Anchors and methods for intestinal bypass sleeves
Inventors
Thompson, Paul J. • Belhe, Kedar R. • Grafov, Alexander D.
Assignees
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Publication Number
US-9278019-B2
Publication Date
2016-03-08
Expiration Date
Abstract
A gastrointestinal device for implanting within a pylorus, a duodenal bulb, and a duodenum of a patient's gastrointestinal tract includes an expandable structure including a proximal portion having a plurality of spring arms and a distal portion having a plurality of spring arms, the proximal and distal portions coupled by a rigid central cylinder having a diameter capable of fitting within the pylorus and having a length greater than a width of the pylorus. An intestinal bypass sleeve is coupled to at least one of the proximal and distal portions of the expandable structure and having a length sufficient to extend at least partially into the duodenum. In the expanded configuration, the proximal portion has a diameter larger than a maximum opening diameter of the pylorus and further wherein, in the expanded configuration, the distal portion has a diameter larger than a maximum opening diameter of the pylorus.
Core Innovation
The invention is an endoscopically deliverable gastrointestinal implant system including an intestinal bypass sleeve coupled to an expandable structure configured for an expanded configuration and a contracted configuration for implanting within a pylorus, a duodenal bulb, and a duodenum. The expandable structure includes proximal and distal portions that engage different pyloric/duodenal walls adjacent the pyloric antrum and adjacent the duodenal bulb, respectively, with a central cylinder portion that does not restrict flow through the pylorus while fitting within the pylorus.
The expandable structure provides the engagement using coil compression spring portions extending radially outward to first and second diameters while extending circumferentially around the central cylinder. In the expanded configuration, the proximal and distal portions have diameters larger than a maximum opening diameter of the pylorus, and the proximal and distal portions are spaced apart at discrete locations along the central cylinder. The system further includes a membrane coupled to and covering at least a portion of one of the proximal portion and the distal portion of the expandable structure.
The device includes intestinal bypass and flow control features within a central lumen, including an anti-reflux valve function adapted to prevent reflux of duodenal contents back into the stomach, with embodiments described using valves such as duck-bill, ball-and-cage, bi-leaflet, or quadrifoliate valve structures and related frames and posts. The bypass sleeve length is described as extending at least partially into the duodenum, including embodiments extending at least partially into the jejunum.
Claims Coverage
The partial content includes three independent claims (clm-00001, clm-00007, clm-00013). Across the independent claims, the coverage centers on an expandable pyloric implant with a central cylinder portion that does not restrict pyloric flow, coupled spring-engaged proximal and distal portions, and optional valve, bypass-sleeve, and pump functions for specific treatment contexts.
Expandable pyloric implant with non-restrictive central cylinder
A gastrointestinal device configured to have an expanded configuration and a contracted configuration, the device comprising an expandable structure including a proximal portion and a distal portion with coil compression springs coupled by a central cylinder portion whose diameter is less than the proximal and distal diameters yet equal to or larger than a maximum diameter of the pylorus so that the central cylinder portion does not restrict flow through the pylorus, the central cylinder having a length greater than a width of the pylorus, with the coil compression springs extending radially outward and circumferentially around the central cylinder.
Membrane-covered expandable structure
A membrane coupled to and covering at least a portion of one of the proximal portion and the distal portion of the expandable structure.
Intestinal bypass sleeve coupling
An intestinal bypass sleeve coupled to at least one of the proximal and distal portions of the expandable structure and having a length sufficient to extend at least partially into the duodenum, with the expanded configuration having proximal and distal portion diameters larger than a maximum opening diameter of the pylorus and the proximal and distal portions spaced apart at discrete locations along the central cylinder.
Gastroparesis pyloric device with pump
A gastrointestinal device for treatment of gastroparesis configured to have an expanded configuration and a contracted configuration, comprising a membrane coupled to and covering at least a portion of one of the proximal portion and the distal portion, and a pump device adapted for coupling at least partially within the central cylinder portion and adapted to pump chyme from a stomach, through the pylorus, to a duodenum, with the expandable structure having proximal and distal portions and a central cylinder portion that does not restrict flow through the pylorus.
Intestinal bypass sleeve with anti-reflux valve closing the sleeve
A gastrointestinal device comprising an intestinal bypass sleeve coupled to at least one of the proximal and distal portions of the expandable structure and having a length sufficient to extend at least partially into the duodenum, and an anti-reflux valve coupled to the central cylinder and adapted to close one end of the bypass sleeve, wherein the central cylinder portion has a length less than a width of the pylorus so as to enable the expandable structure to exert a compressive force on the pylorus, and the proximal and distal portions are spaced apart at discrete locations along the central cylinder.
The independent claims collectively require an implantable expandable structure with proximal and distal spring-engaging portions and a central cylinder portion sized so the central cylinder does not restrict pyloric flow, together with membrane covering and an intestinal bypass sleeve extending into the duodenum. Claim coverage further adds, depending on the claim, treatment of gastroparesis with a pump configured to pump chyme through the pylorus to the duodenum, and an anti-reflux valve coupled to the central cylinder adapted to close one end of the bypass sleeve.
Stated Advantages
Central cylinder portion does not restrict flow through the pylorus.
Anti-reflux valve function is adapted to close one end of the bypass sleeve and embodiments describe preventing reflux of duodenal contents back into the stomach.
Expandable structure is configured to exert a compressive force on the pylorus.
Pump device is adapted to pump chyme from a stomach, through the pylorus, to a duodenum for treatment of gastroparesis.
Documented Applications
Treatment of gastroparesis using a gastrointestinal device configured to pump chyme from a stomach through the pylorus to a duodenum.
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