THERMOCHROMIC POLYVINYL ALCOHOL BASED HYDROGEL ARTERY

• US 20140257275A1
• Filed: 03/06/2013
• Published: 09/11/2014
• Est. Priority Date: 03/06/2013
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Cho, Euhnee, Willard, Steven N., Kozov, Valentine, Varadharajan, Sukanya
• Granted Patent: US 9,179,997 B2
• Time in Patent Office: Days
• US Class Current: 606/41
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 2010/0006 involving a colour change
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 5/015 By temperature mapping of body part
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• 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 29/04 Polyvinyl alcohol; Partially hydrolysed homopolymers or copolymers of esters of unsaturated alcohols with saturated carboxylic acids

Abstract

A method of creating a thermochromic artificial blood vessel includes physically cross-linking a polyvinyl alcohol solution in a mold shaped to mimic a blood vessel to create an artificial blood vessel. The artificial tissue is then chemically cross-linked with a solution including a chemical cross-linking reagent. A coagulation solution is then applied to the artificial blood vessel to both inhibit the chemical cross-linking and promote physical cross-linking of the artificial blood vessel. The artificial blood vessel can be used to test an ablation catheter. The vessel, when heated by the ablation catheter, changes color and/or transparency at locations where the temperature of artificial blood vessel increases.

Claims

1. A method of creating a thermochromic artificial blood vessel comprising:

physically cross-linking a polyvinyl alcohol solution at a temperature below 0°

C. in a mold shaped to form an artificial blood vessel, the polyvinyl alcohol solution including polyvinyl alcohol and water;

chemically cross-linking the artificial blood vessel with a chemical cross-linking solution, the chemical cross-linking solution including a chemical cross-linking reagent and water; and

applying a coagulation solution to the artificial blood vessel to both inhibit the chemical cross-linking and promote physical cross-linking of the artificial blood vessel, the coagulation solution including water, a base, and a cross-linking promoter.

2. The method of claim 1, wherein the polyvinyl alcohol solution further comprises dimethyl sulfoxide, the chemical cross-linking reagent is glutaraldehyde, the base is potassium hydroxide, and the cross-linking promoter is sodium sulfate.

3. A method of testing an ablation catheter comprising the steps of:

obtaining a thermochromic artificial blood vessel according to the method of claim 1;

providing an ablation catheter including one or more ablation elements configured to contact an inner wall of the artificial blood vessel;

inserting the ablation elements into a lumen of the artificial blood vessel;

contacting at least one of the ablation elements with the inner wall of the artificial blood vessel;

emitting energy from at least one of the ablation elements; and

determining the extent of a change in at least one of a color or transparency of the artificial blood vessel.

4. A method of creating a thermochromic artificial tissue comprising the steps of:

physically cross-linking a polyvinyl alcohol solution in a mold shaped to mimic an animal tissue to create the artificial tissue;

chemically cross-linking the artificial tissue; and

applying a coagulation solution to the artificial tissue to both inhibit chemical cross-linking and promote physical cross-linking of the artificial blood vessel.

5. The method of claim 4, wherein the artificial tissue comprises an artificial blood vessel.

6. The method of claim 5, wherein the polyvinyl alcohol solution includes polyvinyl alcohol and water.

7. The method of claim 6, wherein the polyvinyl alcohol has a molecular weight of between about 146,000 to 186,000 Daltons.

8. The method of claim 7, wherein the polyvinyl alcohol is at least about 99% hydrolyzed.

9. The method of claim 6, wherein the polyvinyl alcohol solution further comprises dimethyl sulfoxide.

10. The method of claim 6, further comprising the steps of freezing the polyvinyl alcohol solution and thawing the frozen polyvinyl alcohol solution.

11. The method of claim 10, wherein the steps of freezing the polyvinyl alcohol solution and thawing the frozen polyvinyl alcohol solution are each repeated in succession at least once.

12. The method of claim 5, wherein the step of chemically cross-linking the artificial blood vessel further comprises the step of applying a chemical cross-linking solution to the artificial blood vessel, the chemical cross-linking solution including a chemical cross-linking reagent and water.

13. The method of claim 12, wherein the chemical cross-linking reagent is glutaraldehyde.

14. The method of claim 13, wherein the chemical cross-linking solution further includes a pH modifying agent.

15. The method of claim 14, wherein the pH modifying agent is sulfuric acid.

16. The method of claim 5, wherein the coagulation solution includes water, a base, and a cross-linking promoter.

17. The method of claim 16, wherein the base is potassium hydroxide.

18. The method of claim 17, wherein the cross-linking promoter is sodium sulfate.

19. A thermochromic artificial blood vessel comprising:

a body of synthetic material in the form of a blood vessel, said body comprising thermochromic material.

20. The thermochromic artificial blood vessel of claim 19, wherein the synthetic material comprises a polyvinyl alcohol material.

21. The thermochromic artificial blood vessel of claim 20, wherein the polyvinyl alcohol material is cross-linked.

22. A method of testing an ablation catheter comprising:

obtaining a thermochromic artificial blood vessel;

inserting an ablation catheter having at least one ablation element into a lumen of the artificial blood vessel;

contacting a location on an inner wall of the lumen with the at least one ablation element; and

heating the location with the at least one ablation element.