Patent Application
20250177763
The present disclosure is directed to providing an indication to a patient that a power source is secured to provide power to an ambulatory medical device.
Heart failure, if left untreated, can lead to certain life-threatening arrhythmias. Both atrial and ventricular arrhythmias are common in patients with heart failure. One of the deadliest cardiac arrhythmias is ventricular fibrillation, which occurs when normal, regular electrical impulses are replaced by irregular and rapid impulses, causing the heart muscle to stop normal contractions. Because the victim has no perceptible warning of the impending fibrillation, death often occurs before the necessary medical assistance can arrive. Other cardiac arrhythmias can include excessively slow heart rates known as bradycardia or excessively fast heart rates known as tachycardia. Cardiac arrest can occur when a patient in which various arrhythmias of the heart, such as ventricular fibrillation, ventricular tachycardia, pulseless electrical activity (PEA), and asystole (heart stops all electrical activity), result in the heart providing insufficient levels of blood flow to the brain and other vital organs for the support of life. It is generally useful to monitor heart failure patients to assess heart failure symptoms early and provide interventional therapies as soon as possible.
Patients who are at risk, have been hospitalized for, or otherwise are suffering from, adverse heart conditions can be prescribed a wearable cardiac monitoring and/or treatment device. In addition to the wearable device, the patient can also be given a battery charger and a set of rechargeable batteries. As the wearable device is generally prescribed for continuous or near-continuous use (e.g., only to be removed when bathing), the patient is generally instructed to keep a battery in the device at all times and one battery on the charger at all times. Thus, as one battery is being depleted by the device, the second battery is being charged. By following these instructions, when a battery swap is required, the second battery is charged and ready to power the wearable device. Upon swapping, the battery removed from the wearable device is inserted into the charger, and the process is repeated.
In an example, a wearable cardioversion-defibrillation system for providing battery information to patients is provided. The system includes one or more sensing electrodes configured to output a signal indicative of cardiac activity of a patient, one or more therapy electrodes configured to provide one or more treatment shocks to the patient when a patient wearing the wearable cardioversion-defibrillation system experiences a cardiac arrhythmia, a controller of the wearable cardioversion-defibrillation system, the controller operably coupled to the one or more sensing electrodes and the one or more therapy electrodes, a battery well disposed on the controller; and battery circuitry disposed in either a removable battery or within the battery well. The battery circuitry is configured to detect whether the removable battery is inserted into the battery well and providing power to monitor and/or treat the patient, and provide human-perceptible confirmation via one or more of tactile, visual, or audio feedback to the patient on detecting that the removable battery has been inserted into the battery well and is providing power to monitor and/or treat the patient, wherein upon proper insertion of the removable battery within the battery well, the controller is configured to monitor and/or treat the patient for a cardiac arrhythmia based on power from the removable battery.
Implementations of the wearable cardioversion-defibrillation system for providing battery information to patients can include one or more of the following features.
In examples of the wearable cardioversion-defibrillation system, the battery circuitry can include at least one feedback device configured to output the one or more tactile, visual, or audio feedback. In some examples, the at least one feedback device can include at least one visual indicator configured to transition from a first visual state to a second visual state upon proper insertion of the removable battery into the battery well. In some examples, the at least one feedback device can include at least one audio output device configured to output the audio feedback upon proper insertion of the removable battery into the battery well. In some examples, the at least one audio output device can be adjustable to alter a predetermined frequency range of the audio feedback. In some examples, the at least one audio output device can be adjustable via a control provided during initial patient fitting of the wearable cardioversion-defibrillation system. In some examples, the at least one feedback device can include a vibrational mechanism configured to output the tactile feedback when the removable battery is inserted into the battery well. In some examples, the removable battery can include a housing and the at least one feedback device is integrated into the housing of the removable battery.
In examples of the wearable cardioversion-defibrillation system, the battery well can include an electrical connector configured to receive at least a portion of the removable battery to establish an electrical connection between the removable battery and the controller. In some examples, the battery well can further include a seal configured to at least partially deform when the removable battery is inserted into the battery well to securely enclose the electrical connection between the removable battery and the controller.
In examples of the wearable cardioversion-defibrillation system, the system can further include a battery charger, the battery charger including a charging battery well, the charging battery well including a charging connector. In some examples, the battery circuitry can be disposed in the removable battery and includes at least one additional feedback device configured to provide one or more of the tactile, visual, or audio feedback to the patient when the removable battery is inserted into the charging battery well and a charging electrical connection is established between the removable battery and the charging connector.
In examples of the wearable cardioversion-defibrillation system, the system can further include a battery latching mechanism configured to secure the removable battery in the battery well and provide additional tactile feedback to the patient upon proper insertion of the removable battery within the battery well.
In examples of the wearable cardioversion-defibrillation system, the battery well can include a spring mechanism configured to exert a spring force opposing insertion of the removable battery into the battery well. In some examples, the system can further include a battery latching mechanism configured to secure the removable battery in the battery well and oppose the spring force such that, upon release of the battery latching mechanism, the spring force is configured to assist in removal of the removable battery from the battery well. In some examples, the battery latching mechanism can be further configured to provide additional tactile feedback to the patient upon proper insertion of the removable battery within the battery well.
In examples of the wearable cardioversion-defibrillation system, the battery circuitry can further include battery detection circuitry configured to detect a position of the removable battery within the battery well. In some examples, the battery detection circuitry can include one or more of a Hall effect sensor, an optical position sensor, a mechanical switch, an infrared position sensor, and an electrical connector.
In examples of the wearable cardioversion-defibrillation system, the removable battery can be configured to provide power to the one or more therapy electrodes to deliver the one or more treatment shocks to the patient.
In examples of the wearable cardioversion-defibrillation system, the removable battery can be configured to provide power to the controller to monitor the signal indicative of cardiac activity of the patient for a cardiac arrhythmia.
In another example, a system for providing battery insertion feedback to patients wearing or using a wearable cardioversion-defibrillation device is provided. The system includes a controller of the wearable cardioversion-defibrillation device, a battery well disposed on the controller, a removable battery configured to be inserted into the battery well such that an electrical connection is established between the removable battery and the controller, a mechanical attachment disposed on either the removable battery or within an interior volume of the battery well, the mechanical attachment configured at least to detect the insertion of the removable battery within the battery well, and a visual indicator operably coupled to the mechanical attachment, the visual indicator configured to provide visual feedback to a patient using the wearable cardioversion-defibrillation device that the removable battery is inserted into the battery well and providing power to the wearable cardioversion-defibrillation device to monitor and/or treat the patient.
Implementations of the system for providing battery insertion feedback to patients wearing or using a wearable cardioversion-defibrillation device can include one or more of the following features.
In examples of the system, the mechanical attachment can be further configured to exert an opposition force upon the removable battery as the removable battery is inserted within the battery well. In some examples, the mechanical attachment can be further configured such that, upon release of the removable battery from the battery well, the opposition force causes at least partial ejection of the removable battery from the battery well. In some examples, the visual indicator can be configured to alter the visual feedback in response to changes in the opposition force exerted by the mechanical attachment as the removable battery is inserted within the battery well.
In examples of the system, the mechanical attachment can include at least one movable pawl operably coupled to the visual indicator, the movable pawl configured to be displaced from within an interior volume of the battery well as the removable battery is inserted into the battery well. In some examples, the at least one movable pawl can be shaped such that insertion of the removable battery into the battery causes displacement of at least a portion of the movable pawl. In some examples, movement of the movable pawl can causes movement of at least a portion of the visual indicator, thereby changing the visual feedback provided to the patient.
In examples of the system, the battery well can include an electrical connector configured to receive at least a portion of the removable battery to establish the electrical connection between the removable battery and the controller. In some examples, the battery well can further include a seal configured to at least partially deform when the removable battery is inserted into the battery well to securely enclose the electrical connection between the removable battery and the controller.
In examples of the system, the removable battery can include a housing and the visual indicator is integrated into the housing of the removable battery.
In examples of the system, the system can further include a battery charger, the battery charger including a charging battery well, the charging battery well including a charging connector.
In examples of the system, the system can further include a battery latching mechanism configured to secure the removable battery in the battery well and provide tactile feedback to the patient upon proper insertion of the removable battery within the battery well.
In examples of the system, the battery well can include a spring mechanism configured to exert a spring force opposing insertion of the removable battery into the battery well.
In some examples, the system can include a battery latching mechanism configured to secure the removable battery in the battery well and oppose the spring force such that, upon release of the battery latching mechanism, the spring force is configured to assist in removal of the removable battery from the battery well. In some examples, the battery latching mechanism can be further configured to provide additional tactile feedback to the patient upon proper insertion of the removable battery within the battery well.
In examples of the system, the system can further include battery circuitry disposed in either the removable battery or within the battery well, the battery circuitry configured to detect whether the removable battery is inserted into the battery well and providing power to monitor and/or treat the patient. In some examples, the battery circuitry can include at least one feedback device configured to output the one or more tactile, visual, or audio feedback. In some examples, the at least one feedback device can include at least one audio output device configured to output the audio feedback upon proper insertion of the removable battery into the battery well. In some examples, the at least one audio output device can be adjustable to alter a predetermined frequency range of the audio feedback. In some examples, the at least one audio output device can be adjustable via a control provided during initial patient fitting of the wearable cardioversion-defibrillation system. In some examples, the at least one feedback device can include a vibrational mechanism configured to output the tactile feedback when the removable battery is inserted into the battery well. In some examples, the battery circuitry can further include battery detection circuitry configured to detect a position of the removable battery within the battery well. In some examples, the battery detection circuitry can include one or more of a Hall effect sensor, an optical position sensor, a mechanical switch, an infrared position sensor, and an electrical connector.
In examples of the system, the removable battery can be configured to provide power to one or more therapy electrodes the wearable cardioversion-defibrillation device to deliver one or more treatment shocks to the patient.
In examples of the system, the removable battery can be configured to provide power to a controller the wearable cardioversion-defibrillation device to monitor a signal indicative of cardiac activity of the patient for a cardiac arrhythmia.
Various aspects of at least one example are discussed below with reference to the accompanying figures, which are not intended to be drawn to scale. The figures are included to provide an illustration and a further understanding of the various aspects and examples and are incorporated in and constitute a part of this specification but are not intended to limit the scope of the disclosure. The drawings, together with the remainder of the specification, serve to explain principles and operations of the described and claimed aspects and examples. In the figures, each identical or nearly identical component that is illustrated in various figures is represented by a like numeral. For purposes of clarity, not every component may be labeled in every figure.
Wearable medical devices, such as cardiac event monitoring and/or treatment devices, are used in clinical or outpatient settings to monitor and/or record various ECG and other physiological signals for a patient. These ECG and other physiological signals can be used to determine a current condition for a patient as well as to provide an indication that the patient may require treatment such as a defibrillation shock.
Wearable medical devices are powered by either an integrated rechargeable battery or by a removable rechargeable battery. In some scenarios, where a patient is required to wear a wearable medical device, such as a wearable cardioverter defibrillator (WCD) for multiple hours in a day, e.g., a majority of the hours of the day, and only to removed when bathing, it may not be practical to prescribe a device that includes an integrated rechargeable battery. In such scenarios, the patient can be given two rechargeable batteries and guided to insert one battery in the medical device, to insert the second battery into the charger, and to swap the batteries when the remaining runtime of the battery in the medical device drops below a predetermined threshold value. When the batteries are to be swapped, the first battery is removed from the WCD and temporarily placed aside. The second battery is removed from the charger and inserted into the WCD. Once the WCD has restarted and/or power to the device is resumed, such that the WCD is being properly powered by the second battery, the patient places the first battery onto the charger for charging. By following this guidance, when a battery swap is required (e.g., every 24 hours), a fully charged battery is sitting in the charger and ready to power the WCD.
Example systems and methods disclosed here are advantageous in that they can mitigate potential risks in the event the guidance noted above in connection with battery maintenance for WCDs is not followed. As an example of potential risk, if the patient improperly places a depleted battery onto the charger, when time for the next battery swap arrives, the patient may have a compromised battery (e.g., not completely charged battery or only partially charged) to insert into the medical device. Such a scenario can result in the medical device not functioning appropriately (e.g., wherein substantially all of the safety critical functions are operational) or at all (e.g., the device may not power on at all). The systems and methods disclosed herein, however, advantageously mitigate these concerns by providing visual and/or other feedback to a user alerting them to the situation so that corrective action may be taken. For example, with a WCD, providing a treatment or therapy shock to the patient requires significantly more power than merely providing monitoring of the patient's physiological signals. In such cases, while the WCD may continue to monitor the patient's ECG or other physiological signals with such a compromised battery, it may fail to provide adequate treatment shock(s) if the patient is experiencing, for example, ventricular fibrillation (VF), ventricular tachycardia (VT), or other life-threatening shockable arrhythmias. The systems and methods disclosed herein advantageously mitigate such risks by provide visual and/or other feedback to a user alerting them to the situation so that corrective action may be taken. As yet another example of a potential risk scenario, if a patient improperly and/or incorrectly inserts a charged battery into the WCD monitor/controller, the controller may not receive power and, as such, may not provide safety-critical monitoring of and treatment to the patient. Once again, the systems and methods disclosed herein advantageously mitigate such risks by provide visual and/or other feedback to a user alerting them to the situation.
To address these and other obstacles to successful execution of, and patient adherence to, proper battery maintenance tasks, including correct insertion, removal, verification that the battery is properly charging, and/or verification that the battery is properly providing power to the device, systems and processes for providing feedback regarding certain battery operations including battery insertion are described herein. For example, a rechargeable battery for a wearable medical device such as a WCD can include battery circuitry and a feedback mechanism configured to provide feedback indicating whether the rechargeable battery is properly inserted into either the wearable medical device or a battery charger. For example, the battery circuitry can be configured to determine whether the rechargeable battery is physically and properly inserted into the wearable medical device or battery charger such that the rechargeable battery is fully inserted into a receiving battery well and/or has established an electrical and/or mechanical connection with the wearable medical device or battery charger. In other examples, the battery circuitry can be configured to determine whether current is flowing out of the rechargeable battery (e.g., the rechargeable battery is inserted into and powering the wearable medical device) and/or whether current is flowing into the rechargeable battery (e.g., the rechargeable battery is inserted into the charger and is being charged). The feedback mechanisms and/or processes as described herein can be implemented by mechanical and/or electrical features that are operably coupled to the battery circuitry. For example, the feedback mechanism can include mechanical or electrical features that are configured to output a positive feedback if the battery circuitry provides an indication that the rechargeable battery is properly inserted into the wearable medical device or battery charger. Conversely, the feedback mechanism can be configured to output negative feedback if the battery circuitry provides an indication that the rechargeable battery is improperly inserted into the wearable medical device or battery charger. Positive or negative feedback can be provided via the feedback mechanism through human-perceptible indications that are visual, audible, and/or tactile in nature, in confirming that the rechargeable battery is either properly or improperly inserted into the wearable medical device or battery charger. Non-limiting examples of such positive and negative feedbacks are provided in greater detail below.
In some examples, the battery circuitry and the feedback mechanism can be integrated into the device configured to receive the rechargeable battery. For example, the battery circuitry and the feedback mechanism can be integrated directly into the wearable medical device and/or the battery charger. For example, as described herein, a WCD system can include one or more sensing electrodes for collecting electrical signals indicative of cardiac activity of a patient, one or more therapy electrodes configured to provide one or more treatment shocks to the patient as necessary, and a medical device controller. The controller can include a battery well disposed within its housing and configured to receive a rechargeable battery. The controller can further include battery circuitry configured to detect whether the battery is inserted into the battery well and provide human-perceptible confirmation that the battery has been inserted into the battery well and is providing power to the WCD.
In certain examples, a mechanical attachment mechanism is provided that is displaced or otherwise physically altered upon insertion of a rechargeable battery into a wearable medical device and/or battery charger. In such examples, the mechanical attachment mechanism can include or be operably coupled to a visual indicator that is configured to provide visual feedback to a patient inserting the rechargeable battery into a battery well as described herein. For example, the mechanical attachment mechanism and the visual indicator can be configured to operate in concert such that the visual indicator transitions from a first state (e.g., displaying a first predetermined color, such as the color red) when the battery is not properly inserted to a second state (e.g., displaying a second predetermined color, such as the color green) when the battery is properly inserted.
These examples, and various other similar examples of benefits and advantages of the techniques, processes, and approaches as provided herein, are described in additional detail below.
The various battery insertion detection and feedback devices and processes described herein are implemented, in some examples, with removable and rechargeable batteries configured to provide power to certain types of medical devices. For instance, some examples include a patient monitoring and treatment device. Patient monitoring and treatment devices are used to monitor and record various physiological and/or vital signals for a patient and provide treatment to a patient when necessary. For patients at risk of a cardiac arrhythmia, specialized cardiac monitoring and/or treatment devices such as a cardiac event monitoring device, a WCD, or a hospital wearable defibrillator can be prescribed to and worn by the patient for an extended period of time. For example, a patient having an elevated risk of sudden cardiac death, unexplained syncope, prior symptoms of heart failure, an ejection fraction of less than 45%, less than 35%, or other such threshold deemed of concern by a physician, and other similar patients in a state of degraded cardiac health can be prescribed a specialized cardiac monitoring and/or treatment device.
For example, a WCD such as the LifeVest® Wearable Cardioverter Defibrillator from ZOLL Medical Corporation (Chelmsford, MA), can be prescribed to the patient. As described in further detail below, such a device includes a garment that is configured to be worn about the torso of the patient. The garment can be configured to house various components such as ECG sensing electrodes and therapy electrodes. The components in the garment can be operably connected to a monitoring device that is configured to receive and process signals from the ECG sensing electrodes to determine a patient's cardiac condition and, if necessary, provide treatment to the patient using the therapy electrodes.
In some examples, the patient monitoring medical device can include a medical device controller 100 that includes like components as those described above but does not include the therapy delivery circuitry 102 and the therapy electrodes 120 (shown in dotted lines). That is, in certain implementations, the medical device can include only ECG monitoring components and not provide therapy to the patient. In such implementations, the construction of the patient monitoring medical device is similar in many respects as a WCD medical device controller 100 but need not include the therapy delivery circuitry 102 and associated therapy electrodes 120.
In certain implementations, the controller 100 can further include one or more components for determining whether the rechargeable battery 110 is properly inserted into the controller and providing power to one or more additional components within the controller. For example, as shown in
Upon proper insertion, the rechargeable battery 110 is configured to provide power to the one or more therapy electrodes 120 to delivery one or more treatment shocks to the patient as needed. Similarly, upon proper insertion, the rechargeable battery is configured to provide power to the controller 100 to monitor electrical signals indicative of the cardiac activity of the patient for any cardiac arrhythmias. As such, by receiving feedback that the rechargeable battery 110 is properly inserted into the controller 100, the patient knows that the controller is properly monitoring the patient's cardiac activity and that the patient will be treated with one or more therapeutic shocks if needed.
As further shown in
As further shown in
As also shown in
As further shown in
Additionally or alternatively, the battery circuitry and the feedback mechanism as described herein can be integrated into the battery charger rather than the rechargeable battery as described above in
As further shown in
Depending upon the design of the rechargeable battery 110, the medical device controller 100, and the battery chargers 300 and 350, the battery circuitry (e.g., battery circuitry 132, 202, and 358 as shown in
For example, as listed in Table 1, the battery circuitry can include digital input/output (I/O) monitoring. The digital I/O monitoring can include monitoring a connection such as an electrical bus between the medical device controller and the rechargeable battery, or the battery charger and the rechargeable battery, to determine if the rechargeable battery is properly inserted and electrically coupled to either the medical device controller or the battery charger.
For example, as shown in
In another example as listed in Table 1, the battery circuitry can include monitoring for analog signals between the medical device controller and the rechargeable battery, or the battery charger and the rechargeable battery, to determine if the rechargeable battery is properly inserted and electrically coupled to either the medical device controller or the battery charger.
For example, as shown in
In addition to monitoring circuitry configured to monitor for a digital or analog signal that can be indicative of a connection between a rechargeable battery and a wearable medical device controller or battery charger, the battery circuitry can further include one or more physical sensors and/or detection mechanisms for determining if a rechargeable battery is properly inserted into another device.
In another example as shown in Table 1, the battery circuitry can include a Hall Effect sensor that is configured to measure a magnetic field generated by, for example, a magnet that is positioned adjacent to a position where the rechargeable battery is inserted into the wearable medical device controller or battery charger. For example, a magnet can be integrated into the housing 301 of the battery charger near the battery receiving well 302 as described above. Upon insertion of the rechargeable battery into the battery receiving well 202, the Hall Effect sensor included in the battery circuitry as described herein can measure the magnetic field as generated by the magnet, thereby providing an indication that the rechargeable battery is properly inserted into the battery charger or the wearable medical device controller.
Other powered proximity-type sensors are also included in Table 1. For example, the battery circuitry can include an optical sensor such as an infrared proximity detector that is configured to measure a distance between a portion of the rechargeable battery and a portion of the wearable medical device controller and/or battery charger. Another proximity-type sensor as shown in Table 1 includes an ultrasonic sensor that is configured to emit an ultrasonic sound and measure reflected sound waves to determine whether a rechargeable battery is properly inserted into a wearable medical device controller and/or a battery charger.
In addition to powered proximity-type sensors, the battery circuitry can include mechanical proximity-type sensors as well. For example, the battery circuitry can include a proximity switch that is at least partially depressed or otherwise displaced when the rechargeable battery is inserted into, for example, a wearable medical device controller. In another example, another mechanical proximity interface can include a battery latch that is depressed by the patient when inserting the rechargeable battery. In certain implementations, at least a portion of the battery latch can remain displaced when the rechargeable battery is properly inserted into the wearable medical device controller. In both examples, the battery circuitry can include a switch that is directly connected to the proximity switch or battery latch, and the status of the switch (e.g., opened or closed) can provide a direct indication of whether the rechargeable battery is properly inserted into the wearable medical device controller.
For example,
Another battery circuitry type as noted in Table 1 can include a dedicated electrical connection monitor. For example, the monitor can be configured to detect a signal on a dedicated pin on the connector between the rechargeable battery and the wearable medical device controller. In certain implementations, the dedicated pin can provide a loop-back function that provides a signal to the rechargeable battery that there is an electrical connection with the controller. When implemented, the dedicated electrical connection monitor can be configured to confirm via measurement that an electrical connection has been made between the rechargeable battery and the wearable medical device controller.
For example, as shown in
Another battery circuitry example can be the use of a mechanical switch such as a reed switch that reacts to the presence of, for example, a magnet. Rather than use a powered sensor such as Hall Effect sensor, a reed switch provides for a mechanical solution. For example, as shown in
It should be noted that, in the above examples, when determining a connection between a rechargeable battery and a wearable medical device controller is discussed, the same concepts and techniques can be used to determine a connection between the rechargeable battery and a battery charger. Conversely, in the above examples, when determining a connection between a rechargeable battery and a battery charger is discussed, the same concepts and techniques can be used to determine a connection between the rechargeable battery and a wearable medical device controller.
In certain implementations, the processor can monitor one or more connections between the rechargeable battery and the wearable medical device for the presence or status of one or more signals that can be indicative of a connection between the rechargeable battery and the wearable medical device controller. Examples of such signals indicative of a connection can include a digital communication signal (e.g., as outlined in
As further shown in
It should be noted that the process 500 as shown in
In a use-case example, the above described processes and techniques can be implemented to reduce the risk that a patient wearing a wearable medical device forgets or improperly inserts a rechargeable battery into the device when replacing a depleted rechargeable battery with a charged rechargeable battery during a battery swap. The above described processes and techniques can also reduce the risk that the patient will not properly insert the depleted rechargeable battery into the battery charger for charging. For example, an elderly heart failure patient may be prescribed a WCD for continuous wear while also being given a battery charger and two rechargeable batteries. Upon the initial fitting of the wearable medical device, the patient can be instructed that the rechargeable batteries should be swapped every 24 hours and that, upon removal from the controller, the depleted rechargeable battery should be placed on the battery charger and left until the next battery swap. During the first battery swap, the patient may be confused or forget the instructions and fail to properly insert the depleted rechargeable battery onto the battery charger. Using the techniques and processes as described herein, the patient can quickly determine whether they have properly inserted the rechargeable battery into the battery charger. Similarly, when inserting a recently charged battery into the medical device controller, the patient can receive similar feedback that the rechargeable battery is properly inserted into the medical device controller and that the controller is receiving power from the properly inserted battery.
In addition to including battery circuitry configured to determine when the battery is properly inserted into a battery well as described above, additional mechanical feedback and electromechanical detection and feedback techniques can be used to determine when a rechargeable battery is properly inserted into a battery well in, for example, a medical device controller and/or a battery charger. For example, one or both of the rechargeable battery and the receiving battery well can include a mechanical attachment configured to detect the insertion of the rechargeable battery into an interior volume of the battery well. In certain implementations, the mechanical attachment can protrude from an exterior surface of the rechargeable battery. Similarly, the mechanical attachment can be disposed within an interior volume of the receiving battery well.
In certain implementations, the mechanical attachment can be configured to be disposed, depressed, rotated, or otherwise moved in response to the rechargeable battery being inserted into the battery well. The mechanical attachment can be configured to work in concert with a visual indicator. In some examples, the visual indicator can be integrated into the mechanical attachment. In other examples, the visual indicator can be operably coupled to the mechanical attachment and configured to provide feedback regarding the insertion of the rechargeable battery into the battery well. As the rechargeable battery is inserted, the visual indicator can transition from a first state to a second state (e.g., from red to green). Once the rechargeable battery is fully and properly inserted into the battery well such that the battery is inserted into the receiving battery well and an electrical connection is established between the battery and another device, the visual indicator can remain in the second state, thereby providing visual feedback that the rechargeable battery is properly inserted.
In certain implementations, upon manipulation of the release mechanism 602, the rechargeable battery 600 may become disengaged or otherwise be improperly positioned within the battery well. In such an example, the displayed output as shown by the visual indicator 606 can be updated. For example, as shown in
It should be noted that visual indicators 606 is shown as displaying words indicating the proper or improper insertion of the rechargeable battery 600 by way of example only in
In certain implementations as described herein, a rechargeable battery could include a mechanical attachment and/or set of mechanical attachment features that are configured to lock the battery within a receiving battery well. In some examples, the mechanical attachment features can be configured to physically adjust the visual indicator as the battery is inserted into the receiving battery well. For example, the rechargeable battery can include a set of movable pawls that are configured to be displaced as the battery is inserted into the receiving battery well. As the pawls are displaced, the visual indicator can also be displaced or otherwise moves such that the output of the visual indicator is updated to reflect the current status of the rechargeable battery and provide an indication as to whether the rechargeable battery is properly inserted into the receiving battery well.
For example,
As shown in
As shown in
It should be noted that the mechanical attachment features as shown in
In some examples, a rechargeable battery and receiving battery well can be configured to provide an indication of when the rechargeable battery is partially inserted into the battery well. For example,
In addition to mechanical attachment features and related visual indicators, additional attachment and indicator components or types can be included. For example, as shown in
It should be noted that visual indicator 1002 is described above as including colored LEDs by way of example only. In certain implementations, the visual indicator 1002 can be configured to output dynamically updated text or patterns that provide an indication of the status of the rechargeable battery 1000 with regard to its insertion into a receiving battery well. Additionally, as described herein, additional feedback mechanisms such as an audio output feedback device and a tactile feedback device can be included. For example, the audio output feedback device can be adjustable when the patient is initially fitted with a wearable medical device. A caregiver can administer a hearing test to the patient and record what audio frequencies the patient responds to and/or hears clearly. Based upon the test, the output of the audio output feedback device can be updated accordingly. Similarly, a tactile feedback device can be configured to provide a tactile sensation such as vibrating at a particular frequency that the patient responds to during fitting.
As described above, battery circuitry can be used to determine whether a battery is fully and properly inserted into a receiving battery well. As noted in
Similarly, as shown in
It should be noted that the arrangement of components as shown in
In certain implementations, when properly inserted, the rechargeable battery can latch properly in place within a receiving battery well. As shown in
It should be noted that the spring 1304 is shown in
In some embodiments, the battery seal has solid particle ingress protection rating of one of IP3X, IP4X, IP5X, or IP6X as specified in international standard EN 60529 (British BS EN 60529:1992, European IEC 60509:1989). These ingress protection ratings are shown in Table 3.
In some embodiments, the battery seal includes liquid ingress protection rating of at least one of IPX3, IPX4, IPX5, IPX6, IPX7, or IPX8 as specified in international standard EN 60529 (British BS EN 60529:1992, European IEC 60509:1989) and a solid particle ingress protection rating of one of IP3X, IP4X, IP5X, or IP6X as specified in international standard EN 60529 (British BS EN 60529: 1992, European IEC 60509: 1989).
Upon proper insertion of the rechargeable battery, the seal can compress to both provide an opposition force as well as to provide protection to, for example, one or more electrical connections between the rechargeable battery and the medical device controller that result from the rechargeable battery being inserted into the receiving battery well.
For example, as shown in
In some implementations, as described herein, the battery removal is achieved via a use of a plurality (e.g., at least two) retention pawls with a sliding release lever. In some implementations, as described herein, the battery latch indication includes a predetermined color indicator, e.g., red color latched indicator when the battery is not fully inserted. In some implementations, as described herein, the battery can be located towards an end on a rear side of the controller (e.g., on side opposite the side on which the user interface is disposed). For example, the device status can be provided via one or more indicator lights (e.g., LED-based lights) disposed on a housing of the controller. For example, the indicator can be a tri-color indicator (e.g., includes predetermined colors such as green, yellow, and red). The indicator lights can be used to depict the following states of the device based on battery insertion status. For example, the indicator light can indicate “Ready for use” status by displaying a green slow breath frequency (e.g., a 0.1 to 0.3 Hz), a “Medium priority alert” status by displaying a yellow pulse frequency (e.g., 0.5 Hz), and a “High priority alert” status by displaying red flash frequency (e.g., 2 Hz).
Table 4 below provides a summary of battery-related features in conjunction with an example wearable cardiac monitoring/treatment device as disclosed herein.
Table 5 below provides a summary of battery-related features in conjunction with an example wearable cardiac monitoring/treatment device as disclosed herein.
An example study, conducted according to a predetermined protocol described below, focused on collecting biomechanical forces and participant preferences during simulated battery insertion and removal activities relating to the systems, methods, and devices described herein. For this study, the battery systems, devices, and techniques shown in at least
In the study, twenty-five participants representative of the wearable cardioverter defibrillator user population were asked to simulate battery insertion and removal, pushing or pulling on the battery and battery latch while exerting as much force as possible. Forces were measured using force gauges installed into two mock monitor-battery test fixtures—one for insertion and one for removal. Participants executed 12 different activities (six insertion tasks and six removal tasks), designated as “standard” tasks. Each task was repeated three times. Participants were also asked to perform insertion and removal using their preferred methods as two additional tasks, bringing the total tasks to 14.
Per statistical analysis, body and arm position did not influence the participants' ability to exert their maximum compressive (insertion) or tensile (removal) force on the battery. The minimum force exerted during a standard insertion task was 5.4 lbf—the participant was seated with their arms raised off the table while using their forefingers to apply maximum force.
There was a statistically significant difference in maximum removal forces exerted by participants, with forces exerted during forefinger removal being significantly higher than those exerted during thumb removal. However, the minimum force exerted during a standard removal task was 5.2 lbf while the participant was standing with their arms raised and using their forefingers to apply maximum removal force.
At the conclusion of the activities, participants were asked to insert and remove the battery from a prototype WCD controller in a way that felt most natural to them. Their preferred methods and subjective feedback were recorded. Seventeen of 25 participants used their palm to insert the battery whilst inserting it into the monitor. Eleven of these participants commented that inserting the battery came naturally to them and felt easy to insert while using their palm. The maximum exerted force generated when performing this preferred method of insertion was shown to be significantly greater than the force applied using forefingers in the same position.
In further detail, the evaluation of the devices, systems, and techniques described herein was conducted according to the following protocol. Twenty-five (25) participants were recruited for the study, and each attended a single study session to assess their hand strength while simulating battery insertion and removal tasks. Each session lasted approximately 10-15 minutes, and 14 tasks were performed in total (Table 6). Tasks were performed using the participant's dominant hand. At the start of the session, the participants received an overview of the required insertion and removal. techniques and were taught the proper form for each technique. In addition, participants were taught to accurately read the force values from each measurement device.
As tasks were conducted, the participant reported the recorded maximum force value to the moderator, who then visually confirmed the value by checking the device before zeroing (Zeroing the device between each trial ensured that the reference point from which all measurements were made was maintained at 0 lbf throughout the study and that no drift in the values occurred). Participants were instructed to apply as much force as possible using each technique and hold for approximately 2 seconds, as counted by the moderator. Each task was performed three times for a total of 42 trials. The participants were given time to rest as needed between trials to allow their arm to relax and minimize fatigue. In addition, the order of the tasks was rotated between each participant to reduce hand fatigue.
A summary of the recruited participants can be found in Table 7 below.
The study took place in a private conference room setting in Pittsburgh, Pennsylvania. The study environmental conditions were designed to not impact the participants' experience or ability to perform the desired tasks. Two (2) test fixtures were used for data collection. Test fixtures consisted of a WCD monitor implementing the present methods, systems, and devices (the LifeVest WCD from ZOLL, Chelmsford) outer shell with a digital force gauge installed. One fixture was configured to record compressive force during insertion tasks. The other fixture was used for recording tensile force during removal tasks. A Mark-10 Series 2 Digital Force Gauge, Model M2-100 was installed inside each test fixture. One was used to measure tensile forces during battery removal, and the other was used to measure compressive forces during battery insertion.
Every participant completed each task three times. The average of these three data points was then calculated for each participant for every task they completed. The tasks were separated into two primary categories: Insertion and Removal.
The results of the study are as follows. Regarding battery insertion, the activities were conducted in six different body and arm positions, all using the participant's dominant hand. While seated, participants exerted maximum insertion force using their:
While standing, participants performed two additional insertion tasks using their forefingers and thumb as described below:
Participants performed an additional insertion activity at the end of the session, citing their preferred insertion technique. The mean maximum forced generated by participants for each insertion activity can be seen in
Further, as shown in
Regarding battery removal, Battery removal activities were conducted in six different body and arm positions, all using the participant's dominant hand. While seated, participants exerted maximum removal force using their forefinger and thumb as described below:
While standing, participants performed two additional removal tasks using their forefinger and thumb as described below:
The mean maximum forces generated by participants for standard (forefinger and thumb) removal activity can be seen in
Further, as shown in
Participants in this study expressed positive opinions when interacting with the systems, devices, and techniques described herein. Further, the amount of force, tactile, and audio feedback were all mentioned positively. Of the 17 participants for whom palm insertion was their preferred method, 11 participants mentioned that the palm insertion felt easier and more natural to them. One participant found the battery and monitor easy to pick up and interact with. One participant mentioned that the force required to insert and remove the monitor was “just right”, and that they could interact with it all day. Two participants mentioned that the WCD monitor/controller itself was easy to pick up and understand how to insert and remove the battery without prior instruction.
Arm and body positions had no effect on the participants' ability to exert force during insertion or removal tasks. Mean insertion force across all standard tasks was similar, falling within a 1.5-lbf range. Palm insertion was most cited as a preferred insertion method, and palm insertion force was significantly greater than the insertion force applied using the forefingers. From observations, the force applied via the palm allowed for more efficient use of arm strength, rather than hand and finger strength in the case of the forefinger/thumb insertions. Participants exerted significantly greater force during forefinger removal tasks compared with thumb removal tasks. There existed a difference of ˜6 pounds of force between thumb and forefinger removal, with forefinger removal having an average of 18.4 lbf applied and thumb removal only 12.4 lbf. This may be a result of the forefingers using more surface area to grip onto and apply force to the battery latch than a single thumb, assuming that any combination of multiple forefingers will be able to work in tandem to exert greater force than a singular finger.
The teachings of the present disclosure can be generally applied to external medical monitoring and/or treatment devices that are powered by a battery. Such external medical devices can include, for example, ambulatory medical devices as described herein that are capable of and designed for moving with the patient as the patient goes about his or her daily routine. An example ambulatory medical device can be a wearable medical device such as a WCD, a wearable cardiac monitoring device, an in-hospital device such as an in-hospital wearable defibrillator (HWD), a short-term wearable cardiac monitoring and/or therapeutic device, mobile cardiac event monitoring devices, and other similar wearable medical devices.
The wearable medical device can be capable of continuous use by the patient. In some implementations, the continuous use can be substantially or nearly continuous in nature. That is, the wearable medical device can be continuously used, except for sporadic periods during which the use temporarily ceases (e.g., while the patient bathes, while the patient is refit with a new and/or a different garment, while the battery is charged/changed, while the garment is laundered, etc.). Such substantially or nearly continuous use as described herein may nonetheless be considered continuous use. For example, the wearable medical device can be configured to be worn by a patient for as many as 24 hours a day. In some implementations, the patient can remove the wearable medical device for a short portion of the day (e.g., for half an hour to bathe).
Further, the wearable medical device can be configured as a long term or extended use medical device. Such devices can be configured to be used by the patient for an extended period of several days, weeks, months, or even years. In some examples, the wearable medical device can be used by a patient for an extended period of at least one week. In some examples, the wearable medical device can be used by a patient for an extended period of at least 30 days. In some examples, the wearable medical device can be used by a patient for an extended period of at least one month. In some examples, the wearable medical device can be used by a patient for an extended period of at least two months. In some examples, the wearable medical device can be used by a patient for an extended period of at least three months. In some examples, the wearable medical device can be used by a patient for an extended period of at least six months. In some examples, the wearable medical device can be used by a patient for an extended period of at least one year. In some implementations, the extended use can be uninterrupted until a physician or other HCP provides specific instruction to the patient to stop use of the wearable medical device.
Regardless of the extended period of wear, the use of the wearable medical device can include continuous or nearly continuous wear by the patient as described above. For example, the continuous use can include continuous wear or attachment of the wearable medical device to the patient, e.g., through one or more of the electrodes as described herein, during both periods of monitoring and periods when the device may not be monitoring the patient but is otherwise still worn by or otherwise attached to the patient. The wearable medical device can be configured to continuously monitor the patient for cardiac-related information (e.g., ECG information, including arrhythmia information, cardio-vibrations, etc.) and/or non-cardiac information (e.g., blood oxygen, the patient's temperature, glucose levels, tissue fluid levels, and/or lung vibrations). The wearable medical device can carry out its monitoring in periodic or aperiodic time intervals or times. For example, the monitoring during intervals or times can be triggered by a user action or another event.
As noted above, the wearable medical device can be configured to monitor other physiologic parameters of the patient in addition to cardiac related parameters. For example, the wearable medical device can be configured to monitor, for example, pulmonary-vibrations (e.g., using microphones and/or accelerometers), breath vibrations, sleep related parameters (e.g., snoring, sleep apnea), tissue fluids (e.g., using radio-frequency transmitters and sensors), among others.
Other example wearable medical devices include automated cardiac monitors and/or defibrillators for use in certain specialized conditions and/or environments such as in combat zones or within emergency vehicles. Such devices can be configured so that they can be used immediately (or substantially immediately) in a life-saving emergency. In some examples, the ambulatory medical devices described herein can be pacing-enabled, e.g., capable of providing therapeutic pacing pulses to the patient. In some examples, the ambulatory medical devices can be configured to monitor for and/or measure ECG metrics including, for example, heart rate (such as average, median, mode, or other statistical measure of the heart rate, and/or maximum, minimum, resting, pre-exercise, and post-exercise heart rate values and/or ranges), heart rate variability metrics, PVC burden or counts, atrial fibrillation burden metrics, pauses, heart rate turbulence, QRS height, QRS width, changes in a size or shape of morphology of the ECG information, cosine R-T, artificial pacing, QT interval, QT variability, T wave width, T wave alternans, T-wave variability, and ST segment changes.
As noted above,
Pacing pulses can be used to treat cardiac arrhythmia conditions such as bradycardia (e.g., less than 30 beats per minute) and tachycardia (e.g., more than 150 beats per minute) using, for example, fixed rate pacing, demand pacing, anti-tachycardia pacing, and the like. Defibrillation pulses can be used to treat ventricular tachycardia and/or ventricular fibrillation.
The capacitors can include a parallel-connected capacitor bank consisting of a plurality of capacitors (e.g., two, three, four or more capacitors). In some examples, the capacitors can include a single film or electrolytic capacitor as a series connected device including a bank of the same capacitors. These capacitors can be switched into a series connection during discharge for a defibrillation pulse. For example, a single capacitor of approximately 140 uF or larger, or four capacitors of approximately 650 uF can be used. The capacitors can have a 1600 VDC or higher rating for a single capacitor, or a surge rating between approximately 350 to 500 VDC for paralleled capacitors and can be charged in approximately 15 to 30 seconds from a battery pack.
For example, each defibrillation pulse can deliver between 60 to 180 joules of energy. In some implementations, the defibrillating pulse can be a biphasic truncated exponential waveform, whereby the signal can switch between a positive and a negative portion (e.g., charge directions). This type of waveform can be effective at defibrillating patients at lower energy levels when compared to other types of defibrillation pulses (e.g., such as monophasic pulses). For example, an amplitude and a width of the two phases of the energy waveform can be automatically adjusted to deliver a precise energy amount (e.g., 150 joules) regardless of the patient's body impedance. The therapy delivery circuitry 102 can be configured to perform the switching and pulse delivery operations, e.g., under control of the processor 118. As the energy is delivered to the patient, the amount of energy being delivered can be tracked. For example, the amount of energy can be kept to a predetermined constant value even as the pulse waveform is dynamically controlled based on factors such as the patient's body impedance which the pulse is being delivered.
In certain examples, the therapy delivery circuitry 102 can be configured to deliver a set of cardioversion pulses to correct, for example, an improperly beating heart. When compared to defibrillation as described above, cardioversion typically includes a less powerful shock that is delivered at a certain frequency to mimic a heart's normal rhythm.
The data storage 104 can include one or more of non-transitory computer-readable media, such as flash memory, solid state memory, magnetic memory, optical memory, cache memory, combinations thereof, and others. The data storage 104 can be configured to store executable instructions and data used for operation of the medical device controller 100. In certain examples, the data storage can include executable instructions that, when executed, are configured to cause the processor 118 to perform one or more operations. In some examples, the data storage 104 can be configured to store information such as ECG data as received from, for example, the sensing electrode interface.
In some examples, the network interface 106 can facilitate the communication of information between the medical device controller 100 and one or more other devices or entities over a communications network. For example, where the medical device controller 100 is included in an ambulatory medical device, the network interface 106 can be configured to communicate with a remote computing device such as a remote server or other similar computing device. The network interface 106 can include communications circuitry for transmitting data in accordance with a Bluetooth® wireless standard for exchanging such data over short distances to an intermediary device. For example, such an intermediary device can be configured as a base station, a “hotspot” device, a smartphone, a tablet, a portable computing device, and/or other devices in proximity of the wearable medical device including the medical device controller 100. The intermediary device(s) may in turn communicate the data to a remote server over a broadband cellular network communications link. The communications link may implement broadband cellular technology (e.g., 2.5G, 2.75G, 3G, 4G, 5G cellular standards) and/or Long-Term Evolution (LTE) technology or GSM/EDGE and UMTS/HSPA technologies for high-speed wireless communication. In some implementations, the intermediary device(s) may communicate with a remote server over a Wi-Fi™ communications link based on the IEEE 802.11 standard.
In certain examples, the user interface 108 can include one or more physical interface devices such as input devices, output devices, and combination input/output devices and a software stack configured to drive operation of the devices. These user interface elements can render visual, audio, and/or tactile content. Thus, the user interface 108 can receive input or provide output, thereby enabling a user to interact with the medical device controller 100.
The medical device controller 100 can also include at least one rechargeable battery 110 configured to provide power to one or more components integrated in the medical device controller 100. The rechargeable battery 110 can include a rechargeable multi-cell battery pack. In one example implementation, the rechargeable battery 110 can include three or more 2200 mAh lithium ion cells that provide electrical power to the other device components within the medical device controller 100. For example, the rechargeable battery 110 can provide its power output in a range of between 20 mA to 1000 mA (e.g., 40 mA) output and can support 24 hours, 48 hours, 72 hours, or more, of runtime between charges. In certain implementations, the battery capacity, runtime, and type (e.g., lithium ion, nickel-cadmium, or nickel-metal hydride) can be changed to best fit the specific application of the medical device controller 100.
The sensor interface 112 can include physiological signal circuitry that is coupled to one or more sensors configured to monitor one or more physiological parameters of the patient. As shown, the sensors can be coupled to the medical device controller 100 via a wired or wireless connection. The sensors can include one or more ECG sensing electrodes 122, and non-ECG physiological sensors 123 such as vibration sensor 124, tissue fluid monitors 126 (e.g., based on ultra-wide band radiofrequency devices), and motion sensors (e.g., accelerometers, gyroscopes, and/or magnetometers). In some implementations, the sensors can include a plurality of conventional ECG sensing electrodes in addition to digital sensing electrodes.
The sensing electrodes 122 can be configured to monitor a patient's ECG information. For example, by design, the digital sensing electrodes 122 can include skin-contacting electrode surfaces that may be deemed polarizable or non-polarizable depending on a variety of factors including the metals and/or coatings used in constructing the electrode surface. All such electrodes can be used with the principles, techniques, devices and systems described herein. For example, the electrode surfaces can be based on stainless steel, noble metals such as platinum, or Ag-AgCl.
In some examples, the electrodes 122 can be used with an electrolytic gel dispersed between the electrode surface and the patient's skin. In certain implementations, the electrodes 122 can be dry electrodes that do not need an electrolytic material. As an example, such a dry electrode can be based on tantalum metal and having a tantalum pentoxide coating as is described above. Such dry electrodes can be more comfortable for long term monitoring applications.
Referring back to
The tissue fluid monitors 126 can use radio frequency (RF) based techniques to assess fluid levels and accumulation in a patient's body tissue. For example, the tissue fluid monitors 126 can be configured to measure fluid content in the lungs, typically for diagnosis and follow-up of pulmonary edema or lung congestion in heart failure patients. The tissue fluid monitors 126 can include one or more antennas configured to direct RF waves through a patient's tissue and measure output RF signals in response to the waves that have passed through the tissue. In certain implementations, the output RF signals include parameters indicative of a fluid level in the patient's tissue. The tissue fluid monitors 126 can transmit information descriptive of the tissue fluid levels to the sensor interface 112 for subsequent analysis.
In certain implementations, the cardiac event detector 116 can be configured to monitor a patient's ECG signal for an occurrence of a cardiac event such as an arrhythmia or other similar cardiac event. The cardiac event detector can be configured to operate in concert with the processor 118 to execute one or more methods that process received ECG signals from, for example, the sensing electrodes 122 and determine the likelihood that a patient is experiencing a cardiac event. The cardiac event detector 116 can be implemented using hardware or a combination of hardware and software. For instance, in some examples, cardiac event detector 116 can be implemented as a software component that is stored within the data storage 104 and executed by the processor 118. In this example, the instructions included in the cardiac event detector 116 can cause the processor 118 to perform one or more methods for analyzing a received ECG signal to determine whether an adverse cardiac event is occurring. In other examples, the cardiac event detector 116 can be an application-specific integrated circuit (ASIC) that is coupled to the processor 118 and configured to monitor ECG signals for adverse cardiac event occurrences. Thus, examples of the cardiac event detector 116 are not limited to a particular hardware or software implementation.
In some implementations, the processor 118 includes one or more processors (or one or more processor cores) that each are configured to perform a series of instructions that result in manipulated data and/or control the operation of the other components of the medical device controller 100. In some implementations, when executing a specific process (e.g., cardiac monitoring), the processor 118 can be configured to make specific logic-based determinations based on input data received and be further configured to provide one or more outputs that can be used to control or otherwise inform subsequent processing to be carried out by the processor 118 and/or other processors or circuitry with which processor 118 is communicatively coupled. Thus, the processor 118 reacts to specific input stimulus in a specific way and generates a corresponding output based on that input stimulus. In some example cases, the processor 118 can proceed through a sequence of logical transitions in which various internal register states and/or other bit cell states internal or external to the processor 118 can be set to logic high or logic low. As referred to herein, the processor 118 can be configured to execute a function where software is stored in a data store coupled to the processor 118, the software being configured to cause the processor 118 to proceed through a sequence of various logic decisions that result in the function being executed. The various components that are described herein as being executable by the processor 118 can be implemented in various forms of specialized hardware, software, or a combination thereof. For example, the processor 118 can be a digital signal processor (DSP) such as a 24-bit DSP. The processor 118 can be a multi-core processor, e.g., having two or more processing cores. The processor 118 can be an Advanced RISC Machine (ARM) processor such as a 32-bit ARM processor or a 64-bit ARM processor. The processor 118 can execute an embedded operating system, and include services provided by the operating system that can be used for file system manipulation, display & audio generation, basic networking, firewalling, data encryption and communications.
As noted above, an ambulatory medical device such as a WCD can be designed to include a digital front-end where analog signals sensed by skin-contacting electrode surfaces of a set of digital sensing electrodes are converted to digital signals for processing. Typical ambulatory medical devices with analog front-end configurations use circuitry to accommodate a signal from a high source impedance from the sensing electrode (e.g., having an internal impedance range from approximately 100 Kiloohms to one or more Megaohms). This high source impedance signal is processed and transmitted to a monitoring device such as processor 118 of the controller 100 as described above for further processing. In certain implementations, the monitoring device, or another similar processor such as a microprocessor or another dedicated processor operably coupled to the sensing electrodes, can be configured to receive a common noise signal from each of the sensing electrodes, sum the common noise signals, invert the summed common noise signals and feed the inverted signal back into the patient as a driven ground using, for example, a driven right leg circuit to cancel out common mode signals.
The medical device 1500 can include one or more of the following: a garment 1510, one or more ECG sensing electrodes 1512, one or more non-ECG physiological sensors 1513, one or more therapy electrodes 1514a and 1514b (collectively referred to herein as therapy electrodes 1514), a medical device controller 1520 (e.g., controller 100 as described above in the discussion of
The medical device controller 1520 can be operatively coupled to the sensing electrodes 1512, which can be affixed to the garment 1510, e.g., assembled into the garment 1510 or removably attached to the garment, e.g., using hook and loop fasteners. In some implementations, the sensing electrodes 1512 can be permanently integrated into the garment 1510. The medical device controller 1520 can be operatively coupled to the therapy electrodes 1514. For example, the therapy electrodes 1514 can also be assembled into the garment 1510, or, in some implementations, the therapy electrodes 1514 can be permanently integrated into the garment 1510. In an example, the medical device controller 1520 includes a patient user interface 1560 to allow a patient interface with the externally-worn device. For example, the patient can use the patient user interface 1560 to respond to pre-and post-workout questions, prompts, and surveys as described herein.
Component configurations other than those shown in
The sensing electrodes 1512 can be configured to detect one or more cardiac signals. Examples of such signals include ECG signals and/or other sensed cardiac physiological signals from the patient. In certain examples, as described herein, the non-ECG physiological sensors 1513 such as accelerometers, vibrational sensors, and other measuring devices for recording additional non-ECG physiological parameters. For example, as described above, the such non-ECG physiological sensors are configured to detect other types of patient physiological parameters and acoustic signals, such as tissue fluid levels, cardio-vibrations, lung vibrations, respiration vibrations, patient movement, etc.
In some examples, the therapy electrodes 1514 can also be configured to include sensors configured to detect ECG signals as well as other physiological signals of the patient. The connection pod 1530 can, in some examples, include a signal processor configured to amplify, filter, and digitize these cardiac signals prior to transmitting the cardiac signals to the medical device controller 1520. One or more of the therapy electrodes 1514 can be configured to deliver one or more therapeutic defibrillating shocks to the body of the patient 1502 when the medical device 1500 determines that such treatment is warranted based on the signals detected by the sensing electrodes 1512 and processed by the medical device controller 1520. Example therapy electrodes 1514 can include metal electrodes such as stainless-steel electrodes that include one or more conductive gel deployment devices configured to deliver conductive gel to the metal electrode prior to delivery of a therapeutic shock.
In some implementations, medical devices as described herein can be configured to switch between a therapeutic medical device and a monitoring medical device that is configured to only monitor a patient (e.g., not provide or perform any therapeutic functions). For example, therapeutic components such as the therapy electrodes 1514 and associated circuitry can be optionally decoupled from (or coupled to) or switched out of (or switched in to) the medical device. For example, a medical device can have optional therapeutic elements (e.g., defibrillation and/or pacing electrodes, components, and associated circuitry) that are configured to operate in a therapeutic mode. The optional therapeutic elements can be physically decoupled from the medical device to convert the therapeutic medical device into a monitoring medical device for a specific use (e.g., for operating in a monitoring-only mode) or a patient. Alternatively, the optional therapeutic elements can be deactivated (e.g., via a physical or a software switch), essentially rendering the therapeutic medical device as a monitoring medical device for a specific physiologic purpose or a particular patient. As an example of a software switch, an authorized person can access a protected user interface of the medical device and select a preconfigured option or perform some other user action via the user interface to deactivate the therapeutic elements of the medical device.
A patient being monitored by a hospital wearable defibrillator and/or pacing device may be confined to a hospital bed or room for a significant amount of time (e.g., 75% or more of the patient's stay in the hospital). As a result, a user interface 1560a can be configured to interact with a user other than the patient, e.g., a nurse, for device-related functions such as initial device baselining, setting and adjusting patient parameters, and changing the device batteries.
In some implementations, an example of a therapeutic medical device that includes a digital front-end in accordance with the systems and methods described herein can include a short-term defibrillator and/or pacing device. For example, such a short-term device can be prescribed by a physician for patients presenting with syncope. A wearable defibrillator can be configured to monitor patients presenting with syncope by, e.g., analyzing the patient's physiological and cardiac activity for aberrant patterns that can indicate abnormal physiological function. For example, such aberrant patterns can occur prior to, during, or after the onset of syncope. In such an example implementation of the short-term wearable defibrillator, the electrode assembly can be adhesively attached to the patient's skin and have a similar configuration as the hospital wearable defibrillator described above in connection with
Referring to
Referring to
In some examples, the devices described herein (e.g.,
Although the subject matter contained herein has been described in detail for the purpose of illustration, it is to be understood that such detail is solely for that purpose and that the present disclosure is not limited to the disclosed embodiments, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the scope of the appended claims. For example, it is to be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.
Other examples are within the scope of the description and claims. Additionally, certain functions described above can be implemented using software, hardware, firmware, hardwiring, or combinations of any of these. Features implementing functions can also be physically located at various positions, including being distributed such that portions of functions are implemented at different physical locations.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2023/010392 | 1/9/2023 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63298020 | Jan 2022 | US |
