Leadless cardiac stimulation systems

• US 9,925,386 B2
• Filed: 03/02/2016
• Issued: 03/27/2018
• Est. Priority Date: 10/20/2004
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (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:
  US15/058,920
• Publication Number:
  US 20160175599A1
• Time in Patent Office: 755 Days
• 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. A method for implanting a leadless cardiac stimulation assembly into a heart of a patient, the leadless cardiac stimulation assembly having a stimulation electrode at or near its distal end, the method comprising:

delivering the leadless cardiac stimulation assembly adjacent to a first implant site within the heart of the patient using a delivery catheter with the leadless cardiac stimulation assembly disposed entirely within a distal end of the delivery catheter;

advancing at least part of the leadless cardiac stimulation assembly, including the stimulation electrode, out the distal end of the delivery catheter to engage the first implant site;

with the leadless cardiac stimulation assembly at the first implant site, and with at least part of the leadless cardiac stimulation assembly including the stimulation electrode advanced out the distal end of the delivery catheter and in engagement with the first implant site, and while retaining a connection to the leadless cardiac stimulation assembly, pacing the heart at the first implant site using the stimulation electrode of the leadless cardiac stimulation assembly;

when a response to the pacing at the first implant site is acceptable, releasing the connection to the leadless cardiac stimulation assembly and withdrawing the delivery catheter from the heart; and

when the response to the pacing at the first implant site is not acceptable, repositioning the leadless cardiac stimulation assembly from the first implant site to a second implant site via the delivery catheter, wherein the second implant site is different from the first implant site, and while retaining a connection to the leadless cardiac stimulation assembly, pacing the heart at the second implant site using the stimulation electrode of the leadless cardiac stimulation assembly.

2. The method of claim 1, further comprises retaining the connection with the leadless cardiac stimulation assembly via a tether.

3. The method of claim 2, wherein the tether extends through the delivery catheter.

4. The method of claim 1, wherein the leadless cardiac stimulation assembly is repositioned from the first implant site to the second implant site while at least part of the leadless cardiac stimulation assembly is within the distal part of the delivery catheter.

5. The method of claim 1, further comprising pushing the leadless cardiac stimulation assembly out of the distal part of the delivery catheter.

6. The method of claim 5, wherein the leadless cardiac stimulation assembly comprises an anchor mechanism for securing the leadless cardiac stimulation assembly to the heart, and wherein the anchor mechanism is deployed to engage the heart as the leadless cardiac stimulation assembly is pushed out of the distal part of the delivery catheter.

7. The method of claim 6, wherein the anchor mechanism comprises tines, and wherein the tines are deployed by pushing the leadless cardiac stimulation assembly out of the distal part of the delivery catheter and freeing the tines from constraints imposed by being confined in the distal part of the delivery catheter.

8. The method of claim 1, wherein the leadless cardiac stimulation assembly comprises an anchor mechanism for securing the leadless cardiac stimulation assembly to the heart.

9. The method of claim 1, further comprising sending a first wireless signal to the leadless cardiac stimulation assembly, which causes the leadless cardiac stimulation assembly to pace the heart at the first implant site.

10. The method of claim 9, wherein when the response to the pacing at the first implant site is not acceptable, and the leadless cardiac stimulation assembly is repositioned from the first implant site to the second implant site via the delivery device, the method further comprising sending a second wireless signal to the leadless cardiac stimulation assembly, which causes the leadless cardiac stimulation assembly to pace the heart at the second implant site.

11. The method of claim 1, wherein repositioning the leadless cardiac stimulation assembly from the first implant site to the second implant site comprises retracting at least part of the leadless cardiac stimulation assembly into the distal end of the delivery catheter, moving the distal end of the delivery catheter adjacent to the second implant site, and then advancing at least part of the leadless cardiac stimulation assembly relative to the delivery catheter to engage the second implant site.

12. The method of claim 11, further comprises retaining the connection with the leadless cardiac stimulation assembly via a tether, and wherein retracting at least part of the leadless cardiac stimulation assembly into the distal end of the delivery catheter comprising pulling the leadless cardiac stimulation assembly toward the delivery catheter via the tether.

13. A method for implanting a leadless cardiac stimulation assembly into a heart of a patient, the leadless cardiac stimulation assembly having a stimulation electrode at or near its distal end, the method comprising:

delivering the leadless cardiac stimulation assembly adjacent to a first implant site within the heart of the patient using a delivery catheter with the leadless cardiac stimulation assembly disposed entirely within a distal end of the delivery catheter;

advancing at least part of the leadless cardiac stimulation assembly, including the stimulation electrode, out the distal end of the delivery catheter to engage the first implant site;

sending a first wireless signal to the leadless cardiac stimulation assembly;

with the leadless cardiac stimulation assembly at the first implant site in the heart, and in response to the first wireless signal, pacing the heart using the stimulation electrode of the leadless cardiac stimulation assembly; and

when a detected response to the pacing at the first implant site is not acceptable, repositioning the leadless cardiac stimulation assembly from the first implant site to a second implant site via the delivery catheter while retaining a connection to the leadless cardiac stimulation assembly, wherein the second implant site is different from the first implant site, and pacing the heart at the second implant site using the stimulation electrode of the leadless cardiac stimulation assembly.

14. The method of claim 13, wherein the leadless cardiac stimulation assembly comprises sensing circuitry for detecting the response.

15. The method of claim 13, wherein when the detected response to the pacing at the first implant site is not acceptable, and the leadless cardiac stimulation assembly is repositioned from the first implant site to the second implant site, the method further comprising sending a second wireless signal to the leadless cardiac stimulation assembly, which causes the leadless cardiac stimulation assembly to pace the heart at the second implant site.

16. A method for implanting a leadless cardiac stimulation assembly into a heart of a patient, the leadless cardiac stimulation assembly having a stimulation electrode at or near its distal end, the method comprising:

delivering the leadless cardiac stimulation assembly adjacent to a first implant site of the heart of the patient using a delivery catheter with the leadless cardiac stimulation assembly disposed entirely within the delivery catheter;

advancing at least part of the leadless cardiac stimulation assembly, including the stimulation electrode, out the delivery catheter to engage the first implant site;

with the leadless cardiac stimulation assembly at the first implant site of the heart, receiving a first wireless signal at the leadless cardiac stimulation assembly, which causes the leadless cardiac stimulation assembly to pace the heart using the stimulation electrode of the leadless cardiac stimulation assembly;

detecting a response of the heart to the pacing; and

when the detected response to the pacing at the first implant site is not acceptable, repositioning the leadless cardiac stimulation assembly from the first implant site to a second implant site using the delivery catheter while retaining a connection to the leadless cardiac stimulation assembly, wherein the second implant site is different from the first implant site, and with the leadless cardiac stimulation assembly at the second implant site in the heart, receiving a second wireless signal at the leadless cardiac stimulation assembly, which causes the leadless cardiac stimulation assembly to pace the heart at the second implant site using the stimulation electrode of the leadless cardiac stimulation assembly.

17. The method of claim 16, wherein the leadless cardiac stimulation assembly remains connected to a tether when repositioning the leadless cardiac stimulation assembly from the first implant site to a second implant site.

18. The method of claim 17, further comprising releasing the leadless cardiac stimulation assembly from the tether when the detected response to the pacing at the first implant site is acceptable.