Source: https://patents.google.com/patent/US20140018874A1/en
Timestamp: 2019-02-20 08:17:28
Document Index: 235801472

Matched Legal Cases: ['§120', '§120', '§120', '§119', 'art.\n3', 'art.\n11', 'art.\n13', 'art.\n17']

US20140018874A1 - Systems, devices and methods for monitoring efficiency of pacing - Google Patents
US20140018874A1
US20140018874A1 US14/027,568 US201314027568A US2014018874A1 US 20140018874 A1 US20140018874 A1 US 20140018874A1 US 201314027568 A US201314027568 A US 201314027568A US 2014018874 A1 US2014018874 A1 US 2014018874A1
US14/027,568
US8934969B2 (en
Newstim Inc
2004-12-20 Priority to AR20040104782 priority Critical
2004-12-20 Priority to ARP040104782 priority patent/AR047851A1/en
2005-12-13 Priority to US11/300,242 priority patent/US8346358B2/en
2005-12-13 Priority to US11/300,611 priority patent/US7512440B2/en
2007-06-29 Priority to US94730807P priority
2011-08-25 Priority to US13/217,776 priority patent/US8538521B2/en
2013-09-16 Priority to US14/027,568 priority patent/US8934969B2/en
2013-09-16 Application filed by Cardiac Pacemakers Inc filed Critical Cardiac Pacemakers Inc
2014-01-16 Publication of US20140018874A1 publication Critical patent/US20140018874A1/en
2015-01-13 Publication of US8934969B2 publication Critical patent/US8934969B2/en
2016-09-14 Assigned to NEWSTIM, INC. reassignment NEWSTIM, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: CARDIAC PACEMAKERS, INC.
This application is a continuation of and claims the benefit of priority under 35 U.S.C. §120 to Zhu et al., U.S. patent application Ser. No. 13/217,776, entitled “Systems, Devices And Methods For Monitoring Efficiency Of Pacing,” filed on Aug. 25, 2011, which is a continuation of and claims the benefit of priority under 35 U.S.C. §120 to Zhu et al., U.S. patent application Ser. No. 12/147,369, entitled “Systems, Devices And Methods For Monitoring Efficiency Of Pacing,” filed on Jun. 26, 2008, (Attorney Docket No. 279.H29US1), now issued as U.S. Pat. No. 8,010,191, which in turn is a continuation-in-part of and claims priority under 35 U.S.C. §120 both to U.S. patent application Ser. No. 11/300,611, filed Dec. 13, 2005 (Ventricular Pacing) to Daniel Felipe Ortega et al. (AMED.002PA), now issued as U.S. Pat. No. 7,512,440 and to U.S. patent application Ser. No. 11/300,242, filed Dec. 13, 2005 (Pacemaker Which Reestablishes Or Keeps The Physiological Electric Conduction Of The Heart And A Method Of Application) to Daniel Felipe Ortega et al. (AMED.003PA), now issued as U.S. Pat. No. 8,346,358, which in turn claim priority to Argentine Patent Application Ser. No. 20040104782, filed Dec. 20, 2004 (A New Pacemaker Which Reestablishes Or Keeps The Physiological Electric Conduction Of The Heart And A Method Of Application), to Daniel Felipe Ortega et al.; the benefit of priority is hereby presently claimed to each of the above, and each of which is hereby incorporated by reference herein in its respective entirety.
This patent document also claims the benefit, under 35 U.S.C. §119(e), of U.S. Provisional Patent Applications concurrently filed on Jun. 29, 2007 to Qingsheng Zhu and identified by the following Serial Nos.: 60/947,308 (Endocardial Pacing For Resynchronization), and 60/947,322 (System And Method For Ventricular Pacing With Monitoring And Responsiveness To Pacing Effectiveness); the benefit of priority is hereby presently claimed to each of the above, and each of which is hereby incorporated by reference in its respective entirety.
Pacemakers are perhaps the most well known devices that provide chronic electrical stimulus, such as cardiac rhythm management. Pacemakers have been implanted for medical therapy. Other examples of cardiac stimulators include implantable cardiac defibrillators (ICDs) and implantable devices capable of performing pacing and defibrillating functions. Such implantable devices provide electrical stimulation to selected portions of the heart in order to treat disorders of cardiac rhythm. An implantable pacemaker paces the heart with timed pacing pulses. The pacing pulses can be timed from other pacing pulses or sensed electrical activity. If functioning properly, the pacemaker makes up for the heart's inability to pace itself at an appropriate rhythm in order to meet metabolic demand by enforcing a minimum heart rate. Some pacing devices synchronize pacing pulses delivered to different areas of the heart in order to coordinate the contractions. Coordinated contractions allow the heart to pump efficiently while providing sufficient cardiac output. Clinical data has shown that cardiac resynchronization, achieved through synchronized biventricular pacing, results in a significant improvement in cardiac function. Cardiac resynchronization therapy improves cardiac function in heart failure patients. Heart failure patients have reduced autonomic balance, which is associated with LV (left-ventricle) dysfunction and increased mortality.
The skilled artisan will appreciate that the His bundle is also known as the atrioventricular (AV) bundle and previously characterized as an area of heart muscle cells that provide electrical conduction for transmitting the electrical impulses from an area near the AV node (located between the atria and the ventricles). In connection with implementations of the present invention, it has been discovered that certain cells in and around the His bundle can be manipulated to respond to certain electrical stimulus in unexpected ways. Some aspects and implementations of the present invention facilitate modulation of the His bundle to improve the heart condition in unexpected ways.
In other specific examples, implementations involve pacing from the right ventricle to treat LBBB, diffuse-distal block characterized by large QRS width (e.g., QRS >120 ms) and fractionated ECG (electrocardiograph or electrocardiogram) signals. Consistent therewith, a specific method involves the use of a pacing profile having opposite-polarity pulses (relative to body common) delivered for a cardiac capture (defined as the presence of contractions in the heart in direct response to electrical stimulation signals from an external source). In various contexts, such a pacing profile is referred to herein as an “Xstim” pacing profile or simply as Xstim.
FIG. 25 depicts a system for use in pacing and monitoring in connection with the various embodiments discussed herein;
In connection with the various drawing figures and relevant discussions, the following disclosures are incorporated herein by reference in their entirety: U.S. Pat. Nos. 6,230,061 B1 to Hartung issued May 8, 2001, for details of a cardiac pacemaker with localization of the stimulating pulses and U.S. Pat. No. 6,907,285 to Denker, et al., dated Jun. 14, 2004, for details of a wireless defibrillation system; U.S. patent application Publ. No. 2004/0153127 published Aug. 5, 2004 for details related to the use of a microstimulator in the proximity of at least one anatomical structure to produce muscular contractions; U.S. Pat. No. 6,643,546 B2 to Mathis et al. dated Nov. 4, 2003, for details related to the treatment of congestive heart failure.
In addition, the catheter LB5 within the right ventricle can have multiple electrodes along its length (as shown in FIG. 7). Individual pairs of these electrodes E1E4 can be switched on or off over time so that the appropriate pair of electrodes within the right ventricle is selected for optimized left ventricular pacing.
In another embodiment, the pulses shown by the figures are applied to the ring and tip electrodes, such as those illustrated in FIG. 22. The polarity of the voltages, as relative to each other and/or a reference voltage, may be alternated periodically (e.g., beat by beat or every N pulses). As discussed above, such alternating may be particularly useful for mitigating anodal blocking Moreover, alternating of pulses may also mitigate corrosion of the electrodes.
In a specific embodiment, inner sheath 154 is located within outer sheath 156. Inner sheath 154 may be adjusted, relative to outer sheath 156, using adjustment mechanism 152. In one instance, the adjustment mechanism 152 includes an adjustable track wheel or another similar mechanism. Additionally, inner sheath 154 may contain a pacing lead and/or a guide wire for additional stability. The adjustment of inner sheath 154 may be accomplished through a number of different techniques. According to one such technique, the inner sheath is allowed freedom to advance through the outer sheath and to move along the septum. In another example technique, the inner sheath may be arranged to direct the lead placement (e.g., by allowing for the adjustment of its curvature). The inner sheath and / or the outer sheath may have an electrode at their tip to use for pace mapping the locus for Xstim (following procedures discussed herein), facilitating the insertion of the pacing lead for chronic pacing. The inner and out sheaths may be peelable so that the pacemaker lead is kept in place while the sheaths are removed.
In a particular embodiment, one or more pulses may be withheld as shown by the lack of a pulse on the ring electrode that corresponds to pulse AS on the tip. In this sense the ring electrode pulse has effectively been withheld or skipped. In certain embodiments, either or both of the pulses may be withheld. Such withholding of pulses may be periodically implemented (e.g., once per every N pulses, or once every 20 minutes per 24 hours to allow heart to be conditioned by its own intrinsic contraction if the intrinsic heart rate is above a certain acceptable rate, such as 50 beats/minute). In another instance, the withholding may be responsive to feedback from a sensing electrode or ECG input.
Aspects of the present invention relate to an external pacing system that is useful for implementing a chronic pacing device according to embodiments of the present invention. Such an external pacing system can contain pacing output circuitry which is selectively controlled to generate Xstim or other pacing waveforms. In a specific implementation, the pacing locations are located near the His bundle and the pacing profile is an Xstim profile.
a monitoring circuit configured to monitor a left ventricular contraction elicited at least partially in response to an electrostimulation delivered from a location at or near a His bundle of a subject heart; and
a processor circuit configured to:
determine an efficacy of the delivered electrostimulation using information about a subject QRS width, the information provided by the monitoring circuit and obtained during the left ventricular contraction; and
adjust an electrostimulation parameter for subsequent electrostimulation using information about the determined efficacy.
2. The apparatus of claim 1, wherein the monitoring circuit is configured to monitor a left ventricular contraction elicited at least partially in response to an electrostimulation delivered from a location in a right ventricle of the subject heart.
3. The apparatus of claim 2, wherein the monitoring circuit is configured to monitor a left ventricular contraction elicited at least partially in response to an electrostimulation comprising partially overlapping opposite polarity waveforms.
4. The apparatus of claim 3, comprising a pulse generator circuit configured to generate the electrostimulation comprising the partially overlapping opposite polarity waveforms.
5. The apparatus of claim 4, further comprising an implantable lead assembly including a first electrode and a second electrode; and
wherein the pulse generator circuit is configured to generate the electrostimulation comprising the partially overlapping opposite polarity waveforms including a first polarity waveform for delivery using the first electrode and a second polarity waveform for delivery using the second electrode.
6. The apparatus of claim 1, wherein the processor circuit is configured to determine the efficacy using information about the left ventricular contraction and a second left ventricular contraction elicited via an electrostimulation delivered from a different site.
7. The apparatus of claim 1, wherein the processor circuit is configured to determine the efficacy of delivered electrostimulation in response to electrostimulation delivered in a septal region of the right ventricle at or near the His bundle.
8. The apparatus of claim 1, wherein determining the efficacy of the delivered electrostimulation includes determining a relative indication of information about a QRS width associated with the monitored contraction relative to an earlier monitored QRS width or a reference QRS width.
determine an efficacy of the delivered electrostimulation using information about an electrogram fractionation, the information provided by the monitoring circuit and obtained during the left ventricular contraction; and
10. The apparatus of claim 9, wherein the monitoring circuit is configured to monitor a left ventricular contraction elicited at least partially in response to an electrostimulation delivered from a location in a right ventricle of the subject heart.
11. The apparatus of claim 10, wherein the monitoring circuit is configured to monitor a left ventricular contraction elicited at least partially in response to an electrostimulation comprising partially overlapping opposite polarity waveforms.
12. The apparatus of claim 9, wherein the processor is configured to determine the efficacy at least in part by the pressure generated by the heart.
13. The apparatus of claim 9, wherein the processor is configured to determine the efficacy at least in part by a timing of activation of a late activation site of the left ventricle.
14. The apparatus of claim 9, wherein the processor is configured to determine the efficacy at least in part by the QRS width.
determine an efficacy of the delivered electrostimulation using information provided by the monitoring circuit obtained during the left ventricular contraction about at least one of a pressure generated by the heart and a timing activation of a late activation site of the left ventricle; and
16. The apparatus of claim 15, wherein the monitoring circuit is configured to monitor a left ventricular contraction elicited at least partially in response to an electrostimulation delivered from a location in a right ventricle of the subject heart.
17. The apparatus of claim 16, wherein the monitoring circuit is configured to monitor a left ventricular contraction elicited at least partially in response to an electrostimulation comprising partially overlapping opposite polarity waveforms.
18. The apparatus of claim 15, wherein the processor is configured to determine the efficacy at least in part by the electrogram fractionation.
19. The apparatus of claim 15, wherein the processor is configured to determine the efficacy at least in part by the QRS width.
20. The apparatus of claim 19, wherein determining the efficacy of the delivered electrostimulation includes determining a relative indication of information about a QRS width associated with the monitored contraction relative to an earlier monitored QRS width or a reference QRS width.
US14/027,568 2004-12-20 2013-09-16 Systems, devices and methods for monitoring efficiency of pacing Active US8934969B2 (en)
AR20040104782 2004-12-20
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US14/027,568 US8934969B2 (en) 2004-12-20 2013-09-16 Systems, devices and methods for monitoring efficiency of pacing
US13/217,776 Continuation US8538521B2 (en) 2004-12-20 2011-08-25 Systems, devices and methods for monitoring efficiency of pacing
US20140018874A1 true US20140018874A1 (en) 2014-01-16
US8934969B2 US8934969B2 (en) 2015-01-13
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