Methods and devices for medical implants

Abstract

A method of minimally invasive alleviating at least one of reflux disease and obesity of a patient can include attaching a permanent stent to a ring, and inserting the combined permanent stent and ring into an esophagus of a patient through a mouth of the patient prior. A top of the permanent stent can be off-set from a top of the ring.

Description

[0001] METHODS AND DEVICES FOR MEDICAL IMPLANTS

[0002] FIELD

[0003] The presently disclosed technology relates generally to medical devices, prosthesis, and methods of using and / or implanting same. More particularly, one embodiment of the presently disclosed technology relates to methods and devices to place long-term implants in the wall and / or lumen of the esophagus of a patient to treat any of a variety of ailments, including but not limited to gastro-esophageal reflux disease and / or obesity, often without surgery.

[0004] BACKGROUD

[0005] Obesity, for example, affects up to 40% of the world population. Removal of portions of the stomach, sometimes referred to as sleeve-gastrectomy, and gastric by-pass are known treatments that are invasive and challenging procedures. Developing safe and relatively non-invasive methods of treatment could have an important impact on large segments of the population.

[0006] New state of the art clinical trials in drug development show that obesity treatments also improve diabetes, and possibly heart disease, as seen with the new GLP-1 agonist therapies (e.g., semaglutide, Ozempic™) and other similar drugs (e.g., exenatide, liraglutide, duraglutide and tirzepatide (Mounjaro™).

[0007] Reflux is an ailment that also affects a large portion of the world population. It is known to use a prosthesis to treat Gastro-Esophageal Reflux Disease (GERD) and / or to help a patient reduce their weight. Examples of such prior art devices are disclosed in WO 2019 / 155284, WO 2018 / 222819, and WO 2013 / 050381, which are hereby incorporated by reference.

[0008] Despite benefits, existing methods and devices used to treat reflux and / or obesity have drawbacks. For example, in WO 2019 / 155284, the mesh ring is not attached to the helical spring ring with sutures and the device tends to fall into the stomach before it can be integrated into the wall.

[0009] BRIEF SUMMARY

[0010] While the prior art systems are beneficial in numerous ways, the systems, methods and devices of the presently disclosed technology provide benefits over what is currently known in the art. In one optional embodiment, the presently disclosed technology is directed to a stent, sometimes referred to as a permanent stent because it is intended to remain in the esophagus permanently or indefinitely. This permanent stent can hold itself and or other devices, including eluting devices that can incorporate or hold different functions.

[0011] Referring to WO 2018 / 222819, a challenge with a thicker ring that does not have springs to hold the ring against the wall of the esophagus is that the food could be blocked within the device where the food should pass. If a spring is included, the thickness of the wall will be less important as the ring can expand more easily and the food is able to pass. Alternatively, if sutures are placed to hold the ring (even where there are no springs as described later) to a permanent stent, the permanent stent can expand the ring of the devices and the wall can also be thinner and the food can pass more easily.

[0012] One challenge is to place one or more devices with relatively thin walls, which can mean either reinforced by springs to avoid polymer walls only (usually implant grade silicon) that are too thick and can block the passage of food, or to attach the ring of an anti-reflux device (e.g., Gastro-intestinal Anti-Reflux Devices (GARD™)) with sutures to another device such as a new type of permanent stent, incorporated in the esophageal wall, which is described herein, or use springs for long lasting devices (e.g., Therapeutic-GARD™ (Th- GARD™)). The anti-reflux device can stay temporarily or short term (e.g., weeks) in the esophagus with spring pressure only, which can decrease peristalsis but not sufficiently to keep the devices in the esophagus long-term.

[0013] In order to place a device for longer-term (e.g., for months or years) in the esophagus, a permanent stent can be placed in the esophagus. Therapeutic devices (e.g., GARD for GERD or Obesity devices) can then be attached or fixed to the permanent stent using a variety of methods.

[0014] In one optional embodiment, a temporary medical device, the Diagnosis and Management GARD™ is placed in the esophagus after careful balloon calibration of the diameter of the esophagus with a balloon and the proper size device (diameter in millimeters) is then chosen. Optionally, it can be preferred not to use devices that are self-expandable, as it can be challenging to be sure of the pressure exerted on the esophageal wall to stay long-enough in the esophagus. As a result, careful calibration and appropriate choice of the diameters of the devices can be important at this stage since it guarantees placement against the esophageal wall and an idea of the pressure exerted (enough to hold the devices in place but not too much to cause serious lesions to the esophageal wall).

[0015] Optionally, a preferred placement of the Diagnosis and Management GARD™ (see FIG.l) has two reasons: the first one is to determine if the active or tubular part of the device below the ring help decrease the patient's symptoms of GERD essentially and for obesity allows patients to eat normally if they cut their food properly and chew carefully and see if they tolerate the device and want placement of a long-term device or adapt the length of the tube to their symptoms and comfort.

[0016] A challenging and yet untreated condition that could be treated by the GARD™ for GERD devices is to determine if a patient who has Refractory GERD, which is a condition that by definition does not respond to Proton pump inhibitors are improved by the devices described herein.

[0017] Refractory GERD is often associated with bile in the stomach that comes back up from the duodenum and gastric hydrochloric acid (HCI) secreted by the stomach, which can cause a mild acid reflux but is serious as some basic research has shown that a mix of bile and acid could increase the risk of precancerous lesions of the esophagus (Barrett's esophagus) and adenocarcinoma. That is why before considering placing devices described herein in the esophagus, in addition to measuring the esophageal diameter with a calibration balloon and graduation block / card, careful biopsies of the esophagus should be done to rule out any precancerous or cancerous lesions of the esophagus that are contra-indications to the use of the devices described herein.

[0018] Another important reason to position a DM-GARD™ in place, is that the ring of the DM-GARD™ exerts pressure on the esophageal wall and compresses the wall without causing a lesion if the proper diameter is chosen. The wall of the esophagus is about 3 mm wide and any perforation can cause serious infections, such as mediastinitis. Once removed, the DM-GARD™ leaves a "niche" or depression in the wall of the esophagus. This will allow the placement of our long-term (possibly indefinite) permanent stent in the wall of the esophagus, that will not be placed if the efficacy and tolerance of the DM- GARD™ has not been demonstrated. As the placement of the permanent stent helps keep the devices in position long-term (e.g., months and years), it can be helpful to position the Th-GARD™ in relation with the permanent stent. To make this phase easier, certainly in the beginning, but also long-term, it is possible to bind the Th-GARD™ to the permanent stent immediately, using the easiest removable technique which are simple sutures. The advantage of sutures is that they are solid, easy to place and easy to cut at endoscopy if needed. Other techniques such as tilt-tag staples and removable staples can also be options, but it may be beneficial to reserve those for replacement devices.

[0019] With time, food in the esophagus / stomach can affect the devices described herein in the esophagus and will possibly need replacement. The first Th- GARD™ sutured on the permanent stent can be cut, the first Th-GARD™ can then be removed and replaced by a new one. The new replacement device can be adapted to the patient's conditions, with versions that block more reflux or less reflux or identical, shorter or longer OB-Tubes.

[0020] Existing techniques such as Endoscopic Mucosal Resection (EMR) and Endoscopic Submucosal Dissection (ESD) could be adapted as needed to remove the first Th-GARD™, review the permanent stent in place and place the replacement Th-GARD™.

[0021] Thus, in one optional embodiment, after a diagnostic / preparation endoscopy done in any case for these patients, a healthcare professional would:

[0022] 1. Place a Diagnosis and Management GARD (DM-GARD); and

[0023] 2. Then place the permanent stent with the Th-GARD™.

[0024] The most common reason for treatment of lesions of the esophagus is GERD. GERD is almost always treated with Proton Pump Inhibitors and / or antacids that block acid production so that the reflux is much less or not acidic anymore and the esophageal lesions heal.

[0025] All of the above can be done at standard endoscopy through the mouth, so no open or laparoscopic surgery.

[0026] In one optional embodiment, the presently disclosed technology is directed to a device and method used to implant a variety of Gastro-intestinal Anti-Reflux Devices (GARD™) placed minimally-invasively or non-invasively through the mouth of the patient to treat gastro-esophageal reflux disease and obesity with autologous biological compounds.

[0027] It is noted that the term GARD™ can refer to a Gastro-intestinal Anti-Reflux Device, as mentioned above, but the term GARD™ can also refer herein to a Gastroesophageal Anti-Reflux Device.

[0028] Optionally, the presently disclosed technology includes different versions of a technique to hold a Permanent stent within the esophageal wall, as the Permanent stent can help support new medical devices to treat first GERD and Obesity, as well as other applications in gastroenterology if the technique is applied in the duodenum or colon for example. Then a series of potential other applications in cardiology, pulmonary medicine, spine medicine, pancreatic surveillance and other applications can be considered with the development of Al and imaging techniques where different devices can be placed in the intermediary soft-wall and optionally an elastic wall silicon ring can be employed.

[0029] In one embodiment, the presently disclosed technology includes a Permanent stent configured to be placed in a patient to treat any of a variety of ailments. The permanent stent can include a plurality of spaced-apart horizontal supports and a plurality of spaced-apart vertical supports. Each of the plurality of spaced-apart vertical supports can extend from a bottom-most one of the plurality of spaced-apart horizontal supports to top-most one of the plurality of spaced-apart horizontal supports. The permanent stent can further include a plurality of spaced-apart connectors. Each connector can be positioned between a pair of the plurality of spaced-apart horizontal supports and a pair of the plurality of spaced-apart vertical supports. A unique feature of this permanent stent is that Th-GARD™ device is fixed to the permanent stent creating a device that can be called "2 in 1".

[0030] Optionally, the device can be held in place for more than 6 months, and optionally from 3 to 5 years or forever. For example, a permanent stent can be configured to stay in place in the wall of the esophagus and help keep the Th- GARD™ for this length of time safely in the esophageal lumen. Presently the DM1-GARD™ stays in place on its own up to 4 months in the esophageal lumen, but after that period of time falls into the stomach. A healthcare professional can determine if the permanent stent can help hold the Th- GARD™ in place and the best method to do so. The therapeutic part (e.g., lamellar or tubular tube) can be removed and exchanged safely over time so when food or acid impacts the active part of the device, it can be exchanged.

[0031] BRIEF DESCRIPTION OF THE DRAWINGS.

[0032] The foregoing summary, as well as the following detailed description of the presently disclosed technology, will be better understood when read in conjunction with the appended drawings, wherein like numerals designate like elements throughout. For the purpose of illustrating the presently disclosed technology, there are shown in the drawings various illustrative embodiments. It should be understood, however, that the presently disclosed technology is not limited to the precise arrangements and instrumentalities shown. In the drawings:

[0033] FIG 1 illustrates a Diagnosis and Management (DM) GARD™ according to one embodiment of the presently disclosed technology;

[0034] FIG 2A illustrates a tubular-type GARD™ for GERD;

[0035] FIG 2B illustrates a lamellar-type GARD™ for GERD;

[0036] FIG 2C illustrates a reversed lamellar-type GARD™for GERD during vomiting;

[0037] FIG 3A illustrates one type of Obesity GARD™ according to one embodiment of the presently disclosed technology;

[0038] FIG 3B illustrates another type of Obesity GARD™ according to one embodiment of the presently disclosed technology;

[0039] FIG 3C illustrates yet another type of Obesity GARD™ according to one embodiment of the presently disclosed technology;

[0040] FIG 4A illustrates normal layers of the esophageal wall of a human being;

[0041] FIG 4B illustrates adult stem cells at the level of the basal membrane of the esophageal epithelium;

[0042] FIG 5 shows a niche created by the ring of the DM-1 GARD™ compressing the different layers of the esophageal wall. FIG 6 illustrates different layers of the esophageal wall with the depth of penetration (level) of different methods of endoscopic resection of the esophageal wall;

[0043] FIG 7 illustrates that after mucosal resection (X), biopsy forceps can be used;

[0044] FIG 8A illustrates one embodiment of the presently disclosed technology where a delivery catheter with a balloon that is used to deploy the mesh ring held on the delivery catheter with a stretchable magnetic bead ring;

[0045] FIG 8B shows the inflated balloon pressing the mesh ring on the bleeding niche where platelet-rich plasma (PRP) and calcium gluconate were sprayed to integrate the mesh ring in the coagulating blood;

[0046] FIG 8C shows the magnetic bead ring that has been removed by pulling on threads and the net ring is pressed with the balloon against the wall of the niche. The slip knot on the tube is still in place and holds the GARD™ for GERD device allowing removal of the magnetic beads while keeping the position of the device;

[0047] FIG 9A illustrates one embodiment of the presently disclosed technology, wherein instead of a balloon, a helical spring ring is placed inside the mesh ring and folded on the delivery, similarly to the introduction of the DM GARD™. Knots are holding the mesh ring on the helical spring to avoid any displacement of the mesh ring when the slip knots are pulled out and the helical spring is deployed;

[0048] FIG 9B illustrates that the surgical threads holding the mesh ring will be cut or pulled endoscopically once the helical spring is deployed and the mesh ring is in contact with the patient's blood, PRP and calcium gluconate in the bottom of the niche;

[0049] FIG 9C illustrates that the helical spring is delicately removed and pulled out leaving the mesh ring in place in contact with the coagulating mixture in the bottom of the niche;

[0050] FIG 9D illustrates that the mesh ring is free in the bleeding niche with PRP and gluconate calcium. The slip knot holding the tubular part of the GARD™ for GERD is still in position to maintain device in place; FIG 10A illustrates that fragments of the biopsies of the epithelium cells obtained in the beginning of the procedure with or without cultured epithelial cells obtained when the DM GARD™ was placed originally are sprayed in a PRP / calcium gluconate solution on the "luminal" side of the mesh to reconstitute the esophageal epithelium;

[0051] FIG 10B illustrates that the mesh ring is now "sandwiched" between the bottom of the coagulating niche and the reconstituted autologous epithelium of the esophageal wall;

[0052] FIG 11A shows the different layers of the normal esophageal wall;

[0053] FIG 11B illustrates the different depths of placement of the mesh ring depending how deep the mucosal resections are according to one embodiment of the present disclosed technology;

[0054] FIG 12 illustrated a ring of one embodiment of the presently disclosed technology that is used at the end of the procedure to compress the area once the mesh has been covered with epithelial cells and the ring is left in position for a period of time before possible removal. All other remaining devices have been removed from the esophagus. The slip knot is removed from the tube and the tube opens;

[0055] FIG 13A is a top perspective view of a permanent stent or ring of one embodiment of the presently disclosed technology;

[0056] FIG 13B is a side perspective view of the device shown in FIG 13A;

[0057] FIG 13C is a perspective view of the device shown in FIG 13A attached or glued to a tubular part;

[0058] FIG 14A is a top perspective view of a medical device or Permanent stent of another embodiment of the presently disclosed technology;

[0059] FIG 14B is a perspective view of the device shown in FIG. 14A attached or glued to a lamellar or grooved tubular part;

[0060] FIG 14C is a perspective view of the device shown in FIG 14A attached or glued to a smooth tubular part; FIG 15A is a series of perspective views of a lamellar or grooved tubular part, the device shown in FIG 14A, and a combination of the two;

[0061] FIG 15B is a schematic perspective view of the device shown in FIG 14A with points of suture or stitches to attach the device to a ring;

[0062] FIG 15C is a schematic perspective view of an upper end of the device shown in FIG 14A with surgical threads extending therethrough to attach to a ring according to one technique of the presently disclosed technology;

[0063] FIG 15D is a schematic perspective view of an upper end of the device shown in FIG 14A with surgical threads extending therethrough to attach to a ring according to another technique of the presently disclosed technology;

[0064] FIG 16A is a perspective view of a lamellar or grooved tubular part having a magnetic wrap on a portion thereof;

[0065] FIG 16B is a partially or completely magnetic medical device or Permanent stent in the style of that shown in FIG 14A;

[0066] FIG 16C is a side elevational view of a portion of a magnetic medical device or sent of one embodiment of the presently disclosed technology;

[0067] FIG 16D is a cross-sectional view of a portion of several components of one embodiment of the presently disclosed technology in combination;

[0068] FIG 16E is another cross-sectional view of a portion of several components of another embodiment of the presently disclosed technology in combination;

[0069] FIG 17A is a cross-sectional elevation view of several components of one embodiment of the presently disclosed technology placed within a patient;

[0070] FIG 17B is an enlarged, cross-sectional view of a portion of a device of one embodiment of the presently disclosed technology within the patient;

[0071] FIG 18A is a perspective view of a magnetized ring being inserted into the device shown in FIG 14A in accordance with one embodiment of the presently disclosed technology; FIG 18B is a perspective view of the ring inside the medical device shown in FIG 18A;

[0072] FIG 18C is a perspective view of a tube and helical ring being inserted into the combined device shown in FIG 18B;

[0073] FIG 18D is a cross-sectional view of a portion of the combination shown in FIG 18C;

[0074] FIG 19A is a perspective view of a non-magnetized ring being inserted into the device shown in FIG 14A in accordance with one embodiment of the presently disclosed technology;

[0075] FIG 19B is a perspective view of the ring inside the medical device shown in FIG 19A;

[0076] FIG 19C is a perspective view of a tube and helical ring being inserted into the combined device shown in FIG 19B;

[0077] FIG 19D is a cross-sectional view of a portion of the combination shown in FIG 19C;

[0078] FIG 20A is a perspective view of a lamellar or grooved tubular part having a magnetic wrap on a portion thereof and a helical spring attached thereto;

[0079] FIG 20B is another version of a partially or completely magnetic medical device or Permanent stent in the style of that shown in FIG 14A, wherein the magnets are located on the inside of the permanent stent;

[0080] FIG 20C is a side elevational view of a portion of a magnetic medical device or sent according to one embodiment of the presently disclosed technology;

[0081] FIG 20D is a perspective view of a Th-GARD™ being inserted into the device shown in FIG 20B;

[0082] FIG 20E is a perspective view of a Th-GARD™ inside the device shown in FIG 20B;

[0083] FIG 20F is a perspective view of a Th-GARD™ inside the device shown in FIG 20B; FIG 20G is a perspective view of a Th-GARD™ inside the device shown in FIG 20B;

[0084] FIG 21 is a perspective view of the device shown in FIG 20B attached to a lamellar or grooved Therapeutic GARD™ in or at a specific location according to one embodiment of the presently disclosed technology;

[0085] FIG 22 is a perspective view of the device shown in FIG 20B attached to a tubular Therapeutic GARD™ in or at the specific location according to one embodiment of the presently disclosed technology;

[0086] FIG 23 is a perspective view of one stage of installation of one or more medical devices or prostheses inserted into a patient;

[0087] FIG 24 is a perspective view of one or more medical devices or prostheses inserted into a patient according to one embodiment of the presently disclosed technology;

[0088] FIG 25 is an alternative version of the medical devices or prostheses shown in FIG 24 inserted into the patient;

[0089] FIG 26 is another alternative version of the medical devices or prostheses shown in FIG 24 inserted into the patient;

[0090] FIG 1 is a perspective view of a medical device or prostheses inserted into a patient according to one embodiment of the presently disclosed technology;

[0091] FIG 28 is a perspective view of a medical device or protheses inserted into a patient according to one embodiment of the presently disclosed technology;

[0092] FIG 29 is a magnified view of area surrounded by the broken line circle in FIG 28;

[0093] FIG 30 is a perspective view of a medical device or protheses inserted into a patient according to one embodiment of the presently disclosed technology;

[0094] FIG 31 is a perspective view of a medical device or protheses inserted into a patient according to one embodiment of the presently disclosed technology; FIG 32 is a perspective view of a medical device or permanent stent of another embodiment of the presently disclosed technology;

[0095] FIG 33 is a perspective view of a medical device or permanent stent of another embodiment of the presently disclosed technology;

[0096] FIG 34 is a magnified view of an upper portion or third of the permanent stent shown in FIG 32 or FIG 33, wherein sutures are shown extending at an angle with respect to vertical bars of the permanent stent;

[0097] FIG 35 is a perspective view of a medical device or permanent stent of another embodiment of the presently disclosed technology;

[0098] FIG 36 is a perspective view of a medical device or permanent Stent of another embodiment of the presently disclosed technology;

[0099] FIG 37 is a perspective view of a medical device or permanent Stent of another embodiment of the presently disclosed technology; and

[0100] FIG 38 is a perspective view of the Permanent Stent of FIG 37 being attached to a Th-GARD™ without a helical ring in accordance with one embodiment of the presently disclosed technology;

[0101] FIG 39 is a perspective view of the Permanent Stent of FIG 37 being attached to a Th-GARD™ with a replacement GARD and a helical ring in accordance with one embodiment of the presently disclosed technology;

[0102] FIG 40 is a perspective view of a medical device or permanent Stent of another embodiment of the presently disclosed technology;

[0103] FIG 41 is a perspective view of a medical device or permanent Stent of another embodiment of the presently disclosed technology;

[0104] FIG 42 is a perspective view of a medical device or permanent Stent of another embodiment of the presently disclosed technology; and

[0105] FIG 43 is a perspective view of a medical device or permanent Stent of another embodiment of the presently disclosed technology.

[0106] DETAILED DESCRIPTION While systems, devices and methods are described herein by way of examples and embodiments, those skilled in the art recognize that the presently disclosed technology is not limited to the embodiments or drawings described. Rather, the presently disclosed technology covers all modifications, equivalents and alternatives falling within the spirit and scope of the appended claims. Features of any one embodiment disclosed herein can be omitted or incorporated into another embodiment.

[0107] Any headings used herein are for organizational purposes only and are not meant to limit the scope of the description or the claims. As used herein, the words "may" and "can" are used in a permissive sense (i.e., meaning having the potential to or optionally) rather than the mandatory sense (i.e., meaning must). Unless specifically set forth herein, the terms "a," "an" and "the" are not limited to one element but instead should be read as meaning "at least one." The terminology includes the words noted above, derivatives thereof and words of similar import.

[0108] The method according to one embodiment of the presently disclosed technology includes GARDs™ placed through the mouth of a patient after calibration of the diameter of the patient's esophagus to select appropriately sized devices with a new Therapeutic Endoscopy technique to which autologous biological compounds are added, called a Therapeutic BIO- Endoscopy (TBE) procedure.

[0109] In one embodiment, first a DM GARD™ is placed to evaluate tolerance and efficacy but also to create a circular pressure niche in the esophageal wall of the patient. The DM GARD™ is then removed from the esophageal wall of the patient. Once the DM GARD™ is removed, the Therapeutic GARD™ device can be placed in the esophageal wall of the patient.

[0110] Therapeutic GARDs™ (e.g.., the GARD™ for GERD and Obesity devices) are optionally made of 2 parts: a ring made out of a circular soft mesh in one embodiment or a permanent stent, made out of metal or an alloy material like nitinol in another embodiment, and a tubular part. Collectively, the two parts comprise a structure sometimes referred to herein as a "prosthesis."

[0111] In one embodiment, the permanent stent is a woven, knitted, or braided mesh structure, optionally in the form of a cylinder. The permanent stent can be made from any of a variety of materials, such as stainless steel, nitinol (nickel titanium), or chrome-cobalt alloy, for example. In one embodiment, the permanent stent can be formed of any material that provides super elastic capacity for folding to pass the permanent stent through the mouth of the patient and its elasticity when released to expand and reach the niche when the permanent stent is released.

[0112] In one embodiment, the mesh ring is placed within the wall of the esophagus after localized resection of the esophageal wall using a series of biopsies or deeper resection with Endoscopic Mucosal Resection (EMR) or Endoscopic Submucosal Dissection (ESD). The resection causes bleeding and plasma or PRP prepared from the patient's blood is injected or sprayed (e.g., through a catheter) to speed up coagulation and healing. Gluconate calcium can optionally be added to the PRP so that the solution is more viscous and helps adhere better to the bleeding niche.

[0113] The mesh ring of the Therapeutic GARD™ is then pressed mechanically with either a balloon mounted on the introduction delivery system that presses the mesh ring on the coagulating mix of blood and PRP / calcium gluconate or a selfdeploying helical spring ring on which the mesh ring supporting the tube is mounted.

[0114] In the balloon embodiment, the balloon is then slowly deflated and removed or the knots holding the mesh ring to the helical spring are cut or pulled out if slip knots have been used and the ring is delicately pulled back in the esophagus or out of the body through the mouth leaving the mesh ring in place.

[0115] The patient's epithelial stems cells and possibly fibroblasts are optionally removed with the biopsies taken during placement of the DM GARD™ and put in culture in a laboratory. Alternatively, the stem cells can be obtained when the biopsies (or EMR / ESD) are taken from the niche at the beginning of the therapeutic procedure are then placed in a PRP / calcium gluconate solution and are sprayed on the mesh ring on the luminal side of the mesh that supports the tubular devices. This is done to help reconstitute the epithelial layers of cells removed previously at resection. A balloon on the delivery catheter is inflated and presses the epithelial stem cells in PRP on the mesh and / or a third ring is placed at the end of the procedure to exert pressure for a longer period of time than an inflated balloon place through the mouth can. In one embodiment, the mesh ring is integrated in the wall of the esophagus between the esophageal wall side (external) where the bottom of the niche and the coagulating blood with PRP / calcium gluconate mix is located and the luminal side (internal) that is reconstituted with the patient's own epithelial stems cells from the biopsies added to the PRP / calcium gluconate solution. In this way, the surgical mesh is "sandwiched" in the reconstituted wall.

[0116] The surgical mesh can be made of several different non-resorbable compounds, such as but not limited to polypropylene, polyester, polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF) among others that are all used safely for many years in surgery as well as some mesh that include animal collagen, and mixtures thereof. A ring is added in the lumen of the esophagus at the end of the procedure to help put pressure and help heal the esophageal wall now holding the mesh ring supporting the Therapeutic GARD™ in the gastro-intestinal lumen.

[0117] This new approach to Therapeutic Endoscopy is called Therapeutic BioEndoscopy (TBE) as a biological component is added, namely the autologous cells of the esophageal wall that have been resected and then reinjected to reconstitute the esophageal wall after the mesh of the devices supporting all the devices has been placed in the esophageal wall in the patient's platelet rich plasma (PRP), which is known to help heal lesions in other areas of medicine or dentistry. When only fragments of the esophageal biopsies containing stem cells (that have not been previously placed in cell culture in the laboratory) are used with a PRP / calcium gluconate solution, a localized "in vivo" culture milieu to reconstitute the esophageal wall is created. Other tissues (e.g., bone, tendon, cartilage, skin, hair, etc.) have been regenerated using PRP and appropriate stem cells.

[0118] See (1) Yamada Y, Ueda M, Naiki Tet al., Autogenous injectable bone for regeneration with mesenchymal stem cells and platelet-rich plasma: tissue- engineered bone regeneration. Tissue Eng. 2004 May-Jun; 10(5-6): 955-64. (2) Zhu M, Kong D, Tian R et aL, Platelet sonicates activate hair follicle stem cells and mediate hair follicle regeneration, J Cell Mol Med. 2020 Jan; 24(2): 1786- 1794. (3) Paoloni, J. et aL, Platelet-rich plasma treatment for ligament and tendon injuries, Clin J Sport Med. 2011 Jan:21(l): 37-45. (4) Etulain J. Platelets in wound healing and regenerative medicine. Platelets 2018 Sep; 29(6): 556- 568. The disclosure of each of these references is incorporated by reference. Table 1 below shows a summary of the GARD™ family of devices with the temporary DM-GARD™ placed first then removed and the Therapeutic- GARD™ separated in 2 families, the GARD™ device for GERD models and the Obesity GARD™ models for obesity.

[0119] Table 1:

[0120] Family of GARD™ of devices

[0121] 6 models of GARDs™ divided in 3 groups.

[0122] I. Diagnosis and Management (DM) GARD™

[0123] (short term implant)

[0124] Group 1. The DM-GARD™

[0125] (1 model with several sizes of rings)

[0126] II. Therapeutic GARDS™

[0127] (long term implants)

[0128] Group 2. GARD™ for GERD.

[0129] (2 models with several sizes of rings)

[0130] -The lamellar GARD™ for GERD for mild to moderate GARD.

[0131] -The tubular GARD™ for GERD for moderate to severe GERD.

[0132] Group 3. The OBESITY GARDs™

[0133] (3 models with several sizes of rings)

[0134] - OBI -GARD™, obesity Class 1 (BMI 30 to 34.9)

[0135] The GARD tube reaches the stomach.

[0136] - OB2-GARD™, obesity Class 2 (BMI 35 to 39.9)

[0137] The GARD tube reaches the duodenum

[0138] - OB3-GARD™, obesity Class 3 (BMI more than 40)

[0139] The GARD tube reaches the jejunum

[0140] Various techniques are helpful to hold anti-reflux devices and anti-obesity devices in the lower esophagus of the living organism or patient. For example, the patient's adult stem cells can be "cultured" in vivo in the patient's own PRP obtained from the patient's blood. Another technique is to culture biopsies from the esophagus in an existing device made for cell culture / sorters in a lab. Using only components that can be reinjected in animals without immortalized cells, it is possible to culture their esophageal stem cells and demonstrate that in addition or instead of using in vivo cultures, one can use in vitro cultures in the lab taken from the animal, cultured and the cells that have multiplied can be used to recreate and / or repair an esophageal epithelium and thereby covering the nitinol permanent stent holding the tubular devices for GERD (lamellar or tubular (e.g., smooth, continuous, and / or uninterrupted) and longer tubular devices as needed for the obesity GARDs™ (OB-1, OB-2 and OB- 3), as shown in Fig 3A-3C.

[0141] It is known to place staples at flexible endoscopy and perforate the wall of the esophagus to hold the GARD™ in place. One problem is that the staples can cause small holes through the different layers of the esophageal wall and secretions, often acid, passed from the lumen of the esophagus into the thorax and can cause mediastinitis in pigs.

[0142] Now, with the major development of laparoscopic surgery and even more with robotic surgery, it is possible to use laparoscopic technology to place a few sutures that have a greater range of motion and precision to place the sutures (2 to 10, preferably 3 to 5 sutures) using classical surgical curved needles through the abdomen than the classical laparoscopic techniques and give a better vision of the lower esophagus. When fluoroscopy is used additionally, it is easy for the healthcare professional to place his / her suture through the esophagus and through a nitinol permanent stent, for example, to attach the permanent stent securely to the wall of the esophagus. To avoid perforation as seen with metallic (e.g., nitinol) staples, the luminal side as mentioned earlier can be covered with stem cells in PRP or provided by in vitro cultures as described earlier.

[0143] For the peritoneal / mediastinal sides of the sutures and the knot which the healthcare professional sees through the robot, a fibrin glue or fibrin sealant can seal the passage of the surgical thread through the wall of the esophagus as well as the knot tied by the healthcare professional on the "external" or peritoneal / mediastinal side) of the esophagus.

[0144] These techniques should prevent leakages and mediastinitis and / or peritonitis caused by placing sutures precisely under visual and X-ray control to suture the ring of the nitinol permanent stent within the wall of the esophagus into the luminal side. Benefits are also seen by placing the sutures from the laparoscopic side as well as using methods to "close" any "holes" caused by the passage of the surgical threads through the wall of the esophagus on the internal and external side, namely stem cells with PRP inside (lumen) and Tisseel (fibrin sealant) outside. A double approach can be employed, from inside the esophagus with endoscopy and outside the esophagus with laparoscopic surgery, preferably with a robot. Another important method is to use the Apollo Endostitch device that allows a healthcare professional to do sutures through the mouth with a flexible endoscope and more recently with the Sx model using a classical one working channel endoscope, which most endoscopists use (instead of a 2 working channel endoscope that only very few endoscopists have as previously). It is now possible to secure the nitinol permanent stent of the GARD™ in the wall of the esophagus using sutures placed through the mouth during placement of the Therapeutic GARD™ using the Apollo Endostitch Sx. This technique is beneficial as it can be done without surgery, through the mouth, on outpatients.

[0145] Referring now to the drawings in detail, wherein like numerals indicate like elements throughout, FIG 1 illustrates the DM GARD™ placed in the esophagus (1) and the tubular (e.g., cylindrical and / or conical) part (10) reaching or extending into the stomach (2). The tubular part (10) is optionally flexible. Here, a hiatus hernia (4) often associated with moderate to severe GERD is shown. The diaphragm (3) separates the abdominal cavity underneath from the thorax above. The DM GARD™'s thick ring (7) holds in the esophagus mainly through pressure on the esophageal wall and makes the esophageal wall bulge creating a "niche" (8) that will be used to place the long-term permanent stent with the Therapeutic GARD™ after the DM GARD™ has been removed. FIG 1 also shows the lumen (40) of the esophagus.

[0146] FIGS 2A-2C illustrate the 2 main models used to treat GERD, namely in FIG 2A, the GARD™ GERD device that blocks reflux and can also help patients who are overweight lose a few pounds. The GARD™ for GERD device blocks vomiting as surgery for reflux with its most common operation called the Nissen fundoplication also does. In FIG 2B, the lamellar model (12) will also block reflux and allow vomiting when the lamellae under vomiting pressure turn back on themselves (FIG 2C), but will have less effect on weight loss. An important feature is the radio-opaque zone (18) placed or located between the thinner mesh ring (9) and the tube (10) or the lamellae (12). This radio-opaque zone (18) will help locate the devices with fluoroscopy in case of need without having to do an endoscopy. FIGS 2A-2C also show the lumen (40) of the esophagus. Optionally, the mesh ring (9) can be molded in silicone.

[0147] FIGS 3A-3C illustrate 3 models of the Obesity GARD™. FIG 3A shows the OB1- GARD™. FIG 3B show the OB2-GARD™. FIG 3C show the OB3-GARD™. In FIG 3A, the tube (10) of OB1-GARD™ device ends in, terminates in, and / or extends into the stomach and can be used for people having class 1 obesity, which is a Body Mass Index (BMI) of 30 to 34.9. In this device, the effect is mainly restriction to help lose weight, which means that people will have to eat smaller quantities and chew their food longer.

[0148] In FIG 3B, the tube (10) of the device reaches the duodenum (5) so the device will cross or pass the whole stomach entering the stomach (2) where the lower esophagus (1) meets the stomach (2) and ending in the duodenum (5). This device mimics the effect of the "sleeve gastrectomy" where the healthcare professional cuts % of the stomach on the greater curvature side leaving a narrow band along the lesser curvature now occupied by the tube (10). Of course, with the OB2-GARD™, the whole stomach is spared and % of the stomach are not removed. The OB2-GARD™ can be used for patients who have class 2 obesity with a BMI of 35 to 39.9. Note that the mesh ring supporting the tube will have to be implanted over a higher surface of the esophageal mucosa and certainly deeper than for the GARD™ for GERD devices or the OBI devices.

[0149] For morbid obesity or patients having BMIs of over 40, the OB3-GARD™ (FIG 3C) can be placed with the tube ending in the jejunum (6). As in the surgical gastric by-pass, the OB3-GARD™ will help lose weight both by restriction as for the OB2-GARD™ but also by creating malabsorption as food will stay in the tube and will not be in contact with enzymes from the pancreas, or duodenum nor with bile before reaching the duodenum, in many ways similarly to the effect of gastric by-pass but again without surgery and surgical risk as the mortality of gastric by-pass is estimated to be about 1% because these patients are obviously high risk patients because of their morbid obesity. Again, the mesh ring supporting the OB3-GARD™ tube with have to cover a larger surface in the lower third of the esophagus and placed deeper in the esophageal wall. FIGS 3A-3C also show the lumen (40) of the esophagus.

[0150] FIG 4A illustrates schematically the different layers of the normal human esophageal wall. If one considers that the esophagus is a tube, the innermost layer in contact with food ingested through the mouth and passing through the esophagus into the stomach is the esophageal epithelium (13) and the outermost layer is a muscular layer that will "push" the food down into the stomach from the mouth using a progressive wave of contraction called the peristaltic wave (20). The esophageal epithelium (13) is at the top of FIG 4A. The bottom of the esophageal epithelium is similar to a wave called the basal membrane (14) that carries cells called adult stem cells (see element 15 of FIG 4B) that play an essential role in repairing the esophageal epithelium if the wall is injured by disease or in our case by esophageal resection as in biopsies of the esophagus or deeper resections such as endoscopic mucosal resection (EMR) or endoscopic submucosal resection (ESD). The lamina propria immediately under the basal membrane (16) is part of the mucosa and the muscularis mucosae (19) separates the mucosa from the submucosa (17). The muscularis propria (20) itself has 2 layers with complex nerve systems (not shown). This demonstrates that the esophagus that appears to be a simple tube is in fact a much more complex organ than expected at first sight.

[0151] FIG 5 illustrates the compression niche (8) left after removal of the DM GARD™ and its thick ring that presses on the esophageal wall as shown in FIG 1. This niche will facilitate the positioning of the permanent stent for esophageal wall integration with the Therapeutic GARD™ in the lumen of the esophagus. Elements 13, 14, 16, 17, 19, and 20 of FIG 5 show the different layers of the esophageal wall that have been compressed by the ring of the DM GARD™.

[0152] FIG 6 illustrates the different depths of esophageal endoscopic resection that can be used. In most cases, Level A reaching the basal membrane with standard biopsies or level B reaching the lamina propria with endoscopic mucosal resection (EMR) should be sufficient to place the mesh of the Therapeutic GARD™ in position. Level C (submucosa) using Endoscopic submucosal dissection should only be used if longer, heavier tubes such as the OB2-GARD and OB3-GARD are needed to treat obesity since complications of using ESD are not unusual.

[0153] Fibroblasts (22) from the lamina propria and the submucosa can also be cultured with the epithelial cells and reinjected once the mesh ring has been positioned in place. Blood vessels in the submucosa (21) are also shown. In certain cases, Level A and Level B can be combined by doing EMR and biopsies as well as Level B and Level C by doing EMR and ESD and some standard biopsies can be added.

[0154] FIG 7 symbolizes the partial resection of the wall of the esophagus with biopsies where forceps (26) are used. Alternatively, to simplify the technique and reduce costs, 10-20 standard biopsies can be completed inside the niche inside the whole perimeter of the niche and after the permanent stent is placed in the niche. Natural coagulation will bind the metal permanent stent to the bottom of the niche with no need to use PRP, gluconate or blue methylene nor a fibrin glue such as Tisseel from Baxter. However, to secure the permanent stent in the wall of the esophagus, these "biological agents" remain an option.

[0155] In FIG 8A, the mesh ring (28) of the Therapeutic GARD™, here the GARD™ for GERD in its tubular form, is passed folded on the balloon (31) of a delivery catheter (27) through the mouth and into the esophagus and kept in place with a stretchable ring of magnetic beads (29). The tube of the GARD™ for GERD is also folded on the delivery catheter with a slip knot (33). The mesh is placed facing the bleeding niche (8) under endoscopic vision. Element 24 in FIG 7 is the sites of the biopsies where viscous PRP has been sprayed. FIG 8A shows the lumen (40) of the esophagus.

[0156] FIG 8B illustrates the balloon (31) that is inflated and the mesh ring is held in position with the stretched ring of magnetic beads (29) that presses the mesh ring on the niche (8), where the mucosal biopsies have been made and the PRP with calcium gluconate have been added (see FIG 7). The 2 strings holding the magnetic bead ring (29) are loose. The tubular part of the GARD for GERD device (32) is held folded on the delivery (27) with the slip knot.

[0157] As shown in FIG 8C, the magnetic bead ring (29) has been pulled from the mesh ring (9) by pulling on the other end of the threads (30) at the head of the delivery catheter (not shown). This allows the inflated balloon (31) on the delivery catheter (27) to compress the mesh ring (9) on the niche with the coagulating blood and the added PRP with gluconate calcium (see FIG 7). FIG 8C shows the lumen (40) of the esophagus.

[0158] According to another embodiment of the presently disclosed technology, FIG 9A illustrates a method of placement of the GARD™ for GERD on the niche (8) using a free helical pressure ring (34) similar to the ring of the DM-GARD (7) in FIG 1 placed inside the mesh ring (9) that is folded and held In position on the delivery catheter (27) with a slip knot (33). When in position facing the bleeding niche (8), the slip knot is pulled. FIG 9B shows the lumen (40) of the esophagus. The delivery catheter also has a balloon (31) placed on the delivery catheter. However, with the helical pressure ring, the balloon is not necessary since the mesh with the helical ring (e.g., nitinol helical spring ring) can deploy on its own.

[0159] FIG 9B illustrates the GARD™ for GERD deployed with the helical pressure ring (34) exerting pressure on the mesh ring (9) on the niche (8). One or more knots (35) can hold the mesh ring (9) on the helical ring or spring (34) (e.g., the helical ring can contain or comprise a nitinol helical spring). Each knot (35) can be a slip knot that can be easily pulled out or a regular knot that have to be cut with a scissor through the endoscope (not shown). FIG 9B shows the lumen (40) of the esophagus.

[0160] FIG 9C illustrates that the knots (35) have been removed and the helical spring is gently pulled out with a forceps (36) leaving the mesh ring (9) positioned on the niche (8) where biopsies have been taken (x) and the coagulating blood with viscous PRP and calcium gluconate have been added (see FIG 7). The slip knot (33) holding the tubular part of the GARD™ for GERD is still in position to exert a counterforce to the traction on the helical spring. FIG 9C shows the lumen (40) of the esophagus.

[0161] FIG 9D illustrates the mesh ring (9) is in position and the delivery catheter (27) is still kept in place holding the tubular valve with the slip knot. FIG 9D shows the lumen (40) of the esophagus. The removable helical spring (34) has been pulled back towards the top of the esophagus to free access to the "inner" or luminal side of the mesh ring (9). The balloon (31) is not inflated and the slip knot (33) on the tubular part of the delivery is still in position.

[0162] FIG 10A illustrates that the mesh ring (9) is sprayed through the endoscope (38) with epithelial cells that have been placed in culture when the DM-GARD was first positioned in the esophagus and / or fragments of the biopsies of the esophageal wall containing adult stem cells of the epithelium of the esophageal wall cut up after biopsies were taken in the bottom of the niche (see FIG 9) at the beginning of the procedure placing the Therapeutic GARD devices in the esophagus. In FIG 10A, a balloon (31) that is fixed or otherwise secured on the delivery catheter is shown as not yet inflated.

[0163] The slip knot (33) of the tube is still in place and the delivery catheter (27) is in position. The helical spring (34) has been pulled upwards and the endoscope (38) passes through the helical spring to spray the luminal side of the mesh ring (9) with epithelial cells in PRP with calcium gluconate (37) to make the mixture more viscous and adhering to the mesh ring (9) so as to reconstitute the epithelial layer of the esophageal wall.

[0164] FIG 10B illustrates the inflated balloon (31) on the delivery catheter pressing outwardly on the epithelial cells that were just sprayed on the mesh ring (9) so that the mesh ring (9) is "sandwiched" between the "external" niche containing coagulating blood and PRP / calcium gluconate and the "internal" reconstitution of the epithelial layer after spraying the adult stem cells in PRP to regenerate the epithelial layer in vivo.

[0165] FIG 11A illustrates a transverse view of the esophagus as shown in a longitudinal view in FIG 6A. Visible in FIG 11A is the esophageal epithelium (13), the basal epithelium (14), the lamina propria (16), the muscularis mucosae (19) separating the mucosal part (13, 14, 16) from the submucosa (17) and the muscularis propria (20). FIG 11A shows the lumen (40) of the esophagus.

[0166] FIG 11B illustrates various options for the depth of placement of the mesh ring in the esophageal wall at the end of the procedure. Location (39A) is the most superficial placement of the mesh ring at the level of the basal epithelium (Level A of FIG 6). Location (39B) is the mid-level placement of the mesh ring in the lamina propria (16) of the mucosal wall (Level B of FIG 6). Location (39C) is the deepest placement of the mesh ring in the submucosa (17) (Level C of FIG 6).

[0167] Optionally, the different possible positions of the permanent stent are the same or identical to the position of the mesh ring at the different levels of depth of the esophageal wall (13,14, 16).

[0168] FIG 12 illustrates a final compression ring (41) that is introduced to put pressure on the "reconstituted" esophageal wall after placement of the mesh ring (9) shown integrated in the esophageal wall (39) supporting the tubular or conical valve (10) of the Therapeutic GARDs™ within the esophageal lumen (40). FIG 12 shows the esophagus (1) and the radio-opaque zone (18) of the Therapeutic GARD that allows location of the Therapeutic GARD after the compression ring with its nitinol radio-opaque springs is removed.

[0169] FIGS 13A-13C show one embodiment of the presently disclosed technology that includes a circular ring 42, optionally formed of nitinol. In one embodiment, the ring 42 is molded in silicone and the DM GARD™ is put in place only temporarily to prepare the esophageal wall for placement of the Therapeutic GARD. In this embodiment, the ring 42 can optionally be removed after a predetermined period of time, such as but not limited to 1 to 4 weeks. In another embodiment of the presently disclosed technology, the ring 42 is not molded in silicone. As a result, in this embodiment, the ring 42 can be permanently integrated into by the esophageal wall.

[0170] An advantage of using the nitinol ring 42 is that when the healthcare professional pulls on the strings of the delivery catheter, the ring 42 springs into place. As a result, the ring 42 is placed on the bleeding site caused by the biopsies made just previously. This helps direct the adult stem cells of the esophagus that are injected in the Platelet rich plasma (PRP) solution on the luminal side of the esophagus, thereby covering the nitinol ring 42 with cells that should reconstitute the normal internal wall (mucosa) of the esophagus. Other materials that have the same desirable properties as nitinol could be used to form the ring 42.

[0171] In another embodiment, the ring 42 can be formed of a polymeric material.

[0172] Until the presently disclosed technology was developed, healthcare professionals had not been able to place permanent stents (nitinol or plastic) in the esophagus if there was no narrowing of the esophagus. The presently disclosed technology provides this benefit. In addition, previously healthcare professionals had not been able to hold a device in the lumen for therapeutic purposes, which the presently disclosed technology accomplishes.

[0173] Thus, in one embodiment the presently disclosed technology includes a combination of a niche created by the DM-GARD™ that is first placed in the esophagus and puts pressure on the wall of the esophagus creating a kind of bedding for the Therapeutic GARD™ (then the DM-GARD™ is removed). In addition, bleeding made by endoscopic biopsies and therefore coagulation after the bleeding helps hold the nitinol ring that support the anti-reflux and / or anti-obesity devices in the lumen of the esophagus and stomach. Furthermore, the presently disclosed technology, which can include putting the esophageal adult stem cells from the patient obtained by the biopsies in PRP, was found to be a good milieu to put cells in culture or repair tissues (but not described to hold a foreign device like the Therapeutic GARD™ in position) and is used to reconstitute and / or repair the internal mucosa of the esophagus in vivo after damaging it with the biopsies. The above allows for the integration of the permanent stent in the esophageal wall at the mucosal- submucosal level of the esophageal wall and allows holding the anti-reflux and / or the anti-obesity devices in the lumen opening. This creates a completely new era of endoscopic treatment (without surgery) of these very common diseases on an ambulatory basis.

[0174] In one embodiment, injection of botulinum toxin will paralyze locally for a few weeks the peristaltic contraction and help the biological sealing of the nitinol ring that is thin (in the order of 0.3 mm thick) in the wall of the esophagus. In some embodiments, the botulinum toxin injection is above the nitinol ring.

[0175] Optionally, the nitinol ring is thin, such as in the order of 0.3 mm think. When combined with the muscular layer, the two are about 3 mm thick, at most.

[0176] In one embodiment, a method of the presently disclosed technology can include first calibrating the diameter of the esophagus at the level of the esophagus (e.g., lower third) where the healthcare professional intends to put the Therapeutic GARD. Next, the healthcare professional can place the DM-1 GARD™ in and / or at the level identified above for approximately 1-2 weeks to create a niche (e.g., see Fig. 5). Eventually, an experienced healthcare professional could optionally skip this stage to avoid an additional endoscopy. Third, the method can include preparing the PRP from the patient's blood by spinning the blood twice. Fourth, the DM GARD™ is removed from the esophagus. Fifth, at least one and up to twelve biopsies can be taken from the bottom of the niche. For example, ten biopsies can be used for their stem cells and two biopsies can be used to have regular pathology to make sure the basal membrane is present as the adult esophageal stem cells are known to be right at the level of the basal membrane. This can be done for the control of the quality of the biopsies so they include stem cells.

[0177] The sixth step of the above-identified embodiment can include placing the biopsies (e.g., possibly cut-up in 2-3 pieces) in the PRP solution. Seventh, the nitinol permanent stent of the Therapeutic GARD™ can be placed on the bleeding niche. Eighth, the PRP with esophageal adult stem cells can be injected on the internal (luminal) side of the nitinol permanent stent. Ninth, the PRP and stem cells can be compressed on the nitinol permanent stent, such as with a balloon. An optional tenth step can include injecting botulinum toxin above the ring of the Therapeutic GARD™. An optional eleventh step can include positioning an additional helical spring ring on the nitinol permanent stent for additional compression, such as for 1-2 weeks. In another embodiment, a method of the presently disclosed technology can include calibration. Second, the DM-1 device can be placed at the desired site for a predetermined period of time (e.g., 1 week), thereby creating a niche. Third, the DM-1 device can be removed, and biopsies can be made at the bottom of the niche to obtain adult stem cells. Fourth, the biopsies can be kept in the PRP obtained from the host (e.g., minipigs or patients). Fifth, the nitinol permanent stent (DM-2 or Therapeutic GARD) can be placed on the bleeding site with the ring part in the bleeding niche. Optionally, lamellar devices can be used. Sixth, the PRP with the biopsies that include adult stem cells can be injected or sprayed on the luminal side of the ring to reconstitute the esophageal wall and incorporate the nitinol ring in the esophageal wall. Seventh, the DM-3 compression ring can be placed on the site for a predetermined amount of time (e.g., a week). Eight, the DM-3 ring can be removed after a predetermined amount of time (e.g., a week). Optionally, some PRP can be added and compressed with a balloon for a predetermined amount of time (e.g., 5-10 minutes). Once the balloon is removed, the procedure is finished.

[0178] FIGS 14A-14C show another embodiment of a medical device, permanent stent, or ring 42' of the presently disclosed technology. The permanent stent 42' of the present embodiment is substantially similar to permanent stents described above. Like features between the embodiments are distinguished in the present embodiment by a prime (') symbol. Certain notably differences are described below.

[0179] The permanent stent 42' of the present embodiment can optionally include one or a plurality of spaced-apart connectors 43'. In one optional embodiment, each connector 43' is in the form of a lozenge or diamond, and the permanent stent 42' includes five, equally spaced-apart connectors 43' located at a vertical midpoint of the permanent stent 42'. Of course, the permanent stent 42' can include more or fewer connectors 43'. Optionally, the top half of the permanent stent 42' is a mirror image of the lower half of the permanent stent 42'.

[0180] Optionally, each connector 43' contributes to allowing the permanent stent 42' to easily expand when starting in a collapsed configuration, or easily collapse when starting in an expanded configuration. This functionality can be useful, for example when the permanent stent 42' is introduced through the mouth of the patient and then expanded when released in position in the esophagus. In another optional embodiment, the connectors 43' are omitted from the permanent stent 42', such that the permanent stent 42' includes an opening or open spaced between an upper portion and a lower portion thereof.

[0181] The permanent stent 42' can further optionally include a plurality of equally spaced-apart horizontal bars or supports 44' and a plurality of equally spacedapart vertical bars or supports 45'. In one embodiment, the horizontal bars 44' extend perpendicularly to the vertical bars 45'. Each vertical support 45' can extend from a bottom-most one of the horizontal supports 44' to a top-most one of the horizontal supports 44'.

[0182] In one optional embodiment, the permanent stent 42' can include six horizontal supports 44' above a row of connectors 43' and six horizontal supports 44' below the row of connectors 43'. In one optional embodiment, the permanent stent 42' can include five spaced-apart vertical supports 45'.

[0183] As shown in FIG 14A, each horizontal support 44' can include a plurality of spaced-apart grooves or bends 46', optionally located in vertical alignment with one of the connectors 43'. The grooves or bends 46' contribute to the permanent stent 42' being easily and / or selectively expanded, collapsed, and / or folded.

[0184] Optionally, any pair of vertical supports 45' can be separated by a connector 43', optionally located equidistantly therebetween. The connector part on top and bottom of the permanent stent facilitates the attachment with knots to the ring 7' that is soft with no spring in the ring 7'. The ring 7' can optionally be made of 2 thin silicone rings, the external ring can have holes so the inflammatory cells creating a scar can pass easily through the connector for example 43' in FIG 14A then through the holes of the external layer of the ring 7' but not through the internal layer that does not have holes.

[0185] In one embodiment, such as shown in FIGS 14B and 14C, at least a portion of the permanent stent 42' can be attached, such as by adhesive 47', to at least a portion of a tube 10', optionally of lamellar (FIG 14E3) or smooth (FIG 14C) configuration. In particular, a lower portion, such as a lower third or quarter, can be glued to an upper portion of the tube 10'.

[0186] The permanent stent 42' is optionally formed of nitinol. In one optional embodiment, the permanent stent 42' is reconfigurable between an expanded configuration (e.g., for use in the patient) and a folded configuration (e.g., for removal from and / or insertion into the patient).

[0187] In another embodiment, such as that shown in FIGS 15A-15D, the permanent stent 42' can be placed on its own in the wall of the patient's esophagus and can be linked or attached to a ring 7' holding the active part (e.g., the DM2- GARD™ or DM-2). Optionally, the link or attachment can be one or more spaced-apart surgical sutures or staples 48' with knots or hooks, which can extend around at least a portion of each of the ring 7' and the permanent stent 42'. The link can also be insured by pressure of the helical spring of the Therapeutic-GARD™ on the stent.

[0188] FIGS 16A-16D show yet another embodiment of the presently disclosed technology, where at least a portion of the device is magnetized. In particular, at least a portion or an entirety of the permanent stent 42' is magnetized, which attracts the therapeutic parts of the ring holding the tube 10' in addition to pressure exerted by the helical spring used with the DM1-GARD™.

[0189] For example, a ferromagnetic wrap 49' (see FIG 16A) can extend around the ring 7'. The permanent stent 42' shown in FIG 16B can extend over the wrap 49'.

[0190] In operation of one or more of the above embodiments, after a preliminary (or preparatory endoscopy) where balloon calibration of the esophagus is done to determine the size of the esophagus above a predetermined line, which can be at the mucosal border between the esophagus and the stomach, and before any biopsies are taken, then a regular endoscopy with a prior basic blood workup that includes at the very least a complete blood count, standard coagulation studies (CBC with platelets and INR), basic liver and kidney functions can be performed before standard intravenous sedation is done (with Propofol or Flurazepam) to determine if there is any reflux esophagitis present then biopsied to rule out Barrett's esophagus, a well-known precancerous condition always checked by endoscopists, eosinophilic esophagitis, a less frequent allergic related esophagitis, any esophageal or other lesions.

[0191] If the patient has chronic esophagitis and responds to proton pump inhibitors (e.g., omeprazole, Nexium™ (esomeprazole), Dexilant™ (dexlansoprazole), Pantoprazole, etc. ), but does not want to continue the medicine forever and if the symptoms of heartburn recur after stopping the PPIs and does not want to consider surgery (now mainly the laparoscopic Nissen operation or variations with an incomplete fundoplication, or any another endoscopic method developed for GERD or obesity), the endoscopist can optionally order the appropriate size kit to place the GARD™ with the versions that will reach the market.

[0192] If the patient does not have a classical reflux disease symptomatically but has esophageal complaints that do not respond well to PPIs, then the patient may need an additional work-up that can also be done for standard GERD, with preferably a 48 to 96 hours telemetric pH study with a small capsule placed in the esophagus to prevent reflux (called the Bravo capsule), as well as esophageal manometry, or an esophageal impedance test that can replace the telemetric pH metric studies. If GERD is demonstrated and no other disease is diagnosed during this work-up, then placing the GARD is certainly a valid option.

[0193] In the embodiment shown in FIGS 14A-C, the permanent stent 42' can optionally include silicon covering or located on the lower part of the permanent stent 42'. Optionally, about or exactly 25% or 30% of the total length of the permanent stent 42' can be covered in silicon to glue the lamellar tube to the permanent stent 42'. For example, about or exactly 70% or 75% of the upper portion of the permanent stent 42' is not covered by silicon, but the lower (e.g., optionally six) horizontal bars 44' can be covered with the silicone of the tube 10'. Of course, the number of horizontal bars 44' can covered with silicone can vary, with possibly fewer bars or more bars depending on clinical experience.

[0194] For Obesity, the tube 10' will be longer than for non-obesity application, even much longer to go to the stomach, and if possible cross the stomach (mimicking a "sleeve gastrectomy" operation for obesity), but without surgery and reach the duodenum and into the jejunum to mimic a gastric by-pass operation. As a result, the permanent stent 42' might be a little longer (e.g., at least 30 mm long instead of 25 mm presently) and at least 10 mm covered with silicone to hold the tubes 10' in place than in non-obesity applications.

[0195] Referring again to FIG 15A, the permanent stent 42' has approximately the same size as the ring 7' or DM1 that has been removed and the entire permanent stent 42' can be placed in the niche. This is unlike one optional use of the embodiment of FIGS 14A-C, in which optionally only the top % of the permanent stent 42' is placed in the niche. The Therapeutic GARD™ of FIG 15A can optionally include a silicone ring 7' with a lamellae or tubular tube 10' that is placed within the ring 7' , except without the helical spring 34' (see FIG 16D) (sometimes referred to as the DM2), and is attached to the permanent stent 42' with knots 48', for example, using surgical suture thread. In one version of the present embodiment, the silicone ring 7' does not have a helical nitinol spring within the ring as the DM1-GARD™ has.

[0196] A difference between one use of the embodiment of FIGS 14A-C and the embodiments of FIG 15A-D is that in the former glue, such as silicone glue, can be used to bind the GARD to the sent 42' or blood can be left to coagulate spontaneously. In the latter, knots can be placed between the permanent stent and the DM2.

[0197] In the embodiments of FIG 15A-D, the knots 48' can optionally be placed from, at, or around the vertical bars 45' toward the lumen of the DM2 where food passes from the mouth to the stomach. For that reason, in one embodiment, the knots 48' are placed on the permanent stent 42' side (e.g., the outer side).

[0198] As shown in FIGS. 15C and 15D, the thread used to form the knots 48' is shown passing through the wall of the endoscopy, particularly if the threads are black on a light silicone background. Optionally, hooks could be an alternative to sutures, but hooks can be more completed to remove, if necessary, than cutting sutures.

[0199] Optionally, the presently disclosed technology can include twenty spaced-apart knots 48' is a 5 x 4 array (see, e.g., FIG 15C). In another arrangement, the presently disclosed technology can include ten spaced-apart knots 48' in a 5 x 2 array (see, e.g., FIG 15D). Other arrangements are also possible, including greater or fewer total number of knots, in different array configurations.

[0200] Optionally, ten spaced-apart knots would in principle decrease infection risk and favor a microcosm pocket of reparatory cells between the DM2 and the permanent stent 42' in the wall of the esophagus. Without the helical spring inside the ring 7', it is possible to fold the DM2 part of the Therapeutic GARD™ attached to the permanent stent 42' and fold it on the delivery held on the delivery catheter with the escape knots. If the helical spring 34' is used as in the DM1-GARD™ with the hard helical spring inside, it can be more difficult to fold the permanent stent and the ring with the helical spring tightly enough because the two rings are too strong to be kept folded tightly on the delivery catheter to be passed through the mouth and throat (pharynx) and upper esophagus through the strong upper esophageal sphincter without risking to hurt the patient or risk deploying the devices prematurely before the lower esophagus is reached where they should be placed. This situation could have very challenging if the patient's airways are obstructed.

[0201] Optionally, the silicone ring 7' will not put much pressure on the permanent stent 42', but should efficiently prevent the inflammatory cells trying to penetrate the esophageal lumen from doing so and retain the inflammatory cells in several cavities between the permanent stent and the back of the silicone ring.

[0202] A main procedure difference of the embodiment of FIG 15A is that since the permanent stent 42' and the DM2 are placed together, the healthcare professional selects to spray the fibrin glue, it should be done immediately after the biopsies of the niche is done, and before both the permanent stent 42' and the DM2 are placed together. Once in place, a DM3 device can be placed within the ring 7' for at least 1 month, but then would need to be removed at a third endoscopy, which would be better if it could be avoided. So, in certain applications, an advantage of the embodiment of FIG 15A over the embodiment of FIGS 14A-C is that a third endoscopy might be potentially avoided with the embodiment of FIG 15A.

[0203] Optionally, to avoid or limit the risk of infection from threads between the DM2 and the permanent stent 42', antibiotics can be injected at the time the Therapeutic GARD™ is installed.

[0204] Referring to the embodiments of FIGS 16A-E, an advantage of a magnetic link or connection between the DM2 and the permanent stent 42' is that the lack of a physical connection could decrease an infection risk. This is because even if minute particles, e.g., of food, could penetrate or enter between the DM2 and the permanent stent 42', the particles would be flushed with white blood cells and mononuclear cells (e.g., lymphocytes, monocytes, macrophages) specialized in fighting any infection.

[0205] In the case of a magnetic connection between the DM2 and the permanent stent 42' holding the DM2 part in place, both the permanent stent 42' and the DM2 will need one or more relatively strong magnets. In one optional embodiment, the magnetic part could be the vertical bars 45' of the permanent stent 42', or the entire permanent stent 42' could be magnetic, but should still retain its elasticity to be introduce in the through the mouth into the esophagus. The DM2 can be made magnetic with different options. For example, one option is to have multiple, spaced-apart, and relatively small magnets 50' on or in the permanent stent 42'. For example, the magnets 50' can be anywhere between 1mm and 10 mm in diameter, but optionally 3 mm to 5 mm in diameter, and optionally can be attached (e.g., via glue) on the top and bottom vertical bars 45' and / or the horizontal bars 44', for example, of the permanent stent 42'. Optionally, the magnets 50' can be located on the inside of the permanent stent 42' and placed in the bleeding niche as described above. The magnets can have any of a variety of shapes, such as circular or square.

[0206] In one embodiment, such as that shown in FIG 16B, the ferromagnetic sheet 49' can be attached (e.g., via glue) to the outside of the DM2 ring optionally with a helical spring in the ring as mentioned above. The silicone ring of the DM2 supporting the tube 10' can have a diameter of 1mm to 2 mm less than the internal permanent stent diameter to facilitate placement of the permanent stent and pass the folded DM2 device described earlier through the permanent stent 42' with the magnets facing inwards.

[0207] In operation of one embodiment, the DM2 can be placed exactly at the level of the permanent stent and released by pulling on the slip knots so that the outside part of the DM2 ring with the magnetic sensitive ferromagnetic ring faces with the endoscopically and give access to the inflammatory cells around the ring through the permanent stent around the ring (see FIG 16D). If a magnetic connection is used, it would allow replacement of the device by pulling on the DM2 with so-called rat tooth or crocodile tooth forceps sold on the professional endoscopy market by the Olympus company and other companies selling endoscopic appliances.

[0208] In a similar but opposite design, the magnet(s) 50' can be placed outside of the permanent stent 42' (instead of inside as described here above) that is on the side facing the esophageal wall. This makes it easier to glue or otherwise attach the magnet(s) 50' on the permanent stent 42' from the exterior of the permanent stent 42'. Even if the magnets are anywhere between 1 mm to 5 mm thick, this thickness does not let the ring of the DM2 device have an immediate contact to the interior of the permanent stent 42' because of the "bump" created with the magnet. Optionally, the thread of the magnet is only 0.3 mm thick in one embodiment. Optionally, each magnet can be about 2 mm to 8 mm in diameter and 2-3 mm in thickness, and can be glued or otherwise to the upper and / or lower parts inside the permanent stent 42'.

[0209] In one embodiment, such as that shown in FIG 16C, the presently disclosed technology can include four small neodymium or other magnet composition (e.g., rare earth, etc.), two on top and two on the bottom part of each of the five areas between the five vertical bars 45'. Optionally, the magnets 50' are placed in such a way that it is possible to fold the magnet and place the magnet bearing permanent stent on a delivery catheter, and introduce the permanent stent and delivery in the patient's esophagus as described previously.

[0210] The cross section shown in FIG 16D shows the silicon ring with the ferromagnetic layer of the DM2-GARD™. In FIG 16E, the permanent stent 42' and magnets 50' were added to that shown in FIG 16D.

[0211] It is possible to calculate the physical forces involved with magnets 50' depending on their size and compositions and make prototypes to determine if the strength between the permanent stent 42' and any DM-GARD, the DM1 GARD™, or the DM2 GARD™, and whether the permanent stent42' would be strong enough to help hold the device in place.

[0212] If the permanent stent 42' is placed in the mucosa-submucosa area of the esophageal wall, as described above, the infectious and immune cells will rapidly gather locally around the permanent stent 42' and try to push the permanent stent 42' with the help of the muscular layers of the esophagus (muscularis mucosae, circular internal muscular layer). This will try to compress the permanent stent 42' into the lumen of the esophagus and longitudinal external muscular layer that will attempt to push the permanent stent 42' into the stomach (peristaltic wave). The pressure on the permanent stent 42' to be pushed into the esophageal lumen, this pressure would be opposed by the counter-pressure created by the DM2 device with its fairly strong helical spring in this case very similar to the DM1 device. So, the DM2- GARD™ can counter-act the pressure on the permanent stent 42' if the pressures are more or less equivalent and help keep both the permanent stent42' in the slayer of the esophageal wall (mucosa-submucosa) and the DM2-GARD™ in the lumen. With time if both devices cannot be eliminated and fall into the stomach, it is reasonable to believe that scar tissue will develop and hold the DM2-GARD™ also known as the Therapeutic-GARD™ in place.

[0213] In one optional embodiment, the permanent stent is deployed at the same time as the Therapeutic-GARD™ with its strong helical spring that provides both of the following functions: a) placement of the Therapeutic-GARD™ against the permanent stent that is placed in the niche to be incorporated in the wall of the esophagus; and b) maintaining the lamellar or tubular devices in the esophagus, stomach, duodenum and jejunum to treat GERD and / or obesity. In certain situations, it is possible to have a mixed tubular part on top near the ring and a lamellar part in the bottom part of the Therapeutic GARD™.

[0214] In FIG 17A, the permanent stent 42' is seen at the limit of the mucosasubmucosa, more or less at the lever of the muscularis mucosae. In one embodiment, the DM1-GARD™ penetrates for at most 1 mm into the mucosa of the esophagus and creates a niche. Optionally, after 1-2 weeks, the DM1- GARD™ can be pulled out and biopsies are taken of the niche and the permanent stent 42' can be placed using a delivery system. Optionally, fibrin glue can be sprayed on the permanent stent 42', then the DM2-GARD™ can placed in the lumen as shown in FIG 17A.

[0215] In FIG 17A, a tubular DM2-GARD™ (instead of a Lamellar active part of the device as shown in all the preceding versions) and a stomach that has been operated with a sleeve-gastrectomy for obesity is shown. The fundus is very small in comparison to a normal gastric fundus. It is known that at least 15% of the patients that are operated for obesity with the sleeve gastrectomy have very severe reflux, even some patients who did not have reflux before surgery despite their obesity which is a risk factor for GERD. Gastric bypass patients lose between 50 to 80 percent of excess bodyweight within 12 to 18 months, on average. Gastric sleeve patients lose between 60 and 70 percent of their excess body weight within 12 to 18 months, on average.

[0216] Referring to FIGS 18A and 19A, the ring 7', such as an intermediary silicon ring, can be placed into the permanent stent 42', and then the combined ring 7' and permanent stent 42' can be placed together in the esophagus. As shown in FIG 18A, the ring 7' can optionally include one or more of a plurality of spacedapart magnets 50' therein or thereon, which can be attracted to the magnets 50' of or on the permanent stent 42'. As shown in FIG 19A, the magnets 50' can be omitted from the ring 7'.

[0217] Once the combined ring 7' and permanent stent 42' are within the esophagus, the device to the right in FIGS 18A and 19B is placed in the combined ring 7' and permanent stent 42'. The permanent stent 42' with the helicoidal ring 34' stays in position because of the size, or diameter, of the rings.

[0218] In FIG 19A, the permanent stent 42' can have a diameter of approximately or exactly 27 mm. The ring in FIG 19A can have a diameter of approximately or exactly 26 mm, and can be placed within the permanent stent 42' during manufacturing and the knots are tied. This part of the device is placed on the first delivery catheter and liberated within the esophagus. The ring optionally deploys because it is pulled by the permanent stent to which it is attached with knots. Optionally, one or two balloons can be employed to install the device shown to the right in FIG 19A. When inflated, the balloon(s) will help the device deploy as the ring is optionally quite soft and elastic, made only with silicone without a spring, but can still be removed and replaced, if necessary.

[0219] The following optional operation of the first endoscopy can be utilized by one or more of the embodiments described above. The appropriate size DM1- GARD™ can be placed in the esophagus using a delivery system for approximately 2 weeks. Optionally, the symptoms of the patient should be assessed (e.g., a GERD score used before and after placement can be used) after one week to determine if there is improvement and a second pH metric study over 24-48 hours can be part of the clinical trials, but could also be used in Refractory GERD patients (that is, patients not responding or responding badly to PPIs that are frequent and are often referred to specialized Gastroenterologists / Endoscopist that are faced with no good option and the GARD method).

[0220] In one embodiment, a unique advantage with the GARD™ is that the DM1- GARD™ should not go beyond 4 weeks (optionally 2 to 4 weeks) that will let the healthcare professional know if the GARD method is helpful to the patient or not. This feature is unique as no other surgical or endoscopic method offers the possibility to test the technique in a given patient before moving on to a definitive phase.

[0221] After 2-4 weeks, the DM1 can be pulled out very easily with standard endoscopic forceps. If the device helped the patients, the endoscopist can place the final permanent stent by making about 20 biopsies with the standard biopsy forceps around the niche made by the DM-GARD™, release the permanent stent with the lamellar anti-reflux device in the niche covered with blood so that the permanent stent is lodged in the niche and the lamellar tube below closer to the stomach (distally to the mouth) and spray the niche with adhesive (e.g., fibrin glue) to fixate the permanent stent in the niche or just let the blood coagulate normally without using fibrin glue. Before starting this phase, the endoscopist can optionally have chosen between two different permanent stents - either the permanent stent with the lamellar silicone tube glued to the permanent stent as described above (e.g., FIGS 14, 16, and / or 17) or the independent permanent stent (e.g., FIG 15) with a silicone ring without a spring within the ring that has knots attaching the silicone ring with the lamellar tube to the permanent stent. The ring and lamellar tube are similar to the DM1 device but without a helical spring. The ring of the Therapeutic device of FIG 15 is attached with surgical sutures to the permanent stent.

[0222] Optionally, in each of the embodiments shown in FIGS 14-17, the normal regenerative esophageal cells will try to expel the permanent stent from the esophagus wall into the lumen of the esophagus as they do for any foreign object in the following days, weeks and months following implantation. In the upper and lower parts of the permanent stent that is identical in FIGS 14 and 15, the regenerative cells should have more difficulty to pass through the permanent stent in the upper and lower part because there is less space between the horizontal nitinol little bars of the permanent stent. This is particularly true in the embodiment of FIG 14, as the lower part of the horizontal nitinol bars are covered by the silicone used in the intermediate part of the device, that is the part where the silicone is glued to the permanent stent where no cells should be able to pass from "outside" the permanent stent to "inside" the permanent stent or from the wall of the esophagus where the permanent stent is implanted towards the lumen of the esophagus. On the other hand, in the middle of the permanent stent where the lozenges are located, there is lots of space and the regenerative cells should favor this route and in fact pass on the inside of the permanent stent and envelope the permanent stent with neutrophils (one of the main types of white cells that defend the body from infections.

[0223] Normally, if a foreign body cannot be expelled of the body as is expected to happen with the design of the permanent stent described herein, it will then be surrounded by monocytes and local macrophages that will attempt to destroy, literally eating fragments of the foreign material. In one embodiment of the presently disclosed technology, the nitinol is quite elastic, but is made of a very resistant material that should not be affected by the monocytes and macrophages nor should the silicone. Therefore, one can expect that the permanent stent will stay locally in the esophageal mucosa "wrapped" by inflammatory cells and eventually develop a small then larger quantity of local scar tissue that is strong and help the permanent stent stay within the esophageal wall with the silicone device glued to it indefinitely and therefore block reflux with the lamellae that are in the esophageal lumen that let food pass but at low reflux pressure block the reflux and at high reflux pressure as in vomiting will fold back up to let the body expel the food through the mouth. As one usually drinks water after vomiting to rinse one's mouths and esophagus, the water will help the lamellae resume their original position. A tubular device is much more efficient in stopping reflux but will probably resist vomiting forces and vomiting risks tearing the device. In some cases, such as after a sleeve gastrectomy for obesity, the second most frequent obesity operation after a gastric by-pass, % of the stomach has been removed and the vomiting forces should be much weaker. As these patients often have severe reflux after the operation, a tubular valve could be often indicated. This can be an important point in obesity surgery as the "sleeve" operation is much easier to perform in very obese patients than the gastric by-pass and has much less complications except severe reflux in a number of patients who have to be reoperated to change their sleeve gastrectomy into a gastric by-pass. These operations in very obese patients have at least a 1% mortality that could be prevented by using the GARD™ technique.

[0224] In one embodiment, once the permanent stent with glued lamellae is in position, to avoid having the regenerative cells that will normally invade the permanent stent as described enter the esophagus and risk creating a narrowing (stenosis) of the esophagus which is a known risk, a small device that includes only the ring of the DM1-GARD™, optionally called the DM3, can be placed for a few months (e.g., 1 to 6 months) on the esophageal area of the permanent stent to prevent any stenosis and help fixate the permanent stent in the wall of the esophagus until scarring around the permanent stent occurs.

[0225] With respect to the embodiments of FIGS 14 and 15, optionally the Therapeutic GARD™ device can be safely and efficiently in place between 3 to 5 years with a lamellar device described previously, if with time the lamellae are covered with food or attacked by acid or both, it will be fairly easy to cut off the lamellae at endoscopy and replace this first device with another new device will be available to replace the device. This approach will allow then to choose different devices of the same family either for GERD by changing the number of lamellae, between 4 and 20, and optionally between 4 and 12 with the more lamellae present decreasing the risk of displacement during vomiting but normally also decreasing in theory the efficacy of reflux protection (this point has yet to be proved in vivo). The replacement of the original device can be done in only one endoscopy. Options to treat overweight patients and obesity will also be available over time once the permanent stent holding the devices in the wall of the esophagus is well in place and blocked with natural scarring tissues, similarly to coronary or vascular permanent stent although the situation in the esophagus (as in the rest of the gastrointestinal tract) is very different from vascular mucosa as the mucosa is different and behaves differently in vascular tissues (with an endothelium) than in the gastrointestinal tract.

[0226] One achievement of the technique of one embodiment of the presently disclosed technology is to put a platform in place in the esophageal wall and esophageal lumen where different devices (e.g., number of lamellae of the lamellar tube, length of the tubular valve stopping or potentially crossing the stomach) can be employed and then depending on the length could mimic the sleeve gastrectomy with a tube crossing the stomach or ending right before the pylorus or if with time a longer tube can be used and a peristaltic technique of the tube installed in the tube. A device that could mimic the sleeve gastrectomy with its technique of restriction (e.g., the tube) and malabsorption (e.g., the food in the tube cannot touch the mucosa or be in contact with bile, pancreatic secretion or duodenal / small bowel secretions that are absolutely necessary to allow food absorption). This technique would then allow important weight loss as needed in more severe type 2 or 3 obesity that is morbid obesity, all without surgery and without scars, all through the mouth and potentially with experience a same day procedure.

[0227] In the embodiments of FIGS 18 and 19, the active device (i.e., the combination shown in FIGS 18C and 19C once the combination of the permanent stent and the ring are moved to the top of the tub) can be replaced by pulling out the device. So, removing the devices and replacing them should be easier than at least some of the other embodiments.

[0228] Another option would be to first place a permanent stent with magnets inside the permanent stent, facing the lumen of the esophagus as shown in FIG 16C in the bleeding niche with a first delivery catheter, then place a Therapeutic device (this method avoids a third device DM2 as described in FIG 18A and FIG 18C with the vertical magnets as described in FIG 18A or the ferromagnetic sheet described in FIG 16A using the method described in FIG 18C).

[0229] FIGS 20A-20E show an embodiment with a plurality of spaced-apart magnets 50' on an inside of the permanent stent 42'. By using this method showed in FIGS 20A-20E, an advantage of placing the permanent stent in one procedure with the magnets to reinforce the contact between the ring of the Therapeutic Device placed during the same procedure with a second delivery catheter. To prevent having food pass between the Therapeutic magnetized device and the permanent stent, a rim could be placed at the top of the Therapeutic GARD device with a thickness corresponding to the addition of the thickness of the magnets inside the permanent stent (e.g., about 1-2 mm) and the thickness of the ferromagnetic sheet or vertical magnetic bars shown on the top figure of FIG 18A. With this method, the following requirements would be fulfilled: a) have only 2 endoscopies, the first one placing the DM1 Diagnosis GARD to determine if a long-term device is helpful to the patient objectively and subjectively as described earlier. Then place the permanent stent with magnets and the Therapeutic GARD during a second procedure. b) using this technique for Therapeutic GARDs or Obesity GARDs c) replacing the Therapeutic devices when and if needed with the same basic design in the new Therapeutic device or adapted to any changes the patient has had to his / her symptoms, as doctors would do by changing the dosages of any medication the patient is taking if the symptoms improve or worsen and then a gastroscopy is performed to confirm that the change of symptoms correlate to a change of endoscopic pathology. d) with a circular rim decrease the risk that food can pass between the permanent stent and the Therapeutic GARD.

[0230] Other applications of the techniques of the presently disclosed technology can include placing the permanent stent 42' in a desired location for monitoring the heart, which can be just in front of the esophagus such as for a long-term term transthoracic echocardiogram. This and other applications in cardiology are possible, as well as in food monitoring, lung monitoring, body temperature variation monitoring, as well as ultrasound monitoring of the chest and / or spine.

[0231] Optionally, the permanent stent 42' can form part of supported platform concept in other parts of the gastrointestinal (Gl) tract, in particular in the colon or in the duodenum to monitor suspicious lesions in the pancreas, such as some pancreatic cysts that could develop into cancer with time, particularly if new blood monitoring techniques based on detecting some known mutated circulating cell-free DNA associated with cancers or pre-cancerous lesions now in development, some focused on the pancreas where lesions are often detected very late to be cured continue to develop very rapidly as well as in the lung where cancers are often detected quite late. The permanent stent 42' could of course be used in the esophagus, which is why the first endoscopy to rule-out any precancerous lesions, such as Barrett's, is important. So even if one embodiment of the present platform is intended to stay in place for many years, but at least last for 6 to 12 months, it could have many other applications than only treating GERD or obesity.

[0232] Optionally, it is possible to proceed without spraying the niche with the biopsies with a fibrin clotting device (for example Tisseel by Baxter) before placing the permanent stent on the niche. However, doing so, at least in certain circumstances, may be prudent to ensure that the permanent stent stay in position.

[0233] As shown in FIG 20D and 20E, in one optional embodiment, a rim, flange, or belt 51' can extend around the top of the ring of the Therapeutic GARD. The rim 51' can extend radially outwardly at least slightly beyond the outer wall of the ring. In one optional embodiment, the ring can be about or exactly 2 mm wide. In one optional embodiment, since the magnet 50' on the permanent stent 42' will be 1 mm thick as well as the vertical magnets 50' on the ring, the rim 51' will avoid food to pass too easily between the ring of the Therapeutic GARD and the permanent stent where the food could stagnate and potentially cause an infection.

[0234] In any one or more of the above-described embodiments shown in FIG 14A- 20E, there can be a total overlap between the ring 7' and the permanent stent 42'. As a result, the ring 7' can cover the entire inside of the permanent stent 42', such that no portion of the permanent stent 42' extends above or below the ring 7'.

[0235] In any one or more of the above-described embodiments shown in FIG 14A- 20E, the ring 7' can be approximately or exactly 25 mm high or in height.

[0236] Referring to FIG 21 and 22, it can be beneficial to attach the permanent stent 42' to the ring 7', the tube 10', and / or the Th-GARD™ device at a location that is off-set from or below a top, for example the rim 51', of the ring 7', the tube 10', and / or the Th-GARD™ device. This type of non-coplanar arrangement can be referred to as partial overlap between the ring 7' and the permanent stent 42'.

[0237] In one embodiment, a top of the permanent stent 42' can be positioned at a predetermined distance, such as 1-10 mm, 1-2 mm, or 5-10 mm, below the top of the ring 7', the tube 10', and / or the Th-GARD™ device. In one embodiment, a top of the permanent stent 42' can be positioned a predetermined distance, such as 5-10 mm, above a bottom of the ring 7' of the Th-GARD™ device.

[0238] The permanent stent 42' can be secured in this positioned with respect to the ring 7', the tube 10', and / or the Th-GARD™ device by one or more spacedapart sutures 48' . In one optional embodiment, each of the sutures 48' can extend around a periphery of the permanent stent 42' at a single level or in a single plane. Each suture 48' can be in the form of or include a double slip knot.

[0239] Each suture 48' can be cut if a medical professional wishes to replace the ring 7', the tube 10', and / or the Th-GARD™ device. By cutting the suture(s) 48', the ring 7', the tube 10', and / or the Th-GARD™ device can be moved (e.g., upward; see arrows in FIG 21 and 22) with respect to the permanent stent 42' to remove the ring 7', the tube 10', and / or the Th-GARD™ device through the mouth of the patient while the permanent stent 42' stays in place and / or remains in the esophagus.

[0240] The permanent stent 42' has the ability to keep itself and the ring 7', the tube 10', and / or the Th-GARD™ device in the desired position in the esophagus, while allowing the ring 7', the tube 10', and / or the Th-GARD™ device to be selectively removed from the esophagus and optionally replaced. The lamellar device allows vomiting, while the tubular device will block vomiting, so a stronger fixation is needed for the tubular device to avoid displacement if ever vomiting occurs.

[0241] It can be helpful for tissue to easily penetrate the permanent stent 42' as the ring 7' of the Th-GARD™ device exerts pressure of an inner side of the permanent stent 42', which blocks repair cells from the niche to enter on the internal side of the permanent stent 42'. The design shown in FIG 21 and 22 allow for the tissue to easily penetrate the permanent stent 42' due to the offset from the ring 7'. In one optional embodiment, about or exactly 80% of the permanent stent42' is not blocked by the ring 7'. In particular, the permanent stent 42' can have a height of about or exactly 25 mm, and the superposition of the ring 7' and the permanent stent 42' can measure about or exactly 5 mm.

[0242] What this means functionally is that approximately 80% of the bottom part of the permanent stent 42' is in direct contact with the niche and when the cells of the niche grow back to repair the niche, they incorporate the 80% of the lower part of the permanent stent 42' as there is some space and no pressure from the ring 7' to block this repair of the niche. The exactly or approximately 80% of the lower part of the permanent stent 7' has the function of fixing the whole permanent stent 42' and Th-GARD device to the wall of the esophagus.

[0243] Combining the ring 7', the tube 10', and / or the Th-GARD™ device and the permanent stent 42' in the above-described manner, essentially as a two-in- one device and releasing the combination together, can be more precise in having the permanent stent42' cover the niche area made by the DM-GARD and / or the biopsies.

[0244] The embodiments shown in FIG 21 and 22 eliminate or at least minimize the occurrence of the ring 7' putting pressure on the inside part of the permanent stent 42', which could block the repair cells from the niche to incorporate the permanent stent 42' and therefore hold the Th-GARD™ device in place.

[0245] Optionally, the top 5 mm of the permanent stent 42' ensures fixation of the permanent stent 42' to the ring 7' of the Th-GARD™ device, and the lower 20 mm of the permanent stent 42' is available to integrate into and / or attached to the wall of the esophagus 1.

[0246] In an alternative embodiment of that shown in FIG 21 and 22, a diameter of the permanent stent 42' is greater, optionally 1 mm or more, than a diameter of the ring and / or Th-GARD™. The stent can then extend 1 mm or more into the esophageal wall than the ring and / or Th-GARD™. This arrangement applies pressure on the esophageal wall when using a calibration balloon, so there is greater pressure deploying the permanent stent 42' on the bleeding niche, which allows the stent to remain or hold in the esophageal wall without causing mediastinitis or perforation. Optionally, the Th-GARD™ that has a circular helicoidal ring with silicone does not have holes extending therethrough or cavities therein, so the tissues cannot grow through. Instead, the tissues can go over and / or around the ring and completely bury the Th-GARD™ within the esophageal wall.

[0247] In one optional embodiment, once in place within the esophagus, a slight oblique axis or angle, such as 10-20 degrees, can exist between the axis of the Th-GARD™ and the axis of the stent. This alone, or in combination with the ring being 1 mm less in diameter than the stent, the bottom of the ring can be squeezed to the stop of the stent, which can help maintain the device(s) in place within the esophagus.

[0248] As a result, pressure alone, not mechanical or chemical means, such as sutures, staples and / or glue, can be used to maintain the device(s) in place within the esophagus.

[0249] Referring to FIG 23 and 24, in one embodiment, two vertically spaced-apart permanent stents 42' can be placed within and / or attached to the patient's esophagus.

[0250] As shown in FIG 23, in one optional method of the presently disclosed technology, in order to place two permanent stents 42' within the patient, the endoscopist or healthcare professional can insert a preliminary DM-GARD with a tubular tube into the patient's esophagus before an additional ring (i.e., without a tube), sometimes referred to herein as a DM3, is inserted into the patient's esophagus. Once inserted, the DM-GARD can be spaced-apart from and below the DM3, such as by a predetermined distance X, as shown in Fig. 23. The distance X can optionally be approximately or exactly 15 mm, or optionally between 12-18 mm. The DM3 can create a higher niche used for placement of the top or upper permanent stent 42', and the DM-GARD can create a lower niche used for placement of the bottom or lower permanent stent 42'.

[0251] Optionally, in one embodiment, the device can be formed of three components, namely an upper permanent stent 42', a lower permanent stent 42', and an OB-GARD, where there is at least a slight overlap between an upper portion of the OB-GARD and a lower portion of the upper permanent stent 42', as well as an upper part of the lower permanent stent 42' to the OB-GARD. The OB-GARD can be any one of those OB-1, OB-2, and OB-3. In one optional embodiment, an advantage of the lamellar fixation method with only a single permanent stent 42' is that combination should be easier to replace then when two permanent stent 42' are employed.

[0252] The botulinum toxin helps to keep the devices in place so that the Permanent Stent(s) 42' can integrate the esophageal wall (which is 2-3 mm thick), without perforating the wall of the esophagus.

[0253] Referring to FIG 25 and 26, in one or more optional embodiments, the Obesity devices (e.g., OB-2 or OB-GARD2; see Fig. 3B) should have a similar general disposition with different sizes and a tube with different lengths that could mimic a "sleeve gastrectomy" at least partially for OB-2 devices without taking out 3 quarters of the stomach as surgery does. Eventually, the OB-3 that will reach the duodenum and jejunum (e.g., first part of the small bowel) and can mimic the by-pass operation, which has a 1% mortality risk because of the morbid obesity of the patients and their health issues (e.g., type 2 diabetes, high blood pressure, increased cardio-vascular risk).

[0254] In one optional embodiment, the OB-3 could need additional features if peristaltic equivalents are needed for food to progress in longer tubes. Removable and replacement could also be possible with sutures at the top and bottom of the OB-rings fixating the top and bottom of the superposition areas with removable sutures replaceable with removable staples.

[0255] In order to have the permanent stent(s) 42' fixated and even integrated the esophageal submucosa so that it can help hold the Th-GARD™ device in place, it can be beneficial to have a pressure niche caused by the temporary placement of the DM GARD device (see, e.g., Fig 1). The ring of the DM-GARD can create a pressure niche after two weeks or more of placement in the esophagus when calibration has been done, which means putting a significant pressure with a calibration balloon and card on the esophageal wall during calibration and using wider sizes for our DM-GARD (1 to 2 mm more) to guarantee placement for at least two weeks and niche formation.

[0256] The above-described temporary placement has two main functions. First and foremost, assess if the DM-GARD (lamellar) helps the patient control his / her reflux objectively (e.g., by measuring pH reflux and subjectively by using a GERD score or just speaking to the patient). Once the DM-GARD is removed through the mouth, the niche is prepared for the permanent stent positioning by doing standard biopsies and in addition make the niche bleed a bit with a few pricks of the niche with a small needle placed through the endoscope.

[0257] In one optional embodiment, an inside (luminal side) of the permanent stent 42' can be covered with a thin inside silicone tube or layer that has dots or spaced-apart spots of glue or adhesive to fix it on the inside of a Permanent Stent leaving free spaces therebetween. This thin silicone tube that matches the inside diameter of the permanent stent has an important function as the esophageal wall cells that will repair the niche will also incorporate the permanent stent. But it can be desirable to prevent the esophageal "repair" cells to invade the lumen of the esophagus and block the esophageal lumen as they could do, so the thin silicone tube leaves some space between the inside of the permanent stent and the thin silicone tube to have repair cells integrate the permanent stent in the wall, but not block the lumen and cause esophageal stenosis.

[0258] Optionally, the top 10 mm or so of the ring 7' of the Th-GARD™ device will extend above the permanent stent 42'. Optionally, at least a portion of each lamellae extend at least partly into a lumen of the permanent stent 42'.

[0259] One or more of the sutures 48' can hold the bottom of the ring 7' to the top of the permanent stent 42'. These sutures 48' can be easy to cut at endoscopy and the initial Th-GARD™ can be removed and another or a new Th-GARD™ device can be placed at the same position.

[0260] In some instances, fixation of the new part of the new replaced Th-GARD™ device can be an issue, but a removable staple, as disclosed in U.S. Application Publication No. 2008 / 0228030, which is hereby incorporated by reference, can be employed to address fixation.

[0261] Optionally, the standard number of lamellae is 8 lamellae. However, if the reflux is more severe, that can be decreased to 6 or 4 lamellae. If the risk of vomiting is more important in a given patient, the number of lamellae can be increased to 10 or 12.

[0262] Referring to FIG 27-29, another embodiment of the presently disclosed technology can be substantially similar to the prior embodiments. Certain similarities may be omitted herein for convenience and brevity only, but such omissions are not limiting. A distinguishing feature of the embodiment shown in FIG 27-29 is that the ring 7' is smaller and / or has a shorter height than in previous embodiments. While the ring 7' of the Th-GARD™ in one or more previous embodiment is 25 mm high (e.g., see Fig 20E), a height of the ring 7' in the present embodiment is less, such as 5 mm, 8 mm, 10 mm, or from 5-10 mm high. One or more spaced apart sutures 48' can be used to compensate for this decrease in height, while ensuring stability between the shorter ring 7' and the corresponding about of the top of the permanent stent 42'.

[0263] In FIG 27-29, the ring 7' is inside of the top of the permanent stent 42' only, and the ring 7' is attached to the permanent stent 42' with sutures 48' to stabilize the contact between the ring 7' of the Th-GARD and the 20% top of the permanent stent 42'. Optionally, the lamellae (or later silicon tubes) are free or unobstructed in the lower 80% of the permanent stent 42' and do not put pressure on the inside 80% lower part of the permanent stent 42', which enables to have the lower 80% of the permanent stent 42' to be incorporated in the wall.

[0264] When using tubular devices for obesity that need a stronger fixation of the permanent stent 42' to the wall of the esophagus 1, the height H (see FIG 27) of the permanent stent 42' can be increased to 30 mm, 40 mm, or 50 mm, or anywhere between 30-50 mm, and the relative proportions of the obesity rings height and the permanent stents could vary between roughly 20% and 25%.

[0265] Optionally, the ring 7' can be 8-10 mm high.

[0266] As an example, for the OB-1, which is a tubular device for obesity that is 10 cm high (similar to the 10cm lamellar tubes), the permanent stent 42' could be 30 mm heigh and the ring of the OB could be 6 mm high, which would meet the 20% ratio.

[0267] For the OB-2, with tubes reaching the pylorus (going through the stomach), the height of the permanent stent 42' could be 40 mm and the ring 10 mm high, which would result in a 25% overlap.

[0268] For the OB-3, with tubes reaching the duodenum and jejunum, so starting to mimic gastric-bypasses, the permanent stent 42' could be 50 mm high, the ring 10 mm high, which could create a 20% overlap. Locating the ring 7' inside the permanent stent 42' ensures or at least improves the stability of the ring 7' , and / or the entire Th-GARD™ device, and the permanent stent 42' inside the esophagus 1. For example, the portion of the permanent stent 42' that is not overlapping with the ring 7' can integrate into the wall of the esophagus 1.

[0269] In one optional embodiment, the height of the ring 7' occupies a predetermined upper portion of an inside surface of the permanent stent 42. Optionally, the predetermined upper portion is approximately or exactly a specific percentage, such as one third, of the height of the permanent stent 42'. As a result, in such an optional embodiment, two thirds of the height of the permanent stent 42' (i.e., the middle and lower portion thereof) extend below a bottom edge of the ring 7'. The height of each ring 7' can vary, approximately 1-2 mm, because of the number of turns the helical spring needs to make to be stable and exerting proper pressure within the ring 7', as well as having at each end a small turn on itself to avoid piercing the silicon with the spring nitinol sharp ends.

[0270] This one third rule / two thirds rule allows a maximum surface of the permanent stent 42' to be in direct contact with the niche tissues, thereby guaranteeing as much as possible long-term permanent stent fixation to the esophageal wall with its lower two thirds part of the permanent stent 42', and the upper third of the permanent stent 42' holds the ring 7' in place. The design of the permanent stent 42' with both ends (top and bottom) extending horizontally and / or in parallel, and the connector 43' being free from any portion of the ring 7' in the middle of the permanent stent 42' helps to accomplish the above objective.

[0271] Referring to Fig. 30, in one optional embodiment, a height of the tube 7' is a predetermined percentage of the height of the permanent stent 42'. For example, the predetermined percentage can be approximately or exactly one third. Optionally, in such an embodiment, an upper third of the height of the permanent stent 42' is coextensive with the height of the tube 7'. In this example, the permanent stent 42' can be 30 mm high, where a top 10 mm of the permanent stent 42' contacts and / or holds the ring 7' and the bottom 20 mm of the permanent stent 42' binds to the interior of the esophagus 1. Either a lamellar or a tubular tube 10' can be used. Other height options of the permanent stent 42' include 25 mm (24 mm, 3x8 mm-25 mm)-30 3x10 mm for lamellar (and tubular) and 39 mm-40 mm (3x13 mm) for longer tubes. Optionally, a helical spring 34', as disclosed in prior embodiments, can be employed to increase the pressure to hold one or more of the components in place in the esophagus 1.

[0272] The above-described configuration is beneficial because it gives a healthcare provider the option to exchange the Th-GARD™ device from lamellar to tubular (e.g., for obesity), and to lengthen the tubes for more efficacy. A healthcare professional can also change the numbers of lamellae from an average of 8 to 6 or 4 increasing the efficacy of the anti-reflux device or doing the opposite by increasing the numbers of lamellae to 10 or 12, with less anti-reflux efficacy, but avoiding blocking vomiting, if necessary, in some patients.

[0273] The above-described approach gives a healthcare profession a flexibility almost as simple as changing the dosage of a drug for a patient. There are no known endoscopic procedures in gastroenterology, or even cardiology, that provide such a benefit.

[0274] Referring to FIG 31, in one optional embodiment, a top rim or belt 51', in addition to the one or more sutures 48', will avoid or at least reduce the likelihood of the ring 7' and / or entire Th-GARD™ device from moving toward or falling in the stomach. In particular, the rim or belt 51' can prevent the ring 7' and / or the entire Th-GARD™ device from slipping through or past the permanent stent 42', but will not prevent the ring 7' and / or the entire Th- GARD™ device from being pulled up and out of the permanent stent 42' to exchange for a new ring 7' and / or entire Th-GARD™ device.

[0275] In one optional embodiment, a height of the top rim or belt 51' can be in the range of 2-3 mm high.

[0276] At least a portion of the rim or belt 51' can extend radially outwardly beyond a remainder of the ring 7' around an entire circumference of the ring 7'. Optionally, a top edge of the permanent stent 42' can contact a bottom surface of the rim or belt 51'.

[0277] In one optional embodiment, an outer periphery of the permanent stent 42' is coplanar with an outer periphery of the rim or belt 51' around an entire circumference of the rim or belt 51'. In another optional embodiment, an outer periphery of the rim or belt 51' extends at least slightly radially outwardly beyond the outer periphery of the permanent stent 42' around an entire circumference of the rim or belt 51'. FIG 32 shows another embodiment of a medical device, permanent stent, or ring 42' of the presently disclosed technology. The permanent stent 42' of the present embodiment is substantially similar to permanent stents described above. For example, although perhaps not as explicitly shown as in FIG 14A, the permanent stent 42' of the present embodiment is also three-dimensional and / or symmetrical, as is the permanent stent 42' in FIG 14A. Omission herein of the discussion of any similarities between the embodiments is for convenience and brevity only, and is not limiting.

[0278] As compared to the permanent stent shown in FIG 14A, a distinguishing feature of the permanent stent 42' shown in FIG 32 is the increased number of vertical bars or supports 45' and the decreased number of horizontal bars or supports 44'. In particular, the permanent stent 42' shown in FIG 32 can include as many as two or three times, or even more, of spaced-apart vertical bars 45' than in the permanent stent 42' shown in FIG 14A. Further, the permanent stent 42' shown in FIG 32 can include as many as a half or a third, or even less, of the horizontal bars 44' than in the permanent stent 42' shown in FIG 14A.

[0279] Optionally, the permanent stent 42' of FIG 32 can include a plurality of the vertical bars 45' that extend continuously or uninterrupted from a bottommost one of the horizontal bars 44' to a top-most one of the horizontal bars 44'. Further, the permanent stent 42' of FIG 32 can include a plurality of the vertical bars 45' that are connected or divided by one or more of the horizontal bars 44'.

[0280] Similar to the Permanent Stent 42' of FIG 14A, the permanent stent 42' of FIG 32 can optionally include one or more spaced-apart connectors 43', which can separate the two inner or middle horizontal bars 44'. In the present embodiment, each connector 43' can optionally be in the shape of a diamond.

[0281] Another distinguishing feature of the permanent stent 42' shown in FIG 32 is that it is divided into three portions - an upper portion, a midportion, and a lower portion. Optionally, each portion can occupy a third of the height of the Permanent Stent 42'. Optionally, the upper portion and the lower portion are mirror images of each other, and / or include the same spacing of vertical bars 45'. In contrast, the midportion can be more open, and can include a different (e.g., greater) spacing of the vertical bars 45'. As shown in FIG 34, one benefit of the increased number of the vertical bars 45' is that the sutures or staples 48' can be attached to the Permanent Stent 42' and the helical spring 34' (optionally molded in silicone) and / or the ring 7' at an angle. Optionally, the angle is 1 degree or greater (e.g., approximately or exactly 45 degrees, or between 30 and 60 degrees) with respect to the horizontal axis and / or to one of the horizontal bars 44'. In contrast, the sutures 48' shown in prior embodiments have been shown to extend horizontally or parallel to the horizontal axis. This angle can make the sutures 48' easier for a healthcare professional to cut.

[0282] Another distinguishing feature of the permanent stent 42' of FIG 32 is that at least some of the vertical bars 45' are spaced closer together than in the permanent stent 42' of FIG 14A. A benefit of such an arrangement can be that it may be easier to replace the Th-GARD™ device and attach removable stables that with hold a new Th-GARD™ device in the desired position or location.

[0283] FIG 33 shows another embodiment of a medical device, permanent stent, or ring 42' of the presently disclosed technology. The permanent stent 42' of the present embodiment is substantially similar to permanent stent 42' shown in FIG 32 and described above. Omission herein of the discussion of any similarities between the embodiments is for convenience and brevity only, and is not limiting.

[0284] A distinguishing feature of the permanent stent 42' of FIG 33 is that it omits the connector(s) 43'. Such a design may be less expensive and quicker to manufacture.

[0285] FIG 35 shows another embodiment of a medical device, permanent stent, or ring 42' of the presently disclosed technology. The permanent stent 42' of the present embodiment is substantially similar to permanent stent 42' shown in FIG 32 and described above. Omission herein of the discussion of any similarities between the embodiments is for convenience and brevity only, and is not limiting.

[0286] A distinguishing feature of the permanent stent 42' of FIG 35 is that the connector 43' is in the shape of hexagon. The hexagon shape could optionally be replaced with any of a variety of shapes that accomplish the same functionality. FIG 36 shows another embodiment of a medical device, permanent stent, or ring 42' of the presently disclosed technology. The Permanent Stent 42' of the present embodiment is substantially similar to permanent stent 42' shown in FIG 32 and described above. Omission herein of the discussion of any similarities between the embodiments is for convenience and brevity only, and is not limiting.

[0287] An upper and lower portion and / or third of the permanent stent 42' shown in FIG 36 can include a plurality of relatively small squares or rectangles formed by the crisscrossing horizontal and vertical bars 44', 45'. Such a grid or net pattern can be beneficial to hold and / or space the sutures or staples 48' and / or other components of the presently disclosed technology.

[0288] FIG 37 shows another embodiment of a medical device, permanent stent, or ring 42' of the presently disclosed technology. The permanent stent 42' of the present embodiment is substantially similar to permanent stent 42' shown in FIGS 32, 35, and 36 and described above. Omission herein of the discussion of any similarities between the embodiments is for convenience and brevity only, and is not limiting.

[0289] As shown in FIG 38, in operation, the permanent stent 42' can be placed over the ring 7' of a first Th-GARD™ that does not include a helical spring. At a later time, when appropriate or determined by a healthcare profession, the initial Th-GARD™ shown in FIG 38 can be replaced with a replacement Th-GARD™ having a ring with holes or openings 17 and a zig-zag or wave-like spring 15. Optionally, each opening 17 can extend only partially into and not completely through the ring 7'.

[0290] One purpose of the removable sutures or staples 48' is to hold the replacement Th-GARD™ to and / or against a portion of the permanent stent 42', such as the upper portion or third thereof. The partial holes within the ring of the replacement Th-GARD™ can be used to properly or beneficially space the sutures or staples 48'.

[0291] FIG 40 shows another embodiment of a medical device, permanent stent, or ring 42' of the presently disclosed technology. The permanent stent 42' of the present embodiment is substantially similar to permanent stent 42' shown in FIG 37 described above. Omission herein of the discussion of any similarities between the embodiments is for convenience and brevity only, and is not limiting. A distinguishing feature of the permanent stent 42' shown in FIG 40 is the relatively condensed grid of horizontal and vertical bars 44' , 45' in the upper and lower portions (e.g., l / 3rds).

[0292] FIG 41 shows another embodiment of a medical device, permanent stent, or ring 42' of the presently disclosed technology. The permanent stent 42' of the present embodiment is substantially similar to permanent stent 42' shown in FIG 40 described above. Omission herein of the discussion of any similarities between the embodiments is for convenience and brevity only, and is not limiting.

[0293] A distinguishing feature of the permanent stent 42' shown in FIG 41 is the relatively open or spaced-apart grid of horizontal and vertical bars 44', 45' in the upper and lower portions (e.g., l / 3rds).

[0294] FIG 42 shows another embodiment of a medical device, permanent stent, or ring 42' of the presently disclosed technology. The permanent stent 42' of the present embodiment is substantially similar to permanent stent 42' shown in FIG 40 and 41 described above. Omission herein of the discussion of any similarities between the embodiments is for convenience and brevity only, and is not limiting.

[0295] A distinguishing feature of the permanent stent 42' shown in FIG 42 is the upper portion being similar to the embodiment shown in FIG 40 and the lower portion being similar to the embodiment shown in FIG 41.

[0296] FIG 43 shows another embodiment of a medical device, permanent stent, or ring 42' of the presently disclosed technology. The permanent stent 42' of the present embodiment is substantially similar to permanent stent 42' shown in FIG 42 described above. Omission herein of the discussion of any similarities between the embodiments is for convenience and brevity only, and is not limiting.

[0297] A distinguishing feature of the permanent stent 42' shown in FIG 43 is that this embodiment essentially the inverse or flip of the embodiment shown in FIG 42. The following exemplary embodiments further describe optional aspects of the presently disclosed technology and are part of this Detailed Description. These exemplary embodiments are set forth in a format substantially akin to claims (each set including a numerical designation followed by a letter (e.g., "A," "B," etc.), although they are not technically claims of the present application. The following exemplary embodiments refer to each other in dependent relationships as "embodiments" instead of "claims."

[0298] IA. A method for maintaining a medical device in place in a lumen of a hollow organ of a patient for a period of months or years without using a metal or bioresorbable permanent stent.

[0299] IB. A method for placement of a medical device in a lumen of the gastrointestinal tract of a patient using a flexible endoscope having at least one 2.8 mm working channel for placement of a guidewire, biopsy forceps, endoscopic mucosal resection or endoscopic submucosal dissection devices as well as injection and spraying devices and aspiration of fluids and aspiration of air or blood or secretions.

[0300] IC. A method for placement of a permanent medical device in a wall of an esophagus of a patient using a first short-term device that is similar to a final device but without incorporation in the wall of the esophagus to evaluate safety and efficacy of the final device before permanent placement in the wall of the esophagus of the final device.

[0301] ID. A temporary device using essentially pressure on a wall of a lumen of an esophagus after calibration of a size of the esophagus that can be easily removed through the mouth after a period of one day to 1 month, usually 2 to 3 weeks.

[0302] IE. A temporary device with a thick ring leaving a niche on an esophageal wall once removed that is used to place a soft mesh ring of one of long-term Therapeutic-GARDs.

[0303] IF. A method for placement of medical devices using mucosal resection with standard biopsies or larger and deeper pieces of an esophageal wall using endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) removing esophageal mucosa and having the wall of the esophagus bleed, then spraying platelet rich plasma (PRP) solution obtained from the patient's blood prior to placement of the devices to help a longer-term device incorporate within to the esophageal wall.

[0304] IG. A method of isolating a portion of the esophagus to place temporary or permanent medical devices in a wall of the esophagus using biopsies to make the wall of the esophagus bleed adding platelet rich plasma to help adhesion and incorporation of medical devices in the esophageal wall made with an incorporated upper mesh ring and tubular devices placed in the luminal wall to treat at least one of Gastroesophageal reflux disease (GERD) or obesity.

[0305] IH. A method of isolating a portion of an esophagus of a patient to place temporary or permanent medical devices in a wall of an esophagus using local injection of botulinum toxin to decrease peristaltic contraction of the esophagus for a few weeks or months to keep the device in place to help a permanent device stay in position.

[0306] II. A temporary device leaving a pressure niche on a wall of an esophagus of a patient that will be used to place longer term devices for treatment of at least one of Gastroesophageal Reflux Disease (GERD) or excess body weight.

[0307] IJ. A method of using a combination of biopsies of an esophageal epithelium to obtain esophageal cells for culture and reinjection at a later endoscopy or immediately for repairing the esophageal epithelium resected to place a net or mesh ring within a wall of esophagus.

[0308] IK. A method of using culture of esophageal cells for reinjection at a later endoscopy or immediate reinjection of esophageal cells in platelet rich plasma (PRP) with calcium gluconate as a culture medium in vivo for repairing esophageal epithelium resected to contain a net or mesh ring in a wall of an esophagus of a patient that supports medical devices in a lumen of the esophagus.

[0309] IL. A method of using bleeding and injection of autologous platelet rich plasma (PRP) solution in an esophagus of a patient to help heal lesions caused by mucosal resection to obtain epithelial cells for culture or incorporation of a mesh net ring in an esophageal wall.

[0310] IM. A method of using platelet rich plasma with small fragments of about 1 mm of epithelial mucosa to culture an epithelium on a luminal side of a mesh ring so as to repair the epithelium and help incorporate safely the mesh ring at a flexible endoscopy to support luminal devices.

[0311] IN. A method of using platelet rich plasma with small fragments of epithelial mucosa to culture an epithelium on a luminal side of a mesh ring so as to repair the epithelium and help incorporate safely the mesh ring at a flexible endoscopy to support luminal devices to treat gastroesophageal reflux.

[0312] IO. A method of using platelet rich plasma with small fragments of epithelial mucosa to culture an epithelium on an external side (submucosal and muscular side of the esophagus) of a mesh ring so as to repair a wall and help incorporate safely the mesh ring using cultures of epithelial cells or culture of fibroblasts from a lamina propria obtained at flexible endoscopy to support luminal devices.

[0313] IP. A method of using platelet rich plasma with small fragments of epithelial mucosa to culture an epithelium on a luminal side of a mesh ring so as to repair the epithelium and help incorporate safely the mesh ring at flexible endoscopy to support luminal devices to treat gastroesophageal reflux blocking reflux yet allowing vomiting (lamellar device).

[0314] IQ. A method of using platelet rich plasma with small fragments of epithelial mucosa to culture an epithelium on a luminal side of a mesh ring so as to repair an epithelium and help incorporate safely the mesh ring at flexible endoscopy to support luminal devices to treat obesity.

[0315] IR. A method of culturing esophageal cells in vitro obtained from biopsies at a time of placement of the temporary device to supplement the endogenous culture of epithelial cells if needed at the time of the second definitive device for treatment of gastroesophageal reflux or obesity.

[0316] IS. A helical ring used to deploy a soft mesh ring of a definitive device, help place the mesh ring in position and exert pressure on the mesh ring so as to pressure the mesh in position on the bleeding, coagulating mix of blood, PRP and calcium gluconate.

[0317] IT. A delivery catheter using a helical spring to put pressure on an esophageal wall side of a mesh in a niche and help the mesh adhere to a mix of blood, PRP and gluconate calcium in the niche and a balloon on a delivery to press on the luminal epithelial cell layer after epithelial cells with PRP have been sprayed on the mesh to help sandwich the mesh in the wall of the esophagus.

[0318] III. A soft mesh ring comprising or consisting of polypropylene, polyester, polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), synthetic compounds integrating animal collagen components, and mixtures thereof, among others.

[0319] IV. The use of a delivery device to insert a definitive device and a mesh ring into a patient, the use comprising releasing the definitive device and the mesh ring in position under endoscopic control.

[0320] IW. The use of a balloon to introduce a definitive device, the use comprising inflating the mesh net ring in position and exert pressure on the mesh before removing the balloon to allow cultured endogenous or exogenous autologous epithelial cells to be injected to repair and restore original esophageal epithelium.

[0321] IX. A mesh ring that is radio-opaque to localize the mesh ring with fluoroscopy without repeating a gastroscopy.

[0322] IY. A glue used to have the mesh of the ring adhere to the tubular part of a Gastro-intestinal Anti-Reflux Device (GARD) that is radio-opaque by mixing silicon glue with a radio-opaque substance.

[0323] IZ. A glue inducing adhesion of a mesh of a ring to a tubular part of a Gastro-intestinal Anti-Reflux Device (GARD) that is radio-opaque by mixing silicon glue with a radio-opaque substance such as barium sulfate.

[0324] IAA. A tubular or lamellar GARD made of a medical grade plastic.

[0325] IAB. A tubular or lamellar GARD made of a medical grade implantable silicone.

[0326] IAC. A method of allowing integration of a mesh ring using platelet rich plasma (PRP) obtained from a patient's own blood, wherein a mesh ring is integrated within a wall of the patient's esophagus between the PRP added to the biopsy sites of the wall of the esophagus that helps coagulation and grips the mesh on an external side of the mesh ring, wherein esophageal cell wall stem cells that are obtained from biopsies and are reinjected on an internal or luminal side of the mesh ring.

[0327] IAD. A method of preventing displacement of a prosthesis, optionally a permanent stent and optionally formed of nitinol, the method comprising: inserting the prosthesis into a preexisting passageway of a living organism, the prosthesis contacting an interior wall of the passageway; and applying plasma, optionally platelet rich plasma (PRP), to at least one of the wall and the prosthesis so that the prosthesis becomes integrated into the wall of the passageway.

[0328] IAE. A system comprising: a prosthesis, optionally a permanent stent and optionally formed of nitinol, configured to contact or engage an interior wall of a preexisting passageway of a living organism, and plasma, optionally platelet rich plasma (PRP), for applying to at least one of the wall and the prosthesis so that the prosthesis becomes integrated into the wall of the passageway.

[0329] 2AE. The system of embodiment 1AE, wherein the system is configured to prevent displacement of the prosthesis in the passageway.

[0330] 3AE. The system of embodiment 1AE or 2AE, wherein the plasma is sprayed or injected.

[0331] 4AE. The system of embodiment 1A, 2AE, or 3AE, wherein the prosthesis is sutured to at least a portion of the passageway.

[0332] 5AE. The system of embodiment 1A, 2AE, 3AE, or 4AE, wherein the plasma is compressed onto the prosthesis.

[0333] IAF. A method where biopsies are made all around a niche made by a first short-term device after the first short-term device has been removed and a permanent stent is placed in the biopsy bleeding niche and held in place by the natural normal coagulation of the biopsies that cover the permanent stent.

[0334] IAG. A method where biopsies are made all around a niche made by a first short-term device after the first short-term device has been removed and a permanent stent is placed in the biopsy bleeding niche and held in place by adding biological or chemical compounds such as PRP, calcium gluconate, methylene blue and / or fibrin glue.

[0335] IAH. Methods where a permanent stent is linked to a final long-term device by glue, knots, magnets, or simply by its own pressure conferred by the helical spring.

[0336] IAI. A method where a nitinol ring with an inner wall that is smooth and an outer wall that has holes is attached to a vertical part of a permanent stent by one or more knots.

[0337] IAJ. A method where the natural healing process of the niche and biopsies of the esophageal wall will integrate the permanent stent in the esophageal wall with stem cells, inflammatory and immunological cell.

[0338] IAK. A method where in addition to a permanent stent a silicone ring is knotted to the permanent stent with an inner smooth surface and an outer surface with holes is an intermediary device between the fixed permanent stent and a "semi-permanent" long-term Therapeutic device in the lumen of the esophagus, that can be removed and replaced if acid, bile, or food alters the long-term device after a number of months or years in place with a simple endoscopic procedure of removing the old Therapeutic device and replacing the new Therapeutic device through the mouth. lAL The type of Therapeutic device can be adapted to the patient's clinical condition ( lamellar to tubular or vice-versa) or more or less lamellae if the patient is at more or less risk of vomiting (more lamellae are thinner and will reverse more easily in case of vomiting), fewer lamellae will be more efficient in blocking reflux in the patient needs it), the tubular Therapeutic device being the most efficient in blocking GERD but will block vomiting proportionally to the length of the tube, the longer the tube as in GARD for Obesity, the more the tube will collapse in the stomach and will not allow vomiting as is the case in gastric-bypass operations for obesity.

[0339] 1AM. A method where three pressures exerted on the devices reach an equilibrium namely the pressure of the esophageal wall cells on the permanent stent to push the permanent stent into the lumen of the esophagus (that is the pressure from the wall of the esophagus toward the lumen of the esophagus), the counter-pressure exerted by the helical spring and the silicone ring of the device from the lumen towards the wall of the esophagus and the injection of botulinum toxin in the wall of the esophagus right above the device that blocks at least for a few weeks, as described in U.S. Patent Application No.

[0340] 16 / 610,612 and granted as U.S. Patent No. 11,571,289 as of February 7, 2023, which is hereby incorporated by reference. After a few weeks, the permanent stent should have been included in the wall of the esophagus by the inflammatory cells who have started to scar the permanent stent in the wall of the esophagus, a natural occurrence that the body uses to isolate a foreign body that it cannot expel.

[0341] IAN. A method where magnets or parts of ferromagnetic sheets are placed in the permanent stent facing the lumen to strengthen the contact with the vertical band magnets or ferromagnetic sheet on the external part of the Therapeutic Magnetic GARD.

[0342] IAO. A permanent stent configured to be placed in a patient to treat any of a variety of ailments, the permanent stent comprising: a plurality of spaced-apart horizontal supports; a plurality of spaced-apart vertical supports, each of the plurality of spaced-apart vertical supports extending from a bottom-most one of the plurality of spaced-apart horizontal supports to top-most one of the plurality of spaced-apart horizontal supports; and a plurality of spaced-apart connectors, each connector being positioned between a pair of the plurality of spaced-apart horizontal supports and a pair of the plurality of spaced-apart vertical supports.

[0343] IAP. The permanent stent of embodiment 1AO, wherein the Permanent Stent is configured to be placed in an esophagus of the patient.

[0344] IAQ. The permanent stent of embodiment 1AO, wherein adjacent pair of the plurality of spaced-apart horizontal supports are equidistantly spaced-apart.

[0345] IAR. The permanent stent of embodiment 1AO, wherein adjacent pair of the plurality of spaced-apart vertical supports are equidistantly spaced-apart.

[0346] IAS. The permanent stent of embodiment 1AO, wherein adjacent pair of the plurality of spaced-apart connectors are equidistantly spaced-apart.

[0347] IAT. The permanent stent of embodiment IAS, wherein each of the plurality of spaced-apart connectors is in the form of a lozenge, diamond, oval, or circle. IAU. The permanent stent of embodiment 1AO, wherein the permanent stent is configured to be attached to a tubular part by adhesive.

[0348] IAV. The permanent stent of embodiment 1AO, wherein the permanent stent is configured to be attached to a ring.

[0349] IAW. The permanent stent of embodiment 1AU or 1AV, wherein a helical spring is not employed during use of the permanent stent in the patient.

[0350] IAX. The permanent stent of embodiment 1AO, wherein the permanent stent is configured to be attached to a ring by surgical sutures with knots.

[0351] IAY. The permanent stent of embodiment 1AO, wherein the permanent stent is configured to be attached to at least one of a ring and a tubular part by one or more magnets.

[0352] IAZ. The permanent stent of embodiment 1AY, wherein the one or more magnets include a plurality of spaced-apart magnets, each magnet extending over two or more of the plurality of spaced-apart horizontal supports or over two or more of the plurality of spaced-apart vertical supports.

[0353] IAZA. The permanent stent of embodiment 1AZ, wherein each magnet is attached to the inside of the permanent stent.

[0354] IAZB. The permanent stent of embodiment 1AZ, wherein each magnet is attached to the outside of the permanent stent.

[0355] IAZC. The permanent stent of embodiment 1AO, wherein one or more spaced- apart magnets are attached to at least one of the horizontal supports or at least one of the vertical supports.

[0356] IAZD. The permanent stent of embodiment 1AO, wherein the permanent stent is reconfigurable between an expanded configuration and a folded configuration.

[0357] 1BA. A method of minimally invasive treatment of at least one of reflux disease and obesity of a patient, the method comprising: inserting a permanent stent through a mouth of the patient, the permanent stent including a plurality of spaced-apart horizontal supports, a plurality of spaced-apart vertical supports, and a plurality of spaced-apart connectors; each of the plurality of spaced-apart vertical supports extending from a bottom-most one of the plurality of spaced-apart horizontal supports to top-most one of the plurality of spaced-apart horizontal supports; and each connector being positioned between a pair of the plurality of spaced-apart horizontal supports and a pair of the plurality of spaced-apart vertical supports.

[0358] IBB. The method of embodiment 1BA, further comprising: attaching one or more spaced-apart magnets to the permanent stent.

[0359] IBC. The method of embodiment 1BA, further comprising: attaching the permanent stent to a tube with adhesive prior to inserting the permanent stent into the patient.

[0360] IBD. The method of embodiment 1BA, further comprising: attaching the permanent stent to a ring using surgical thread to create a plurality of knots around the permanent stent and the ring prior to inserting the sent into the patient.

[0361] IC. A method of using one or more magnets on a permanent stent and on a device to hold the device in place in a lumen of an esophagus of a patient.

[0362] ID. A method of stopping reflux or obesity of a patient, the method comprising: using the pressure-counter pressure principle, where the pressure on a permanent stent from a body to push the permanent stent in a lumen of an esophagus of a patient is countered by pressure of a ring of a device with a helical spring for horizonal pressures, and injecting botulinum toxin above the permanent stent in a wall of the esophagus after placement of the permanent stent, wherein a therapeutic device counteracts peristalsis contraction of the esophagus to push the therapeutic device down into a stomach of the patient, wherein balance is kept long enough for inflammatory cells to create a scar around the permanent stent and the helical ring.

[0363] While the presently disclosed technology has been described in detail and with reference to specific examples thereof, it will be apparent to one skilled in the art that various changes and modifications can be made therein without departing from the spirit and scope thereof. It is understood, therefore, that the presently disclosed technology is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the presently disclosed technology as defined by the appended claims.

Claims

CLAIMS1. A method of minimally invasive alleviating at least one of reflux disease and obesity of a patient, the method comprising: attaching a permanent stent to a ring; and inserting the combined permanent stent and ring into an esophagus of a patient through a mouth of the patient prior, wherein a top of the permanent stent is off-set from a top of the ring.

2. The method of claim 1, wherein the permanent stent is attached to the ring by surgical thread forming at least one or a plurality of spaced-apart knots extending around at least a portion of the permanent stent and at least a portion of the ring.

3. The method of any previous claim, wherein the top of the permanent stent is below the top of the ring.

4. The method of any previous claim, wherein a height of the permanent stent is greater than a height of the ring, such that at least a portion of the permanent stent extends below a bottom of the ring.

5. The method of claim 4, wherein the height of the ring is one-third the height of the permanent stent.

6. The method of any previous claim, wherein the permanent stent includes a plurality of spaced-apart horizontal supports, a plurality of spaced- apart vertical supports, and a plurality of spaced-apart connectors; wherein each of the plurality of spaced-apart vertical supports extend from a bottom-most one of the plurality of spaced-apart horizontal supports to top-most one of the plurality of spaced-apart horizontal supports; and wherein each connector is positioned between a pair of the plurality of spaced-apart horizontal supports and a pair of the plurality of spaced-apart vertical supports.

7. The method of any previous claim, wherein the ring includes a rim that extends radially outwardly from a remainder of the ring, and wherein the top of the permanent stent contacts a bottom of the rim.

8. The method of any previous claim, wherein a tubular or lamellar device or a combination thereof extends downwardly from a bottom surface of the ring.

9. A combination configured to be placed in a patient to treat any of a variety of ailments, the combination comprising: a permanent stent attached to a ring by surgical thread forming at least one or a plurality of spaced-apart knots around at least a portion of the permanent stent and around at least a portion of the ring, wherein a top of the permanent stent is off-set from a top of the ring.

10. The combination of claim 9, wherein the permanent stent comprises: a plurality of spaced-apart horizontal supports; a plurality of spaced-apart vertical supports, each of the plurality of spaced-apart vertical supports extending from a bottom-most one of the plurality of spaced-apart horizontal supports to top-most one of the plurality of spaced-apart horizontal supports; and a plurality of spaced-apart connectors, each connector being positioned between a pair of the plurality of spaced-apart horizontal supports and a pair of the plurality of spaced-apart vertical supports.

11. The combination of claim 9 or 10, wherein the combination is configured to be placed in an esophagus of the patient.

12. The combination of any one of claims 9-11, wherein adjacent pair of the plurality of spaced-apart horizontal supports are equidistantly spaced- apart, wherein adjacent pair of the plurality of spaced-apart vertical supports are equidistantly spaced-apart, and wherein adjacent pair of the plurality of spaced-apart connectors are equidistantly spaced-apart.

13. The combination of claim 12, wherein each of the plurality of spaced-apart connectors is in the form of a lozenge or diamond.

14. The combination of any one of claims 9-13, wherein the permanent stent is reconfigurable between an expanded configuration and a folded configuration.

15. A method of minimally invasive alleviating at least one of reflux disease and obesity of a patient, the method comprising:inserting two permanent stent through a mouth of the patient, a first one of the two permanent stent affixing to a first part of an esophageal wall of the patient, a second one of the two permanent stent affixing to a second part of the esophageal wall of the patient, the first part being spaced-apart from the second part.

16. The method of claim 15, further comprising: attaching a lower portion of the first one of the two permanent stent to an upper portion of a ring; and attaching an upper portion of the second one of the two permanent stent to a lower portion of the ring.

17. The method of claim 16, wherein each of the two permanent stent is attached to the ring by surgical thread forming at least one or a plurality of spaced-apart knots.

18. The method of claim 16, wherein each of the two permanent stent is attached to the ring by one or more magnets.

19. The method of any one of claims 15-18, wherein each permanent stent includes a plurality of spaced-apart horizontal supports, a plurality of spaced-apart vertical supports, and a plurality of spaced-apart connectors; each of the plurality of spaced-apart vertical supports extending from a bottom-most one of the plurality of spaced-apart horizontal supports to topmost one of the plurality of spaced-apart horizontal supports; and each connector being positioned between a pair of the plurality of spaced-apart horizontal supports and a pair of the plurality of spaced-apart vertical supports.

20. The method of any one of claims 15-19, wherein a tubular or lamellar device extends downwardly from a bottom surface of the ring.

21. A permanent stent configured to be placed in a patient to alleviate any of a variety of ailments, the permanent stent comprising: a plurality of spaced-apart horizontal supports; and a plurality of spaced-apart vertical supports, at least one of the spaced- apart vertical supports extending from a bottom-most one of the plurality of spaced-apart horizontal supports to top-most one of the plurality of spaced- apart horizontal supports,wherein the permanent stent is divided into three portions, the three portions include an upper portion, a midportion, and a lower portion, and wherein the upper portion and the lower portion are mirror images of each other.

22. The permanent stent of claim 21, further comprising a plurality of spaced-apart connectors, each connector being positioned between a pair of the plurality of spaced-apart horizontal supports and a pair of the plurality of spaced-apart vertical supports.

23. The permanent stent of claim 21 or 22, wherein the upper portion includes two or fewer horizontal supports.

24. The permanent stent of claim 21 or 22, wherein the midportion includes two or fewer horizontal supports.

25. The permanent stent of any one of claims 21-24, wherein the permanent stent includes four or fewer horizontal supports.

26. The permanent stent of any one of claims 21-25, wherein the permanent stent is configured to be placed in an esophagus of the patient.

27. The permanent stent of any one of claims 21-26, wherein adjacent pair of the plurality of spaced-apart horizontal supports are equidistantly spaced-apart.

28. The permanent stent of any one of claims 21-27, wherein adjacent pair of the plurality of spaced-apart vertical supports are equidistantly spaced- apart.

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