Membrane-type artificial scaffold and method for fabricating same

Inventors

Shim, Jin-Hyung • Cho, Dong-Woo • Kim, Jeoung Yong • Kim, Jong Young

Assignees

T&R Biofab Co Ltd

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Publication Number

US-9439764-B2

Patent

Publication Date

2016-09-13

Expiration Date


Abstract

Provided herein are a membrane-type artificial scaffold for guided bone regeneration (GBR) and a method for fabricating the same. The membrane-type artificial scaffold according to the present invention comprises: a first layer made of at least one fiber layer arranged in parallel with each other with a first spacing therebetween such that the fiber layer contacts a bone tissue in vivo; and a second layer stacked on the first layer and made of at least one fiber layer arranged parallel to each other with a second spacing therebetween such that the fiber layer contacts a soft tissue in vivo. The first spacing is larger than the second spacing.

Core Innovation

A membrane type scaffold is provided for guided bone regeneration, including a first layer configured to contact bone tissue and a second layer laminated on the first layer and configured to contact soft tissue. The first layer includes first fibers arranged in parallel at first intervals and extending in a first direction, while the second layer includes second fibers arranged in parallel at second intervals and extending in a second direction crossing the first direction. The first interval is larger than the second interval.

The scaffold defines quantitative spacing and uniformity constraints for the two fiber sets. The first intervals are in a range of 150 µm to 400 µm with uniformity having an error range within ±20 µm, and the second intervals are in a range of 30 µm to 50 µm with uniformity having an error range within ±10 µm. The claim set further specifies fiber heights in a range of 50 µm to 100 µm.

The scaffold supports fiber orientation and optional additional fiber substructures, including crossing fiber directions between the first and second fiber sets, and further fiber arrangements such as third and fourth fibers crossing in the first layer and fifth and sixth fibers crossing in the second layer. The document also describes material configurations where the fibers can include polycaprolactone (PCL), with options for hydroxyapatite and/or tricalcium phosphate (TCP) in the first fibers, and accessory components selected from polylactic acid (PLA), polyglycolic acid (PGA), and polylactic-co-glycolic acid (PLGA). A manufacturing approach uses a deposition arrangement where two biopolymers are supplied and sprayed to form the first and second laminated layers with the specified fiber interval relationships.

The document states technical effects associated with the structure and manufacturing constraints, including improved fusion with bone tissue and reduced soft-tissue permeation. It further describes increased mechanical strength and space maintenance through regular voids, and prevention of layer stripping between laminated layers by using regular-shaped voids and constrained layer heights.

Claims Coverage

The document includes two independent claims covering a membrane-type scaffold structure and a manufacturing method. Across these claims, the inventive features focus on laminated, dual-fiber-layer scaffolds with different fiber intervals for bone-contact and soft-tissue-contact functions, specified quantitative interval ranges and uniformity error margins, and an associated biopolymer-spraying manufacturing sequence that forms the laminated layers.

Laminated dual-fiber membrane scaffold with different fiber intervals for bone and soft tissue

A membrane type scaffold with a first layer for contact with bone tissue including first fibers arranged in parallel at first intervals and extending in a first direction, and a second layer laminated on the first layer for contact with soft tissue including second fibers arranged in parallel at second intervals and extending in a second direction crossing the first direction, wherein the first interval is larger than the second interval.

Specified fiber interval ranges and uniformity error margins for both layers

The scaffold wherein the first intervals are in a range of 150 µm to 400 µm and are uniform with an error range within ±20 µm, and wherein the second intervals are in a range of 30 µm to 50 µm and are uniform with an error range within ±10 µm.

Spray-based manufacturing of the laminated first and second fiber layers

A method of manufacturing a membrane type scaffold including providing a first biopolymer and a second biopolymer to syringes of a first deposition head and a second deposition head, respectively; spraying the first biopolymer through a nozzle of the first deposition head to form a first layer including first fibers arranged in parallel at first intervals and extending in a first direction; and spraying the second biopolymer through a nozzle of the second deposition head on the first layer to form a second layer including second fibers arranged in parallel at second intervals and extending in a second direction crossing the first direction, wherein the first interval and the second interval have different values and the first interval is larger than the second interval.

Specified fiber interval ranges and uniformity error margins in the manufacturing method

The method wherein the first intervals are in a range of 150 µm to 400 µm and are uniform with an error range within ±20 µm, and wherein the second intervals are in a range of 30 µm to 50 µm and are uniform with an error range within ±10 µm, with the first layer configured to contact bone tissue and the second layer configured to contact soft tissue.

Overall, the claim coverage centers on a membrane-type, laminated scaffold that uses parallel fibers in each layer with crossing directions between the layers, enforces different fiber interval sizes with the first interval larger than the second interval, and requires specified interval ranges with defined uniformity error margins; it also includes a manufacturing method that forms the two layers by spraying first and second biopolymers in sequence.

Stated Advantages

Improved fusion with bone tissue.

Reduced soft-tissue permeation.

Increased mechanical strength and space maintenance via regular voids.

Prevention of layer stripping between laminated layers using regular-shaped voids and constrained layer heights.

Documented Applications

Guided bone regeneration (GBR) using a membrane-type artificial scaffold configured for contacting bone tissue and soft tissue.

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