Systems and methods for automated capture threshold testing and associated his bundle pacing

Patent metadata

Field	Value
Publication number	US-10981001-B2
Application number	US-201715653357-A
Country	US
Kind code	B2
Filing date	Jul 18, 2017
Priority date	Jul 18, 2017
Publication date	Apr 20, 2021
Grant date	Apr 20, 2021

Abstract

A method of pacing a His bundle of a patient heart using a stimulation system including a memory, a pulse generator, a stimulating electrode and at least one sensing electrode includes applying a plurality of impulses through the stimulating electrode to induce a plurality of responses from the patient heart. Each impulse of the plurality of impulses is delivered at a different impulse energy corresponding to a respective output setting of the stimulation system. The response characteristics for each of the plurality of responses are measured and each impulse is assigned a classification based on whether the respective response characteristics indicate capture of one or both of the His bundle and a ventricle of the patient heart. The output setting and classification for each impulse is then stored in the memory.

First claim

What is claimed:

1. A method of pacing a His bundle of a patient heart using a stimulation system, the stimulation system having a memory, a pulse generator, a stimulating electrode disposed in proximity to the His bundle, and at least one sensing electrode adapted to sense electrical activity of the patient heart, the method comprising:
applying, using the pulse generator, a plurality of impulses through the stimulating electrode to induce a plurality of responses from the patient heart, the plurality of impulses having different impulse energies corresponding to a respective output setting of the stimulation system;
measuring, using the sensing electrode, response characteristics for the plurality of responses;
assigning corresponding classifications to the plurality of responses based on whether the respective response characteristics indicate capture of one or both of the His bundle and a ventricle of the patient heart, the response characteristics including an evoked response delay, the assigning based at least in part on the evoked response delay; and
for each impulse, storing each of the output setting and the classification associated with the impulse in the memory.

2. The method of claim 1 , wherein the response characteristics further include a QRS complex duration, the assigning comprising assigning a classification of selective HIS bundle capture when the response characteristic has a first QRS complex and assigning a classification of non-selective HIS bundle capture when the response characteristic has a second QRS complex that is wider than the first QRS complex.

3. The method of claim 2 , wherein determining the QRS complex duration comprises:
calculating first derivative data of the response characteristics; identifying each of a QRS complex start time and a QRS complex end time by comparing the first derivative data to a predetermined threshold; and
calculating the QRS complex duration as the difference between the QRS end time and the QRS start time.

4. The method of claim 1 , wherein the output setting comprises at least one of a stimulation voltage and an impulse duration.

5. The method of claim 1 , further comprising:
generating a plurality of templates, each template corresponding to values indicating capture of cardiac tissue; and
storing the plurality of templates in the memory,
wherein assigning an impulse a classification comprises identifying a template of the plurality of templates corresponding to the response characteristics of the impulse.

6. The method of claim 5 , wherein the plurality of templates comprise templates for identifying each of selective His bundle capture, non-selective His bundle capture, ventricle-only capture, and non-capture of the His bundle and the ventricle.

7. The method of claim 5 , wherein generating a template of the plurality of templates comprises:
applying a predetermined impulse selected to capture specific cardiac tissue;
measuring response characteristics of the predetermined impulse; and assigning a value or range of values to the template based on the response characteristics of the predetermined impulse.

8. The method of claim 1 , wherein the memory comprises an ordered table arranged in order of impulse energy, and wherein storing each of the output settings and the classification in the memory comprises generating a record in the ordered table including the output settings and the classification.

9. The method of claim 1 , further comprising configuring output settings of the stimulation system, wherein configuring output settings of the stimulation system comprises:
identifying a lowest-energy impulse of the plurality of impulses classified as resulting in capture of at least the His bundle or, if no impulse is classified as resulting in capture of the His bundle, as resulting in capture of the ventricle;
retrieving, from the memory, the output settings associated with the lowest-energy impulse; and
setting the output setting of the stimulation system based on the output settings associated with the lowest-energy impulse.

10. The method of claim 9 , wherein setting the output setting of the stimulation system comprises setting the output setting of the stimulation system to the output settings associated with the lowest-energy impulse augmented by a safety factor.

11. The method of claim 1 , further comprising, for each impulse classified as indicating non-capture of the His bundle and the ventricle, applying a back-up impulse, the back-up impulse having an energy sufficient to capture at least one of the His bundle and the ventricle.

12. The method of claim 1 , wherein the assigning further comprises assigning a classification of selective HIS bundle capture when the response characteristic has a first evoked response delay and assigning a classification of non-selective HIS bundle capture when the response characteristic has a second evoked response delay that is shorter than the first evoked response delay.

13. The method of claim 12 , wherein the selective His bundle capture indicates that only the His bundle was captured by the corresponding one of the plurality of impulses and the myocardium was not excited, wherein the non-selective HIS bundle capture indicates that the corresponding one of the stimulus results in simultaneous capture of both the His bundle and the myocardium.

14. A cardiac stimulation system, the system comprising:
a stimulation electrode;
one or more sensing electrodes;
a pulse generator adapted to generate electrical impulses for pacing the His bundle;
a processor communicatively coupled to the pulse generator and adapted to receive response characteristics from the one or more sensing electrodes; and
a memory communicatively coupled to the processor, the memory including instructions executable by the processor that, when executed by the processor, cause the processor to:
generate, using the pulse generator, a plurality of impulses to induce a plurality of responses from the patient heart, the plurality of impulses corresponding to different output settings of the pulse generator;
receive, from the sensing electrode, response characteristics for the plurality of responses;
assign corresponding classifications to the plurality of responses based on whether the respective response characteristics indicate capture of one or both of the His bundle and the ventricle, the response characteristics including an evoked response delay, the classification assigned at least in part based on the evoked response delay; and
for each impulse, store the output setting and the classification associated with the impulse in the memory.

15. The cardiac stimulation system of claim 14 , wherein the instructions further cause the processor to:
identify, from the memory, a lowest-energy impulse of the plurality of impulses classified as resulting in capture of at least the His bundle or, if no impulse is classified as resulting in capture of the His bundle, as resulting in capture of the ventricle; and
set an output setting of the pulse generator based on the output settings associated with the lowest-energy impulse.

16. The cardiac stimulation system of claim 15 , wherein identifying the lowest-energy impulse comprises accessing a table stored in the memory, the table including a plurality of entries, each entry including a respective output setting and a respective classification.

17. The cardiac stimulation system of claim 15 , wherein the instructions further cause the processor to:
apply, using the pulse generator, a pacing impulse to the patient heart using the output s

Assignees

• Pacesetter Inc

Inventors

• Prillinger Julie
• Bornzin Gene A
• Rosenberg Stuart
• Goil Aditya
• Li Wenwen
• Toutam Pritika
• Theret Didier
• Qu Fujian

Classifications

• A61N1/056 Primary

  Transvascular endocardial electrode systems · CPC title

• A61N1/385

  Devices for inducing an abnormal cardiac function, e.g. fibrillation · CPC title

• A61N1/3627

  for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy · CPC title

• A61N1/37

  Monitoring; Protecting · CPC title

• A61N1/3686

  configured for selecting the electrode configuration on a lead (A61N1/3688 takes precedence) · CPC title