WO2020112776A1

WO2020112776A1 - Telemetry electrodes for continuous atrial electrogram monitoring

Info

Publication number: WO2020112776A1
Application number: PCT/US2019/063257
Authority: WO
Inventors: Hoang H. NGUYEN; Ra-id ABDULLA; Raymond MORALES
Original assignee: Rush University Medical Center
Priority date: 2018-11-29
Filing date: 2019-11-26
Publication date: 2020-06-04

Abstract

The disclosure is directed to a system and device for generating and monitoring atrial electrograms. The device includes a first receptacle electronically connecting to an atrial lead wire. The device includes a first plug electronically connecting to a first intermediate wire. When the first plug and the first receptacle are in a plugged configuration, a proximal portion of the first plug is disposed inside a proximal portion of the first receptacle so that the first intermediate wire electrically connects to the atrial lead wire and the first intermediate wire transmits atrial electrogram signal to a telemetry unit. When the first plug and the first receptacle are in an un-plugged configuration, the proximal portion of the first plug is disposed outside the proximal portion of the first receptacle.

Description

TELEMETRY ELECTRODES FOR CONTINUOUS ATRIAL ELECTROGRAM

MONITORING

RELATED APPLICATION

[0001] This application claims priority to U.S. Provisional Application No. 62/772,694, filed with the United States Patent and Trademark Office on November 29, 2018, which is incorporated by reference in its entirety.

BACKGROUND

1. Technical Field

[0002] An apparatus and system for generating and monitoring atrial electrograms are provided and in particular, the apparatus and the system include telemetry electrodes to generate and monitor atrial electrograms.

2. Background Information

[0003] An atrial electrogram is an electrocardiogram (ECG) obtained from wires connecting directly to the heart. The atrial electrogram gives a sharp and augmented atrial signal and thus facilitates prompt recognition and correct diagnosis of post-operative arrhythmias. The existing conventional method includes attaching pacemaker wires to electrodes of a telemetry unit to obtain the atrial electrogram on telemetry. However, the existing method has multiple issues, including the difficulties of attaching and removing the pacemaker wires due to the sticky telemetry electrodes that are secured with adhesive tabs. Moreover, frequent manipulation of the pacemaker wires due to daily replacement of the telemetry electrodes may damage the pacemaker wires.

[0004] The present disclosure is directed toward addressing one or more drawbacks, including but not limited to those set forth above. BRIEF SUMMARY

[0005] The present disclosure describes a device for monitoring an atrial electrogram. The device includes a first receptacle electronically connecting to an atrial lead wire. The device includes a first plug electronically connecting to a first intermediate wire. The first plug and the first receptacle include a plugged configuration and an un-plugged configuration. When the first plug and the first receptacle are in the plugged configuration, a proximal portion of the first plug is disposed inside a proximal portion of the first receptacle so that the first intermediate wire electrically connects to the atrial lead wire and the first intermediate wire transmits atrial electrogram signal to a telemetry unit. When the first plug and the first receptacle are in the un plugged configuration, the proximal portion of the first plug is disposed outside the proximal portion of the first receptacle.

[0006] The present disclosure also describes a system for generating an atrial electrogram. The system includes an implantable medical device. The implantable medical device includes an atrial lead wire implanted in an atrium of a subject. The system includes a first receptacle electronically connecting to the atrial lead wire. The system includes a first plug electronically connecting to a first intermediate wire. The first plug and the first receptacle include a plugged configuration and an un-plugged configuration. When the first plug and the first receptacle are in the plugged configuration, a proximal portion of the first plug is disposed inside a proximal portion of the first receptacle so that the first intermediate wire electrically connects to the atrial lead wire. When the first plug and the first receptacle are in the un-plugged configuration, the proximal portion of the first plug is disposed outside the proximal portion of the first receptacle. The system includes a telemetry unit configured to receive atrial electrogram signal via the first intermediate wire and generate an atrial electrogram.

BRIEF DESCRIPTION OF THE DRAWINGS

[0007] FIG. 1A is one embodiment of a system of the present disclosure. [0008] FIG. IB is another embodiment of a system of the present disclosure. [0009] FIG. 2 shows a schematic of a receptacle and a plug in the unplugged configuration of the present disclosure.

[0010] FIG. 3 shows a schematic of a receptacle and a plug in the plugged configuration of the present disclosure.

[0011] FIG. 4A-4E shows a schematic of embodiments of cross-section shaped for a receptacle and a plug.

[0012] FIG. 5 is an embodiment including more than one set of receptacles [0013] FIG. 6 shows clamp buttons and clamp members of the present disclosure.

DETAILED DESCRIPTION OF THE DISCLOSURE

[0014] The invention will now be described in detail hereinafter with reference to the accompanied drawings, which form a part of the present invention, and which show, by way of illustration, specific examples of embodiments. Please note that the invention may, however, be embodied in a variety of different forms and, therefore, the covered or claimed subject matter is intended to be construed as not being limited to any of the embodiments to be set forth below. Please also note that the invention may be embodied as methods, devices, components, or systems. Accordingly, embodiments of the invention may, for example, take the form of hardware, software, firmware or any combination thereof.

[0015] Throughout the specification and claims, terms may have nuanced meanings suggested or implied in context beyond an explicitly stated meaning. Likewise, the phrase“in one embodiment” as used herein does not necessarily refer to the same embodiment and the phrase“in another embodiment” as used herein does not necessarily refer to a different embodiment. It is intended, for example, that claimed subject matter includes combinations of exemplary embodiments in whole or in part.

[0016] In general, terminology may be understood at least in part from usage in context. For example, terms, such as“and”,“or”, or“and/or,” as used herein may include a variety of meanings that may depend at least in part upon the context in which such terms are used. Typically,“or” if used to associate a list, such as A, B or C, is intended to mean A, B, and C, here used in the inclusive sense, as well as A, B or C, here used in the exclusive sense. In addition, the term“one or more” or“at least one” as used herein, depending at least in part upon context, may be used to describe any feature, structure, or characteristic in a singular sense or may be used to describe combinations of features, structures or characteristics in a plural sense. Similarly, terms, such as“a”,“an”, or“the”, again, may be understood to convey a singular usage or to convey a plural usage, depending at least in part upon context. In addition, the term “based on” or“determined by” may be understood as not necessarily intended to convey an exclusive set of factors and may, instead, allow for existence of additional factors not necessarily expressly described, again, depending at least in part on context.

[0017] Post-operative arrhythmias are common after surgery for congenital heart disease with a reported incidence as high as 48%. Children that undergo surgical repair of congenital heart disease often have significant hemodynamic compromise in the post-operative period that could be incited and/or further worsened by these post-operative arrhythmias. Therefore, prompt recognition and correct diagnosis of post-operative arrhythmias are crucial in reducing the mortality and morbidity of these patients.

[0018] Some post-operative arrhythmia such as ectopic atrial tachycardia is difficult to diagnose even with careful scrutiny of a conventional/standard electrocardiogram (ECG), for example, a conventional 12-lead ECG. One of the main barriers to the correct diagnosis is the inability to visualize the P-wave on telemetry. Skin acts as a resistor in the active conduction of ECG signals from the heart and creates a loss of the ECG signals. Other factors such as heavy chest bandages also prevents optimal electrode-to-skin contact or post-operative myocardial changes. All these factors lead to reduction of ECG signals across the skin from the heart.

[0019] In this disclosure, as shown in FIG. 1A, a system 100 may be used to visualize P- wave. The system 100 may include an implantable medical device 120, a connecting device 140, and a telemetry unit 160. Wires 124 of the implantable medical device 120 may connect to the telemetry unit 160 via the connecting device 140. The implantable medical device 120 may include many types of implantable medical device related to the heart, for example and not limited to, a pacemaker having pacemaker wires. [0020] In one embodiment, the pacemaker wires 124 may connect to a pacemaker 120, and the pacemaker 120 has cardiac wires 122 directly implanted in a heart 1 10. In one

implementation, the cardiac wires 122 may include an atrial wire sutured directly on a right atrium of the heart 110. A proximal end 124-1 of the pacemaker wires 124 may be routed outside the body. Since the cardiac wires 122 are connected directly to the heart, the system 100 may give a sharp and augmented atrial signal thereby generating an atrial electrogram to facilitate visualization of the P-wave.

[0021] In another embodiment, the cardiac wires 122 may include at least two cardiac wires: one cardiac wire may be an atrial wire connecting to an atrium and another cardiac wire may be a ventricle wire connecting to a ventricle.

[0022] The procedure to obtain an atrial electrogram may be time consuming, and involve an electrogram technician who would need to set-up the electrogram machine and put on the electrodes leading to a delay in the correct diagnosis of the arrhythmias. Moreover, some arrhythmias may be intermittent and may not last long enough to be caught yet their presence may dictate significant changes in the management of these patients. For example, a patient with continued intermittent arrhythmias may need to be on chronic anti-arrhythmic therapy after discharge from the hospital. The present disclosure solves one or more drawbacks, including but not limited to those set forth above.

[0023] The telemetry unit 160 may include a standard ECG functionality, for example, 7- lead ECG or 12-lead ECG. The telemetry unit 160 may connect proximal ends 162-1 of telemetry electrodes 162 to the connecting device 140 and receive atrial signal from the pacemaker wires 124 and the cardiac wires 122. The atrial signal may be large enough to be clearly discemable on the telemetry unit 160. This hook-up scheme may allow a physician to promptly and correctly diagnose different post-operative arrhythmias.

[0024] In another embodiment as shown in FIG. IB, the system 100 may include a wireless terminal 150. The wireless terminal may connect proximal ends 152-1 of wireless terminal electrodes 152 to the connecting device and receive atrial signal from the pacemaker wires 124 and the cardiac wires 122. The wireless terminal 150 may transmit the atrial signal to the telemetry unit 160 via a wireless network. The wireless network may include and may not be limited to Wi-Fi, Bluetooth, ZigBee, Wide area network (WAN).

[0025] Two types of electrodes in common use are a flat paper-thin sticker and a self- adhesive circular pad. A conventional screwed-on connection between the pacemaker wire 124 and telemetry electrodes 162 or wireless terminal electrodes 152 may have several drawbacks. One drawback may be that it is difficult to attach and remove the pacemaker wires from the telemetry electrodes because the telemetry electrodes are sticky. Another drawback may be that frequent manipulation of the pacemaker wires due to daily replacement of the telemetry electrodes may damage these fragile wires. In the present disclosure, the connecting device 140 may include at least one set of receptacle and plug to address one or more drawbacks, including but not limited to those set forth above.

[0026] In one embodiment as shown in FIG. 2, the connecting device 140 may include a receptacle 142 and a plug 144. The receptacle 142 may include an enclosure 142-0 made of electrically insulating materials, for example but not limited to plastic, resin, Teflon, and rubber. The enclosure 142-0 include an open proximal end 142-1 and an at least partially closed distal end 142-2. The enclosure 142-0 include a chamber 142-9, into which at least a portion of the plug 144 may be inserted. A proximal end 124-1 of a pacemaker wire 124 may feed through the distal end 142-2 into a chamber of the enclosure 142-0. An electrically conductive member 142- 3 electrically connects to the proximal end 124-1 of the pacemaker wire 124 and is disposed inside the chamber of the enclosure 142-0. The electrically conductive member 142-3 may be under spring-tension and may be deformed during the process of connecting the receptacle 142 with the plug 144.

[0027] The plug 144 may include an enclosure 144-0 made of electrically insulating materials. The plug 144 may include a proximal end 144-1 and a distal end 144-2. The proximal end 144-1 of the plug 144 include a conductor 144-3. The conductor 144-3 is made of electrically conducting materials, for example but not limited to, copper and aluminum. The distal end 144-2 of the plug 144 is partially made of electrically insulating materials. A proximal end 162-1 of a telemetry electrode 162 may feed through the distal end 144-2 of the plug 144 and electrically connect to the conductor 144-3. [0028] When a receptacle 142 and a plug 144 are in an un-plugged configuration, as shown in FIG. 2, the plug 144 is outside of the chamber of the receptacle 142, and the pacemaker wire 124 is not electrically connected with the telemetry electrode 162.

[0029] When a receptacle 142 and a plug 144 are in a plugged configuration, as shown in FIG. 3, the plug 144 may insert at least partially into of the chamber of the receptacle 142. A proximal portion 144-1 of the plug inserts into a chamber of the receptacle 142 so that a conductor 144-3 of the plug 144 electrically connects to an electrically conductive member 142- 3 of the receptacle 142. In the plugged configuration, a telemetry electrode 162 electrically connects to a pacemaker wire 124 so that atrial electrogram signal is transmitted to a telemetry unit via the receptacle 142 and the plug 144. In some embodiments, the entire tip of the plug is covered to decrease noise in the system and to protect the tip.

[0030] In the present disclosure, a receptacle and a plug may have same or different cross- section shapes, for example but not limited to, the shapes as shown in FIG. 4A-4E. In FIG. 4A, a receptacle 142 and a plug 144 may have a rectangular shape. In one implementation, the rectangular shape may be a square shape. An outer dimension of the plug 144 may be slightly smaller than an inter dimension of the receptacle 142 so that, in a plugged configuration, the plug 144 may fit snuggly in the chamber of the receptacle 142. In one implementation, in the plugged configuration, there may be one or more O-rings between the plug 144 and the receptacle 142 so as to achieve a substantial water-tight seal. This will minimize the risk of any environmental interference to the atrial electrogram signal. Here and in the present disclosure, the term “slightly” may refer to be within 5% of the reference value or smaller than 2 mm.

[0031] In another embodiment as FIG. 4B, the receptacle 142 may include a guiding member 142-6 and the plug 144 may include a guiding channel 144-6. The guiding member 142-6 may be located at a middle position of one side of the receptacle 142. The guiding member 142-6 may have a substantially similar dimension as the guiding channel 144-6 or may have a slightly smaller dimension than the guiding channel 144-6, so that, in the plugged configuration, a rotation of the plug 144 is fixed relative to the receptacle 142.

[0032] In another embodiment as FIG. 4C, a cross section of the receptacle 142 may have a rectangular shape which may include a square shape. A cross section of the plug 144 may have a different shape, for example but not limited to, a circular shape. An outer dimension of the plug 144 may be slightly smaller than an inter dimension of the receptacle 142 so that, in a plugged configuration, the plug 144 may fit in the chamber of the receptacle 142.

[0033] In another embodiment as FIG. 4D, a cross section of the receptacle 142 and the plug 144 may have a circular shape. An outer dimension of the plug 144 may be slightly smaller than an inter dimension of the receptacle 142 so that, in a plugged configuration, the plug 144 may fit snuggly in the chamber of the receptacle 142. In one implementation as FIG. 4E, the receptacle 142 may include a guiding member 142-6 and the plug 144 may include a guiding channel 144- 6, so as to limit the relative rotation between the receptacle 142 and the plug 144. In another implementation, in the plugged configuration, there may be one or more O-rings between the plug 144 and the receptacle 142, so as to achieve a substantially water-tight seal.

[0034] In another embodiment, a connecting device 140 may include more than one sets of receptacles and plugs, for example, 2 sets, 3 sets, and 5 sets. Each receptacle may have same or different color as another receptacle so that a user can easily distinguish a receptacle by its color during usage. The colors of the receptacles may correspond to colors of wires connecting to the receptacles, respectively. Similarly, each plug may have the same or a different color as another plug so that a user can easily distinguish a plug by its color during usage. The colors of the plugs may correspond to colors of electrodes connecting to the plugs, respectively.

[0035] FIG. 5 shows one embodiment, wherein a connecting device include two sets of receptacles and plugs: a first receptacle 520, a second receptacle 530, a first plug 540, and a second plug 550. The first plug 540 and the second plug 550 may have different colors. For example but not limited to, the first plug 540 may have a brown color and connect to a wire 580 with a brown color, and the second plug 550 may have a green color and connect to a wire 590 with a green color.

[0036] The first and second receptacles may be separate from each other, or may be an integrated piece. The first and second receptacles may have same or different colors. For example but not limited to, as shown in FIG. 5, the first receptacle 520 and the second receptacle 530 are connected together as an integrated piece and have same color such as a white color. The first receptacle 520 may connect to a wire 512 with a brown color, and the second receptacle 530 may connect to a wire 514 with a green color.

[0037] In one embodiment, a receptacle may have a lock and release mechanism to lock/release a plug. As shown in FIG. 6, a first receptacle 520 may include a clamp button 522, which may physically connect to a clamp member 524 disposed inside a chamber of the first receptacle 520. A second receptacle 530 may include a clamp button 532, which may physically connect to a clamp member 534 disposed inside a chamber of the second receptacle 530. The clamp buttons 522 and 532 may be under tension of a spring, facilitate tool-free connection and/or disconnection of the plug and the receptacle.

[0038] During a connection process, the clamp button 522 or 523 may be pushed down and a plug may be inserted into the chamber of the receptacle 520 or 530. Then, when the clamp button 522 or 523 is released, under the load of spring force, a clamp member 524 or 534 may engage the plug to lock the plug in place.

[0039] During a disconnection process, the clamp button 522 or 523 may be pushed down to disengage the clamp member 524 or 534 from a plug. Then, the plug may be released from the receptacle.

[0040] A telemetry unit 160 may generate and monitor an atrial electrogram based on one or more electrodes from the connecting device 140. The atrial electrogram is generated based on a first telemetry electrode and a second telemetry electrode.

[0041] In one implementation, the first telemetry electrode may connect to an atrial lead wire via the connecting device 140. The atrial lead wire may be one wire of pacemaker wires. The second telemetry electrode may connect to a ventricular lead wire via the connecting device 140. The ventricular lead wire may be another wire of the pacemaker wires.

[0042] In another implementation, the first telemetry electrode may connect to an atrial lead wire including one wire of pacemaker wires. The second telemetry electrode may connect to a common virtual electrode. The common virtual electrode may be, for example but not limited to, a Wilson's central terminal, which may be produced by averaging the measurements from one or more electrodes of a conventional ECG configuration. In a conventional 12-lead ECG, the Wilson’s central terminal may be produced by averaging RA-electrode on the right arm, LA- electrode on the left arm, and LL-electrode on the left leg.

[0043] The present disclosure describes a system for using a connecting device to replace a conventional sticky ends of electrodes, so that the user may easily clip the temporary pacemaker wires to the telemetry electrode without a high risk of damaging these wires. The wires may also be taken off easily without the need of peeling sticky glue residue. Using the disclosed system and device, a continuous atrial electrogram on the telemetry unit may be obtained and the electrodes may be easily replaced. The system is configured for single-handed operation.

[0044] The disclosed system and device has been tested on numerous consecutive pediatric patients who underwent surgery for congenital heart disease. Post-operative arrhythmias may be promptly and correctly diagnosed. With obtaining and monitoring continuous atrial electrogram on telemetry unit, intermittent episodes of arrhythmias that occurred overnight were identified, which would have been elusive with the conventional method.

[0045] While the particular invention has been described with reference to illustrative embodiments, this description is not meant to be limiting. Various modifications of the illustrative embodiments and additional embodiments of the invention will be apparent to one of ordinary skill in the art from this description. Those skilled in the art will readily recognize that these and various other modifications can be made to the exemplary embodiments, illustrated and described herein, without departing from the spirit and scope of the present invention. It is therefore contemplated that the appended claims will cover any such modifications and alternate embodiments. Certain proportions within the illustrations may be exaggerated, while other proportions may be minimized. Accordingly, the disclosure and the figures are to be regarded as illustrative rather than restrictive.

Claims

1. A device for monitoring an atrial electrogram, the device comprising:

a first receptacle electronically connecting to an atrial lead wire; and

a first plug electronically connecting to a first intermediate wire, the first plug and the first receptacle comprising a plugged configuration and an un-plugged configuration, wherein:

when the first plug and the first receptacle are in the plugged configuration, a proximal portion of the first plug is disposed inside a proximal portion of the first receptacle so that the first intermediate wire electrically connects to the atrial lead wire and the first intermediate wire transmits atrial electrogram signal to a telemetry unit, and

when the first plug and the first receptacle are in the un-plugged configuration, the proximal portion of the first plug is disposed outside the proximal portion of the first receptacle.

2. The device according to claim 1, wherein the atrial lead wire electrically connects to an implantable medical device implanted in an atrium of a subject.

3. The device according to claim 2, wherein the implantable medical device is a pacemaker.

4. The device according to claim 1, further comprising:

a second receptacle electronically connecting to a ventricular lead wire; and

a second plug electronically connecting to a second intermediate wire, the second plug comprising a plugged configuration and an un-plugged configuration, wherein: when the second plug is in the plugged configuration, a proximal portion of the second plug is disposed inside a proximal portion of the second receptacle so that the second intermediate wire electrically connects to the ventricular lead wire and the second intermediate wire transmits ventricular electrogram signal to the telemetry unit, and when the second plug is in the un-plugged configuration, the proximal portion of the second plug is disposed outside the proximal portion of the first receptacle.

5. The device according to claim 4, wherein the first receptacle and the second receptacle are configured to be fixed together as an integrated piece.

6. The device according to claim 4, wherein a color of the first plug is different from a color of the second plug.

7. The device according to claim 4, wherein the ventricular lead wire electrically connects to an implantable medical device implanted in a ventricle of a subject.

8. The device according to claim 7, wherein the implantable medical device is a pacemaker.

9. The device according to claim 4, wherein the telemetry unit is configured to generate an atrial electrogram based on the atrial lead wire and the ventricular lead wire.

10. The device according to claim 1, wherein the telemetry unit is configured to generate an atrial electrogram based on the atrial lead wire and a common virtual electrode.

11. The device according to claim 10, wherein the common virtual electrode comprises a Wilson’s central terminal.

12. The device according to claim 1, wherein the first intermediate wire electronically connects to a wireless terminal, and the wireless terminal is configured to transmit the atrial electrogram signal to the telemetry unit via a wireless communication.

13. The device according to claim 1, wherein the first receptacle further comprises: a clamp button; and

a clamp member disposed inside a chamber of the first receptacle, the clamp member physically connecting to the clamp button, wherein:

when the clamp button is pressed in the plugged configuration, the clamp member is configured to release the first plug, and

when the clamp button is released in the plugged configuration, the clamp member is configured to lock the first plug.

14. A system for generating an atrial electrogram, the system comprising:

an implantable medical device comprising an atrial lead wire implanted in an atrium of a subject;

a first receptacle electronically connecting to the atrial lead wire;

when the first plug and the first receptacle are in the plugged configuration, a proximal portion of the first plug is disposed inside a proximal portion of the first receptacle so that the first intermediate wire electrically connects to the atrial lead wire, and when the first plug and the first receptacle are in the un-plugged configuration, the proximal portion of the first plug is disposed outside the proximal portion of the first receptacle; and

a telemetry unit configured to receive atrial electrogram signal via the first intermediate wire and generate an atrial electrogram.

15. The system according to claim 14, further comprising:

a second receptacle electronically connecting to a ventricular lead wire; and

a second plug electronically connecting to a second intermediate wire, the second plug comprising a plugged configuration and an un-plugged configuration, wherein:

when the second plug is in the plugged configuration, a proximal portion of the second plug is disposed inside a proximal portion of the second receptacle so that the second

intermediate wire electrically connects to the ventricular lead wire and the second intermediate wire transmits ventricular electrogram signal to the telemetry unit, and

when the second plug is in the un-plugged configuration, the proximal portion of the second plug is disposed outside the proximal portion of the first receptacle.

16. The system according to claim 15, wherein a color of the first plug is different from a color of the second plug.

17. The system according to claim 14, wherein the first intermediate wire

electronically connects to a wireless terminal, and the wireless terminal is configured to transmit the atrial electrogram signal to the telemetry unit via a wireless communication.

18. The system according to claim 14, wherein the implantable medical device is a pacemaker.