High efficiency tissue stimulating and signal sensing electrode

• US 5,318,572 A
• Filed: 06/02/1992
• Issued: 06/07/1994
• Est. Priority Date: 06/02/1992
• Status: Expired due to Term

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Siemens Pacesetter, Inc. (Abbott Laboratories)
• Inventors: Helland, John R., Muff, Diane M.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Getzow, Scott M.
• Application Number:
  US07/892,463
• Time in Patent Office: 735 Days
• Field of Search: 128/784, 128/785, 128/786, 128/642
• US Class Current: 607/121
• CPC Class Codes: A61N 1/0565 Electrode heads

Abstract

A pacing lead having a porous electrode of platinum-iridium with recessed areas or grooves formed into the surface. The grooves allow for acute electrode stabilization as a result of clot formation and endocardial tissue capture during insertion and immediate immobilization upon implant. At least one layer of a porous coating of 20-200 micron diameter spherical particles are deposited on the surface of the base electrode to obtain a porous macrostructure for promoting chronic tissue ingrowth. Additionally, a microstructure surface coating is applied to increase the active surface area and enhance electrical efficiency by lowering electrochemical polarization and increasing electrical capacitance.

Claims

1. An implantable pacing lead for use with a cardiac pacemaker comprising:

an electrical conductor having a proximal end and a distal end;

an insulative sheath covering said conductor;

an electrical connector coupled to said proximal end of said conductor; and

an electrode coupled to said distal end of said conductor, said electrode having an electrode tip geometry macrostructure defining at least two plateau sections separated by at least one recessed groove section, said plateau sections and said recessed groove section including surfaces having affixed thereto at least one layer of generally spheroidal conductive particles, said spheroidal particles coated with a layer of nonmetallic material selected from the group consisting of titanium nitride, iridium oxide, titanium oxide, platinum oxide, palladium oxide and activated forms of carbon, said layer of material having a surface morphology which results in a porosity of greater than about fifty percent.

2. The pacing lead of claim 1, wherein said generally spherical conductive particles have diameters ranging from about 10-200 microns, said particles configured in at least one layer on said electrode surfaces to provide interstitial porosity for tissue ingrowth.

3. The pacing lead of claim 2, wherein said electrode includes two recessed areas configured to intersect one another defining a cross shape.

4. The pacing lead of claim 2, wherein said electrode includes at least two sets of multiple, parallel aligned, recessed areas, configured to have said multiple aligned recessed areas of said sets intersecting one another.

5. The pacing lead of claim 1, wherein said spheroidal conductive particles are formed of a material selected from the group consisting of platinum, titanium, palladium, platinum-iridium, and carbon, said particles configured in at least one layer on said electrode surfaces to provide interstitial porosity for tissue ingrowth.

6. The pacing lead of claim 5, wherein a majority of said interstitial porosity areas between said particles have a plurality of passage diameters greater than six microns to allow passage of blood cells

7. The pacing lead of claim 5, wherein said electrode includes at least two parallel aligned recessed areas defining at least three generally aligned plateau areas, and wherein the corners of said plateau areas each define an angle of at least sixty degrees.

8. The pacing lead of claim 5, wherein said at least one recessed groove section has a profile defined by a depth of between 0.1 and 1.0 millimeters, a width of between about 0.2 and 1.5 millimeters, and each edge of said groove is radiused with a radius of curvature of between about 0.001 and 0.5 millimeters.

9. An implantable pacing lead for use with a cardiac pacemaker comprising:

an electrical conductor having a proximal end and a distal end;

an insulative sheath covering said conductor;

an electrical connector affixed to said proximal end of said conductor; and

an electrode assembly affixed to said distal end of said conductor, said electrode assembly including a porous electrode distal tip having a polarization index PI which is less than 100 mV/mm².

10. The implantable pacing lead of claim 9, wherein said electrode distal tip further comprises:

at least one recessed area for capturing blood cells during insertion of said electrode assembly into a human recipient, and for promoting clot formation and endocardial tissue capture thereof to aid fixation of said electrode distal tip to endocardial tissue;

means for providing interstitial porosity and for increasing surface area of said electrode distal tip; and

coating means for enhancing the electrical characteristics of said electrode distal tip, for increasing the electrical capacitance, and for reducing electrochemical polarization at the electrode-endocardial tissue interface during pacing use.

11. The implantable pacing lead of claim 10, wherein said

at least one recessed area traverses said electrode distal tip, said at least one recessed area having a generally U-shaped profile defined by generally vertical walls and a base, said base having a transverse profile shape selected from the group consisting of semi-hemispherical, flat and concave.

12. The implantable pacing lead of claim 11, wherein said means for providing interstitial porosity and increasing surface area comprises:

a plurality of generally smooth surfaced spheroidal particles affixed to the surfaces of said electrode distal tip including said walls and base of said at least one recessed area.

13. The implantable pacing lead of claim 12, wherein said coating means comprises:

a surface coating applied to the surfaces of said distal tip electrode and said spheroidal particles thereon, said surface coating comprising a microscopically thin layer of a nonmetallic material selected from the group consisting of titanium nitride, titanium oxide, carbon, iridium oxide, and platinum oxide, said surface coating applied by a process selected from the group consisting of sintering, vapor deposition, electroplating and sputtering.

14. The implantable lead of claim 13, wherein said electrode distal tip further comprises:

at least two plateau areas separated by said at least one recessed area, said plateau areas having a generally semi-hemispherical profile.

15. The implantable pacing lead of claim 13, wherein said electrode distal tip includes two recessed areas configured to intersect one another, defining a cross-like shape.

16. The implantable pacing lead of claim 13, wherein said electrode distal tip includes at least two parallel aligned recessed areas defining at least three generally aligned plateau areas.

17. The implantable pacing lead of claim 13, wherein said electrode distal tip includes at least two sets of multiple, parallel aligned recessed areas, configured to have said multiple aligned recessed areas of said sets intersecting one another.

18. The implantable pacing lead of claim 13, wherein said at least one recessed area has a depth of between 0.1 and 1.0 millimeters and a width of between about 0.2 and 1.5 millimeters.

19. The implantable pacing lead of claim 13, wherein said plurality of generally smooth surfaced spheroidal particles have diameters distributed in the range of between about 10-200 microns, said particles formed of a material selected from the group consisting of platinum, platinum-iridium, titanium, palladium and carbon.

20. The implantable pacing lead of claim 13, wherein said electrode assembly has an electrode distal tip having a polarization index PI which is less than 50 mV/mm².

21. A method of forming an implantable pacing lead for use with a cardiac pacemaker comprising:

providing an electrical conductor having a proximal end and a distal end;

covering said conductor in an insulative sheath;

coupling an electrical connector to said proximal end of said conductor;

forming an electrode having an electrode tip geometry macrostructure defining at least two plateau sections separated by at least one recessed groove section;

affixing to said plateau sections and said recessed groove section a plurality of generally spherical conductive particles;

coating said particles with a layer of nonmetallic material selected from the group consisting of titanium nitride, palladium, platinum oxide, iridium oxide, and activated carbon; and

coupling said electrode to said distal end of said conductor.

22. The method of forming an implantable pacing lead of claim 21, wherein said coating of said particles is performed by a process selected from the group consisting of vapor deposition sintering, electroplating and electrode sputtering to a thickness of between 20-30 microns.

23. The method of forming the implantable pacing lead of claim 21, wherein said generally spherical conductive particles are affixed to said electrode distal tip by a process selected from the group consisting of powder sintering, laser fusion, welding, injection molding, and casting.

24. The method of claim 23, wherein said generally spheroidal conductive particles are affixed by one of said processes in a series of successive steps in which a portion of the particles are affixed by said process in each of said successive steps.