Implantable stimulation electrode

• US 5,964,794 A
• Filed: 03/20/1997
• Issued: 10/12/1999
• Est. Priority Date: 03/21/1996
• Status: Expired due to Term

• Current Assignee: Biotronik Mess-Und Therapiegeraete GmbH & Company Ingenieurbuero Berlin (Biotronik SE & Company KG), Max-Planck-Gesellschaft Zur Foerderung Der Wissenschaften e.V. (Max-Planck-Gesellschaft zur Frderung der Wissenschaften e)
• Original Assignee: Biotronik Mess-Und Therapiegeraete GmbH & Company Ingenieurbuero Berlin (Biotronik SE & Company KG), Max-Planck-Gesellschaft Zur Foerderung Der Wissenschaften e.V. (Max-Planck-Gesellschaft zur Frderung der Wissenschaften e)
• Inventors: Wagner, Roland, Schmitt, Johannes, Diederich, Anke, Cassier, Thorsten, Froehlch, Ronald, Stelzle, Martin, Bolz, Armin
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US08/821,292
• Time in Patent Office: 936 Days
• Field of Search: 607/119, 607/120, 607/121, 607/116, 600/372, 600/373, 600/374
• US Class Current: 607/121
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence

Abstract

An implantable stimulation electrode for use with an implantable tissue stimulator, in particular a pacemaker, defibrillator, bone or neurostimulator, having a metal substrate body and a coating, applied to the substrate body, for reducing the electrode impedance and/or increasing the tissue compatability, in which a ultrathin, specifically functionalized organic coating forming the entire outer surface of the stimulation electrode is provided, which adheres to the underlying surface as a consequence of irreversible physisorption or covalent chemical bonding.

Claims

1. An implantable stimulation electrode (1;

1'"'"';

10;

E1, E2) for use with an implantable tissue stimulator (100), in particular a pacemaker, defibrillator, bone or neurostimulator, having a metal substrate body (1a, 1a'"'"';

     11) and a coating (1b;

1b'"'"', 1c'"'"';

1b", 1d;

1b"'"'"';

12,

     17), applied to the substrate body, for reducing the electrode impedance and/or increasing the tissue compatability, characterized in that

a thin, specifically functionalized organic coating (1b;

1c'"'"';

1b", 1d;

1b"'"'"';

     17) forming the entire outer surface of the stimulation electrode is provided, which adheres firmly to the underlying surface as a consequence of irreversible physisorption or covalent chemical bonding.

2. The implantable stimulation electrode of claim 1, characterized in that the organic coating (1b;

1c'"'"') has a polymeric network structure formed by substantially lateral polymerization.

3. The implantable stimulation electrode of claim 1, characterized in that the organic coating has a multilayer structure (1b"'"'"') formed by successive adsorption of one anionic and one cationic polyelectrolyte (A, B).

4. The implantable stimulation electrode of claim 3, characterized in that the medicinal active ingredient (1c"'"'"') is substantially embedded between constituent layers of the multilayer structure (1b"'"'"').

5. The implantable stimulation electrode of claim 3, characterized in that the organic coating has between 2 and 50 pairs or triplets of one anionic and one cationic layer former.

6. The implantable stimulation electrode of claim 3, characterized in that the organic coating has alternating layers A of polystyrene sulfonate or polystyrene sulfonate sodium salt, or poly-4-vinylbenzyl (N,N-diethyl-N-methyl) ammonium iodide and B comprising polyvinyl sulfonate or polyvinyl sulfonate potassium salt, or a polyallylamine or polyallylamine hydrochloride.

7. The implantable stimulation electrode of claim 3, characterized in that the organic layer (1b;

1b"'"'"') is terminated on the outer surface by an uncharged polymer (1c;

1d), in particular polyethylene oxide or polyethylene glycol.

8. The implantable stimulation electrode of claim 7, characterized in that the sensor molecules (1c") are embedded in the organic layer substantially underneath the uncharged polymer (1d).

9. The implantable stimulation electrode of claim 1, characterized in that the organic layer (1b") has sensor molecules (1c"), in particular enzyme molecules, in such a way that the stimulation electrode can act as a biosensor electrode.

10. The implantable stimulation electrode of claim 1, characterized in that the organic layer (1b"'"'"') has a medicinal active ingredient (1c"'"'"'), in particular an anti-inflammatory medication, which can be exported from the organic layer by diffusion control or solution control.

11. The implantable stimulation electrode of claim 1, characterized in that the layer thickness of the organic coating is in the range between 1 and 200 nm.

12. The implantable stimulation electrode of claim 1, characterized in that the organic coating has a relative dielectric constant of greater than 100, and in particular greater than 300.

13. The implantable stimulation electrode of claim 1, characterized in that the underlying surface has a surface roughness or surface porosity such that the effective physisorption surface area is larger by at least one order of magnitude than the surface resulting from the geometrical basic shape of the stimulation electrode.

14. The implantable stimulation electrode of claim 1, characterized in that the underlying surface has a fractal surface geometry such that the effective physisorption surface area is greater by two to more than three orders of magnitude than the surface area resulting from the geometric basic shape of the stimulation electrode.

15. The implantable stimulation electrode of claim 1, characterized in that a nonmetallic layer (12), in particular a layer having carbon, an oxide, carbide, nitride or carbonitride, is provided between the metal substrate body (11) and the organic coating (17).

16. The implantable stimulation electrode of claim 1, characterized in that between the metal substrate body (1a'"'"';

11) and the organic layer (1c'"'"';

     17), a layer (1b'"'"';

     12) of iridium, iridium nitride or iridium oxide is provided.

17. The implantable stimulation electrode of claim 1, characterized in that the organic coating has a nonorganic polymeric constituent layer (1b), in particular a polysiloxane layer.

18. The implantable stimulation electrode of claim 1, characterized in that the organic layer has reactive groups, to which at least one compound adapted to a desired physiological function, in particular as a ligand, is specifically bonded.

19. The implantable stimulation electrode of claim 1, characterized in that the outer surface (1c;

1d) of the organic layer effects a passivation with respect to an adsorption of biological macromolecules and cells.

20. The implantable stimulation electrode of claim 1, characterized in that the outer surface of the organic layer has a compound for controlling the wettability, in particular a compound having a molecule with an OH, COOH or NH₂ terminal group for increasing the wettability, or a compound having a CH₃ -- group or a perfluorinated alkyl chain for reducing the wettability.