Endoscopic adjustable gastric barrier eagb

Abstract

The Endoscopic Adjustable Gastric Barrier represents a groundbreaking innovation in the management of obesity, offering a unique, minimal invasive approach without the complications and limitation of other currently available interventional managements., this revolutionary technique works by dividing the stomach into a smaller, tube-like space for food, without altering the stomach's natural anatomy or functions. This preserves the stomach's function to produce hormones and digestive juices, while effectively reducing food intake hence significant weight loss. What makes this innovation (EAGB) unique is its adjustability and reversibility, and when ideal weight is achieved it can be removed endoscopically. It is secured to the stomach by clips with minimal injury and without risk of necrosis and leak. Additionally, all endoscopic and laparoscopic interventions are possible as normal population.

Description

[0001] Description

[0002] Title of the innovation: Endoscopic Adjustable Gastric Barrier EAGB

[0003] Field of innovation:

[0004] Endoscopic management of obesity

[0005] Endoscopic Adjustable Gastric Barrier used in management of obesity and introduced Endoscopically through OGD and decrease the capacity of stomach as a reservoir without affecting other functions of stomach

[0006] Background:

[0007] Obesity is considered a disease according to WHO definition and it's a risk factor of other diseases such as hypertension, diabetes and many types of cancer, and because of this concern management of obesity considered one of the challenges for hospitals and communities and good budget consumed on it.

[0008] Surgical and minimal invasive procedures took their share in the management of obesity, and they have their advantage and disadvantage in the form of early and late complications.

[0009] Sleeve gastrectomy done by laparoscopy and divide stomach by endo-staplers

[0010] And only a tube-like stomach remains, and major part of the stomach is removed thus decreasing the capacity of stomach permanently and thus weight loss.

[0011] Gastric bypass: this type of operation consists of bypassing stomach and duodenum and majority of jejunum this its malabsorptive procedure mean that most of the food is not absorbed and lead to lose weight.

[0012] Endoscopic sleeve gastroplasty: this technique by Applying stich to the stomach endoscopically and decrease it capacity to food and lead to lose weight.

[0013] Balloon: fluid containing balloons occupying stomach to decrease its capacity for foods and balloons maybe inserted endoscopically or without endoscopy

[0014] And this is service as a temporary measure for weight loss and will require removal by endoscopy or will leave stomach spontaneously. Gastric bands: this is applying a band from outside of stomach to decrease the propagation of food to stomach and small intestine and thus lose weight.

[0015] Technical problem:

[0016] Sleeve gastroplasty: it is a restrictive type of surgery by laparoscopy under general anesthesia, consist of removal of 80-85% of stomach and thus affecting capacity of stomach

[0017] Problems can be classified according to early and late, early such as bleeding and leak the latter is most serious problem and its management is challenging to the surgeon and disaster to the patient, late is due to affecting physiological and hormonal function of stomach leading to vitamin deficiency and problem associated with that, and dumping syndrome also my occur, and contra indicated in case of GORD

[0018] Gastric bypass: it's a malabsorptive type of surgery it done under GA by laparoscopy, it associated with more severe vitamin and mineral deficiency than sleeve gastrectomy it has complication as leak, bleeding and in some cases afferent loop syndrome and closed stomach dilatation without possibility of endoscopically management, and future need for ERCP is difficult or impossible

[0019] Endoscopic sleeve gastroplasty: done under sedation or GA and it restrict the stomach by multiple stiches applied endoscopically, this led to change morphology of stomach and if ulcer and tumor develop in the folded stomach it's difficult to diagnose and examine endoscopically.

[0020] Intragastric balloon: this will occupy stomach and give feeling of fullness all the time it has pain I the first few days and patient my not tolerate and seek to remove it and it has less weight loss in comparison to other techniques and last 1 year as a maximum.

[0021] Solution to problems:

[0022] EAGB expected to have effect on the weight loss same as sleeve gastroplasty

[0023] As mentioned in the previous section the problems of the previous approaches and techniques, EAGB solves those problems and is differ to other techniques

[0024] In comparison to Sleeve gastroplasty: EAGB does not involve resection of any part of stomach and will not affect the anatomy ,th is point is important as physiological effect of stomach not affected and the procedure is reversible when needed or indicated, EAGB is inserted and fixed by clips endoscopically under sedation and serosal layer of stomach not bridged and if bridged by clips they will be closed when the clips applied and thus no risk of leak or bleeding and no risk of vitamin deficiency as intrinsic factor production not affected

[0025] Preserving the anatomy of stomach has the advantage of using that stomach in future procedure when indicated as in fundoplication.

[0026] Comparison to gastric bypass: there is no malabsorptive portion in EAGB and thus no vitamin deficiency and no risk of bleeding and leaks, and anatomy of Gl tract not affected making examination of stomach is possible due to EAGB design and ERCP is possible

[0027] Comparison to Intragastric balloon: this cause feal of fullness and patient discomfort but EAGB will not cause that as it's a physical barrier not space occupying object, balloon its temporary because maximuml year but EAGB can be used temporarily or permanently as indicated, when patient wishes or decided by the manufactured material.

[0028] Comparison to Endoscopic sleeve gastric barrier: EAGB design allows to future examination of the stomach through OGD and screening and detection of mucosal lesions and bleeding without affecting the function of the barrier

[0029] Comparison summary:

[0030] 1- EAGB will be inserted by Endoscopy under sedation and no need for intubation or GA thus less or no problems in relation to anesthesia.

[0031] 2- EAGB will be fixed by clips and not injure serosa and not leaving serosal defect thus no risk of leak and bleeding.

[0032] 3- EAGB works as a physical barrier that decreases the capacity of stomach as preferred and suitable to anatomy of stomach to a great extent and not causing over inflation of stomach as by balloons and thus patient more comfortable.

[0033] 4- EAGB does not affect the physiological effect of stomach as the excluded part of stomach still functions and its secretion drained to distal part of stomach, this means no deficiency in intrinsic factors and no vitamin and mineral deficiency.

[0034] 5- EAGB design allows for future examination of stomach as screening or interventions without leaving effect of the function of the EAGB.

[0035] 6- It allows the other procedure to be done in future like fundoplication as the fundus is excluded but preserved, and ERCP is possible

[0036] 7- It can be inserted temporarily and permanently depending on the patient's wish and goals and depending on the material used.

[0037] Brief Description of Drawings

[0038] Figure 1: This figure shows the endoscopic adjustable gastric barrier and shows the passage of food from the esophagus to the duodenum through a tube-like space.

[0039] Figure 2: This figure shows the endoscopic adjustable gastric barrier, illustrated on the central cleft in the barrier. This cleft facilitates the fixation of the barrier to the stomach and the cleft is closed by endoscopic clips and it can be opened when needed with endoscopic clips removal to allow future endoscopic examination of the stomach if necessary

[0040] Figure 3: This figure shows the EAC after fixation the clip arms introduced through special opening in the EAGB, the clips sharp arm penetrates the opening in the other arm in this figure the clips are used to secure the endoscopically adjustable barrier in place inside the stomach.

[0041] Figure 4: This image shows the endoscopically adjustable gastric barrier and the circular opening that allows for introducing the clips arm and in between there is larger oval opening to grasp the mucosa toward the clips center. The image shows the passing the clip arms through the opening and securing it to the stomach wall.

[0042] Figure 5: This figure shows the central cleft in the endoscopically adjustable gastric barrier and its shape, with an oval opening for gripping the mucous membrane and a circular opening for the endoscopic clips. The figure clearly shows the design details of the barrier, and the openings used to secure it to the stomach with clips.

[0043] Figure 6: This figure shows the endoscopically adjustable gastric barrier as it would appear through the endoscope. It elaborates how the barrier appears inside the stomach when using the endoscope, explaining the monitoring and evaluation of its function, as well as in identifying any potential issues or complications.

[0044] Figure 7: This figure displays the endoscopically adjustable gastric barrier with membrane-like extensions from its edges, it works as one-way valve to prevent food from bypassing the barrier. These membrane-like extensions demonstrate how the barrier's ability to restrict food passage is enhanced, preventing it from entering the excluded part of stomach.

[0045] Figure 8: This figure shows the distal end functioning as a one-way valve, allowing gastric juices to pass into the duodenum while preventing food from entering the excluded part of stomach beyond the endoscopically adjustable gastric barrier.

[0046] Detailed description of the invention:

[0047] The EAGB is barrier work as a physical barrier which divide stomach and create ad decrease its capacity as reservoir for food, its inserted by Endoscopy (double channel preferred) and fixed to the wall of stomach by specialized clips (Endoscopic Anchoring Clips), it has an extra thin distal extension which works as a one way valve allowing the passage of secretions from the excluded part of stomach to the pylorus and same extension found on the sides to more securing and work on intragastric pressure to push the EAGB to the wall of stomach, EAGD has a slit int its center which facilitate the fixation and allows future Endoscopic examination of excluded part of stomach and this will be closed at the end of the procedure by clips, EAGB also has special points for insertion of the clips and slits for grasping the mucosa, the importance of delivery the mucosa toward the lumen make sure great bite including submucosa to be pierced, EAGB can be manufactured in different size and material according to the cost and assumed time to remain inside stomach and the material should be non-cancerous , extra soft and flexible like polyurethane and silicon's

[0048] Equipment's:

[0049] 1- Endoscopic Adjustable Gastric barrier

[0050] 2- OGD (double channel)

[0051] 3- Over tube to be inserted to Esophagus.

[0052] 4- Endoscopic grasper

[0053] 5- Endoscopic anchoring clips.

[0054] This procedure is done as a day case procedure and the patient should be NPO for at least six hours to ensure empty stomach, and it's done under sedation with estimated time of procedure is 30 to 40 minutes.

[0055] Application Steps:

[0056] 1- First endoscopic examination of the stomach was done for assessment of the mucosa and exclusion of any mucosal lesions and abnormal vascular pattern, and to measure the length from pylorus to GEJ to choose appropriate EAGB.

[0057] 2- Over tube inserted to cover the esophagus and protect its mucosa from multiple esophageal intubations by OGD

[0058] 3- EAGB inserted and left inside stomach

[0059] 4- The grasper introduced from an OGD channel and the clip from the other channel

[0060] 5- The mucosa is grasped and pulled through the slit and clips applied from its special opening, and this will fix the EAGB to the wall of stomach, these are specialized clips which anchor without causing ischemia and thus last as long as needed

[0061] 6- The proximal end and distal ends are fixed and distant from GEJ is decided by the operating surgeon as indicated such as in the case of GERD prefer to make a space for food to prevent regurgitation.

[0062] 7- Last the patient recovers and put on soft diet for next few days and then start regular diet and follow up

Claims

claims:

1. Endoscopic Adjustable Gastric Barrier2. According to claim (1), the adjustable gastric barrier is an interventional management for obesity and is performed endoscopically under sedation or general anesthesia.

3. According to claim (1), the adjustable gastric barrier divides the stomach, leaving a tube-like space for food passage without distorting or removing any part of the stomach. It does not affect the stomach's function in producing hormones, intrinsic factors, or gastric juices, which are propagated to the distal end of stomach and duodenum by the pressure of stomach movements. In the distal part of the barrier there is a membrane that acts as a one-way valve.

4. According to claim (1), the adjustable gastric barrier is fixed in the stomach by clips (endoscopic anchoring clips) that penetrate the stomach layers without causing ischemia and necrosis in the clipped part of the stomach, and therefore, the clips are not displaced and remain in place as needed5. According to claim (1), the adjustable gastric barrier allows for post-operative examination of the stomach for diagnostic and therapeutic purposes, as it contains a cleft in the center of the barrier that can be closed with clips, then clips can be removed, and reapplied again after the endoscopic examination.

6. According to claim (1), the adjustable gastric barrier can be made of polyurethane or silicone or any other type of material with high flexibility, softness, and safety for use in the human body.

7. According to claim (1), the adjustable gastric barrier can be used temporarily or permanently. It can be removed when achieving the ideal weight or when the patient's request or used for a long period to achieve ideal weight.

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