Devices, methods, and systems for the treatment and/or monitoring of damaged tissue

Inventors

Lawson, Daryl • Arena, Christopher Brian

Assignees

Adlore Inc

Abstract

Disclosed are methods, devices, and systems for treatment of an abnormal wound healing response. The methods, devices, and systems can be used to treat solid ulcerated tissue, such as diabetic foot ulcers (DFUs), arthritic tissue, muscle soreness, joint pain, varicose veins, obesity, and peripheral artery disease. Additionally, the methods, devices, and systems can promote the healing of xenograft, allograft, autograft, or engineered tissue following reconstruction surgery. The methods, devices, and systems include the ability to determine an optimal set of pulse parameters that are specific to wound healing. In embodiments, the methods, devices, and systems include components for guiding the user on electrode placement based on anatomical or electrical measurements, delivering a custom series of electric pulses, applying heat, and using feedback from physiologic measurements to control the device.

Core Innovation

The disclosed invention provides a therapeutic device for an area of a patient that includes skin and damaged tissue forming an ulcer. The device includes a covering configured to form a sleeve conforming to and enclosing a portion of the patient's body, with a patient touching side made of a material comfortable to the touch and configured to adhere poorly to wounds, and a heating component that generates heat to apply and transfer heat to the area through the skin adjacent the damaged tissue while warming the patient's body beyond the area.

The heating component is adapted to raise the temperature of the portion of the patient's body above the patient's normal body temperature range so as to increase blood flow or blood perfusion in the portion of the patient's body and thereby in the area and damaged tissue. A plurality of electrodes is adapted to apply electrical pulse stimulation to the portion of the patient's body spaced from the ulcer, together with an electrical pulse generator configured to generate electrical pulses that induce neuromuscular stimulation (NMES) or microtens (MCT) stimulation.

The device includes a sensor to detect blood flow or blood perfusion in the area of the damaged tissue. A control unit communicates with the sensor and the heating component and is configured to control the heating component to adjust heat based on input from the sensor, and in related implementations controls the pulse generator and the heating component to apply heat and electrical stimulation at the same time.

Claims Coverage

The provided excerpt includes three independent claims (1, 9, and 13). Across these claims, the inventive coverage centers on an enclosed sleeve with a heating component used to warm beyond the ulcer area, combined with spaced-from-ulcer electrical pulse stimulation producing NMES or MCT, together with sensor detection of blood flow or perfusion and control that adjusts heat and/or electrical pulses based on sensor input.

Across claims 1, 9, and 13, the independent coverage combines a sleeve-form covering with heating above normal temperature, spaced-from-ulcer electrical pulse stimulation inducing NMES or microtens stimulation, and blood flow or perfusion sensing with control that adjusts heating and/or electrical pulses based on sensor input.

Stated Advantages

Documented Applications