Strategic treatment of pressure ulcers using subepidermal water content.

Abstract

This disclosure provides methods for identifying patients requiring treatment for pressure ulcers and for treating these patients using clinical interventions selected based on subepidermal water content. This disclosure also provides methods for grouping patients based on pressure ulcer risk and methods for reducing the incidence of pressure ulcers in nursing facilities.

Description

[0001] This application is a divisional application of the PCT application with international application number PCT / US2018 / 061494, international application date November 16, 2018, which entered the Chinese national phase, with application number 201880070842.0 and title "Strategic Treatment of Pressure Ulcers Using Subepidermal Moisture Values".

[0002] Cross-reference to related applications

[0003] This application claims the benefits of U.S. Provisional Application No. 62 / 587,337, filed November 16, 2017, and U.S. Provisional Application No. 62 / 693,810, filed July 3, 2018. The entire contents of these applications are incorporated herein by reference. Technical Field

[0004] This disclosure provides methods for identifying patients requiring treatment for pressure ulcers and for treating these patients using clinical interventions selected based on subepidermal water content. This disclosure also provides methods for grouping patients based on pressure ulcer risk and methods for reducing the incidence of pressure ulcers in nursing facilities. Background Technology

[0005] The skin is the largest organ in the human body. It is susceptible to various injuries and damages. Ulcers can form when the skin and surrounding tissues are unable to redistribute external pressure and mechanical forces. Even prolonged exposure to moderate pressure (such as the pressure exerted on the skin surface of the back of a supine patient by their body weight) can lead to pressure ulcers. In the presence of other injuries (such as neuropathy induced by diabetes and weakening of surrounding tissues), even intermittent exposure to moderate pressure and stress can cause ulcers, such as foot ulcers.

[0006] In the United States, approximately 2.5 million people develop pressure ulcers each year, while the figure is equal in the European Union. Up to 25% of elderly and immobile patients develop pressure ulcers in long-term and critical care settings. Approximately 60,000 patients in the United States die each year due to infections and other complications arising from pressure ulcers.

[0007] Detecting tissue damage before the skin breaks down and intervening with appropriate treatments to prevent further deterioration of underlying tissues is desirable not only for patients but also for society. The average cost of treating pressure-induced damage at the earliest visible signs (stage 1 ulcers) is only $2,000, but this cost rises to $129,000 when the ulcer is deep enough to expose muscle or bone (stage 4 ulcers). Currently, patients typically receive generalized prevention for pressure ulcers, meaning that prevention is not targeted at any specific anatomical location. Patients only receive targeted, localized ulcer treatment when a pressure ulcer has developed to the point where it can be identified by visual assessment. The current standard for detecting pressure ulcers is by visual inspection, which is subjective, unreliable, outdated, and lacks specificity. Therefore, even when a patient is experiencing skin inflammation (a precursor to ulcer development), he or she will not receive targeted, localized treatment for the developing ulcer. Instead, the inflammation will continue to develop into a full-blown ulcer. Summary of the Invention

[0008] In one aspect, this disclosure provides and includes a method for identifying and providing appropriate levels of pressure ulcer care to a patient based on multiple subepidermal moisture (SEM) measurements. In another aspect, a pressure ulcer intervention with increasing effectiveness is provided to the patient based on changes in SEM measurements. In yet another aspect, a lower-intensity pressure ulcer intervention is given to the patient based on changes in SEM measurements.

[0009] In one aspect, this disclosure provides and includes a method for assessing a patient, the method comprising the steps of: performing an initial SEM scan on a body location selected for monitoring, and assigning the patient to a risk category selected from a group comprising multiple risk categories, wherein the assignment is based in part on the initial SEM scan of the body location.

[0010] In one aspect, this disclosure provides and includes a method for managing patient care, the method comprising the steps of: performing an initial assessment on the patient and performing an initial SEM scan on all body locations selected for monitoring upon admission; calculating an initial incremental value for each body location selected for monitoring; determining a patient deviation and setting an intervention level N=1 if any initial incremental value is greater than or equal to a first threshold; implementing an N-level intervention for each body location having an incremental value greater than or equal to the first threshold; and performing SEM scans on all body locations at a frequency of N levels and calculating new incremental values.

[0011] In one aspect, this disclosure provides and includes a method for identifying and treating a patient in need of treatment for pressure ulcers, the method comprising the steps of: assessing the patient's risk of developing pressure ulcers upon admission to a care facility, wherein the assessment step includes performing a first multiple subepidermal water (SEM) measurement in the patient; calculating a first incremental value based on a portion of the first multiple SEM measurements; determining whether the first incremental value exceeds a first threshold; if the first incremental value does not exceed the first threshold, applying a first intervention at level 0, and if the first incremental value exceeds the first threshold, applying a first intervention at level N, wherein N is an integer and the value of N is 1 or greater. In another aspect, this disclosure provides and includes: performing a second series of SEM measurements in a patient at a first predetermined frequency corresponding to the level of the applied intervention; calculating a second incremental value based on a portion of the second series of SEM measurements; determining whether the second incremental value exceeds a second threshold; if the second incremental value does not exceed the second threshold, continuing to apply the first intervention; if the second incremental value does not exceed the second threshold, continuing to perform multiple SEM measurements at the first predetermined frequency; if the second incremental value exceeds the second threshold, applying a second intervention at level M, where M is an integer and M is greater than N; and if the second incremental value exceeds the second threshold, performing multiple SEM measurements at a second predetermined frequency corresponding to level M. In yet another aspect, this disclosure provides and includes: determining whether the second incremental value is less than a third threshold; if the second incremental value is less than the third threshold and if the first intervention is not level 0, applying an intervention at level (N-1); and if the second incremental value is less than the third threshold, performing multiple SEM measurements at a predetermined frequency corresponding to level (N-1).

[0012] In one aspect, this disclosure provides and includes a method for slowing the progression of pressure ulcers in a patient with this need, the method comprising the steps of: identifying a current intervention of grade K received by the patient; performing multiple subepidermal water (SEM) measurements in the patient; calculating an incremental value based on a portion of the multiple SEM measurements; determining whether the incremental value exceeds a first threshold; if the incremental value does not exceed the first threshold, continuing to apply the current intervention; if the incremental value does not exceed the first threshold, continuing to perform multiple SEM measurements at a predetermined frequency corresponding to grade K; if the incremental value exceeds the first threshold, applying a new intervention of grade N, wherein N has a value greater than K; and if the incremental value exceeds the first threshold, performing multiple SEM measurements at a predetermined frequency corresponding to grade N. In yet another aspect, this disclosure provides and includes: determining whether the incremental value is less than a second threshold; if the incremental value is less than the second threshold, applying an intervention of grade L, wherein L has a non-negative value less than K; and if the incremental value is less than the second threshold, performing multiple SEM measurements at a predetermined frequency corresponding to grade L.

[0013] In one aspect, this disclosure provides and includes a method for classifying patient groups in a care facility based on the risk of pressure ulcers, the method comprising the steps of: performing multiple subepidermal water (SEM) measurements on each patient; calculating incremental values ​​based on a portion of the multiple SEM measurements on each patient; determining whether each incremental value exceeds any value in a set of thresholds corresponding to N care levels, and assigning a care level to each patient; and rearranging the patient groups based on the care level assigned to each patient.

[0014] In one aspect, this disclosure provides and includes a method for reducing the incidence of pressure ulcers in patients admitted to a care facility, the method comprising the steps of: assessing the risk of pressure ulcers in a patient upon admission to a care facility, wherein the assessment step includes performing a first multiple subepidermal water (SEM) measurement in the patient; calculating a first incremental value based on a portion of the first multiple SEM measurements; determining whether the first incremental value exceeds a first threshold; if the first incremental value does not exceed the first threshold, applying a first intervention at level 0; and if the first incremental value exceeds the first threshold, applying a second intervention at level N, where N is an integer and the value of N is 1 or greater.

[0015] In one aspect, this disclosure provides and includes a method for identifying and treating a patient who requires the application of a protective cream to their heel, the method comprising the steps of: performing multiple subepidermal moisture (SEM) measurements at the patient's heel; calculating an incremental value based on a portion of the multiple SEM measurements; determining whether the incremental value exceeds a threshold corresponding to level N, where N is greater than or equal to 2; if the incremental value exceeds the threshold, applying a protective cream to the patient's heel; and if the incremental value exceeds the threshold, performing multiple SEM measurements every two hours.

[0016] In one aspect, this disclosure provides and includes a method for identifying and treating a patient requiring neuromuscular stimulation of their heel, the method comprising the steps of: performing multiple subepidermal water (SEM) measurements at the patient's heel; calculating an incremental value based on a portion of the multiple SEM measurements; determining whether the incremental value exceeds a threshold corresponding to level N, where N is greater than or equal to 2; if the incremental value exceeds the threshold, applying neuromuscular stimulation to the patient's heel; and if the incremental value exceeds the threshold, performing multiple SEM measurements per hour.

[0017] In one aspect, this disclosure provides and includes a method for identifying and treating a patient who requires application of a topical cream to their heel, the method comprising the steps of: performing multiple subepidermal moisture (SEM) measurements at the patient's heel; calculating an incremental value based on a portion of the multiple SEM measurements; determining whether the incremental value exceeds a threshold corresponding to level N, where N is greater than or equal to 2; if the incremental value exceeds the threshold, applying a topical cream to the patient's heel; and if the incremental value exceeds the threshold, performing multiple SEM measurements every half hour.

[0018] In one aspect, this disclosure provides and includes a method for identifying and treating a patient who requires the application of a protective cream to their sacrum, the method comprising the steps of: performing multiple subepidermal moisture (SEM) measurements at the patient's sacrum; calculating an incremental value based on a portion of the multiple SEM measurements; determining whether the incremental value exceeds a threshold corresponding to level N, where N is greater than or equal to 2; if the incremental value exceeds the threshold, applying a protective cream to the patient's sacrum; and if the incremental value exceeds the threshold, performing multiple SEM measurements every six hours.

[0019] In one aspect, this disclosure provides and includes a method for identifying and treating a patient requiring neuromuscular stimulation of the sacrum, the method comprising the steps of: performing multiple subcutaneous water (SEM) measurements at the sacrum of the patient; calculating an incremental value based on a portion of the multiple SEM measurements; determining whether the incremental value exceeds a threshold corresponding to level N, where N is greater than or equal to 2; if the incremental value exceeds the threshold, applying neuromuscular stimulation to the sacrum of the patient; and if the incremental value exceeds the threshold, performing multiple SEM measurements every four hours.

[0020] In one aspect, this disclosure provides and includes a method for identifying and treating a patient requiring application of a topical cream to their sacrum, the method comprising the steps of: performing multiple subepidermal moisture (SEM) measurements at the patient's sacrum; calculating an incremental value based on a portion of the multiple SEM measurements; determining whether the incremental value exceeds a threshold corresponding to level N, where N is greater than or equal to 2; if the incremental value exceeds the threshold, applying a topical cream to the patient's sacrum; and if the incremental value exceeds the threshold, performing multiple SEM measurements every two hours. Attached Figure Description

[0021] This patent or application document contains at least one color drawing. Copies of this patent or patent application publication containing multiple color drawings will be provided by the Patent Office upon request, at the cost of the necessary fees.

[0022] Referring now to the accompanying drawings, various aspects of this disclosure have been described herein by way of example only. Referring now to the drawings in particular detail, it is important to emphasize that the details shown are by way of example only and are for illustrative purposes. In this regard, the description and drawings, considered individually and together, will make it apparent to those skilled in the art how to practice various aspects of this disclosure.

[0023] Figure 1 An example is described of the entire process of selecting treatment for pressure ulcers based on SEM values ​​from admission to care facility to discharge from care facility, in accordance with this disclosure.

[0024] Figure 2A It is a visual assessment of a sample of a health organization based on this disclosure.

[0025] Figure 2B It is a graph of the average values ​​of SEM measurements taken at each location in and around the healthy sacrum according to this disclosure.

[0026] Figure 3A It is a visual assessment based on samples of damaged tissue disclosed herein.

[0027] Figure 3B It is a graph of the average values ​​of SEM measurements taken at each location in and around the damaged sacrum according to this disclosure.

[0028] Figure 4 This is a diagram illustrating the process of selecting intervention and monitoring levels based on the amount by which incremental values ​​derived from SEM measurements exceed a threshold, as disclosed in this disclosure.

[0029] Figure 5 This is an example of a workflow guidance matrix, in which a new intervention level is selected using the current intervention level and a new increment value, according to this disclosure.

[0030] Figure 6A , Figure 6B and Figure 6C An example progression over time of incremental values ​​in a single patient at a single location where a pressure ulcer develops is depicted, according to this disclosure.

[0031] Figure 6D This is an example graph showing the change of incremental values ​​over time in a single patient at a single location where a pressure ulcer has developed, according to this disclosure.

[0032] Figure 7A and Figure 7B This is an example of a method for mapping tissue damage areas according to this disclosure.

[0033] Figure 8AThis is an example of a currently recommended treatment decision-making approach that uses a combination of risk assessment and visual assessment to prevent pressure ulcers in hospital patients.

[0034] Figure 8B This is an example of a currently implemented enhanced treatment decision-making approach for the prevention of pressure ulcers in some healthcare facilities.

[0035] Figure 9 This is an example flowchart illustrating how to use a SEM scanner in an independent process to prevent pressure ulcers, based on this disclosure.

[0036] Figure 10 This disclosure further improves upon how to use a SEM scanner as an accessory. Figure 8B Example flowchart of the enhanced treatment decision-making pathway. Detailed Implementation

[0037] This specification is not intended to be a detailed list of all different ways in which this disclosure may be implemented, nor is it intended to be a detailed list of all features that may be added to this disclosure. For example, a feature shown with respect to one embodiment may be incorporated into other embodiments, and a feature shown with respect to a particular embodiment may be removed from that embodiment. Therefore, this disclosure contemplates that any feature or combination of features set forth herein may be excluded or omitted in some embodiments of this disclosure. Furthermore, many variations and additions to the various embodiments suggested herein will be apparent to those skilled in the art, without departing from this disclosure. In other instances, well-known structures, interfaces, and processes have not been shown in detail to avoid unnecessarily obscuring the invention. No part of this specification should be construed as negating any part of the full scope of the invention. Therefore, the following description is intended to illustrate some specific embodiments of this disclosure, rather than exhaustively specifying all substitutions, combinations, and variations thereof.

[0038] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. The terminology used in this disclosure is for the purpose of describing particular aspects or embodiments only and is not intended to be limiting of this disclosure.

[0039] All publications, patent applications, patents, and other references cited herein are incorporated in their entirety by reference for the teaching purposes relating to the sentences and / or paragraphs for which the references are provided. The term "technology" as used herein refers to technology commonly understood in the art, including variations of those technologies or substitutions of equivalent technology that are obvious to those skilled in the art.

[0040] U.S. Patent Application Serial No. 14 / 827,375 (“375 application”) discloses an apparatus for measuring subepidermal capacitance using radio frequency (RF) energy, wherein the subepidermal capacitance corresponds to the water content of a target area of ​​a patient’s skin. 375 application also discloses arrays of these bipolar sensors of different sizes.

[0041] U.S. Patent Application Serial No. 15 / 134,110 discloses a device for measuring subepidermal water, similar to the device shown in Figure 3, wherein the device transmits and receives RF signals at a frequency of 32 kHz via a single coaxial sensor and generates a bioelectrical impedance signal, which is then converted into SEM values.

[0042] U.S. Patent Application Serials 14 / 827,375 and 15 / 134,110 are both incorporated herein by reference in their entirety. However, the SEM values ​​of this application can be measured by any similar or equivalent device or technique that is obvious to a person skilled in the art. For example, the device for measuring the SEM values ​​of this application can be a wired device, a wireless device, or a system comprising various components that communicate with each other.

[0043] Unless the context otherwise requires, the various features specifically intended for use in the disclosure described herein may be used in any combination. Furthermore, this disclosure also contemplates that in some embodiments of this disclosure, any feature or combination of features set forth herein may be excluded or omitted.

[0044] The methods disclosed herein include and comprise one or more steps or actions for implementing the described methods. These steps and / or actions may be interchanged without departing from the scope of this disclosure. In other words, unless the correct operation of an embodiment requires a specific order of steps or actions, the order and / or use of particular steps and / or actions may be modified without departing from the scope of this disclosure.

[0045] As used in this disclosure and the appended claims, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise.

[0046] As used herein, “and / or” means and covers any and all possible combinations of one or more associated listed items, as well as combinations that are missing when interpreted in an alternative manner (“or”).

[0047] As used in this article, the terms “approximately” and “about” when referring to measurable values ​​(such as length, frequency, or SEM values) mean that the package covers a variation of ±20%, ±10%, ±5%, ±1%, ±0.5%, or even ±0.1% of a specific quantity.

[0048] As used herein, phrases such as “between X and Y” and “between approximately X and Y” should be interpreted as including both X and Y. As used herein, phrases such as “between approximately X and Y” mean “between approximately X and approximately Y”, and phrases such as “from approximately X to Y” mean “from approximately X to approximately Y”.

[0049] As used in this article, the term "subepidermal water" or "SEM" refers to the increase in tissue fluid and localized edema caused by vascular leakage and other changes that alter the underlying structure of damaged tissue under conditions of sustained tissue pressure, apoptosis, necrosis, and inflammation.

[0050] As used in this article, "patient" can be a human or animal subject.

[0051] As used in this article, "increment" refers to the difference calculated between two SEM values.

[0052] As used in this article, the variables “K”, “L”, “M” and “N” are non-negative integers.

[0053] Figure 1 This disclosure describes a process 100 for selecting treatment for pressure ulcers based on SEM values ​​generated from SEM measurements using a SEM scanner, from admission to discharge from the nursing facility. In one aspect, the nursing facility is selected from a group comprising: hospitals, assisted living facilities, residential care facilities, nursing homes, long-term care facilities, continuing care communities, and independent living communities. In one aspect, the nursing facility may be the patient's home or other residence, thus the "admission" step 102 would be the initial assessment of the patient by a nurse or other caregiver at the patient's home. In one aspect, the schedule for intervention and assessment intervals used in the home setting may differ from the corresponding interventions and intervals used in the hospital.

[0054] In one aspect, in process 100, a newly admitted patient receives an intake assessment in step 104, which includes one or more of the following: visual examination of a portion of the patient's skin; completion of at least a portion of a risk protocol program assessing one or more of nutrition, mobility, physical activity, strength, and communication; and SEM measurements at one or more locations on the patient's skin. In one aspect, SEM measurements may include multiple SEM measurements at a single "location" on the patient's skin. In one aspect, a "location" is considered a region rather than a single point, such that SEM measurements can be performed at spatially separated points within that location. For example, a "heel" location includes the middle surface, transverse surface, and posterior surface around the heel, as well as the posterior part of the sole of the foot.

[0055] In one aspect, once the assessment steps are completed, step 106 determines whether the patient has “deviated”—that is, whether the combination of the results of the various elements of the assessment indicates that the patient is at risk of developing tissue damage that could lead to pressure ulcers, or is at that risk. Each element of the assessment may have individual risk level criteria; for example, a scoring system with thresholds indicates unacceptable risk. In one aspect, there are protocols for combining criteria to generate composite parameters that can be used to select the level of intervention.

[0056] In one aspect, if the patient is determined to be at an acceptable risk level, the process branches to step 108, where the lowest level of intervention is implemented, referred to herein as “Level 0” or “Grade 0”. Proceeding to steps 110 and 112, the patient will be reassessed in step 114 at least using the SEM measurement protocol at a frequency associated with Grade 0 or at the opposite time interval. Process 100 then loops back to step 106 to evaluate the results of the SEM measurements performed in step 114.

[0057] In one aspect, if it is determined in step 106 that the patient is deviating, the process then branches to step 122, which implements a higher level of intervention. In one aspect, there is a defined hierarchy of intervention levels, where each level implements a more effective intervention than the next level. In one aspect, each level also has defined monitoring intervals or indications of how often a set of SEM measurements should be performed, where higher levels typically have shorter intervals. In this example, the process has been defined by the hospital or other governing body to elevate a level to Level 1 intervention at this point. In another aspect, step 122 could implement Level 2 or higher intervention. The process now enters a new loop starting from step 130, in which the patient will now be monitored at a frequency of Level N, where N ranges from 1 to n, and n is the highest defined level of intervention and monitoring.

[0058] In one aspect, in step 134, the patient's medical history is assessed to determine if their condition is improving. If the patient's condition is improving, for example, as evidenced by a decreasing increment value, then the process then branches to step 142. In this example, step 142 continues to implement the current level of intervention, and the process loops through steps 140 to 130-132-134-142-140 until the increment value falls below a threshold. In one aspect, in step 142, as the increment value tends to decrease, the intervention level can be reduced based on the magnitude of the increment value.

[0059] In one aspect, if the patient does not show improvement in step 134, then in step 136, if the skin is not broken, i.e., no open ulcer has formed, the process branches to step 138, increasing the level of intervention. If an open ulcer has already formed, a SEM scan will now be performed around the periphery of the open wound in step 144 to map other early signs of inflammation or ulcer spread. The ulcer itself is treated in step 148, and this cycle of 144-146-148-150 continues until the wound closes, after which the process returns to step 130.

[0060] In one aspect, at any time during process 100, the patient's discharge branch proceeds to step 118, in which the patient's condition at discharge or transfer is recorded. In one aspect, step 118 includes performing a final set of SEM measurements at one or more locations on the patient's body. In one aspect, these locations include areas that have not received intervention and have not previously been identified as being at risk. In one aspect, this information is provided to the receiving caregiver. Then, in step 120, the patient is discharged or transferred.

[0061] In one aspect, this disclosure provides and includes a method for identifying and treating a patient requiring treatment for pressure ulcers, the method comprising the steps of: assessing the patient's risk of pressure ulcers upon admission to a care facility, wherein the assessment step includes performing a first multiple subepidermal water (SEM) measurement on the patient; calculating a first incremental value based on a portion of the first multiple SEM measurements; determining whether the first incremental value exceeds a first threshold; if the first incremental value does not exceed the first threshold, applying a level 0 first intervention; and if the first incremental value exceeds the first threshold, applying a level N first intervention, wherein N is an integer and the value of N is 1 or greater.

[0062] In one aspect, first multiple SEM measurements are taken at and around one or more anatomical locations selected from a group consisting of the patient's sternum, sacrum, heel, scapula, elbow, ear, and other fleshy tissues. In one aspect, the first multiple SEM measurements are subgrouped for analysis based on the general location where the measurements were taken. In one aspect, the first multiple SEM measurements are taken at locations located in one or more concentric circles centered on the anatomical location. In one aspect, the first multiple SEM measurements are taken at locations on a straight line approximately equidistant from the anatomical location.

[0063] In one aspect, a first increment value is determined by the difference between the maximum and minimum SEM values ​​collected from a first set of SEM measurements. In another aspect, a first increment value is determined by the difference between the maximum average SEM value of measurements taken at one location and the minimum average SEM value of measurements taken at a second location. In one aspect, a first increment value is determined for a portion of a first set of SEM measurements, which consists of a subgroup defined by the taken locations. In one aspect, the average SEM value at a location is obtained based on two, three, four, five, six, seven, eight, nine, ten, or more SEM values ​​measured at that location. In one aspect, a first increment value is determined by the difference between SEM values ​​obtained from measurements taken at two bisymmetrical locations relative to a centerline.

[0064] In one aspect, among several methods, an incremental value can be calculated based on multiple SEM measurements taken at or around a specific location. In one aspect, multiple SEM measurements are performed on a predetermined pattern on the skin, and the incremental value is calculated by subtracting the SEM value associated with the predetermined location in the pattern from the maximum SEM value obtained at other locations in the pattern. In another aspect, multiple SEM measurements are performed on a predetermined pattern on the skin, and the incremental value is calculated by identifying the SEM value associated with the predetermined location within the pattern and subtracting the maximum SEM value obtained at other locations in the pattern. In one aspect, an average SEM value can be calculated based on a subset of SEM values ​​generated from multiple SEM measurements at a single location, and the incremental value is calculated as the maximum difference between the average of the same set of SEM values ​​and the individual SEM value. In one aspect, the incremental value can be calculated as the ratio of the maximum SEM value to the minimum SEM value within a set of SEM values.

[0065] In one respect, the first threshold can be 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 aspect, the range of the first threshold can be from 0.1 to 8.0, such as from 0.1 to 1.0, from 1.1 to 2.0, from 2.1 to 3.0, from 3.1 to 4.0, from 4.1 to 5.0, from 5.1 to 6.0, from 6.1 to 7.0, from 7.1 to 8.0, from 0.1 to 7.5, from 0.5 to 8.0, from 1.0 to 7.0, from 1.5 to 6.5, from 2.0 to 6.0, from 3.0 to 5.5, from 3.5 to 5.0, or from 4.0 to 4.5. In one aspect, the first threshold can be scaled by a factor or multiple based on the values ​​provided herein. It should be understood that the threshold is not limited by design; rather, those skilled in the art will be able to select a predetermined value based on a given SEM unit. In one aspect, the thresholds of this disclosure vary depending on a specific part of the patient’s body being measured, or on one or more characteristics of the patient such as age, height, weight, family history, ethnicity, and other physical characteristics or medical conditions.

[0066] In one aspect, N ranges from 1 to 50, such as from 1 to 2, from 1 to 3, from 1 to 4, from 1 to 5, from 1 to 6, from 1 to 7, from 1 to 8, from 1 to 9, from 1 to 10, from 1 to 15, from 1 to 20, from 1 to 25, from 1 to 30, from 1 to 35, from 1 to 40, or from 1 to 45.

[0067] In one aspect, N is determined by the amount by which the first increment value exceeds a first threshold. In another aspect, the amount by which the increment value exceeds a threshold set for (N+1) is greater than the amount by which the increment value exceeds a threshold set for N. In yet another aspect, the amount by which the increment value exceeds a threshold set for (N-1) is less than the amount by which the increment value exceeds a threshold set for N.

[0068] In one aspect, a Level 1 (N=1) intervention is applied to patients whose incremental values ​​exceed a threshold but do not exceed 100% of the threshold, such as not exceeding 95% of the threshold, not exceeding 90% of the threshold, not exceeding 85% of the threshold, not exceeding 80% of the threshold, not exceeding 75% of the threshold, not exceeding 70% of the threshold, not exceeding 65% of the threshold, not exceeding 60% of the threshold, not exceeding 55% of the threshold, not exceeding 50% of the threshold, not exceeding 45% of the threshold, not exceeding 40% of the threshold, not exceeding 35% of the threshold, not exceeding 30% of the threshold, not exceeding 25% of the threshold, not exceeding 20% ​​of the threshold, not exceeding 15% of the threshold, not exceeding 10% of the threshold, or not exceeding 5% of the threshold.

[0069] In one aspect, for patients whose incremental values ​​exceed a threshold by no more than 150% of the threshold, a Level 2 (N=2) intervention is applied, such as no more than 145% of the threshold, no more than 140% of the threshold, no more than 135% of the threshold, no more than 130% of the threshold, no more than 125% of the threshold, no more than 120% of the threshold, no more than 115% of the threshold, no more than 110% of the threshold, no more than 100% of the threshold, no more than 95% of the threshold, no more than 90% of the threshold, no more than 85% of the threshold, no more than 80% of the threshold, no more than 75% of the threshold, no more than 70% of the threshold, no more than 65% of the threshold, no more than 60% of the threshold, no more than 55% of the threshold, no more than 50% of the threshold, no more than 45% of the threshold, no more than 40% of the threshold, no more than 35% of the threshold, no more than 30% of the threshold, no more than 25% of the threshold, no more than 20% of the threshold, no more than 15% of the threshold, no more than 10% of the threshold, or no more than 5% of the threshold.

[0070] In one aspect, for patients whose incremental values ​​exceed a threshold but do not exceed 200% of the threshold, a three-level (N=3) intervention is applied, such as not exceeding 195%, not exceeding 190%, not exceeding 185%, not exceeding 180%, not exceeding 175%, not exceeding 170%, not exceeding 165%, not exceeding 160%, not exceeding 155%, not exceeding 150%, not exceeding 145% of the threshold, not exceeding 140% of the threshold, not exceeding 135% of the threshold, not exceeding 130% of the threshold, not exceeding 125% of the threshold, not exceeding 120% of the threshold, not exceeding 115% of the threshold, and not exceeding 1% of the threshold. 10%, not exceeding 100% of the threshold, not exceeding 95% of the threshold, not exceeding 90% of the threshold, not exceeding 85% of the threshold, not exceeding 80% of the threshold, not exceeding 75% of the threshold, not exceeding 70% of the threshold, not exceeding 65% of the threshold, not exceeding 60% of the threshold, not exceeding 55% of the threshold, not exceeding 50% of the threshold, not exceeding 45% of the threshold, not exceeding 40% of the threshold, not exceeding 35% of the threshold, not exceeding 30% of the threshold, not exceeding 25% of the threshold, not exceeding 20% ​​of the threshold, not exceeding 15% of the threshold, not exceeding 10% of the threshold, or not exceeding 5% of the threshold.

[0071] In one aspect, for patients whose incremental values ​​exceed a threshold but do not exceed 250% of the threshold, a level 4 (N=4) intervention is applied, such as not exceeding 245% of the threshold, not exceeding 240% of the threshold, not exceeding 235% of the threshold, not exceeding 230% of the threshold, not exceeding 225% of the threshold, not exceeding 220% of the threshold, not exceeding 215% of the threshold, not exceeding 210% of the threshold, not exceeding 205% of the threshold, not exceeding 200% of the threshold, not exceeding 195% of the threshold, not exceeding 190% of the threshold, not exceeding 185% of the threshold, not exceeding 180% of the threshold, not exceeding 175% of the threshold, not exceeding 170% of the threshold, not exceeding 165% of the threshold, not exceeding 160% of the threshold, not exceeding 155% of the threshold, not exceeding 150% of the threshold, not exceeding 145% of the threshold, not exceeding... 140% above the threshold, 135% below the threshold, 130% below the threshold, 125% below the threshold, 120% below the threshold, 115% below the threshold, 110% below the threshold, 100% below the threshold, 95% below the threshold, 90% below the threshold, 85% below the threshold, 80% below the threshold, 75% below the threshold, 70% below the threshold, 65% below the threshold, 60% below the threshold, 55% below the threshold, 50% below the threshold, 45% below the threshold, 40% below the threshold, 35% below the threshold, 30% below the threshold, 25% below the threshold, 20% below the threshold, 15% below the threshold, 10% below the threshold, or 5% below the threshold.

[0072] In one aspect, for patients whose incremental values ​​exceed a threshold but do not exceed 300% of the threshold, a 5-level (N=5) intervention is applied, such as not exceeding 295%, not exceeding 290% of the threshold, not exceeding 285% of the threshold, not exceeding 280% of the threshold, not exceeding 275% of the threshold, not exceeding 270% of the threshold, not exceeding 265% of the threshold, not exceeding 260% of the threshold, not exceeding 255% of the threshold, not exceeding 250% of the threshold, not exceeding 245% of the threshold, not exceeding 240% of the threshold, not exceeding 235% of the threshold, not exceeding 230% of the threshold, not exceeding 225% of the threshold, not exceeding 220% of the threshold, not exceeding 215% of the threshold, not exceeding 210% of the threshold, not exceeding 205% of the threshold, not exceeding 200% of the threshold, not exceeding 195% of the threshold, not exceeding 190% of the threshold, not exceeding 185% of the threshold, not exceeding 180% of the threshold, not exceeding 175% of the threshold, not exceeding 170% of the threshold, not exceeding 295%, not exceeding 290% of the threshold, not exceeding 285% of the threshold, not exceeding 280% of the threshold, not exceeding 280% of the threshold, not exceeding 285% of the threshold, not exceeding 180% of the threshold, not exceeding 175% of the threshold, not exceeding 170% of the threshold, not exceeding 295% of the threshold, not exceeding 290% of the threshold, not exceeding 28 ... 165% of the threshold, not exceeding 160% of the threshold, not exceeding 155% of the threshold, not exceeding 150% of the threshold, not exceeding 145% of the threshold, not exceeding 140% of the threshold, not exceeding 135% of the threshold, not exceeding 130% of the threshold, not exceeding 125% of the threshold, not exceeding 120% of the threshold, not exceeding 115% of the threshold, not exceeding 110% of the threshold, not exceeding 100% of the threshold, not exceeding 95% of the threshold, not exceeding 90% of the threshold, not exceeding 85% of the threshold, not exceeding 80% of the threshold, not exceeding 75% of the threshold, not exceeding 70% of the threshold, not exceeding 65% of the threshold, not exceeding 60% of the threshold, not exceeding 55% of the threshold, not exceeding 50% of the threshold, not exceeding 45% of the threshold, not exceeding 40% of the threshold, not exceeding 35% of the threshold, not exceeding 30% of the threshold, not exceeding 25% of the threshold, not exceeding 20% ​​of the threshold, not exceeding 15% of the threshold, not exceeding 10% of the threshold, or not exceeding 5% of the threshold.

[0073] In one aspect, for patients whose incremental values ​​exceed a threshold but do not exceed 350% of the threshold, a 6-level (N=6) intervention is applied, such as not exceeding 345% of the threshold, not exceeding 340% of the threshold, not exceeding 335% of the threshold, not exceeding 330% of the threshold, not exceeding 325% of the threshold, not exceeding 320% of the threshold, not exceeding 315% of the threshold, not exceeding 310% of the threshold, not exceeding 305% of the threshold, not exceeding 300% of the threshold, not exceeding 295% of the threshold, not exceeding 290% of the threshold, not exceeding 285% of the threshold, not exceeding 2... 80%, not exceeding 275% of the threshold, not exceeding 270% of the threshold, not exceeding 265% of the threshold, not exceeding 260% of the threshold, not exceeding 255% of the threshold, not exceeding 250% of the threshold, not exceeding 245% of the threshold, not exceeding 240% of the threshold, not exceeding 235% of the threshold, not exceeding 230% of the threshold, not exceeding 225% of the threshold, not exceeding 220% of the threshold, not exceeding 215% of the threshold, not exceeding 210% of the threshold, not exceeding 205% of the threshold, not exceeding 200% of the threshold, not exceeding 195% of the threshold, not exceeding 190% above the threshold, 185% below the threshold, 175% below the threshold, 165% below the threshold, 155% below the threshold, 145% below the threshold, 135% below the threshold, 130% below the threshold, 125% below the threshold, 115% below the threshold, 110% below the threshold, 1% above the threshold 00%, not exceeding 95% of the threshold, not exceeding 90% of the threshold, not exceeding 85% of the threshold, not exceeding 80% of the threshold, not exceeding 75% of the threshold, not exceeding 70% of the threshold, not exceeding 65% of the threshold, not exceeding 60% of the threshold, not exceeding 55% of the threshold, not exceeding 50% of the threshold, not exceeding 45% of the threshold, not exceeding 40% of the threshold, not exceeding 35% of the threshold, not exceeding 30% of the threshold, not exceeding 25% of the threshold, not exceeding 20% ​​of the threshold, not exceeding 15% of the threshold, not exceeding 10% of the threshold, or not exceeding 5% of the threshold.

[0074] In one aspect, for patients whose incremental values ​​exceed a threshold but do not exceed 400% of the threshold, a 7-level (N=7) intervention is applied, such as not exceeding 395%, not exceeding 390%, not exceeding 385%, not exceeding 380%, not exceeding 375%, not exceeding 370%, not exceeding 365%, not exceeding 360%, not exceeding 355%, not exceeding 350%, not exceeding 345%, not exceeding 340%, not exceeding 335%, not exceeding 330%, not exceeding 325%, not exceeding 320%, not exceeding 320%, and not exceeding 395%. 315% above the threshold, 310% below the threshold, 305% below the threshold, 300% below the threshold, 295% below the threshold, 290% below the threshold, 285% below the threshold, 280% below the threshold, 275% below the threshold, 270% below the threshold, 265% below the threshold, 260% below the threshold, 255% below the threshold, 250% below the threshold, 245% below the threshold, 240% below the threshold, 235% below the threshold, 230% below the threshold, 225% below the threshold, 220% below the threshold, not exceeding 215% above the threshold, 210% below the threshold, 205% below the threshold, 200% below the threshold, 195% below the threshold, 190% below the threshold, 185% below the threshold, 180% below the threshold, 175% below the threshold, 170% below the threshold, 165% below the threshold, 160% below the threshold, 155% below the threshold, 150% below the threshold, 145% below the threshold, 140% below the threshold, 135% below the threshold, 130% below the threshold, 125% below the threshold, 120% below the threshold, not exceeding Exceeding 115% of the threshold, not exceeding 110% of the threshold, not exceeding 100% of the threshold, not exceeding 95% of the threshold, not exceeding 90% of the threshold, not exceeding 85% of the threshold, not exceeding 80% of the threshold, not exceeding 75% of the threshold, not exceeding 70% of the threshold, not exceeding 65% of the threshold, not exceeding 60% of the threshold, not exceeding 55% of the threshold, not exceeding 50% of the threshold, not exceeding 45% of the threshold, not exceeding 40% of the threshold, not exceeding 35% of the threshold, not exceeding 30% of the threshold, not exceeding 25% of the threshold, not exceeding 20% ​​of the threshold, not exceeding 15% of the threshold, not exceeding 10% of the threshold, or not exceeding 5% of the threshold.

[0075] In one aspect, for patients whose incremental values ​​exceed a threshold but do not exceed 450% of the threshold, an 8-level (N=8) intervention is applied, such as not exceeding 445% of the threshold, not exceeding 440% of the threshold, not exceeding 435% of the threshold, not exceeding 430% of the threshold, not exceeding 425% of the threshold, not exceeding 420% of the threshold, not exceeding 415% of the threshold, not exceeding 410% of the threshold, not exceeding 405% of the threshold, not exceeding 400% of the threshold, not exceeding 395% of the threshold, not exceeding 390% of the threshold, not exceeding 385% of the threshold, not exceeding 380% of the threshold, not exceeding 375% of the threshold, not exceeding 370% of the threshold, not exceeding 365% of the threshold, not exceeding 360% of the threshold, not exceeding 3... 55%, not exceeding 350% of the threshold, not exceeding 345% of the threshold, not exceeding 340% of the threshold, not exceeding 335% of the threshold, not exceeding 330% of the threshold, not exceeding 325% of the threshold, not exceeding 320% of the threshold, not exceeding 315% of the threshold, not exceeding 310% of the threshold, not exceeding 305% of the threshold, not exceeding 300% of the threshold, not exceeding 295% of the threshold, not exceeding 290% of the threshold, not exceeding 285% of the threshold, not exceeding 280% of the threshold, not exceeding 275% of the threshold, not exceeding 270% of the threshold, not exceeding 265% of the threshold, not exceeding 260% of the threshold, not exceeding 255% of the threshold, not exceeding 250% of the threshold, not exceeding 245% of the threshold, not exceeding 240% above the threshold, 235% below the threshold, 230% below the threshold, 225% below the threshold, 220% below the threshold, 215% below the threshold, 210% below the threshold, 205% below the threshold, 200% below the threshold, 195% below the threshold, 190% below the threshold, 185% below the threshold, 180% below the threshold, 175% below the threshold, 170% below the threshold, 165% below the threshold, 160% below the threshold, 155% below the threshold, 150% below the threshold, 145% below the threshold, 140% below the threshold, 135% below the threshold, 1% below the threshold 30%, not exceeding 125% of the threshold, not exceeding 120% of the threshold, not exceeding 115% of the threshold, not exceeding 110% of the threshold, not exceeding 100% of the threshold, not exceeding 95% of the threshold, not exceeding 90% of the threshold, not exceeding 85% of the threshold, not exceeding 80% of the threshold, not exceeding 75% of the threshold, not exceeding 70% of the threshold, not exceeding 65% of the threshold, not exceeding 60% of the threshold, not exceeding 55% of the threshold, not exceeding 50% of the threshold, not exceeding 45% of the threshold, not exceeding 40% of the threshold, not exceeding 35% of the threshold, not exceeding 30% of the threshold, not exceeding 25% of the threshold, not exceeding 20% ​​of the threshold, not exceeding 15% of the threshold, not exceeding 10% of the threshold, or not exceeding 5% of the threshold.

[0076] In one aspect, for patients whose incremental values ​​exceed a threshold but do not exceed 500% of the threshold, a 9-level (N=9) intervention is applied, such as not exceeding 495% of the threshold, not exceeding 490% of the threshold, not exceeding 485% of the threshold, not exceeding 480% of the threshold, not exceeding 475% of the threshold, not exceeding 470% of the threshold, not exceeding 465% of the threshold, not exceeding 460% of the threshold, not exceeding 455% of the threshold, not exceeding 450% of the threshold, not exceeding 445% of the threshold, not exceeding 440% of the threshold, not exceeding 435% of the threshold, not exceeding 430% of the threshold, not exceeding 425% of the threshold, not exceeding 420% of the threshold, not exceeding 415% of the threshold, not exceeding 410% of the threshold, and not exceeding 405% of the threshold. Not exceeding 400% of the threshold, not exceeding 395% of the threshold, not exceeding 390% of the threshold, not exceeding 385% of the threshold, not exceeding 380% of the threshold, not exceeding 375% of the threshold, not exceeding 370% of the threshold, not exceeding 365% of the threshold, not exceeding 360% of the threshold, not exceeding 355% of the threshold, not exceeding 350% of the threshold, not exceeding 345% of the threshold, not exceeding 340% of the threshold, not exceeding 335% of the threshold, not exceeding 330% of the threshold, not exceeding 325% of the threshold, not exceeding 320% of the threshold, not exceeding 315% of the threshold, not exceeding 310% of the threshold, not exceeding 305% of the threshold, not exceeding 300% of the threshold, not exceeding 295% of the threshold, not exceeding 2% of the threshold. 90%, not exceeding 285% of the threshold, not exceeding 280% of the threshold, not exceeding 275% of the threshold, not exceeding 270% of the threshold, not exceeding 265% of the threshold, not exceeding 260% of the threshold, not exceeding 255% of the threshold, not exceeding 250% of the threshold, not exceeding 245% of the threshold, not exceeding 240% of the threshold, not exceeding 235% of the threshold, not exceeding 230% of the threshold, not exceeding 225% of the threshold, not exceeding 220% of the threshold, not exceeding 215% of the threshold, not exceeding 210% of the threshold, not exceeding 205% of the threshold, not exceeding 200% of the threshold, not exceeding 195% of the threshold, not exceeding 190% of the threshold, not exceeding 185% of the threshold, not exceeding 180% of the threshold, not exceeding the threshold 175% of the value, not exceeding 170% of the threshold, not exceeding 165% of the threshold, not exceeding 160% of the threshold, not exceeding 155% of the threshold, not exceeding 150% of the threshold, not exceeding 145% of the threshold, not exceeding 140% of the threshold, not exceeding 135% of the threshold, not exceeding 130% of the threshold, not exceeding 125% of the threshold, not exceeding 120% of the threshold, not exceeding 115% of the threshold, not exceeding 110% of the threshold, not exceeding 100% of the threshold, not exceeding 95% of the threshold, not exceeding 90% of the threshold, not exceeding 85% of the threshold, not exceeding 80% of the threshold, not exceeding 75% of the threshold, not exceeding 70% of the threshold, not exceeding 65% of the threshold, not exceeding 60% of the threshold, not exceeding 55% of the threshold.Not exceeding 50% of the threshold, not exceeding 45% of the threshold, not exceeding 40% of the threshold, not exceeding 35% of the threshold, not exceeding 30% of the threshold, not exceeding 25% of the threshold, not exceeding 20% ​​of the threshold, not exceeding 15% of the threshold, not exceeding 10% of the threshold, or not exceeding 5% of the threshold.

[0077] In one aspect, for patients whose incremental values ​​exceed a threshold but do not exceed 550% of the threshold, a 10-level (N=10) intervention is applied, such as not exceeding 545% of the threshold, not exceeding 540% of the threshold, not exceeding 535% of the threshold, not exceeding 530% of the threshold, not exceeding 525% of the threshold, not exceeding 520% ​​of the threshold, not exceeding 515% of the threshold, not exceeding 510% of the threshold, not exceeding 505% of the threshold, not exceeding 500% of the threshold, not exceeding 495% of the threshold, not exceeding 490% of the threshold, not exceeding 485% of the threshold, not exceeding 480% of the threshold, not exceeding 475% of the threshold, not exceeding 470% of the threshold, not exceeding 465% of the threshold, not exceeding 460% of the threshold, not exceeding 45% of the threshold. 5%, not exceeding 450% of the threshold, not exceeding 445% of the threshold, not exceeding 440% of the threshold, not exceeding 435% of the threshold, not exceeding 430% of the threshold, not exceeding 425% of the threshold, not exceeding 420% of the threshold, not exceeding 415% of the threshold, not exceeding 410% of the threshold, not exceeding 405% of the threshold, not exceeding 400% of the threshold, not exceeding 395% of the threshold, not exceeding 390% of the threshold, not exceeding 385% of the threshold, not exceeding 380% of the threshold, not exceeding 375% of the threshold, not exceeding 370% of the threshold, not exceeding 365% of the threshold, not exceeding 360% of the threshold, not exceeding 355% of the threshold, not exceeding 350% of the threshold, not exceeding 345% of the threshold, not exceeding the threshold 340%, not exceeding 335% of the threshold, not exceeding 330% of the threshold, not exceeding 325% of the threshold, not exceeding 320% of the threshold, not exceeding 315% of the threshold, not exceeding 310% of the threshold, not exceeding 305% of the threshold, not exceeding 300% of the threshold, not exceeding 295% of the threshold, not exceeding 290% of the threshold, not exceeding 285% of the threshold, not exceeding 280% of the threshold, not exceeding 275% of the threshold, not exceeding 270% of the threshold, not exceeding 265% of the threshold, not exceeding 260% of the threshold, not exceeding 255% of the threshold, not exceeding 250% of the threshold, not exceeding 245% of the threshold, not exceeding 240% of the threshold, not exceeding 235% of the threshold, not exceeding 230% of the threshold, not exceeding 225% above the threshold, 220% below the threshold, 215% below the threshold, 210% below the threshold, 205% below the threshold, 200% below the threshold, 195% below the threshold, 190% below the threshold, 185% below the threshold, 180% below the threshold, 175% below the threshold, 170% below the threshold, 165% below the threshold, 160% below the threshold, 155% below the threshold, 150% below the threshold, 145% below the threshold, 140% below the threshold, 135% below the threshold, 130% below the threshold, 125% below the threshold, 120% below the threshold, 115% below the threshold.Not exceeding 110% of the threshold, not exceeding 100% of the threshold, not exceeding 95% of the threshold, not exceeding 90% of the threshold, not exceeding 85% of the threshold, not exceeding 80% of the threshold, not exceeding 75% of the threshold, not exceeding 70% of the threshold, not exceeding 65% of the threshold, not exceeding 60% of the threshold, not exceeding 55% of the threshold, not exceeding 50% of the threshold, not exceeding 45% of the threshold, not exceeding 40% of the threshold, not exceeding 35% of the threshold, not exceeding 30% of the threshold, not exceeding 25% of the threshold, not exceeding 20% ​​of the threshold, not exceeding 15% of the threshold, not exceeding 10% of the threshold, or not exceeding 5% of the threshold.

[0078] In one aspect, level N intervention is more effective than level 0 intervention. In another aspect, level N+1 intervention is more effective than level N intervention. In yet another aspect, level N-1 intervention is less effective than level N intervention.

[0079] In one aspect, the assessment steps of this disclosure further include performing a visual assessment. In one aspect, the visual assessment is conducted in accordance with the guidelines of the National Pressure Ulcer Advisory Group (NPUAP).

[0080] In one aspect, the assessment steps of this disclosure further include performing a risk assessment. In one aspect, the risk assessment is performed based on a test selected from a group consisting of the following: the Braden Scale, the Gosnell Scale, the Norton Scale, and the Waterlow Scale.

[0081] In one aspect, this disclosure provides and includes: performing a second series of SEM measurements on a patient at a first predetermined frequency corresponding to the level of intervention applied; calculating a second incremental value based on a portion of the second series of SEM measurements; determining whether the second incremental value exceeds a second threshold; if the second incremental value does not exceed the second threshold, continuing to apply a first intervention; if the second incremental value does not exceed the second threshold, continuing to perform multiple SEM measurements at the first predetermined frequency; if the second incremental value exceeds the second threshold, applying a second intervention at level M, where M is an integer and M is greater than N; and if the second incremental value exceeds the second threshold, performing multiple SEM measurements at a second predetermined frequency corresponding to level M.

[0082] In one aspect, the predetermined frequency is selected from the following groups: at least once every 72 hours, at least once every 48 hours, at least once every 24 hours, at least once every 12 hours, at least once every 8 hours, at least once every 6 hours, at least once every 4 hours, at least once every 3 hours, at least once every 2 hours, at least once every hour, and at least once every half hour.

[0083] In one aspect, according to

[0060] , a second series of SEM measurements are performed at the same locations where the first series of SEM measurements were performed. In one aspect, the second series of SEM measurements are performed at some of the same locations where the first series of SEM measurements were performed. In one aspect, the second series of SEM measurements are performed near the locations where the first series of SEM measurements were performed. In one aspect, the second series of SEM measurements are performed at locations different from where the first series of SEM measurements were performed.

[0084] In one aspect, the second increment value is determined by the difference between the maximum and minimum SEM values ​​from a second set of SEM measurements. In another aspect, the second increment value is determined by the difference between the maximum average SEM value of measurements taken at one location and the minimum average SEM value of measurements taken at a second location. In yet another aspect, the second increment value is determined for a portion of the second set of SEM measurements, which consists of a subgroup defined by the taken locations.

[0085] In one aspect, the second threshold can be 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 aspect, the range of the second threshold may be from 0.1 to 8.0, such as from 0.1 to 1.0, from 1.1 to 2.0, from 2.1 to 3.0, from 3.1 to 4.0, from 4.1 to 5.0, from 5.1 to 6.0, from 6.1 to 7.0, from 7.1 to 8.0, from 0.1 to 7.5, from 0.5 to 8.0, from 1.0 to 7.0, from 1.5 to 6.5, from 2.0 to 6.0, from 3.0 to 5.5, from 3.5 to 5.0, or from 4.0 to 4.5. In one aspect, the second threshold may be scaled by a factor or multiple based on the values ​​provided herein. In one aspect, the second threshold may be the same as the first threshold. In one aspect, the second threshold may be greater than the first threshold. In one aspect, the second threshold may be less than the first threshold.

[0086] In one aspect, M ranges from 2 to 50, such as from 2 to 3, from 2 to 4, from 2 to 5, from 2 to 6, from 2 to 7, from 2 to 8, from 2 to 9, from 2 to 10, from 2 to 15, from 2 to 20, from 2 to 25, from 2 to 30, from 2 to 35, from 2 to 40, or from 2 to 45.

[0087] In one aspect, M is determined by the amount by which the second increment value exceeds the second threshold. In another aspect, the amount by which the increment value exceeds the threshold set for (M+1) is greater than the amount by which the increment value exceeds the threshold set for M. In yet another aspect, the amount by which the increment value exceeds the threshold set for (M-1) is less than the amount by which the increment value exceeds the threshold set for M.

[0088] In one aspect, an M-level intervention is selected according to

[0066] to

[0075] so that N can be replaced by M.

[0089] In one aspect, this disclosure provides and includes: determining whether a second incremental value is less than a third threshold; if the second incremental value is less than the third threshold and if the first intervention is not level 0, then applying an (N-1) level intervention; and if the second incremental value is less than the third threshold, then performing multiple SEM measurements at a predetermined frequency corresponding to the (N-1) level.

[0090] In one aspect, the third threshold can be 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 aspect, the range of the third threshold can be from 0.1 to 8.0, such as from 0.1 to 1.0, from 1.1 to 2.0, from 2.1 to 3.0, from 3.1 to 4.0, from 4.1 to 5.0, from 5.1 to 6.0, from 6.1 to 7.0, from 7.1 to 8.0, from 0.1 to 7.5, from 0.5 to 8.0, from 1.0 to 7.0, from 1.5 to 6.5, from 2.0 to 6.0, from 3.0 to 5.5, from 3.5 to 5.0, or from 4.0 to 4.5. In one aspect, the third threshold can be scaled by a factor or multiple based on the values ​​provided herein. In one aspect, the third threshold can be the same as the second threshold. In one aspect, the third threshold can be greater than the second threshold. In one aspect, the third threshold can be less than the second threshold. In one aspect, the third threshold can be the same as the first threshold. In one aspect, the third threshold can be greater than the first threshold. In one aspect, the third threshold can be less than the first threshold.

[0091] In one aspect, the second increment value can be 0.1-99.5% of the third threshold, such as 0.1-1% of the third threshold, 0.1-5% of the third threshold, 1-5% of the third threshold, 5-15% of the third threshold, 10-20% of the third threshold, 15-25% of the third threshold, 20-30% of the third threshold, 25-35% of the third threshold, 30-40% of the third threshold, 35-45% of the third threshold, 40-50% of the third threshold, 0.1-25% of the third threshold, 15-35% of the third threshold, 25-50% of the third threshold. 25-75% of the third threshold, 45-55% of the third threshold, 50-60% of the third threshold, 55-65% of the third threshold, 60-70% of the third threshold, 65-75% of the third threshold, 40-55% of the third threshold, 50-75% of the third threshold, 50-99.5% of the third threshold, 70-80% of the third threshold, 75-85% of the third threshold, 80-90% of the third threshold, 85-95% of the third threshold, 90-99.5% of the third threshold, 65-85% of the third threshold, or 75-99.5% of the third threshold.

[0092] In one aspect, this disclosure provides and includes a method for slowing the progression of pressure ulcers in a patient with this need, the method comprising the steps of: identifying a current intervention of grade K received by the patient; performing multiple subepidermal water (SEM) measurements on the patient; calculating an incremental value based on a portion of the multiple SEM measurements; determining whether the incremental value exceeds a first threshold; if the incremental value does not exceed the first threshold, continuing to apply the current intervention; if the incremental value does not exceed the first threshold, continuing to perform multiple SEM measurements at a predetermined frequency corresponding to grade K; if the incremental value exceeds the first threshold, applying a new intervention of grade N, wherein N has a value greater than K; and if the incremental value exceeds the first threshold, performing multiple SEM measurements at a predetermined frequency corresponding to grade N. In one aspect, the patient with this need is a patient experiencing changes in care, mobility, nutrition, sensation, or a combination thereof. In one aspect, the patient with this need is a patient who has developed an open ulcer. In one aspect, the patient with this need is a patient who has recovered from an open ulcer. In one aspect, the patient with this need is a patient who has undergone surgery. In one aspect, the patient requiring this is one who receives spinal analgesia or sacral analgesia during surgery. In another aspect, the patient requiring this is one whose surgery lasts for four or more hours, such as five or more hours, six or more hours, seven or more hours, eight or more hours, nine or more hours, ten or more hours, eleven or more hours, or twelve or more hours. In another aspect, the surgery has a duration of one or more hours, such as two or more hours, or three or more hours.

[0093] In one aspect, multiple SEM measurements are taken according to

[0060] . In one aspect, an incremental value is determined according to

[0061] . In one aspect, a first threshold is determined according to

[0063] .

[0094] In one aspect, K ranges from 2 to 50, such as from 2 to 3, from 2 to 4, from 2 to 5, from 2 to 6, from 2 to 7, from 2 to 8, from 2 to 9, from 2 to 10, from 2 to 15, from 2 to 20, from 2 to 25, from 2 to 30, from 2 to 35, from 2 to 40, or from 2 to 45.

[0095] In one aspect, K is determined by the amount by which the increment exceeds a threshold. In another aspect, the amount by which the increment exceeds a threshold set for (K+1) is greater than the amount by which the increment exceeds a threshold set for K. In yet another aspect, the amount by which the increment exceeds a threshold set for (K-1) is less than the amount by which the increment exceeds a threshold set for K.

[0096] In one aspect, a K-level intervention is selected according to

[0066] to

[0075] in order to replace N with K.

[0097] In one aspect, the disclosure further provides and includes: determining whether the incremental value is less than a second threshold; if the incremental value is less than the second threshold, applying an L-level intervention, wherein L has a non-negative value less than K; and if the incremental value is less than the second threshold, performing multiple SEM measurements at a predetermined frequency corresponding to the L-level.

[0098] In one aspect, the second threshold is determined according to

[0083] .

[0099] In one aspect, 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 aspect, if the increment value is 90-99.5% of the second threshold, such as 90-95%, 91-96%, 92-97%, 93-98%, 94-99%, or 95-99.5% of the second threshold, then L is K-1, unless K-1 is less than 0, in which case L will be 0. In one aspect, if the increment value is 80-89.9% of the second threshold, such as 80-85%, 81-86%, 82-87%, 83-88%, 84-89%, or 85-89.9% of the second threshold, then L is K-2, unless K-2 is less than 0, in which case L will be 0. In another aspect, if the increment value is 70-79.9% of the second threshold, such as 70-75%, 71-76%, 72-77%, 73-78%, 74-79%, or 75-79.9% of the second threshold, then L is K-3, unless K-3 is less than 0, in which case L will be 0. In one aspect, if the increment value is 60-69.9% of the second threshold, such as 60-65%, 61-66%, 62-67%, 63-68%, 64-69%, or 65-69.9% of the second threshold, then L is K-4, unless K-4 is less than 0, in which case L will be 0. In another aspect, if the increment value is 50-59.9% of the second threshold, such as 50-55%, 51-56%, 52-57%, 53-58%, 54-59%, or 55-59.9% of the second threshold, then L is K-5, unless K-5 is less than 0, in which case L will be 0. In one aspect, if the increment value is 40-49.9% of the second threshold, such as 40-45%, 41-46%, 42-47%, 43-48%, 44-49%, or 45-49.9% of the second threshold, then L is K-6, unless K-6 is less than 0, in which case L will be 0. In another aspect, if the increment value is 30-39.9% of the second threshold, such as 30-35%, 31-36%, 32-37%, 33-38%, 34-39%, or 35-39.9% of the second threshold, then L is K-7, unless K-7 is less than 0, in which case L will be 0.In one aspect, if the increment value is 20-29.9% of the second threshold, such as 20-25%, 21-26%, 22-27%, 23-28%, 24-29%, or 25-29.9% of the second threshold, then L is K-8, unless K-8 is less than 0, in which case L will be 0. In another aspect, if the increment value is 10-19.9% ​​of the second threshold, such as 10-15%, 11-16%, 12-17%, 13-18%, 14-19%, or 15-19.9% ​​of the second threshold, then L is K-9, unless K-9 is less than 0, in which case L will be 0. In one aspect, if the increment value is 0.1-9.9% of the second threshold, such as 0.1-5% of the second threshold, 1-6% of the second threshold, 2-7% of the second threshold, 3-8% of the second threshold, 4-9% of the second threshold, or 5-9.9% of the second threshold, then L is K-10, unless K-10 is less than 0, in which case L will be 0.

[0100] In one aspect, this disclosure provides and includes a method for classifying patient groups in a care facility based on the risk of pressure ulcers, the method comprising the steps of: performing multiple subepidermal water (SEM) measurements on each patient; calculating incremental values ​​based on a portion of the multiple SEM measurements on each patient; determining whether each incremental value exceeds any value in a set of thresholds corresponding to N care levels, and assigning a care level to each patient; and rearranging the patient groups based on the care level assigned to each patient.

[0101] In one aspect, this disclosure provides and includes a method for reducing the incidence of pressure ulcers in patients admitted to a nursing facility, the method comprising the steps of: assessing the risk of pressure ulcers in patients upon admission to the nursing facility, wherein the assessment step includes performing a first multiple subepidermal water (SEM) measurement on the patient; calculating a first incremental value based on a portion of the first multiple SEM measurements; determining whether the first incremental value exceeds a first threshold; if the first incremental value does not exceed the first threshold, applying a first intervention at level 0; and if the first incremental value exceeds the first threshold, applying a first intervention at level N, where N is an integer and the value of N is 1 or greater. In one aspect, the incidence of ulcers in patients in the nursing facility is reduced to less than 1 / 100, less than 1 / 200, less than 1 / 300, less than 1 / 400, less than 1 / 500, less than 1 / 600, less than 1 / 700, less than 1 / 800, less than 1 / 900, or less than 1 / 1000.

[0102] In one aspect, this disclosure provides and includes a method for identifying and treating a patient requiring application of a protective cream to their heel, the method comprising the steps of: performing multiple subepidermal moisture (SEM) measurements at the patient's heel; calculating an incremental value based on a portion of the multiple SEM measurements; determining whether the incremental value exceeds a threshold corresponding to level N, where N is greater than or equal to 2; if the incremental value exceeds the threshold, applying a protective cream to the patient's heel; and if the incremental value exceeds the threshold, performing multiple SEM measurements every two hours. In one aspect, if the incremental value exceeds the threshold, multiple SEM measurements are performed at least once per hour or at least once every half hour.

[0103] In one aspect, this disclosure provides and includes a method for identifying and treating a patient requiring neuromuscular stimulation of their heel, the method comprising the steps of: performing multiple subepidermal water (SEM) measurements at the patient's heel; calculating an increment value based on a portion of the multiple SEM measurements; determining whether the increment value exceeds a threshold corresponding to level N, where N is greater than or equal to 2; if the increment value exceeds the threshold, applying neuromuscular stimulation to the patient's heel; and if the increment value exceeds the threshold, performing multiple SEM measurements per hour. In one aspect, if the increment value exceeds the threshold, multiple SEM measurements are performed at least once every half hour.

[0104] In one aspect, this disclosure provides and includes a method for identifying and treating a patient who requires application of a topical cream to their heel, the method comprising the steps of: performing multiple subepidermal moisture (SEM) measurements at the patient's heel; calculating an incremental value based on a portion of the multiple SEM measurements; determining whether the incremental value exceeds a threshold corresponding to level N, where N is greater than or equal to 2; if the incremental value exceeds the threshold, applying a topical cream to the patient's heel; and if the incremental value exceeds the threshold, performing multiple SEM measurements every half hour.

[0105] In one aspect, this disclosure provides and includes a method for identifying and treating a patient requiring application of a protective cream to their sacrum, the method comprising the steps of: performing multiple subepidermal moisture (SEM) measurements at the patient's sacrum; calculating an increment value based on a portion of the multiple SEM measurements; determining whether the increment value exceeds a threshold corresponding to level N, where N is greater than or equal to 2; if the increment value exceeds the threshold, applying a protective cream to the patient's sacrum; and if the increment value exceeds the threshold, performing multiple SEM measurements every six hours. In one aspect, if the increment value exceeds the threshold, multiple SEM measurements are performed at least every four hours, at least every three hours, at least every two hours, at least every hour, or at least every half hour.

[0106] In one aspect, this disclosure provides and includes a method for identifying and treating a patient requiring neuromuscular stimulation of the sacrum, the method comprising the steps of: performing multiple subepidermal water (SEM) measurements at the patient's heel; calculating an increment value based on a portion of the multiple SEM measurements; determining whether the increment value exceeds a threshold corresponding to level N, where N is greater than or equal to 2; if the increment value exceeds the threshold, applying neuromuscular stimulation to the patient's sacrum; and if the increment value exceeds the threshold, performing multiple SEM measurements every four hours. In one aspect, if the increment value exceeds the threshold, multiple SEM measurements are performed at least every three hours, at least every two hours, at least every hour, or at least every half hour.

[0107] In one aspect, this disclosure provides and includes a method for identifying and treating a patient requiring application of a topical cream to their sacrum, the method comprising the steps of: performing multiple subepidermal moisture (SEM) measurements at the patient's sacrum; calculating an incremental value based on a portion of the multiple SEM measurements; determining whether the incremental value exceeds a threshold corresponding to level N, where N is greater than or equal to 2; if the incremental value exceeds the threshold, applying a topical cream to the patient's sacrum; and if the incremental value exceeds the threshold, performing multiple SEM measurements every two hours. In one aspect, if the incremental value exceeds the threshold, multiple SEM measurements are performed at least once per hour or at least once every half hour.

[0108] In one aspect, the method of this disclosure is performed using the apparatus disclosed in U.S. Patent Applications Nos. 14 / 827,375 and 15 / 134,110. In one aspect, the moisture content is equal to the SEM value on a predetermined scale. In one aspect, the predetermined scale can range from 0 to 20, such as from 0 to 1, 0 to 2, 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 11, 0 to 12, 0 to 13, 0 to 14, 0 to 15, 0 to 16, 0 to 17, 0 to 18, and 0 to 19. In one aspect, the predetermined scale can be scaled by factors or multiples based on the values ​​provided herein.

[0109] In one aspect, this disclosure further provides and includes targeted therapy for anatomical locations identified as affected by a combination of visual assessment and SEM scanning measurements. In one aspect, targeted therapy is provided for common locations of pressure ulcers selected from the group consisting of: toes, heels, sacrum, spine, elbows, scapula, occipital bone, and ischial tuberosity. In one aspect, targeted therapy is simultaneously provided for a second common location of pressure ulcers selected from the group consisting of: toes, heels, sacrum, spine, elbows, scapula, occipital bone, and ischial tuberosity. In one aspect, it is known that receiving targeted therapy at a first location leads to the development of a pressure ulcer at the second location.

[0110] This disclosure is illustrated by the following examples. The examples set forth herein illustrate several aspects of this disclosure, but should not be construed as limiting the scope of this disclosure in any way.

[0111] Example

[0112] Example 1: Intervention levels for treating pressure ulcers on the heel

[0113] Subjects identified as being at risk of developing heel pressure ulcers will be treated according to the following protocol:

[0114] Table 1: Example intervention protocols for treating pressure ulcers of the heel.

[0115]

[0116]

[0117] Example 2: Intervention levels for treating sacral pressure ulcers. Subjects identified as being at risk of developing sacral pressure ulcers were treated according to the following protocol:

[0118] Table 2: Example intervention protocols for treating pressure ulcers of the sacrum

[0119]

[0120]

[0121] Example 3: Identifying patients requiring level 0 intervention at the sacrum

[0122] Using a device capable of SEM measurements, multiple SEM measurements are performed on the patient at and around the bony prominence of the sacrum. Before performing the measurements, surface moisture and substances are removed from the patient's skin. Sufficient pressure is applied to the electrodes of the device onto the patient's skin to ensure complete contact for approximately one second, thus obtaining the results for each SEM measurement.

[0123] SEM measurements were taken along a straight line passing through the patient's sacrum. Multiple measurements were taken at the given measurement locations. Figure 2A It is a visual assessment of samples from healthy tissues. Figure 2B This is the corresponding curve of the average SEM measurements taken at each location. A threshold of 0.5 was chosen. The increment value was calculated as the difference between the maximum and minimum average SEM values, which was determined to be less than 0.5. Because the SEM increment value was below the threshold, the patient was identified as requiring level 0 intervention. Therefore, the patient was placed on a standard mattress and turned over every 24 hours.

[0124] Additional SEM measurements were taken every 24 hours until discharge. There was no change in the level of intervention.

[0125] Example 4: Identifying patients requiring n-level intervention at the sacrum

[0126] Following the same procedure as described in Example 3, multiple SEM measurements were performed on the patient along a straight line passing through the sacrum.

[0127] Figure 3A It is a visual assessment of samples of damaged tissue. Figure 3B This is the corresponding curve of the average SEM measurements taken at each location. A threshold of 0.5 was selected. The increment value was calculated as the difference between the maximum and minimum average SEM values, which was determined to be greater than 0.5. Because the SEM increment value exceeded the threshold by more than 200%, the patient was identified as requiring level 8 intervention. Accordingly, the patient was placed on a silicone pad and monitored hourly until an SEM increment value less than 170% of the threshold was observed, at which point the patient was switched to level 7 intervention.

[0128] Example 5: Sample process for selecting intervention and monitoring levels

[0129] Figure 4 This is an illustration of process 400 for selecting intervention and monitoring levels based on the amount by which incremental values ​​derived from SEM measurements exceed a threshold. Here, in step 402, a caregiver uses an SEM scanner to perform multiple SEM measurements at a location on the patient's skin, where each measurement generates an SEM value. Using a portion of these SEM values, an incremental value "Δ" is calculated in step 404. The incremental value is calculated by subtracting the minimum SEM value from the maximum SEM value generated from the multiple SEM measurements.

[0130] In step 406, the calculated incremental value is compared to a threshold “T”. If the incremental value is less than or equal to the threshold, step 408 is executed, and the caregiver waits until the monitoring interval associated with the current level of care has elapsed, then repeats the SEM measurement in step 402. If the incremental value is greater than the threshold, the amount by which the incremental value exceeds the threshold is compared to a series of cascading differences.

[0131] In some cases, the increment value is positive, and a comparison is performed by subtracting a threshold from the increment value, which produces a positive difference. Then, in step 410, it is determined whether the difference exceeds a first difference D1. If the difference is less than D1, the process branches to step 412 and then proceeds to step 414 to implement the intervention and measurement intervals associated with level N+1 accordingly. In this example, N has a value equal to or greater than zero.

[0132] In some cases, the increment value is negative, for example, if from Figure 3B Subtract from the average of the SEM values ​​at the leftmost and rightmost positions Figure 3B The SEM measurements at the center location of the data. In this case, the differences D1, D2 to Dn are selected to have negative values, which can have absolute values ​​different from the corresponding differences D1, D2 to Dn used for the positive increment values. Alternatively, the comparisons in steps 410, 420, and 430 are changed to Figure 4 The symbol shown is “≤” instead of “≥”.

[0133] Example 6: Workflow Guidance Matrix

[0134] Figure 5 This is an example of a workflow guidance matrix 500, where a new intervention level 506 is selected using the current intervention level 502 and a new increment value 504. Here, caregivers monitor a patient's condition by periodically taking multiple SEM measurements at one or more locations on the patient's skin. While these measurements are being taken, the patient receives care associated with the intervention and monitoring level. In this example, level 0 (zero) is associated with a patient deemed to have no significant risk of developing a pressure ulcer. Higher levels of intervention and monitoring are identified as having a higher intervention level, for example, based on cost, implementation difficulty, or other parameters identified by the care facility. When caregivers perform a new set of SEM measurements, they consult the matrix by identifying the current intervention level 502, the increment value determined from the latest set of SEM measurements, and identifying the intervention level in the new intervention level 506 at the intersection of the current intervention level 502 and the new increment value 504. Caregivers can consider the identified intervention level, along with the current intervention level and increment value, when selecting the intervention level for the next time period.

[0135] In some cases, the values ​​of the new intervention level 506 are similar row by row. In some cases, the values ​​of the new intervention level 506 in adjacent cells differ by one or more levels. In some cases, the values ​​of the new intervention level 506 in adjacent cells are the same.

[0136] Example 7: Progression of tissue conditions leading to pressure ulcers

[0137] Figure 6A , Figure 6B and Figure 6C Illustrative, non-limiting examples of the progression of tissue conditions leading to pressure ulcers over time are depicted. Figure 6A A cross-section of healthy tissue 600, including the stratum corneum 602 and healthy cells 604 in the epidermis / dermis, is depicted. The central electrode 606 and annular electrode 608 of the SEM scanner are shown as cross-sections in contact with the stratum corneum 602. A schematic indication of the sensitive area of ​​the SEM scanner is shown as an oval region 610. Region 610 has a sensitivity depth. In some cases, the sensitivity depth is in the range of 0.14-0.16 inches. In some cases, the sensitivity depth is less than 0.16 inches.

[0138] Figure 6B This is a schematic cross-section of slightly damaged tissue 620. Cellular damage, for example, caused by prolonged application of low-level pressure, has affected the tissue. Without theoretical limitation, some of the cells 622 have ruptured, thereby releasing fluid contents into the intercellular spaces 624. Alternatively, and without theoretical limitation, an inflammatory response has caused fluid migration into the intercellular spaces 624. This damage is not visible on the skin surface.

[0139] Figure 6C This is a schematic cross-section 640 of a higher level of injury. Without being bound by theory, the tissue is now primarily composed of ruptured cells 622, which provide little mechanical structure to withstand continuously applied pressure. Tissue thickness is reduced, with bone 642 now closer to the skin surface. The ruptured cells 622 and intercellular spaces 624 are compressed, expelling fluid 644 from the local tissue as indicated by arrow 646.

[0140] Figure 6DAn illustrative plot 660 shows the incremental values ​​of a single patient at a single location where a pressure ulcer has developed. SEM values ​​were measured using a SEM scanner. The incremental values ​​were generated from a set of SEM measurements taken over the incremental time interval. Point 672 is the measurement at time = zero, where all SEM values ​​have a baseline value associated with healthy tissue, and the incremental value is zero. At time t1, another set of SEM measurements was performed, and the associated incremental value is shown at point 674. This incremental value is below the threshold 662, and therefore, there is no obvious indication of subsurface damage.

[0141] At time t2, the damage continued to develop, and the increment value 676 was greater than the threshold 662, indicating significant damage. This damage remained invisible on the skin. Nevertheless, the increment value greater than the threshold 662 indicated cellular damage at a depth less than the sensitivity depth of the SEM scanner.

[0142] At time t3, the damage continued, but the amount of fluid in the intercellular spaces decreased due to mechanical expulsion, such as... Figure 6C As shown in the figure. This reduces the SEM values ​​taken on the damaged area, thus reducing the calculated incremental value by 678, because the SEM values ​​of healthy tissue remain substantially the same as during previous measurements.

[0143] At time t4, the damage develops into something visible on the skin surface, such as... Figure 3A As shown in the diagram. In some cases, time t4 can occur before one or both of t2 and t3. In some cases, time t4 can occur after time t3 and before t5, when the increment value has reached zero again along curve 670. Arrow 665 indicates that the damage is still visible after time t4. In some cases, the tissue can be considered a "stage 1" pressure ulcer after time t4.

[0144] At time t5, the damage progressed to the point where sufficient fluid was drained from the local tissue, and the SEM values ​​measured in the damaged area were lower than those in healthy tissue. This resulted in a negative increment value of 680, as... Figure 3B As shown in the diagram. In some cases, a negative increment will indicate severe tissue damage. In other cases, a negative increment will indicate that a portion of the tissue at the location of the lowest SEM value is necrotic.

[0145] Example 8: Method for drawing potentially damaged region I

[0146] Figure 7AThis is an example of a method for mapping potentially damaged areas. The damaged area 700 is surrounded by healthy tissue 708. The central area 730 is severely damaged. The first surrounding area 720 is less damaged, and the second surrounding area 710 is less damaged but still not healthy tissue. The skin in all these areas has the same appearance and texture, with no signs of subsurface damage. The series of dashed circles 740, 742, 744, 746, 748, and 750 indicate examples of a set of locations where SEM measurements were taken. SEM measurements taken at locations 740, 742, and 750 typically produce SEM values ​​associated with healthy tissue, identified as “H” in this example. SEM measurements taken at locations 744 and 748 typically produce SEM values ​​“J” slightly higher than H. SEM measurements taken at location 746 typically produce SEM values ​​“P” greater than J. All of these measurements are considered to have been taken at a single “location” on the patient’s body (e.g., the sacrum), even if the individual locations are spatially dispersed within that location. For this set of SEM values, the increment is the difference between the highest SEM value (which may occur at position 746) and the lowest SEM value (which may occur at one of positions 740, 742, and 750). If the increment is greater than the threshold "T", it indicates that there is significant damage at this location. The exact location of the maximum damage is likely close to the measurement position 746 that produced the maximum SEM value.

[0147] Example 9: Method for drawing potentially damaged area II

[0148] Figure 7B A second example depicts the mapping of potentially damaged areas. In this example, the approximate location of the maximum damage is known, for example, from... Figure 7AThe method shown is in a previous application. The purpose of this method is to plot the boundary between regions 710 and 720 to determine the extent of damage. For simplicity, the SEM values ​​generated by the measurements are the same in each region, and the SEM values ​​increase from region 710 to region 720 and then to region 730. The first SEM measurement is taken at location 760, which is known to be an approximate location of the maximum damage. Subsequent measurements are taken at locations 762, 764, 766, and 768 in the order indicated by path 780. The SEM value generated at location 764 is slightly higher than the SEM values ​​generated at locations 762 and 766, indicating that location 764 is partially within region 720, while locations 762 and 766 are entirely within the less damaged region 710. The boundary can be approximated by interpolation between the various measurement locations. For example, the SEM value generated at location 770 is high enough to suggest that it is entirely within region 720, and therefore does not help in identifying the boundary between regions 710 and 720. Therefore, the subsequent position 772 is directly away from the starting position 760. In this example, since position 760 is now entirely within region 710, the boundary between region 710 and region 720 can be interpolated to lie between positions 770 and 772. The SEM value generated from the measurement at position 774 is similar to the SEM value from position 770 and is sufficient to identify the boundary as being outside position 774 without requiring another measurement at the position corresponding to position 772.

[0149] This set of measurements allows for the creation of a map of a specific level of damage, such as region 720. Repeating this mapping process at regular time intervals will provide indications of whether region 720 is growing (which could indicate that an increased level of intervention is appropriate) or shrinking (which could indicate that the current level of intervention is allowing the damage to heal).

[0150] Example 10: Treatment decision-making pathways for classifying patients and providing appropriate treatment

[0151] Figure 8A This paper outlines the currently recommended treatment decision-making pathway for the prevention of pressure ulcers in hospitalized patients, presented by the National Institute for Health Care Excellence (NICE) in its clinical guideline *Pressure Ulcers: Prevention and Management*, published April 23, 2014. The guideline recommends a risk analysis for each patient admitted to a nursing facility who exhibits one or more risk factors, such as significant limitation of mobility, significant loss of sensation, prior or current pressure ulcers, nutritional deficiencies, disorientation, or severe cognitive impairment. Risk assessment is typically performed using scoring checklists, such as the Braden Scale, which assesses the severity of specific risk factors.

[0152] Upon completion of the risk assessment, patients were identified as (i) at low risk of developing pressure ulcers, (ii) at high risk of developing pressure ulcers, or (iii) at high risk of developing pressure ulcers. Based on the classification of the patient's risk level, patients underwent different treatment sequences and assessments via visual evaluation.

[0153] All patients are at potential risk of developing pressure ulcers. They are more likely to occur in people with serious illnesses or neurological disorders, mobility impairments, malnutrition, poor posture, or deformities.

[0154] Pressure ulcers are graded from stage 1 to stage 4, with stage 1 being the lowest. The National Pressure Ulcer Advisory Panel (NPUAP) defines a stage 1 ulcer as an area of ​​intact skin with a localized, non-whitish erythema. "Whiskered" indicates that the tissue loses all its redness under pressure, while "non-whitkered" tissue retains its redness under pressure due to the presence of extravasated red blood cells. In some patients, the whitish erythema or changes in sensation, temperature, or hardness may precede visual changes.

[0155] Visual skin assessment (VSA) is the current method for identifying pressure ulcers. Trained healthcare professionals evaluate the appearance of the skin visually and tactilely, looking for changes in redness or tissue firmness, tissue temperature, or moisture.

[0156] If a patient is identified as having a low risk of developing a pressure ulcer, simply monitor for changes in their clinical status, such as surgery, potential worsening of their condition, or changes in mobility. High-grade foam pads or equivalent pressure-distributing pads may be provided to patients using wheelchairs or sitting for extended periods. If there are no changes in their clinical status, low-risk patients will not be reassessed according to this guideline and will remain on the same treatment and assessment pathway until they are discharged from the nursing facility.

[0157] If a patient is identified as being at risk of developing a pressure ulcer, they will be scheduled to be turned over, or “flipped,” every 6 hours. As with low-risk patients, a high-specification foam mat may be provided if the patient uses a wheelchair or sits for extended periods. The NICE guidelines do not recommend further monitoring or intervention.

[0158] High-risk patients who are in wheelchairs or sit for extended periods will receive a high-specification foam mattress as a precaution, and will be turned every 4 hours. Patients will undergo daily VSA examination of all areas of their body. If an area is found to have a non-whitening erythema, appropriate intervention will be implemented, and the area will be re-examined by VSA every 2 hours. Areas without non-whitening erythema will be re-examined daily by VSA. An individualized care plan will be developed for each high-risk patient.

[0159] This flowchart illustrates that caregivers will spend the majority of their time on high-risk patients. While this may be appropriate, it leaves at-risk patients unmonitored, and they may develop stage 1 ulcers before caregivers can observe the condition. Furthermore, relying on VSA to detect problems inevitably means that patients will develop stage 1 ulcers before intervention is selected or implemented. Once the damage has progressed to stage 1, it is possible that, despite intervention, the skin will still rupture and become a stage 2 ulcer. Clearly, earlier identification of tissue damage is needed so that intervention can prevent subepidermal damage from progressing to stage 1 and beyond.

[0160] Figure 8B This is an example of an enhanced treatment decision-making approach currently implemented in some healthcare facilities for the prevention of pressure ulcers. The enhanced approach adds a monitoring step to both the high-risk and low-risk pathways. Low-risk patients undergo a risk assessment weekly, such as completing the Braden Scale. Patients identified as high-risk in the initial assessment will receive a high-specification foam mattress as a precaution and will be assessed daily by a VSA. A care plan will be developed for the monitoring and treatment of high-risk patients. For high-risk patients, there are no changes in care.

[0161] The benefit of an enhanced program is that it provides basic monitoring for all patients with pressure ulcers. However, the additional steps require additional time, necessitating either additional staff or further burdening existing staff at home. Despite being superior to... Figure 8A The recommended nursing approach, but Figure 8B The nursing approach in this area requires more resources and remains limited by the patient's certainty that the lesion will develop into a stage 1 ulcer before the VSA identifies the injury.

[0162] Different hospitals and nursing facilities use varying numbers of risk categories, ranging from two categories (low risk and high risk) to four or more, thus adding categories such as "very high risk" to the list. Figure 8B The examples are categorized. Based on the results of the initial risk assessment, patients are assigned to various categories.

[0163] Figure 9This is an example flowchart illustrating how a SEM scanner can be used in an independent procedure to prevent pressure ulcers, according to this disclosure. Each admitted patient undergoes a full SEM scan assessment of all selected body locations for monitoring. These selected locations may include areas recommended in the SEM scanner's instruction manual (IFU), such as the sacrum and heel. Additional locations may be identified by the hospital and integrated into their internal practice. Multiple SEM measurements are taken at each body location and its surroundings at locations separate from each other, although this is often referred to as taking multiple measurements at a body location. The SEM scanner calculates an "incremental" value for each location based on the set of measurements taken at and around that location. The incremental value is then compared to one or more thresholds to classify the patient. In this example, the patient is assigned to one of two risk categories: low risk and high risk.

[0164] In one approach, clinicians will perform SEM scans at first intervals on body locations identified as potentially lesioning in the initial SEM scan. Clinicians will also perform SEM scans on all other body locations selected for monitoring at second intervals longer than the first interval. In one approach, the values ​​of the first and second intervals differ based on the risk category the patient has been assigned. For example, a high-risk patient would have a 4-hour first interval and a 1-day second interval, while an at-risk patient would have a 1-day first interval and a 1-week second interval. In one approach, the intervals can be event-based, such as a change of attending physician or shift change, rather than strictly time-based. Generally, body locations with elevated incremental values ​​are scanned more frequently than other body locations monitored but with normal incremental values ​​in previous SEM scans.

[0165] In one aspect, the interval for performing SEM scans is determined by the incremental values ​​from previous SEM scans. For example, for body locations that have an incremental value greater than or equal to a first threshold in previous SEM scans, SEM scans are performed at a first time interval, while for body locations that have an incremental value greater than or equal to a second threshold higher than the first threshold in previous SEM scans, SEM scans are performed at a second time interval shorter than the first time interval.

[0166] In this example, low-risk patients undergo weekly SEM scans of all body locations selected for monitoring. This is the most effortless measure to provide basic protection even for the healthiest patients, as weekly SEM scans may detect tissue damage before it becomes visible to VSA.

[0167] At-risk patients, this will include those who will Figure 8A and Figure 8BPatients identified as high-risk in the current care pathway will receive specialized care based on body position, which shows an increment above a threshold. For example, if the sacral body position has an increment exceeding a threshold, the patient will be repositioned every 6 hours and receive a daily SEM scan of the sacrum and weekly SEM scans of other body positions.

[0168] Figure 10 This disclosure further improves upon how to use a SEM scanner as an accessory. Figure 8B An example flowchart of an enhanced treatment decision-making pathway. Income patients undergo risk assessment and SEM scans of all body locations for monitoring, as determined by the hospital, and are assigned to risk categories based partly on the risk assessment and partly on the SEM scan results. An initial increment value greater than a threshold indicates that a lesion may exist in that body location. In one aspect, this assignment is based solely on the largest initial increment value found during the initial SEM scan.

[0169] Although the presence of early subcutaneous injury is uncertain, current decisions regarding intervention, such as turning the patient at the first interval, are based on VSA and risk assessment. In one aspect, the decision to intervene in a specific body site or generally (such as using a high-density mattress) is based on the incremental value of the needle at that site as detected in a SEM scan. If the incremental value is less than a predetermined threshold, no intervention is needed. If the incremental value is greater than the predetermined threshold, intervention is then selected and implemented partly based on the body location and partly based on the incremental value at that body location. The predetermined threshold used for selecting and implementing an intervention can be higher or lower than the threshold used to determine the potential presence of injury at that body location.

[0170] supply Figure 8A , Figure 8B , Figure 9 and Figure 10 Cost comparisons of care pathways reveal one of the benefits of using SEM scanners to monitor patients. It is important to note that the costs cited in this article are for patients without pressure ulcers or who have not developed pressure ulcers; in this case, the estimated treatment cost for stage 1 ulcers would increase significantly to $2000.

[0171] The baseline used for this comparison is Figure 8BThis enhanced current practice represents the current "best practice" for hospitals striving to reduce the incidence of pressure ulcers. The estimated cost of providing a low-risk care pathway is $26 per patient, averaging $121 per patient for patients at risk, and $165 per patient for patients at high risk, based on an average hospital stay of 5.6 days. All care pathways rely on visual acuity testing (VSA) to detect pressure ulcers and interventions are implemented based on "typical" patient progression rather than the specific condition of each patient.

[0172] like Figure 10 As shown, integrating a SEM scanner into the current "best practice" workflow does not reduce the cost of any care pathway because no work element is eliminated. The benefit lies in the ability to detect tissue damage at an early stage with minimal incremental cost. The incremental cost of adding a SEM scan to a risk-free care pathway is $2, increasing the cost from approximately $26 to $28. The expected cost of caring for a risky patient without an elevated SEM scan increment (i.e., without subcutaneous tissue damage) also increases by only $2. However, if a risky patient is found to have an elevated SEM scan increment, the patient will be upgraded to a high-risk category, where the expected cost of care increases from $165 to $169. While this may seem like an additional cost, it represents an improvement in the level of protection provided to risky patients.

[0173] Figure 9 This represents an example workflow that relies solely on SEM scanners to monitor patients, abandoning routine VSA examinations. Compared to... Figure 10 The cost of an integrated low-risk care pathway is $28, compared to the expected cost of $4 for preventative care for low-risk patients. For at-risk patients, this is... Figure 9 The only other category of SEM scanner care pathways, compared to those targeting Figure 10 The cost of the integrated care approach for at-risk and high-risk patients is $123-$169, compared to the expected cost of $97.

[0174] Based on the foregoing, it is understood that this disclosure can be implemented in various ways, including but not limited to the following:

[0175] Example 1. A method for identifying and treating patients requiring treatment for pressure ulcers, the method comprising the steps of: assessing the risk of the patient for pressure ulcers upon admission to a care facility, wherein the assessment includes performing a first multiple subepidermal water (SEM) measurement on the patient; calculating a first incremental value based on a portion of the first multiple SEM measurements; determining whether the first incremental value exceeds a first threshold; if the first incremental value does not exceed the first threshold, applying a level 0 first intervention, and if the first incremental value exceeds the first threshold, applying a first level N intervention, wherein N is an integer and the value of N is 1 or greater.

[0176] Example 2. According to the method of Example 1, the step of performing the first multiple SEM measurements includes: using a SEM scanner to perform each SEM measurement and generate a corresponding SEM value; and the step of calculating the first incremental value includes: comparing the SEM values ​​generated from a portion of the first multiple SEM measurements.

[0177] Example 3. According to the method of Example 1, the step of performing a first set of multiple SEM measurements includes: performing a subset of first SEM measurements at a first location and at least one additional subset of SEM measurements at a second location; the step of calculating a first increment value includes: calculating a first increment value at a first location based on a subset of the first measurements, and calculating a first increment value at a second location based on a subset of the second measurements; the step of determining whether the first increment value exceeds a first threshold includes: determining whether the first increment value at a first location exceeds a first threshold at a first location and determining whether the first increment value at a second location exceeds a first threshold at a second location; the step of applying a level 0 first intervention includes: applying a level 0 intervention specific to a first location if the first increment at a first location does not exceed a first threshold at a first location and applying a level 0 intervention specific to a second location if the first increment at a second location does not exceed a first threshold at a second location; and the step of applying a level N first intervention includes: applying a level N intervention specific to a first location if the first increment at a first location exceeds a first threshold at a first location, and applying a level N intervention specific to a second location if the first increment at a second location exceeds a first threshold at a second location.

[0178] Example 4. The method according to Example 1, wherein the evaluation step further includes performing a visual evaluation.

[0179] Example 5. The method according to Example 4, wherein the patient has no visible symptoms of pressure ulcers.

[0180] Example 6. The method according to Example 1, wherein the evaluation step further includes performing a risk assessment.

[0181] Example 7. The method according to Example 1, wherein N has a value equal to 1.

[0182] Example 8. According to the method of Example 1, wherein the value of N is 2 or greater based on the amount by which the first incremental value exceeds the first threshold.

[0183] Example 9. The method according to Example 1, wherein N has a value not exceeding 10.

[0184] Example 10. According to the method of Example 1, wherein the first intervention at level N is a more effective intervention than the first intervention at level 0.

[0185] Example 11. The method according to Example 1 further includes the following steps: performing a second multiple SEM measurement on the patient at a first predetermined frequency corresponding to the applied intervention level; calculating a second incremental value based on a portion of the second multiple SEM measurement; determining whether the second incremental value exceeds a second threshold; if the second incremental value does not exceed the second threshold, continuing to apply the first intervention; if the second incremental value does not exceed the second threshold, continuing to perform multiple SEM measurements at the first predetermined frequency; if the second incremental value exceeds the second threshold, applying a second intervention at level M, where M is an integer and M is greater than N; and if the second incremental value exceeds the second threshold, performing multiple SEM measurements at a second predetermined frequency corresponding to level M.

[0186] Example 12. The method according to Example 11, wherein the second threshold is the same as the first threshold.

[0187] Example 13. According to the method of Example 11, wherein the second threshold is greater than the first threshold.

[0188] Example 14. According to the method of Example 11, where M has a value equal to N+1 but not exceeding 10.

[0189] Example 15. According to the method of Example 11, wherein the value of M is proportional to the amount by which the second increment value exceeds the second threshold.

[0190] Example 16. The method according to Example 11 further includes the following steps: determining whether a second incremental value is less than a third threshold; if the second incremental value is less than the third threshold and if the first intervention is not level 0, then applying an (N-1) level intervention, and if the second incremental value is less than the third threshold, then performing multiple SEM measurements at a predetermined frequency corresponding to the (N-1) level.

[0191] Example 17. According to the method of Example 1, wherein the level 0 intervention is selected from the group consisting of: providing good nutrition, standard mattress, turning over every 24 hours and combinations thereof.

[0192] Example 18. According to the method of Example 1, wherein the first incremental value exceeding the first threshold is calculated based on a portion of the first multiple SEM measurements performed at the patient's heel.

[0193] Example 19. According to the method of Example 18, wherein the first-level intervention is to provide the patient with a heel boot.

[0194] Example 20. The method according to Example 18, wherein the second-level intervention is to change the patient's supporting surface.

[0195] Example 21. The method according to Example 18, wherein the third-level intervention is to apply a dressing to the back or side of the patient's heel.

[0196] Example 22. According to the method of Example 18, wherein the level 4 intervention is to replace the patient’s bed sheets with low-friction bed sheets.

[0197] Example 23. The method of Example 18, wherein the 5th level intervention is to provide a low-friction mattress surface for the patient's lower leg.

[0198] Example 24. The method according to Example 18, wherein the 6th level intervention involves turning the patient over in a shorter time than currently provided.

[0199] Example 25. The method according to Example 18, wherein the 7th level intervention is the application of protective cream to the patient's heel.

[0200] Example 26. The method according to Example 18, wherein the 8th level intervention is the application of neuromuscular stimulation to the patient's heel.

[0201] Example 27. The method of Example 18, wherein the level 9 intervention is the application of a topical cream to the patient's heel to enhance perfusion.

[0202] Example 28. The method according to Example 18, wherein the 10th level intervention is to provide a silicone pad for the patient's lower leg.

[0203] Example 29. According to the method of Example 1, wherein the first incremental value exceeding the first threshold is calculated based on a portion of the first multiple SEM measurements performed at the sacrum of the patient.

[0204] Example 30. According to the method of Example 29, wherein the Level 1 intervention is selected from the group consisting of: repositioning the patient using a wedge, keeping the patient's sacrum dry, and combinations thereof.

[0205] Example 31. The method of Example 29, wherein the level 2 intervention replaces the patient’s mattress with a pressure-relieving mattress.

[0206] Example 32. The method according to Example 29, wherein the third-level intervention involves applying a dressing to the patient's sacrum.

[0207] Example 33. The method according to Example 29, wherein the level 4 intervention is to replace the patient’s mattress with a dynamic mattress.

[0208] Example 34. The method of Example 29, wherein the level 5 intervention is the application of protective cream to the patient's sacrum.

[0209] Example 35. The method according to Example 29, wherein the 6th level intervention is the application of neuromuscular stimulation to the patient's sacrum.

[0210] Example 36. The method of Example 29, wherein the 7th level intervention is the application of a topical cream to the patient's sacrum to enhance perfusion.

[0211] Example 37. The method according to Example 29, wherein the 8th level intervention involves providing a silicone pad under the patient's body.

[0212] Example 38. The method according to Example 1, wherein the predetermined frequency of level 0 is once every 24 hours.

[0213] Example 39. According to the method of Example 1, wherein the predetermined frequency of Level 1 is once every 10 hours.

[0214] Example 40. According to the method of Example 1, wherein the second-level predetermined frequency is at the beginning of each nursing shift.

[0215] Example 41. According to the method of Example 1, wherein the predetermined frequency of level 3 is once every 12 hours.

[0216] Example 42. According to the method of Example 1, wherein the predetermined frequency of level 4 is once every 8 hours.

[0217] Example 43. According to the method of Example 1, wherein the predetermined frequency of level 5 is once every 6 hours.

[0218] Example 44. According to the method of Example 1, wherein the predetermined frequency of level 6 is once every 4 hours.

[0219] Example 45. According to the method of Example 1, wherein the predetermined frequency of level 7 is once every 2 hours.

[0220] Example 46. The method according to Example 1, wherein the predetermined frequency of level 8 is once every hour.

[0221] Example 47. According to the method of Example 1, wherein the predetermined frequency of level 9 is once every 0.5 hours.

[0222] Example 48. A method for slowing the progression of pressure ulcers in a patient with this need, the method comprising the steps of: identifying a current intervention of grade K received by the patient; performing multiple subepidermal water (SEM) measurements on the patient; calculating an incremental value based on a portion of the multiple SEM measurements; determining whether the incremental value exceeds a first threshold; if the incremental value does not exceed the first threshold, continuing to apply the current intervention; if the incremental value does not exceed the first threshold, continuing to perform multiple SEM measurements at a predetermined frequency corresponding to grade K; if the incremental value exceeds the first threshold, applying a new intervention of grade N, wherein N has a value greater than K; and if the incremental value exceeds the first threshold, performing multiple SEM measurements at a predetermined frequency corresponding to grade N.

[0223] Example 49. The method according to Example 48, wherein N has a value equal to K+1 but not exceeding 10.

[0224] Example 50. According to the method of Example 48, the value of N is proportional to the amount by which the incremental value exceeds a first threshold.

[0225] Example 51. The method according to Example 48 further includes the following steps: determining whether the incremental value is less than a second threshold; if the incremental value is less than the second threshold, applying an L-level intervention, wherein L has a non-negative value less than K; and if the incremental value is less than the second threshold, performing multiple SEM measurements at a predetermined frequency corresponding to the L-level.

[0226] Example 52. According to the method of Example 51, wherein L has a value equal to L-1.

[0227] Example 53. According to the method of Example 51, the value of L is selected based on the amount by which the incremental value is lower than the second threshold.

[0228] Example 54. The method according to Example 48, wherein the patient in need is a patient experiencing a change in care.

[0229] Example 55. The method according to Example 48, wherein the patient in need is a patient experiencing changes in mobility.

[0230] Example 56. The method according to Example 48, wherein the patient in need is a patient experiencing nutritional changes.

[0231] Example 57. The method according to Example 48, wherein the patient in need is a patient experiencing sensory changes.

[0232] Example 58. The method according to Example 48, wherein the patient in need is a patient who has developed an open ulcer.

[0233] Example 59. The method according to Example 48, wherein the patient in need of this is a patient recovering from an open ulcer.

[0234] Example 60. The method according to Example 48, wherein the patient in need is a patient undergoing surgery.

[0235] Example 61. The method according to Example 48, wherein the patient receives spinal analgesia during surgery.

[0236] Example 62. The method according to Example 60, wherein the patient receives sacral analgesia during surgery.

[0237] Example 63. The method according to Example 60, wherein the operation lasts for more than 4 hours.

[0238] Example 64. A method for selecting treatment for pressure ulcers in a patient, the method comprising the following steps: assessing the patient's risk of pressure ulcers upon admission to a nursing facility, wherein the assessment step comprises performing a first multiple subepidermal water (SEM) measurement on the patient; calculating a first incremental value based on a portion of the first multiple SEM measurements; determining whether the first incremental value exceeds a first threshold; if the first incremental value does not exceed the first threshold, applying a first intervention at level 0; and if the first incremental value exceeds the first threshold, applying a first intervention at level N, where N is an integer and the value of N is 1 or greater.

[0239] Example 65. A method for classifying patient groups in a nursing facility based on the risk of pressure ulcers, the method comprising the steps of: performing multiple subepidermal water (SEM) measurements on each patient; calculating incremental values ​​based on a portion of the multiple SEM measurements on each patient; determining whether each incremental value exceeds any value in a set of thresholds corresponding to N care levels, and assigning a care level to each patient; and rearranging the patient groups based on the care level assigned to each patient.

[0240] Example 66. A method for reducing the incidence of pressure ulcers in patients admitted to a nursing facility, the method comprising the steps of: assessing the risk of pressure ulcers in patients upon admission to the nursing facility, wherein the assessment step includes performing a first multiple subepidermal water (SEM) measurement on the patient; calculating a first incremental value based on a portion of the first multiple SEM measurements; determining whether the first incremental value exceeds a first threshold; if the first incremental value does not exceed the first threshold, applying a first intervention at level 0; and if the first incremental value exceeds the first threshold, applying a first intervention at level N, wherein N is an integer and the value of N is 1 or greater.

[0241] Example 67. The method of Example 66, wherein the incidence of ulcers in patients in nursing facilities is reduced to 1 / 100.

[0242] Example 68. A method for identifying and treating a patient who requires the application of a protective cream to their heel, the method comprising the steps of: performing multiple subepidermal moisture (SEM) measurements at the patient's heel; calculating an incremental value based on a portion of the multiple SEM measurements; determining whether the incremental value exceeds a threshold corresponding to level N, where N is greater than or equal to 2; if the incremental value exceeds the threshold, applying a protective cream to the patient's heel; and if the incremental value exceeds the threshold, performing multiple SEM measurements every two hours.

[0243] Example 69. A method for identifying and treating a patient who requires neuromuscular stimulation of their heel, the method comprising the steps of: performing multiple subepidermal water (SEM) measurements at the patient's heel; calculating an incremental value based on a portion of the multiple SEM measurements; determining whether the incremental value exceeds a threshold corresponding to level N, where N is greater than or equal to 2; if the incremental value exceeds the threshold, applying neuromuscular stimulation to the patient's heel; and if the incremental value exceeds the threshold, performing multiple SEM measurements per hour.

[0244] Example 70. A method for identifying and treating a patient requiring application of a topical cream to their heel, the method comprising the steps of: performing multiple subepidermal moisture (SEM) measurements at the patient's heel; calculating an incremental value based on a portion of the multiple SEM measurements; determining whether the incremental value exceeds a threshold corresponding to level N, where N is greater than or equal to 2; if the incremental value exceeds the threshold, applying a topical cream to the patient's heel; and if the incremental value exceeds the threshold, performing multiple SEM measurements every half hour.

[0245] Example 71. A method for identifying and treating a patient requiring the application of a protective cream to their sacrum, the method comprising the steps of: performing multiple subepidermal moisture (SEM) measurements at the patient's sacrum; calculating an incremental value based on a portion of the multiple SEM measurements; determining whether the incremental value exceeds a threshold corresponding to level N, where N is greater than or equal to 2; if the incremental value exceeds the threshold, applying a protective cream to the patient's sacrum; and if the incremental value exceeds the threshold, performing multiple SEM measurements every six hours.

[0246] Example 72. A method for identifying and treating a patient requiring neuromuscular stimulation of the sacrum, the method comprising the steps of: performing multiple subcutaneous water (SEM) measurements at the sacrum of the patient; calculating an incremental value based on a portion of the multiple SEM measurements; determining whether the incremental value exceeds a threshold corresponding to level N, where N is greater than or equal to 2; if the incremental value exceeds the threshold, applying neuromuscular stimulation to the sacrum of the patient; and if the incremental value exceeds the threshold, performing multiple SEM measurements every four hours.

[0247] Example 73. A method for identifying and treating a patient requiring application of a topical cream to their sacrum, the method comprising the steps of: performing multiple subepidermal moisture (SEM) measurements at the patient's sacrum; calculating an incremental value based on a portion of the multiple SEM measurements; determining whether the incremental value exceeds a threshold corresponding to level N, where N is greater than or equal to 2; if the incremental value exceeds the threshold, applying a topical cream to the patient's sacrum; and if the incremental value exceeds the threshold, performing multiple SEM measurements every two hours.

[0248] While this disclosure has been described with reference to specific aspects, those skilled in the art will understand that various changes can be made and elements can be substituted with equivalents without departing from the scope of this disclosure. Furthermore, many modifications can be made to specific instances or materials of the teachings of this disclosure without departing from the scope of this disclosure. Therefore, this disclosure is not intended to be limited to the specific aspects disclosed, but rather to include all aspects falling within the scope and spirit of the appended claims.

Claims

1. A system for assessing a patient, the system comprising: (a) Subepidermal water SEM scanner, configured to perform SEM scanning; (b) A processor, electrically connected to the SEM scanner and configured to receive the SEM scan; and (c) A non-transitory computer-readable medium electrically connected to the processor and including instructions stored thereon, which, when executed by the processor, perform the following steps: (i) Receive initial SEM scans of the selected body locations for monitoring. (ii) The patient is assigned to a risk category selected from a group comprising multiple risk categories, wherein the assignment is based in part on the initial SEM scan of the body location. (iii) Calculate the initial incremental value of the body position based on the initial SEM scan. (iv) If the initial increment value is greater than the first threshold, then it is determined that there may be damage at the body location. (v) When the initial increment value is greater than the first threshold, subsequent SEM scans of the body location are received at a first time interval. (vi) When the initial increment value is less than the first threshold, subsequent SEM scans of the body location are received at a second time interval, wherein the second time interval is longer than the first time interval, and (vii) Calculate the subsequent incremental value for each subsequent SEM scan.

2. The system of claim 1, wherein the step of assigning the patient to the risk category is in part based on the initial increment value.

3. The system of claim 1, wherein the non-transitory computer-readable medium further performs the following steps: If the initial increment value is less than the second threshold, it indicates that no intervention is needed.

4. The system of claim 3, wherein the non-transitory computer-readable medium further performs the following steps: When the subsequent incremental value is less than the second threshold, it indicates that no intervention is needed on the body position.

5. The system of claim 3, wherein the non-transitory computer-readable medium further performs the following steps: When the subsequent incremental value is greater than or equal to the second threshold, it indicates that intervention should be performed on the body position.

6. The system of claim 1, wherein the non-transitory computer-readable medium further performs the following steps: If the initial increment value is greater than or equal to the second threshold, intervention is indicated.

7. The system of claim 6, wherein the intervention is selected in part based on the body position and in part based on the initial increment value.

8. The system of claim 7, wherein the intervention is selected from the group consisting of: standard mattress, high-specification mattress, low-friction sheet, low-friction mattress surface, silicone padding, dressing, heel boot, protective cream, topical cream for enhanced perfusion, turning the patient at a first interval, and turning the patient at a second interval shorter than the first interval.

9. The system of claim 6, wherein the non-transitory computer-readable medium further performs the following steps: When the subsequent incremental value is less than the second threshold, it indicates that no intervention will be made on the body position.

10. The system of claim 6, wherein the non-transitory computer-readable medium further performs the following steps: When the subsequent incremental value is greater than or equal to the second threshold, it indicates that intervention should be performed on the body position.

11. The system according to claim 1, wherein, The first time interval and the second time interval depend on the assigned risk category.

12. The system of claim 1, wherein the group of risk categories includes a low-risk category and a risky category.

13. The system of claim 12, wherein the group of risk categories further includes a high-risk category.

14. The system according to claim 1, wherein: The steps of receiving the initial SEM scan include receiving the patient's initial risk assessment, and The allocation of the risk categories is partly based on the results of the initial risk assessment.

15. A system for evaluating a patient who has previously undergone subcutaneous water SEM scanning at a body location, the system comprising: (a) A SEM scanner configured to receive the SEM scan; (b) A processor, electrically connected to the SEM scanner and configured to receive the SEM scans; and (c) A non-transitory computer-readable medium electrically connected to the processor and including instructions stored thereon, which, when executed by the processor, perform the following steps: (i) The patient is assigned to a risk category selected from a group comprising multiple risk categories, wherein the assignment is based in part on a previous SEM scan of the body location. (ii) Calculate the previous incremental values ​​from previous SEM scans to establish a first threshold. (iii) Receive SEM scan of the body location, (iv) Calculate the incremental value of the SEM scan. (v) When the incremental value is greater than or equal to the first threshold, receive subsequent SEM scans of the body location at a first time interval, and (vi) When the incremental value is greater than or equal to a second threshold that is higher than the first threshold, a subsequent SEM scan of the body location is received at a second time interval that is shorter than the first time interval.

16. A system for assessing a patient, the system comprising: (a) Subepidermal moisture SEM scanner, configured to perform capacitive scanning; (b) A processor, electrically connected to the SEM scanner and configured to receive the capacitive scan; and (c) A non-transitory computer-readable medium electrically connected to the processor and including instructions stored thereon, which, when executed by the processor, perform the following steps: (i) Receive an initial capacitance scan of the selected body location for monitoring. (ii) Convert the capacitance measurements from the initial capacitance scan into SEM values. (iii) The patient is assigned to a risk category selected from a group comprising multiple risk categories, wherein the assignment is based in part on the initial capacitance scan of the body location. (iv) Calculate the initial incremental value of the body position based on the SEM value. (v) If the initial increment value is greater than the first threshold, then it is determined that there may be damage at the body location. (vi) When the initial increment value is greater than the first threshold, subsequent capacitance scans of the body position are received at a first time interval. (vii) When the initial increment value is less than the first threshold, a subsequent capacitive scan of the body position is received at a second time interval, wherein the second time interval is longer than the first time interval, and (viii) Calculate the subsequent increment value for each subsequent capacitance scan.

17. The system according to claim 16, wherein, The step of assigning the patient to the risk category is based in part on the initial increment value.

18. The system of claim 16, wherein the non-transitory computer-readable medium further performs the following steps: If the initial increment value is less than the second threshold, it indicates that no intervention is needed.

19. The system of claim 18, wherein the non-transitory computer-readable medium further performs the following steps: When the subsequent incremental value is less than the second threshold, it indicates that no intervention will be made on the body position.

20. The system of claim 18, wherein the non-transitory computer-readable medium further performs the following steps: When the subsequent incremental value is greater than or equal to the second threshold, it indicates that intervention should be performed on the body position.

21. The system of claim 16, wherein the non-transitory computer-readable medium further performs the following steps: If the initial increment value is greater than or equal to the second threshold, intervention is indicated.

22. The system according to claim 21, wherein, The intervention is selected in part based on the body position and in part based on the initial increment value.

23. The system of claim 22, wherein the intervention is selected from the group consisting of: standard mattress, high-specification mattress, low-friction sheet, low-friction mattress surface, silicone padding, dressing, heel boot, protective cream, topical cream for enhanced perfusion, turning the patient at a first interval, and turning the patient at a second interval shorter than the first interval.

24. The system of claim 21, wherein the non-transitory computer-readable medium further performs the following steps: When the subsequent incremental value is less than the second threshold, it indicates that no intervention will be made on the body position.

25. The system of claim 21, wherein the non-transitory computer-readable medium further performs the following steps: When the subsequent incremental value is greater than or equal to the second threshold, it indicates that intervention should be performed on the body position.

26. The system according to claim 16, wherein, The first time interval and the second time interval depend on the assigned risk category.

27. The system of claim 16, wherein the group of risk categories includes a low-risk category and a risky category.

28. The system of claim 27, wherein the group of risk categories further includes a high-risk category.

29. The system according to claim 16, wherein: The step of receiving the initial capacitance scan includes receiving the patient's initial risk assessment, and The allocation of the risk categories is partly based on the results of the initial risk assessment.

30. A system for evaluating a patient who has previously undergone capacitive scanning in a body position, the system comprising: (a) A subepidermal moisture SEM scanner, configured to receive the capacitive scan; (b) A processor, electrically connected to the SEM scanner and configured to receive the capacitive scan; and (c) A non-transitory computer-readable medium electrically connected to the processor and including instructions stored thereon, which, when executed by the processor, perform the following steps: (i) The patient is assigned to a risk category selected from a group comprising multiple risk categories, wherein the assignment is based in part on a previous capacitive scan of the body location. (ii) Calculate the previous increment value of the previous capacitance scan to establish a first threshold. (iii) Receive a capacitance scan of the body position, (iv) Calculate the increment value of the capacitance scan. (v) When the incremental value is greater than or equal to the first threshold, receive subsequent capacitive scans of the body position at a first time interval, and (vi) When the incremental value is greater than or equal to a second threshold that is higher than the first threshold, a subsequent capacitive scan of the body position is received at a second time interval that is shorter than the first time interval.

31. A system for managing patient care, the system comprising: (a) Subepidermal moisture SEM scanner, configured to perform capacitive scanning; (b) A processor, electrically connected to the SEM scanner and configured to receive the capacitive scan; and (c) A non-transitory computer-readable medium electrically connected to the processor and including instructions stored thereon, which, when executed by the processor, perform the following steps: (i) Initial assessment of the patient upon admission and initial capacitance scans of all body positions selected for monitoring. (ii) Convert the capacitance measurements from the initial capacitance scan into SEM values. (iii) Calculate the initial increment value selected for each body location to be monitored. (iv) If any initial increment value is greater than or equal to the first threshold, then the patient is identified as deviating and the intervention level is set to N=1. (v) Instructs for N-level intervention at each body location where the incremental value is greater than or equal to the first threshold, and (vi) Receive a capacitance scan of all body positions at an N-level frequency and calculate the new increment value.

32. The system of claim 31, wherein the non-transitory computer-readable medium further performs the following steps: If any new increment at the same body location is greater than or equal to the previous increment, the intervention level N is increased to N+1, indicating an N+1 intervention, and a capacitance scan is received at the N+1 frequency.

33. The system of claim 31, wherein the non-transitory computer-readable medium further performs the following steps: If all new incremental values ​​above the first threshold at the same body location are less than the corresponding previous incremental values, then N intervention is instructed to continue and capacitance scans are received at N frequency.

34. The system of claim 31, wherein the non-transitory computer-readable medium further performs the following steps: If all new incremental values ​​are less than a second threshold that is lower than the first threshold, then a capacitance scan is received at a frequency of N-1.

35. The system according to claim 31, wherein, If the patient is to be transferred or discharged, the non-transitory computer-readable medium performs the following steps: Receive the final set of capacitance scans for all body locations selected for monitoring. The capacitance measurements from the last set of capacitance scans are converted into SEM values. Calculate the last set of incremental values ​​for each body location scanned, and Record the last set of incremental values.

36. A system for managing patient care, the system comprising: (a) Subepidermal water SEM scanner, configured to perform SEM scanning; (b) A processor, electrically connected to the SEM scanner and configured to receive the SEM scan; and (c) A non-transitory computer-readable medium electrically connected to the processor and including instructions stored thereon, which, when executed by the processor, perform the following steps: (i) Receive the patient's initial assessment and initial SEM scans at each body location selected for monitoring upon admission. (ii) Calculate a set of initial incremental values ​​for each body location selected for monitoring. (iii) If any initial increment value in the set of initial increment values ​​is greater than or equal to the first threshold, then the patient is determined to have deviated and the intervention level is set to N=1. (iv) Instruct N-level intervention for each body location from the set of initial increment values ​​that is greater than or equal to the first threshold. (v) Receive subsequent SEM scans at N-level frequencies for each body location selected for monitoring, and (vi) Calculate a set of subsequent increment values.

37. The system of claim 36, wherein the non-transitory computer-readable medium further performs the following steps: If any subsequent increment from the set of subsequent increments at the same body location is greater than or equal to any initial increment from the set of initial increments, then an N+1 level intervention is indicated, and further SEM scans are received at an N+1 level frequency.

38. The system of claim 36, wherein the non-transitory computer-readable medium further performs the following steps: If all subsequent incremental values ​​from the set of subsequent incremental values ​​above the first threshold at the same body location are less than the corresponding previous incremental value, then N-level intervention is indicated and further SEM scans are received at N-level frequency.

39. The system of claim 36, wherein the non-transitory computer-readable medium further performs the following steps: If all subsequent incremental values ​​from the set of subsequent incremental values ​​are less than a second threshold lower than the first threshold, then an N-1 level intervention is indicated, and further SEM scans are received at an N-1 level frequency.

40. The system according to claim 36, wherein, If the patient is to be transferred or discharged, the non-transitory computer-readable medium performs the following steps: Receive the final set of SEM scans for all body locations selected for monitoring. Calculate the last set of incremental values ​​for each body location scanned, and Record the last set of incremental values.

41. The system of claim 36, wherein the N-level intervention is selected from the group consisting of: standard mattress, high-specification mattress, low-friction sheet, low-friction mattress surface, silicone padding, dressing, heel boot, protective cream, topical cream for enhanced perfusion, turning the patient at a first interval, and turning the patient at a second interval shorter than the first interval.

42. The system according to claim 37, wherein, The N+1 level frequency is greater than the N level frequency.

43. The system according to claim 39, wherein, The N-1 level frequency is lower than the N level frequency.

44. The system of claim 36, wherein the first-level intervention is providing the patient with a heel boot.

45. The system of claim 36, wherein the second-level intervention is to alter the patient's supporting surface.

46. ​​The system of claim 36, wherein the third-level intervention is applying the dressing to the back or side of the patient's heel.

47. The system of claim 36, wherein the fourth-level intervention is replacing the patient's bed sheets with low-friction bed sheets.

48. The system of claim 36, wherein the 5th level intervention is to provide a low-friction mattress surface for the patient's lower leg.

49. The system of claim 36, wherein the 6th level intervention involves turning the patient over at shorter intervals than currently provided.

50. The system of claim 36, wherein the 7th level intervention is the application of a protective cream to the patient's heel.

51. The system of claim 36, wherein the 8th level intervention is the application of neuromuscular stimulation to the patient's heel.

52. The system of claim 36, wherein the level 9 intervention involves applying a topical cream to the patient's heel to enhance perfusion.

53. The system of claim 36, wherein the 10th level intervention is to provide a silicone pad for the patient's lower leg.

54. The system of claim 36, wherein the initial assessment is at least one of risk assessment and visual evaluation.

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