System and method for affecting intestinal microbial flora
Inventors
Belhe, Kedar R. • Stangenes, Todd
Assignees
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Publication Number
US-11793839-B2
Publication Date
2023-10-24
Expiration Date
Abstract
Described is a system for affecting intestinal microbial flora. The system includes an intestinal sleeve that is implanted in a patient and bypasses a section of the intestine; and probiotics, prebiotics or pharmacologic therapy used in combination with the intestinal sleeve. Also described are related methods.
Core Innovation
The patent discloses an implant system and associated methods for altering intestinal microbial flora in a patient to treat obesity or diabetes. The approach involves implanting an intestinal sleeve along a treatment length of the intestine to prevent nutrients from reaching an initial microbial population, thereby reducing the initial microbial population without the use of antibiotics.
After the microbial population has been reduced, the method includes removing the intestinal sleeve from the intestine of the patient. Following removal, probiotic therapy is administered to the intestine after removing the intestinal sleeve to promote beneficial intestinal microbial flora at least along the treatment length of the intestine.
The intestinal sleeve is described as endoscopically placeable and finite in duration, with anchoring at the pyloric junction and/or pylorus. The sleeve is described as having an anchoring element with two flanges and optionally a biocompatible polymer or fabric covering, and may be configured to deliver or hold agents via impregnation or coating.
Claims Coverage
The document provides two independent methods of treating obesity or diabetes. Across the independent claims, the inventive concept contains three core inventive features: nutrient-blocking via an intestinal sleeve, reduction of the initial microbial population without antibiotics, and post-removal probiotic therapy to increase beneficial intestinal microbial flora along the modified intestinal area.
Nutrient-blocking intestinal sleeve to reduce initial microbial population without antibiotics
Implanting an intestinal sleeve along a treatment length of the intestine, the sleeve configured to prevent nutrients from reaching the initial microbial population to thereby reduce the initial microbial population along the treatment length to a reduced microbial population without the use of antibiotics.
Removal of the intestinal sleeve after microbial population reduction
Removing the intestinal sleeve from the intestine of the patient after a reduction in the initial microbial population.
Post-removal probiotic therapy to increase beneficial intestinal microbial flora
Administering probiotic therapy to the intestine of the patient after removing the intestinal sleeve to promote beneficial intestinal microbial flora at least along the treatment length of the intestine and increase the reduced microbial population within the area of the intestine modified by the sleeve.
Both independent claims are directed to a two-phase therapeutic sequence: implanting an intestinal sleeve that prevents nutrients from reaching an initial microbial population and reduces that population without antibiotics, then removing the sleeve and administering probiotic therapy to increase beneficial intestinal microbial flora within an area of the intestine modified by the sleeve.
Stated Advantages
Reduces the initial microbial population along the treatment length without the use of antibiotics.
Promotes beneficial intestinal microbial flora at least along the treatment length of the intestine after sleeve removal.
Increases the reduced microbial population within an area of the intestine modified by the sleeve.
Illustratively provides reduction of “bad” bacteria and normalization of glucose parameters.
Documented Applications
Treating obesity.
Treating diabetes.
Metabolic and autoimmune conditions including type 2 diabetes and rheumatoid arthritis.
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