Integrated lead for applying cardiac resynchronization therapy and neural stimulation therapy

• US 20060206153A1
• Filed: 03/11/2005
• Published: 09/14/2006
• Est. Priority Date: 03/11/2005
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Spinelli, Julio C., Westlund, Randy, Moffitt, Julia, Libbus, Imad, Wang, Sophia H.
• Granted Patent: US 7,840,266 B2
• Time in Patent Office: Days
• US Class Current: 607/9
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

An embodiment includes a main lead assembly having a proximal portion adapted for connection to a device and a distal portion adapted for placement in a coronary sinus, the distal portion terminating in a distal end for placement proximal a left ventricle. Additionally, the main lead assembly includes a left ventricular electrode located at its distal end which is adapted to deliver cardiac resynchronization therapy to reduce ventricular wall stress. The main lead assembly also includes a fat pad electrode disposed along the main lead assembly a distance from the distal end to position the fat pad electrode proximal to at least one parasympathetic ganglia located in a fat pad bounded by an inferior vena cava and a left atrium. The fat pad electrode is adapted to stimulate the parasympathetic ganglia to reduce ventricular wall stress.

Claims

1. An apparatus, comprising:

a main lead assembly having a proximal portion adapted for connection to a device and a distal portion adapted for placement in a coronary sinus, the distal portion terminating in a distal end for placement proximal a left ventricle;

a left ventricular electrode located at the distal end, the left ventricular electrode adapted to deliver cardiac resynchronization therapy to reduce ventricular wall stress; and

a fat pad electrode disposed along the main lead assembly a distance from the distal end to position the fat pad electrode proximal parasympathetic ganglia located in a fat pad bounded by an inferior vena cava and a left atrium, the fat pad electrode adapted to stimulate the parasympathetic ganglia to reduce ventricular wall stress.

2. The apparatus of claim 1, wherein the main lead assembly includes a main lead body extending from the proximal portion of the main lead assembly and toward the distal end of the main lead assembly, the main lead body defining at least two lumens, one of the at least two lumens being adapted to receive a second lead body.

3. The apparatus of claim 1, wherein the main lead assembly includes a main lead body extending from the proximal portion of the main lead assembly and toward the distal end of the main lead assembly, the main lead body defining at least two lumens, one of the at least two lumens being adapted to receive a stylet.

4. The apparatus of claim 1, wherein the main lead assembly includes a main lead body extending from the proximal portion of the main lead assembly and toward the distal end of the main lead assembly, the main lead body defining at least two lumens, one of the at least two lumens being adapted to receive a guidewire.

5. The apparatus of claim 1, wherein the main lead assembly includes:

a main lead body extending from the proximal portion of the main lead assembly and toward the distal end of the main lead assembly to a position beyond the fat pad electrode, and connected to the fat pad electrode, the main lead body defining a main lead body lumen extending from the proximal portion and terminating in an opening, the opening located in a position distal to the fat pad electrode; and

a second lead body connected to the left ventricular electrode and having a near portion and a far portion, the second lead body disposed in the main lead body lumen with the near portion located at the proximal portion of the main lead body and the far portion extending past the opening located in a position distal to the fat pad electrode.

6. The apparatus of claim 5, wherein the second lead body defines a second lead body lumen within the second lead body.

7. The apparatus of claim 6, wherein the second lead body lumen is adapted for passage of a slidable wire.

8. The apparatus of claim 5, wherein the fat pad electrode includes at least one conductive band at least partially circumscribing the main lead body.

9. The apparatus of claim 8, wherein for each conductive band an insulated conductor is disposed in the main lead body and connected to the conductive band, the insulated conductor extending to the proximal portion of the main lead body.

10. The apparatus of claim 9, wherein the main lead assembly includes a vascular wall abutting helix shaped bias proximal the fat pad electrode.

11. The apparatus of claim 10, wherein the vascular wall abutting helix shaped bias includes predetermined bends in a wire coil in the main lead body.

12. The apparatus of claim 10, wherein the vascular wall abutting helix shaped bias includes predetermined bends in an insulator in the main lead body.

13. The apparatus of claim 1 connected to a cardiac therapy system, the cardiac therapy system including a programmable pulse generator connected to the main lead assembly at the proximal portion, the cardiac therapy system including a second lead connected to the programmable pulse generator, the second lead sized for placement through a right atrium and in a right ventricle, the second lead adapted to deliver cardiac resynchronization therapy to reduce ventricular wall stress.

14. An apparatus, comprising:

a main lead assembly sized for placement in a coronary sinus and proximal a left ventricle, the main lead assembly having a proximal portion and a distal portion and defining a puncture body lumen extending along the main lead assembly;

a steerable extravascular lead body slidably disposed in the puncture body lumen, the steerable extravascular lead body having a near portion positioned at the proximal portion of the main lead assembly, and a far portion extending to a distance along the puncture body lumen to locate the far portion proximal a fat pad bounded by an inferior vena cava and a left atrium, the steerable extravascular lead body adapted to puncture the main lead assembly; and

a fat pad electrode connected to the steerable extravascular lead body at the far portion, the fat pad electrode adapted to stimulate parasympathetic ganglia located in the fat pad bounded by the inferior vena cava and the left atrium to reduce ventricular wall stress.

15. The apparatus of claim 14, wherein the main lead assembly includes a portion constructed of a resilient material, and an area of weakened resilient material, the area of weakened resilient material positioned adjacent the far portion of the steerable extravascular lead body.

16. The apparatus of claim 15, having a first position in which the far portion of the steerable extravascular lead body is disposed in the puncture body lumen, and a second position, in which the far portion of the steerable extravascular lead is disposed through a ruptured portion proximal the area of weakened resilient material.

17. The apparatus of claim 15, the area of weakened resilient material having at least one radioopaque marking feature.

18. The apparatus of claim 14, wherein the steerable extravascular lead body includes extracellular matrix.

19. The apparatus of claim 18, wherein the extracellular matrix is disposed along the steerable extravascular lead body at the far portion to position the extracellular matrix proximal punctured vasculature wall.

20. The apparatus of claim 14, wherein the fat pad electrode includes a conductive tissue piercing tip.

21. A method comprising:

placing a left ventricular electrode proximal a left ventricle;

placing a fat pad electrode proximal at least one parasympathetic ganglia located in a fat pad bounded by an inferior vena cava and a left atrium;

placing a right ventricular electrode proximal a right ventricle; and

reducing ventricular wall stress including;

delivering cardiac resynchronization therapy to the left ventricular electrode and the right ventricular electrode; and

delivering electrical pulses to the fat pad electrode and inducing parasympathetic response.

22. The method of claim 21, including directing a first lead into the right side of the heart.

23. The method of claim 21, including directing a lead assembly including the left ventricular electrode and the fat pad electrode into the coronary sinus.

24. The method of claim 21, including directing the fat pad electrode outside a volume defined by the coronary sinus.

25. The method of claim 24, including placing the fat pad electrode into the fat pad bounded by the inferior vena cava and the left atrium.

26. The method of claim 24, including anchoring the fat pad electrode in a myocardium proximal the fat pad bounded by the inferior vena cava and the left atrium.

27. The method of claim 24, including controlling the delivery of electrical pulses to the left ventricular electrode, the right ventricular electrode, and the fat pad electrode with a programmable controller.

28. The method of claim 27, including:

selecting a first configuration of multiple regions on the fat pad electrode;

inducing parasympathetic response with electrical pulses delivered to the first configuration of multiple regions on the fat pad electrode;

measuring a reaction; and

selecting a second configuration of multiple regions on the fat pad electrode.

29. The method of claim 21, including inducing a parasympathetic response exclusive of myocardial stimulation.

30. The method of claim 21, including inducing a parasympathetic response during a refractory period.

31. The method of claim 21, including:

transxiphoidally placing the left ventricular electrode proximal the left ventricle;

transxiphoidally placing the fat pad electrode proximal parasympathetic ganglia located in the fat pad bounded by the inferior vena cava and the left atrium; and

transxiphoidally placing a right ventricular electrode proximal the right ventricle.

32. The method of claim 31, including implanting the programmable pulse generator submuscularly in a patient'"'"'s chest, and extending at least one lead transxiphoidally to at least one of the group including the left ventricular electrode, the right ventricular electrode, or the fat pad electrode.

33. The method of claim 21, including:

transthoracically placing the left ventricular electrode proximal the left ventricle;

transthoracically placing the fat pad electrode proximal parasympathetic ganglia located in the fat pad bounded by the inferior vena cava and the left atrium; and

transthoracically placing a right ventricular electrode proximal the right ventricle.

34. The method of claim 33, including implanting the programmable pulse generator submuscularly in a patient'"'"'s chest, and extending at least one lead transthoracically to at least one of the group including the left ventricular electrode, the right ventricular electrode, or the fat pad electrode.

35. A lead assembly, comprising:

means for positioning a left ventricle electrode proximal a left ventricle, the left ventricular electrode adapted to deliver cardiac resynchronization therapy to reduce ventricular wall stress; and

means for positioning a fat pad electrode proximal parasympathetic ganglia located in a fat pad bounded by a inferior vena cava and a left atrium, the fat pad electrode adapted to stimulate the parasympathetic ganglia located in the fat pad bounded by the inferior vena cava and the left atrium to reduce ventricular wall stress.

36. The apparatus of claim 35, including:

a main lead body extending from the proximal portion of the main lead assembly to at least the fat pad electrode, and connected to the fat pad electrode, the main lead body defining a main lead body lumen extending from the proximal portion to an opening in the end of the main lead body; and

a second lead body connected to the left ventricular electrode and having a near portion and a far portion, the second lead body disposed in the main lead body lumen with the near portion located at the proximal portion of the main lead body and the far portion extending past the opening in the end of the main lead body a length adapted to position the far portion adjacent the left ventricle.

37. The apparatus of claim 36, wherein the second lead body includes means for puncturing the main lead body lumen, and means for locating the fat pad electrode in the fat pad bounded by the inferior vena cava and the left atrium.