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Publication Number
US-7976488-B2
Publication Date
2011-07-12
Expiration Date
Abstract
A collapsible gastrointestinal anchor can be characterized in various embodiments by a radial force of about 0.1 Newtons (N) or greater at a compressed diameter of 25 millimeters (mm); by an average spring rate of about 13 Newtons/meter (N/m) or greater in a range of motion between a relaxed diameter and a compressive elastic deformation diameter; or by a radial force over the range of motion of about 0.1 N or greater. Typically, the anchor can be adapted to be retained within a subject's intestine, more typically in the duodenum, or particularly in the duodenal bulb just distal to the pylorus.A gastrointestinal implant device includes the collapsible gastrointestinal anchor and a floppy sleeve. The sleeve is open at both ends and adapted to extend into a subject's intestine, the anchor being coupled to a proximal portion of the sleeve.Also include are methods of implanting the gastrointestinal implant device in a subject, and methods of treating a subject for disease.The disclosed gastrointestinal invention leads to an improved ability to secure anchors and devices in the gastrointestinal tract while tending to minimize migration.
Core Innovation
The invention is directed to a gastrointestinal implant device that includes a flexible sleeve, open at both ends, adapted to extend into a subject's intestine, and a collapsible gastrointestinal anchor coupled to a proximal portion of the sleeve. The anchor is characterized by specified radial force behavior tied to a compressed diameter of 25 mm and by radial force behavior over a range of motion within a diameter range that includes a relaxed diameter and a compressive elastic deformation diameter.
The collapsible gastrointestinal anchor provides a radial force of between about 0.3 Newtons and about 1.5 Newtons at a compressed diameter of 25 mm. The anchor is further characterized by a radial force of between about 0.1 Newtons and about 1.5 Newtons over a range of motion of at least about 20 mm, with the range of motion occurring within the relaxed diameter and compressive elastic deformation diameter constraints.
The described problem is inadequate force and migration associated with previous wave/mesh anchors that do not provide sufficient retention and instead allow migration. The invention addresses this by tailoring anchor compliance so that force decreases with expansion without over-dilating, thereby achieving retention while minimizing migration.
Claims Coverage
The independent claim defines a gastrointestinal implant device with a flexible open-ended sleeve coupled to a collapsible anchor having specified radial force at a compressed diameter of 25 mm and specified radial force over a range of motion within defined relaxed and compressive elastic deformation diameters. One independent claim is explicitly identified.
Flexible sleeve with open ends coupled to a collapsible gastrointestinal anchor
A gastrointestinal implant device comprising a flexible sleeve, open at both ends and adapted to extend into a subject's intestine, and a collapsible gastrointestinal anchor coupled to a proximal portion of the sleeve.
Radial force at 25 mm compressed diameter within specified range
The collapsible gastrointestinal anchor characterized by a radial force of between about 0.3 N and about 1.5 N at a compressed diameter of 25 mm.
Radial force over at least 20 mm range of motion within relaxed vs compressive elastic deformation diameter range
The collapsible gastrointestinal anchor further characterized by a radial force of between about 0.1 N and about 1.5 N over a range of motion of at least about 20 mm, the range of motion being within a diameter range defined by a relaxed diameter and a compressive elastic deformation diameter, the diameter range including 25 mm.
The claim coverage centers on specifying anchor compliance through radial force at a 25 mm compressed diameter and radial force across at least 20 mm of motion defined by relaxed and compressive elastic deformation diameters. The core inventive structure remains the sleeve coupled to the collapsible anchor with defined force-compliance behavior.
Stated Advantages
Minimizes migration of the gastrointestinal implant device.
Provides retention by tailoring anchor compliance so that force decreases with expansion without over-dilating.
Documented Applications
Used in treating obesity or Type-II diabetes.
Supported by pig implantation and postoperative X-ray observations for retention and migration assessment, with compliance curves and hysteresis plots.
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