Automatic capture verification within leadless implantable medical devices

• US 10,004,907 B2
• Filed: 02/21/2014
• Issued: 06/26/2018
• Est. Priority Date: 02/21/2014
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Bornzin, Gene A.
• Primary Examiner(s): Voorhees, Catherine
• Application Number:
  US14/186,658
• Publication Number:
  US 20150238768A1
• Time in Patent Office: 1,586 Days
• CPC Class Codes: A61N 1/0565 Electrode heads
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 1/371 Capture, i.e. successful stimulation
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

In one example, a leadless implantable medical device (LIMD) generates a cathodal stimulation pulse with anodal recharge for delivery to patient heart tissues using the tip electrode and the anode electrode. The LIMD then verifies capture of the cathodal stimulation pulse and, if capture is not verified, delivers a cathodal backup stimulation pulse with anodal recharge using the tip electrode and the anode electrode. Automatic capture verification is thereby provided within an LIMD to allow for a reduction in the magnitude of stimulation pulses and to extend the lifetime of the device. In one particular example, the anode is a middle portion of a cylindrical case with a surface area sufficient to prevent anodal stimulation. Other portions of the case are coated with an electrically insulating material to render those portions substantially electrically inert. A voltage halver may be used to further reduce power consumption.

Claims

1. A leadless implantable medical device (LIMD) for implant within the heart of a patient, comprising:

a case, wherein at least a portion of the case being configured as an anode electrode, wherein the anode electrode has a surface area of at least 133 mm² to substantially prevent anodal stimulation;

a tip electrode extending from the case;

a pulse generator coupled to the tip electrode and the anode electrode and equipped to generate a cathodal stimulation pulse for delivery to patient tissues with an anodal recharge;

a sensing system equipped to sense electrocardiac signals using the tip electrode with reference to the anode electrode; and

an automatic capture verification system operative to verify capture of the cathodal stimulation pulse based on sensed electrocardiac signals.

2. The LIMD of claim 1 further comprising a backup stimulation pulse system operative upon loss of capture to control the pulse generator to generate a cathodal backup stimulation pulse, the backup stimulation pulse also delivered using the tip and anode electrodes with anodal recharge.

3. The LIMD of claim 1 wherein the automatic capture verification system includes a digital processor coupled to the sensing system and equipped to detect a derivative of the evoked response to verify capture.

4. The LIMD of claim 1 wherein the tip electrode comprises an active fixation screw-in electrode.

5. The LIMD of claim 1 wherein the tip electrode and the anode electrode are spaced from one another by a distance in the range of 5 to 17 mm.

6. The LIMD of claim 1 wherein the anode electrode is coated with a low-polarization coating by an amount sufficient to reduce polarization due to pacing pulses to acceptable levels for capture verification.

7. The method of claim 6 wherein the low-polarization coating includes one or more of tin, iridium oxide, and platinum black.

8. The LIMD of claim 1 wherein the anode electrode comprises a cylindrical portion of the case that is substantially electrically un-insulated.

9. The LIMD of claim 8 wherein the anode portion of the case has a length in the range of 7 to 8 mm from a proximal to a distal end.

10. The LIMD of claim 8 wherein at least a portion of the case, excluding the anodal portion, is coated with a material sufficient to render it substantially electrically inert.

11. The LIMD of claim 10 wherein the material coating the portion of the case excluding an uninsulated anodal portion is perylene.

12. The LIMD of claim 1 wherein the LIMD further comprises a single feedthrough connecting the cathode electrode to the pulse generator and to the sensing system.

13. The LIMD of claim 1 configured for implant within the right ventricle of the heart of the patient.

14. The LIMD of claim 1 further comprising a voltage halver equipped to selectively half a voltage of power generated by a power supply of the device prior to generation of a cathodal stimulation pulse.

15. The LIMD of claim 14 wherein the voltage halver is selectively invoked for pulses of 1.25 volts or less.

16. A system for use with a leadless implantable medical device (LIMD) for implant within a patient, the LIMD having a tip electrode and an anode electrode, the system comprising:

means for generating a cathodal stimulation pulse with anodal recharge for delivery to patient tissues using the tip electrode and the anode electrode, wherein the anode electrode has a surface area of at least 133 mm² to substantially prevent anodal stimulation;

means for verifying capture of the cathodal stimulation pulse; and

means for delivering a cathodal backup stimulation pulse with anodal recharge using the tip electrode and the anode electrode when capture is not verified.

17. A leadless implantable medical device (LIMD) for implant within the heart of a patient, comprising:

a case, wherein at least a portion of the case being configured as an anode electrode;

a tip electrode extending from the case;

a pulse generator coupled to the tip electrode and the anode electrode and equipped to generate a cathodal stimulation pulse for delivery to patient tissues with an anodal recharge;

a sensing system equipped to sense electrocardiac signals using the tip electrode with reference to the anode electrode; and

an automatic capture verification system operative to verify capture of the cathodal stimulation pulse based on sensed electrocardiac signals, wherein the automatic capture verification system includes a biquad amplifier coupled to the sensing system with a center frequency and a Q value sufficient to detect a positive derivative within the electrocardiac signals to verify capture.

18. The LIMD of claim 17 wherein the center frequency of the biquad amplifier is about 50 hertz and the Q value of the biquad amplifier is about 1.4.