Multipolar pacing method and apparatus

• US 20040064158A1
• Filed: 09/30/2002
• Published: 04/01/2004
• Est. Priority Date: 09/30/2002
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Laske, Timothy G., Klein, George J.
• Granted Patent: US 7,082,335 B2
• Time in Patent Office: Days
• US Class Current: 607/9
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook

Abstract

A physiological pacing system including a physiological pacing lead having an electrode array and a means for fixation, including a collar for securing the fixation means to a lead body of the pacing lead, is inserted into a bore within a heart wall at a physiological pacing site. The system further includes a means to create the bore, the means being a piercing tip, which is either coupled to a piercing tool or the pacing lead. The piercing tool may be an elongated hollow shaft into which the pacing lead is slideably insertable or a stylet wire, which is slideably insertable within a lumen of the pacing lead. Once the electrode array is implanted within the bore, a first pair of electrodes is selected for sensing and a second pair of electrodes is selected for pacing.

Claims

1. A system for delivering physiological pacing comprising:

a lead body having a proximal end and a distal end;

an electrode array being disposed at the distal end of the lead body, the electrode array including an alternating series of electrodes and spacer elements, the alternating electrodes including a most proximal electrode and a most distal electrode;

a collar being disposed coaxially about a portion of a circumference of the lead body, having an outer diameter greater than an outer diameter of the lead body, and being positioned at a point spaced proximally from the most proximal electrode; and

a distal fixation element being fixed to the lead body by means of the collar.

2. The lead of claim 1, wherein the distal fixation element includes a helical hook having a proximal portion and a distal portion;

the proximal portion being disposed coaxially about the lead body forming approximately between 1 and 5 turns about the lead body, the approximately between 1 and 5 turns being embedded within the collar; and

the distal portion extending out from the collar, forming approximately one turn about the lead body, and having an inner diameter greater than the outer diameter of the collar.

3. The system of claim 2, wherein the electrode array further includes a means for steroid elution.

4. The system of claim 3, wherein the means for steroid elution includes a coating covering all or a portion of the electrode array.

5. The system of claim 4, wherein the coating includes a steroid material selected from the group including:

Dexamethasone Acetate and Beclomethasone Diproprionate.

6. The system of claim 2, wherein the distal portion of the helical hook of the fixation element includes a means for steroid elution, the means for steroid elution being a coating covering all or a portion of the distal portion of helical hook.

7. The system of claim 6, wherein the coating includes a steroid material selected from the group including:

Dexamethasone Acetate and Beclomethasone Diproprionate.

8. The system of claim 2, wherein the collar includes a distal edge and the most proximal electrode ring includes and proximal edge;

the distal edge of the collar being spaced between approximately 0.07 inches and 0.09 inches from the proximal edge of the most proximal electrode ring.

9. The system of claim 1, further comprising a guide catheter and a piercing tool;

wherein the lead body and the piercing tool are slideably insertable within the guide catheter.

10. The system of claim 9, wherein the piercing tool includes a piercing distal tip and an elongated hollow shaft and the lead body is slideably insertable within the shaft.

11. The system of claim 10, wherein the piercing tool further includes wall portions forming a longitudinal recess having a proximal edge disposed proximal to the fixation element of the lead body, and a piercing edge terminating the piercing distal tip and being disposed distal to the most distal electrode of the lead body.

12. The system of claim 11, wherein the elongated hollow shaft further includes a semi-rigid wall section being terminated along the piercing edge and a flexible wall section being terminated along the longitudinal recess.

13. The system of claim 12, wherein the distal fixation element includes a helical hook having a proximal portion and a distal portion;

the proximal portion being disposed coaxially about the lead body forming approximately between 1 and 5 turns about the lead body, the approximately between 1 and 5 turns being embedded within the collar; and

the distal portion extending out from the collar, forming approximately one turn about the piercing tool shaft, and having an inner diameter greater than the outer diameter of the piercing tool shaft.

14. The system of claim 13, wherein the lead body further includes a lumen extending from the proximal end to the distal end of the lead body;

and further comprising a stiffening stylet wire being slideably insertable within the lumen.

15. The system of claim 9, wherein the lead body further includes a lumen extending from the proximal end to the distal end of the lead body, and the piercing tool comprises a piercing stylet having a piercing distal tip and being slideably insertable within the lumen.

16. The system of claim 15, wherein the lumen includes a distal opening having a seal member and the piercing distal tip of the piercing stylet extends distally from the distal opening.

17. The system of claim 1, further comprising:

a piercing tip terminating the distal end of the lead body;

a lumen extending from the proximal end to the distal end of the lead body;

a stiffening stylet wire being slideably insertable within the lumen; and

a guide catheter, the lead body being slideably insertable within the guide catheter.

18. A method for delivering physiological pacing comprising:

creating a bore in a heart wall at a physiological pacing site;

advancing an electrode array having a plurality of electrodes, coupled to a lead body, within the bore;

engaging a distal fixation element, coupled to the lead body, with the heart wall;

positioning at least one indifferent electrode subcutaneously;

selecting a first pair of electrodes for sensing;

measuring pacing thresholds between pairs of electrodes formed between the multiple electrodes and between the multiple electrodes and the indifferent electrode; and

selecting a second pair of electrodes from the pairs of electrodes for pacing therapy.

19. The method of claim 18, wherein the step for creating a bore in a heart wall at physiological pacing site includes:

inserting a physiological pacing lead having an electrode array into a piercing tool to form a delivery system;

inserting the delivery system into a guide catheter; and

advancing the delivery system within the guide catheter until a piercing tip of the piercing tool penetrates the heart wall at the physiological pacing site.

20. The method of claim 18, wherein the step for creating a bore in a heart wall at physiological pacing site includes:

inserting a piercing stylet into a guide catheter; and

advancing the piercing stylet within the guide catheter until a piercing tip of the piercing stylet penetrates the heart wall at the physiological pacing site.

21. The method of claim 20, wherein the piercing stylet is within a lumen of the physiological pacing lead and the piercing tip of the piercing stylet extends distally from a distal opening of the lumen of the physiological pacing lead.

22. The method of claim 18, wherein the physiological pacing site is the Bundle of His.