Corrugated microporous tissue interface for improved performance and infection resistance of vascular grafts and other implantable devices
Inventors
Marshall, Andrew J. • Scanlan, Brandt • Maginness, Max • Oda, Adrienne • Connolly, Michael J. • MacDonald, Chad
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-10751203-B2
Publication Date
2020-08-25
Expiration Date
Abstract
Provided herein are implantable devices, such as vascular grafts and access port for hemodialysis, that include a microporous sheath layer having a corrugated outer surface, and use therefore for reducing the risk of infection or stenosis.
Core Innovation
The invention provides a microporous sheath surrounding a skin-breaching component of an implantable device. The microporous sheath is made of a biocompatible elastomeric biomaterial having a corrugated outer surface and an open-pore network of interconnected pores extending from the corrugated outer surface to an interface between the microporous sheath and an exterior surface of the skin-breaching component.
Substantially all interconnected pores are each connected to at least two other pores, and adjacent pores are connected by a throat. The pores and throats are defined by a mean pore diameter between about 5 and about 90 micrometers and a mean throat diameter of at least 5 micrometers, and the sheath includes a base portion and a plurality of ridges extending from the base portion, with adjacent ridges defining grooves so that ridges and grooves alternate to provide the corrugated outer surface.
The grooves and ridges are oriented circumferentially or spirally around the skin-breaching component, and the base portion thickness is 0.8–3 times of a mean height of the ridges. The described configuration addresses exit site infection by shaping the interface presented to skin through a corrugated outer contour and an interconnected pore structure that extends to the skin-breaching interface exterior surface.
Claims Coverage
Two independent claims are provided, centered on a corrugated microporous elastomeric sheath around a skin-breaching component for preventing exit site infection, and on providing hemodialysis access using a percutaneous port through skin that interfaces with an arteriovenous vascular graft via the same type of corrugated open-pore microporous sheath. Each independent claim defines the interconnected pore/throat structure and the corrugated ridge/groove geometry, including pore and throat mean diameters and the base portion thickness relative to ridge mean height.
Interconnected open-pore network microporous sheath around skin-breaching component
A biocompatible elastomeric biomaterial microporous sheath surrounding a skin-breaching component, the sheath having an open-pore network of interconnected pores extending from a corrugated outer surface to an interface between the microporous sheath and an exterior surface of the skin-breaching component, where substantially all pores are each connected to at least two other pores and adjacent pores are connected by a throat.
Defined pore and throat mean diameters
The pores having a mean diameter between about 5 and about 90 micrometers and any two adjacent pores being connected by a throat having a mean diameter of at least 5 micrometers.
Corrugated outer surface formed by alternating ridges and grooves
The microporous sheath includes a base portion and a plurality of ridges extending from the base portion, each two adjacent ridges defining a groove so that ridges and grooves alternate to provide the corrugated outer surface.
Circumferential or spiral ridge/groove orientation with constrained base thickness
The grooves and ridges are oriented circumferentially or spirally around the skin-breaching component and the base portion has a thickness that is 0.8–3 times of a mean height of the ridges.
Hemodialysis access via percutaneous port connected to arteriovenous vascular graft
Implanting a percutaneous port through skin configured to connect to an arteriovenous vascular graft, where the percutaneous port contacts skin via a skin-breaching component surrounded by the microporous sheath having the defined open-pore network and corrugated outer surface.
The claims define a corrugated outer microporous elastomeric sheath for a skin-breaching component with a specified interconnected open-pore network and a corrugated ridge/groove geometry. One independent claim applies this sheath to a method for preventing exit site infection, and the other applies it to a method providing hemodialysis access through a percutaneous port connected to an arteriovenous vascular graft.
Stated Advantages
Preventing exit site infection of an implantable device having a skin-breaching component.
Providing hemodialysis access to a subject in need thereof.
Documented Applications
Providing hemodialysis access by implanting a percutaneous port through skin configured to connect to an arteriovenous vascular graft, with the percutaneous port contacting skin via a skin-breaching component surrounded by the microporous sheath.
Preventing exit site infection of an implantable device having a skin-breaching component.
Interested in licensing this patent?