Methods and apparatus for anchoring within the gastrointestinal tract
Inventors
Meade, John C. • Levine, Andy H. • Melanson, David A. • Cvinar, John F.
Assignees
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Publication Number
US-7815589-B2
Publication Date
2010-10-19
Expiration Date
Abstract
The present invention relates to an anchor configured for minimally-invasive implantation and sized to remain securely positioned within at least a portion of the gastrointestinal tract of an animal. The anchor includes a radial spring formed from an elongated resilient member shaped into an annular wave pattern about a central axis. The anchor defines a central lumen and provides an outward radial force, while allowing for substantial flexure about its perimeter. The anchor is generally removable, but can include fasteners, such as barbs, to further secure it to the surrounding anatomy. In some embodiments, the anchor includes a connector coupling a fixed portion to a removable portion. Further, the anchor can be used to secure a medical device within the body, such as a flexible sleeve within the intestine.
Core Innovation
The invention relates to a gastrointestinal implant device for extending into the intestine, including an unsupported, flexible sleeve that is open at both ends. A wave anchor is coupled to a proximal portion of the sleeve and is adapted for attachment within an animal body and engaging a wall of a gastrointestinal tract. The wave anchor has only a single wave in only a single revolution, including a single annular wave pattern, formed of an elongated resilient member about a central axis.
The wave anchor defines a central lumen adapted to accommodate an adult human intestine diameter, and the device includes a proximal portion attached to the sleeve by the wave anchor means. The wave anchor is defined by an axial length within about 25 millimeters to about 50 millimeters, and the resilient member is configured such that there is no wave of elongated resilient member other than the single wave.
The disclosure further describes that implantation and secure retention may use attachment structures and couplings that support placement of the gastrointestinal implant device while maintaining chyme passage through the central lumen. The described retention structures include fasteners and removable versus fixed-anchor embodiments, along with two-piece coupling arrangements such as clasp or magnetic coupling, and barrier/sleeve configurations associated with blocking uptake or hormone triggering for obesity treatment and intestinal disorders.
Claims Coverage
The relevant independent claim set includes three independent claims (clm-00001, clm-00027, and clm-00028). Across these claims, the inventive coverage is centered on a gastrointestinal implant device with an unsupported, open-ended flexible sleeve and a wave anchor limited to only a single wave formed of an elongated resilient member, with defined axial length and central lumen sizing for an adult human intestine diameter.
Unsupported open-ended flexible sleeve extending into the intestine
The gastrointestinal implant device includes an unsupported, flexible sleeve that is open at both ends and adapted to extend into the intestine.
Single-wave single-revolution wave anchor formed of an elongated resilient member
A wave anchor coupled to a proximal portion of the sleeve has only a single wave in only a single revolution, including a single annular wave pattern, formed of an elongated resilient member, with there being no wave of elongated resilient member other than said single wave.
Axial length range for the single wave anchor
The single wave has an axial length within a range of about 25 millimeters to about 50 millimeters.
Central lumen accommodating adult human intestine diameter
The wave anchor defines a central lumen and accommodates a diameter of an adult human's intestine of about 45 millimeters.
Oscillating pattern about the central axis between first and second axial ends
The annular wave pattern defines an oscillating pattern about the central axis alternating between first and second axial ends of the anchor, separated by the axial length within about 25 millimeters to about 50 millimeters.
The independent claims collectively require an unsupported flexible sleeve open at both ends extending into the intestine and a proximal wave anchor defined by exactly one wave in one revolution from an elongated resilient member, with an axial-length range about 25–50 mm and a central lumen sized to accommodate an adult human intestine diameter of about 45 mm.
Stated Advantages
Secure retention in the GI tract while allowing chyme passage through the central lumen.
Compliance behavior supported by described compliance curves and spring-rate comparisons.
Documented Applications
Obesity treatment using barrier/sleeve configurations associated with blocking uptake or hormone triggering in the gastrointestinal tract.
Treatment of intestinal disorders using the described gastrointestinal implant device and retention/coverage configurations.
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