Pyloric anchors and methods for intestinal bypass sleeves
Inventors
Stangenes, Todd • Schwarz, Werner • Belhe, Kedar R. • Ziebol, Mathew • Anderson, Edward
Assignees
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Publication Number
US-10729573-B2
Publication Date
2020-08-04
Expiration Date
Abstract
A gastrointestinal device for implanting within a patient's gastrointestinal tract, the device having a central axis and a first expandable portion comprising a hollow tubular braided structure of wire and having a first cylinder extending parallel to the central axis, the first cylinder having a length and a first face; a neck portion extending from the first face of the first expandable portion parallel to the central axis, the neck portion having a first end, a second end, a wall extending between the first end and second end, and a diameter sized to fit within a pylorus; and a second expandable portion comprising a hollow tubular braided structure of wire and having a second cylinder extending parallel to the central axis, the second cylinder having a second face located at the proximal end of the second cylinder and oriented transverse to the central axis.
Core Innovation
The patent describes a gastrointestinal implant for use within a pylorus, a duodenal bulb, and a duodenum of a patient. The implant has an expanded configuration and a contracted configuration, and includes an anchor having a longitudinal axis with a proximal portion, a neck portion, and a distal portion, each formed with hollow tubular braided structure of wire and respective cylindrical walls and openings to define outer and inner circumferences.
The neck portion includes a cylinder with a proximal end attached to an opening and a neck wall extending from the proximal end to a distal end. The distal portion includes a hollow tubular braided structure of wire with an outer wall and a second wall extending radially inward, where the second wall has an outer circumference and a second opening defining an inner circumference, and the distal portion is attached to the neck portion at the distal end.
The implant further includes a plurality of rings attached to the distal portion. The plurality of rings is oriented in planes and intersects planes of one or more other rings, and the patent additionally defines configurations in which ring planes are nonparallel and ring attachment portions are located at circumferential positions adjacent to outer and inner circumferences of the second wall, including spacing relationships based on angular separation.
Claims Coverage
The claim set includes three independent claims. Across these independent claims, the inventive features are centered on a pylorus/duodenal bulb/duodenum-sized implant with an anchor having proximal, neck, and distal hollow tubular braided wire structures plus a distal plurality of rings with defined planar orientation and specified ring-to-wall attachment geometry and circumferential positioning.
Pylorus/duodenal bulb/duodenum implant with expanded and contracted anchor
A gastrointestinal implant for use within a pylorus, a duodenal bulb, and a duodenum of a patient, the implant having an expanded configuration and a contracted configuration and comprising an anchor having a longitudinal axis including a proximal portion, a neck portion, and a distal portion, each including hollow tubular braided structure of wire and defining cylindrical walls and openings with outer and inner circumferences.
Ring plurality with intersecting ring planes and two-section attachment
A plurality of rings attached to the distal portion, wherein each ring has a first section attached to the outer wall of the distal portion and a second section attached to at least one of the second wall and the neck portion, and wherein each ring is oriented in a plane that is offset from and intersects one or more planes of one or more other rings.
Ring planar orientation with defined inner/outer circumferential attachment portions
A plurality of rings attached to the distal portion, each ring oriented in a plane, wherein the first section of each ring is attached to a first portion of the distal portion adjacent the outer circumference of the second wall and the second section is attached to a second portion adjacent the inner circumference of the second wall.
Nonparallel ring planes
Each ring of the plurality of rings is oriented in a plane, and the plurality of rings includes at least one planar orientation relationship in which the rings are nonparallel to one another.
At least three rings attached about 120 degrees apart along the outer wall circumference
The plurality of rings includes at least three rings, wherein each ring of the at least three rings is attached along a circumference of the outer wall at a location about 120 degrees apart from each of the other rings.
The independent claims collectively require an implant sized for placement within the pylorus, duodenal bulb, and duodenum, with an anchor that transitions from proximal to neck to distal hollow tubular braided wire structures, and a distal plurality of rings. The key differentiation is the geometry and placement of the rings: rings are defined by first and second sections attached to outer-wall and inner/neck-related structures, arranged in planes that intersect and/or are nonparallel, with embodiments specifying circumferential angular spacing relationships.
Stated Advantages
Improved anchoring.
Reduced sleeve eversion/obstruction.
Treatment-related improvements including gastroparesis.
Treatment-related improvements including glycemic control/diabetes.
Documented Applications
Treatment of gastroparesis.
Treatment for glycemic control/diabetes.
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