Cardiovascular implants of enhanced biocompatibility

• US 5,683,442 A
• Filed: 11/08/1996
• Issued: 11/04/1997
• Est. Priority Date: 12/21/1989
• Status: Expired due to Fees

• Current Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Original Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Inventors: Davidson, James A.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US08/745,221
• Time in Patent Office: 361 Days
• Field of Search: 607/116, 607/119, 607/120, 607/122, 607/639, 128/642
• US Class Current: 607/116
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2406 without fixed axis
• CPC Class Codes: A61F 2/2421 with non-pivoting rigid closure members
• CPC Class Codes: A61F 2/2424 Ball valves
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 27/06 Titanium or titanium alloys
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 33/022 Metal or alloys
• CPC Class Codes: A61M 60/196 replacing the entire heart, e.g. total artificial hearts [TAH]
• CPC Class Codes: A61M 60/878 Electrical connections within the patient's body
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: C22C 14/00 Alloys based on titanium
• CPC Class Codes: C22C 30/00 Alloys containing less than 50% by weight of each constituent

Abstract

Medical leads fabricated from low-modulus Ti-Nb-Zr alloys to provide enhanced biocompatibility and hemocompatibility. The medical leads may be surface hardened by oxygen or nitrogen diffusion or by coating with a tightly adherent, hard, wear-resistant, hemocompatible ceramic coating. It is contemplated that the Ti-Nb-Zr alloy can be substituted as a fabrication material for any portion of a medical lead that either comes into contact with blood thereby demanding high levels of hemocompatibility, or that is subject to microfretting, corrosion, or other wear and so that a low modulus metal with a corrosion-resistant, hardened surface would be desirable.

Claims

1. A biocompatible lead for conducting electrical signals to or from an organ in a living body, the lead having enhanced hemocompatibility, comprising:

an elongate flexible body having distal and proximal ends and an electrically conductive core for conducting electrical signals, the core at least partially fabricated from a biocompatible and hemocompatible metal alloy, the alloy comprising;

(i) titanium; and

(ii) niobium selected from a non-continuous range of about 10 to about 20 wt. % niobium and from about 35 to about 50 wt % niobium.

2. The lead of claim 1, further having an electrically insulative layer surrounding the electrically conductive core.

3. The lead of claim 2, wherein the electrically insulative layer comprises material selected from the group of electrically insulative materials consisting of metal oxides, metal nitrides and metal carbides.

4. The lead of claim 1, wherein at least a portion of the titanium is β

-phase titanium and said alloy further comprises an amount of zirconium sufficient to retard the transformation of β

-phase titanium.

5. The lead of claim 4, wherein the metal alloy comprises about 13 wt. % niobium, about 13 wt. % zirconium and the remainder titanium.

6. The lead of claim 4, wherein the amount of zirconium sufficient to retard the transformation of β

-phase titanium is less than about 20 wt. % zirconium.

7. The lead of claim 4, wherein the metal alloy comprises from about 0.5 to about 20 wt. % zirconium.

8. The lead of claim 4, further having an electrically insulative layer surrounding the electrically conductive core.

9. The lead of claim 8, wherein the electrically insulative layer comprises material selected from the group of electrically insulative materials consisting of metal oxides, metal nitrides and metal carbides.

10. The lead of claim 1 or claim 4, wherein the core is a single non-coiled wire of said alloy.

11. The lead of claim 1 or claim 4, wherein the core is multiple wires of said alloy.

12. The lead of claim 1, or claim 2 or claim 4, wherein surfaces of the lead that come into contact with body tissue or fluid are at least partially coated with a composition selected from the group consisting of anticoagulants, antimicrobial agents, antibiotics, and medicaments.

13. The lead of claim 1, or claim 2 or claim 4, further comprising a low friction wear-resistant boron-containing outer surface layer on at least a portion of the lead.

14. The lead of claim 1, or claim 2 or claim 4, further comprising a low friction wear-resistant silver-containing outer surface layer on at least a portion of the lead.

15. A biocompatible lead for conducting electrical signals to or from an organ in a living body, the lead having enhanced hemocompatibility, comprising:

an elongate flexible body having distal and proximal ends and an electrically conductive core for conducting electrical signals, the core at least partially fabricated from a biocompatible and hemocompatible metal alloy, the alloy comprising;

(i) titanium; and

(ii) niobium and tantalum, with a combined wt. % of niobium and tantalum selected from a non-continuous range of about 10 to about 20 wt. % and from about 35 to about 50 wt. %.

16. The lead of claim 15, further having an electrically insulative layer surrounding the electrically conductive core.

17. The lead of claim 16, wherein the electrically insulative layer comprises material selected from the group of electrically insulative materials consisting of metal oxides, metal nitrides and metal carbides.

18. The lead of claim 15, wherein at least a portion of the titanium is β

-phase titanium and said alloy further comprises an amount of zirconium sufficient to retard the transformation of β

-phase titanium.

19. The lead of claim 18, wherein the metal alloy comprises from about 0.5 to about 20 wt. % zirconium.

20. The lead of claim 18, further comprising an electrically insulative layer surrounding the electrically conductive core.

21. The lead of claim 20, wherein the electrically insulative layer comprises material selected from the group of electrically insulative materials consisting of metal oxides, metal nitrides and metal carbides.

22. The lead of claim 15 or claim 20, wherein the core is a single non-coiled wire of said alloy.

23. The lead of claim 15 or claim 20, wherein the core is multiple wires of said alloy.

24. The lead of claim 15, or claim 16 or claim 18, further having lead surfaces that come into contact with body tissue or fluid, said surfaces at least partially coated with a composition selected from the group consisting of anticoagulants, antimicrobial agents, antibiotics, and medicaments.

25. The lead of claim 15, or claim 16 or claim 18, further comprising a low friction wear-resistant boron-containing outer surface layer on at least a portion of the lead.

26. The lead of claim 15, or claim 16 or claim 18, further comprising a low friction wear-resistant silver-containing outer surface layer on at least a portion of the lead.