LEADLESS CARDIAC STIMULATION SYSTEMS

• US 20140012344A1
• Filed: 06/27/2013
• Published: 01/09/2014
• 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.
• Granted Patent: US 9,072,911 B2
• Time in Patent Office: Days
• US Class Current: 607/17
• 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. (canceled)

2. An implantable wireless electrostimulation electrode assembly, including:

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

a first helical tine mechanically coupled to the body portion and configured to securely engage heart tissue when rotated in a first direction;

a second helical tine mechanically coupled to the body portion and configured to securely engage heart tissue when rotated in a second direction opposite the first direction; and

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

3. The implantable wireless electrostimulation electrode assembly of claim 2, 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.

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

5. The implantable wireless electrostimulation electrode assembly of claim 3, wherein the second helical tine is configured to engage heart tissue in response to actuation of an elongate member by a user.

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

and

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

7. The implantable wireless electrostimulation electrode assembly of claim 3, 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.

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

9. The implantable wireless electrostimulation electrode assembly of claim 7, wherein the user actuation includes triggering heating and wherein the region configured to mechanical couple the actuator rod to the body portion decouples the body portion of the actuator rod in response to the heating.

10. The implantable wireless electrostimulation electrode assembly of claim 7, 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.

11. The implantable wireless electrostimulation electrode assembly of claim 2, wherein the first helical tine is oriented in a first direction with respect to the body portion;

and

wherein the second helical tine is oriented in a different second direction with respect to the first direction.

12. The implantable wireless electrostimulation electrode assembly of claim 2, wherein one of the first or second helical tines includes an electrostimulation electrode coupled to the electrostimulation circuit.

13. 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 helical tine mechanically coupled to the body portion and configured to securely engage heart tissue when rotated in a first direction;

a second helical tine mechanically coupled to the body portion and configured to securely engage heart tissue when rotated in a second direction opposite the first direction; 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;

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

15. The system of claim 13, comprising a second elongate member sized and shaped to pass through the lumen;

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

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

and

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

17. The system of claim 13, wherein the actuator rod configured to decouple from the region of the body portion in response to a user actuation.

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

19. The system of claim 17, 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.

20. An implantable wireless electrostimulation electrode assembly, including:

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

a first helical tine mechanically coupled to the body portion and having a first orientation;

a second helical tine mechanically coupled to the body portion and having a different second orientation opposite the first orientation;

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

21. The implantable wireless electrostimulation electrode assembly claim 20, 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.