The present technology generally relates to methods and systems for stimulating cardiac tissue, and more particularly to systems and methods for delivering stimulation electrodes to endocardial or other tissues.
Electrical stimulation of body tissue is used throughout medicine for treatment of both chronic and acute conditions. Among many examples, peripheral muscle stimulation is reported to accelerate healing of strains and tears, bone stimulation is likewise indicated to increase the rate of bone regrowth/repair in fractures, and nerve stimulation is used to alleviate chronic pain. Further there is encouraging research in the use of electrical stimulation to treat a variety of nerve and brain conditions, such as essential tremor, Parkinson's disease, migraine headaches, functional deficits due to stroke, and epileptic seizures.
Cardiac pacemakers and implantable defibrillators are examples of commonly implanted device utilizing electrical stimulation to stimulate cardiac and other tissues. A pacemaker is a battery-powered electronic device implanted under the skin, connected to the heart by an insulated metal lead wire with a tip electrode. Pacemakers were initially developed for and are most commonly used to treat slow heart rates (bradycardia), which may result from a number of conditions. More recently, advancements in pacemaker complexity, and associated sensing and pacing algorithms have allowed progress in using pacemakers for the treatment of other conditions, notably heart failure (HF) and fast heart rhythms (tachyarrhythmia/tachycardia).
Electrical energy sources connected to electrode/lead wire systems have typically been used to stimulate tissue within the body. The use of lead wires is associated with significant problems such as complications due to infection, lead failure, and electrode/lead dislodgement. The requirement for leads in order to accomplish stimulation also limits the number of accessible locations in the body. The requirement for leads has also limited the ability to stimulate at multiple sites (multisite stimulation).
Wireless stimulation electrodes are typically delivered via catheter-based delivery systems. One difficulty associated with implanting wireless stimulation electrodes is visualizing and determining the position of a distal end of a delivery catheter relative to a desired target location for implantation of the stimulation electrode. In particular, conventional delivery systems typically provide little or no tactile feedback that allows the implanter (e.g., a clinician) to know when the delivery catheter is close to or in contact with the target tissue. Accordingly, typical delivery methods include the use of fluoroscopic and/or echocardiographic techniques to provide visual feedback of the position and location of delivery catheter relative to the target tissue.
Many aspects of the present disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on clearly illustrating the principles of the present disclosure.
Aspects of the present disclosure are directed generally to systems and methods for delivering one or more stimulation electrodes to tissue of a patient, such as endocardial tissue, for implantation therein. In several of the embodiments described below, for example a delivery system for use in delivering a stimulation electrode can include (i) an elongate sheath having a distal portion, (ii) a balloon coupled to the distal portion of the sheath, and (iii) a fluid circuit configured to be in fluid communication with the balloon. The fluid circuit can include a pressure source (e.g., a syringe) that is fluidly connectable to the balloon and that is configured to inflate and deflate the balloon. The fluid circuit can further include a pressure sensor configured to monitor a pressure within the balloon.
The distal portion of the sheath and the balloon are configured to be advanced through the vasculature of a patient (e.g., a human patient) and into a heart chamber thereof, such as the left ventricle. The balloon can then be moved into contact with an endocardial wall of the heart chamber. When the balloon contacts the endocardial wall or is otherwise moved by the endocardial wall (e.g., during contraction thereof), the contact forces can displace the balloon-thereby causing pressure variations within the balloon that are detectable by the pressure sensor. In some embodiments, the delivery system can further include a computing device electrically coupled to the pressure sensor. The pressure sensor can convert the sensed pressure within the balloon to an electrical signal and pass the electrical signal to the computing device. The computing device can process the electrical signal to detect and analyze the pressure variations to determine, for example, (i) that the balloon is in contact with the wall of the heart chamber, (ii), a motion of the wall of the heart chamber, and/or (iii) blood flow characteristics within the heart chamber.
Specific details of several embodiments of the present technology are described herein with reference to
The terminology used in the description presented below is intended to be interpreted in its broadest reasonable manner, even though it is being used in conjunction with a detailed description of certain specific embodiments of the disclosure. Certain terms can even be emphasized below; however, any terminology intended to be interpreted in any restricted manner will be overtly and specifically defined as such in this Detailed Description section.
The accompanying Figures depict embodiments of the present technology and are not intended to be limiting of its scope. The sizes of various depicted elements are not necessarily drawn to scale, and these various elements can be arbitrarily enlarged to improve legibility. Component details can be abstracted in the Figures to exclude details such as position of components and certain precise connections between such components when such details are unnecessary for a complete understanding of how to make and use the present technology. Many of the details, dimensions, angles, and other features shown in the Figures are merely illustrative of particular embodiments of the disclosure. Accordingly, other embodiments can have other details, dimensions, angles, and features without departing from the spirit or scope of the present technology.
In some embodiments, the system 100 can further include a programmer 130 in operable communication with the controller-transmitter 120. The programmer 130 can be positioned outside the body 104 and can be operable to program various parameters of the controller-transmitter 120 and/or to receive diagnostic information from the controller-transmitter 120. In some embodiments, the system 100 can further include a co-implant device 132 (e.g., an implantable cardioverter defibrillator (ICD) or pacemaker) coupled to pacing leads 134 for delivering stimulation pulses to one or more portions of the heart 102 other than the area stimulated by the receiver-stimulator 110. In other embodiments, the co-implant device 132 can be a leadless pacemaker which is implanted directly into the heart 102 to eliminate the need for separate pacing leads 134. The co-implant device 132 and the controller-transmitter 120 can be configured to operate in tandem and deliver stimulation signals to the heart 102 to cause a synchronized heartbeat. In some embodiments, the controller-transmitter 120 can receive signals (e.g., electrocardiogram signals) from the heart 102 to determine information related to the heart 102, such as a heart rate, heart rhythm, including the output of the pacing leads 134 located in the heart 102. In some embodiments, the controller-transmitter 120 can alternatively or additionally be configured to receive information (e.g., diagnostic signals) from the receiver-stimulator 110. The received signals can be used to adjust the ultrasound energy signals delivered to the receiver-stimulator 110.
The receiver-stimulator 110, the controller-transmitter 120, and/or the programmer 130 can include a machine-readable (e.g., computer-readable) or controller-readable medium containing instructions for generating, transmitting, and/or receiving suitable signals (e.g., stimulation signals, diagnostic signals). The receiver-stimulator 110, the controller-transmitter 120, and/or the programmer 130 can include one or more processor(s), memory unit(s), and/or input/output device(s). Accordingly, the process of providing stimulation signals and/or executing other associated functions can be performed by computer-executable instructions contained by, on, or in computer-readable media located at the receiver-stimulator 110, the controller-transmitter 120, and/or the programmer 130. Further, the receiver-stimulator 110, the controller-transmitter 120, and/or the programmer 130 can include dedicated hardware, firmware, and/or software for executing computer-executable instructions that, when executed, perform any one or more methods, processes, and/or sub-processes described herein. The dedicated hardware, firmware, and/or software also serve as “means for” performing the methods, processes, and/or sub-processes described herein.
In some embodiments, the system 100 can include several features generally similar or identical to those of the leadless tissue stimulation systems disclosed in (i) U.S. Pat. No. 7,610,092, filed Dec. 21, 2005, and titled “LEADLESS TISSUE STIMULATION SYSTEMS AND METHODS,” (ii) U.S. Pat. No. 8,315,701, filed Sep. 4, 2009, and titled “LEADLESS TISSUE STIMULATION SYSTEMS AND METHODS,” and/or (iii) U.S. Pat. No. 8,718,773, filed May 23, 2007, and titled “OPTIMIZING ENERGY TRANSMISSION IN A LEADLESS TISSUE STIMULATION SYSTEM.”
In the illustrated, the sheath assembly 250 further includes a balloon 258 coupled to the distal portion 253 of the sheath 252. In some embodiments, the balloon 258 can be secured around an entire periphery (e.g., circumference) of the distal portion 253 of the sheath 252. The balloon 258 can be formed of a flexible, compliant material and can be inflated from a deflated (e.g., collapsed) configuration to an inflated (e.g., expanded) configuration shown in
In the illustrated embodiment, the balloon 258 is operably coupled to an inflation and monitoring circuit 260 via a fluid line 259 extending through the sheath 252 and the handle 254. The fluid line 259 can include one or more tubes, pipes, lumens, and/or the like fluidly connecting the balloon 258 to the inflation and monitoring circuit 260. The inflation and monitoring circuit 260 can include a pressure source 262 and a pressure sensor 264 (e.g., a pressure transducer) configured to be in fluid communication within the balloon 258 via the fluid line 259. More specifically, in the illustrated embodiment the inflation and monitoring circuit 260 includes a connector 270 (e.g., a T-connector) having (i) a first branch 271 configured to be in fluid communication with the pressure source 262 via a first fluid control device 266, (ii) a second branch 273 fluidly connected to the pressure sensor 264, and (iii) a third branch 275 configured to be in fluid communication with the fluid line 259 via a second fluid control device 268 and a conduit 269 extending between the second fluid control device 268 and the fluid line 259. In other embodiments, the pressure source 262 and the pressure sensor 264 can be fluidly connected to the balloon 258 in other manners, such as via different combinations of fluid control devices, connectors, conduits, and the like.
In the illustrated embodiment, the pressure source 262 is a syringe having a plunger 263. In other embodiments, the pressure source 262 can be a pump, blower, and/or other suitable pressure source. The pressure source 262 (e.g., the plunger 263) is configured to drive a fluid 261 through the inflation and monitoring circuit 260 toward/away from the balloon 258 to inflate/deflate the balloon 258. The fluid 261 can be a saline solution, air, and/or other gas or liquid. In some embodiments, the fluid 261 can include a contrast agent visible via an imaging system (e.g., a fluoroscopic imaging system). For example, the fluid 261 can be a 50%-50% mixture of normal saline (e.g., distilled H2O and 0.9% NaCl) and an X-ray dye contrast agent. In some embodiments, the first and second fluid control devices 266, 268 are stopcocks or other components manually actuatable by a user or automatically actuatable to fluidly connect the pressure source 262 to the connector 270 and the connector 270 to the conduit 269, respectively. The pressure sensor 264 can be a digital or manual device for quantifying an inflation pressure of the balloon 258. In some embodiments, the pressure sensor 264 can be one or more of the types manufactured by Opsens Solutions of Quebec City, Canada. In some embodiments, the pressure sensor 264 can be sensitive enough to detect pressure changes within the balloon 258 at the millibar level.
In some embodiments, the pressure sensor 264 can be operably coupled (e.g., via an electrical connection, wireless connection, wired connection) to a digital pressure readout 272 and/or a computing device 274 (e.g., a processing device). The digital readout 272 can be configured to display a readout of the inflation pressure of the balloon 258 (e.g., “100 PSI”) determined by the pressure sensor 264. The computing device 274 can be a computer, laptop, tablet, smartphone, etc., and can comprise a processor and a non-transitory computer-readable storage medium that stores instructions that when executed by the processor, carry out the functions attributed to the computing device as described herein. Although not required, aspects and embodiments of the present technology can be described in the general context of computer-executable instructions, such as routines executed by a general-purpose computer, e.g., a server or personal computer. Those skilled in the relevant art will appreciate that the present technology can be practiced with other computer system configurations, including Internet appliances, hand-held devices, wearable computers, cellular or mobile phones, multi-processor systems, microprocessor-based or programmable consumer electronics, set-top boxes, network PCs, mini-computers, mainframe computers and the like. The present technology can be embodied in a special purpose computer or data processor that is specifically programmed, configured or constructed to perform one or more of the computer-executable instructions explained in detail below. Indeed, the term “computer” (and like terms), as used generally herein, refers to any of the above devices, as well as any data processor or any device capable of communicating with a network, including consumer electronic goods such as game devices, cameras, or other electronic devices having a processor and other components, e.g., network communication circuitry.
The present technology can also be practiced in distributed computing environments, where tasks or modules are performed by remote processing devices, which are linked through a communications network, such as a Local Area Network (“LAN”), Wide Area Network (“WAN”), or the Internet. In a distributed computing environment, program modules or sub-routines can be located in both local and remote memory storage devices. Aspects of the present technology described below can be stored or distributed on computer-readable media, including magnetic and optically readable and removable computer discs, stored as in chips (e.g., EEPROM or flash memory chips). Alternatively, aspects of the present technology can be distributed electronically over the Internet or over other networks (including wireless networks). Those skilled in the relevant art will recognize that portions of the present technology can reside on a server computer, while corresponding portions reside on a client computer. Data structures and transmission of data particular to aspects of the present technology are also encompassed within the scope of the present technology.
In operation, a user (e.g., a physician or other clinician) or an automated device (e.g., the computing device 274) can inflate the balloon 258 by opening the first and second fluid control devices 266, 268 and depressing the plunger 263 of the syringe 262 to increase the pressure in the balloon 258 (and the intermediate components of the delivery system 240 such as the connector 270, the conduit 269, and the fluid line 259) by forcing a portion of the fluid 261 from the syringe 262 into the inflation and monitoring circuit 260. Similarly, the user can deflate the balloon 258 by opening the first and second fluid control devices 266, 268 and withdrawing the plunger 263 of the syringe 262 to decrease the pressure in the balloon 258 by drawing a portion of the fluid 261 from the inflation and monitoring circuit 260 into the syringe 262. Closing the first fluid control device 266 can fluidly disconnect the pressure source 262 from the balloon 258 and the inflation and monitoring circuit 260, thereby fixing (e.g., locking, setting) the inflation pressure of the balloon 258 at a constant pressure (e.g., “100 PSI”). With the first fluid control device 266 closed and the second fluid control device 268 open, the pressure sensor 264 can sense/monitor the constant inflation pressure of the balloon 258 and can also detect any pressure changes attributable to external forces acting on the balloon 258.
More specifically, for example,
In the illustrated embodiment, the delivery system 240 further includes a receiver-stimulator 310 (omitted in
In the illustrated embodiment, the balloon 258 is inflated and the delivery system 240 is positioned such that (i) the balloon 258 is positioned against the endocardial wall 382 and (ii) the receiver-stimulator 310 contacts (e.g., electrically contacts, is inserted in) the endocardial wall 382. In some embodiments, the sheath 252 can be advanced into the heart chamber 380 with the balloon 258 in the deflated configuration, and the balloon 258 can then be inflated within the heart chamber 380 before being advanced toward the endocardial wall 382. Referring to
In some embodiments, the computing device 274 can further process the signals from the pressure sensor 264 to determine (e.g., quantify) a contact force at which the balloon 258 contacts the endocardial wall 382. The contact force can be used to determine whether the delivery system 240 is in proper contact or improper contact with the endocardial wall 382 by, for example, comparing the determined contact force to a preselected or predetermined desired contact force. For example, an improper contact force can be determined as (i) a force above a preselected force at which implantation of the receiver-stimulator 310 might result in the receiver-stimulator 310 being positioned too deep within the tissue of the endocardial wall 382 and/or (ii) a force below a preselected force at which implantation of the receiver-stimulator 310 might result in the receiver-stimulator 310 being positioned too shallow within the tissue of the endocardial wall 382.
In some embodiments, the delivery system 240 can provide one or more indications to the user (e.g., a physician implanting the receiver-stimulator 310) that the delivery system 240 has properly contacted the endocardial wall 382. For example, the delivery system 240 can be configured to provide tactile feedback, visual feedback, and/or auditory feedback to the user that contact has occurred and/or that the contact is at or proximate the desired contact force. In some embodiments, the indicator 257 and/or one or more additional display devices (e.g., indicator lights; not shown) can illuminate in different colors (e.g., red, blue, yellow) and/or in different patterns (e.g., constant light, blinking light) to indicate proper contact, no contact, and/or improper contact.
Accordingly, in some aspects of the present technology the delivery system 240 is configured to provide an indication of endocardial wall contact to the user. This indication can be helpful to the user because the sheath 252 and the receiver-stimulator 310 may provide little or no tactile feedback that allows the user to know when they are close to or in contact with the endocardial wall 382. Therefore, by detecting and quantifying endocardial wall contact, the delivery system 240 can decrease the likelihood of implanting the receiver-stimulator 310 at (i) too shallow of a depth at which stimulation may not be effective or (ii) too deep a depth at which the receiver-stimulator 310 could puncture the endocardial wall 382—thereby increasing the likelihood of successfully implanting the receiver-stimulator 310 at a target position and depth where stimulation therapy is likely to be effective. In contrast to the present technology, some cardiac pacing technologies use fluoroscopy and/or echocardiography (e.g., intracardiac or transesophageal echocardiography) to provide visual feedback of the position and location of a sheath and receiver electrode catheter system relative to an endocardial wall and a target implant position. However, such techniques require expensive and complicated additional machinery and imaging techniques, and the visual feedback from such systems can become occluded.
In addition to sensing endocardial wall contact, in some embodiments the computing device 274 can process the signals from the pressure sensor 264 to determine one or more characteristics of the heart chamber 380. For example, movement of the endocardial wall 283 and/or blood flow (e.g., pulsatile blood flow during depolarization) through the heart chamber 380 can act against the balloon 258 to create detectable pressure changes within the balloon 258. For example, as the endocardial wall 382 contracts and relaxes, the pressure in the balloon 258 can vary creating a pulsatile waveform. Accordingly, such pressure variations can be processed to determine mechanical motion characteristics of and/or blood flow characteristics within the heart chamber 380.
In some embodiments, pressure changes in the balloon 258 from mechanical motion of the heart chamber 380 can be used—in addition to or instead of electrical information detected from the heart—to help detect abnormal motion of the endocardial wall 382 and/or to help select a target site for implantation of the receiver-stimulator 310 along the endocardial wall 382. More specifically, for example,
Referring first to
The EMG signal can provide an electrical analog to the balloon pressure signal. For example, as shown in
Referring next to
As described above, the EMG signal can provide an electrical analog to the balloon pressure signal. For example, as shown in
Accordingly, in some aspects of the present technology the pressure of the balloon 258 can provide an indication that a region of the endocardial wall 382 adjacent the delivery system 240 (e.g., the second portion 386) moves abnormally during the cardiac cycle as indicated, for example, by the delay 596. In some embodiments, such regions are good candidates for implantation of the receiver-stimulator 310 (
At block 691, the method 690 includes advancing the delivery system 240 to a first target site along the endocardial wall 382 of the heart chamber 380. For example, the balloon 258 can be inflated and advanced into contact with the endocardial wall 382 at the first target site. At block 692, the method 690 includes detecting a first interval at the first target site indicating asynchronous contraction of the heart chamber 380. The first interval can be the interval 594 determined from the EMG signal and/or the delay 596 determined from the balloon pressure signal. At block 693, the method 690 includes moving the delivery system 240 to a second target site along the endocardial wall 382. At block 694, the method 690 includes detecting a second interval at the second target site indicating asynchronous contraction of the heart chamber 380. The second interval can be the interval 594 determined from the EMG signal and/or the delay 596 determined from the balloon pressure signal.
At block 695, the method 690 includes comparing the first interval to the second interval. If the first interval is greater than the second interval, the method 690 can include selecting the first target site for implantation of the receiver-stimulator 310. If the second interval is greater than the first interval, the method 690 can include selecting the second target site for implantation of the receiver-stimulator 310. In some embodiments, the selection can be based on both the intervals 594 determined from the EMG signal and the delays 596 determined from the balloon pressure signal at blocks 692 and 694 such that the target site is selected based on both electrical information of the heart (from the EMG signal) and mechanical motion information of the heart (from the balloon pressure signal). Moreover, in some embodiments more than two different target sites can be compared to determine a target site with the longest interval.
In contrast to the present technology, determining sections of a heart chamber with abnormal wall motion typically requires performing an echocardiogram strain study on a patient. Such studies require pre-testing the patient by performing the echocardiogram strain study before a surgical implant procedure, and then ensuring during the surgical procedure that the location of the implant matches the target location identified in the pre-testing echocardiogram strain study. Accordingly, in some aspects of the present technology the delivery system 240 can be used to intraoperatively determine abnormal wall motion at multiple target sites-thereby reducing or eliminating the need for preoperative tests, such as echocardiograms, and making it easier to ensure that an implant is at a correct target site within the heart chamber.
The following examples are illustrative of several embodiments of the present technology:
1. A delivery system for a medical implant, comprising:
2. The delivery system of example 1 wherein the distal portion of the sheath includes a distal terminus, and wherein the balloon extends distally past the distal terminus in the inflated configuration.
3. The delivery system of example 1 or example 2 wherein—
4. The delivery system of any one of examples 1-3 wherein the pressure source is a syringe.
5. The delivery system of any one of examples 1-4 wherein the elongate sheath is sized and shaped to be advanced into a heart chamber of a patient such that the balloon contacts a wall of the heart chamber.
6. The delivery system of example 5, further comprising a computing device electrically coupled to the pressure sensor, wherein—
7. The delivery system of example 5 or example 6, further comprising a computing device electrically coupled to the pressure sensor, wherein—
8. The delivery system of any one of examples 5-7, further comprising a computing device electrically coupled to the pressure sensor, wherein—
9. The delivery system of any one of examples 1-8, further comprising an indicator operably coupled to the pressure sensor, wherein the indicator is configured to provide an audible and/or visual indication that the pressure within the balloon is at a selected inflation pressure.
10. A method of sensing contact of a delivery system with a wall of a heart chamber, the method comprising:
11. The method of example 10 wherein sensing the change in pressure within the balloon includes sensing an increase in pressure within the balloon.
12. The method of example 10 or example 11 wherein monitoring the pressure within the balloon includes fluidly coupling a digital pressure sensor to the balloon.
13. The method of any one of examples 10-2 wherein inflating the balloon includes fluidly connecting a syringe to the balloon and actuating the syringe to drive a fluid into the balloon, and wherein monitoring the pressure within the balloon further includes fluidly disconnecting the syringe from the balloon after inflating the balloon.
14. The method of any one of examples 10-13 wherein inflating the balloon includes inflating the balloon to a selected inflation pressure of about 100 pounds per square inch.
15. The method of any one of examples 10-14 wherein the method further comprises providing a visual and/or auditory indication that the delivery system has contacted the wall.
16. A method of selecting a target site of an endocardial wall for a medical implant, the method comprising:
17. The method of example 16 wherein comparing the first delay to the second delay to select the first site or the second site as the target site includes determining the greater of the first delay and the second delay and selecting the first site or the second site as the target site based on the greater of the first delay and the second delay.
18. The method of example 16 or example 17 wherein monitoring the pressure within the balloon to detect the first delay includes sensing a first decrease in the pressure within the balloon, and wherein monitoring the pressure within the balloon to detect the second delay includes sensing a second decrease in the pressure within the balloon.
19. The method of any one of examples 16-18 wherein the method further comprises:
20. The method of any one of examples 16-19 wherein the endocardial wall is within the left ventricle.
The above detailed description of embodiments of the technology are not intended to be exhaustive or to limit the technology to the precise form disclosed above. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology as those skilled in the relevant art will recognize. For example, although steps are presented in a given order, alternative embodiments can perform steps in a different order. Likewise, the various electronic components and functions can be separated into more or fewer electronic circuit elements and/or functional blocks. The various components and/or functionalities of the embodiments described herein can also be combined to provide further embodiments.
From the foregoing, it will be appreciated that specific embodiments of the technology have been described herein for purposes of illustration, but well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the technology. Where the context permits, singular or plural terms can also include the plural or singular term, respectively.
Moreover, unless the word “or” is expressly limited to mean only a single item exclusive from the other items in reference to a list of two or more items, then the use of “or” in such a list is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Additionally, the term “comprising” is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and/or additional types of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications can be made without deviating from the technology. Further, while advantages associated with some embodiments of the technology have been described in the context of those embodiments, other embodiments can also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.
This application claims the benefit of U.S. Provisional Patent Application No. 63/066,699, filed Aug. 17, 2020, and titled “SYSTEMS AND METHODS FOR ENDOCARDIAL CONTACT SENSING WITH A SHEATH BALLOON FOR WIRELESS ENDOCARDIAL PACING ELECTRODES,” which is incorporated herein by reference in its entirety.
Number | Date | Country | |
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63066699 | Aug 2020 | US |