Granted Patent B2

US 12,721,927 · App. 18/272,687 · Granted Sep 1, 2026

Inventors: Alexandre Anthis (Zürich, CH); Inge Herrmann (Seiben/Wangen, CH); Tino Matter (Zürich, CH)

Assignees: EMPA EIDGENÖSSISCHE MATERIALPRÜFUNGS- UND FORSCHUNGSANSTALT; ETH ZÜRICH

A61L24/0031A61L24/001A61L24/0015A61L24/046A61L24/06B33Y80/00A61L2300/102A61L2300/232A61L2400/14

Abstract

Claims (100)

1 . A kit of parts ready to use in a surgical method comprising a first part and a second part, wherein

the first part is a shaped article in the form of a patch for application on a sutured site, a stapled site or a stoma site of a subject in need thereof, the patch comprising a hydrogel support layer, optionally a backing layer, and optionally functional components selected from sensing components, and therapeutic components, and

the second part is an impregnating fluid for application on a sutured site, a stapled site or a stoma site of a subject in need thereof, and on the patch, wherein the impregnating fluid comprises a pharmaceutically acceptable liquid, curable monomers, optionally curing initiators, and optionally additives;

wherein the curable monomers present in the impregnating fluid are in an uncured, monomeric state when the impregnating fluid is not applied on the patch, and

wherein

the hydrogel support layer comprises a non-degradable, synthetic hydrogel; and

the optional backing layer comprises a non-adhesive polymer; and

the liquid is selected from water and/or glycerol; and

the optional curing initiator is adapted for curing the curable monomers; and

the patch and the impregnating fluid are each separately packed for transport and/or sale and prior to the use in a surgical method; and

the patch is impregnated with the fluid shortly before application on a tissue, such that curing of the monomers that are present in the impregnating fluid is initiated after application of the patch.

2 . The kit according to claim 1 , wherein the hydrogel support layer comprises a non-degradable, synthetic hydrogel comprising monomeric units selected from the group consisting of methacrylates, acrylates, vinyls, thiols, polyurethane forming monomers, and mixtures thereof.

3 . The kit according to claim 1 , wherein the backing layer is present and the non-adhesive polymer is selected from the group consisting of

synthetic polymers comprising monomeric units selected from the group consisting of methacrylates, acrylates, vinyls, thiols, polyurethane forming monomers, and mixtures thereof; and/or

natural polymers, and/or

acrylated natural polymers.

4 . The kit according to claim 1 , wherein the impregnating fluid comprises:

curable monomers selected from the group consisting of methacrylates, acrylates, vinyls, thiols, and mixtures thereof, and

optionally curing initiators selected from the group consisting of photoinitiators, oxidizing curing initiators, radical generators, enzymes or heat-activatable curing initiators.

5 . The kit according to claim 1 , wherein the patch further comprises functional components that are sensing components,

the sensing components being present either in the hydrogel support layer and/or in the backing layer, or in an additional layer of the patch; and

the sensing components being selected from the group consisting of synthetic gas-containing microbubbles and/or gas-containing vesicles, and/or carbonates and/or inorganic nanoparticles and/or hydrophobic aerogels.

6 . The kit according to claim 1 , wherein the patch further comprises functional components that are therapeutic components,

the therapeutic components being present either in the hydrogel support layer and/or in the backing layer, or in an additional layer of the patch;

the therapeutic components being selected from the group consisting of antimicrobials, growth factors, flavonoids, metal oxide nanoparticles, alginate, and peptides.

7 . The kit according to claim 1 , wherein the impregnating fluid comprises additives, the additives being selected from the group consisting of

transglutaminase;

ionic strength adjusting media, including buffers and salts; and

surface active substances, including non-ionic, cationic, anionic and amphoteric surfactants.

8 . The kit according to claim 1 , wherein

in a first embodiment

the patch consists of a hydrogel support layer;

the hydrogel support layer comprises monomeric units selected from the group consisting of acrylamide, acrylic acid, methyl acrylate, 2-hydroxyethyl acrylate, 2-hydroxyethyl acrylamide, sodium 2-acrylamido-2-methylpropane sulfonate, N-acryloyl glycinamide, styrene sulfonate, N-tris (hydroxymethyl) methyl acrylamide, bis-acrylamide, poly ethylene glycol diacrylate, and N,N′-bis (acryloyl) cystamine; and

the curable monomers of the impregnating fluid are selected from the group consisting of acrylamide, acrylic acid, methyl acrylate, 2-hydroxyethyl acrylate, 2-hydroxyethyl acrylamide, sodium 2-acrylamido-2-methylpropane sulfonate, N-acryloyl glycinamide, styrene sulfonate, N-tris (hydroxymethyl) methyl acrylamide, bis-acrylamide, poly ethylene glycol diacrylate, and N,N′-bis (acryloyl) cystamine; or

in a second embodiment

the patch consists of a hydrogel support layer and a backing layer;

the hydrogel support layer comprises monomeric units selected from the group consisting of acrylamide, acrylic acid, methyl acrylate, 2-hydroxyethyl acrylate, 2-hydroxyethyl acrylamide, sodium 2-acrylamido-2-methylpropane sulfonate, N-acryloyl glycinamide, styrene sulfonate, N-tris (hydroxymethyl) methyl acrylamide, bis-acrylamide, poly ethylene glycol diacrylate, and N,N′-bis (acryloyl) cystamine;

the backing layer comprises monomeric units selected from the group consisting of acrylamide, acrylic acid, methyl acrylate, 2-hydroxyethyl acrylate, 2-hydroxyethyl acrylamide, sodium 2-acrylamido-2-methylpropane sulfonate, N-acryloyl glycinamide, styrene sulfonate, N-tris (hydroxymethyl) methyl acrylamide, bis-acrylamide, poly ethylene glycol diacrylate, and N,N′-bis (acryloyl) cystamine; and/or one or more natural polymers selected from the group consisting of carboxymethylcellulose, and alginate; and

the curable monomers of the impregnating fluid are selected from the group consisting of acrylamide, acrylic acid, methyl acrylate, 2-hydroxyethyl acrylate, 2-hydroxyethyl acrylamide, sodium 2-acrylamido-2-methylpropane sulfonate, N-acryloyl glycinamide, styrene sulfonate, N-Tris (hydroxymethyl) methyl acrylamide, bis-acrylamide, poly ethylene glycol diacrylate, and N,N′-bis (acryloyl) cystamine; or

in a third embodiment

the patch consists of a hydrogel support layer, a backing layer, and sensing components;

the hydrogel support layer comprises monomeric units selected from the group consisting of acrylamide, acrylic acid, methyl acrylate, 2-hydroxyethyl acrylate, 2-hydroxyethyl acrylamide, sodium 2-acrylamido-2-methylpropane sulfonate, N-acryloyl glycinamide, styrene sulfonate, N-Tris (hydroxymethyl) methyl acrylamide, bis-acrylamide, poly ethylene glycol diacrylate, and N,N′-bis (acryloyl) cystamine;

the backing layer comprises monomeric units selected from the group consisting of acrylamide, acrylic acid, methyl acrylate, 2-hydroxyethyl acrylate, 2-hydroxyethyl acrylamide, sodium 2-acrylamido-2-methylpropane sulfonate, N-acryloyl glycinamide, styrene sulfonate, N-tris (hydroxymethyl) methyl acrylamide, bis-acrylamide, poly ethylene glycol diacrylate, and N,N′-bis (acryloyl) cystamine and/or one or more natural polymers selected from the group consisting of carboxy methyl-cellulose, and alginate;

the sensing components are selected from the group consisting of NaHCO 3 , Na 2 CO 3 , CaCO 3 , gas-containing vesicles and/or synthetic gas-containing microbubbles, iron oxide nanoparticles, and zinc oxide nanoparticles; and

the curable monomers of the impregnating fluid are selected from the group consisting of acrylamide, acrylic acid, methyl acrylate, 2-hydroxyethyl acrylate, 2-hydroxyethyl acrylamide, sodium 2-acrylamido-2-methylpropane sulfonate, N-acryloyl glycinamide, styrene sulfonate, N-tris (hydroxymethyl) methyl acrylamide, bis-acrylamide, poly ethylene glycol diacrylate, and N,N′-bis (acryloyl) cystamine; or

in a fourth embodiment

the patch consists of a hydrogel support layer, a backing layer, sensing components, and therapeutic components;

the hydrogel support layer comprises monomeric units selected from the group consisting of acrylamide, acrylic acid, methyl acrylate, 2-hydroxyethyl acrylate, 2-hydroxyethyl acrylamide, sodium 2-acrylamido-2-methylpropane sulfonate, N-acryloyl glycinamide, styrene sulfonate, N-tris (hydroxymethyl) methyl acrylamide, bis-acrylamide, poly ethylene glycol diacrylate, and N,N′-bis (acryloyl) cystamine;

the backing layer comprises monomeric units selected from the group consisting of acrylamide, acrylic acid, methyl acrylate, 2-hydroxyethyl acrylate, 2-hydroxyethyl acrylamide, sodium 2-acrylamido-2-methylpropane sulfonate, N-acryloyl glycinamide, styrene sulfonate, N-tris (hydroxymethyl) methyl acrylamide, bis-acrylamide, poly ethylene glycol diacrylate, and N,N′-bis (acryloyl) cystamine and/or one or more natural polymers selected form the group consisting of carboxymethylcellulose and alginate;

the sensing components are selected from the group consisting of NaHCO 3 , Na 2 CO 3 , CaCO 3 , gas-containing vesicles and/or synthetic gas-containing microbubbles, iron oxide nanoparticles, and zinc oxide nanoparticles;

the therapeutic components are selected from the group consisting of antimicrobials and compounds that support wound healing; and

the curable monomers of the impregnating fluid are selected from the group consisting of acrylamide, acrylic acid, methyl acrylate, 2-hydroxyethyl acrylate, 2-hydroxyethyl acrylamide, sodium 2-acrylamido-2-methylpropane sulfonate, N-acryloyl glycinamide, styrene sulfonate, N-tris (hydroxymethyl) methyl acrylamide, bis-acrylamide, poly ethylene glycol diacrylate, and N,N′-bis (acryloyl) cystamine; or

in a fifth embodiment

the patch consists of a hydrogel support layer, a backing layer, and therapeutic components;

the hydrogel support layer comprises monomeric units selected from the group consisting of acrylamide, acrylic acid, methyl acrylate, 2-hydroxyethyl acrylate, 2-hydroxyethyl acrylamide, sodium 2-acrylamido-2-methylpropane sulfonate, N-acryloyl glycinamide, styrene sulfonate, N-tris (hydroxymethyl) methyl acrylamide, bis-acrylamide, poly ethylene glycol diacrylate, and N,N′-bis (acryloyl) cystamine;

the backing layer comprises monomeric units selected from the group consisting of acrylamide, acrylic acid, methyl acrylate, 2-hydroxyethyl acrylate, 2-hydroxyethyl acrylamide, sodium 2-acrylamido-2-methylpropane sulfonate, N-acryloyl glycinamide, styrene sulfonate, N-tris (hydroxymethyl) methyl acrylamide, bis-acrylamide, poly ethylene glycol diacrylate, and N,N′-bis (acryloyl) cystamine and/or one or more natural polymers selected form the group consisting of carboxymethylcellulose and alginate;

the therapeutic components are selected from the group consisting of antimicrobials and compounds that support wound healing; and

the curable monomers of the impregnating fluid are selected from the group consisting of acrylamide, acrylic acid, methyl acrylate, 2-hydroxyethyl acrylate, 2-hydroxyethyl acrylamide, sodium 2-acrylamido-2-methylpropane sulfonate, N-acryloyl glycinamide, styrene sulfonate, N-tris (hydroxymethyl) methyl acrylamide, bis-acrylamide, poly ethylene glycol diacrylate, and N,N′-bis (acryloyl) cystamine.

9 . The kit according to claim 1 , wherein the patch

in a first embodiment

consists of a hydrogel support layer and a backing layer; and

the hydrogel support layer comprises one or more groups of the functional components; or

in a second embodiment

consists of a hydrogel support layer and a backing layer;

the hydrogel support layer comprises one group of the functional components; and

the backing layer comprises another group of the functional components; or

in a third embodiment

consists of a hydrogel support layer, a backing layer and an additional layer; and

the additional layer comprises one or more groups of the functional components; or

in a fourth embodiment

consists of a hydrogel support layer and a backing layer;

the hydrogel support layer comprises one or more groups of the functional components; and

the backing layer comprises one or more groups of the functional components.

10 . The kit according to claim 1 ,

wherein the patch comprises a hydrogel support layer and a backing layer, wherein

the non-degradable, synthetic hydrogel is poly (2-acrylamido-2-methyl-1-propanesulfonic acid);

the non-adhesive polymer is poly (N-hydroxyethylacrylamide) or a hydrophilic polyurethane;

the curable monomers are N-acryloyl glycinamide monomers; and

the pharmaceutically acceptable liquid is water.

11 . The kit according to claim 1 , wherein the patch

has a shape selected from cylindrical, rectangular, rhombohedral, trapezoidal and triangular shape; and/or

has dimensions in the range of 0.5-40 mm thickness, 5-15000 mm length and 5-10000 mm width.

12 . A process for manufacturing a kit according to claim 1 , wherein the patch is manufactured by

a) providing a solution comprising monomers that are part of the hydrogel support layer and a curing initiator adapted for curing the monomers,

b) subjecting the solution to a 3D-printing or mold-curing step to thereby obtain a sheet-like material,

c) optionally cutting the thus obtained sheet like material to obtain a patch, and

d) packaging the patch; and

wherein the impregnating fluid is manufactured by

combining the pharmaceutically acceptable liquid, the curable monomers, optionally curing initiators, and optionally additives to obtain a fluid and

packaging the fluid.

13 . The kit of parts according to claim 1 , wherein the surgical method comprises the steps of

a) contacting the patch with the impregnating fluid; and then

b) contacting the sutured site, stapled site or stoma site with the impregnating fluid; and then

c) applying the patch to the sutured site or stapled site or stoma site

d) curing the curable monomers within the impregnating fluid.

14 . An impregnating fluid for use in a surgical method for adhering a patch to a sutured site, a stapled site or a stoma site of a subject in need thereof, wherein

the impregnating fluid comprises a pharmaceutically acceptable liquid selected from water and/or glycerol; and curable monomers;

the curable monomers present in the impregnating fluid are in an uncured, monomeric state when the impregnating fluid is not applied on the patch; and

the patch comprises a hydrogel support layer comprising a non-degradable, synthetic hydrogel.

15 . The impregnating fluid for use according to claim 14 wherein the surgical method comprises a method of artificial stoma seal.

Assignments (1)

Priority Claims (1)

Continuity (1)

References Cited (35)