Pressure measurement

Abstract

This invention provides methods for evaluating tissue structure in damaged or healing tissue. [Solution] A method for evaluating the results of pressure measurements on an undamaged patient's skin, a) A step of obtaining a pressure measurement scan on the patient's skin, b) A step of generating a pressure measurement map, Methods that include...

Description

Technical Field

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

[0002] The present disclosure provides methods and devices for evaluating tissue structures in damaged or healing tissues. The present disclosure also provides a method for identifying a patient at risk of developing a pressure ulcer or having a risk of onset of a pressure ulcer and treating the patient with a clinical intervention specific to a biological structure selected based on pressure measurement results. The present disclosure also provides a method for stratifying a group of patients based on the risk of wound occurrence and a method for reducing the incidence or severity of tissue damage in patients admitted to a healthcare facility. The present disclosure also provides a method for detecting tissue damage before it becomes visible on the patient's skin.

Background Art

[0003] The skin is the largest organ in the human body. It is easily exposed to various types of injuries and traumas. Skin injuries and traumas occur when the skin and its surrounding tissues cannot redistribute external pressure and mechanical forces, and ulcers may be formed. 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 continuously exposed over a long period of time. In the presence of other injuries, such as neuropathy induced by diabetes and vulnerability of peripheral tissues, regular exposure to a moderate level 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 care settings, up to 25% of elderly, less mobile patients develop pressure ulcers. Infections and other complications from pressure ulcers cause approximately 60,000 deaths annually in the United States.

[0005] Most pressure ulcers develop on bony prominences where there is less tissue to compress and the pressure gradient within the vascular network changes. Pressure ulcers are classified into one of six stages, ranging from the earliest recognized stage (skin intact but red on the bony prominence) (Stage 1), to a stage where tissue is destroyed and bone, tendon, or muscle is exposed (Stage 4), to a stage of deep tissue pressure injury showing non-branched crimson, maroon, or purple discoloration, and finally to an indistinct loss of skin and tissue throughout the thickness (undeterminable). Detecting and treating pressure ulcers before skin rupture to prevent progression to later stages is a goal for policymakers and healthcare providers in major economies. Most pressure ulcers are preventable, and if identified before the first stage of ulcer formation, the deterioration of the underlying tissue can be halted.

[0006] Detecting tissue damage before the skin ruptures and intervening with appropriate therapy to prevent further deterioration of the underlying tissue is desirable not only for the patient but also for society. The cost of treating pressure ulcers averages around $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 generally receive generalized pressure ulcer prophylaxis, which means that this prophylaxis does not target specific anatomical sites. Patients only receive targeted treatment for localized ulcers after the ulcer has progressed to a degree that can be identified by visual assessment. Current criteria for detecting pressure ulcers are based on visual inspection, making them subjective, unreliable, premature, and lacking in specificity. For example, see 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, even if patients suffer from skin inflammation, which is a precursor to ulcer development, they do not receive local treatment for the developed ulcer. On the contrary, the inflammation progresses further and develops into a full-blown ulcer.

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

[0008] Pressure measurement allows for the detection of contact pressure on the patient's skin. Pressure measurement may be performed between the patient and the resting surface. Pressure measurement is inexpensive and non-invasive. [Overview of the project]

[0009] A systematic method is provided for identifying the risk of pressure ulcers before visible skin damage occurs through non-invasive and objective measurements, and then implementing individualized interventions on specific biological structures. Furthermore, a method is provided for monitoring the progress of wound healing and the consistency of intervention adherence.

[0010] In one embodiment, the present disclosure provides and encompasses a method for evaluating pressure measurement results on intact skin of a patient, comprising the steps of: acquiring pressure measurement results at multiple locations on the patient's skin; and generating a pressure measurement map.

[0011] In one embodiment, the Disclosure provides and encompasses a method for reducing the incidence of tissue injury in patients admitted to a medical care facility, the method comprising: assessing the patient for risk of tissue injury upon admission to the medical care facility; implementing a Level 0 intervention if the mean pressure value is below a first threshold; and implementing a Level N intervention (where N is an integer greater than or equal to 1) if the mean pressure value is above the first threshold. In one embodiment, the assessment step comprises obtaining pressure measurement results from the patient at one or more body locations at risk of injury; and determining the mean pressure value of the pressure measurement results.

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

[0013] In one embodiment, the Disclosure provides and encompasses a method for stratifying multiple patients in a medical care facility based on medical care levels, the method comprising: obtaining pressure measurement results for one of the multiple patients at one or more body locations selected for monitoring; determining the average pressure value of the patient's pressure measurement results; determining a medical care level from among N medical care levels that corresponds to the average pressure value; assigning the medical care level to the patient; and grouping the multiple patients based on each of the medical care levels assigned to the patient.

[0014] In one embodiment, one or more body parts at risk of wound development are selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient. In another embodiment, one or more body parts at risk of wound development include one or more anatomical sites that are in prolonged contact with the medical device, and are selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen.

[0015] In one embodiment, the Disclosure provides and encompasses a method for identifying and providing an appropriate level of medical care to a patient in a medical care facility, the method comprising: obtaining multiple pressure measurement results from one or more body parts of the patient; determining an average pressure value from the multiple pressure measurement results of the patient; providing one or more biostructure-specific interventions based on the average pressure value; increasing the level of biostructure-specific interventions based on an increase in the average pressure value; and decreasing the level of biostructure-specific interventions based on a decrease in the average pressure value.

[0016] In one embodiment, the Disclosure provides and encompasses a method for assigning a patient in a medical care facility to one risk category selected from a plurality of risk categories, the method comprising: obtaining initial pressure measurement results at one or more body locations selected for monitoring; determining an average pressure value of the pressure measurement results; and assigning the patient to one risk category selected from a plurality of risk categories, based in part on the average pressure value of the pressure measurement results.

[0017] In one embodiment, the body part is selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient. In one embodiment, the body part includes one or more anatomical sites that will be in long-term contact with the medical device, and is selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen.

[0018] In one embodiment, the Disclosure provides and encompasses a method for managing a patient's medical care, which includes the steps of: obtaining a first set of pressure measurement results 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 measurement results; setting an intervention level of N=1 if one of the average pressure values ​​of the first set of pressure measurement results exceeds a first threshold; performing an intervention of level N for each of the one or more body locations where the average pressure value exceeds the first threshold; obtaining a subsequent set of pressure measurement results 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, one or more body parts selected for monitoring are selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient. In one embodiment, one or more body parts selected for monitoring include one or more anatomical sites that will be 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 embodiment, the Disclosure provides and encompasses a method for identifying and treating a patient at risk of tissue damage, the method comprising: assessing the patient for risk of tissue damage upon admission to a medical care facility; implementing a first intervention at level 0 if a first mean pressure value is below a first threshold; and implementing a first intervention at level N (where N is an integer greater than or equal to 1) if the first mean pressure value is above a first threshold. In one embodiment, the assessment step comprises obtaining a first set of pressure measurement results from the patient and determining a first mean pressure value from an initial set of pressure measurement results.

[0021] In one embodiment, the method further includes the steps of: obtaining a second set of pressure measurement results of a patient at a first predetermined frequency corresponding to the level of intervention performed; determining a second average pressure value of the second set of pressure measurement results; determining whether the second average pressure value exceeds a second threshold; continuing to perform the first intervention if the second average pressure value does not exceed the second threshold; continuing to obtain a second set of pressure measurement results at a first predetermined frequency if the second average pressure value does not exceed the second threshold; performing a second intervention of level M (where M is an integer greater than N) if the second average pressure value exceeds the second threshold; and obtaining a second set of pressure measurement results at a second predetermined frequency corresponding to level M if the second average pressure value exceeds the second threshold.

[0022] In one embodiment, the method further includes the steps of: determining whether a second average pressure value is less than a third threshold; continuing to perform a first intervention if the second average pressure value is greater than or equal to the third threshold; continuing to acquire multiple pressure measurement results at a predetermined first frequency if the second average pressure value is greater than or equal to the third threshold; performing a third intervention of level L (where 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 acquiring multiple pressure measurement results at a predetermined frequency corresponding to level L if the second average pressure value is less than the third threshold.

[0023] In one embodiment, the first intervention at level N 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 mattress surfaces with low-friction pads.

[0024] In one aspect, the second intervention at level M is selected from the group consisting of heel boots, barrier cream, neuromuscular stimulation, topical cream, ultrasound therapy, shock wave therapy, 30-degree wedge, composite dressing, hybrid mattress, dynamic mattress, support surface, silicon pad, low-friction sheet cover, and mattress surface with low-friction pad.

[0025] In one aspect, the third intervention at level L is selected from the group consisting of heel boots, barrier cream, neuromuscular stimulation, topical cream, ultrasound therapy, shock wave therapy, 30-degree wedge, composite dressing, hybrid mattress, dynamic mattress, support surface, silicon pad, low-friction sheet cover, and mattress surface with low-friction pad.

[0026] In one aspect, the first average pressure value is determined by a subset of the first plurality of pressure measurement results. In one aspect, the second average pressure value is determined by a subset of the second plurality of pressure measurement results.

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

[0028] In one aspect, the present disclosure provides and includes a method for identifying and treating a patient who requires an intervention for a pressure ulcer, the method comprising: obtaining a plurality of pressure measurement results at an anatomical site of the patient; determining an average pressure value of the plurality of pressure measurement results; determining whether the average pressure value exceeds a threshold corresponding to level N (where N is 2 or more); if the average pressure value exceeds the threshold, performing an intervention for the pressure ulcer at the anatomical site; and if the average pressure value exceeds the threshold, obtaining a plurality of pressure measurement results every 2 hours.

[0029] In one embodiment, the anatomical sites are selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient. In one embodiment, the intervention for pressure ulcers 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 mattress surfaces with low-friction pads.

[0030] In one embodiment, the Disclosure provides and encompasses a method for identifying damaged tissue, comprising the steps of: obtaining a first pressure measurement result from a first site on the skin of a patient; obtaining a second pressure measurement result from a second site symmetrical to the first site; determining the average pressure value of the first and second pressure measurement results, respectively; determining the average pressure value from the first and second pressure measurement results, respectively; determining the difference in average pressure values ​​between the first and second pressure measurement results; and determining that if the difference in average pressure values ​​exceeds a threshold, tissue damage is present at the first or second site.

[0031] In one embodiment, the first site is selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient.

[0032] In one embodiment, the Disclosure provides and encompasses a method for detecting tissue damage before it becomes visible on a patient's skin, comprising the steps of: acquiring a plurality of pressure measurement results at a location on the patient's skin with a time difference; determining an average pressure value from each of the plurality of pressure measurement results; calculating a slope between the most recent average pressure value and the previous 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 above-mentioned locations are selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient. In one embodiment, this method is performed at multiple locations.

[0034] In one embodiment, the Disclosure provides and encompasses a method for detecting tissue damage before it becomes visible on a patient's skin, comprising the steps of: acquiring multiple pressure measurement results at multiple locations on the patient's skin with a time difference; determining an average pressure value from each of the multiple pressure measurement results; calculating the pressure difference between the maximum average pressure value and the minimum average pressure value over time; calculating the derivative of the pressure difference with respect to time; comparing the derivative with 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 a group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient. In one embodiment, this method is performed at multiple locations.

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

[0037] In one embodiment, the Disclosure provides and encompasses a method for detecting tissue damage before it becomes visible on a patient's skin, comprising the steps of: acquiring a plurality of pressure measurement results at a location on the patient's skin at a plurality of time differences; determining an average pressure value from each of the plurality of pressure measurement results; calculating the pressure difference between a maximum average pressure value and a minimum average pressure value for each time difference; fitting a curve to a predetermined number of recent pressure differences; calculating the curvature of the fitted curve; comparing the curvature with a threshold; and determining that tissue damage is present if the curvature exceeds the threshold.

[0038] In one embodiment, the above-mentioned locations are selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient. In one embodiment, this method is performed at multiple locations.

[0039] While embodiments of the present disclosure are described herein with reference to the accompanying drawings, these are merely examples. By referring here to the drawings in detail, it is emphasized that the illustrated features are illustrative and intended to illustrate embodiments of the present disclosure. In this regard, both individually and collectively, this specification and the drawings will make available to those skilled in the art how to implement embodiments of the present disclosure. [Brief explanation of the drawing]

[0040] [Figure 1A] This figure illustrates an example of a currently recommended treatment decision-making pathway for pressure ulcer prevention in hospitalized patients, using a combination of risk assessment and visual assessment. [Figure 1B] This figure shows an example of the current extended treatment decision-making pathways for pressure ulcer prevention implemented in several medical and nursing care facilities. [Figure 2] This is an illustrative flowchart of a method in which an apparatus for evaluating the pressure characteristics on a patient's skin may be used in an independent process for preventing pressure ulcers relating to this disclosure. [Figure 3] This is an illustrative flowchart illustrating how a device for evaluating pressure characteristics on a patient's skin may be used as an aid to further improve the extended treatment decision pathway shown in Figure 1B of this disclosure. [Figure 4A] This figure shows an example of a pair of symmetrical locations on the sacral region related to this disclosure. [Figure 4B] This figure shows an example of a pair of symmetrical locations on the soles of both feet related to this disclosure. [Figure 4C] This figure shows an example of a pair of symmetrical locations on the sides and soles of both feet as per this disclosure. [Figure 5A] This diagram shows the locations on the left and right feet for pressure measurement related to this disclosure. [Figure 5B] This is a plot of pressure values ​​associated with known relative locations for identifying symmetrical locations related to this disclosure. [Figure 6] This figure shows an integrated system for measuring, evaluating, storing, and transferring pressure measurement results related to this disclosure. [Figure 7A] This diagram shows various pressure points on a patient's body at different locations. [Figure 7B] This diagram shows various pressure points on a patient's body at different locations. [Figure 7C] This diagram shows various pressure points on a patient's body at different locations. [Figure 7D] This diagram shows various pressure points on a patient's body at different locations. [Modes for carrying out the invention]

[0041] This specification is not intended to be a detailed catalog of all different ways in which the disclosure may be carried out or all features that may be added to the disclosure. For example, features illustrated in one embodiment may be incorporated into another embodiment, and features illustrated in a particular embodiment may be omitted from that embodiment. Thus, this disclosure assumes that in some of its embodiments, any features or combinations of features shown herein may be excluded or omitted. Furthermore, those skilled in the art will see, in light of this disclosure, numerous variations and additions to the various embodiments proposed herein without departing from the disclosure. In other examples, well-known structures, interfaces, and processes are not shown in detail so as not to unnecessarily obscure the invention. Nothing in this specification is intended to be construed as not to negate any part of the entire scope of the invention. Thus, the following description is intended to illustrate some specific embodiments of the disclosure and is not intended to exhaustively specify all permutations, combinations, and variations thereof.

[0042] Unless otherwise specified, all technical and scientific terms used herein have the same meaning as they would be commonly understood by those skilled in the art to which this disclosure belongs. The technical terms used herein are solely for the purpose of describing specific aspects or embodiments and are not intended to limit this disclosure.

[0043] All publications, patent applications, patents, and other references cited herein are incorporated by reference to the full extent of the teachings relating to the sentences and / or paragraphs in which such references are presented. References to the technology employed herein are intended to represent the technology as commonly understood in the art, including variations of the technology or substitutions of equivalent technologies that would be apparent to those skilled in the art.

[0044] Unless otherwise specified in the context, it is expressly intended that the various features of the Disclosure described herein may be used in any combination. Furthermore, the Disclosure assumes that in some embodiments thereof, any feature or combination of features shown herein may be excluded or omitted.

[0045] The methods disclosed herein encompass and cover one or more steps or actions for implementing the described methods. The steps and / or actions of these methods may be interchangeable without departing from the scope of the disclosure. In other words, where a particular order of steps or actions is not required for the proper operation of an embodiment, the order and / or use of any particular steps and / or actions may be modified without departing from the scope of the disclosure.

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

[0047] As used herein, “and / or” encompasses and excludes all possible combinations of one or more of the related list items, as well as combinations that are interpreted as options (“or”).

[0048] As used herein, the terms “about” and “approximately” when referring to measurable values ​​such as length, frequency, or measured values ​​are intended to encompass variations of ±20%, ±10%, ±5%, ±1%, ±0.5%, or ±0.1% of a given value.

[0049] As used herein, expressions such as "between X and Y" and "about X and Y" shall be interpreted as including X and Y. As used herein, expressions such as "between about X and Y" mean "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 an example, case, or representation. No embodiment or aspect described as “exemplary” is necessarily construed as being more preferable or advantageous than other embodiments or aspects, nor is it intended to exclude equivalent structures and techniques known to those skilled in the art. Rather, the use of the term “exemplary” is intended to concretely present a concept, and the subject matter of the disclosure 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 an aggregate of similar cells of the same origin and their respective extracellular matrices that collectively perform a specific function. In some embodiments, tissue includes multiple layers of a patient’s body, beginning with the stratum corneum and including additional deep structures such as the epidermis, dermis, and parts of deep tissue including blood vessels. In one embodiment, tissue does not include 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. Wounds may be open or closed. Wounds may be caused by surgery. Wounds may be burns. In one embodiment, a wound is a pressure ulcer. In another embodiment, a pressure ulcer is subcutaneous. In one embodiment, a pressure ulcer is a pressure ulcer resulting from prolonged use of medical devices such as masks, tubes, or straps. In one embodiment, a wound is a diabetic foot ulcer. In one embodiment, a 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 constrained by theory, the higher the fluid content in the tissue, the higher the biocapacitance value. In some embodiments, the methods described herein include the step of measuring the biocapacitance of tissue. In some embodiments, the methods described herein include the step of measuring the biocapacitance of skin.

[0056] As used herein, the term “time delta” refers to the difference calculated between two values ​​derived from measurement results obtained from an object at different times. In one embodiment, the two values ​​are the average values ​​calculated from measurement results obtained at approximately the same time. In another embodiment, the two values ​​are the sums calculated from measurement results obtained at approximately the same time. In another embodiment, the two measurement results are obtained at approximately the same time (a difference of 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).

[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 site where specific pressure measurement results were obtained.

[0059] As used herein, "system" may refer to a group of devices connected to one another by wire or wireless means.

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

[0061] As used herein, the term “pressure measuring device” includes any device that acquires pressure information at one or more points distributed in 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 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” means electromagnetic energy having wavelengths 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 and is generally understood as “ultraviolet” light. In one embodiment, this range is 390 to 700 nanometers and is generally understood as “visible” light. In one embodiment, this range is 700 nanometers to 1 millimeter and is generally understood as “infrared” radiation. In one embodiment, this range is 700 to 900 nanometers and is generally understood as “near-infrared” radiation. In one embodiment, this light may be a narrowband of wavelengths with respect to a particular wavelength. In one embodiment, this particular wavelength is 760 and / or 830 nanometers.

[0063] In this specification, since the wavelength and frequency of light are uniquely associated, the identification of light as having a particular wavelength is equivalent to the identification of that light as having a particular frequency. References to the frequency of light are considered equivalent and interchangeable with references to the wavelength of the same light.

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

[0065] Method for evaluating pressure measurement results In one embodiment, the present disclosure provides a method for evaluating pressure measurement results on intact skin of a patient, comprising the steps of: obtaining a pressure measurement scan on the patient's skin; and generating a pressure measurement map.

[0066] In one embodiment, a pressure measurement scan includes obtaining a pressure measurement result at a single location on the patient's skin. In one embodiment, a pressure measurement scan includes obtaining pressure measurement results at multiple locations on the patient's skin. In one embodiment, a pressure measurement scan includes obtaining multiple pressure measurement results at multiple locations on the patient's skin. In one embodiment, evaluating the patient includes determining the average pressure value of the pressure measurement results. In one embodiment, evaluating the patient includes determining the average pressure value of multiple pressure measurement results. In one embodiment, a pressure measurement map shows a map of the pressure applied to the skin.

[0067] In one embodiment, the average pressure value at a certain location is determined from two, three, four, five, six, seven, eight, nine, ten, or eleven or more pressure values ​​measured at that location. In another embodiment, the pressure difference is determined by the difference in average pressure values ​​derived from measurement results obtained at two symmetrical locations with respect to the centerline.

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

[0069] In one embodiment, the method provided herein is based on pressure values ​​measured on the patient's skin. In one embodiment, the method provided herein is applied from the time the patient is admitted to a medical care facility until the patient is discharged from the medical care facility.

[0070] In one embodiment, the wound is a pressure ulcer. In one embodiment, the pressure ulcer is a result of prolonged use of medical devices such as masks, tubes, or straps. 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 to reduce the incidence of tissue damage In one embodiment, the Disclosure provides and encompasses a method for reducing the incidence of tissue injury in patients admitted to a medical care facility, the method comprising: a step of assessing the patient's risk of tissue injury upon admission to the medical care facility, the step of obtaining pressure measurement results from the patient at one or more body sites at risk of wound development, and determining the average pressure value of the pressure measurement results; a step of implementing a level 0 intervention if the average pressure value is below a first threshold, and a step of implementing a level N (where N is an integer greater than or equal to 1) intervention if the average pressure value is above the first threshold. In one embodiment, the incidence of ulcers in patients in a medical care facility 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, and less than 1 in 1000.

[0072] In one embodiment, the medical care facility is selected from a group consisting of hospitals, rehabilitation facilities, assisted living facilities, home-based medical care facilities, nursing homes, long-term medical care facilities, continuing medical care communities, and independent living communities. In one embodiment, the medical care facility may be the patient's home or other residence, in which case the “admission” step is the first assessment at 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 method disclosed herein includes evaluating a newly admitted patient for the risk of tissue injury. In one embodiment, the evaluation of the patient includes performing a visual assessment. In one embodiment, the visual assessment is performed in accordance with the guidance of the National Pressure Ulcer Advisory Board (NPUAP).

[0074] In one embodiment, evaluating a 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, Gosnell scale, Norton scale, and Waterlow scale. In one embodiment, evaluating a patient further includes performing an assessment using one or more objective measurements selected from the group consisting of subcutaneous water, bioimpedance, hemoperfusion, biocapacitance, blood oxygenation, spectral imaging, PET imaging, capillary pressure, magnetic resonance imaging, infrared imaging, ultrasound imaging, transcutaneous water loss, and detection of the presence of interleukin-1 alpha in one or more anatomical sites of interest.

[0075] Figures 7A to 7D show circles indicating locations of tissue injury risk in patients at various positions. In one embodiment, one or more body locations at risk of pressure injury are selected from the group consisting of the back of the head, shoulder, base of spine, buttocks, heel, toes, elbow, ear, hip, thigh, leg, rib cage, and knee. In another embodiment, one or more body locations at risk of tissue injury are selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient.

[0076] In one embodiment, a newly admitted patient undergoes an acceptance assessment which includes completion of at least one part of a risk assessment protocol that evaluates one or more of the following: a visual examination of a portion of the patient's skin, nutrition, exercise, physical activity, fitness, and communication ability, and pressure measurement results are obtained at one or more locations on the patient's skin. In one embodiment, a pressure measurement scan includes obtaining multiple pressure measurement results at a single “location” on the patient’s skin. In one embodiment, the “location” is considered an area rather than a single point such that pressure measurement results can be produced at spatially separated points within that location. For example, the heel area includes the inner, outer, and posterior surfaces around the heel, as well as the posterior part of the sole of the foot. In one embodiment, the pressure measurement scan includes obtaining a pressure measurement result at a single location on the patient's skin. In one embodiment, the pressure measurement scan includes obtaining pressure measurement results at multiple locations on the patient's skin. In one embodiment, the pressure measurement scan includes obtaining multiple pressure measurement results at multiple locations on the patient's skin. In one embodiment, evaluating the patient includes determining the average pressure value of the pressure measurement results. In one embodiment, evaluating the patient includes determining the average pressure value of multiple pressure measurement results.

[0077] How to assign patients to risk categories In one embodiment, once the assessment step is complete, a determination is made as to whether the patient's measurements are abnormal, i.e., whether the combination of results from the various elements of the assessment indicates that the patient has or is at risk of developing further damage to the wound tissue. 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 average pressure value is below a first threshold, a level 0 intervention is performed. In another embodiment, if the average pressure value exceeds the first threshold, a level N intervention is performed. 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, 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 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 may be scaled by a coefficient or multiplier based on the values ​​given herein. It is understood that the threshold is not constrained by the design, but rather that a person skilled in the art can select a predetermined value. In one embodiment, the threshold of this disclosure may be modified according to a specific part of the patient's body being measured, 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.

[0079] In one embodiment, an average pressure value exceeding a first threshold indicates a patient at risk of developing pressure ulcers or tissue damage.

[0080] In one embodiment, if the patient is determined to be at an acceptable risk level, the lowest level of intervention, designated herein as "Level Zero" or "Level 0," is performed, and the patient is re-evaluated using at least a pressure measurement protocol at a 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 is performed.

[0081] In one embodiment, if the patient is determined to have abnormal measurements, a higher level of intervention is implemented. In one embodiment, a hierarchy of intervention levels is defined, where each level implements a stronger intervention than the level below it. Also in one embodiment, each level is defined as a monitoring interval or frequency indicating how often a set of pressure measurement results should be produced, with higher levels generally having shorter intervals. In one embodiment, the process at this point is mandated by the hospital or other governing body to implement the next level up, Level 1 intervention. In another embodiment, interventions of Level 2 or higher may be implemented. The process then enters a new loop, where the patient is monitored at a frequency of Level N (where N is in the range of 1 to n (where n is the highest mandated level of intervention and monitoring)). In one embodiment, if the mean pressure value exceeds a threshold, a Level N intervention is implemented. In one embodiment, the Level N intervention is biostructure-specific.

[0082] In one embodiment, pressure measurements are taken at a first time interval for body parts identified as having possible injuries in an initial set of pressure measurements. In one embodiment, pressure measurements are taken at a second time interval longer than the first time interval for all other body parts selected for monitoring. 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, high-risk patients may have a first time interval of 4 hours and a second time interval of 1 day, while low-risk patients may have a first time interval of 1 day and a second time interval of 1 week. In one embodiment, the time intervals may not be strictly based on time but may be event-based (e.g., staff or shift change-based). Generally, body parts with high pressure values ​​are scanned more frequently than other body parts that are being monitored while having normal pressure values ​​in past pressure measurement sessions.

[0083] In one embodiment, the interval at which pressure measurement results are acquired is determined by the pressure values ​​from a preceding pressure measurement session. For example, if a body part had a pressure value equal to or greater than a first threshold in a previous measurement session, pressure measurements are performed at a first time interval. On the other hand, if a preceding pressure value at a body part was equal to or greater than a second threshold, which is higher than the first threshold, pressure measurements are performed at a second time interval, which is shorter than the first time interval.

[0084] How to assign patients to risk categories In one embodiment, the Disclosure provides and encompasses a method for assigning a patient in a medical care facility to one risk category selected from a plurality of risk categories, the method comprising: obtaining initial pressure measurement results for one or more body parts selected for monitoring; determining an average pressure value of the pressure measurement results; and assigning the patient to one risk category selected from a plurality of risk categories, based in part on the average pressure value of the pressure measurement results.

[0085] In one embodiment, the patient's risk level is entirely determined by pressure measurement. In one embodiment, the patient's risk level is entirely determined by the patient's visual examination. In one embodiment, the patient's risk level is entirely determined by the implementation of a risk assessment protocol on the patient. In one embodiment, the patient's risk level is determined by the patient's pressure measurement and visual examination. In one embodiment, the patient's risk level is determined by the implementation of a risk assessment protocol on the patient and the patient's visual examination. In one embodiment, the patient's risk level is determined by pressure measurement and the implementation of a risk assessment protocol on the patient. In one embodiment, the patient's risk level is determined by pressure measurement, the implementation of a risk assessment protocol on the patient, and the patient's visual examination. In one embodiment, there exists a protocol that generates a composite parameter that can be used to select the level of intervention by a combination of criteria.

[0086] In one embodiment, a patient is assigned to one risk category selected from multiple risk categories. In one embodiment, the risk categories include high-risk and high-risk categories. In one embodiment, the risk categories include low-risk and high-risk categories. In one embodiment, the risk categories include low-risk, high-risk, and high-risk categories. In one embodiment, there are one, two, three, four, five, six, seven, eight, nine, or ten risk categories. In one embodiment, the risk categories are associated with a corresponding level of medical care. In one embodiment, the risk categories are associated with a corresponding level of intervention. In one embodiment, the risk categories are associated with a corresponding frequency of subsequent pressure measurements.

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

[0088] How to assign patients to medical care and intervention levels In one embodiment, the Disclosure provides and encompasses a method for stratifying multiple patients in a medical care facility based on medical care levels, the method comprising: obtaining pressure measurement results for one of the multiple patients at one or more body locations selected for monitoring; determining the average pressure value of the patient's pressure measurement results; determining a medical care level from among N medical care levels that corresponds to the average pressure value; assigning the medical care level to the patient; and grouping the multiple patients based on each of the medical care levels assigned to the patient.

[0089] In one embodiment, patients are assigned to a medical care level based on their average pressure values. In one embodiment, a patient is assigned to a medical care level corresponding to an average pressure value from among N medical care levels. In one embodiment, there are one, two, three, four, five, six, seven, eight, nine, or ten medical care levels. In one embodiment, each of the N medical care levels corresponds to an average pressure value within a certain range. In one embodiment, a medical care level is associated with a corresponding intervention level. In one embodiment, a medical care level is associated with a corresponding frequency of subsequent pressure measurements. In one embodiment, multiple patients are grouped and arranged according to their respective assigned medical care levels. In one embodiment, multiple patients are grouped such that patients within a certain group are assigned to the same medical care level. In one embodiment, multiple patients are grouped such that patients within a certain group are given the same intervention.

[0090] In one embodiment, the Disclosure provides a method for identifying and providing an appropriate level of medical care to a patient in a medical care facility, comprising the steps of: obtaining multiple pressure measurement results from a patient at one or more body locations; determining an average pressure value from the patient's pressure measurement results; providing one or more biostructure-specific interventions based on the average pressure value; increasing the level of biostructure-specific interventions based on an increase in the average pressure value; and decreasing the level of biostructure-specific interventions based on a decrease in the average pressure value.

[0091] In one embodiment, patients are assigned to a medical care level based on their average pressure values. In one embodiment, the patient is assigned to a medical care level corresponding to an average pressure value from among N medical care levels. In one embodiment, there are one, two, three, four, five, six, seven, eight, nine, or ten medical care levels. In one embodiment, each of the N medical care levels corresponds to an average pressure value within a certain range. In one embodiment, the medical care levels are associated with a corresponding intervention level. In one embodiment, the medical care levels are 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 mean pressure, the intervention level is lowered. In one embodiment, the current intervention level continues until the mean pressure falls below a threshold. In one embodiment, if the mean pressure is decreasing, the intervention level may be lowered based on the magnitude of the mean pressure. If the patient's condition is worsening, for example, as evidenced by an increase in mean pressure, the intervention level is raised. In one embodiment, the current intervention level continues until the mean pressure rises above a threshold. In one embodiment, if the mean pressure is increasing, the intervention level may be raised based on the magnitude of the mean pressure.

[0093] In one embodiment, if the patient shows no improvement, assuming that the skin is not damaged, i.e., no open wound has developed, the process branches to an increased level of intervention. If an open wound has developed, pressure measurements will be taken around the open wound to map out inflammation or other signs of wound expansion. The open wound itself will be treated, and the area around it will be monitored until the wound closes.

[0094] In one embodiment, the biological structure-specific 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 mattress surfaces with low-friction pads.

[0095] In one embodiment, the decision to implement an intervention on a specific body part or a general intervention such as a high-performance mattress is based on the pressure value found at that body part in a pressure measurement scan. If the pressure value is below a predetermined threshold, no intervention is required. If the pressure value is above the predetermined threshold, an intervention is selected and implemented based on the body part and the average pressure value of that body part, respectively. The predetermined threshold for selecting and implementing an intervention may be higher or lower than the threshold for determining whether there is a possibility of injury at that body part.

[0096] Methods for managing medical care and nursing care In one embodiment, the Disclosure provides a method for managing a patient's medical care, comprising the steps of: obtaining a first set of pressure measurement results 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 measurement results; setting an intervention level of N=1 if one of the average pressure values ​​of the first set of pressure measurement results exceeds a first threshold; performing an intervention of level N for each of the one or more body locations where the average pressure value exceeds the first threshold; obtaining a subsequent set of pressure measurement results 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 aspect, 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, 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 coefficient or multiplier based on the values ​​given herein. It is understood that the threshold is not constrained by the design, but rather a person skilled in the art can select a predetermined value based on a given unit of pressure value. In one embodiment, the threshold of this disclosure is modified according to a specific part of the patient's body in which the measurement is being taken, or according to one or more of the patient's characteristics, such as age, height, weight, family history, ethnicity, and other physical characteristics or medical conditions.

[0098] In one embodiment, the range of N is 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 by which a first mean pressure value exceeds a first threshold. In one embodiment, an intervention at level N corresponds to a mean pressure value within a certain range. In one embodiment, an intervention at level N is associated with a corresponding biostructure-specific intervention. In one embodiment, an intervention at level N is associated with a corresponding frequency of subsequent pressure measurements. In one embodiment, an intervention at level N 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, and dynamic mattresses, support surfaces, silicone pads, low-friction sheet covers, and mattress surfaces with low-friction pads.

[0099] In one embodiment, the patient's medical care is discharge from or transfer to a medical care facility. In one embodiment, the patient's condition at the time of discharge or transfer is documented. In one embodiment, prior to discharge or transfer, a final set of pressure measurement results is obtained at one or more locations on the patient's body. In one embodiment, a final set of pressure measurement results is created at one or more locations on the patient's body. 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 that have not been previously identified as risk. In one embodiment, this information is provided to the receiving medical care provider.

[0100] Methods for identifying and treating patients at risk of tissue damage In one embodiment, the disclosure provides and encompasses a method for identifying and treating patients at risk of tissue damage. In one embodiment, the method includes the steps of: assessing a patient for risk of tissue damage upon admission to a medical care facility; obtaining a first set of pressure measurement results from the patient; determining a first mean pressure value from the first set of pressure measurement results; and implementing a first intervention at level 0 if the first mean pressure value is less than or equal to a first threshold; and implementing a first intervention at level N (where N is an integer greater than or equal to 1) if the first mean pressure value is greater than the first threshold. In one embodiment, the first mean pressure value is determined by a subset of the first set of pressure measurement results.

[0101] Figures 7A to 7D show circles indicating locations of tissue injury risk in a patient at various positions. In one embodiment, the first set of pressure measurements is obtained at or around one or more body locations selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient. In one embodiment, the first set of pressure measurements is obtained at or around one or more anatomical sites that are in prolonged contact with the medical device, the anatomical sites being selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen. In one embodiment, the first set of pressure measurements is separated into subgroups for analysis based on the approximate location where the measurements are obtained. In one embodiment, the mean pressure value is determined by a subset of the first set of pressure measurements. In one embodiment, the first set of pressure measurements is obtained at locations on one or more concentric circles centered on the anatomical site. In one embodiment, the first set of pressure measurements is obtained at locations on a straight line approximately equidistant from the anatomical site.

[0102] In one embodiment, the first pressure difference is determined by the difference between the maximum and minimum pressure values ​​from a first set of collected pressure measurement results. In one embodiment, the first pressure difference is determined by the difference between the maximum average pressure value of measurement results obtained at one location and the minimum average pressure value of measurement results obtained at a second location. In one embodiment, the first pressure difference is determined by the difference between the maximum average pressure value of measurement results obtained at one location and the absolute minimum pressure value of measurement results obtained at a second location. In one embodiment, the first pressure difference is determined by the difference between the absolute maximum pressure value of measurement results obtained at one location and the minimum average pressure value of measurement results obtained at a second location. In one embodiment, the first pressure difference is determined by the difference between the maximum average pressure value and the minimum average pressure value of measurement results obtained at the same location at different times. In one embodiment, the first pressure value is determined for a portion of the first set of pressure measurement results, which are comprised of subgroups defined by the acquisition locations. In one embodiment, the average pressure value at a certain location is determined from two, three, four, five, six, seven, eight, nine, ten, or eleven or more pressure values ​​measured at that location. In one embodiment, the first pressure difference is determined by the difference in average pressure values ​​derived from measurement results obtained at two symmetrical locations with respect to a center line. In one embodiment, the first pressure difference is the difference in absolute pressure values ​​derived from measurement results obtained at two symmetrical locations with respect to a center line. In one embodiment, the first pressure difference 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 embodiment, the pressure value may be calculated from a plurality of pressure measurement results made at or very close to a specific location in one of the methods disclosed herein. In one embodiment, a plurality of pressure measurement results are made in a predetermined pattern on the skin, and the pressure value is calculated by subtracting the pressure value associated with a predetermined location in the pattern from the maximum pressure value made at other locations in the pattern. In one embodiment, a plurality of pressure measurement results are made in a predetermined pattern on the skin, and the pressure value is calculated by identifying the pressure value associated with a predetermined location in the pattern and subtracting the maximum pressure value made at other locations in the pattern. In one embodiment, the average pressure value may be calculated from a portion of a set of pressure values ​​generated by a plurality of pressure measurement results 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 embodiment, the average pressure value may be calculated as the ratio of the maximum pressure value in a set of pressure values ​​to the minimum pressure value.

[0104] In one aspect, 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, 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 coefficient or multiplier based on the values ​​given herein. It is understood that the threshold is not constrained by the design, but rather a person skilled in the art can select a predetermined value based on a given unit of pressure value. In one embodiment, the threshold of this disclosure is modified according to a specific part of the patient's body in which the measurement is being taken, or according to one or more of the patient's characteristics, such as age, height, weight, family history, ethnicity, and other physical characteristics or medical conditions.

[0105] In one embodiment, the range of N is 1 to 50 (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, etc.).

[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 set for (N+1) exceeds the first threshold is greater than the amount by which the threshold set for N exceeds the first threshold. In one embodiment, the amount by which the threshold set for (N-1) exceeds the first threshold is less than the amount by which the threshold set for N exceeds the first threshold. In one embodiment, the threshold set for (N+1) is greater than the threshold set for N. In one embodiment, the threshold set for N is greater than the threshold set for (N-1).

[0107] Selection of intervention level In one embodiment, a Level 1 (N=1) intervention is applied to patients whose average pressure value exceeding the threshold is 100% or less of the threshold (e.g., 95% 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 1 intervention is applied to the site where the measurement was taken.

[0108] In one embodiment, Level 2 (N=2) intervention is applied to patients whose average pressure value exceeding the threshold is 150% or less of the threshold (e.g., 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 2 intervention is applied to the site where the measurement was taken.

[0109] In one embodiment, Level 3 (N=3) intervention is applied to patients whose average pressure value exceeding the threshold is 200% or less of the threshold (e.g., 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 3 intervention is applied to the area where the measurement was performed.

[0110] In one aspect, 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, 13 Level 4 intervention (N=4) is applied to patients with a blood glucose level 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 to the site where the measurement was taken.

[0111] In one aspect, the average pressure value exceeding 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% or less, 16 Level 5 intervention (N=5) is applied to patients with a blood glucose level of 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, etc. In one embodiment, Level 5 intervention is applied to the site where the measurement was taken.

[0112] In one aspect, 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, 18 Level 6 intervention (N=6) is applied to patients with a blood glucose level of 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, etc. In one embodiment, Level 6 intervention is applied to the site where the measurement was taken.

[0113] In one aspect, 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) intervention is applied to patients with a percentage of 0%, 205%, 200%, 195%, 190%, 185%, 180%, 175%, 170%, 165%, 160%, 155%, 150%, 145%, 140%, 135%, 130%, 125%, 120%, 115%, 110%, 100%, 95%, 90%, 85%, 80%, 75%, 70%, 65%, 60%, 55%, 50%, 45%, 40%, 35%, 30%, 25%, 20%, 15%, 10%, or 5%, etc. In one embodiment, a Level 7 intervention is applied to the area where the measurement was performed.

[0114] In one aspect, the average pressure value exceeding 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 intervention (N=8) is applied to patients whose percentage is 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%, etc. In one embodiment, Level 8 intervention is applied to the site where the measurement was taken.

[0115] In one aspect, 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, 395% or less). 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 intervention (N=9) is applied to patients with a percentage of 0%, 125%, 120%, 115%, 110%, 100%, 95%, 90%, 85%, 80%, 75%, 70%, 65%, 60%, 55%, 50%, 45%, 40%, 35%, 30%, 25%, 20%, 15%, 10%, or 5%, etc. In one embodiment, Level 9 intervention is applied to the site where the measurement was taken.

[0116] In one aspect, the mean pressure value located at 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). , 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 applied to patients whose percentage is 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 applied to the site where the measurement was taken.

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

[0118] Methods for identifying and treating patients at risk of tissue damage (subsequent imaging) In one embodiment, the disclosure further provides and includes the steps of: obtaining a second set of pressure measurement results of a patient at a first predetermined frequency corresponding to the level of intervention performed; determining a second average pressure value from the second set of pressure measurement results; determining whether the second average pressure value exceeds a second threshold; continuing to perform the first intervention if the second average pressure value does not exceed the second threshold; continuing to obtain a second set of pressure measurement results at a first predetermined frequency if the second average pressure value does not exceed the second threshold; performing a second intervention of level M (where M is an integer greater than N) if the second average pressure value exceeds the second threshold; and obtaining a second set of pressure measurement results at a 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 1 hour, and at least once every half hour.

[0120] In one embodiment, the second set of multiple pressure measurements is obtained at or around one or more body locations selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient. In one embodiment, the second set of multiple pressure measurements is obtained at or around one or more anatomical sites that are in prolonged contact with the medical device, the anatomical sites being selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen. In one embodiment, the second set of multiple pressure measurements is separated into subgroups for analysis based on the approximate location where the measurement results are obtained. In one embodiment, a second mean pressure value is determined by a subset of the second set of multiple pressure measurements. In one embodiment, the second set of multiple pressure measurements is obtained at locations on one or more concentric circles centered on the anatomical site. In one embodiment, the second set of multiple pressure measurements is obtained at locations on a straight line approximately equidistant from the anatomical site.

[0121] In one embodiment, the second pressure difference is determined by the difference between the maximum and minimum pressure values ​​from a second set of collected pressure measurements. In one embodiment, the second pressure difference is determined by the difference between the maximum average pressure value of measurements taken at one location and the minimum pressure value of measurements taken at a second location. In one embodiment, the second pressure difference is determined by the difference between the maximum average pressure value of measurements taken at the same location and the minimum pressure value of the measurements. In one embodiment, the second average pressure value is determined for a portion of the second set of pressure measurements, consisting of subgroups defined by the acquisition locations. In one embodiment, the second average pressure value at a location is obtained from two, three, four, five, six, seven, eight, nine, ten, or eleven or more pressure values ​​measured at that location. In one embodiment, the second pressure difference is determined by the difference in average pressure values ​​derived from measurements taken at two symmetrical locations with respect to a centerline. In one embodiment, a second set of pressure measurement results is generated at the same location where the first set of pressure measurement results was obtained. In one embodiment, a second set of pressure measurement results is generated in a portion of the same location where the first set of pressure measurement results was obtained. In one embodiment, a second set of pressure measurement results is generated near the location where the first set of pressure measurement results was obtained. In one embodiment, a second set of pressure measurement results is generated at a location different from where the first set of pressure measurement results was obtained.

[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, 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 coefficient or multiplier based on the values ​​given herein. In one embodiment, the second threshold may be 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 smaller than the first threshold.

[0123] In one aspect, the second average pressure value is 0.1 to 99.5% of the second threshold (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%). Percentages of ~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%, etc., are possible.

[0124] In one embodiment, the range of M is 2 to 50 (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, etc.).

[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 set for (M+1) exceeds the second threshold is greater than the amount by which the threshold set for M exceeds the second threshold. In one embodiment, the amount by which the threshold set for (M-1) exceeds the second threshold is less than the amount by which the threshold set for M exceeds the second threshold. In one embodiment, the threshold set for (M+1) is greater than the threshold set for M. In one embodiment, the threshold set for M is greater than the threshold set for (M-1).

[0126] In one embodiment, an intervention of level M is selected according to the above “Selection of Intervention Level” in this disclosure, with N replaced by M.

[0127] In one embodiment, the disclosure further provides and includes the steps of: determining whether a second average pressure value is less than or equal to a third threshold; continuing to perform a first intervention if the second average pressure value is less than the third threshold; continuing to acquire a plurality of pressure measurement results at a first predetermined frequency if the second average pressure value is greater than or equal to the third threshold; performing a third intervention at level L (where 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 at level 0; and acquiring a plurality of pressure measurement results at a predetermined frequency corresponding to level L if the second average pressure value is less than the third threshold.

[0128] In one embodiment, the range of L is 0 to 50 (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, etc.).

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

[0130] In one aspect, 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, 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 coefficient or multiplier based on the values ​​given herein. In one embodiment, the third threshold may be 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 can be greater than the second threshold. In one embodiment, the third threshold can be smaller than the second threshold.

[0131] In one aspect, the second average pressure value is 0.1 to 99.5% of the third threshold (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% of the third threshold). Percentages of ~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%, etc., are possible.

[0132] In one embodiment, an intervention of level L is selected according to the above “Selection of Intervention Level” in this disclosure, with N replaced by L.

[0133] In one embodiment, Level N interventions are 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, dynamic mattresses, support surfaces, silicone pads, low-friction sheet covers, and mattress surfaces with low-friction pads. In one embodiment, Level M interventions are 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, dynamic mattresses, support surfaces, silicone pads, low-friction sheet covers, and mattress surfaces with low-friction pads. In one embodiment, Level L interventions are 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, dynamic mattresses, support surfaces, silicone pads, low-friction sheet covers, and mattress surfaces with low-friction pads.

[0134] Methods to slow the progression of skin and tissue damage In one embodiment, the Disclosure provides and encompasses a method for slowing the progression of a patient's skin and tissue damage as needed, comprising: identifying a current level K intervention the patient is receiving; obtaining a plurality of pressure measurement results from the patient; calculating an average pressure value from a subset of the plurality of pressure measurement results; determining whether the average pressure value exceeds a first threshold; if the average pressure value does not exceed the first threshold, continuing the current intervention; if the average pressure value does not exceed the first threshold, continuing to obtain a plurality of pressure measurement results at a predetermined frequency corresponding to level K; if the average pressure value exceeds the first threshold, implementing a new level N (where N is a value greater than K) intervention; and if the average pressure value exceeds the first threshold, obtaining a plurality of pressure measurement results at a predetermined frequency corresponding to level N.

[0135] In one embodiment, the patients in need are those experiencing changes in medical care, mobility, nutrition, sensory changes, or a combination thereof. In one embodiment, the patients in need are those who have developed an open wound. In one embodiment, the patients in need are those whose open wounds have healed. In one embodiment, the patients in need are those undergoing surgery. In one embodiment, the patients who require this are those who have recovered from surgery. In one embodiment, the patients who require this are those who receive spinal or sacral analgesics during surgery. In one embodiment, the patients who require this are those who undergo surgery for a duration of 4 hours or more (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, etc.). In one embodiment, the duration of the surgery is 1 hour or more (2 hours or more or 3 hours or more, etc.).

[0136] In one embodiment, multiple pressure measurements are obtained at or around one or more body locations selected from a group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient. In one embodiment, multiple pressure measurements are obtained at or around one or more anatomical sites that are in prolonged contact with the medical device, the anatomical sites being selected from a group consisting of the cheek, nose, chest, stomach, and lower abdomen. In one embodiment, multiple pressure measurements are separated into subgroups for analysis based on the approximate location where the measurements are obtained. In one embodiment, the average pressure value is determined by a subset of the multiple pressure measurements. In one embodiment, multiple pressure measurements are obtained at locations on one or more concentric circles centered on the anatomical site. In one embodiment, multiple pressure measurements are obtained at locations on a straight line approximately equidistant from the anatomical site.

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

[0138] In one aspect, 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, 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 coefficient or multiplier based on the values ​​given herein.

[0139] In one embodiment, the range of K is 2 to 50 (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, etc.).

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

[0141] In one embodiment, an intervention of level K is selected according to the above “Selection of intervention level” in this disclosure, with N replaced by K.

[0142] In one embodiment, the disclosure further provides and includes the steps of determining whether the average pressure value is less than a second threshold, if the average pressure value is less than the second threshold, performing an intervention of level L (where L is a non-negative value less than K), and if the average pressure value is less than the second threshold, producing pressure measurement results 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, 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 coefficient or multiplier 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 smaller 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, if 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%), L is K-1, except when K-1 is less than 0 (in this case, L is 0). In one embodiment, when the average pressure value is 80-89.9% of the second threshold (e.g., 80-85%, 81-86%, 82-87%, 83-88%, 84-89%, or 85-89.9%), L is K-2, except when K-2 is less than 0 (in this case, L is 0). In one embodiment, when the average pressure value is 70-79.9% of the second threshold (e.g., 70-75%, 71-76%, 72-77%, 73-78%, 74-79%, or 75-79.9%), L is K-3, except when K-3 is less than 0 (in this 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 this 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 this 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 this 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 this 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 this 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 this case, L is 0). In one embodiment, when the average pressure value is 0.1 to 9.9% of the second threshold (e.g., 0.1 to 5%, 1 to 6%, 2 to 7%, 3 to 8%, 4 to 9%, or 5 to 9.9% of the second threshold), L is K-10, except when K-10 is less than 0 (in this case, L is 0).

[0145] Methods for identifying and treating patients who require intervention for pressure ulcers. In one embodiment, the present disclosure provides a method for identifying and treating a patient who requires intervention for a pressure ulcer, comprising the steps of: obtaining multiple pressure measurement results at an anatomical site of the patient; determining the average pressure value of the multiple pressure measurement results; determining whether the average pressure value exceeds a threshold corresponding to level N (where N is 2 or greater); if the average pressure value exceeds the threshold, performing an intervention for the pressure ulcer at the anatomical site; and if the average pressure value exceeds the threshold, obtaining multiple pressure measurement results every two hours.

[0146] In one embodiment, the anatomical sites are selected from a group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient.

[0147] In one embodiment, interventions for pressure ulcers 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 sheet covers, and mattress surfaces with low-friction pads.

[0148] In one embodiment, the Disclosure provides and encompasses a method for identifying and treating a patient who requires the application of a barrier cream to the patient's heel, the method comprising: creating a plurality of pressure measurement results on the patient's heel; calculating an average pressure value from a subset of the plurality of pressure measurement results; determining whether the average pressure value exceeds a threshold corresponding to level N (where N is 2 or greater); if the average pressure value exceeds the threshold, applying the barrier cream to the patient's heel; and if the average pressure value exceeds the threshold, creating a plurality of pressure measurement results every two hours. In one embodiment, if the average pressure value exceeds the threshold, a plurality of pressure measurement results are created at least once every hour or at least once every half hour.

[0149] In one embodiment, the Disclosure provides and encompasses a method for identifying and treating a patient who requires the application of neuromuscular stimulation to the patient's heel, the method comprising: creating a plurality of pressure measurement results at the patient's heel; calculating an average pressure value from a subset of the plurality of pressure measurement results; determining whether the average pressure value exceeds a threshold corresponding to level N (where N is 2 or greater); if the average pressure value exceeds the threshold, applying neuromuscular stimulation to the patient's heel; and if the average pressure value exceeds the threshold, creating a plurality of pressure measurement results every hour. In one embodiment, if the average pressure value exceeds the threshold, a plurality of pressure measurement results are created at least once every half hour.

[0150] In one embodiment, the Disclosure provides and encompasses a method for identifying and treating a patient who requires the application of a topical cream to the patient's heel, the method comprising: creating a plurality of pressure measurement results on the patient's heel; calculating an average pressure value from a subset of the plurality of pressure measurement results; determining whether the average pressure value exceeds a threshold corresponding to level N (where 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, creating a plurality of pressure measurement results every half hour.

[0151] In one embodiment, the Disclosure provides and encompasses a method for identifying and treating a patient who requires the application of heel boots to the patient's heel, the method comprising: creating a plurality of pressure measurement results at the patient's heel; calculating an average pressure value from a subset of the plurality of pressure measurement results; determining whether the average pressure value exceeds a threshold corresponding to level N (where N is 2 or greater); if the average pressure value exceeds the threshold, applying heel boots to the patient's heel; and if the average pressure value exceeds the threshold, creating a plurality of pressure measurement results every half hour.

[0152] In one embodiment, the Disclosure provides and encompasses a method for identifying and treating a patient who requires the application of a barrier cream to the patient's sacrum, the method comprising: creating a plurality of pressure measurement results at the patient's sacrum; calculating an average pressure value from a subset of the plurality of pressure measurement results; determining whether the average pressure value exceeds a threshold corresponding to level N (where N is 2 or greater); if the average pressure value exceeds the threshold, applying the barrier cream to the patient's sacrum; and if the average pressure value exceeds the threshold, creating a plurality of pressure measurement results every 6 hours. In one embodiment, if the average pressure value exceeds the threshold, the plurality of pressure measurement results are created at least once every 4 hours, at least once every 3 hours, at least once every 2 hours, at least once every 1 hour, or at least once every half hour.

[0153] In one embodiment, the Disclosure provides and encompasses a method for identifying and treating a patient who requires the application of neuromuscular stimulation to the patient's sacrum, the method comprising: creating a plurality of pressure measurement results at the patient's sacrum; calculating an average pressure value from a subset of the plurality of pressure measurement results; determining whether the average pressure value exceeds a threshold corresponding to level N (where N is 2 or greater); applying neuromuscular stimulation to the patient's sacrum if the average pressure value exceeds the threshold; and creating a plurality of pressure measurement results every four hours if the average pressure value exceeds the threshold. In one embodiment, if the average pressure value exceeds the threshold, a plurality of pressure measurement results are created 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 embodiment, the Disclosure provides and encompasses a method for identifying and treating a patient who requires the application of a topical cream to the patient's sacrum, the method comprising: creating a plurality of pressure measurement results on the patient's sacrum; calculating an average pressure value from a subset of the plurality of pressure measurement results; determining whether the average pressure value exceeds a threshold corresponding to level N (where N is 2 or greater); if the average pressure value exceeds the threshold, applying the topical cream to the patient's sacrum; and if the average pressure value exceeds the threshold, creating a plurality of pressure measurement results every two hours. In one embodiment, if the average pressure value exceeds the threshold, a plurality of pressure measurement results are created at least once every hour or at least once every half hour.

[0155] In one embodiment, the Disclosure provides and encompasses a method for identifying and treating a patient requiring the application of ultrasound therapy, comprising the steps of: creating a plurality of pressure measurement results at an anatomical site of the patient; calculating an average pressure value from a subset of the plurality of pressure measurement results; determining whether the average pressure value exceeds a threshold corresponding to level N (where N is 2 or greater); applying ultrasound therapy to the anatomical site if the average pressure value exceeds the threshold; and creating a plurality of pressure measurement results every two hours if the average pressure value exceeds the threshold. In one embodiment, the anatomical site is selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient.

[0156] In one embodiment, the Disclosure provides and encompasses a method for identifying and treating a patient requiring the application of shock wave therapy, comprising the steps of: creating a plurality of pressure measurement results at an anatomical site of the patient; calculating an average pressure value from a subset of the plurality of pressure measurement results; determining whether the average pressure value exceeds a threshold corresponding to level N (where N is 2 or greater); applying shock wave therapy to the anatomical site if the average pressure value exceeds the threshold; and creating a plurality of pressure measurement results every two hours if the average pressure value exceeds the threshold. In one embodiment, the anatomical site is selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient. In one embodiment, the shock wave therapy is provided by electromagnetic pulses or pressurized air.

[0157] In one embodiment, the Disclosure provides and encompasses a method for identifying and treating a patient requiring the application of a 30-degree wedge, comprising the steps of: creating a plurality of pressure measurement results at an anatomical site of the patient; calculating an average pressure value from a subset of the plurality of pressure measurement results; determining whether the average pressure value exceeds a threshold corresponding to level N (where N is 2 or greater); applying the 30-degree wedge to the anatomical site if the average pressure value exceeds the threshold; and creating a plurality of pressure measurement results every two hours if the average pressure value exceeds the threshold. In one embodiment, the anatomical site is selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient.

[0158] In one embodiment, the Disclosure provides and encompasses a method for identifying and treating a patient requiring the application of a composite dressing, comprising the steps of: creating a plurality of pressure measurement results at an anatomical site of the patient; calculating an average pressure value from a subset of the plurality of pressure measurement results; determining whether the average pressure value exceeds a threshold corresponding to level N (where N is 2 or greater); 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, creating a plurality of pressure measurement results every two hours. In one embodiment, the anatomical site is selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient.

[0159] In one embodiment, the Disclosure provides and encompasses a method for identifying and treating a patient requiring a hybrid mattress, comprising the steps of: creating a plurality of pressure measurement results at an anatomical site of the patient; calculating an average pressure value from a subset of the plurality of pressure measurement results; determining whether the average pressure value exceeds a threshold corresponding to level N (where N is 2 or greater); providing the hybrid mattress to support the patient if the average pressure value exceeds the threshold; and creating a plurality of pressure measurement results every two hours if the average pressure value exceeds the threshold. In one embodiment, the anatomical site is selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient.

[0160] In one embodiment, the Disclosure provides and encompasses a method for identifying and treating a patient requiring a dynamic mattress, comprising the steps of: creating a plurality of pressure measurement results at an anatomical site of the patient; calculating an average pressure value from a subset of the plurality of pressure measurement results; determining whether the average pressure value exceeds a threshold corresponding to level N (where N is 2 or greater); providing the dynamic mattress to support the patient if the average pressure value exceeds the threshold; and creating a plurality of pressure measurement results every two hours if the average pressure value exceeds the threshold. In one embodiment, the anatomical site is selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient.

[0161] In one embodiment, the Disclosure provides and encompasses a method for identifying and moving a bedridden patient in need, comprising the steps of: providing a motion sensor equipped with an accelerometer and a gyro sensor; monitoring the frequency and range of the patient's movement; issuing an alarm if the motion sensor does not detect movement of more than 1 / 4 rotation over a specified period of time; and moving the patient in response to the alarm.

[0162] In one embodiment, the disclosure further provides and encompasses a step of applying a structure-specific intervention to an anatomical site of a patient identified as injured by a combination of visual assessment and pressure measurement results. In one embodiment, the structure-specific intervention is applied 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 embodiment, the structure-specific intervention is also applied simultaneously 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 embodiment, the first site receiving the structure-specific intervention is known to be the cause of wound development at the second site.

[0163] Identification of damaged tissue by comparing symmetrical pressure measurement results. In one embodiment, the Disclosure provides and encompasses a method for identifying damaged tissue, comprising the steps of: obtaining a first pressure measurement result from a first site on the skin of a patient; obtaining a second pressure measurement result from a second site symmetrical to the first site; determining the average pressure value of the first and second pressure measurement results, respectively; determining the average pressure value from the first and second pressure measurement results, respectively; determining the difference in average pressure values ​​between the first and second pressure measurement results; and determining that if the difference in average pressure values ​​exceeds a threshold, tissue damage is present at the first or second site.

[0164] Figure 4A shows the sacral region of patient 410's back. By drawing a line of symmetry 412 down the center of the back, the back can be divided into left and right mirror images. Location 414 is at approximately the same distance and height as the line of symmetry 412, and is therefore considered to be a symmetrical location on patient 410's back.

[0165] Figure 4B shows the left foot 420L and right foot 420R of patient 410 as seen when the patient 410 is lying supine on a bed (not shown) and an observer is standing at the foot of the bed. With respect to the soles 422L and 422R of feet 420L and 420R, locations 424L and 424R are considered to be approximately equivalent locations (for example, on the posterior surface, i.e., at the same distance from the heel and at the same distance from the inner side of each foot 420L or 420R) and are considered to be symmetrical.

[0166] Figure 4C shows additional exemplary bilaterally symmetrical locations 432L and 432R located on the sides of feet 420L and 420R, and bilaterally symmetrical locations 434L and 434R located on the back surfaces 422L and 422R of feet 420L and 420R, respectively. In one embodiment, locations 432R and 430R are considered bilaterally symmetrical with respect to foot 420R when considered independently without reference to foot 420L.

[0167] Without being limited to any particular theory, comparing pressure measurements obtained at symmetrical locations can compensate for the offset of a particular patient's measurements from the patient population. For example, a patient may be dehydrated on a particular day when measurements are taken. A comparison of pressure values ​​in healthy tissue of the same patient in a dehydrated state may deviate from the pressure values ​​in the same tissue at the same location when the patient is adequately hydrated. If tissue at one location is healthy while tissue at a symmetrical location is damaged, comparing measurements obtained at symmetrical locations will more reliably indicate that tissue is damaged at one location by excluding the "common mode" effect of dehydration fluctuations at both locations.

[0168] For measurements at multiple locations (for example, a first measurement at a first location and a second measurement at a second location symmetrical to the first location), a pressure measuring device 600 as shown in Figure 6 may be used. In one embodiment, the device 600 may include a processor that can be configured to determine the characteristics of measurement results obtained at multiple locations or parameters associated with the measurement results or parameters derived from the measurement results (for example, one or more of the differences, averages, or differences from a common mean of pressure values ​​derived from each of the multiple measurement results) by instructions stored in a non-transient computer-readable medium. In one embodiment, the device 600 may include a display configured to display one or more parameters associated with the measurement results (for example, an average pressure value derived from measurement results obtained at two symmetrical locations).

[0169] In one embodiment, the difference in average pressure values ​​is determined, and a difference exceeding a predetermined threshold indicates tissue damage at one of the locations where the corresponding pressure measurement results were obtained. In one embodiment, the average of the pressure values ​​obtained at each symmetrical location is determined and compared. In one embodiment, the median or mode of the average pressure values ​​obtained at each symmetrical location is determined and compared. In one embodiment, damage is shown to be associated with a larger average pressure value. In one embodiment, damage is shown to be associated with a smaller average pressure value. In one embodiment, the determination of whether tissue damage is present includes one or more comparisons of individual average pressure values ​​against one or more predetermined ranges or thresholds, and comparisons of differences against one or more predetermined ranges or thresholds. In one embodiment, the specified range may be 0.1 to 8.0 (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, etc.). In one embodiment, the specified range may be 0.1 to 4.0 (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, etc.). In one embodiment, the specified 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 aspect, 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, 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 coefficient or multiplier based on the values ​​given herein. It is understood that the predetermined value is not constrained by the design, but rather that a person skilled in the art can select the predetermined value. In one embodiment, the scope and thresholds of this disclosure may be modified according to specific bilateral symmetrical locations, parts of the patient's body on which measurements are 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 areas of the body may be defined. In one embodiment, measurements taken within a certain area are considered comparable to one another. An area may be defined as an area on the skin of the body from which measurement results can be obtained at any point within it. In one embodiment, the region corresponds to an anatomical region (e.g., heel, ankle, hip). In one embodiment, the region may be defined as a set of two or more specific points for an anatomical feature where the measurement results can only be obtained. In one embodiment, the region may include multiple discontinuous regions on the body. In one embodiment, a set of specific locations may include points in multiple discontinuous areas.

[0171] In one embodiment, the region is defined by its surface area. In one embodiment, the region is, for example, 5 to 200 cm². 2 5-100cm 2 , 5-50cm 2 , 10-50cm 2 10-25cm 2 , or 5-25cm 2 That's fine.

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

[0173] In one embodiment, the pressure measuring device of the present disclosure may further comprise a plurality of contact sensors that surround each receiver on the same plane, thereby bringing the device into complete contact with the skin surface. The plurality of contact sensors may comprise a plurality of pressure sensors, a plurality of light sensors, a plurality of temperature sensors, a plurality of pH sensors, a plurality of sweat sensors, a plurality of ultrasonic sensors, a plurality of bone growth promoting sensors, or a plurality of combinations thereof. In one embodiment, the plurality of contact sensors may comprise four, five, six, seven, eight, nine, or ten or more contact sensors.

[0174] Figures 5A and 5B illustrate an example of a method relating to the present disclosure for identifying symmetrical locations by comparing pressure values ​​associated with measurement results at known relative locations. In this example, pressure measuring devices 630 are shown at non-overlapping locations marked "A" to "H" in Figure 5A, traversing the contact area 502R of the right foot (e.g., 420R in Figure 4C). The pressure values ​​measured at each location are plotted in the graph of Figure 5B. In this example, the pressure values ​​at locations "A" and "H" are few or zero, reflecting that the pressure measuring devices 630 do not overlap with the contact area 502R at these locations. The numerous pressure values ​​associated with locations "B" and "G" indicate that the pressure measuring devices 630 overlap with parts of the contact area 502R at these locations. The numerous pressure values ​​at locations CDEF are approximately the same in this example, indicating that the pressure measuring devices 630 are entirely within the contact area 502R at these locations. In one embodiment, a pressure measuring device such as a pressure measuring instrument 630 may determine that specific locations (for example, locations "C" and "F") are symmetrical with respect to the center line 504R of the right foot 420R. In one embodiment, if a similar set of measurements is performed at locations A' to H' on the left foot 420L, locations on each foot 420L and 420R (for example, locations E and E') may be determined to be approximately symmetrical.

[0175] Figure 6 is a schematic diagram of an integrated system 600 for measuring, evaluating, storing, and transmitting pressure measurement results according to the present disclosure. In this example, the system 600 comprises a Wi-Fi access point 610 and a pressure measuring device 630 that is wirelessly capable of doing so. The pressure measuring device 630 communicates with one or more of the following: 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, the laptop computer 620 and the smartphone 640 are carried by the user of the pressure measuring device 630 (e.g., a nurse), and the application provides feedback and information to the user. In one embodiment, patient information received from the pressure measuring device 630 is stored in a database 660. In one embodiment, the information received from the pressure measuring device 630 is transmitted via a network 655 to another server 680, which stores some of the information in the patient's electronic medical record (EMR) 670. In one embodiment, information from the pressure measuring device 630 or information read from the database 660 or EMR 670 is transferred to an external server 690 and then to a computer 695 (for example, a computer in the office of a doctor providing medical care to a patient).

[0176] Methods for detecting tissue damage before it becomes visible In one embodiment, the Disclosure provides and encompasses a method for detecting tissue damage before it becomes visible on a patient's skin, comprising the steps of: acquiring a plurality of pressure measurements at a location on the patient's skin with a time delay; determining an average pressure value from each of the plurality of pressure measurements; calculating the slope between the most recent pressure value and the previous pressure value; comparing the slope to a threshold; and determining that tissue damage is present if the derivative exceeds the threshold. In one embodiment, the method is performed at multiple locations.

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

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

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

[0180] In one embodiment, the Disclosure provides and encompasses a method for detecting tissue damage before it becomes visible on a patient's skin, comprising the steps of: acquiring a plurality of pressure measurement results at a location on the patient's skin at a plurality of time differences; determining an average pressure value from each of the plurality of pressure measurement results; calculating the difference between a maximum average pressure value and a minimum average pressure value for each time difference; fitting a curve to a predetermined number of recent difference values; calculating the curvature of the fitted curve; comparing this curvature to a threshold; and determining that tissue damage is present if the curvature exceeds the threshold. In one embodiment, the method is performed at a plurality of locations.

[0181] In one embodiment, the curvature of the fitting curve of the differential value over time indicates tissue damage. In another embodiment, an increase in the curvature of the fitting curve of the differential value over time indicates worsening of tissue damage. In another embodiment, an increase in the curvature of the fitting curve of the differential value over time indicates the formation of a pressure ulcer.

[0182] In one embodiment, multiple pressure measurement results are acquired with a time difference. In one embodiment, the time difference is approximately once every 1 second, once every 15 seconds, once every 30 seconds, once every 1 minute, once every 10 minutes, once every 15 minutes, once every 30 minutes, once every 1 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 1 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, and once every 10 days.

[0183] In one aspect, the 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, 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 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 may be scaled by a coefficient or multiplier based on the values ​​given herein. It is understood that the threshold is not constrained by the design, but rather that a person skilled in the art can select a predetermined value. In one embodiment, the threshold of this disclosure may be modified according to a specific part of the patient's body being measured, 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.

[0184] In one embodiment, the number of pressure values ​​exceeding a predetermined threshold indicates epidermal damage that may lead to a pressure ulcer. The time interval between the first occurrence of a pressure value above this threshold and the onset of visible symptoms of a pressure ulcer may represent a first duration in which the pressure value increases linearly. This first duration may be five days or longer (six days or longer, seven days or longer, eight days or longer, nine days or longer, or ten days or longer).

[0185] In another embodiment, if a plot of pressure values ​​over time shows an upward curvature or other deviation rather than a linear progression, visible symptoms may appear within a shorter time (e.g., 2-3 days, 1-4 days, 1-3 days, 1-2 days, or 2-4 days). These pressure values ​​are tracked, and the trend of the pressure values, i.e., the slope and curvature of the curve connecting these pressure values, is analyzed. In one embodiment, the amount by which an incremental pressure value exceeds a linear prediction based on a preceding pressure value is compared to a predetermined threshold. In another 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 another embodiment, sequential pressure values ​​exceeding 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 each threshold.

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

[0187] In one embodiment, the trend curve of the pressure value is a straight line connection between points. In another embodiment, this trend curve is a best-fit curve adapted to the pressure value. In another embodiment, the adapted curve is required to intersect with the nearest number of pressure values.

[0188] The present invention has been broadly described above, but the same will be more readily apparent by referring to the following examples, which are provided for illustrative purposes and are not intended to limit the present disclosure unless otherwise specified. [Examples]

[0189] Example 1: Intervention level for treating heel pressure ulcers

[0190] Subjects identified as being at risk of heel pressure ulcers will be treated according to the following scheme.

[0191] One or more pressure measurements of the patient's heel are obtained. The pressure values ​​are calculated. As shown in Table 1, patients are assigned an intervention level based on their mean pressure value compared to their threshold intensity. An appropriate intervention corresponding to the assigned intervention level is then performed. Furthermore, subsequent pressure measurements are performed at a frequency determined by the assigned intervention level. The patient's assigned intervention level may be changed (up or down) or kept the same depending on the average pressure value of the subsequent measurements.

[0192] JPEG2026062821000002.jpg156170

[0193] Example 2: Intervention level for treating sacral pressure ulcers

[0194] Subjects identified as being at risk of sacral pressure ulcers will be treated according to the following scheme.

[0195] One or more pressure measurements are taken from the patient at the sacrum. The mean pressure value is calculated. As shown in Table 2, the patient is assigned an intervention level based on the mean pressure value compared to the threshold intensity. 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 (up or down) or kept the same depending on the mean pressure value of the subsequent measurements.

[0196] JPEG2026062821000003.jpg140170

[0197] Example 3: Treatment decision pathway for stratifying patients and providing appropriate treatment.

[0198] Pressure ulcers are classified into stages 1 through 4, with stage 1 being the least severe. The National Pressure Ulcer Advisory Committee (NPUAP) defines a stage 1 ulcer as a localized non-blanchable erythema on intact skin. Erythema (redness of the superficial layer of skin) is classified as "blanchable" if it turns white when pressed, or "non-blanchable" if it remains red when pressed, and is thought to be caused by the presence of red blood cells outside the blood vessels (petechiae). In some patients, blanchable erythema or changes in sensation, temperature, or hardness may precede any visible changes. While all patients are potentially at risk, pressure ulcers are more likely to occur in patients with serious illnesses or those with neurological disorders, motor impairments, nutritional deficiencies, poor posture, or deformities.

[0199] Currently, visual skin assessment (VSA) is the method used to identify pressure ulcers. Trained healthcare professionals visually and tactilely assess the appearance of the skin to check for redness or tissue hardness, tissue temperature, or changes in moisture content.

[0200] Figure 1A outlines the currently recommended treatment decision pathways for preventing pressure ulcers in hospitalized patients, as presented in the clinical guidelines "Pressure ulcers: prevention and management," published by the National Institute for Health and Care Excellence (NICE) on April 23, 2014. These guidelines recommend that all patients admitted to healthcare facilities undergo a risk analysis identifying one or more risk factors, such as significantly restricted mobility, significant sensory loss, past or present pressure ulcers, malnutrition, inability to reposition oneself, or significant cognitive impairment. Risk assessment is generally performed using score-based checklists, such as the Braden Scale, which assess 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, mobility, friction and shear, and nutritional status.

[0201] Risk assessment identifies patients as (i) low risk of developing pressure ulcers, (ii) at risk of developing pressure ulcers, or (iii) high risk of developing pressure ulcers. Patients receive treatment and follow-up assessments with visual evaluation in a different sequence depending on their classified risk level.

[0202] If a patient is identified as being at low risk of developing pressure ulcers, only changes in their clinical condition (e.g., events such as surgery, worsening of underlying conditions, changes in mobility) are monitored. Patients using wheelchairs or those who sit for extended periods may be provided with high-performance foam chair cushions or equivalent pressure-relieving cushions. If there are no changes in clinical condition, low-risk patients will not be re-evaluated under this set of guidelines and will remain within the same treatment and evaluation pathway until discharge from the healthcare facility.

[0203] If a patient is identified as being at risk of developing pressure ulcers, they will be scheduled to have their position changed every six hours, i.e., "rounds." Similar to low-risk patients, if the patient uses a wheelchair or sits for extended periods, a high-performance foam chair cushion may be provided. Under the NICE guidelines, no further monitoring or intervention is recommended.

[0204] If a patient is identified as being at high risk of developing pressure ulcers, they will receive a high-performance foam mattress as a preventative measure, or, if they use a wheelchair or sit for extended periods, a high-performance chair cushion will be provided. Patients will also have their position changed every four hours. Patients will receive daily VSA (Various Body Stimulation Assessment) of all areas of their body. If non-leukoderma is observed in any area, appropriate intervention will be implemented, and that area will be re-checked with VSA every two hours. Areas not showing non-leukoderma will be re-checked with VSA daily. An individualized medical care plan will be developed for each high-risk patient.

[0205] This flowchart (Figure 1A) shows that healthcare workers spend most of their time with high-risk patients. While this may seem appropriate, it means that high-risk patients may be left unmonitored, potentially leading to the development of stage 1 ulcers before the healthcare worker detects their condition. Furthermore, relying on VSA to detect problems inevitably means that patients may develop stage 1 ulcers before intervention is selected or implemented. By the time the injury has progressed to stage 1, intervention is likely to result in skin rupture and stage 2 ulcers. Early detection of tissue damage is clearly necessary so that intervention can prevent subepidermal injury from progressing beyond stage 1.

[0206] Figure 1B shows an example of an extended treatment decision pathway for pressure ulcer prevention currently implemented in several healthcare facilities. The extended pathway adds monitoring steps to both the high-risk and low-risk pathways. Low-risk patients will undergo weekly risk assessments (e.g., completion of Braden Scale assessment). High-risk patients will receive a high-performance foam mattress as a preventative measure and will be assessed daily with a VSA. A healthcare plan will be developed to monitor and treat high-risk patients. There will be no changes to the healthcare for high-risk patients.

[0207] This extended plan has the advantage of providing basic monitoring of pressure ulcers in all patients. However, these additional steps will require extra time due to the increased number of staff or the increased burden on existing staff. The medical care route in Figure 1B is superior to the recommended medical care route in Figure 1A, but it still has limitations, requiring more resources and the patient must have developed 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" beyond those shown in the example in Figure 1B. Patients are assigned to one of these categories based on the results of their initial risk assessment.

[0209] Figure 2 is an illustrative flowchart of how a device for evaluating pressure measurement results on a patient's skin may be used in an independent process for preventing pressure ulcers, as per the present disclosure. All visiting patients undergo evaluation of complete pressure measurements at all body locations selected for monitoring. These selections may include areas recommended in the Instructions for Use (IFU) of the pressure measurement device, such as the sacrum and heel. Additional locations may be identified by the hospital and incorporated into their respective practices. Multiple pressure measurement results are acquired at and around each selected body location at spatially distinct locations. From a set of measurement results, an average pressure value for each location is calculated for that location and its surroundings. 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 receive weekly pressure measurements of all body parts selected for monitoring. This is low-cost, yet beneficial even for the healthiest patients, as weekly pressure scans increase the likelihood of detecting tissue damage before it becomes visible on the VSA.

[0211] In the current healthcare pathways shown in Figures 1A and 1B, high-risk patients, including those identified as high-risk, will receive specialized healthcare based on body parts exhibiting pressure values ​​above a threshold. For example, if sacral pressure exceeds a threshold, the patient will have their position changed every six hours and receive daily sacral pressure measurements, while other body parts, such as the heels, will receive weekly pressure measurements.

[0212] Figure 3 is a flowchart illustrating how a device for measuring pressure on a patient's skin may be used as an aid to further improve the extended treatment decision pathway of Figure 1B, as relating to this disclosure. Patients visiting the hospital undergo both pressure-measuring scans of all body parts identified by the hospital for risk assessment and monitoring, but the patient's assignment to a risk category is based partly on risk assessment and partly on pressure-measuring results. An initial pressure value above a threshold indicates the possibility of injury at that body part.

[0213] The decision to perform an intervention (e.g., repositioning the patient at the first interval) is currently based on VSA and risk assessment, even though it is unclear whether there is initial damage beneath the skin. However, when pressure measurement is used as an adjunct to the extended treatment decision pathway as shown in Figure 3, the decision to perform an intervention at a specific body site is based on the pressure value found at that site in the pressure measurement scan. If the pressure value is below a predetermined threshold, no intervention is required. If the pressure value is above the predetermined threshold, an intervention is selected and performed, partly for the body site and partly based on the pressure value at that body site. The predetermined threshold for selecting and performing an intervention may be higher or lower than the threshold for determining whether there is potential damage at that body site.

[0214] The cost comparison of providing medical care pathways shown in Figures 1A, 1B, 2, and 3 reveals one of the advantages of monitoring patients using pressure measuring devices. However, the costs cited herein are for patients who have or have not developed pressure ulcers, in which case the estimated treatment cost jumps up to $2,000 for stage 1 ulcers.

[0215] The benchmark for this comparison is the expanded current model in Figure 1B, which represents current "best practices" for hospitals striving to reduce pressure ulcer incidence. Low-risk care pathways are expected to cost an average of $26 per patient with an average hospital stay of 5.6 days, while care for high-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 for pressure ulcer detection; otherwise, interventions are based on a "typical" patient course rather than the specific patient's condition.

[0216] As shown in Figure 3, integrating pressure measurement devices into the current "best practice" workflow does not eliminate any work elements and therefore does not reduce the cost of any healthcare pathway. However, the benefit lies in the ability to detect tissue damage early with minimal incremental cost. The incremental cost of adding pressure measurement scans to a low-risk healthcare pathway is $2, increasing the cost from approximately $26 to $28. The expected healthcare cost for high-risk patients without high pressure values, i.e., those without subepidermal tissue damage, also increases by only $2. However, if a high-risk patient is found to have high pressure values, that patient is moved up to the high-risk category, and the expected healthcare cost increases from $165 to $169. This demonstrates that the additional cost is minimal compared to the benefit of early detection of tissue damage in both low-risk and high-risk patients.

[0217] Figure 2 illustrates an exemplary workflow that relies solely on pressure measurement for patient monitoring, without using a standard VSA. The estimated cost of preventive care for low-risk patients is $4 using pressure measurement alone, compared to $28 using the integrated low-risk care route in Figure 3. As shown in Figure 2, for high-risk patients using pressure measurement alone, the estimated cost is $97, compared to $123–$169 for high-risk and high-risk patients using the integrated care route in Figure 3.

[0218] Example 4: Risk level based on pressure value

[0219] Subjects identified as being at risk of pressure ulcers will be treated according to the following scheme.

[0220] One or more pressure measurements are taken from one or more target body parts of a patient. For each scanned body part, an average pressure value is calculated. Average pressure values ​​from various body parts of many patients, regardless of the presence of pressure injuries, have been acquired in the past and used to construct a histogram of average pressure values. As shown in Table 3, patients whose average pressure value falls within the first tertile (less than 33.3% of maximum intensity) are assigned risk level 0, while patients whose average pressure value falls within the second tertile (33.3-66.6% of maximum intensity) and the third tertile (greater than 66.6% of maximum intensity) are assigned risk levels 1 and 2, respectively. Appropriate interventions corresponding to the assigned risk level are implemented. Subsequent pressure measurements are performed at a frequency determined by the assigned intervention level. The patient's assigned intervention level may be changed (up or down) or kept the same depending on the average pressure value of subsequent measurements.

[0221] JPEG2026062821000004.jpg100170

[0222] From the above, it goes without saying that the present invention can be embodied in a variety of ways, not limited to the following.

[0223] Embodiment 1. A method for evaluating pressure measurement results on intact skin of a patient, 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 medical care facility, comprising: (a) a step of evaluating a patient for the risk of tissue injury upon admission to a medical care facility, which includes (i) obtaining pressure measurement results from the patient at one or more body parts at risk of wound development, and (ii) determining the average pressure value of the pressure measurement results; (b) a step of implementing a level 0 intervention if the average pressure value is below a first threshold, and (c) a step of implementing a level N (where N is an integer of 1 or more) intervention if the average pressure value exceeds the first threshold.

[0225] Embodiment 3. The method according to Embodiment 2, wherein one or more body locations at risk of wound development are selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient.

[0226] Embodiment 4. The method according to Embodiment 2 or 3, wherein one or more body parts at risk of wound formation are in long-term contact with the medical device at one or more anatomical sites.

[0227] Embodiment 5. The method according to Embodiment 4, wherein the body parts at risk of wound formation are selected from the group consisting of the cheeks, nose, chest, stomach, and lower abdomen.

[0228] Embodiment 6. A method for stratifying multiple patients in a medical care facility based on medical care levels, comprising: (a) obtaining pressure measurement results for one of the multiple patients at one or more body locations selected for monitoring; (b) determining the average pressure value of the patient's pressure measurement results; (c) determining a medical care level from among N medical care levels that corresponds to the average pressure value; (d) assigning the medical care level to the patient; and (e) grouping the multiple patients based on each of the medical care levels assigned to the patient.

[0229] Embodiment 7. The method according to Embodiment 6, wherein one or more body locations at risk of wound development are selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient.

[0230] Embodiment 8. The method according to Embodiment 6, wherein one or more body parts at risk of wound formation include one or more anatomical sites that are in prolonged contact with the medical device, 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, comprising: (a) obtaining multiple pressure measurement results from a patient at one or more body parts; (b) determining the average pressure value of the patient's multiple pressure measurement results; (c) providing one or more biostructure-specific interventions based on the average pressure value; (d) increasing the level of biostructure-specific interventions based on an increase in the average pressure value; and (e) decreasing the level of biostructure-specific interventions based on a decrease in the average pressure value.

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

[0233] Embodiment 11. The method according to Embodiment 10, wherein the body part is selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient.

[0234] Embodiment 12. The method according to Embodiment 10, wherein the body part includes one or more anatomical sites that are in long-term 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 for managing medical care for a patient, comprising: (a) acquiring a first set of pressure measurement results 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 measurement results; (c) setting the intervention level to N=1 if one of the average pressure values ​​of the first set of pressure measurement results exceeds a first threshold; (d) performing an intervention of level N for each of the one or more body locations whose average pressure value exceeds the first threshold; (e) acquiring a subsequent set of pressure measurement results 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 according to Embodiment 13, wherein one or more body locations selected for monitoring are selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient.

[0237] Embodiment 15. The method according to Embodiment 13, wherein one or more body parts selected for monitoring include one or more anatomical sites that are in prolonged contact with the medical device, and are selected from the group consisting of the 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) a step of evaluating a patient for risk of tissue damage upon admission to a medical care facility, which includes (i) obtaining a first set of pressure measurement results of the patient, and (ii) determining a first average pressure value of an initial set of pressure measurement results; and (b) a step of implementing a first intervention at level 0 if the first average pressure value is less than or equal to a first threshold, and (c) a step of implementing a first intervention at level N (where 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 according to Embodiment 16, further comprising: (a) acquiring a second set of pressure measurement results of a patient at a first predetermined frequency corresponding to the level of intervention performed; (b) determining a second average pressure value from the second set of pressure measurement results; (c) determining whether the second average pressure value exceeds a second threshold; (d) continuing to perform the first intervention if the second average pressure value does not exceed a second threshold; (e) continuing to acquire a second set of pressure measurement results at a first predetermined frequency if the second average pressure value does not exceed a second threshold; (f) performing a second intervention of level M (where M is an integer greater than N) if the second average pressure value exceeds a second threshold; and (g) acquiring a second set of pressure measurement results at a second predetermined frequency corresponding to level M if the second average pressure value exceeds a second threshold.

[0240] Embodiment 18. The method according to Embodiment 16 or 17, further comprising: (a) determining whether a second average pressure value is less than a third threshold; (b) continuing to perform a first intervention if the second average pressure value is greater than or equal to the third threshold; (c) continuing to acquire a plurality of pressure measurement results at a first predetermined frequency if the second average pressure value is greater than or equal to the third threshold; (d) performing a third intervention at level L (where 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 at level 0; and (e) acquiring a plurality of 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 according to any one of Embodiments 16 to 18, wherein the first intervention at level N 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 mattress surfaces with low-friction pads.

[0242] Embodiment 20. The method according to any one of Embodiments 17 to 19, wherein the second intervention at level M 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 mattress surfaces with low-friction pads.

[0243] Embodiment 21. The method according to any one of Embodiments 18 to 20, wherein the third intervention at level L 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 mattress surfaces with low-friction pads.

[0244] Embodiment 22. The method according to any one of Embodiments 16 to 21, wherein the first average pressure value is determined by a subset of the first plurality of pressure measurement results.

[0245] Embodiment 23. The method according to any one of Embodiments 17 to 22, wherein the second average pressure value is determined by a subset of a second set of pressure measurement results.

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

[0247] Embodiment 25. The method according to 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 who requires intervention for a pressure ulcer, comprising: (a) obtaining multiple pressure measurement results at an anatomical site of the patient; (b) determining the average pressure value of the multiple pressure measurement results; (c) determining whether the average pressure value exceeds a threshold corresponding to level N (where N is 2 or greater); (d) if the average pressure value exceeds the threshold, performing an intervention for the pressure ulcer at the anatomical site; and (e) if the average pressure value exceeds the threshold, obtaining multiple pressure measurement results every two hours.

[0249] Embodiment 27. The method according to Embodiment 26, wherein the anatomical site is selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient.

[0250] Embodiment 28. The method according to Embodiment 26 or 27, wherein the intervention for pressure ulcers 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 mattress surfaces with low-friction pads.

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

[0252] Embodiment 30. The method according to Embodiment 29, wherein the first site is selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient.

[0253] Embodiment 31. A method for detecting tissue damage before it becomes visible on a patient's skin, comprising: (a) acquiring a plurality of pressure measurement results at a certain location on the patient's skin with a time difference; (b) determining an average pressure value from each of the plurality of pressure measurement results; (c) calculating the slope between the most recent average pressure value and the previous average pressure value; (d) comparing the slope with a threshold; and (e) determining that tissue damage is present if the slope exceeds the threshold.

[0254] Embodiment 32. The method according to Embodiment 31, wherein the above-mentioned area is selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient.

[0255] Embodiment 33. The method according to 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: (a) acquiring a plurality of pressure measurement results at a certain location on the patient's skin with a time difference; (b) determining an average pressure value from each of the plurality of pressure measurement results; (c) calculating the pressure difference between the maximum average pressure value and the minimum average pressure value at each time interval; (d) calculating the derivative of the pressure difference with respect to time; (e) comparing the derivative with a threshold; and (f) determining that tissue damage is present if the derivative exceeds the threshold.

[0257] Embodiment 35. The method according to Embodiment 34, wherein multiple locations are selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient.

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

[0259] Embodiment 37. The method according to any one of Embodiments 34 to 36, which is performed at multiple locations.

[0260] Embodiment 38. A method for detecting tissue damage before it becomes visible on a patient's skin, comprising: (a) acquiring a plurality of pressure measurement results at a certain location on the patient's skin at a plurality of time differences; (b) determining an average pressure value from each of the plurality of pressure measurement results; (c) calculating the pressure difference between the maximum average pressure value and the minimum average pressure value for each time difference; (d) fitting a curve to a predetermined number of recent pressure differences; (e) calculating the curvature of the fitted curve; (f) comparing this curvature with a threshold; and (g) determining that tissue damage exists if the curvature exceeds the threshold.

[0261] Embodiment 39. The method according to Embodiment 38, wherein the above-mentioned area is selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient.

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

[0263] While the present invention has been described above with reference to specific embodiments, those skilled in the art will understand that various modifications can be made without departing from the scope of the invention, and that equivalents can be substituted for its elements. Furthermore, many improvements can be made to specific situations or materials in accordance with the teachings of the invention, without departing from the scope of the invention. Accordingly, the present invention is not limited to the specific embodiments disclosed, but is intended to include all embodiments contained in the appended claims and their spirit.

Claims

1. A method for evaluating pressure measurement results on an intact patient's skin, a) A step of obtaining a pressure measurement scan on the patient's skin, b) A step of generating a pressure measurement map, Methods that include...

2. A method for reducing the incidence of tissue damage in patients admitted to medical and nursing care facilities, a) A step in which the patient's risk of tissue damage is assessed when admitted to the aforementioned medical and nursing care facility, i) Obtain pressure measurement results from the patient at one or more body parts where there is a risk of wound formation, ii) Determining the average pressure value of the pressure measurement results, Steps including, b) If the average pressure value falls below a first threshold, the step of implementing a level 0 intervention, c) If the average pressure value exceeds the first threshold, the step of performing an intervention of level N (where N is an integer of 1 or more), Methods that include...

3. The method according to claim 2, wherein the one or more body parts at risk of wound formation are selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient.

4. The method according to claim 2 or 3, wherein the one or more body parts at risk of wound formation include one or more anatomical sites that are in long-term contact with a medical device.

5. The method according to claim 4, wherein the body part at risk of wound formation is selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen.

6. A method for stratifying multiple patients in a medical care facility based on their medical care level, comprising: a) obtaining pressure measurement results for one of the multiple patients at one or more body parts selected for monitoring; b) A step of determining the average pressure value of the pressure measurement results of the patient, c) A step of determining the medical care level corresponding to the average pressure value among N medical care levels, d) The step of assigning the medical care level to the patient, e) The step of grouping the patients from among the multiple patients based on the respective medical care levels assigned to the patients, Methods that include...

7. The method according to claim 6, wherein the one or more body parts at risk of wound formation are selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient.

8. The method according to claim 6, wherein one or more body parts at risk of wound formation include one or more anatomical sites that are in prolonged contact with the medical device, selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen.

9. A method for identifying and providing appropriate medical and nursing care levels to patients in medical and nursing care facilities, a) A step of obtaining multiple pressure measurement results of the patient at one or more body parts, b) A step of determining the average pressure value of the patient's multiple pressure measurement results, c) A step of providing one or more biological structure-specific interventions based on the average pressure value, d) A step of increasing the level of biological structure-specific intervention based on the increase in the average pressure value, e) A step of lowering the level of biological structure-specific intervention based on the reduction in the average pressure value, Methods that include...

10. A method for assigning patients in medical and nursing care facilities to one risk category selected from multiple risk categories, a) A step of obtaining initial pressure measurement results at one or more body parts selected for monitoring, b) A step of determining the average pressure value of the pressure measurement results, c) A step of 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 measurement results, Methods that include...

11. The method according to claim 10, wherein the body part is selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient.

12. The method according to claim 10, wherein the body part includes one or more anatomical parts that are in long-term contact with the medical device, and is selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen.

13. A method for managing the medical care and nursing of patients, a) The step of obtaining a first set of pressure measurement results at one or more body parts selected for monitoring when admitted to a medical care facility, b) A step of determining a first average pressure value for each of the first set of pressure measurement results, c) If one of the average pressure values ​​of the first set of pressure measurement results exceeds the first threshold, the intervention level is set to N=1. d) A step of performing an intervention of level N for each of the one or more body parts where the average pressure value exceeds a first threshold, e) A step of obtaining multiple subsequent sets of pressure measurement results at each of the one or more body parts at a frequency of level N, f) A step of determining a new average pressure value for each of the one or more body parts, Methods that include...

14. The method according to claim 13, wherein the one or more body parts selected for monitoring are selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient.

15. The method according to claim 13, wherein one or more body parts selected for monitoring include one or more anatomical sites that are in prolonged contact with the medical device, and are selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen.

16. A method for identifying and treating patients at risk of tissue damage, a) This is a step in assessing the risk of tissue damage to a patient before admission to a medical or nursing care facility. i) Obtaining a first set of pressure measurement results from the patient, ii) Determining a first average pressure value of the initial set of pressure measurement results, Steps including, b) If the first average pressure value is less than or equal to the first threshold, the step of performing a first intervention of level 0, c) If the first average pressure value exceeds the first threshold, the step of performing a first intervention of level N (where N is an integer of 1 or more), Methods that include...

17. a) A step of acquiring a second set of pressure measurement results of the patient at a first predetermined frequency corresponding to the level of intervention performed, b) A step of determining a second average pressure value of the second plurality of pressure measurement results, c) A step of determining whether the second average pressure value exceeds a second threshold, d) If the second average pressure value does not exceed the second threshold, the first intervention is continued; e) If the second average pressure value does not exceed the second threshold, the step of continuing to acquire a plurality of pressure measurement results at the first predetermined frequency, f) If the second average pressure value exceeds the second threshold, the step of performing a second intervention of level M (where M is an integer greater than N), g) If the second average pressure value exceeds the second threshold, the step of acquiring a plurality of pressure measurement results at a second predetermined frequency corresponding to level M, The method according to claim 16, further comprising:

18. a) A step of determining whether the second average pressure value is less than a third threshold, b) If the second average pressure value is equal to or greater than the third threshold, the first intervention is continued; c) If the second average pressure value is equal to or greater than the third threshold, the step of continuing to acquire a plurality of pressure measurement results at the first predetermined frequency, d) If the second average pressure value is less than the third threshold and the first intervention is not at level 0, the step of performing a third intervention at level L (where L is an integer less than N), e) If the second average pressure value is less than the third threshold, the step of acquiring a plurality of pressure measurement results at a predetermined frequency corresponding to level L, The method according to claim 16 or 17, further comprising:

19. The method according to any one of claims 16 to 18, wherein the first intervention at level N 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 mattress surfaces with low-friction pads.

20. The method according to any one of claims 17 to 19, wherein the second intervention at level M 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 mattress surfaces with low-friction pads.

21. The method according to any one of claims 18 to 20, wherein the third intervention at level L 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 mattress surfaces with low-friction pads.

22. The method according to any one of claims 16 to 21, wherein the first average pressure value is determined by a subset of the first plurality of pressure measurement results.

23. The method according to any one of claims 17 to 22, wherein the second average pressure value is determined by a subset of the second plurality of pressure measurement results.

24. The method according to any one of claims 17 to 23, wherein the second threshold is equal to the first threshold.

25. The method according to any one of claims 18 to 24, wherein the third threshold is equal to the first threshold.

26. A method for identifying and treating patients who require intervention for pressure ulcers, a) A step of obtaining multiple pressure measurement results at anatomical sites of the patient, b) A step of determining the average pressure value of the plurality of pressure measurement results, c) A step of determining whether the average pressure value exceeds a threshold corresponding to level N (where N is 2 or more), d) If the average pressure value exceeds the threshold, the step of performing the intervention for pressure ulcers on the anatomical site, e) If the average pressure value exceeds the threshold, the step of acquiring multiple pressure measurement results every two hours, Methods that include...

27. The method according to claim 26, wherein the anatomical site is selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient.

28. The method according to claim 26 or 27, wherein the intervention for pressure ulcers 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 mattress surfaces with low-friction pads.

29. A method for identifying damaged tissue, a) A step of obtaining a first pressure measurement result from a first location on the patient's skin, b) A step of obtaining a second pressure measurement result from a second location that is symmetrical to the first location, c) A step of determining the average pressure value of the first pressure measurement result and the second pressure measurement result, d) A step of determining the difference in the average pressure value between the first pressure measurement result and the second pressure measurement result, e) If the difference in average pressure values ​​exceeds a threshold, the step of determining that tissue damage exists at the first location or the second location, Methods that include...

30. The method according to claim 29, wherein the first location is selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient.

31. A method for detecting tissue damage before it becomes visible on the patient's skin, a) A step of obtaining multiple pressure measurement results at a certain location on the patient's skin with a time difference, b) A step of determining the average pressure value from each of the multiple pressure measurement results, c) A step of calculating the slope between the latest average pressure value and the previous average pressure value, d) A step of comparing the slope with a threshold, e) A step of determining that tissue damage exists if the slope exceeds the threshold, Methods that include...

32. The method according to claim 31, wherein the location is selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient.

33. The method according to claim 31 or 32, which is performed at multiple locations.

34. A method for detecting tissue damage before it becomes visible on the patient's skin, a) A step of obtaining multiple pressure measurement results at a certain location on the patient's skin with a time difference, b) A step of determining the average pressure value from each of the multiple pressure measurement results, c) A step of calculating the pressure difference between the maximum average pressure value and the minimum average pressure value at each time interval, d) A step of calculating the time derivative of the pressure difference, e) A step of comparing the derivative with a threshold, f) A step of determining that tissue damage exists if the derivative exceeds the threshold, Methods that include...

35. The method according to claim 34, wherein the plurality of locations are selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient.

36. The method according to claim 34 or 35, wherein the derivative of the difference value with respect to time is calculated from two most recent difference values.

37. The method according to any one of claims 34 to 36, which is performed at multiple locations.

38. A method for detecting tissue damage before it becomes visible on the patient's skin, a) A step of obtaining multiple pressure measurement results at a certain location on the patient's skin at multiple time differences, b) A step of determining the average pressure value from each of the multiple pressure measurement results, c) A step of calculating the pressure difference between the maximum average pressure value and the minimum average pressure value for each time difference, d) A step of fitting the curve to a predetermined number of recent pressure differences, e) A step of calculating the curvature of the fitted curve, f) A step of comparing the curvature with a threshold, g) A step of determining that tissue damage exists if the curvature exceeds the threshold, Methods that include...

39. The method according to claim 38, wherein the location is selected from the group consisting of the sternum, sacrum, heel, scapula (os latum scapularum), elbow, ear, and other muscle tissue on bony prominences of the patient.

40. The method according to claim 38 or 39, which is performed at multiple locations.

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