Pacing lead with porous electrode for stable low threshold high impedance pacing

• US 5,991,667 A
• Filed: 11/10/1997
• Issued: 11/23/1999
• Est. Priority Date: 11/10/1997
• Status: Expired due to Term

• Current Assignee: Vitatron Medical BV (Medtronic Plc)
• Original Assignee: Vitatron Medical BV (Medtronic Plc)
• Inventors: Feith, Frederick
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US08/966,916
• Time in Patent Office: 743 Days
• Field of Search: 607/120-128, 600/373-375, 600/381
• US Class Current: 607/120
• CPC Class Codes: A61N 1/0568 with drug delivery
• CPC Class Codes: Y10S 977/708 with distinct switching device
• CPC Class Codes: Y10S 977/768 Helical wire

Abstract

A pacing lead, and system for pacing, where the lead has an improved distal tip designed to provide reliable chronic fixation of the electrode-heart interface, while also providing low pacing threshold. The distal end of the lead has a standard surface, of roughly hemispherical shape, made of a porous material. In one embodiment, the tip surface is suitably about 6-8 square mm, and there is a smaller surface of about 1.5-2.0 square mm which is electrically isolated from the remainder of the porous surface; the smaller surface acts as a high impedance electrode, providing low threshold, while the larger porous surface provides the stable fixation. A steroid source is housed in the distal end of the lead, so as to provide an eluted steroid to the electrode surface area, as well as at least part of the remaining porous surface, whereby the overall porous surface and the eluted steroid minimizes the resulting capsule of non-excitable tissue around the electrode, providing for a stable reduced threshold. In another embodiment, a switching network is provided, suitably in the pacemaker, for selectively connecting one or both portions as the active electrode for pacing and for sensing.

Claims

1. A pacing lead for delivering pacing pulses to a patient'"'"'s heart from a pacemaker and for sensing cardiac signals from said patient'"'"'s heart and delivering said sensed cardiac signals to said pacemaker, comprising:

a lead body with a proximal end and a distal end, said lead body having conductive means for conducting said pacing pulses from said proximal end to said distal end and for conducting said sensed cardiac signals from said distal end to said proximal end;

a tip said distal end with an overall tip surface, said tip surface having first and second portions made of a porous material for engaging the inner heart wall and insulating means for electrically isolating said first and second portions, said first portion being axially located and constructed from a conductive material and said second portion being annularly positioned around said first portion; and

connecting means for connecting at least one of said first and second portions to said conductive means, said connecting means has means for connecting only said first portion to said conductive means, whereby said first portion is connected as an electrode and said second portions is not active as an electrode.

2. The lead as described in claim 1, wherein said overall tip surface is a substantially hemispherical surface having an area of at least about 6-8 square mm.

3. The lead as described in claim 2, wherein said first portion has a surface area no greater than about 2.0 square mm.

4. The lead as described in claim 2, wherein said second portion has a surface no greater than about 2.0 square mm, and said connecting means has means for connecting only said second portion to said conductive means, whereby said second portion is connected as an electrode and said first portion is not active as an electrode.

5. The lead as described in claim 1, wherein said tip is made of a rigid material.

6. The lead as described in claim 1, wherein said connecting means comprises means for connecting said first and second portions commonly to said conductive means, whereby said first and second portions function together as a common pacing and sensing electrode.

7. The lead as described in claim 1, wherein said conductive means comprises first and second conductive paths, and said connecting means comprises means for connecting said first portion to said first path and second portion to said second path, whereby said portions can be connected as respective pacing and sensing electrodes.

8. The lead as described in claim 7, wherein said connecting means further comprises selection means for selecting which of said first and second portions are connected to said conductive means.

9. The lead as described in claim 1, wherein said insulating means has a surface area which is less than 10% of said hemispherical surface area.

10. The lead as described in claim 1, wherein said first and second portion have a combined surface area of 6-8 square mm, and said first portion has a surface of no greater than 2 square mm.

11. A cardiac pacing system, comprising:

a pacemaker having pulse means for generating pacing pulses, and sense means for receiving sensed cardiac signals;

a lead for delivering said pacing pulses to the patient'"'"'s heart and for sensing cardiac signals and delivering said sensed cardiac signals to the pacemaker, said lead having a proximal end for connection to said pacemaker, a distal end, conductive means between said proximal and distal ends for conducting said pulses and said sensed cardiac signals, and a tip electrode at said distal end, said tip electrode having a surface for interfacing with the patient'"'"'s heart wall, said tip surface having first and second surface areas, insulating means for electrically isolating said first and second surfaces, and connecting means for connecting said first surface to said conductive means; and

said pacemaker further having selective connecting means for selectively connecting said pacemaker to said conductive means so that said first surface delivers said pacing pulses, and so that said sense means receives said sensed cardiac signals from said first surface.

12. The system as described in claim 11, wherein said lead comprises first and second conductors extending from the tip proximal end to the tip distal end, and said selective connecting means comprises switch means for connecting selected ones of said first and second conductors to said pulse means and to said sense means.

13. The pacing system as described in claim 11, wherein said tip surface comprises a porous material.

14. A pacing lead for delivering pacing pulses from a cardiac pacemaker to a patient'"'"'s heart, and for sensing patient cardiac signals and delivering said signals to the pacemaker, said lead having a proximal end, a distal end, and a length therebetween, and conductive means for conducting said pulses and said sensed signals respectively along said length, said lead further having a tip configuration at said distal end, said tip configuration comprising:

a substantially hemispherical overall tip surface area, said tip surface area having a porous surface material;

a first surface area within said overall tip area, centered substantially at the axial center of said tip area, a second surface area within said overall tip area and positioned around said first area, and insulating means for electrically insulating said first and second areas from each other;

eluting means for eluting an eluant to one of said first and second surface areas and at least a portion of said other of said first and second surface areas; and

connecting means for connecting only said one surface areas to said conductive means.

15. The lead as described in claim 14, wherein said second surface area is annular around said first surface area, and said eluting means elutes eluant to substantially all of said first and second surface areas.

16. The lead as described in claim 14, wherein said connecting means comprises first means for connecting said first surface area to said conductive means.

17. The lead as described in claim 14, wherein said connecting means comprises second means for connecting said second surface area to said conductive means.

18. The lead as described in claim 14, wherein said first surface is no greater than about 2 square mm, and said overall surface area is at least about 6 square mm.

19. The lead as described in claim 14, wherein said first and second surface areas are of substantially equal size.

20. The lead as described in claim 14, wherein said insulating means comprises a surface area which is less than 10% of said overall tip surface area.