TRANS-SEPTAL PACING METHOD AND APPARATUS

• US 20100298841A1
• Filed: 05/12/2010
• Published: 11/25/2010
• Est. Priority Date: 11/29/2001
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Struble, Chester W., Prinzen, Frits W.
• Application Number:
  US12/778,679
• Publication Number:
  US 20100298841A1
• Time in Patent Office: Days
• US Class Current: 606/129
• 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
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• CPC Class Codes: A61N 1/37254 Pacemaker or defibrillator security, e.g. to prevent or inhibit programming alterations by hackers or unauthorised individuals

Abstract

A medical electrical trans-septal pacing lead includes a lead body, a tine-like structure terminating a distal end of the lead body and a distal electrode coupled to the lead body at a position proximal to and in close proximity to the structure. A method for delivering left ventricular pacing to a heart includes inserting the trans-septal pacing lead through an inter-ventricular septal wall of the heart, from a right ventricle to a left ventricle, and positioning the distal electrode in a left ventricular endocardial surface of the septal wall.

Claims

1. A medical electrical trans-septal pacing lead, comprising:

a lead body including a distal end;

a tine-like structure terminating the distal end; and

a distal electrode coupled to the lead body at a position proximal to, and in close proximity to the structure.

2. The lead of claim 1, further comprising a second electrode coupled to the lead body at a position proximal to the distal electrode.

3. The lead of claim 2, wherein:

a spacing between the tine-like structure and the distal electrode is such that a portion of the distal electrode would be located within a left ventricular endocardial surface of an inter-ventricular septal wall of a heart when the structure is positioned within a left ventricle adjacent to the left ventricular endocardial surface; and

a spacing between the distal electrode and the second electrode is such that a portion of the second electrode would be located within a more central portion of the inter-ventricular septal wall when the portion of the distal electrode is located within the left ventricular endocardial surface.

4. The lead of claim 2, wherein:

a spacing between the tine-like structure and the distal electrode is such that a portion of the distal electrode would be located within a left ventricular endocardial surface of an inter-ventricular septal wall of a heart when the structure is positioned within a left ventricle adjacent to the left ventricular endocardial surface; and

a spacing between the distal electrode and the second electrode is such that a portion of the second electrode would be located within a right ventricular endocardial surface of the inter-ventricular septal wall when the portion of the distal electrode is located within the left ventricular endocardial surface.

5. The lead of claim 2, further comprising a third electrode coupled to the lead body at a position proximal to the second electrode.

6. The lead of claim 3, further comprising:

a third electrode coupled to the lead body at a position proximal to the second electrode;

wherein a spacing between the third electrode and the second electrode is such that a portion of the third electrode would be located within a right ventricular endocardial surface when the portion of the second electrode is located within the more central portion of the inter-ventricular septal wall.

7. The lead of claim 1, wherein the tine-like structure is formed of a material dissolvable in blood.

8. The lead of claim 1, wherein the distal electrode includes an outer surface protruding radially from an adjacent portion of the lead, which is proximal to the distal electrode.

9. A system for delivering pacing, comprising:

a delivery catheter including a lumen;

a needle slidably received by the delivery catheter lumen, adapted to puncture through a septal wall being supported by the delivery catheter, and including a needle lumen; and

a trans-septal pacing lead slideably received by the needle lumen comprising;

a lead body including a distal end;

a tine-like structure terminating the distal end; and

a distal electrode coupled to the lead body at a position proximal to, and in close proximity to the structure.

10. The system of claim 9 wherein the lead further comprises a second electrode coupled to the lead body at a position proximal to the distal electrode.

11. The system of claim 10, wherein:

a spacing between the tine-like structure and the distal electrode is such that a portion of the distal electrode would be located within a left ventricular endocardial surface of an inter-ventricular septal wall of a heart when the structure is positioned within a left ventricle adjacent to the left ventricular endocardial surface; and

a spacing between the distal electrode and the second electrode is such that a portion of the second electrode would be located within a more central portion of the inter-ventricular septal wall when the portion of the distal electrode is located within the left ventricular endocardial surface.

12. The system of claim 10, wherein:

a spacing between the tine-like structure and the distal electrode is such that a portion of the distal electrode would be located within a left ventricular endocardial surface of an inter-ventricular septal wall of a heart when the structure is positioned within a left ventricle adjacent to the left ventricular endocardial surface; and

a spacing between the distal electrode and the second electrode is such that a portion of the second electrode would be located within a right ventricular endocardial surface of the inter-ventricular septal wall when the portion of the distal electrode is located within the left ventricular endocardial surface.

13. The system of claim 10, wherein the lead further comprises a third electrode coupled to the lead body at a position proximal to the second electrode.

14. The system of claim 11, wherein the lead further comprises:

a third electrode coupled to the lead body at a position proximal to the second electrode;

wherein a spacing between the third electrode and the second electrode is such that a portion of the third electrode would be located within a right ventricular endocardial surface when the portion of the second electrode is located within the more central portion of the inter-ventricular septal wall.

15. The system of claim 9, wherein the tine-like structure is formed of a material dissolvable in blood.

16. The system of claim 9, wherein the distal electrode includes an outer surface protruding radially from an adjacent portion of the lead, which is proximal to the distal electrode.

17. The system of claim 9, wherein the needle includes an electrode positioned in proximity to a distal tip of the needle.

18. A method for delivering ventricular pacing to a heart, comprising the steps of:

passing a distal portion of a pacing lead through an inter-ventricular septal wall, from a right ventricle to a left ventricle;

positioning a distal electrode coupled to the distal portion of the lead such that a portion of the distal electrode is located within a left ventricular endocardial surface; and

delivering pacing pulses via the distal electrode.

19. The method of claim 18, wherein the distal portion of the lead further includes a second electrode proximal to the distal electrode, a portion of which is positioned within a more central portion of the inter-ventricular septal wall when the distal electrode is positioned in the left ventricular endocardial surface and wherein the second electrode forms a bipolar pair with the first electrode for delivering pacing pulses.

20. The method of claim 18, wherein the distal portion of the lead further includes a second electrode proximal to the distal electrode, a portion of which is positioned within a right ventricular endocardial surface when the distal electrode is positioned in the left ventricular endocardial surface.

21. The method of claim 19, wherein the distal portion of the lead further includes a third electrode, located proximal to the second electrode, a portion of which is positioned within a right ventricular endocardial surface when the distal electrode is positioned in the left ventricular endocardial surface and wherein the third electrode forms a bipolar pair with the second electrode for delivering pacing pulses.

22. The method of claim 18, further comprising a step of piercing through the interventricular septal wall with a needle, which includes a lumen, and wherein the distal portion of the lead is passed through the septal wall through the lumen of the needle.

23. The method of claim 22, wherein the needle further includes an electrode coupled in proximity to a distal tip of the needle and further comprising the step of sensing electrical activity in the interventricular septal wall via the electrode.

24. The method of claim 22, wherein the needle further includes an electrode coupled in proximity to a distal tip of the needle and further comprising the step of pacing in the interventricular septal wall via the electrode.

25. The method of claim 18, wherein the step of positioning the distal electrode includes retracting the distal portion of the lead until a resistance to the retraction is felt, after passing the distal portion through the septal wall.

26. The method of claim 25, wherein the resistance to retraction is caused by a tine-like structure contacting the left ventricular endocardial surface;

and wherein the tine-like structure terminates a distal end of the distal portion of the lead.

27. The method of claim 18, wherein the distal electrode includes an outer surface protruding radially from an adjacent portion of the distal portion of the lead, which is proximal to the distal electrode.

28. The method of claim 18, wherein a location in the inter-ventricular septal wall through which the distal portion of the lead is passed is along a lower portion of the septal wall, in proximity to an apex of the heart.

29. The method of claim 20, wherein the step of delivering pacing pulses is further defined by an interval between a pulse delivered via the distal electrode and a pulse delivered via the second electrode.

30. The method of claim 29, wherein the pulse delivered via the first electrode is unipolar and the pulse delivered via the second electrode is unipolar.

31. The method of claim 29, wherein the pulse delivered via the distal electrode is bipolar, the distal electrode acting as a cathode and the second electrode acting as an anode, and the pulse delivered via the second electrode is bipolar, the second electrode acting as the cathode and the distal electrode acting as the anode.

32. The method of claim 29, wherein the interval is between approximately 0.5 milliseconds and approximately 100 milliseconds.

33. The method of claim 29, wherein the pulse delivered via the first electrode precedes the pulse delivered via the second electrode.

34. The method of claim 29, wherein the pulse delivered via the second electrode precedes the pulse delivered via the first electrode.

35. The method of claim 21, wherein the step of delivering pacing pulses is further defined by an interval between a pulse delivered via the distal electrode and the second electrode and a pulse delivered via the third electrode and the second electrode.

36. The method of claim 35, wherein the interval is between approximately 0.5 milliseconds and approximately 100 milliseconds.

37. The method of claim 35, wherein the pulse delivered via the distal electrode and the second electrode precedes the pulse delivered via the third electrode and the second electrode.

38. The method of claim 35, wherein the pulse delivered via the third electrode and the second electrode precedes the pulse delivered via the distal electrode and the second electrode.

39. The method of claim 35, wherein a polarity of the pulse delivered via the distal electrode and the second electrode is opposite to a polarity of the pulse delivered via the third electrode and the second electrode.