Cardiac stimulation system with delivery of conductive agent

• US 7,317,950 B2
• Filed: 02/24/2003
• Issued: 01/08/2008
• Est. Priority Date: 11/16/2002
• Status: Expired due to Fees

• Current Assignee: Regents of the University of California (University of California)
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Lee, Randall J.
• Primary Examiner(s): DROESCH, KRISTEN L
• Application Number:
  US10/374,899
• Publication Number:
  US 20040098075A1
• Time in Patent Office: 1,779 Days
• Field of Search: None
• US Class Current: 607/122
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/0568 with drug delivery
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

A cardiac stimulation assembly includes an energy source coupled to an energy emitter that extends form a delivery member into a region of tissue in the heart. An array of the emitters are adapted to extend from a delivery assembly and into unique locations along the region of tissue, such as by use of extendable, pre-shaped needles. A volume of conductive agent is delivered into the region and enhances stimulation of the region with the energy emitter. The agent may be an injectable preparation of living cells that express production of connexin, e.g. connexin 43, and may be genetically modified to over-express such production. The agent may include a non-living material, such as conductive polymer or metal or combination thereof. The combination of energy emitters and conductive agent enhances stimulation of the region. Delivering the stimulation assembly and conductive agent into the interventricular septum allows for improved biventricular septal pacing.

Claims

1. A cardiac stimulation system, comprising:

a cardiac stimulator assembly with an electrical energy source, and an electrical energy emitter that is adapted to be coupled to the electrical energy source and to be positioned within a region of a heart of a patient to be stimulated;

means for enhancing electrical stimulation of the region with the electrical energy from the electrical energy emitter; and

means for stimulating the septum of the heart, with the cardiac stimulator assembly and means for enhancing stimulation.

2. The system of claim 1, wherein the cardiac stimulation assembly comprises:

a delivery member with a proximal end portion and a distal end portion that is adapted to be positioned at a location within a heart of a patient; and

an array of extendable electrode assemblies cooperating with the delivery member and that each includes a stimulation electrode that is adjustable to extend from the delivery member at the location and into a unique location relative to the other extendable electrode assemblies within the region of tissue.

3. The system of claim 2, wherein each of the array of extendable electrode assemblies comprises an extendable needle that is adjustable to extend from the distal end portion of the delivery assembly and into cardiac tissue so as to position the respective stimulation electrode at the unique location.

4. The system of claim 3, wherein the stimulation electrode of each extendable electrode assembly is integrated with the needle.

5. The system of claim 3, wherein the stimulation electrode of each extendable electrode assembly is adjustable to extend from the respective needle to the unique respective location.

6. The system of claim 3, wherein the needle has a curved shape.

7. The system of claim 3, wherein the needle comprises a superelastic metal alloy.

8. The system of claim 3, wherein the needle comprises a shape memory metal alloy.

9. The system of claim 3, wherein the needle comprises a nickel-titanium alloy.

10. The system of claim 2, wherein:

each of the array of extendable electrode assemblies comprises a relatively pliable tubular body with an inner lumen;

each stimulation electrode is located along the tubular body of the respective extendable electrode assembly; and

wherein each relatively pliable tubular body is adapted to be deflected and steered through the region of tissue so as to place the respective stimulation electrode at the respective unique location.

11. The system of claim 10, further comprising:

a moveable stylet that is adapted to be moveably engaged within the inner lumen of at least one of the tubular bodies so as to adjust the tubular body to extend from the delivery member and advance through the region of tissue such that the respective stimulation electrode is positioned at the respective unique location.

12. The system of claim 11, wherein:

the moveable stylet has a proximal end portion and a shaped distal end portion that is torquable within the inner lumen by torquing the proximal end portion proximally and externally of the tubular body so as to deflect and steer the tubular body in order to place the electrode.

13. The system of claim 2, further comprising:

an anchor that is extendable from the delivery member and adapted to anchor the distal end portion at the location such that the array of extendable electrode assemblies is adapted to be positioned at the respective unique locations along the region of tissue.

14. The system of claim 13, wherein the anchor comprises a stimulation electrode.

15. The system of claim 14, wherein:

the distal end portion of the delivery member comprises a distal tip; and

a stimulation electrode is located at the distal tip.

16. The system of claim 1, wherein the cardiac stimulation assembly comprises:

a cardiac pacemaker.

17. The system of claim 16, wherein the cardiac pacemaker comprises:

a bi-ventricular cardiac pacemaker.

18. The system of claim 1, wherein the cardiac stimulation assembly comprises:

a cardiac defibrillator.

19. The system of claim 1, wherein the conductive agent comprises isolated living cells.

20. The system of claim 19, wherein the living cells comprise at least one of myoblasts, fibroblasts, or stem cells.

21. The system of claim 19, wherein the living cells are adapted to express a connexin at gap junctions with cardiac cells in the region of tissue.

22. The system of claim 21, wherein the living cells are adapted to express connexin 43 at the gap junctions.

23. The system of claim 22, wherein the living cells are genetically modified to over-express production of connexin 43.

24. The system of claim 1, wherein the conductive agent comprises an injectable preparation of a conductive non-living material that is adapted to enhance electrical conduction in the region.

25. The system of claim 24, wherein the conductive non-living material comprises an injectable preparation of a conductive metal.

26. The system of claim 1, wherein:

the cardiac stimulation assembly comprises at least one electrical lead that is adapted to be positioned so as to emit electrical current into the region; and

the system further comprises a delivery assembly that is adapted to deliver the at least one electrical lead and also the volume of conductive agent to the region of tissue.

27. The system of claim 26, wherein the delivery member comprises:

a septal perforator delivery assembly that is adapted to couple the cardiac stimulation assembly to the region of tissue via at least one septal perforator vessel, and also to deliver the volume of conductive agent to the region via the at least one septal perforator vessel.

28. The system of claim 26, wherein the delivery assembly comprises:

a transcardiac delivery member.

29. The system of claim 1, wherein the means for enhancing electrical stimulation of the region comprises:

means for delivering a conductive agent to the region.

30. The system of claim 29, wherein the means for delivering a conductive agent to the region comprises:

means for producing a connexin, or analog, derivative, or biological equivalent thereof, in the region.

31. The system of claim 30, wherein the means for producing a connexin in the region comprises:

means for producing connexin 43, or analog, derivative, or biological equivalent thereof, in the region.

32. The system of claim 31, wherein the means for producing connexin 43 comprises:

means for genetically modifying cells that over-express connexin 43, or analog, derivative, or biological equivalent thereof, and

means for producing the connexin 43 in the region with the genetically modified cells.

33. The system of claim 1, wherein the means for stimulating the septum comprises:

means for pacing the heart from the septum.

34. The system of claim 33, wherein the means for pacing the heart from the septum comprises:

means for providing bi-ventricular pacing from the septum.

35. The system of claim 1, wherein the means for stimulating the septum comprises:

means for defibrillating the heart via the septum.

36. The system of claim 1, wherein the means for stimulating the septum comprises:

means for stimulating the septum via at least one septal perforator vessel.

37. A cardiac stimulation assembly, comprising:

an elongate body having a proximal end portion, a distal end portion that is adapted to be positioned at least in part at a location within a heart of a patient, and a delivery lumen extending at least in part along the distal end portion;

means for delivering electrical energy into a region of tissue within the heart of the patient;

means for enhancing stimulation of the region of tissue from electrical energy delivered from the means for delivering electrical energy; and

means for stimulating the septum of the heart with the cardiac stimulation assembly and means for enhancing stimulation;

wherein the means for delivering electrical energy and means for enhancing stimulation are adapted to cooperate with the elongate body.

38. The assembly of claim 37, wherein the means for delivering electrical energy into the region comprises:

means for delivering a stimulation electrode into the region.

39. The assembly of claim 38, wherein the means for delivering the stimulation electrode into the region comprises:

means for extending the stimulation electrode from a delivery catheter at a location within a cardiac chamber adjacent to the region and into the region.

40. The assembly of claim 39, wherein the means for extending the stimulation electrode comprises:

means for positioning the stimulation electrode at a location that is off-axis from the longitudinal axis from the distal end portion of the catheter adjacent the region.

41. The assembly of claim 37, wherein the means for delivering a stimulation electrode to the region comprises:

means for delivering an array of stimulation electrodes to the region.

42. The assembly of claim 41, wherein the means for delivering an array of stimulation electrodes to the region comprises:

means for positioning each of the stimulation electrodes at a unique respective position relative to the other stimulation electrodes within the region.

43. The assembly of claim 41, wherein the means for positioning each of the stimulation electrodes comprises:

means for extending a plurality of electroded members from a delivery member.

44. The assembly of claim 37, wherein the means for delivering a stimulation electrode to the region comprises:

means for delivering the stimulation electrode into a septal perforator vessel.

45. The assembly of claim 37, wherein the means for delivering electrical energy to the region comprises:

means for pacing the heart from the region.

46. The assembly of claim 45, wherein the means for pacing the heart from the region comprises:

means for providing bi-ventricular pacing of the heart from the septum.

47. The assembly of claim 37, wherein the means for enhancing stimulation of the region comprises:

means for delivering a conductive agent to the region.

48. The system of claim 47, wherein the means for delivering a conductive agent to the region comprises:

means for producing a connexin, or analog, derivative, or biological equivalent thereof, in the region.

49. The assembly of claim 48, wherein the means for producing a connexin in the region comprises:

means for producing connexin 43, or analog, derivative, or biological equivalent thereof, in the region.

50. The assembly of claim 49, wherein the means for producing connexin 43 comprises:

means for genetically modifying cells that over-express connexin 43, or analog, derivative, or biological equivalent thereof; and

means for producing connexin 43 in the region with the genetically modified cells.

51. The cardiac stimulation assembly of claim 37, further comprising:

an electrical energy delivery assembly with an electrical energy emitter that is coupled to the elongate body and is adjustable to extend from the distal end portion and into a region of tissue within the heart when the distal end portion is at the location, and also with an electrical energy lead that is adapted to couple to the electrical energy emitter and also to a source of electrical energy along the proximal end portion when the electrical energy emitter is in the second position; and

a volume of conductive agent coupled to the lumen and that is adapted to be delivered through the lumen into the region of tissue when the distal end portion is at the location and the electrical energy emitter is in the second position.

52. The assembly of claim 51, wherein the electrical energy emitter comprises a stimulation electrode.

53. The assembly of claim 51, wherein the electrical energy delivery assembly comprises:

an array of extendable electrode assemblies coupled to the elongate body and that each includes a stimulation electrode that is adjustable to extend from the elongate body at the location and into a unique location relative to the other extendable electrode assemblies within the region of tissue.

54. The assembly of claim 53, wherein each of the array of extendable electrode assemblies comprises an extendable needle that is adjustable to extend from the distal end portion of the elongate body and into cardiac tissue so as to position the respective stimulation electrode at the unique location.

55. The assembly of claim 54, wherein the stimulation electrode of each extendable electrode assembly is integrated with the needle.

56. The assembly of claim 54, wherein the stimulation electrode of each extendable electrode assembly is adjustable to extend from the respective needle to the unique respective location.

57. The assembly of claim 54, wherein the needle of at least one of the extendable electrode assemblies has a curved shape.

58. The assembly of claim 54, wherein the needle of at least one of the electrode assemblies comprises a superelastic metal alloy.

59. The assembly of claim 54, wherein the needle of at least one of the electrode assemblies comprises a shape memory metal alloy.

60. The assembly of claim 54, wherein the needle of at least one of the electrode assemblies comprises a nickel-titanium alloy.

61. The assembly of claim 53, wherein:

each of the array of extendable electrode assemblies comprises a relatively pliable tubular body with an inner lumen;

each stimulation electrode is located along the tubular body of the respective extendable electrode assembly; and

wherein each relatively pliable tubular body is adapted to be deflected and steered through the region of tissue so as to place the respective stimulation electrode at the respective unique location.

62. The assembly of claim 61, further comprising:

a moveable stylet that is adapted to be moveably engaged within the inner lumen of at least one of the tubular bodies so as to adjust the tubular body to extend from the distal end portion of the elongate body and advance through the region of tissue such that the respective stimulation electrode is positioned at the respective unique location.

63. The assembly of claim 62, wherein:

the moveable stylet has a proximal end portion and a shaped distal end portion that is torquable within the inner lumen by torquing the proximal end portion proximally and externally of the tubular body so as to deflect and steer the tubular body in order to place the electrode.

64. The assembly of claim 53, further comprising:

an anchor that is extendable from the elongate body and adapted to anchor the distal end portion at the location such that the array of extendable electrode assemblies is adapted to be positioned at the respective unique locations along the region of tissue.

65. The assembly of claim 64, wherein the anchor comprises a stimulation electrode.

66. The assembly of claim 65, wherein:

the distal end portion of the elongate body comprises a distal tip; and

a stimulation electrode is located at the distal tip.

67. The assembly of claim 51, wherein the cardiac stimulation assembly comprises:

a cardiac pacemaker.

68. The assembly of claim 67, wherein the cardiac pacemaker comprises:

a bi-ventricular cardiac pacemaker.

69. The assembly of claim 51, wherein the cardiac stimulation assembly comprises:

a cardiac defibrillator.

70. The assembly of claim 51, wherein the conductive agent comprises isolated living cells.

71. The assembly of claim 70, wherein the living cells comprise at least one of myoblasts, fibroblasts, or stem cells.

72. The assembly of claim 70, wherein the living cells are adapted to express a connexin at gap junctions with cardiac cells in the region of tissue.

73. The assembly of claim 72, wherein the living cells are adapted to express connexin 43 at the gap junctions.

74. The assembly of claim 73, wherein the living cells are genetically modified to over-express production of connexin 43.

75. The assembly of claim 51, wherein the conductive agent comprises an injectable preparation of a conductive non-living material that is adapted to enhance electrical conduction in the region.

76. The assembly of claim 75, wherein the conductive non-living material comprises an injectable preparation of a conductive metal.