Apparatus and methods for determining damaged tissue using sub-epidermal moisture measurements
US-2018360344-A1 · Dec 20, 2018 · US
US2022400956A1 · US · A1
| Field | Value |
|---|---|
| Publication number | US-2022400956-A1 |
| Application number | US-202017776774-A |
| Country | US |
| Kind code | A1 |
| Filing date | Nov 12, 2020 |
| Priority date | Nov 15, 2019 |
| Publication date | Dec 22, 2022 |
| Grant date | — |
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The present disclosure provides methods and apparatus for evaluating tissue structure in damaged or healing tissue. The present disclosure also provides methods of identifying a patient at the onset of risk of pressure ulcer or at risk of the onset of pressure ulcer, and treating the patient with anatomy-specific clinical interventions selected, based on spectral imaging (SI). The present disclosure also provides methods of stratifying groups of patients based on risk of wound development and methods of reducing incidence of tissue damage in a care facility. The present disclosure also provides methods to analyze trends of SI intensities to detect tissue damage before it is visible, and methods to compare bisymmetric SI intensities to identify damaged tissue.
Opening claim text (preview).
We claim: 1 . A method of assessing spectral imaging (SI) characteristics in tissue below a patient's intact skin, the method comprising the steps of: a) obtaining an SI image, and b) assessing the SI image for SI signal intensity. 2 . The method of claim 1 , wherein the spectral imaging is multispectral imaging. 3 . The method of claim 1 , wherein the spectral imaging is hyperspectral imaging. 4 . A method of reducing the incidence of tissue damage in patients admitted to a care facility, the method comprising the steps of: a) evaluating a patient for a risk of tissue damage upon admission to the care facility, wherein evaluating comprises: i) taking a SI image of the patient at one or more body locations at risk of wound development, and ii) determining an average SI intensity of the SI images; b) administering an intervention of level-0 if the average SI intensity is below a first threshold, and c) administering an intervention of level-N if the average SI intensity is above a first threshold, wherein N is an integer and N has a value of 1 or greater. 5 . The method of claim 4 , wherein the one or more body locations at risk of wound development are selected from the group consisting of a sternum, a sacrum, a heel, a scapula (os latum scapularum), an elbow, an ear, and other fleshy tissues over a bony prominence of a patient. 6 . The method of claim 4 or 5 , wherein the one or more body locations at risk of wound development comprise one or more anatomical sites in long-term contact with a medical device. 7 . The method of claim 6 , wherein the body location at risk of wound development is selected from the group consisting of a cheek, a nose, a chest, a stomach, and a lower abdomen area. 8 . A method of stratifying a plurality of patients in a care facility based on care levels, the method comprising the steps of: a) taking an SI image of a patient in the plurality of patients at one or more body locations selected for monitoring; b) determining an average SI intensity of the SI image of the patient; c) determining a care level of N care levels that corresponds to the average SI intensity; d) assigning the care level to the patient; and e) arranging the patient of the plurality of patients into groups based on each of the patient's assigned care levels. 9 . The method of claim 8 , wherein the one or more body locations at risk of wound development are selected from the group consisting of a sternum, a sacrum, a heel, a scapula (os latum scapularum), an elbow, an ear, and other fleshy tissues over a bony prominence of a patient. 10 . The method of claim 8 , wherein one or more body locations at risk of wound development comprise one or more anatomical sites in long-term contact with a medical device, and are selected from the group consisting of a cheek, a nose, a chest, a stomach, and a lower abdomen area. 11 . A method for identifying and providing an appropriate level of care to a patient in a care facility, the method comprising the steps of: a) taking a plurality of SI images of the patient at one or more body locations; b) determining an average SI intensity of the SI image of the patient; c) providing one or more anatomy-specific interventions based on the average SI intensity; d) increasing the level of anatomy-specific interventions based on an increase in the average SI intensity; and e) decreasing the level of anatomy-specific interventions based on a decrease in the average SI intensity. 12 . A method of assigning a patient in a care facility to a risk category selected from a plurality of risk categories, the method comprising the steps of: a) taking an initial SI image of one or more locations of the body selected for monitoring; b) determining an average SI intensity of the SI image; and c) assigning the patient to a risk category selected from the plurality of risk categories, wherein the assigning is based partially on the average SI intensity of the SI image. 13 . The method of claim 12 , wherein the locations of the body are selected from the group consisting of a sternum, a sacrum, a heel, a scapula (os latum scapularum), an elbow, an ear, and other fleshy tissues over a bony prominence of a patient. 14 . The method of claim 12 , wherein the locations of the body comprise one or more anatomical sites in long-term contact with a medical device, and are selected from the group consisting of a cheek, a nose, a chest, a stomach, and a lower abdomen area. 15 . A method of managing care of a patient, the method comprising the steps of: a) taking a first set of SI images at one or more body locations selected for monitoring upon admission to a care facility; b) determining a first average SI intensity of each of the first set of SI images; c) setting an intervention level to N=1 if one of the average SI intensity of the first set of SI images is above a first threshold; d) implementing a level-N intervention for each of the one or more body locations having an average SI intensity above a first threshold; e) taking subsequent sets of SI images at each of the one or more body locations at a level-N frequency; and f) determining new average SI intensities for each of the one or more body locations. 16 . The method of claim 15 , wherein the one or more body locations selected for monitoring are selected from the group consisting of a sternum, a sacrum, a heel, a scapula (os latum scapularum), an elbow, an ear, and other fleshy tissues over a bony prominence of a patient. 17 . The method of claim 15 , wherein one or more body locations selected for monitoring comprise one or more anatomical sites in long-term contact with a medical device, and are selected from the group consisting of a cheek, a nose, a chest, a stomach, and a lower abdomen area. 18 . A method of identifying and treating a patient at risk of tissue damage, the method comprising the steps of: a) evaluating a patient for a risk of tissue damage upon admission to a care facility, wherein the evaluating step comprises: i) taking a first plurality of SI images in the patient; ii) determining a first average SI intensity of the initial set of SI images; b) administering a first intervention of level-0 if the first average SI intensity is below or equal to a first threshold; and c) administering a first intervention of level-N if the first average SI intensity is above the first threshold, where N is an integer and N has a value of 1 or greater. 19 . The method of claim 18 , further comprising the steps of: a) taking a second plurality of SI images in the patient at a first pre-determined frequency corresponding to the administered intervention level; b) determining a second average SI intensity of the second plurality of SI images; c) determining whether the second average SI intensity value exceeds a second threshold; d) continuing to administer the first intervention if the second average SI intensity does not exceed the second threshold; e) continuing to take a plurality of SI images at the first pre-determined frequency if the second average SI intensity value does not exceed the second threshold; f) administering a second intervention of level-M if the second average SI intensity value exceeds the second threshold, where M is an integer and M is greater than N; and g) taking a plurality of SI images at a second pre-determined frequency corresponding to level-M if the second average SI intensity exceeds the second threshold. 20 . The method of cla
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