Pressure measurement

Abstract

The present disclosure provides methods and devices for assessing tissue structure in damaged or healing tissue. The present disclosure also provides methods for identifying patients at risk for developing or developing pressure ulcers and treating them with selected anatomical structure-specific clinical interventions based on pressure measurements. The present disclosure also provides methods for stratifying patient groups based on risk for wound development and for reducing the incidence of tissue damage in healthcare facilities. The present disclosure also provides methods for analyzing trends in pressure readings to detect tissue damage before it becomes visible and for comparing symmetric pressure readings to identify damaged tissue.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 936,381, filed November 15, 2019, and U.S. Provisional Patent Application No. 63 / 109,026, filed November 3, 2020, the entire contents of each of which are incorporated herein by reference.

[0002] The present disclosure provides methods and devices for assessing tissue structure in damaged or healing tissue. The present disclosure also provides methods for identifying patients at risk for developing or developing a pressure ulcer and treating the patient with selected anatomical structure-specific clinical interventions based on pressure measurements. The present disclosure also provides methods for stratifying patient groups based on risk for wound development and for reducing the incidence or severity of tissue damage in institutionalized patients. The present disclosure also provides methods for detecting tissue damage before it becomes visible on the patient's skin. [Background technology]

[0003] Skin is the largest organ in the human body. It is susceptible to many types of damage and injury. Skin damage and injury occur when the skin and surrounding tissues are unable to redistribute external pressure and mechanical forces, which can lead to the formation of ulcers. Even moderate pressure, such as the pressure generated on the dorsal skin surface by the weight of a supine patient, can cause pressure ulcers if exposed continuously for extended periods of time. In the presence of other damage, such as neuropathy and peripheral tissue weakening that can be induced by diabetes, even regular exposure to even moderate levels of pressure and stress can lead to ulcers (e.g., foot ulcers).

[0004] Pressure ulcers affect approximately 2.5 million people annually in the United States and a similar number in the European Union. In long-term critical care settings, up to 25% of elderly, immobile patients develop pressure ulcers. Infections and other complications from pressure ulcers are responsible for approximately 60,000 patient deaths annually in the United States.

[0005] Most pressure ulcers develop over bony prominences where there is less tissue to compress and altered pressure gradients within the vascular network. Pressure ulcers are classified into one of six stages, ranging from the earliest recognized stage (redness over bony prominences with intact skin) (Stage 1), through tissue breakdown exposing bone, tendon, or muscle (Stage 4), to deep tissue pressure injury manifesting as non-blanching crimson, maroon, or purple discoloration, and finally, to full-thickness, indistinct skin and tissue loss (Unclear). Detecting and treating pressure ulcers before skin breakdown to prevent progression to later stages is a goal of policymakers and healthcare providers in major economies. Most pressure ulcers are preventable; if identified before the first stage of ulceration, deterioration of the underlying tissue can be halted.

[0006] Detecting tissue damage before the skin breaks and intervening with appropriate therapy to prevent further deterioration of the underlying tissue is desirable for both patients and society. The cost of treating pressure injuries averages approximately $2,000 for the earliest visible signs (stage 1 ulcers) but rises to $129,000 for ulcers deep enough to expose muscle or bone (stage 4 ulcers). See, for example, Brem, H. et al. (2010). High Cost of Stage IV Pressure Ulcers. Am. J. Surg. Oct; 200(4):473-477. Currently, patients typically receive universal pressure ulcer prevention, which means that prevention does not target specific anatomical locations. Patients receive targeted, localized ulcer treatment only after the ulcer has progressed to a point where it can be identified by visual assessment. Current criteria for detecting pressure ulcers rely on visual inspection, which is subjective, unreliable, premature, and lacks specificity. See, for example, Pancorbo-Hidalgo P. et al. (2006). Risk assessment scales for pressure ulcer prevention: a systematic review. Journal of Advanced Nursing, 54, 94-110 and Garcia-Fernandez, FP (2014). Predictive Capacity of Risk Assessment Scales and Clinical Judgment for Pressure Ulcers: A Meta-analysis. Journal of Wound, Ostomy and Continence Nursing, 41, 24-34. As a result, patients often experience skin inflammation, a precursor to ulcer development, but do not receive targeted localized treatment for the ulcer. Instead, the inflammation progresses and develops into a full-blown ulcer.

[0007] Skin damage and injury can also be the result of certain surgical procedures (e.g., reconstructive surgery involving skin flaps) that sever blood vessels in or around the surgical area. Healing of damaged or separated tissue depends on the restoration of adequate blood flow throughout the damaged area. Determining whether an area of ​​tissue has healed, i.e., whether blood flow through the tissue has increased to normal levels, is difficult by visual inspection. Existing devices can measure certain attributes, such as blood oxygen concentration, but these are only indirect measures of blood flow.

[0008] Pressure measurements allow for the detection of contact pressure on the patient's skin, which may be between the patient and a resting surface, and are inexpensive and non-invasive. Summary of the Invention

[0009] Non-invasive, objective measurements provide a systematic method for identifying the onset of pressure ulcer risk before visible skin breakdown occurs, followed by targeted interventions to specific anatomy. Also, non-invasive, objective measurements provide a systematic method for identifying the onset of pressure ulcer risk before visible skin breakdown occurs, followed by targeted interventions to specific anatomy. Methods for monitoring wound healing progress and consistency of intervention compliance are further provided.

[0010] In one aspect, the present disclosure provides and encompasses a method of evaluating pressure measurements on intact skin of a patient, the method including obtaining pressure measurements at multiple locations on the patient's skin and generating a pressure measurement map.

[0011] In one aspect, the present disclosure provides and encompasses a method of reducing the incidence of tissue injury in a patient admitted to a healthcare facility, the method comprising: assessing the patient for risk of tissue injury upon admission to the healthcare facility, implementing a Level 0 intervention if the average pressure value is below a first threshold, and implementing a Level N intervention if the average pressure value is above the first threshold, where N is an integer equal to or greater than 1. In one aspect, the assessing step comprises obtaining pressure measurements of the patient at one or more body locations at risk for wound development and determining an average pressure value of the pressure measurements.

[0012] In one embodiment, the one or more body areas at risk for wound development are selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on bony prominences of a patient. In one embodiment, the one or more body areas at risk for wound development include one or more anatomical sites that are in prolonged contact with a medical device. In one embodiment, the body area at risk for wound development is selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen.

[0013] In one aspect, the present disclosure provides and encompasses a method for stratifying a plurality of patients in a healthcare facility based on level of care, the method including the steps of obtaining a pressure measurement of one of the plurality of patients at one or more body locations selected for monitoring, determining an average pressure value of the pressure measurements of the patient, determining a healthcare level among N levels that corresponds to the average pressure value, assigning a healthcare level to the patient, and placing the patient among the plurality of patients into a group based on each of the healthcare levels assigned to the patient.

[0014] In one embodiment, the one or more body locations at risk for wound development are selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of a patient. In one embodiment, the one or more body locations at risk for wound development include one or more anatomical sites in prolonged contact with a medical device and are selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen.

[0015] In one aspect, the present disclosure provides and encompasses a method of identifying and providing an appropriate level of medical care to a patient in a medical-care facility, the method including obtaining a plurality of pressure measurements of the patient at one or more body locations; determining an average pressure value of the plurality of pressure measurements of the patient; administering one or more anatomical-specific interventions based on the average pressure value; increasing the level of the anatomical-specific intervention based on an increase in the average pressure value; and decreasing the level of the anatomical-specific intervention based on a decrease in the average pressure value.

[0016] In one aspect, the present disclosure provides and encompasses a method for assigning a patient in a healthcare facility to a risk category selected from a plurality of risk categories, the method including the steps of obtaining initial pressure measurements at one or more body locations selected for monitoring, determining an average pressure value of the pressure measurements, and assigning the patient to the risk category selected from the plurality of risk categories based in part on the average pressure value of the pressure measurements.

[0017] In one embodiment, the body site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of a patient. In one embodiment, the body site includes one or more anatomical sites in prolonged contact with a medical device and is selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen.

[0018] In one aspect, the present disclosure provides and encompasses a method of managing the medical care of a patient, the method including the steps of obtaining a first set of pressure measurements at one or more body locations selected for monitoring upon admission to a medical-care facility; determining a first average pressure value for each of the first set of pressure measurements; if one of the average pressure values ​​of the first set of pressure measurements exceeds a first threshold, setting an intervention level N=1; implementing an intervention of level N for each of the one or more body locations whose average pressure value exceeds the first threshold; obtaining subsequent sets of pressure measurements at each of the one or more body locations at a frequency of level N; and determining a new average pressure value for each of the one or more body locations.

[0019] In one embodiment, the one or more body locations selected for monitoring are selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue on a bony prominence of the patient. In one embodiment, the one or more body locations selected for monitoring include one or more anatomical sites in prolonged contact with the medical device and are selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen.

[0020] In one aspect, the present disclosure provides and encompasses a method of identifying and treating a patient at risk for tissue damage, the method including: assessing a patient for risk of tissue damage upon admission to a healthcare facility, implementing a first intervention at Level 0 if a first average pressure value is less than or equal to a first threshold, and implementing a first intervention at Level N (N is an integer greater than or equal to 1) if the first average pressure value is greater than the first threshold. In one aspect, the assessing step includes obtaining a first plurality of pressure measurements of the patient and determining a first average pressure value of the initial set of pressure measurements.

[0021] In one aspect, the method further includes obtaining a second plurality of pressure measurements of the patient at a first predetermined frequency corresponding to the implemented intervention level; determining a second average pressure value of the second plurality of pressure measurements; determining whether the second average pressure value exceeds a second threshold; continuing to implement the first intervention if the second average pressure value does not exceed the second threshold; continuing to obtain the multiple pressure measurements at the first predetermined frequency if the second average pressure value does not exceed the second threshold; implementing a second intervention at level M (M is an integer greater than N) if the second average pressure value exceeds the second threshold; and obtaining the multiple pressure measurements at the second predetermined frequency corresponding to level M if the second average pressure value exceeds the second threshold.

[0022] In one aspect, the method further includes determining whether the second average pressure value is less than a third threshold; continuing to implement the first intervention if the second average pressure value is greater than or equal to the third threshold; continuing to obtain multiple pressure measurements at a first predetermined frequency if the second average pressure value is greater than or equal to the third threshold; implementing a third intervention at level L (L is an integer less than N) if the second average pressure value is less than the third threshold and the first intervention is not level 0; and obtaining multiple pressure measurements at a predetermined frequency corresponding to level L if the second average pressure value is less than the third threshold.

[0023] In one aspect, the Level N first intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, a 30-degree wedge, a composite dressing, a hybrid mattress, a dynamic mattress, a support surface, a silicone pad, a low-friction seat cover, and a low-friction padded mattress surface.

[0024] In one aspect, the Level M second intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, a 30-degree wedge, a composite dressing, a hybrid mattress, a dynamic mattress, a support surface, a silicone pad, a low-friction seat cover, and a low-friction padded mattress surface.

[0025] In one aspect, the Level L third intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, a 30-degree wedge, a composite dressing, a hybrid mattress, a dynamic mattress, a support surface, a silicone pad, a low-friction seat cover, and a low-friction padded mattress surface.

[0026] In one embodiment, the first average pressure value is determined from a subset of the first plurality of pressure measurements. In one embodiment, the second average pressure value is determined from a subset of the second plurality of pressure measurements.

[0027] In one embodiment, the second threshold is equal to the first threshold, hi one embodiment, the third threshold is equal to the first threshold.

[0028] In one aspect, the present disclosure provides and encompasses a method for identifying and treating a patient requiring pressure ulcer intervention, the method including the steps of obtaining a plurality of pressure measurements at an anatomical site of the patient, determining an average pressure value of the plurality of pressure measurements, determining whether the average pressure value exceeds a threshold corresponding to level N (N is 2 or greater), and if the average pressure value exceeds the threshold, administering pressure ulcer intervention at the anatomical site, and if the average pressure value exceeds the threshold, obtaining a plurality of pressure measurements every two hours.

[0029] In one embodiment, the anatomical site is selected from the group consisting of the sternum, sacrum, heel, shoulder blade (os latum scapularum), elbow, ear, and other fleshy tissue over a bony prominence of the patient. In one embodiment, the pressure ulcer intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, 30-degree wedges, composite dressings, hybrid mattresses, dynamic mattresses, support surfaces, silicone pads, low-friction sheet covers, and low-friction padded mattress surfaces.

[0030] In one aspect, the present disclosure provides and encompasses a method for identifying damaged tissue, the method including the steps of obtaining a first pressure measurement from a first location on a patient's skin, obtaining a second pressure measurement from a second location symmetrical to the first location, determining an average pressure value for each of the first and second pressure measurements, determining an average pressure value from each of the first and second pressure measurements, determining a difference in the average pressure values ​​between the first and second pressure measurements, and determining that tissue damage is present at the first or second location if the difference in the average pressure values ​​exceeds a threshold.

[0031] In one embodiment, the first location is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient.

[0032] In one aspect, the present disclosure provides and encompasses a method for detecting tissue damage before it becomes visible on a patient's skin, the method including the steps of obtaining a plurality of pressure measurements at a location on the patient's skin at different times, determining an average pressure value from each of the plurality of pressure measurements, calculating a slope between the most recent average pressure value and the immediately preceding average pressure value, comparing the slope to a threshold, and determining that tissue damage is present if the slope exceeds the threshold.

[0033] In one embodiment, the location is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient. In one embodiment, the method is performed at multiple locations.

[0034] In one aspect, the present disclosure provides and encompasses a method for detecting tissue damage before it becomes visible on a patient's skin, the method comprising the steps of obtaining multiple pressure measurements at multiple locations on the patient's skin at different times; determining an average pressure value from each of the multiple pressure measurements; calculating a pressure difference between the maximum and minimum average pressure values ​​for each time period; calculating a derivative of the pressure difference with respect to time; comparing the derivative to a threshold; and determining that tissue damage is present if the derivative exceeds the threshold.

[0035] In one embodiment, the multiple locations are selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient.

[0036] In one embodiment, the derivative with respect to time of the difference value is calculated from the two most recent difference values.

[0037] In one aspect, the present disclosure provides and encompasses a method for detecting tissue damage before it becomes visible on a patient's skin, the method comprising the steps of obtaining a plurality of pressure measurements at a location on the patient's skin at each of a plurality of time intervals; determining an average pressure value from each of the plurality of pressure measurements; calculating a pressure differential between the maximum and minimum average pressure values ​​for each time interval; fitting a curve to a predetermined number of recent pressure differentials; calculating the curvature of the fitted curve; comparing the curvature to a threshold; and determining that tissue damage is present if the curvature exceeds the threshold.

[0038] In one embodiment, the location is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient. In one embodiment, the method is performed at multiple locations.

[0039] Aspects of the present disclosure are described herein, by way of example only, with reference to the accompanying drawings. Referring now in detail to the drawings, it is emphasized that the specific details shown are by way of example and are intended to illustrate aspects of the present disclosure. In this regard, the specification and drawings, considered individually and together, will make apparent to those skilled in the art how aspects of the present disclosure can be practiced. [Brief explanation of the drawings]

[0040] [Figure 1A] Figure 1 shows an example of a currently recommended treatment decision pathway for preventing pressure ulcers in hospitalized patients using a combination of risk assessment and visual assessment. [Figure 1B] FIG. 1 illustrates an example of a current expanded treatment decision pathway for pressure ulcer prevention currently implemented in some healthcare facilities. [Figure 2] 1 is an exemplary flowchart of a method in which a device for assessing pressure characteristics on a patient's skin may be used in a stand-alone process for preventing pressure sores according to the present disclosure. [Figure 3] 1C is an exemplary flowchart of a method in which a device for assessing pressure characteristics on a patient's skin may be used as an aid to further refine the extended treatment decision pathway of FIG. 1B, according to the present disclosure. [Figure 4A] FIG. 1 illustrates an example of a pair of symmetrical locations on the sacral region according to the present disclosure. [Figure 4B] 1A and 1B are diagrams illustrating an example of a pair of symmetrical locations on the bottom surfaces of both feet according to the present disclosure. [Figure 4C] 1A and 1B are diagrams illustrating an example of a pair of symmetrical locations on the sides and soles of both feet according to the present disclosure. [Figure 5A] FIG. 1 illustrates locations on the left and right feet for pressure measurements according to the present disclosure. [Figure 5B] FIG. 10 is a plot of pressure values ​​associated with known relative locations for identifying symmetrical locations in accordance with the present disclosure. [Figure 6] FIG. 1 illustrates an integrated system for measuring, evaluating, storing, and transmitting pressure measurements in accordance with the present disclosure. [Figure 7A] 1 is a diagram showing various pressure points on a patient's body in various positions. [Figure 7B] 1 is a diagram showing various pressure points on a patient's body in various positions. [Figure 7C] 1 is a diagram showing various pressure points on a patient's body in various positions. [Figure 7D] 1 is a diagram showing various pressure points on a patient's body in various positions. DETAILED DESCRIPTION OF THE INVENTION

[0041] This specification is not intended to be a detailed catalog of all the different ways in which the present disclosure may be implemented or all the features that may be added to the present disclosure. For example, features illustrated with respect to one embodiment may be incorporated into other embodiments, or features illustrated with respect to a particular embodiment may be deleted from that embodiment. Accordingly, the present disclosure contemplates that, in some of its embodiments, any feature or combination of features illustrated herein may be excluded or omitted. Also, numerous modifications and additions to the various embodiments proposed herein will become apparent to those skilled in the art in light of this disclosure without departing from the present disclosure. In other instances, well-known structures, interfaces, and processes have not been shown in detail so as not to unnecessarily obscure the present invention. It is intended that no portion of this specification be construed as denying any portion of the full scope of the present invention. Accordingly, the following description is intended to describe some specific embodiments of the present disclosure, but is not intended to exhaustively specify all permutations, combinations, and variations thereof.

[0042] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. The terminology used herein of the present disclosure is for the purpose of describing particular aspects or embodiments only and is not intended to be limiting of the disclosure.

[0043] All publications, patent applications, patents, and other references cited herein are incorporated by reference in their entirety for the teachings relevant to the sentence and / or paragraph in which the reference is presented. References to technology employed herein are intended to represent the technology as commonly understood in the art, including variations on or substitutions of equivalent technologies that will be apparent to those skilled in the art.

[0044] Unless the context clearly indicates otherwise, it is expressly intended that the various features of the present disclosure described herein may be used in any combination. Furthermore, the present disclosure contemplates that in some embodiments thereof, any feature or combination of features set forth herein may be excluded or omitted.

[0045] The methods disclosed herein include and cover one or more steps or actions for achieving the described method. These method steps and / or actions may be interchanged with one another without departing from the scope of the present disclosure. In other words, where a specific order of steps or actions is not required for the proper operation of an embodiment, the order and / or use of specific steps and / or actions may be modified without departing from the scope of the present disclosure.

[0046] As used in the specification of this disclosure and the appended claims, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise.

[0047] As used herein, "and / or" denotes and covers all possible combinations of one or more of the associated listed items, as well as the exclusion of combinations when interpreted as alternatives ("or").

[0048] As used herein, the terms "about" and "approximately" when describing a measurable value such as a length, frequency, or measurement, are intended to encompass variations of ±20%, ±10%, ±5%, ±1%, ±0.5%, or ±0.1% of the stated value.

[0049] As used herein, expressions such as "between X and Y" and "between about X and Y" shall be interpreted to include X and Y. As used herein, expressions such as "between about X and Y" mean "between about X and about Y," and expressions such as "from about X to Y" mean "from about X to about Y."

[0050] As used herein, the term "exemplary" is used to mean serving as an example, instance, or illustration. Any embodiment or aspect described as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments or aspects, nor is it intended to exclude equivalent structures and techniques known to those skilled in the art. Rather, use of the term exemplary is intended to present concepts in a concrete manner, and the disclosed subject matter is not limited by such examples.

[0051] As used herein, the term "patient" includes both human and animal subjects.

[0052] As used herein, the term "skin" refers to the surface of a patient's body.

[0053] As used herein, the term "tissue" refers to a collection of similar cells of the same origin and their respective extracellular matrices that together perform a specific function. In some embodiments, the tissue comprises multiple layers of a patient's body, beginning with the stratum corneum and including additional deeper structures such as the epidermis, dermis, and portions of the deeper tissues that contain blood vessels. In one embodiment, the tissue does not comprise the stratum corneum.

[0054] As used herein, the term "wound" refers to damaged or injured tissue, which may or may not be visible on the surface of the skin. A wound may be open or closed. A wound may be caused by surgery. A wound may be a burn. In one embodiment, the wound is a pressure ulcer. In another embodiment, the pressure ulcer is subcutaneous. In one embodiment, the pressure ulcer is a result of prolonged use of a medical device, such as a mask, tubing, or strap. In one embodiment, the wound is a diabetic foot ulcer. In one embodiment, the wound is a vascular ulcer.

[0055] As used herein, "tissue biocapacitance" refers to a biophysical marker that detects early tissue damage based on an increase in the level of fluid accumulated in the interstitial space. Without being bound by theory, the greater the fluid content in the tissue, the higher the biocapacitance value. In some embodiments, the methods described herein comprise measuring tissue biocapacitance. In some embodiments, the methods described herein comprise measuring skin biocapacitance.

[0056] As used herein, the term "time delta" refers to the difference calculated between two values ​​derived from measurements obtained from a subject at different times. In one embodiment, each of the two values ​​is an average calculated from measurements obtained at approximately the same time. In one embodiment, each of the two values ​​is a sum calculated from measurements obtained at approximately the same time. In one embodiment, the two measurements are obtained at approximately the same time (approximately 10 hours or less, approximately 8 hours or less, approximately 6 hours or less, approximately 5 hours or less, approximately 4 hours or less, approximately 3 hours or less, approximately 2 hours or less, or approximately 1 hour or less apart).

[0057] As used herein, the variables "K", "L", "M", and "N" are non-negative integers.

[0058] As used herein, the term "anatomy-specific" refers to the application of a clinical intervention to the same location where a particular pressure measurement is obtained.

[0059] As used herein, a "system" may be a group of devices in wired or wireless communication with each other.

[0060] As used herein, "bisymmetric" refers to a pair of locations that are approximately equidistant from a line of symmetry.

[0061] As used herein, the term "pressure measuring device" includes any device that captures pressure information at one or more points distributed over a two-dimensional area. In one embodiment, the pressure measuring device is a strain gauge. In one embodiment, the pressure measuring device is a piezoresistive strain gauge. In one embodiment, the pressure measuring device is a capacitive pressure sensor. In one embodiment, the pressure measuring device is a piezoelectric pressure sensor. In one embodiment, the pressure measuring device provides information about whether pressure is being applied to a surface. In one embodiment, the pressure measuring device measures the absolute pressure applied to a surface.

[0062] As used herein, the term "light" refers to electromagnetic energy having a wavelength in the range of 1 picometer to 1 meter. In one embodiment, this range is 1 nanometer to 1 millimeter and includes "ultraviolet," "visible," and "infrared" light. In one embodiment, this range is 10 to 390 nanometers, commonly understood as "ultraviolet" light. In one embodiment, this range is 390 to 700 nanometers, commonly understood as "visible" light. In one embodiment, this range is 700 nanometers to 1 millimeter, commonly understood as "infrared" radiation. In one embodiment, this range is 700 to 900 nanometers, commonly understood as "near-infrared" radiation. In one embodiment, the light may be a narrow band of wavelengths, with respect to a particular wavelength. In one embodiment, the particular wavelength is 760 and / or 830 nanometers.

[0063] As used herein, wavelengths and frequencies of light are uniquely related, so that identifying light as having a particular wavelength is equivalent to identifying that light as having a particular frequency, and references to frequencies of light are considered equivalent and interchangeable with references to wavelengths of the same light.

[0064] As used herein, the term "method" includes a sequence of operations (e.g., steps). In certain embodiments, the steps must be performed in a particular order, while in other embodiments, the sequence of operations may be interchanged. "Method" is considered equivalent to and interchangeable with "process." In certain embodiments, one or more disclosed steps are omitted.

[0065] How to evaluate pressure measurement results In one aspect, the present disclosure provides a method of evaluating tonometry results on intact skin of a patient, the method comprising obtaining a tonometry scan on the patient's skin and generating a tonometry map.

[0066] In one aspect, the tonometry scan includes taking a pressure measurement at a single location on the patient's skin. In one aspect, the tonometry scan includes taking a pressure measurement at multiple locations on the patient's skin. In one aspect, the tonometry scan includes taking a plurality of pressure measurements at multiple locations on the patient's skin. In one aspect, assessing the patient includes determining an average pressure value of the pressure measurements. In one aspect, assessing the patient includes determining an average pressure value of the plurality of pressure measurements. In one aspect, the tonometry map shows a map of pressures applied to the skin.

[0067] In one embodiment, the mean pressure value at a location is determined from two, three, four, five, six, seven, eight, nine, ten, or more pressure values ​​measured at that location. In one embodiment, the pressure differential is determined by the difference between mean pressure values ​​from measurements taken at two symmetrical locations about the centerline.

[0068] In one aspect, a pressure value may be calculated from multiple pressure measurements made at a specific location or in close proximity to a specific location in the methods disclosed herein. In one aspect, multiple pressure measurements are made in a predetermined pattern on the skin, and a pressure value is calculated by subtracting a pressure value associated with a specific location in the pattern from a maximum pressure value made at other locations in the pattern. In one aspect, multiple pressure measurements are made in a predetermined pattern on the skin, and a pressure value is calculated by identifying a pressure value associated with a specific location in the pattern and subtracting the maximum pressure value made at other locations in the pattern. In one aspect, a pressure value may be calculated from a portion of a set of pressure values ​​generated by multiple pressure measurements at a single location, and a pressure value calculated as the maximum difference between the average value of the same set and a single pressure value. In one aspect, a pressure value may be calculated as the ratio of the maximum pressure value to the minimum pressure value in the set of pressure values.

[0069] In one aspect, the methods provided herein are based on pressure values ​​measured on the patient's skin. In one aspect, the methods provided herein are applied from the time the patient is admitted to a healthcare facility until the patient is discharged from the healthcare facility.

[0070] In one embodiment, the wound is a pressure ulcer. In one embodiment, the pressure ulcer is a pressure ulcer resulting from prolonged use of a medical device, such as a mask, tubing, or strap. In one embodiment, the wound is a diabetic foot ulcer. In one embodiment, the wound is a vascular ulcer. In one embodiment, the wound is a burn.

[0071] Methods for reducing the incidence of tissue damage In one aspect, the present disclosure provides and encompasses a method of reducing the incidence of tissue injury in patients admitted to a healthcare facility, the method comprising: assessing the patient for risk of tissue injury upon admission to the healthcare facility, the step comprising obtaining pressure measurements of the patient at one or more body locations at risk of developing a wound and determining an average pressure value of the pressure measurements; and implementing a Level 0 intervention if the average pressure value is below a first threshold; and implementing a Level N intervention if the average pressure value exceeds the first threshold, where N is an integer equal to or greater than 1. In one aspect, the incidence of ulcers in healthcare facility patients is reduced to less than 1 in 100, less than 1 in 200, less than 1 in 300, less than 1 in 400, less than 1 in 500, less than 1 in 600, less than 1 in 700, less than 1 in 800, less than 1 in 900, or less than 1 in 1000.

[0072] In one embodiment, the healthcare facility is selected from the group consisting of a hospital, a recovery facility, an assisted living facility, a home health care facility, a nursing home, a long-term care facility, a continuing care community, and an independent living community. In one embodiment, the healthcare facility may be the patient's home or other residence, in which case the "admission" step is an initial assessment in the patient's home by a nurse or other caregiver. In one embodiment, the schedule of interventions and assessment intervals used in the home environment may differ from the corresponding interventions and intervals used in the hospital.

[0073] In one embodiment, the methods disclosed herein include assessing a newly admitted patient for risk of tissue damage. In one embodiment, assessing the patient includes performing a visual assessment. In one embodiment, the visual assessment is performed according to guidance from the National Pressure Ulcer Advisory Panel (NPUAP).

[0074] In one embodiment, evaluating the patient includes performing a risk assessment. In one embodiment, the risk assessment is performed according to a test selected from the group consisting of the Braden Scale, the Gosnell Scale, the Norton Scale, and the Waterlow Scale. In one embodiment, evaluating the patient further includes performing an assessment using one or more objective measurements selected from the group consisting of subepidermal water, bioimpedance, blood perfusion, biocapacitance, blood oxygenation, spectral imaging, PET imaging, capillary pressure, magnetic resonance imaging, infrared imaging, ultrasound imaging, transepidermal water loss, and detecting the presence of interleukin-1 alpha at one or more anatomical sites of interest.

[0075] 7A-7D illustrate, with circles, various locations of a patient's tissue injury risk. In one embodiment, the one or more body locations at risk for developing pressure injury are selected from the group consisting of the back of the head, shoulders, base of the spine, buttocks, heels, feet, elbows, ears, lower back, thighs, legs, rib cage, and knees. In one embodiment, the one or more body locations at risk for developing tissue injury are selected from the group consisting of the sternum, sacrum, heels, os latum scapularum, elbows, ears, and other fleshy tissues over bony prominences of a patient.

[0076] In one embodiment, a newly admitted patient undergoes an intake assessment including one or more of a visual inspection of a portion of the patient's skin, completion of at least a portion of a risk assessment protocol evaluating one or more of nutrition, exercise, physical activity, strength, and communication skills, and pressure measurements are obtained at one or more locations on the patient's skin. In one embodiment, the pressure measurement scan includes obtaining multiple pressure measurements at a single "location" on the patient's skin. In one embodiment, a "location" is considered an area rather than a single point, such that pressure measurements may be made at spatially separated points within the location. For example, a heel location includes the inner, outer, and posterior surfaces of the heel perimeter, as well as the rear of the plantar surface of the foot. In one embodiment, the pressure measurement scan includes obtaining pressure measurements at a single location on the patient's skin. In one embodiment, the pressure measurement scan includes obtaining pressure measurements at multiple locations on the patient's skin. In one embodiment, the pressure measurement scan includes obtaining multiple pressure measurements at multiple locations on the patient's skin. In one embodiment, evaluating the patient includes determining an average pressure value of the pressure measurements. In one aspect, assessing the patient includes determining an average pressure value of a plurality of pressure measurements.

[0077] How to assign patients to risk categories In one aspect, once the assessment steps are completed, a determination is made as to whether the patient's measurements are abnormal, i.e., whether the combined results of the various elements of the assessment indicate that the patient has or is at risk for developing additional wound tissue damage. Each element of the assessment may have individual criteria for the level of risk (e.g., a scoring system with thresholds indicating unacceptable risk).

[0078] In one embodiment, if the mean pressure value is less than or equal to the first threshold, a Level 0 intervention is implemented. In one embodiment, if the mean pressure value is greater than the first threshold, a Level N intervention is implemented. In one embodiment, the first threshold is approximately 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, The color may be 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, or 7.5. In one embodiment, the threshold value may be in the range of 0.1 to 8.0 (e.g., 0.1 to 1.0, 1.1 to 2.0, 2.1 to 3.0, 3.1 to 4.0, 4.1 to 5.0, 5.1 to 6.0, 6.1 to 7.0, 7.1 to 8.0, 0.1 to 7.5, 0.5 to 8.0, 1.0 to 7.0, 1.5 to 6.5, 2.0 to 6.0, 3.0 to 5.5, 3.5 to 5.0, or 4.0 to 4.5). In one embodiment, the threshold value may be scaled by a factor or multiple based on the values ​​provided herein. It is understood that the threshold value is not constrained by design, but rather, one of skill in the art may select a predetermined value. In one embodiment, the threshold values ​​of the present disclosure are modified according to the particular part of the patient's body on which the measurement is being taken, or one or more characteristics of the patient, such as age, height, weight, family history, ethnicity, and other physical characteristics or medical conditions.

[0079] In one embodiment, a mean pressure value above a first threshold is indicative of a patient at risk for developing a pressure sore or tissue damage.

[0080] In one embodiment, if the patient is determined to be at an acceptable risk level, a minimum level of intervention, designated herein as "Level Zero" or "Level 0," will be implemented, and the patient will be reassessed using at least a pressure measurement protocol at the frequency (or conversely, time interval) associated with Level 0. In one embodiment, if the mean pressure value falls below a threshold, a Level 0 intervention will be implemented.

[0081] In one embodiment, if the patient is determined to have an abnormal reading, a higher level of intervention is implemented. In one embodiment, a hierarchy of intervention levels is defined, with each level implementing a more intensive intervention than the level below it. Also, in one embodiment, each level is defined with a monitoring interval or frequency indicating how often a set of pressure measurements should be made, generally with shorter intervals for higher levels. In one embodiment, the process is defined at this point by the hospital or other governing body to implement the next level of Level 1 intervention. In another embodiment, Level 2 or higher levels of intervention may be implemented. The process now enters a new loop, with the patient being monitored at a frequency of Level N, where N ranges from 1 to n, where n is the highest defined level of intervention and monitoring. In one embodiment, if the average pressure value is above a threshold, Level N intervention is implemented. In one embodiment, Level N intervention is anatomical specific.

[0082] In one embodiment, pressure measurements of body locations identified in an initial set of pressure measurements as having possible damage are obtained at a first time interval. In one embodiment, pressure measurements of all other body locations selected for monitoring are obtained at a second time interval longer than the first time interval. In one embodiment, the values ​​of the first and second time intervals vary depending on the risk category to which the patient is assigned. For example, a high-risk patient may have a first time interval of 4 hours and a second time interval of 1 day, while a low-risk patient may have a first time interval of 1 day and a second time interval of 1 week. In one embodiment, the time intervals may be event-based (e.g., based on staff or shift changes) rather than strictly time-based. Generally, body locations with elevated pressure values ​​are scanned more frequently than other body locations being monitored that have normal pressure values ​​in previous pressure measurement sessions.

[0083] In one embodiment, the intervals at which pressure measurements are taken are determined by pressure values ​​from previous pressure measurement sessions, such that for body locations where pressure values ​​in previous measurement sessions were equal to or greater than a first threshold, pressure measurements are taken at a first time interval, while for body locations where the previous pressure values ​​were equal to or greater than a second threshold that is higher than the first threshold, pressure measurements are taken at a second time interval that is shorter than the first time interval.

[0084] How to assign patients to risk categories In one aspect, the present disclosure provides and encompasses a method for assigning a patient in a healthcare facility to a risk category selected from a plurality of risk categories, the method including obtaining initial pressure measurements of one or more body locations selected for monitoring, determining an average pressure value of the pressure measurements, and assigning the patient to the risk category selected from the plurality of risk categories based in part on the average pressure value of the pressure measurements.

[0085] In one embodiment, a patient's risk level is determined entirely by pressure measurements. In one embodiment, a patient's risk level is determined entirely by visual inspection of the patient. In one embodiment, a patient's risk level is determined entirely by administration of a risk assessment protocol to the patient. In one embodiment, a patient's risk level is determined by pressure measurements and visual inspection of the patient. In one embodiment, a patient's risk level is determined by administration of a risk assessment protocol to the patient and visual inspection of the patient. In one embodiment, a patient's risk level is determined by pressure measurements and administration of a risk assessment protocol to the patient. In one embodiment, a patient's risk level is determined by pressure measurements, administration of a risk assessment protocol to the patient, and visual inspection of the patient. In one embodiment, a protocol exists in which a combination of criteria produces a composite parameter that can be used to select a level of intervention.

[0086] In one embodiment, a patient is assigned to a risk category selected from a plurality of risk categories. In one embodiment, the risk categories include a high risk category and a high risk category. In one embodiment, the risk categories include a low risk category and a high risk category. In one embodiment, the risk categories include a low risk category, a high risk category, and a high risk category. In one embodiment, there are 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 risk categories. In one embodiment, the risk categories are associated with corresponding levels of medical care. In one embodiment, the risk categories are associated with corresponding levels of intervention. In one embodiment, the risk categories are associated with corresponding frequencies of subsequent pressure measurements.

[0087] In one embodiment, a patient is assigned to a risk category based on an average pressure value. In one embodiment, a patient is assigned to a risk category based on an absolute average pressure value. In one embodiment, a patient is assigned to a risk category by comparing the average pressure value to a threshold value. In one embodiment, a patient is assigned to a risk category by comparing the average pressure value to a maximum intensity value. In one embodiment, assignment is based solely on an initial maximum pressure value found during an initial pressure measurement scan.

[0088] Methods for assigning patients to levels of care and intervention In one aspect, the present disclosure provides and encompasses a method for stratifying a plurality of patients in a healthcare facility based on level of care, the method including the steps of obtaining a pressure measurement of one of the plurality of patients at one or more body locations selected for monitoring, determining an average pressure value of the pressure measurements of the patient, determining a healthcare level among N levels that corresponds to the average pressure value, assigning a healthcare level to the patient, and placing the patient among the plurality of patients into a group based on each of the healthcare levels assigned to the patient.

[0089] In one embodiment, a patient is assigned to a level of care based on an average pressure value. In one embodiment, a patient is assigned to a level of care corresponding to an average pressure value out of N levels of care. In one embodiment, there are 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 levels of care. In one embodiment, each of the N levels of care corresponds to a range of average pressure values. In one embodiment, a level of care is associated with a corresponding level of intervention. In one embodiment, a level of care is associated with a corresponding frequency of subsequent pressure measurements. In one embodiment, multiple patients are grouped and arranged according to their assigned level of care. In one embodiment, multiple patients are grouped such that patients within a group are assigned the same level of care. In one embodiment, multiple patients are grouped such that patients within a group are provided with the same intervention.

[0090] In one aspect, the present disclosure provides a method of identifying and providing an appropriate level of medical care to a patient in a medical-care facility, the method comprising obtaining a plurality of pressure measurements of the patient at one or more body locations; determining an average pressure value of the patient's pressure measurements; administering one or more anatomical-specific interventions based on the average pressure value; increasing the level of the anatomical-specific intervention based on an increase in the average pressure value; and decreasing the level of the anatomical-specific intervention based on a decrease in the average pressure value.

[0091] In one embodiment, a patient is assigned to a level of care based on the average pressure value. In one embodiment, a patient is assigned to a level of care among N levels of care that corresponds to the average pressure value. In one embodiment, there are 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 levels of care. In one embodiment, each of the N levels of care corresponds to a range of average pressure values. In one embodiment, a level of care is associated with a corresponding level of intervention. In one embodiment, a level of care is associated with a corresponding frequency of subsequent pressure measurements.

[0092] In one embodiment, the patient's history is evaluated to determine whether the patient's condition is improving. If the patient's condition is improving, for example, as evidenced by a decrease in the mean pressure value, the intervention level is decreased. In one embodiment, the current intervention level is maintained until the mean pressure value falls below a threshold value. In one embodiment, if the mean pressure value is trending downward, the level of intervention may be decreased based on the magnitude of the mean pressure value. If the patient's condition is worsening, for example, as evidenced by an increase in the mean pressure value, the intervention level is increased. In one embodiment, the current intervention level is maintained until the mean pressure value exceeds a threshold value. In one embodiment, if the mean pressure value is trending upward, the level of intervention may be increased based on the magnitude of the mean pressure value.

[0093] In one aspect, if the patient does not show improvement, the process branches to an escalating level of intervention, assuming the skin has not broken down, i.e., an open wound has not developed. If an open wound has developed, pressure measurements will be taken around the open wound to map inflammation or other precursors to wound expansion. The open wound itself will be treated, and the perimeter will be monitored until the wound closes.

[0094] In one aspect, the anatomy-specific intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, a 30-degree wedge, a composite dressing, a hybrid mattress, a dynamic mattress, a support surface, a silicone pad, a low-friction seat cover, and a low-friction padded mattress surface.

[0095] In one aspect, the decision to perform an intervention for a particular body part or a general intervention such as a smart mattress is based on the pressure value found at that part in the pressure measurement scan. If the pressure value is below a predetermined threshold, no intervention is required. If the pressure value is above a predetermined threshold, an intervention is selected and performed based in part on the body part and the average pressure value for that body part. The predetermined threshold for selecting and performing an intervention may be higher or lower than the threshold for determining that an injury may exist at that body part.

[0096] How to manage medical care In one aspect, the disclosure provides a method of managing the medical care of a patient, the method including, upon admission to a medical-care facility, obtaining a first set of pressure measurements at one or more body locations selected for monitoring; determining a first average pressure value for each of the first set of pressure measurements; if one of the average pressure values ​​of the first set of pressure measurements exceeds a first threshold, setting an intervention level N=1; implementing an intervention of level N for each of the one or more body locations whose average pressure value exceeds the first threshold; obtaining subsequent sets of pressure measurements at each of the one or more body locations at a frequency of level N; and determining a new average pressure value for each of the one or more body locations.

[0097] In one embodiment, the first threshold is approximately 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, The color may be 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, or 7.5. In one embodiment, the first threshold value may be in the range of 0.1 to 8.0 (e.g., 0.1 to 1.0, 1.1 to 2.0, 2.1 to 3.0, 3.1 to 4.0, 4.1 to 5.0, 5.1 to 6.0, 6.1 to 7.0, 7.1 to 8.0, 0.1 to 7.5, 0.5 to 8.0, 1.0 to 7.0, 1.5 to 6.5, 2.0 to 6.0, 3.0 to 5.5, 3.5 to 5.0, or 4.0 to 4.5). In one embodiment, the first threshold value may be scaled by a factor or multiple based on the values ​​provided herein. It is understood that the threshold value is not constrained by design, but rather, one of skill in the art can select a predetermined value based on the given units of the pressure value. In one aspect, the threshold values ​​of the present disclosure are modified according to the particular part of the patient's body where the measurement is being taken, or according to one or more characteristics of the patient, such as age, height, weight, family history, ethnicity, and other physical characteristics or medical conditions.

[0098] In one embodiment, N ranges from 1 to 50 (e.g., 1 to 2, 1 to 3, 1 to 4, 1 to 5, 1 to 6, 1 to 7, 1 to 8, 1 to 9, 1 to 10, 1 to 15, 1 to 20, 1 to 25, 1 to 30, 1 to 35, 1 to 40, or 1 to 45). In one embodiment, N is determined by the amount the first average pressure value exceeds a first threshold. In one embodiment, Level N intervention corresponds to a range of average pressure values. In one embodiment, Level N intervention is associated with a corresponding anatomical structure-specific intervention. In one embodiment, Level N intervention is associated with a corresponding frequency of subsequent pressure measurements. In one embodiment, Level N intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shockwave therapy, 30-degree wedges, composite dressings, hybrid mattresses, and dynamic mattresses, support surfaces, silicone pads, low-friction seat covers, and low-friction padded mattress surfaces.

[0099] In one embodiment, the patient's medical care is discharge or transfer from a medical care facility. In one embodiment, the patient's condition upon discharge or transfer is documented. In one embodiment, a final set of pressure measurements at one or more locations on the patient's body is obtained prior to discharge or transfer. In one embodiment, a final set of pressure measurements at one or more locations on the patient's body is generated. In one embodiment, these locations are one or more body locations selected for monitoring. In one embodiment, these locations include areas that have not received intervention and areas not previously identified as risk. In one embodiment, this information is provided to the receiving medical caregiver.

[0100] Methods for identifying and treating patients at risk for tissue injury In one aspect, the present disclosure provides and encompasses a method for identifying and treating a patient at risk for tissue damage. In one aspect, the method includes the steps of assessing a patient for risk of tissue damage upon admission to a healthcare facility, the step including obtaining a first plurality of pressure measurements of the patient and determining a first average pressure value of the first plurality of pressure measurements, and implementing a first intervention at Level 0 if the first average pressure value is less than or equal to a first threshold, and implementing a first intervention at Level N (N is an integer greater than or equal to 1) if the first average pressure value is greater than the first threshold. In one aspect, the first average pressure value is determined from a subset of the first plurality of pressure measurements.

[0101] 7A-7D illustrate, as circles, locations of risk of tissue injury on a patient at various locations. In one embodiment, the first plurality of pressure measurements are taken at or around one or more body locations selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on a patient's bony prominences. In one embodiment, the first plurality of pressure measurements are taken at and around one or more anatomical locations that are in chronic contact with the medical device, the anatomical locations being selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen. In one embodiment, the first plurality of pressure measurements are separated into subgroups for analysis based on the approximate locations at which the measurements are taken. In one embodiment, an average pressure value is determined from a subset of the first plurality of pressure measurements. In one embodiment, the first plurality of pressure measurements are taken at locations on one or more concentric circles centered on the anatomical location. In one embodiment, the first plurality of pressure measurements are taken at locations on a line approximately equidistant from the anatomical location.

[0102] In one embodiment, the first pressure differential is determined by the difference between the maximum and minimum pressure values ​​from the collected first plurality of pressure measurements. In one embodiment, the first pressure differential is determined by the difference between the maximum average pressure value of measurements taken at one location and the minimum average pressure value of measurements taken at a second location. In one embodiment, the first pressure differential is determined by the difference between the maximum average pressure value of measurements taken at one location and the absolute minimum pressure value of measurements taken at a second location. In one embodiment, the first pressure differential is determined by the difference between the absolute maximum pressure value of measurements taken at one location and the minimum average pressure value of measurements taken at a second location. In one embodiment, the first pressure differential is determined by the difference between the maximum average pressure value of measurements taken at the same location but at different times. In one embodiment, the first pressure value is determined for a subset of the first plurality of pressure measurements, each subset being defined by the location from which the measurements were taken. In one embodiment, the average pressure value at a location is determined from two, three, four, five, six, seven, eight, nine, ten, or more pressure values ​​measured at that location. In one embodiment, the first pressure differential is determined by the difference in average pressure values ​​from measurements taken at two symmetrical locations about the centerline. In one embodiment, the first pressure differential is the difference in absolute pressure values ​​from measurements taken at two symmetrical locations about the centerline. In one embodiment, the first pressure differential is the difference in pressure values ​​measured at a location on the left side of the body (e.g., the left heel) and the same location on the right side of the body (e.g., the right heel).

[0103] In one aspect, a pressure value may be calculated from multiple pressure measurements made at a specific location or in close proximity to a specific location in the methods disclosed herein. In one aspect, multiple pressure measurements are made in a predetermined pattern on the skin, and a pressure value is calculated by subtracting a pressure value associated with a specific location in the pattern from a maximum pressure value made at other locations in the pattern. In one aspect, multiple pressure measurements are made in a predetermined pattern on the skin, and a pressure value is calculated by identifying a pressure value associated with a specific location in the pattern and subtracting the maximum pressure value made at other locations in the pattern. In one aspect, an average pressure value may be calculated from a portion of a set of pressure values ​​generated by multiple pressure measurements at a single location, and an average pressure value calculated as the maximum difference between the average value of the same set and a single pressure value. In one aspect, an average pressure value may be calculated as the ratio of the maximum pressure value to the minimum pressure value in the set of pressure values.

[0104] In one embodiment, the first threshold is approximately 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, The color may be 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, or 7.5. In one embodiment, the first threshold value may be in the range of 0.1 to 8.0 (e.g., 0.1 to 1.0, 1.1 to 2.0, 2.1 to 3.0, 3.1 to 4.0, 4.1 to 5.0, 5.1 to 6.0, 6.1 to 7.0, 7.1 to 8.0, 0.1 to 7.5, 0.5 to 8.0, 1.0 to 7.0, 1.5 to 6.5, 2.0 to 6.0, 3.0 to 5.5, 3.5 to 5.0, or 4.0 to 4.5). In one embodiment, the first threshold value may be scaled by a factor or multiple based on the values ​​provided herein. It is understood that the threshold value is not constrained by design, but rather, one of skill in the art can select a predetermined value based on the given units of the pressure value. In one aspect, the threshold values ​​of the present disclosure are modified according to the particular part of the patient's body where the measurement is being taken, or according to one or more characteristics of the patient, such as age, height, weight, family history, ethnicity, and other physical characteristics or medical conditions.

[0105] In one embodiment, N ranges from 1 to 50 (such as 1 to 2, 1 to 3, 1 to 4, 1 to 5, 1 to 6, 1 to 7, 1 to 8, 1 to 9, 1 to 10, 1 to 15, 1 to 20, 1 to 25, 1 to 30, 1 to 35, 1 to 40, or 1 to 45).

[0106] In one embodiment, N is determined by the amount by which the first average pressure value exceeds a first threshold. In one embodiment, the amount by which the threshold established for (N+1) exceeds the first threshold is greater than the amount by which the threshold established for N exceeds the first threshold. In one embodiment, the amount by which the threshold established for (N-1) exceeds the first threshold is less than the amount by which the threshold established for N exceeds the first threshold. In one embodiment, the threshold established for (N+1) is greater than the threshold established for N. In one embodiment, the threshold established for N is greater than the threshold established for (N-1).

[0107] Choosing the level of intervention In one embodiment, Level 1 (N=1) intervention is applied to patients with mean pressure values ​​above the threshold that are 100% or less of the threshold (such as 95% or less, 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less of the threshold). In one embodiment, Level 1 intervention is applied where measurements were taken.

[0108] In one embodiment, Level 2 (N=2) intervention is applied to patients with mean pressure values ​​above the threshold that are 150% or less of the threshold (such as 145% or less, 140% or less, 135% or less, 130% or less, 125% or less, 120% or less, 115% or less, 110% or less, 100% or less, 95% or less, 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less of the threshold). In one embodiment, Level 2 intervention is applied where measurements were taken.

[0109] In one aspect, Level 3 (N=3) intervention is applied to patients with mean pressure values ​​above the threshold that are 200% or less of the threshold (such as 195% or less, 190% or less, 185% or less, 180% or less, 175% or less, 170% or less, 165% or less, 160% or less, 155% or less, 150% or less, 145% or less, 140% or less, 135% or less, 130% or less, 125% or less, 120% or less, 115% or less, 110% or less, 100% or less, 95% or less, 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less of the threshold). In one embodiment, a level 3 intervention is applied where the measurement was taken.

[0110] In one embodiment, the average pressure value exceeding the threshold is 250% or less of the threshold (245% or less, 240% or less, 235% or less, 230% or less, 225% or less, 220% or less, 215% or less, 210% or less, 205% or less, 200% or less, 195% or less, 190% or less, 185% or less, 180% or less, 175% or less, 170% or less, 165% or less, 160% or less, 155% or less, 150% or less, 145% or less, 140% or less, 130% or less of the threshold). Level 4 (N=4) intervention is applied to patients with a mean saturation of 5% or less, 130% or less, 125% or less, 120% or less, 115% or less, 110% or less, 100% or less, 95% or less, 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less, etc. In one embodiment, Level 4 intervention is applied where measurements were taken.

[0111] In one embodiment, the average pressure value above the threshold is 300% or less of the threshold (295% or less, 290% or less, 285% or less, 280% or less, 275% or less, 270% or less, 265% or less, 260% or less, 255% or less, 250% or less, 245% or less, 240% or less, 235% or less, 230% or less, 225% or less, 220% or less, 215% or less, 210% or less, 205% or less, 200% or less, 195% or less, 190% or less, 185% or less, 180% or less, 175% or less, 170% or less, 165 ... Level 5 (N=5) intervention is applied to patients with a mean (e.g., 0% or less, 155% or less, 150% or less, 145% or less, 140% or less, 135% or less, 130% or less, 125% or less, 120% or less, 115% or less, 110% or less, 100% or less, 95% or less, 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less). In one embodiment, Level 5 intervention is applied where measurements were taken.

[0112] In one embodiment, the average pressure value exceeding the threshold is 350% or less of the threshold (345% or less, 340% or less, 335% or less, 330% or less, 325% or less, 320% or less, 315% or less, 310% or less, 305% or less, 300% or less, 295% or less, 290% or less, 285% or less, 280% or less, 275% or less, 270% or less, 265% or less, 260% or less, 255% or less, 250% or less, 245% or less, 240% or less, 235% or less, 230% or less, 225% or less, 220% or less, 215% or less, 210% or less, 205% or less, 200% or less, 195% or less, 190% or less, 180% or less, 195% or less, 190% or less, 180% or less, 185 ... Level 6 (N=6) intervention is applied to patients with a mean (e.g., 5% or less, 180% or less, 175% or less, 170% or less, 165% or less, 160% or less, 155% or less, 150% or less, 145% or less, 140% or less, 135% or less, 130% or less, 125% or less, 120% or less, 115% or less, 110% or less, 100% or less, 95% or less, 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less). In one embodiment, Level 6 intervention is applied to patients where measurements were taken.

[0113] In one embodiment, the average pressure value exceeding the threshold is 400% or less of the threshold (395% or less, 390% or less, 385% or less, 380% or less, 375% or less, 370% or less, 365% or less, 360% or less, 355% or less, 350% or less, 345% or less, 340% or less, 335% or less, 330% or less, 325% or less, 320% or less, 315% or less, 310% or less, 305% or less, 300% or less, 295% or less, 290% or less, 285% or less, 280% or less, 275% or less, 270% or less, 265% or less, 260% or less, 255% or less, 250% or less, 245% or less, 240% or less, 235% or less, 230% or less, 225% or less, 220% or less, 215% or less, 21 ... Level 7 (N=7) interventions were applied to patients with a mean CI of 0% or less, 205% or less, 200% or less, 195% or less, 190% or less, 185% or less, 180% or less, 175% or less, 170% or less, 165% or less, 160% or less, 155% or less, 150% or less, 145% or less, 140% or less, 135% or less, 130% or less, 125% or less, 120% or less, 115% or less, 110% or less, 100% or less, 95% or less, 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less. In one embodiment, a level 7 intervention is applied where the measurement was taken.

[0114] In one embodiment, the average pressure value above the threshold is 450% or less of the threshold (445% or less, 440% or less, 435% or less, 430% or less, 425% or less, 420% or less, 415% or less, 410% or less, 405% or less, 400% or less, 395% or less, 390% or less, 385% or less, 380% or less, 375% or less, 370% or less, 365% or less, 360% or less, 355% or less of the threshold). Lower, 350% or less, 345% or less, 340% or less, 335% or less, 330% or less, 325% or less, 320% or less, 315% or less, 310% or less, 305% or less, 300% or less, 295 % or less, 290% or less, 285% or less, 280% or less, 275% or less, 270% or less, 265% or less, 260% or less, 255% or less, 250% or less, 245% or less, 240% or less, 23 5% or less, 230% or less, 225% or less, 220% or less, 215% or less, 210% or less, 205% or less, 200% or less, 195% or less, 190% or less, 185% or less, 180% or less, 175% or less, 170% or less, 165% or less, 160% or less, 155% or less, 150% or less, 145% or less, 140% or less, 135% or less, 130% or less, 125% or less, 120% or less Level 8 (N=8) intervention is applied to patients with a mean (e.g., below 115%, below 110%, below 100%, below 95%, below 90%, below 85%, below 80%, below 75%, below 70%, below 65%, below 60%, below 55%, below 50%, below 45%, below 40%, below 35%, below 30%, below 25%, below 20%, below 15%, below 10%, or below 5%. In one embodiment, Level 8 intervention is applied where measurements were taken.

[0115] In one embodiment, the average pressure value exceeding the threshold is 500% or less of the threshold (495% or less, 490% or less, 485% or less, 480% or less, 475% or less, 470% or less, 465% or less, 460% or less, 455% or less, 450% or less, 445% or less, 440% or less, 435% or less, 430% or less, 425% or less, 420% or less, 415% or less, 410% or less, 405% or less, 400% or less, 395% or less, 395% or less, 4 ... 0% or less, 385% or less, 380% or less, 375% or less, 370% or less, 365% or less, 360% or less, 355% or less, 350% or less, 345% or less, 340% or less, 335% or less, 330% or less, 32 5% or less, 320% or less, 315% or less, 310% or less, 305% or less, 300% or less, 295% or less, 290% or less, 285% or less, 280% or less, 275% or less, 270% or less, 265% or less, 26 0% or less, 255% or less, 250% or less, 245% or less, 240% or less, 235% or less, 230% or less, 225% or less, 220% or less, 215% or less, 210% or less, 205% or less, 200% or less, 19 5% or less, 190% or less, 185% or less, 180% or less, 175% or less, 170% or less, 165% or less, 160% or less, 155% or less, 150% or less, 145% or less, 140% or less, 135% or less, 13 Level 9 (N=9) intervention is applied to patients with a mean (e.g., 0% or less, 125% or less, 120% or less, 115% or less, 110% or less, 100% or less, 95% or less, 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less). In one embodiment, Level 9 intervention is applied where measurements were taken.

[0116] In one embodiment, the average pressure value exceeding the threshold is 550% or less of the threshold (545% or less, 540% or less, 535% or less, 530% or less, 525% or less, 520% ​​or less, 515% or less, 510% or less, 505% or less, 500% or less, 495% or less, 490% or less, 485% or less, 480% or less, 475% or less, 470% or less, 465% or less, 460% or less, 455% or less, 450% or less, 445% or less, 440% or less, 435% or less, 430% or less of the threshold). , 425% or less, 420% or less, 415% or less, 410% or less, 405% or less, 400% or less, 395% or less, 390% or less, 385% or less, 380% or less, 375% or less, 370% or less, 365% or less, 360% or less, 3 55% or less, 350% or less, 345% or less, 340% or less, 335% or less, 330% or less, 325% or less, 320% or less, 315% or less, 310% or less, 305% or less, 300% or less, 295% or less, 290% or less, 285 % or less, 280% or less, 275% or less, 270% or less, 265% or less, 260% or less, 255% or less, 250% or less, 245% or less, 240% or less, 235% or less, 230% or less, 225% or less, 220% or less, 215% or less Lower, 210% or less, 205% or less, 200% or less, 195% or less, 190% or less, 185% or less, 180% or less, 175% or less, 170% or less, 165% or less, 160% or less, 155% or less, 150% or less, 145% or less, Level 10 (N=10) intervention is administered to patients with a mean HR of 140% or less, 135% or less, 130% or less, 125% or less, 120% or less, 115% or less, 110% or less, 100% or less, 95% or less, 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less, etc. In one embodiment, Level 10 intervention is administered where measurements were taken.

[0117] In one embodiment, level N intervention is stronger than level 0 intervention. In one embodiment, level (N+1) intervention is stronger than level N intervention. In one embodiment, level (N-1) intervention is weaker than level N intervention.

[0118] Methods for identifying and treating patients at risk for tissue damage (subsequent imaging) In one aspect, the present disclosure further provides and encompasses the steps of obtaining a second plurality of pressure measurements of the patient at a first predetermined frequency corresponding to the level of intervention implemented; determining a second average pressure value from the second plurality of pressure measurements; determining whether the second average pressure value exceeds a second threshold; continuing to implement the first intervention if the second average pressure value does not exceed the second threshold; continuing to obtain multiple pressure measurements at the first predetermined frequency if the second average pressure value does not exceed the second threshold; implementing a second intervention at level M (M is an integer greater than N) if the second average pressure value exceeds the second threshold; and obtaining multiple pressure measurements at the second predetermined frequency corresponding to level M if the second average pressure value exceeds the second threshold.

[0119] In one embodiment, the predetermined frequency is selected from the group consisting of at least once every 72 hours, at least once every 48 hours, at least once every 24 hours, at least once every 12 hours, at least once every 8 hours, at least once every 6 hours, at least once every 4 hours, at least once every 3 hours, at least once every 2 hours, at least once every hour, and at least once every half hour.

[0120] In one embodiment, the second plurality of pressure measurements are taken at or around one or more body locations selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient. In one embodiment, the second plurality of pressure measurements are taken at and around one or more anatomical locations in chronic contact with the medical device, the anatomical locations being selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen. In one embodiment, the second plurality of pressure measurements are separated into subgroups for analysis based on the approximate locations at which the measurements are taken. In one embodiment, a second average pressure value is determined from a subset of the second plurality of pressure measurements. In one embodiment, the second plurality of pressure measurements are taken at locations on one or more concentric circles centered on the anatomical location. In one embodiment, the second plurality of pressure measurements are taken at locations on a line approximately equidistant from the anatomical location.

[0121] In one embodiment, the second pressure differential is determined by the difference between the maximum and minimum pressure values ​​from the collected second plurality of pressure measurements. In one embodiment, the second pressure differential is determined by the difference between the maximum average pressure value of measurements taken at a location and the minimum pressure value of measurements taken at a second location. In one embodiment, the second pressure differential is determined by the difference between the maximum average pressure value of measurements taken at the same location and the minimum pressure value of measurements taken at the same location. In one embodiment, the second average pressure value is determined for a subset of the second plurality of pressure measurements, the subset being defined by the locations at which the measurements were taken. In one embodiment, the second average pressure value at a location is determined from two, three, four, five, six, seven, eight, nine, ten, or more pressure values ​​measured at the location. In one embodiment, the second pressure differential is determined by the difference between the average pressure values ​​from measurements taken at two symmetrical locations about the centerline. In one embodiment, the second plurality of pressure measurements are made at the same locations where the first plurality of pressure measurements were taken. In one embodiment, the second plurality of pressure measurements are made at some of the same locations where the first plurality of pressure measurements were taken. In one embodiment, the second plurality of pressure measurements are made near the locations where the first plurality of pressure measurements were taken. In one embodiment, the second plurality of pressure measurements are made at a different location than where the first plurality of pressure measurements were taken.

[0122] In one embodiment, the second threshold is equal to the first threshold. In one embodiment, the second threshold is approximately 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, The color may be 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, or 7.5. In one embodiment, the second threshold may be in the range of 0.1 to 8.0 (e.g., 0.1 to 1.0, 1.1 to 2.0, 2.1 to 3.0, 3.1 to 4.0, 4.1 to 5.0, 5.1 to 6.0, 6.1 to 7.0, 7.1 to 8.0, 0.1 to 7.5, 0.5 to 8.0, 1.0 to 7.0, 1.5 to 6.5, 2.0 to 6.0, 3.0 to 5.5, 3.5 to 5.0, or 4.0 to 4.5). In one embodiment, the second threshold may be scaled by a factor or multiple based on the values ​​given herein. In one embodiment, the second threshold is the same as the first threshold. In one embodiment, the second threshold may be greater than the first threshold. In one embodiment, the second threshold may be less than the first threshold.

[0123] In one embodiment, the second average pressure value is 0.1 to 99.5% of the second threshold value (0.1 to 1%, 0.1 to 5%, 1 to 5%, 5 to 15%, 10 to 20%, 15 to 25%, 20 to 30%, 25 to 35%, 30 to 40%, 35 to 45%, 40 to 50%, 0.1 to 25%, 15 to 35%, 25 Possible values ​​include: up to 50%, 25-75%, 45-55%, 50-60%, 55-65%, 60-70%, 65-75%, 40-55%, 50-75%, 50-99.5%, 70-80%, 75%-85%, 80-90%, 85-95%, 90-99.5%, 65-85%, or 75-99.5%.

[0124] In one embodiment, M ranges from 2 to 50 (such as 2 to 3, 2 to 4, 2 to 5, 2 to 6, 2 to 7, 2 to 8, 2 to 9, 2 to 10, 2 to 15, 2 to 20, 2 to 25, 2 to 30, 2 to 35, 2 to 40, or 2 to 45).

[0125] In one embodiment, M is determined by the amount by which the second pressure value exceeds the second threshold. In one embodiment, the amount by which the threshold established for (M+1) exceeds the second threshold is greater than the amount by which the threshold established for M exceeds the second threshold. In one embodiment, the amount by which the threshold established for (M-1) exceeds the second threshold is less than the amount by which the threshold established for M exceeds the second threshold. In one embodiment, the threshold established for (M+1) is greater than the threshold established for M. In one embodiment, the threshold established for M is greater than the threshold established for (M-1).

[0126] In one embodiment, level M of intervention is selected according to the above "Selecting Level of Intervention" section of this disclosure, substituting M for N.

[0127] In one aspect, the present disclosure further provides and encompasses the steps of determining whether the second average pressure value is less than or equal to a third threshold; continuing to implement the first intervention if the second average pressure value is less than the third threshold; continuing to obtain multiple pressure measurements at a first predetermined frequency if the second average pressure value is greater than or equal to the third threshold; implementing a third intervention at level L (L is an integer less than N) if the second average pressure value is less than the third threshold and the first intervention is not level 0; and obtaining multiple pressure measurements at a predetermined frequency corresponding to level L if the second average pressure value is less than the third threshold.

[0128] In one embodiment, L ranges from 0 to 50 (such as 0 to 3, 0 to 4, 0 to 5, 0 to 6, 0 to 7, 0 to 8, 0 to 9, 0 to 10, 0 to 15, 0 to 20, 0 to 25, 0 to 30, 0 to 35, 0 to 40, or 0 to 45).

[0129] In one embodiment, L is determined by the amount by which the second average pressure value falls below a third threshold. In one embodiment, the amount by which the threshold established for (L-1) falls below the third threshold is greater than the amount by which the threshold established for L falls below the third threshold. In one embodiment, the amount by which the threshold established for (L+1) falls below the third threshold is less than the amount by which the threshold established for L falls below the third threshold. In one embodiment, the threshold established for (L+1) is greater than the threshold established for L. In one embodiment, the threshold established for L is greater than the threshold established for (L-1).

[0130] In one embodiment, the third threshold is approximately 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, The color may be 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, or 7.5. In one embodiment, the third threshold may be in the range of 0.1 to 8.0 (e.g., 0.1 to 1.0, 1.1 to 2.0, 2.1 to 3.0, 3.1 to 4.0, 4.1 to 5.0, 5.1 to 6.0, 6.1 to 7.0, 7.1 to 8.0, 0.1 to 7.5, 0.5 to 8.0, 1.0 to 7.0, 1.5 to 6.5, 2.0 to 6.0, 3.0 to 5.5, 3.5 to 5.0, or 4.0 to 4.5). In one embodiment, the third threshold may be scaled by a factor or multiple based on the values ​​given herein. In one embodiment, the third threshold is equal to the first threshold. In one embodiment, the third threshold may be greater than the first threshold. In one embodiment, the third threshold may be less than the first threshold. In one embodiment, the third threshold is equal to the second threshold. In one embodiment, the third threshold value can be greater than the second threshold value. In one embodiment, the third threshold value can be less than the second threshold value.

[0131] In one aspect, the second average pressure value is 0.1 to 99.5% of the third threshold value (0.1 to 1%, 0.1 to 5%, 1 to 5%, 5 to 15%, 10 to 20%, 15 to 25%, 20 to 30%, 25 to 35%, 30 to 40%, 35 to 45%, 40 to 50%, 0.1 to 25%, 15 to 35%, 25 Possible values ​​include: up to 50%, 25-75%, 45-55%, 50-60%, 55-65%, 60-70%, 65-75%, 40-55%, 50-75%, 50-99.5%, 70-80%, 75%-85%, 80-90%, 85-95%, 90-99.5%, 65-85%, or 75-99.5%.

[0132] In one embodiment, level L of intervention is selected according to the above "Selection of Intervention Level" of this disclosure, substituting L for N.

[0133] In one embodiment, Level N interventions are selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, 30-degree wedges, composite dressings, hybrid mattresses, dynamic mattresses, support surfaces, silicone pads, low-friction seat covers, and low-friction padded mattress surfaces. In one embodiment, Level M interventions are selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, 30-degree wedges, composite dressings, hybrid mattresses, dynamic mattresses, support surfaces, silicone pads, low-friction seat covers, and low-friction padded mattress surfaces. In one embodiment, Level L interventions are selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, 30-degree wedges, composite dressings, hybrid mattresses, dynamic mattresses, support surfaces, silicone pads, low-friction seat covers, and low-friction padded mattress surfaces.

[0134] Methods for slowing the progression of skin and tissue damage In one aspect, the present disclosure provides and encompasses a method for slowing the progression of skin and tissue damage in a patient in need thereof, the method comprising: identifying a current level K intervention for the patient; obtaining a plurality of pressure measurements from the patient; calculating an average pressure value from a portion of the plurality of pressure measurements; determining whether the average pressure value exceeds a first threshold; if the average pressure value does not exceed the first threshold, continuing to implement the current intervention; if the average pressure value does not exceed the first threshold, continuing to obtain a plurality of pressure measurements at a predetermined frequency corresponding to level K; if the average pressure value exceeds the first threshold, implementing a new level N intervention (N greater than K); and if the average pressure value exceeds the first threshold, obtaining a plurality of pressure measurements at a predetermined frequency corresponding to level N.

[0135] In one embodiment, the patient in need is a patient experiencing a change in medical care, a change in mobility, a change in nutrition, a change in sensation, or a combination thereof. In one embodiment, the patient in need is a patient who has developed an open wound. In one embodiment, the patient in need is a patient who has healed from an open wound. In one embodiment, the patient in need is a patient who will undergo surgery. In one embodiment, the patient in need is a patient who has recovered from surgery. In one embodiment, the patient in need is a patient who will receive spinal or sacral analgesia during surgery. In one embodiment, the patient in need is a patient who will undergo surgery for a duration of 4 hours or more (such as 5 hours or more, 6 hours or more, 7 hours or more, 8 hours or more, 9 hours or more, 10 hours or more, 11 hours or more, or 12 hours or more). In one embodiment, the duration of the surgery is 1 hour or more (such as 2 hours or more or 3 hours or more).

[0136] In one embodiment, the multiple pressure measurements are taken at or around one or more body locations selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient. In one embodiment, the multiple pressure measurements are taken at and around one or more anatomical locations that are in chronic contact with the medical device, the anatomical locations being selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen. In one embodiment, the multiple pressure measurements are separated into subgroups for analysis based on the approximate location at which the measurements are taken. In one embodiment, an average pressure value is determined from a subset of the multiple pressure measurements. In one embodiment, the multiple pressure measurements are taken at locations on one or more concentric circles centered on the anatomical location. In one embodiment, the multiple pressure measurements are taken at locations on a line approximately equidistant from the anatomical location.

[0137] In one aspect, the average pressure value may be calculated from multiple pressure measurements made at a specific location or in close proximity to a specific location in the methods disclosed herein. In one aspect, multiple pressure measurements are made in a predetermined pattern on the skin, and the average pressure value is calculated by subtracting a pressure value associated with a specific location in the pattern from a maximum pressure value made at other locations in the pattern. In one aspect, multiple pressure measurements are made in a predetermined pattern on the skin, and the average pressure value is calculated by identifying a pressure value associated with a specific location in the pattern and subtracting the maximum pressure value made at other locations in the pattern. In one aspect, the average pressure value may be calculated from a portion of a set of pressure values ​​generated by multiple pressure measurements at a single location, and the average pressure value calculated as the maximum difference between the average value of the same set and a single pressure value. In one aspect, the average pressure value may be calculated as the ratio of the maximum pressure value to the minimum pressure value in the set of pressure values.

[0138] In one embodiment, the first threshold is approximately 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, The color may be 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, or 7.5. In one embodiment, the first threshold may be in the range of 0.1 to 8.0 (e.g., 0.1 to 1.0, 1.1 to 2.0, 2.1 to 3.0, 3.1 to 4.0, 4.1 to 5.0, 5.1 to 6.0, 6.1 to 7.0, 7.1 to 8.0, 0.1 to 7.5, 0.5 to 8.0, 1.0 to 7.0, 1.5 to 6.5, 2.0 to 6.0, 3.0 to 5.5, 3.5 to 5.0, or 4.0 to 4.5). In one embodiment, the first threshold may be scaled by a factor or multiple based on the values ​​given herein.

[0139] In one embodiment, K ranges from 2 to 50 (such as 2 to 3, 2 to 4, 2 to 5, 2 to 6, 2 to 7, 2 to 8, 2 to 9, 2 to 10, 2 to 15, 2 to 20, 2 to 25, 2 to 30, 2 to 35, 2 to 40, or 2 to 45).

[0140] In one embodiment, K is determined by the amount by which the average pressure value exceeds a threshold value. In one embodiment, the amount by which the average pressure value exceeds a threshold value established for (K+1) is greater than the amount by which the average pressure value exceeds a threshold value established for K. In one embodiment, the amount by which the average pressure value exceeds a threshold value established for (K-1) is less than the amount by which the average pressure value exceeds a threshold value established for K.

[0141] In one embodiment, level K intervention is selected according to the above "Selection of Intervention Level" of this disclosure, substituting K for N.

[0142] In one aspect, the present disclosure further provides and encompasses the steps of determining whether the average pressure value is less than a second threshold, and if the average pressure value is less than the second threshold, implementing an intervention of level L (L is a non-negative value less than K), and if the average pressure value is less than the second threshold, producing pressure measurements at a predetermined frequency corresponding to level L.

[0143] In one embodiment, the second threshold is equal to the first threshold. In one embodiment, the second threshold is approximately 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, The color may be 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, or 7.5. In one embodiment, the second threshold may be in the range of 0.1 to 8.0 (e.g., 0.1 to 1.0, 1.1 to 2.0, 2.1 to 3.0, 3.1 to 4.0, 4.1 to 5.0, 5.1 to 6.0, 6.1 to 7.0, 7.1 to 8.0, 0.1 to 7.5, 0.5 to 8.0, 1.0 to 7.0, 1.5 to 6.5, 2.0 to 6.0, 3.0 to 5.5, 3.5 to 5.0, or 4.0 to 4.5). In one embodiment, the second threshold may be scaled by a factor or multiple based on the values ​​given herein. In one embodiment, the second threshold is equal to the first threshold. In one embodiment, the second threshold may be greater than the first threshold. In one embodiment, the second threshold may be less than the first threshold.

[0144] In one embodiment, L can be K-1, K-2, K-3, K-4, K-5, K-6, K-7, K-8, K-9, or K-10. In one embodiment, L is K-1 when the average pressure value is 90-99.5% of the second threshold (e.g., 90-95%, 91-96%, 92-97%, 93-98%, 94-99%, or 95-99.5% of the second threshold), except when K-1 is less than 0 (in which case L is 0). In one embodiment, when the average pressure value is 80 to 89.9% of the second threshold (e.g., 80 to 85%, 81 to 86%, 82 to 87%, 83 to 88%, 84 to 89%, or 85 to 89.9% of the second threshold), L is K-2, except when K-2 is less than 0 (in which case L is 0). In one embodiment, when the average pressure value is 70 to 79.9% of the second threshold (e.g., 70 to 75%, 71 to 76%, 72 to 77%, 73 to 78%, 74 to 79%, or 75 to 79.9% of the second threshold), L is K-3, except when K-3 is less than 0 (in which case L is 0). In one embodiment, when the average pressure value is 60-69.9% of the second threshold (e.g., 60-65%, 61-66%, 62-67%, 63-68%, 64-69%, or 65-69.9% of the second threshold), L is K-4, except when K-4 is less than 0 (in which case L is 0). In one embodiment, when the average pressure value is 50-59.9% of the second threshold (e.g., 50-55%, 51-56%, 52-57%, 53-58%, 54-59%, or 55-59.9% of the second threshold), L is K-5, except when K-5 is less than 0 (in which case L is 0). In one embodiment, when the average pressure value is 40-49.9% of the second threshold (e.g., 40-45%, 41-46%, 42-47%, 43-48%, 44-49%, or 45-49.9% of the second threshold), L is K-6, except when K-6 is less than 0 (in which case L is 0). In one embodiment, when the average pressure value is 30-39.9% of the second threshold (e.g., 30-35%, 31-36%, 32-37%, 33-38%, 34-39%, or 35-39.9% of the second threshold), L is K-7, except when K-7 is less than 0 (in which case L is 0).In one embodiment, when the average pressure value is 20-29.9% of the second threshold (e.g., 20-25%, 21-26%, 22-27%, 23-28%, 24-29%, or 25-29.9% of the second threshold), L is K-8, except when K-8 is less than 0 (in which case L is 0). In one embodiment, when the average pressure value is 10-19.9% ​​of the second threshold (e.g., 10-15%, 11-16%, 12-17%, 13-18%, 14-19%, or 15-19.9% ​​of the second threshold), L is K-9, except when K-9 is less than 0 (in which case L is 0). In one embodiment, if the average pressure value is between 0.1 and 9.9% of the second threshold (e.g., between 0.1 and 5%, between 1 and 6%, between 2 and 7%, between 3 and 8%, between 4 and 9%, or between 5 and 9.9% of the second threshold), then L is K-10, except when K-10 is less than 0 (in which case L is 0).

[0145] How to identify and treat patients who require pressure ulcer intervention In one aspect, the present disclosure provides a method for identifying and treating a patient requiring pressure ulcer intervention, the method comprising obtaining a plurality of pressure measurements at an anatomical site of the patient; determining an average pressure value of the plurality of pressure measurements; determining whether the average pressure value exceeds a threshold value corresponding to level N (N is 2 or greater); if the average pressure value exceeds the threshold value, administering a pressure ulcer intervention at the anatomical site; and if the average pressure value exceeds the threshold value, obtaining a plurality of pressure measurements every two hours.

[0146] In one embodiment, the anatomical site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient.

[0147] In one aspect, the pressure ulcer intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, a 30-degree wedge, a composite dressing, a hybrid mattress, a dynamic mattress, a support surface, a silicone pad, a low-friction sheet cover, and a low-friction padded mattress surface.

[0148] In one aspect, the present disclosure provides and encompasses a method for identifying and treating a patient in need of application of a barrier cream to the patient's heel, the method comprising the steps of: making a plurality of pressure measurements at the patient's heel; calculating an average pressure value from a portion of the plurality of pressure measurements; determining whether the average pressure value exceeds a threshold corresponding to Level N (N is 2 or greater); applying the barrier cream to the patient's heel if the average pressure value exceeds the threshold; and making a plurality of pressure measurements every two hours if the average pressure value exceeds the threshold. In one aspect, if the average pressure value exceeds the threshold, the plurality of pressure measurements are made at least hourly or at least half-hourly.

[0149] In one aspect, the present disclosure provides and encompasses a method for identifying and treating a patient in need of neuromuscular stimulation to the patient's heel, the method comprising: making a plurality of pressure measurements at the patient's heel; calculating an average pressure value from a portion of the plurality of pressure measurements; determining whether the average pressure value exceeds a threshold corresponding to level N (N is greater than or equal to 1); applying neuromuscular stimulation to the patient's heel if the average pressure value exceeds the threshold; and making a plurality of pressure measurements hourly if the average pressure value exceeds the threshold. In one aspect, if the average pressure value exceeds the threshold, the plurality of pressure measurements are made at least once every half hour.

[0150] In one aspect, the present disclosure provides and encompasses a method for identifying and treating a patient in need of application of a topical cream to the patient's heel, the method comprising the steps of: making a plurality of pressure measurements at the patient's heel; calculating an average pressure value from a portion of the plurality of pressure measurements; determining whether the average pressure value exceeds a threshold corresponding to level N (N is 2 or greater); if the average pressure value exceeds the threshold, applying the topical cream to the patient's heel; and if the average pressure value exceeds the threshold, making a plurality of pressure measurements every half hour.

[0151] In one aspect, the present disclosure provides and encompasses a method of identifying and treating a patient in need of application of a heel boot to the patient's heel, the method comprising the steps of: making a plurality of pressure measurements at the patient's heel; calculating an average pressure value from a portion of the plurality of pressure measurements; determining whether the average pressure value exceeds a threshold corresponding to level N (N is 2 or greater); if the average pressure value exceeds the threshold, applying a heel boot to the patient's heel; and if the average pressure value exceeds the threshold, making a plurality of pressure measurements every half hour.

[0152] In one aspect, the present disclosure provides and encompasses a method for identifying and treating a patient in need of application of a barrier cream to the patient's sacrum, the method comprising: making a plurality of pressure measurements at the patient's sacrum; calculating an average pressure value from a portion of the plurality of pressure measurements; determining whether the average pressure value exceeds a threshold corresponding to Level N (N is greater than or equal to 2); applying the barrier cream to the patient's sacrum if the average pressure value exceeds the threshold; and making a plurality of pressure measurements every six hours if the average pressure value exceeds the threshold. In one aspect, if the average pressure value exceeds the threshold, the plurality of pressure measurements are made at least once every four hours, at least once every three hours, at least once every two hours, at least once every hour, or at least once every half hour.

[0153] In one aspect, the present disclosure provides and encompasses a method of identifying and treating a patient in need of application of neuromuscular stimulation to the patient's sacrum, the method including the steps of: making a plurality of pressure measurements at the patient's sacrum; calculating an average pressure value from a portion of the plurality of pressure measurements; determining whether the average pressure value exceeds a threshold corresponding to level N (N is 2 or greater); applying neuromuscular stimulation to the patient's sacrum if the average pressure value exceeds the threshold; and making a plurality of pressure measurements every four hours if the average pressure value exceeds the threshold. In one aspect, if the average pressure value exceeds the threshold, the plurality of pressure measurements are made at least once every three hours, at least once every two hours, at least once every hour, or at least once every half hour.

[0154] In one aspect, the present disclosure provides and encompasses a method for identifying and treating a patient in need of application of a topical cream to the patient's sacrum, the method including the steps of: making a plurality of pressure measurements at the patient's sacrum; calculating an average pressure value from a portion of the plurality of pressure measurements; determining whether the average pressure value exceeds a threshold corresponding to level N (N is 2 or greater); applying the topical cream to the patient's sacrum if the average pressure value exceeds the threshold; and making a plurality of pressure measurements every two hours if the average pressure value exceeds the threshold. In one aspect, if the average pressure value exceeds the threshold, the plurality of pressure measurements are made at least hourly or at least half-hourly.

[0155] In one aspect, the present disclosure provides and encompasses a method of identifying and treating a patient in need of ultrasound therapy, comprising: making a plurality of pressure measurements at an anatomical site of the patient; calculating an average pressure value from a portion of the plurality of pressure measurements; determining whether the average pressure value exceeds a threshold corresponding to level N (N is 2 or greater); applying ultrasound therapy to the anatomical site if the average pressure value exceeds the threshold; and making a plurality of pressure measurements every two hours if the average pressure value exceeds the threshold. In one aspect, the anatomical site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient.

[0156] In one aspect, the present disclosure provides and encompasses a method for identifying and treating a patient in need of shockwave therapy, comprising: making a plurality of pressure measurements at an anatomical site of the patient; calculating an average pressure value from a portion of the plurality of pressure measurements; determining whether the average pressure value exceeds a threshold corresponding to level N (N is 2 or greater); applying shockwave therapy to the anatomical site if the average pressure value exceeds the threshold; and making a plurality of pressure measurements every two hours if the average pressure value exceeds the threshold. In one aspect, the anatomical site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient. In one aspect, the shockwave therapy is provided by electromagnetic pulses or pressurized air.

[0157] In one aspect, the present disclosure provides and encompasses a method of identifying and treating a patient in need of application of a 30-degree wedge, comprising the steps of: making a plurality of pressure measurements at an anatomical site of the patient; calculating an average pressure value from a portion of the plurality of pressure measurements; determining whether the average pressure value exceeds a threshold corresponding to level N (N is 2 or greater); if the average pressure value exceeds the threshold, applying a 30-degree wedge to the anatomical site; and if the average pressure value exceeds the threshold, making a plurality of pressure measurements every two hours. In one aspect, the anatomical site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient.

[0158] In one aspect, the present disclosure provides and encompasses a method of identifying and treating a patient requiring application of a composite dressing, the method comprising the steps of: making a plurality of pressure measurements at an anatomical site of the patient; calculating an average pressure value from a portion of the plurality of pressure measurements; determining whether the average pressure value exceeds a threshold corresponding to level N (N is greater than or equal to 1); if the average pressure value exceeds the threshold, applying the composite dressing to the anatomical site; and if the average pressure value exceeds the threshold, making a plurality of pressure measurements every two hours. In one aspect, the anatomical site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient.

[0159] In one aspect, the present disclosure provides and encompasses a method of identifying and treating a patient in need of a hybrid mattress, the method including the steps of: making a plurality of pressure measurements at an anatomical site of the patient; calculating an average pressure value from a portion of the plurality of pressure measurements; determining whether the average pressure value exceeds a threshold corresponding to level N (N is greater than or equal to 2); providing a hybrid mattress to support the patient if the average pressure value exceeds the threshold; and making a plurality of pressure measurements every two hours if the average pressure value exceeds the threshold. In one aspect, the anatomical site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient.

[0160] In one aspect, the present disclosure provides and encompasses a method of identifying and treating a patient in need of a dynamic mattress, the method comprising the steps of: making a plurality of pressure measurements at an anatomical site of the patient; calculating an average pressure value from a portion of the plurality of pressure measurements; determining whether the average pressure value exceeds a threshold corresponding to level N (N is greater than or equal to 2); providing a dynamic mattress to support the patient if the average pressure value exceeds the threshold; and making a plurality of pressure measurements every two hours if the average pressure value exceeds the threshold. In one aspect, the anatomical site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient.

[0161] In one aspect, the present disclosure provides and encompasses a method for identifying and ambulating a bedridden patient in need, the method comprising the steps of providing a movement sensor with an accelerometer and a gyro sensor, monitoring the frequency and extent of patient movement, providing an alert if the movement sensor does not detect movement of more than a quarter turn for a specified period of time, and ambulating the patient upon the alert.

[0162] In one aspect, the present disclosure further provides and encompasses the step of administering an anatomy-specific intervention to a patient's anatomical site identified as injured by the combination of visual assessment and pressure measurements. In one aspect, the anatomy-specific intervention is administered to a common site of wound development selected from the group consisting of the toes, heels, sacrum, spine, elbows, scapulae, occipital region, and ischial tuberosity. In one aspect, the anatomy-specific intervention is simultaneously administered to a second common site of wound development selected from the group consisting of the toes, heels, sacrum, spine, elbows, scapulae, occipital region, and ischial tuberosity. In one aspect, the first site receiving the anatomy-specific intervention is known to be responsible for the development of wounds at the second site.

[0163] Identification of damaged tissue by comparing bilateral pressure measurements In one aspect, the present disclosure provides and encompasses a method for identifying damaged tissue, the method including the steps of obtaining a first pressure measurement from a first location on a patient's skin, obtaining a second pressure measurement from a second location symmetrical to the first location, determining an average pressure value for each of the first and second pressure measurements, determining an average pressure value from each of the first and second pressure measurements, determining a difference in the average pressure values ​​between the first and second pressure measurements, and determining that tissue damage is present at the first or second location if the difference in the average pressure values ​​exceeds a threshold.

[0164] 4A shows the sacral region of the back of a patient 410. A line of symmetry 412 can be drawn down the center of the back to divide the back into left and right mirror images. Point 414 is considered to be the left and right mirror image of the back of patient 410 because it is approximately the same distance and height from line of symmetry 412.

[0165] 4B shows left foot 420L and right foot 420R of patient 410 as they would appear if they were lying face up on a bed (not shown) with an observer standing at the foot of the bed. On the undersides 422L and 422R of feet 420L and 420R, locations 424L and 424R are at approximately equivalent locations (e.g., the same distance from the rear or heel and the same distance from the medial side of each foot 420L or 420R) and are considered symmetrical locations.

[0166] 4C illustrates additional exemplary symmetrical locations 432L and 432R located on the sides of feet 420L and 420R, and symmetrical locations 434L and 434R located on the bottom surfaces 422L and 422R of feet 420L and 420R, respectively. In one aspect, locations 432R and 430R are considered symmetrical with respect to foot 420R when considered alone without reference to foot 420L.

[0167] Without being limited to a particular theory, comparing pressure measurements taken at symmetrical locations can compensate for offsets in measurements from a particular patient relative to the patient population. For example, a patient may be dehydrated on a particular day when measurements are taken. Comparing pressure values ​​in healthy tissue of the same patient in a dehydrated state may deviate from pressure values ​​of the same tissue at the same location when the patient is well hydrated. If tissue at one location is healthy while tissue at the symmetrical location is damaged, comparing measurements taken at symmetrical locations will more reliably indicate tissue damage at one location, eliminating the "common mode" effect of variations in dehydration at both locations.

[0168] Measurements at multiple locations (e.g., a first measurement at a first location and a second measurement at a second location symmetrical to the first location) may be made using a pressure measurement device 600, such as that shown in Figure 6. In one embodiment, device 600 includes a processor that may be configured, in accordance with instructions stored on a non-transitory computer-readable medium, to determine characteristics of measurements taken at the multiple locations or parameters associated with or derived from the measurements (e.g., one or more of a difference, an average, or differences from a common average of pressure values ​​resulting from each of the multiple measurements). In one embodiment, device 600 includes a display configured to display one or more parameters associated with the measurements (e.g., an average pressure value resulting from measurements taken at two symmetrical locations).

[0169] In one embodiment, a difference in mean pressure values ​​is determined, with a difference exceeding a predetermined threshold indicating tissue damage at one of the locations at which the corresponding pressure measurements were taken. In one embodiment, an average of the pressure values ​​taken at each symmetrical location is determined and compared. In one embodiment, a median or mode of the mean pressure values ​​taken at each symmetrical location is determined and compared. In one embodiment, damage is indicated at locations associated with larger mean pressure values. In one embodiment, damage is indicated at locations associated with smaller mean pressure values. In one embodiment, determining whether tissue damage is present includes one or more of comparing individual mean pressure values ​​to one or more predetermined ranges or thresholds and comparing the difference to one or more predetermined ranges or thresholds. In one embodiment, the predetermined range may be 0.1 to 8.0 (e.g., 0.1 to 1.0, 1.1 to 2.0, 2.1 to 3.0, 3.1 to 4.0, 4.1 to 5.0, 5.1 to 6.0, 6.1 to 7.0, 7.1 to 8.0, 0.1 to 7.5, 0.5 to 8.0, 1.0 to 7.0, 1.5 to 6.5, 2.0 to 6.0, 3.0 to 5.5, 3.5 to 5.0, or 4.0 to 4.5). In another embodiment, the predetermined range may be 0.1 to 4.0 (e.g., 0.5 to 4.0, 0.1 to 3.5, 1.0 to 3.5, 1.5 to 4.0, 1.5 to 3.5, 2.0 to 4.0, 2.5 to 3.5, 2.0 to 3.0, 2.0 to 2.5, or 2.5 to 3.0). In one embodiment, the predetermined range may be 4.1 to 8.0 (4.5 to 8.0, 4.1 to 7.5, 5.0 to 7.5, 5.5 to 7.0, 5.5 to 7.5, 6.0 to 8.0, 6.5 to 7.5, 6.0 to 7.0, 6.0 to 6.5, or 6.5 to 7.0, etc.).In one embodiment, the predetermined thresholds are approximately 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, The color may be 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, or 7.5. In one embodiment, the predetermined threshold may be in the range of 0.1 to 8.0 (e.g., 0.1 to 1.0, 1.1 to 2.0, 2.1 to 3.0, 3.1 to 4.0, 4.1 to 5.0, 5.1 to 6.0, 6.1 to 7.0, 7.1 to 8.0, 0.1 to 7.5, 0.5 to 8.0, 1.0 to 7.0, 1.5 to 6.5, 2.0 to 6.0, 3.0 to 5.5, 3.5 to 5.0, or 4.0 to 4.5). In one embodiment, the predetermined range or threshold may be scaled by a factor or multiple based on the values ​​provided herein. It is understood that the predetermined value is not constrained by design, but rather, one of ordinary skill in the art may select the predetermined value. In one aspect, the ranges and thresholds of the present disclosure are modified according to the particular bilateral location, the part of the patient's body on which the measurement is being taken, or one or more characteristics of the patient, such as age, height, weight, family history, ethnicity, and other physical characteristics or medical conditions.

[0170] One or more regions of the body may be defined. In one embodiment, measurements taken within a region may be considered comparable to one another. A region may be defined as an area on the skin of the body where measurements may be taken at any point within the body. In one embodiment, a region corresponds to an anatomical region (e.g., heel, ankle, hip). In one embodiment, a region may be defined as a set of two or more specific points relative to an anatomical feature where measurements are only taken. In one embodiment, a region may include multiple discrete areas on the body. In one embodiment, a set of specific locations may include points in multiple discrete areas.

[0171] In one embodiment, the region is defined by a surface area. In one embodiment, the region is defined by a surface area, e.g., 5 to 200 cm. 2 , 5~100cm 2 , 5~50cm 2 , 10~50cm 2 , 10~25cm 2 , or 5 to 25 cm 2 may be.

[0172] In one embodiment, measurements may be taken in a specific pattern or portion thereof. In one embodiment, the pattern of measurements comprises a pattern centered around the area of ​​interest. In one embodiment, measurements are taken in one or more circular patterns of varying size, T-shaped patterns, a set of specific locations, or random traverses of the tissue or region. In one embodiment, the pattern may be positioned on the body by defining a first measurement location of the pattern relative to an anatomical feature and defining other measurement locations of the pattern as offsets from the first measurement location.

[0173] In one embodiment, the pressure measurement device of the present disclosure may further include a plurality of contact sensors that are coplanar with and surround the respective receivers, thereby bringing the device into full contact with the skin surface. The plurality of contact sensors may be a plurality of pressure sensors, a plurality of optical sensors, a plurality of temperature sensors, a plurality of pH sensors, a plurality of sweat sensors, a plurality of ultrasound sensors, a plurality of bone growth sensors, or a plurality of combinations thereof. In one embodiment, the plurality of contact sensors may include four, five, six, seven, eight, nine, ten, or more contact sensors.

[0174] 5A and 5B illustrate an example of a method for identifying symmetrical locations by comparing pressure values ​​associated with measurements at known relative locations according to the present disclosure. In this example, a pressure measuring device 630 is shown across contact area 502R (e.g., 420R in FIG. 4C) on the right foot at non-overlapping locations marked "A" through "H" in FIG. 5A. The pressure values ​​measured at each location are plotted on the graph in FIG. 5B. In this example, the pressure values ​​at locations "A" and "H" are small or zero, reflecting that pressure measuring device 630 does not overlap contact area 502R at these locations. The large pressure values ​​associated with locations "B" and "G" are due to pressure measuring device 630 partially overlapping contact area 502R at these locations. The pressure values ​​at locations C, D, E, and F are large and, in this example, substantially identical, indicating that pressure measuring device 630 is completely within contact area 502R at these locations. In one embodiment, a pressure measurement device, such as pressure measurement instrument 630, may determine that certain locations (e.g., locations "C" and "F") are symmetrical about centerline 504R of right foot 420R. In one embodiment, if a similar set of measurements is taken at locations A'-H' on left foot 420L, locations on each foot 420L and 420R (e.g., locations E and E') may be determined to be substantially symmetrical.

[0175] FIG. 6 is a schematic diagram of an integrated system 600 for measuring, evaluating, storing, and transferring pressure measurements according to the present disclosure. In this example, system 600 includes a pressure measurement device 630 capable of wirelessly communicating with a Wi-Fi access point 610. Pressure measurement device 630 communicates with one or more of a pressure measurement application running on a server 650, a laptop computer 620, a smartphone 640, or an application running on another digital device. In one embodiment, laptop computer 620 and smartphone 640 are carried by a user of pressure measurement device 630 (e.g., a nurse), and the application provides feedback and information to the user. In one embodiment, patient information received from pressure measurement device 630 is stored in database 660. In one embodiment, information received from pressure measurement device 630 is forwarded via network 655 to another server 680, which stores a portion of the information in the patient's electronic medical record (EMR) 670. In one embodiment, information from pressure measuring device 630 or information retrieved from database 660 or EMR 670 is transferred to an external server 690 and then to a computer 695 (e.g., a computer in the office of a doctor providing medical care to the patient).

[0176] Methods for detecting tissue damage before it becomes visible In one aspect, the present disclosure provides and encompasses a method for detecting tissue damage before it becomes visible on a patient's skin, the method comprising the steps of obtaining multiple pressure measurements at a location on the patient's skin at different times, determining an average pressure value from each of the multiple pressure measurements, calculating a slope between the most recent pressure value and the immediately preceding pressure value, comparing the slope to a threshold, and determining that tissue damage is present if the derivative exceeds the threshold. In one aspect, the method is performed at multiple locations.

[0177] In one aspect, a slope between the most recent average pressure value and the immediately preceding average pressure value indicates tissue damage. In one aspect, a positive slope between the most recent average pressure value and the immediately preceding average pressure value indicates worsening tissue damage. In one aspect, a positive slope between the most recent average pressure value and the immediately preceding average pressure value indicates the formation of a pressure sore.

[0178] In one aspect, the present disclosure provides and encompasses a method for detecting tissue damage before it becomes visible on a patient's skin, the method comprising the steps of: obtaining multiple pressure measurements at multiple locations on the patient's skin at different times; determining an average pressure value from each of the multiple pressure measurements; calculating a difference value between the maximum and minimum average pressure values ​​for each time period; calculating a derivative with respect to time of the difference value; comparing the derivative to a threshold; and determining that tissue damage is present if the derivative exceeds the threshold. In one aspect, the method is performed at multiple locations.

[0179] In one embodiment, the difference value between the maximum and minimum average pressure values ​​over time indicates tissue damage. In one embodiment, the derivative of the difference value with respect to time is calculated from two different times. In one embodiment, the derivative of the difference value with respect to time is calculated from the two most recent difference values. In one embodiment, the derivative of the difference value with respect to time is calculated from difference values ​​measured at two consecutive time points. In one embodiment, the derivative of the difference value with respect to time is calculated from difference values ​​measured at two non-consecutive time points. In one embodiment, a positive derivative indicates worsening tissue damage. In one embodiment, a positive derivative indicates the formation of a pressure sore.

[0180] In one aspect, the present disclosure provides and encompasses a method for detecting tissue damage before it becomes visible on a patient's skin, the method comprising the steps of obtaining a plurality of pressure measurements at a location on the patient's skin at each of a plurality of time intervals, determining an average pressure value from each of the plurality of pressure measurements, calculating a difference value between the maximum and minimum average pressure values ​​for each time interval, fitting a curve to a predetermined number of recent difference values, calculating the curvature of the fitted curve, comparing the curvature to a threshold, and determining that tissue damage is present if the curvature exceeds the threshold. In one aspect, the method is performed at multiple locations.

[0181] In one aspect, the curvature of the fitting curve of the difference values ​​over time is indicative of tissue damage. In one aspect, an increase in the curvature of the fitting curve of the difference values ​​over time is indicative of worsening tissue damage. In one aspect, an increase in the curvature of the fitting curve of the difference values ​​over time is indicative of the formation of a pressure sore.

[0182] In one embodiment, the pressure measurements are taken at intervals of approximately once every second, once every 15 seconds, once every 30 seconds, once every minute, once every 10 minutes, once every 15 minutes, once every 30 minutes, once every hour, once every hour, once every 2 hours, once every 3 hours, once every 4 hours, once every 6 hours, once every 12 hours, once every 24 hours, once every day, once every 2 days, once every 3 days, once every 4 days, once every 5 days, once every 6 days, once every 7 days, once every 8 days, once every 9 days, or once every 10 days.

[0183] In one embodiment, the threshold values ​​are approximately 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.10, 4.11, 4.12, 4.13, 4.14, 4.15, 4.16, 4.17, 4.18, 4.19, 4.20, 4.21, 4.22, 4.23, 4.24, 4.25, 4.26, 4.27, 4.28, 4.29, 5.30, 5.31, 5.32, 5.33, 5.34, 5.35, 5.36, 5.37, 5.38, 5.39, 5.40, 5.41, 5.42, 5.43, 5.44, 5.45, 5.46, 5.47, 5.48, 5.49, 5.50, 5.51, 5.52, 5.53, 5.54, The color may be 4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, or 7.5. In one embodiment, the threshold value may be in the range of 0.1 to 8.0 (e.g., 0.1 to 1.0, 1.1 to 2.0, 2.1 to 3.0, 3.1 to 4.0, 4.1 to 5.0, 5.1 to 6.0, 6.1 to 7.0, 7.1 to 8.0, 0.1 to 7.5, 0.5 to 8.0, 1.0 to 7.0, 1.5 to 6.5, 2.0 to 6.0, 3.0 to 5.5, 3.5 to 5.0, or 4.0 to 4.5). In one embodiment, the threshold value may be scaled by a factor or multiple based on the values ​​provided herein. It is understood that the threshold value is not constrained by design, but rather, one of skill in the art may select a predetermined value. In one embodiment, the threshold values ​​of the present disclosure are modified according to the particular part of the patient's body on which the measurement is being taken, or one or more characteristics of the patient, such as age, height, weight, family history, ethnicity, and other physical characteristics or medical conditions.

[0184] In one embodiment, the number of pressure values ​​above a predetermined threshold indicates epidermal damage that may lead to a pressure ulcer. The time interval between the first pressure value at or above this threshold and the occurrence of visible symptoms of a pressure ulcer may be a first duration during which the pressure values ​​increase linearly. The first duration may be 5 days or more (6 days or more, 7 days or more, 8 days or more, 9 days or more, or 10 days or more).

[0185] In another embodiment, if a plot of pressure values ​​over time shows an upward curvature or other deviation from a linear progression, visible symptoms may appear within a shorter time period (e.g., 2-3 days, 1-4 days, 1-3 days, 1-2 days, or 2-4 days). These pressure values ​​are tracked and analyzed for trend, i.e., the slope and curvature of the curve connecting these pressure values. In one embodiment, the amount by which an incremental pressure value exceeds a linear prediction based on preceding pressure values ​​is compared to a predetermined threshold. In one embodiment, the amount by which an incremental pressure value exceeds the most recent preceding pressure value is compared to a predetermined threshold. In one embodiment, the curvature of a best-fit curve fitted to a predetermined number of recent pressure values ​​is compared to a predetermined threshold. In one embodiment, consecutive pressure values ​​that exceed a predetermined threshold are compared to a measurement count threshold. In each of these embodiments, the pressure measurement scanner notifies when the comparison parameter exceeds the respective threshold.

[0186] In one aspect, the trend analysis may ignore a single pressure value below a threshold if both the preceding and subsequent pressure values ​​are above the threshold.

[0187] In one embodiment, the trend curve of the pressure values ​​is a straight line connection between the points. In one embodiment, the trend curve is a best fit curve fitted to the pressure values. In one embodiment, the fit curve is required to intersect the most recent number of pressure values.

[0188] Having generally described the invention above, the same will be more readily understood by reference to the following examples, which are provided for illustrative purposes and are not intended to limit the disclosure unless specified. [Example]

[0189] Example 1: Intervention Levels for Treating Pressure Ulcers of the Heel

[0190] Subjects identified as being at risk for heel pressure ulcers are treated according to the following scheme.

[0191] One or more pressure measurements of the patient at the heel are obtained. A pressure value is calculated. The patient is assigned an intervention level based on the average pressure value compared to a threshold intensity, as shown in Table 1. The appropriate intervention corresponding to the assigned intervention level is implemented. Subsequent pressure measurements are also taken at a frequency determined by the assigned intervention level. The patient's assigned intervention level may be changed (either higher or lower) or may remain the same depending on the average pressure value of the subsequent measurements.

[0192] TIFF0007798765000001.tif157170

[0193] Example 2: Intervention Levels for Treating Sacral Pressure Ulcers

[0194] Subjects identified as being at risk for sacral pressure ulcers are treated according to the following scheme.

[0195] One or more pressure measurements of the patient at the sacrum are obtained. An average pressure value is calculated. The patient is assigned an intervention level based on the average pressure value compared to a threshold intensity, as shown in Table 2. An appropriate intervention corresponding to the assigned intervention level is performed at the sacrum. Subsequent pressure measurements are also performed at a frequency determined by the assigned intervention level. The patient's assigned intervention level may be changed (either higher or lower) or may remain the same depending on the average pressure value of the subsequent measurements.

[0196] TIFF0007798765000002.tif140170

[0197] Example 3: Treatment decision pathway to stratify patients and provide appropriate treatment

[0198] Pressure ulcers are classified as stages 1 through 4, with stage 1 being the least severe. The National Pressure Ulcer Advisory Panel (NPUAP) defines a stage 1 ulcer as a localized, nonblanching erythema on intact skin. The erythema (redness of the superficial layer of skin) is "blanchable" if it whitens when pressed, and "non-blanchable" if it remains red when pressed, possibly due to the presence of red blood cells outside of blood vessels (extravasation). In some patients, blanching erythema or changes in sensation, temperature, or consistency may precede visible changes. While all patients are potentially at risk, pressure ulcers are more likely to develop in critically ill patients or those with neurological disorders, movement disorders, nutritional disorders, poor posture, or deformities.

[0199] Currently, visual skin assessment (VSA) is the method of identifying pressure ulcers: trained healthcare professionals visually and tactilely assess the appearance of the skin, looking for changes in redness or tissue firmness, tissue temperature, or moisture.

[0200] Figure 1A outlines the currently recommended treatment decision pathway for preventing pressure ulcers in hospitalized patients, as presented in the clinical guideline "Pressure ulcers: prevention and management," published by the National Institute for Health and Care Excellence (NICE) on April 23, 2014. These guidelines recommend that a risk analysis be performed on all patients admitted to a care facility, indicating one or more risk factors, such as significantly restricted mobility, significant sensory loss, past or current pressure ulcers, nutritional deficiencies, inability to self-position, or significant cognitive impairment. Risk assessment is typically performed using a scored checklist, such as the Braden Scale, which assesses the severity of specific risk factors. See, for example, Bergstrom et al., Nurs Res, 36(4):205–210 (1987). This scale consists of six subscales reflecting sensation, skin moisture, activity, movement, friction and shear, and nutritional status.

[0201] The risk assessment identifies patients as being at (i) low risk of developing a pressure ulcer, (ii) at risk of developing a pressure ulcer, or (iii) at high risk of developing a pressure ulcer. Depending on the level of risk classified, patients undergo follow-up evaluation with various sequences of treatment and visual assessment.

[0202] If a patient is identified as being at low risk for developing a pressure ulcer, they are simply monitored for changes in their clinical status (e.g., events such as surgery, worsening of underlying conditions, changes in mobility). Patients who use wheelchairs or who sit for long periods of time may be provided with high-performance foam chair cushions or equivalent pressure-redistributing cushions. If there is no change in clinical status, low-risk patients will not be reassessed under this set of guidelines and will remain in the same treatment and evaluation pathway until discharge from the healthcare facility.

[0203] If a patient is identified as at risk for developing a pressure ulcer, they will be scheduled for repositioning, or "roundings," every six hours. As with low-risk patients, patients may be provided with high-performance foam chair cushions if they use a wheelchair or sit for long periods of time. No other monitoring or intervention is recommended under the NICE guidelines.

[0204] If a patient is identified as being at high risk for developing a pressure ulcer, they will receive a high-performance foam mattress as a preventative measure, or if they use a wheelchair or sit for long periods of time, they will be provided with a high-performance chair cushion. Patients will also be repositioned every four hours. Patients will undergo daily VSAs of all areas of their body. If an area shows non-blanching erythema, appropriate intervention will be implemented and the area will be rechecked with VSAs every two hours. Areas not showing non-blanching erythema will be rechecked daily with VSAs. Each high-risk patient will have an individualized medical care plan.

[0205] This flowchart (Figure 1A) shows that caregivers spend the majority of their time with high-risk patients. While this may be appropriate, it also means that at-risk patients may be left unmonitored and develop a Stage 1 ulcer before the condition is detected by caregivers. Furthermore, relying on VSA to detect a problem necessarily means that patients will develop a Stage 1 ulcer before intervention can be selected or implemented. By the time damage has progressed to Stage 1, intervention is likely to result in skin breakdown and a Stage 2 ulcer. Early detection of tissue damage is clearly necessary so that intervention can prevent subepidermal damage from progressing beyond Stage 1.

[0206] Figure 1B is an example of an enhanced treatment decision pathway for pressure ulcer prevention currently implemented in some healthcare facilities. The enhanced pathway adds a monitoring step to both the high-risk and low-risk pathways. Low-risk patients would undergo a weekly risk assessment (e.g., completing a Braden Scale assessment). At-risk patients would receive a high-performance foam mattress as a preventative measure and would be assessed daily with a VSA. A medical care plan would be developed to monitor and treat at-risk patients. There would be no change in the medical care of high-risk patients.

[0207] This expanded plan has the advantage of providing basic monitoring of pressure ulcers for all patients. However, these additional steps require additional time due to increased staffing or increased workload for existing staff. While the care pathway in Figure 1B is superior to the recommended care pathway in Figure 1A, it requires more resources and still has the limitation that patients must have a stage 1 ulcer before the VSA can identify the injury.

[0208] Different hospitals and healthcare facilities use different numbers of risk categories. These range from two categories (low risk and high risk) to four or more categories, with additional categories such as "very high risk" in addition to the categories shown in the example in Figure 1B. Patients are assigned to various categories based on the results of their initial risk assessment.

[0209] FIG. 2 is an exemplary flowchart of a method in which a device for evaluating pressure measurements on a patient's skin may be used in an independent process to prevent pressure ulcers according to the present disclosure. Every patient visit undergoes a complete pressure measurement evaluation of all body locations selected for monitoring. These selected locations may include areas recommended in the pressure measurement device's Instructions for Use (IFU), such as the sacrum and heels. Additional locations may be identified by hospitals and incorporated into their in-house practices. Multiple pressure measurements are taken at and around each selected body location at spatially distinct locations. From the set of measurements, an average pressure value for each location is calculated at and around that location. The average pressure value is then compared to one or more thresholds to classify the patient.

[0210] In this example, patients are assigned to one of two risk categories: low risk and high risk. Low-risk patients undergo weekly pressure measurements at all body locations selected for monitoring. This is a low-cost approach, yet beneficial for even the healthiest patients, as weekly pressure measurement scans increase the likelihood of detecting tissue damage before it becomes visible on VSA.

[0211] At-risk patients, which would include those identified as high-risk in the current care pathway of Figures 1A and 1B, would receive specialized care based on the body location that exhibits pressure values ​​above a threshold. For example, if the sacrum pressure value is above a threshold, the patient would be repositioned every six hours and would also have daily pressure measurements at the sacrum, while other body locations, such as the heel, would have weekly pressure measurements.

[0212] 3 is a flowchart of a method in which a device for measuring pressure on a patient's skin may be used to aid in further refining the enhanced treatment decision pathway of FIG. 1B, according to the present disclosure. An incoming patient undergoes both a risk assessment and a pressure measurement scan of all body locations identified by the hospital for monitoring, with the patient's assignment to a risk category based in part on the risk assessment and in part on the pressure measurement results. An initial pressure value greater than a threshold indicates the possibility of injury at that body location.

[0213] Currently, the decision to perform an intervention (e.g., repositioning the patient at the first interval) is based on VSA and risk assessment, even though it is unknown whether early-stage damage exists beneath the skin. However, when pressure measurements are used as an adjunct to an extended treatment decision pathway such as that shown in FIG. 3, the decision to perform an intervention at a particular body location is based on the pressure value found at that location in the pressure measurement scan. If the pressure value is below a predetermined threshold, no intervention is required. If the pressure value is above a predetermined threshold, an intervention is selected and performed based in part on the body location and in part on the pressure value at that body location. The predetermined threshold for selecting and performing an intervention may be higher or lower than the threshold for determining that damage may exist at that body location.

[0214] One of the advantages of utilizing pressure measurement devices to monitor patients becomes apparent from a comparison of the costs of providing the medical care pathways shown in Figures 1A, 1B, 2, and 3. However, the costs quoted herein are for patients who do not have or develop a pressure ulcer, where estimated treatment costs can jump to $2000 for a stage 1 ulcer.

[0215] The baseline for this comparison is the expanded current system in Figure 1B, which represents current "best practice" for hospitals striving to reduce pressure ulcer incidence. Low-risk care pathway care delivery is expected to cost an average of $26 per patient with an average hospital stay of 5.6 days, while care for at-risk patients is expected to cost an average of $121 and care for high-risk patients is expected to cost $165. All current care pathways rely on VSA to detect pressure ulcers and otherwise implement interventions based on a "typical" patient's course rather than a specific patient's condition.

[0216] As shown in Figure 3, incorporating a pressure measurement device into the current "best practice" workflow does not reduce the cost of either care pathway because it does not eliminate the work element. However, the benefit is early detection of tissue damage at minimal incremental cost. The incremental cost of adding a pressure measurement scan to the low-risk care pathway is $2, increasing costs from approximately $26 to $28. The expected cost of care for at-risk patients without elevated pressure readings, i.e., those without subcutaneous tissue damage, also increases by $2. However, if an at-risk patient is found to have elevated pressure readings, that patient would be elevated to the high-risk category, increasing the expected cost of care from $165 to $169. This represents a small incremental cost relative to the benefit of early detection of tissue damage in both low-risk and at-risk patients.

[0217] Figure 2 depicts an exemplary workflow that relies solely on manometry devices to monitor patients without the use of conventional VSA. The expected cost of preventive care for low-risk patients is $4 using manometry alone, compared to $28 using the integrated low-risk care pathway of Figure 3. As shown in Figure 2, for at-risk patients using manometry alone, the expected cost is $97, compared to $123-$169 for at-risk and high-risk patients using the integrated care pathway of Figure 3.

[0218] Example 4: Risk Levels Based on Pressure Values

[0219] Subjects identified as being at risk for pressure ulcers are treated according to the following scheme.

[0220] One or more pressure measurements are obtained for a patient at one or more target body locations. An average pressure value is calculated for each scanned body location. Average pressure values ​​are previously obtained at various body locations for many patients, both with and without pressure injuries, and used to construct a histogram of average pressure values. As shown in Table 3, patients with average pressure values ​​in the first tertile (less than 33.3% of maximum intensity) are assigned to risk level 0, while patients with average pressure values ​​in the second tertile (33.3-66.6% of maximum intensity) and the third tertile (greater than 66.6% of maximum intensity) are assigned to risk levels 1 and 2, respectively. An appropriate intervention corresponding to the assigned risk level is implemented. Subsequent pressure measurements are performed at a frequency determined by the assigned intervention level. A patient's assigned intervention level may be changed (either higher or lower) depending on the average pressure value of subsequent measurements, or it may remain the same.

[0221] TIFF0007798765000003.tif100170

[0222] From the above, it will be appreciated that the present invention can be embodied in a variety of forms, including but not limited to the following.

[0223] Embodiment 1. A method for evaluating pressure measurements on intact skin of a patient, the method comprising the steps of: (a) obtaining a pressure measurement scan on the patient's skin; and (b) generating a pressure measurement map.

[0224] Embodiment 2. A method for reducing the incidence of tissue injury in patients admitted to a healthcare facility, comprising: (a) assessing the patient for risk of tissue injury upon admission to the healthcare facility, the step comprising: (i) obtaining pressure measurements of the patient at one or more body locations at risk of developing a wound; and (ii) determining an average pressure value of the pressure measurements; (b) implementing a Level 0 intervention if the average pressure value is below a first threshold; and (c) implementing a Level N intervention, where N is an integer greater than or equal to 1, if the average pressure value exceeds the first threshold.

[0225] Embodiment 3. The method of embodiment 2, wherein the one or more body locations at risk for wound development are selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over bony prominences of the patient.

[0226] Embodiment 4. The method of embodiment 2 or 3, wherein the one or more body locations at risk for wound development include one or more anatomical sites in prolonged contact with a medical device.

[0227] Embodiment 5. The method of embodiment 4, wherein the body area at risk for wound development is selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen.

[0228] Embodiment 6. A method for stratifying a plurality of patients at a healthcare facility based on level of care, comprising: (a) obtaining pressure measurements of one of the plurality of patients at one or more body locations selected for monitoring; (b) determining an average pressure value of the pressure measurements of the patient; (c) determining a healthcare level, among N levels of care, that corresponds to the average pressure value; (d) assigning a healthcare level to the patient; and (e) placing the patient, among the plurality of patients, into a group based on each of the healthcare levels assigned to the patient.

[0229] Embodiment 7. The method of embodiment 6, wherein the one or more body locations at risk for wound development are selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over bony prominences of the patient.

[0230] Embodiment 8. The method of embodiment 6, wherein the one or more body locations at risk for wound development include one or more anatomical sites in prolonged contact with a medical device and are selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen.

[0231] Embodiment 9. A method for identifying and providing an appropriate level of medical care to a patient in a medical-care facility, the method comprising: (a) obtaining a plurality of pressure measurements of the patient at one or more body locations; (b) determining an average pressure value of the plurality of pressure measurements of the patient; (c) providing one or more anatomical-specific interventions based on the average pressure values; (d) increasing the level of the anatomical-specific intervention based on an increase in the average pressure values; and (e) decreasing the level of the anatomical-specific intervention based on a decrease in the average pressure values.

[0232] Embodiment 10. A method for assigning a patient in a healthcare facility to one risk category selected from a plurality of risk categories, the method comprising: (a) obtaining initial pressure measurements at one or more body locations selected for monitoring; (b) determining an average pressure value of the pressure measurements; and (c) assigning the patient to one risk category selected from the plurality of risk categories based in part on the average pressure value of the pressure measurements.

[0233] Embodiment 11. The method of embodiment 10, wherein the body site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient.

[0234] Embodiment 12. The method of embodiment 10, wherein the body site comprises one or more anatomical sites in prolonged contact with the medical device and is selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen.

[0235] Embodiment 13. A method of managing a patient's medical care, comprising: (a) obtaining a first set of pressure measurements at one or more body locations selected for monitoring upon admission to a medical care facility; (b) determining a first average pressure value for each of the first set of pressure measurements; (c) setting an intervention level N=1 if one of the average pressure values ​​of the first set of pressure measurements exceeds a first threshold; (d) implementing an intervention of level N for each of the one or more body locations whose average pressure value exceeds the first threshold; (e) obtaining subsequent sets of pressure measurements at each of the one or more body locations at a frequency of level N; and (f) determining a new average pressure value for each of the one or more body locations.

[0236] Embodiment 14. The method of embodiment 13, wherein the one or more body locations selected for monitoring are selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient.

[0237] Embodiment 15. The method of embodiment 13, wherein the one or more body locations selected for monitoring include one or more anatomical sites in prolonged contact with the medical device and are selected from the group consisting of cheek, nose, chest, stomach, and lower abdomen.

[0238] Embodiment 16. A method for identifying and treating a patient at risk of tissue damage, comprising: (a) assessing the patient for risk of tissue damage upon admission to a healthcare facility, the step comprising: (i) obtaining a first plurality of pressure measurements of the patient; and (ii) determining a first average pressure value of the initial set of pressure measurements; (b) implementing a first intervention at level 0 if the first average pressure value is less than or equal to a first threshold; and (c) implementing a first intervention at level N (N is an integer greater than or equal to 1) if the first average pressure value is greater than the first threshold.

[0239] Embodiment 17. The method of embodiment 16, further comprising: (a) acquiring a second plurality of pressure measurements of the patient at a first predetermined frequency corresponding to the intervention level implemented; (b) determining a second average pressure value from the second plurality of pressure measurements; (c) determining whether the second average pressure value exceeds a second threshold; (d) continuing to implement the first intervention if the second average pressure value does not exceed the second threshold; (e) continuing to acquire a plurality of pressure measurements at the first predetermined frequency if the second average pressure value does not exceed the second threshold; (f) implementing a second intervention of level M (M is an integer greater than N) if the second average pressure value exceeds the second threshold; and (g) acquiring a plurality of pressure measurements at a second predetermined frequency corresponding to level M if the second average pressure value exceeds the second threshold.

[0240] Embodiment 18. The method of embodiment 16 or 17, further comprising: (a) determining whether the second average pressure value is less than a third threshold; (b) continuing to implement a first intervention if the second average pressure value is greater than or equal to the third threshold; (c) continuing to obtain multiple pressure measurement results at a first predetermined frequency if the second average pressure value is greater than or equal to the third threshold; (d) implementing a third intervention at level L (L is an integer less than N) if the second average pressure value is less than the third threshold and the first intervention is not level 0; and (e) obtaining multiple pressure measurement results at a predetermined frequency corresponding to level L if the second average pressure value is less than the third threshold.

[0241] Embodiment 19. The method of any one of embodiments 16 to 18, wherein the Level N first intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, a 30-degree wedge, a composite dressing, a hybrid mattress, a dynamic mattress, a support surface, a silicone pad, a low-friction seat cover, and a low-friction padded mattress surface.

[0242] Embodiment 20. The method of any one of embodiments 17 to 19, wherein the Level M second intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, a 30-degree wedge, a composite dressing, a hybrid mattress, a dynamic mattress, a support surface, a silicone pad, a low-friction seat cover, and a low-friction padded mattress surface.

[0243] Embodiment 21. The method of any one of embodiments 18 to 20, wherein the Level L third intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, a 30-degree wedge, a composite dressing, a hybrid mattress, a dynamic mattress, a support surface, a silicone pad, a low-friction seat cover, and a low-friction padded mattress surface.

[0244] Embodiment 22. The method of any one of embodiments 16 to 21, wherein the first average pressure value is determined from a subset of the first plurality of pressure measurements.

[0245] Embodiment 23. The method of any one of embodiments 17 to 22, wherein the second average pressure value is determined from a subset of the second plurality of pressure measurements.

[0246] Embodiment 24. The method of any one of embodiments 17 to 23, wherein the second threshold is equal to the first threshold.

[0247] Embodiment 25. The method of any one of embodiments 18 to 24, wherein the third threshold is equal to the first threshold.

[0248] Embodiment 26. A method for identifying and treating a patient requiring intervention for a pressure ulcer, comprising: (a) obtaining a plurality of pressure measurements at an anatomical site of the patient; (b) determining an average pressure value of the plurality of pressure measurements; (c) determining whether the average pressure value exceeds a threshold corresponding to level N (N is 2 or greater); (d) administering an intervention for the pressure ulcer to the anatomical site if the average pressure value exceeds the threshold; and (e) obtaining a plurality of pressure measurements every two hours if the average pressure value exceeds the threshold.

[0249] Embodiment 27. The method of embodiment 26, wherein the anatomical site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient.

[0250] Embodiment 28. The method of embodiment 26 or 27, wherein the intervention for the pressure ulcer is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, 30-degree wedges, composite dressings, hybrid mattresses, dynamic mattresses, support surfaces, silicone pads, low-friction sheet covers, and low-friction padded mattress surfaces.

[0251] Embodiment 29. A method for identifying damaged tissue, comprising: (a) obtaining a first pressure measurement from a first location on a patient's skin; (b) obtaining a second pressure measurement from a second location symmetrical to the first location; (c) determining an average pressure value for each of the first and second pressure measurements; (d) determining a difference in the average pressure values ​​between the first and second pressure measurements; and (e) determining that tissue damage is present at the first or second location if the difference in the average pressure values ​​exceeds a threshold.

[0252] Embodiment 30. The method of embodiment 29, wherein the first location is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient.

[0253] Embodiment 31. A method for detecting tissue damage before it becomes visible on a patient's skin, comprising the steps of: (a) obtaining multiple pressure measurements at a location on the patient's skin at different times; (b) determining an average pressure value from each of the multiple pressure measurements; (c) calculating a slope between the most recent average pressure value and the immediately preceding average pressure value; (d) comparing the slope with a threshold; and (e) determining that tissue damage exists if the slope exceeds the threshold.

[0254] Embodiment 32. The method of embodiment 31, wherein the location is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient.

[0255] Embodiment 33. The method of embodiment 31 or 32, performed at multiple locations.

[0256] Embodiment 34. A method for detecting tissue damage before it becomes visible on a patient's skin, comprising the steps of: (a) obtaining multiple pressure measurements at a location on the patient's skin at different times; (b) determining an average pressure value from each of the multiple pressure measurements; (c) calculating a pressure difference between the maximum and minimum average pressure values ​​over time; (d) calculating a derivative with respect to time of the pressure difference; (e) comparing the derivative with a threshold; and (f) determining that tissue damage exists if the derivative exceeds the threshold.

[0257] Embodiment 35. The method of embodiment 34, wherein the plurality of locations is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient.

[0258] Embodiment 36. The method of embodiment 34 or 35, wherein the derivative of the difference value with respect to time is calculated from the two most recent difference values.

[0259] Embodiment 37. The method of any one of embodiments 34 to 36, performed at multiple locations.

[0260] Embodiment 38. A method for detecting tissue damage before it becomes visible on a patient's skin, comprising the steps of: (a) obtaining a plurality of pressure measurements at a location on the patient's skin at each of a plurality of time intervals; (b) determining an average pressure value from each of the plurality of pressure measurements; (c) calculating a pressure differential between the maximum and minimum average pressure values ​​for each time interval; (d) fitting a curve to a predetermined number of recent pressure differentials; (e) calculating the curvature of the fitted curve; (f) comparing the curvature with a threshold; and (g) determining that tissue damage is present if the curvature exceeds the threshold.

[0261] Embodiment 39. The method of embodiment 38, wherein the location is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of the patient.

[0262] Embodiment 40. The method of embodiment 38 or 39, performed at multiple locations.

[0263] While the present invention has been described with reference to specific embodiments, those skilled in the art will recognize that various modifications may be made and equivalents may be substituted for the elements without departing from the scope of the invention. Furthermore, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from its scope. Therefore, it is intended that the present invention not be limited to the particular embodiments disclosed, but rather to include all embodiments coming within the scope and spirit of the appended claims.

Claims

1. 1. A system for identifying patients at risk for tissue damage and making treatment decisions, comprising: a. a pressure measurement device configured to obtain a pressure measurement, the pressure measurement detecting contact pressure on the patient's skin; b. a processor coupled to the pressure measurement device; c. electronically coupled to said processor; i. assessing the patient for risk of tissue injury after admission to a healthcare facility; 1. Obtaining a first plurality of pressure measurements of the patient; 2. Determining a first average pressure value of the first plurality of pressure measurements; and ii. if the first average pressure value is less than or equal to a first threshold, (1) determining a first intervention of Level 0; and (2) obtaining a second plurality of pressure measurements of the patient at a first predetermined frequency corresponding to the first intervention level of Level 0; iii. If the first average pressure value is above the first threshold, (1) determining a first intervention at level N (N is an integer greater than or equal to 1); and (2) obtaining a second plurality of pressure measurements of the patient at a first predetermined frequency corresponding to the first intervention level of level N. a non-transitory computer-readable medium containing stored instructions that, when executed on said processor, execute: A system equipped with

2. the non-transitory computer-readable medium comprising: iv. determining a second average pressure value of the second plurality of pressure measurements; v. determining whether the second average pressure value exceeds a second threshold; vi) deciding to continue the first intervention if the second mean pressure value does not exceed the second threshold; vii. if the second average pressure value does not exceed the second threshold, continuing to obtain multiple pressure measurements at the first predetermined frequency; viii. determining a second intervention of level M (M is an integer greater than N) if the second mean pressure value exceeds the second threshold; xi. if the second average pressure value exceeds the second threshold, obtaining a plurality of pressure measurements at a second predetermined frequency corresponding to a level M; 10. The system of claim 1, further comprising stored instructions that, when executed on the processor, perform:

3. the non-transitory computer-readable medium comprising: x. determining whether the second average pressure value is less than a third threshold; xi. Deciding to continue the first intervention if the second mean pressure value is greater than or equal to the third threshold value; xii. if the second average pressure value is greater than or equal to the third threshold, continuing to obtain multiple pressure measurements at the first predetermined frequency; xiii. If the second mean pressure value is less than the third threshold and the first intervention is not level 0, determining a third intervention of level L (L is an integer less than N); xiv. if the second average pressure value is less than the third threshold, obtaining a plurality of pressure measurements at a third predetermined frequency corresponding to a level L; 3. The system of claim 2, further comprising stored instructions that, when executed on the processor, perform:

4. 4. The system of claim 1, wherein the Level N first intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, a 30 degree wedge, a composite dressing, a hybrid mattress, a dynamic mattress, a support surface, a silicone pad, a low friction seat cover, and a low friction padded mattress surface.

5. 4. The system of claim 2 or 3, wherein the Level M second intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, a 30-degree wedge, a composite dressing, a hybrid mattress, a dynamic mattress, a support surface, a silicone pad, a low-friction seat cover, and a low-friction padded mattress surface.

6. 4. The system of claim 3, wherein the Level L third intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, a 30-degree wedge, a composite dressing, a hybrid mattress, a dynamic mattress, a support surface, a silicone pad, a low-friction seat cover, and a low-friction padded mattress surface.

7. The system of any one of claims 1 to 6, wherein the first average pressure value is determined from a subset of the first plurality of pressure measurements.

8. The system of claim 2 , 3 , 5 , or 6 , wherein the second average pressure value is determined by a subset of the second plurality of pressure measurements.

9. 9. The system of claim 2, wherein the second threshold is equal to the first threshold.

10. The system of claim 3 or 6, wherein the third threshold is equal to the first threshold.

11. The system of any one of claims 1 to 10, further comprising a display configured to receive the pressure measurements and to present the pressure measurements.

12. To evaluate, a. Multiple risk factors for barotrauma; b. a plurality of signs of skin breakdown or pressure injury at at least one body location of the patient, wherein a first assessment of the plurality of signs of skin breakdown or pressure injury comprises performing a first subepidermal moisture (SEM) scan of the at least one body location of the patient; c. the patient's level of nutrition, and d. Current Interventions The system of any one of claims 1 to 11, further comprising evaluating the patient for:

13. 13. The system of any one of claims 1 to 12, wherein Level 0 interventions are selected from the group consisting of providing nutrition, providing a standard mattress, and repositioning the patient every 24 hours.

14. 13. The system of any one of claims 1 to 12, wherein Level 1 intervention is selected from the group consisting of providing heeled boots, repositioning the patient with a wedge, providing the patient with a foam cushion, providing the patient with a pressure-relieving cushion, and maintaining a dry surface on the patient's body part.

15. The system of any one of claims 1 to 12, wherein the level 2 intervention is selected from the group consisting of changing the support surface and providing a pressure-relieving mattress.

16. 13. The system of any one of claims 1 to 12, wherein a level 3 intervention is selected from the group consisting of applying a dressing to a posterior aspect of the patient's body part and applying a dressing to a lateral aspect of the patient's body part.

17. The system of any one of claims 1 to 12, wherein a level 4 intervention is selected from the group consisting of providing the patient with a low friction seat cover and providing the patient with a dynamic mattress.

18. 13. The system of any one of claims 1-12, wherein a Level 5 or higher intervention is selected from the group consisting of providing a low friction padded mattress surface to the patient's body location, applying a barrier cream to the patient's body location, repositioning the patient at intervals of less than 24 hours, providing neuromuscular stimulation, applying a topical cream to promote perfusion, applying neuromuscular stimulation, and providing a silicone pad to the patient's body location.

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