Device and method for preventing stenosis at an anastomosis site
Inventors
Assignees
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Publication Number
US-12156799-B2
Publication Date
2024-12-03
Expiration Date
Abstract
The present invention relates to treating or preventing stenosis at an anastomosis site. In one embodiment, the present invention is a stent is curved along the longitudinal axis for placement in and adjacent to the graft orifice. In a further embodiment, the stent is drug coated to allow delivery of antivasculoproliferative drugs directly to the vicinity of the graft orifice. In a further embodiment, the stent is expandable by use of an external wire. In another embodiment, the present invention is a kit comprising the specially configured stent together with a sleeve comprising a biocompatible matrix material and a pharmaceutical agent, wherein the sleeve is applied to the external surface of the vessel or graft, resulting in extravascular delivery of a pharmaceutical agent. Methods for treating or preventing stenosis at an anastomosis site by applying the extravascular sleeve and the intravascular stent are also provided.
Core Innovation
The invention relates to preventing stenosis in a vascular structure having an anastomosis by forming the anastomosis and deploying a drug-free stent at or in the vicinity of the anastomosis. Locally and externally to the vascular structure containing the stent, an effective amount of rapamycin or an analogue of rapamycin is applied via a biocompatible matrix material that carries the rapamycin or analogue of rapamycin. The steps are performed in a single surgical procedure.
The stent is deployed as a drug-free stent and may be expandable from a contracted configuration to an expanded configuration. The stent may be beveled at an edge and/or curved along the longitudinal axis, and it may be self-expanding or balloon expandable. It may include a polymer or fabric coverage, including a PTFE cover.
The drug is delivered extravascularly using an external sleeve or wrap that comprises a biocompatible matrix material imbibed with an anti-vasculoproliferative drug or anti-proliferative agent. The biocompatible matrix material may include collagen, fibrin, chitosan, cellulose, proteins, polysaccharides, or mixtures thereof, and may provide an anti-vasculoproliferative delivery to the vicinity of the anastomosis.
The document further relates to preventing stenosis at an AV anastomosis by creating an AV fistula by joining a vein to an artery and applying the rapamycin or analogue via a biocompatible matrix to the anastomosis and adjacent vein and/or artery.
Claims Coverage
The claims identify five independent claim groupings covering prevention of stenosis at an anastomosis using a drug-free stent and an external matrix-based delivery of rapamycin, an analogue of rapamycin, an anti-vasculoproliferative drug, an anti-proliferative agent, or a therapeutic agent, all in a single surgical procedure.
Single-surgical-procedure drug-free stent with locally and externally matrix-delivered rapamycin
Preventing stenosis in a vascular structure having an anastomosis by forming the anastomosis, deploying a drug-free stent within the lumen at or in the vicinity of the anastomosis, and applying locally and externally to the vascular structure containing the stent an effective amount of rapamycin or an analogue of rapamycin via a biocompatible matrix material that carries the rapamycin or analogue of rapamycin.
Single-surgical-procedure sleeve consisting essentially of matrix and anti-vasculoproliferative drug
Preventing stenosis in a vascular structure having an anastomosis by forming an anastomosis, deploying a drug-free stent within the lumen at or in the vicinity of the anastomosis, and applying a sleeve locally and externally to the vascular structure containing the stent, the sleeve consisting essentially of a biocompatible matrix material and an anti-vasculoproliferative drug.
Expandable beveled or curved drug-free stent with external matrix-imbibed sleeve
A drug-free stent that is an essentially tubular body with a longitudinal axis and circumferential diameter, expandable from a contracted configuration to an expanded configuration, and beveled at an edge and/or curved along the longitudinal axis for placement at or in the vicinity of the anastomosis, with a sleeve on the external surface of the vascular structure containing the stent, the sleeve comprising a biocompatible matrix material imbibed with an anti-proliferative agent.
Self-expanding beveled or curved stent with external sleeve of biocompatible matrix imbibed with therapeutic agent
A self-expanding stent expandable from a contracted configuration to an expanded configuration and beveled at an edge and/or curved along the longitudinal axis for placement at the anastomosis, with a sleeve comprising a biocompatible matrix material imbibed with a therapeutic agent applied to the external surface of the vascular structure containing the stent.
Kit including drug-free stent and external sleeve with biocompatible matrix imbibed with therapeutic agent
A kit packaged for use in a single surgical procedure for preventing stenosis of a vascular structure that includes an anastomosis site, comprising a drug-free stent for deployment within the vascular structure and a sleeve comprising a biocompatible matrix material imbibed with a therapeutic agent for placement on the external surface of the vascular structure containing the stent.
Across the independent claims, the core structure is prevention of stenosis at an anastomosis, including AV fistula contexts, using a drug-free stent deployed at or near the anastomosis and a locally or externally applied sleeve or matrix carrying rapamycin, a rapamycin analogue, an anti-proliferative agent, an anti-vasculoproliferative drug, or a therapeutic agent. The claims also recite expandable, beveled, curved, and self-expanding stent features, together with a single surgical procedure and, in one claim group, a packaged kit.
Stated Advantages
Prevents stenosis in a vascular structure having an anastomosis.
Prevents stenosis in an AV fistula by creating an AV fistula and deploying a drug-free stent at the anastomosis and adjacent vein and/or artery with locally applied rapamycin or a rapamycin analogue via a biocompatible matrix.
Is performed in a single surgical procedure.
Documented Applications
Preventing stenosis at an AV anastomosis by creating an AV fistula by joining a vein to an artery and applying rapamycin or a rapamycin analogue via a biocompatible matrix to the anastomosis and adjacent vein and/or artery.
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