Pacemaker which reestablishes or keeps the physiological electric conduction of the heart and a method of application

• US 8,346,358 B2
• Filed: 12/13/2005
• Issued: 01/01/2013
• Est. Priority Date: 12/20/2004
• Status: Active Grant

• Current Assignee: Newstim, Inc.
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Ortega, Daniel Felipe, Giniger, Alberto German
• Primary Examiner(s): DIETRICH, JOSEPH M
• Application Number:
  US11/300,242
• Publication Number:
  US 20060142812A1
• Time in Patent Office: 2,576 Days
• Field of Search: 607/9, 607/11, 607/15, 607/36, 607/122
• US Class Current: 607/9
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• 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 1/371 Capture, i.e. successful stimulation

Abstract

A pacemaker is disclosed which reestablishes or keeps the physiological electric conduction of the heart and a method of application. The pacemaker is a pulse generator, it has a ventricular output including at least two superimposed monopolar pulsewaves of reversed polarity between each other, with programmable configuration, with respect to a neutral which can be the pacemaker'"'"'s metallic box or a third electrode in the case of a tripolar catheter. The catheter can have a deflectable sheath, with an electrode on its distal tip. The invention consists of a new pacemaker, and a method of application in the right ventricular septum, being able to use in order to facilitate the implantation and to avoid the connection and the disconnection, a sheath to check a proper place and then screw the catheter in said place. This method and the pacemaker are the responsible of reestablishing or preserving the physiological electrical conduction of the heart due to the creation of an alternative electric circuit and to the creation of a virtual electrode.

Claims

1. A method comprising:

delivering electrostimulation pulses to a first septal location in the right ventricle of the heart near a His bundle to stimulate the conduction system of the heart near the His bundle, the electrostimulation pulses comprising at least partially overlapping opposite polarity signals;

determining if a resulting contraction of the ventricles elicited via the delivery of the electrostimulation pulses to the first location exhibits one or more of a normal depolarization-repolarization pattern and a narrow QRS;

delivering the electrostimulation pulses to a second septal location in response to a determination that the resulting contraction of the ventricles elicited via the delivery of the electrostimulation pulses to the first location did not exhibit one or more of a normal depolarization-repolarization pattern and a narrow QRS width; and

securing an electrode at the second septal location in response to a determination that the contraction elicited in response to delivering electrostimulation pulses to the second septal location exhibits one or more of a normal depolarization-repolarization pattern and a narrow QRS width.

2. The method of claim 1, wherein determining if a resulting contraction of the ventricles exhibits one or more of a normal depolarization-repolarization pattern and a narrow QRS includes determining if the depolarization-repolarization pattern of the resulting contraction includes a delay shorter than a delay associated with a conduction abnormality, the delays determined from an earliest QRS activation to the deflection corresponding to the left ventricle activation measured by a catheter placed in the coronary sinus.

3. The method of claim 1, wherein determining if a resulting contraction of the ventricles exhibits one or more of a normal depolarization-repolarization pattern and a narrow QRS includes determining whether the QRS width of the resulting contraction is narrower than a QRS width associated with a conduction abnormality.

4. The method of claim 1, wherein the heart manifests a bundle branch block that results in a QRS width that is longer in duration than a corresponding QRS width in the absence of the bundle branch block.

5. The method of claim 1, wherein the heart manifests a left bundle branch block that results in a QRS width that is longer in duration than a corresponding QRS width in the absence of the left bundle branch block.

6. The method of claim 1, wherein the heart manifests a bundle branch block that results in a large intrinsic QRS width and wherein the resulting contraction exhibits a narrow QRS relative to the intrinsic QRS width.

7. The method of claim 1, wherein the location in the right ventricle of the heart is sufficiently near a blocked region of the His bundle to produce electrical bypass of the blocked region.

8. The method of claim 1, wherein the delivered electrostimulation pulses improve the synchronicity of ventricular contractions in the heart, the improvement relative to intrinsic ventricular contractions.

9. The method of claim 1, comprising:

using a sheath including at least one sheath electrode to deliver the electrostimulation pulses at the septal location in the right ventricle of the heart near the His bundle.

10. The method of claim 9, comprising:

using the sheath to guide a catheter to a septal location at which contraction elicited via the electrostimulation pulses exhibits one or more of a normal depolarization-repolarization pattern and a narrow QRS width as compared with an QRS width associated with a conduction abnormality.

11. The method of claim 10, comprising:

receiving a signal indicative of electrical conduction of the heart in response to the delivered electrostimulation pulses;

in response to the received signal indicative of electrical conduction of the heart, providing a feedback signal useful for indicating that the at least one sheath electrode is at a location which is sufficiently near the His bundle to provide electrical bypass of a conduction abnormality of the heart.

12. The method of claim 1, wherein delivering the electrostimulation pulses comprises delivering unipolar signals.

13. The method of claim 1, wherein delivering the electrostimulation pulses comprises delivering biphasic electrostimulation signals.

14. The method of claim 1, comprising, after securing the pacing electrode, removing the sheath and then delivering the electrostimulation pulses to the heart using the electrode.