Leadless cardiac stimulation systems

• US 9,072,911 B2
• Filed: 06/27/2013
• Issued: 07/07/2015
• Est. Priority Date: 10/20/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Hastings, Roger, Drasler, William J., Lafontaine, Daniel M., Sadasiva, Anupama, Smith, Scott R.
• Primary Examiner(s): Heller, Tammie K
• Application Number:
  US13/929,286
• Publication Number:
  US 20140012344A1
• Time in Patent Office: 740 Days
• Field of Search: 607126-127
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/059 Anchoring means
• 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 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/37223 Circuits for electromagnetic coupling
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/37241 providing test stimulations
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

Various configurations of systems that employ leadless electrodes to provide pacing therapy are provided. In one example, a system that provides multiple sites for pacing of myocardium of a heart includes wireless pacing electrodes that are implantable at sites proximate the myocardium using a percutaneous, transluminal, catheter delivery system. Each of the electrodes contains a source of electrical energy for pacing the myocardium and is adapted to receive electromagnetic energy from a source outside the myocardium. The system also includes a source adapted for placement outside the myocardium and that uses locally measured electrocardiograms to synchronize pacing of the heart by sending electromagnetic commands to the electrodes to pace the myocardium surrounding the electrodes. Also disclosed is various configurations of such systems, wireless electrode assemblies, and delivery catheters for delivering and implanting the electrode assemblies.

Claims

1. An implantable wireless electrostimulation electrode assembly, including:

a body portion sized and shaped for intravascular delivery to a location within a heart;

a first spring mechanically coupled to the body portion and aligned along a longitudinal axis of the body portion, the first spring having a first rotational orientation and configured to securely engage heart tissue when rotated about the longitudinal axis in a first direction;

a second spring having a second rotational orientation opposite the first rotational orientation, the second spring mechanically coupled to the body portion and configured to securely engage heart tissue to event rotation and translation of the body through heart tissue together with the first spring; and

an electrostimulation circuit included with the body portion and configured to deliver an electrostimulation to the heart using an electrostimulation electrode;

wherein the first and second springs are electrically isolated from the electrostimulation circuit.

2. The implantable wireless electrostimulation electrode assembly of claim 1, wherein the body portion is configured to be manipulated using an actuator rod;

and

wherein the body portion includes a region configured to mechanically couple the actuator rod to the body portion.

3. The implantable wireless electrostimulation electrode assembly of claim 2, wherein the first spring is configured to be deployed from a stowed configuration to an actuated configuration in response to user actuation of the actuator rod.

4. The implantable wireless electrostimulation electrode assembly of claim 2, wherein the second spring is configured to engage heart tissue in response to actuation of an elongate member by a user.

5. The implantable wireless electrostimulation electrode assembly of claim 4, wherein the elongate member includes a sheath;

and

wherein the second spring is configured to engage heart tissue in response to retraction of the sheath by the user.

6. The implantable wireless electrostimulation electrode assembly of claim 2, wherein the region configured to mechanically couple the actuator rod to the body portion is configured to decouple the body portion from the actuator rod in response to a user actuation.

7. The implantable wireless electrostimulation electrode assembly of claim 6, wherein the user actuation includes a rotation of the actuator rod.

8. The implantable wireless electrostimulation electrode assembly of claim 6, wherein the user actuation includes triggering heating and wherein the region configure to mechanically couple the actuator rod to the body portion decouples the body portion of the actuator rod in response to the heating.

9. The implantable wireless electrostimulation electrode assembly of claim 6, wherein the electrostimulation circuit is configured to deliver a specified electrostimulation to the heart for evaluation of a prospective electrostimulation site before the actuator rod is decoupled from the body portion.

10. The implantable wireless electrostimulation electrode assembly of claim 1, wherein the first spring is oriented in a first direction with respect to the body portion;

and

wherein the second spring is oriented n a different second direction with respect to the first direction.

11. The implantable wireless electrostimulation electrode assembly of claim 1, wherein one of the first or second springs includes an electrostimulation electrode coupled to the electrostimulation circuit.

12. A system, comprising:

a first intravascularly-deliverable elongate member defining a lumen;

an implantable wireless electrostimulation electrode assembly, including;

a body portion sized and shaped for intravascular delivery to a location within a heart via the lumen;

a first spring mechanically coupled to the body portion and aligned along a longitudinal axis of the body portion, the first spring having a first rotational orientation and configured to securely engage heart tissue when rotated about the longitudinal axis in a first direction;

a second spring having a second rotational orientation opposite the first rotational orientation, the second spring mechanically coupled to the body portion and configured to securely engage heart tissue to prevent rotation and translation of the body through heart tissue together with the first spring; and

an electrostimulation circuit included with the body portion and configured to deliver an electrostimulation to the heart using an electrostimulation electrode; and

an actuator rod mechanically coupled to a region of the body portion, the actuator configured to manipulate the body portion of the implantable wireless electrode assembly, the actuator rod sized and shaped to pass through the lumen;

wherein the first and second springs are electrically isolated from the electrostimulation circuit.

13. The system of claim 12, wherein the first spring is configured to be deployed from a stowed configuration to an actuated configuration in response to user actuation of the actuator rod.

14. The system of claim 12, comprising a second elongate member sized and shaped to pass through the lumen;

wherein the second spring is configured to engage heart tissue in response to actuation of the second elongate member by a user.

15. The implantable wireless electrostimulation electrode assembly of claim 14, wherein the second elongate member includes a sheath;

and

wherein the second spring is configured to engage heart tissue in response to retraction of the sheath by the user.

16. The system of claim 12, wherein the actuator rod configured to decouple from the region of the body portion in response to a user actuation.

17. The system of claim 16, wherein the user actuation includes a rotation of the actuator rod.

18. The system of claim 16, wherein the electrostimulation circuit is configured to deliver a specified electrostimulation to the heart for evaluation of a prospective electrostimulation site before the actuator rod is decoupled from the body portion.

19. An implantable wireless electrostimulation electrode assembly, including:

a body portion sized and shaped for intravascular delivery to a location within a heart;

a first spring mechanically coupled to the body portion and aligned along a longitudinal axis of the body portion, the first spring having a first rotational orientation including a first helical portion extending outward from the body portion and configured to securely engage heart tissue when rotated in a first direction around the longitudinal axis of the body portion;

a second spring having a second rotational orientation opposite the first rotational orientation, the second spring mechanically coupled to the body portion and including a second helical portion extending outward from the body portion and configured to securely engage heart tissue to prevent rotation and translation of the body through heart tissue together with the first spring; and

an electrostimulation circuit included with the body portion and configured to deliver an electrostimulation to the heart using an electrostimulation electrode;

wherein the first and second springs are electrically isolated from the electrostimulation circuit.

20. The implantable wireless electrostimulation electrode assembly claim 19, wherein the electrostimulation circuit is configured to deliver a specified electrostimulation to the heart for evaluation of a prospective electrostimulation site before an actuator rod is decoupled from the body portion.