Biodegradable supporting device

Inventors

Mangiardi, Eric K.

Assignees

Q3 Medical Devices Ltd

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Publication Number

US-11903851-B2

Patent

Publication Date

2024-02-20

Expiration Date


Abstract

A biodegradable in vivo supporting device is disclosed. The in vivo supporting device comprises a biodegradable metal scaffold and a biodegradable polymer coating covering at least a portion of the biodegradable metal scaffold, wherein the biodegradable polymer coating has a degradation rate that is faster than the degradation rate of the biodegradable metal scaffold.

Core Innovation

The invention relates to a biodegradable in vivo supporting device and to producing such a device using a biodegradable metal scaffold comprising metal struts and a biodegradable polymer coating. The biodegradable polymer coating coats the metal struts while not covering openings between the struts, thereby forming coated metal struts, and the polymer coating has a degradation rate different from the degradation rate of the biodegradable metal scaffold.

In the production approach, the coated metal struts and openings are fully encapsulated with biodegradable polymer coating, including fully covering the coated struts and openings therebetween. The disclosure further includes configurations that enable direct contact between metal struts and body fluid when placed in a body lumen through one or more holes in the polymer coating.

The disclosed devices include embodiments in which the biodegradable metal scaffold is a magnesium alloy with manganese and rare earth metals, including neodymium and cerium within the rare earth metal group. The polymer coating may be formed from copolymers of polylactides and polyglycolides, and may include permeability and multi-layer coatings with different degradation behaviors. The disclosure further limits scaffold content by weight, such that the biodegradable metal scaffold makes up less than 50 w/w of the supporting device.

Claims Coverage

The independent claim set provided includes one independent claim (a method claim). Across the independent claim and its dependent refinements, the coverage focuses on four inventive features: strut-only polymer coating relative to openings between struts, a polymer degradation rate different from the metal scaffold degradation rate, full encapsulation of coated struts and openings with biodegradable polymer coating, and optional holes enabling direct body-fluid contact, together with dependent composition and weight-limit refinements.

Strut-only polymer coating with openings not covered

Coating at least a portion of a biodegradable metal scaffold with a biodegradable polymer coating so that the biodegradable polymer coating coats the metal struts but does not cover openings between struts, thereby forming coated metal struts.

Polymer degradation rate different from biodegradable metal scaffold

Making the biodegradable polymer coating have a degradation rate different than the degradation rate of the biodegradable metal scaffold.

Fully encapsulating coated struts and openings with polymer

Fully encapsulating the struts from the biodegradable metal scaffold with the biodegradable polymer coating and fully covering the coated struts and openings therebetween with a biodegradable polymer coating.

Polymer coating with holes for direct contact with body fluid

Coating the metal struts with a biodegradable polymer coating that includes one or more holes permitting direct contact of the metal struts with body fluid when placed in a body lumen.

Biodegradable metal scaffold as magnesium alloy with specified composition

Specifying the biodegradable metal scaffold comprises metal with a composition including magnesium content and manganese content and at least one rare earth metal, with defined wt.% ranges.

Rare earth metal neodymium in the scaffold

Implementing the biodegradable metal scaffold using the rare earth metal neodymium.

Biodegradable polymer coating as polylactide/polyglycolide copolymers

Using a biodegradable polymer coating made from copolymers of polylactides and polyglycolides.

Supporting device scaffold content less than 50 w/w

Limiting the biodegradable metal scaffold to less than 50 w/w of the supporting device.

The claims coverage is centered on producing a biodegradable in vivo supporting device by forming a biodegradable metal scaffold with metal struts, coating the struts with a biodegradable polymer while leaving openings between struts not covered, ensuring polymer and metal have different degradation rates, and then fully encapsulating the coated struts and openings with biodegradable polymer coating. Dependent refinements add optional hole(s) for direct body-fluid contact, define scaffold composition within magnesium/manganese/rare-earth ranges including neodymium, specify polymer composition as polylactide/polyglycolide copolymers, and limit scaffold weight fraction to less than 50 w/w.

Stated Advantages

Documented Applications

No documented applications found

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