Implants and method for forming an implant

Inventors

Chhaya, MohitDESAI, ARPITAKHANI, NavidLUCAROTTI, SARA

Assignees

Bellaseno GmbH

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Publication Number

US-11957567-B2

Patent

Publication Date

2024-04-16

Expiration Date


Abstract

Embodiments herein relate to an implant for insertion into a patient. The implant comprises a plurality of unit cells arranged to form a three-dimensional lattice structure, the three-dimensional structure comprising a resting volume of the implant. The plurality of unit cells are arranged to form a porous network of the three-dimensional structure, and wherein the three-dimensional structure is a reversibly compressible three-dimensional structure, wherein a bulk porosity of the three-dimensional structure of the implant is at least 50%. Also disclosed is a method of tissue reconstruction or tissue augmentation. The method comprises implanting into the body of a subject an implant of the disclosure.

Core Innovation

The document describes an absorbable soft-tissue reconstruction implant comprising a porous, reversibly compressible three-dimensional lattice structure made of a plurality of repeated unit cells connected to each other. The lattice structure includes a resting volume of the implant and provides bulk porosity of at least 50%. The repeated unit cells form a porous network, configured to exhibit spring-like reversibility toward the resting volume.

The implant further includes a plurality of surface filler portions arranged to form a plurality of surface filler columns at an outer surface region, and a plurality of open columns at the outer surface region that are free from surface filler portions. The outer surface region includes a first outer surface region with a first surface curvature and a second outer surface region with a second surface curvature, where the second outer surface region is contiguous to the first outer surface region at a perimeter.

The second outer surface region has a geometry that represents a breast region to be constructed by the implant, including an upper pole portion and a lower pole portion coincident at an apex region. Openings at the second outer surface region have a pore size that varies from about 0.5 mm at the upper pole interface region to about 2 mm or 5 mm at the apex region, and from 10 mm or 8 mm or 6 mm at the lower pole interface region up to about 0.5 mm towards the apex region.

Claims Coverage

The independent claim defines a soft tissue reconstruction implant with a reversibly compressible, porous 3D lattice having bulk porosity at least 50% and a breast-shaped outer surface region with upper and lower pole geometries and defined pore-size gradients, plus alternating surface filler columns and open columns. Dependent claims further narrow softness, compressibility, material density, pore-size relationships, and filler-line filling behavior at an outer surface region.

Reversibly compressible porous 3D lattice with bulk porosity at least 50%

A plurality of repeated unit cells connected to form a three-dimensional lattice structure having a resting volume, arranged as a porous network and configured as a reversibly compressible three-dimensional lattice structure, with bulk porosity of at least 50%.

Surface filler columns and open columns at an outer surface region

A plurality of surface filler portions arranged to form a plurality of surface filler columns at an outer surface region, and a plurality of open columns at the outer surface region free from surface filler portions.

Breast-region outer surface geometry with upper and lower pole portions coincident at an apex

A first outer surface region with a first surface curvature and a second outer surface region contiguous to the first outer surface region at a perimeter, where the geometry of the second outer surface region represents a breast region, including an upper pole portion and a lower pole portion coincident at an apex region.

Defined pore-size gradient from upper pole to apex and from lower pole to apex

A pore size of openings at the second outer surface region that varies from about 0.5 mm at the upper pole interface region to about 2 mm or 5 mm at the apex region, and from 10 mm or 8 mm or 6 mm at the lower pole interface region up to about 0.5 mm towards the apex region.

Softness metric c-value within a specified range

The implant having a softness c-value between 20 N and 200 N.

Reversible compressibility threshold relative to resting volume

The implant’s three-dimensional lattice structure is compressible to at least 80% of its resting volume.

Material density range

An implant material density between 0.1 gr/cm3 and 2 gr/cm3.

Pore-size relationship between outer surface regions

The first outer surface region has an average pore size at least 25% larger than the second outer surface region.

Filler lines configured to at least partially fill openings

A surface filler portion includes one or more filler lines configured to at least partially fill an opening at an outer surface region of the three-dimensional lattice structure.

Overall, the claim set covers a soft tissue reconstruction implant combining a reversibly compressible porous 3D lattice with an outer surface region that represents a breast region, including upper and lower pole geometries with an apex and a defined pore-size gradient. It also includes alternating surface filler columns and open columns, with dependent claims further narrowing softness, compressibility relative to resting volume, material density, pore-size relationships between regions, and filler-line filling of surface openings.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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