Biodegradable supporting device

Inventors

Mangiardi, Eric K.

Assignees

Q3 Medical Devices Ltd

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Publication Number

US-11051958-B2

Patent

Publication Date

2021-07-06

Expiration Date


Abstract

A biodegradable in vivo supporting device is disclosed. In one embodiment, a coated stent device includes a biodegradable metal alloy scaffold made from a magnesium alloy, iron alloy, zinc alloy, or combination thereof, and the metal scaffold comprises a plurality of metal struts. The metal struts are at least partially covered with a biodegradable polymer coating. A method for making and a method for using a biodegradable in vivo supporting device are also disclosed.

Core Innovation

The disclosed invention provides a biodegradable balloon-expandable in vivo supporting device. The device includes a biodegradable metal alloy scaffold made from an alloy comprising magnesium, manganese, and at least one rare earth metal, where the scaffold comprises a plurality of metal struts. The metal alloy scaffold is associated with a cylinder-shaped stent body having a central lumen.

The stent body includes a plurality of axially arranged rows of struts in a wave pattern, with each row configured in a substantially antiparallel arrangement relative to adjacent row(s) and connected only by a plurality of curved connectors. The invention further provides a biodegradable polymer coating at least partially covering the metal struts, with coated struts having a cross-sectional width between 100-600 μm and the polymer coating having a thickness between 10-100 μm.

The polymer coating is described as controlling degradation and body-fluid contact, including embodiments with holes, porous coating, or fissures to create controlled permeable contact with body fluids. The scaffold can include additional features such as interlayer coatings to delay metal degradation, while maintaining a biodegradable polymer-coated metal strut structure.

Claims Coverage

The independent claims cover three variants of a biodegradable balloon-expandable in vivo supporting device. Across the independent claims, the coverage centers on the same stent geometry, coated metal struts with specified cross-sectional width and coating thickness, and selection of biodegradable metal alloy composition.

Rare earth magnesium alloy scaffold with wave-pattern antiparallel strut rows

A biodegradable metal alloy scaffold made from an alloy comprising magnesium, manganese and at least one rare earth metal, including a plurality of metal struts, with the metal scaffold comprising a cylinder-shaped stent body consisting of a plurality of axially arranged rows of struts encircling a central lumen in a wave pattern; each row configured in a substantially antiparallel arrangement relative to its adjacent row(s) and solely connected to an adjacent row by a plurality of curved connectors.

Biodegradable polymer coating dimensioned for coated struts

A biodegradable polymer coating at least partially covering the metal struts, wherein coated struts have a cross-sectional width between 100-600 μm and the polymer coating has a thickness between 10-100 μm.

Magnesium/iron/zinc alloy scaffold with manganese content

A biodegradable metal alloy scaffold made from a magnesium alloy, an iron alloy, a zinc alloy, or combination thereof, comprising a plurality of metal struts, wherein the magnesium alloy, iron alloy, and/or zinc alloy has a manganese content of at least 1 wt.%.

Neodymium or cerium magnesium alloy scaffold

A biodegradable metal alloy scaffold made from a magnesium alloy including magnesium, manganese, and neodymium or cerium, comprising a plurality of metal struts.

The independent claims consistently require a cylinder-shaped wave-pattern stent geometry with substantially antiparallel adjacent rows connected only by curved connectors, plus a biodegradable polymer coating dimensioned so that coated struts have cross-sectional width between 100-600 μm and polymer coating thickness between 10-100 μm. The main variation across the independent claims is the specified biodegradable metal alloy composition.

Stated Advantages

Documented Applications

No documented applications found

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