Articles and methods of making articles are described. In one embodiment, an electrode is described, comprising an ionically-conductive hydrogel layer comprising a first major surface and opposing major surface. The electrode further comprises a discontinuous primer layer disposed on the first major surface ionically-conducting hydrogel layer and an electrically conductive member or a connector component thereof, in contact with the first major surface of the ionically-conducting hydrogel layer. In another embodiment, an article is described comprising a hydrogel layer comprising a first major surface and opposing major surface; a discontinuous hydrophobic primer layer disposed on the first hydrogel layer; and a hydrophobic adhesive or hydrophobic backing bonded to the primer and discontinuous hydrophobic primer layer of the hydrogel.

Some embodiments include processing data via an executable file on a monitor to reduce the dimensionality of the data being transmitted over the wireless network. The output of the executable file also encrypts the data before being transmitted wireless to a remote server. The remote server receives the transmitted data and makes likelihood inferences based on the recorded data.

A method for constructing a stress-pliant physiological electrode assembly is provided. An electrode backing is formed from a stretchable woven textile material compatible to contact the skin on at least one surface. A pair of flexile wires is provided to serve as electrode circuit trace and electrode signal pickup. At least one of the flexile wires is sewn into the textile material which provides a stress-pliant malleability. Each of the flexile wires has an electrically-contacting area functioning for electric signal pickup. The electrically-contacting area may be sewn into the woven textile or affixed to the woven textile via conductive adhesives. The stress-pliant physiological electrode assembly is applicable for a wide array of physiological monitors, including ECG monitors, and especially is suitable for long-term wear. The method disclosed is both environmentally friendly and low-cost.

Non-invasive “drawable”, or “paintable”, electrode for electrical stimulation or biological signal sensing comprising a pervious and electrically conductive layer (1), at least one electrically insulating element (2) for maintaining the electrically conductive layer (1) separated from the skin (11), and a conductive material (3) that is deposed using a delivery system (4) on desired areas (5) of the electrically conductive layer (1). The conductive material (3) can penetrate the electrically conductive layer (1) and any other part of the electrode underlying the desired areas (5), thus reaching the skin. The conductive material (3) creates an electrical connection between the desired areas (5) of the electrically conductive layer (1) and the skin. Therefore, the shape of the desired areas (5) electrically connected with the skin, can be customized by the user deposing (or “drawing”) the conductive material (3). Thus, the conductive material (3) enables the fabrication of electrodes with custom-shaped electrically conductive areas in desired positions.

Physiological monitoring can be provided through a syncope sensor imbedded into an electrocardiography monitor, which correlates syncope events and electrocardiographic data. 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 at the sternal midline and includes a unique narrow “hourglass”-like shape, significantly improving the ability of the monitor to cutaneously sense cardiac electrical potential signals, particularly the P-wave and QRS interval signals, which indicate ventricular activity in electrocardiographic waveforms. The electrocardiographic electrodes on the electrode patch are tailored for axial positioning along the midline of the sternum to capture action potential propagation in an orientation that corresponds to the aVF lead in a conventional 12-lead electrocardiogram, which senses positive P-waves.

An patch and sensor assembly for use in an EP mapping system has two portions: a reusable portion and a disposable portion. The reusable portion houses the biosensors used in magnetic based location and mapping systems and the electrical lead necessary to communicate between the biosensor and the mapping system. The reusable portion may also contain a portion of the electrode necessary to receive electrical signals from the body of the patient. The disposable portion of the patch and sensor assembly contains an adhesive covered flexible patch having at least a portion of the electrode used to receive electrical signals form the body of the patient and may contain the electrical lead necessary to communicate such an electrical signal to the mapping system. The disposable portion contains a receptacle adapted to receive and mechanically secure the reusable portion to the disposable portion of the assembly. Such a patch and sensor assembly is useful in hybrid magnetic and impedance based location and mapping systems such as those used in electrophysiology.

Electrodes, multi-electrode patches, and electrodes for biomedical systems are provided. The electrode includes an adhesive film layer having a top surface and a bottom surface. A conductive element is substantially surrounded by the adhesive film layer. A conductive gel layer covers at least portion of a surface of the conductive element. The conducting gel comprises a material that does not result in significant skin irritation on a human subject after a period of at least about one week.

A gel distribution apparatus can include modules so that each module is connected to a respective sensor of a sensor array included in headgear. Each module can be configured to facilitate the distribution of a gel onto a scalp of a patient to permit deployment of the gel at locations on the head of a patient near the sensor to which the module is adjacently positioned or attached. The modules can each include at least one flange to permit a user to pull the module away from the scalp while also pressing a compressible gel reservoir of the module toward the scalp for directing the gel onto the scalp. The pulling force can help counteract internal pressure generated from compression of the reservoir to expel the gel so that the gel flows along a desired gel flow path without excessive back pressure.

Physiological monitoring can be provided through an actigraphy sensor imbedded into an electrocardiography monitor, which correlates movement and electrocardiographic data. Physiological monitoring can be provided through a wearable monitor that includes two components, a flexible extended wear electrode patch and a removable reusable monitor recorder. The wearable monitor sits centrally on the patient's chest along the sternum. The patient can place an electrode patch anywhere within the general region of the sternum. The occurrence of actigraphy events are monitored by the monitor recorder through an actigraphy sensor. Actigraphy becomes a recordable actigraphy event occurrence when the movement of the wearable monitor and, therefore, the patient, exceeds a certain criteria threshold of acceleration or deceleration as detected by the actigraphy sensor. Certain actigraphy event occurrences as recorded by the monitor recorder are considered to be actionable, that is, of sufficient importance to warrant flagging for further consideration to a following physician.

A monitor comprises circuitry to receive a signal and process the signal to monitor at least one characteristic of a subject, and a flexible polymer casing forming a waterproof enclosure for the circuitry. The flexible polymer casing is infused with a conductive material at at least one location to form at least one infused electrode that extends from an exterior of the flexible polymer casing to an interior of the flexible polymer casing, and the at least one infused electrode is coupled to the circuitry so as to allow the signal to pass from outside the flexible polymer casing to the circuitry. A polymer in a portion of the flexible polymer casing that is infused with the conductive material at the at least one location is cross-linked with a polymer in a portion of the flexible polymer casing that is not infused with the conductive material.