Bardy Diagnostics, Inc.

Hydrogel containment solutions in wearable medical devices are provided. The hydrogel containment solution partially encloses a hydrogel laterally such that the hydrogel does not leave an area between an electrode and a surface of a patient’s skin during use of the wearable medical device. The hydrogel containment solution may incorporate an insert to support the position of the hydrogel.

An electrocardiography patch is provided. A backing has an elongated strip with a midsection connecting two rounded ends. The midsection tapers in from each of the rounded ends and is narrower than each of the two rounded ends. Each electrode, of a pair of electrodes, is positioned on one of the rounded ends of the backing, on a contact surface, to capture electrocardiographic signals. A flex circuit is coupled to each of the electrodes. A non-conductive receptacle is affixed on an outer surface of the backing, opposite the contact surface. Electrical contacts are provided on a surface of the non-conductive receptacle opposite the backing. A battery is provided on the outer surface of the backing and a processor is powered by the battery to write the electrocardiographic signals into memory.

A system includes a key service, that is configured to authenticate requests from an external manufacturing system (“EMS”), receive a request for generating a keyset, generate the keyset, send the keyset to the EMS, and send the keyset to a persistent cloud storage system, wherein an external cloud system accesses the keyset for use in secure communication with a hardware device.

Physiological monitoring can be provided through a lightweight wearable monitor that includes two components, a flexible extended wear electrode patch and a reusable monitor recorder that removably snaps into a receptacle on the electrode patch. The wearable monitor sits centrally on the patient's chest along the sternum oriented top-to-bottom. The placement of the wearable monitor in a location at the sternal midline, with its unique narrow “hourglass”-like shape, significantly improves the ability of the wearable monitor to cutaneously sense cardiac electrical potential signals, particularly the P-wave and the QRS interval signals indicating ventricular activity in the ECG waveforms. In particular, the ECG electrodes on the electrode patch are tailored to be positioned axially along the midline of the sternum for capturing action potential propagation in an orientation that corresponds to the aVF lead used in a conventional 12-lead ECG that is used to sense positive or upright P-waves.

An implantable medical device is disclosed. A housing includes a hollow body forming a first electrode on an outer surface with end caps affixed to opposite ends, one end cap forming a second electrode. A microcontroller circuit is provided and includes a microcontroller operable under program instructions stored within a non-volatile memory device. An analog front end is interfaced to the electrodes to sense electrocardiographic signals. A transceiver circuit is operable to wirelessly communicate with an external data device. The program instructions define instructions to continuously sample the electrocardiographic signals into the non-volatile memory device and to offload the non-volatile memory device to the external data device. A receiving coil and a charging circuit are operable to charge an onboard power source for the microcontroller circuit.

A system for electrocardiography monitoring includes a wearable electrocardiography monitoring device and a clinical portal. The clinical portal associates the wearable electrocardiography monitoring device with an individual user. The clinical portal presents (1) patient-specific information and (2) device-specific information to a clinician.

An adhesive system for a wearable medical device is provided. The adhesive system for a includes an electrode patch with one or more electrodes for sensing a signal indicative of a physiological characteristic of a patient. The adhesive system further includes a removable section disposed at least partially around a perimeter of the electrode patch that is configured to be removed from the adhesive system.

A Direct Current (DC) coupled analog front end for an electrocardiogram (ECG) measuring device is provided that includes an amplifying stage including a first op-amp that is configured to receive a signal input from an ECG patch at a first input port and a feedback signal at a second input port and to produce an amplified output of an ECG signal via a first output port; a feedback stage including a second op-amp that is configured to receive the amplified output and produce the feedback signal at a second output port; and a DC source, coupled between the signal input from the ECG patch and the first input port.

An analog to digital converter for use in an electrocardiogram device is provided that includes a voltage supply; an operational amplifier, including: a positive input pin; an inverting input pin; and an output pin; an output node, connected directly to the output pin and the inverting input pin; an ECG electrode, connected to the output node via a first resistor; a reference voltage, connected directly to the output node; and a feedback node, connected to directly to the positive input pin, connected to the voltage supply via a second resistor, and connected to a ground via a third resistor and a first capacitor, wherein the third resistor and the first capacitor are connected in parallel between the feedback node and the ground.

An apparatus is provided. A strip has first and second end sections, and a first surface and second surface. Two electrocardiographic electrodes are provided on the strip with one of the electrocardiographic electrodes provided on the first surface of the first end section of the strip and another of the electrocardiographic electrodes positioned on the first surface on the second end section of the strip. A flexible circuit is mounted to the second surface of the strip and includes a circuit trace electrically coupled to each of the electrocardiographic electrodes. A wireless transceiver is affixed on one of the first or second end sections, and a battery is positioned on one of the first or second end sections. A processor is positioned on one of the first or second end sections and is housed separate from the battery.