Apparatus and methods for preventing or treating failure of hemodialysis vascular access and other vascular grafts
Inventors
Iyer, Sriram S. • Kipshidze, Nicholas N. • Nikolaychik, Victor V.
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-8858982-B2
Publication Date
2014-10-14
Expiration Date
Abstract
This invention is a prosthetic device generally placed on the outside surface of the vessel or graft which then elutes antiproliferative drugs or agents from a drug-eluting matrix material. Methods of perivascular antiproliferative drug administration also are disclosed.
Core Innovation
The invention provides an implantable antiproliferative agent-administering perivascular cylindrical sleeve adapted to be placed circumvascularly and directly in contact with the exterior of a vascular structure. The sleeve includes a flexible, cylindrical, bioabsorbing, agent-eluting collagen matrix material that has a vascular-sized lumen passing substantially through the matrix material, with antiproliferative drug provided by dispersing rapamycin or its analogues within the collagen matrix material.
The invention further provides an implantable antiproliferative agent-administering circumvascular sleeve adapted to be placed in contact with, and to be directly secured to, the exterior of a vascular structure. The sleeve delivers an antiproliferative agent from outside the vascular wall through the vessel wall, and comprises a flexible, cylindrical, resorbable, agent-eluting collagen matrix material with a vascular-sized lumen passing substantially through the sleeve, the lumen diameter being defined by the exterior diameter of the vascular structure, with rapamycin or its analogues dispersed in the matrix.
The device concepts include circumvascular placement in direct contact with the vessel exterior and configurations for securing the sleeve, including adhesion/self-fixation and wrapping/interlocking constructions. Layered constructions are described, including collagen-based sleeves and multi-material arrangements, and additional antiproliferative or adjuvant components are described in combination with rapamycin-based delivery.
Claims Coverage
The document describes two independent claims. Across these claims, the inventive concepts focus on an implantable circumvascular/perivascular drug-eluting sleeve with a bioabsorbing/resorbable collagen matrix, a vascular-sized lumen, and rapamycin or analogues dispersed in the matrix, including configurations that place the sleeve in direct contact and secure it to the exterior of a vascular structure for delivery through the vessel wall.
Antiproliferative perivascular cylindrical collagen sleeve with rapamycin dispersed in the matrix
An implantable, antiproliferative agent-administering perivascular cylindrical sleeve adapted to be placed circumvascularly and directly in contact with the exterior of a vascular structure, comprising a flexible, cylindrical, bioabsorbing, agent-eluting collagen matrix material having a vascular-sized lumen passing substantially through the matrix material, with rapamycin or its analogues dispersed therein.
Antiproliferative circumvascular sleeve delivering rapamycin through the vessel wall
An implantable, antiproliferative agent-administering circumvascular sleeve adapted to be placed in contact with, and to be directly secured to, the exterior of a vascular structure to deliver an antiproliferative agent from outside the vascular wall through the vessel wall, comprising a flexible, cylindrical, resorbable, agent-eluting collagen matrix material with a vascular-sized lumen passing substantially through the sleeve, the lumen diameter defined by the exterior diameter of the vascular structure, and rapamycin or its analogues dispersed therein.
Both independent claims cover an implantable circumvascular/perivascular sleeve that uses a flexible, cylindrical collagen matrix with a vascular-sized lumen and rapamycin or analogues dispersed within, with direct securing to the exterior for delivery through the vessel wall.
Stated Advantages
Prevention or treatment of hemodialysis vascular access and vascular graft failure by reducing neointimal hyperplasia and smooth muscle cell proliferation.
Sustained growth inhibition of human smooth muscle cells with collagen/rapamycin compared with rapid-release actinomycin D.
Documented Applications
Hemodialysis vascular access and vascular graft failure, including stenosis/occlusion and neointimal hyperplasia, using a perivascular/extravascular drug-eluting circumvascular sleeve with rapamycin-based delivery.
Vascular access/graft context in a porcine AV loop model to assess patency and neointimal hyperplasia markers.
Interested in licensing this patent?