first lumen of the mesh but outside of a majority of the second lumen of the sleeve. In some embodiments, the inner catheter is operationally attached to the sleeve at a distal end of the inner catheter such that, when actuated, the inner catheter pushes the sleeve out of the coaxial catheter system and is then detached from the sleeve to deliver the intragastric device in the gastrointestinal tract.

Figure 29E is a flow chart illustrating the steps involved in delivering an intragastric device using the delivery device of Figure 29A, in accordance with one embodiment of the present specification. At step 2920, the delivery device is slid over a guidewire into position within a patient’s gastrointestinal tract. At step 2921, a physician uses the first handle to position the distal end of the delivery device body in a duodenum of the patient. Optionally, at step 2922, the physician inflates a balloon at the distal end of the device body to anchor the

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2016328478 30 Aug 2018 delivery device in the patient’s gastrointestinal tract. The physician then pushes the second handle (approximately 60 cm) to advance the plunger and inner catheter until the sleeve is pushed out of the delivery device body and fully deployed at step 2923. Optionally, the plunger includes a stopper so the physician knows when to stop pushing the second handle. At step

2924, the physician repositions the device by pulling it back approximately 5 to 10 cm so that the distal end of the funnel section of the sleeve is within the stomach. Then, at step 2925, the physician pulls back on the first handle while holding the second handle steady to deploy the funnel section of the sleeve and the wire mesh structure in the stomach. This pulls the device body back while keeping the plunger and inner catheter in place, thus releasing the wire mesh structure. The delivery device is then removed from the patient at step 2926, leaving the intragastric device deployed in the patient’s gastrointestinal tract.

Figure 30A is an illustration of a seventh exemplary delivery device 3000 for an intragastric device, in accordance with one embodiment of the present specification. The delivery device 3000 comprises a coaxial delivery system having flexible outer catheter 3002 and flexible inner catheter 3001 shafts on which an intragastric device is preloaded. The outer catheter 3002 includes a proximal end and a distal end and a lumen within. The inner catheter 3001 is positioned within the lumen of the outer catheter 3002 and also includes a proximal end and a distal end and a lumen within. The lumen of the inner catheter 3001 is configured to receive a guide wire. In various embodiments, the delivery device 3000 is approximately 3 meters in length and is used to deliver an intragastric device trans-orally into the stomach and duodenum or jejunum of a patient. The delivery device 3000 has a variable stiffness along its length providing sufficient flexibility to track through the small intestinal loops while also having sufficient pushability to prevent gastric looping. In various embodiments, the outer catheter 3002 has a length of approximately 1.5 meters. In some embodiments, a distal portion of the outer catheter 3002 includes a lubricious hydrophilic coating which can be activated just prior to delivery to ease navigation. In one embodiment, the coating covers approximately the distal 0.65 meters of the outer catheter 3002. The proximal end of the device 3000 includes a proximal portion of the inner catheter 3001 not covered by the outer catheter 3002. A pair of stopping mechanisms 3004, 3006 are positioned on the inner catheter 3001 as further described with reference to Figures 30E and 30G. A first handle 3003, having a proximal end, a distal end, and lumen configured to receive a guide wire, is attached to the proximal end of the inner catheter 3001. A second handle 3008, having a proximal end, a distal end, and a lumen configured to receive said inner catheter 3001, is attached to the proximal end of the outer catheter 3002 and is positioned coaxially about, and slidably over, the inner catheter 3001.

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Movement of the second handle 3008 proximally and distally relative to the first handle 3003 results in sliding of the outer catheter 3002 over the inner catheter 3001 proximally and distally.

Extending distally from the distal end of the inner catheter 3001 is a pilot component

3007. The pilot component comprises an elongate ultra-flexible rod having a proximal end and a distal end. The proximal end of the pilot component includes a proximal spherical component, or olive as described with reference to Figures 30D and 30E below. The distal end of the pilot component 3007 includes a distal spherical component, or olive, as described further with reference to Figures 30D and 30F below. In some embodiments, the pilot component 3007 is also covered with a lubricious hydrophilic coating.

Figure 30B is an illustration of one exemplary embodiment of an outer catheter 3050 for use in the delivery device of Figure 30A. The outer catheter 3050 includes three segments of varying stiffness, each having a proximal end, a distal end, and a lumen: a proximal segment 3051, a center segment 3052, and a distal segment 3053. Attached to the proximal end of the proximal segment 3051 is the second handle 3054. Attached to the distal end of the distal segment 3053 is a soft tip 3055. Both the second handle 3054 and soft tip 3055 include lumens for receiving an inner catheter. In one embodiment, the outer catheter 3050 includes a first radiopaque marker 3056 at the junction of the soft tip 3055 with the distal segment 3053 and a second radiopaque marker 3057 on the center segment 3052, approximately 4-6 cm from the junction of the center segment 3052 with the proximal segment 3051. In various embodiments, the proximal segment 3051 has a length of approximately 85 cm and a stiffness which is 120% of the stiffness of the center segment 3052. In various embodiments, the center segment 3052 has a length in a range of approximately 52-54 cm. In various embodiments, the distal segment 3053 has a length in a range of approximately 11-13 cm and a stiffness which is 80% of the stiffness of the center segment 3052. In various embodiments, the outer catheter 3050 has an overall length in a range of 150-152 cm, not including the second handle 3054 or soft tip 3055. In one embodiment, the second handle 3054 has a length of 10 cm. In one embodiment, the soft tip 3055 has a length of 0.5 cm. During delivery, the second handle 3054 is positioned outside the patient’s body. In some embodiments, during delivery, approximately the proximal 50 cm of the proximal segment 3051 is positioned in the esophagus. In some embodiments, during delivery, approximately the distal 35 cm of the proximal segment 3051 and the proximal 4-6 cm of the center segment 3052 are positioned in the stomach. In some embodiments, during delivery, approximately the distal 48 cm of the center segment 3052 and the entirety of the distal segment 3053 and soft tip 3055 are positioned in the intestine.

Figure 30C is an illustration of another embodiment of an outer catheter 3070 depicting the dimensions a compressed sleeve 3062 and compressed wire mesh structure 3061 of an

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2016328478 30 Aug 2018 intragastric device 3060 relative to the dimensions of the outer catheter 3070. The outer catheter

3070 of Figure 30C includes only a proximal segment 3071 and a distal segment 3073. The distal segment 3073 has a length in a range of 63-67 cm, with 59-61 cm positioned in the intestine and 4-6 cm positioned in the stomach. The compressed sleeve 3062 has a length in a range of 54-56 cm, is contained fully within the distal segment 3073, and is positioned entirely within the intestine. The compressed wire mesh structure 3061 has a length in a range of approximately 29-31 cm. Approximately 9-11 cm of wire mesh structure 3061 is contained within the proximal end of the distal segment 3073 and 19-21 cm of the wire mesh structure 3061 is contained within the distal end of the proximal segment 3071. Approximately 4-6 cm of the wire mesh structure 3061 is positioned in the intestine and 24-26 cm of the wire mesh structure is positioned in the stomach.

Figure 30D is a close up illustration of the distal end of the delivery device 3000 of Figure 30A, depicting the pilot component 3007 and proximal 3011 and distal 3013 spherical components. The proximal spherical component 3011 is shaped to be atraumatic and includes a radiopaque marker 3012 for radiographic visualization during delivery. The distal spherical component 3013 is configured in a ball-tip shape and is also designed to be atraumatic to body tissues. The design of the pilot component 3007 and proximal 3011 and distal 3013 spherical components is configured to facilitate atraumatic and easy ‘over-the-guide wire’ tracking through the intestinal loops. The stiffness of the pilot component 3007 is less than the stiffness of the distal portion of the outer catheter. In some embodiments, the pilot component 3007 has a variable stiffness with a stiffness close to the stiffness of the distal end of the outer catheter at its proximal end and a stiffness close to that of a 0.035” guidewire at its distal end.

Figure 30E is an illustration of the proximal end of the delivery device of Figure 30A, depicting the outer catheter 3002 retracted to a first stopping mechanism 3004. During delivery of an intragastric device which has been preloaded on the delivery device, a user steadies the first handle 3003 to hold inner catheter 3001 in place while using the second handle 3008 to retract, or slide proximally, the outer catheter 3002 over the inner catheter 3001. The outer catheter 3002 is retracted until a proximal end of the second handle 3008 contacts a first stopping mechanism 3004. A second stopping mechanism 3006 is also positioned on the inner catheter 3001, proximal to the first stopping mechanism 3004. In some embodiments, the stopping mechanisms 3004, 3006 comprise plastic rings firmly secured to the inner catheter using wing nuts 3004a, 3006a. In some embodiments, the first handle 3003 includes a first port 3013 for injection of a fluid, such as saline or water, for flushing the lumen of the inner catheter 3001. In some embodiments, the second handle 3008 includes a second port 3018 for injection of a fluid, such as saline or water, for flushing the lumen of the outer catheter 3002.

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Figure 30F is an illustration of one embodiment of a sleeve 3022 of an intragastric device partially deployed corresponding to the outer catheter 3002 position depicted in Figure

30E. Referring to Figures 30E and 30F simultaneously, when the outer catheter 3002 has been retracted such that the proximal end of the second handle 3008 is in contact with the first stopping mechanism 3004, the sleeve 3022 has been partially deployed as depicted in Figure 30F. The portion of the sleeve 3022 deployed is the cylindrical distal portion 1622d as described with reference to Figure 16D. This is the portion of the sleeve 3022 which resides in the small intestine of the patient. The outer catheter 3002 has been retracted to the junction point 1622j of the sleeve described in Figure 16D. As pictured in Figure 30F, in some embodiments, the sleeve 3022 is wrapped coaxially around the inner catheter 3001 of the delivery device. In other words, the inner catheter 3001 does not pass through the lumen of the sleeve 3022. In one embodiment, the distal end of the outer catheter 3002 includes a radiopaque marker 3009 to ensure proper placement of the delivery device under radiographic visualization.

Figure 30G is an illustration of the proximal end of the delivery device of Figure 30A, depicting the outer catheter 3002 retracted to a second stopping mechanism 3006. The first stopping mechanism has been removed to allow further retraction of the outer catheter 3002. Continuing with delivery of an intragastric device, the user steadies the first handle 3003 to hold inner catheter 3001 in place while using the second handle 3008 to further retract the outer catheter 3002 over the inner catheter 3001. The outer catheter 3002 is retracted until a proximal end of the second handle 3008 contacts the second stopping mechanism 3006.

Figure 3 OH is an illustration of one embodiment of a wire mesh structure 3021 of an intragastric device partially deployed corresponding to the outer catheter 3002 position depicted in Figure 30G. Referring to Figures 30G and 30H simultaneously, when the outer catheter 3002 has been retracted such that the proximal end of the second handle 3008 is in contact with the second stopping mechanism 3006, the wire mesh structure 3021 has been partially deployed as depicted in Figure 30H. The anti-migration collar 3024 of the wire mesh structure 3021 has been deployed and, as a result of its shape memory properties, has everted to its postdeployment configuration from its pre-deployment configuration as depicted in Figure 1 ID.

The proximal end of the now fully deployed sleeve 3022 is depicted attached to the antimigration collar 3024. As pictured in Figure 30H, in some embodiments, the inner catheter 3001 is passed through spaces between the wires of wire mesh structure 3021 along a side of said structure 3021. In other words, the inner catheter 3001 does not pass through the center of the wire mesh structure 3021.

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Figure 301 is a flow chart illustrating the steps involved in delivering an intragastric device using the delivery device of Figure 30A, in accordance with one embodiment of the present specification. At step 3030, optionally, the distal end of the delivery device is wetted to activate a lubricious hydrophilic coating, which will ease insertion and navigation of the delivery device. The delivery device is then slid over a guide wire and into a patient’s gastrointestinal tract at step 3032. Fluoroscopy is used at step 3034 to determine the location of the distal end of the outer catheter to ensure correct positioning of the delivery device. While the first handle is held firmly to keep the inner catheter in place, the outer catheter is retracted to the first stopping mechanism to deploy and position a portion of the sleeve of a pre-loaded intragastric device within an intestinal portion of the patient’s gastrointestinal tract at step 3036.

Then, at step 3038, the entire delivery device is retracted until the distal end of the outer catheter is positioned just proximal to the pylorus. The first stopping mechanism is removed from the inner catheter at step 3040. While the first handle is held firmly to keep the inner catheter in place, the outer catheter is retracted to the second stopping mechanism to deploy and position a portion of the sleeve and a portion of the wire mesh structure of the intragastric device within a stomach portion of the patient’s gastrointestinal tract at step 3042. At step 3044, the second stopping mechanism is removed from the inner catheter. While the first handle is held firmly to keep the inner catheter in place, the outer catheter is retracted to the first handle to deploy and position all of the wire mesh structure within the stomach portion of the patient’s gastrointestinal tract at step 3046. The delivery device is then removed from the patient at step 3048.

Figure 31A is an illustration of a wire mesh structure 3101 of an intragastric device 3100 being loaded onto a delivery device, in accordance with one embodiment of the present specification. Referring to Figure 31 A, a portion of the inner catheter 3131 and pilot component

3137 of the delivery device are depicted. The delivery device includes a proximal spherical component 3135 at the transition from inner catheter 3101 to pilot component 3137. The wire mesh structure 3101 includes a sleeve 3102 attached to its anti-migration collar 3104. When loading the intragastric device 3100 onto the delivery device, the pilot component 3137 is passed through an off-center opening between the wires of the wire mesh structure 3101 such that the proximal spherical component 3135 is positioned just distal to the wire mesh structure 3101 and the inner catheter 3131 lies within the internal volume of the wire mesh structure 3101.

Figure 3IB is an illustration of the wire mesh structure 3101 of Figure 31A further loaded onto the delivery device. The proximal end of the wire mesh structure 3101 has been compressed and is now contained within the distal end of the outer catheter 3132 of the delivery

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2016328478 30 Aug 2018 device. The proximal spherical component is no longer visible as the wire mesh structure 3101 has been advanced proximally along the inner catheter 3131. Referring to Figure 3 IB, the inner catheter is depicted exiting the wire mesh structure 3101 through an opening offset from center of the wire mesh structure 3101. The sleeve is then wrapped coaxially about the inner catheter as described with reference to Figure 31C. In another embodiment, the inner catheter (and attached pilot component) continues within the wire mesh structure and exits through an opening in a side of the proximal, funnel shaped portion of the sleeve. In another embodiment, the inner catheter continues within the wire mesh structure and exits through an opening in a side of the distal, cylindrically shaped portion of the sleeve. In yet another embodiment, the inner catheter continues within the wire mesh structure, passes through the entire sleeve, and exits through the opening in the distal end of the sleeve.

Figure 31C is an illustration of the wire mesh structure 3101 of Figure 31A loaded onto the delivery device such that only the anti-migration collar 3104 remains to be loaded. Figure 3 ID is an illustration of the wire mesh structure of Figure 31A fully loaded onto the delivery device. Referring to Figure 3 ID, the wire mesh structure is no longer visible as it is fully contained within the distal end of the outer catheter 3132. The sleeve 3102 is depicted wrapped coaxially about the inner catheter 3131.

Figure 3 IE is an illustration of a sleeve 3102 of the intragastric device of Figure 31A partially loaded onto the delivery device. A portion of the sleeve 3102, wrapped coaxially about the inner catheter 3131, is visible extending from the distal end of the outer catheter 3132. Figure 3 IF is an illustration of the intragastric device of Figure 31A fully loaded onto the delivery device. The proximal spherical component 3135 is positioned at the distal end of the outer catheter 3132. In one embodiment, a plurality of sutures 3105 extending from the distal end of the sleeve are tied about the proximal spherical component 3135 to maintain the intragastric device in place until ready for delivery. Prior to delivery, the sutures 3105 are undone so the intragastric device may be deployed.

Figure 32A is an illustration of a retrieval device 3200 for removing an intragastric device in accordance with another embodiment of the present specification. The retrieval device 3200 includes a flexible outer tube 3202 comprising an elongate body having a proximal end, a distal end, and a lumen within. A first handle 3212 is attached to the proximal end and an opening 3222 is positioned at the distal end of the outer tube 3202. A flexible inner member 3204 comprising an elongate body with a proximal end and a distal end is disposed within the lumen of the outer tube 3202. In one embodiment, the inner member 3204 comprises a flexible metal wire. A second handle 3214 is attached to the proximal end and a retrieval mechanism

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3224 is formed from the distal end of the inner member 3204. In one embodiment, the retrieval mechanism 3224 comprises a hook. In one embodiment, the hook is lockable.

Figure 32B is a flow chart illustrating the steps involved in removing an intragastric device from a patient using the retrieval device of Figure 32A, in accordance with one embodiment of the present specification. At step 3232, a physician inserts the outer tube of the retrieval device into a working channel of an endoscope inserted into a patient. At this point, the retrieval mechanism at the distal end of the inner member is contained within the distal end of the outer tube. At step 3234, the physician holds the first handle securely to position the retrieval device within the gastrointestinal tract of the patient. Then, at step 3236, the physician pushes on the second handle to extend the retrieval mechanism through the opening and beyond the distal end of the outer tube. The physician manipulates the second handle to grasp a proximal end of the intragastric device with the retrieval mechanism at step 3238. In one embodiment, the proximal end of the intragastric device includes a set of staggered nodes, as depicted as nodes 1615 with reference to Figure 16B, to ease grasping with the retrieval mechanism. Once the intragastric device has been secured by the retrieval mechanism, the physician pulls on the second handle to pull the retrieval mechanism and at least a portion of the attached intragastric device into the distal end of the outer tube at step 3240. The intragastric device is composed of a shape memory metal so that it is easily compressible to a size capable of fitting into said outer tube. Optionally, at step 3242, the physician actuates a locking mechanism on the retrieval device to prevent the retrieval mechanism and attached intragastric device from slipping out of the distal end of the outer tube. Finally, at step 3244, the physician removes the retrieval device and attached intragastric device from the patient.

Figure 33A is an illustration of an embodiment of an intragastric device 3300 in an exemplary post-deployment configuration having a dumbbell shape. The device 3300 includes a first, upper wire mesh 3361 at its proximal end and a second, lower wire mesh 3362 at its distal end. The internal volumes of the two wire meshes 3361, 3362 are in fluid communication with one another. In various embodiments, the size of the second wire mesh 3362 is equal to or smaller than the size of the upper wire mesh 3361. The device 3300 further includes a first opening 3363 at the proximal end of the upper wire mesh 3361 and a second, larger opening

3364 at the distal end of the lower wire mesh 3362. Food enters the device 3300 at the first opening 3363, travels through the internal volume of the upper wire mesh 3361, into and through the internal volume of the lower wire mesh 3362, and exits through the second opening

3364. In one embodiment, the wire mesh of the lower wire mesh portion 3362 is an extension of the wire mesh of the upper wire mesh portion 3361. In another embodiment, the two wire mesh portions 3361, 3362 are comprised of separate wire mesh structures which are then

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2016328478 30 Aug 2018 attached prior to deployment. In the pictured embodiment, the device 3300 includes a membrane 3367 covering the entire outer surface of the device 3300 with the exception of the two openings 3363, 3364.

Figure 33B is an illustration of an embodiment of an intragastric device 3320 having a 5 double-wire mesh structure wherein the lower wire mesh is formed from an everted antimigration component 3324. The device 3320 has a dumbbell shaped structure similar to the double-mesh device structure embodiments discussed in the present specification and functions similarly to those devices. The upper wire mesh 3322 is similar to the wire mesh structure 210 of Figure 2B and the lower mesh structure is similar to the anti-migration collar 214 of Figure

2B except that the lower mesh structure 3324 is larger and everts or curves completely in a proximal direction to form said lower mesh structure 3324 as depicted in Figure 33B. The first wire mesh structure 3322 comprises a plurality of free ends extending from its lower portion, or base. One portion of said plurality of free ends are curved upon themselves to create the everted portion 3324 on the right side while a second portion of said plurality of free ends are curved upon themselves to create the everted portion 3324 on the left side. It should be appreciate that this eversion can occur around the entire periphery of the first wire structure thereby creating a torus, which may be elongated, elliptical, or egg shape.

In various embodiments, the device 3300 has a total length ranging between 50 and 500 mm. In a preferred embodiment, the device 3300 has a total length of 180 mm. In various embodiments, the upper wire mesh 3361 has a length ranging between 30 and 250 mm. In a preferred embodiment, the upper wire mesh 3361 has a length of 140 mm. In various embodiments, the lower wire mesh 3362 has a length ranging between 1 and 250 mm. In a preferred embodiment, the lower wire mesh 3362 has a length of 10 mm. In various embodiments, the upper wire mesh 3361 has a width ranging between 30 and 300 mm. In a preferred embodiment, the upper wire mesh 3361 has a width of 120 mm. In various embodiments, the lower wire mesh 3362 has a width ranging between 10 and 300 mm. In a preferred embodiment, the lower wire mesh 3362 has a width of 60 mm. In various embodiments, the first opening 3363 has a diameter ranging between 5 and 50 mm. In a preferred embodiment, the first opening 3363 has a diameter of 20 mm. In various embodiments, the second opening 3364 has a diameter ranging from 10 to 75 mm. In a preferred embodiment, the second opening 3364 has a diameter of 30 mm.

Figure 34A is an illustration of another exemplary double-wire mesh intragastric device 3400a in a post-deployment configuration in accordance with one embodiment of the present specification. The pictured embodiment includes a first wire mesh structure 3401 positioned on top of a second wire mesh structure 3411 and a sleeve 3402 coupled to the distal end of the

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2016328478 30 Aug 2018 second wire mesh structure 3411. A first anti-migration component 3404 at the base of the first wire mesh structure 3401 rests inside the second wire mesh structure 3411 and functions to couple the two wire mesh structures 3401, 3411 together. The first anti-migration component

3404 also helps to prevent the second wire mesh structure 3411 from being compressed by gastric contractions and keeps the device 3400a out of the pylorus. A second anti-migration component 3414, at the base of the second wire mesh structure 3411, acts to prevent the entirety of the device 3400a from being passed through the pylorus. Food first passes through openings in the top of the combined intragastric device 3400a and is sequestered in the first wire mesh structure 3401. The food then slowly passes into, and is sequestered in, the second wire mesh structure 3411. Finally, the food slowly releases through the openings in the bottom of the combined intragastric device 3400a into a sleeve 3402 attached to distal end of the second wire mesh structure 3411 that bypasses the pylorus to release the food into the small intestine. In one embodiment, there is no attached sleeve 3402 and the food is released through the openings in the bottom of the combined intragastric device 3400a back into the stomach. The combined wire mesh structures 3401, 3411 work together to occupy an increased volume in a patient’s stomach and further delay the passage of food through the gastrointestinal tract. The combined two wire mesh structures 3401, 3411 also act to induce satiety even more quickly and induce a longer lasting satiety than a single mesh structure device. The two wire-mesh structures are able to move relative to each other as compared to a single structure, allowing them to adjust better to the shape of the stomach, resulting in better tolerability and/or less complications.

Figure 34B is an illustration of another exemplary double-wire mesh intragastric device

3400b in a post-deployment configuration in accordance with one embodiment of the present specification. The pictured embodiment includes a first wire mesh structure 3421 positioned on top of a second wire mesh structure 3431. The two wire mesh structures 3421, 3431 work together to occupy an increased volume in a patient’s stomach and further delay the passage of food through the gastrointestinal tract. The two wire-mesh structures are able to move relative to each other as compared to a single structure, allowing them to adjust better to the shape of the stomach, resulting in better tolerability and/or less complications.

Figure 34C is an illustration of another exemplary double-wire mesh intragastric device

3400c in a post-deployment configuration in accordance with one embodiment of the present specification. The pictured embodiment includes a first wire mesh structure 3451 positioned on top of a second wire mesh structure 3461. An anti-migration component 3464 at the base of the second wire mesh structure 3461 acts to prevent the entirety of the device 3400c from being passed through the pylorus. The two wire mesh structures 3451, 3461 work together to occupy an increased volume in a patient’s stomach and further delay the passage of food through the

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2016328478 30 Aug 2018 gastrointestinal tract. The two wire-mesh structures are able to move relative to each other as compared to a single structure, allowing them to adjust better to the shape of the stomach, resulting in better tolerability and/or less complications.

Figure 34D is an illustration of another exemplary double-wire mesh intragastric device

3400d in a post-deployment configuration in accordance with one embodiment of the present specification. The pictured embodiment includes a first wire mesh structure 3471 positioned on top of a second wire mesh structure 3481. A first anti-migration component 3474 at the base of the first wire mesh structure 3471 rests inside the second wire mesh structure 3481 and functions to couple the two wire mesh structures 3471, 3481 together. The first anti-migration component 3474 also helps to prevent the second wire mesh structure 3481 from being compressed by gastric contractions and keeps the device 3400d out of the pylorus. A second anti-migration component 3484 at the base of the second wire mesh structure 3481 acts to prevent the entirety of the device 3400d from being passed through the pylorus. The two wire mesh structures 3471, 3481 work together to occupy an increased volume in a patient’s stomach and further delay the passage of food through the gastrointestinal tract.

Figure 34E is an illustration of another exemplary double-wire mesh intragastric device

3400e in a post-deployment configuration in accordance with one embodiment of the present specification. The pictured embodiment includes a first wire mesh structure 3493 positioned on top of a second wire mesh structure 3495. An anti-migration component 3497 at the base of the first wire mesh structure 3493 rests inside the second wire mesh structure 3495 and functions to couple the two wire mesh structures 3493, 3495 together. The anti-migration component 3497 also helps to prevent the second wire mesh structure 3495 from being compressed by gastric contractions and keeps the device 3400e out of the pylorus. The two wire mesh structures 3493, 3495 work together to occupy an increased volume in a patient’s stomach and further delay the passage of food through the gastrointestinal tract.

In various embodiments, any of the double-wire mesh intragastric devices of Figures

34B-34E further includes a sleeve attached to the distal end of the second wire mesh structure. In various embodiments, the anti-migration components, or collars, of the devices of the present specification have a length ranging from 1 mm to 100 mm and an outer diameter of 25 mm to

75 mm for a ratio of length to outer diameter ranging from 0.01 to 4. In one embodiment, the anti-migration component, or collar, has a length equal to 15 mm and an outer diameter of 60 mm for a ratio of length to outer diameter of 0.25. In various embodiments, the wire meshes of the intragastric devices of the present specification are configured to be fatigue resistant for a period of at least six months, wherein fatigue resistant is defined as break resistant under intended use.

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2016328478 30 Aug 2018

Figure 34F is an illustration of another exemplary double-wire mesh intragastric device

3400f in a post-deployment configuration in accordance with one embodiment of the present specification. The pictured embodiment includes a first wire mesh structure 3491 positioned on top of a second wire mesh structure 3499 and a sleeve 3492 coupled to the distal end of the second wire mesh structure 3499. An anti-migration component 3494 at the base of the second wire mesh structure 3499 acts to prevent the entirety of the device 3400f from being passed through the pylorus. The two wire mesh structures 3491, 3499 work together to occupy an increased volume in a patient’s stomach and further delay the passage of food through the gastrointestinal tract.

Figure 34G is an illustration of another exemplary double-wire mesh intragastric device

3400g in a post-deployment configuration in accordance with one embodiment of the present specification. The pictured embodiment includes a first wire mesh structure 3403 positioned on top of a second wire mesh structure 3405 and a sleeve 3407 coupled to the distal end of the second wire mesh structure 3405. A first anti-migration feature 3409 at the base of the first wire mesh structure 3403 functions to couple the two wire mesh structures 3403, 3405 together. The first anti-migration feature 3409 also helps to prevent the second wire mesh structure 3403 from being compressed by gastric contractions when the first wire mesh structure 3405 is being compressed and keeps the device 3400f from passing through the pylorus in its entirety. A second anti-migration component 3413, at the base of the second wire mesh structure 3405, acts to prevent the entirety of the device 3400g from being passed through the pylorus. The combined wire mesh structures 3403, 3405 work together to occupy an increased volume in a patient’s stomach and further delay the passage of food through the gastrointestinal tract. In an embodiment, the device 3400g is covered with a protective covering such as a silicon or a PTFE sheath. In some embodiments, the first and second wire mesh structures 3403, 3405 are made of hand braided Nitinol wires having a thickness in a range of 0.1 mm to 1.0 mm and, more preferably, approximately 0.4 mm, and the sleeve 3407 is made of machine braided Nitinol wires having a thickness in a range of 0.05 mm to 0.7 mm and, more preferably, approximately 0.127 mm.

In an embodiment, the device 3400g has a total length of approximately 100 to 850 mm.

In an embodiment, the first wire mesh 3403 has a central diameter of approximately 90 mm. In an embodiment, the lengths of each of the first wire mesh 3403 and the second wire mesh 3405 are approximately 70 mm and a total length measured from the proximal end of the first wire mesh 3403, including the first anti-migration component 3409, to the distal end of the second mesh 3405 is approximately 145 mm. In various embodiments, the diameter of an opening 3425 in the proximal end is approximately 5 mm to 25 mm and the diameter of an opening 3423 in

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2016328478 30 Aug 2018 the distal end of the sleeve 3407 ranges from 5 mm to 35 mm. Also, in an embodiment, the width of the first anti-migration component 3409 at the base of the first wire mesh structure

3403 is approximately 5 mm. In an embodiment, the diameter of the sleeve 3407 is approximately 25 mm. Further, in an embodiment, an overall length of the sleeve is approximately 505 mm, wherein the length from proximal point 3415 to midpoint 3417 is approximately 137 mm, and the length from distal point 3419 to distal end 3423 is approximately 57 mm.

FIG. 34H illustrates an intragastric device 3400h having two wire meshes coupled with an anti-migration feature, in accordance with an embodiment of the present specification. As shown, the device 3400h comprises a first wire mesh structure 3462 positioned on top of a second wire mesh structure 3472 and an anti-migration collar 3473 coupled to the distal end of the second wire mesh structure 3472. A first anti-migration feature 3463 at the base of the first wire mesh structure 3462 functions to couple the two wire mesh structures 3462, 3472 together. The first anti-migration feature 3463 also helps to prevent the first wire mesh structure 3462 from being compressed by antral contractions while the second wire mesh structure 3472 is being compressed by the antral contractions and keeps the device 3400h out of the pylorus. The anti-migration collar 3473, at the base of the second wire mesh structure 3472, acts to prevent the entirety of the device 3400g from being passed through the pylorus.

In various embodiments, the total length of device 3400h ranges from 30 mm to 300 mm. In an embodiment, the first wire mesh 3462 has a central diameter of approximately 90 mm, range 20 to 200. In an embodiment, the lengths of each of the first wire mesh 3462 and the second wire mesh 3472 are in a range of 20 mm to 100 mm and, more preferably, approximately 70 mm, and a total length measured from the proximal end of the first wire mesh 3462, including the first anti-migration feature 3463, to the distal end of the second mesh 3472 in a range of 30 mm to 200 mm, and more preferably, approximately 145 mm. In an embodiment, the diameter of an opening 3465 in the proximal end is approximately 5mm to 35 mm and the diameter of an opening 3475 in the distal end ranges from 5 mm to 60 mm. Also, in an embodiment, the width of the first anti-migration component 3463 at the base of the first wire mesh structure 3462 is approximately 5 mm. In some embodiments, the length of the anti30 migration collar 3473 ranges from 5 mm to 100 mm. In embodiments, an inner diameter 3476 of anti-migration collar 3473 ranges from approximately 10 mm to 30 mm while an outer diameter 3477 ranges from 25 mm to 77 mm.

In embodiments, (as explained with reference to FIG. 3D and 3E), the wire mesh device 3400h comprises a plurality of loops formed in the wires of the first and second wire mesh structures 3462, 3472 at their proximal and distal ends as well as the distal end of anti-migration

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2016328478 30 Aug 2018 collar 3473. In an embodiment, a thickness of the wire forming the loops, such as wire loop

3466, is approximately 0.4 mm and a diameter of a circular portion 3467 of wire loop 3466 is approximately 2 mm. In an embodiment, the distal end of anti-migration collar 3473 comprises loops, such as the wire loop 3466 shown in Figure 34H. In various embodiments, first anti5 migration component 3463 is attached to the first and second wire mesh structure 3462, 3472 by means of soft PTFE wires 3468 having a diameter of approximately 0.20 mm. Also, in embodiments, anti-migration collar 3473 is also attached to the wire mesh 3472 by means of soft PTFE wires 3438 having a diameter of approximately 0.20 mm.

Figure 35 is an illustration of one single intragastric device 3530 being passed over a 10 guidewire 3535 and attached to a previously deployed single intragastric device 3520 in a stomach 3512. A catheter 3521 is depicted passing through the esophagus 3511 and into the stomach 3512. The catheter 3521 is deploying the second single intragastric device 3530 and assisting in its attachment to the previously deployed intragastric device 3520. Operationally, the catheter 3521 will be passed into an opening of the existing intragastric device 3520, preferably the opening used by the original catheter to deploy the device. The second device 3530 is then deployed with a portion of the second device, such as a neck, protrusion, or other member, fixedly attached to the first device 3520, thereby anchoring the two devices together. In another embodiment, the two devices are pre-attached outside the body and are than deployed inside a human subject as a single unit.

Figure 36 is an illustration of a fully deployed combined intragastric device 3600 in a stomach 3612. The two single intragastric devices 3620, 3630 are depicted attached one on top of the other, occupying a greater stomach 3612 volume than one single intragastric device 3620.

Figures 37A and 37B are side and oblique perspective views, respectively, of another exemplary combined or dual-wire mesh intragastric device 3700 in a post-deployment configuration, in accordance with an embodiment of the present specification. The pictured embodiment includes a first wire mesh structure 3701 flexibly connected, attached or coupled to a second wire mesh structure 3702 to form a substantially dumbbell or barbell shaped intragastric device 3700. In a pre-deployment configuration, corresponding to a fully compressed or constrained state, the first wire mesh structure 3701 has a first volume and, in a post-deployment configuration, corresponding to a fully expanded or relaxed state, the first wire mesh structure 3701 has a second volume. In various embodiments, the first volume is less than the second volume. In a pre-deployment configuration, corresponding to a fully compressed or constrained state, the second wire mesh structure 3702 has a third volume and, in a postdeployment configuration, corresponding to a fully expanded or relaxed state, the second wire

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2016328478 30 Aug 2018 mesh structure 3702 has a fourth volume. In various embodiments, the third volume is less than the fourth volume.

In accordance with embodiments, the first wire mesh structure 3701 has a first shape and size or dimension in a pre-deployment configuration and a second shape and size or dimension in a post-deployment configuration. In accordance with embodiments, the second wire mesh structure 3702 has a third shape and size or dimension in a pre-deployment configuration and a fourth shape and size or dimension in a post-deployment configuration. In some embodiments, the post-deployment shapes and dimensions are similar for the first and second wire mesh structures 3701, 3702. In other embodiments, the post-deployment shapes and dimensions are dissimilar for the first and second wire mesh structures 3701, 3702. In various embodiments, the post-deployment shapes are substantially spherical, oval, obloid, kidney bean, ovoid or inverted egg shapes.

In various embodiments of the present specification, the first wire mesh structure and/or the second wire mesh structure 3702 has a variable post-deployment volume such that one or both can be expanded to different sizes. During deployment, variable levels of deployment size are used to check the position of the device and any deployment issues. For example, in some embodiments, the device is slowly deployed in steps of deployment and is checked for appropriate deployment and positioning at the different steps. After full deployment, in some embodiments, the size is fixed. In some embodiments, the two wire mesh structures are weaved separately or the wire mesh design in a single weave is different, allowing for different stiffness, compression, and sizing of the two wire mesh structures.

In a preferred embodiment, the post-deployment shapes are substantially spherical or elliptical with similar dimensions.

In various embodiments, the present specification provides a wire mesh device as a prosthetic that is sized small enough such that the device may be easily delivered via a catheter into a patient’s body but is also large enough such that it does not pass through the patient’s antrum/pylorus and cause damage. In addition, the device is adequately sized to be effective in sequestering food and delaying gastric emptying. For example, in various embodiments, a device having a combined post-deployment volume of less than 50 ml is not effective in sequestering food and delaying gastric emptying and could be passed through the pylorus, while a device having a post-deployment volume of greater than 3,500 ml is too large and would adversely affect digestive processes. Further, the wire mesh devices are not anchored or permanently attached to any stomach structure, are free floating, and serve to position the optional sleeve in the patient’s intestine, without a physician having to physically attach or anchor the sleeve to the patient’s GI tract. This allows both the mesh and sleeve structure to

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2016328478 30 Aug 2018 move relative to the GI tract wall. In various embodiments, the devices are free to move about the stomach such that a patient’s pylorus is blocked less than 100% of time and said blocking comprises less than 100% of an opening defined by the pylorus. In various embodiments, the devices block the pylorus over 50% of the time, more preferably over 90% of the time, and most preferably over 95% of the time.

In various embodiments, the wire mesh structures, both single and double wire mesh configurations, of the intragastric devices of the present specification, provide several benefits over conventional gastrointestinal space-occupying balloons. While traditional balloons can be deformed by gastric pressure, the volume of the balloons is substantially constant. High stomach wall pressure is reciprocated by fixed volume balloons and water filled balloons can create pressure ulcers due to gravity and/or inertia. Air filled balloons can create a gassy feeling in the patient. Since the volume of the wire mesh devices of the present specification is variable, the wire mesh devices avoid these problems. Additionally, over stretching trauma of the stomach wall can occur with traditional balloons as food cannot enter the balloon. Food is intended to pass through the wire mesh devices of the present specification and therefore over stretching is not a concern. The intragastric devices of the present specification also allow for delayed gastric emptying as food is retained in the wire mesh structure, a benefit that is not provided by traditional balloons. The constant low outward pressure of the wire mesh structures also induces satiety while the variable volume and shape provide natural comfort.

Table 1 lists ranges of post-deployment diameter, height, volume and pre-deployment compressed length of various intragastric double-mesh devices, in accordance with some embodiments of the present specification. In some embodiments, a double-mesh intragastric device has a post-deployment diameter, at its widest point, ranging from 20 to 200 mm. More preferably, in some embodiments, a double-mesh intragastric device has a post-deployment diameter, at its widest point, ranging from 50 to 150 mm, and, still more preferably, ranging from 80 to 100 mm. In one embodiment, a double-mesh intragastric device has a postdeployment diameter of 90 mm. In some embodiments, a double-mesh intragastric device has a post-deployment height ranging from 45 to 400 mm. More preferably, in some embodiments, a double-mesh intragastric device has a post-deployment height ranging from 105 to 300 mm, and, still more preferably, a post-deployment height of 145 mm. In some embodiments, a first wire mesh structure has a first length equal to or less than 75 cm, and more preferably, approximately 15 cm. In some embodiments, a first wire mesh structure has a pre-deployment volume equal to or less than 5 ml, and more preferably, equal to or less than 110 ml and a postdeployment volume equal to or greater than 5 ml, and more preferably, equal to or greater than

125 ml. In some embodiments, a second wire mesh structure has a second length equal to or

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2016328478 30 Aug 2018 less than 70 cm. In some embodiments, a second wire mesh structure has a pre-deployment volume equal to or less than 5 ml, and more preferably, equal to or less than 100 ml and a postdeployment volume equal to or greater than 5 ml, and more preferably, equal to or greater than

110 ml. In some embodiments, the first wire mesh structure has a post deployment volume greater than 5 ml and less than 5000 ml. In some embodiments, the second wire mesh structure has a post deployment volume greater than 20 ml and less than 4000 ml. In some embodiments, a double-mesh intragastric device has a post-deployment volume (both meshes together) ranging from 8 to 8381 ml. More preferably, in some embodiments, a double-mesh intragastric device has a post-deployment volume (both meshes together) ranging from 131 to 3536 ml, and, still more preferably, ranging from 442 to 826 ml. In one embodiment, a double-mesh intragastric device has a post-deployment volume (both meshes together) of 657 ml. In some embodiments, a double-mesh intragastric device has a pre-deployment compressed length ranging from 63 to 629 mm. Pre-deployment compressed length refers to the total length of the device when compressed into a catheter for deployment into a subject’s body. More preferably, in some embodiments, a double-mesh intragastric device has a pre-deployment compressed length ranging from 157 to 471 mm, and, still more preferably, ranging from 236 to 290 mm. In one embodiment, a double-mesh intragastric device has a pre-deployment compressed length of 269 mm.

Table 1

Diameter (mm)	Height (mm)	Volume (ml) two meshes	Compressed Length (mm)
200	400	8381	629
150	300	3536	471
100	145	826	290
90	145	657	269
80	145	442	236
50	105	131	157
20	45	8	63

Each of the first and second wire mesh structure 3701, 3702 has a top or upper half surface or hemisphere, a bottom or lower half surface or hemisphere and an interior volume defined by the respective post-deployment shapes and sizes or dimensions of the wire mesh structures 3701, 3702. The first wire mesh structure 3701 includes at least one first opening (or first surface area of openings) 3705 proximate the top or upper half surface or hemisphere and at least one second opening (or second surface area of openings) 3706 proximate the bottom or lower half surface or hemisphere such that food enters the structure 3701 through the at least one first opening 3705, passes through the interior, and exits the structure 3701 through the at

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2016328478 30 Aug 2018 least one second opening 3706. The second wire mesh structure 3702 includes at least one third opening (or third surface area of openings) 3707 proximate the top or upper hemisphere and at least one fourth opening (or fourth surface area of openings) 3708 proximate the bottom or lower hemisphere such that food enters the structure 3702 through the at least one third opening

3707, passes through the interior, and exits the structure 3702 through the at least one fourth opening 3708. In various embodiments, the post-deployment shape of the first wire mesh structure includes a first plurality of curved surfaces defined by an arc which is determined by a radius in a range of 0.2 cm to 20 cm and a central angle in a range of 5 to 175 degrees. In various embodiments, the post-deployment shape of the second wire mesh structure includes a second plurality of curved surfaces defined by an arc which is determined by a radius in a range of 0.1 cm to 15 cm and a central angle in a range of 1 to 179 degrees.

In accordance with some embodiments, the first and second wire mesh structures 3701, 3702 are porous structures. In other embodiments, the first and second wire mesh structures 3701, 3702 are substantially covered with a membrane to further impede the passage of food out of the intragastric device 3700. In various embodiments, the membrane covers 10% to 99% of the device 3700 leaving only the at least one first, second, third and fourth openings 3705, 3706, 3707, 3708 uncovered. This directs the food to enter the device 3700 through the at least one first opening 3705 and leave the device 3700 through the at least one fourth opening 3708.

The first wire mesh structure 3701 includes a first plurality of free ends or nodes positioned at the at least one first opening 3705 and a second plurality of free ends or nodes positioned at the at least one second opening 3706. The second wire mesh structure 3702 includes a third plurality of free ends or nodes positioned at the at least one third opening 3707 and a fourth plurality of free ends or nodes positioned at the at least one fourth opening 3708. The pluralities of nodes comprise bends or curves in the wires of the wire mesh structures 3701,

3702 which are unsupported or not connected to other portions of the wire mesh. In other words, the pluralities of nodes are loops or bends comprising the free ends at each end of the wire mesh structures 3701, 3702. In accordance with various embodiments, the first, second, third and fourth pluralities of nodes include hoops. In one embodiment, hoops are formed from twisting the free ends of the pluralities of nodes into a hoop shape. In another embodiment, the hoops comprise separate wire hoops that are sutured to the free ends of the pluralities of nodes.

In various embodiments, a connection is formed between a portion of a plurality of free ends of the first wire mesh structure defining said second surface area of openings 3706 and a portion of a plurality of free ends of the second wire mesh structure defining said third surface area of openings 3707. In some embodiments, the connection comprises a first flexible suture attached, at one end, to a first point on said second surface area of openings 3706 and, at a

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2016328478 30 Aug 2018 second end, to a second point on said third surface area of openings 3707. In various embodiments, a length of the connection is in a range of 0 mm to 200 mm wherein a lower bound ranges from 0 mm to 2 mm and every increment therein. In some embodiments, the connection comprises a second flexible suture attached, at one end, to a third point on said second surface area of openings 3706 and, at a second end, to a fourth point on said third surface area of openings 3707 wherein said third point is different from the first point and said fourth point is different from the second point. In various embodiments, a length of the connection, including the second flexible suture, is in a range of 0 mm to 300 mm wherein a lower bound ranges from 0 mm to 2 mm and every increment therein. In some embodiments, the connection comprises a third flexible suture attached, at one end, to a fifth point on said second surface area of openings 3706 and, at a second end, to a sixth point on said third surface area of openings 3707, wherein said fifth point is different from the first point and the third point and wherein said sixth point is different from the second point and the fourth point. In various embodiments, a length of the connection, including the third flexible suture, is in a range of 0 mm to 300 mm wherein a lower bound ranges from 0 mm to 2 mm and every increment therein. In some embodiments, the connection comprises a fourth flexible suture attached, at one end, to a seventh point on said second surface area of openings 3706 and, at a second end, to an eighth point on said third surface area of openings 3707, wherein said seventh point is different from said the first point, the third point, and the fifth point and wherein said eighth point is different from the second point, the fourth point, and the sixth point. In various embodiments, a length of the connection, including the second flexible suture, is in a range of 0 mm to 300 mm wherein a lower bound ranges from 0 mm to 2 mm and every increment therein.

As shown in Figure 37C, in accordance with an aspect of the present specification, a portion of the second pluralities of nodes 3701n of the first wire mesh structure 3701 are flexibly connected, coupled or attached to a portion of the third pluralities of nodes 3702n of the second wire mesh structure 3702 using a plurality of sufficiently loose sutures or suture knots 3710. Though sutures are depicted in Figure 37C, in other embodiments, the flexible connection between the first wire mesh structure and the second wire mesh structure can comprise any flexible member, such as a flexible metal wire or plastic component. In these other embodiments, a suture is not required. In some embodiments, the plurality of sutures 3710 includes at least two standalone flexible connection or suture points wherein at least two nodes of the second pluralities of nodes 3701n of the first wire mesh structure 3701 are flexibly coupled to at least two nodes of the third pluralities of nodes 3702n of the second wire mesh structure 3702. In a preferred embodiment, the plurality of sutures 3710 includes three or four standalone flexible connection or suture points. In various embodiments, a length of the

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2016328478 30 Aug 2018 connection between the openings on the lower surface of the first wire mesh structure and the openings on the upper surface of the second wire mesh structure is in a range of 0 mm - 300 mm. In various embodiments, the connection of the first wire mesh structure to the second wire mesh structure has a length such that the first wire mesh structure can be compressed up to a range of 1% to 99%, and more preferably, 40% to 99%, and all increments therein, of its equatorial diameter without leading to a compression of the second wire mesh structure. In various embodiments, the plurality of sutures 3710 are distributed equidistantly along the peripheries of the second and third openings 3706, 3707. Figure 37E shows two connection or suture points 3711 utilized to flexibly connect the first and second wire mesh structures 3701,

3702. In an embodiment, the two connection or suture points 3711 are separated from one another by 180 degrees.

In an alternate embodiment, the first and second wire mesh structures 3701, 3702 are flexibly coupled by interweaving or meshing (instead of using a plurality of sutures or suture knots) a portion of the second pluralities of nodes 3701n of the first wire mesh structure 3701 to a portion of the third pluralities of nodes 3702n of the second wire mesh structure 3702.

In an optional embodiment, as shown in Figure 37D, a sleeve 3725, having a proximal end, a distal end, and a lumen, is coupled at its proximal end to the lower portion of the second wire mesh structure 3702. The sleeve 3725 includes, at its proximal end, a first opening 3741 in fluid communication with the fourth opening or fourth surface area of openings (3708 of

Figure 37A) of the second wire mesh structure 3702 and a second opening 3742 at said distal end. In some embodiments, the sleeve 3725 is coupled, via a plurality of sutures, to the fourth plurality of nodes 3702p of the second wire mesh structure 3702. The optionally coupled sleeve 3725, when deployed, extends from the patient’s stomach into the duodenum where it empties, or, in other embodiments, through the duodenum and into the jejunum. In one embodiment, the sleeve 3725 functions to transit sequestered food/chyme from the intragastric device 3700 directly to the mid-duodenum or mid-jejunum.

Referring now to Figures 37A through 37C, it should be appreciated that, in various embodiments, the first and second wire mesh structures 3701, 3702 are woven and constructed separately and flexibly attached or sutured, thereafter, either inside (as described earlier with reference to Figures 35, 36) or outside a patient’s body. It should also be appreciated that the coupling sutures can be cut for removal of the two structures 3701, 3702 separately, from the patients’ stomach.

In various embodiments, each of the connection or suture points comprises a figure eight knot, optionally, additionally secured with glue and a heat shrink tube. In one embodiment, each knot comprises 30 lb. break-strength ultra-high-molecular-weight-polyethylene

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2016328478 30 Aug 2018 (UHMWPE) braided suture line to provide a reliable connection between the first and second wire mesh structures 3701, 3702.

In accordance with various aspects of the present specification, the flexible connection or attachment of the first and second wire mesh structures 3701, 3702, using the plurality of sutures 3710, and the resultant intragastric device 3700 provides various benefits and functionalities (discussed below).

The flexible connection or attachment enables a fluid communication between the first and second wire mesh structures 3701, 3702. That is, food first passes through the at least one first opening 3705 in the top of the combined intragastric device 3700 and is sequestered in the first wire mesh structure 3701. The food then slowly passes into, and is sequestered in, the second wire mesh structure 3702. Finally, the food slowly releases through the at least one fourth opening 3708 in the bottom of the combined intragastric device 3700 and back into the stomach. The connected wire mesh structures 3701, 3702 work together to occupy an increased volume in a patient’s stomach and further delay the passage of food through the gastrointestinal tract. The connected two wire mesh structures 3701, 3702 also act to induce satiety even more quickly and induce a longer lasting satiety than a single mesh structure device.

The flexible connection or attachment enables the first and second wire mesh structures 3701, 3702 to pivot, bend or move in substantially all directions relative to each other. Referring to Figure 37F, the first wire mesh structure 3701 has a first longitudinal axis 3715 passing through a center of the first structure 3701, a center of a first surface area of openings 3721 at the proximal end of the first structure 3701, and a center of a second surface area of openings 3722 at the distal end of the first structure while the second wire mesh structure 3702 has a second longitudinal axis 3716 passing through a center of the second structure 3702, a center of a third surface area of openings 3731 at a proximal end of the second structure 3702, and a center of a fourth surface area of openings 3732 at a distal end of the second structure. A degree of movement of the two structures 3701, 3702, relative to each other, is illustrated and defined by an angular displacement 3717 between the first and second longitudinal axes 3715, 3716. In various embodiments, the flexible connection points 3711 enable the first and second wire mesh structures 3701, 3702 to have a degree of movement (or angular displacement 3717 between the first and second longitudinal axes 3715, 3716) of up to 90 degrees relative to each other in all directions. In some embodiments, the connection of the first wire mesh structure to the second wire mesh structure has a length such that, upon more than 90% compression of the first wire mesh structure, the second wire mesh structure has an angular displacement relative to the first wire mesh structure of 10% or less.

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During a process of deployment, the flexible connection or attachment enables one wire mesh structure, for example the first wire mesh structure 3701, to open almost completely without the need to deploy the other wire mesh structure, for example the second wire mesh structure 3702. Figure 38A illustrates a process of deployment of a combined intragastric device

3800. As shown, the device 3800 further includes a catheter or over-tube 3820 wherein a first wire mesh structure 3801 is nearly or almost completely deployed while a second wire mesh structure 3802, connected or attached to the first wire mesh structure 3801 via a plurality of sutures 3810, is still constrained serially within the catheter or over-tube 3820. In some embodiments, the catheter 3820 comprises a housing and a lumen extending through the housing. In some embodiments, the lumen has a diameter equal to or less than 2 cm, and more preferably, approximately 0.9 cm. On compression of one wire mesh structure, for example the second wire mesh structure 3702, into a tubular structure (such as an over-tube or catheter) during a process of withdrawal or removal, the flexible connection or attachment enables alignment of the other wire mesh structure, for example the first wire mesh structure 3701, to be compressed into the tubular structure. Figures 38B through 38D illustrate a process of withdrawal or removal of the combined intragastric device 3800. As shown in Figure 38B, the second wire mesh structure 3802 is partially compressed as it is being withdrawn into the catheter 3820 using a grasper 3822 through an endoscope 3825 (for example), while the first wire mesh structure 3801 remains unconstrained or in a deployed configuration. As the second wire mesh structure 3802 is fully compressed due to its full withdrawal into the catheter 3820, as shown in Figure 38C, the plurality of sutures 3810 enable alignment or orientation of the first wire mesh structure 3801 for compression into the catheter 3820 for removal. Finally, as shown in Figure 38D, the aligned or oriented first wire mesh structure 3801 begins getting constrained or compressed into the catheter 3820 for removal, as the fully compressed second wire mesh structure 3802 is further withdrawn into the catheter 3820 using the endoscope 3825.

Thus, the flexible connection or attachment enables one wire mesh structure to be compressed or withdrawn and released or deployed independent of the other wire mesh structure.

Referring now to Figures 37A through 37F, it should be noted that the plurality of sutures 3710 need to be long enough to enable the pivoting, bending or relative degree of movement of the two wire mesh structures 3701, 3702 but short enough to communicate compression forces from one wire mesh structure (as it is being withdrawn or deployed) to the other wire mesh structure. In some embodiments, one wire mesh structure can be compressed up to 99% of its equatorial diameter (in embodiments where the first and second wire mesh structures 3701, 3702 are substantially spherical) without radially compressing the other wire

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2016328478 30 Aug 2018 mesh structure - but beyond that, the compression is communicated. This has an anti-migration advantage in that the intragastric device 3700 is unlikely to pass through a fully relaxed pylorus even if one of the two wire mesh structures is substantially compressed while in a postdeployment configuration. In various embodiments, a length of a connection or suture point, from a node of the second pluralities of nodes to a node of the third pluralities of nodes, is in a range of 1 mm and twice the diameter of the third opening 3707 of the second wire mesh 3702 (Figures 37A, 37B).

The combined or dual-wire mesh intragastric device 3700 of the present specification provides various benefits or advantages compared to deploying a single large device. Firstly, the combined intragastric device 3700 offers better protection against migration of the device 3700 through a relaxed pylorus of a patient. If a single large device gets compressed it can migrate relatively easily through the relaxed pylorus. However, it is unlikely for both the wire mesh structures 3701, 3702 of the intragastric device 3700 to be compressed accidentally thereby offering mitigation against migration risk.

Secondly, a single large device will be relatively inflexible, thereby, putting excessive pressure against the patient’s stomach lining, at least for some of the time. In contrast, the intragastric device 3700 has a sufficiently large post-deployment structure or occupied volume while still minimizing excessive pressure against the stomach wall (and prevent abrasions on the stomach wall or lining) because the intragastric device 3700 will bend and move (owing to the flexible connection or attachment of the two connected wire mesh structures 3701, 3702), thereby better suiting the stomach contours. Thus, the intragastric device 3700 of the present specification, when deployed, offers improved balance or optimization between a need to occupy a large stomach volume and a need to minimize pressure on the stomach. In various embodiments, the intragastric device 3700, when deployed, occupies 25% to 95% of the gastric volume or the patient’s stomach volume.

It should be appreciated that the present disclosure is intended to provide a teaching of several exemplary embodiments of the present invention and is should not be limited to the specific structures disclosed herein. Other variations of the disclosed embodiments, which would be understood by those of ordinary skill, are covered by the present application and are within the scope of the invention, as further defined by the claims.

In the claims that follow and in the preceding description of the invention, except where the context requires otherwise due to express language or necessary implication, the word “comprise” or variations such as “comprises” or “comprising” is used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention.

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It is to be understood that, if any prior art is referred to herein, such reference does not constitute an admission that such prior art forms a part of the common general knowledge in the art, in Australia or any other country.

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Claims

2016328478 30 Aug 2018

1. An intragastric device configured for deployment in a stomach of a person, said device comprising:

a catheter comprising a housing and a lumen extending through said housing, wherein the lumen has an internal diameter and wherein the internal diameter is equal to or less than 2 cm;

a first wire mesh structure having a pre-deployment shape that is compressed within said lumen of the catheter and a post-deployment shape that is expanded within the stomach of the person, wherein said pre-deployment shape has a first volume that is equal or less than 110 ml and a first length that is equal to or less than 75 cm and wherein said postdeployment shape has a porous, enclosed second volume, defined by a first plurality of curved surfaces, that is equal to or greater than 125 ml, said first wire mesh structure further comprising an upper portion and a lower portion wherein the upper portion has a first surface area of openings configured to permit material to enter from outside the second volume to inside the second volume and wherein the lower portion has a second surface area of openings;

a second wire mesh structure, separate from the first wire mesh structure, having a predeployment shape that is compressed within said lumen of the catheter and a postdeployment shape that is expanded within the stomach of the person, wherein said predeployment shape has a third volume that is equal or less than 100 ml and a second length that is equal to or less than 70 cm and wherein said post-deployment shape has a porous, enclosed fourth volume, defined by a second plurality of curved surfaces, that is equal to or greater than 110 ml, said second wire mesh structure further comprising an upper portion and a lower portion wherein the upper portion has a third surface area of openings configured to permit material to enter from outside the fourth volume to inside the fourth volume and wherein the lower portion has a fourth surface area of openings;

a connection to flexibly couple said first and second wire mesh structures, wherein said connection is formed between a portion of the first wire mesh structure defining said second surface area of openings and a portion of the second wire mesh structure defining said third surface area of openings.
2. The intragastric device of claim 1 wherein the first wire mesh structure and the second wire mesh structure are positioned serially within the lumen of the catheter.

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3. The intragastric device of claim 1 wherein at least one of the first plurality of curved surfaces is defined by an arc and wherein said arc is determined by a radius in a range of 0.2 cm to 20 cm and a central angle in a range of 5 to 175 degrees.
4. The intragastric device of claim 3 wherein at least one of the second plurality of curved surfaces is defined by an arc and wherein said arc is determined by a radius in a range of 0.1 cm to 15 cm and a central angle in a range of 1 to 179 degrees.
5. The intragastric device of claim 1 wherein said connection is formed between a portion of a plurality of free ends of the first wire mesh structure defining said second surface area of openings and a portion of a plurality of free ends of the second wire mesh structure defining said third surface area of openings.
6. The intragastric device of claim 1 wherein the first wire mesh structure has at least one of a spherical and elliptical shape.
7. The intragastric device of claim 6 wherein the second wire mesh structure has at least one of a spherical and elliptical shape.
8. The intragastric device of claim 1, wherein said connection comprises a plurality of sutures.
9. The intragastric device of claim 8, wherein said plurality of sutures include a first flexible suture attached, at one end, to a first point on said second surface area of openings and, at a second end, to a second point on said third surface area of openings.
10. The intragastric device of claim 1, wherein a length of a connection, from the first point on the second surface area of openings to the second point on said third surface area of openings, is in a range of 0.01 mm to 200 mm.
11. The intragastric device of claim 9, wherein said plurality of sutures include a second flexible suture attached, at one end, to a third point on said second surface area of openings and, at a second end, to a fourth point on said third surface area of openings, wherein said first point is different from the third point and wherein said second point is different from the fourth point.
12. The intragastric device of claim 11, wherein a length of a connection, from third point on the second surface area of openings to the fourth point on said third surface area of openings, is in a range of 0.01 mm and 300 mm.
13. The intragastric device of claim 11, wherein the first flexible suture and the second flexible suture are separated by 180 degrees.
14. The intragastric device of claim 11, wherein said plurality of sutures include a third flexible suture attached, at one end, to a fifth point on said second surface area of openings and, at a second end, to a sixth point on said third surface area of openings, wherein said fifth point

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2016328478 30 Aug 2018 is different from the first point and the third point and wherein said sixth point is different from the second point and the fourth point.
15. The intragastric device of claim 14, wherein a length of a connection, from the fifth point on the second surface area of openings to the sixth point on said third surface area of openings, is in a range of 0.01 mm and 300 mm.
16. The intragastric device of claim 14, wherein said plurality of sutures include a fourth flexible suture attached, at one end, to a seventh point on said second surface area of openings and, at a second end, to a eighth point on said third surface area of openings, wherein said seventh point is different from the first point, the third point, and the fifth point and wherein said eighth point is different from the second point, the fourth point and the sixth point.
17. The intragastric device of claim 16, wherein a length of a connection, from seventh point on the second surface area of openings to the eighth point on said third surface area of openings, is in a range of 0.01 mm and 300 mm.
18. The intragastric device of claim 1, wherein said first and second wire mesh structures have a degree of movement in all directions relative to each other, said degree of movement being defined by an angular displacement between a first longitudinal axis passing through a center of said first wire mesh structure, a center of the first surface area of openings, and a center of the second surface area of openings and a second longitudinal axis passing through a center of said second wire mesh structure, a center of the third surface area of openings, and a center of the fourth surface area of openings.
19. The intragastric device of claim 18, wherein said angular displacement is equal to, or less than, 90 degrees.
20. The intragastric device of claim 1, wherein the connection of said first wire mesh structure to the second wire mesh structure has a length such that the first wire mesh structure can be compressed up to 99% of its equatorial diameter without leading to a compression of said second wire mesh structure.
21. The intragastric device of claim 1, wherein the connection of said first wire mesh structure to the second wire mesh structure has a length such that, upon more than 90% compression of the first wire mesh structure, the second wire mesh structure has an angular displacement relative to the first wire mesh structure of 10% or less, wherein said angular displacement is defined by a relative angle between a first longitudinal axis passing through a center of said first wire mesh structure, a center of the first surface area of openings, and a center of the second surface area of openings and a second longitudinal axis passing through a center

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2016328478 30 Aug 2018 of said second wire mesh structure, a center of the third surface area of openings, and a center of the fourth surface area of openings.
22. The intragastric device of claim 1, wherein said first wire mesh structure and said second wire mesh structure are connected by said connection within the lumen of the catheter.
23. The intragastric device of claim 1, wherein said first wire mesh structure and said second wire mesh structure are not connected by said connection within the lumen of the catheter.
24. The intragastric device of claim 1, wherein said connection is formed by interweaving a portion of a plurality of free ends of said second surface area of openings and a portion of a plurality of free ends of said third surface area of openings.
25. The intragastric device of claim 1, wherein said second and fourth volumes together occupy 25% to 95% of the stomach.
26. The intragastric device of claim 1, further comprising a sleeve having a proximal end, a distal end, and a lumen, wherein said proximal end is coupled to said lower portion of said second wire mesh structure and said distal end is positioned in a duodenum of a patient, said sleeve further comprising a first opening in fluid communication with said fourth surface area of openings and a second opening at said distal end, wherein said sleeve is configured to transmit food from said intragastric device to said duodenum.
27. An intragastric device of claim 1, wherein said first wire mesh structure has at least one of a spherical shape and an elliptical shape and wherein said first wire mesh structure has a volume that is greater than 5 ml and less than 5000 ml.
28. An intragastric device of claim 27, wherein said second wire mesh structure has at least one of a spherical shape and an elliptical shape and wherein said second wire mesh structure has a volume that is greater than 20 ml and less than 4000 ml.
29. An intragastric device configured for deployment in a stomach of a person, said device comprising:

a first wire mesh structure having a pre-deployment shape that is compressed within a lumen of a catheter and a post-deployment shape that is expanded within the stomach of the person, wherein said pre-deployment shape has a first volume that is equal or less than 110 ml and a first length that is equal to or less than 75 cm and wherein said post-deployment shape has a porous, enclosed second volume, defined by a first plurality of curved surfaces, that is equal to or greater than 125 ml, said first wire mesh structure further comprising an upper portion and a lower portion wherein the upper portion has a first surface area of openings configured to permit material to enter from outside the second volume to inside the second volume and wherein the lower portion has a second surface area of openings;

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2016328478 30 Aug 2018 a second wire mesh structure having a pre-deployment shape that is compressed within said lumen of the catheter and a post-deployment shape that is expanded within the stomach of the person, wherein said pre-deployment shape has a third volume that is equal or less than 100 ml and a second length that is equal to or less than 70 cm and wherein said postdeployment shape has a porous, enclosed fourth volume, defined by a second plurality of curved surfaces, that is equal to or greater than 110 ml, said first wire mesh structure further comprising an upper portion and a lower portion wherein the upper portion has a third surface area of openings configured to permit material to enter from outside the fourth volume to inside the fourth volume and wherein the lower portion has a fourth surface area of openings;

a plurality of flexible members to flexibly couple said first and second wire mesh structures, wherein said plurality of flexible members include a first flexible member attached, at one end, to a first point on said second surface area of openings and, at a second end, to a second point on said third surface area of openings and wherein said plurality of flexible members include a second flexible member attached, at one end, to a third point on said second surface area of openings and, at a second end, to a fourth point on said third surface area of openings, wherein said first point is different from the third point and wherein said second point is different from the fourth point.
30. The intragastric device of claim 29, wherein a length of said first flexible member, from the first point on the second surface area of openings to the second point on said third surface area of openings, is in a range of 0.01 mm and 300 mm.
31. The intragastric device of claim 30, wherein a length of said second flexible member, from the third point on the second surface area of openings to the fourth point on said third surface area of openings, is in a range of 0.01 mm and 100 mm.
32. The intragastric device of claim 29, wherein the first flexible member and the second flexible member are separated by 180 degrees.
33. The intragastric device of claim 29, wherein said plurality of flexible members include a third flexible member attached, at one end, to a fifth point on said second surface area of openings and, at a second end, to a sixth point on said third surface area of openings, wherein said fifth point is different from the first point and the third point and wherein said sixth point is different from the second point and the fourth point.
34. The intragastric device of claim 33, wherein a length of said third flexible member, from the fifth point on the second surface area of openings to the sixth point on said third surface area of openings, is in a range of 0.01 mm and 300 mm.

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35. The intragastric device of claim 33, wherein said plurality of flexible members include a fourth flexible member attached, at one end, to a seventh point on said second surface area of openings and, at a second end, to a eighth point on said third surface area of openings, wherein said seventh point is different from the first point, the third point, and the fifth point and wherein said eighth point is different from the second point, the fourth point and the sixth point.
36. The intragastric device of claim 35, wherein a length of said fourth flexible member, from seventh point on the second surface area of openings to the eighth point on said third surface area of openings, is in a range of 0.01 mm and 100 mm.
37. The intragastric device of claim 29, wherein said first and second wire mesh structures have a degree of movement in all directions relative to each other, said degree of movement being defined by an angular displacement between a first longitudinal axis passing through a center of said first wire mesh structure, a center of the first surface area of openings, and a center of the second surface area of openings and a second longitudinal axis passing through a center of said second wire mesh structure, a center of the third surface area of openings, and a center of the fourth surface area of openings.
38. The intragastric device of claim 37, wherein said angular displacement is equal to, or less than, 90 degrees.
39. The intragastric device of claim 29, wherein each of the plurality of flexible members has a length such that the first wire mesh structure can be compressed up to 95% of its equatorial diameter without leading to a compression of said second wire mesh structure.
40. The intragastric device of claim 1, wherein each of the plurality of flexible members has a length such that, upon more than 90% compression of the first wire mesh structure, the second wire mesh structure has an angular displacement relative to the first wire mesh structure of 10% or less, wherein said angular displacement is defined by a relative angle between a first longitudinal axis passing through a center of said first wire mesh structure, a center of the first surface area of openings, and a center of the second surface area of openings and a second longitudinal axis passing through a center of said second wire mesh structure, a center of the third surface area of openings, and a center of the fourth surface area of openings.

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2016328478 30 Aug 2018

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LD (Yl (Yl

FIG. 22

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2350

FIG. 23

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2458

Ύί ft

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2414

2416

FIG. 24B

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2500

2550

FIG. 25A

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FIG. 25B

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FIG. 25C

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FIG. 26A

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FIG. 26B

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FIG. 26C

2630

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FIG. 26D

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2700 ·»

FIG. 27A

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2704

FIG. 27B

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FIG. 27D

2715

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2830

FIG. 28A

2848

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FIG. 28B

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2902 2915

FIG. 29A

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2930

2935

FIG. 29D

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2936-

FIG. 29C

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Ά

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3013

FIG. 30D

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FIG. 30E

3009

FIG. 30F

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FIG. 30G

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FIG. 31E

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FIG. 33A

3361

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3322

FIG. 33B

3324

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FIG. 34A

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3400c

3400b X

3421

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FIG. 34B

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FIG. 34C

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FIG. 34E

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FIG. 34G

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3400h

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FIG. 34H

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FIG. 37C

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3742

FIG. 37D

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3820

FIG. 38A

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3800

FIG. 38B

3800

3802

3820

3825 \ \.|&%Z2?· ^x x X \ ^fl······ \^x

FIG. 38C

3801

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3800

3825

3801

FIG. 38D