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Publication Number

US-12156802-B2

Patent

Publication Date

2024-12-03

Expiration Date


Abstract

Absorbable implants can be used to create volume and shape in the breast of a patient with regenerated tissue. The implants comprise scaffolds formed from layers of parallel filaments. The layers of filaments can be stacked and bonded together to form scaffolds with porous crisscross arrangements of filaments. The implant's scaffolds may be coated or filled with cells and tissues, including autologous fat graft, and/or a vascular pedicle may be inserted into the implant. The implants are particularly suitable for use in plastic surgery procedures, for example, to regenerate or augment breast tissue following mastectomy or in mastopexy procedures, and can provide an alternative to the use of permanent breast implants in these procedures.

Core Innovation

The invention relates to a breast implant comprising a porous three-dimensional scaffold with a defined back area and a front area opposite the back area. The front area includes a front bottom for placement in the lower pole of the breast, a front top for placement in the upper pole of the breast, and a front intermediate-region for placement under the skin of the patient. The implant has a compressive modulus of 0.1 kPa to 10 MPa.

The scaffold is formed from at least two adjacent parallel planes of filaments bonded to each other, where the filaments in each plane extend in the same direction. The disclosed structures include a crisscross porous infill arrangement and triangular open pore architecture as part of the porous three-dimensional scaffold. The scaffold can include hollow openings or channels to enable tissue and vascular pedicle insertion.

The scaffold is disclosed as being manufacured as an absorbable implant and can be coated/filled with cells or tissue, including autologous fat or injectable fat, cells, collagen, hyaluronic acid, and bioactive agents. The document further describes implant mechanical property engineering, including a compressive modulus range and optional anisotropic properties, together with supporting manufacturing approaches including 3D printing and melt extrusion deposition printing.

Claims Coverage

The document provides two independent claims (a device claim and a manufacturing method claim). Each independent claim focuses on a porous three-dimensional scaffold for a breast implant with a compressive modulus of 0.1 kPa to 10 MPa and with scaffold formation from at least two adjacent bonded parallel planes of filaments extending in the same direction within each plane.

Porous breast implant scaffold with defined breast-region placement

A breast implant comprising a porous three-dimensional scaffold with a back area for placement on the chest wall of a patient, and a front area opposite the back area, the front area comprising a front bottom for placement in the lower pole of the breast, a front top for placement in the upper pole of the breast, and a front intermediate-region for placement under the skin of the patient.

Compressive modulus engineered for breast implant

The implant has a compressive modulus of 0.1 kPa to 10 MPa.

Bonded adjacent parallel filament planes forming scaffold

The scaffold comprises at least two adjacent parallel planes of filaments bonded to each other.

In-plane filament alignment

The filaments in each plane extend in the same direction.

Manufacturing by 3D printing or melt extrusion deposition printing

A method of manufacturing a breast implant where the scaffold is formed by one of (i) forming at least two parallel planes of filaments from a polymeric composition by 3D printing of the filaments, and (ii) forming at least two parallel planes of filaments from a polymeric composition by melt extrusion deposition printing.

Overall, claim coverage centers on a breast implant having region-specific front/back placement features and a porous scaffold characterized by a compressive modulus of 0.1 kPa to 10 MPa, with at least two adjacent bonded parallel planes of filaments whose filaments extend in the same direction within each plane. The manufacturing independent claim limits formation of the parallel-filament planes to either 3D printing or melt extrusion deposition printing.

Stated Advantages

Documented Applications

No documented applications found

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