Subcutaneous implantable cardioverter/defibrillator

• US 20060122649A1
• Filed: 12/03/2004
• Published: 06/08/2006
• Est. Priority Date: 12/03/2004
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Ghanem, Raja N., Olson, Walter H.
• Granted Patent: US 7,496,408 B2
• Time in Patent Office: Days
• US Class Current: 607/9
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/3629 in combination with non-electric therapy

Abstract

A cardiac pacemaker and method of its use. The pacemaker is provided with a pacing electrode array configured for location at a left anterior portion of a patient'"'"'s thorax between the patients third and sixth ribs, outside the patient'"'"'s thoracic cavity. The pacing electrode array includes multiple pacing electrodes and preferably includes one or more steering electrodes for configuring the electrical field produced by delivery of pacing pulses to avoid unwanted nerve and muscle stimulation while allowing cardiac stimulation. The electrode array may be located subcutaneously, submuscularly or on the patient'"'"'s skin.

Claims

23. A method of cardiac pacing, comprising:

applying an array of at least three pacing electrodes each having surface areas of about two square centimeters or less to a patient'"'"'s thorax, outside of the patient'"'"'s thoracic cavity and delivering pacing pulses to the electrode array.

24. A method according to claim 23 wherein applying the array comprises implanting the array subcutaneously.

25. A method according to claim 23 or claim 24, wherein delivering pacing pulses comprises selecting at least one pair of the electrodes of the array and delivering pacing pulses to the selected pair.

26. A method according to claim 25 wherein the array is located on at least one medical electrical lead and wherein placing the array comprises placing the lead and wherein delivering pacing pulses comprises delivering pulses to the electrodes via the lead.

27. A method according to claim 25 wherein the array is located on the housing of a cardiac pacemaker and wherein placing the array comprises placing the pacemaker.

28. A method according to claim 23 or claim 24, wherein delivering pacing pulses comprises delivering pacing pulses to at least three electrodes of the array.

29. A method according to claim 28 wherein the array is located on at least one medical electrical lead and wherein placing the array comprises placing the lead and wherein delivering pacing pulses comprises delivering pulses to the electrodes via the lead.

30. A method according to claim 28 wherein the array is located on the housing of a cardiac pacemaker and wherein placing the array comprises placing the pacemaker.

31. A method according to claim 23 or claim 24, wherein delivering pacing pulses comprises delivering pacing pulses to at least three electrodes of the array such that a first and second of the electrodes are at a first polarity and a third of the electrodes is at an opposite polarity.

32. A method according to claim 31 wherein delivering pacing pulses comprises delivering pacing pulses such that energy delivered between the first and third electrodes is different from energy delivered between the first and second electrodes.

33. A method according to claim 31 wherein delivering pacing pulses further comprises adjusting relative energy levels delivered between the first and third electrodes and the first and second electrodes.

34. A method according to claim 31 wherein the array is located on at least one medical electrical lead and wherein placing the array comprises placing the lead and wherein delivering pacing pulses comprises delivering pulses to the electrodes via the lead.

35. A method according to claim 31 wherein the array is located on the housing of a cardiac pacemaker and wherein placing the array comprises placing the pacemaker.

36. A method of cardiac pacing, comprising:

applying an array comprising least three pacing electrodes and having a maximum dimension of no more than about 12 centimeters to a patient'"'"'s thorax, outside of the patient'"'"'s thoracic cavity and delivering pacing pulses to the electrode array.

37. A method according to claim 36 wherein applying the array comprises implanting the array subcutaneously.

38. A method according to claim 36 or claim 37, wherein delivering pacing pulses comprises selecting at least one pair of the electrodes of the array and delivering pacing pulses to the selected pair.

39. A method according to claim 38 wherein the array is located on at least one medical electrical lead and wherein placing the array comprises placing the lead and wherein delivering pacing pulses comprises delivering pulses to the electrodes via the lead.

40. A method according to claim 38 wherein the array is located on the housing of a cardiac pacemaker and wherein placing the array comprises placing the pacemaker.

41. A method according to claim 36 or claim 37, wherein delivering pacing pulses comprises delivering pacing pulses to at least three electrodes of the array.

42. A method according to claim 41 wherein the array is located on at least one medical electrical lead and wherein placing the array comprises placing the lead and wherein delivering pacing pulses comprises delivering pulses to the electrodes via the lead.

43. A method according to claim 41 wherein the array is located on the housing of a cardiac pacemaker and wherein placing the array comprises placing the pacemaker.

44. A method according to claim 36 or claim 37, wherein delivering pacing pulses comprises delivering pacing pulses to at least three electrodes of the array such that a first and second of the electrodes are at a first polarity and a third of the electrodes is at an opposite polarity.

45. A method according to claim 44 wherein delivering pacing pulses comprises delivering pacing pulses such that energy delivered between the first and third electrodes is different from energy delivered between the first and second electrodes.

46. A method according to claim 44 wherein delivering pacing pulses further comprises adjusting relative energy levels delivered between the first and third electrodes and the first and second electrodes.

47. A method according to claim 44 wherein the array is located on at least one medical electrical lead and wherein placing the array comprises placing the lead and wherein delivering pacing pulses comprises delivering pulses to the electrodes via the lead.

48. A method according to claim 44 wherein the array is located on the housing of a cardiac pacemaker and wherein placing the array comprises placing the pacemaker.

52. A cardiac pacemaker, comprising:

a pacing electrode array comprising two outer electrodes and a central electrode located between the two outer electrodes and a first steering electrode laterally offset from the outer and central electrodes; and

pacing pulse generator means for delivering pacing pulses to the outer and central electrodes with the outer electrodes at a first polarity and the central electrode a second polarity and to the first steering electrode at the same polarity as the outer electrodes.

1. A method of cardiac pacing, comprising:

placing an array of at least two pacing electrodes each having surface areas of approximately two square centimeters or less at the left anterior portion of a patients thorax, between the patient'"'"'s third and sixth ribs; and

delivering pacing pulses to the electrode array.

2. A method according to claim 1 wherein placing the array comprises placing the array subcutaneously.

3. A method according to claim 1 or claim 2 wherein:

the array comprises an outer electrode and a central electrode located concentrically within the outer electrode; and

wherein delivering pacing pulses comprises delivering the pacing pulses to the ring and central electrode, with the outer electrode at a first polarity and the central electrode a second polarity.

4. A method according to claim 3 wherein the array further comprises a steering electrode laterally offset from the outer and central electrodes and the method further comprises delivering electrical pulses to the steering electrode.

5. A method according to claim 4 wherein delivering electrical pulses to the steering electrode further comprises adjusting the energy of the electrical pulses.

6. A method according to claim 3 wherein the array comprises multiple steering electrodes laterally offset from the outer and central electrodes, the method further comprising selecting a steering electrode and delivering electrical pulses to the selected steering electrode at the same polarity as the outer electrode.

9. A method according to claim 1 or claim 2 wherein:

the array comprises two outer electrodes and a central electrode located between the two outer electrodes and wherein delivering pacing pulses comprises delivering the pacing pulses to the outer and central electrodes with the outer electrodes at a first polarity and the central electrode a second polarity.

10. A method according to claim 9 wherein the array further comprises a steering electrode laterally offset from the outer and central electrodes, the method further comprising delivering electrical pulses to the steering electrode at the same polarity as the outer electrodes.

11. A method according to claim 10 wherein delivering electrical pulses to the steering electrode further comprises adjusting the energy of the electrical pulses.

12. A method according to claim 9 wherein the array comprises multiple steering electrodes laterally offset from the outer and central electrodes, the method further comprising selecting a steering electrode and delivering electrical pulses to the selected steering electrode at the same polarity as the outer electrode.

13. A method according to claim 9 wherein the array is located on at least one medical electrical lead and wherein placing the array comprises placing the lead and wherein delivering pacing pulses comprises delivering pulses to the electrodes via the lead.

14. A method according to claim 9 wherein the array is located on the housing of a cardiac pacemaker and wherein placing the array comprises placing the pacemaker.

15. A method according to claim 1 or claim 2 wherein:

the array comprises first, second and third electrodes; and

wherein delivering pacing pulses comprises delivering the pacing pulses to the first, second and third electrodes with the first and third electrodes at a first polarity and the second electrode at a second polarity.

16. A method according to claim 15 wherein delivering pacing pulses to the first, second and third electrodes comprises delivering the pacing pulses such that energy delivered between the first and second electrodes is less then energy delivered between the second and third electrodes.

17. A method according to claim 15 wherein delivering pacing pulses to the first, second and third electrodes further comprises adjusting energies of the pacing pulses.

18. A method according to claim 15 wherein the array is located on at least one medical electrical lead and wherein placing the array comprises placing the lead and wherein delivering pacing pulses comprises delivering pulses to the electrodes via the lead.

19. A method according to claim 15 wherein the array is located on the housing of a cardiac pacemaker and wherein placing the array comprises placing the pacemaker.

20. A method according to claim 1 or claim 2 wherein:

the array comprises at least three electrodes; and

wherein delivering pacing pulses comprises electing at least two of the electrodes and delivering the pacing pulses to the selected electrodes.

49. A method according to any of claims 1, 2, 23, or 36, further comprising delivering prepulse inhibition pulses prior to delivering pacing pulses.

50. A method according to any of claims 1, 2, 23, or 36, further comprising delivering neurostimulation pulses in conjunction with delivering pacing pulses.

51. A method according to any of claims 1, 2, 23, or 36, further comprising delivering a drug in conjunction with delivering pacing pulses.

53. A pacemaker according to claim 52 wherein the pacemaker is an implantable pacemaker having a device housing and wherein the pacing electrode array located on the device housing.

54. A pacemaker according to claim 52 wherein the pacemaker is an external pacemaker provided with an implantable lead and wherein the pacing electrode array located on the implantable lead.

55. A pacemaker according to claim 52 wherein the pacemaker is an external pacemaker provided with an external lead and wherein the pacing electrode array is located on the external lead.

61. A pacemaker according to claim 52 or claim 56, wherein the pacemaker further comprises means for adjusting pacing pulse energy delivered between pairs of electrodes within the pacing electrode array.

62. A pacemaker according to claim 52 or claim 56, wherein the pacemaker further comprises a second steering electrode and an electrode selector operable to select delivery of pacing pulses to either of the first and second steering electrodes.

70. A pacemaker according to claim 52 or claim 56 or claim 63, wherein the pacemaker further comprises a neurostimulator operable in conjunction with the pacing pulse generator means.

71. A pacemaker according to claim 52 or claim 56 or claim 63, wherein the pacemaker further comprises a drug dispenser operable in conjunction with the pacing pulse generator means.

72. A pacemaker according to claim 52 or claim 56 or claim 63, wherein the pacemaker further comprises means for providing prepulse inhibition pulses prior to delivery of pacing pulses.

53-1. A pacemaker according to claim 52 wherein the pacemaker is an implantable pacemaker provided with an implantable lead and wherein the pacing electrode array located on the implantable lead.

56. A cardiac pacemaker, comprising:

a pacing electrode array comprising an outer ring electrode and a central electrode located concentric to the two outer ring electrode and a first steering electrode laterally offset from the outer ring and central electrodes; and

pacing pulse generator means for delivering pacing pulses to the outer and central electrodes with the outer and ring electrodes at differing polarities and to the first steering electrode at the same polarity as one of the outer ring and central electrodes.

57. A pacemaker according to claim 56 wherein the pacemaker is an implantable pacemaker having a device housing and wherein the pacing electrode array located on the device housing.

58. A pacemaker according to claim 56 wherein the pacemaker is an implantable pacemaker provided with an implantable lead and wherein the pacing electrode array located on the implantable lead.

59. A pacemaker according to claim 56 wherein the pacemaker is an external pacemaker provided with an implantable lead and wherein the pacing electrode array located on the implantable lead.

60. A pacemaker according to claim 56 wherein the pacemaker is an external pacemaker provided with an external lead and wherein the pacing electrode array is located on the external lead.

63. A cardiac pacemaker, comprising:

a pacing electrode array comprising two concentric ring electrodes and a central electrode located concentric to the ring electrodes;

an electrode selector operable to select two electrodes within the electrode array; and

pacing pulse generator means for delivering pacing pulses to the selected electrodes with the selected electrodes at differing polarities.

64. A pacemaker according to claim 63 wherein the pacemaker is an implantable pacemaker having a device housing and wherein the pacing electrode array located on the device housing.

65. A pacemaker according to claim 63 wherein the pacemaker is an implantable pacemaker provided with an implantable lead and wherein the pacing electrode array located on the implantable lead.

66. A pacemaker according to claim 63 wherein the pacemaker is an external pacemaker provided with an implantable lead and wherein the pacing electrode array located on the implantable lead.

67. A pacemaker according to claim 63 wherein the pacemaker is an external pacemaker provided with an external lead and wherein the pacing electrode array is located on the external lead.

68. A pacemaker according to claim 63, wherein the pacemaker further comprises means for adjusting pacing pulse energy delivered between pairs of electrodes within the pacing electrode array.

69. A pacemaker according to claim 63, wherein the pacemaker further comprises a second steering electrode and an electrode selector operable to select delivery of pacing pulses to either of the first and second steering electrodes.