Therapeutic methods involving gastrointestinal implants for administering metabolic agents
Inventors
Assignees
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Publication Number
US-11179325-B2
Publication Date
2021-11-23
Expiration Date
Abstract
The present invention provides combination therapies for treating a metabolic disorder, such as type 2 diabetes, obesity, and related comorbidities (e.g., NASH or NAFLD)) in an individual undergoing treatment with a gastrointestinal implant. The combination therapies described herein include methods for treating an individual with a gastrointestinal implant with a metabolic agent, a bariatric procedure, and/or a microbiota modulator.
Core Innovation
The invention relates to treating a metabolic disorder in an individual undergoing treatment with a gastrointestinal implant configured to bypass at least part of a small intestine. The gastrointestinal implant includes a sleeve, and in at least one described implementation comprises a wave anchor. The sleeve has a length from about 1 ft to about 5 ft.
The invention addresses treatment approaches in which metabolic agents are administered in an effective amount and for a duration to treat the metabolic disorder while the individual is receiving the gastrointestinal implant. The metabolic agents include incretin modulators such as GLP-1 receptor agonists and DPP-4 inhibitors, with administration that may be via enteral and/or parenteral routes and may be given at a frequency of per day, per week, or per month.
The invention further combines the gastrointestinal implant treatment with adjunct approaches that include one or more bariatric procedures and/or one or more microbiota modulators. Bariatric procedures include restrictive bariatric procedures such as an intragastric balloon or a gastroplasty with transmural tissue anchor plications in the gastric fundus and body, and microbiota modulators include bacterial species and bacteriophage, including a fecal microbiota transplant.
Claims Coverage
Independent claim coverage is provided by three independent claims: one directed to administering metabolic agents during gastrointestinal implant treatment, one directed to adding bariatric procedures, and one directed to administering microbiota modulators, each in the context of a gastrointestinal implant configured to bypass at least part of a small intestine. Across the independent claims, the inventive features include the gastrointestinal implant context, specific adjunct therapy categories, and in some claim sets the implant structural characteristic of a wave anchor and the sleeve length range.
Metabolic-agent administration with a bypassing gastrointestinal implant
A method of treating a metabolic disorder in an individual undergoing treatment with a gastrointestinal implant configured to bypass at least part of a small intestine, comprising administering one or more metabolic agents to the individual in an effective amount and for a duration to treat the metabolic disorder, wherein the gastrointestinal implant comprises a wave anchor and a sleeve with a length from about 1 ft to about 5 ft.
Restrictive bariatric procedures with a bypassing gastrointestinal implant
A method of treating a metabolic disorder in an individual undergoing treatment with a gastrointestinal implant configured to bypass at least part of a small intestine, comprising one or more bariatric procedures to treat the metabolic disorder.
Microbiota-modulator administration with a bypassing gastrointestinal implant
A method of treating a metabolic disorder in an individual undergoing treatment with a gastrointestinal implant configured to bypass at least part of a small intestine, comprising administering one or more microbiota modulators to an individual in an effective amount and for a duration to treat the metabolic disorder, wherein the gastrointestinal implant comprises a sleeve with a length from about 1 ft to about 5 ft.
The claims cover treating metabolic disorders in individuals receiving a bypassing gastrointestinal implant by administering metabolic agents, adding one or more bariatric procedures, and/or administering microbiota modulators. Dependent claim refinements described in the provided claim set include restrictive bariatric procedures, microbiota modulators defined by bacterial species and bacteriophage, including fecal microbiota transplant, and timing and route refinements.
Stated Advantages
Example outcomes indicate superiority of combined therapy over implant-only or agent-only approaches.
Documented Applications
Treating metabolic disorders in patients undergoing treatment with a gastrointestinal implant configured to bypass at least part of the small intestine, including type 2 diabetes, obesity, NASH, and NAFLD.
Treating metabolic disorders using a gastrointestinal implant in combination with incretin modulators (GLP-1 receptor agonists and/or DPP-4 inhibitors).
Treating metabolic disorders using a gastrointestinal implant in combination with restrictive bariatric procedures such as an intragastric balloon or gastroplasty with transmural tissue anchor plications in the gastric fundus and body.
Treating metabolic disorders using a gastrointestinal implant in combination with microbiota modulators, including bacterial species, bacteriophage, and fecal microbiota transplant.
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