Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-9962278-B2
Publication Date
2018-05-08
Expiration Date
Abstract
A modular system for therapy within a gastrointestinal system. The system includes anchoring or attachment functionality embodied in a low-profile implant technology and removable therapy components, which can be reversibly attached to these low-profile implants to accomplish various therapies. This modular design allows the physician to tailor the therapy to the patient's needs. The modular system has the potential to create conduits for diversion and/or restriction of food and organ secretions and to facilitate the treatment of metabolic disorders such as obesity and T2DM.
Core Innovation
The modular system for treating metabolic disorders includes an anchoring element configured to be retained at a pyloric junction. The anchoring element includes an expandable structure with a first reduced configuration for implantation and a second expanded configuration for engaging the pylorus, and includes flanges defining outer diameters in the expanded configuration and a neck portion with an outer diameter smaller than the outer diameters of the flanges.
The flanges are sized larger than a maximum diameter of a pyloric orifice such that movement of the anchoring element toward the intestine is inhibited by contact of the first flange with the stomach side of the pylorus and movement toward the stomach is inhibited by contact of the second flange with the intestinal side of the pylorus. The anchoring element does not penetrate into or exert a radial force upon a duodenal bulb, and the anchoring element includes a docking feature.
A tubular implant adapted for placement within the gastro-intestinal tract includes a coupling feature for engaging and coupling with the docking feature of the anchoring element. The docking feature and coupling feature are configured such that the tubular implant is releasably coupled to the anchoring element to facilitate removal of the tubular implant. The system includes tubular implants configured to act as a conduit for food and organ secretions, including optional flow restriction and an anti-reflux valve.
Claims Coverage
The independent claims cover a modular system for treating metabolic disorders using a pylorus-retained anchoring element with an expandable structure and a docking feature, together with one or more tubular implants that releasably couple to enable removal while avoiding penetration or radial force on the duodenal bulb. Across the independent claims, the main inventive features are pylorus-side retention via expandable proximal and distal portions or flanges, inclusion of a docking feature on the anchoring element, and a tubular implant coupling feature that provides releasable coupling for removal.
Pyloric anchoring with expandable structure and sized flanges inhibiting movement
An anchoring element configured to be retained at a pyloric junction, including an expandable structure with a first reduced configuration configured for implantation and a second expanded configuration configured for engaging a pylorus, with a first flange and a second flange defining outer diameters in the expanded configuration and a neck portion extending between them, where the outer diameters of the flanges are larger than a maximum diameter of a pyloric orifice such that movement is inhibited by contact with the stomach side and intestinal side of the pylorus.
No penetration or radial force upon duodenal bulb while providing a docking feature
The anchoring element does not penetrate into or exert a radial force upon a duodenal bulb, and the anchoring element includes a docking feature.
Releasably coupled tubular implant with coupling feature to docking feature
A tubular implant adapted for placement within the gastro-intestinal tract having a coupling feature for engaging and coupling with the docking feature of the anchoring element, wherein the tubular implant is releasably coupled to the anchoring element to facilitate removal of the tubular implant.
Pylorus-retaining proximal and distal portions without penetration or radial force
An anchoring element including an expandable structure with a first reduced configuration for implantation and a second expanded configuration for retaining the anchoring element within a pylorus, with a proximal portion and a distal portion each having an outer diameter larger than a maximum outer diameter of a pyloric orifice, and with the proximal portion and distal portion configured such that neither penetrates into or exerts a radial force on the pyloric antrum wall or a duodenal bulb.
Multiple pylorus-spanning anchoring elements with constrained neck and no duodenal bulb radial force
A plurality of anchoring elements each having a docking feature, each with a reduced configuration configured for implantation and an expanded configuration configured to retain within a pylorus, and including a proximal portion, a distal portion, and a neck portion with an outer diameter less than the outer diameter of the proximal portion and distal portion, while not penetrating into or exerting a radial force upon a duodenal bulb.
Duodenum and stomach tubular implants each releasably coupled for removal of first tubular implant
A first tubular implant adapted for placement within the duodenum and a second tubular implant adapted for placement within the stomach, each having a coupling feature for coupling with the docking feature of one of the plurality of anchoring elements, wherein the first tubular implant is releasably coupled to facilitate removal of the first tubular implant.
Across the independent claims, the modular system is defined by a pylorus-retained expandable anchoring element with a docking feature, avoidance of penetration or radial force on the duodenal bulb, and one or more tubular implants having coupling features that releasably couple to the docking feature to facilitate removal.
Stated Advantages
Facilitates removal of the tubular implant.
The anchoring element does not penetrate into or exert a radial force upon a duodenal bulb.
Movement of the anchoring element toward the intestine is inhibited by contact of a flange with the stomach side of the pylorus, and movement toward the stomach is inhibited by contact of another flange with the intestinal side.
Documented Applications
Treating metabolic disorders.
Treating metabolic disorders that include obesity and Type-2 diabetes mellitus (T2DM).
Treating gastrointestinal conditions including GERD.
Interested in licensing this patent?