Full contour breast implant

Inventors

Limem, Skander • Rizk, Said • Williams, Simon F.

Assignees

Tepha Inc

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Publication Number

US-11903816-B2

Patent

Publication Date

2024-02-20

Expiration Date


Abstract

Full contour absorbable implants for breast surgery redistribute breast volume between the breast's upper and lower poles in exact and desirable ratios. The implants preferably redistribute breast volume so that the upper pole breast volume is 20-40% of the total volume, and the lower pole breast volume is 60-80% of the total volume. The implants are also designed to provide specific curvatures to the poles of the breast, and to angulate the nipple areolar complex slightly skyward so that the patient's nipple is positioned at an angle above the nipple meridian reference line. The implants are designed to be transitory, with sufficient strength retention to allow transition from support of the breast by the implant to support by regenerated host tissue growing in and around the implants, without any significant loss of support during or subsequent to remodeling. The implants may optionally be used with permanent breast implants.

Core Innovation

The invention provides absorbable, full-contour breast implants engineered to create a predetermined breast shape by controlling upper and lower pole volume ratios. The upper pole volume is 20–40% of the total breast volume, and the lower pole volume is 60–80% of the total breast volume. The implant also creates predetermined upper and lower pole curvatures, where the lower pole curvature is convex and the upper pole curvature is straight or slightly concave.

The invention further controls nipple positioning through NAC angulation relative to the nipple meridian reference line. The nipple is angulated in a slightly skyward direction, positioned between 1 and 27 degrees above the nipple meridian reference line, with preferred angulation values of about 12–27 degrees and about 18–22 degrees.

The invention emphasizes transitory scaffold behavior, including controlled degradation and strength retention to transfer support to regenerated host tissue. The absorbable implant can optionally include compatibility with permanent silicone or saline breast implants, while using materials and scaffold constructs such as P4HB and copolymers and porous or mesh constructs. Implant structural features include an NAC aperture, reinforcing or flexible pillars, and tissue-attachment tabs, with molded porous constructs.

Claims Coverage

The partial content includes two independent method claims. Each independent claim centers on implantation of a shaped implant that sets upper and lower pole curvature and a slightly skyward NAC angulation relative to a nipple meridian reference line, with claim-specific structural emphasis in one claim.

Implant positioning to set pole curvature and skyward NAC angulation

Positioning an implant on a breast mound so that the nipple areola complex protrudes through an opening for the NAC in the implant, where a convex curvature of the implant contacts the lower pole of the breast mound and a straight or slightly concave curvature contacts the upper pole of the breast mound, while the nipple is angulated in a slightly skyward direction.

Securing to redistribute upper and lower pole volumes

Securing the implant to the tissue surrounding the breast mound such that the upper pole breast volume is 20–40% of the total breast volume and the lower pole breast volume is 60–80% of the total breast volume, with the curvature of the lower pole convex and the curvature of the upper pole slightly concave or straight.

Nipple angulation relative to the nipple meridian reference line

Angulating the nipple areolar complex slightly skyward so that the patient's nipple is positioned between 1 and 27 degrees above the nipple meridian reference line.

Radially extending reinforcing pillars from the NAC aperture to the outer edge

Providing the implant with a plurality of reinforcing pillars radially extending from the aperture to an outer edge of the implant.

Across the independent claims, the core claim coverage is an implantation method that positions an implant to produce specified upper and lower pole curvature and a slightly skyward NAC orientation, secures the implant to redistribute upper and lower pole volumes, and in one independent claim requires radially extending reinforcing pillars from the aperture to the outer edge.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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