Methods and apparatus for detection of tissue damage in patients using a medical device for an extended period of time are disclosed.

In some embodiments, a wound monitoring and/or therapy apparatus includes a wound dressing configured to be positioned in contact with a wound, the wound dressing comprising one or more sensors configured to obtain measurement data of at least one of the wound or periwound. The apparatus can also include a controller configured to maintain a device clock indicative of a non-real time clock, receive measurement data obtained by the one or more sensors, and transmit measurement data to a remote computing device according to a security protocol, the security protocol comprising including the device clock associated with the measurement data in the transmission.

Embodiments of apparatuses, systems, methods for monitoring wound pH are disclosed. In some embodiments, a wound dressing includes one or more optical sensors configured to measure a change in color of a pH-sensitive adhesive that changes color in response to changes in wound exudate pH. In some embodiments, the wound dressing may further comprise hydrophilic channels that direct wound exudate to a pH-sensitive material over the optical sensors. Such dressings may also be used in combination with a negative pressure wound therapy system.

Embodiments of apparatuses and methods for determining an emplacement of sensors in a wound dressing are disclosed. In some embodiments, a wound dressing includes a plurality of sensors configured to measure wound or patient characteristics. One or more processors are configured to receive wound or patient characteristics data as well as emplacement data. The received data can be used to determine an emplacement of the plurality of sensors, the wound dressing, or a wound. The sensors can include a set of nanosensors. The wound dressing can include pH sensitive ink which can be utilized for determining a placement of the wound dressing and determining a pH associated with the wound. The wound dressing can be used in a negative pressure wound therapy system.

A wound dressing and a monitor device is disclosed, the wound dressing comprising a top layer; a first adhesive layer with a proximal surface configured for attachment of the wound dressing to the skin surface of a user; an absorbent core layer; an electrode assembly comprising a plurality of electrodes arranged on a distal side of the absorbent core layer; and a monitor interface configured for connecting the wound dressing to a monitor device, the monitor interface comprising a plurality of terminals configured to form electrical connections with respective terminals of the monitor device, wherein the wound dressing comprises a flexible element, the flexible element being bendable and/or twistable between a first flexible element end and a second flexible element end, and wherein the monitor interface comprises a coupling part positioned at the first flexible element end.

Machine learning systems and methods are disclosed for prediction of wound healing, such as for diabetic foot ulcers or other wounds, and for assessment implementations such as segmentation of images into wound regions and non-wound regions. Systems for assessing or predicting wound healing can include a light detection element configured to collect light of at least a first wavelength reflected from a tissue region including a wound, and one or more processors configured to generate an image based on a signal from the light detection element having pixels depicting the tissue region, determine reflectance intensity values for at least a subset of the pixels, determine one or more quantitative features of the subset of the plurality of pixels based on the reflectance intensity values, and generate a predicted or assessed healing parameter associated with the wound over a predetermined time interval.

An apparatus includes a sensor configured to capture an image of an affected part, and a processor configured to obtain information about a size of the affected part in the captured image, and control timing to capture an image of the affected part or control timing to prompt a user to perform an imaging operation based on the information about the size of the affected part.

A volume of a wound is estimated using a dynamic pressure response measured during instillation of fluid to the wound using a negative pressure wound therapy system. A previously estimated wound volume may be used to detect and prevent overfill of fluid to the wound during future instillation events. For example, real-time pressure measurements may be compared to model data representative of expected pressure at a wound having a volume equal to the previously estimated wound volume, with instillation being stopped if the observed pressure varies from the expected pressure. A comparison of a total volume of fluid instilled to the wound may also be compared to the previously estimated wound volume to prevent overfill. The comparison of wound volume estimated based on an instillation event may also be compared to a wound volume estimated using other methods to provide a higher confidence wound volume estimate.

Methods and apparatus for detection of tissue damage in patients using a medical device for an extended period of time are disclosed.

A method of monitoring a patient's foot forms a thermogram of the sole of at least one foot of the patient, and determines whether the thermogram presents at least one of a plurality of prescribed patterns. The method also compares the thermogram against a prior thermogram of the same foot, and produces output information indicating the emergence of an ulcer on a given portion on the at least one foot as a function of 1) whether the thermogram is determined to present the at least one pattern, and 2) the comparison with the prior thermogram, which shows non-ulcerated tissue at the given location.