Source: https://patents.google.com/patent/US9974963B2/en
Timestamp: 2018-12-14 06:20:01
Document Index: 135150552

Matched Legal Cases: ['art.\n18', 'Application No. 201080025213', 'Application No. 13192236', 'Application No. 10767635', 'Application No. 10767635', 'Application No. 13192236', 'Application No. 201080025213']

US9974963B2 - Apparatus and method for the detection and treatment of atrial fibrillation - Google Patents
US9974963B2
US9974963B2 US14812247 US201514812247A US9974963B2 US 9974963 B2 US9974963 B2 US 9974963B2 US 14812247 US14812247 US 14812247 US 201514812247 A US201514812247 A US 201514812247A US 9974963 B2 US9974963 B2 US 9974963B2
US14812247
US20160022998A1 (en )
FIGS. 8a-8c are graphs showing an EKG for normal sinus rhythm (FIG. 8a ) and during an episode of atrial fibrillation, including the ventricles (FIG. 8b ) and atria (FIG. 8c ).
Electrode assembly 50 can be attached to the heart wall HW through several different means. According to an embodiment shown in FIG. 6b , the patch can include one or more attachment elements 57 that have tissue penetrating anchoring portions 57 a which penetrate and anchor into the heart wall HW. Suitable attachment elements 57 can include various helical coils or barbed needles as is shown in FIG. 6b . Patch 53 may also be attached to the heart wall through use of biocompatible adhesives known in the art. In specific embodiments, the adhesive can comprise thermally activated adhesives that are activated by heat from flowing blood or electrical energy delivered from electrodes 52.
In exemplary embodiments of methods for using the invention, system 5 and atrially positioned leads 40 can be used to detect and treat atrial fibrillation in the following fashion. The distributed electrode assemblies can be used to monitor the patient's EKG including the P wave as well as map conduction in the area within or adjacent that circumscribed by the electrode assemblies, preferably this area includes the SA node. Atrial fibrillation can be detected based on the elimination or abnormality of the P wave as is shown in FIGS. 8b and 8c . When AF occurs, using the conduction map, the location of the ectopic or other foci causing the atrial fibrillation can be identified by looking at the time course of depolarization and identifying locations that depolarize before the SA node. Cardioversion can then be performed as described below to return the heart to normal sinus rhythm.
After cardioversion is performed and the heart returned to normal sinus rhythm, the electrode assemblies nearest that foci can then be used to send a pacing signal to that site and surrounding tissue to prevent the site from causing another episode of atrial fibrillation. Also, the location of that site can be stored in memory of the pacemaker so that next time abnormal atrial depolarization is detected, a pacing signal can be sent immediately to that site to prevent the occurrence of AF. In some embodiments, a site of early activation can be paced continuously. Atrial pacing can be performed to produce a stimulated P wave, Ps which can be triggered off the R wave, R, or the R to R interval, Ri as is shown in FIGS. 8a and 8b with appropriate time adjustment Ta for firing during the time period Tp when the normal P wave would be expected to occur.
As described above, when an episode of atrial fibrillation has been detected embodiments of the invention can also be used for performing cardioversion to convert the atria from a fibrillative state back to normal sinus rhythm. In these and related embodiments, the pacemaker can simultaneously send a higher voltage pacing signal (in the range of 8 to 10 volts) to all or majority of the pairs of distributed electrodes to simultaneously depolarize (also described herein as conductively capture) a large enough area of the atrial myocardium to stop the aberrant currents causing the atrial fibrillation. These voltages, while higher than those used for pacing to prevent AF, are much lower than those typically used during conventional internal cardio version (in the hundreds of volts) or external cardioverions (in the thousands of volts). Such lower voltages can be used because the stimulation is delivered by a multipoint source (resulting in higher current densities) and to a much smaller area of the heart than during typical internal or external cardioversion. By using voltages lower than those typically used during internal or external cardioversion, the pain experienced by the patient can be greatly reduced. The other benefit of this approach is that by using bipolar electrodes at each site, the electrical energy delivered to the heart can be contained to a relatively small region so that the risk of stimulating the ventricles (an unwanted effect in this case) is very small. The voltage level for achieving cardioversion can be adjusted based on one or more of the following factors (the “conversion voltage adjustment factors”): i) the size of the area of tissue bounded by distributed electrode pairs (smaller areas require less voltage); ii) the location of the ectopic foci (the closer the foci to a particular electrode pair the less the required voltage; iii) the number of foci (larger number of foci may require larger voltages); iv) the number of electrode pairs defining the area (the more electrodes the lower the voltage); and v) the number of prior episodes of AF (a larger number of episodes may require higher voltage). One or more of these factors can be programmed into the algorithm resident within the pacemaker which controls the cardioverion process. Also the conversion algorithm can programmed to use the lowest possible voltage at first, and then progressively increase it until conversion is achieved. The voltage which achieves conversion can then be stored in memory and used again as a starting point in a subsequent conversion attempt with tuning or fine tuning using one or more of the five conversion voltage adjustment factors described above.
1. An apparatus for detection and treatment of cardiac arrhythmia, the apparatus comprising:
an electrical lead having a proximal and distal portion, the distal portion configured to be positioned in a chamber of a heart, the proximal portion having an end configured to be coupled to a pacemaker device, the electrical lead comprising a plurality of conductive wires;
a plurality of pairs of electrodes, wherein at least one pair of electrodes is positioned on each membrane patch, the electrodes of each pair being (i) coupled to a conductive wire of the electrical lead, and (ii) configured to at least sense an electrical signal of the wall of the heart; and
wherein the distribution of the plurality of membrane patches and electrode pairs along the electrical lead is configured to allow the plurality of electrode pairs to be distributed in a pattern on the wall of the heart, the pattern configured to i) detect a location of a foci of aberrant electrical activity located within or adjacent to an area, and ii) send a pacing signal to that location to prevent or stop an occurrence of fibrillation caused by that foci.
an accelerometer coupled to at least one of the conductive wires, the accelerometer configured to be positioned on the wall of the heart and configured to sense motion of the wall of the heart.
18. A system configured to detect and treat cardiac arrhythmia, the system comprising:
a pacemaker configured to be implanted; and
US14812247 2009-04-21 2015-07-29 Apparatus and method for the detection and treatment of atrial fibrillation Active 2029-05-11 US9974963B2 (en)
US14224900 Continuation US9138160B2 (en) 2009-04-21 2014-03-25 Apparatus and method for the detection and treatment of atrial fibrillation
US15939659 Continuation US20180296842A1 (en) 2009-04-21 2018-03-29 Apparatus and method for the detection and treatment of atrial fibrillation
US20160022998A1 true US20160022998A1 (en) 2016-01-28
US9974963B2 true US9974963B2 (en) 2018-05-22
JP2003529389A (en) 1999-02-12 2003-10-07 ザ・トラスティーズ・オブ・コランビア・ユニバーシティー・イン・ザ・シティー・オブ・ニューヨーク Remodeling of the binding of the heart
Chinese Office Action dated Oct. 15, 2013 in CN Application No. 201080025213.
Communication dated Feb. 3, 2014 in European Application No. 13192236.1.
Communication dated Sep. 11, 2012 in European Application No. 10767635.5.
Intent to Grant dated Jul. 2, 2013 in European Application No. 10767635.5.
International Search Report, Written Opinion and Notice of Transmittal of same dated Nov. 29, 2010 for PCT/US2010/031748.
Search Report dated Feb. 3, 2014 for European Application No. 13192236.1.
Second Office Action dated May 19, 2014 in CN Application No. 201080025213.
US9138160B2 (en) 2015-09-22 grant
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:IMRAN, MIR;HARRIS, JOEL;SIGNING DATES FROM 20090512 TO 20090526;REEL/FRAME:036208/0037