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
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Publication Number
US-10420659-B2
Publication Date
2019-09-24
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
An implantable tubular device is provided with a multi-layer composite wall defining a longitudinal passageway. The multi-layer composite wall includes an inner layer and a microporous sheath layer having a corrugated outer surface, and the microporous sheath layer is formed of a biocompatible elastomeric biomaterial with an open-pore network of interconnected pores extending from the corrugated outer surface to an interface between the inner layer and the microporous sheath layer.
The microporous sheath layer includes a base portion and a plurality of ridges extending from the base portion, where each two adjacent ridges define a groove, and ridges and grooves alternate to provide the corrugated outer surface. The grooves and ridges are oriented circumferentially or spirally around the tubular implantable device, and the base portion has a thickness that is 0.8-3 times of a mean height of the ridges.
A vascular graft embodiment is also provided with a single microporous layer defining an inner luminal surface and having a corrugated outer surface. The single microporous layer is formed of a biocompatible elastomeric biomaterial with an open-pore network of a plurality of interconnected pores extending from the inner luminal surface to the corrugated outer surface, with substantially all interconnected pores each connected to at least two other pores and any two adjacent pores connected by a throat.
Claims Coverage
The document contains two independent claims. Together, the independent claims define a biocompatible elastomeric microporous layer with corrugated ridge-and-groove geometry oriented circumferentially or spirally, and they include quantitative relationships for ridge height, base thickness, and pore/throat dimensions.
Corrugated open-pore microporous elastomeric sheath layer spanning to inner-layer interface
A tubular implantable device with a multi-layer composite wall defining a longitudinal passageway, where the multi-layer composite wall includes an inner layer and a microporous sheath layer formed of a biocompatible elastomeric biomaterial having an open-pore network of interconnected pores extending from the corrugated outer surface to an interface between the inner layer and the microporous sheath layer.
Alternating circumferential or spiral ridges and grooves with base thickness tied to ridge height
The microporous sheath layer includes a base portion and a plurality of ridges extending from the base portion, each two adjacent ridges defining a groove, and ridges and grooves alternating to provide the corrugated outer surface, with grooves and ridges oriented circumferentially or spirally around the tubular implantable device, wherein the base portion has a thickness that is 0.8-3 times of a mean height of the ridges.
Single corrugated open-pore microporous layer spanning inner luminal surface to outer surface
A vascular graft comprising a single microporous layer defining an inner luminal surface and having a corrugated outer surface, wherein the single microporous layer is formed of a biocompatible elastomeric biomaterial having an open-pore network of a plurality of interconnected pores extending from the inner luminal surface to the corrugated outer surface.
Interconnected pores and throats with specified mean diameters and ridge/base dimensions
Substantially all interconnected pores are each connected to at least two other pores, and any two adjacent pores are connected by a throat, with pores having a mean diameter between about 5 and about 90 micrometers and throats having a mean diameter of at least 5 micrometers, and with ridges and grooves alternating to provide the corrugated outer surface and grooves and ridges oriented circumferentially or spirally around the vascular graft.
Overall claim coverage is centered on a biocompatible elastomeric microporous open-pore network with corrugated ridge-and-groove outer geometry oriented circumferentially or spirally, with specified relationships between base thickness and ridge height and specified pore and throat dimensional constraints.
Stated Advantages
Improving infection resistance by promoting macrophage coating
Supporting macrophage/neutrophil infiltration through the open-pore network
Promoting capillary/immune-cell transport
Suppressing foreign body response and capsular fibrosis
Providing a wicking “sponge effect” and self-sealing/hemostasis after cannulation
Reducing infection related to blood/hematoma formation
Reducing anastomotic suture-hole leakage and leakage after cannulation
Speeding biointegration via epidermal edge nesting into groove bases
Restricting dead scab tissue
Reducing localized stress by nesting the epidermal edge into groove bases
Documented Applications
Implantable device including an interface with skin for a hemodialysis percutaneous port and cannulation context
Implantable vascular graft with a dialysis access port configured to interface with skin
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