Formed sheet product and hemostatic material

Patent metadata

Field	Value
Publication number	US-10485894-B2
Application number	US-201314399117-A
Country	US
Kind code	B2
Filing date	May 13, 2013
Priority date	May 14, 2012
Publication date	Nov 26, 2019
Grant date	Nov 26, 2019

Abstract

A formed sheet product of a polymer composition comprising at least one protein selected from the group consisting of fibrinogen and thrombin and at least one polymer selected from the group consisting of an aliphatic polyester and a water-soluble polymer, and a laminated formed sheet product comprising a first polymer composition layer composed of fibrinogen and a water-soluble polymer and a second polymer composition layer composed of thrombin and an aliphatic polyester are provided. These formed products are applied onto a wound site and function as a hemostatic material.

First claim

The invention claimed is:

1. A laminated formed sheet product comprising a first polymer composition layer comprising fibrinogen and a water-soluble polymer and a second polymer composition layer comprising thrombin and an aliphatic polyester, wherein at least part of said fibrinogen is incorporated into said water-soluble polymer and at least part of said thrombin is incorporated into said aliphatic polyester.

2. The laminated formed sheet product according to claim 1 , wherein the water-soluble polymer is at least one selected from the group consisting of a cellulose derivative, a polymer having an N-vinyl cyclic lactam unit, polyethylene oxide, polyvinyl alcohol, hyaluronic acid, dextran, pullulan, starch, and a mixture thereof.

3. The laminated formed sheet product according to claim 1 , wherein the water-soluble polymer is at least one selected from the group consisting of hydroxypropyl cellulose, methyl cellulose, hydroxyethyl cellulose, hydroxypropylmethyl cellulose, carboxymethyl cellulose sodium, and a mixture thereof.

4. The laminated formed sheet product according to claim 1 , wherein the aliphatic polyester is at least one selected from the group consisting of polyglycolic acid, polylactic acid, polycaprolactone, a copolymer thereof, and a mixture thereof.

5. The laminated formed sheet product according to claim 1 , wherein the first polymer composition layer contains at least one additive selected from the group consisting of blood coagulation factor XIII, albumin, isoleucine, glycine, arginine, glutamic acid, phenylalanine, histidine, a surfactant, sodium chloride, sugar alcohol, trehalose, sodium citrate, aprotinin, and calcium chloride.

6. The laminated formed sheet product according to claim 1 , wherein the first polymer composition layer is composed of a formed film product or a formed fiber product.

7. The laminated formed sheet product according to claim 1 , wherein the first polymer composition layer is composed of a formed film product.

8. The laminated formed sheet product according claim 7 , wherein the formed film product has content of the water-soluble polymer of 0.1 to 50 mass %.

9. The laminated formed sheet product according to claim 7 , wherein the formed film product contains fibrinogen at 0.05 to 10 mg/cm2.

10. The laminated formed sheet product according to claim 7 , wherein formed film product is manufactured from a suspension composed of a water soluble polymer solution and fibrinogen powder.

11. The laminated formed sheet product according to claim 1 , wherein the second polymer composition layer is composed of a formed fiber product.

12. The laminated formed sheet product according to claims 1 to 11 , wherein the fibrinogen or a mixture of the fibrinogen and an additive(s) and/or thrombin or a mixture of the thrombin and an additive(s) is/are dispersed as protein particles in at least one polymer selected from the group consisting of an aliphatic polyester and a water-soluble polymer.

13. The laminated formed sheet product according to claim 12 , wherein the hemostatic protein is thrombin.

14. The laminated formed sheet product according to claim 13 , wherein a ratio by weight of the protein particles to the aliphatic polyester is 10:10 to 10:100.

15. The laminated formed sheet product according to claim 12 , wherein the formed fiber product is manufactured from a suspension composed of an aliphatic polyester solution and thrombin powder.

16. A hemostatic material comprising the laminated formed sheet product according to claim 1 .

17. A tissue adhesive material or tissue closure material comprising the laminated formed sheet product according to any of claim 1 .

18. A method for treatment a wound site, comprising a step of applying the hemostatic material according to claim 16 onto the wound site.

19. A method for treatment a wound site, comprising a step of applying the tissue closure material according to claim 17 onto the wound site.

Assignees

• Teijin Ltd
• Teijin Pharma Ltd
• The Chemo Sero Therapeutic Res Institute
• Km Biologics Co Ltd

Inventors

• Kageyama Yukako
• Fujinaga Kentaro
• Yamaguchi Ayuko
• Akiyama Yusuke
• Oono Akitoshi
• Honda Susumu
• Satake Makoto
• Kaneko Hiroaki
• Imamura Takayuki
• Kawamura Ryoichi
• Hirashima Masaki

Classifications

• A61P41/00

  Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution · CPC title

• A61P7/04

  Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents · CPC title

• A61L26/009

  Materials resorbable by the body · CPC title

• A61L26/0085

  Porous materials, e.g. foams or sponges · CPC title

• A61K38/4833

  Thrombin (3.4.21.5) · CPC title