Medical device for treating anorectal disorders

Abstract

The present invention provides a novel device positioned within the lumen of a hollow organ or a portion thereof, which includes a mesh that enables the fixation of a tubular sleeve to the lumen surface of the hollow organ by physically engaging with the surface of the lumen of the hollow organ.

Description

[Technical Field]

[0001] The present invention relates to a novel apparatus and method of using the same. Specifically, the present invention provides a novel apparatus and method for treating and / or promoting the recovery of anorectal disorders and similar disorders. [Background technology]

[0002] Lower gastrointestinal disorders affect millions of people worldwide every year. In many cases, these disorders dramatically alter a patient's quality of life and may require long (sometimes prolonged) and painful treatment and recovery. Anorectal disorders, such as anal fistulas and anal fissures, are the most common conditions of the lower GI tract. One of the significant characteristics of these disorders is that they are lesions that form on the inner lining of the intestinal tract. For example, an anal fistula is characterized by the formation of an abnormal tunnel beneath the skin that connects the anal canal to the skin near the anus. Most anal fistulas form in response to anal gland infections (abscesses) that cause pus to accumulate, thus posing an imminent threat of systemic infection. Anal fissures are conditions in which small tears or cracks appear in the inner lining of the anus. Both of these conditions result in pain, bleeding, and complications, and can lead to a long and painful recovery. Untreated anal fistulas and anal fissures can become breeding grounds for bacteria and lead to infection. When an open wound is constantly exposed to fecal matter, the risk of bacterial contamination increases. Chronic anal fissures left untreated can lead to the development of anal fistula, fecal incontinence, anal stenosis, and psychological distress.

[0003] Most anal fistulas require surgery to heal. Most anal fissures are thought to require no treatment other than self-care, and may only require a prescribed ointment for temporary pain relief. However, fissures lasting several weeks are determined to be chronic and require more advanced treatment. In many cases, treatment for anal fistulas and chronic anal fissures may require various invasive surgical procedures, which may require a longer recovery period or even hospitalization, depending on the severity. These procedures are often painful, and patients may experience complications such as bleeding, infection, and recurrence.

[0004] To date, no effective minimally invasive or non-invasive treatments for anorectal conditions have successfully entered the market, leaving patients with poor quality of life and persistent complications. Therefore, there is an urgent and unmet need for less invasive, cost-effective, and safe treatment options for patients suffering from lower GI duct disorders. [Overview of the Initiative] [Problems that the invention aims to solve]

[0005] The primary objective of this invention is to provide a therapeutic solution that overcomes the shortcomings of current treatment options and offers a safe, effective, and minimally invasive alternative for treating anorectal disorders. [Means for solving the problem]

[0006] In some embodiments, the present invention provides a device that can be easily inserted into the anal canal, which acts as a sealant that prevents leakage of fecal matter and other bodily fluids from the anal canal into the lesion, i.e., facilitates the healing process.

[0007] In some embodiments, the present invention provides a tubular sleeve designed to be positioned within the lumen of at least one hollow organ or a portion thereof, wherein at least a portion of the tubular sleeve includes a mesh, which physically engages with the surface of the lumen of the hollow organ, thereby enabling the tubular sleeve to be fixed to the surface of the lumen of the hollow organ.

[0008] In some embodiments of the tubular sleeve described above, at least one hollow organ is part of the gastrointestinal tract (GI tract) or digestive tract.

[0009] In some embodiments of the tubular sleeve described above, at least one hollow organ or part thereof is selected from the group including the food tract, hindgut, colon, rectum, and anal canal.

[0010] In some embodiments of the tubular sleeve described above, the inner surface is the gastrointestinal wall or the rectal wall.

[0011] In some embodiments of the tubular sleeve described above, the tubular sleeve includes a mesh at its proximal end and / or distal end.

[0012] In some embodiments of the tubular sleeve described above, two or more portions of the tubular sleeve include a mesh.

[0013] In some embodiments of the tubular sleeve described above, the mesh is selected from the group including knitted mesh, braided mesh, woven mesh, or a combination thereof.

[0014] In some embodiments of the tubular sleeve described above, the mesh is a surgical mesh or a biological mesh (biomesh).

[0015] In some embodiments of the tubular sleeve described above, the mesh is made of a material selected from the group consisting of synthetic materials, semi-synthetic materials, natural materials, animal-derived materials, polymers, and any combination thereof.

[0016] In some embodiments of the tubular sleeve described above, the material is selected from the group including polyester (POL), polyvinylidene fluoride (PVDF), polyethylene terephthalate (PET), polypropylene (PP), polytetrafluoroethylene (PTFE), ePTFE, cellulose, oxidized regenerated cellulose (ORC), polyglutin, vicryl (polyglutin), polyglecaprone, polyethylene (PE), poly(glycolic acid) (PGA), polyglecaprone, polylactic acid (PLA), poly(lactic acid-coglycolic acid) (PLGA), carboxymethylcellulose (CMC), polydioxanone (PDO, PDS), silk, nylon, collagen, any suitable material, and any combination thereof.

[0017] In some embodiments of the tubular sleeve described above, the animal-derived material is selected from the group including porcine dermis, porcine small intestine submucosa, bovine dermis or pericardium, human cadaver dermis or fascia lata, collagen, any suitable material, and any combination thereof.

[0018] In some embodiments of the tubular sleeve described above, the material is characterized by being at least one of the following: absorbent material, non-absorbent material, inactive material, infection-resistant material, fistula-resistant material, non-carcinogenic material, non-allergenic material, highly sensitive material, sterilizable material, adjustable material, physical manipulation-resistant material, durable material, and any combination thereof.

[0019] In some embodiments of the tubular sleeve described above, the mesh is characterized by having a pore size type selected from monofilament, duofilament, and multifilament types.

[0020] In some embodiments of the tubular sleeve described above, the mesh further includes a coating.

[0021] According to some embodiments of the above-described tubular sleeve, the coating comprises at least one compound selected from the group consisting of cellulose, collagen, fatty acids, phospholipids, fibers, laminin, and any combination thereof.

[0022] According to some embodiments of the above-described tubular sleeve, the outer surface of at least one segment of the tubular sleeve further comprises at least one structure selected from the group consisting of ridges, ribs, skeletons, sponges, membranes, any suitable structure, and any combination thereof.

[0023] According to some embodiments of the above-described tubular sleeve, at least one structure is made of a polymer, silicone, phospholipid, fiber, collagen, laminin, and any combination thereof.

[0024] According to some embodiments of the above-described tubular sleeve, the polymer is selected from the group consisting of natural polymers, modified polymers, synthetic polymers, and semi-synthetic polymers.

[0025] The tubular sleeve according to some of the above further comprises a chemical fastener and / or an adhesive.

[0026] According to some embodiments of the above-described tubular sleeve, the chemical fastener and / or the adhesive comprises at least one coagulation factor, at least one cross-linking agent, at least one hemostatic agent, or any combination thereof.

[0027] According to some embodiments of the above-described tubular sleeve, the chemical fastener and / or the adhesive comprises at least one compound selected from the group consisting of fibrinogen (or factor I), thrombin (factor IIa), prothrombin (factor II), factor IV, factor V, factor VII, factor VIII, factor IX, factor X, factor XIII (fibrin stabilizing factor), prothrombin complex concentrate (PCC or factor IX complex), prekallikrein (PK), high molecular weight kininogen (HK), and any combination thereof.

[0028] In some embodiments of the tubular sleeve described above, the chemical fastener and / or adhesive may contain aprotinin, fibronectin, pancreatic trypsin inhibitor (BPTI), cell adhesion molecules (CAM), phospholipids, and calcium (Ca 2+ ), further comprising compounds selected from the group including calcium chloride (CaCl2), calcium alginate, oxidized cellulose (OC), and any combination thereof.

[0029] In some embodiments of the tubular sleeve described above, the adhesive and / or chemical fastener is selected from the group including fibrin glue, fibrin sealant, GRFG (gelatin-resorcinol-formaldehyde / glutaraldehyde) glue, cyanoacrylate glue, polysaccharide adhesive, polypeptide-based adhesive, polymer-based adhesive, polyethylene glycol (PEG)-based adhesive, and substrate protein adhesive.

[0030] In some embodiments of the tubular sleeve described above, the adhesive and / or chemical fastener is biocompatible, non-toxic, bioabsorbable, or a combination thereof.

[0031] A tubular sleeve according to some of the embodiments described above further includes an extraluminal segment.

[0032] In some embodiments of the tubular sleeve described above, the extraluminal section is positioned adjacent to the orifice of the hollow organ.

[0033] In some embodiments of the tubular sleeve described above, the orifice is the anus.

[0034] In some embodiments of the tubular sleeve described above, the extraluminal section is designed to expand radially away from the orifice.

[0035] In some embodiments of the tubular sleeve described above, the extraluminal section further includes a plurality of quasi-connecting segments.

[0036] In some embodiments of the tubular sleeve described above, the tubular sleeve is flexible, expandable, elastic, or a combination thereof.

[0037] Some of the tubular sleeves in the embodiments described above are made of an impermeable material.

[0038] In some embodiments of the tubular sleeve described above, the impermeable material is impermeable to bodily fluids and / or solids and / or bodily excretions present in and / or passing through hollow organs.

[0039] In some embodiments of the tubular sleeve described above, the material is selected from the group including silicone, polyurethane, thermoplastic elastomer, rubber, polyvinyl chloride resin, Gore-Tex, perfluoroalkyl substances and polyfluoroalkyl substances (PFAS or PFASs), polytetrafluoroethylene (PTFE), stretched PTFE (ePTFE), polyethylene, polypropylene, and any combination thereof.

[0040] A tubular sleeve according to some of the embodiments described above further includes a mechanical attachment mechanism and / or a sensor.

[0041] In some embodiments of the tubular sleeve described above, the mechanical attachment is selected from the group including a balloon, a hook, any suitable attachment, and any combination thereof.

[0042] Another objective of the present invention is, a. Providing one of the tubular sleeves from the above embodiments, b. The step of inserting the tubular sleeve into the lumen of the hollow organ. c. Positioning at least a portion of the tubular sleeve containing the mesh in close proximity to the surface of the lumen, thereby enabling physical contact between at least a portion of the tubular sleeve containing the mesh and the surface of the lumen of the hollow organ, and d. The step of enabling at least a portion of the tubular sleeve containing the mesh to adhere to the surface of the lumen of the hollow organ, thereby placing the tubular sleeve in the hollow organ. The objective is to provide a method for placing a tubular sleeve containing a hollow organ, a portion of a hollow organ, and / or an area adjacent to a hollow organ for a predetermined period of time.

[0043] In some embodiments of the above method of placing a tubular sleeve into a hollow organ, the hollow organ is a part of the gastrointestinal tract (GI tract) or digestive tract.

[0044] In some embodiments of the above method of placing a tubular sleeve into a hollow organ, the hollow organ is selected from the group including the food tract, hindgut, colon, rectum, anal canal, and any combination thereof.

[0045] In some embodiments of the above method of placing the tubular sleeve in a hollow organ, the luminal surface is the gastrointestinal wall or the rectal wall.

[0046] Some of the methods according to the embodiments described above further include the step of applying a chemical fastener and / or adhesive to the surface of the mesh and / or lumen.

[0047] In some embodiments of the above method of placing a tubular sleeve into a hollow organ, the step of adding a chemical fastener and / or adhesive precedes step a.

[0048] In some embodiments of the above method of placing the tubular sleeve into the hollow organ, the step of adding a chemical fastener and / or adhesive precedes step d.

[0049] In some embodiments of the above method of placing a tubular sleeve into a hollow organ, the chemical fastener and / or adhesive comprises at least one coagulation factor, at least one crosslinking agent, at least one hemostatic agent, or any combination thereof.

[0050] In some embodiments of the above method of placing a tubular sleeve in a hollow organ, the chemical fastener and / or adhesive comprises at least one compound selected from the group including fibrinogen (or factor I), thrombin (factor IIa), prothrombin (factor II), factor IV, factor V, factor VII, factor VIII, factor IX, factor X, factor XIII (fibrin stabilizing factors), prothrombin complex concentrate (PCC or factor IX complex), prekallikrein (PK), high molecular weight kininogen (HK), and any combination thereof.

[0051] In some embodiments of the above method of placing a tubular sleeve in a hollow organ, the chemical fastener and / or adhesive may contain aprotinin, fibronectin, pancreatic trypsin inhibitor (BPTI), cell adhesion molecules (CAM), phospholipids, calcium (Ca 2+ ), further comprising compounds selected from the group including calcium chloride (CaCl2), calcium alginate, oxidized cellulose (OC), and any combination thereof.

[0052] In some embodiments of the above method for placing a tubular sleeve in a hollow organ, the adhesive and / or chemical fastener is selected from the group including fibrin glue, fibrin sealant, GRFG (gelatin-resorcinol-formaldehyde / glutaraldehyde) glue, cyanoacrylate glue, polysaccharide adhesive, polypeptide adhesive, polymer adhesive, polyethylene glycol (PEG) adhesive, and substrate protein adhesive.

[0053] In some embodiments of the above method of placing a tubular sleeve in a hollow organ, at least one hollow organ, a portion of a hollow organ, and / or a region adjacent to a hollow organ includes at least one lesion.

[0054] In some embodiments of the above method of placing a tubular sleeve in a hollow organ, the tubular sleeve is designed to isolate the lesion from the contents of at least one of the following: the lumen of the hollow organ, a portion of the hollow organ, and / or a region adjacent to the hollow organ, or a combination thereof.

[0055] In some embodiments of the above method of placing a tubular sleeve in a hollow organ, at least one lesion is selected from anastomosis, laceration, and fistula.

[0056] A method according to some of the above embodiments for placing a tubular sleeve in a hollow organ further includes the step of preparing the tubular sleeve and / or a portion of the tubular sleeve.

[0057] In some embodiments of the above method for placing the tubular sleeve into a hollow organ, the step of preparing the tubular sleeve and / or a portion of the tubular sleeve precedes step b.

[0058] In some embodiments of the above method of placing a tubular sleeve in a hollow organ, the predetermined period is between 1 and 28 days.

[0059] Another object of the present invention is to provide a method for accelerating the recovery of at least one lesion in a hollow organ, a portion of a hollow organ, a region adjacent to a hollow organ, or any combination thereof, by isolating the lesion from the contents of the hollow organ, this portion of a hollow organ, a region adjacent to a hollow organ, or any combination thereof, the step of temporarily placing at least a portion of a tubular sleeve of any of the embodiments described above into the lumen.

[0060] In the method for accelerating recovery according to some of the embodiments described above, the step of placing at least a portion of the tubular sleeve into the lumen is: a. The step of providing a tubular sleeve from any of the embodiments described above, b. The step of inserting the tubular sleeve into the lumen, c. Positioning at least a portion of the tubular sleeve containing the mesh in close proximity to the surface of the lumen, and enabling physical contact of at least a portion of the tubular sleeve containing the mesh with the surface of the lumen, and d. A step that allows at least a portion of the tubular sleeve containing the mesh to be fixed to the surface of the lumen, Includes.

[0061] A method for accelerating recovery according to some of the embodiments described above further includes the step of applying a chemical fastener and / or adhesive to the surface of the mesh and / or lumen.

[0062] In some embodiments of the above method, the step of adding a chemical fastener and / or adhesive precedes step a.

[0063] In some embodiments of the above method, the step of adding a chemical fastener and / or adhesive precedes step d.

[0064] In some embodiments of the above method, the chemical fastener and / or adhesive comprises at least one coagulation factor, at least one crosslinking agent, at least one hemostatic agent, or any combination thereof.

[0065] In some embodiments of the above method, the chemical fastener and / or adhesive comprises at least one compound selected from the group including fibrinogen (or factor I), thrombin (factor IIa), prothrombin (factor II), factor IV, factor V, factor VII, factor VIII, factor IX, factor X, factor XIII (fibrin stabilizing factors), prothrombin complex concentrate (PCC or factor IX complex), prekallikrein (PK), high molecular weight kininogen (HK), and any combination thereof.

[0066] In some embodiments of the above method, the chemical fastener and / or adhesive contains aprotinin, fibronectin, pancreatic trypsin inhibitor (BPTI), cell adhesion molecule (CAM), phospholipid, calcium (Ca 2+ ), further comprising compounds selected from the group including calcium chloride (CaCl2), calcium alginate, oxidized cellulose (OC), and any combination thereof.

[0067] In some embodiments of the above method, the adhesive and / or chemical fastener is selected from the group including fibrin glue, fibrin sealant, GRFG (gelatin-resorcinol-formaldehyde / glutaraldehyde) glue, cyanoacrylate glue, polysaccharide adhesive, polypeptide-based adhesive, polymer-based adhesive, polyethylene glycol (PEG)-based adhesive, and substrate protein adhesive.

[0068] A method according to some of the embodiments described above further includes the step of adding at least one therapeutic agent to the surface of the lumen.

[0069] In some embodiments of the above method, the step of applying at least one therapeutic agent to the surface of the lumen is repeated at least twice.

[0070] In some embodiments of the above method, the therapeutic agent is selected from the group comprising anti-inflammatory compounds, antibiotics, antiviral drugs, coagulants, healing-promoting factors, and any combination thereof.

[0071] Another object of the present invention is to provide a method for shielding at least one lesion on a surface of a hollow organ, a portion of a hollow organ, a region adjacent to a hollow organ, or any combination thereof, from the contents of the hollow organ, this portion of a hollow organ, a region adjacent to a hollow organ, or any combination thereof, the step of placing at least a portion of a tubular sleeve of any of the embodiments described above into a lumen.

[0072] In some of the embodiments described above, the step of placing at least a portion of the tubular sleeve into the lumen is: a. The step of providing a tubular sleeve according to any of the embodiments described above, b. The step of inserting the tubular sleeve into the lumen, c. Positioning at least a portion of the tubular sleeve containing the mesh in close proximity to the surface of the lumen, and enabling physical contact of at least a portion of the tubular sleeve containing the mesh with the surface of the lumen, and d. A step that allows at least a portion of the tubular sleeve containing the mesh to be fixed to the surface of the lumen, Includes.

[0073] Some of the methods according to the embodiments described above further include the step of applying a chemical fastener and / or adhesive to the surface of the mesh and / or lumen.

[0074] In some embodiments of the above method, the step of adding a chemical fastener and / or adhesive precedes step a.

[0075] In some embodiments of the above method, the step of adding a chemical fastener and / or adhesive precedes step d.

[0076] In some embodiments of the above method, the chemical fastener and / or adhesive comprises at least one coagulation factor, at least one crosslinking agent, at least one hemostatic agent, or any combination thereof.

[0077] In some embodiments of the above method, the chemical fastener and / or adhesive comprises at least one compound selected from the group including fibrinogen (or factor I), thrombin (factor IIa), prothrombin (factor II), factor IV, factor V, factor VII, factor VIII, factor IX, factor X, factor XIII (fibrin stabilizing factors), prothrombin complex concentrate (PCC or factor IX complex), prekallikrein (PK), high molecular weight kininogen (HK), and any combination thereof.

[0078] In some embodiments of the above method, the chemical fastener and / or adhesive contains aprotinin, fibronectin, pancreatic trypsin inhibitor (BPTI), cell adhesion molecule (CAM), phospholipid, calcium (Ca 2+ ), further comprising compounds selected from the group including calcium chloride (CaCl2), calcium alginate, oxidized cellulose (OC), and any combination thereof.

[0079] In some embodiments of the above method, the adhesive and / or chemical fastener is selected from the group including fibrin glue, fibrin sealant, GRFG (gelatin-resorcinol-formaldehyde / glutaraldehyde) glue, cyanoacrylate glue, polysaccharide adhesive, polypeptide-based adhesive, polymer-based adhesive, polyethylene glycol (PEG)-based adhesive, and substrate protein adhesive.

[0080] Another object of the present invention is to provide a tubular sleeve from any of the above embodiments for use in accelerating the recovery of at least one lesion in a hollow organ, a portion of a hollow organ, a region adjacent to a hollow organ, or any combination thereof.

[0081] Another object of the present invention is to provide a tubular sleeve designed to be positioned within the lumen of a hollow organ, wherein at least a portion of the tubular sleeve comprises a mesh, the mesh enabling the tubular sleeve to adhere to the side wall of the lumen of the hollow organ by physically engaging with the tissue of the side wall of the lumen of the hollow organ. [Brief explanation of the drawing]

[0082] [Figure 1] This figure illustrates the anatomical structure of the colon and shows a longitudinal section of the anus. [Figure 2] This diagram shows a longitudinal section of the anatomical structure of the anus, along with cross-sections of anorectal disorders, illustrating an anal fistula in the upper right image and an anal fissure in the lower right image. [Figure 3] This figure illustrates a device inserted into the anus according to one embodiment of the present invention, and shows a longitudinal cross-section of the anus to which the device is fixed. [Modes for carrying out the invention]

[0083] The present invention will now be described more fully with reference to the accompanying embodiments and drawings illustrating embodiments of the invention. However, the present invention can be embodied in many different forms and should not be construed as being limited to the embodiments listed herein, but rather these embodiments are provided so as to complete the disclosure of the present invention and so as to fully convey the scope of the invention to those skilled in the art.

[0084] The present invention aims to address problems associated with disorders of the lower GI canal, such as anal fistulas and anal fissures, by providing a medical device that can be inserted into the rectum and positioned internally. The device creates a seal between the rectum and the skin, diverting feces away from the site of injury, allowing the site to heal naturally, thereby avoiding the need for surgical intervention and preventing leakage.

[0085] In some embodiments, the present invention provides a non-invasive device for the treatment of gastrointestinal or digestive problems.

[0086] In some embodiments, the present invention provides a tubular sleeve designed to be positioned within the lumen of at least one hollow organ or part thereof. In the context of the present invention, the term “sleeve” means, but is not limited to, an article configured to take on a cylindrical and / or cylindrical hollow structure when positioned within the lumen of at least one hollow organ or part thereof. In some embodiments, when positioned, the sleeve is designed to conduct human waste. In the context of the present invention, the term “sleeve” may be referred to as and / or used interchangeably with the terms “conduit,” “tube,” “pipe,” “channel,” “duct,” and “tunnel.”

[0087] As used herein, the term "hollow organ" means, but is not limited to, a body organ having an internal volume, lumen, and / or cavity. As used herein, the term "lum" means, but is not limited to, the internal volume or cavity of a hollow organ and / or a part of a hollow organ.

[0088] Typically, hollow organs have a lumen and a wall, while the tissue reinforcing the lumen wall, which can also be called a "surface" or "surface of the lumen," is continuously exposed to the contents of the lumen. The internal volume or lumen may be continuously, intermittently, and / or periodically filled with a liquid, gas, solid, emulsion, dispersion, solution, suspension, and / or any combination thereof.

[0089] In some embodiments, the hollow organ is part of the GI tract. In the context of this invention, the term “gastrointestinal tract” (also called the GI tract, digestive tract, or food tract) means, but is not limited to, at least part of the tube or passage of the digestive system that connects the mouth to the anus.

[0090] The term "wall" refers to the structure that forms the inner surface of a hollow organ. In some embodiments, the inner surface or wall is the gastrointestinal wall. In some embodiments, a mucous membrane or mucosa is present. In some embodiments of the present invention, the mucosa includes epithelium, lamina propria, and muscularis mucosa.

[0091] In some embodiments, the hollow organ is part of the lower GI duct. In the context of this invention, the term “lower GI duct” means, but is not limited to, the portion of the GI duct where extensive reabsorption of water and salt occurs in the right colon / proximal colon and continues throughout. The lower GI duct begins in the cecum and includes the appendix (in humans only), the colon, the rectum, the anal canal, and the anus. A common alternative name for the lower GI duct is the “large intestine.” The primary function of the large intestine is to dehydrate and store fecal matter. In the context of this invention, the terms “fecal matter,” “fecal matter,” “feces,” “stool,” or “excrement” are interchangeable and mean, but are not limited to, the waste released from the large intestine through the anus during defecation. Fecal matter is considered part of human excrement and typically consists of 75 percent water and 25 percent solids.

[0092] In some embodiments, at least a portion of the tubular sleeve includes a mesh. In the context of this invention, the term “mesh” is to be understood as any knitted or woven material such as a net, grid, or fabric having space therein. In some embodiments, the mesh is a knitted mesh, a braided mesh, and / or a woven mesh.

[0093] In some embodiments, the mesh is a surgical mesh. In the context of this invention, the term “surgical mesh” means, but is not limited to, a loosely woven mesh used in surgery as a structural support, whether permanent or temporary, for organs and other tissues. Surgical meshes can be made from both inorganic and biological materials and are used in a variety of surgeries.

[0094] In some embodiments, the mesh is a biological mesh (biomesh). As used herein, the term “biomesh” means, but is not limited to, a type of surgical mesh made from organic biomaterials. A non-limiting list of organic biomaterials for biomesh includes porcine dermis, porcine small intestine submucosa, bovine dermis or pericardium, and human cadaver dermis or fascia lata.

[0095] Depending on the embodiment, a non-limiting list of materials from which the mesh is made includes synthetic materials, semi-synthetic materials, natural materials, animal-derived materials, polymers, or any other suitable materials, and / or any combination thereof.

[0096] Depending on the embodiment, a non-limiting list of materials from which the mesh is made includes polyester (POL), polyvinylidene fluoride (PVDF), polypropylene (PP), polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), stretched polytetrafluoroethylene (ePTFE), cellulose, oxidized regenerated cellulose (ORC), polyglutinin, vicryl (polyglutinin), poly(glycolic acid) (PGA), polyglecaprone, polyethylene (PE), polylactic acid (PLA), polyglecaprone, polydioxanone (PDO, PDS), poly(lactic acid-coglycolic acid) (PLGA), carboxymethylcellulose (CMC), silk, nylon, collagen, or any other suitable material and / or any combination thereof.

[0097] Depending on the embodiment, the mesh may be made from animal-derived material. A non-limiting list of animal-derived materials includes, but is not limited to, porcine dermis, porcine small intestine submucosa, bovine dermis or pericardium, human cadaver dermis or fascia lata, collagen, or any other suitable material, and / or any combination thereof.

[0098] Depending on the embodiment, the material from which the mesh is made is characterized by being at least one of the following: absorbent material, non-absorbent material, inactive material, infection-resistant material, fistula-resistant material, non-carcinogenic material, non-allergenic material, highly sensitive material, sterilizable material, adjustable material, physical manipulation-resistant material, durable material, flexible material, elastic material, bactericidal material, or any other suitable material, and / or any combination thereof.

[0099] As used herein, the term “absorbable” means, but is not limited to, a material that can dissolve naturally over time and be absorbed by the body. In some embodiments, absorbable materials are hydrolyzed or broken down by adjacent cells, tissues, or their contents, or by hollow organs. In connection with the present invention, the term “absorbable” may be called and / or used interchangeably with “disintegrable,” “hydrolyzable,” “soluble,” and “degradable.”

[0100] In some embodiments of the present invention, the mesh is absorbed between 1 and 28 days. In some preferred embodiments, the mesh is absorbed between 3 and 21 days. In some embodiments, the mesh is absorbed between 7 and 18 days. In one embodiment, the mesh is absorbed between 7 and 14 days.

[0101] In some embodiments, the mesh is characterized by having a pore size type selected from, but not limited to, monofilament, duofilament, and / or multifilament types. In some embodiments, the pore size type of the mesh can be, but not limited to, macroporous type I, microporous type II, macroporous having multifilamentary components and / or microporous component type III, or biomaterial having a pore size type IV of less than a micrometer.

[0102] In some of the embodiments described above, the mesh pore size depends on the material from which the mesh is made.

[0103] In some of the embodiments described above, the pore size may be 1000 μm or more for PP mesh, or 600 μm or more for PVDF mesh.

[0104] In some of the embodiments described above, the orientation of the mesh can be aligned with the physiological elasticity of the tissue.

[0105] In some of the embodiments described above, the mesh includes a coating. In some embodiments, the coating includes, but is not limited to, at least one of cellulose, collagen, fatty acids, phospholipids, fibers, laminin, or any other suitable material, and / or any combination thereof.

[0106] In some of the embodiments described above, the mesh becomes physically engaged with the surface of the lumen of the hollow organ, thereby facilitating and / or enabling the attachment of the tubular sleeve to the surface of the lumen of the hollow organ.

[0107] In some embodiments of the present invention, the mesh may be, but is not limited to, a knitted mesh, a braided mesh, a woven mesh, and / or any combination thereof, or any other type of mesh, fabric, or net.

[0108] In some embodiments, the mesh material is - Inert to the contents of hollow organs and their walls or tissues. - Minimizing the formation of adhesive areas. - Resistant to infection, - Resistant to fistula formation, - Pain and serum cyst formation are minimal. - Possesses excellent tissue endoproliferation, - Rapid engagement with host tissue / penetration into its interior, - Not carcinogenic, - Non-allergenic, It is characterized as such, but is not limited to this.

[0109] In some embodiments, the mesh has the following biomechanical properties, namely: - A function that maintains sufficient long-term tensile strength to prevent early recurrence. -Minimal shrinkage, -anisotropy, -elastic, -stretchability, - Function to maintain the natural respiratory movement of the stomach wall, -Durability, It is characterized by having [this characteristic].

[0110] In some embodiments, the mesh is - Sterilizable, - Adjustable, - Easy to handle, It is characterized as something.

[0111] In some embodiments, the mesh is positioned at the proximal end of the tubular sleeve. As used herein, the term “proximal end” means, but is not limited to, the sleeve end positioned or placed near the center of the body and away from the opening.

[0112] In some embodiments, at least two portions of the tubular sleeve of the present invention include a mesh. In some embodiments, the mesh is positioned at the distal end of the sleeve.

[0113] The term "distal end" refers to the sleeve end that is furthest from the center of the body and closest to the opening of the hollow organ. In some embodiments, the distal end is extraluminal and located outside the lumen of the hollow organ.

[0114] In some embodiments of the present invention, two or more portions of the tubular sleeve include a mesh.

[0115] In some embodiments, the outer surface of at least one segment of the tubular sleeve further includes at least one structure. The structure is selected from, but is not limited to, a protrusion, ridge, skeleton, sponge, membrane, any combination thereof, or any other related structure.

[0116] In some embodiments of the tubular sleeve described above, at least one structure is made of a polymer, silicone, phospholipid, fiber, collagen, laminin, or any other suitable material, and / or any combination thereof.

[0117] In some embodiments of the present invention, the polymer is selected from an indefinite group including natural polymers, modified polymers, synthetic polymers, and semi-synthetic polymers.

[0118] In some of the embodiments described above, the tubular sleeve or mesh further includes a chemical fastener and / or adhesive.

[0119] The terms “adhesive” and “chemical fastener” mean, but are not limited to, any material that is applied to at least one of two separate surfaces to bond or connect these surfaces together and resist separation of the surfaces. The term adhesive can be used interchangeably with the terms glue, cement, rubber glue, and paste. In some embodiments, adhesive or chemical fastener is characterized as a surgical adhesive, tissue adhesive or tissue glue, or bioadhesive. In one embodiment, adhesive or chemical fastener is characterized as a pressure-sensitive adhesive (PSA).

[0120] In some embodiments, tissue glues or bioadhesives can be characterized as natural protein-based (such as fibrin glues, thrombin glues, gelatin glues, and albumin glues), synthetic glues (such as cyanoacrylates, polyethylene glycol, and glutaraldehyde), biomimetic glues (glues secreted by lizards and mussels), and hybrid glues (which can be activated by light or temperature). Typically, glues consist of monomers and / or polymers functionalized with reactive groups, such as nitrile acrylates, thiols, and others.

[0121] In some embodiments, a chemical fastener and / or adhesive forms multiple blood clots (thrombi), fibrin clots, fibrin skeletons, cross-linked fibrin protein networks, or any combination thereof between the mesh and the tissue of a hollow organ. In some embodiments, the clots are formed between, around, through, inside, and / or on the fibers of the mesh, the pores of the mesh, or any combination thereof. In some embodiments, the cross-linked fibrin protein network or fibrin skeleton is woven with the mesh of the present invention.

[0122] In some embodiments of the present invention, the chemical fastener and / or adhesive comprises at least one coagulation factor, at least one crosslinking agent, at least one hemostatic agent, or any other suitable material, and / or any combination thereof.

[0123] In some embodiments, the chemical fastener or adhesive comprises at least two coagulation factors.

[0124] In some embodiments of the present invention, the chemical fastener and / or adhesive comprises at least one compound selected from a non-limiting group including fibrinogen (or factor I), thrombin (factor IIa), prothrombin (factor II), factor IV, factor V, factor VII, factor VIII, factor IX, factor X, factor XIII (fibrin stabilizing factors), prothrombin complex concentrate (PCC or factor IX complex), prekallikrein (PK), high molecular weight kininogen (HK), or any other suitable compound, and / or any combination thereof.

[0125] In some embodiments of the present invention, chemical fasteners and / or adhesives contain aprotinin, fibronectin, pancreatic trypsin inhibitors (BPTI), cell adhesion molecules (CAM), phospholipids, and calcium (Ca 2+ ), further comprising compounds selected from an unrestricted group including calcium chloride (CaCl2), calcium alginate, oxidized cellulose (OC), or any other suitable compound, and / or any combination thereof.

[0126] In some embodiments, the adhesive and / or chemical fastener is selected from the group including fibrin glue, fibrin sealant, cyanoacrylate glue, GRFG (gelatin-resorcinol-formaldehyde / glutaraldehyde) glue, polysaccharide adhesive, polypeptide adhesive, polymer adhesive, polyethylene glycol (PEG) adhesive, and substrate protein adhesive.

[0127] In some embodiments of the present invention, the adhesive and / or chemical fastener is biocompatible, non-toxic or non-cytotoxic, bioabsorbable, or a combination thereof.

[0128] In some embodiments of the present invention, the adhesive and / or chemical fastener is absorbed between 1 and 28 days. In some embodiments, the adhesive and / or chemical fastener is absorbed between 3 and 21 days. In some embodiments, the adhesive and / or chemical fastener is absorbed between 7 and 18 days. In one embodiment, the adhesive and / or chemical fastener is absorbed between 7 and 14 days.

[0129] In some embodiments of the present invention, the tubular sleeve further includes an extraluminal segment or portion. The term “extraluminal” means a segment of the sleeve found outside the lumen of the hollow organ. In some embodiments of the present invention, the extraluminal section is positioned adjacent to the orifice of the hollow organ.

[0130] The term "orifice" (or body orifice) means any opening in the body of a human or animal. In the context of this invention, the term "orifice" may be referred to as "opening" and "hole" and / or may be used interchangeably with these terms.

[0131] In some embodiments of the present invention, the orifice is the anus.

[0132] In some embodiments of the present invention, the extraluminal section is designed or configured to extend radially away from the orifice.

[0133] In another embodiment of the present invention, the extraluminal section further includes a plurality of quasi-connecting segments.

[0134] In some embodiments of the present invention, the extraluminal section physically engages with the outer surface of the lumen of the hollow organ, thereby enabling the tubular sleeve to be fixed to the outer surface of the lumen of the hollow organ. In one embodiment, this outer surface is the skin around the anal opening. In one embodiment, the extraluminal section further comprises a chemical fastener and / or adhesive.

[0135] In some embodiments of the present invention, the tubular sleeve is flexible, expandable, elastic, or a combination thereof.

[0136] In some embodiments of the present invention, the tubular sleeve is made of an impermeable material. In some embodiments of the present invention, the impermeable material is impermeable to bodily fluids, solids, and / or bodily excretions present in and / or passing through a hollow organ.

[0137] In some of the embodiments described above, the impermeable material may be, but is not limited to, silicone, polyurethane, thermoplastic elastomer, rubber, polyvinyl chloride resin, Gore-Tex, perfluoroalkyl and polyfluoroalkyl substances (PFAS or PFASs), polytetrafluoroethylene (PTFE), stretched PTFE (ePTFE), polyethylene, polypropylene, or any other suitable material and / or any combination thereof.

[0138] In some embodiments of the present invention, the surface of at least one segment of the tubular sleeve further includes a coating. In some embodiments of the present invention, the sleeve includes a coating on its inner surface, outer surface, or both.

[0139] In one embodiment, the coating comprises a therapeutic agent or an active pharmaceutical ingredient (API). In one embodiment, the therapeutic agent is selected from an open group consisting of anti-inflammatory compounds, antibiotics, antiviral agents, coagulants, and any other suitable compounds, and / or any combination thereof.

[0140] In some embodiments of the present invention, the tubular sleeve further includes a mechanical attachment mechanism and / or a sensor.

[0141] In some embodiments, the mechanical attachment is selected from an indefinite group including balloons, hooks, and any combination thereof.

[0142] In some embodiments of the present invention, the sleeve further includes a fluid conduit for injecting a fluid into a hollow organ. In some embodiments, the conduit injects the fluid into a space or volume formed between the outer surface and the inner surface of the tubular sleeve. In some embodiments, the fluid may be a solution, suspension, dispersion, emulsion, or a combination thereof. In some embodiments, the fluid may contain a therapeutic agent or an active pharmaceutical ingredient (API). In some embodiments, the therapeutic agent may be selected from an unspecified group consisting of anti-inflammatory compounds, antibiotics, antiviral agents, coagulants, and combinations thereof.

[0143] In some embodiments of the present invention, the surface of at least one segment of a tubular sleeve or mesh is functionalized or treated. The surface can be functionalized or treated by drying, heating, disinfection, or a combination thereof.

[0144] Herein, we refer to Figures 1A to 1C, which illustrate exemplary embodiments of the tubular sleeve of the present invention. Figure 1A shows the proximal end of the tubular sleeve 11 including the mesh 12. Figure 1B shows the tubular sleeve 11 including the mesh 12 forming a quasi-connecting section. Figure 1C shows a detailed view of the mesh 13.

[0145] Herein, we refer to Figures 2A to 2C, which present exemplary embodiments of the tubular sleeve of the present invention configured to be positioned in the anal canal. Figure 2A shows an embodiment of the present invention having a tubular sleeve 21 including a mesh 22 configured to be positioned in the gastric canal and an extraluminal section 23 configured to be positioned in the gastric canal. Figure 2B shows an embodiment of the present invention having a tubular sleeve 21' including a mesh having a quasi-connecting section 22' and an extraluminal section 23'. Figure 2C shows an embodiment of the present invention having a raised tubular sleeve 21'' including a mesh having a quasi-connecting section 22'' and an extraluminal section 23''.

[0146] Refer to Figures 3A to 3C, which present exemplary embodiments of the tubular sleeve of the present invention configured to be positioned within a gastric tube. Figure 2A shows an embodiment of the present invention having a tubular sleeve 21 including a mesh 22 and an extraluminal section 23. Figure 2B shows an embodiment of the present invention having a tubular sleeve 21' including a mesh 22' having a quasi-connecting section and an extraluminal section 23'. Figure 2C shows an embodiment of the present invention having a raised tubular sleeve 21'' including a mesh 22'' having a quasi-connecting section and an extraluminal section 23''.

[0147] In some embodiments, the present invention provides methods for the non-invasive treatment of pathological conditions or diseases of the gastrointestinal tract or digestive system. As used herein, the term “pathological condition” is to be understood as an impairment of any function or structure of the body, particularly the gastric or digestive system, which are normal functions of the body. In some embodiments, a non-limiting list of pathological conditions includes anorectal fistulas, rectovaginal fistulas, enterovaginal fistulas, urethral fistulas, vesicojejunostomies, gastrojejunostomies, gastrocolic fistulas, enterocutaneous fistulas, tracheoesophageal fistulas, and peptic ulcer diseases.

[0148] In some embodiments, the present invention provides a method for placing a tubular sleeve over a hollow organ, a portion of a hollow organ, and / or an area adjacent to a hollow organ for a predetermined period of time.

[0149] In some embodiments, the above method is a. The step of providing a tubular sleeve according to any of the embodiments described above, a. The step of inserting the tubular sleeve into the lumen of the hollow organ. b. Positioning at least a portion of the tubular sleeve containing the mesh in close proximity to the surface of the lumen, thereby enabling physical contact between at least a portion of the tubular sleeve containing the mesh and the surface of the lumen of the hollow organ, and c. The step of placing the tubular sleeve into the hollow organ, by allowing at least a portion of the mesh to adhere to the surface of the lumen of the hollow organ. Includes.

[0150] In some embodiments of the above method, the hollow organ is part of the gastrointestinal tract (GI tract) or digestive tract.

[0151] In some embodiments of the above method, the hollow organ is selected from, but is not limited to, the food tract, hindgut, colon, rectum, anal canal, and any combination thereof.

[0152] In some embodiments of the above method, the luminal surface is the gastrointestinal wall or the rectal wall.

[0153] In some embodiments, the above method further includes the step of applying a chemical fastener and / or adhesive to the surface of the mesh and / or lumen.

[0154] In some embodiments of the above method, the step of adding a chemical fastener and / or adhesive precedes step a.

[0155] In some embodiments of the above method, the step of adding a chemical fastener and / or adhesive precedes step d.

[0156] In some embodiments of the above method, the chemical fastener and / or adhesive may be, but not limited to, at least one coagulation factor, at least one crosslinking agent, at least one hemostatic agent, or any other suitable material, and / or any combination thereof.

[0157] In some embodiments of the above method, the chemical fastener and / or adhesive comprises at least one compound selected from the non-limiting group including fibrinogen (or factor I), thrombin (factor IIa), prothrombin (factor II), factor IV, factor V, factor VII, factor VIII, factor IX, factor X, factor XIII (fibrin stabilizing factors), prothrombin complex concentrate (PCC or factor IX complex), prekallikrein (PK), high molecular weight kininogen (HK), any other suitable material, and any combination thereof.

[0158] In some embodiments of the above method, the chemical fastener and / or adhesive contains aprotinin, fibronectin, pancreatic trypsin inhibitor (BPTI), cell adhesion molecule (CAM), phospholipid, calcium (Ca 2+ ), further comprising compounds selected from an indefinite group including calcium chloride (CaCl2), calcium alginate, oxidized cellulose (OC), any other suitable material, and / or any combination thereof.

[0159] In some embodiments of the above method, the adhesive and / or chemical fastener is selected from, but is not limited to, fibrin glue, fibrin sealant, GRFG (gelatin-resorcinol-formaldehyde / glutaraldehyde) glue, cyanoacrylate glue, polysaccharide adhesive, polypeptide adhesive, polymer adhesive, polyethylene glycol (PEG) adhesive, and substrate protein adhesive.

[0160] In some embodiments of the above method, at least one hollow organ, a portion of a hollow organ, and / or a region adjacent to a hollow organ includes at least one lesion.

[0161] In some embodiments of the methods described above, the tubular sleeve is configured and / or designed to isolate a lesion from the contents of at least one of the following: the lumen of a hollow organ, a portion of a hollow organ, and / or an area adjacent to a hollow organ, or a combination thereof. As used herein, the term “isolate” means, but is not limited to, the process of separating at least one portion of a lumen from its contents. In the context of the present invention, the term “isolate” may be called and / or used interchangeably with “shield,” “separate,” “protect,” “guard,” and “block.”

[0162] In some embodiments of the above method, at least one lesion is selected from, but is not limited to, anastomoses, lacerations, and fistulas. In some embodiments, fistulas can be characterized as anorectal fistulas, rectovaginal fistulas, enterovaginal fistulas, urethral fistulas, vesicojejunostomies, gastrojejunostomies, gastrocolic fistulas, enterocutaneous fistulas, tracheoesophageal fistulas, and peptic ulcers. In other embodiments, the sleeve is configured to prevent leakage after a coloanal anastomosis or rectal / anal perforation.

[0163] In some embodiments, the above method further includes the step of preparing a tubular sleeve and / or a portion of a tubular sleeve.

[0164] In some embodiments of the above method, the step of preparing a tubular sleeve and / or a portion of a tubular sleeve precedes step b.

[0165] In some embodiments, the method further includes at least one step of functionalizing and / or treating a surface of at least one segment of the sleeve. The surface may be treated by drying, heating, disinfection, or a combination thereof, but is not limited to these.

[0166] In some embodiments of the above method, the predetermined period is between 1 and 28 days. In some preferred embodiments, the predetermined period is between 3 and 21 days. In some embodiments, the predetermined period is between 7 and 18 days. In one embodiment, the predetermined period is between 7 and 14 days.

[0167] In some embodiments, the method further includes the step of positioning an extraluminal section. In one embodiment, the extraluminal section is positioned close to the body surface and adjacent to an orifice. In a preferred embodiment, the orifice is the anus.

[0168] In some embodiments, the above method further includes the step of fixing the extraluminal section to a surface. In one embodiment, the step of fixing the extraluminal section to a surface includes the step of applying at least one adhesive.

[0169] In some embodiments, the above method further includes at least one step of functionalizing or treating at least one segment or mesh surface of the sleeve. The surface may be treated by drying, heating, disinfection, or a combination thereof, but is not limited to these.

[0170] In some embodiments, the present invention provides a method for accelerating the recovery of at least one lesion on the surface of a hollow organ, a portion of a hollow organ, a region adjacent to a hollow organ, or any combination thereof, by isolating the lesion from the contents of the hollow organ, this portion of a hollow organ, a region adjacent to a hollow organ, or any combination thereof. In some embodiments, the method includes the step of temporarily placing at least a portion of a tubular sleeve according to any of the embodiments described above.

[0171] When used herein, the term “accelerating recovery” is interchangeable with “accelerating healing” and / or “promoting healing” and / or “improving” and / or “delaying progression” and “slowing progression,” and means, but is not limited to, the beneficial effects that the apparatus of the present invention is thought to have on the clinical progression of a disease. For example, transition from a pathological state to a non-pathological state (complete recovery), alleviation of the severity of symptoms of the disease, reduction of the time to transition from a pathological state to a non-pathological state, and reduction of complications of the disease (such as infections and wounds). The “accelerating recovery” and / or “slowing progression” and / or “preventing progression” of a disease by embodiments of the above methods can be measured using any appropriate questionnaire, method, scale, diagnostic tool, or any other means known in the art or with relevant functions and acceptable to experts. The term “preventing” is not necessarily thought to mean recovery from disease. Therefore, the term “prevent” refers to a situation in which the patient does not exhibit the symptoms, signs, and / or manifestation of the next “stage” of disease severity, as defined by appropriate and acceptable parameters for a particular pathological condition. The term “slow down” or “attenuate” means, but is not limited to, prolonging the time to transition to the next “stage” of disease severity, thereby providing a greater window of opportunity for careful treatment and recovery.

[0172] In some embodiments, at least one lesion can be characterized as anorectal fistula, rectovaginal fistula, enterovaginal fistula, urethral fistula, vesicojejunostomy, gastrojejunostomy, gastrocolic fistula, enterocutaneous fistula, tracheoesophageal fistula, and peptic ulcer disease.

[0173] In some embodiments of the above method, the step of placing at least a portion of the tubular sleeve into the lumen is, a. The step of providing a tubular sleeve from any of the embodiments described above, b. The step of inserting the tubular sleeve into the lumen, c. Positioning at least a portion of the tubular sleeve containing the mesh in close proximity to the surface of the lumen, and enabling physical contact of at least a portion of the tubular sleeve containing the mesh with the surface of the lumen, and d. A step that allows at least a portion of the tubular sleeve containing the mesh to be fixed to the surface of the lumen, Includes.

[0174] In some embodiments, the above method further includes the step of applying a chemical fastener and / or adhesive to the surface of the mesh and / or lumen.

[0175] In one embodiment of this method, the step of adding a chemical fastener and / or adhesive precedes step a.

[0176] In another embodiment of the above method, the step of adding a chemical fastener and / or adhesive precedes step d.

[0177] In some embodiments of this method, the step of adding a chemical fastener and / or adhesive further includes the step of applying pressure.

[0178] In some embodiments of this method, the chemical fastener and / or adhesive comprises at least one coagulation factor, at least one crosslinking agent, at least one hemostatic agent, or any combination thereof.

[0179] In some embodiments of this method, the chemical fastener and / or adhesive comprises, but is not limited to, at least one compound selected from the group consisting of fibrinogen (or factor I), thrombin (factor IIa), prothrombin (factor II), factor IV, factor V, factor VII, factor VIII, factor IX, factor X, factor XIII (fibrin stabilizing factors), prothrombin complex concentrate (PCC or factor IX complex), prekallikrein (PK), high molecular weight kininogen (HK), or any other suitable material, and any combination thereof.

[0180] In some embodiments, the chemical fastener and / or adhesive is aprotinin, fibronectin, pancreatic trypsin inhibitor (BPTI), cell adhesion molecule (CAM), phospholipid, calcium (Ca 2+ The compound further comprises a non-limiting group of compounds including calcium chloride (CaCl2), calcium alginate, oxidized cellulose (OC), or any other suitable material, and any combination thereof.

[0181] In some embodiments of this method, the adhesive and / or chemical fastener is selected from, but is not limited to, the group consisting of fibrin glue, fibrin sealant, GRFG (gelatin-resorcinol-formaldehyde / glutaraldehyde) glue, cyanoacrylate glue, polysaccharide adhesive, polypeptide-based adhesive, polymer-based adhesive, polyethylene glycol (PEG)-based adhesive, and substrate protein adhesive.

[0182] In some embodiments of this method, the method further includes the step of adding at least one therapeutic agent to the surface of the lumen.

[0183] In one embodiment of the above method, the step of applying at least one therapeutic agent to the surface of the lumen is repeated at least twice.

[0184] In some embodiments of this method, the therapeutic agent is selected from a non-limiting group including anti-inflammatory compounds, antibiotics, antiviral drugs, coagulants, healing-promoting factors, and any combination thereof.

[0185] In another embodiment, the method further includes the step of positioning an extraluminal section. In one embodiment, the extraluminal section is positioned close to a body surface and adjacent to an orifice. In a preferred embodiment, the orifice is the anus. In one embodiment, the surface is the skin around the anal opening.

[0186] In one embodiment, the method further includes the step of fixing the extraluminal section to a surface. In one embodiment, the step of fixing the extraluminal section to a surface includes the step of administering at least one adhesive.

[0187] In some embodiments of the present invention, the method further includes at least one step of functionalizing or treating a surface of at least one segment of the sleeve. The surface can be treated by drying, heating, disinfection, or a combination thereof.

[0188] In some embodiments, the present invention provides a method for shielding at least one lesion on a surface of a hollow organ, a portion of a hollow organ, a region adjacent to a hollow organ, or any combination thereof, from the contents of the hollow organ, this portion of the hollow organ, a region adjacent to the hollow organ, or any combination thereof. In some embodiments, the method includes the step of placing at least a portion of a tubular sleeve from any of the above embodiments onto the hollow organ.

[0189] In some embodiments, at least one lesion can be characterized as anorectal fistula, rectovaginal fistula, enterovaginal fistula, urethral fistula, vesicojejunostomy, gastrojejunostomy, gastrocolic fistula, enterocutaneous fistula, tracheoesophageal fistula, and peptic ulcer disease.

[0190] In some embodiments of this method, the step of placing at least a portion of the tubular sleeve into the lumen is, a. The step of providing a tubular sleeve from any of the embodiments described above, b. The step of inserting the tubular sleeve into the lumen, c. Positioning at least a portion of the tubular sleeve containing the mesh in close proximity to the surface of the lumen, and enabling physical contact of at least a portion of the tubular sleeve containing the mesh with the surface of the lumen, and d. A step that allows at least a portion of the tubular sleeve containing the mesh to be fixed to the surface of the lumen, Includes.

[0191] In some embodiments of this method, the method further includes the step of applying a chemical fastener and / or adhesive to the surface of the mesh and / or lumen.

[0192] In some embodiments of the above method, the step of adding a chemical fastener and / or adhesive precedes step a.

[0193] In another embodiment of the above method, the step of adding a chemical fastener and / or adhesive precedes step d.

[0194] In some embodiments of the above method, the step of adding a chemical fastener and / or adhesive further includes the step of applying pressure.

[0195] In some embodiments of the above method, the chemical fastener and / or adhesive comprises, but is not limited to, at least one coagulation factor, at least one crosslinking agent, at least one hemostatic agent, or any other suitable material, or any combination thereof.

[0196] In some embodiments of the above method, the chemical fastener and / or adhesive comprises at least one compound selected from the non-limiting group including fibrinogen (or factor I), thrombin (factor IIa), prothrombin (factor II), factor IV, factor V, factor VII, factor VIII, factor IX, factor X, factor XIII (fibrin stabilizing factors), prothrombin complex concentrate (PCC or factor IX complex), prekallikrein (PK), high molecular weight kininogen (HK), or any other suitable material, and any combination thereof.

[0197] In some embodiments of the above method, the chemical fastener and / or adhesive contains aprotinin, fibronectin, pancreatic trypsin inhibitor (BPTI), cell adhesion molecule (CAM), phospholipid, calcium (Ca 2+ The compound further comprises a non-limiting group of compounds including calcium chloride (CaCl2), calcium alginate, oxidized cellulose (OC), or any other suitable material, and any combination thereof.

[0198] In some embodiments of the above method, the adhesive and / or chemical fastener is selected from, but is not limited to, fibrin glue, fibrin sealant, GRFG (gelatin-resorcinol-formaldehyde / glutaraldehyde) glue, cyanoacrylate glue, polysaccharide adhesive, polypeptide adhesive, polymer adhesive, polyethylene glycol (PEG) adhesive, and substrate protein adhesive.

[0199] In another embodiment, the method further includes the steps of positioning and / or fixing an extraluminal section. In one embodiment, the extraluminal section is positioned close to a body surface and adjacent to an orifice. In a preferred embodiment, the orifice is the anus. In one embodiment, the surface is the skin around the anal opening.

[0200] In some embodiments of the above method, the extraluminal section is fixed to a surface. In one embodiment, the extraluminal section is fixed by applying or administering an adhesive or chemical fastener.

[0201] In some embodiments of the above method, the step of adding or administering an adhesive or chemical fastener further includes a step of applying pressure. In some embodiments of the present invention, the method further includes at least one step of functionalizing or treating the surface of at least one segment of the sleeve. The surface can be treated by drying, heating, disinfection, or a combination thereof.

[0202] In some embodiments, the present invention provides a tubular sleeve according to any of the above embodiments for use in accelerating the recovery of at least one lesion on the surface of a hollow organ, a portion of a hollow organ, a region adjacent to a hollow organ, or any combination thereof.

[0203] In some embodiments, the present invention provides a method for preventing the contents of a hollow organ, a portion of a hollow organ, a region adjacent to a hollow organ, or any combination thereof from leaking from an orifice of a hollow organ, a portion of a hollow organ, or any combination thereof. In some embodiments, the method includes the step of placing at least a portion of a tubular sleeve from any of the above embodiments into the hollow organ.

[0204] In one embodiment of the above method, the sleeve is configured to prevent leakage following a cocolonostomy or after a rectal / anal perforation.

[0205] In some embodiments of the above method, the step of placing at least a portion of the tubular sleeve into the lumen is, a. The step of providing a tubular sleeve from any of the embodiments described above, b. The step of inserting the tubular sleeve into the lumen, c. Positioning at least a portion of the tubular sleeve containing the mesh in close proximity to the surface of the lumen, and enabling physical contact of at least a portion of the tubular sleeve containing the mesh with the surface of the lumen, and d. A step that allows at least a portion of the tubular sleeve containing the mesh to be fixed to the surface of the lumen, Includes.

[0206] In some embodiments of the present invention, the method further includes the step of applying a chemical fastener and / or adhesive to the surface of the mesh and / or lumen.

[0207] In one embodiment of this method, the step of adding a chemical fastener and / or adhesive precedes step a.

[0208] In another embodiment of the above method, the step of adding a chemical fastener and / or adhesive precedes step d.

[0209] In some embodiments of the above method, the step of adding a chemical fastener and / or adhesive further includes the step of applying pressure.

[0210] In some embodiments of the above method, the chemical fastener and / or adhesive comprises, but is not limited to, at least one coagulation factor, at least one cross-linking agent, at least one hemostatic agent, or any other suitable compound, or any combination thereof.

[0211] In some embodiments of the above method, the chemical fastener and / or adhesive comprises at least one compound selected from the non-limiting group consisting of fibrinogen (or factor I), thrombin (factor IIa), prothrombin (factor II), factor IV, factor V, factor VII, factor VIII, factor IX, factor X, factor XIII (fibrin stabilizing factor), prothrombin complex concentrate (PCC or factor IX complex), prekallikrein (PK), high molecular weight kininogen (HK), or any other suitable compound, and any combination thereof.

[0212] In some embodiments of the above method, the chemical fastener and / or adhesive further comprises a compound selected from the non-limiting group consisting of aprotinin, fibronectin, pancreatic trypsin inhibitor (BPTI), cell adhesion molecule (CAM), phospholipid, calcium (Ca 2+ ), calcium chloride (CaCl2), calcium alginate, oxidized cellulose (OC), or any other suitable compound, and any combination thereof.

[0213] In some embodiments of the above method, the adhesive and / or chemical fastener is selected from, but not limited to, fibrin glue, fibrin sealant, GRFG (gelatin-resorcinol-formaldehyde / glutaraldehyde) glue, cyanoacrylate glue, polysaccharide adhesive, polypeptide-based adhesive, polymer-based adhesive, polyethylene glycol (PEG)-based adhesive, and substrate protein adhesive.

[0214] In another embodiment, the method further includes the step of positioning an extraluminal section. In one embodiment of the above method, the extraluminal section is positioned close to a body surface and adjacent to an orifice. In a preferred embodiment of the above method, the orifice is the anus. In another embodiment of the above method, the surface is the skin around the anal opening.

[0215] In some embodiments of the above method, the extraluminal section is fixed to the surface. In a preferred embodiment, the extraluminal section is fixed by adding or administering an adhesive or chemical fastener.

[0216] In some embodiments of the above method, the step of adding or administering an adhesive or chemical fastener further includes the step of applying pressure.

[0217] In some embodiments of the above method, the method further includes at least one step of functionalizing or treating a surface of at least one segment of the sleeve. The surface can be treated by drying, heating, disinfection, or a combination thereof.

[0218] Examples In the following examples, abbreviations not defined above have generally accepted meanings.

[0219] Example 1: Attaching the device to a hollow organ To examine the suitability of the apparatus of the present invention for enabling the attachment of the mesh to tissue, the following steps were taken in vitro: 1. The inner surface of the lumen was cleaned. 2. The components (fibrin glue component containing fibrinogen, thrombin and calcium salt, tubular silicone sleeve containing VKML-Vicryl (polyglutinin) mesh, and any other material) were inspected for integrity. 3. The sleeve and mesh were washed and dried. 4. A fibrin glue component containing fibrinogen, thrombin, and calcium salt was mixed. 5. A mixed fibrin glue component containing fibrinogen, thrombin, and calcium salt was added to the mesh. 6. A mesh containing a mixed fibrin glue component was attached to the surface of the lumen. 7. Pressure was applied to join the mesh to the surface of the lumen. 8. The mesh arrangement and adhesive strength were tested.

[0220] result: Surprisingly, the mesh was found to be suitable for attaching the device to the tissue.

[0221] Example 2: Placing the device of the present invention on the patient To assess the suitability of the device of the present invention, the following steps were taken by placing the device in a patient: 1. The contents of the patient's gastric tube were emptied. 2. The fibrin glue component, the tubular silicone sleeve containing the VKML-Vicryl (polyglutinin) mesh at the proximal end, and any other materials were inspected for integrity. 3. The sleeve and mesh were washed and dried. 4. A mixture of fibrinogen, a component of fibrin glue, thrombin, and calcium salt was prepared. 5. A mixed fibrin glue component containing fibrinogen, thrombin, and calcium salt was added to the mesh. 6. The proximal end of the sleeve was placed in the anal canal. 7. A mesh containing a mixed fibrin glue component was attached to the anal canal wall. 8. Pressure was applied to bond the mesh to the anal canal wall. 9. The placement of the proximal end of the sleeve and the adhesive strength were tested. 10. The extraluminal section and the surface surrounding the anus were cleaned and dried. 11. Adhesive was applied to the extraluminal section at the distal end. 12. The extraluminal section of the sleeve was pressed against the skin surrounding the anus. 13. The adhesive strength was tested.

[0222] result: Remarkably, the device of the present invention can be successfully placed in the patient's anal canal and securely fixed in place.

[0223] Unless otherwise specified, all technical and / or scientific terms used herein have the same meaning as those commonly understood by those skilled in the art relating to the present invention. While methods and materials similar to or equivalent to those described herein may be used in the implementation or testing of embodiments of the present invention, the following descriptions are illustrative. In case of any inconsistency, the present specification, including definitions, shall prevail. Furthermore, the materials, methods, and examples are illustrative and not necessarily intended to be limiting.

[0224] Unless otherwise specified, all terms used herein (including technical and scientific terms) have the same meaning as those generally understood by those skilled in the art to which the present invention belongs. In the context of this specification and the claims, terms as defined in commonly used dictionaries should be interpreted as having a meaning consistent with that definition, and it will be further understood that they should not be interpreted in an ideal or overly formal sense unless expressly specified herein. Known functions or structures may not be described in detail for the purpose of brevity and / or clarity.

[0225] As used herein, the terms “comprises,” “comprising,” “includes,” “including,” “having,” and their conjugations mean “including, but not limited to.”

[0226] The term "composed of" means "to include and be limited to."

[0227] When used herein, unless the context clearly indicates otherwise, the singular forms "a," "an," and "the" include plural nouns. For example, the term "compound" or "at least one compound" may include multiple compounds, including mixtures thereof.

[0228] When an element is referred to as being "on" another element, "attached" to it, "connected" to it, "joined" to it, "contacting" it, "engaging" to it, etc., it will be understood that the element can be directly on the other element, attached to it, connected to it, joined to it, and / or contact it, or an intervening element may be present. In contrast, when an element is referred to, for example, "directly on" another element, "directly attached" to it, "physically engages" with it, "directly connected" to it, "directly joined" to it, or "directly contacts" it, no intervening element is present. Similarly, when a structure or feature is referred to as being "adjacent" to another feature, it will be recognized by those skilled in the art that these structures or feature may have portions that overlap or overlap below the adjacent feature.

[0229] This specification may use terms such as 1, 2, etc., to describe various elements, components, areas, layers, and / or sections, but it will be understood that these elements, components, areas, layers, and / or sections should not be limited by these terms. Rather, these terms are used solely to distinguish one element, component, area, layer, and / or section from another.

[0230] Throughout this application, various embodiments of the present invention can be presented in scope form. It should be understood that the scope form is intended solely for convenience and simplification and should not be interpreted as limiting the flexibility of the scope of the present invention. Accordingly, the scope form should be considered as specifically disclosing all possible sub-ranges and the individual numbers within those ranges. For example, a scope form such as 1 to 6 should be considered as specifically disclosing sub-ranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, and 3 to 6, and the individual numbers within these ranges, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the width of the range.

[0231] Whenever a numerical range is indicated in this specification, it is intended that the range includes all enumerated digits (decimals or integers) within the indicated range. In this specification, the phrases "across / between" the first and second indicated digits, and "across / beyond" the phrases "from" the first indicated digit to the second indicated digit, are used interchangeably and are intended to include the first and second indicated digits and all decimals and integers between them.

[0232] Certain features of the Invention described in the context of separate embodiments for clarity purposes may also be provided in combination in a single embodiment. Conversely, various features of the Invention described in the context of a single embodiment for simplification purposes may also be provided separately, in any suitable partial combination, or as appropriate in any other embodiment of the Invention described. Certain features described in the context of various embodiments shall not be considered essential features of the embodiment unless the embodiment is inoperable without those elements.

[0233] Throughout this application, various documents, published patent applications, and published patents are referenced. To more fully describe the state of the art relating to the present invention, the disclosures of these documents are thus incorporated in their entirety into this application by reference.

[0234] As used herein, the term “method” means a method, means, techniques, and procedures for accomplishing a given task, including but not limited to methods, means, techniques, and procedures that are known to or readily developed from methods, means, techniques, and procedures that are known to or made known to practitioners of the arts of chemistry, pharmacology, biology, biochemistry, and medicine.

[0235] As used herein, the terms “patient” or “subject” are intended to include any mammal. As used herein, “mammal” means any animal classified as a mammal, including but not limited to humans, laboratory animals including monkeys, rats, mice, and guinea pigs, domesticated animals and livestock, zoo animals, sports animals and pet animals such as dogs, horses, cats, and cows, and similar animals.

[0236] As used herein, “to treat” or “to cure” a disease includes preventing the disease, i.e., preventing the development of clinical symptoms of the disease in a mammal that is exposed to or susceptible to the disease but is not yet experiencing or exhibiting symptoms of the disease; suppressing the disease, i.e., being able to prevent or reduce the development of the disease or its clinical symptoms, or alleviating the disease, i.e., bringing about remission of the disease or its clinical symptoms.

[0237] The "therapeutically effective dose" or "effective dose" refers to the amount or dosage of a compound sufficient to achieve treatment of a disease when administered to a subject. The "therapeutically effective dose" will vary depending on the compound, the disease and its severity, and the age, weight, etc., of the subject being treated.

[0238] Those skilled in the art will recognize that the present invention is not limited to what has been specifically shown and described above. Rather, the scope of the invention is defined by the claims and includes both combinations and partial combinations of the various features described above, as well as variations and modifications of these features that are expected to be conceived by those skilled in the art after reading the above description. While certain features of the invention have been illustrated and described herein, many modifications, substitutions, variations, and equivalents are expected to be conceived by those skilled in the art. It is understood that the appended claims are intended to cover all such modifications and variations that fall within the true spirit of the invention. Various embodiments have been presented. Naturally, each of these embodiments may include features from other embodiments presented, and embodiments not specifically described may include various features described herein.

Claims

1. A tubular sleeve designed to be positioned within the lumen of at least one hollow organ or part thereof, At least a portion of the tubular sleeve includes a mesh, The mesh, by physically engaging with the surface of the lumen of the hollow organ, enables the tubular sleeve to be fixed to the surface of the lumen of the hollow organ. Tubular sleeve.

2. The tubular sleeve according to claim 1, wherein the at least one hollow organ is part of the gastrointestinal tract (GI tract) or digestive tract.

3. The tubular sleeve according to claim 1 or 2, wherein the at least one hollow organ or part thereof is selected from the group consisting of the food duct, hindgut, colon, rectum, and anal canal.

4. The tubular sleeve according to any one of claims 1 to 3, wherein the surface of the lumen is the gastrointestinal wall or the rectal wall.

5. A tubular sleeve according to any one of claims 1 to 4, comprising the mesh at the proximal end and / or distal end.

6. A tubular sleeve according to any one of claims 1 to 4, wherein two or more portions of the tubular sleeve include the mesh.

7. The tubular sleeve according to any one of claims 1 to 6, wherein the mesh is selected from the group consisting of knitted mesh, braided mesh, woven mesh, or a combination thereof.

8. The tubular sleeve according to any one of claims 1 to 7, wherein the mesh is a surgical mesh or a biological mesh (biomesh).

9. The tubular sleeve according to any one of claims 1 to 8, wherein the mesh is made of a material selected from the group consisting of synthetic materials, semi-synthetic materials, natural materials, animal-derived materials, polymers, and any combination thereof.

10. The tubular sleeve according to claim 9, wherein the material is selected from the group consisting of polyester (POL), polyvinylidene fluoride (PVDF), polyethylene terephthalate (PET), polypropylene (PP), polytetrafluoroethylene (PTFE), ePTFE, cellulose, oxidized regenerated cellulose (ORC), polyglutin, vicryl (polyglutin), polyglycecapron, polyethylene (PE), poly(glycolic acid) (PGA), polyglycecapron, polylactic acid (PLA), poly(lactic acid-coglycolic acid) (PLGA), carboxymethylcellulose (CMC), polydioxanone (PDO, PDS), silk, nylon, collagen, and any combination thereof.

11. The tubular sleeve according to claim 9, wherein the mesh is made of an animal-derived material selected from the group consisting of porcine dermis, porcine small intestine submucosa, bovine dermis or pericardium, human cadaver dermis or fascia lata, collagen, and any combination thereof.

12. The tubular sleeve according to any one of claims 1 to 11, characterized in that the material is at least one of the following: absorbent material, non-absorbent material, inactive material, infection-resistant material, fistula-resistant material, non-carcinogenic material, non-allergenic material, highly sensitive material, sterilizable material, adjustable material, physical manipulation-resistant material, durable material, and any combination thereof.

13. The tubular sleeve according to any one of claims 1 to 12, characterized in that the mesh has a pore size selected from monofilament type, duofilament type, and multifilament type.

14. The tubular sleeve according to any one of claims 1 to 13, further comprising a coating on the mesh.

15. The tubular sleeve according to claim 14, wherein the coating comprises at least one compound selected from the group consisting of cellulose, collagen, fatty acids, phospholipids, fibers, laminin, and any combination thereof.

16. A tubular sleeve according to any one of claims 1 to 15, wherein the outer surface of at least one segment of the tubular sleeve further comprises at least one structure selected from the group comprising a protrusion, a ridge, a skeleton, a sponge, a membrane, and any combination thereof.

17. The tubular sleeve according to claim 16, wherein the at least one structure is made of a polymer, silicone, phospholipid, fiber, collagen, laminin, or any combination thereof.

18. The tubular sleeve according to claim 17, wherein the polymer is selected from natural polymers, modified polymers, synthetic polymers, and semi-synthetic polymers.

19. A tubular sleeve according to any one of claims 1 to 18, further comprising a chemical fastener and / or adhesive.

20. The tubular sleeve according to claim 19, wherein the chemical fastener and / or adhesive comprises at least one coagulation factor, at least one crosslinking agent, at least one hemostatic agent, or any combination thereof.

21. The tubular sleeve according to claim 19 or 20, wherein the chemical fastener and / or adhesive comprises at least one compound selected from the group consisting of fibrinogen (or factor I), thrombin (factor IIa), prothrombin (factor II), factor IV, factor V, factor VII, factor VIII, factor IX, factor X, factor XIII (fibrin stabilizing factors), prothrombin complex concentrate (PCC or factor IX complex), prekallikrein (PK), high molecular weight kininogen (HK), and any combination thereof.

22. The chemical fastener and / or adhesive is aprotinin, fibronectin, pancreatic trypsin inhibitor (BPTI), cell adhesion molecule (CAM), phospholipid, calcium (Ca 2+ ), calcium chloride (CaCl 2 A tubular sleeve according to any one of claims 19 to 21, further comprising a compound selected from the group consisting of ), calcium alginate, oxidized cellulose (OC), and any combination thereof.

23. The tubular sleeve according to claim 19, wherein the adhesive and / or chemical fastener is selected from the group consisting of fibrin glue, fibrin sealant, GRFG (gelatin-resorcinol-formaldehyde / glutaraldehyde) glue, cyanoacrylate glue, polysaccharide adhesive, polypeptide-based adhesive, polymer-based adhesive, polyethylene glycol (PEG)-based adhesive, and substrate protein adhesive.

24. The tubular sleeve according to any one of claims 19 to 23, wherein the adhesive and / or chemical fastener is biocompatible, non-toxic, bioabsorbable, or a combination thereof.

25. A tubular sleeve according to any one of claims 1 to 24, further comprising an extraluminal segment.

26. The tubular sleeve according to claim 25, wherein the extraluminal section is positioned adjacent to the orifice of the hollow organ.

27. The tubular sleeve according to claim 26, wherein the orifice is the anus.

28. The tubular sleeve according to claim 26 or 27, wherein the extraluminal section is designed to expand radially away from the orifice.

29. The tubular sleeve according to any one of claims 26 to 28, wherein the extraluminal section further comprises a plurality of quasi-connecting segments.

30. A tubular sleeve according to any one of claims 1 to 29, which is flexible, expandable, elastic, or at least one of any combination thereof.

31. A tubular sleeve according to any one of claims 1 to 30, made of an impermeable material.

32. The tubular sleeve according to claim 31, wherein the impermeable material is impermeable to at least one of bodily fluids and / or solid matter and / or bodily excretions present in and / or passing through the hollow organ.

33. The tubular sleeve according to claim 31 or 32, wherein the impermeable material is selected from the group comprising silicone, polyurethane, thermoplastic elastomer, rubber, polyvinyl chloride resin, Gore-Tex, perfluoroalkyl substances and polyfluoroalkyl substances (PFAS or PFASs), polytetrafluoroethylene (PTFE), stretched PTFE (ePTFE), polyethylene, polypropylene, and any combination thereof.

34. A tubular sleeve according to any one of claims 1 to 33, further comprising a mechanical attachment mechanism and / or a sensor.

35. The tubular sleeve according to claim 34, wherein the mechanical attachment is selected from the group including balloons, hooks, and any combination thereof.

36. A method of placing a tubular sleeve over a hollow organ, a portion of the hollow organ, and / or an area adjacent to the hollow organ for a predetermined period of time, a. The step of providing the tubular sleeve according to any one of claims 1 to 35, b. The step of inserting the tubular sleeve into the lumen of the hollow organ, c. Positioning at least a portion of the tubular sleeve containing the mesh in close proximity to the surface of the lumen, thereby enabling physical contact between the at least portion of the tubular sleeve containing the mesh and the surface of the lumen of the hollow organ, and d. The step of enabling the attachment of at least a portion of the tubular sleeve containing the mesh to the surface of the lumen of the hollow organ, thereby placing the tubular sleeve in the hollow organ. A method that includes this.

37. The method according to claim 36, wherein the hollow organ is part of the gastrointestinal tract (GI tract) or digestive tract.

38. The method according to claim 36 or 37, wherein the hollow organ is selected from the group including the food tubule, hindgut, colon, rectum, anal canal, and any combination thereof.

39. The method according to any one of claims 36 to 38, wherein the surface of the lumen is the gastrointestinal wall or the rectal wall.

40. The method according to any one of claims 36 to 39, further comprising the step of applying a chemical fastener and / or adhesive to the surface of the mesh and / or the lumen.

41. The method according to claim 40, wherein the step of adding a chemical fastener and / or adhesive precedes step a.

42. The method of claim 40, wherein the step of adding a chemical fastener and / or adhesive precedes step d.

43. The method according to any one of claims 40 to 42, wherein the chemical fastener and / or adhesive comprises at least one coagulation factor, at least one crosslinking agent, at least one hemostatic agent, or a combination thereof.

44. The method according to any one of claims 40 to 43, wherein the chemical fastener and / or adhesive comprises at least one compound selected from the group consisting of fibrinogen (or factor I), thrombin (factor IIa), prothrombin (factor II), factor IV, factor V, factor VII, factor VIII, factor IX, factor X, factor XIII (fibrin stabilizing factor), prothrombin complex concentrate (PCC or factor IX complex), prekallikrein (PK), high molecular weight kininogen (HK), and any combination thereof.

45. The chemical fastener and / or adhesive is aprotinin, fibronectin, pancreatic trypsin inhibitor (BPTI), cell adhesion molecule (CAM), phospholipid, calcium (Ca 2+ ), calcium chloride (CaCl 2 The method according to claim 43, further comprising a compound selected from the group consisting of calcium alginate, oxidized cellulose (OC), and any combination thereof.

46. The method according to any one of claims 40 to 42, wherein the adhesive and / or chemical fastener is selected from the group consisting of fibrin glue, fibrin sealant, GRFG (gelatin-resorcinol-formaldehyde / glutaraldehyde) glue, cyanoacrylate glue, polysaccharide adhesive, polypeptide-based adhesive, polymer-based adhesive, polyethylene glycol (PEG)-based adhesive, and substrate protein adhesive.

47. The method according to any one of claims 36 to 46, wherein at least one of the hollow organ, a portion of the hollow organ, and / or a region adjacent to the hollow organ includes at least one lesion.

48. The method according to claim 47, wherein the tubular sleeve is designed to isolate the lesion from the contents of at least one of the following: the lumen of the hollow organ, the portion of the hollow organ, and / or the region adjacent to the hollow organ, or a combination thereof.

49. The method according to claim 47 or 48, wherein the at least one lesion is selected from anastomosis, laceration, and fistula.

50. The method according to any one of claims 36 to 49, further comprising the step of preparing the tubular sleeve and / or a portion of the tubular sleeve.

51. The method according to claim 50, wherein the step of preparing the tubular sleeve and / or a portion of the tubular sleeve precedes step b.

52. The method according to any one of claims 36 to 51, wherein the predetermined period is between 1 and 28 days.

53. A method for accelerating the recovery of at least one lesion on a hollow organ, a portion of the hollow organ, a region adjacent to the hollow organ, or any combination thereof, by isolating the at least one lesion from the contents of the hollow organ, the portion of the hollow organ, the region adjacent to the hollow organ, or any combination thereof, The process includes the step of temporarily placing at least a portion of the tubular sleeve described in any one of claims 1 to 35 into the lumen, method.

54. The step of placing at least a portion of the tubular sleeve into the lumen is, a. The step of providing the tubular sleeve according to any one of claims 1 to 35, b. The step of inserting the tubular sleeve into the lumen, c. Positioning at least a portion of the tubular sleeve containing the mesh in close proximity to the surface of the lumen, thereby enabling physical contact between the at least portion of the tubular sleeve containing the mesh and the surface of the lumen, and d. A step that enables the attachment of at least a portion of the tubular sleeve, including the mesh, to the surface of the lumen, including, The method according to claim 53.

55. The method according to claim 53 or 54, further comprising the step of applying a chemical fastener and / or adhesive to the surface of the mesh and / or the lumen.

56. The method of claim 55, wherein the step of adding a chemical fastener and / or adhesive precedes step a.

57. The method of claim 55, wherein the step of adding a chemical fastener and / or adhesive precedes step d.

58. The method according to any one of claims 55 to 57, wherein the chemical fastener and / or adhesive comprises at least one coagulation factor, at least one crosslinking agent, at least one hemostatic agent, or a combination thereof.

59. The method according to any one of claims 55 to 58, wherein the chemical fastener and / or adhesive comprises at least one compound selected from fibrinogen (or factor I), thrombin (factor IIa), prothrombin (factor II), factor IV, factor V, factor VII, factor VIII, factor IX, factor X, factor XIII (fibrin stabilizing factors), prothrombin complex concentrate (PCC or factor IX complex), prekallikrein (PK), high molecular weight kininogen (HK), and any combination thereof.

60. The chemical fastener and / or adhesive is aprotinin, fibronectin, pancreatic trypsin inhibitor (BPTI), cell adhesion molecule (CAM), phospholipid, calcium (Ca 2+ ), calcium chloride (CaCl 2 The method according to claim 59, further comprising a compound selected from calcium alginate, oxidized cellulose (OC), and any combination thereof.

61. The method according to any one of claims 55 to 57, wherein the adhesive and / or chemical fastener is selected from fibrin glue, fibrin sealant, GRFG (gelatin-resorcinol-formaldehyde / glutaraldehyde) glue, cyanoacrylate glue, polysaccharide adhesive, polypeptide-based adhesive, polymer-based adhesive, polyethylene glycol (PEG)-based adhesive, and substrate protein adhesive.

62. The method according to any one of claims 53 to 61, further comprising the step of adding at least one therapeutic agent to the surface of the lumen.

63. The method according to claim 62, wherein the step of adding at least one therapeutic agent to the surface of the lumen is repeated at least twice.

64. The method according to claim 62, wherein the therapeutic agent is selected from the group comprising anti-inflammatory compounds, antibiotics, antiviral drugs, coagulants, healing-promoting factors, and any combination thereof.

65. A method for shielding at least one lesion on a surface of a hollow organ, a portion of the hollow organ, a region adjacent to the hollow organ, or any combination thereof, from the contents of the hollow organ, the portion of the hollow organ, the region adjacent to the hollow organ, or any combination thereof, The process includes the step of placing at least a portion of the tubular sleeve described in any one of claims 1 to 35 into the lumen, method.

66. The step of placing at least a portion of the tubular sleeve into the lumen is, a. The step of providing the tubular sleeve according to any one of claims 1 to 35, b. The step of inserting the tubular sleeve into the lumen, c. The step of positioning at least a portion of the tubular sleeve containing the mesh in close proximity to the surface of the lumen, thereby enabling physical contact between the surface of the lumen and at least a portion of the tubular sleeve containing the mesh, and d. A step that enables the attachment of at least a portion of the tubular sleeve, including the mesh, to the surface of the lumen, including, The method according to claim 65.

67. The method according to claim 65 or 66, further comprising the step of applying a chemical fastener and / or adhesive to the surface of the mesh and / or the lumen.

68. The method according to claim 67, wherein the step of adding a chemical fastener and / or adhesive precedes step a.

69. The method according to claim 67, wherein the step of adding a chemical fastener and / or adhesive precedes step d.

70. The method according to any one of claims 67 to 69, wherein the chemical fastener and / or adhesive comprises at least one coagulation factor, at least one crosslinking agent, at least one hemostatic agent, or a combination thereof.

71. The method according to any one of claims 67 to 70, wherein the chemical fastener and / or adhesive comprises at least one compound selected from fibrinogen (or factor I), thrombin (factor IIa), prothrombin (factor II), factor IV, factor V, factor VII, factor VIII, factor IX, factor X, factor XIII (fibrin stabilizing factors), prothrombin complex concentrate (PCC or factor IX complex), prekallikrein (PK), high molecular weight kininogen (HK), and any combination thereof.

72. The chemical fastener and / or adhesive is aprotinin, fibronectin, pancreatic trypsin inhibitor (BPTI), cell adhesion molecule (CAM), phospholipid, calcium (Ca 2+ ), calcium chloride (CaCl 2 The method according to claim 67, further comprising a compound selected from calcium alginate, oxidized cellulose (OC), and any combination thereof.

73. The method according to any one of claims 67 to 69, wherein the adhesive and / or chemical fastener is selected from fibrin glue, fibrin sealant, GRFG (gelatin-resorcinol-formaldehyde / glutaraldehyde) glue, cyanoacrylate glue, polysaccharide adhesive, polypeptide-based adhesive, polymer-based adhesive, polyethylene glycol (PEG)-based adhesive, and substrate protein adhesive.

74. A tubular sleeve according to any one of claims 1 to 35 for use in accelerating the recovery of at least one lesion on the surface of a hollow organ, a portion of the hollow organ, a region adjacent to the hollow organ, or any combination thereof.

75. A tubular sleeve designed to be positioned within the lumen of a hollow organ, At least a portion of the tubular sleeve includes a mesh, The mesh physically engages with the tissue of the side wall of the lumen of the hollow organ, thereby enabling the tubular sleeve to be fixed to the side wall of the lumen of the hollow organ. Tubular sleeve.

Images