Methods for assessing treatment with a gastrointestinal implant
Inventors
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-12061205-B2
Publication Date
2024-08-13
Expiration Date
Abstract
The present invention provides methods of predicting and monitoring treatment with a gastrointestinal implant (e.g., a gastrointestinal sleeve), including efficacy and complications associated therewith (e.g., complications attributed to the gastrointestinal implant or occurring concurrently with, but independent from, the gastrointestinal implant). Further provided are methods of determining a time point for removing a gastrointestinal implant (e.g., based on one or more biomarkers, e.g., biomarkers associated with safety and efficacy).
Core Innovation
The invention relates to methods for treating an individual undergoing treatment with a gastrointestinal implant comprising a wave anchor and a sleeve. The method includes obtaining a sample during treatment when the individual is not presenting signs or symptoms associated with a complication as a result of treatment with the gastrointestinal implant, and providing a level of one or more safety biomarkers in the sample relative to a reference level to determine a high level of risk of developing the complication.
The complication risk evaluation is based on differences in safety biomarker levels, including biomarkers tied to liver function and safety-associated systemic responses. The biomarker sets described include acute phase and liver-related markers such as CRP and albumin, liver enzymes such as AST/ALT, alkaline phosphatase, bilirubin, and coagulation parameters including prothrombin time/partial thromboplastin time and INR, as well as fibrinogen, hemoglobin, platelet concentration, and glucose.
The invention further ties high complication risk to gastrointestinal permeability and bacterial infection marker patterns. Gastrointestinal permeability and bacterial infection indicators described include citrulline/arginine, zonulin, FABP-1, actomyosin, secreted IgA, calprotectin, Claudin-3, α1-anti-trypsin, LPS, D-lactate, cytokines such as IL-1, IL-6, and IL-17, as well as immune cell measures such as neutrophils and anti-LPS antibodies. After determining high risk, the gastrointestinal implant is removed.
Claims Coverage
Two independent claims are directed to methods of treating an individual with a gastrointestinal implant by evaluating safety biomarkers from samples obtained during treatment to determine high risk of developing a complication, and then removing the implant. Across the independent claims, the core inventive features include obtaining a sample during implant treatment without presenting complication signs, comparing safety biomarker levels to a reference level to determine high risk, and removing the gastrointestinal implant.
Sample-based safety biomarker risk determination during gastrointestinal implant treatment
Obtaining a sample from the individual during treatment with the gastrointestinal implant when the individual is not presenting signs or symptoms associated with a complication, providing a level of one or more safety biomarkers in the sample, using a difference in the level of the one or more safety biomarkers relative to a reference level to determine that the individual has a high level of risk of developing the complication.
High-risk safety biomarker determination using elevated or reduced biomarker levels
Providing a level of one or more safety biomarkers in the sample and using either an elevated level or a reduced level of the one or more safety biomarkers relative to a reference level to determine that the individual is at a high level of risk of developing the complication.
Removing the gastrointestinal implant based on safety biomarker risk determination
Removing the gastrointestinal implant as part of the method after determining high risk of developing the complication using the safety biomarker comparison to a reference level.
The independent claims focus on using safety biomarker levels measured from samples obtained during gastrointestinal implant treatment (in the absence of presenting complication signs) and comparing those levels to reference levels to determine high risk, followed by removal of the gastrointestinal implant. One independent claim uses a difference to determine high risk, while the other provides elevated-level and reduced-level risk determination alternatives.
Stated Advantages
Documented Applications
No documented applications found
Interested in licensing this patent?