Anchors with biodegradable constraints
Inventors
Melanson, David A. • Nutting, Christopher • Maxwell, Barry • Shank, Peter • Panek, John
Assignees
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Abstract
An implant includes a collapsible anchor to be deployed within a lumen and a protrusion coupled to the anchor. The protrusion, in a constrained state, extends a distance from an exterior surface of the anchor and, in an unconstrained state, extends further from the exterior surface of the anchor. Also included is a biodegradable constraint, such as a biodegradable tube or suture, configured to maintain the protrusion in the constrained state until the constraint releases. The implant may include additional biodegradable constraints, each constraint configured to maintain the protrusion in a different constrained state and to degrade over a different predetermined period after the implant has been deployed within the lumen. The protrusion may include a bi-directional barb or an open loop. The protrusion may be configured to penetrate a wall of the lumen and to allow tissue to grow about the protrusion. The implant may also include an unsupported, thin-walled sleeve coupled to the anchor and configured to extend into the lumen upon deployment of the collapsible anchor.
Core Innovation
The described invention provides implants and methods for securing a collapsible anchor within a gastrointestinal lumen. A cylindrical collapsible anchor is deployed with a protrusion that extends from an exterior surface of the collapsible anchor in a constrained state, and the protrusion is maintained in the constrained state by a biodegradable constraint to penetrate a wall of the gastrointestinal lumen and secure the collapsible anchor.
After penetrating the lumen wall, the protrusion is released from the constrained state and is allowed to extend further from the surface of the collapsible anchor. This extension is tied to degradation of the biodegradable constraint over predetermined periods and is described as promoting tissue growth and fibrotic encapsulation to improve long-term anchoring stability while minimizing damage.
The document further specifies protrusion configurations and constraint arrangements used to hold and release the protrusion, including open loop forms, helical protrusions, straight protrusion necks, and bidirectional or compound barbs. The biodegradable constraint includes biodegradable tube and/or biodegradable suture arrangements, and additional optional components include a thin-walled sleeve and configurations involving a restrictor plate for treatment contexts.
The described device context includes endoscopic deployment and removal and uses lumen subtypes such as the duodenum and other parts of the gastrointestinal tract. Treatment-oriented configurations are described in connection with sleeve and restrictor plate arrangements for obesity and type 2 diabetes, where the anchor and protrusion extension support longer-term anchoring via tissue response.
Claims Coverage
The provided independent claims cover two method categories for securing a cylindrical collapsible anchor in a lumen using a protrusion that transitions from a constrained state to an extended state under control of a biodegradable constraint. Across the independent claims, the main inventive features are shared: deployment of a cylindrical collapsible anchor with a protrusion in a constrained state, wall penetration with the constrained protrusion, and further extension after release when the protrusion is no longer constrained.
Biodegradably constrained protrusion held during wall penetration
Deploying a cylindrical collapsible anchor within a lumen, the collapsible anchor having a protrusion that, in a constrained state, extends from an exterior surface of the collapsible anchor; maintaining the protrusion in the constrained state with a biodegradable constraint; and penetrating a wall of the lumen with the protrusion in the constrained state to secure the collapsible anchor.
Further protrusion extension after release from constrained state
Allowing the protrusion to extend further from the surface of the collapsible anchor when the protrusion is released from the constrained state.
Constrained protrusion geometry using first and second segments and axis alignment
The protrusion includes a first segment proximate to the collapsible anchor that extends from the collapsible anchor along a first axis, and a second segment that extends from the first segment along a second axis, the method further comprising collapsing the first segment against the collapsible anchor to place the protrusion in the constrained state, the first axis aligned with the surface of the collapsible anchor, and the second segment, in the constrained state, extending away from the collapsible anchor.
Cylindrical relaxed-diameter anchor with lumen wall penetration
Deploying the collapsible anchor within the gastrointestinal lumen, the collapsible anchor being cylindrical and having a relaxed diameter greater than a diameter of the gastrointestinal lumen, the collapsible anchor comprising a protrusion that, in a constrained state, extends from an exterior surface of the collapsible anchor; maintaining the protrusion in the constrained state with a biodegradable constraint; penetrating a wall of the gastrointestinal lumen with the protrusion in the constrained state to secure the collapsible anchor; and allowing the protrusion to extend further from the surface of the collapsible anchor when the protrusion is released from the constrained state.
Together, the independent claims define securing a cylindrical collapsible anchor in a lumen by using a protrusion constrained by a biodegradable constraint for penetration and initial securing, followed by additional protrusion extension after release from the constrained state. One independent claim further requires a constrained protrusion geometry with first and second segments and specific axis alignment achieved by collapsing the first segment against the collapsible anchor.
Stated Advantages
Improving long-term anchoring stability.
Minimizing damage.
Promoting tissue growth and fibrotic encapsulation.
Documented Applications
Treatment contexts involving obesity and type 2 diabetes using sleeve and restrictor plate configurations coupled to a collapsible anchor.
Implant deployment and removal described in relation to gastrointestinal tract use (including duodenum).
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