Transpyloric anchoring
Inventors
Chamorro, III, Andres • Levine, Andy H. • Melanson, David A. • Maxwell, Barry • Gambale, Richard A.
Assignees
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Publication Number
US-9636245-B2
Publication Date
2017-05-02
Expiration Date
Abstract
A gastrointestinal implant device (2800) comprises a planar proximal element (220) configured to reside in a stomach to resist distal migration, a distal element (222) configured to reside in an intestine to resist proximal migration and one or more tethers (224) coupling the planar proximal element to the distal element.
Core Innovation
The disclosure relates to a transpyloric gastrointestinal implant device that anchors across the pylorus by using a planar proximal element configured to reside in a stomach and resist distal migration. The planar proximal element is coupled to a distal element configured to reside in an intestine and resist proximal migration, and the coupling is provided by one or more tethers. In normal use, a central longitudinal axis of the planar proximal element, perpendicular to a plane in which the planar proximal element lies, is substantially perpendicular to a central longitudinal axis of a lumen of a pyloric sphincter of the stomach.
The planar proximal element is sized so that it is between 40 mm and 100 mm in a first dimension, and between 0.5 mm and 15 mm in a second dimension, orthogonal to the first dimension. The distal element may seal to intestinal tissue to channel chyme from the stomach into the intestine, and the device is described as providing a transpyloric anchoring arrangement without a requirement for proximal sealing into the stomach. Dependent features include distal sealing element types such as a wave anchor, balloons, toroidal objects, restrictors, and flow-related structures.
A further aspect is that the device uses atraumatic and non-penetrating approaches, including embodiments that comprise no tissue penetrating features, and proximal and distal components that can be configured for endoscopic collapsible delivery and removal. The tethers may be configured to control the mechanical behavior of the distal sealing element and may be arranged to allow independent proximal rotation of the planar proximal element.
Claims Coverage
The document provides two independent claims: a gastrointestinal implant device claim and a method-of-treatment claim. Both independent claims share the same core inventive organization of a planar proximal element sized and oriented relative to a pyloric sphincter, a distal element sized for the intestine, and one or more tethers securing the planar proximal element across the pylorus to resist migration of both proximal and distal portions.
Migration resistant planar proximal and distal elements coupled across the pylorus
A planar proximal element configured to reside in a stomach to resist distal migration; a distal element configured to reside in an intestine to resist proximal migration; and one or more tethers coupling the planar proximal element to the distal element across a pylorus.
Planar proximal element size and pyloric sphincter axis orientation
The planar proximal element is between 40 mm and 100 mm in size in a first dimension, and between 0.5 mm and 15 mm in size in a second dimension, orthogonal to the first dimension; and in normal use, a central longitudinal axis of the planar proximal element, perpendicular to a plane in which the planar proximal element lies, is substantially perpendicular to a central longitudinal axis of a lumen of a pyloric sphincter of the stomach.
Treatment resisting migration by tethers across a pylorus using a planar proximal element
A method of treatment comprising with a planar proximal element in a stomach, resisting distal migration of a proximal portion of a gastrointestinal implant device into an intestine; with a distal element in the intestine, resisting proximal migration of a distal portion of the gastrointestinal implant device into the stomach; and with one or more tethers, securing the planar proximal element to the distal element across a pylorus.
Planar proximal size and pyloric sphincter lumen axis in treatment method
The planar proximal element is between 40 mm and 100 mm in size in a first dimension, and between 0.5 mm and 15 mm in size in a second dimension, orthogonal to the first dimension; and in normal use of the implant device, a central longitudinal axis of the planar proximal element, perpendicular to a plane in which the planar proximal element lies, is substantially perpendicular to a central longitudinal axis of a lumen of a pyloric sphincter of the stomach.
Overall, the claim coverage centers on a transpyloric anchoring configuration that fixes the planar proximal element in the stomach with a specified size range and a pyloric-sphincter lumen axis relationship, while a distal element in the intestine resists proximal migration, both linked by one or more tethers to resist migration across the pylorus.
Stated Advantages
Reduced side effects, including reduced bleeding.
Reduced side effects, including reduced discomfort.
Reduced side effects, including reduced migration.
Reduced side effects, including reduced infection.
Use in barrier sleeve therapy for morbid obesity, including satiety.
Potential Type-2 diabetes hormone-trigger treatment.
Documented Applications
Barrier sleeve therapy, including use for morbid obesity and satiety.
Potential Type-2 diabetes hormone-trigger treatment.
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