Cellulose based heart valve prosthesis

• US 8,017,396 B2
• Filed: 02/23/2009
• Issued: 09/13/2011
• Est. Priority Date: 02/22/2008
• Status: Active Grant

• Current Assignee: Medical 21, Inc.
• Original Assignee: Vijay Kumar
• Inventors: Kumar, Vijay
• Primary Examiner(s): KETTER, JAMES S
• Application Number:
  US12/391,249
• Publication Number:
  US 20090222085A1
• Time in Patent Office: 932 Days
• Field of Search: None
• US Class Current: 435/402
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2472 Devices for testing
• CPC Class Codes: A61L 27/20 Polysaccharides
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: C08L 1/26 Cellulose ethers

Abstract

Disclosed are cellulose-based pliable, porous and non-porous prosthesis structures that can be formed to various geometries such as thin films, membranes, hollow tubes, heart valves, including an aortic heart valve. Also disclosed are methods for preparing a cellulose-based porous prosthesis structure.

Claims

1. A method for preparing a cellulose-based porous structure comprising

(a) providing a source of cellulose;

(b) treating the cellulose with paraformaldehyde in anhydrous dimethylsulfoxide (DMSO) under conditions suitable to form methylolcellulose;

(c) mixing the methylolcellulose with a water-soluble porogen;

(d) casting the methylolcellulose and porogen mixture in a form;

then

(e) soaking the methylolcellulose and porogen in a DMSO-miscible organic solvent or mixed solvent system under conditions suitable to form a solid methylolcellulose matrix; and

then

(f) removing the matrix from the form and soaking the solid matrix in water until the solid cellulose-based porous structure is formed.

2. The method of claim 1, wherein the porogen comprises potassium chloride, sodium chloride, lactose, sucrose, galactose, fructose, or a mixture thereof.

3. The method of claim 1, wherein the porogen comprises sodium chloride.

4. The method of claim 1, wherein step (e) comprises soaking the methylolcellulose and porogen in acetone for about 12 hours to about 120 hours.

5. A method for preparing a cellulose-based porous heart valve prosthesis formed as a single unit comprising:

(a) providing a source of cellulose;

(b) treating the cellulose with paraformaldehyde in anhydrous dimethylsulfoxide (DMSO) under conditions suitable to form methylolcellulose;

(c) mixing the methylolcellulose with a water-soluble porogen;

(d) casting the methylolcellulose and porogen mixture in a form;

then

(e) soaking the methylolcellulose matrix in a DMSO-miscible organic solvent or mixed solvent system under conditions suitable to form a solid methylolcellulose matrix; and

then

(f) removing the matrix from the form and soaking the solid matrix in water until the solid cellulose-based porous structure is formed,

wherein the form comprises the shape of a heart valve and stent body.

6. The method of claim 5, wherein the porogen comprises potassium chloride, sodium chloride, lactose, sucrose, galactose, fructose, or a mixture thereof.

7. The method of claim 5, wherein the porogen comprises sodium chloride.

8. The method of claim 5, wherein step (e) comprises soaking in acetone for about 12 hours to about 120 hours.

9. The method of claim 5, further comprising culturing the heart valve prosthesis in cell culture, under conditions that allow for attachment, ingrowth, or propagation of the cell culture on the heart valve prosthesis.

10. The method of claim 9, wherein the cell culture comprises a mammalian cell culture.

11. The method of claim 10, wherein the mammalian cell culture comprises myofibroblast cells or endothelial cells, or both.

12. A method for preparing a cellulose-based heart valve prosthesis formed as a single unit comprising:

(a) providing a source of cellulose;

(b) treating the cellulose with paraformaldehyde in anhydrous dimethylsulfoxide (DMSO) under conditions suitable to form methylolcellulose;

(c) casting the methylolcellulose in an appropriate mold; and

(d) removing the solidified methylolcelllulose matrix from the mold and soaking the solid matrix in water until the solid cellulose-based heart valve is formed,

wherein the mold comprises the shape of a heart valve and stent body.