Left ventricular access lead for heart failure pacing

• US 5,935,160 A
• Filed: 01/24/1997
• Issued: 08/10/1999
• Est. Priority Date: 01/24/1997
• Status: Expired due to Term

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Westlund, Randy, Tockman, Bruce A., Salo, Rodney W., Heil, Ronald W. Jr., Auricchio, Angelo, Chastain, Stuart R.
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US08/787,274
• Time in Patent Office: 928 Days
• Field of Search: 607/120, 607/122, 607/123, 607/126, 607/127, 607/128
• US Class Current: 607/122
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

An elongated monopolar or bipolar coronary vein lead having a reduced outer diameter and especially adapted to be advanced into a selected coronary vein for delivering a pacing signal to a predetermined region of a patient'"'"'s heart, such as the left ventricle. A method of using the lead for pacing a patient'"'"'s heart in the treatment of heart failure is also described. The method for pacing the heart includes advancing the coronary vein lead through both the coronary sinus and into a selected coronary vein of a patient'"'"'s heart, connecting the lead to an electrical pacing source and applying electrical stimulation to a particular chamber of the patient'"'"'s heart via the implanted lead. The lead includes a flexible tip and transition ring that enhances the ability to guide the lead through the coronary veins.

Claims

1. A method of pacing a patient'"'"'s heart, comprising the steps of:

a) transveineously inserting and positioning a lead having a proximal end, a distal end, and a lumen, through a coronary sinus and into a coronary vein of a patient'"'"'s heart, the coronary vein being one of a posterior vein, an anterior vein, a middle vein and a great vein, the lead including an electrode surface disposed on the lead in a zone located near the distal end and a transition ring for transferring a rotational force fixed within the lead;

b) coupling said electrode surface to a means for pacing the patient'"'"'s heart; and

c) applying a pacing pulse from said means for pacing to said electrode surface via said lead to thereby pace the left ventricle of the patient'"'"'s heart.

2. The method as recited in claim 1, wherein the step of inserting includes introducing the lead into the coronary sinus through a guide catheter.

3. The method as recited in claim 1, wherein the step of positioning includes engaging a blade portion of a stylet within a slot formed in said transition ring.

4. The method as recited in claim 2, further comprising the step of removing the guide catheter after the lead has been inserted through both the coronary sinus and into the coronary vein of the patient'"'"'s heart.

5. The method as recited in claim 4, wherein said lead further includes a removable guide means having a blade portion that interlocks with a slot of said transition ring for guiding a predetermined distal portion of said lead through the patient'"'"'s heart, said guide means extending through the lumen of said lead.

6. The method as recited in claim 1, wherein said lead further includes a removable guide means for guiding said lead through the patient'"'"'s heart, said guide means extending through the lumen of said lead.

7. A method of pacing or sensing in a patient'"'"'s heart, comprising the steps of:

a) transveineously inserting a first lead, having at least a first electrode disposed on the first lead in a zone located near a distal end, through a patient'"'"'s coronary sinus and into a coronary vein at a location adjacent the left atrium of the patient'"'"'s heart;

b) transveineously inserting a second lead, having at least a second electrode disposed on the second lead in a zone located near the distal end of said second lead, through the coronary sinus and into a coronary vein adjacent the left ventricle of a patient'"'"'s heart;

c) coupling said first and second leads to a means for pacing the patient'"'"'s heart; and

d) applying first and second pacing pulses from said means for pacing to said first and second electrodes, thereby performing at least one of pacing and sensing of the left atrium and left ventricle of the patient'"'"'s heart.

8. The method as recited in claim 7, wherein the steps of inserting the first and second leads includes introducing the first and second leads into the coronary sinus through corresponding guide catheters.

9. The method as recited in claim 8, further comprising the steps of removing the corresponding guide catheters after the first and second leads have been inserted through both the coronary sinus and into the respective coronary veins of the patient'"'"'s heart.

10. The method as recited in claim 9, wherein each said first and second leads inserted in the coronary veins of a patient'"'"'s heart further includes a lumen extending a length of each lead and adapted for receiving therein a removable guide means for guiding said lead through the patient'"'"'s heart.

11. The method as recited in claim 10 further including the step of, removing said guide means after said leads have been inserted through both the coronary sinus and into the respective coronary veins of the patient'"'"'s heart.

12. The method as recited in claim 7, wherein each said first and second leads further includes a lumen extending a length of each lead and adapted for receiving therein a removable guide means for guiding said lead through the patient'"'"'s heart.

13. A method of pacing a patient'"'"'s heart, comprising the steps of:

a) transveineously inserting and positioning a lead through a coronary sinus and into a coronary vein adjacent the left ventricle of the patient'"'"'s heart, said lead having a proximal end, a distal end, a lumen, and a transition ring positioned within said lumen for transferring a rotational force from a stylet positioned within the lumen to a predetermined distal portion of said lead, said lead including first and second electrodes disposed on the lead, wherein the first electrode is aligned with the left ventricle and the second electrode is aligned with the left atrium;

b) coupling said first and second electrodes to a means for pacing the patient'"'"'s heart; and

c) applying first and second pacing pulses from said means for pacing to said first and second electrodes, via said lead, to thereby pace the left ventricle and left atrium of the patient'"'"'s heart.

14. The method as recited in claim 13, wherein the step of inserting includes introducing the lead into the coronary sinus through a guide catheter.

15. The method as recited in claim 14, further comprising the step of removing the guide catheter after the lead has been inserted through both the coronary sinus and into the coronary vein of the patient'"'"'s heart.

16. The method as recited in claim 14, wherein the stylet further includes a blade portion that interlocks with a slot of said transition ring for guiding the predetermined distal portion of said lead through the patient'"'"'s heart.

17. The method as recited in claim 13, wherein the step of positioning includes engaging a blade portion of the stylet within a slot formed in said transition ring.

18. A method of pacing a patient'"'"'s heart, comprising the steps of:

a) transveineously inserting and positioning a lead through a coronary is sinus and into a coronary vein adjacent the left ventricle of the patient'"'"'s heart, said lead having a proximal end, a distal end, a lumen, and a transition ring positioned within said lumen for transferring a rotational force from a stylet positioned within the lumen to a predetermined distal portion of said lead, said lead including first, second, and third electrodes disposed on the lead, wherein the first electrode is aligned with the left ventricle, the second electrode is aligned with the left atrium, and the third electrode is aligned with the right atrium;

b) coupling said first, second and third electrodes to a means for pacing the patient'"'"'s heart; and

c) applying first, second, and third pacing pulses from said means for pacing to said first, second and third electrodes, via said lead, to thereby pace the left ventricle, left atrium, and right atrium of the patient'"'"'s heart.

19. The method as recited in claim 18, wherein the step of inserting includes introducing the lead into the coronary sinus through a guide catheter.

20. The method as recited in claim 19, further comprising the step of removing the guide catheter after the lead has been inserted through both the coronary sinus and into the coronary vein of the patient'"'"'s heart.

21. The method as recited in claim 19, wherein the stylet further includes a blade portion that interlocks with a slot of said transition ring for guiding the predetermined distal portion of said lead through the patient'"'"'s heart.

22. The method as recited in claim 18, wherein the step of positioning includes engaging a blade portion of the stylet with a slot formed in said transition ring.

23. The method as recited in claim 18, further comprising the step of transveineously inserting a second lead into the right ventricle, said second lead having an electrode pair disposed on said lead adjacent a distal end, and coupling said electrode pair to said cardiac pacer, for selectively performing at least one of pacing and sensing of at least one of the right atrium, the left atrium, the right ventricle and the left ventricle of the patient'"'"'s heart.

24. An elongated coronary vein lead for delivering a pacing signal and sensing electrical impulses in a predetermined region of a patient'"'"'s heart, comprising:

a) an elongated, flexible, insulative main body portion having a proximal and distal end, wherein the distal end has a rounded tip attached thereto;

b) a plurality of electrodes mutually insulated and spaced a predetermined distance from one another and embodied within said main body portion;

c) a plurality of independently insulated conductors, wherein a distal end of each conductor is attached individually to a corresponding one of a plurality of electrodes and a proximal end of each conductor is attached to a corresponding terminal pin, said plurality of independently insulated conductors being helically coiled within said elongated main body portion to define a central lumen;

d) a transition ring fixed within said central lumen a predetermined distance from said distal end of said lead, said transition ring having an inner lumen extending therethrough and aligned with said central lumen; and

e) an elongated guide means for guiding the lead through the patient'"'"'s heart, said guide means interlocking with said transition ring and being removably positioned within the central lumen, for facilitating the routing of the lead body portion into a predetermined coronary vein, a distal end of said elongated guide means being sized to extend through the inner lumen of said transition ring.

25. The lead as recited in claim 24, further comprising a sleeve encompassing said main body, said sleeve having a biomedical steroid impregnated to said sleeve for reducing inflammatory responses of the patient'"'"'s heart tissue to the presence of the lead body.

26. The lead as recited in claim 24, wherein said main body has an outer diameter ranging between 0.023 to 0.092 inches.

27. The lead as recited in claim 24, wherein said transition ring includes a slot that interlocks with a blade formed on said guide means.

28. The lead as recited in claim 24, wherein the rounded tip is formed around a cylindrical cable mesh to provide stability and flexibility to the rounded tip.

29. The lead as recited in claim 24, wherein the rounded tip is formed from a flexible polymer.

30. The lead as recited in claim 24, wherein one of said plurality of independently insulated conductors extends to a distal end of said main body, thereby forming the rounded tip.

31. An elongated coronary vein lead for delivering a pacing signal and sensing electrical impulses in a predetermined region of a patient'"'"'s heart, comprising:

a) an elongated, flexible, insulative main body portion having a proximal and distal end, wherein the distal end has a rounded flexible tip attached thereto;

b) an insulated conductor being helically coiled within said elongated main body portion to define a central lumen;

c) said main body having a window formed in said main body, wherein a portion of said conductor is exposed through said window of said main body, said exposed portion being fused to form an electrode surface;

d) a transition ring fixed within said central lumen a predetermined distance from said distal end of said lead; and

e) an elongated guide means for guiding the lead through the patient'"'"'s heart, said guide means interlocking with said transition ring and being removably positioned within the central lumen, for facilitating the routing of the lead body portion into a predetermined coronary vein.

32. The lead as recited in claim 31, further comprising a sleeve encompassing a predetermined portion said main body, said sleeve having a biomedical steroid impregnated to said sleeve for reducing inflammatory responses of the patient'"'"'s heart tissue to the presence of the lead body.

33. The lead as recited in claim 31, wherein said main body has an outer diameter ranging between 0.023 to 0.092 inches.

34. The lead as recited in claim 31, wherein said transition ring includes a slot that interlocks with a blade formed on said guide means.

35. The lead as recited in claim 31, wherein said rounded flexible tip further comprises an outer sheath having a biomedical steroid impregnated to said sheath for reducing inflammatory responses of the patient'"'"'s heart tissue to the presence of the flexible tip and further includes an inner cylindrical cable mesh surrounded by said outer sheath, said cable mesh designed to provide stability and flexibility to the rounded tip.