EP-3610919-B1 - A SYSTEM COMPRISING A WEARABLE THERAPEUTIC DEVICE

EP3610919B1EP 3610919 B1EP3610919 B1EP 3610919B1EP-3610919-B1

Inventors

KAIB, THOMAS, E.

Dates

Publication Date: 20260506
Application Date: 20130301

Claims (14)

A system comprising a wearable therapeutic device including: a memory; at least one cardiac sensing electrode to detect ECG signals of the patient; at least one treatment electrode configured to apply electrical current to the patient as defibrillation or pacing treatment; at least one processor coupled to the memory and the at least one cardiac sensing electrode and the at least one treatment electrode; a user interface component executed by the at least one processor and configured to receive an update session request and to generate an update session identifier responsive to receiving the request; and a system interface component executed by the at least one processor and configured to receive an encoded request including an encoded identifier of an update session and encoded device update information, to decode the encoded request to generate a decoded request including decoded device update information and a decoded identifier of the update session, to validate the decoded request by determining that the generated update session identifier matches the decoded identifier of the update session, and to apply the decoded device update information to the wearable therapeutic device.
The system of claim 1, further comprising a garment including at least one strap, belt, pocket or receptacle.
The system of any preceding claim, wherein the processor is configured to, responsive to validating the received encoded request, apply the decoded device update information to the configuration information of the wearable therapeutic device.
The system of any of the preceding claims, wherein the decoded device update information comprises changes to parameters of the wearable therapeutic device or information to be gathered via the wearable therapeutic device.
The system of claim 4, wherein the parameters comprises one or more of VT rate threshold, VT response time, VF rate threshold, VF response time, patient sleep interval start time, patient sleep interval end time, response time extension used during the sleep interval, and the amounts of energy to be used in one or more treatments provided by the wearable therapeutic device.
The system of any of the preceding claims, further comprising a display disposed on the wearable therapeutic device configured to display an indication of success or failure of an update.
The system according to any of the preceding claims, wherein the device update information includes information descriptive of at least one of a treatment protocol to be executed by the wearable therapeutic device using the treatment component and device settings to be applied to the wearable therapeutic device.
The system according to any of the preceding claims, wherein the system interface component is configured to decode the encoded request by decrypting the encoded request.
The system according to any of the preceding claims, wherein the system interface component is further configured to: detect at least one of success and failure of the update session; and rollback any device update information applied in response to failure of the update session.
The system according to claim 9, further comprising a display coupled to the at least one processor, wherein the user interface component is further configured to display the update session identifier on the display and display an indication of at least one of success and failure of the update session on the display.
The system according to any of the preceding claims, wherein the memory stores a device identifier that uniquely identifies the wearable therapeutic device, the encoded request further includes an identifier of the wearable therapeutic device, and the system interface component is configured to further validate the decoded request by determining that the device identifier matches the identifier of the wearable therapeutic device.
The system according to any of the preceding claims, wherein the memory stores a patient identifier uniquely identifying the patient assigned to the wearable therapeutic device, the encoded request further includes an identifier of the patient, and the system interface component is configured to further validate the decoded request by determining that the patient identifier matches the identifier of the patient.
The system according to claim 12, wherein the patient identifier and the identifier of the patient include biometric identifiers.
The system according to any of the preceding claims, further comprising a computer system configured to: receive an authorization request; verifying the authorization request; establish, in response to verifying the authorization request, a secure communication channel with the wearable therapeutic device; and transmit the update session request to the wearable therapeutic device via the secure communication channel.

Description

BACKGROUND OF THE INVENTION 1. Field of Invention At least one embodiment of the present invention relates generally to a system comprising a wearable therapeutic device. 2. Discussion of Related Art Heart failure and other chronic conditions are a major health concern worldwide. Heart failure is a progressive disease with varying symptoms such as fatigue, coughing, diminished exercise capacity, shortness of breath, fluid retention, swelling in the abdomen or legs, lung congestion, and cardiac arrhythmias. Heart failure can be treated, and its symptoms mitigated, by lifestyle modifications, medications, surgical procedures such as heart transplants, and mechanical therapies. These efforts can come with side effects and limited success rates. Heart failure continues to reduce the quality of life of victims. US 2008/097793 A1 discloses a method including "receiving patient information, analyzing the patient information to identify a condition for the patient, and formatting a report based on the patient information and the patient condition". WO 2009/122277 A2 discloses "a medical apparatus comprises a machine for treatment of fluids provided with means for treating a patient's blood which exhibits a control unit for sending command signals and receiving information relating to the treatment under way on the patient." "A first aim of the invention is to provide a medical apparatus which can be remote-controlled and which can guarantee high safety standards without causing the network architecture to become over-complex." "The controllable functions of the medical machine are multiple and can comprise, purely by way of example, pump velocity, heparin doses (or other substances), treatment operating parameters, such as the treatment times of the rate of ultrafiltration; further, among the controllable functions are the internal check or diagnostic check procedures, as are the updating or downloading of programs onto the machine." SUMMARY OF THE INVENTION The invention is set out in the appended set of claims. Aspects and embodiments of the present invention are directed to a system comprising a wearable therapeutic device. The device may monitor and collect health related information from the subject, and uses this information to determine if treatment is warranted, to suggest lifestyle modifications, and to adjust treatment regimens. The device can further include an external defibrillator to apply treatment such as defibrillation to the subject when necessary. By monitoring a subject's conditions in a nearly continuous fashion in essentially real time, a comprehensive medical record of the subject can also be developed on a long term basis, for further treatment and analysis. The present invention is a system comprising a wearable therapeutic device as it is defined in claim 1. The treatment device includes a cardiac sensing electrode, a treatment electrode, a user interface, and a sensor. The cardiac sensing electrode can be positioned outside a body of the subject and can detect cardiac information. The treatment electrode can be positioned outside the body of the subject and can apply treatment to the subject. The user interface can receive quality of life information from the subject. The sensor can be positioned outside the body of the subject and can detect subject activity and wellness information indicative of a general wellness of the subject. The treatment device also includes a controller. The controller can communicatively couple to the cardiac sensing electrode, the treatment electrode, the user interface, and the sensor. The controller receives the detected cardiac information, the quality of life information, and the detected subject activity and wellness information, and determines that treatment is to be applied to the body of the subject based upon the detected cardiac information. The controller can also adjust the treatment based on at least one of the detected subject activity and wellness information and the quality of life information. The treatment device can also include an alarm module to provide an alarm after the cardiac information is detected and before the treatment is applied to the body of the subject. In various embodiments, the alarm module can provide a second instance of the alarm after the treatment is applied to the body of the subject. The user interface can prevent application of the treatment to the body of the subject. In one embodiment, the treatment device includes a second sensor. The second sensor can be positioned outside the body of the subject and can detect subject activity and wellness information. The controller can determine that the treatment device is properly positioned on the subject based at least in part on a position of the first sensor and a position of the second sensor. In some embodiments, the controller can provide at least one of the cardiac information and the subject activity and wellness information to a computer server via a network. The c