Stent-type defibrillation electrode structures

• US 5,531,779 A
• Filed: 01/24/1995
• Issued: 07/02/1996
• Est. Priority Date: 10/01/1992
• Status: Expired due to Term

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Wickham, deceased, Robert W., Swanson, David K., Lipson, David, Dahl, Roger W.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): JASTRZAB, JEFFREY R
• Application Number:
  US08/377,494
• Time in Patent Office: 525 Days
• Field of Search: 607/116, 607/119, 607/122-125, 606/45, 606/191, 606/194, 606/195, 606/198, 128/642, 604/21, 623/1
• US Class Current: 607/119
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/0563 specially adapted for defibrillation or cardioversion
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

Implantable electrode structures for use in apparatus for applying electrical therapy to a patient'"'"'s heart in the treatment of arrhythmias such as tachycardias and fibrillations of the heart are herein disclosed. The electrode structures are made in the form of expandable (or self-expanding) intravascular stents for insertion through the patient'"'"'s vascular system to locations in or adjacent the heart. The electrode structures can be inserted into the great veins by insertion techniques used for intravascular stent applications and provide increased electrode surfaces for discharge of electrical energy through the heart in conjunction with other strategically placed electrodes. The wire filament of the stents may be evenly spaced to form a circumferential array or may be non-uniformly spaced to form an elliptical array.

Claims

1. In an apparatus for applying electrical therapy to a patient'"'"'s heart for treatment of cardiac arrhythmias, including tachycardias and fibrillations, comprising pulse generator means for generating pulses, at least two electrode structures implantable within the patient'"'"'s body, and means, electrically connecting the at least two electrode structures to the pulse generator means, for discharging electricity through the heart in response to pulses generated by the pulse generator means, the improvement wherein at least one of said electrode structures comprises an expandable electrically conducting intravascular stent for location in or adjacent the heart and providing substantially unimpeded blood flow therethrough when positioned in the vascular system, the stent comprising an array of substantially linear wire filaments and end members interconnecting the filaments at opposite ends thereof, the filaments being shaped into a radially compressible basket-like configuration.

2. The improvement as defined in claim 1, wherein the wire filaments are non-uniformly spaced.

3. The improvement as defined in claim 2, wherein the wire filaments are arranged in an elliptical array having a major axis and a minor axis, a greater number of wire filaments being disposed along the major axis than the minor axis so as to focus greater current density perpendicular to the major axis.

4. The improvement as defined in claim 1, wherein said end members comprise a distal end crimp tube surrounding the wire filaments at one end thereof and a proximal end crimp tube surrounding the wire filaments at an opposite end thereof.

5. The improvement as defined in claim 4, further including an inner crimp tube within the distal end crimp tube, with respective ends of the wire filaments being trapped between the distal end crimp tube and the inner crimp tube.

6. The improvement as defined in claim 4, wherein the proximal end crimp tube is attached to an electric conductor for connecting the at least one of said electrode structures to the pulse generator means.

7. The improvement as defined in claim 6, wherein the proximal end crimp tube has a first blind bore receiving respective ends of the wire filaments and a second blind bore receiving the electric conductor.

8. The improvement as defined in claim 1, wherein the end members comprise respective ring electrodes and respective ends of the wire filaments have weld connections with the ring electrodes.

9. The improvement as defined in claim 8, wherein the ring electrodes have external grooves receiving the respective ends of the wire filaments and said weld connections.

10. The improvement as defined in claim 1, wherein said at least two electrode structures comprise intravascular stent structures.

11. The improvement as defined in claim 10, wherein each of said at least two electrode structures comprises an array of wire filaments and end members interconnecting the wire filaments at opposite ends thereof, the wire filaments being shaped into at least two radially compressible basket-like configurations.

12. The improvement as defined in claim 11, wherein the wire filaments are non-uniformly spaced.

13. The improvement as defined in claim 12, wherein the wire filaments are arranged in an elliptical array having a major axis and a minor axis, a greater number of wire filaments being disposed along the major axis than the minor axis so as to focus greater current density perpendicular to the major axis.

14. The improvement as defined in claim 11, wherein one of said at least two electrode structures comprises a distal electrode structure wherein the end members comprise crimp tubes in which respective ends of the wire filaments are trapped and the other of said at least two electrode structures comprises a proximal electrode structure wherein the end members comprise ring electrodes to which respective ends of the wire filaments are welded.

15. The improvement as defined in claim 11, wherein each of the at least two electrode structures has an electrical conductor lead for connecting the at least two electrode structures to the pulse generator means, said leads being contained in a common lead body.

16. The improvement as defined in claim 1, wherein the stent is resiliently compressible radially for insertion thereof through the patient'"'"'s vascular system and radially expandable into contact with a vein wall in the vascular system.

17. The improvement as defined in claim 16, and further comprising means for positioning the stent in the patient'"'"'s SVC/IVC extending from above the plane of the patient'"'"'s atrium to below the plane of the patient'"'"'s RV apex.

18. An apparatus for applying electrical therapy to a patient'"'"'s heart for the treatment of cardiac arrhythmias, including tachycardias and fibrillations, comprising:

pulse generator means, adapted to be subcutaneously inserted in the patient'"'"'s body, for generating pulses; and

at least two electrode structures connected to the pulse generator means by respective electrical conductors, the electrode structures adopted to be implanted within the patient'"'"'s body for discharging electrical energy through the patient'"'"'s heart in response to pulses generated by the pulse generator means;

wherein at least one of the electrode structures comprises an expandable electrically conducting intravascular stent, the stent being adopted to be in contact with an inner wall of said passage and providing substantially unimpeded blood flow through the passage and wherein the stent comprises an array of substantially linear wire filaments and end members connecting opposite ends of the wire filaments, the wire filaments being shaped into a basket-like configuration.

19. An apparatus as defined in claim 18, wherein the wire filaments are non-uniformly spaced.

20. An apparatus as defined in claim 18, wherein the wire filaments are arranged in an elliptical array having a major axis and a minor axis, a greater number of wire filaments being disposed along the major axis than the minor axis so as to focus greater current density perpendicular to the major axis.

21. An apparatus as claimed in claim 18, wherein the wire filaments are twisted between said end members about an axis passing between said end members.

22. An apparatus as claimed in claim 18 wherein said at least two electrode structures include a first stent electrode adopted to be positioned with a distal end thereof level with the patient'"'"'s RV apex, a second smaller stent electrode adopted to be positioned in the patient'"'"'s SVC, and a third patch electrode for discharging with the stent electrodes.

23. An apparatus as defined in claim 27, wherein each stent electrode comprises a circumferential array of said wire filaments and end members connecting the respective ends of the wire filaments.

24. An apparatus as claimed in claim 22, wherein the wire filaments are twisted between said end members about an axis passing between said end members.

25. An apparatus as defined in claim 18, wherein the end members comprise crimp tubes in which the respective ends of the wire filaments are trapped.

26. An apparatus as defined in claim 25, wherein the crimp tubes have respective blind bores in which the ends of the wire filaments are trapped, and one of the crimp tubes has a further blind bore for receiving an electrical conductor.

27. An apparatus as defined in claim 26, wherein another of the crimp tubes includes an inner crimp tube within one of the respective blind bores and respective ends of the wire filaments are arranged around the inner crimp tube.

28. An electrode structure for use in a patient-implanted apparatus for applying electrical therapy to a patient'"'"'s heart, the electrode structure comprising:

an electrically conducting expandable intravascular stent having a circumferential array of wire filaments; and

end members respectively connecting opposite ends of the wire filaments, the filaments having a basket-like shape;

wherein the end members comprise ring electrodes and the filaments have weld connections with said ring electrodes.

29. A device for use in applying electrical therapy to a patient'"'"'s heart, the device comprising:

an intravascular stent having a circumferential array of electrically conductive filaments and end members interconnecting the filaments at opposite proximal and distal ends thereof, the filaments being shaped into a radially compressible basket-like configuration;

an electrical conductor having a proximal end and a distal end, and a means for electrically coupling the distal end of the electrical conductor with the proximal ends of the filaments; and

a catheter positioned in surrounding relation to the filaments to radially compress the filaments and maintain the filaments radially compressed to facilitate use of the catheter in delivering the stent to a predetermined intravascular location, the catheter further being removable proximally from the stent to allow the filaments to resiliently self-expand toward the basket-like configuration and into intimate contact with a vascular wall at the predetermined location.

30. The device of claim 29 further including:

an electrically insulative sheath mounted near the proximal ends of the filaments and extending proximally away from the stent in surrounding relation to the conductor.

31. The device of claim 29 wherein:

the filaments are substantially linear.

32. The device of claim 29 wherein:

the filaments when in the basket-like configuration are spaced apart from one another, over most of their lengths between their proximal and distal ends, a distance sufficient to decrease a current density between surfaces of adjacent filaments and at most approximately 3 cm.

33. The device of claim 29 wherein:

the spacing between adjacent ones of the filaments over the majority of a span of filaments between the end members, with the filaments in the basket-like configuration, is approximately 3 cm.

34. An electrode structure positionable at an intravascular location near the heart for applying electrical therapy to the heart;

the electrode structure including;

an array of electrically conductive filaments and end members interconnecting the filaments at opposite proximal and distal ends thereof, the filaments being shaped into a basket-like configuration in which a separation distance between adjacent ones of the filaments, over most of the filament lengths between said opposite ends, is sufficient to decrease the current density between surfaces of the adjacent filaments and is at most approximately 3 cm; and

an electrically conductive pulse delivery path, coupled to the proximal ends of the filaments, for delivering electrical pulses to all of the filaments simultaneously;

wherein the filaments are radially compressible from the basket-like configuration to facilitate intravascular delivery of the array to a predetermined intravascular location, and after said delivery are expandable toward the basket-like configuration into intimate contact with a vascular wall at the predetermined intravascular location.

35. The electrode structure of claim 34 wherein:

said separation distance is approximately 3 cm.

36. The electrode structure of claim 34 wherein:

the filaments are substantially linear.