US 12,239,521 B2
Suture-free coagulation-assisted fixed cardiac patch and preparation method thereof
Yang Zhu, Hangzhou (CN); Yuwen Lu, Hangzhou (CN); Changyou Gao, Hangzhou (CN); Tanchen Ren, Hangzhou (CN); Liyin Shen, Hangzhou (CN); and Xiaoqian Hong, Hangzhou (CN)
Assigned to ZHEJIANG UNIVERSITY, Hangzhou (CN)
Appl. No. 18/695,835
Filed by ZHEJIANG UNIVERSITY, Hangzhou (CN)
PCT Filed Aug. 2, 2022, PCT No. PCT/CN2022/109644
§ 371(c)(1), (2) Date Mar. 27, 2024,
PCT Pub. No. WO2023/045568, PCT Pub. Date Mar. 30, 2023.
Claims priority of application No. 202111133190.0 (CN), filed on Sep. 27, 2021.
Prior Publication US 2024/0335272 A1, Oct. 10, 2024
Int. Cl. A61F 2/00 (2006.01); A61F 2/08 (2006.01)
CPC A61F 2/0063 (2013.01) [A61F 2/0811 (2013.01); A61F 2002/0817 (2013.01); A61F 2002/0847 (2013.01)] 6 Claims
OG exemplary drawing
 
1. A method of fabricating a suture-free coagulation-assisted fixed cardiac patch, comprising the following steps:
(1) printing a first model by 3D printing, wherein the first model comprises a base, with several columns and spherical concave structures formed on a side surface of the base, and the several columns are perpendicular to the side surface;
(2) fixing the first model horizontally in a container with the several columns facing upwards, and pouring a polydimethylsiloxane solution into the container to completely cover the first model, removing bubbles, then heating and curing to obtain a second mold;
wherein the second mold has column hole structures and spherical protrusion structures, the column hole structures being formed by the several columns on the first model, and the spherical protrusion structures being formed by the spherical concave structures on the first model;
(3) first, inserting a barbed microneedle dipped in a high-temperature paraffin into a column hole of the second mold, wherein a barb direction is opposite to an insertion direction, and the barbed microneedle corresponds to the column hole one by one; then casting a first solution on the second mold arranged with a microneedle array and located on a side pointed by the barb direction; finally, after a solvent in the first solution is completely volatilized, removing the second mold, a paraffin, and excess barbed microneedles; wherein a solid structure is formed during a volatilization;
wherein the first solution is obtained by dissolving a polymer used to form a polymeric procoagulant base in a hexafluoroisopropanol solution or a dioxane solution;
wherein the suture-free coagulation-assisted fixed cardiac patch comprises the polymeric procoagulant base and the barbed microneedle fixed on the polymeric procoagulant base, and a side surface of the polymeric procoagulant base with the barbed microneedle has a microporous structure not penetrating a solid base of the polymer;
wherein the barbed microneedle is a microneedle with barbs and biocompatibility, an included angle α between the microneedle and a plane where the polymeric procoagulant base located is 60-90°, and microneedles are evenly distributed on the polymeric procoagulant base with a density of 5-50 threads/cm2; wherein the barbs are located on a curved surface of the microneedle and inclined toward the polymeric procoagulant base;
wherein a material of the polymeric procoagulant base is more than one selected from polyurethane, silicone rubber, polyurethane-polyurea, and polylactic acid-polycaprolactone.