Adaptive sutures dynamically changing wound holding properties post-implantation

Inventors

Andjelic, SasaWisnudel, MarcKeilman, Kenneth M.Kriksunov, Leo B.Tannhauser, Robert J.

Assignees

Ethicon Inc

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Publication Number

US-12156650-B2

Patent

Publication Date

2024-12-03

Expiration Date


Abstract

The present invention is directed to a length adaptive surgical suture comprising a monofilament or a braid of a plurality of filaments, the suture having an original length when implanted and a second length that is different from the original length within a first twenty-four (24) hour period of time after implantation to accommodate tissue swelling. The present invention is also directed to configurations and combinations that enable length adaptive results.

Core Innovation

The invention relates to a length adaptive surgical suture that has an original length when implanted and changes to a different second length after implantation. In one embodiment, the suture becomes 2%-20% longer within a first twenty-four (24) hour period after implantation to accommodate tissue swelling, and elongating is caused by dissolution of a soluble constricting element within 24 hours upon exposure to body fluids and tissues.

Another embodiment provides a suture where the second length is shorter from the original length. At least some of the monofilaments include a semi-crystalline polymer having a glass transition temperature between 40° C. and 55° C. and exhibiting a crystallinity level between 10% and 25%, including an absorbable glycolide and lactide copolymer having a glass transition temperature in between 40° C. and 45° C. and a crystallinity level of about 15%.

A related adaptive suture embodiment further defines a third length thereafter that is less than the original length to tighten the tissue holding as the tissue heals, following an initial elongation phase driven by dissolution of the constricting element within 24 hours. The document describes that the suture tensile strength and knot strength increase post-implantation prior to major degradation and hydrolysis, and that dimensional change is linked to polymer crystallization and morphology changes in semi-crystalline filaments.

Claims Coverage

The partial claims include four independent claim sets. Across these, the inventive features focus on length change timing, soluble constricting-element driven elongation, semi-crystalline polymer property ranges, and dimensional tightening with post-implantation strength increases prior to major degradation and hydrolysis.

Soluble constricting-element length elongation to accommodate swelling

A length adaptive surgical suture that has an original length when implanted and a second length that is 2%-20% longer within a first twenty-four (24) hour period after implantation to accommodate tissue swelling, held by a soluble constricting element in a shortened or constricted state at the original length prior to implantation, wherein elongating is caused by dissolution of the constricting element within 24 hours upon exposure to body fluids and tissues.

Semi-crystalline polymer monofilament with glass transition and crystallinity ranges for shortening

A length adaptive surgical suture comprising a monofilament or a braid of a plurality of monofilaments, having an original length when implanted and a second length that is shorter from the original length, wherein at least some of the monofilaments are a semi-crystalline polymer having a glass transition temperature between 40° C. and 55° C. and exhibiting a crystallinity level between 10% and 25%.

Glycolide/lactide semi-crystalline absorbable polymer with dimensional and strength increases

An adaptive surgical suture comprising a semi-crystalline absorbable synthetic polymer made from glycolide and lactide copolymer having an original length, a glass transition temperature in between 40° C. and 45° C. and a crystallinity level of about 15%, wherein a second length decreases about 15% post-implantation and a diameter increases about 10% in a body post-implantation and wherein suture tensile strength and knot strength increase by at least about 40% in a body post-implantation prior to major degradation and hydrolysis.

Two-stage length adaptation: swelling accommodation then tightening as tissue heals

A length adaptive surgical suture comprising a monofilament or a braid of a plurality of monofilaments, having an original length when implanted and a second length that is greater within the first twenty-four (24) hour period after implantation to accommodate tissue swelling, held by a soluble constricting element in a shortened or constricted state at the original length prior to implantation, wherein elongating is caused by dissolution of the constricting element within 24 hours upon exposure to body fluids and tissues, and the suture having a third length thereafter that is less than the original length to tighten the tissue holding as the tissue heals.

Across the independent claims, the suture length adapts by dissolution-driven elongation from an initially constricted state within about twenty-four hours to accommodate tissue swelling, and/or by shortening characterized by semi-crystalline polymer glass transition temperature and crystallinity ranges. In the described absorbable glycolide/lactide copolymer embodiment, length decreases and diameter increases post-implantation together with tensile and knot strength increases prior to major degradation and hydrolysis. A further claim defines an additional third length thereafter to tighten tissue holding as tissue heals.

Stated Advantages

Accommodates tissue swelling by increasing from an original length to a second length within the first twenty-four (24) hour period.

Tightens tissue holding as the tissue heals by providing a third length less than the original length thereafter.

Increases suture tensile strength post-implantation prior to major degradation and hydrolysis.

Increases knot strength post-implantation prior to major degradation and hydrolysis.

Improves suture dimensional behavior post-implantation via length and diameter changes associated with dissolution and/or crystallization in semi-crystalline polymers.

Documented Applications

Not explicitly described in patent.

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