Devices and methods for transluminal or transthoracic interstitial electrode placement

• US 20070100410A1
• Filed: 10/31/2006
• Published: 05/03/2007
• Est. Priority Date: 04/11/2002
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Makower, Joshua, Lamson, Theodore, Flaherty, J.
• Granted Patent: US 8,295,947 B2
• Time in Patent Office: Days
• US Class Current: 607/119
• CPC Class Codes: A61B 2017/22095 accessing a blood vessel true lumen from the sub-intimal space
• 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 2001/0578 having means for removal or extraction
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

Methods and devices for implanting pacing electrodes or other apparatus, or for delivering substances, to the heart of other tissues within the body. A guided tissue penetrating catheter is inserted into a body lumen (e.g., blood vessel) or into a body cavity or space (e.g., the pericardial space) and a penetrator is advanced from the catheter to a target location. In some embodiments, a substance or an apparatus (such as an electrode) may be delivered through a lumen in the penetrator. In other embodiments, a guidewire may be advanced through the penetrator, the penetrating catheter may then be removed and an apparatus (e.g., electrode) may then be advanced over that guidewire. Also disclosed are various implantable electrodes and electrode anchoring apparatus.

Claims

1-48. -48. (canceled)

49. A method for electrical stimulation of the heart of a human or animal subject, said method comprising the steps of:

A) providing a penetration catheter that comprises an elongate catheter body and a penetrator that has a hollow lumen, said penetrator being advanceable from a retracted position to an extended position;

B) inserting the penetration catheter into the subject'"'"'s vasculature and advancing it to a position within or adjacent to the subject'"'"'s heart;

C) advancing the penetrator into cardiac tissue;

D) implanting an electrode at a desired location in contact with cardiac tissue using an electrode delivery procedure selected from the group consisting of;

i) advancing the electrode through the penetrator lumen;

ii) advancing a guidewire through the penetrator lumen and thereafter advancing the electrode over the guidewire; and

ii) advancing a guidewire through the penetrator lumen, advancing a tract enlarging apparatus over the guidewire, using the tract enlarging apparatus to enlarge the tract created by the penetrator and/or the guidewire and, thereafter, advancing the electrode over the guidewire and through the enlarged penetration tract; and

E) actuating the electrode to deliver electrical stimulation to the heart.

50. A method according to claim 49 wherein the penetrator advances laterally from the penetration catheter body and wherein the penetration catheter further comprises an orientation element that is useable, while the penetrator is in its retracted position, to determine the lateral direction in which the penetrator will subsequently advance as it moves from its retracted position to its extended position, and wherein Step C comprises i) using the orientation element while the penetrator is in its retracted position to adjust the rotational orientation of the catheter body as needed to substantially ensure that subsequent movement of the penetrator to its extended position will cause penetrator to enter the desired location and ii) moving the penetrator from its retracted position to its extended position thereby causing the penetrator to penetrate to the desired location.

51. A method according to claim 49 wherein a single electrode is implanted.

52. A method according to claim 49 wherein at least Step D is carried out to implant a plurality of electrodes.

53. A method according to claim 52 wherein Step E comprises actuating a plurality of the electrodes simultaneously.

54. A method according to claim 52 wherein Step E comprises actuating a plurality of the electrodes separately.

55. A method according to claim 52, wherein the method further comprises:

actuating each electrode separately and determining a response caused by the separate actuation of each electrode;

selecting one or more electrodes that provide the most desirable response; and

,

thereafter actuating the selected one or more electrodes when it is desired to cause the response.

56. A method according to claim 52 wherein:

Step D comprises advancing a microlead having a plurality of spaced apart electrodes thereon through the penetrator lumen and into cardiac tissue; and

Step E comprises i) actuating the electrodes independently and determining a response to the independent actuation of each electrode, ii) selecting the response that is most desirable and, thereafter, iii) actuating the electrode that caused the response that was selected as most desirable.

57. A method according to claim 49 wherein the penetration catheter is advanced into a coronary blood vessel during Step B and the penetrator is advanced through the wall of the coronary blood vessel and into cardiac tissue during Step C.

58. A method according to claim 49 wherein cardiac pacing signals are delivered in Step E.

59. A method according to claim 49 wherein the electrode is adapted to be anchored in tissue and wherein Step D further comprises anchoring the electrode.

60. A method according to claim 49 further comprising the step of retracting the penetrator to its retracted position after the electrode has been implanted.

61. A method according to claim 60 further comprising the step of removing the penetrating catheter.

62. A method according to claim 49 further comprising the step of injecting a substance though the penetrator lumen.

63. A method according to claim 49 wherein the electrode comprises an expandable electrode and wherein Step D further comprises expanding the electrode.