System and Method for Conditioning Implantable Medical Devices

• US 20110200738A1
• Filed: 08/09/2010
• Published: 08/18/2011
• Est. Priority Date: 03/28/2007
• Status: Active Grant

• Current Assignee: Medtronic ATS Medical, Inc. (Medtronic Plc)
• Original Assignee: Medtronic ATS Medical, Inc. (Medtronic Plc)
• Inventors: Pederson, Brian, Peterson, Larry, Hanson, Brian
• Granted Patent: US 8,653,632 B2
• Time in Patent Office: Days
• US Class Current: 427/2.1
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: C25D 17/06 Suspending or supporting devices for articles to be coated

Abstract

A method for passivating a biomaterial surface includes exposing the biomaterial surface to therapeutic electrical energy in the presence of blood or plasma. The biomaterial surface may be removably secured within a chamber of a treatment system, which communicates the therapeutic electrical energy to the biomaterial surface while interfacing the biomaterial surface with blood or plasma.

Claims

1. A treatment system for passivating a biomaterial surface, said treatment system comprising:

a chamber housing defining a chamber within said chamber housing, and having a treatment fluid inlet and a treatment fluid outlet in fluid communication with said chamber; and

a securing mechanism for removably securing said biomaterial surface in said chamber, said securing mechanism further providing an electrical conduction path from said housing to said chamber, wherein said electrical conduction path has an electrical resistance of less than about 1.5 ohms.

2. A treatment system as in claim 1 wherein said securing mechanism includes an engaging member that adjustably applies a securing compression force to said biomaterial surface.

3. A treatment system as in claim 2, including a pair of said engaging members arranged to adjustably apply substantially opposed compression forces to said biomaterial surface.

4. A treatment system as in claim 1 wherein said biomaterial surface is at least a portion of a prosthetic heart valve.

5. A treatment system as in claim 1 wherein said biomaterial surface has an electrical resistivity of less than about 1.5 ohms.

6. A system for passivating a biomaterial surface, said system comprising:

a. a treatment chamber housing defining a chamber therewithin, and having a treatment fluid inlet and a treatment fluid outlet in fluid communication with said chamber;

b. a treatment fluid source;

c. a first treatment fluid conduit for conveying treatment fluid from said source to said treatment chamber;

d. a first electrode electrically coupled to said biomaterial surface in said chamber, said first electrode providing an electrical conduction path from said housing to said chamber; and

e. an electrical energy source for generating therapeutic electrical current, said electrical energy source being capable of delivering said therapeutic electrical current to said first electrode.

7. A system as in claim 6, including a second electrode exposed to the treatment fluid as a return electrode electrically coupled to said electrical energy source.

8. A system as in claim 6 wherein said first electrode adjustably exerts a physical force for securing said biomaterial surface within a treatment fluid flow path in said chamber.

9. A system as in claim 8 wherein said first electrode is threadably engaged through said treatment chamber housing.

10. A system as in claim 8, including a conductor clip electrically connecting said first electrode to said biomaterial surface.

11. A system as in claim 8, including a pair of first electrodes arranged to adjustably exert substantially opposed compression forces to said biomaterial surface.

12. A system as in claim 6 wherein said biomaterial surface is at least a portion of said medical article.

13. A system as in claim 6 wherein the treatment fluid is blood or blood plasma.

14. A system as in claim 6 wherein said treatment chamber housing includes first ands second portions fluidly sealingly engagable with one another to define said chamber, said first and second portions being disengagable to permit removal of said biomaterial surface from said chamber.

15. A system as in claim 6, including a second treatment fluid conduit for conveying treatment fluid from said treatment chamber to a cardiopulmonary bypass system.

16. A package for an implantable medical article, said package comprising:

a housing defining a chamber in which said implantable medical article may be disposed, said housing including first and second portions fluidly sealingly engagable with one another to define said chamber, said first and second portions being disengagable to permit removal of said implantable medical article from said chamber; and

a securing mechanism for removably securing said implantable medical article in said chamber through an adjustable physical force exerted by said securing mechanism to said article, said securing mechanism further providing an electrical conduction path from said housing to said chamber.

17. A package as in claim 16, including inlet and outlet fluid ports in fluid communication with said chamber.

18. A package as in claim 16, including a seat member disposed in said chamber, said seat member being engagable with said implantable medical article to orient and position said article within said chamber.

19. A package as in claim 16 wherein said securing mechanism has an electrical resistivity of less than about 0.5 ohms.

20. A method for passivating a biomaterial surface, said method comprising:

a. providing a passivation system comprising;

i. a treatment chamber housing defining a chamber therewithin, and having a treatment fluid inlet and a treatment fluid outlet in fluid communication with said chamber;

ii. a treatment fluid source;

iii. a first treatment fluid conduit for conveying treatment fluid from said source to said treatment chamber;

iv. a first electrode electrically coupled to said biomaterial surface in said chamber, said first electrode providing an electrical conduction path from said housing to said chamber;

v. an electrical energy source for generating therapeutic electrical current;

b. conveying treatment fluid through said chamber in contact with said biomaterial surface; and

c. delivering said therapeutic electrical current to said first electrode, thereby exposing said biomaterial surface to said therapeutic electrical current in the presence of the treatment fluid.

21. A method as in claim 20 wherein the treatment fluid is blood or blood plasma.

22. A method for implanting a medical article, said method comprising:

a. providing a housing defining a chamber, and including first and second portions fluidly sealingly engagable with one another;

b. securing said medical article within said chamber with a securing mechanism having an engaging member that is adapted to adjustably apply a physical force to said medical article and to provide an electrical conduction path from said housing to said chamber;

c. delivering therapeutic electrical current to said medical article through said engaging member;

d. delivering treatment fluid to said chamber while said therapeutic electrical current is supplied to said medical article;

e. disengaging said first and second portions of said housing from one another;

f. removing said medical article from said chamber; and

g. implanting said medical article into a patient.

23. A method as in claim 22, including moving said medical article directly from said chamber to the patient.

24. A method as in claim 22, wherein said medical article includes an article holder.

25. A method as in claim 22 wherein said securing mechanism includes two or more engaging members which together exert compression forces upon said medical article.

26. A method for qualifying a treatment system for use in passivating a biomaterial surface, wherein said treatment system includes a housing defining a chamber therewithin, and a first electrode providing an electrical conduction path from said housing to said chamber, said first electrode comprising at least two conductor elements, said method comprising:

a. securing said biomaterial surface in said chamber in electrical communication with said conductor elements in an arrangement in which said biomaterial surface is electrically interposed between said conductor elements;

b. measuring electrical resistance across said conductor elements to obtain a first measured electrical resistance; and

c. comparing the first measured electrical resistance to a predetermined first threshold electrical resistance.

27. A method as in claim 26, including measuring electrical resistance between one of said conductor elements and said biomaterial surface to obtain a second measured electrical resistance, and comparing said second measured electrical resistance to a predetermined second threshold electrical resistance.