CN108135719B

CN108135719B - Intragastric device for treating obesity

Info

Publication number: CN108135719B
Application number: CN201680055465.4A
Authority: CN
Inventors: V·K·沙尔马; R·巴苏德
Original assignee: SYNERZ MEDICAL Inc
Current assignee: SYNERZ MEDICAL Inc
Priority date: 2015-09-23
Filing date: 2016-04-20
Publication date: 2020-06-05
Anticipated expiration: 2036-04-20
Also published as: HK1257683A1; CN108135719A; AU2016328478A1; CA2997727A1; JP2018534093A; JP6574313B2; AU2018282461A1; EP3352712A1; AU2020207787A1; WO2017052694A1; CA2997727C; AU2020207787B2; EP3352712A4; AU2016328478B2

Abstract

An intragastric device configured for catheter deployment in the stomach includes a first wire mesh structure and a second wire mesh structure having a pre-deployment shape compressed within a lumen of the catheter, a post-deployment shape expanded within the stomach of a 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 a lower portion of the second wire mesh structure and extends into the human duodenum.

Description

Intragastric device for treating obesity

Cross Reference to Related Applications

This application is a continuation-in-part application entitled "Intragastric Device for treating obesity" filed on 23.9.2015, U.S. patent application No. 14/862,706, which claims priority to the same-named U.S. provisional patent application No. 62/158,406 filed on 7.5.2015 and U.S. provisional patent application No. 62/054,230 filed on 23.9.2014.

U.S. patent application No. 14/862,706, also filed 3, 14, 2014, is a continuation-in-part application entitled "Intragastric Device for Treating Obesity" U.S. patent application No. 14/214,609 filed 9, 30, 2013, which claims priority to U.S. provisional patent application No. 61/884,981 filed 9, 30, 2013, entitled "gastroenterological Device for Treating Obesity" and U.S. provisional patent No. 61/782,564 filed 3, 14, 2013, entitled "Intragastric Device for Treating Obesity".

U.S. patent application No. 14/214,609 is a continuation-in-part of U.S. patent application No. 14/096,505 entitled "intragastric device for Treating Obesity" filed on 12, 4, 2013, which is in turn a continuation-in-part of U.S. patent application No. 12/814,481 filed on 6, 13, 2010 under the same name and U.S. patent No. 8,628,554 granted on 1, 14, 2014.

All of the above applications are incorporated herein by reference in their entirety.

Technical Field

The present invention relates generally to medical devices for treating obesity. More particularly, the present invention relates to a dynamic weight intragastric and gastrointestinal device that reduces gastric volume, slows gastric emptying, and/or bypasses portions of the small intestine, thereby resulting in weight loss in the patient.

Background

Obesity is a common condition and growing public health problem in developed countries, including the united states. By 2009, over two thirds of U.S. adults, approximately 1.27 million, were overweight or obese. Over one third of the us adults are obese. The data show that 300000 americans die prematurely each year from complications associated with obesity. Many children in the united states are also overweight or obese. Therefore, the total number of overweight americans is expected to rise in the future. Obesity has been estimated to cost over 1000 billion dollars annually in the united states in direct and indirect health care expenses and in lost productivity. This trend is also evident in many other developed countries.

For adults, the Body Mass Index (BMI) is used to determine whether a person is overweight or obese. The individual's BMI is calculated by multiplying the weight in pounds by 703 and then dividing the total by the square of the height in inches. The individual's BMI may be expressed in kilograms per square meter. If the BMI of an adult is between 25 and 30kg/m²In between, he or she is considered overweight. Obesity is defined as possessing a weight of 30 to 40kg/m²BMI in between. Greater than 30kg/m²The BMI of (A) is associated with an important syndrome. Morbid obesity is defined as possessing a body weight of more than 100 pounds above the ideal value or greater than 40kg/m²The BMI of (1). Approximately 5% of the U.S. population meets at least one of the criteria for morbid obesity. Morbid obesity is associated with a number of diseases and conditions including, for example: diabetes mellitus; hypertension; heart disease; stroke; dyslipidemia; sleep apnea; pikvick syndrome; asthma; lower back and disc disease; weight bearing osteoarthritis of the hip, knee, ankle and foot; thrombophlebitis and pulmonary emboli; dermatitis due to intertrigo; stress urinary incontinence; gastroesophageal reflux disease (GERD); gallstones; and liver cirrhosis and cancer. Infertility, uterine cancer, and breast cancer are also associated with morbid obesity in women. In conclusion, the diseases associated with morbid obesity significantly reduce the chances of reaching average life span. Sequelae will increase annual mortality in the affected population by 10-fold or more.

Current treatments for obesity include diet, exercise, behavioral therapy, medicine, surgery (open and laparoscopic), and endoscopic devices. New drug treatments for obesity are currently being evaluated in clinical trials. However, highly effective drug therapies have not yet been developed. In addition, the short-term and long-term side effects of current drug therapies often raise concerns for consumers, drug suppliers, and/or their insurers. Generally, diet or drug treatment regimens are consistently disappointing and fail to bring about significant, sustained weight loss in most morbidly obese people.

Currently, most procedures for treating morbid obesity include gastric restriction, which involves the establishment of a small (e.g., 15-35 ml) upper stomach pouch that is expelled through a small exit orifice (e.g., 0.75-1.2 cm), thereby mobilizing the body's satiety mechanism. About 15% of procedures performed in the united states for treating morbid obesity involve combining gastric restriction with malabsorption. Typical malabsorption divides the small intestinal flow into the biliary-pancreatic tract and the food tract. Potential long-term side effects associated with abdominal surgery include hernia formation and small bowel obstruction. In addition, long-term problems with bariatric surgery include gastric outlet obstruction, peripheral ulceration, protein malnutrition, and vitamin deficiencies.

Other surgical strategies for treating obesity include endoscopy, many of which are still under development. Endoscopic procedures and endoscopic devices that produce a gastric pouch and a gastroenteric anastomosis are used to replicate laparoscopy. The placement of the gastric pouch through the endoscope limits the stomach volume and results in satiety for a smaller meal. For example, U.S. patent application No. 10/221,562, now assigned to U.S. patent No. 7,172,613 and assigned to disclass Medical SA (diet card Medical corporation), describes an intragastric device that is inserted through an endoscopic path into a patient's stomach. The device comprises a capsule or envelope having a specific nominal volume. The capsule is sealingly connected to a connecting element comprising a disc forming a support base for the capsule against the inner wall of the stomach. The device further comprises a flexible tube or catheter for connecting the balloon to the filling device, and a capturing element integrated with the tube or catheter. The connection element enables the physician to set and/or remove the capsule and to fix the filling device in the body of the patient or to fix the filling device subcutaneously and to bring the capsule or cuff to its predetermined nominal volume.

Silicone intragastric balloons (IGBs) have been developed as temporary aids to achieve weight savings, particularly for the following population: their body weight was 40% or more of their ideal body weight, and although attended by a multidisciplinary team they had unsatisfactory results in the treatment of their obesity. The treatment is also indicated for morbidly obese patients with high risk of morbidity and mortality for surgery. IGB placement and removal is endoscopic, and the balloon is designed to float freely within the stomach. IGB technology reduces gastric volume and leads to premature satiety. However, the use of IGB did not show convincing evidence of greater weight loss. The relative risk for minor complications, such as gastric ulcers and erosions, is significantly increased. All inflatable IGB devices suffer from the problem of degradation of the balloon over time. This aging can lead to deflation and loss of efficacy, and to complications such as small bowel obstruction secondary to capsule migration. Due to efficacy loss over time, it is recommended that IGB devices be used only for short (<6 months) durations. Furthermore, rapid inflation of the balloon constitutes a risk of esophageal or gastric perforation, both of which are surgical emergencies. Death has been reported in patients treated with IGB.

Endoscopy is also used to deploy a mesh structure into the stomach and create a false feeling of fullness when working to occupy the stomach volume. For example, U.S. patent application number 11/657,231, assigned to Wilson-hook Medical, Inc. (Winson Cuck Medical), describes an intragastric device generally comprising a strip of digestion-resistant mesh material operable between a first configuration and a second configuration. The first configuration is small enough to allow the digestion resistant web material to be introduced into the stomach cavity of a mammal. The second configuration is sufficiently large to prevent the digestion resistant mesh material from passing through the pylorus of the mammal, thereby allowing the mesh member to act as an artificial gastrolith.

Although balloon structures placed by endoscope may be effective, they are not without their associated risks and complications. The mesh structures are effective in occupying the available stomach volume, but they do not address gastric emptying. Migration and small bowel obstruction created by such devices remains a significant problem. Accordingly, there is a need for an intragastric device for treating obesity that combines the advantages obtained by reducing gastric volume, slowing gastric emptying, and providing a bypass for food passing through the pylorus and a portion of the small intestine, while remaining relatively safe. The device should also include means for preventing migration of the entire device from the stomach. The device should limit side effects and be relatively easy to deploy and remove in a non-invasive manner. Furthermore, the device should have the following options: obesity is further treated by including the advantages obtained by malabsorptive shunts. The addition of this optional advantage would make the device effective not only in treating obesity but also in treating type II diabetes.

Typical metal structures cannot be present in the hostile environment of the stomach, particularly with respect to high acidity. Intragastric devices comprising acid sensitive components such as metal wires are typically covered or coated with an acid resistant material (i.e., silicone) to prevent degradation of these components by acidic stomach contents. Conventional manufacturing processes for establishing these coated intragastric devices first coat the metal wires of the device and then form these wires into the desired final shape of the device. As the shape and structure of intragastric devices become more complex, these conventional processes fail to properly establish the desired end product. Shape memory metals such as nitinol are heat set at temperatures in excess of 400 ℃. Coating the metal with an acid resistant material and then heat setting to a final shape can result in damage to the coating during exposure to high temperatures. Accordingly, there is a need for a method of manufacture in which the wire of the intragastric device is first formed into the desired final shape and then coated with a corrosion resistant material. This method is to be careful to prevent coating and covering or plugging the spaces or openings between the individual wires of the wire mesh. This method will also produce a final device that is still flexible enough to transition from the compressed first pre-deployment shape to the expanded post-deployment shape.

Specific surgical options for treating obesity also include Laparoscopic Sleeve Gastrectomy (LSG) and laparoscopic rugby Y type Y gastric bypass (RGB) surgery. Gastrectomy refers to the surgical removal of part or all of the stomach. LSG is a restrictive therapeutic surgical weight loss procedure in which the stomach is reduced to about 25% of its original size by surgically removing a large portion along the main curve. The open edges are then attached together (often with surgical staples) to form a sleeve or tube having a banana shape. This procedure permanently reduces the size of the stomach. The procedure is performed laparoscopically and is irreversible. After the procedure, the stomach empties its contents into the small intestine quickly, but with little or no vomiting (characteristic of other restrictive procedures).

LSG involves longitudinal resection of the stomach on the greater curvature of the stomach starting from the antrum of the stomach up to the hiss angle, as opposed to the lataire nerve. The first step in the procedure is to join the vas deferens of the stomach apart by incising the ligaments of the gastro-colon and gastro-spleen near the stomach. The greater curvature is released completely to the left of the diaphragm to excise the fundus of the ghrelin-secreting cells that harbor the stomach. The second step of the procedure is a longitudinal gastrectomy that "sleeves" the stomach to reduce its shape to a narrow tube. The pylorus and a portion of the antrum are retained, resulting in a "restrictive" gastric sleeve based on the lesser curvature of the stomach.

Sleeve gastrectomy (also known as gastric sleeve) is typically performed on extremely obese patients with a body mass index of 40 or greater, and the risk of gastric bypass or duodenal switch surgery on them may be too great. A two-stage procedure was performed: the first stage is sleeve gastrectomy; the second stage is conversion to gastric bypass or duodenal translocation. Patients typically lose a large amount of their excess weight after a first stage sleeve gastrectomy, but if weight loss ceases, a second step is performed.

For obese but not extremely obese patients, sleeve gastrectomy alone is a suitable procedure with minimal risk. Currently, sleeve gastrectomy is an accepted weight loss surgical option for obese patients as a single procedure. Most surgeons prefer to use bougies (tapered cylindrical tools) with an outer diameter between 32-60 French (French, French unit) in this procedure (the optimal bougie size is 32 Fr-36 Fr). The ideal approximate residual capacity of the stomach after this procedure is 15 ml.

One of the mechanisms involved in the weight loss observed after LSG is a significant reduction in gastric volume. The limiting concept has been widely used in bariatric surgery, in Vertical Banding Gastroplasty (VBG) and Laparoscopic Adjustable Gastric Banding (LAGB). Small gastric pouch expansions in lag b surgery or VBG are intended to result in early satiety, enhanced satiety and reduced hunger experienced by patients after ingestion of small amounts of food.

Hormonal changes induced by LSG are different from those found after purely restrictive surgery such as LAGB. Ghrelin, a peptide hormone produced primarily in the fundus, is thought to be involved in the mechanism that regulates hunger sensation. In the case associated with a fundectomy, there is a significant reduction in ghrelin.

What makes LSG the preferred choice is the fact that: this procedure is a simple procedure that can be performed laparoscopically, even in the case of extremely obese patients. It does not involve any digestive anastomosis and does not have defects in the mesentery, thus eliminating the risk of internal hernia. In addition, no foreign material is used, since in the case of gastric banding the entire digestive tract remains accessible for endoscopy and it is not associated with the dumping syndrome. Moreover, the risk of peptic ulcers is low and the absorption of nutrients, vitamins, minerals and drugs is not altered.

Earlier reports of LSG have indicated that it is safe and effective through significant weight loss and significant reduction in major obesity-related comorbidities. In the long term, the question of whether LSG can act as a sole bariatric therapy has not been answered. For this reason, LSG was proposed as the first step in a phasic approach for the following patients: because of very high BMI (super-obese > BMI 50 or super-obese > BMI 60) and/or diseases whether obesity-related or not, biliopancreatic bypass by duodenal switch (BPD-DS) or RGB appears too dangerous.

Laparoscopic rugby Y type Y gastric bypass (RGB) involves creating a small (20-30 ml) gastric pouch and a rugby limb (typically 75-105 cm) that guides a portion of the digestive tract around the distal stomach and proximal small intestine. After RGB, pleiotropic endocrine responses may contribute to improved glycemic control, loss of appetite, and long-term changes in body weight. RGB also has profound positive effects on obesity-related comorbidities and quality of life. Other advantages include a defined long-term effectiveness for sustained weight loss, reduced co-morbidity, minimal risk of long-term nutritional sequelae, and effective relief of gastroesophageal reflux disease (GERD). RGB is not without risk. Common causes of death include pulmonary embolisms and anastomotic fistulas. Non-fatal perioperative complications include anastomotic fistulas, venous thromboembolism, wound infections, small bowel obstruction, and bleeding. Gastrointestinal complications after surgery include nausea and vomiting, micronutrient deficiencies, and possible weight recovery.

Failure after these bariatric procedures is common and patients begin to regain weight or gradual weight loss ceases at sub-therapeutic levels. Thus, there is a need for rescue therapy following one or more failed bariatric procedures. What is needed is a device for use after bariatric surgery that will combine the benefits of gastric volume reduction, biliary-pancreatic bypass, and/or intestinal bypass to enhance the weight loss effects of the device. What is also needed is a device that will further reduce the volume of the stomach that is limited by surgery to reduce the amount of calories that can be consumed. The device will also bypass the proximal small intestine or the intestinal tract of the Roux limb in order to produce intestinal malabsorption, biliary-pancreatic diversion, or both. The device is also operable to delay gastric emptying, release gastric hormones associated with satiety, and stimulate the gastric nerves associated with satiety. The device may be combined with other therapeutic means such as electrical stimulation, magnetic stimulation or drugs.

The device may be used as a primary treatment for weight loss or as a bridge to surgery for a final weight loss procedure. The device may also be used for the treatment of other conditions including, but not limited to, metabolic syndrome, diabetes, dyslipidemia, and cardiovascular disease.

Disclosure of Invention

An intragastric device configured to be deployed in a human stomach, the device comprising: a catheter comprising a housing and a lumen extending through the housing, wherein the lumen has an inner diameter, and wherein the inner diameter is less than or equal to 2 cm; a first wire mesh structure having a pre-deployment shape compressed within the lumen of the catheter and a post-deployment shape expanded within the stomach of the person, wherein a first volume of the pre-deployment shape is less than or equal to 110ml and a first length is less than or equal to 75cm, and wherein the post-deployment shape has a porous and closed second volume defined by a first plurality of curved surfaces and greater than or equal to 125ml, the first wire mesh structure further comprising an upper portion and a lower portion, wherein the upper portion has a first open surface area configured to allow material from outside the second volume to enter inside the second volume, and wherein the lower portion has a second open surface area; a second wire mesh structure separate from the first wire mesh structure, the second wire mesh structure having a pre-deployment shape compressed within the lumen of the catheter and a post-deployment shape expanded within the stomach of the person, wherein a third volume of the pre-deployment shape is equal to or less than 100ml and a second length is equal to or less than 70cm, and wherein the post-deployment shape has a porous and closed fourth volume defined by a second plurality of curved surfaces and equal to or greater than 110ml, the second wire mesh structure further comprising an upper portion and a lower portion, wherein the upper portion has a third open surface area configured to allow material from outside the fourth volume to inside the fourth volume, and wherein the lower portion has a fourth open surface area; a connecting portion to flexibly couple the first wire mesh structure and the second wire mesh structure, wherein the connecting portion is formed between a portion of the first wire mesh structure defining the second open surface area and a portion of the second wire mesh structure defining the third open surface area.

The first wire mesh structure and the second wire mesh structure may be positioned consecutively (sequentially) within the lumen of the catheter.

Optionally, at least one of the first plurality of curved surfaces is defined by an arc segment, and wherein the arc segment is defined by a radius in a range of 0.2cm to 20cm and a center angle in a range of 5 to 175 degrees.

Optionally, at least one of the second plurality of curved surfaces is defined by an arc segment, and wherein the arc segment is defined by a radius in a range of 0.1cm to 15cm and a center angle in a range of 1 to 179 degrees.

Optionally, the connecting portion is formed between a portion of the plurality of free ends of the first wire mesh structure defining the second open surface area and a portion of the plurality of free ends of the second wire mesh structure defining the third open surface area.

The first wire mesh structure and the second wire mesh structure may have at least one of a spherical shape and an elliptical shape.

Optionally, the connecting portion comprises a plurality of sutures. Optionally, the plurality of stitches includes a first flexible stitch attached at one end to a first point on the second opening surface area and at a second end to a second point on the third opening surface area.

A length of a connection from a first point on the second opening surface area to a second point on the third opening surface area may be in a range of 0.01mm to 200 mm.

Optionally, the plurality of stitches includes a second flexible stitch attached at one end to a third point on the second open surface area and at a second end to a fourth point on the third open surface area, wherein the first point is different from the third point and wherein the second point is different from the fourth point. A length of a connection from a third point on the second opening surface area to a fourth point on the third opening surface area may be in a range of 0.01mm to 300 mm. The first flexible suture and the second flexible suture may be separated by 180 degrees. Optionally, the plurality of stitches includes a third flexible stitch attached at one end to a fifth point on the second opening surface area and at a second end to a sixth point on the third opening surface area, wherein the fifth point is different from the first point and the third point, and wherein the sixth point is different from the second point and the fourth point. A length of a connection from a fifth point on the second opening surface area to a sixth point on the third opening surface area may be in a range of 0.01mm to 300 mm. Optionally, the plurality of stitches includes a fourth flexible stitch attached at one end to a seventh point on the second surface area of openings and at a second end to an eighth point on the third surface area of openings, wherein the seventh point is different from the first point, the third point, and the fifth point, and the eighth point is different from the second point, the fourth point, and the sixth point. A length of a connection portion from a seventh point on the second opening surface area to an eighth point on the third opening surface area may be in a range of 0.01mm to 300 mm.

Optionally, the first and second wire mesh structures have a degree of movement relative to each other in all directions defined by an angular displacement between a first longitudinal axis passing through the center of the first wire mesh structure, the center of the first open surface area and the center of the second open surface area and a second longitudinal axis passing through the center of the second wire mesh structure, the center of the third open surface area and the center of the fourth open surface area. The angular displacement may be less than or equal to 90 degrees.

Optionally, the length of the connection of the first wire mesh structure to the second wire mesh structure is designed such that the first wire mesh structure can be compressed by 99% of its equatorial diameter without causing compression of the second wire mesh structure.

Optionally, the length of the connection of the first wire mesh structure to the second wire mesh structure is designed such that, at a compression of the first wire mesh structure of more than 90%, the angular displacement of the second wire mesh structure relative to the first wire mesh structure is 10% or less, wherein the angular displacement is defined by the relative angle between a first longitudinal axis passing through the center of the first wire mesh structure, the center of the first opening surface area and the center of the second opening surface area and a second longitudinal axis passing through the center of the second wire mesh structure, the center of the third opening surface area and the center of the fourth opening surface area.

Optionally, the first and second wire mesh structures are connected within the lumen of the catheter by the connecting portion.

Optionally, the first and second wire mesh structures are not connected within the lumen of the catheter by the connecting portion.

Optionally, a connection is formed by interweaving a portion of the plurality of free ends of the second open surface area with a portion of the plurality of free ends of the third open surface area.

The second volume and the fourth volume together may occupy 25% to 95% of the stomach.

Optionally, the intragastric device further comprises a sleeve having a proximal end, a distal end, and a lumen, wherein the proximal end is coupled to the lower portion of the second wire mesh structure and the distal end is positioned in the patient's duodenum, the sleeve further comprising a first opening in fluid communication with the fourth opening surface region and a second opening at the distal end, wherein the sleeve is configured to transfer food from the intragastric device to the duodenum.

Optionally, the first wire mesh structure has at least one of a spherical shape and an elliptical shape, and the first wire mesh structure has a volume of more than 5ml and less than 5000 ml.

Optionally, the second wire mesh structure has at least one of a spherical shape and an elliptical shape, and the volume of the second wire mesh structure is greater than 20ml and less than 4000 ml.

The present invention also discloses an intragastric device configured to be deployed in a human stomach, the device comprising: a first wire mesh structure having a pre-deployment shape compressed within the lumen of the catheter and a post-deployment shape expanded within the stomach of the person, wherein a first volume of the pre-deployment shape is less than or equal to 110ml and a first length is less than or equal to 75cm, and wherein the post-deployment shape has a porous and closed second volume defined by a first plurality of curved surfaces and greater than or equal to 125ml, the first wire mesh structure further comprising an upper portion and a lower portion, wherein the upper portion has a first open surface area configured to allow material from outside the second volume to inside the second volume, and wherein the lower portion has a second open surface area; a second wire mesh structure having a pre-deployment shape compressed within the lumen of the catheter and a post-deployment shape expanded within the stomach of the person, wherein a third volume of the pre-deployment shape is less than or equal to 100ml and a second length is less than or equal to 70cm, and wherein the post-deployment shape has a porous and closed fourth volume defined by a second plurality of curved surfaces and greater than or equal to 110ml, the first wire mesh structure further comprising an upper portion and a lower portion, wherein the upper portion has a third open surface area configured to allow material from outside the fourth volume to enter inside the fourth volume, and wherein the lower portion has a fourth open surface area; a plurality of flexible members to flexibly couple the first wire mesh structure and the second wire mesh structure, wherein the plurality of flexible members includes a first flexible member attached at one end to a first point on the second open surface area and at a second end to a second point on the third open surface area, and wherein the plurality of flexible members includes a second flexible member attached at one end to a third point on the second open surface area and at a second end to a fourth point on the third open surface area, wherein the first point is different from the third point, and wherein the second point is different from the fourth point.

Optionally, a length of the first flexible member from a first point on the second opening surface area to a second point on the third opening surface area is in a range of 0.01mm to 300 mm.

Optionally, a length of the second flexible member from a third point on the second open surface area to a fourth point on the third open surface area is in a range of 0.01mm to 100 mm.

The first flexible member and the second flexible member may be separated by 180 degrees.

Optionally, the plurality of flexible members includes a third flexible member attached at one end to a fifth point on the second opening surface area and at a second end to a sixth point on the third opening surface area, wherein the fifth point is different from the first point and the third point, and wherein the sixth point is different from the second point and the fourth point. A length of the third flexible member from a fifth point on the second opening surface area to a sixth point on the third opening surface area may be in a range of 0.01mm to 300 mm. Optionally, the plurality of flexible members includes a fourth flexible member attached at one end to a seventh point on the second opening surface area and attached at a second end to an eighth point on the third opening surface area, wherein the seventh point is different from the first point, the third point, and the fifth point, and the eighth point is different from the second point, the fourth point, and the sixth point. A length of the fourth flexible member from a seventh point on the second opening surface area to an eighth point on the third opening surface area may be in a range of 0.01mm to 100 mm.

Optionally, the length of each of the plurality of flexible members is designed such that the first wire mesh structure can be compressed by 95% of its equatorial diameter without causing compression of the second wire mesh structure.

Optionally, the length of each of the plurality of flexible members is designed such that, at a compression (amount) of the first wire mesh structure of more than 90%, an angular displacement of the second wire mesh structure relative to the first wire mesh structure is 10% or less, wherein the angular displacement is defined by a relative angle between a first longitudinal axis passing through a center of the first wire mesh structure, a center of the first opening surface area, and a center of the second opening surface area, and a second longitudinal axis passing through a center of the second wire mesh structure, a center of the third opening surface area, and a center of the fourth opening surface area.

The present invention also discloses an intragastric device configured to be deployed in a human stomach, the device comprising: a catheter comprising a housing and a lumen extending through the housing, wherein the lumen has an inner diameter, and wherein the inner diameter is less than or equal to 2 cm; a first wire mesh structure having a pre-deployment shape compressed within the lumen of the catheter and a post-deployment shape expanded within the stomach of the person, wherein a first volume of the pre-deployment shape is less than or equal to 110ml and a first length is less than or equal to 75cm, and wherein the post-deployment shape has a porous and closed second volume defined by a first plurality of curved surfaces and greater than or equal to 125ml, the first wire mesh structure further comprising a first upper portion and a first lower portion, wherein the first upper portion has a first opening configured to allow material from outside the second volume to inside the second volume, and wherein the lower portion has a portion of the first plurality of curved surfaces that tapers and converges into a second opening defined by a diameter; and a collar attached to the lower part, wherein the collar is defined by a surface of revolution created by a half turn in three-dimensional space about an axis extending through a center of the second opening, and wherein the collar is defined by a diameter of 25mm or greater.

The present invention also discloses a delivery device for delivering a gastrointestinal device into the gastrointestinal tract of a patient, the gastrointestinal device comprising a porous structure configurable between a compressed pre-deployment configuration and an expanded post-deployment configuration, an anti-migration collar proximate a distal end of the porous structure, and an elongate cannula coupled to the distal end of the porous structure, the delivery device comprising: a flexible outer catheter having a proximal end, a distal end, and an inner lumen; a flexible inner catheter having a proximal end, a distal end, and a lumen configured to slidably receive a guide wire, wherein the inner catheter is coaxially positioned and configured to be slidably movable within the lumen of the outer catheter; wherein the outer catheter is configured to be retracted in a proximal direction over the inner catheter while holding the inner catheter in place to expose the gastrointestinal device from the distal end of the delivery device.

Optionally, the length of the sleeve is such that, once the gastrointestinal device is delivered, the proximal end of the sleeve is positioned proximal to the pylorus of the patient and the distal end of the sleeve is positioned in a portion of the duodenum of the patient.

Optionally, the outer catheter has a length of about 1.5 meters and the delivery device has a total length of about 3 meters.

Optionally, the anti-migration collar of the gastrointestinal device is proximally inclined, wherein the distal portion of the porous structure is folded such that the distally facing end of the porous structure is directed towards the proximal end of the porous structure. Optionally, the anti-migration collar is any curved/non-traumatic structure positioned circumferentially around the distal end of the porous structure.

Optionally, the outer catheter includes radiopaque markers at its distal end for radiographic visualization during delivery.

Optionally, the delivery device further comprises: a first handle attached to the proximal end of the inner catheter and having a proximal end, a distal end, and a lumen configured to slidably receive the guide wire; a second handle attached to the proximal end of the outer catheter and having a proximal end, a distal end, and a lumen configured to slidably receive the inner catheter, wherein, prior to delivery of the intragastric device, a proximal portion of the inner catheter positioned between the first handle and the second handle is exposed and not covered by the outer catheter; an elongated flexible pilot component having a proximal end, a distal end, and a length with variable stiffness, the pilot component comprising a distal spherical component and a proximal spherical component and extending from the distal end of the inner catheter; a first stop mechanism removably attached to the exposed portion of the inner catheter; and a second stop mechanism removably attached to the exposed portion of the inner catheter and positioned proximal to the first stop mechanism; wherein the first and second stopping mechanisms are configured to be sequentially removed from the inner catheter as the outer catheter is retracted.

The delivery device may further comprise a hydrophilic coating on at least one of said pilot component and said distal end of said outer catheter, wherein said hydrophilic coating is adapted to facilitate insertion and threading of said delivery device when activated.

The delivery device may further comprise at least one of a port on the first handle for injecting fluid into the lumen of the inner catheter and a port on the second handle for injecting fluid into the lumen of the outer catheter.

Optionally, the proximal spherical member is configured to be atraumatic and includes radiopaque markers for radiographic visualization during delivery, and the distal spherical member is configured in the shape of an atraumatic ball-tip.

Optionally, the variable stiffness of the pilot component is less than the stiffness of the distal end of the outer catheter at its proximal end and similar to the stiffness of a 0.035 inch guide wire at its distal end.

Optionally, the first and second stop mechanisms comprise plastic rings secured to the inner conduit using wing nuts.

The present invention also discloses a method of delivering a gastrointestinal device into the gastrointestinal tract of a patient using a delivery device comprising a porous structure configurable between a compressed pre-deployment configuration and an expanded post-deployment configuration, an anti-migration collar proximate a distal end of the porous structure, and an elongate cannula coupled to the distal end of the porous structure, the delivery device comprising: a flexible outer catheter having a proximal end, a distal end, and an inner lumen; a flexible inner catheter having a proximal end, a distal end, and a lumen configured to slidably receive a guide wire, wherein the flexible inner catheter is coaxially positioned and adapted to be slidably movable within the lumen of the outer catheter; a first handle attached to the proximal end of the inner catheter and having a proximal end, a distal end, and a lumen configured to slidably receive the guide wire; a second handle attached to the proximal end of the outer catheter and having a proximal end, a distal end, and a lumen configured to slidably receive the inner catheter; a first stop mechanism removably attached to the exposed portion of the inner catheter; and a second stop mechanism removably attached to the exposed portion of the inner catheter and positioned proximal to the first stop mechanism, the method comprising the steps of: sliding the delivery device over a guide wire into the gastrointestinal tract of the patient; determining a position of the distal end of the flexible outer catheter using fluorescence to determine proper positioning of the delivery device; holding said first handle to hold said inner catheter in place and to retract said outer catheter to said first stop mechanism; retracting the entire delivery device until the distal end of the outer catheter is positioned just proximal of the patient's pylorus; removing the first stopping mechanism from the inner catheter; holding said first handle to hold said inner catheter in place and retracting said outer catheter to said second stopping mechanism; removing the second stop mechanism; holding said first handle to hold said inner catheter in place and retracting said outer catheter to said first handle; and removing the delivery device from the patient.

Optionally, a portion of the cannula is delivered to and positioned within an intestinal portion of the patient's gastrointestinal tract when the outer catheter is retracted to the first stop mechanism.

Optionally, a portion of the sleeve and a portion of the porous structure are delivered to and positioned within a stomach portion of the patient's gastrointestinal tract when the outer catheter is retracted to the second stop mechanism.

Optionally, when the outer catheter is retracted to the first handle, the porous structure is fully delivered to and positioned within the intestinal portion of the patient's gastrointestinal tract.

A proximal portion of the inner catheter located between the first and second handles may be exposed and uncovered by the outer catheter prior to delivery of the gastrointestinal device.

Optionally, the delivery device further comprises an elongate flexible pilot member having a distal spherical member and a proximal spherical member and extending from the distal end of the inner catheter.

At least one of the pilot component and the distal end of the outer catheter may include a hydrophilic coating, and the method may further include: activating the hydrophilic coating prior to sliding the delivery device over the guide wire.

The present invention also discloses a delivery system for delivering a gastrointestinal device into the gastrointestinal tract of a patient, the system comprising: a gastrointestinal device, the gastrointestinal device comprising: a porous structure configurable between a compressed pre-deployment configuration and an expanded post-deployment configuration; an anti-migration collar proximate a distal end of the porous structure; and an elongate cannula coupled to a distal end of the porous structure; a delivery device, the delivery device comprising: a flexible outer catheter having a proximal end, a distal end, and an inner lumen; a flexible inner catheter having a proximal end, a distal end, and a lumen configured to slidably receive a guide wire, wherein the inner catheter is coaxially positioned and adapted to be slidably movable within the lumen of the outer catheter; a first handle attached to the proximal end of the inner catheter and having a proximal end, a distal end, and a lumen configured to slidably receive the guide wire; a second handle attached to the proximal end of the outer catheter and having a proximal end, a distal end, and a lumen configured to slidably receive the inner catheter, wherein a proximal portion of the inner catheter between the first and second handles is not entirely covered by the outer catheter; an elongate flexible member including a distal spherical member and a proximal spherical member and extending from the distal end of the inner catheter; a first stop mechanism removably attached to the exposed portion of the inner catheter; a second stop mechanism removably attached to the exposed portion of the inner catheter and positioned proximal to the first stop mechanism; wherein the distal end of the inner catheter is adapted to pass through the opening of the porous structure, wherein the sleeve is coaxially wrapped around the inner catheter, wherein the outer catheter is retractable in a proximal direction over the inner catheter while holding the inner catheter in place, and wherein the first and second stop mechanisms are adapted to be sequentially removed from the inner catheter as the outer catheter is retracted to expose and deliver a gastrointestinal device from the distal end of the delivery device.

The delivery system may further comprise a hydrophilic coating on at least one of the elongate flexible member and the distal end of the outer catheter, wherein the hydrophilic coating facilitates insertion and threading of the delivery device when the hydrophilic coating is activated.

The delivery system to be protected may further comprise at least one of a port on the first handle for injecting fluid into the lumen of the inner catheter and a port on the second handle for injecting fluid into the lumen of the outer catheter.

Optionally, the delivery device has a variable stiffness along its length.

The present invention also discloses a delivery device for endoscopically delivering an intragastric device into the gastrointestinal tract of a patient, the intragastric device comprising a porous structure configurable between a compressed pre-deployment configuration and an expanded post-deployment configuration, and an elongate sleeve coupled to a distal end of the porous structure, the delivery device comprising: an elongated body having a proximal end and a distal end; and a constraining mechanism for tightening the device coaxially over the distal end of the elongate body into a pre-deployment configuration.

In one embodiment, the delivery device further comprises a locking mechanism for locking the delivery device into a particular position.

In one embodiment, the distal end comprises a distal-most portion and a proximal-distal portion, wherein the distal-most portion is more flexible than the proximal-distal portion.

In one embodiment, the delivery device further comprises a wire pull port on the proximal end, wherein the constraining mechanism comprises a wire wound around the device in the pre-deployment configuration.

In one embodiment, the restraining mechanism comprises a zippered sheath coaxially covering the device in the pre-deployment configuration. In another embodiment, the restraining mechanism comprises a pull-apart sheath coaxially covering the device in the pre-deployment configuration. In another embodiment, the restraining mechanism comprises a tear-open sheath coaxially covering the device in the pre-deployment configuration.

The delivery device may comprise an elongate body having a proximal end, a distal end, and a pull-away sheath for coaxially sliding over the intragastric device, the pull-away sheath for coaxially tightening the intragastric device in the pre-deployment configuration over the distal end of the body of the delivery device, and the method of delivering the intragastric device may comprise the steps of: coaxially placing the tightened intragastric device in the pre-deployment configuration over the distal end of the body of the delivery device; endoscopically inserting the delivery device into a patient and advancing the distal end of the body of the delivery device into the patient's duodenum or jejunum; once an intragastric device is positioned, using a working tool to pull the sheath coaxially away to remove the sheath from the tightened intragastric device, thereby allowing the intragastric device to automatically expand to the post-deployment configuration; and sliding the distal end of the body of the delivery device coaxially away from the expanded intragastric device and removing the delivery device from within the patient.

Optionally, the method further comprises the steps of: applying a cooling element to the compressed intragastric device to slow expansion of the porous structure during removal of the sheath, thereby facilitating removal of the delivery device.

The present invention also discloses a retrieval device for endoscopically removing an intragastric device from the gastrointestinal tract of a patient, the intragastric device comprising a porous structure configurable between a compressed pre-deployment configuration and an expanded post-deployment configuration, and comprising at least one circumferential tightening mechanism positioned about the porous structure and a retrieval mechanism at a proximal end thereof, and an elongate sleeve coupled to a distal end of the porous structure, the retrieval device comprising: an elongate body having a proximal end and a distal end and a lumen therein; an elongated metal wire disposed within the lumen and having a proximal end and a distal end; a gripping mechanism formed by the distal end of the wire for gripping a free end of the at least one circumferential tightening mechanism and a retraction mechanism of the porous structure; and an actuator attached to the proximal end of the wire.

Optionally, the retraction device further comprises a handle at the proximal end of the elongate body.

Optionally, the actuator rests in the handle.

In one embodiment, the retrieval device further comprises a grip having two opposing jaws attached to said distal end of said elongated body and operatively connected to said actuator at said proximal end of said wire, and at least one caliper located between each of said jaws of said grip, wherein each of said jaws is configured to compress said caliper about said free end of said at least one circumferential tightening mechanism.

The present invention also discloses a method of delivering an intragastric device into the gastrointestinal tract of a patient using a delivery device, wherein the intragastric device comprises a porous structure configurable between a compressed pre-deployment configuration and an expanded post-deployment configuration, and an elongate sleeve coupled to a distal end of the porous structure, the method comprising the steps of: in a first step, deploying the porous structure without the sleeve and allowing the porous structure to expand to the post-deployment configuration; in a second step, deploying the sleeve within the expanded porous structure; and coupling a proximal end of the sleeve to a distal end of the porous structure during the second step.

Optionally, the method further comprises the steps of: during the first step, applying a cooling element to the compressed intragastric device to slow expansion of the porous structure during deployment.

Optionally, the first step is performed using a first catheter.

Optionally, the second step is performed using a second catheter.

The present invention also discloses a method of retracting a device from the gastrointestinal tract of a patient using a retraction device, wherein the device comprises a porous structure configurable between a compressed pre-deployment configuration and an expanded post-deployment configuration, and comprises at least one circumferential tightening mechanism positioned around the porous structure and a retraction mechanism at a proximal end thereof, and an elongate cannula coupled to a distal end of the porous structure, the retraction device comprising: an elongated body having a proximal end and a distal end and a lumen therein, an elongated metal wire disposed within said lumen and having a proximal end and a distal end, a grasping mechanism formed by said distal end of said wire, a retrieval mechanism for grasping a free end of said at least one circumferential tightening mechanism and said porous structure; and an actuator attached to the proximal end of the wire, the method comprising the steps of: endoscopically inserting the retrieval device into the patient and advancing the distal end of the body of the retrieval device to a proximal end of the device; manipulating the gripping mechanism of the retrieval device to engage a free end of the at least one circumferential tightening mechanism positioned about the porous structure; pulling the actuator of the retrieval device to tighten and automatically lock the at least one circumferential tightening mechanism, thereby compressing the porous structure to the pre-deployment shape; manipulating the gripping mechanism of the retraction mechanism to disengage the free end of the at least one circumferential tightening mechanism; manipulating the grasping mechanism to engage the retrieval mechanism at the proximal end of the porous structure; pulling the actuator to withdraw a proximal portion of the device into the lumen of the retrieval device; and removing the retrieval device and the device from the patient.

The intragastric device may include three circumferential tightening mechanisms positioned about the porous structure, and the method may further include the steps of: sequentially manipulating the gripping mechanism of the retraction device to engage a free end of each of the three circumferential tightening mechanisms; and pulling the actuator of the retrieval device to tighten and automatically lock each of the three circumferential tightening mechanisms to fully compress the porous structure to the pre-deployment shape.

In one embodiment, the method further comprises the steps of: applying a cooling element to the compressed device to inhibit re-expansion of the porous structure during the retrieval and removal of the device.

The retrieval device may further include a grip having two opposing jaws attached to the distal end of the elongated body and operatively connected to the actuator at the proximal end of the wire, and at least one caliper between each of the jaws of the grip, and the method may further include the steps of: manipulating the grip of the retrieval device to apply the at least one caliper to a free end of the at least one circumferential tightening mechanism proximate the compressed cellular structure.

The present invention also discloses a retrieval device for endoscopically removing an intragastric device from a gastrointestinal tract of a patient, the intragastric device comprising a porous structure configurable between a compressed pre-deployment configuration and an expanded post-deployment configuration and comprising an elongate sleeve coupled to a distal end of the porous structure, the retrieval device comprising: a flexible catheter having a proximal end and a distal end and a lumen therein; an elongated metal wire positioned within the lumen of the catheter and having a proximal end and a distal end, wherein a portion of the distal end of the wire forms a gripping mechanism; a handle located at the proximal end of the catheter; and an elongate tube having a proximal end, a distal end, and a first lumen therein, wherein the tube is coaxially located on the catheter, wherein the grasping mechanism is configured to grasp the porous structure, and the elongate tube is configured to receive the porous structure at its distal end.

The handle may comprise a first handle part and a second handle part, wherein the first and second handle parts are disassembled to allow the elongate tube to be slid onto or off the catheter. Optionally, the first and second handle components are assembled and held together using screws.

The elongated tube may further comprise an adapter at a proximal end thereof, wherein the adapter is configured to be attached to the second handle member.

Optionally, the elongate tube further comprises: an inflatable balloon located at the distal end of the elongate tube; an insufflation port located at the proximal end of the elongate tube; a separate second lumen in fluid communication with the inflatable balloon and the insufflation port; and a chamber at the distal end of the elongate tube configured to receive the balloon when the balloon is deflated, wherein the balloon is inflatable through the insufflation port and the second lumen, and when inflated, the balloon is used to assist in compressing the porous structure to its pre-deployment configuration.

Optionally, the elongate tube further comprises a drip port at its proximal end for dripping cold fluid into said first lumen of said elongate tube, wherein said porous structure is comprised of a temperature sensitive material and said cold fluid is used to assist in compressing said porous structure to its pre-deployment configuration.

The catheter may further comprise a sheath for constraining said grasping means. Optionally, the gripping means comprises a hook.

The present invention also discloses a method of withdrawing an intragastric device from the gastrointestinal tract of a patient using a retrieval device, wherein the intragastric device comprises a porous structure configurable between a compressed pre-deployment configuration and an expanded post-deployment configuration, and comprises an elongate sleeve coupled to a distal end of the porous structure, the retrieval device comprising: a flexible catheter having a proximal end and a distal end and a lumen therein; an elongated wire positioned within the lumen of the catheter and having a proximal end and a distal end, wherein a portion of the distal end of the wire forms a gripping mechanism; a handle located at the proximal end of the catheter; and an elongate tube having a proximal end, a distal end, and a first lumen therein, wherein the tube is coaxially located on the catheter, the method comprising the steps of: inserting the catheter into a working channel of an endoscope that has been inserted into the patient; positioning a distal end of the endoscope proximate the patient's stomach and proximate the intragastric device; manipulating the elongate wire to extend the grasping mechanism beyond the distal end of the catheter and grasp the porous structure by the grasping mechanism; removing the handle from the catheter; sliding the elongated tube over the catheter; the handle is reset; pulling the elongate wire to draw the porous structure into the elongate tube; and removing the retrieval device with the intragastric device therein from the patient.

The elongated tube may further comprise: an inflatable balloon located at the distal end of the elongate tube; an insufflation port located at the proximal end of the elongate tube; a separate second lumen in fluid communication with the inflatable balloon and the insufflation port; and a chamber at the distal end of the elongate tube configured to receive the balloon when the balloon is deflated, and the method may further comprise the steps of: inflating the balloon through the insufflation port and the second lumen, wherein the inflated balloon extends from the chamber and serves to assist in compressing the porous structure to its pre-deployment configuration.

Optionally, the elongate tube further comprises a drip port at a proximal end thereof for dripping cold fluid into said first lumen of said elongate tube, wherein said porous structure is comprised of a temperature sensitive material, said method further comprising the steps of: instilling a cold fluid into the first lumen to assist in compressing the porous structure to its pre-deployment configuration.

The invention also discloses an intragastric device comprising: a porous structure comprising a top, a bottom, and an interior and having a pre-expanded shape with a first volume and a post-expanded shape with a second volume greater than the first volume, wherein in the post-expanded shape the porous structure comprises at least one first opening proximate the top and at least one second opening proximate the bottom such that food enters the porous structure through the at least one first opening, passes through the interior, and exits the porous structure through the at least one second opening, wherein the porous structure further comprises: a wire mesh having a substantially spherical expanded shape and including at least a first plurality of nodes at the top, a second plurality of nodes at the bottom, and a third plurality of nodes at a lateral position between the top and the bottom, wherein each node includes a single unsupported free end or bend in a wire of the wire mesh; and a collar at the bottom of the porous structure, the collar having a bend, wherein the bend comprises the wire bending continuing in a direction away from a longitudinal central axis of the porous structure and then in a direction upward toward the top of the porous structure; and a sleeve having a flexible elongate body, a proximal end with a third opening, a distal end with a fourth opening, and a sleeve interior, wherein the proximal end of the sleeve is coupled to the second plurality of nodes of the porous structure such that food exiting the at least one second opening enters the sleeve through the third opening, passes through the sleeve interior, and exits the sleeve through the fourth opening.

Optionally, the proximal end of the sleeve is coupled to the collar.

Each set of the plurality of nodes may include 10 to 100 individual nodes. Optionally, each set of the plurality of nodes comprises 44 nodes. Optionally, each group of the plurality of nodes comprises 36 nodes.

The porous structure has a length, and the porous structure may include 2 to 60 sets of a plurality of nodes distributed at different locations along the length along the weft direction. At least 10% of the total number of nodes in the porous structure may be located at the top and the bottom. Optionally, no more than 75% of the total number of nodes are located in any one of the plurality of nodes.

The wire mesh may be comprised of a shape memory metal.

The wire has a wire thickness and the bend of the collar has a bend radius, wherein when the collar is folded in a distal direction as the porous structure is compressed to the pre-deployment shape, the bend may be defined by a percent bending strain equal to twice the thickness divided by the radius multiplied by 100. Optionally, the percent bending strain is in the range of 0.1 to 20%. Optionally, the percent bending strain does not exceed 8%.

Optionally, the thickness is in the range of 0.1 to 1 mm. Optionally, the bend radius is in the range of 0.013 to 20 cm.

The thickness and bend radius may be configured such that twice the thickness is less than the radius, and the radius is less than 2000 times the thickness.

The invention also discloses an intragastric device comprising: a porous structure comprising a top, a bottom, and an interior and having a pre-expanded shape with a first volume and a post-expanded shape with a second volume greater than the first volume, wherein in the post-expanded shape the porous structure comprises at least one first opening proximate the top and at least one second opening proximate the bottom such that food enters the porous structure through the at least one first opening, passes through the interior, and exits the porous structure through the at least one second opening, wherein the porous structure further comprises: a wire mesh having a substantially spherical expanded shape and including at least a first plurality of nodes at the top, a second plurality of nodes at the bottom, and a third plurality of nodes at a lateral position between the top and the bottom, wherein each node includes a single unsupported free end or bend in a wire of the wire mesh; and a collar at the bottom of the porous structure, the collar having a bend, wherein the bend comprises the wire bending continuing in a direction away from a longitudinal central axis of the porous structure and then in a direction upward toward the top of the porous structure, and wherein the wire has a wire thickness and the bend of the collar has a bend radius, and wherein, when the collar is folded over in a distal direction as the porous structure is compressed into the pre-deployment shape, the bend is defined by a percent bending strain equal to twice the thickness divided by the radius multiplied by 100, further wherein the percent bending strain is in a range of 0.1 to 20%; and a sleeve having a flexible elongate body, a proximal end with a third opening, a distal end with a fourth opening, and a sleeve interior, wherein the proximal end of the sleeve is coupled to the second plurality of nodes of the porous structure such that food exiting the at least one second opening enters the sleeve through the third opening, passes through the sleeve interior, and exits the sleeve through the fourth opening.

Optionally, the percent bending strain is no more than 8%. Optionally, the thickness is in the range of 0.1 to 1 mm. Optionally, the bend radius is in the range of 0.013 to 20 cm.

The invention also discloses an intragastric device comprising: a porous structure comprising a top, a bottom, and an interior and having a pre-expanded shape with a first volume and a post-expanded shape with a second volume greater than the first volume, wherein in the post-expanded shape the porous structure comprises at least one first opening proximate the top and at least one second opening proximate the bottom such that food enters the porous structure through the at least one first opening, passes through the interior, and exits the porous structure through the at least one second opening, wherein the porous structure further comprises: a wire mesh having a substantially spherical expanded shape and comprising at least a first plurality of nodes at the top, a second plurality of nodes at the bottom, and a third plurality of nodes at a lateral position between the top and the bottom, wherein each node comprises a single unsupported free end or bend in a wire of the wire mesh, and wherein each plurality of nodes comprises no more than 44 individual nodes; and a collar at the bottom of the porous structure, the collar having a bend, wherein the bend comprises the wire bending continuing in a direction away from a longitudinal central axis of the porous structure and then in a direction upward toward the top of the porous structure, and wherein the wire has a wire thickness and the bend of the collar has a bend radius, and wherein, when the collar is folded over in a distal direction as the porous structure is compressed into the pre-deployment shape, the bend is defined by a percent bending strain equal to twice the thickness divided by the radius multiplied by 100, further wherein the percent bending strain is in a range of 0.1 to 20%; and a sleeve having a flexible elongate body, a proximal end with a third opening, a distal end with a fourth opening, and a sleeve interior, wherein the proximal end of the sleeve is coupled to the second plurality of nodes of the porous structure such that food exiting the at least one second opening enters the sleeve through the third opening, passes through the sleeve interior, and exits the sleeve through the fourth opening.

The invention also discloses an intragastric device comprising: a porous structure comprising a top, a bottom, and an interior and having a pre-expanded shape with a first volume and a post-expanded shape with a second volume greater than the first volume, wherein in the post-expanded shape the porous structure comprises at least one first opening proximate the top and at least one second opening proximate the bottom such that food enters the porous structure through the at least one first opening, passes through the interior, and exits the porous structure through the at least one second opening; and a sleeve having a flexible elongate body, a proximal end with a third opening, a distal end with a fourth opening, and a sleeve interior, and having a pre-deployed shape with a first length and a post-deployed shape with a second length greater than the first length, wherein the proximal end of the sleeve is coupled to the bottom of the porous structure such that food exiting the at least one second opening enters the sleeve through the third opening, passes through the sleeve interior, and exits the sleeve through the fourth opening when the sleeve is in the post-deployed shape, wherein the sleeve further comprises at least one helical wire extending along the elongate body, the at least one helical wire being configured to provide support to the sleeve when in the post-deployed shape, and wherein a strain percentage of the helical wire support is defined by a thickness of the wire and a pitch of the wire, further wherein the pitch is defined by a distance along the longitudinal axis of the sleeve between any two points of the wire disposed in the same plane.

The helical wire may be formed of a shape memory metal. Optionally, the shape memory metal is nitinol.

The percent strain of the helical wire may be in the range of 0.1 to 20% when the helical wire is compressed as the sleeve is compressed and folded to its pre-deployment shape. Optionally, the percentage strain of the helical wire does not exceed 8% when the helical wire is compressed as the sleeve is compressed and folded to its pre-deployment shape. The pitch may be in the range of 5 to 150 mm. Alternatively, the pitch is equal to 60 mm.

The length of the cannula may be in the range of 1cm to 120cm and may be configured to pass non-invasively into and out of the pylorus of the patient.

The sleeve may be substantially funnel-shaped and decrease in diameter as the sleeve extends from the proximal end to the distal end.

Optionally, a proximal portion of the sleeve is funnel-shaped, wherein the diameter of the proximal end of the sleeve is greater than the diameter of any other portion along the sleeve body, and the proximal end diameter gradually decreases as the sleeve body extends distally.

Optionally, the distal portion of the cannula body comprises two or more layers configured to reinforce the distal portion and maintain the cannula body in an elongate shape when the cannula body is in the post-deployment shape.

Optionally, the sleeve comprises a proximal portion and a distal portion, wherein the proximal portion extends from the proximal end of the sleeve to a transition point on the sleeve body, and the distal portion extends from the transition point to the distal end of the sleeve, further wherein the proximal portion is funnel-shaped and decreases in diameter as the proximal portion extends from the proximal end of the sleeve to the transition point. Also optionally, the distal portion is funnel-shaped and decreases in diameter as it extends from the transition point to the distal end of the cannula. Alternatively, the distal portion is cylindrical and its diameter remains constant as it extends from the transition point to the distal end of the cannula. Optionally, the diameter of the distal portion increases as the distal portion extends from the transition point to the distal end of the cannula.

The sleeve may be comprised of at least one layer of any one or combination of the following: polytetrafluoroethylene (PTFE), Polyethylene (PE), Low Density Polyethylene (LDPE), High Density Polyethylene (HDPE), and Ultra High Molecular Weight Polyethylene (UHMWPE). Optionally, the sleeve comprises at least two layers of any one or a combination of the following: polytetrafluoroethylene (PTFE), Polyethylene (PE), Low Density Polyethylene (LDPE), High Density Polyethylene (HDPE), and Ultra High Molecular Weight Polyethylene (UHMWPE), and further comprising at least one metal wire support between each of said layers.

Optionally, the intragastric device further comprises a component attached to said distal end of said sleeve and configured such that said distal end is atraumatic to body tissue, wherein said component comprises a cylindrical body, a proximal end, a distal end, and a lumen therein, and wherein said component is open at both ends and said lumen of said component is in fluid communication with the interior of said sleeve, further wherein an outer surface of said component comprises a groove and a circular member positioned within said groove, and said component is attached to said sleeve by positioning a portion of said sleeve within said groove and below said circular member.

Optionally, the member further comprises a flange extending from the outer surface, wherein the flange covers a free end of the distal end of the cannula. Alternatively, the component further comprises a heat shrink tube over the circular member and the groove. Also optionally, the distal end of the sleeve is folded over under the circular member such that a free end of the distal end of the sleeve becomes located within the sleeve interior.

Optionally, the intragastric device further comprises at least one tail extending from said distal end of said sleeve, wherein said tail is configured to pull said sleeve in a distal direction to assist in proper orientation of said sleeve within the patient's gastrointestinal tract.

The distal end of the cannula may include a plurality of cannula lips, wherein the lips are attached to a member at the distal end of the cannula, further wherein the member is configured to pull the cannula in a distal direction to assist in proper orientation of the cannula within the patient's gastrointestinal tract. Optionally, the fringe and the distal member are parachute-shaped.

The distal end of the sleeve may include a plurality of sutures, each suture having a proximal end and a distal end, wherein the proximal ends of the sutures are attached to the distal end of the sleeve and the distal ends of the sutures are attached to a member configured to pull the sleeve in a distal direction to assist in proper orientation of the sleeve within the gastrointestinal tract of a patient. Optionally, the fringe and the distal member are parachute-shaped.

The distal end of the sleeve may include a plurality of sutures, each suture having a proximal end and a distal end, wherein the proximal ends of the sutures are attached to the distal end of the sleeve and the distal ends of the sutures are each attached to a separate member, wherein each separate member is configured to pull the sleeve in a distal direction to assist in proper orientation of the sleeve within the gastrointestinal tract of a patient.

Optionally, the sleeve is folded over itself at least once along its longitudinal axis to provide additional structure to the sleeve.

The cannula may include at least one channel extending along a longitudinal axis of the cannula, wherein the at least one channel receives a support member to provide additional structure to the cannula.

At least a portion of the sleeve may have a corrugated structure of alternating grooves and ridges to provide additional structure to the sleeve.

At least a portion of the sleeve may include flexible wires configured in a woven structure to provide additional structure to the sleeve.

The cannula may include at least one channel extending along a longitudinal axis of the cannula, wherein the at least one channel is configured to receive a fluid to provide additional structure to the cannula.

The invention also discloses an intragastric device comprising: a porous structure comprising a top, a bottom, and an interior and having a pre-expanded shape with a first volume and a post-expanded shape with a second volume greater than the first volume, wherein in the post-expanded shape the porous structure comprises at least one first opening proximate the top and at least one second opening proximate the bottom such that food enters the porous structure through the at least one first opening, passes through the interior, and exits the porous structure through the at least one second opening; and a sleeve having a flexible elongate body, a proximal end with a third opening, a distal end with a fourth opening, and a sleeve interior, and having a pre-deployed shape with a first length and a post-deployed shape with a second length greater than the first length, wherein the proximal end of the sleeve is coupled to the bottom of the porous structure such that food exiting the at least one second opening enters the sleeve through the third opening, passes through the sleeve interior, and exits the sleeve through the fourth opening when the sleeve is in the post-deployed shape, wherein the sleeve further comprises three helical wires extending along the elongate body, the three helical wires configured to provide support to the sleeve when in the post-deployed shape, and wherein each of the helical wire supports has an individual strain percentage, the percent strain is defined by a thickness of the individual wire and an individual pitch of the individual wire, further wherein the individual pitch is defined by a distance along a longitudinal axis of the cannula between any two points along the individual wire that lie in the same plane.

Each of the helical wires may be formed of a shape memory metal. Optionally, the shape memory metal is nitinol.

The percent strain of each of the helical wires may be in the range of 0.1 to 20% when each of the helical wires is compressed as the sleeve is compressed and folded to its pre-deployment shape. Optionally, the percentage strain of each of the helical wires when compressed as the sleeve is compressed and folded to its pre-deployment shape is no more than 8%.

The individual pitch of each of the helical wires may be in the range 5 to 150 mm. Optionally, the individual pitch of each said helical wire is equal to 60 mm.

Optionally, each of the wires comprises an adjacent wire pitch defined by a distance along the longitudinal axis of the sleeve between any two points along two adjacent wires lying in the same plane, wherein the adjacent wire pitch is equal to 20 mm.

The invention also discloses an intragastric device comprising: a porous structure comprising a top, a bottom, and an interior and having a pre-expanded shape with a first volume and a post-expanded shape with a second volume greater than the first volume, wherein in the post-expanded shape the porous structure comprises at least one first opening proximate the top and at least one second opening proximate the bottom such that food enters the porous structure through the at least one first opening, passes through the interior, and exits the porous structure through the at least one second opening; and a sleeve having a flexible elongate body, a proximal end with a third opening, a distal end with a fourth opening, and a sleeve interior, and having a pre-deployed shape with a first length and a post-deployed shape with a second length greater than the first length, wherein the proximal end of the sleeve is coupled to the bottom of the porous structure such that food exiting the at least one second opening enters the sleeve through the third opening, passes through the sleeve interior, and exits the sleeve through the fourth opening when the sleeve is in the post-deployed shape, wherein the sleeve further comprises at least one helical wire extending along the elongate body, the at least one helical wire being configured to provide support to the sleeve when in the post-deployed shape, and wherein a strain percentage of the helical wire support is defined by a thickness of the wire and a pitch of the wire, wherein the sleeve is invertible on itself at least five times such that the percentage strain does not exceed 20%, further wherein the pitch is defined by the distance along the longitudinal axis of the sleeve between any two points along the wire that lie in the same plane.

The invention also discloses an intragastric device comprising: a porous structure comprising a top, a bottom, and an interior and having a pre-expanded shape with a first volume and a post-expanded shape with a second volume greater than the first volume, wherein in the post-expanded shape the porous structure comprises at least one first opening proximate the top and at least one second opening proximate the bottom such that food enters the porous structure through the at least one first opening, passes through the interior, and exits the porous structure through the at least one second opening, wherein the porous structure further comprises: a wire mesh having a substantially spherical expanded shape and including at least a first plurality of nodes at the top, a second plurality of nodes at the bottom, and a third plurality of nodes at a lateral position between the top and the bottom, wherein each node includes a single unsupported free end or bend in a wire of the wire mesh; and a collar at the bottom of the porous structure, the collar having a bend, wherein the bend comprises the wire bending continuing in a direction away from a longitudinal central axis of the porous structure and then in a direction upward toward the top of the porous structure; and a sleeve having a flexible elongate body, a proximal end with a third opening, a distal end with a fourth opening, and a sleeve interior, wherein the proximal end of the sleeve is coupled to the second plurality of nodes of the porous structure such that food exiting the at least one second opening enters the sleeve through the third opening, passes through the sleeve interior, and exits the sleeve through the fourth opening, wherein at least a portion of a total number of nodes in the second plurality of nodes are coupled to the proximal end of the sleeve by sutures.

Each node in the portion of the total number of nodes in the second plurality of nodes may be sutured to the proximal end of the cannula at a distal-most location of each node. Optionally, a portion of the total number of nodes in the second plurality of nodes comprises all of the nodes in the second plurality of nodes. Optionally, a portion of the total number of nodes in the second plurality of nodes comprises every other node in the second plurality of nodes.

Sutures may be loosely applied to allow some relative movement between the wire mesh and the sleeve.

Each suture coupling the sleeve to each of the nodes of the portion of the total number of nodes in the second plurality of nodes may include only one knot.

The wires of the wire mesh may comprise at least two ends, wherein the ends are joined and crimped together using a metal tube.

The wire mesh may comprise at least two ends, wherein each of the ends loops back to the wire to create a non-traumatic wire end, or loops outward to create an attachment point to the cannula.

The sleeve may comprise a wire for support, and the wire may comprise at least two ends, wherein each of the ends loops back the wire to create a non-traumatic wire end, loops outward to create an attachment point for coupling to the wire mesh, or to pull the sleeve during compression of the device.

The invention also discloses an intragastric device comprising: a porous structure comprising a top, a bottom, and an interior and having a pre-expanded shape with a first volume and a post-expanded shape with a second volume greater than the first volume, wherein in the post-expanded shape the porous structure comprises at least one first opening proximate the top and at least one second opening proximate the bottom such that food enters the porous structure through the at least one first opening, passes through the interior, and exits the porous structure through the at least one second opening, wherein the porous structure further comprises: a wire mesh having a substantially spherical expanded shape and including at least a first plurality of nodes at the top, a second plurality of nodes at the bottom, and a third plurality of nodes at a lateral position between the top and the bottom, wherein each node includes a single unsupported free end or bend in a wire of the wire mesh; and a collar at the bottom of the porous structure, the collar having a bend, wherein the bend comprises the wire bending continuing in a direction away from a longitudinal central axis of the porous structure and then in a direction upward toward the top of the porous structure; and a sleeve having a flexible elongate body, a proximal end with a third opening, a distal end with a fourth opening, and a sleeve interior, wherein the proximal end of the sleeve is coupled to the second plurality of nodes of the porous structure such that food exiting the at least one second opening enters the sleeve through the third opening, passes through the sleeve interior, and exits the sleeve through the fourth opening, wherein a portion of the wire proximate each node intersects another portion of the wire proximate an adjacent node to create intersection points, and wherein at least a portion of the total number of intersection points at the bottom of the porous structure is coupled to the proximal end of the sleeve by a suture.

Optionally, a portion of the total number of the intersection points at the bottom of the porous structure includes all of the intersection points proximate to the bottom of the porous structure. Optionally, a portion of the total number of intersection points at the bottom of the porous structure comprises every other intersection point proximate the bottom of the porous structure.

Each suture coupling the sleeve to each of the intersection points of the total number of intersection points proximate the portion at the bottom of the porous structure may include only one knot.

The present invention also discloses a method of compressing an intragastric device for loading onto a delivery device prior to deployment, the intragastric device comprising: a porous structure comprising a top, a bottom, and an interior and having a pre-expanded shape with a first volume and a post-expanded shape with a second volume greater than the first volume, wherein in the post-expanded shape the porous structure comprises at least one first opening proximate the top and at least one second opening proximate the bottom such that food enters the porous structure through the at least one first opening, passes through the interior, and exits the porous structure through the at least one second opening, wherein the porous structure further comprises: a wire mesh having a substantially spherical expanded shape and including at least a first plurality of nodes at the top, a second plurality of nodes at the bottom, and a third plurality of nodes at a lateral position between the top and the bottom, wherein each node includes a single unsupported free end or bend in a wire of the wire mesh; and a collar at the bottom of the porous structure, the collar having a bend, wherein the bend comprises the wire bending continuing in a direction away from a longitudinal central axis of the porous structure and then in a direction upward toward the top of the porous structure; and a sleeve having a flexible elongate body, a proximal end with a third opening, a distal end with a fourth opening, and a sleeve interior, wherein the proximal end of the sleeve is coupled to the second plurality of nodes of the porous structure such that food exiting the at least one second opening enters the sleeve through the third opening, passes through the sleeve interior, and exits the sleeve through the fourth opening, wherein at least a portion of a total number of nodes in the second plurality of nodes are coupled to the proximal end of the sleeve by sutures, the method comprising the steps of: compressing the wire mesh about a longitudinal central axis of the porous structure; and pulling the distal end of the sleeve, thereby causing the bend of the collar to bend in a downward direction such that the collar becomes substantially straight.

The invention also discloses an intragastric device comprising: a porous structure comprising a top, a bottom, and an interior and having a pre-expanded shape with a first volume and a post-expanded shape with a second volume greater than the first volume, wherein in the post-expanded shape the porous structure comprises at least one first opening proximate the top and at least one second opening proximate the bottom such that food enters the porous structure through the at least one first opening, passes through the interior, and exits the porous structure through the at least one second opening; and a sleeve having a flexible elongate body, a proximal end with a third opening, a distal end with a fourth opening, and a sleeve interior, and having a pre-deployed shape with a first length and a post-deployed shape with a second length greater than the first length, wherein the proximal end of the sleeve is coupled to the bottom of the porous structure such that when the sleeve is in the post-deployed shape, food exiting the at least one second opening enters the sleeve through the third opening, passes through the sleeve interior, and exits the sleeve through the fourth opening, wherein a coefficient of friction of the sleeve allows the sleeve to at least fold over itself, wrap around a portion of a deployment device, pull back and forth during deployment, and fully deploy without any structural damage to the sleeve.

The coefficient of friction may be in the range of 0.01-0.45. Optionally, the coefficient of friction is equal to or less than 0.10.

The sleeve has an outer surface, and wherein the outer surface may be a matte surface. A particulate material may be applied to the outer surface of the sleeve. Optionally, the particulate material is corn starch. Optionally, the particulate material is a biocompatible powder.

The sleeve may be folded over on itself at least twice.

The present invention also discloses a method of delivering an intragastric device into the gastrointestinal tract of a patient, the intragastric device comprising: a porous structure comprising a top, a bottom, and an interior and having a pre-expanded shape with a first volume and a post-expanded shape with a second volume greater than the first volume, wherein in the post-expanded shape the porous structure comprises at least one first opening proximate the top and at least one second opening proximate the bottom such that food enters the porous structure through the at least one first opening, passes through the interior, and exits the porous structure through the at least one second opening; and a cannula having a flexible elongate body, a proximal end with a third opening, a distal end with a fourth opening, and a cannula interior, and has a pre-deployment shape with a first length and a post-deployment shape with a second length greater than the first length, wherein the proximal end of the sleeve is coupled to the bottom of the porous structure such that when the sleeve is in the post-deployment shape, food exiting the at least one second opening enters the sleeve through the third opening, passes through the interior of the sleeve and exits the sleeve through the fourth opening, wherein the sleeve has a coefficient of friction that allows the sleeve to fold over at least upon itself, wrap around a portion of a deployment device, pull back and forth during deployment, and fully deploy without any structural damage to the sleeve, the method comprising the steps of: loading the porous structure to a delivery device; folding the sleeve over on itself; winding the folded over cannula around a portion of the delivery device; inserting the delivery device comprising the porous structure and the cannula into the gastrointestinal tract of the patient; manipulating the delivery device to fully deploy the cannula; further manipulating the delivery device to fully deploy the porous structure; and removing the delivery device from the patient.

The coefficient of friction may be in the range of 0.01-0.45.

The method may further comprise the steps of: applying particulate matter to an outer surface of the sleeve prior to folding the sleeve over on itself. Optionally, the particulate material is corn starch. Optionally, the particulate material is a biocompatible powder.

The sleeve may be folded over on itself at least twice.

The present invention also discloses a method of delivering an intragastric device into the gastrointestinal tract of a patient, the intragastric device comprising: a porous structure comprising a top, a bottom, and an interior and having a pre-expanded shape with a first volume and a post-expanded shape with a second volume greater than the first volume, wherein in the post-expanded shape the porous structure comprises at least one first opening proximate the top and at least one second opening proximate the bottom such that food enters the porous structure through the at least one first opening, passes through the interior, and exits the porous structure through the at least one second opening; and a cannula having a flexible elongate body, a proximal end with a third opening, a distal end with a fourth opening, and a cannula interior, and has a pre-deployment shape with a first length and a post-deployment shape with a second length greater than the first length, wherein the proximal end of the sleeve is coupled to the bottom of the porous structure such that when the sleeve is in the post-deployment shape, food exiting the at least one second opening enters the sleeve through the third opening, passes through the interior of the sleeve and exits the sleeve through the fourth opening, wherein the sleeve has a coefficient of friction that allows the sleeve to fold over at least upon itself, wrap around a portion of a deployment device, pull back and forth during deployment, and fully deploy without any structural damage to the sleeve, the method comprising the steps of: loading the porous structure to a delivery device; folding the sleeve over on itself; winding the folded over cannula around a portion of the delivery device; inserting the delivery device comprising the porous structure and the cannula into the gastrointestinal tract of the patient; manipulating the delivery device to partially deploy the cannula, wherein the cannula is fully released from the delivery device but only partially untwisted from the fold; further manipulating the delivery device to fully deploy the porous structure; removing the delivery device from the patient; and allowing the sleeve to fully unravel by action of peristaltic intestinal contractions on the sleeve.

The coefficient of friction may be in the range of 0.01-0.45.

The sleeve may be folded over on itself at least twice.

The present invention also discloses a delivery device for delivering an intragastric device into the gastrointestinal tract of a patient, the intragastric device comprising a porous structure configurable between a compressed pre-deployment configuration and an expanded post-deployment configuration, and an elongate sleeve coupled to a distal end of the porous structure, the delivery device comprising: a flexible elongate body having a proximal end, a distal end, and a body lumen therein, the body including an opening at the distal end and a first handle attached to the proximal end; a flexible plunger member coaxially positioned and longitudinally movable within the lumen of the body, the plunger including a proximal end, a distal end and a plunger lumen therein, and including a tip at the distal end and a second handle attached to the proximal end; a flexible elongate rod coaxially positioned and longitudinally movable within said plunger lumen, said rod including a proximal end and a distal end, and including a first spherical member positioned proximate said distal end and a second spherical member positioned at said distal end, wherein said first spherical member has a diameter greater than a diameter of said second spherical member, said rod further including a third handle attached to said proximal end; and a traction mechanism comprising a first end and a second end, wherein the first end is attached to the sleeve of the intragastric device and the second end is removably coupled to the rod at a location between the first spherical component and the second spherical component, wherein the intragastric device is loaded for delivery within the delivery device such that: the porous structure is located within the body lumen distal to the plunger tip and proximal to the cannula, and wherein the rod passes through at least two openings in the porous structure, and wherein the at least two openings are not located along a central longitudinal axis of the porous structure; the sleeve is positioned within the body lumen distal from the porous structure and proximal to the first spherical member, and wherein the sleeve is folded over on itself and then wrapped around a portion of the rod, further wherein the sleeve is attached to the first end of the pulling mechanism.

The delivery device may also include a stop on the plunger between the tip and the second handle.

Optionally, the pulling mechanism is biodegradable and comprises sutures or hooks. Alternatively, the pulling mechanism is non-biodegradable and comprises a suture with looped ends.

Optionally, the sleeve is constrained by an annular, conical or umbrella-shaped constraining means.

Optionally, the tip of the plunger comprises a mesh retention member comprising a plurality of fins, wherein a proximal portion of the porous structure is located on the fins such that when the plunger is moved in a proximal direction, the fins cause the porous structure to move in a proximal direction.

The sleeve may be folded over itself two to ten times and then wrapped around the rod.

The delivery device may further include an inflatable balloon at the distal end of the body, an input port at the proximal end of the body, and a channel extending along the elongate body and in fluid communication with the balloon and the port, wherein the balloon is inflated using the port and the channel, and the inflated balloon is used to anchor the delivery device within the gastrointestinal tract of the patient.

Optionally, the delivery device further comprises a flushing or irrigating mechanism to reduce the deployment force during delivery.

The elongated body includes a length, and the length can include a variable stiffness. Optionally, the length comprises at least three regions, the distal-most region being more flexible than the central distal region, the central distal region being more flexible than the proximal-most region.

The elongate body may comprise a braided catheter.

The distal ends of the elongate body, plunger, and rod may be configured to be atraumatic.

The present invention also discloses a delivery device for delivering an intragastric device into the gastrointestinal tract of a patient, the intragastric device comprising a porous structure configurable between a compressed pre-deployment configuration and an expanded post-deployment configuration, and an elongate sleeve coupled to a distal end of the porous structure, the delivery device comprising: a flexible elongate body having a proximal end, a distal end, and a body lumen therein, the body including an opening at the distal end and an actuation mechanism attached to the proximal end; a flexible plunger member coaxially positioned and longitudinally movable within the lumen of the body, the plunger including a proximal end, a distal end and a plunger lumen therein, and including a tip at the distal end, and wherein the proximal end is operatively attached to the actuation structure; an actuator handle and actuator trip member attached to the actuation structure and configured to cause the actuation structure to move the plunger back and forth longitudinally relative to the elongate body when operated; a flexible elongate rod coaxially positioned and longitudinally movable within said plunger lumen, said rod including a proximal end and a distal end, and including a first spherical member positioned proximate said distal end and a second spherical member positioned at said distal end, wherein said first spherical member has a diameter greater than a diameter of said second spherical member, said rod further including a rod handle attached to said proximal end; and a traction mechanism comprising a first end and a second end, wherein the first end is attached to the sleeve of the intragastric device and the second end is removably coupled to the rod at a location between the first spherical component and the second spherical component, wherein the intragastric device is loaded for delivery within the delivery device such that: the porous structure is located within the body lumen distal to the plunger tip and proximal to the cannula, and wherein the rod passes through at least two openings in the porous structure, and wherein the at least two openings are not located along a central longitudinal axis of the porous structure; the sleeve is positioned within the body lumen distal from the porous structure and proximal to the first spherical member, and wherein the sleeve is folded over on itself and then wrapped around a portion of the rod, further wherein the sleeve is attached to the first end of the pulling mechanism.

The delivery device may also include a stop on the plunger between the tip and the actuation mechanism.

Optionally, the cannula is constrained by an annular, conical or umbrella-shaped constraint.

The elongate body may comprise a braided catheter.

The present invention also discloses a method of delivering an intragastric device into the gastrointestinal tract of a patient, the intragastric device comprising a porous structure configurable between a compressed pre-deployment configuration and an expanded post-deployment configuration, and an elongate sleeve coupled to a distal end of the porous structure, the delivery device comprising: a flexible elongate body having a proximal end, a distal end, and a body lumen therein, the body including an opening at the distal end and a first handle attached to the proximal end; a flexible plunger member coaxially positioned and longitudinally movable within the lumen of the body, the plunger including a proximal end, a distal end and a plunger lumen therein, and including a tip at the distal end and a second handle attached to the proximal end; a flexible elongate rod coaxially positioned and longitudinally movable within said plunger lumen, said rod including a proximal end and a distal end, and including a first spherical member positioned proximate said distal end and a second spherical member positioned at said distal end, wherein said first spherical member has a diameter greater than a diameter of said second spherical member, said rod further including a third handle attached to said proximal end; and a traction mechanism comprising a first end and a second end, wherein the first end is attached to the sleeve of the intragastric device and the second end is removably coupled to the rod at a location between the first spherical component and the second spherical component, wherein the intragastric device is loaded for delivery within the delivery device such that: the porous structure is located within the body lumen distal to the plunger tip and proximal to the cannula, and wherein the rod passes through at least two openings in the porous structure, and wherein the at least two openings are not located along a central longitudinal axis of the porous structure; the sleeve is positioned within the body lumen distal to the porous structure and proximal to the first spherical member, and wherein the sleeve is folded over on itself and then wrapped around a portion of the rod, further wherein the sleeve is attached to the first end of the pulling mechanism, the method comprising the steps of: sliding the delivery device over a guide wire into the gastrointestinal tract of the patient; positioning a distal end of the elongate body within a duodenum of a patient using a first handle; pushing on the second handle to push in the plunger member until the cannula is pushed out of the elongate body; pushing on the third handle to advance the rod within the plunger lumen until the cannula is fully deployed; retracting the delivery device to reposition the distal end of the elongate body within the stomach of the patient; pulling back the first handle while holding the second handle steady, thereby holding the plunger in place and releasing the wire mesh structure; and removing the delivery device from the patient.

The delivery device may further comprise a stop on the plunger between the tip and the second handle, wherein the stop is configured to stop further distal movement of the plunger once the cannula has been pushed out of the elongate body.

The delivery device may further comprise an inflatable balloon at the distal end of the body, an input port at the proximal end of the body, and a channel extending along the elongate body and in fluid communication with the balloon and the port, and the method may further comprise the steps of: inflating the balloon using the port and the channel to anchor the delivery device within the gastrointestinal tract of the patient.

The present invention also discloses a delivery device for delivering an intragastric device into the gastrointestinal tract of a patient, the intragastric device comprising a porous structure configurable between a compressed pre-deployment configuration and an expanded post-deployment configuration, and an elongate sleeve coupled to a distal end of the porous structure, the delivery device comprising: a flexible elongate body having a proximal end, a distal end, and a body lumen therein, the body including an opening at the distal end and a first handle attached to the proximal end; a flexible elongate shaft coaxially positioned and longitudinally movable within said body lumen, said shaft including a proximal end and a distal end, and including a first spherical member positioned proximate said distal end and a second spherical member at said distal end, wherein said first spherical member has a diameter greater than a diameter of said second spherical member, said shaft further including a second handle attached to said proximal end; a flexible plunger member coaxially located on a proximal portion of said flexible elongate rod and longitudinally movable therewith, said plunger including a proximal end and a distal end and including a tip at said distal end and being attached to said second handle at said proximal end; a pulling mechanism comprising a first end and a second end, wherein the first end is attached to the sleeve of the intragastric device and the second end is removably coupled to the rod at a location between the first spherical component and the second spherical component, wherein the intragastric device is loaded for delivery within the delivery device such that: the porous structure is located within the body lumen distal to the plunger tip and proximal to the cannula, and wherein the rod passes through at least two openings in the porous structure, and wherein the at least two openings are not located along a central longitudinal axis of the porous structure; the sleeve is positioned within the body lumen distal from the porous structure and proximal to the first spherical member, and wherein the sleeve is folded over on itself and then wrapped around a portion of the rod, further wherein the sleeve is attached to the first end of the pulling mechanism.

The pulling mechanism may be biodegradable and include sutures or hooks. Alternatively, the pulling mechanism is non-biodegradable and comprises a suture with looped ends.

The sleeve may be constrained by an annular, conical or umbrella-shaped constraint.

Alternatively, the sleeve may be folded over on itself two to ten times before being wrapped around the rod.

Optionally, the delivery device further comprises an inflatable balloon at the distal end of the body, an input port at the proximal end of the body, and a channel extending along the elongate body and in fluid communication with the balloon and the port, wherein the balloon is inflated using the port and the channel, and the inflated balloon is used to anchor the delivery device within the gastrointestinal tract of the patient.

The elongated body includes a length, and the length includes a variable stiffness.

The elongate body may include at least three regions, wherein a distal-most region is more flexible than a central distal region, which is more flexible than a proximal-most region.

The elongate body may comprise a braided catheter.

The present invention also discloses a method of delivering an intragastric device into the gastrointestinal tract of a patient, the intragastric device comprising a porous structure configurable between a compressed pre-deployment configuration and an expanded post-deployment configuration, and an elongate sleeve coupled to a distal end of the porous structure, the delivery device comprising: a flexible elongate body having a proximal end, a distal end, and a body lumen therein, the body including an opening at the distal end and a first handle attached to the proximal end; a flexible elongate shaft coaxially positioned and longitudinally movable within said body lumen, said shaft including a proximal end and a distal end, and including a first spherical member positioned proximate said distal end and a second spherical member at said distal end, wherein said first spherical member has a diameter greater than a diameter of said second spherical member, said shaft further including a second handle attached to said proximal end; a flexible plunger member coaxially located on a proximal portion of said flexible elongate rod and longitudinally movable therewith, said plunger including a proximal end and a distal end and including a tip at said distal end and being attached to said second handle at said proximal end; and a traction mechanism comprising a first end and a second end, wherein the first end is attached to the sleeve of the intragastric device and the second end is removably coupled to the rod at a location between the first spherical component and the second spherical component, wherein the intragastric device is loaded for delivery within the delivery device such that: the porous structure is located within the body lumen distal to the plunger tip and proximal to the sleeve, and wherein the rod passes through at least two openings in the porous structure, and wherein the at least two openings are not positioned along a central longitudinal axis of the porous structure, wherein the sleeve is located within the body lumen distal to the porous structure and proximal to the first spherical component, and wherein the sleeve is folded over on itself and then wrapped around a portion of the rod, further wherein the sleeve is attached to the first end of the pulling mechanism, the method comprising the steps of: sliding the delivery device over a guide wire into the gastrointestinal tract of the patient; positioning a distal end of the elongate body within a duodenum of a patient using a first handle; pushing on the second handle to push in the plunger member and rod until the cannula is fully deployed; retracting the delivery device to reposition the distal end of the elongate body within the stomach of the patient; pulling back the first handle while holding the second handle steady, thereby holding the plunger and rod in place and releasing the wire mesh structure; and removing the delivery device from the patient.

Optionally, the delivery device further comprises a stop on the plunger between the tip and the second handle, wherein the stop is configured to stop further distal movement of the plunger and rod once the cannula has been pushed out of the elongate body.

Optionally, the delivery device further comprises an inflatable balloon at the distal end of the body, an input port at the proximal end of the body, and a channel extending along the elongate body and in fluid communication with the balloon and the port, and the method further comprises the steps of: inflating the balloon using the port and the channel to anchor the delivery device within the gastrointestinal tract of the patient.

The present invention also discloses a delivery system for delivering an intragastric device, the delivery system comprising: an outer catheter having a proximal end and a distal end and having a variable stiffness along its length; and a flexible inner catheter positioned coaxially within the outer catheter and having a proximal end, a non-traumatic distal end, and a lumen for receiving a guide device; wherein the intragastric device is located in a space between an inner catheter and an outer catheter, and the inner catheter comprises a flexible extension at its distal end that is at least 5cm long, the flexible extension extending beyond the distal end of the outer catheter.

Optionally, the guiding means is a guide wire. Alternatively, the guiding device is an endoscope for endoscopic delivery.

The atraumatic distal end may be a spherical tip.

The inner conduit may have a variable stiffness along its length.

Optionally, the flexible extension comprises a proximal end and a distal end and has a variable stiffness along its length, wherein the stiffness varies between a stiffness of the guide wire at the distal end and a stiffness of the inner catheter at the proximal end.

The invention also discloses an intragastric device comprising: a porous structure comprising a top, a bottom, and an interior and having a pre-expanded shape with a first volume and a post-expanded shape with a second volume greater than the first volume, wherein in the post-expanded shape the porous structure comprises at least one first opening proximate the top and at least one second opening proximate the bottom such that food enters the porous structure through the at least one first opening, passes through the interior, and exits the porous structure through the at least one second opening, wherein the porous structure further comprises: a wire mesh having a substantially spherical expanded shape; and a collar at the bottom of the porous structure, the collar having a bend, wherein the bend comprises the wire bending continuing in a direction away from a longitudinal central axis of the porous structure and then in a direction upward toward the top of the porous structure; and a sleeve having a flexible elongate body, a proximal end with a third opening, a distal end with a fourth opening, and a sleeve interior, wherein the proximal end of the sleeve is coupled to the collar such that food exiting the at least one second opening enters the sleeve through the third opening, passes through the sleeve interior, and exits the sleeve through the fourth opening, wherein the sleeve is designed to intermittently engage the patient's pylorus without occluding the pylorus and to allow food to pass from the stomach into the small intestine through the inner lumen of the sleeve.

The present invention also discloses a system for delivering an intragastric device to the gastrointestinal tract of a patient, comprising: a porous mesh structure having a first lumen; a cannula attached to the porous mesh structure and having a second lumen; a coaxial catheter system comprising an outer catheter and an inner catheter, wherein, prior to delivery, the porous mesh structure and the sleeve are constrained into a space between the outer catheter and the inner catheter, and wherein the outer catheter covers a substantial portion of the intragastric device and the inner catheter passes within a substantial portion of the first lumen of the mesh but outside a substantial portion of the second lumen of the sleeve.

Optionally, the inner catheter is operatively 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 then separates from the sleeve to deliver the intragastric device into the gastrointestinal tract.

The present invention also discloses a system for promoting weight loss in a patient, the system comprising an intragastric device, a delivery device, and a retrieval device, wherein the intragastric device is configured to be temporarily deployed within the gastrointestinal tract of a patient, the intragastric device comprising: a porous structure comprising a top, a bottom, and an interior and having a pre-expanded shape with a first volume and a post-expanded shape with a second volume greater than the first volume, wherein, in the expanded shape, the porous structure comprises at least one first opening proximate the top and at least one second opening proximate the bottom, such that food enters the porous structure through the at least one first opening, passes through the interior, and exits the porous structure through the at least one second opening, the porous structure further comprising a collar at the bottom of the porous structure, the collar having a bend, wherein the bend comprises a continuation of the porous structure bend in a direction away from a longitudinal central axis of the porous structure and then in a direction upward toward the top of the porous structure; and a sleeve having a flexible elongate body, a proximal end with a third opening, a distal end with a fourth opening, and a sleeve interior, wherein the proximal end of the sleeve is coupled to the bottom of the porous structure such that food exiting the at least one second opening enters the sleeve through the third opening, passes through the sleeve interior, and exits the sleeve through the fourth opening; wherein, once the intragastric device has been deployed within the patient's gastrointestinal tract, at least a portion of the intragastric device is in constant physical contact with a portion of the patient's gastrointestinal tract without physically attaching to any portion of the patient's anatomy.

The physical contact may be caused by peristalsis of the small intestine which pulls the sleeve of the intragastric device within the small intestine.

A portion of the intragastric device may comprise a portion of the porous structure, and the portion of the gastrointestinal tract of the patient may comprise a portion of the stomach proximate the pylorus. Optionally, a portion of the stomach comprises the gastric-emptying region of the stomach, and the intragastric device does not occlude the region.

A portion of the intragastric device may comprise a portion of the sleeve, and the portion of the gastrointestinal tract of the patient may comprise a portion of the pylorus.

A portion of the intragastric device may comprise a portion of the sleeve, and the portion of the gastrointestinal tract of the patient may comprise a portion of the duodenum.

Intragastric devices can direct food through themselves, allowing food to pass from a patient's stomach into the patient's small intestine without blocking the passage of the food. Optionally, at least 10%, and preferably 50%, of the food that passes from the patient's stomach into the patient's small intestine passes through the intragastric device.

The intragastric device may provide a constant and substantially complete bypass of the patient's pylorus. Optionally, the intragastric device provides a constant and substantially complete bypass of the patient's pylorus and duodenum.

The present invention also discloses a system for promoting weight loss in a patient, the system comprising an intragastric device, a delivery device, and a retrieval device, wherein the intragastric device is configured to be temporarily deployed within the gastrointestinal tract of a patient, the intragastric device comprising: a porous structure comprising a top, a bottom, and an interior and having a pre-expanded shape with a first volume and a post-expanded shape with a second volume greater than the first volume, wherein, in the expanded shape, the porous structure comprises at least one first opening proximate the top and at least one second opening proximate the bottom, such that food enters the porous structure through the at least one first opening, passes through the interior, and exits the porous structure through the at least one second opening, the porous structure further comprising a collar at the bottom of the porous structure, the collar having a bend, wherein the bend comprises a continuation of the porous structure bend in a direction away from a longitudinal central axis of the porous structure and then in a direction upward toward the top of the porous structure; and a sleeve having a flexible elongate body, a proximal end with a third opening, a distal end with a fourth opening, and a sleeve interior, wherein the proximal end of the sleeve is coupled to the bottom of the porous structure such that food exiting the at least one second opening enters the sleeve through the third opening, passes through the sleeve interior, and exits the sleeve through the fourth opening; wherein, once the intragastric device has been deployed within the gastrointestinal tract of the patient, the porous structure is positioned within and in physical contact with a portion of the patient's stomach, and the sleeve is positioned within the pylorus and duodenum of the patient such that the intragastric device provides a constant and substantially complete bypass of the patient's pylorus, wherein food digested by the patient cannot physically contact any portion of the pylorus.

Physical contact with the portion of the stomach may be caused by peristalsis of the small intestine, which pulls the sleeve of the intragastric device within the small intestine.

Optionally, the intragastric device is not physically attached to any portion of the patient's anatomy.

The present invention also discloses a system for promoting weight loss in a patient, the system comprising an intragastric device, a delivery device, and a retrieval device, wherein the intragastric device is configured to be temporarily deployed within the gastrointestinal tract of a patient, the intragastric device comprising: a porous structure comprising a top, a bottom, and an interior and having a pre-expanded shape with a first volume and a post-expanded shape with a second volume greater than the first volume, wherein, in the expanded shape, the porous structure comprises at least one first opening proximate the top and at least one second opening proximate the bottom, such that food enters the porous structure through the at least one first opening, passes through the interior, and exits the porous structure through the at least one second opening, the porous structure further comprising a collar at the bottom of the porous structure, the collar having a bend, wherein the bend comprises a continuation of the porous structure bend in a direction away from a longitudinal central axis of the porous structure and then in a direction upward toward the top of the porous structure; and a sleeve having a flexible elongate body, a proximal end with a third opening, a distal end with a fourth opening, and a sleeve interior, wherein the proximal end of the sleeve is coupled to the bottom of the porous structure such that food exiting the at least one second opening enters the sleeve through the third opening, passes through the sleeve interior, and exits the sleeve through the fourth opening; wherein, once the intragastric device has been deployed within the gastrointestinal tract of the patient, the porous structure is positioned within and in physical contact with a portion of the patient's stomach, and the sleeve is positioned within the pylorus and duodenum of the patient such that the intragastric device provides a constant and substantially complete bypass of the patient's duodenum, wherein food digested by the patient cannot physically contact any portion of the duodenum.

The system physical contact with the portion of the stomach may be caused by peristalsis of the small intestine, which pulls the sleeve of the intragastric device within the small intestine.

The foregoing and other embodiments of the invention are described in more detail in the drawings and detailed description provided below.

Drawings

These and other features and advantages of the present invention will be better understood and appreciated by reference to the following detailed description when considered in connection with the accompanying drawings wherein:

FIG. 1 is a schematic diagram of an upper gastrointestinal system;

fig. 2A is a schematic view of a wire mesh structure with a proximally angled anti-migration disc or collar attached at the distal end of the wire mesh structure in a post deployment configuration according to one embodiment of the present invention;

fig. 2B is a schematic view of a wire mesh structure with a proximally curved anti-migration collar formed at a distal end of the wire mesh structure in a post-deployment configuration according to one embodiment of the present invention;

fig. 2C is another schematic view of a wire mesh structure according to an embodiment of the present invention;

fig. 3A is a schematic view illustrating a plurality of free ends or nodes positioned at the proximal and distal ends of a wire mesh structure according to one embodiment of the present invention;

fig. 3B is a schematic view illustrating a plurality of overlapping nodes positioned at one end of a wire mesh structure according to one embodiment of the present invention;

fig. 3C is a schematic view illustrating a first plurality of nodes positioned at one end of a wire mesh structure according to one embodiment of the present invention and a second plurality of nodes positioned proximal to the first plurality of nodes;

fig. 3D is a schematic view of a first plurality of nodes and a second plurality of nodes at an end of a wire mesh structure according to one embodiment of the present invention, showing loops formed in wires of the first plurality of nodes;

fig. 3E is a schematic view of a first plurality of nodes and a second plurality of nodes at an end of a wire mesh structure according to one embodiment of the present invention, showing loops formed in wires of the second plurality of nodes;

fig. 3F is a schematic view of a first plurality of nodes and a second plurality of nodes at an end of a wire mesh structure according to one embodiment of the present invention, showing loops formed in alternating wires in the first and second plurality of nodes;

fig. 3G is a schematic view illustrating a wire mesh structure having a first plurality of nodes at a proximal end thereof and a second plurality of nodes at a distal end thereof according to one embodiment of the present invention;

fig. 3H is a schematic view illustrating a wire mesh structure having a first and second plurality of nodes at its proximal and distal ends, respectively, and a third and fourth plurality of nodes distributed along its surface, according to one embodiment of the present invention;

FIG. 3I is a schematic diagram illustrating various possible node shapes in accordance with various embodiments of the invention;

FIG. 4A is a close-up schematic view of a non-traumatic anti-migration collar of a wire mesh structure of an intragastric device according to one embodiment of the present invention;

FIG. 4B is a close-up schematic view of a non-traumatic anti-migration collar of a wire mesh structure of an intragastric device according to another embodiment of the present invention;

FIG. 4C is a close-up schematic view of a non-traumatic anti-migration collar of a wire mesh structure of an intragastric device according to yet another embodiment of the present invention;

FIG. 5A is a schematic view of a portion of a sleeve component of the intragastric device in a post-deployment configuration, showing a single wire support coiled along the body of the sleeve, according to one embodiment of the present invention;

FIG. 5B is a schematic view of a portion of the sleeve component of the intragastric device in a post-deployment configuration, showing a plurality of wire supports coiled along the body of the sleeve, according to one embodiment of the present invention;

FIG. 5C is a schematic view of a funnel-shaped sleeve component of the intragastric device in a post-deployment configuration, showing a coiled wire loop support on the sleeve, according to one embodiment of the present invention;

FIG. 5D is a schematic view of a sleeve component of the intragastric device in a post-deployment configuration, showing a funnel-shaped opening at the proximal end of the sleeve, according to one embodiment of the present invention;

FIG. 5E is a schematic view of a funnel-shaped sleeve component of the intragastric device in a post-deployment configuration showing a plurality of markings on the outer surface of the sleeve body, according to one embodiment of the present invention;

FIG. 5F is a schematic view of a funnel-shaped sleeve component of the intragastric device in a post-deployment configuration showing a marker line extending along the length of the sleeve on the outer surface of the sleeve body, according to one embodiment of the present invention;

FIG. 5G is a schematic view of a funnel-shaped sleeve component of the intragastric device in a post-deployment configuration, showing a marker line extending along the length of the sleeve, and a plurality of markers, on the outer surface of the sleeve body, in accordance with an embodiment of the present invention;

FIG. 6A is a schematic cross-sectional view of a funnel-shaped sleeve component of the intragastric device in a post-deployment configuration showing multiple sleeve layers, according to one embodiment of the present invention;

FIG. 6B is a schematic cross-sectional view of a funnel-shaped sleeve component of the intragastric device in a post-deployment configuration showing multiple sleeve layers, according to another embodiment of the present invention;

FIG. 6C is a schematic cross-sectional view of a funnel-shaped sleeve component of the intragastric device in a post-deployment configuration showing multiple sleeve layers according to another embodiment of the present invention;

FIG. 6D is a schematic cross-sectional view of a funnel-shaped sleeve component of the intragastric device in a post-deployment configuration showing multiple sleeve layers according to another embodiment of the present invention;

FIG. 6E is a schematic cross-sectional view of a funnel-shaped sleeve component of the intragastric device in a post-deployment configuration according to yet another embodiment of the present invention;

FIG. 6F is a schematic view of a stent support for a sleeve component of an intragastric device according to one embodiment of the present invention;

FIG. 6G is a schematic view of a sleeve component of the intragastric device having the stent support of FIG. 6F;

FIG. 6H shows a portion of a sleeve of a wire mesh device covered with a nanofiber membrane according to one embodiment of the present invention;

FIG. 7 is a schematic view of a funnel-shaped sleeve for use in an intragastric device according to one embodiment of the present invention;

FIG. 8 is a schematic view of a funnel-shaped sleeve for an intragastric device according to another embodiment of the present invention;

fig. 9A is a schematic view of a wire mesh structure with attached cannula components in a post deployment configuration showing a blunt end of the wire mesh support toward the proximal end of the cannula according to one embodiment of the present invention;

fig. 9B is a schematic view of a wire mesh structure with a proximal portion of a cannula component attached in a post-deployment configuration showing a delivery catheter positioned within the wire mesh structure, according to one embodiment of the present invention;

FIG. 10A is a schematic view of a funnel-shaped braided short sleeve component in a deployed configuration, according to one embodiment of the present invention;

FIG. 10B is a schematic view of a funnel shaped braided short sleeve component with a conical distal end in a post-deployment configuration according to one embodiment of the present invention;

FIG. 10C is a schematic view of a (round) tapered braided short sleeve component in a post-deployment configuration, according to an embodiment of the present invention;

FIG. 10D is a schematic view of the conically braided sleeve component of FIG. 10C attached to a wire mesh structure in accordance with an embodiment of the present invention;

FIG. 10E is a schematic view of a conically braided sleeve member in a post-deployment configuration, according to another embodiment of the present invention;

FIG. 10F is a schematic view of the conically braided sleeve component of FIG. 10E attached to a wire mesh structure in accordance with an embodiment of the present invention;

FIG. 10G is a schematic view of a (round) tapered braided short sleeve component with a non-traumatic distal tip in a post-deployment configuration, according to an embodiment of the invention;

FIG. 10H is a schematic view of a (round) tapered braided short sleeve component with a non-traumatic distal tip in a post-deployment configuration according to another embodiment of the invention;

FIG. 11A is a schematic cross-sectional view illustrating one embodiment of the intragastric device with an attached sleeve in a post-deployment configuration;

FIG. 11B is a schematic cross-sectional view illustrating the intragastric device of FIG. 11A in a pre-deployment configuration;

FIG. 11C is a schematic cross-sectional view illustrating another embodiment of the intragastric device with an attached sleeve in a post-deployment configuration;

FIG. 11D is a schematic cross-sectional view illustrating the intragastric device of FIG. 11C in a pre-deployment configuration;

fig. 12A is a schematic view of a plurality of nodes positioned at a distal end of a wire mesh structure connected to a proximal end of a funnel-shaped sleeve according to one embodiment of the present invention;

fig. 12B is a schematic view of a plurality of nodes positioned at a distal end of a wire mesh structure connected to a proximal end of a funnel-shaped sleeve according to another embodiment of the present invention;

fig. 12C is a schematic view of a plurality of nodes positioned at a distal end of a wire mesh structure connected to a proximal end of a funnel-shaped sleeve according to another embodiment of the present invention;

fig. 12D is a schematic view of a plurality of nodes positioned at a distal end of a wire mesh structure connected to a proximal end of a funnel-shaped sleeve according to another embodiment of the present invention;

fig. 12E is a schematic view of a plurality of nodes positioned at a distal end of a wire mesh structure connected to a proximal end of a funnel-shaped sleeve according to another embodiment of the present invention;

fig. 12F is a schematic view of a plurality of nodes positioned at the distal end of a wire mesh structure connected to the proximal end of a funnel-shaped sleeve according to yet another embodiment of the present invention;

fig. 13A is a schematic view of a plurality of nodes positioned at a distal end of a wire mesh structure connected to a proximal end of a funnel-shaped sleeve, in accordance with an embodiment of the present invention;

FIG. 13B is a schematic view of the distal end of the wire structure and the connected proximal end of the funnel-shaped sleeve covered with the heat shrink tube according to one embodiment of the present invention;

FIG. 14 is a schematic view of an intragastric device with a funnel-shaped sleeve in a post-deployment configuration, in accordance with an embodiment of the present invention;

FIG. 15 is a schematic view of an intragastric device with a cylindrical sleeve in a post-deployment configuration, in accordance with an embodiment of the present invention;

FIG. 16A is a close-up schematic view of a funnel shaped sleeve attached to an anti-migration collar of a wire mesh structure of an intra-gastric device according to one embodiment of the present disclosure;

FIG. 16B is a close-up schematic view of a funnel-shaped sleeve according to another embodiment of the present disclosure attached to an anti-migration collar of a wire mesh structure of an intra-gastric device and a proximal sleeve end having a ravel edge;

FIG. 16C is a schematic view of an intragastric device comprising a wire mesh structure and an attached sleeve, according to one embodiment of the present invention;

FIG. 16D is a schematic view of the intragastric device of FIG. 16C, wherein the sleeve is straight to show the size of the device relative to the surrounding anatomy;

FIG. 16E is a schematic view of the wire mesh and sleeve of the intragastric device showing a retrieval pull cord on the wire mesh, according to one embodiment of the present invention;

FIG. 16F is a schematic view of the wire mesh and sleeve of the intragastric device showing a single retrieval pull cord on the wire mesh, according to one embodiment of the present invention;

FIG. 17A is a schematic cross-sectional view of the distal end of the cannula illustrating one embodiment of a component designed to configure the distal end to prevent trauma to body tissue;

FIG. 17B is a schematic cross-sectional view of the distal end of the cannula showing another embodiment of a component designed to configure the distal end to prevent trauma to body tissue;

FIG. 17C is a schematic cross-sectional view of the distal end of the cannula showing another embodiment of a component designed to configure the distal end to prevent trauma to body tissue;

FIG. 18 is a schematic view of the distal end of a cannula with an attached positioning tail according to one embodiment of the present invention;

FIG. 19A is a schematic illustration of the distal end of a cannula including a plurality of tassel edges coupled to an annulus according to one embodiment of the invention;

FIG. 19B is a schematic view of the distal end of a cannula including a plurality of tassel edges attached to a bulb, according to one embodiment of the present invention;

FIG. 19C is a cross-sectional schematic view of a bulb attached to the distal end of a cannula according to one embodiment of the invention;

FIG. 19D is a schematic view of the distal end of the sleeve having a plurality of sutures extending from the distal end of the sleeve and attached to the bulb, according to one embodiment of the invention;

FIG. 19E is a schematic view of the distal end of a cannula having at least one suture with an attached suture loop or ball extending therefrom in accordance with one embodiment of the present invention;

FIG. 20A is a schematic view of the distal end of a cannula showing at least one fold in the cannula wall, according to one embodiment of the present invention;

FIG. 20B is a schematic view of the distal end of a cannula showing at least one channel in the wall of the cannula and a support structure according to one embodiment of the invention;

FIG. 20C is a schematic view of a portion of a sleeve showing a corrugated sleeve wall according to an embodiment of the present invention;

FIG. 20D is a schematic view of a portion of a sleeve according to an embodiment of the present invention, showing the sleeve wall woven;

FIG. 20E is a schematic view of a portion of a cannula according to one embodiment of the present invention, showing the woven cannula wall and the distal cannula end having a ravel edge;

FIG. 20F is a schematic illustration of an exemplary sleeve weave pattern according to various embodiments of the invention;

FIG. 21A is a schematic view of an intragastric device having an ovoid wire mesh structure deployed within the gastrointestinal tract of a patient in accordance with one embodiment of the present invention;

FIG. 21B is a schematic view of an intragastric device having an ovoid wire mesh structure deployed within the gastrointestinal tract of a patient in accordance with another embodiment of the present invention;

FIG. 21C is a plurality of schematic illustrations of a sleeve with and without an intragastric device therethrough with a pylorus of a patient in an open and closed state, according to certain embodiments of the present invention;

FIG. 22 is a schematic view of an expanded wire mesh structure of a first intragastric device and a tightened wire mesh structure of a second intragastric device coupled to the distal end of an implant catheter, in accordance with one embodiment of the present invention;

FIG. 23 is a schematic view of an intragastric device with a partially constrained wire mesh structure on a delivery catheter, according to one embodiment of the present invention;

FIG. 24A is a schematic view of a first exemplary delivery device for use in an intragastric device according to one embodiment of the present invention;

FIG. 24B is a flowchart illustrating the steps involved in delivering an intragastric device using the delivery device of FIG. 24A, in accordance with an embodiment of the present invention;

FIG. 25A is a schematic view of a second exemplary delivery device for an intragastric device according to one embodiment of the present invention;

FIG. 25B is a flowchart illustrating the steps involved in delivering an intragastric device using the delivery device of FIG. 25A, in accordance with an embodiment of the present invention;

FIG. 25C is a flow chart illustrating the steps involved in delivering an intragastric device using a delivery device including a pull-apart sheath according to one embodiment of the present invention;

FIG. 26A is a schematic view of a third exemplary delivery device for an intragastric device according to one embodiment of the present invention;

FIG. 26B is a flow chart illustrating the steps involved in using the delivery device of FIG. 26A to deliver an intragastric device according to one embodiment of the present invention;

FIG. 26C is a flow chart illustrating the steps involved in using the delivery device of FIG. 26A to deliver an intragastric device according to another embodiment of the present invention;

FIG. 26D is a flowchart illustrating the steps involved in separately delivering the wire mesh and sleeve and assembling the intragastric device within the gastrointestinal tract of a patient;

FIG. 27A is a schematic view of a fourth exemplary delivery device for an intragastric device according to one embodiment of the present invention;

FIG. 27B is another schematic view of the delivery device of FIG. 27A, showing the relative lengths of the various components of the delivery device;

fig. 27C is a schematic view of the distal end of a delivery device showing a pilot olive for threading, according to one embodiment of the invention;

fig. 27D is a schematic view of a portion of a delivery device showing a mesh retention feature according to an embodiment of the present invention;

FIG. 27E is a flowchart illustrating the steps involved in using the delivery device of FIG. 27A to deliver an intragastric device according to one embodiment of the present invention;

FIG. 28A is a schematic view of a fifth exemplary delivery device for an intragastric device according to one embodiment of the present invention;

FIG. 28B is a flow chart illustrating the steps involved in delivering an intragastric device using the delivery device of FIG. 28A in accordance with one embodiment of the present invention;

FIG. 29A is a schematic view of a sixth exemplary delivery device for an intragastric device according to one embodiment of the present invention;

FIG. 29B is a cross-sectional schematic view of a pre-deployment coaxial arrangement of a sleeve of an intragastric device within a delivery device according to one embodiment of the present invention;

FIG. 29C is a cross-sectional schematic view of a pre-deployment coaxial arrangement of a sleeve of an intragastric device within a delivery device according to another embodiment of the present invention; and

FIG. 29D is a cross-sectional schematic view of the pre-deployment coaxial arrangement of the sleeve shown endoscopically of the intragastric device within the delivery device according to one embodiment of the present invention;

FIG. 29E is a flowchart illustrating the steps involved in delivering an intragastric device using the delivery device of FIG. 29A, in accordance with an embodiment of the present invention;

FIG. 30A is a schematic view of a seventh exemplary delivery device for an intragastric device according to one embodiment of the present invention;

FIG. 30B is a schematic view of an exemplary embodiment of an outer catheter for use in the delivery device of FIG. 30A;

FIG. 30C is a schematic view of another embodiment of an outer catheter showing the dimensions of the compressed sleeve and compressed wire mesh structure of the intragastric device relative to the dimensions of the outer catheter;

fig. 30D is a close-up schematic view of the distal end of the delivery device of fig. 30A, showing the pilot component and the proximal and distal spherical components;

FIG. 30E is a schematic view of the proximal end of the delivery device of FIG. 30A, showing the outer catheter retracted to the first stop mechanism;

FIG. 30F is a schematic view of an embodiment of a sleeve of the partially deployed intragastric device corresponding to the position of the outer catheter shown in FIG. 30E;

FIG. 30G is a schematic view of the proximal end of the delivery device of FIG. 30A, showing the outer catheter retracted to a second stop mechanism;

FIG. 30H is a schematic view of an embodiment of a wire mesh structure of the partially deployed intragastric device corresponding to the position of the outer catheter shown in FIG. 30I;

FIG. 30I is a flow chart illustrating the steps involved in using the delivery device of FIG. 30A to deliver an intragastric device according to one embodiment of the present invention;

fig. 31A is a schematic view of a wire mesh structure of an intragastric device loaded onto a delivery device according to one embodiment of the present invention;

fig. 31B is a schematic view of the wire mesh structure of fig. 31A further loaded onto a delivery device;

FIG. 31C is a schematic view of the wire mesh structure of FIG. 31A loaded onto a delivery device, thus only further loading of an anti-migration collar;

fig. 31D is a schematic view of the wire mesh structure of fig. 31A fully loaded onto a delivery device;

FIG. 31E is a schematic view of the sleeve of the intragastric device of FIG. 31A partially loaded onto a delivery device;

FIG. 31F is a schematic view of the intragastric device of FIG. 31A fully loaded onto the delivery device;

FIG. 32A is a schematic view of a retrieval device for removing the intragastric device, according to one embodiment of the present invention;

FIG. 32B is a flow chart illustrating the steps involved in removing the intragastric device from the patient using the retrieval device of FIG. 31A, in accordance with one embodiment of the present invention;

FIG. 33A is a schematic view of an embodiment of the intragastric device in an exemplary post-deployment configuration having a dumbbell shape;

FIG. 33B is a schematic view of an embodiment of an intragastric device having a two-wire mesh structure, wherein the lower wire mesh is formed from an everted anti-migration component;

FIG. 34A is a schematic view of an exemplary intragastric device having a dual wire mesh structure in a post-deployment configuration, in accordance with an embodiment of the present invention;

FIG. 34B is a schematic view of another exemplary intragastric device having a dual wire mesh structure in a post-deployment configuration, in accordance with an embodiment of the present invention;

FIG. 34C is a schematic view of another exemplary intragastric device having a dual wire mesh structure in a post-deployment configuration, in accordance with an embodiment of the present invention;

FIG. 34D is a schematic view of another exemplary intragastric device having a dual wire mesh structure in a post-deployment configuration, in accordance with an embodiment of the present invention;

FIG. 34E is a schematic view of another exemplary intragastric device having a dual wire mesh structure in a post-deployment configuration, in accordance with an embodiment of the present invention;

FIG. 34F is a schematic view of another exemplary intragastric device having a dual wire mesh structure in a post-deployment configuration, in accordance with an embodiment of the present invention;

FIG. 34G is a schematic view of another exemplary bi-wire mesh intragastric device in a post-deployment configuration, in accordance with an embodiment of the present invention;

FIG. 34H shows an intragastric device having two wire meshes coupled with an anti-migration feature, in accordance with embodiments of the present invention;

FIG. 35 is a schematic view of a single exemplary intragastric device attached to a single intragastric device previously deployed in the stomach;

FIG. 36 is a schematic view of an exemplary fully deployed assembled intragastric device in the stomach;

FIG. 37A is a side perspective view of an exemplary intragastric device having a combined double wire mesh structure in a post-deployment configuration, according to one embodiment of the present invention;

FIG. 37B is an oblique perspective view of the intragastric device of FIG. 37A;

FIG. 37C is a schematic view of a plurality of sutures used to flexibly connect the first and second wire mesh structures of the intragastric device of FIG. 37A;

FIG. 37D is a schematic view of a sleeve coupled to the intragastric device of FIG. 37A, in accordance with an embodiment of the present invention;

fig. 37E is a schematic view of two exemplary suture points flexibly connecting first and second wire mesh structures of the intragastric device of fig. 37A;

FIG. 37F is a schematic illustration of the relative degree of motion of the first and second wire mesh structures of the intragastric device of FIG. 37A;

FIG. 38A is a schematic illustration of the process of deploying a combined intragastric device, wherein one wire mesh structure is almost fully deployed while the other wire mesh structure is still constrained in the catheter;

FIG. 38B is a schematic illustration of the process of withdrawing or removing the combined intragastric device, wherein one wire mesh structure is partially constrained within the catheter while the other wire mesh structure is still in an unconstrained or deployed state;

fig. 38C is a schematic illustration of a process of withdrawing or removing a combined intragastric device, wherein one wire mesh structure, when fully constrained within a catheter, causes another wire mesh structure to align or orient for intracatheter compression; and

fig. 38D shows that as the fully compressed wire mesh structure is further withdrawn into the catheter, the aligned or oriented wire mesh structure begins to bind or compress into the catheter for removal.

Detailed Description

In one embodiment, the present invention is directed to a dynamic weight intragastric device for obese patients to induce weight loss. In various embodiments, the intragastric device comprises a porous three-dimensional structure having a pre-deployment shape and a post-deployment shape. In one embodiment, the porous three-dimensional structure is a non-inflatable wire mesh structure, or a helical structure made of a shape memory metal or shape memory polymer that changes from a compressed cylindrical shape before deployment to a spherical, ovoid, kidney bean shape or any predetermined shape with significant capacity after deployment. In another embodiment, the intragastric device is made of plastic or a polymer such as Polyetheretherketone (PEEK) or polyester or a bioabsorbable material. The device changes back and forth from the pre-deployment shape to the post-deployment shape by a temperature change and/or minimal mechanical force due to the post-deployment shape rising from room temperature to body temperature. The device is delivered endoscopically to the stomach via a catheter. The device may be placed endoscopically, over an endoscope, or over a guide wire with guidance/assistance from an endoscope or fluoroscope.

The device has a pre-deployment compressed shape for ease of insertion and a post-deployment expanded shape residing within the gastric cavity. The device has a volume after deployment that is significantly greater than the volume before deployment. In one embodiment, the volume of the device after deployment is at least 100 mL. The deployed device occupies a significant volume in the stomach, reducing the available stomach volume available for storing ingested food. This limits food intake and induces satiety and controls the appetite of the person. In one embodiment, the device is further designed to intermittently slow or obstruct the passage of food from the stomach into the small intestine by peristalsis, thereby slowing gastric emptying. In various embodiments, the device also functions to establish biliopancreatic diversion by bypassing ingested food around pancreatic secretions or by bypassing ingested food.

In one embodiment, the device includes a shape memory metal and self-expands to change from a pre-deployment shape to a post-deployment shape once deployed. In another embodiment, the device includes a temperature sensitive metal that is cooled in a pre-deployment shape and then self-expands to achieve its post-deployment shape when exposed to human body temperature. In another embodiment, a dilation tool is used to apply a minimal mechanical force to change the shape of the device from its pre-deployment shape to its post-deployment shape. In another embodiment, the intragastric device is constructed using plastic, polymer, carbon fiber, or bioabsorbable materials.

In one embodiment, the wire structure contains materials of different weights to aid in proper positioning within the stomach. In one embodiment, the lighter weight material is positioned at the top of the wire structure proximate the top opening and the heavier weight material is positioned at the bottom of the structure proximate the bottom opening. The differential weight ensures that the device will be properly positioned within the stomach to result in the intended effect of slower gastric emptying. In addition, the differentiated weight provides proper stomach positioning without physically anchoring the wire mesh structure to the stomach wall. The differentiated weight characteristics may also be provided by ingested food materials that enter the device and selectively accumulate to the bottom of the device as a result of gravity pull. The differentiated weight is also provided by using different amounts of material in the top and bottom halves. The wire mesh structure is free to move around in the stomach while still being pulled by gravity to maintain its proper top-to-bottom alignment.

In one embodiment, the device comprises a wire mesh structure that, when in the deployed shape, comprises mesh openings between the wires of the wire structure. In one embodiment, the diameter of the mesh openings is greater than 1 mm. In one embodiment, each wire of the wire mesh structure is coated with a corrosion resistant material. Once deployed, the corrosion resistant material prevents exposure of the wires of the wire mesh structure to acidic gastric contents and subsequent degradation thereby. The corrosion resistant material completely covers the wires of the wire mesh but does not cover the mesh openings. In one embodiment, the corrosion resistant material comprises Parylene. Parylene is beneficial as a coating because it is durable, mitigates nickel ion leaching, and has a low profile (thin after application). In various embodiments, the corrosion resistant material includes silicone, polyester, Polyetheretherketone (PEEK), medical grade epoxy, ceramic, additional metal, or any other suitable flexible corrosion resistant material. In one embodiment, the coating metal is tantalum. Tantalum provides corrosion resistance and radiopacity. In one embodiment, where the coating is ceramic, the thickness of the ceramic coating is a few angstroms. In various embodiments, any one or combination of the above corrosion resistant materials are used to coat the metal of the wire mesh structure.

In one embodiment, the mesh openings are configured differently to regulate the flow of food into and out of the mesh. In one embodiment, at least one opening on the bottom half of the device is larger than any opening on the top half of the device, thereby allowing food entering the mesh to exit without further reduction in the food material size.

In another embodiment, the intragastric device further comprises an anti-migration component or collar coupled to a portion of its distal end. Similar to the wire mesh of the intragastric device, the anti-migration component may be configured between a first compressed configuration for delivery and a second expanded configuration after deployment. The anti-migration component acts as a physical stop that blocks passage of the intragastric device through the pylorus. In various embodiments, the diameter of the anti-migration component is greater than the diameter of the relaxed pylorus. In one embodiment, the anti-migration component comprises an extension of the wire mesh structure of the intragastric device. In another embodiment, the anti-migration component is a separate wire mesh that is attached to a portion of the distal end of the intra-gastric device. In various embodiments, the anti-migration component is shaped to approximate a bumper, a half-bumper, a disc, a disk, or any other shape that prevents the device from migrating through the pylorus. In general, the dimensions such as diameter or length of the anti-migration collar: 1) larger than the diameter of the distal opening of the wire mesh structure, and 2) attached to or integrally formed with the wire mesh structure distal to the distal opening. In one embodiment, the diameter or length is in the range of 10mm to 300 mm.

In other embodiments, a sleeve may be attached to the intragastric device, wherein the sleeve extends from the stomach into the duodenum to which the stomach empties, or through the duodenum into the jejunum. In one embodiment, the sleeve functions to deliver the sequestered chyme from the wire mesh structure directly into the duodenum or into the pylorus. In another embodiment, the sleeve is coupled to the intragastric device but does not directly receive food from the device. In this embodiment, the proximal end of the sleeve is located distal to the device and receives food directly from the stomach or duodenum. Food entering the sleeve exits at the distal end and enters the duodenum or jejunum, thereby bypassing a portion of the small intestine.

Thus, the sleeve acts to bypass portions of the Gastrointestinal (GI) tract, thereby limiting absorption of particular materials in the small intestine. The benefits provided by the cannula are similar to those provided by the robust type-Y gastric bypass surgery, i.e., weight loss and improvement in type II diabetes.

After implantation, the gastrointestinal device of the present invention, and in particular the collar, is in constant physical contact with, but not actually physically attached to, the patient's anatomy. This is achieved by the sleeve being pulled down by the peristaltic movement of the small intestine. As the sleeve is pulled down, the loop of the wire mesh contacts the stomach proximal to the pylorus. The sleeve is in physical constant contact with the pylorus. However, this constant contact with the pylorus does not obstruct the food passageway. The openings of the wire mesh structure and the lumen of the sleeve allow food to pass through the pylorus without obstructing the food at any location, thereby allowing the food to enter the intestine. The intragastric device of the present invention physically links the gastric emptying region of the stomach without completely blocking the region at any location. The intragastric device of the present invention functions as a variable vent rather than as a stop for the passage of food.

The gastrointestinal device of the present invention is designed to maximize the amount of food that is captured and passed through the cannula into the intestine, rather than minimizing the amount of food that enters the intestine. The device is designed to prevent food from passing around and outside the device by constant contact with the pylorus and stomach. In various embodiments, at least 10% of the food exiting the patient's stomach passes through the device rather than bypassing the device. In one embodiment, at least 50% of the food exiting the patient's stomach passes through the device without bypassing the device. In various embodiments, the food entering the device and passing through the cannula never contacts the patient's duodenum, thereby allowing the device to function as a true pyloric bypass.

In one embodiment, the device is an inflatable balloon with an attached cannula, wherein the balloon is not in fluid communication with the lumen of the cannula, but rather the balloon only functions to hold the cannula in place without anchoring or securing the cannula to the wall of the gastrointestinal tract. The balloon may be filled with fluid or drained of fluid and is designed to reside in a person's stomach. A sleeve is flexibly attached to the balloon and has a proximal opening designed to reside proximal to the ampulla of the patient and a distal opening designed to reside distal to the ampulla of the patient. Partially digested food enters the proximal opening and exits the distal opening, bypassing the ampulla region. The sleeve is not anchored or fixed to any portion of the gastrointestinal tract wall.

Wire net structure

In various embodiments, the intragastric device comprises a porous three-dimensional structure having a pre-deployment shape and a post-deployment shape. In one embodiment, the device in the post-deployment configuration includes a three-dimensional wire mesh structure defining an interior volume and having a distal end and a proximal end.

In various embodiments, the wire mesh structure comprises free ends or "nodes" comprising bends or curves of the wires in the wire mesh structure, wherein these bends or curves are unsupported and not connected to any other portion of the wire mesh. In certain embodiments, the wire mesh structure comprises two pluralities of nodes. The first plurality of nodes is positioned at a proximal end of the structure and the second plurality of nodes is positioned at a distal end of the structure. When the wire mesh structure is compressed to its pre-deployment configuration, the first and second pluralities of nodes, located at the proximal and distal ends of the structure, respectively, become bunched together or "bunched up". This creates a larger cross-sectional area (or diameter) at the proximal and distal ends of the structure compared to the cross-sectional area of the compressed structure between the ends. As their cross-sectional area becomes larger, compressed wire mesh structures become increasingly difficult to deploy through narrow delivery devices or catheters. The delivery problem can be solved in at least two different ways. In various embodiments, the number of nodes in each of the plurality of nodes is reduced. Reducing the number of nodes in each of the plurality of nodes makes the structure more compressible and produces a smaller cross-sectional area at each end of the structure. This reduces the force applied to the delivery catheter by the compression structure, making it easier to pass the compression structure through the catheter. In various embodiments, a portion of the nodes from one or both of the first and second pluralities of nodes are moved from each of the ends of the structure and positioned along the body of the structure, thereby creating an additional plurality of nodes. This "staggering" of the nodes reduces the cross-sectional area of the compression structure at any given point and distributes the force applied by the compression structure to the delivery catheter, thereby further facilitating passage of the delivery structure through the catheter. In various embodiments, the number of nodes in each set (kind) of multiple nodes is reduced and the nodes are staggered multiple times throughout the structure to reduce and distribute the force applied by the compression structure to the delivery catheter. Reducing and distributing the force allows for easier delivery and allows for the use of a delivery catheter with a smaller diameter. The reduced and distributed forces also allow for the manufacture of larger mesh structures that can be compressed to smaller sizes.

In various embodiments, each plurality of nodes comprises 10 to 100 individual nodes. In one embodiment, each set of the plurality of nodes includes 44 nodes. In another embodiment, each set of the plurality of nodes includes 36 nodes. In various embodiments, the wire mesh structure comprises 2 to 60 sets of a plurality of nodes distributed at different locations along its length in the weft direction. In one embodiment, the nodes are staggered such that at least 10% of the total number of nodes in the structure are located at the proximal and distal ends. In various embodiments, no more than 75% of the total number of nodes are located in any set of the plurality of nodes. In various embodiments, the nodes are distributed within at least three different sets of lateral pluralities of nodes along the length of the structure.

The compressibility of the wire mesh structure also depends on the flexibility of the mesh. The flexibility in turn depends on the thickness of the wires, the angle at which the wires intersect, the number of wires, and other variables. With respect to the angle at which the wires intersect, the structure becomes more flexible as the wires of the structure are arranged more parallel to each other. In various embodiments, the total length of the wire mesh structure in the pre-deployment configuration is 5 to 50cm, and the thickness of each wire is in the range of 0.1 to 1 mm. In one embodiment, the thickness of each wire is 0.44 mm. Each wire of the wire mesh structure has a bending strain that determines how the wires behave as the structure is compressed. In various embodiments, the wire is comprised of a shape memory metal, such as nitinol in one embodiment. Shape memory metals have a certain percentage of bending strain beyond which the metal loses its ability to accurately return to its original shape. The percent (%) strain may be defined by the following equation:

2t/R x 100%

Where t is the wire thickness and R is the bend radius. In one embodiment, once the percent strain reaches 8%, a permanent change is introduced to the shape memory metal so that the shape memory metal will no longer fully return to its original shape. This factor becomes important as the wire mesh structure is compressed to its pre-deployment shape for delivery. In various embodiments, the wire mesh structure includes a loop or rounded extension of the wire mesh at its distal end that acts as an anti-migration feature. During compression, the collar must be folded distally outward so that the compressed structure will fit into the delivery device or catheter. As the collar is folded outwardly during compression, "nubs" in the wire mesh structure are introduced. A strain percentage of less than 8% creates smaller bumps in the compressed wire mesh structure, allowing the compressed structure to pass through the delivery catheter more easily. Thus, in various embodiments, the wire mesh structure is configured to have a wire thickness and a bend radius at the loop such that the percent strain at the loop will not exceed 20%, and preferably is less than 8%. In various embodiments, the radius of the collar is less than 10 times the thickness of the wire. In various embodiments, the percent strain is in the range of 0.1 to 20%. In various embodiments, the thickness of the wires of the wire mesh is 0.1 to 1.0mm and the bending radius of the collar is 0.013 to 20 cm. In one embodiment, the wires of the wire mesh have a thickness of 0.4 mm. In various embodiments, the wire thickness and bend radius are configured to satisfy the following expression:

2t<R<2000t

where t is the wire thickness and R is the bend radius.

In various embodiments, the ends of the wires of the wire mesh structure terminate so as to minimize the possibility of trauma to body tissue during delivery and retraction, as well as when deployed. In certain embodiments, the wire mesh structure comprises a single wire folded into a three-dimensional structure. In other embodiments, the wire mesh structure comprises more than one wire joined and folded into a three-dimensional structure. In various embodiments, the respective free ends of the wire or wires are joined by crimping a tantalum or nitinol (or other shape memory metal) tube over each of the free ends. In other embodiments, the free ends of the wire or wires are joined by welding the free end points together. In one embodiment, the intersection of the wires is not welded. In another embodiment, the crossing points of the wires are welded.

Sleeve pipe

In various embodiments, the intragastric device of the present invention further comprises a flexible sleeve member coupled to the wire mesh structure. In various embodiments, any of the wire mesh structures described above is coupled with any of the sleeve components described below. The cannula member includes an elongate tubular body having proximal and distal ends and a lumen therein.

In one embodiment, the cannula has a uniform diameter along its entire length. In other embodiments, the sleeve includes a funnel shape proximate its proximal end, wherein the diameter of the sleeve is greatest at the first opening at the proximal end of the sleeve body and then gradually decreases as the sleeve extends distally until reaching a minimum diameter at a location proximate a midpoint of its length. This diameter then remains constant distally along the remainder of the cannula length.

In various embodiments, wherein the wire mesh structure comprises a loop at its distal end, the proximal end of the cannula is attached to the bottom surface of said loop by one of the means listed above. In various embodiments, the sleeve body is pulled over the device to assist in folding the collar outwardly when the device is compressed to its pre-deployment configuration. If the proximal end of the cannula is attached to the bottom surface of the collar as described above, the collar does not straighten out completely when folded over, resulting in a large bulge at the collar when the device is in the pre-deployment configuration. The protrusions have a major diameter that includes the thickness of the wire mesh structure and twice the thickness of the sleeve. Thus, in a preferred embodiment, the proximal end of the sleeve is attached to the free end or node of the collar by a plurality of loose sutures. The method of sewing the sleeve to each node is very similar to the method of attaching the fabric of an umbrella to the end of each rib of an umbrella. When the umbrella is closed, the fabric collapses to allow compression. The intragastric device of the present invention functions in a similar manner. In various embodiments, the distal end of the sleeve is pulled over the wire mesh structure as the wire mesh structure is compressed for loading to the delivery device. The loose sutures attaching the sleeve to the nodes of the wire mesh allow the sleeve to move relative to the wire mesh structure such that the loop is pulled distally and extends to a more linear shape. Such attachment avoids the creation of large protrusions at the collar in the pre-deployment configuration. When the collar body is pulled during compression, the collar is turned more completely outward and the resulting protrusion has a smaller diameter that includes only the thickness of the wire mesh structure. In various embodiments, there is a minimum to zero overlap between the collar and the sleeve when the intragastric device is in the pre-deployment configuration. Upon deployment, the shape memory properties of the wire mesh cause the collar to pull the sleeve onto the collar itself as the wire mesh expands, much like an umbrella expands its fabric as it opens.

In various embodiments, each node at the distal end of the wire mesh structure (or collar) is attached to the proximal end of the sleeve by suturing. This may result in a bulge at the attachment of the wire mesh structure to the sleeve. Thus, in other embodiments, fewer nodes are stitched to the casing. For example, in one embodiment, every other node is sutured to the sleeve to reduce the number of sutured knots and reduce tenting. The inclusion of glue and multiple loops in each suture knot may also result in a bulge at the point of attachment of the wire mesh structure to the sleeve. Thus, in various embodiments, no glue is used and each sewing knot is limited to one loop. Suturing the sleeve to the node may cause the suture knot to slide along the length of the wire comprising the plurality of nodes, resulting in undesired movement of the sleeve relative to the wire mesh structure. To prevent slippage, in various embodiments, each suture knot is placed at the first joint of the wire proximal to each node. In fact, each suture is placed over two wires and cannot slide along one or the other in order to eliminate excess tenting, in various embodiments, less than each (and not every) first wire joint is sutured to the sleeve. For example, in one embodiment, every other first wire joint is stitched to the sleeve.

In various embodiments, any sharp ends of the individual wires in the wire mesh and/or sleeve are crimped or looped over themselves or outwardly as a pull point for moving the sleeve into the small intestine or for connecting the sleeve to the wire mesh structure.

The distal end of the sleeve may be designed to be weighted such that the sleeve maintains an elongated shape that extends through a portion of the duodenum. In one embodiment, the cannula includes a small weight attached to its distal end. In another embodiment, wherein the second opening at the distal end of the cannula body is located along the cannula body at the distal end thereof, the distal end of the cannula body further comprises a blind sac. The blind sac functions to intermittently trap a small portion of food or fluid therein. The captured food or fluid acts to weigh the distal end of the cannula body, thereby keeping the cannula member elongated. In one embodiment, the distal end of the cannula is reinforced by at least a second layer to assist in retaining the downwardly positioned distal end and to prevent the distal end from being folded upward.

In one embodiment, the sleeve comprises a wire mesh construction having a plurality of nodes, similar to the construction described above for the wire mesh structure.

In another embodiment, the sleeve member comprises a membrane which is flexible and compressible by contraction of the small intestine. In one embodiment, the sleeve includes a minimum level of structure that imparts a minimum amount of structural strength to the sleeve to resist bulging caused by gastrointestinal forces and maintain functionality. In one embodiment, the lowest level of structure comprises a single structure extending along at least 10% of the length of the casing to provide linear strength to the casing. In certain embodiments, the single structure is a straight wire, a wire spiral, or a wire mesh. In one embodiment, the membranous sleeve component includes a plurality of horizontal and/or vertical support elements along the length of the sleeve body. In one embodiment, the horizontal elements comprise wire loops spaced along the length of the sleeve body. In various embodiments, the rings are spaced between 2 and 24 inches apart. In one embodiment, the rings are spaced 6 inches apart. In one embodiment, the vertical support elements comprise elongated metal wires. In various embodiments, each wire is between 2 and 60 inches in length. In one embodiment, the length of the metal wire is 6 inches. In another embodiment, the membranous sleeve component comprises a helical metal wire extending along its length. The helical wire provides support for the sleeve member and maintains the elongated shape of the sleeve member. In various embodiments, the helical metal wire is constructed of a shape memory metal such as nitinol. The helical wire must not be so tight that once the cannula is compressed for delivery, the helical wire kinks and cannot recover its full shape. In various embodiments, the helical metal wire of the sleeve has a thickness of 0.1 to 1.0 mm. In one embodiment, the thickness of the helical metal wire of the sleeve is 0.2 mm. Similar to that discussed above with reference to the bend radius of the collar, the bend radius of the helical metal wire of the sleeve should be such as to produce a strain percentage in the range of 0.1 to 20% and preferably less than 8%. In various embodiments, the percent strain (%) of the helical metal wire may be defined by the following equation:

where d is the wire diameter, Rf is the final bend radius, and Ri is the initial bend radius. Thus, in various embodiments, the pitch of the helical metal wire is in the range of 5 to 150 mm. In one embodiment, the pitch of the helical metal wire is 60 mm. In various embodiments, the cannula includes more than one helical metal wire to provide better support while still preventing permanent kinking (buckling). In one embodiment, the sleeve comprises three helical metal wires, wherein the pitch of each individual wire is 60mm and the wires are spaced such that the distance between two separate wires is 20 mm. In another embodiment, the sleeve comprises six coiled or helical wires to provide structural support to the sleeve. In various embodiments, the film of the sleeve component extends proximally over and covers all or a portion of the lower portion of the wire mesh structure.

The cannula is flexible and compressible such that during delivery, the cannula is constrained in a compressed configuration on the distal end of the delivery device. In one embodiment, the cannula nests within itself to shorten its length and facilitate delivery. In addition, when the device is in the pre-deployment configuration, the sleeve may be folded over onto itself to shorten its length and facilitate placement in a delivery device or catheter. In various embodiments, the cannula is folded 2 to 10 times over on itself and then folded or wrapped along the delivery device or catheter for delivery. In one embodiment, the cannula is fed coaxially over a guide wire, delivery device, or catheter. In another embodiment, the cannula is folded over along the sides or around the delivery device or catheter. This helps prevent the sleeve from sticking to the guide wire and/or delivery device/catheter as the guide wire and delivery device/catheter are retracted, which sometimes is encountered when the sleeve has been coaxially fed over the guide wire or delivery device/catheter.

In other embodiments, certain intragastric devices of the present invention comprise a sleeve of shorter length than that described above. In various embodiments, the short sleeve has a total length of 100 and 120 mm. In various embodiments, the short sleeve has a funnel shape or a conical shape. In certain embodiments, the short sleeve comprises wires forming a braid or wire mesh structure having a plurality of nodes, similar to the configuration described above for the wire mesh structure. In one embodiment, the braid is manufactured using a single wire. In one embodiment, the wire is comprised of a shape memory metal. In one embodiment, the shape memory metal is nitinol. In other embodiments, the braid is manufactured by machine knitting a plurality of wires. In some embodiments, the pitch, or distance between nodes, is uniform. In other embodiments, the pitch is variable. Each end of the braid is designed to be atraumatic. In one embodiment, each end is blunted. In another embodiment, each end is capped with a soft polymer tip. In certain embodiments, a portion of the short sleeve is coated with a covering. In some embodiments, the covered portion includes a floating node. In one embodiment, the cover is silicone. In various embodiments, the diameter of the proximal end of the sleeve is approximately equal to the outer diameter of the anti-migration collar at the distal end of the wire mesh structure. In such an embodiment, the proximal end of the cannula is mounted on and attached to the anti-migration collar. In other embodiments, the diameter of the proximal end of the sleeve is less than the outer diameter of the anti-migration collar and is approximately equal to the diameter of the collar neck connecting the collar to the wire mesh structure. In these embodiments, the proximal end of the cannula is attached to the neck of the collar.

In one embodiment, the number of nodes is uniform across the braid (over the entire braid). In one embodiment, the number of nodes is 24. In other embodiments, the number of nodes is uniform across the braid. For example, in various embodiments, the short sleeve braid comprises 24 nodes at the proximal end and 18 or 12 nodes at the distal end. In these embodiments, the nodes comprising the difference in number of nodes between the two ends (e.g., 6 or 12 nodes) are floating nodes and are positioned along the body of the short sleeve.

Once the intragastric device with the short sleeve is deployed, the short sleeve intermittently links and occludes the patient's pylorus without being anchored to the pylorus. This prevents food from passing through the pylorus and forces food from the stomach through the short sleeve into the duodenum, thereby regulating gastric outflow. In various embodiments, the diameter of the opening at the distal end of the short cannula is 1-30 mm, wherein the size of the diameter determines the gastric outflow rate. In one embodiment, the opening may be 0mm when the pylorus is attached, thereby completely obstructing outflow. Thus, food is allowed to pass from the stomach into the duodenum only when the pylorus is not attached or only partially attached.

In various embodiments, the sleeve has a high coefficient of friction compared to prior art sleeves. In various embodiments, the coefficient of friction of the sleeve is in the range of 0.01-0.45. In one embodiment, the coefficient of friction of the sleeve is equal to or less than 0.10. Has been encountered in relatively smooth casings: during deployment, the lubricious sleeve may become adhered to the interior of the delivery catheter or to itself, causing damage to the sleeve as force is applied to release the sleeve. Thus, a cannula with a rougher outer surface can be more easily fed into a delivery device or catheter and then deployed. In various embodiments, the sleeve includes a non-smooth outer surface. In other embodiments, a particulate object such as corn starch or a biocompatible powder or a relatively coarse substance is applied to the outer surface of the cannula prior to loading and deployment of the cannula into the delivery device.

In various embodiments, the cannula includes one or more radiopaque markers to ensure proper positioning of the cannula using radiographic images. In various embodiments, the radiopaque marker comprises a plurality of individual markers along the outer surface of the cannula body. In other embodiments, the radiopaque marker comprises a single line extending along the outer surface of the cannula body. A single line of the helix may indicate the twist of the cannula. In other embodiments, the radiopaque marker comprises a plurality of individual markers and a single line extending along the outer surface of the cannula body. In other embodiments, radiopaque markers are not required because the wire thickness of the support element of the cannula is large enough to allow visualization of the radiographic image.

Retracting mechanism

In various embodiments, the wire mesh structure or the wire mesh structure coupled with the sleeve component comprises one or more retraction mechanisms, wherein at least one retraction mechanism is positioned proximate to at least one opening at the proximal end of the wire mesh structure. In one embodiment, the retrieval mechanism comprises a retrieval suture having a breaking strength rating of 80lb (pounds).

Anti-migration component

In various embodiments, the wire mesh structure or the wire mesh structure coupled with the sleeve component includes one or more anti-migration features or collars. In one embodiment, the anti-migration feature is comprised of metal. In one embodiment, the metal is a shape memory metal such as nitinol. The anti-migration component is preferably positioned at the distal end of the wire mesh structure (in embodiments of the device including the sleeve, at the junction of the wire mesh structure and the sleeve component) and rests proximal to the pylorus once the device is deployed. The anti-migration feature acts to prevent passage of the wire mesh structure or the entire device through the pylorus. The anti-migration component is in the form of: a collar, an open annulus, or a surface of revolution created by a half turn in three-dimensional space around an axis extending through the center of the wire mesh (spherical or elliptical) device or the center of the opening of the lower portion of the wire mesh device.

In various embodiments, various components of the device, including the wire mesh structure, the retrieval mechanism, and/or the anti-migration component, are coated with a therapeutic drug to enhance the function of the device.

In various embodiments, the wire mesh, hooks, and/or anti-migration features include radiopaque markers for radiographic visualization to facilitate delivery and retrieval. In various embodiments, the wire mesh, hooks, and/or anti-migration components include ultrasonic markers for ultrasonic visualization to facilitate delivery and retrieval.

Delivery device

Various embodiments of a delivery device for deploying an intragastric device within a gastrointestinal tract of a patient are also disclosed. The intragastric device is preloaded onto a delivery device, which is then used to deliver the wire mesh of the intragastric device into the stomach and the sleeve of the intragastric device into the proximal small intestine.

In one embodiment, a delivery device includes an elongate tubular body having a coaxial plunger and catheter and a plurality of handles. Each handle is manipulated to deploy the sleeve and wire mesh structure of the intragastric device in multiple stages. In one embodiment, the tubular body includes a trigger that controls movement of various components of the delivery device to effect deployment of the intragastric device.

In various embodiments, the intragastric device may be retracted using a standard overtube (overtube), endoscope, and grasper.

The present invention relates to various embodiments. The following disclosure is provided to enable one skilled in the art to practice the invention. No language in the specification should be construed as indicating any general disavowal of any particular embodiment or as limiting the claims by virtue of language beyond that used in the claims. The general principles defined herein may be applied to other embodiments and applications without departing from the spirit and scope of the present invention. Also, the phraseology and terminology used is for the purpose of describing the exemplary embodiments and should not be regarded as 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 the purpose of clarity, details relating to technical material that is known in the technical fields related to the invention have not been described in detail so as not to unnecessarily obscure the invention.

FIG. 1 is a schematic diagram of an upper gastrointestinal system. After swallowing, food rapidly passes through the esophagus 111 into the stomach 112. There, the food is digested for a period of time and undergoes dilution to an isotonic concentration by milling and mixing with gastric juice. The stomach 112 relaxes to accommodate the volume of food that is digested. As the stomach 112 fills with food, a feeling of fullness or satiety is created by stretch receptors in the stomach wall, and the person stops eating. Next, an isotonic food called chyme passes through the pylorus 113 into the duodenum. The entry of chyme into the duodenum 114 results in the release of enzyme-rich pancreatic secretions from the pancreas 115, and bile salt-rich bile secretions from the liver 116. Bile secretions pass through the common bile duct 117 where they combine with pancreatic secretions that reach it through the pancreatic duct 118 and the two ducts combine to form a vater ampulla 119. The ampulla 119 serves as an entry point for secretions to be deposited into the duodenum 114. In the jejunum 120, the mixing of pancreatic and bile secretions with chyme results in the digestion of proteins, fats, and carbohydrates, which are then absorbed into the blood stream.

Fig. 2A is a schematic view of a wire mesh structure 201 of an intragastric device in a post-deployment configuration with a proximally-sloped anti-migration disc or collar 204, the anti-migration disc or collar 204 extending from or attached to a distal end of the wire mesh structure, according to one embodiment of the present invention. The wire mesh structure 201 includes a three-dimensional porous structure having an interior volume. The wire mesh structure 201 has an oval shape and includes a retraction mechanism 203. In one embodiment, the retraction mechanism is a wire suture loop. In one embodiment, the retraction mechanism is an 80lb (pound) retraction suture. The anti-migration collar 204 is proximally angled as it comprises a distal portion of the wire mesh 201 that is folded such that a distally facing end of the wire mesh 201 is directed towards a proximal end of the wire mesh 201. In other embodiments, the collar 204 comprises any curved/non-traumatic structure positioned circumferentially around the distal end of the wire mesh structure 201. The collar 204 helps to prevent the wire mesh 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 a flared distal end. In one embodiment, the distal half of the structure is covered by a film to prevent food from coming out of the structure 201, thereby directing food through the distal opening. In one embodiment, structure 201 has an optional anti-reflux valve at the proximal end and another optional valve at the distal end. The valve at the distal end functions to control the flow of chyme or partially digested food from the interior of the structure 201 to the exterior of the structure 201.

Fig. 2B is a schematic illustration of a wire mesh structure 210 with a proximally curved anti-migration loop 214 in a post-deployment configuration, the anti-migration loop 204 being formed at a distal end of the wire mesh structure 210, according to one embodiment of the present invention. 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 a proximal end thereof and a second opening 219 at a distal end thereof. 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 has a set of staggered nodes 217 at its proximal end. Each staggered node 217 at the proximal end provides a location for grasping, thereby increasing ease of retraction. The anti-migration loop 214 is formed by a continuation of the wires of the wire mesh structure 210 at its distal end. The anti-migration loop 214 is bent proximally, towards the body of the wire mesh structure 210, and the end 215 of the anti-migration loop 214 is formed in a rounded manner to prevent trauma to the body tissue. In various embodiments, the wire mesh structure 210 does not have sharp edges, thereby preventing the occurrence of chaffing, and has a radial force that is sufficiently large to prevent any significant or permanent deformation caused by gastric contractions and passing through the pylorus, and is sufficiently small that the wire mesh structure 210 is not too rigid, thereby allowing the wire mesh structure 210 to be affected by gastric contractions to an extent sufficient to facilitate movement of food through the wire mesh structure 210. In certain embodiments, the wire mesh structure may withstand a contractive force of up to 200 mmhg without being fully compressed. The anti-migration collar 214 is defined by a surface of revolution formed by a half turn in three-dimensional space about an axis extending through the center of the second opening 219 of the lower portion of the wire mesh device. The collar 214 is further defined by a diameter of 25mm or greater.

Fig. 2C is another schematic view of a wire mesh structure according to an embodiment of the present invention. In various embodiments, the length of the wire mesh structure measured from the proximal end 222 to the distal end 224 of the anti-migration loop 214 is in the range of 169mm to 180 mm. In certain embodiments, the length measured from the proximal end 222 to the distal end 226 of the ovoid structure is about 141mm, and the length of the anti-migration loop 214 measured from the proximal end 228 to the distal end 224 of the anti-migration loop 214 is in the range of 31mm to 36 mm. In an embodiment, the length of the middle portion 230 of the ovoid structure measured from the distal end of the proximal node group 233 to the proximal end of the distal node group 239 is about 109mm, while the length of the portion 232 measured from the proximal end of the proximal node group 233 to the distal end of the distal node group 239 is 117 mm. Further, in an embodiment, a proximal portion 234 extending from the proximal end 222 to the proximal end of the proximal node group and a distal portion 236 extending from the distal end of the distal node group 239 to the distal end 226 of the ovoid structure are 12mm in length. In other embodiments, the length of the portion 232 ranges between 114mm and 129mm, while the length of the proximal and

distal portions

234 and 236 of the ovoid structure ranges between 8mm and 12mm and 7mm and 14mm, respectively. In an embodiment, the inner diameter 238 of the anti-migration collar 214 defining the opening at the distal end 224 of the device ranges between 27mm and 35mm, while the outer diameter 240 defining the outer limit of the anti-migration collar 214 ranges between 58mm and 77 mm. Further, in certain embodiments, the diameter of the wire mesh structure at the central widest portion of the ovoid ranges between 116mm and 123 mm. In an embodiment, the diameter of the circular opening 250 at the proximal end 222 ranges between 17mm and 20 mm.

As set forth with reference to fig. 2A and 2B, the wire mesh structure includes a plurality of openings or gaps 242 that form a mesh. In certain embodiments, gaps 242 are diamond-shaped due to the criss-crossing pattern of wires of the wire mesh structure. In an embodiment, the width 244 of the gap 242 in the intermediate portion 230 of the mesh ranges between 9.6mm and 9.7mm, while the length 246 is 16 mm. In various embodiments, individual pieces of wire, such as wire pieces 248, are joined together using a process such as riveting or crimping to form a wire mesh structure. In certain embodiments, the wire piece 248 ranges between 5mm to 5.5mm in length and is about 1mm in diameter.

In an embodiment, as set forth with reference to fig. 3D and 3E, the wire mesh structure includes a plurality of loops formed in the wires of the proximal end 222 of the mesh, the distal end 224 of the anti-migration loop 214, and the distal end 236 of the ovoid structure. In certain embodiments, the thickness of the wire forming a loop, such as the wire loop 252 shown in fig. 2C, is about 0.4mm, the diameter of the circular portion 254 of the wire loop 252 is about 2mm, and the thickness 256 of the loop 252 is about 1 mm. In an embodiment, the distal end 224 of the anti-migration loop 214 includes 9 loops, such as the wire loop 252 shown in fig. 2C.

Fig. 3A is a schematic view showing a plurality of free ends or

nodes

301, 302 positioned at the proximal and distal ends of a wire mesh structure according to one embodiment of the invention. Node 301 is positioned at the proximal end of the wire mesh structure and node 302 is positioned at the distal end of the wire mesh structure. These nodes include bends or curves in each wire of the wire mesh structure that are not supported or connected to other portions of the wire mesh. In other words, these nodes are loops or bends comprising a free end at each end of the wire mesh structure. Each wire mesh structure comprises at least two groups of a plurality of nodes: a set of multiple nodes 301 at its proximal end and at least a set of multiple nodes 302 at its distal end. Other wire mesh embodiments, such as those discussed below with reference to fig. 3B and 3C, include more than two sets of multiple nodes that impart greater compressibility to the wire mesh structure. 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 length of the body of the structure.

Fig. 3B is a schematic diagram illustrating a plurality of overlapping nodes 303 positioned at one end of a wire mesh structure according to one embodiment of the invention. As shown in fig. 3B, each node 303 is positioned at the same lateral position. Such positioning creates a bulge in the lateral position when the wire mesh structure is compressed into the pre-deployment configuration. During delivery of the wire mesh structure, the protrusions create a resistance on the delivery device or catheter. Fig. 3C is a schematic diagram illustrating a first plurality of nodes 304 positioned at one end of a wire mesh structure according to one embodiment of the present invention and a second plurality of nodes 305 positioned proximal to the first plurality of nodes 304. The two pluralities of

nodes

304, 305 are staggered at two different lateral positions in fig. 3C. This staggering of the nodes results in smaller protrusions when the wire mesh structure is compressed into its pre-deployment shape, resulting in less resistance applied to the delivery device or catheter, and thus easier delivery and retrieval of the wire mesh structure.

Fig. 3D is a schematic view of a first plurality of nodes 306 and a second plurality of nodes 307 at the end of a wire mesh structure according to one embodiment of the invention, showing loops 308 formed in the wires of the first plurality of nodes 306. Referring to fig. 3D, the loop 308 extends in a direction toward the center of the wire mesh structure. In other embodiments, the loops extend outwardly in a direction away from the center of the wire mesh structure. In certain embodiments, as discussed further with reference to fig. 4B and 4C, the ring 308 serves as an attachment point for other device components, such as a sleeve component.

Fig. 3E is a schematic view of the first plurality of nodes 316 and the second plurality of nodes 317 at the ends of the wire mesh structure according to one embodiment of the invention, showing loops 318 formed in the wires of the second plurality of nodes 317. Fig. 3F is a schematic view of the first and second pluralities of

nodes

310, 319 at the end of the wire mesh structure according to one embodiment of the invention, showing

loops

313, 314 formed in alternating wires in the first and second pluralities of

nodes

310, 319. The embodiments of the wire loop described in fig. 3D through 3F disclose only various options for node looping and are not intended to be limiting. In various embodiments, any number percentage of the wires of the first plurality of nodes, the second plurality of nodes, or the first plurality of nodes and the second plurality of nodes may be looped. For example, in one embodiment, only the outermost nodes relative to the center of the wire mesh structure are looped. In another embodiment, only nodes that are immediately proximal to the outermost node are looped. In certain embodiments, a percentage of nodes between 0 and 100% are looped. In one embodiment, 50% of the nodes are looped. In another embodiment, 30% of the nodes are looped.

Fig. 3G is a schematic diagram illustrating a wire mesh structure 315 having a first plurality of nodes 311 at a proximal end thereof and a second plurality of nodes 312 at a distal end thereof, according to one embodiment of the present invention. The wire mesh structure 315 of fig. 3G includes the fewest (two) sets of multiple nodes possible and will have the largest projections at its proximal and distal ends when compressed into its pre-deployment configuration. Fig. 3H is a schematic diagram illustrating a wire mesh structure 320 having a first plurality of nodes 321 and a second plurality of nodes 322 at its proximal and distal ends, respectively, and a third plurality of nodes 323 and a fourth plurality of nodes 324 distributed along its surface, according to one embodiment of the present invention. The increased number of node groups allows fewer individual nodes to be positioned at lateral locations of each group of multiple nodes. Thus, when compressed, the wire mesh structure will include a bump at each lateral location of each set of multiple nodes, but each bump will be smaller in diameter than the bumps created at the proximal and distal ends when the wire mesh structure is compressed as seen in fig. 3G. Thus, the compressed pre-deployment configuration of the wire mesh structure of fig. 3H will create less resistance on the delivery device or catheter and will be easier to deploy. Although four sets of

multiple nodes

321, 322, 323, 324 are shown in the wire mesh structure 320 of fig. 3H, the wire mesh structure may have three or more sets of multiple nodes. In various embodiments, the wire mesh structure comprises 2 to 60 sets of a plurality of nodes positioned at different lateral positions.

FIG. 3I is a schematic diagram illustrating various possible node shapes according to various embodiments of the invention. Possible node shapes include, but are not limited to, a sharp bend 331, a shallow bend 332, a sharp bend 333, a rounded bend 334, and a shape similar to the end of a safety pin 335, including a loop 345 of wire at the end of the node.

Fig. 4A is a close-up schematic view of an atraumatic anti-migration collar 414 of a wire mesh structure 410 of an intragastric device 400 according to one embodiment of the invention. The anti-migration collar 414 has an annular bulbous shape and includes a rounded end 410 extending proximally toward the wire mesh structure 415. Rounded end 415 is designed to prevent trauma to body tissue. As described above, in certain embodiments, each end 415 is divided into various nodes to prevent bunching (bunching) of the wires when compressed, which can lead to corrosion. The long axis of the collar 412 is bent at an angle 413 greater than 90 ° compared to the long axis of the mesh 411, such that the rounded end 415 points in the direction of the wire mesh structure 410.

Fig. 4B is a close-up schematic view of an atraumatic anti-migration loop 424 of a wire mesh structure 421 of an intragastric device 420 according to another embodiment of the invention. The anti-migration collar 424 has an annular bulbous shape and includes a rounded end 421 extending proximally toward the wire mesh structure 425. The rounded end 425 is designed to prevent trauma to body tissue. In certain embodiments, each end 425 is divided into various nodes 427l, 427s to prevent bunching (bunching) of the wires when compressed, which can lead to corrosion. The plurality of nodes includes long nodes 427l and short nodes 427s, wherein the long nodes 427l extend back more in a proximal direction toward the top of the wire mesh structure 421 than the short nodes 427 s. In some embodiments, collar 424 includes 9 long nodes 427l and 9 short nodes 427 s. The free end of the long nodes 427l includes a loop 428 for suturing the proximal end of the cannula member. The loop 428 extends outwardly away from the free end of the long node 427 l. In one embodiment, the loop 428a is formed by twisting the free end of the long node 427l into a loop. In another embodiment, loop 428b comprises a separate loop of wire stitched to the free end of long node 427 l. In certain embodiments, once the sleeve is attached, additional suture knots are located at the junctions of the twisted or separated loops to prevent slippage of the sleeve attachment.

Fig. 4C is a close-up schematic view of an atraumatic anti-migration loop 430 of a wire mesh structure 431 of an intragastric device 434 according to yet another embodiment of the invention. The anti-migration collar 434 has an annular bulbous shape and includes a rounded end 435 extending proximally toward the wire mesh structure 431. Rounded end 435 is designed to prevent trauma to body tissue. In some embodiments, each end 435 is divided into various nodes 437l, 437s to prevent bunching (bunching) of the wires when compressed, which can lead to corrosion. The plurality of nodes includes long nodes 437l and short nodes 437s, wherein long nodes 437l extend back more (farther) in a proximal direction toward the top of wire mesh 431 than short nodes 437 s. In some embodiments, collar 434 includes 9 long nodes 437l and 9 short nodes 437 s. The free end of the long node 437l includes a loop 439 for suturing the proximal end of the cannula member. The loops 439 extend inwardly toward the curve at the distal end of the wire mesh structure 431. In one embodiment, the loop 439a is formed by looping the free end of the long node 437 l. In another embodiment, the loop 439b comprises a separate loop of wire stitched to the free end of the long node 437 l. In some embodiments, once the sleeve is attached, additional suture ties are located at the joints of the looped or separated loops to prevent slippage of the sleeve attachment.

In certain embodiments, the sleeve member is attached to the distal end of the wire mesh structure or to a collar of the intra-gastric device. In various embodiments, the sleeve component of the present invention is made of the following materials: 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 fluoropolymer or silicone. In one embodiment, the silicone sleeve is manufactured by hand casting and weaving. In another embodiment, the silicone sleeve is manufactured by machine knitting. In various embodiments, the length of the sleeve member is in the range of 6 inches to 6 feet or more. In one embodiment, the sleeve member is 24 inches in length. In another embodiment, the sleeve member is 30 inches in length. In various embodiments, the diameter of the sleeve member is in the range of 1cm to 10 cm. In one embodiment the diameter of the sleeve part is 3 cm.

Fig. 5A is a schematic view of a portion of a sleeve component 500 of an intragastric device in a post-deployment configuration, showing a single wire support 501 coiled along the body of the sleeve 500, according to one embodiment of the present invention. The metal wire needs to have a sufficiently tight helix to provide support, but must not be so tight that once the cannula is compressed for delivery, the metal wire kinks and cannot recover its full shape. Referring to fig. 5A, the pitch of the helical wire 501 is shown by a length l, which is equal to 60 mm. The pitch gives the helical metal wire a percentage strain which will not exceed 20% and preferably is less than 8% when the wire is 0.1 to 1mm thick.

Fig. 5B is a schematic view of a portion of a sleeve component 505 of an intragastric device in a post-deployment configuration, showing a plurality of wire supports 506, 507, 508 coiled along the body of the sleeve 505, according to one embodiment of the present invention. The sleeve includes more than one helical metal wire to provide better support while still preventing permanent kinking. Referring to FIG. 5B, the pitch of each

individual wire

506, 507, 508 is defined by a length l₁Shown, length l₁Equal to 60 mm. The

wires

506, 507, 508 are spaced so as to be of length l₂The pitch between the two separate wires shown is equal to 20 mm.

Fig. 5C is a schematic view of a funnel-shaped sleeve component 510 of the intragastric device in a post-deployment configuration according to one embodiment of the present invention, showing a helical

wire loop support

511, 513 on the sleeve 510. In the embodiment shown in fig. 5C, the sleeve 510 includes two sets of wire loop supports 511, 513. Each set of wire loop supports 511, 513 includes a loop that includes two separate wires, thereby forming a total of four wires on sleeve 510. Each

wire loop support

511, 513 terminates in a blunt end 515 to prevent trauma to body tissue. The wire loop supports 511, 513 are twisted into a helical configuration and looped along the length of the sleeve 510. In one embodiment, the pitch or distance between each loop 511, 513 (and between each wire of each loop 511, 513) is defined by a length/and is about 15 mm.

Fig. 5D is a schematic view of the sleeve component 520 of the intragastric device in a post-deployment configuration, showing a funnel-shaped opening 521 at the proximal end of the sleeve, according to one embodiment of the present invention. As discussed in detail below with reference to fig. 11C and 11D, the funnel-shaped opening 521 is well suited for attachment to the node of a collar positioned at the distal end of the wire mesh structure of certain embodiments of the intragastric device of the present invention.

Fig. 5E is a schematic view of a funnel-shaped sleeve component 525 of the intragastric device in a post-deployment configuration, showing a plurality of markings 527 on the outer surface of the sleeve body, according to one embodiment of the present invention. Markers 527 are radiopaque and their radiographic visibility aids in proper placement of the cannula during device delivery.

Fig. 5F is a schematic view of a funnel-shaped sleeve component 530 of the intragastric device in a post-deployment configuration, showing a marker line 533 extending along the length of the sleeve 530 on the outer surface of the sleeve body, according to one embodiment of the present invention. Wire 533 is radiopaque and its radiographic visibility facilitates proper placement of the cannula during device delivery. Further, the coiling or rotation of the wire about the central axis of the cannula may indicate twisting of the cannula.

Fig. 5G is a schematic view of a funnel-shaped sleeve component 535 of the intragastric device in a post-deployment configuration, showing a marker line 538, and a plurality of markers 537 extending along the length of the sleeve 535 on the outer surface of the sleeve body, according to one embodiment of the invention. The markers 537 and wire 538 are radiopaque and their radiographic visibility aids in proper placement of the cannula during device delivery and in detecting twisting of the cannula 535.

Fig. 6A is a schematic cross-sectional view of a funnel-shaped sleeve component 600 of the intragastric device in a post-deployment configuration showing

multiple sleeve layers

606, 607, 608, 609, according to one embodiment of the present invention. In one embodiment, the casing layers 606, 607, 608, 609 are constructed of PTFE. The sleeve 600 includes an innermost first layer 606, the first layer 606 being about 0.06mm thick and extending 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 comprises a second layer 607, the second layer 607 being superposed on said first layer 607 On one layer 606, the second layer 607 is about 0.06mm thick and extends only along the proximal portion 616 of the cannula 600 and the distal portion 618 of the cannula 600. In one embodiment, proximal portion 616 includes a funnel portion 601 and a length/that extends distally beyond the funnel portion 601 by about 30-40 mm₁The additional part of (2). In one embodiment, sleeve 600 includes a length l₂About 20-30 mm distal. The distal portion 618 includes only about the length l₂10mm proximal most. In one embodiment, the second layer 607 extends in a configuration along the width of the sleeve 600. Sleeve 600 includes a third layer 608 overlying second layer 607 and central portion 617 of first layer 606. The third layer 608 is approximately 0.06mm thick and extends in a configuration along the width of the sleeve 600. The sleeve 600 comprises a fourth layer 609, the fourth layer 609 being superimposed on said third layer 608, the fourth layer 609 being approximately 0.06mm thick and extending in a configuration along the length of the sleeve 600. Thus, in the embodiment shown in fig. 6A, cannula 600 includes four layers at its proximal section 616, three layers at its central section 617, and four layers at its distal section 618. The

layers

606, 607, 608, 609 are bonded across the layers, or applied in various different configurations (along the length and width of the sleeve 600) to impart additional durability to the sleeve. In one embodiment, sleeve 600 further includes a metal wire support 605 between second layer 607 and third layer 608 (or between first layer 606 and third layer 608 in central portion 617 of sleeve 600) to provide structural support. In one embodiment, the sleeve includes stitch points 619 for connection to a wire mesh structure.

Fig. 6B is a schematic cross-sectional view of a funnel-shaped sleeve component 620 of an intragastric device in a post-deployment configuration according to another embodiment of the present invention, showing 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 the following: 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, the first PTFE layer 643 being about 0.06mm thick and extending in a configuration along the length of the sleeve. First PTFE layer626 extend along the entire length of the cannula 620. The sleeve 620 includes a

second PTFE layer

627, 626 overlying the first PTFE layer 620, the second PTFE layer 620 being about 0.06mm thick and extending only along the proximal portion 636 of the sleeve 640 and the distal portion 638 of the sleeve 600. In one embodiment, proximal portion 636 comprises a funnel portion 621 and a length/extending distally beyond said funnel portion 621 by about 30-40 mm₁The additional part of (2). In one embodiment, the sleeve 620 includes a length l₂About 20-30 mm distal. The distal portion 638 includes only about the length l₂10mm proximal most. In one embodiment, the second PTFE layer 627 extends in a configuration along the width of the sleeve 620. The sleeve 620 includes a third PTFE layer 628, the third PTFE layer 628 overlying the second PTFE layer 627 and the central portion 637 of the first PTFE layer 626. The third PTFE layer 628 is approximately 0.06mm thick and extends in a configuration along the width of the sleeve 620. The sleeve 620 includes a fourth PTFE layer 629, a fourth PTFE layer 628 superposed on said third PTFE layer 620, the fourth PTFE layer 647 being about 0.06mm thick and extending in a configuration along the length of the sleeve 640. In one embodiment, the sleeve further comprises a fifth PTFE layer 630, the fifth PTFE layer 630 being sandwiched between the third PTFE layer 628 and the fourth PTFE layer 629. In one embodiment, the fifth PTFE layer 630 is about 0.06mm thick and extends in a configuration along the length of the sleeve 620. Thus, in the embodiment shown in fig. 6B, the cannula 620 includes a total of five layers at its proximal section 636, a total of four layers at its central section 637, and a total of five layers at its distal section 638. In various embodiments, the

layers

626, 627, 628, 629, 630 are bonded across the layers, or applied in various different configurations (along the length of the cannula 620 and along the width of the cannula 620) to impart additional durability to the cannula. In one embodiment, the sleeve 620 further includes a metal wire support 625 between the second and third PTFE layers 627, 628 (or between the first and third PTFE layers 626, 628 in the central portion 637 of the sleeve 620) to provide structural support. In one embodiment, the sleeve includes stitching points 639 for connection to a wire mesh structure.

FIG. 6C is a funnel of the intragastric device in a post-deployment configuration, according to one embodiment of the present inventionA schematic cross-sectional view of the shaped sleeve member 640 shows 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 of the following or a combination thereof: 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, the first PTFE layer 643 being about 0.06mm thick and extending in a configuration along the length of the sleeve. The first PTFE layer 643 extends along the entire length of the sleeve 640. The cannula 640 includes a second layer 644 of PTFE, the second layer 644 of PTFE overlying the first layer 643 of PTFE, the second layer 644 of PTFE being about 0.06mm thick and extending only along the proximal portion 656 of the cannula 640 and the distal portion 658 of the cannula 600. In one embodiment, proximal portion 656 includes a funnel portion 641 and a length/extending distally beyond funnel portion 641 by about 30-40 mm₁The additional part of (2). In one embodiment, the sleeve 640 includes a length l₂About 20-30 mm distal. The distal portion 658 includes only about the length l₂10mm proximal most. 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, the third PTFE layer 646 overlying the second PTFE layer 644 and the central portion 657 of the first PTFE layer 643. The third PTFE layer 646 is about 0.06mm thick and extends in a configuration along the width of the sleeve 640. The sleeve further includes a first intermediate PTFE layer 648 and a second intermediate PTFE layer 649 sandwiched between a second PTFE layer 644 and a third PTFE layer 646. In one embodiment, both the first intermediate PTFE layer 648 and the second intermediate PTFE layer 649 are about 0.06mm thick. In one embodiment, both the first intermediate PTFE layer 648 and the second intermediate PTFE layer 649 extend in a configuration along the length of the sleeve 640. In another embodiment, both the first intermediate PTFE layer 648 and the second intermediate PTFE layer 649 extend in a configuration along the width of the sleeve 640. In another embodiment, the first intermediate PTFE layer 648 extends in a configuration along the length of the sleeve 640, while the second intermediate PTFE layer 649 extends in a configuration along the width of the sleeve 640. In yet another embodiment, the first intermediate PTFE layer 648 extends in a configuration along the width of the sleeve 640, while the second intermediate PTFE layer 649 extends in a configuration along the sleeve 640The configuration of the length extends. The sleeve 640 includes a fourth layer of PTFE 647 overlying the third layer of PTFE 646, the fourth layer of PTFE 647 being about 0.06mm thick and extending in a configuration along the length of the sleeve 640. The sleeve further includes a third intermediate PTFE layer 650, the third intermediate PTFE layer 650 sandwiched between the third PTFE layer 646 and a fourth PTFE layer 647. In one embodiment, the third intermediate PTFE layer 650 is about 0.06mm thick and extends in a configuration along the length of the sleeve 640. Thus, in the embodiment shown in fig. 6C, the cannula 640 includes a total of seven layers at its proximal section 656, a total of six layers at its central section 657, and a total of seven layers at its distal section 658. In various embodiments, the

layers

643, 644, 646, 647, 648, 649, 650 are bonded across layers or applied in various different configurations (along the length of the sleeve 640 and along the width of the sleeve 640) to impart additional durability to the sleeve. In one embodiment, the sleeve 640 further includes a metal wire support 645 between the first intermediate PTFE layer 648 and the second intermediate PTFE layer 649 to provide structural support. In one embodiment, the sleeve includes stitching points 659 for connecting to a wire mesh structure.

Although fig. 6A-6C illustrate cannulas having multiple layers of PTFE, these configurations are not intended to be limiting and embodiments of other cannulas having more or fewer layers of PTFE or layers comprising other materials with varying stacks of layers are contemplated.

Fig. 6D is a schematic cross-sectional view of a funnel-shaped sleeve component 660 of the intragastric device in a post-deployment configuration, showing multiple sleeve layers, in accordance with yet another embodiment of the present invention. The sleeve includes a cylindrical portion 660c and a funnel portion 660 f. In certain embodiments, the length l of the cylindrical portion 660c_cAbout 500mm, length l of the funnel portion_fAbout 100 mm. The sleeve component 660 of fig. 6D is constructed from a single machine-braided wire 661 sandwiched between multiple sleeve layers. In one embodiment, a single machine-braided wire 661 is in an axially-stretched configuration. A single machine-braided wire 661 extends only along a proximal portion of cylindrical portion 660c of cannula 660. In one embodiment, about 450mm of the proximal portion of the cylindrical portion 660c of the cannula 660Comprising a single machine braided wire 661, while at least 50mm at the distal end of cannula 660 contains no wire. In one embodiment, the distal end of cannula 660 includes a distal opening 682 of approximately 24.5mm in diameter. Funnel portion 660f includes a wire support 671 terminating proximally at a plurality of nodes 672. In one embodiment, the casing 660 includes a total of 18 nodes equidistant from each other, including the long and short nodes described above. In certain embodiments, the sleeve layer extends proximally a distance of at least 5mm beyond the long node. In one embodiment, the proximal end of the cannula 660 includes a proximal opening 681 that is approximately 63mm in diameter. In various embodiments, the single machine-braided wire 661 and the wire support 671 each comprise wires having a diameter in the range of 0.100 to 0.150 mm. In one embodiment, the single machine-braided wire 661 and wire support 671 each comprise wire having a diameter of 0.127 mm. In another embodiment, the single machine-braided wire 661 and wire support 671 each comprise wire having a diameter of 0.140 mm.

The sleeve 660 includes an innermost first PTFE layer 662, the first PTFE layer 662 extending 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 thickness of the first PTFE layer 662 is about 0.06 mm. A single machine braided wire 661 overlies the first PTFE layer 662 along a proximal portion of the cylindrical portion 660c and a wire support 671 overlies the first PTFE layer 662 along a funnel portion 660f of the cannula 660. Proximal intermediate PTFE layer 663p overlies wire support 671 along funnel portion 660f and extends distally about 5 to 7mm over single machine-braided wire 661 of cylindrical portion 660c of cannula 660. A distal intermediate PTFE layer 663d overlies the first PTFE layer 662 at the distal end of the sleeve and extends proximally about 5 to 7mm over the single machine-braided wire 661 of the cylindrical portion 660c of the sleeve 660. A plurality of cylindrical intermediate PTFE layers 663c are stacked on a single machine braided wire 661 along multiple sections of the cylindrical portion of the cannula 660. In certain embodiments, the sleeve 660 includes three cylindrical intermediate PTFE layers 663c, each intermediate PTFE layer 663c being about 3 to 5mm in length and spaced apart from each other and from the proximal intermediate PTFE layer 663p and the distal intermediate PTFE layer 663d, respectively, at the proximal and distal ends of the sleeve by 70 to 80 mm. The cannula 660 includes an outermost second PTFE layer 664, which is about 0.06mm thick and extends in a configuration along the length of the cannula 660.

In certain embodiments, cannula 660 further comprises at least one marker for visualization in radiographic examinations to determine proper placement after delivery. Referring to fig. 6D, the sleeve includes three markings 665 positioned near a proximal end of the single machine-braided wire 661, near a center of the single machine-braided wire 661, and near a distal end of the single machine-braided wire, respectively. In one embodiment, each marker 665 is covered and held in place by a PTFE block 666, the PTFE block 666 having a length of about 5mm, a width of about 5mm, and a thickness of about 0.06 mm. In one embodiment, the markings 665 are separated from each other by a distance of about 145mm to 155 mm. In one embodiment, the markings 665 are positioned at every other cylindrical intermediate PTFE layer 663 c. In one embodiment, the marker 665 is positioned on a side of the cannula 660. In one embodiment, mark 665 is a tantalum mark.

Referring to fig. 6A through 6D, in various embodiments, the sleeve layer composed of PTFE may also be composed of: polyethylene (PE), Low Density Polyethylene (LDPE), High Density Polyethylene (HDPE), and Ultra High Molecular Weight Polyethylene (UHMWPE). Instead of being bonded, the sleeve layers may be stitched.

Fig. 6E is a schematic cross-sectional view of a funnel-shaped sleeve component 690 of the intragastric device in a post-deployment configuration according to yet another embodiment of the present invention. Referring to fig. 6E, the cannula 690 includes a proximal funnel portion 690p and a distal cylindrical portion 690 d. The proximal portion 690p includes a hand-woven nitinol wire mesh 691 covered by PTFE. The distal portion 690d includes a machine braided nitinol wire mesh 692 covered by PTFE. The distal portion 690d also includes at least one overlying fluoropolymer ribbon 695 for improving bonding of the nitinol wire mesh to the PTFE. At least one radiopaque marker band 693 is also included in distal portion 690 d.

Figure 6F is a schematic illustration of a stent support 680 for a sleeve component of an intragastric device according to one embodiment of the present invention. In the illustrated embodiment, the stent support 680 includes a plurality of rings 683 formed from "Z" shaped sections of wire. In another embodiment, the stent support comprises a continuous helical wire support wherein the helical wire is configured in a "Z" shape. In one embodiment, the shape of the stent support 680 is similar to the pattern 2033 shown in fig. 20F. Referring again to fig. 6F, in one embodiment, each of the rings 683 are connected by straight wires 684 such that there are spaces 685 between each of the rings 683, which spaces 685 will only include the remaining layers of the sleeve component. In certain embodiments, the length of each ring 683 is in the range of 1-2 cm. In certain embodiments, the length of each connected straight wire 684 is in the range of 1-2 inches, and the length of each space 685 is also in the range of 1-2 inches. In one embodiment, the proximal end of stent support 680 includes a funnel-shaped annulus section 686. In one embodiment, funnel-shaped ring segment 686 includes a suture connector 687 with first distal ring 683 a. In various embodiments, the diameter of the funnel-shaped ring segment 686 is sized to match the diameter of the anti-migration component at the distal end of the wire mesh structure to which the funnel-shaped ring segment 686 will be attached.

Fig. 6G is a schematic view of sleeve component 688 of the intragastric device having stent support 680 of fig. 6F. The stent support 680 includes rings 683 connected by straight wires 684. Additional layers 689 of sleeve component 688, such as PTFE, are shown between each set of rings 683. The "Z" shaped stent support 680 provides structural integrity to the sleeve member 688 such that the sleeve member 688 will not collapse due to bowel contraction, while still allowing the sleeve member 688 to be flexible enough to conform to the curves of the gastrointestinal tract.

In embodiments, the sleeve and wire mesh of the gastric wire mesh device of the present invention may be covered by a web to make the sleeve portion flexible and kink-resistant (kink-resistant) while controlling the porosity of the device. In an embodiment, a web is produced by electrospinning PTFE into polymeric fibers, the thickness of which is very small, in the range of 0.10 nanometers to 100 micrometers. Electrospinning allows materials with high surface-to-weight and volume ratios (specific surface areas) while still maintaining excellent mechanical properties. It is essentially similar to expanded PTFE, but has a lower basis weight and comparable chemical and temperature resistance. If the strand web breaks, it can be easily repaired. In embodiments, the first web layer is reticulated over the sleeve of the intragastric device. Next, the stent following the second web layer is placed on the first web layer to form an outer layer, thus encapsulating the nitinol or polymer stent.

In embodiments, the mesh devices of the present invention may comprise a braided sleeve or outer braid, which is produced using tensile fibers, expandable and flexible for the aerospace, automotive and medical markets. The woven braid protects against abrasion and provides additional chemical resistance and flexibility to the sleeve of the wire mesh device of the present invention. In embodiments, the drawn fiber may be a Perfluoroalkoxy (PFA) drawn fiber, a Fluorinated Ethylene Propylene (FEP) drawn fiber, an Ethylene Tetrafluoroethylene (ETFE) drawn fiber, a Polyetheretherketone (PEEK) drawn fiber, a polyvinylidene fluoride (PVDF) drawn fiber, or an Ethylene Chlorotrifluoroethylene (ECTFE) drawn fiber. In an embodiment, a high temperature resistant nanofiber membrane with the ability to capture particles greater than 0.1 micron in size may be used to cover the wire mesh device of the present invention. Fig. 6H shows a portion 603 of a sleeve of a wire mesh device covered with a nanofiber membrane 605, according to an embodiment of the invention.

FIG. 7 is a schematic view of a funnel-shaped sleeve 700 for use in an intragastric device according to one embodiment of the present invention. The cannula 700 has a funnel shape wherein the cannula diameter decreases as the cannula extends from a first opening 713 at its proximal end to a second opening 719 at its distal end. The sleeve 700 includes at least one wire 702, the wire 702 being folded over on itself to create a funnel shape with a staggered weave pattern. As sleeve 700 extends distally, its diameter decreases and the intersections of the interwoven wires become closer together. The cannula 700 includes a curved or free end at its proximal and distal ends. The free end is designed to prevent trauma to body tissue. In certain embodiments, the diameter of the first opening 713 is substantially equal to or slightly larger than the diameter of the anti-migration collar of the wire mesh structure. The sleeve 700 is slid over the anti-migration collar and then the sleeve 700 is secured in place by suturing the free end 714 at the proximal end of the sleeve to a node comprising the anti-migration collar. The free end 718 at the distal end of the cannula 700 surrounds the second opening 719. In various embodiments, cannula 700 is a short cannula having an overall length in the range of 1 cm-120 cm. In one embodiment, the cannula 700 is a short cannula having a total length of 10 cm. In the illustrated embodiment, the conical funnel section comprises 100% of the length of the sleeve.

FIG. 8 is a schematic view of a funnel-shaped sleeve 800 for use in an intragastric device according to another embodiment of the present invention. The cannula includes a proximal end with a first opening 813 and a distal end with a second opening 819. Cannula 800 also includes a proximal portion 811 and a distal portion 816. Both proximal portion 811 and distal portion 816 of cannula 800 are funnel shaped and each have a diameter that decreases as

portions

811, 816 extend distally. The diameter of proximal portion 811 is greatest at the proximal end of sleeve 800 at the location of first opening 813 and decreases as proximal portion 811 extends distally until sleeve 800 transitions to its distal portion 816 at transition point 803. At transition point 803, proximal portion 811 and distal portion 816 are equal in diameter. The diameter of the distal portion 816 then decreases as the 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 800 of the sleeve 816 terminates at a second opening 819 at the distal end of the intragastric device 800. The proximal portion includes a first wire 802, the first wire 802 folded over onto itself to create a funnel shape with a first interlaced weave pattern. The distal portion includes a second wire 812 folded over onto itself to create a funnel shape with a second interwoven pattern. In some embodiments, the second wire 812 is an extension of the first wire 802. In other embodiments, the first wire 802 and the second wire 812 are separate wires that are joined together at the transition point 803. In one embodiment, the separate wires are spot welded together. In both the proximal and

distal portions

811, 816, as the

portions

811, 816 extend distally and the funnel shape narrows, the various intersecting sections of wire become closer to each other so that the weave pattern becomes tighter at the distal ends of the

portions

811, 816. In one embodiment, proximal portion 811 has the same weave pattern as distal portion 816. In another embodiment, the braid pattern of the proximal portion 811 is tighter than the braid 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 length of the proximal portion 811 is equal to the length of the distal portion 816. In another embodiment, the length of the proximal portion 811 is less than the length of the distal portion 816. In another embodiment, the length of the proximal portion 811 is greater than the length of the distal portion 816. The cannula 800 includes a curved or free end at its proximal and distal ends. The free end is designed to prevent trauma to body tissue. In certain embodiments, the diameter of the first opening 813 is substantially equal to or slightly smaller than the diameter of the neck of the anti-migration collar of the wire mesh structure. The sleeve 800 is slid into the neck of the anti-migration collar and then secured in place by suturing the free end 814 at the proximal end of the sleeve to the intersection of the wires in the neck of the anti-migration collar. A free end 818 at the distal end of the cannula 800 surrounds the second opening 819. In various embodiments, cannula 800 is a short cannula having an overall length in the range of 1 cm-120 cm. In one embodiment, the cannula 800 is a short cannula having a total length of 10 cm. In the illustrated embodiment, the conical funnel section comprises 100% of the length of the sleeve.

Fig. 9A is a schematic view of a wire mesh structure 930 with attached cannula member 944 in a post-deployment configuration, showing a blunt end 952 of the wire mesh support toward the proximal end of the cannula 944, according to one embodiment of the present invention. The cannula 944 is connected to a proximally curved and 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 central section 955 having three layers.

Fig. 9B is a schematic view of a wire mesh 957 with a proximal portion of a sleeve member 959 attached in a post-deployment configuration showing a delivery catheter 969 positioned within the wire mesh 957, according to one embodiment of the invention. The sleeve 959 is attached to a proximally curved anti-migration component 958.

Fig. 10A is a schematic view of a funnel-shaped braided short sleeve component 1000 in a deployed configuration according to one embodiment of the present invention. The cannula 1000 includes a wire-shaped braided structure having a plurality of nodes 1001 at the proximal and distal ends of the cannula 1000. Each node 1001 is similar in structure to those described above with reference to fig. 3A and includes unsupported free bends in the wires 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 cannula 1000 is equal to the number of nodes at the distal end of the cannula 1000. In one embodiment, the consistent number of nodes is 24 per end. In one embodiment, the number of nodes is variable such that the number of nodes at the proximal end of the cannula 1000 is different than the number of nodes at the distal end of the cannula 1000. Any nodes not present at the distal end of the cannula are staggered within the body of the cannula. For example, in one embodiment, the cannula includes 24 nodes at the proximal end and 18 nodes at the distal end. The remaining 6 nodes are staggered within the body of the casing. In another embodiment, the cannula includes 24 nodes at the proximal end and 12 nodes at the distal end. The remaining 12 nodes are staggered within the body of the casing. Different embodiments include different node interleaving. In one embodiment, the distal portion of the cannula includes a coating 1002. In various embodiments, about 30-60 mm of the distal end is covered with coating 1002. In one embodiment, coating 1002 is silicone. In one embodiment, the staggered nodes are positioned in the distal portion with the coating 1002 and are covered to eliminate traumatic surfaces.

The cannula 1000 shown in fig. 10A includes a funnel portion 1005 at its proximal end and a cylindrical portion 1006 at its distal end. In one embodiment, funnel portion 1005 includes a length/₁And includes a distal portion. In one embodiment, the length l₁About 30 mm. The entire funnel portion has a length l₂In one embodiment, the length l₂About 60 mm. The cylindrical portion 1006 has a length l₃In one embodiment, the length l₃About 60 mm. Thus, in one embodiment, the overall length l of the cannula 1000_tAbout 120 mm. Cannula 1000 has a diameter d at its proximal end₁ First opening 1003. In one embodiment, the diameter d₁Approximately 75 mm. The cannula has a second opening 1004 at its distal end. In various embodiments, the diameter d of the second opening 1004₂Is 1-30 mm.

Fig. 10B is a schematic illustration of a funnel-shaped braided short sleeve component 1010 with a conical distal end 1017 in a post-deployment configuration, according to one embodiment of the present invention. In various embodiments, sleeve 1010 is constructed of a braided structure of wires having a plurality of nodes 1011, wherein the plurality of nodes are uniform or variable as described with reference to fig. 10A. In one embodiment, the distal portion of the cannula includes a coating 1012. In various embodiments, about 30-60 mm of the distal end is covered with coating 1012. In one embodiment, coating 1012 is silicone. In one embodiment, the staggered nodes are positioned in the distal portion with the coating 1012 and covered to eliminate traumatic surfaces.

The cannula 1010 shown in fig. 10B includes a funnel shaped portion 1015 at its proximal end and a conical portion 1017 at its distal end. In one embodiment, the funnel portion 1015 comprises a length/₁And includes a distal portion. In one embodiment, the length l₁About 30 mm. The entire funnel portion has a length l₂In one embodiment, the length l₂About 60 mm. The conical portion 1017 has a length l₃In one embodiment, the length l₃About 55 mm. In one embodiment, the short straight section 1016 of the sleeve is positioned between the funnel portion 1015 and the conical portion 1017. In one embodiment, the length of the short straight section 1016 is 5 mm. Thus, in one embodiment, the overall length l of the cannula 1010_tAbout 120 mm. The cannula 1010 has a diameter d at its proximal end₁The first opening 1013. In one embodiment, the diameter d₁Approximately 75 mm. The cannula has a diameter d at its distal end₂ Second opening 1014. In one embodiment, the diameter d₂About 10 mm.

Figure 10C is a schematic view of a (round) tapered braided short sleeve component 1020 in a post-deployment configuration, according to one embodiment of the present invention. In various embodiments, sleeve 1020 is constructed of a wire weave structure having a plurality of nodes 1021, wherein the plurality of nodes are uniform or variable as described with reference to fig. 10A. In one embodiment, the distal portion of the cannula includes a coating 1022. In various embodiments, about 30-60 mm of the distal end is covered with coating 1022. In one embodiment, coating 1022 is silicone. In one embodiment, the staggered nodes are positioned in the distal portion with coating 1022 and covered to eliminate traumatic surfaces. In one embodiment, the overall length/of the sleeve 1020 is about 120 mm. Cannula 1020 has a diameter d at its proximal end₁And first opening 1023. In one embodiment, the diameter d₁Approximately 75 mm. The cannula has a diameter d at its distal end₂ Second opening 1024. In one embodiment, the diameter d₂About 10 mm.

FIG. 10D is a schematic view of the conically braided sleeve member 1020 of FIG. 10C attached to a wire mesh structure 1030 in accordance with one embodiment of the present invention. Referring to fig. 10C and 10D together, diameter D of first opening 1023 of sleeve 1020₁Is sized to be similar to the diameter of the anti-migration loop 1034 of the wire mesh structure 1030. To attach the wire mesh 1030 and sleeve 1020, as indicated by dashed line 1035, the sleeve 1020 is slid over the anti-migration collar 1034 and attached to the anti-migration collar 1034. Since the

sleeves

1000 and 1010 of fig. 10A and 10B, respectively, include first openings having similarly sized diameters, they are attached to the wire mesh structure in the same manner as the sleeve 1020 of fig. 10C. In other words, the

sleeves

1000, 1010 slide over the anti-migration loops of the wire mesh structure.

FIG. 10E is a schematic view of a conically braided short sleeve component 1040 in a post-deployment configuration, according to another embodiment of the invention. Cannula 1040 is similar to cannula 1020 of fig. 10C, except that cannula 1040 has a smaller first opening 1043. Referring to fig. 10E, in various embodiments, sleeve 1040 is formed from a wire having a plurality of nodes 1041A braided structure, wherein the plurality of nodes are uniform or variable, as described with reference to fig. 10A. In one embodiment, the distal portion of the cannula includes a coating 1042. In various embodiments, about 30-60 mm of the distal end is covered with a coating 1042. In one embodiment, coating 1042 is silicone. In one embodiment, the staggered nodes are positioned in the distal portion with coating 1042 and covered to eliminate traumatic surfaces. In one embodiment, the overall length/of sleeve 1040 is about 120 mm. Sleeve 1040 has a diameter d at its proximal end₁ First opening 1043. In one embodiment, the diameter d₁About 30 mm. The cannula has a diameter d at its distal end₂ Second opening 1044. In one embodiment, the diameter d₂About 10 mm.

Fig. 10F is a schematic view of the conically braided short sleeve component 1040 of fig. 10E attached to a wire mesh structure 1050, according to one embodiment of the invention. Referring to fig. 10E and 10F together, the diameter d of the first opening 1043 of the sleeve 1040₁Is sized to be similar to the diameter of the neck 1052 of the anti-migration collar 1054 of the wire mesh structure 1050. The outer diameter of the anti-migration collar 1054 itself is larger than the diameter d₁. Thus, to attach the wire mesh structure 1050 and the sleeve 1040, as indicated by dashed lines 1055, the sleeve 1040 is slid into the anti-migration collar 1054 and attached to the collar neck 1052.

Fig. 10G and 10H are schematic illustrations of conical

braided sleeve components

1060, 1065 with atraumatic

distal tips

1062, 1067 in a post-deployment configuration, according to embodiments of the invention. Referring to fig. 10G and 10H concurrently, the

wires

1061, 1066 of the

cannula parts

1060, 1065 do not extend into the

distal tips

1062, 1067. The

distal tips

1062, 1067 include only a more flexible sleeve layer, such as PTFE, and thereby prevent trauma to the gastrointestinal mucosa. In certain embodiments, the diameter d of the

distal tips

1062, 1067₁About 10cm and a length in the range of 5-15 cm. In certain embodiments, the cannula components shown in fig. 10A-10F each include a non-traumatic distal tip similar to those discussed with reference to fig. 10G and 10H.

Fig. 11A is a schematic cross-sectional view illustrating 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, the wire mesh structure 1103 having a collar 1113 positioned at a distal end thereof. The sleeve 1102 has a cylindrical body with a proximal end attached to the bottom surface of the collar 1103. Fig. 11B is a schematic cross-sectional view illustrating the intragastric device 1100 of fig. 11A in a pre-deployment configuration. As the device 1100 is compressed to its pre-deployment configuration, the body of the sleeve 1102 is pulled over the device 1103 to assist in turning the loops 1113 of the wire mesh structure 1101 outward. The collar 1103 must be folded over so that the device 1100 will have a small enough diameter to fit through a delivery device or catheter. Referring to fig. 11B, as the proximal end of the cannula 1102 is attached to the bottom surface of the collar 1103, when the collar 1103 is folded over, the collar 1103 creates a bulge comprising the thickness 1103 'of the collar and twice the thickness 1102', 1102 "of the cannula.

FIG. 11C is a schematic cross-sectional view illustrating 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, the wire mesh structure 1111 having a loop 1113 positioned at a distal end thereof. The sleeve 1112 has a cylindrical body with a funnel-shaped proximal end attached to a node or free end at the distal end of the collar 1113. The sleeve 1112 is attached to the collar 1113 by a plurality of sutures 1117. Fig. 11D is a cross-sectional schematic view illustrating the intragastric device of fig. 11C in a pre-deployment configuration. As the device 1110 is compressed to its pre-deployment configuration, the body of the sleeve 1112 is pulled over the device 1113 to assist in folding the loop 1113 of the wire mesh structure 1111 outward. Suture 1117 coupling sleeve 1112 to loop 1113 is loosely secured to allow some minimal movement between sleeve 1112 and loop 1113. Thus, as seen in fig. 11D, when the collar 1113 is folded outwardly, the funnel of the sleeve 1112 and the collar 1113 move relative to each other such that the resulting protrusion in the compressed arrangement comprises only the thickness 1113' of the collar. This creates a smaller cross-sectional area or diameter in the compressed device and allows for easier deployment through a delivery device or catheter.

Further, the collar 1113 shown in fig. 11C has a bend (more rounded) that is less pointed (less pointed) than the collar 1103 shown in fig. 11A. A less-cusped bend in the loop will make the loop less traumatic to body tissue and will allow the loop to retain its shape since the loop will have a lower percentage of strain.

Fig. 12A is a schematic view 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, according to one embodiment of the present invention. As seen in fig. 11C and 11D, a node 1205 is positioned at the distal end of the wire mesh structure or distal end of the collar. Referring to fig. 12A, each node 1205 is attached to a sleeve 1202 by a suture 1208. As described with reference to fig. 11C and 11D, the suture is loosely secured to allow some degree of movement of the sleeve 1202 relative to the wire mesh structure.

Fig. 12B is a schematic view 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, according to another embodiment of the present invention. As shown in fig. 12B, only every other node 1215 is attached to the sleeve by sutures 1218. While still fixedly attaching the wire mesh structure to the sleeve 1212, the reduction in the number of sutures 1218 compared to the embodiment shown in fig. 12A results in a device having smaller diameter protrusions in the compressed pre-deployment configuration. Such a compressed device will more easily pass through the delivery device or catheter.

Securing the suture directly to the most distal end of the node may result in: as the suture slides along the wires of each node, excessive movement of the sleeve relative to the wire mesh structure. Fig. 12C is a schematic view 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, according to another embodiment of the invention. Rather than placing sutures at the distal-most end of each node 1225, sutures 1228 are placed near the intersection 1229 of the wires of two adjacent nodes 1225. This prevents the suture from sliding too far along either wire, while still allowing minimal movement of sleeve 1222 relative to the wire mesh structure during compression.

Fig. 12D is a schematic view 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, according to another embodiment of the present invention. As shown in fig. 12D, only every other intersection 1239 of the wires of adjacent nodes 1235 is attached to the cannula by stitches 1238. While still fixedly attaching the wire mesh structure to the sleeve 1232, the reduced number of stitches 1238 compared to the embodiment shown in fig. 12C results in a device with smaller diameter protrusions in the compressed pre-deployment configuration. Such a compressed device will more easily pass through the delivery device or catheter.

Fig. 12E is a schematic view 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 according to another embodiment of the invention. The nodes 1245 are positioned at the distal end of the wire mesh structure or at the distal end of the anti-migration collar and include loops 1245 formed by the wires of the nodes 1246 and extending toward the center of the wire mesh structure. Each loop 1205 of each node 1246 is attached to a sleeve 1248 by a suture 1242.

Fig. 12F is a schematic view 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, according to yet another embodiment of the present invention. Nodes 1255 are positioned at the distal end of the wire mesh structure or at the distal end of the anti-migration collar and include loops 1256 formed by the wires of nodes 1255 and extending toward the center of the wire mesh structure. Each ring 1256 of each node 1255 is attached to a sleeve 1252 by a suture 1258. As shown in fig. 12F, only every other node 1255 is attached to the sleeve by stitches 1258. While still fixedly attaching the wire mesh structure to the sleeve 1252, the reduction in the number of stitches 1258 as compared to the embodiment shown in fig. 12E results in a device having a smaller diameter protrusion in the compressed pre-deployment configuration. Such a compressed device will more easily pass through the delivery device or catheter.

Fig. 13A is a schematic view 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, according to an embodiment of the present invention. As shown in fig. 13A, the intersection 1309 between some adjacent nodes 1305 and the end 1304 of some nodes 1305 are both stitched to the sleeve 1302 by a knot 1308.

In one embodiment, the distal end of the wire mesh structure is connected to the proximal end of the cannula at 9 separate connection points. Each connection point comprises an 8-shaped knot additionally fixed by glue and a heat shrinkable tube. In one embodiment, each knot is an Ultra High Molecular Weight Polyethylene (UHMWPE) braided suture having a break strength of 30lb (pounds) to provide a reliable connection between the wire mesh and the cannula. Fig. 13B is a schematic illustration of the distal end of the wire mesh structure 1320 and the attached proximal end of the funnel-shaped sleeve covered with a heat shrink tube 1326 according to one embodiment of the present invention.

Fig. 14 is a schematic illustration of an intragastric device 1400 with a funnel-shaped sleeve 1410 in a post-deployment configuration according to one embodiment of the present invention. The intragastric device 1400 includes a wire mesh structure 1405, a wire mesh structure 1420 having a proximal end and a distal end with an anti-migration loop 1520 formed at the distal end. The cannula 1410 includes a proximal end and a distal end and is attached by its proximal end to an anti-migration collar 1420.

The wire mesh structure 1405 includes at least one metal wire folded over upon itself to create a criss-cross weave pattern along the structure through a plurality of free curvilinear ends or nodes. In the expanded deployed configuration of the wire mesh structure 1405, the wire mesh structure 1405 has an ovoid shape. To facilitate optimal expansion and compression for easier delivery and removal, the wire mesh structure 1405 includes a plurality of alternating

nodes

1406, 1407, 1408, 1409 along the length. A first set of staggered nodes 1406 is located at the proximal end of the wire mesh structure 1405 and surrounds the first opening 1401. In one embodiment, each node in the first set of staggered nodes 1406 is bent upward to extend in a direction opposite to the interior of the wire mesh structure 1405. During removal of the intragastric device 1400, each node of the first set of staggered nodes 1406 serves as a grasping point for a retrieval device. The wire mesh structure 1405 includes a second set of interleaved nodes 1407, the second set of interleaved nodes 1407 being distal to the first set of interleaved nodes 1406 and proximal to a midpoint of the wire mesh structure 1405. A third set of staggered nodes 1408 is distal to the midpoint and proximal to the distal end of the wire mesh structure 1405. A fourth set of staggered nodes 1409 is located at the distal end of the wire mesh structure 1405 and includes the free end of the anti-migration component 1420. All curves, including nodes in each set of interleaved

nodes

1406, 1407, 1408, 1409, are designed to have a curvature that prevents trauma to body tissue. As the structure is compressed to its pre-deployment configuration, the nodes are staggered to prevent bunching of the bending points of the wires and bulging of the wire mesh structure, spreading the nodes apart along the wire mesh structure allowing the device to have an overall smaller diameter once the device is compressed.

The cannula 1410 includes a proximal portion 1411 and a distal portion 1416, the distal portion 1415 joining the proximal portion 1511 at a transition point 1515 along the body of the cannula 1410. Both the proximal and

distal portions

1411, 1416 of the cannula 1410 are funnel shaped and each have 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 1411 at the proximal end of the proximal portion 1420. As the proximal portion 1411 extends distally until the cannula 1411 transitions to its distal portion 1410, the diameter of the proximal portion 1416 decreases, at which point the proximal and

distal portions

1411, 1416 are equal in diameter. The diameter of the distal portion 1416 then decreases as the distal portion 1416 extends distally. Distal portion 1410 of sleeve 1416 terminates at a second opening 1419 at the distal end of intragastric device 1400. In one embodiment, the length of the proximal portion 1411 is less than the length of the distal portion 1416. In various embodiments, funnel-shaped sleeve 1410 includes at least one wire support. In certain embodiments, the at least one wire support comprises the same wire located in both the proximal portion 1411 and the distal portion 1416. In other embodiments, the proximal portion 1411 and the 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 wires are folded over on themselves to create a cross-weave pattern in the sleeve 1410. In both the proximal and

distal portions

1411, 1416, as the

portions

1411, 1416 extend distally and the funnel shape narrows, the respective intersecting sections of the wires become closer to each other such that the weave pattern becomes tighter at the distal ends of the

portions

1411, 1416. The sleeve 1410 includes curved or free ends at its proximal and distal ends similar to the nodes of the wire mesh structure 1405. The free end is designed to prevent trauma to body tissue. The free end at the proximal end of the sleeve 1410 is attached to each node of a fourth set of staggered nodes 1422 of the wire mesh structure 1405 by one or more stitches 1409. The free end at the distal end of the sleeve 1410 surrounds the second opening 1419. In various embodiments, the cannula 1410 is a short cannula having an overall length in the range of 5 cm-120 cm. In one embodiment, the cannula 1410 is a short cannula having a total length of 60 cm. In one embodiment, the cannula 1410 includes a soft, non-traumatic tip 1430 at its distal end. The tip 1430 contains no wire and the tip 1530 is included to prevent damage to the intestinal mucosa by 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 slides over at least a portion of the anti-migration component 1420 and covers at least a portion of the anti-migration component 1420 such that the proximal portion 1411 of the sleeve 1410 covers the 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 the interior of the sleeve 1410 and establishes a food path from the first opening 1401 into the interior of the wire mesh structure 1405 and out of the second opening 1419 through the interior of the sleeve 1410.

Fig. 15 is a schematic view of an intragastric device 1500 with a cylindrical sleeve 1510 in a post-deployment configuration, in accordance with an embodiment of the present invention. The intragastric device 1500 includes a wire mesh structure 1505, the wire mesh structure 1505 having a proximal end and a distal end with an anti-migration loop 1520 formed at the distal end. The sleeve 1510 includes a proximal end and a distal end and is attached by its proximal end to an anti-migration collar 1520. In one embodiment, the cannula 1510 includes a soft atraumatic tip 1530 at its distal end. The tip 1530 does not contain a wire and the tip 1530 is included to prevent damage to the intestinal mucosa by the cannula tip.

The wire mesh structure 1505 is similar to the structure 1405 discussed with reference to fig. 14, including an oval shape with a cross-weave pattern, a plurality of

staggered nodes

1506, 1507, 1508, 1509, and a first opening 1501 at a proximal end thereof. All curves, including nodes in each set of

staggered nodes

1506, 1507, 1508, 1509, are designed to have a curvature that prevents trauma to the body tissue.

The cannula 1510 includes a proximal portion 1511 and a distal portion 1516, the distal portion 1516 joining the proximal portion 1511 at a transition point 1515 along the body of the cannula 1510. 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 the proximal end of the proximal portion 1511. As the proximal portion 1511 extends distally until the sleeve 1510 transitions to its distal portion 1516, the diameter of the proximal portion 1511 decreases, at which point the proximal portion 1511 and distal portion 1516 are equal in diameter. The diameter of distal portion 1516 then remains the same size as the distal portion 1516 extends distally, giving distal portion 1516 a substantially cylindrical shape. Distal portion 1516 of sleeve 1510 terminates in a second opening 1519 at the distal end of intragastric device 1500. In one embodiment, the length of the proximal portion 1511 is less than the 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 wires are folded over on themselves to create a cross weave pattern in the sleeve 1510. As the portion 1511 extends distally and the funnel shape narrows, the intersecting sections of the wires become closer to each other so 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 uniform pitch such that the resulting helically braided structure has a uniform pattern along the length of the distal portion 1516 of the cannula 1510. In certain embodiments, the helical wire support of the distal portion 1516 is an extension of at least one wire support of the proximal portion 1511. In other embodiments, the proximal portion 1511 and the distal portion 1516 comprise separate wire supports, and the wires are joined together at the distal end of the proximal portion 1511 and the proximal end of the distal portion 1516. In one embodiment, the separate wires are spot welded together. The sleeve 1510 includes a curved or free end at its proximal and distal ends similar to the nodes of the wire mesh structure 1505. The free end is designed to prevent trauma to body tissue. The free end at the proximal end of the sleeve 1510 is attached to each node of a fourth set of staggered nodes 1509 of the wire mesh structure 1505 by one or more sutures 1522. The free end at the distal end of the sleeve 1510 surrounds the second opening 1519. In various embodiments, sleeve 1510 is a short sleeve having an overall length in the range of 5 cm-120 cm. In one embodiment, sleeve 1510 is a short sleeve having an overall length of 60 cm. The funnel-shaped conical section may vary from 1% of the total length of the cannula to 100% of the total length of the cannula.

When the sleeve 1510 is attached to the wire mesh structure 1505, the proximal end of the proximal portion 1511 of the sleeve 1510 slides over the anti-migration component 1520 such that the proximal portion 1511 of the sleeve 1510 covers the 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 the interior of the sleeve 1510, and establishes a food path from the first opening 1501 into the interior of the wire mesh structure 1505 and out of the second opening 1519 through the interior of the sleeve 1510.

Fig. 16A is a close-up schematic view of a funnel-shaped sleeve 1602 attached to an anti-migration collar 1604 of a wire mesh structure 1604 of an intragastric device 1600 in accordance with one embodiment of the present invention. The sleeve 1602 is attached to an anti-migration collar 1604 by a plurality of sutures 1608.

Fig. 16B is a close-up schematic view of the anti-migration collar 1614 of the funnel-shaped sleeve 1612 attached to the wire mesh 1615 of the intragastric device 1610, according to another embodiment of the invention. The cannula 1612, which is attached to the anti-migration collar 1614 by a plurality of sutures 1618, includes a plurality of ravel edges 1611 at its proximal end to make the edges less traumatic to body tissue.

Fig. 16C is a schematic view of an intragastric device 1620, the intragastric device 1620 comprising a wire mesh 1625 and an attached sleeve 1622, according to one embodiment of the present invention. Wire mesh 1625 is non-anchored and includes non-traumatic wire ends. In one embodiment, wire mesh structure 1625 is comprised of nitinol. The wire mesh structure 1625 includes an anti-migration collar 1624, and a sleeve 1622 is attached to the collar 1624. Referring to fig. 16E, in some embodiments, the wire mesh structure 1625 includes a retrieval string near its proximal end. The sleeve 1622 includes a non-anchored and impermeable fluoropolymer liner designed to extend into the proximal portion of the small intestine, particularly the middle duodenum. In various embodiments, the sleeve 1622 comprises a nitinol stent structure embedded within a polymer layer such that the sleeve 1622 is atraumatic and no portion of the nitinol is in contact with the small intestine. In one embodiment, the cannula 1622 includes radiopaque markers to assist in proper delivery and placement.

Wire mesh 1625 is non-anchored and occupies some space within the stomach. The wire mesh 1625 is free floating within the stomach and intermittently exerts a gentle and non-traumatic stretching force on a portion of the stomach as the wire mesh 1625 contacts the inner stomach wall. This stretching force causes satiety in the patient. The anti-migration collar 1624 is suitably shaped to receive the attached cannula 1622. Gastric contents enter the wire mesh 1625 through a first opening 1621 at the proximal end of the wire mesh 1625 or through openings 1629 between the wires of the wire mesh 1625 and are directed to the attached sleeve 1622. The stomach contents then pass through the sleeve 1622 and exit through a second opening 1623 at the distal end of the sleeve 1622, entering the duodenum or jejunum depending on the length of the sleeve 1622. The sleeve 1622 is pre-attached to an anti-migration collar 1624 of a wire mesh structure 1625. The nitinol stent structure embedded in the sleeve 1622 provides support for the sleeve 1622 and prevents the sleeve 1622 from twisting or kinking (buckling) by the action of the intestinal musculature. Additionally, the nitinol stent structure provides gentle radial tension on the small intestine wall, thereby causing satiety in the patient and impeding the passage of chyme around the sleeve 1622.

FIG. 16D is a schematic view of the intragastric device 1620 of FIG. 16C, wherein the sleeve 1622 is straight to show the dimensions of the device 1620 relative to the surrounding anatomy. The sleeve 1622 includes a funnel-shaped or conical proximal portion 1622p attached to an anti-migration collar of a wire mesh structure and a cylindrical portion 1622d extending distally from the proximal portion 1622 p. The wire mesh 1625 and the proximal portion 1622p of the sleeve 1622 are configured to reside in the patient's stomach, and together have a maximum outer diameter of about 8 inches and a length l₁. In certain embodiments, the length l₁About 10 inches. In certain embodiments, the fully deployed wire mesh structure 1625 has a capacity of about 1 liter. The proximal portion 1622p of the cannula 1622 and the distal portion 1622d of the cannula 1622 contact at a junction 1622j, the junction 1622j configured to seat at a pylorus of a patient. The distal portion 1622d of the cannula 1622 is configured to reside in the small intestine, and particularly the duodenum, of a patient and has a maximum outer diameter of about 1.0 inch and a length l₂. In certain embodiments, the length l₂About 10 to 25 inches. In some embodiments, the length l of the distal portion 1622d₂Such that the distal end of the sleeve 1622 is positioned in the duodenum, the stomach contents pass from the stomach, through the device 1620, and directly into the duodenum, thereby bypassing the pylorus. In other embodiments, the length l₂Designed so that the distal end of the sleeve 1622 is positioned in the jejunum, the stomach contents pass from the stomach, through the device 1620, and directly into the jejunum, thereby bypassing the pylorus and duodenum. In other embodiments, the wire mesh structure has a maximum diameter of 18 inches, a maximum length of 24 inches, and a maximum capacity of 2.5 liters.

Fig. 16E is a schematic view of the wire mesh 1635 and sleeve 1632 of the intragastric device 1630 showing the

retrieval pull cords

1637, 1638 on the wire mesh 1635 in accordance with one embodiment of the invention. The cannula 1632 is attached to an anti-migration collar 1635 located at the distal end of the wire mesh structure 1634. In certain embodiments, the anti-migration collar 1634 comprises loops in the node wire at the distal ends of the nodes as seen with reference to fig. 4C, and the sleeve 1634 is sutured to the anti-migration collar 1632 at these loops. In the illustrated embodiment, a pair of

retraction pull cords

1637, 1638 are located on the wire structure 1635 near the proximal end. The first pull cord 1637 is positioned at the proximal end of the wire mesh structure 1635 and the second pull cord 1638 is positioned distal to the first pull cord 1637 but still near the proximal end of the wire mesh structure 1635. The

withdrawal cords

1637, 1638 are drawn through the openings between the wires of the wire mesh 1635. During retraction, the wire mesh 1635 may be removed endoscopically from the patient by pulling the free ends of the

retraction cords

1637, 1638 using the graspers to tighten the wire mesh 1635 to a smaller outer diameter. In one embodiment, the two

pull cords

1637, 1638 are operably connected to each other such that tightening one pull cord causes the other pull cord to be tightened simultaneously.

Fig. 16F is a schematic view of a wire mesh 1645 and a sleeve 1642 of an intragastric device 1640 according to an embodiment of the invention, showing a single retrieval pull-cord 1648 on said wire mesh 1645. The sleeve 1642 is attached to an anti-migration collar 1644 at the distal end of the wire mesh structure 1645. In certain embodiments, the anti-migration loop 1644 comprises loops in the node wire at the distal end of the node as seen with reference to fig. 4C, and the sleeve 1642 is stitched to the anti-migration loop 1644 at these loops. In the illustrated embodiment, a single retraction cord 1648 is located on the wire structure 1645 near the proximal end. The withdrawal string 1648 is passed through the openings between the wires of the wire mesh structure 1645. During retraction, the wire mesh 1645 can be removed from the patient endoscopically by pulling the free end of the retraction cord 1648 using the grasper to tighten the wire mesh 1645 to a smaller outer diameter. In the illustrated embodiment, a single draw cord 1648 is sufficient to tighten the two sets of the plurality of

nodes

1647, 1649 on the wire mesh structure 1645, wherein the first set of the plurality of nodes 1647 is located at a proximal end of the wire mesh structure 1645 and the second set of the plurality of nodes 1649 is located at an elevation (level) of the draw cord 1648. In other embodiments, a single pull cord is sufficient to tighten one or more than two pluralities of nodes on the wire mesh structure.

In certain embodiments where the cannula comprises a metal wire support, the end of the or each wire is designed to prevent trauma to body tissue. In various embodiments, the wire ends are blunt and are folded over the wire or welded to other wire ends. In other embodiments, the distal end of the cannula includes a feature designed such that the distal end prevents trauma to body tissue. Fig. 17A is a cross-sectional schematic view of the distal end of the cannula 1705 showing one embodiment of a feature 1710 designed to configure the distal end to prevent trauma to body tissue. The member 1710 has a cylindrical shape and has a proximal end 1711, a distal end 1719, and a lumen 1716 therein. The member 1710 is open at both ends 1711, 1719. The lumen 1710 of the member 1716 is in fluid communication with the lumen 1706 of the sleeve 1705 to allow food to pass through the wire mesh, sleeve 1705 and member 1710 of the device. The distal end 1719 is rounded to a blunt shape that prevents trauma to body tissue. The outer surface of the component 1710 includes a groove 1713, the groove 1714 configured to receive a circular member or O-ring 1734. To attach the member 1710 to the sleeve 1705, the distal end of the sleeve 1705 is coaxially slid onto the proximal end 1710 of the member 1711 such that a portion of the sleeve 1705 is positioned over the slot 1713. Next, an O-ring 1714 is placed over the sleeve 1705 and into the slot 1713, thereby providing a secure connection of the sleeve 1705 to the component 1710. The distal sleeve end 1707 is then folded back in a proximal direction towards the body of the sleeve 1705. In one embodiment, the member 1710 includes a circular flange 1712, the circular flange 1712 extending outwardly from an outer surface of the member 1710 and then extending in a proximal direction. The flange 1712 functions to cover any pointed ends present in the folded over distal cannula end 1707 and thereby protect the body from trauma. In various embodiments, the length of the member 1710 is in the range of 5mm to 500mm, the outer diameter is in the range of 3mm to 30mm, and the inner diameter is in the range of 0.5 to 50 mm.

Fig. 17B is a cross-sectional schematic view of the distal end of the cannula 1705 showing another embodiment of a member 1720, the member 1720 designed to configure the distal end to prevent trauma to body tissue. The member 1720 has a cylindrical shape and has a proximal end 1721, a distal end 1729 and a lumen 1726 therein. Member 1720 is open at both ends 1721, 1729. The lumen 1720 of the member 1726 is in fluid communication with the lumen 1706 of the sleeve 1705 to allow food to pass through the wire mesh, the sleeve 1705, and the member 1720 of the device. The distal end 1729 is rounded to a blunt shape that prevents trauma to body tissue. The outer surface of component 1720 includes a groove 1723, the groove 1724 configured to receive a circular member or O-ring 1734. To attach the member 1720 to the sleeve 1705, the distal end of the sleeve 1705 is slid coaxially over the proximal end 1720 of the member 1721 such that a portion of the sleeve 1705 is positioned over the slot 1723. An O-ring 1724 is placed over the sleeve 1705 and into the groove 1723. The distal sleeve end is then folded back in a proximal direction towards the body of the sleeve 1705. Next, a heat shrink tube 1725 is placed over the distal sleeve end and the O-ring 1724. Heat is applied to the heat shrink tube 1725 to shrink the tube 1725 such that the tube 1725 fixedly connects the sleeve 1705 to the component 1720. Any of the distal sleeve ends are contained under the heat shrink tube 1725 without exposure to body tissue.

Fig. 17C is a cross-sectional schematic view of the distal end of the cannula 1705 showing another embodiment of a component 1730, the component 1730 being designed to configure the distal end to prevent trauma to body tissue. The component 1730 has a cylindrical shape with a proximal end 1731, a distal end 1739, and a lumen 1736 therein. The component 1730 is open at both ends 1731, 1739. The lumen 1736 of the member 1730 is in fluid communication with the lumen 1706 of the sleeve 1705 to allow food to pass through the wire mesh of the device, the sleeve 1705 and the member 1730. Distal end 1739 is rounded to a blunt shape that prevents trauma to body tissue. The outer surface of the component 1730 includes a groove 1733, the groove 1733 configured to receive a circular member or O-ring 1734. To attach the member 1730 to the sleeve 1705, the sleeve 1705 is first everted inside out. The distal end of the sleeve 1705 is then slid coaxially over the distal end 1739 of the member 1730 so that a portion of the sleeve 1705 is positioned over the slot 1733. An O-ring 1734 is placed over the sleeve 1705 and into the groove 1733. The cannula 1705 is then folded back in a proximal direction over the O-ring 1734 and the proximal end 1731 of the component 1730, thereby providing a secure connection of the cannula 1705 to the component 1730. This process of connecting the sleeve 1705 to the member 1730 ensures that the distal sleeve end 1707 will be positioned within the sleeve lumen 1706. Any of the distal sleeve ends 1707 are contained within the sleeve lumen 1706 without exposure to body tissue.

Fig. 18 is a schematic illustration of the distal end of cannula 1805 with an attached positioning tail 1810, according to an embodiment of the present invention. A positioning tail 1810 is attached to the distal end of short cannula 1805, short cannula 1805 having a length of 5mm to 500 mm. The positioning tail 1810 includes a strip of material that extends from the distal end of the sleeve 1805 into the patient's duodenum and serves to help maintain the sleeve 1805 in a proper implanted orientation with respect to the patient's pylorus. In various embodiments, the length/of the positioning tail 1810 is in the range of 5mm to 500 mm. In one embodiment, the length/of the positioning tail 1810 is about 25 mm. In one embodiment, the distal end of the positioning tail 1810 includes a ball 1815 for weighting the distal end. In another embodiment, the distal end of the positioning tail 1810 includes a plurality of separate free ends similar to a ponytail. In other embodiments, positioning the distal end of the tail includes any mechanism or component designed to provide additional weight or drag to the distal end to allow the tail to be pulled to ensure proper cannula orientation. In one embodiment, the distal end of the positioning tail does not include any additional components.

Fig. 19A is a schematic illustration of the distal end of a cannula 1905 including a plurality of tassel edges 1907 coupled to an annulus 1908, according to one embodiment of the invention. In various embodiments, the distal end of the cannula 1905 includes two or more tassel edges 1907. In one embodiment, the distal end of the cannula 1905 includes four ear edges 1907. Each fringe 1907 includes a portion of the sleeve material that is separated from an adjacent fringe 1907. The ear edges 1907 are separated from one another by a space 1906 that allows food passing through the intragastric device to exit from the sleeve 1905. In various embodiments, each ear edge 1907 has a length in the range of 5mm to 500mm and a width in the range of 1mm to 15 mm. In certain embodiments, the width of each ear edge 1907 decreases as the ear edge 1907 extends distally. The ear rim 1907 is connected to the ring 1908 at the distal-most end of the sleeve 1905. The ring 1908 includes a central opening 1909 that serves as a food passage. In certain embodiments, ring 1908 is semi-rigid. In various embodiments, the outer diameter of ring 1908 is in the range of 1mm to 30mm, and the inner diameter is in the range of 1mm to 30 mm. In various embodiments, ring 1908 is attached to each ear edge 1907 by stitching, gluing, bonding, or any other means of attachment. The ring 1908 acts to link the ear edges 1907 together and weigh the distal end of the cannula 1905 to aid in proper device orientation. The surface of ring 1908 is passivated to prevent trauma to body tissue. In certain embodiments, the fringe 1907 and the ring 1908 are parachute-shaped.

Fig. 19B is a schematic illustration of the distal end of a cannula 1910 including a plurality of tassel edges 1912 attached to a bulb 1913 according to one embodiment of the present invention. In various embodiments, the distal end of the cannula 1910 includes two or more fringe edges 1912. In one embodiment, the distal end of the cannula 1910 includes four ear edges 1912. Each rim 1912 includes a portion of the sleeve material separated from an adjacent rim 1912. The ear rims 1912 are separated from one another by a space 1911 that allows food passing through the intragastric device to exit from the sleeve 1910. In various embodiments, each fringe edge 1912 has a length in the range of 5mm to 500mm and a width in the range of 1mm to 15 mm. In certain embodiments, the width of each ear edge 1912 decreases as the ear edge 1912 extends distally. The ear rim 1912 is attached to the bulb 1913 at the distal most end of the sleeve 1910. In various embodiments, the diameter of bulb 1913 is in the range of 2mm to 30 mm. In various embodiments, the bulb 1913 is glued or bonded to each ear rim 1907. Bulb 1913 acts to tie ear rim 1912 together and weigh the distal end of sleeve 1910 to aid in proper device orientation. Since bulb 1913 has a spherical shape, bulb 1913 does not have a pointed edge and prevents trauma to body tissue. In another embodiment, the distal-most ends of the fringe rim 1912 are tied together as a knot to form the bulb 1913 without the need for additional spherical components. In certain embodiments, the fringe 1912 and bulb 1913 are parachute-shaped.

In one embodiment, as seen in fig. 19C, bulb 1913 includes a lumen 1933 to allow a guide wire to pass therethrough. In another embodiment, bulb 1913 has a groove or recess 1932 to receive an internally pushed catheter or plunger of a delivery device. In one embodiment, the circumference of the bulb is designed to be positioned inside the outer catheter of the delivery device.

FIG. 19D is a schematic illustration of the distal end of the sleeve 1915 with a plurality of sutures 1917 extending from the distal end of the sleeve 1915 and attached to the bulb 1918, according to one embodiment of the invention. In various embodiments, the cannula 1915 includes two or more sutures 1917. In one embodiment, the sleeve 1915 includes six sutures 1917. In various embodiments, the length of the suture 1917 is in a range of 5mm to 500 mm. In one embodiment, the suture 1917 is constructed of nylon. The proximal end of each suture 1917 is attached to the distal end of the sleeve 1915, and the distal end of each suture 1917 is attached to the bulb 1918. In various embodiments, a bulb 1918 is glued to each suture 1917. In various embodiments, the bulb has a diameter in the range of 3mm to 30 mm. The bulb 1918 is designed to add weight to the distal end of the cannula 1915 to pull the cannula 1915 to the proper implantation orientation. Since bulb 1918 has a spherical shape, bulb 1913 does not have a pointed edge and prevents trauma to body tissue. Food exits the distal end of the cannula 1915 and passes through the spaces 1916 between the sutures 1917. In one embodiment, the bulb 1918 includes a central opening 1919 for guiding a wire therethrough. In various embodiments, the bulb 1918 is replaced with a ring or similarly designed component to weigh the sleeve 1915 and ensure proper device orientation. In certain embodiments, the suture 1917 and bulb 1918 are parachute-shaped.

Fig. 19E is a schematic representation of the distal end of a cannula 1920 having at least one suture 1922 with an attached suture loop or ball 1923 extending therefrom in accordance with one embodiment of the present invention. In one embodiment, the sleeve 1920 includes six sutures 1922. In various embodiments, the length of the stitches 1922 is in the range of 5mm to 500 mm. In one embodiment, the stitches 1922 are constructed of UHMWPE. The proximal end of each suture 1922 is attached to the distal end of the sleeve 1920, and the distal end of each suture 1922 includes an attached suture loop or ball 1923. The suture loop or ball 1923 is designed to add weight to the distal end of the cannula 1920 to pull the cannula 1920 to the proper orientation for implantation. Because each suture loop or ball 1923 has a spherical shape, the suture loops or balls 1923 do not have sharp edges and prevent trauma to body tissue.

Fig. 20A is a schematic view of the distal end of a sleeve 2005 showing at least one fold 2007 in the sleeve wall 2006, according to one embodiment of the invention. In one embodiment, the sleeve 2005 includes three folds 2007 in its wall 2006. The fold 2007 is created along the longitudinal axis of the sleeve 2005. In various embodiments, the folds 2007 are positioned equidistant from each other. Referring to fig. 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 heat fused together. The folding of the sleeve wall 2006 creates a pleating effect, which adds structure and stability to the sleeve 2005. The added structure helps to keep the sleeve 2005 in the proper orientation relative to the patient's pylorus and helps to prevent deformation of the sleeve 2005 due to patient's gastrointestinal tract actions.

Fig. 20B is a schematic view of the distal end of cannula 2010, showing at least one channel 2012 in cannula wall 2011 and support structure 2013, in accordance with an embodiment of the present invention. In one embodiment, the cannula 2010 includes four channels 2012 in its wall 2011, and each channel 2012 includes a support structure 2013 therein. In various embodiments, the support structures 2013 comprise tubes or balls. In various embodiments, support structure 2013 is sized to fit snugly within channel 2012. The channel 2012 extends along a longitudinal axis of the cannula 2010. In one embodiment, channel 2012 extends the entire length of cannula 2010. In other embodiments, the channel extends along only a portion of the distal end of the cannula 2010. In various embodiments, the channels 2012 are positioned equidistant from each other. Including channels 2012 and support structures 2013 adds structure and stability to the cannula 2010. The added structure helps to keep cannula 2010 in the proper orientation relative to the patient's pylorus and helps to prevent cannula 2010 from deforming due to the action of the patient's gastrointestinal tract. In one embodiment, channel 2012 is a hollow channel, and channel 2012 may be filled or inflated with a fluid, such as water or air, to provide rigidity and/or structure to cannula 2010.

Fig. 20C is a schematic view of a portion of a casing 2015 according to an embodiment of the invention, showing corrugated casing walls. 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 constructed of fluoropolymer or Polyethylene (PE). Referring to fig. 20C, in one embodiment, the corrugated portion of the sleeve 2015 is cylindrical and includes a uniform 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 to prevent trauma to body tissue. The corrugated structure helps to keep the sleeve 2015 in a proper orientation relative to the patient's pylorus and helps to prevent the sleeve 2015 from deforming due to the patient's gastrointestinal tract actions.

Fig. 20D is a schematic view of a portion of a sleeve 2020, showing a woven (knitted) sleeve wall, according to an embodiment of the invention. The cannula 2020 includes a woven wire pattern 2021 extending along its length. In one embodiment, the entire sleeve 2020 is woven. In other embodiments, only certain portions of the cannula 2020, such as the distal end, are woven. Referring to fig. 20D, in one embodiment, the woven portion of the sleeve 2020 is cylindrical and includes a uniform diameter along its entire length. In various embodiments, the diameter of cannula 2020 is in the range of 1 cm-10 cm. In one embodiment, the cannula is 25mm in diameter and 500mm in length. In another embodiment, the woven 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 woven cannula 2020 is configured to be soft, rounded, and to prevent trauma to body tissue. The woven structure helps to maintain the sleeve 2020 in a proper orientation with respect to the pylorus of the patient and helps to resist deformation of the sleeve 2020 due to gastrointestinal activity of the patient. The woven structure provides structural integrity to the cannula 2020 and prevents the cannula 2020 from becoming kinked, twisted or occluded. In various embodiments, the sleeve 2020 has a radial force that is large enough to resist deformation due to peristalsis of the gastrointestinal tract, but small enough that the sleeve 2020 can be compressed to allow food to pass through the sleeve 2020. In addition, the radial force is small enough that the cannula is not too rigid to cause trauma to the gastrointestinal tract, including abrasion. In one embodiment, the woven structure of the sleeve 2020 acts like a stent, thereby keeping the sleeve 2020 properly positioned in the patient's small intestine.

Fig. 20E is a schematic view of a portion of a sleeve 2025 according to one embodiment of the present invention, showing the woven sleeve wall and the distal sleeve end with a ravel edge 2028. The sleeve 2025 includes a woven wire pattern 2026 extending along its length. The ravel edge 2028 at the distal end of the cannula 2025 is less likely to cause trauma to body tissue.

Fig. 20F is a schematic illustration of exemplary

sleeve weave patterns

2031, 2032, 2033, 2034, 2035, 2036, 2037, according to various embodiments of the invention.

Fig. 21A is a schematic illustration of an intragastric device 2130 having an ovoid wire mesh 2131 deployed within the gastrointestinal tract of a patient, in accordance with one embodiment of the present invention. In the illustrated embodiment, the device 2130 includes a wire mesh structure 2131 with an anti-migration collar 2134 and an attached sleeve 2132. The device 2130 is deployed such that the wire mesh structure 2131 is left within the stomach 2160 and the anti-migration collar 2134 is positioned just proximal of the pylorus 2161, while the cannula 2132 extends through the pylorus 2161 into the duodenum 2170. The distal end of the sleeve 2132 remains within the duodenum 2170. The anti-migration collar prevents bulk migration of the device 2130 through the pylorus 2161 into the duodenum 2170. The device 2130 occupies a volume of the stomach 2160, does not move bodily past the pylorus 2161, and provides a bypass for food passing through the pylorus 2161 and a portion of the duodenum 2170. In various embodiments, sleeve 2132 is a short sleeve having a length in the range of 5cm to 120 cm. In one embodiment, sleeve 2132 is a short sleeve having a total length of 60 cm. In certain embodiments, the short sleeve 2132 acts to weigh the wire mesh structure 2131 and orient the wire mesh structure 2131 in the correct direction toward the pylorus 2161. Further, in one embodiment, the device 2130 with the short cannula 2132 is free to move within the patient's stomach 2160 after deployment. The short sleeve 2131 can pass back and forth through the pylorus 2161 atraumatically. The short sleeve also serves to obstruct and regulate food flow into the pylorus 2161 during situations when the device 2130 has been moved such that the short sleeve 2132 is not positioned within the pylorus 2161 and duodenum 2170, but is positioned within the stomach 2160 along with the remainder of the device 2130. 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, wherein the progression of the food is slowed as it passes through the funnel-shaped sleeve 2132. The device is never fixedly or permanently anchored to the wall of the gastrointestinal tract during reasonable functioning of the device. After deployment, at least a portion of the device, or the entire device, is free to move relative to the stomach or small intestine for a majority of the duration of the device's action. Due to the lumen contained by the device, during its normal function, the device never completely or permanently blocks the passage of gastric contents into the small intestine for any clinically meaningful period of time. Based on the shape of the cannula, in various embodiments, the device may increase gastric emptying, decrease gastric emptying, or have no effect on gastric emptying.

Fig. 21B is a schematic view of an intragastric device 2140 having an ovoid wire mesh structure 2141 deployed within a patient's gastrointestinal tract, in accordance with another embodiment of the present invention. The wire mesh structure 2141 is positioned within the patient's stomach 2160 and includes an anti-migration collar 2144, and a cannula 2142 is attached to the collar 2144. The sleeve 2142 includes a proximal funnel portion 2142p, the proximal funnel portion 2142p residing within the stomach and just proximal to the pylorus 2161. The sleeve 2142 further includes a distal cylindrical portion 2142d, the distal cylindrical portion 2142d passing through the pylorus 2161 and duodenum 2170 and terminating in the jejunum 2172 where the distal cylindrical portion 2142d releases gastric contents passing through the gastric device 2140, effectively bypassing the pylorus 2161 and duodenum 2170. In another embodiment, the sleeve has a shorter length and terminates in the duodenum such that stomach contents passing through the intragastric device bypass only the pylorus and the proximal portion of the duodenum. The device is never fixedly or permanently anchored to the wall of the gastrointestinal tract during reasonable functioning of the device. After deployment, at least a portion of the device, or the entire device, is free to move relative to the stomach or small intestine for a majority of the duration of the device's action. Due to the lumen contained by the device, during its normal function, the device never completely or permanently blocks the passage of gastric contents into the small intestine for any clinically meaningful period of time. Based on the shape of the cannula, in various embodiments, the device may increase gastric emptying, decrease gastric emptying, or have no effect on gastric emptying.

Fig. 21C is a plurality of

schematic views

2121, 2122, 2123, 2124 of a patient's pylorus 2125 in an open state and in a closed state, with and without a sleeve 2126 of an intragastric device passing therethrough, according to some embodiments of the invention. In view 2121, the pylorus 2125 is closed and no sleeve extends therethrough. View 2122 shows the pylorus 2125 closed, with the sleeve 2126 extending therethrough.

Views

2123 and 2124 show the partially and fully opened pylorus 2125, respectively, both having a sleeve 2126 extending therethrough. In various embodiments, the sleeve 2126 includes a collapsible tubular reinforcement membrane opposite the intra-pyloric intraoral diameter wall. In various embodiments, the maximum inner diameter of the sleeve 2126 is in the range of 25 mm-40 mm, and the wall thickness is about 0.2 mm. Any membrane that passes through the pylorus, such as the sleeve 2126, will have a negligible but limited cross-sectional area. In various embodiments, the cross-sectional area of the sleeve 2126 is about 15mm²This equates to a plug of approximately 4.4mm diameter. In other words, when the sleeve 2126 passes through the pyloric opening, the dynamic cross-sectional area of the pyloric opening will always be reduced by about 15mm²。

Fig. 22 is a schematic view of an expanded wire mesh structure 2201 of a first intragastric device 2200 in a post-deployment configuration and a tightened wire mesh structure 2221 of a second intragastric device 2220 coupled to a distal end of an implant catheter 2250 in accordance with an embodiment of the present invention. The second intragastric device 2220 also includes a sleeve 2222 coupled to the distal end of the wire mesh structure 2221. The wire mesh 2221 and sleeve 2222 of the second intragastric device 2220 have been compressed and slid coaxially onto the distal end of the implant catheter 2250. In the illustrated embodiment, the wire mesh 2221 and the sleeve 2222 are held in their compressed configurations by a suture or wire 2225, which has been wrapped around both the wire mesh 2221 and the sleeve 2225. Once the device 2220 has been positioned in the patient's stomach and duodenum, the suture or wire 2225 is unwound and the wire mesh 2221 and sleeve 2222 are expanded to their deployed configurations. As the device 2220 is expanded, the device 2220 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 on the implantation catheter by an overlying coaxial sheath. Once deployed, the sheath is unwrapped, pulled away, or torn in a vertical direction to release the device.

Fig. 23 is a schematic view 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 invention. The device 2300 also includes a coupled sleeve 2302 and an anti-migration member 2304. In the illustrated embodiment, the proximal end of the wire mesh structure 2301 is still cinched by a suture or wire 2340. As the cinched suture or wire has been removed from these components, the sleeve 2302, the anti-migration component 2304, and a portion of the wire mesh structure 2301 have begun to expand.

Fig. 24A is a schematic view of a first exemplary delivery device 2450 for an intragastric device 2400 according to an embodiment of the present invention. The intragastric device 2402, including the compressed wire mesh 2400 and the sleeve 2401, is positioned coaxially around the distal end of the delivery device or catheter 2450. A suture or wire 2440 is wrapped around the intragastric device 2400, thereby maintaining the intragastric device 2400 in its compressed configuration. The catheter 2450 also includes a wire port 2458 from which a suture or wire 2440 used to compress the intragastric device 2400 exits the proximal end of the catheter 2450. The surgeon pulls on the free end 2459 of the suture or wire 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 place.

Fig. 24B is a flow chart illustrating the steps involved in delivering an intragastric device using the delivery device of fig. 24A, according to one embodiment of the present invention. In step 2410, the compressed intragastric device is placed coaxially over the distal end of the delivery device or catheter. Next, in step 2412, the catheter is inserted into the patient through the endoscope and the distal end of the catheter is advanced to the duodenum. Next, in step 2414, the distal end of the catheter is positioned such that the wire mesh structure of the intragastric device is within the stomach, just proximal to the pylorus, and the sleeve of the device passes through the pylorus into the duodenum. In step 2416, the surgeon pulls on the free end of the wire to remove the cinching wire from around the intragastric device, thereby allowing the intragastric device to self-expand. Finally, in step 2418, the catheter is slid coaxially away from the intragastric device and removed from the patient.

Fig. 25A is a schematic view of a second exemplary delivery device 2550 for an intragastric device 2500, according to one embodiment of the present invention. An intragastric device 2502, including a compressed wire mesh structure 2500 and a sleeve 2501, is positioned coaxially around the distal end of a delivery device or catheter 2550. The zippered restraining sheath 2541 is positioned coaxially over the intragastric device 2500, thereby maintaining the intragastric device 2500 in its compressed configuration.

Fig. 25B is a flow chart illustrating the steps involved in delivering an intragastric device using the delivery device of fig. 25A, according to one embodiment of the present invention. In step 2510, the compressed intragastric device is placed coaxially over the distal end of the delivery device or catheter. Next, in step 2512, a catheter is inserted into the patient through the endoscope and the distal end of the catheter is advanced to the duodenum. Next, in step 2514, the distal end of the catheter is positioned such that the wire mesh structure of the intragastric device is within the stomach, just proximal to the pylorus, and the sleeve of the device passes through the pylorus into the duodenum. In step 2516, a working tool is used to pull the compression sheath around the intragastric device, allowing the intragastric device to self-expand. Finally, in 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, and the sheath 2541 is pulled down from the intragastric device to release the intragastric device in the desired position. Fig. 25C is a flow chart illustrating the steps involved in delivering an intragastric device using a delivery device including a pull-apart sheath according to one embodiment of the present invention. In step 2550, the compressed intragastric device is placed coaxially over the distal end of the delivery device or catheter. Next, in step 2552, a catheter is inserted into the patient via the endoscope and the distal end of the catheter is advanced to the duodenum. Next, in step 2554, the distal end of the catheter is positioned such that the wire mesh structure of the intragastric device is within the stomach, just proximal to the pylorus, and the sleeve of the device passes through the pylorus into the duodenum. In step 2556, a working tool is used to coaxially pull the compression sheath away from around the intragastric device, thereby allowing the intragastric device to automatically expand. Finally, in step 2558, the catheter is slid coaxially away from the intragastric device and removed from the patient.

Fig. 26A is a schematic view of a third exemplary delivery device 2650 for an intragastric device 2600 in accordance with an embodiment of the present invention. The intragastric device 2600, including the compressed wire mesh 2601 and the sleeve 2602, is positioned coaxially around the distal end of a delivery device or catheter 2650. The tear-open restraining sheath 2642 is positioned coaxially over the intragastric device 2600, thereby maintaining the intragastric device 2600 in its compressed configuration.

Fig. 26B is a flow chart illustrating the steps involved in using the delivery device of fig. 26A to deliver an intragastric device according to one embodiment of the present invention. In step 2610, the compressed intragastric device is placed coaxially over the distal end of a delivery device or catheter. Next, in step 2612, the catheter is inserted into the patient through the endoscope and the distal end of the catheter is advanced to the duodenum. Next, in step 2614, the distal end of the catheter is positioned such that the wire mesh structure of the intragastric device is within the stomach, just proximal to the pylorus, and the sleeve of the device passes through the pylorus into the duodenum. In step 2616, a working tool is used to tear open a compression sheath around the intragastric device, thereby allowing the intragastric device to self-expand. Finally, in step 2618, the catheter is slid coaxially away from the intragastric device and removed from the patient.

Fig. 26C is a flow chart illustrating the steps involved in delivering an intragastric device using the delivery device of fig. 26A in accordance with another embodiment of the present invention. In step 2620, a compressed intragastric device is placed coaxially over the distal end of the delivery device or catheter. Next, in step 2622, the catheter is inserted into the patient through the endoscope and the distal end of the catheter is advanced to the stomach. Next, in step 2624, the distal end of the catheter is positioned such that both the wire mesh structure and the sleeve of the intragastric device are located proximal to the pylorus. In step 2626, a working tool is used to tear open a compression sheath around the intragastric device, thereby allowing the intragastric device to automatically expand. In step 2628, the catheter is slid coaxially away from the intragastric device and removed from the patient. Finally, in step 2630, gastric peristalsis pushes a sleeve of the intragastric device through the pylorus into the duodenum.

Fig. 26D is a flow chart illustrating the steps involved in separately delivering the wire mesh and sleeve and assembling the intragastric device within the gastrointestinal tract of a patient. In step 2660, the wire mesh structure is delivered into the stomach of the patient through a first catheter. Next, in step 2662, a cannula is delivered through a second catheter into the wire mesh structure. Next, in step 2664, the distal end of the cannula is extended through the distal opening in the wire mesh structure. Finally, in step 2666, the proximal end of the cannula is coupled to the distal end of the wire mesh structure.

Fig. 27A and 27B are schematic illustrations of a fourth exemplary delivery device 2700 for an intragastric device according to one embodiment of the present invention. The delivery device 2700 includes a flexible elongate device body or outer catheter 2704 with a distal end, a proximal end, and a lumen therein. The distal end includes an opening 2703 and the proximal end is attached to a first handle 2705. The first handle 2705 is used to position the delivery device 2700 in the gastrointestinal tract of the patient. The flexible plunger component 2716 is coaxially positioned and is longitudinally movable within the lumen of the device body 2704. The plunger 2716 includes a proximal end, a distal end, and a lumen therein. The distal tip 2716 of the plunger 2714 includes a mesh retention member 2719, and the mesh retention member 2715 includes a plurality of fins 2845. The fins 2715 serve to securely hold the wire mesh 2701 of the intragastric device and push and pull the wire mesh 2704 as the plunger 2701 moves back and forth within the device body 2716. A second handle 2706 is positioned at the proximal end of the plunger 2716 for longitudinal movement of the plunger 2716 within the lumen of the device body 2704. Optionally, in one embodiment, the plunger 2716 includes a stopper 2718, the stopper 2718 preventing the plunger 2716 from moving too far distally. A flexible elongate shaft or inner catheter 2717 is coaxially positioned and is longitudinally movable within the lumen of the plunger 2716. The shaft 2717 includes a proximal end and a distal end. Positioned proximal to the distal end of the rod 2717 is a first spherical component or olive 2708, while positioned at the distal end of the rod 2717 is a second spherical component or olive 2709. The diameter of the first spherical member or olive 2708 is similar to or larger than the diameter of the second spherical member or olive 2709. Attached to the proximal end of the rod 2717 is a third handle 2707, the third handle 2707 being used to move the rod 2717 longitudinally within the lumen of the plunger 2716. The intragastric device, including the wire mesh 2701 and the sleeve 2702, is positioned within the delivery device 2700 prior to deployment. The wire mesh 2701 is placed in a side loop around the shaft 2717 and distal to the tip 2716 of the plunger 2714, with a portion of the wire mesh 2701 hooked over the fins 2714 of the tip 2715. In certain embodiments, the rods 2717 pass through at least two openings in the wire mesh 2701, wherein the openings are not located on the central longitudinal axis of the wire mesh 2701. In one embodiment, wire mesh 2701 is compressed for positioning within delivery device 2700 such that the compressed length of wire mesh 2901 is about 20 cm. A sleeve 2701 attached to the wire mesh 2702 is positioned distal to the wire mesh 2701 and proximal to the first spherical member or olive 2708. The sleeve 2702 is folded over itself 2 to 10 times and then wrapped around the rod 2717. In one embodiment, the sleeve 2702 is 80cm in length and is folded over on itself 3 times, resulting in a compressed length of about 30 cm. The sleeve 2702 is not threaded coaxially over the shaft 2717. Attached to the sleeve 2702 and looped over the shaft 2717 in a position distal to the first spherical member or olive 2708 are first and second ends, respectively, of a suture loop 2713. The suture loop 2713 around the rod has a diameter that is less than the diameter of the first spherical part or olive 2708, but greater than the diameter of the second spherical part or olive 2709. As the rod 2717 is pushed out of the device body 2704, the first spherical member or olive 2708 pushes on the suture loop 2713, and the suture loop 2702 pulls the attached cannula 2704 out of the device body 2834. When the delivery device 2700 is removed from the patient's gastrointestinal tract with the rod 2717, the suture loop 2713 slides over the smaller diameter second spherical member or olive 2709, allowing the intragastric device to be left 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 2704 at the distal end of the device body 2710. The channel 2711 extends along the length of the device body 2704 and includes an input port 2704 at the proximal end of the device body 2712. The balloon 2711 is inflated using the input port 2710 and channel 2712 to anchor the delivery device in the patient's gastrointestinal tract. The anchor provides greater tension to the delivery device to allow the delivery device to be pushed and pulled during delivery of the intragastric device.

In certain embodiments, the delivery device 2700 also includes a flushing or irrigation mechanism to reduce the deployment force during delivery.

In various embodiments, the delivery device or catheter has a variable stiffness along its length. The delivery device is more flexible at its distal end and becomes less flexible along its length towards its proximal end. In certain embodiments, the delivery device has three flexible regions: a proximal region, a central region, and a distal region. In one embodiment, the proximal region is 100cm in length and 55D flexible, the central region is 20cm in length and 40D flexible, and the distal region is 30cm in length and 35D flexible. Optionally, in one embodiment, the distal region is divided into two additional regions, the two additional regions comprising a more distal region and a more proximal region. Both regions were 15cm in length, with the closer region having a flexibility of 35D and the further region having a flexibility of 25D. In one embodiment, the proximal region is braided, while the central region and the distal region are coiled.

The delivery device includes a non-invasive distal end and the three handle system of the delivery device allows for a shorter overall length of the device itself. In various embodiments, referring to fig. 27B, the dimensions of the delivery device are as follows: the total length is in the range of 275 cm-320 cm; the length of the device body or outer catheter 2704 is in the range of 100 cm-150 cm; the plunger 2716 has a length in the range of 120cm to 150 cm; the length of the rod or inner conduit 2717 is in the range of 275 and 320 cm; the length of each

handle

2705, 2706, 2707 is equal to 10 cm; the distance between the second spherical member or olive 2709 and the first spherical member or olive 2708 is in the range of 15 cm-30 cm; the distance between said first handle 2705 and said second handle 2706 is equal to 60cm when in the initial configuration before delivery; and the distance between said second handle 2706 and said third handle 2707 is equal to 50cm when in the initial configuration before delivery. In certain embodiments, the outer diameter of the device body or outer catheter 2704 is 10mm or less. In one embodiment, the delivery device can be deployed over a 0.035 inch guide wire. In various embodiments, the plunger 2716 and rod 2717 are sufficiently flexible to allow atraumatic intestinal navigation. In certain embodiments, the solid outer conduit can be bent to 80 degrees and can be threaded through a curve having a radius of 30mm to 50 mm. In certain embodiments, if the solid outer catheter is coiled to a radius of about 50mm, the sleeve and mesh will kink or bind in place without deploying. Thus, as shown in fig. 27C, in certain embodiments, the device body or outer catheter 2704 comprises a flexible braided catheter. The flexible braided catheter is able to bend and wind beyond the above limits without causing failure of the deployment of the sleeve and wire mesh.

Fig. 27C is a schematic view of the distal end of a delivery device 2700 showing a pilot olive or first spherical component 2709 for threading, according to one embodiment of the present invention. The pilot olive 2709 comprises a small ball 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 tissue. Referring to fig. 27C, a portion of the inner catheter 2717 extending from the outer catheter 2704 includes a pilot component. The stiffness of the pilot component is less than the stiffness of the distal portion of the outer catheter 2704. In certain embodiments, the pilot component has a variable stiffness, wherein the stiffness at the proximal end of the pilot component is close to the stiffness of the distal end of the outer catheter 2704, and the stiffness at the distal end of the pilot component is close to the stiffness of the 0.035 "guide wire.

Fig. 27D is a schematic view of a portion of a delivery device 2700 showing a mesh retention component 2719, according to one embodiment of the present invention. The mesh retention component 2719 includes a plurality of fins 2715. The fins 2715 serve to securely hold the wire mesh of the intragastric device and push and pull the wire mesh as the plunger 2716 moves back and forth within the device body 2704.

In one embodiment, the sleeve is only partially deployed during delivery. The wire mesh structure acts as an anchor to hold the device in place. When the patient eats, the sleeve unravels and becomes fully deployed due to the movement of the gastrointestinal tract.

Fig. 27E is a flow chart illustrating the steps involved in using the delivery device of fig. 27A to deliver an intragastric device according to one embodiment of the present invention. At step 2720, the delivery device is slid over the guide wire into position within the gastrointestinal tract of the patient. At step 2721, the surgeon positions the distal end of the delivery device body within the duodenum of the patient using the first handle. Optionally, at step 2722, the surgeon inflates a balloon located at the distal end of the device body to anchor the delivery device within the gastrointestinal tract of the patient. Next, at step 2723, the surgeon pushes on the second handle, pushing in the plunger member until the cannula is pushed out of the device body. Optionally, the plunger includes a stop so that the surgeon knows when to stop pushing the second handle. At this point, the cannula has advanced about 20cm past the first spherical member and is positioned just proximal of the second spherical member. The wire mesh structure is positioned just proximal of the first spherical member, and the opening is positioned at the distal end of the device body. Next, at step 2724, the surgeon pushes on the third handle to advance the rod about 60cm within the lumen of the plunger until the cannula is fully deployed (fully deployed) and fully stretched or decompressed. At step 2725, the surgeon repositions the device by pulling it back about 5 to 10cm so that the distal end of the funnel section of the sleeve is within the stomach. Next, at step 2726, the surgeon 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 holding the plunger in place, thus releasing the wire mesh structure. Next, at step 2727, the delivery device is removed from the patient, leaving the intragastric device deployed in the gastrointestinal tract of the patient.

Fig. 28A is a schematic view of a fifth exemplary delivery device 2830 for an intragastric device according to one embodiment of the present invention. The delivery device 2830 includes a flexible elongate device body or outer catheter 2834 with a distal end, a proximal end, and a lumen therein. The distal end includes an opening 2833 and the proximal end is attached to an actuation mechanism 2835. The actuation mechanism 2835 includes an actuator handle 2849 and an actuator trigger 2848, and is used to move the various components of the delivery device relative to one another. The actuation mechanism is also used to position the delivery device 2830 in the gastrointestinal tract of the patient. The flexible plunger member 2846 is coaxially positioned and longitudinally movable within the inner lumen of the device body 2834. The plunger 2846 includes a proximal end, a distal end, and further includes a lumen therein. The distal tip 2844 of the plunger 2846 includes a mesh retention component 2819, the mesh retention component 2819 including a plurality of fins 2845. The fins 2845 serve to securely hold the wire mesh 2831 of the intragastric device and push and pull the wire mesh 2831 as the plunger 2846 moves back and forth within the device body 2834. The proximal end of the plunger 2846 is positioned within the actuation mechanism, wherein pulling the actuation trigger 2848 causes the plunger 2846 to move longitudinally back and forth within the interior cavity of the device body 2834. A flexible elongate shaft or inner conduit 2847 is positioned within the lumen of the plunger 2846. The rod 2847 includes a proximal end and a distal end. Positioned proximal to the distal end of the rod 2847 is a first spherical member or olive 2838, while positioned at the distal end of the rod 2847 is a second spherical member or olive 2839. The

olives

2838, 2839 include ball attachments that help guide the delivery of the intragastric device. The diameter of the first spherical member or olive 2838 is greater than the diameter of the second spherical member or olive 2839. Attached to the proximal end of the rod 2847 is a rod handle 2837, the rod handle 2837 being used to move the rod 2847 longitudinally within the lumen of the plunger 2846. The intragastric device, including the wire mesh 2831 and sleeve 2832, is positioned within the delivery device 2830 prior to deployment. In various embodiments, the sleeve is axially compressed. In other embodiments, the sleeve is not axially compressed. The wire mesh 2831 is placed in a side loop around the rod 2847 and distal to the tip 2844 of the plunger 2846, with a portion of the wire mesh 2831 hooked over the fin 2845 of the tip 2844. A sleeve 2831 attached to the wire mesh 2832 is positioned distal to the wire mesh 2831 and proximal to the first spherical member or olive 2838. The sleeve 2832 is folded over on itself 2 to 10 times and then wrapped around the rod 2847. The sleeve 2832 is not coaxially threaded onto the rod 2847. Attached to the sleeve 2832 and looped over the rod 2847 in a position distal to the first spherical member or olive 2838 is a sewing ring 2843. The suture ring 2843 around the rod 2847 has a diameter that is less than the diameter of the first ball-shaped member or olive 2838, but greater than the diameter of the second ball-shaped member or olive 2839. As the rod 2847 is pushed out of the device body 2834, the first spherical member or olive 2838 pushes the sewing ring 2843, and the sewing ring 2843 pulls the attached sleeve 2832 out of the device body 2834. When the delivery device 2830 is removed from the patient's gastrointestinal tract with the rod 2847, the sewing ring 2843 slides over the smaller diameter second spherical member or olive 2839, thereby allowing the intragastric device to remain in the patient. In one embodiment, the sewing ring 2843 is biodegradable and dissolves over time. In other embodiments, the sewing ring 2843 is a biodegradable hook, ring, cone, or umbrella.

Optionally, in one embodiment, the delivery device 2830 further includes a balloon 2840 at the distal end of the device body 2834. The 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 the channel 2841 to anchor the delivery device within the patient's gastrointestinal tract. The anchor provides greater tension to the delivery device to allow the delivery device to be pushed and pulled during delivery of the intragastric device.

Fig. 28B is a flow chart illustrating the steps involved in delivering an intragastric device using the delivery device of fig. 28A, according to one embodiment of the present invention. In step 2850, the delivery device is slid over the guide wire into position within the gastrointestinal tract of the patient. In step 2851, the surgeon positions the distal end of the delivery device body within the duodenum of the patient using the actuation mechanism. Optionally, in step 2852, the surgeon inflates a balloon located at the distal end of the device body to anchor the delivery device within the patient's gastrointestinal tract. Next, in step 2853, the surgeon pulls on the actuation trigger until it is first locked, pushing in the lever handle until the sleeve is pushed out of the device body. Optionally, the plunger includes a stop so that the surgeon knows when to stop pushing the second handle. At this point, the cannula has advanced about 20cm past the first spherical member and is positioned just proximal of the second spherical member. The wire mesh structure is positioned just proximal of the first spherical member, and the opening is positioned at the distal end of the device body. Optionally, in step 2854, the surgeon pulls on the trigger to advance the plunger by about 60cm until the cannula is fully deployed and fully extended or decompressed. At step 2855, the surgeon repositions the device by pulling the device back approximately 5 to 10cm so that the distal end of the funnel section of the sleeve is within the stomach. Next, in step 2856, the surgeon pulls the actuation trigger (trigger) again until it locks for a second time. This pulls the device body back while holding the plunger in place, thus releasing the funnel section of the sleeve and the wire mesh structure. Next, in step 2857, the delivery device is removed from the patient, leaving the intragastric device deployed in the gastrointestinal tract of the patient.

Fig. 29A is a schematic view of yet another exemplary delivery device 2900 for an intragastric device according to an embodiment of the invention. The delivery device 2900 of fig. 29A differs from the delivery device 2700 shown in fig. 27A in that the delivery device 2900 includes only two

handles

2905, 2906, and a device body or outer conduit 2904, and a rod or inner conduit 2917. The delivery device 2900 of fig. 29A does not include a separate plunger with its own handle. Alternatively, the plunger 2916 is integral with the second handle 2906 and coaxially wraps around a proximal portion of the inner catheter 2917. The delivery device 2900 includes a flexible elongate device body or outer catheter 2904 with a distal end, a proximal end, and a lumen therein. The distal end includes an opening 2903 and the proximal end is attached to a first handle 2905. The first handle 2905 is used to position 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 shaft or inner conduit 2917 is coaxially positioned and longitudinally movable within the lumen of plunger 2904. The rod 2917 includes a proximal end attached to the second handle 2906 and includes a distal end. The flexible plunger component 2916 is coaxially positioned on a proximal portion of the inner catheter 2917 and is longitudinally movable with the inner catheter 2917. The plunger 2916 includes a proximal end that is also attached to the second handle 2906 and includes a distal end. The distal tip of the plunger 2916 includes a mesh retention component 2919, and the mesh retention component 2919 includes a plurality of fins 2915. The fins 2915 serve to securely hold the wire mesh 2901 of the intragastric device and push and pull the wire mesh 2901 as the plunger 2916 and inner catheter 2917 move back and forth within the outer catheter 2904. A second handle 2906 is positioned at the proximal end of the plunger 2916 and the inner catheter 2917 for longitudinal movement of the plunger 2916 and the inner catheter 2917 within the lumen of the outer catheter 2904. Optionally, in one embodiment, the plunger comprises a stopper that prevents the plunger and inner catheter from moving too far distally. Positioned proximal to the distal end of the inner catheter 2917 is a first spherical component or olive 2908, while positioned at the distal end of the inner catheter 2917 is a second spherical component or olive 2909. The diameter of the first spherical member or olive 2908 is greater than the diameter of the second spherical member or olive 2909. The intragastric device, including wire mesh structure 2901 and sleeve 2902, is positioned within delivery device 2900 prior to deployment. The wire mesh 2901 is placed around the rod 2917 in a side loop, distal to the tip of the plunger 2916, with a portion of the wire mesh 2901 hooked over the fin 2915 of the holding component 2919. In certain embodiments, the rod 2917 passes through at least two openings in the wire mesh 2901, wherein the openings are not located on the central longitudinal axis of the wire mesh 2901. In one embodiment, the wire mesh 2901 is compressed for positioning within the delivery device 2900 such that the compressed length of the wire mesh 2901 is about 30 cm. A sleeve 2902 attached to the wire mesh structure 2901 is positioned distal to the wire mesh structure 2901 and proximal to the first spherical member or olive 2908. Sleeve 2902 is folded over itself 2 to 10 times and then wrapped around inner conduit 2917. In one embodiment, sleeve 2902 is 80cm in length and is folded over on itself 3 times, resulting in a compressed length of about 30 cm. Cannula 2902 is threaded non-coaxially over inner catheter 2917. Attached to the cannula 2902 and looped over the inner conduit 2917 in a position distal to the first spherical member or olive 2908 are first and second ends, respectively, of a suture ring 2913. The diameter of the suture ring 2913 around the stem is smaller than the diameter of the first spherical member or olive 2908, but larger than the diameter of the second spherical member or olive 2909. As the inner conduit 2917 is pushed out of the outer conduit 2904, the first spherical member or olive 2908 pushes the suture ring 2913, the suture ring 2913 pulling the attached cannula 2902 out of the outer conduit 2904. When the delivery device 2900 is removed from the patient's gastrointestinal tract with the inner catheter 2917, the suture ring 2913 slides over the smaller diameter second spherical member or olive 2909, allowing the intragastric device to remain in the patient. In one embodiment, the suture ring 2913 is biodegradable and dissolves over time. In other embodiments, suture ring 2913 is a biodegradable hook, ring, cone, or umbrella.

Optionally, in one embodiment, delivery device 2900 further comprises a balloon at the distal end of the device body. The 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 the channel to anchor the delivery device within the gastrointestinal tract of the patient. The anchor provides greater tension to the delivery device to allow the delivery device to be pushed and pulled during delivery of the intragastric device.

In certain embodiments, the delivery device 2900 also includes a flush or irrigation mechanism to reduce deployment forces during delivery.

The delivery device includes a non-invasive distal end and the two handle system of the delivery device allows for a shorter overall length of the device body. In various embodiments, the dimensions of the delivery device are as follows: the total length is in the range of 265 cm-310 cm; the length of the device body or outer catheter 2904 is in the range of 100 cm-150 cm; the length of the plunger 2916 is in the range of 120 cm-150 cm; the length of the rod or inner conduit 1917 is in the range of 265-310 cm; the length of each

handle

2905, 2906, 2907 is equal to 10 cm; the distance between the second spherical member or olive 2909 and the first spherical member or olive 2908 is in the range of 15 cm-30 cm; the distance between the first handle 2905 and the second handle 2906 is equal to 110cm when in an initial configuration prior to delivery. In certain embodiments, the outer diameter of the device body or outer catheter 2904 is 10mm or less. In one embodiment, the delivery device can be deployed over a 0.035 inch guide wire. In various embodiments, plunger 2916 and inner catheter 2917 are sufficiently flexible to allow atraumatic intestinal transit. In certain embodiments, the solid outer conduit can be bent to 80 degrees and can be threaded through a curve having a radius of 30mm to 50 mm. In certain embodiments, if the solid outer catheter is coiled to a radius of about 50mm, the sleeve and mesh will kink or bind in place without deploying. Thus, in certain embodiments, outer catheter 2904 comprises a flexible braided catheter. The flexible braided catheter is able to bend and wind beyond the above limits without causing failure of the deployment of the sleeve and wire mesh.

In certain embodiments, the outer catheter has a variable stiffness along its length, and the inner catheter, positioned coaxially inside the outer catheter, comprises a non-invasive distal end and a lumen for receiving a guiding device. Prior to delivery, the intragastric device is positioned in the space between the inner and outer catheters. The inner catheter further comprises a flexible extension at its distal end of at least 5cm in length, the flexible extension extending beyond the distal end of the outer catheter. In certain embodiments, the guide device is a guide wire. In other embodiments, the guiding device is an endoscope for endoscopic delivery. In certain embodiments, the atraumatic distal end of the inner catheter is a ball tip. In certain embodiments, the inner conduit has a variable stiffness along its length. In some embodiments, the 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 guide wire at the distal end and a stiffness of the inner catheter at the proximal end. In other embodiments, the stiffness of the flexible extension is constant along its length.

Fig. 29B is a cross-sectional schematic view of a pre-deployment coaxial arrangement of a sleeve 2935 of an intragastric device within a delivery device 2930 according to one embodiment of the present invention. The delivery device 2930 includes an inner catheter 2933, the inner catheter 2933 being positioned coaxially within the inner lumen 2936 of the outer catheter 2937. The inner catheter 2933 includes a guide wire port 2932 for inserting a guide wire to aid in guiding delivery. In various embodiments, the guide wire is an ultra-rigid guide wire having a diameter in the range of 0.035 to 0.038 inches. In the arrangement shown in fig. 29B, the sleeve 2935 is shown surrounding the inner catheter 2933 such that the inner catheter 2933 is positioned within the inner lumen 2934 of the sleeve 2935.

Fig. 29C is a cross-sectional schematic view of a pre-deployment coaxial arrangement of a sleeve 2935 of an intragastric device within a delivery device 2930 according to another embodiment of the present invention. The delivery device 2930 includes an inner catheter 2933, the inner catheter 2933 being positioned coaxially within the inner lumen 2936 of the outer catheter 2937. The inner catheter 2933 includes a guide wire port 2932 for inserting a guide wire to aid in guiding delivery. In the arrangement shown in FIG. 29C, the sleeve 2935 is shown adjacent the inner catheter 2933 such that the inner catheter 2933 is positioned outside the inner lumen 2934 of the sleeve 2935.

Fig. 29D is a cross-sectional schematic view of the pre-deployment coaxial arrangement of a sleeve 2933 shown on an endoscope 2939 of an intragastric device within a delivery device 2930 according to one embodiment of the present invention. The delivery device 2930 includes an inner catheter 2933, the inner catheter 2933 being positioned coaxially within the inner lumen 2936 of the outer catheter 2937. The inner catheter 2933 includes an endoscope port 2938, and an endoscope 2939 is positioned within the endoscope port 2938 to aid in guiding delivery. In the arrangement shown in fig. 29D, the sleeve 2935 is shown surrounding the inner catheter 2933 such that the inner catheter 2933 is positioned within the inner lumen 2934 of the sleeve 2935.

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

Fig. 29E is a flowchart illustrating the steps involved in delivering an intragastric device using the delivery device of fig. 29A, in accordance with an embodiment of the present invention. In step 2920, the delivery device is slid over the guide wire into position within the gastrointestinal tract of the patient. In step 2921, the surgeon positions the distal end of the delivery device body within the patient's duodenum using the first handle. Optionally, in step 2922, the surgeon inflates a balloon located at the distal end of the device body to anchor the delivery device within the patient's gastrointestinal tract. Next, in step 2923, the surgeon pushes on the second handle (about 60cm) to advance the plunger and inner catheter until the cannula is pushed out of the delivery device body and fully deployed. Optionally, the plunger includes a stop so that the surgeon knows when to stop pushing the second handle. In step 2924, the surgeon repositions the device by pulling the device back approximately 5 to 10cm so that the distal end of the funnel section of the sleeve is within the stomach. Next, in step 2925, the surgeon 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 holding the plunger and inner catheter in place, thus releasing the wire mesh structure. Next, in step 2926, the delivery device is removed from the patient, leaving the intragastric device deployed in the patient's gastrointestinal tract.

Fig. 30A is a schematic view of a seventh exemplary delivery device 3000 for an intragastric device according to one embodiment of the present invention. Delivery device 3000 includes a coaxial delivery system having a flexible outer catheter 3002 and a flexible inner catheter 3001 shaft on which an intra-gastric device is preloaded. The outer catheter 3002 comprises a proximal end, a distal end, and a lumen therein. The inner catheter 3001 is positioned within the lumen of the outer catheter 3002 and also includes a proximal end, a distal end, and a lumen therein. 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 long and is used to deliver the intragastric device transorally into the stomach and duodenum or jejunum of a patient. The delivery device 3000 has variable stiffness along its length, providing sufficient flexibility to pass through the small intestine loop, while also having sufficient pushability to resist gastric looping. In various embodiments, the length of the outer catheter 3002 is about 1.5 meters. In certain embodiments, the distal portion of the outer catheter 3002 comprises a lubricious hydrophilic coating that can be activated prior to delivery to facilitate threading. In one embodiment, the coating covers about 0.65 meters of the distal side of the outer catheter 3002. The proximal end of the device 3000 includes the proximal portion of the inner catheter 3001 that is not covered by the outer catheter 3002. As further described with reference to fig. 30E and 30G, a pair of

stop mechanisms

3004, 3006 are positioned on the inner catheter 3001 with a first handle 3003 attached to the proximal end of the inner catheter 3001, the first handle 3003 having a proximal end, a distal end, and a lumen configured to receive a guide wire. A second handle 3008 is attached to the proximal end of the outer catheter 3002 and is coaxially positioned about the inner catheter 3001 and is slidable over the inner catheter 3001, the second handle 3008 having a proximal end, a distal end, and a lumen configured to receive the inner catheter 3001. Proximal and distal movement of the second handle 3008 relative to the first handle 3003 causes the outer catheter 3002 to slide proximally and distally over the inner catheter 3001.

Extending distally from the distal end of the inner catheter 3001 is a pilot component 3007. The pilot component includes an elongated, ultra-flexible shaft having a proximal end and a distal end. As described below with reference to fig. 30D and 30E, the proximal end of the pilot component includes a proximal spherical component or olive. As described further below with reference to fig. 30D and 30F, the distal end of the pilot component 3007 includes a distal spherical component or olive. In some embodiments, the pilot component 3007 is also covered with a lubricious hydrophilic coating.

Fig. 30B is a schematic view of an exemplary embodiment of an outer catheter 3050 for use in the delivery device of fig. 30A. The outer tube 3050 comprises three sections of different stiffness: a proximal segment 3051, a central segment 3052, and a distal segment 3053, each segment having a proximal end, a distal end, and a lumen. Attached to the proximal end of the proximal section 3051 is a second handle 3054. Attached to the distal end of the distal section 3053 is a soft tip 3055. Both the second handle 3054 and the soft tip 3055 include a lumen for receiving an inner catheter. In one embodiment, outer catheter 3050 comprises a first radiopaque marker 3056 at the junction of soft tip 3055 and distal section 3053 and a second radiopaque marker 3057 on central section 3052 about 4-6 cm from the junction of central section 3052 and proximal section 3051. In various embodiments, the proximal section 3051 is about 85cm in length and has a stiffness that is 120% of the stiffness of the central section 3052. In various embodiments, the length of the central section 3052 is in the range of about 52-54 cm. In various embodiments, the distal segment 3053 has a length in the range of about 11-13 cm and a stiffness that is 80% of the stiffness of the central segment 3052. In various embodiments, the outer conduit 3050 has an overall length in the range of 150 and 152cm, and does not include the second handle 3054 or soft tip 3055. In one embodiment, the second handle 3054 is 10cm in length. In one embodiment, the soft tip 3055 is 0.5cm in length. During delivery, the second handle 3054 is positioned outside of the patient's body. In certain embodiments, about 50cm proximal of the proximal section 3051 is positioned in the esophagus during delivery. In certain embodiments, about 35cm distal of the proximal section 3051 and 4-6 cm proximal of the central section 3052 are positioned in the stomach during delivery. In certain embodiments, during delivery, about 48cm distal of the central segment 3052 and the entire distal segment 3053 and soft tip 3055 are positioned in the intestine.

Fig. 30C is a schematic view of another embodiment of an outer catheter 3070, illustrating the dimensions of the compressed sleeve 3062 and the compressed wire mesh structure 3061 of the intragastric device 3060 relative to the dimensions of the outer catheter 3070. The outer catheter 3070 of fig. 30C includes only a proximal segment 3071 and a distal segment 3073. The distal section 3073 has a length in the range of 63-67 cm, with 59-61 cm positioned in the intestine and 4-6 cm positioned in the stomach. The compression sleeve 3062 has a length in the range of 54-56 cm, is completely contained within the distal segment 3073 and is positioned entirely within the intestinal tract. The length of the compressed wire mesh 3061 is in the range of 29-31 cm. Approximately 9-11 cm of the wire mesh structure 3061 is contained within the proximal end of the distal section 3073, and 19-21 cm of the wire mesh structure 3061 is contained within the distal end of the proximal section 3071. About 4-6 cm of the wire mesh 3061 is positioned in the intestine and about 24-26 cm of the wire mesh is positioned in the stomach.

Fig. 30D is a close-up schematic view of the distal end of the delivery device 3000 of fig. 30A, showing the pilot component 3007 and the proximal and distal

spherical components

3011 and 3013. The proximal spherical component 3011 is shaped to be non-traumatic and includes radiopaque markers 3012 for radiographic visualization during delivery. The distal spherical component 3013 is configured in a spherical tip shape and is also designed to be non-traumatic to body tissue. The design of the pilot component 3007 and the proximal and distal

spherical components

3011 and 3013 is configured to facilitate atraumatic and ease of passage "over the guide wire" through the small bowel loop. The pilot component 3007 has a stiffness less than a stiffness of the distal portion of the outer catheter. In certain embodiments, the pilot component 3007 has a variable stiffness, wherein the stiffness at the proximal end of the pilot component 3007 is close to the stiffness of the distal end of the outer catheter, while the stiffness at the distal end of the pilot component 3007 is close to the stiffness of the 0.035 "guide wire.

Fig. 30E is a schematic view of the proximal end of the delivery device of fig. 30A, showing outer catheter 3002 retracted to first stop mechanism 3004. During delivery of the intragastric device that has been preloaded onto the delivery device, the user stabilizes the first handle 3003 to hold the inner catheter 3001 in place while using the second handle 3008 to retract or slide the outer catheter 3002 proximally over the inner catheter 3001. The outer catheter 3002 is retracted until the proximal end of the second handle 3008 contacts the first stop mechanism 3004. A second stop mechanism 3006 is also positioned on the inner catheter 3001 proximal to the first stop mechanism 3004. In certain embodiments, stop

mechanisms

3004, 3006 comprise plastic rings that are securely fixed to the inner catheter using

wing nuts

3004a, 3006 a. In some embodiments, the first handle 3003 includes a first port 3013 for injecting a fluid, such as saline or water, to flush the lumen of the inner catheter 3001. In certain embodiments, the second handle 3008 includes a second port 3018 for injecting a fluid, such as saline or water, to flush the lumen of the outer catheter 3002.

Fig. 30F is a schematic view of an embodiment of a sleeve 3022 of a partially deployed intragastric device corresponding to the position of the outer catheter 3002 shown in fig. 30E. Referring to both FIGS. 30E and 30F, when outer catheter 3002 has been retracted such that the proximal end of second handle 3008 is in contact with first stop mechanism 3004, cannula 3022 has been partially deployed as shown in FIG. 30F. This portion of the deployment of the cannula 3022 is a cylindrical distal portion 1622D as described with reference to fig. 16D. This is the portion of the cannula 3022 that remains in the small intestine of the patient. The outer catheter 3002 has been retracted to the junction 1622j of the cannula depicted in fig. 16D. As illustrated in fig. 30F, in certain embodiments, the sleeve 3022 is coaxially wrapped around the inner catheter 3001 of the delivery device. In other words, the inner catheter 3001 does not pass through the lumen of the cannula 3022. In one embodiment, the distal end of the outer catheter 3002 includes radiopaque markers 3009 to ensure proper placement of the delivery device under radiographic visualization.

Fig. 30G is a schematic view of the proximal end of the delivery device of fig. 30A, showing outer catheter 3002 retracted to second stop mechanism 3006. The first stop mechanism has been removed to allow further retraction of the outer catheter 3002. Continuing to deliver the intragastric device, the user stabilizes the first handle 3003 to hold the inner catheter 3001 in place while using the second handle 3008 to further retract the outer catheter 3002 over the inner catheter 3001. Outer catheter 3002 is retracted until the proximal end of second handle 3008 contacts second stop mechanism 3006.

Fig. 30H is a schematic view of one embodiment of a wire mesh structure 3021 of a partially deployed intragastric device corresponding to the position of the outer catheter 3002 shown in fig. 30G. Referring to fig. 30G and 30H concurrently, when the outer catheter 3002 has been retracted such that the proximal end of the second handle 3008 is in contact with the second stop mechanism 3006, the wire mesh structure 3021 has been partially deployed as shown in fig. 30H. The anti-migration loop 3024 of the wire mesh structure 3021 has been deployed and everted due to its shape memory properties from its pre-deployment configuration as shown in fig. 11D to its post-deployment configuration. The proximal end of the now fully deployed cannula 3022 is shown attached to an anti-migration collar 3024. As illustrated in fig. 30H, in certain embodiments, the inner catheter 3001 passes through the spaces between the wires of the wire mesh structure 3021 along one side of the structure 3021. In other words, the inner catheter 3001 does not pass through the center of the wire mesh structure 3021.

Fig. 30I is a flow chart illustrating the steps involved in using the delivery device of fig. 30A to deliver an intragastric device according to one embodiment of the present invention. In step 3030, the distal end of the delivery device is optionally wetted to activate the lubricious hydrophilic coating so that the delivery device will be easily inserted and threaded. Next, in step 3032, the delivery device is slid over the guide wire into the gastrointestinal tract of the patient. In step 3034, the position of the distal end of the outer catheter is determined using fluoroscopy to ensure proper positioning of the delivery device. In step 3036, while the first handle is held firmly to hold the inner catheter in place, the outer catheter is retracted back toward the first stop mechanism to deploy and position a portion of the sleeve of the preloaded intragastric device within the portion of the patient's intestine. Next, in step 3038, the entire delivery device is retracted until the distal end of the outer catheter is positioned proximal to the pylorus. In step 3040, the first stop mechanism is removed from the inner catheter. At step 3042, while the first handle is held firmly to hold the inner catheter in place, the outer catheter is retracted back toward the second stop 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. In step 3044, the second stopping mechanism is removed from the inner catheter. At step 3046, the outer catheter is retracted back toward the first handle to deploy and position the entirety of the wire mesh structure within the stomach portion of the patient's gastrointestinal tract while the first handle is held firmly to hold the inner catheter in place. Next, in step 3048, the delivery device is removed from the patient.

Fig. 31A is a schematic view of a wire mesh structure 3101 of an intragastric device 3100 loaded onto a delivery device, according to an embodiment of the invention. Referring to fig. 31A, a portion of an inner catheter 3131 and a pilot component 3137 of a delivery device are shown. The delivery device includes a proximal spherical component 3135 located at the transition from the inner catheter 3101 to the pilot component 3137. The wire mesh structure 3101 includes a sleeve 3102, which sleeve 3102 is attached to an anti-migration collar 3104 of the wire mesh structure. When loading the intragastric device 3100 onto the delivery device, the pilot component 3137 passes through the eccentric openings between the wires of the wire mesh structure 3101 such that the proximal spherical component 3135 is positioned just distal of the wire mesh structure 3101 and the inner catheter 3131 is located within the interior volume of the wire mesh structure 3101.

Fig. 31B is a schematic view of the wire mesh structure 3101 of fig. 31A further loaded onto a 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 device. Since the wire mesh structure 3101 has advanced proximally along the inner catheter 3131, the proximal spherical component is no longer visible. Referring to fig. 31B, the inner catheter is shown exiting the wire mesh structure 3101 through an opening offset from the center of the wire mesh structure 3101. In another embodiment, the inner catheter (and attached pilot component) continues within the wire mesh structure and exits through an opening in one side of the proximal funnel portion of the cannula. In another embodiment, the inner catheter continues within the wire mesh structure and exits through an opening in one side of the distal cylindrical portion of the sleeve. In yet another embodiment, the inner catheter continues within the wire mesh structure, passes through the entire cannula, and exits through an opening in the distal end of the cannula.

Fig. 31C is a schematic view of the wire mesh structure 3101 of fig. 31A loaded onto a delivery device, thus only further loading with an anti-migration loop 3104. Fig. 31D is a schematic view of the wire mesh structure 3101 of fig. 31A fully loaded onto a delivery device. Referring to fig. 31D, 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 shown coaxially wrapped around the inner catheter 3131.

Fig. 31E is a schematic view of the sleeve 3102 of the intragastric device of fig. 31A partially loaded onto a delivery device. It can be seen that a portion of the sleeve 3102 that is coaxially wrapped around the inner catheter 3131 extends from the distal end of the outer catheter 3132. Fig. 31F is a schematic view of the intragastric device of fig. 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 around the proximal spherical component 3135 to hold the intragastric device in place until ready for delivery. Prior to delivery, the suture 3105 is unraveled so that the intragastric device may be deployed.

Fig. 32A is a schematic view of a retrieval device 3200 for removing an intragastric device according to another embodiment of the present invention. The retrieval device 3200 includes a flexible outer tube 3202, the flexible outer tube 3202 including an elongate body having a proximal end, a distal end, and a lumen therein. The first handle 3212 is attached to the proximal end of the outer tube 3202, and an opening 3222 is positioned at the distal end of the outer tube 3202. A flexible inner member 3204, comprising an elongated body with a proximal end and a distal end, is disposed within the lumen of the outer tube 3202. In one embodiment, inner member 3204 comprises a flexible metal wire. A second handle 3214 is attached to the proximal end of inner member 3204, and a retraction mechanism 3224 is formed by the distal end of inner member 3204. In one embodiment, the retrieval mechanism 3224 includes a hook. In one embodiment, the hook is lockable.

FIG. 32B is a flow chart illustrating the steps involved in removing the intragastric device from the patient using the retrieval device of FIG. 32A, in accordance with one embodiment of the present invention. At step 3232, the surgeon inserts the outer tube of the retrieval device into the working channel of the endoscope, which is inserted into the patient. At this point, the retraction mechanism at the distal end of the inner member is contained within the distal end of the outer tube. At step 3234, the surgeon holds the first handle securely to position the retrieval device within the patient's gastrointestinal tract. Next, at step 3236, the surgeon pushes on the second handle to extend the retraction mechanism through the opening of the outer tube and beyond the distal end of the outer tube. At step 3238, the surgeon manipulates the second handle to grasp the proximal end of the intragastric device via the retrieval mechanism. In one embodiment, the proximal end of the intragastric device includes a set of staggered nodes, as shown as nodes 1615 with reference to fig. 16B, to facilitate grasping by a retrieval mechanism. In step 3240, once the intragastric device has been secured by the retrieval mechanism, the surgeon 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 catheter. The intragastric device is constructed of a shape memory metal such that it can be easily compressed to a size that can fit within the outer tube. Optionally, in step 3242, the surgeon actuates a locking mechanism on the retrieval device to prevent the retrieval mechanism and attached intragastric device from sliding out of the distal end of the outer tube. Finally, in step 3244, the surgeon removes the retrieval device and attached intragastric device from the patient.

Fig. 33A is a schematic view of an embodiment of the 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 each other. In various embodiments, the second wire mesh 3362 has a size equal to or smaller than the size of the upper wire mesh 3361. The device 3300 also 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 entering the device 3300 at the first opening 3363 travels through the interior volume of the upper wire mesh 3361, enters and passes through the interior 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 comprise separate wire mesh structures that are attached prior to deployment. In the illustrated embodiment, the device 3300 includes a membrane 3367, the membrane 3367 covering the entire outer surface of the device 3300, except for two

openings

3363, 3364.

Fig. 33B is a schematic view of an embodiment of an intragastric device 3320 having a two-wire mesh structure, wherein the lower wire mesh is formed from an everted anti-migration component 3324. The device 3320 has a dumbbell-shaped structure similar to the dual mesh device structure embodiments discussed in this disclosure and functions similarly to those devices. The upper wire mesh 3322 is similar to the wire mesh 210 of fig. 2B and the lower wire mesh is similar to the anti-migration collar 214 of fig. 2B, except that the lower mesh 3324 is larger and completely everted or bent in the proximal direction to form the lower mesh 3324 as shown in fig. 33B. The first wire mesh structure 3322 includes a plurality of free ends extending from a lower portion or base thereof. A portion of the plurality of free ends are bent onto itself to create the everted portion 3324 on the right while a second portion of the plurality of free ends are bent onto itself to create the everted portion 3324 on the left. It will be appreciated that this eversion may occur around the entire perimeter of the first wire structure, creating a torus, which may be elongated (elongated), elliptical or oval.

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

Fig. 34A is a schematic view of another exemplary bi-wire mesh intragastric device 3400a in a post-deployment configuration, in accordance with an embodiment of the present invention. The illustrated embodiment includes a first wire mesh structure 3401 located atop a second wire mesh structure 3411 and a sleeve 3402 coupled to a distal end of the second wire mesh structure 3411. The 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 due to gastric contractions and to hold the device 3400a outside the pylorus. The second anti-migration component 3414 at the base of the second wire mesh structure 3411 functions to prevent the entire device 3400a from passing through the pylorus. Food first passes through the openings in the top of the combined intragastric device 3400a and is isolated in the first wire mesh 3401. Then, the food slowly penetrates into and is isolated in the second wire mesh structure 3411. Finally, food is slowly released through the opening in the bottom of the combined intragastric device 3400a into the sleeve 3402, which sleeve 3402 is attached to the distal end of the second wire mesh structure 3411, which passes around the pylorus to release the food into the small intestine. In one embodiment, there is no sleeve 3402 attached, and food is released back into the stomach through an opening in the bottom of the combined intragastric device 3400 a. The combined

wire mesh structures

3401, 3411 together function to occupy increased volume in the patient's stomach and further retard food transit through the gastrointestinal tract. The combined two

wire mesh structures

3401, 3411 also function to induce satiety more quickly and to induce a sustained longer feeling of satiety than a single mesh structure device. Compared to a single structure, the two wire mesh structures are able to move relative to each other, which allows them to better adapt to the shape of the stomach, resulting in better tolerance and/or fewer complications.

Fig. 34B is a schematic view of another exemplary bi-wire mesh intragastric device 3400B in a post-deployment configuration, in accordance with an embodiment of the present invention. The illustrated 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 collectively function to occupy increased volume in the patient's stomach and further retard food passage through the gastrointestinal tract. Compared to a single structure, the two wire mesh structures are able to move relative to each other, which allows them to better adapt to the shape of the stomach, resulting in better tolerance and/or fewer complications.

Figure 34C is a schematic view of another exemplary bi-wire mesh intragastric device 3400C in a post-deployment configuration, in accordance with an embodiment of the present invention. The illustrated embodiment includes a first wire mesh structure 3451 positioned on top of a second wire mesh structure 3461. The anti-migration component 3464 at the base of the second wire mesh structure 3461 acts to prevent the entire device 3400c from passing through the pylorus. The two

wire mesh structures

3451, 3461 collectively function to occupy increased volume in the patient's stomach and further retard food passage through the gastrointestinal tract. Compared to a single structure, the two wire mesh structures are able to move relative to each other, which allows them to better adapt to the shape of the stomach, resulting in better tolerance and/or fewer complications.

Figure 34D is a schematic view of another exemplary bi-wire mesh intragastric device 3400c in a post-deployment configuration, in accordance with an embodiment of the present invention. The illustrated embodiment includes a first wire mesh structure 3471 positioned on top of a second wire mesh structure 3481. The first anti-migration component 3474 at the base of the first wire mesh structure 3471 rests inside the second wire mesh structure 3481 and serves 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 due to stomach contractions and to hold the device 3400d outside the pylorus. The second anti-migration component 3484 at the base of the second wire mesh structure 3481 acts to prevent the entire device 3400d from passing through the pylorus. The two

wire mesh structures

3471, 3481 collectively function to occupy increased volume in the patient's stomach and further retard food passage through the gastrointestinal tract.

Figure 34E is a schematic view of another exemplary bi-wire mesh intragastric device 3400E in a post-deployment configuration, in accordance with an embodiment of the present invention. The illustrated embodiment includes a first wire mesh structure 3493 positioned on top of a second wire mesh structure 3495. The anti-migration component 3497 at the base of the first wire mesh structure 3493 rests inside the second wire mesh structure 3495 and serves 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 due to gastric contractions and to hold the device 3400e outside the pylorus. The two

wire mesh structures

3493, 3495 collectively function to occupy increased volume in the patient's stomach and further retard food passage through the gastrointestinal tract.

In various embodiments, any of fig. 34B-34E further comprises a sleeve attached to a distal end of the second wire mesh structure. In various embodiments, the anti-migration feature or collar of the device of the present invention has a length ranging from 1mm to 100mm and an outer diameter ranging from 25mm to 75mm such that the ratio of the length to the outer diameter ranges from 0.01 to 4. In one embodiment, the length of the anti-migration feature or collar is equal to 15mm and the outer diameter is 60mm such that the ratio of the length to the outer diameter is 0.25. In various embodiments, the wire mesh of the intragastric device of the present invention is configured to be fatigue resistant over a period of at least six months, wherein fatigue resistance is defined as resistance to breakage in intended use.

Fig. 34F is a schematic view of another exemplary bi-wire mesh intragastric device 3400F in a post-deployment configuration, in accordance with an embodiment of the present invention. The illustrated embodiment includes a first wire mesh structure 3491 located atop a second wire mesh structure 3499 and a cannula 3492 coupled to a distal end of the second wire mesh structure 3499. The anti-migration component 3494 at the base of the second wire mesh structure 3499 acts to prevent the entire device 3400f from passing through the pylorus. The two

wire mesh structures

3491, 3499 collectively function to occupy increased volume in the patient's stomach and further retard food passage through the gastrointestinal tract.

Fig. 34G is a schematic view of another exemplary bi-wire mesh intragastric device 3400G in a post-deployment configuration, in accordance with an embodiment of the present invention. The illustrated embodiment includes a first wire mesh structure 3403 located atop a second wire mesh structure 3405 and a sleeve 3407 coupled to a distal end of the second wire mesh structure 3405. The first anti-migration component 3409 at the base of the first wire mesh structure 3403 serves 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 due to stomach contractions when the first wire mesh structure 3405 is compressed and prevents the device 3400f from passing entirely through the pylorus. The second anti-migration component 3413 at the base of the second wire mesh structure 3405 acts to prevent the entire device 3400g from passing through the pylorus. The combined

wire mesh structures

3403, 3405 together act to occupy increased volume in the patient's stomach and further retard food transit through the gastrointestinal tract. In an embodiment, device 3400g is covered with a protective covering, such as a silicon or PTFE sheath. In certain embodiments, the first wire mesh structure 3403 and the second wire mesh structure 3405 are made of hand-woven nitinol wires having a thickness in a range of 0.1mm to 1.0mm, and more preferably about 0.4mm, and the sleeve 3407 is made of machine-woven nitinol wires having a thickness in a range of 0.05mm to 0.7mm, and more preferably about 0.127 mm.

In an embodiment, the total length of the device 3400g is about 100 to 850 mm. In an embodiment, the first wire mesh 3403 has a center diameter of about 90 mm. In an embodiment, each of the first and

second wire mesh

3403 and 3405 has a length of about 70mm and a total length measured from the proximal end of the first wire mesh 3403 including the first anti-migration member 3409 to the distal end of the second mesh 3405 is about 145 mm. In various embodiments, the diameter of the opening 3425 in the proximal end is about 5mm to 25mm, and the diameter of the opening 3423 in the distal end of the cannula 3407 ranges from 5mm to 35 mm. Further, in an embodiment, the width of the first anti-migration component 3409 located at the base of the first wire mesh structure 3403 is about 5 mm. In an embodiment, the diameter of the cannula 3407 is about 25 mm. Further, in an embodiment, the overall length of the cannula is about 505mm, with a length from proximal point 3415 to midpoint 3417 of about 137mm and a length from distal point 3419 to distal end 3423 of about 57 mm.

Fig. 34H shows an intragastric device 3400H having two wire meshes coupled with an anti-migration feature, according to an embodiment of the present invention. As shown, the device 3400h includes a first wire mesh structure 3462 on top of a second wire mesh structure 3472 and an anti-migration loop 3473 coupled to a distal end of the second wire mesh structure 3472. The first anti-migration component 3463 at the base of the first wire mesh structure 3462 serves to couple the two

wire mesh structures

3462, 3472 together. The first anti-migration features 3463 also help to prevent the first wire mesh structure 3462 from being compressed due to sinus constriction when the second wire mesh structure 3472 is compressed due to sinus constriction and to maintain the device 3400h outside the pylorus. The anti-migration collar 3473 at the base of the second wire mesh structure 3472 acts to prevent the entire device 3400g from passing through the pylorus.

In various embodiments, the total length of device 3400h is in the range of 30mm to 300 mm. In an embodiment, the first wire mesh 3462 has a center diameter of about 90mm, between 20 and 200. In an embodiment, the length of each of the first and

second wire mesh

3462, 3472 is in the range of 20mm to 100mm and more preferably about 70mm, and the total length measured from the proximal end of the first wire mesh 3462 including the first anti-migration component 3463 to the distal end of the second mesh 3472 is in the range of 30mm to 200mm and more preferably about 145 mm. In an embodiment, the diameter of the opening 3465 in the proximal end is about 5mm to 35mm, and the diameter of the opening 3475 in the distal end ranges from 5mm to 60 mm. Further, in an embodiment, the width of the first anti-migration component 3463 located at the base of the first wire mesh structure 3462 is about 5 mm. In certain embodiments, the length of the anti-migration collar 3473 is in the range of 5mm to 100 mm. In an embodiment, the inner diameter 3476 of the anti-migration collar 3473 is in the range of about 10mm to 30mm, and the outer diameter 3477 is in the range of 25mm to 77 mm.

In an embodiment (as set forth with reference to fig. 3D and 3E), the wire mesh device 3400h includes a plurality of loops formed in the wires of the first and second

wire mesh structures

3462, 3472 at the proximal and distal ends thereof and at the distal end of the anti-migration loop 3473. In an embodiment, the thickness of the wire forming the loop, such as wire loop 3466, is about 0.4mm, and the diameter of the circular portion 3467 of wire loop 3466 is about 2 mm. In an embodiment, the distal end of the anti-migration loop 3473 comprises 9 loops, such as the wire loop 3466 shown in fig. 34H. In various embodiments, the first anti-migration component 3463 is attached to the first wire mesh structure 3462 and the second wire mesh structure 3472 by means of soft PTFE wires 3468 having a diameter of about 0.20 mm. Further, in an embodiment, the anti-migration collar 3473 is also attached to the wire mesh 3472 by a soft PTFE wire 3438 having a diameter of about 0.20 mm.

Fig. 35 is a schematic view of a single intragastric device 3530 threaded over a guide wire 3535 and attached to a single intragastric device 3520 previously deployed in the stomach 3512. Catheter 3521 is shown passing through esophagus 3511 into stomach 3512. The catheter 3521 is deploying (deploying) a second single intragastric device 3530 and facilitates its attachment to a previously deployed intragastric device 3520. The catheter 3521 will operatively penetrate the opening of an existing intragastric device 3520, preferably the opening that the original catheter used to (deploy) the device. The second device 3530 is then deployed, wherein a portion of the second device, such as a neck, tab, or other member, is fixedly attached to the first device 3520, thereby anchoring the two devices together. In other embodiments, both devices are pre-attached outside the body and then deployed inside the body as a single unit.

Fig. 36 is a schematic view of an exemplary assembled intragastric device 3600 fully deployed in a stomach 3612. Two single

intragastric devices

3620, 3630 are shown attached one atop the other, occupying more of the stomach 3612 than one single intragastric device 3620.

Fig. 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, according to an embodiment of the present invention. The illustrated embodiment includes a first wire mesh structure 3701, the first wire mesh structure 3701 being flexibly connected, attached or coupled to a second wire mesh structure 3702 to form a generally dumbbell-shaped or barbell-shaped intragastric device 3700. In the pre-expanded configuration, corresponding to a fully compressed or constrained state, the first wire mesh structure 3701 has a first volume, while in the post-expanded 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. The second wire mesh structure 3702 has a third volume in a pre-deployment configuration corresponding to a fully compressed or constrained state, and a fourth volume in a post-deployment configuration corresponding to a fully expanded or relaxed state. In various embodiments, the third volume is less than the fourth volume.

According to an embodiment, 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. According to various 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 certain embodiments, the pre-deployment shape and size are similar for the first wire mesh structure 3701 and the second wire mesh structure 3702. In other embodiments, the post-deployment shape and size are dissimilar for the first wire mesh structure 3701 and the second wire mesh structure 3702. In various embodiments, the post-deployment shape is substantially spherical, ovoid, soft-spherical, kidney-shaped, bean-shaped, ovoid, or inverted egg-shaped.

In various embodiments of the present invention, the first and/or second wire mesh structures 3702 have 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 and any deployment events of the device. For example, in certain embodiments, the device is slowly deployed during the deployment step, and is checked for proper deployment and positioning during the different steps. In some embodiments, after full deployment, the dimensions are fixed. In certain embodiments, the two wire mesh structures are woven separately, or the wire mesh design in a single fabric is different, allowing for different stiffness, compression, and size of the two wire mesh structures.

In a preferred embodiment, the post-deployment shape is a generally spherical or elliptical shape of similar size.

In various embodiments, the present invention provides a wire mesh device as a prosthesis that is small enough that the device can be easily delivered to a patient via a catheter, but large enough that it does not pass through the patient's antrum/pylorus causing injury. In addition, the device is of sufficient size to effectively sequester food and delay gastric emptying. For example, in various embodiments, devices having a combined post-deployment volume of less than 50ml are not effective at insulating food and delaying gastric emptying and may pass through the pylorus, while devices having a post-deployment volume of greater than 3500ml are too large to adversely affect the digestive process. Furthermore, the wire mesh device is not anchored or permanently attached to any gastric structure, is free floating, and functions to position the optional cannula within the patient's intestinal tract without the surgeon having to physically attach or anchor the cannula to the patient's gastrointestinal tract. This allows both the mesh and the sleeve structure to move relative to the wall of the gastrointestinal tract. In various embodiments, the device is free to move around the stomach such that the patient's pylorus is occluded less than 100% of the time, and the occlusion comprises less than 100% of the opening defined by the pylorus. In various embodiments, the device blocks the pylorus more than 50% of the time, more preferably more than 90% of the time, and most preferably more than 95% of the time.

In various embodiments, the wire mesh structures of the intragastric device of the present invention, both single and dual wire mesh structures, provide several benefits over conventional balloons that occupy gastrointestinal space. Although conventional balloons can be deformed by gastric pressure, the volume of the balloon is substantially constant. The fixed volume balloon causes high gastric wall pressure and the water filled balloon can create pressure ulcers due to gravity and/or inertia. The air-filled balloon may create a feeling of inflation in the patient. These problems are avoided by the wire mesh devices of the present invention, since the volume of the wire mesh devices is variable. In addition, traditional balloons may develop overstretched trauma to the stomach wall due to the inability of food to enter the balloon. The food is to be passed through the wire netting device of the present invention so there is no fear of excessive stretching. The intragastric device of the present invention also allows delayed gastric emptying, as food is retained in the wire mesh structure, a benefit not provided by conventional balloons. The continuous low outward pressure of the wire mesh structure also causes satiety while the variable volume and shape provide natural comfort.

Table 1 lists the post-deployment diameter, height, volume, and pre-deployment compressed length of various intragastric dual-mesh devices according to certain embodiments of the present invention. In certain embodiments, the post-deployment diameter of the dual-mesh intragastric device at its widest point ranges from 20 to 200 mm. More preferably, in certain embodiments, the post-deployment diameter of the dual-mesh intragastric device at its widest point ranges from 50 to 150mm, and more preferably ranges from 80 to 100 mm. In one embodiment, the post-deployment diameter of the dual-mesh gastric device is 90 mm. In certain embodiments, the post-deployment height of the dual-mesh gastric device ranges from 45 to 400 mm. More preferably, in certain embodiments, the dual-mesh gastric device has a post-deployment height in the range of 105 to 300mm, and more preferably a post-deployment height of 145 mm. In certain embodiments, the first length of the first wire mesh structure is less than or equal to 75cm, and more preferably about 15 cm. In certain embodiments, the first wire mesh structure has a pre-deployment volume of less than or equal to 5ml, and more preferably less than or equal to 110ml, and a post-deployment volume of greater than or equal to 5ml, and more preferably greater than or equal to 125 ml. In certain embodiments, the second length of the second wire mesh structure is less than or equal to 70 cm. In certain embodiments, the second wire mesh structure has a pre-deployment volume of 5ml or less, and more preferably 100ml or less, and a post-deployment volume of 5ml or more, and more preferably 110ml or more. In certain embodiments, the first wire mesh structure has a post-deployment volume of greater than 5ml and less than 5000 ml. In certain embodiments, the post-deployment volume of the second wire mesh structure is greater than 20ml and less than 4000 ml. In certain embodiments, the post-deployment volume of the dual-mesh gastric device (which are cross-linked together) ranges from 8 to 8381 ml. More preferably, in certain embodiments, the post-deployment volume of the dual-mesh intragastric device (which are cross-linked together) ranges from 131 to 3536ml, and more preferably ranges from 442 to 826 ml. In one embodiment, the post-deployment diameter of the dual-mesh gastric device (which are cross-linked together) is 657 ml. In certain embodiments, the pre-deployment compressed length of the dual-mesh gastric device ranges from 63 to 629 mm. The pre-deployment compressed length refers to the overall length of the device when compressed into a catheter for deployment into the body. More preferably, in certain embodiments, the pre-deployment compressed length of the dual-mesh gastric device is in the range of 157 to 471mm, and more preferably in the range of 236 to 290 mm. In one embodiment, the pre-deployment diameter of the dual-mesh intragastric device is 269 mm.

TABLE 1

Each of the first wire mesh structure 3701 and the second wire mesh structure 3702 has an internal volume, a top or upper half surface or hemisphere, a bottom or lower half surface or hemisphere defined by the respective expanded shape and size or dimensions of the

wire mesh structures

3701, 3702. The first wire mesh structure 3701 includes at least one first opening (or first opening surface area) 3705 proximate the top or upper half surface or hemisphere and at least one second opening (or second opening surface area) 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 least one second opening 3706. The second wire mesh structure 3702 includes at least one third opening (or third opening surface area) 3707 near the top or upper hemisphere and at least one fourth opening (or fourth opening surface area) 3708 near the bottom or lower hemisphere, such that food enters the structure 3707 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 comprises a first plurality of curved surfaces defined by arc segments defined by radii in a range of 0.2cm to 20cm 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 comprises a second plurality of curved surfaces defined by arc segments defined by radii in a range of 0.1cm to 15cm and a central angle in a range of 1 to 179 degrees.

According to some embodiments, the first wire mesh structure 3701 and the second wire mesh structure 3702 are porous structures. In other embodiments, the first wire mesh structure 3701 and the second wire mesh structure 3702 are substantially covered with a film to further prevent food from passing out of the intragastric device 3700. In various embodiments, the film covers 10% to 99% of the device 3700, leaving only at least one first 3705, second 3706, third 3707, and fourth 3708 openings uncovered. This directs food entering the device 3700 through at least one first opening 3705 and exiting the device 3700 through at least one fourth opening 3708.

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

wire mesh structures

3701, 3702 that are not supported or connected to other portions of the wire mesh. In other words, the plurality of nodes are loops or bends comprising a free end at each end of the

wire mesh structures

3701, 3702. According to various embodiments, the first, second, third and fourth plurality of nodes comprise circles. In one embodiment, the loop is formed by twisting the free ends of the plurality of nodes into a loop. In another embodiment, each loop comprises a separate loop of wire stitched to the free ends of the plurality of nodes.

In various embodiments, a connection is formed between a portion of the plurality of free ends of the first wire mesh structure defining the second open surface area 3706 and a portion of the plurality of free ends of the second wire mesh structure defining the third open surface area 3707. In some embodiments, the connection comprises a first flexible suture attached at one end to a first point on said second opening surface area 3706 and at a second end to a second point on said third opening surface area 3707. In various embodiments, the length of the connection ranges from 0mm to 200mm, with the lower bound ranging from 0mm to 2mm and each increment therein. In certain embodiments, the connection comprises a second flexible stitch attached at one end to a third point on the second open surface area 3706 and at a second end to a fourth point on the third open surface area 3707, wherein the third point is different from the first point and the fourth point is different from the second point. In various embodiments, the length of the connection, including the second flexible suture, ranges from 0mm to 300mm, with the lower bound ranging from 0mm to 2mm and each increment therein. In certain embodiments, the connection comprises a third flexible suture attached at one end to a fifth point on the second opening surface area 3706 and at a second end to a sixth point on the third opening surface area 3707, wherein the fifth point is different from the first and third points and the sixth point is different from the second and fourth points. In various embodiments, the length of the connection, including the third flexible suture, ranges from 0mm to 300mm, with the lower bound ranging from 0mm to 2mm and each increment therein. In certain embodiments, the connection comprises a fourth flexible stitch attached at one end to a seventh point on the second opening surface region 3706 and at a second end to an eighth point on the third opening surface region 3707, wherein the seventh point is different from the first, third, and fifth points and the eighth point is different from the second, fourth, and sixth points. In various embodiments, the length of the connecting portion including the second flexible suture ranges from 0mm to 300mm, with the lower bound ranging from 0mm to 2mm and each increment therein.

As shown in fig. 37C, in accordance with an aspect of the present invention, a portion of the second plurality of nodes 3701n of the first wire mesh structure 3701 is flexibly connected, coupled or attached to a portion of the third plurality of nodes 3702n of the second wire structure 3702 using a plurality of sufficiently loose stitches or stitch knots 3710. Although sutures are shown in fig. 37C, in other embodiments, the flexible connection between the first and second wire mesh structures may comprise any flexible member, such as a flexible metal wire or plastic component. In these other embodiments, no sutures are required. In certain embodiments, the plurality of stitches 3710 comprise at least two independent flexible connections or stitch points, wherein at least two nodes of the second plurality of nodes 3701n of the first wire mesh structure 3701 are flexibly coupled to at least two nodes of the third plurality of nodes 3702n of the second wire mesh structure 3702. In preferred embodiments, the plurality of sutures 3710 include three or four separate flexible connections or suture points. In various embodiments, the length of the 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 ranges from 0mm to 300 mm. In various embodiments, the length of the connection of the first wire mesh structure to the second wire mesh structure is such that the first wire mesh structure can be compressed between 1% and 99%, and more preferably between 40% and 99% of its equatorial diameter and all increments therebetween without causing compression of the second wire mesh structure. In various embodiments, the plurality of sutures 3710 are distributed equidistantly along the perimeter of the second and

third openings

3706 and 3707. Fig. 37E shows two connection or stitch points 3711 for flexibly connecting the first wire mesh structure 3701 and the second wire mesh structure 3702. In an embodiment, the two attachment points or stitch points 3711 are spaced 180 degrees apart from each other.

In another embodiment, the first wire mesh structure 3701 and the second wire mesh structure 3702 are flexibly coupled (rather than using multiple stitches or stitch bonds) by interweaving or webbing a portion of the second plurality of nodes 3701n of the first wire mesh structure 3701 with a portion of the third plurality of nodes 3702n of the second wire mesh structure 3702.

In an alternative embodiment, as shown in fig. 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 a first opening 3741 at its proximal end and a second opening 3742 at the distal end, the first opening 2741 being in fluid communication with a fourth opening or fourth open surface region (surface region opening) 3708 of the second wire mesh structure 3702 (fig. 37A). In certain embodiments, the sleeve 3725 is coupled to the fourth plurality of nodes 3702p of the second wire mesh structure 3702 via a plurality of stitches. When deployed, the optionally attached sleeve extends from the patient's stomach into the duodenum it empties, or in other embodiments, through the duodenum into the jejunum. In one embodiment, the sleeve 3725 functions to deliver the isolated food/chyme from the intragastric device 3700 directly into the duodenum or jejunum.

Referring now to fig. 37A-37C, it should be appreciated that in various embodiments, the first wire mesh structure 3701 and the second wire mesh structure 3702 are separately woven and constructed and thereafter flexibly attached or sutured in vivo (as previously described with reference to fig. 35, 36) or ex vivo in a patient. It should be understood that the coupling sutures may be severed to remove the two

structures

3701, 3702, respectively, from the patient's stomach.

In various embodiments, each connection or stitch point comprises an 8-knot optionally additionally secured by glue and heat shrink tubing. In one embodiment, the knot is an Ultra High Molecular Weight Polyethylene (UHMWPE) braided suture having a break strength of 30lb (pounds) per knot to provide a reliable connection between the first wire mesh 3701 and the second wire mesh 3702.

According to aspects of the present invention, the flexible connection or attachment of the first and second

wire mesh structures

3701 and 3702 using the plurality of sutures 3710 and the resulting intragastric device 3700 provide various benefits and functions (as described below).

The flexible connection or attachment allows for fluid communication between the first wire mesh structure 3701 and the second wire mesh structure 3702. That is, food is first passed through at least one first opening 3705 in the top of the combined intragastric device 3700 and insulated in the first wire mesh structure 3701. The food then slowly penetrates and is isolated in the second wire mesh 3702. Finally, the food is slowly released through 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 collectively function to occupy increased volume in the patient's stomach and further retard food transit through the gastrointestinal tract. The two

wire mesh structures

3701, 3702 in combination also function to induce satiety more quickly and for a longer duration than a single mesh structure device.

The flexible connection or attachment enables the first wire mesh structure 3701 and the second wire mesh structure 3702 to pivot, bend, or move relative to each other in substantially all directions. Referring to fig. 37F, the first wire mesh structure 3701 has a first longitudinal axis 3715 passing through the center of the first structure 3701, the center of the first open surface region (first surface region opening) 3721 at the proximal end of the first structure 3701, and the center of the second open surface region (second surface region opening) 3722 at the distal end of the first structure, while the second wire mesh structure 3702 has a second longitudinal axis 3716 passing through the center of the second structure 3702, the center of the third open surface region (third surface region opening) 3731 at the proximal end of the second structure 3702, and the center of the fourth open surface region (fourth surface region opening) 3732 at the distal end of the second structure. The degree of motion of the two

structures

3701, 3702 relative to each other is illustrated and defined by the angular displacement 3717 between the first longitudinal axis 3715 and the second longitudinal axis 3716. In various embodiments, the flexible connection points 3711 enable the first wire mesh structure 3701 and the second wire mesh structure 3702 to have a degree of motion (or angular displacement 3717 between the first longitudinal axis 3715 and the second longitudinal axis 3716) of up to 90 degrees in all directions relative to each other. In certain embodiments, the length of the connection of the first wire mesh structure to the second wire mesh structure is designed such that when the first wire mesh structure is compressed more than 90%, the angular displacement of the second wire mesh structure relative to the first wire mesh structure is 10% or less.

During the deployment process, the flexible connection or attachment enables one wire mesh structure, such as the first wire mesh structure 3701, to be almost completely opened without the need to deploy the other wire mesh structure, such as the second wire mesh structure 3702. Fig. 38A illustrates the deployment process of the combined intragastric device 3800. As shown, the device 3800 also includes a catheter or outer tube (over-tube)3820, wherein the first wire mesh structure 3801 is nearly or near fully deployed while the second wire mesh structure 3802, which is connected or attached to the first wire mesh structure 3801 via a plurality of sutures 3810, remains continuously constrained within the catheter or spanning tube 3820. In certain embodiments, the catheter 3820 includes a housing and a lumen extending through the housing. In certain embodiments, the diameter of the lumen is less than or equal to 2cm, and more preferably about 0.9 cm. As one wire mesh structure, e.g., the second wire mesh structure 3702, is compressed into a tubular structure (such as an outer tube or catheter) during an extraction or removal process, the flexible coupling or attachment allows for alignment (alignment) of another wire mesh structure, e.g., the first wire mesh structure 3701, to be compressed into the tubular structure. Fig. 38B-38D illustrate the withdrawal or removal process of the combined intragastric device 3800. As shown in fig. 38B, as the second wire mesh structure 3802 is withdrawn into the catheter 3820, for example, through the endoscope 3825 using the grasper 3822, the second wire mesh structure 3802 is partially compressed while the first wire mesh structure 3801 remains unconstrained or in the deployed configuration. As shown in fig. 38C, the plurality of sutures 3810 allow for the alignment (alignment ) or orientation of the first wire mesh structure 3801 for removal for compression into the catheter 3820 as the second wire mesh structure 3802 is fully compressed as it is fully withdrawn into the catheter 3820. Finally, as shown in fig. 38D, as the fully compressed second wire mesh structure 3802 is further withdrawn into the catheter 3820 by use of the endoscope 3825, the aligned or oriented first wire mesh structure 3801 begins to be constrained or compressed into the catheter 3820 for removal. Thus, the flexible connection or attachment enables one wire mesh structure to be compressed or withdrawn and released or deployed independently of another wire mesh structure.

Referring now to fig. 37A-37F, it should be noted that the plurality of sutures 3710 need to be long enough to allow for pivoting, bending, or relative degree of motion of the two

wire meshes

3701, 3702, but short enough to transfer the compressive force from one wire mesh (as it is withdrawn or deployed) to the other. In some embodiments, one wire mesh structure may be compressed by 99% of its equatorial diameter without radially compressing the other wire mesh structure (in embodiments where the first wire mesh structure 3701 and the second wire mesh structure 3702 are substantially spherical), but beyond this length, compression is transmitted. This has the advantage of being resistant to migration, in particular in that, when in the post-deployment configuration, the intragastric device 3700 cannot pass through a completely relaxed pylorus even if one of the two wire mesh structures is substantially compressed. In various embodiments, the length of the connection or stitch point from a node of the second plurality of nodes to a node of the third plurality of nodes ranges from 1mm to twice the diameter of the third opening 3707 of the second wire mesh 3702 (fig. 37A, 37B).

The combined or dual wire mesh intragastric device 3700 of the present invention provides various benefits or advantages over deploying a single large device. First, the combined intragastric device 3700 provides better protection so that the device 3700 does not migrate through the patient's relaxed pylorus. If a single large device is compressed, it can migrate relatively easily through a relaxed pylorus. However, the two

wire meshes

3701, 3702 of the intragastric device 3700 are less likely to both be accidentally compressed, thereby reducing the risk of migration.

Second, a single large device would be relatively inflexible, applying excessive pressure to the inside of the patient's stomach during at least some time. In contrast, the intragastric device 3700 has a sufficiently large post-deployment structure or volume occupied while still minimizing excessive pressure on the stomach wall (and preventing wear on the stomach wall or interior) because the intragastric device 3700 will flex and move (due to the flexible connection or attachment of the two connected wire mesh structures 3701, 3702) to better fit the contours of the stomach. Thus, the intragastric device 3700 of the present invention, when deployed, provides an improved balance and optimization between the need to occupy a larger stomach volume and the need to minimize pressure on the stomach. In various embodiments, when deployed, the intragastric device 3700 occupies 25% to 95% of the stomach volume or patient's stomach volume.

It is to be understood that this disclosure is intended to provide teachings of several exemplary embodiments of the invention and should not be limited to the specific constructions disclosed herein. This application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.

Claims

1. An intragastric device configured to be deployed in a human stomach, the intragastric device comprising:

a catheter comprising a housing and a lumen extending through the housing, wherein the lumen has an inner diameter, and wherein the inner diameter is 2cm or less;

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

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

a connecting portion to flexibly couple the first wire mesh structure and the second wire mesh structure, wherein the connecting portion is formed between a portion of the first wire mesh structure defining the second open surface area and a portion of the second wire mesh structure defining the third open surface area,

wherein the connecting portion is formed between a portion of the plurality of free ends of the first wire mesh structure defining the second open surface area and a portion of the plurality of free ends of the second wire mesh structure defining the third open surface area.

2. The intragastric device of claim 1, wherein said first wire mesh structure and said second wire mesh structure are positioned continuously within said lumen of said catheter.

3. The intragastric device of claim 1, wherein at least one of said first plurality of curved surfaces is defined by an arc segment, and wherein said arc segment is defined by a radius in the range of 0.2cm to 20cm and a central angle in the range of 5 to 175 degrees.

4. The intragastric device of claim 3, wherein at least one of said second plurality of curved surfaces is defined by an arc segment, and wherein said arc segment is defined by a radius in the range of 0.1cm to 15cm and a center angle in the range of 1 to 179 degrees.

5. The intragastric device of claim 1, wherein said first wire mesh structure has at least one of a spherical shape and an elliptical shape.

6. The intragastric device of claim 5, wherein said second wire mesh structure has at least one of a spherical shape and an elliptical shape.

7. The intragastric device of claim 1, wherein said connection comprises a plurality of sutures.

8. The intragastric device of claim 7, 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.

9. The intragastric device of claim 1, wherein a length of a connection from a first point on said second surface area of openings to a second point on said third surface area of openings is in the range of 0.01mm to 200 mm.

10. The intragastric device of claim 8, 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 said third point and said second point is different from said fourth point.

11. The intragastric device of claim 10, wherein a length of a connection from said third point on said second surface area of openings to said fourth point on said third surface area of openings is in a range of 0.01mm to 300 mm.

12. The intragastric device of claim 10, wherein said first flexible suture and said second flexible suture are 180 degrees apart.

13. The intragastric device of claim 10, 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 is different from said first point and said third point and said sixth point is different from said second point and said fourth point.

14. The intragastric device of claim 13, wherein a length of a connection from said fifth point on said second surface area of openings to said sixth point on said third surface area of openings is in a range of 0.01mm to 300 mm.

15. The intragastric device of claim 13, 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 an eighth point on said third surface area of openings, wherein said seventh point is different from said first point, said third point, and said fifth point, and said eighth point is different from said second point, said fourth point, and said sixth point.

16. The intragastric device of claim 15, wherein a length of a connection from said seventh point on said second surface area of openings to said eighth point on said third surface area of openings is in a range of 0.01mm to 300 mm.

17. The intragastric device of claim 1, wherein said first and second wire mesh structures have a degree of motion relative to each other in all directions defined by an angular displacement between a first longitudinal axis passing through a center of said first wire mesh structure, a center of said first surface area of openings, and a center of said second surface area of openings and a second longitudinal axis passing through a center of said second wire mesh structure, a center of said third surface area of openings, and a center of said fourth surface area of openings.

18. The intragastric device of claim 17, wherein said angular displacement is equal to or less than 90 degrees.

19. The intragastric device of claim 1, wherein the length of the connection of said first wire mesh structure to said second wire mesh structure is designed such that said first wire mesh structure can be compressed by 99% of its equatorial diameter without causing compression of said second wire mesh structure.

20. The intragastric device of claim 1, wherein the length of the connection of said first wire mesh structure to said second wire mesh structure is designed such that, at a compression of said first wire mesh structure of more than 90%, the angular displacement of said second wire mesh structure relative to said first wire mesh structure is 10% or less, wherein said angular displacement is defined by the relative angle between a first longitudinal axis passing through the center of said first wire mesh structure, the center of said first opening surface area and the center of said second opening surface area and a second longitudinal axis passing through the center of said second wire mesh structure, the center of said third opening surface area and the center of said fourth opening surface area.

21. The intragastric device of claim 1, wherein said first wire mesh structure and said second wire mesh structure are connected within said lumen of said catheter by said connection.

22. The intragastric device of claim 1, wherein said first wire mesh structure and said second wire mesh structure are not connected within said lumen of said catheter by said connection.

23. The intragastric device of claim 1, wherein said connection is formed by interweaving between a portion of the plurality of free ends of said second surface area of openings and a portion of the plurality of free ends of said third surface area of openings.

24. The intragastric device of claim 1, wherein said second volume and said fourth volume together occupy 25% to 95% of the stomach.

25. 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 patient's duodenum, 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 pass food from said intragastric device to said duodenum.

26. The 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 a volume of said first wire mesh structure is greater than 5ml and less than 5000 ml.

27. The intragastric device of claim 26, wherein said second wire mesh structure has at least one of a spherical shape and an elliptical shape, and wherein a volume of said second wire mesh structure is greater than 20ml and less than 4000 ml.

28. An intragastric device configured to be deployed in a human stomach, the intragastric device comprising:

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

a second wire mesh structure having a pre-deployment shape compressed within the lumen of the catheter and a post-deployment shape expanded within the human stomach, wherein a third volume of the pre-deployment shape is equal to or less than 100ml and a second length is equal to or less than 70cm, and wherein the post-deployment shape has a porous and closed fourth volume defined by a second plurality of curved surfaces and equal to or greater than 110ml, the first wire mesh structure further comprising an upper portion and a lower portion, wherein the upper portion has a third open surface area configured to allow material to pass from outside the fourth volume to inside the fourth volume, and wherein the lower portion has a fourth open surface area;

a plurality of flexible members to flexibly couple the plurality of free ends of the first wire mesh structure and the plurality of free ends of the second wire mesh structure, wherein the plurality of flexible members includes a first flexible member attached at one end to a first point on the second open surface area and attached at a second end to a second point on the third open surface area, and the plurality of flexible members includes a second flexible member attached at one end to a third point on the second open surface area and attached at a second end to a fourth point on the third open surface area, wherein the first point is different from the third point, and wherein the second point is different from the fourth point.

29. The intragastric device of claim 28, wherein a length of said first flexible member from said first point on said second surface area of openings to said second point on said third surface area of openings is in a range of 0.01mm to 300 mm.

30. The intragastric device of claim 29, wherein a length of said second flexible member from said third point on said second surface area of openings to said fourth point on said third surface area of openings is in a range of 0.01mm to 100 mm.

31. The intragastric device of claim 28, wherein said first flexible member and said second flexible member are 180 degrees apart.

32. The intragastric device of claim 28, wherein said plurality of flexible members includes 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 said first point and said third point, and wherein said sixth point is different from said second point and said fourth point.

33. The intragastric device of claim 32, wherein a length of said third flexible member from said fifth point on said second surface area of openings to said sixth point on said third surface area of openings is in a range of 0.01mm to 300 mm.

34. The intragastric device of claim 32, wherein said plurality of flexible members includes 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 an eighth point on said third surface area of openings, wherein said seventh point is different from said first point, said third point, and said fifth point, and wherein said eighth point is different from said second point, said fourth point, and said sixth point.

35. The intragastric device of claim 34, wherein a length of said fourth flexible member from said seventh point on said second surface area of openings to said eighth point on said third surface area of openings is in a range of 0.01mm to 100 mm.

36. The intragastric device of claim 28, wherein said first and second wire mesh structures have a degree of motion relative to each other in all directions defined by an angular displacement between a first longitudinal axis passing through a center of said first wire mesh structure, a center of said first surface area of openings, and a center of said second surface area of openings and a second longitudinal axis passing through a center of said second wire mesh structure, a center of said third surface area of openings, and a center of said fourth surface area of openings.

37. The intragastric device of claim 36, wherein said angular displacement is equal to or less than 90 degrees.

38. The intragastric device of claim 28, wherein each of said plurality of flexible members has a length such that said first wire mesh structure can be compressed 95% of its equatorial diameter without causing compression of said second wire mesh structure.

39. The intragastric device of claim 28, wherein each of said plurality of flexible members has a length such that, upon compression of said first wire mesh structure by more than 90%, an angular displacement of said second wire mesh structure relative to said first wire mesh structure is 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 said first opening surface area, and a center of said second opening surface area, and a second longitudinal axis passing through a center of said second wire mesh structure, a center of said third opening surface area, and a center of said fourth opening surface area.