US20190147990A1 - Providing a continuity of care across multiple care settings - Google Patents

Providing a continuity of care across multiple care settings Download PDF

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US20190147990A1
US20190147990A1 US16/193,707 US201816193707A US2019147990A1 US 20190147990 A1 US20190147990 A1 US 20190147990A1 US 201816193707 A US201816193707 A US 201816193707A US 2019147990 A1 US2019147990 A1 US 2019147990A1
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patient
sem
threshold
delta value
care
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Martin F. BURNS
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Bruin Biometrics LLC
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Bruin Biometrics LLC
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Assigned to BRUIN BIOMETRICS, LLC reassignment BRUIN BIOMETRICS, LLC ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BURNS, Martin F.
Assigned to BRUIN BIOMETRICS, LLC reassignment BRUIN BIOMETRICS, LLC ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BURNS, Martin F.
Assigned to BRUIN BIOMETRICS, LLC reassignment BRUIN BIOMETRICS, LLC ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BURNS, Martin F.
Publication of US20190147990A1 publication Critical patent/US20190147990A1/en
Priority to US16/677,623 priority patent/US20200069241A1/en
Priority to US18/159,068 priority patent/US20230363698A9/en
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Definitions

  • the present disclosure provides methods of transferring and handling patient information, in particular information related to the risk of developing a pressure ulcer, to improve care when a patient receives care in multiple settings.
  • the skin is the largest organ in the human body. It is readily exposed to different kinds of damages and injuries. When the skin and its surrounding tissues are unable to redistribute external pressure and mechanical forces, ulcers may be formed. Prolonged continuous exposure to even modest pressure, such as the pressure created by the body weight of a supine patient on their posterior skin surfaces, may lead to a pressure ulcer. In the presence of other damage, such as the neuropathy and peripheral tissue weakening that can be induced by diabetes, even periodic exposure to moderate levels of pressure and stress may lead to an ulcer, for example a foot ulcer.
  • Pressure ulcers are developed by approximately 2.5 million people a year in the United States and an equivalent number in the European Union. In long-term and critical-care settings, up to 25% of elderly and immobile patients develop pressure ulcers. Approximately 60,000 U.S. patients die per year due to infection and other complications from pressure ulcers.
  • Detecting tissue damage before the skin breaks and intervening with the appropriate therapy to avoid further deterioration of the underlying tissue is desirable not only for the patient but society.
  • the average cost of treating pressure-induced damage at the earliest visible sign is only $2,000 but this rises to $129,000 when the ulcer is deep enough to expose muscle or bone (a Stage 4 ulcer.)
  • Patients normally receive universal prevention of pressure ulcers, meaning that the prevention does not target to any particular anatomical sites.
  • Patients only receive a targeted, localized, treatment of ulcer after the pressure ulcer is developed to the point that it can be identified by a visual assessment.
  • the current standard to detect pressure ulcers is by visual inspection, which is subjective, unreliable, untimely, and lacks specificity. Therefore, even when a patient is experiencing inflammation of the skin, a precursor of ulcer development, he or she would not be receiving a targeted, localized treatment for the developing ulcer. Instead, the inflammation would continue to develop into a full-blown ulcer.
  • the present disclosure provides for, and includes, a method of identifying and providing an appropriate level of pressure ulcer care to a patient based on a plurality of Sub-Epidermal Moisture (SEM) measurements.
  • SEM Sub-Epidermal Moisture
  • a patient is provided with increasingly effective pressure ulcer interventions based on changes in SEM measurements.
  • a patient is given less intensive pressure ulcer interventions based on changes in SEM measurements.
  • a method of providing a continuity of care for a patient during transfer between care settings comprising the steps of: deciding to transfer a patient from a first care setting to a second care setting, performing a first assessment of the patient in the first care setting, preparing a transfer record of the assessment, and transferring the transfer record with the patient to the second care setting.
  • the present disclosure provides for, and includes, a method of identifying and treating a patient in need of pressure ulcer treatment, the method comprising the steps of: evaluating a patient for a risk of pressure ulcer in a patient upon admission to a care facility, where the evaluating step comprises making a first plurality of Sub-Epidermal Moisture (SEM) measurements in the patient, calculating a first delta value from a portion of the first plurality of SEM measurements, determining whether the first delta value exceeds a first threshold, administering a first intervention of level-0 if the first delta value does not exceed the first threshold, and administering a first intervention of level-N if the first delta value exceeds the first threshold, where N is an integer and N has a value of 1 or greater.
  • SEM Sub-Epidermal Moisture
  • the present disclosure provides for, and includes, making a second plurality of SEM measurements in the patient at a first pre-determined frequency corresponding to the administered intervention level, calculating a second delta value from a portion of the second plurality of SEM measurements, determining whether the second delta value exceeds a second threshold, continuing to administer the first intervention if the second delta value does not exceed the second threshold, continuing to make a plurality of SEM measurements at the first pre-determined frequency if the second delta value does not exceed the second threshold, administering a second intervention of level-M if the second delta value exceeds the second threshold, where M is an integer and M is greater than N, and making a plurality of SEM measurements at a second pre-determined frequency corresponding to level-M if the second delta value exceeds the second threshold.
  • the present disclosure provides for, and includes, determining whether the second delta value is less than a third threshold, administering a level-(N ⁇ 1) intervention if the second delta value is less than the third threshold and if the first intervention is not of level-0, and making a plurality of SEM measurements at a pre-determined frequency corresponding to level-(N ⁇ 1) if the second delta value is less than the third threshold.
  • the present disclosure provides for, and includes, a method of slowing the progression of pressure ulcer development in a patient in need thereof, the method comprising the steps of: identifying a current intervention of level-K received by the patient, making a plurality of Sub-Epidermal Moisture (SEM) measurements in the patient, calculating a delta value from a portion of the plurality of SEM measurements, determining whether the delta value exceeds a first threshold, continuing to administer the current intervention if the delta value does not exceed the first threshold, continuing to make a plurality of SEM measurements at a pre-determined frequency corresponding to level-K if the delta value does not exceed the first threshold, administering a new intervention of level-N if the delta value exceeds the first threshold, where N has a value greater than K, and making a plurality of SEM measurements at a pre-determined frequency corresponding to level-N if the delta value exceeds the first threshold.
  • SEM Sub-Epidermal Moisture
  • the present disclosure provides for, and includes, determining whether the delta value is less than a second threshold, administering a level-L intervention if the delta value is less than the second threshold, where L has a non-negative value less than K, and making a plurality of SEM measurements at a pre-determined frequency corresponding to level-L if the delta value is less than the second threshold.
  • the present disclosure provides for, and includes, a method of stratifying groups of patients in a care facility based on pressure ulcer risk, the method comprising the steps of: making a plurality of Sub-Epidermal Moisture (SEM) measurements in each of the patients, calculating a delta value from a portion of the plurality of SEM measurements for each of the patients, determining whether each delta value exceeds any values in a set of threshold values corresponding to N care levels and assigning a care level to each of the patients, rearranging the group of patients based on each of the patient's assigned care levels.
  • SEM Sub-Epidermal Moisture
  • the present disclosure provides for, and includes, a method of reducing incidence of pressure ulcer in patients admitted to a care facility, the method comprising the steps of: evaluating a patient for a risk of pressure ulcer upon admission to the care facility, where the evaluating step comprises making a first plurality of Sub-Epidermal Moisture (SEM) measurements in the patient, calculating a first delta value from a portion of the first plurality of SEM measurements, determining whether the first delta value exceeds a first threshold, administering a first intervention of level-0 if the first delta value does not exceed the first threshold, and administering a & intervention of level-N if the first delta value exceeds the first threshold, where N is an integer and N has a value of 1 or greater.
  • SEM Sub-Epidermal Moisture
  • the present disclosure provides for, and includes, a method of identifying and treating a patient in need of application of a barrier cream to the patient's heel, the method comprising the steps of: making a plurality of Sub-Epidermal Moisture (SEM) measurements at the patient's heel, calculating a delta value from a portion of the plurality of SEM measurements, determining whether the delta value exceeds a threshold corresponding to level N, where N is greater than or equal to 2, administering a barrier cream to the patient's heel if the delta value exceeds the threshold, and making a plurality of SEM measurements every two hours if the delta value exceeds the threshold.
  • SEM Sub-Epidermal Moisture
  • the present disclosure provides for, and includes, a method of identifying and treating a patient in need of application of a neuro-muscular stimulation to the patient's heel, the method comprising the steps of: making a plurality of Sub-Epidermal Moisture (SEM) measurements at the patient's heel, calculating a delta value from a portion of the plurality of SEM measurements, determining whether the delta value exceeds a threshold corresponding to level N, where N is greater than or equal to 2, administering a neuro-muscular stimulation to the patient's heel if the delta value exceeds the threshold, and making a plurality of SEM measurements every hour if the delta value exceeds the threshold.
  • SEM Sub-Epidermal Moisture
  • the present disclosure provides for, and includes, a method of identifying and treating a patient in need of application of a topical cream to the patient's heel, the method comprising the steps of: making a plurality of Sub-Epidermal Moisture (SEM) measurements at the patient's heel, calculating a delta value from a portion of the plurality of SEM measurements, determining whether the delta value exceeds a threshold corresponding to level N, where N is greater than or equal to 2, administering a topical cream to the patient's heel if the delta value exceeds the threshold, and making a plurality of SEM measurements every half an hour if the delta value exceeds the threshold.
  • SEM Sub-Epidermal Moisture
  • the present disclosure provides for, and includes, a method of identifying and treating a patient in need of application of a barrier cream to the patient's sacrum, the method comprising the steps of: making a plurality of Sub-Epidermal Moisture (SEM) measurements at the patient's sacrum, calculating a delta value from a portion of the plurality of SEM measurements, determining whether the delta value exceeds a threshold corresponding to level N, where N is greater than or equal to 2, administering a barrier cream to the patient's sacrum if the delta value exceeds the threshold, and making a plurality of SEM measurements every six hours if the delta value exceeds the threshold.
  • SEM Sub-Epidermal Moisture
  • the present disclosure provides for, and includes, a method of identifying and treating a patient in need of application of a neuro-muscular stimulation to the patient's sacrum, the method comprising the steps of: making a plurality of Sub-Epidermal Moisture (SEM) measurements at the patient's sacrum, calculating a delta value from a portion of the plurality of SEM measurements, determining whether the delta value exceeds a threshold corresponding to level N, where N is greater than or equal to 2, administering a neuro-muscular stimulation to the patient's sacrum if the delta value exceeds the threshold, and making a plurality of SEM measurements every four hours if the delta value exceeds the threshold.
  • SEM Sub-Epidermal Moisture
  • the present disclosure provides for, and includes, a method of identifying and treating a patient in need of application of a topical cream to the patient's sacrum, the method comprising the steps of: making a plurality of Sub-Epidermal Moisture (SEM) measurements at the patient's sacrum, calculating a delta value from a portion of the plurality of SEM measurements, determining whether the delta value exceeds a threshold corresponding to level N, where N is greater than or equal to 2, administering a topical cream to the patient's sacrum if the delta value exceeds the threshold, and making a plurality of SEM measurements every two hours if the delta value exceeds the threshold.
  • SEM Sub-Epidermal Moisture
  • FIG. 1 depicts an example of an overall process for selecting a pressure ulcer treatment based on SEM values from admission to a care facility until discharge from the care facility, in accordance with the present disclosure.
  • FIG. 2A is a sample visual assessment of healthy tissue in accordance with the present disclosure.
  • FIG. 2B is a plot of the averages of SEM measurements taken at each location at and around a healthy sacrum in accordance with the present disclosure.
  • FIG. 3A is a sample visual assessment of damaged tissue in accordance with the present disclosure.
  • FIG. 3B is a plot of the averages of SEM measurements taken at each location at and around a damaged sacrum in accordance with the present disclosure.
  • FIG. 4 is an illustration of a process for selecting a level of intervention and monitoring based on the amount by which a delta value derived from SEM measurements exceeds a threshold value in accordance with the present disclosure.
  • FIG. 5 is an example of a workflow guidance matrix where the current level of intervention and the new delta value are used to select the new level of intervention in accordance with the present disclosure.
  • FIGS. 6A, 6B, and 6C depict an example progression over time of a delta value for a single patient at a single location where a pressure ulcer develops in accordance with the present disclosure.
  • FIG. 6D is an example plot of a delta value change over time for a single patient at a single location where a pressure ulcer develops in accordance with the present disclosure.
  • FIGS. 7A and 7B are examples of methods of mapping areas of tissue damage in accordance with the present disclosure.
  • FIG. 8A is an example of a currently recommended treatment decision pathway for preventing pressure ulcers in hospital patients using a combination of risk assessment and visual assessment.
  • FIG. 8B is an example of a current augmented treatment decision pathway for preventing pressure ulcers as currently implemented at some health care facilities.
  • FIG. 9 is an example flowchart of how a SEM Scanner may be used in a stand-alone process to prevent pressure ulcers, in accordance with the present disclosure.
  • FIG. 10 is an example flowchart of how a SEM Scanner may be used as an adjunct to further improve the augmented treatment decision pathway of FIG. 8B , in accordance with the present disclosure.
  • FIG. 11 illustrates the concept of providing a continuity of care across multiple care settings, in accordance with the present disclosure.
  • U.S. patent application Ser. No. 14/827,375 (“the '375 application”) discloses an apparatus that uses radio frequency (RF) energy to measure the sub-epidermal capacitance using a bipolar sensor, where the sub-epidermal capacitance corresponds to the moisture content of the target region of skin of a patient.
  • RF radio frequency
  • U.S. patent application Ser. No. 15/134,110 discloses an apparatus for measuring sub-epidermal moisture (SEM) similar to the device shown in FIG. 3 , where the device emits and receives an RF signal at a frequency of 32 kHz through a single coaxial sensor and generates a bioimpedance signal, then converts this signal to a SEM value.
  • SEM sub-epidermal moisture
  • a device measuring the SEM values of this application may be a wired device, a wireless device, or a system comprising various components in communication with each other.
  • the methods disclosed herein include and comprise one or more steps or actions for achieving the described method.
  • the method steps and/or actions may be interchanged with one another without departing from the scope of the present disclosure.
  • the order and/or use of specific steps and/or actions may be modified without departing from the scope of the present disclosure.
  • phrases such as “between X and Y” and “between about X and Y” should be interpreted to include X and Y.
  • phrases such as “between about X and Y” mean “between about X and about Y” and phrases such as “from about X to Y” mean “from about X to about Y.”
  • sub-epidermal moisture refers to the increase in tissue fluid and local edema caused by vascular leakiness and other changes that modify the underlying structure of the damaged tissue in the presence of continued pressure on tissue, apoptosis, necrosis, and the inflammatory process.
  • a “patient” may be a human or animal subject.
  • delta refers to a calculated difference between two SEM values.
  • FIG. 1 depicts an overall process 100 for selecting a pressure ulcer treatment based on SEM values produced from SEM measurements made using an SEM scanner in accordance with this disclosure, from admission to a care facility until discharge from the care facility.
  • a care facility is selected from the group consisting of a hospital, an assisted living facility, a residential care facility, a nursing home, a long-term care facility, a continuing care community, and an independent living community.
  • a care facility may be a home or other residence of the patient, whereupon the “admit” step 102 will be a first evaluation of a patient at their home by a nurse or other caregiver.
  • the schedule of interventions and evaluation intervals used in a home setting may be different than the corresponding interventions and intervals used at a hospital.
  • a newly admitted patient receives an intake evaluation in step 104 that includes one or more of a visual examination of a portion of the patient's skin, completion of at least a portion of a risk assessment protocol that evaluates one or more of nutrition, mobility, physical activity, physical strength, and ability to communicate, and SEM measurements made in one or more locations on the patient's skin.
  • the SEM measurements may include making a plurality of SEM measurements at a single “location” on the patient's skin.
  • “location” is considered as an area rather than a single point such that SEM measurements may be made at spatially separated points within the location.
  • a “heel” location includes the medial, lateral, and posterior surfaces around the heel as well as the posterior portion of the sole of that foot.
  • Each element of the evaluation may have an individual criterion for level of risk, for example a scoring system with threshold value that indicates an unacceptable risk.
  • step 108 which implements the lowest level of intervention, designated herein as “level-zero” or “level-0.”
  • the patient will be re-assessed using at least the SEM measurement protocol in step 114 at a frequency, or conversely a time interval, associated with level-0.
  • the process 100 then loops back to step 106 to evaluate the results of the SEM measurements made in step 114 .
  • step 122 which implements a higher level of intervention.
  • there is a defined hierarchy of intervention levels with each level implementing a more effective intervention than the next-lower level.
  • each level also has a defined monitoring interval or frequency indicating how often a set of SEM measurements should be made, where higher levels will generally have shorter intervals.
  • the process has been defined by the hospital, or other administering organization, to step up one level to a level-1 intervention at this point.
  • step 122 may implement a level-2 or higher level of intervention.
  • the process now enters a new loop starting at step 130 where the patient will now be monitored at a level-N frequency where N is in the range of 1 to n, n being the highest defined level of intervention and monitoring.
  • step 134 the patient's history is evaluated to determine whether their condition is improving. If the patient's condition is improving, for example as evidenced by a decreasing delta value, then the process branches to step 142 .
  • step 142 continues to implement the current level of intervention and the process loops through step 140 to steps 130 - 132 - 134 - 142 - 140 until the delta value drops below the threshold.
  • the level of intervention may be reduced in step 142 based on the magnitude of the delta value as the delta value trends downward.
  • the process branches to an increase in the level of intervention in step 138 provided that the skin is not broken, i.e., an open ulcer has not developed, in step 136 . If an open ulcer has developed, the SEM scanning will now be performed around the periphery of the open wound in step 144 to map inflammation or other precursor indication of the ulcer spreading. The ulcer itself is treated in step 148 and this secondary loop 144 - 146 - 148 - 150 continues until the wound closes, whereupon the process returns to step 130 .
  • step 118 comprises a final set of SEM measurements at one of more locations on the patient's body. In an aspect, these locations include areas that were not receiving an intervention and were not previously identified as at risk. In an aspect, this information is provided to the receiving caregiver. The patient is then discharged or transferred in step 120 .
  • the present disclosure provides for, and includes, a method of identifying and treating a patient in need of pressure ulcer treatment, the method comprising the steps of: evaluating a patient for a risk of pressure ulcer in a patient upon admission to a care facility, where the evaluating step comprises making a first plurality of Sub-Epidermal Moisture (SEM) measurements in the patient, calculating a first delta value from a portion of the first plurality of SEM measurements, determining whether the first delta value exceeds a first threshold, administering a first intervention of level-0 if the first delta value does not exceed the first threshold, and administering a first intervention of level-N if the first delta value exceeds the first threshold, where N is an integer and N has a value of 1 or greater.
  • SEM Sub-Epidermal Moisture
  • a first plurality of SEM measurements is taken at and around one or more anatomical sites selected from the group consisting of a sternum, a sacrum, a heel, a scapula, an elbow, an ear, and other fleshy tissues of a patient.
  • a first plurality of SEM measurements is separated into sub-groups for analysis based on the general location at which a measurement is taken.
  • a first plurality of SEM measurements is taken at locations located on one or more concentric circles centered around an anatomical site.
  • a first plurality of SEM measurements is taken at locations located on a straight line at approximately equidistance from an anatomical site.
  • a first delta value is determined by the difference between the maximum SEM value and the minimum SEM value from the first plurality of SEM measurements collected. In an aspect, a first delta value is determined by the difference between the maximum SEM average of measurements taken at one location and the minimum SEM average of measurements taken at a second location. In one aspect, a first delta value is determined for a portion of a first plurality of SEM measurements made up of a sub-group as defined by location taken. In an aspect, an average SEM value at a location is obtained from two, three, four, five, six, seven, eight, nine, ten, or more than ten SEM values measured at that location. In one aspect, a first delta value is determined by the difference between SEM values derived from measurements taken at two bisymmetric locations with respect to a centerline.
  • a delta value may be calculated from a plurality of SEM measurements made at a certain location, or in close proximity around a specific location, in a plurality of methods.
  • a plurality of SEM measurements are made in a pre-determined pattern on the skin and the delta value is calculated by subtracting the SEM value associated with a pre-determined position within the pattern from the largest SEM value made at the other positions in the pattern.
  • a plurality of SEM measurements are made in a pre-determined pattern on the skin and the delta value is calculated by identifying the SEM value associated with a pre-determined position within the pattern and subtracting the largest SEM value made at the other positions in the pattern.
  • an average SEM value may be calculated from a portion of a set of SEM values generated by a plurality of SEM measurements at a single location and a delta value calculated as the largest difference between the average and a single SEM value of the same set.
  • a delta value may be calculated as a ratio of the largest SEM value to the smallest SEM value within a set of SEM values.
  • a first threshold may be about 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.
  • a first threshold may range 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.
  • a first threshold can be scaled by a factor or a multiple based on the values provided herein.
  • thresholds of the present disclosure are varied according to the specific portion of a patient's body on which measurements are being made, or one or more characteristics of the patient such as age, height, weight, family history, ethnic group, and other physical characteristics or medical conditions.
  • 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.
  • N is determined by the amount by which the first delta value exceeds the first threshold. In an aspect, the amount by which a delta value exceeds a threshold established for (N+1) is greater than the amount by which a delta value exceeds a threshold established for N. In one aspect, the amount by which a delta value exceeds a threshold established for (N ⁇ 1) is less than the amount by which a delta value exceeds a threshold established for N.
  • a level-N intervention is more effective than a level-0 intervention. In an aspect, a level-(N+1) intervention is more effective than a level-N intervention. In one aspect, a level-(N ⁇ 1) intervention is less effective than a level-N intervention.
  • the evaluating step of the present disclosure further comprises performing a visual assessment.
  • the visual assessment is performed in accordance with the guidelines of the National Pressure Ulcer Advisory Panel (NPUAP).
  • the evaluating step of the present disclosure further comprises performing a risk assessment.
  • the risk assessment is performed in accordance with a test selected from the group consisting of the Braden Scale, the Gosnell Scale, the Norton Scale, and the Waterlow Scale.
  • the present disclosure further provides for, and includes, making a second plurality of SEM measurements in the patient at a first pre-determined frequency corresponding to the administered intervention level, calculating a second delta value from a portion of the second plurality of SEM measurements, determining whether the second delta value exceeds a second threshold, continuing to administer the first intervention if the second delta value does not exceed the second threshold, continuing to make a plurality of SEM measurements at the first pre-determined frequency if the second delta value does not exceed the second threshold, administering a second intervention of level-M if the second delta value exceeds the second threshold, where M is an integer and M is greater than N, and making a plurality of SEM measurements at a second pre-determined frequency corresponding to level-M if the second delta value exceeds the second threshold.
  • a pre-determined frequency is selected from the group consisting of at least once every 72 hours, at least once every 48 hours, at least once every 24 hours, at least once every 12 hours, at least once every 8 hours, at least once every 6 hours, at least once every 4 hours, at least once every 3 hours, at least once every 2 hours, at least once every hour, and at least once every half an hour.
  • a second plurality of SEM measurements are taken in accordance with
  • a second plurality of SEM measurements are made at the same locations where a first plurality of SEM measurements were taken. In one aspect, a second plurality of SEM measurements are made at some of the same locations where a first plurality of SEM measurements were taken. In an aspect, a second plurality of SEM measurements are made near the locations where a first plurality of SEM measurements were taken. In one aspect, a second plurality of SEM measurements are made at different locations than where a first plurality of SEM measurements were taken.
  • a second delta value is determined by the difference between the maximum SEM value and the minimum SEM value from the second plurality of SEM measurements collected. In one aspect, a second delta value is determined by the difference between the maximum SEM average of measurements taken at one location and the minimum SEM average of measurements taken at a second location. In one aspect, a second delta value is determined for a portion of a second plurality of SEM measurements made up of a sub-group as defined by location taken.
  • a second threshold may be about 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.
  • a second threshold may range 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.
  • a second threshold can be scaled by a factor or a multiple based on the values provided herein.
  • a second threshold can be the same as a first threshold.
  • a second threshold can be greater than a first threshold.
  • a second threshold can be less than a first threshold.
  • 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.
  • M is determined by the amount by which the second delta value exceeds the second threshold. In an aspect, the amount by which a delta value exceeds a threshold established for (M+1) is greater than the amount by which a delta value exceeds a threshold established for M. In one aspect, the amount by which a delta value exceeds a threshold established for (M ⁇ 1) is less than the amount by which a delta value exceeds a threshold established for M.
  • a level M intervention is chosen in accordance with [0063] to [0072], replacing N with M.
  • the present disclosure further provides for, and includes, determining whether the second delta value is less than a third threshold, administering a level-(N ⁇ 1) intervention if the second delta value is less than the third threshold and if the first intervention is not of level-0, and making a plurality of SEM measurements at a pre-determined frequency corresponding to level-(N ⁇ 1) if the second delta value is less than the third threshold.
  • a third threshold may be about 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.
  • a third threshold may range 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.
  • a third threshold can be scaled by a factor or a multiple based on the values provided herein.
  • a third threshold can be the same as a second threshold.
  • a third threshold can be greater than a second threshold. In one aspect, a third threshold can be less than a second threshold. In one aspect, a third threshold can be the same as a first threshold. In an aspect, a third threshold can be greater than a first threshold. In one aspect, a third threshold can be less than a first threshold.
  • a second delta value can be 0.1-99.5% of the third threshold, such as 0.1-1%, 0.1-5%, 1-5%, 5-15%, 10-20%, 15-25%, 20-30%, 25-35%, 30-40%, 35-45%, 40-50%, 0.1-25%, 15-35%, 25-50%, 25-75%, 45-55%, 50-60%, 55-65%, 60-70%, 65-75%, 40-55%, 50-75%, 50-99.5%, 70-80%, 75%-85%, 80-90%, 85-95%, 90-99.5%, 65-85%, or 75-99.5% of the third threshold.
  • the third threshold such as 0.1-1%, 0.1-5%, 1-5%, 5-15%, 10-20%, 15-25%, 20-30%, 25-35%, 30-40%, 35-45%, 40-50%, 0.1-25%, 15-35%, 25-50%, 25-75%, 45-55%, 50-60%, 55-65%, 60-70%, 65-75%, 40-55%, 50-75%, 50-99.5%
  • the present disclosure provides for, and includes, a method of slowing the progression of pressure ulcer development in a patient in need thereof, the method comprising the steps of: identifying a current intervention of level-K received by the patient, making a plurality of Sub-Epidermal Moisture (SEM) measurements in the patient, calculating a delta value from a portion of the plurality of SEM measurements, determining whether the delta value exceeds a first threshold, continuing to administer the current intervention if the delta value does not exceed the first threshold, continuing to make a plurality of SEM measurements at a pre-determined frequency corresponding to level-K if the delta value does not exceed the first threshold, administering a new intervention of level-N if the delta value exceeds the first threshold, where N has a value greater than K, and making a plurality of SEM measurements at a pre-determined frequency corresponding to level-N if the delta value exceeds the first threshold.
  • SEM Sub-Epidermal Moisture
  • a patient in need thereof is a patient experiencing a change of care, a change in mobility, a change in nutrition, a change in sensory perception, or a combination thereof.
  • a patient in need thereof is a patient having developed an open ulcer.
  • a patient in need thereof is a patient having recovered from an open ulcer.
  • a patient in need thereof is a patient receiving surgery.
  • a patient in need thereof is a patient receiving spinal analgesics or sacral analgesics during a surgery.
  • a patient in need thereof is a patient receiving a surgery for a duration of 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.
  • a surgery has a duration of one or more hours, such as two or more hours, or three or more hours.
  • a plurality of SEM measurements are taken in accordance with [0057].
  • a delta value is determined in accordance with [0058].
  • a first threshold is determined in accordance with [0060].
  • 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.
  • K is determined by the amount by which the delta value exceeds the threshold. In an aspect, the amount by which a delta value exceeds a threshold established for (K+1) is greater than the amount by which a delta value exceeds a threshold established for K. In one aspect, the amount by which a delta value exceeds a threshold established for (K ⁇ 1) is less than the amount by which a delta value exceeds a threshold established for K.
  • a level K intervention is chosen in accordance with [0063] to [0072], replacing N with K.
  • the present disclosure further provides for, and includes, determining whether the delta value is less than a second threshold, administering a level-L intervention if the delta value is less than the second threshold, where L has a non-negative value less than K, and making a plurality of SEM measurements at a pre-determined frequency corresponding to level-L if the delta value is less than the second threshold.
  • a second threshold is determined in accordance with [0080].
  • L can be K ⁇ 1, K ⁇ 2, K ⁇ 3, K ⁇ 4, K ⁇ 5, K ⁇ 6, K ⁇ 7, K ⁇ 8, K ⁇ 9, or K ⁇ 10.
  • L is K ⁇ 1 if a delta 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, unless K ⁇ 1 is less than 0, in which case L would be 0.
  • L is K ⁇ 2 if a delta 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, unless K ⁇ 2 is less than 0, in which case L would be 0.
  • L is K ⁇ 3 if a delta 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, unless K ⁇ 3 is less than 0, in which case L would be 0.
  • L is K ⁇ 4 if a delta 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, unless K ⁇ 4 is less than 0, in which case L would be 0.
  • L is K ⁇ 5 if a delta 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, unless K ⁇ 5 is less than 0, in which case L would be 0.
  • L is K ⁇ 6 if a delta 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, unless K ⁇ 6 is less than 0, in which case L would be 0.
  • L is K ⁇ 7 if a delta 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, unless K ⁇ 7 is less than 0, in which case L would be 0.
  • L is K ⁇ 8 if a delta 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, unless K ⁇ 8 is less than 0, in which case L would be 0.
  • L is K ⁇ 9 if a delta 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, unless K ⁇ 9 is less than 0, in which case L would be 0.
  • L is K ⁇ 10 if a delta value is 0.1-9.9% of the second threshold, such as 0.1-5%, 1-6%, 2-7%, 3-8%, 4-9%, or 5-9.9% of the second threshold, unless K ⁇ 10 is less than 0, in which case L would be 0.
  • the present disclosure provides for, and includes, a method of stratifying groups of patients in a care facility based on pressure ulcer risk, the method comprising the steps of: making a plurality of Sub-Epidermal Moisture (SEM) measurements in each of the patients, calculating a delta value from a portion of the plurality of SEM measurements for each of the patients, determining whether each delta value exceeds any values in a set of threshold values corresponding to N care levels and assigning a care level to each of the patients, rearranging the group of patients based on each of the patient's assigned care levels.
  • SEM Sub-Epidermal Moisture
  • the present disclosure provides for, and includes, a method of reducing incidence of pressure ulcer in patients admitted to a care facility, the method comprising the steps of: evaluating a patient for a risk of pressure ulcer upon admission to the care facility, where the evaluating step comprises making a first plurality of Sub-Epidermal Moisture (SEM) measurements in the patient, calculating a first delta value from a portion of the first plurality of SEM measurements, determining whether the first delta value exceeds a first threshold, administering a first intervention of level-0 if the first delta value does not exceed the first threshold, and administering a first intervention of level-N if the first delta value exceeds the first threshold, where N is an integer and N has a value of 1 or greater.
  • SEM Sub-Epidermal Moisture
  • the incidence of ulcers in patients in the care facility is reduced to less than 1 in 100, less than 1 in 200, less than 1 in 300, less than 1 in 400, less than 1 in 500, less than 1 in 600, less than 1 in 700, less than 1 in 800, less than 1 in 900, or less than 1 in 1000.
  • the present disclosure provides for, and includes, a method of identifying and treating a patient in need of application of a barrier cream to the patient's heel, the method comprising the steps of: making a plurality of Sub-Epidermal Moisture (SEM) measurements at the patient's heel, calculating a delta value from a portion of the plurality of SEM measurements, determining whether the delta value exceeds a threshold corresponding to level N, where N is greater than or equal to 2, administering a barrier cream to the patient's heel if the delta value exceeds the threshold, and making a plurality of SEM measurements every two hours if the delta value exceeds the threshold.
  • a plurality of SEM measurements are made at least once every hour or at least once every half an hour if the delta value exceeds the threshold.
  • the present disclosure provides for, and includes, a method of identifying and treating a patient in need of application of a neuro-muscular stimulation to the patient's heel, the method comprising the steps of: making a plurality of Sub-Epidermal Moisture (SEM) measurements at the patient's heel, calculating a delta value from a portion of the plurality of SEM measurements, determining whether the delta value exceeds a threshold corresponding to level N, where N is greater than or equal to 2, administering a neuro-muscular stimulation to the patient's heel if the delta value exceeds the threshold, and making a plurality of SEM measurements every hour if the delta value exceeds the threshold.
  • a plurality of SEM measurements are made at least once every half an hour if the delta value exceeds the threshold.
  • the present disclosure provides for, and includes, a method of identifying and treating a patient in need of application of a topical cream to the patient's heel, the method comprising the steps of: making a plurality of Sub-Epidermal Moisture (SEM) measurements at the patient's heel, calculating a delta value from a portion of the plurality of SEM measurements, determining whether the delta value exceeds a threshold corresponding to level N, where N is greater than or equal to 2, administering a topical cream to the patient's heel if the delta value exceeds the threshold, and making a plurality of SEM measurements every half an hour if the delta value exceeds the threshold.
  • SEM Sub-Epidermal Moisture
  • the present disclosure provides for, and includes, a method of identifying and treating a patient in need of application of a barrier cream to the patient's sacrum, the method comprising the steps of: making a plurality of Sub-Epidermal Moisture (SEM) measurements at the patient's sacrum, calculating a delta value from a portion of the plurality of SEM measurements, determining whether the delta value exceeds a threshold corresponding to level N, where N is greater than or equal to 2, administering a barrier cream to the patient's sacrum if the delta value exceeds the threshold, and making a plurality of SEM measurements every six hours if the delta value exceeds the threshold.
  • a plurality of SEM measurements are made at least once every four hours, at least once every three hours, at least once every two hours, at least once an hour, or at least once every half an hour if the delta value exceeds the threshold.
  • the present disclosure provides for, and includes, a method of identifying and treating a patient in need of application of a neuro-muscular stimulation to the patient's sacrum, the method comprising the steps of: making a plurality of Sub-Epidermal Moisture (SEM) measurements at the patient's sacrum, calculating a delta value from a portion of the plurality of SEM measurements, determining whether the delta value exceeds a threshold corresponding to level N, where N is greater than or equal to 2, administering a neuro-muscular stimulation to the patient's sacrum if the delta value exceeds the threshold, and making a plurality of SEM measurements every four hours if the delta value exceeds the threshold.
  • a plurality of SEM measurements are made at least once every three hours, at least once every two hours, at least once an hour, or at least once every half an hour if the delta value exceeds the threshold.
  • the present disclosure provides for, and includes, a method of identifying and treating a patient in need of application of a topical cream to the patient's sacrum, the method comprising the steps of: making a plurality of Sub-Epidermal Moisture (SEM) measurements at the patient's sacrum, calculating a delta value from a portion of the plurality of SEM measurements, determining whether the delta value exceeds a threshold corresponding to level N, where N is greater than or equal to 2, administering a topical cream to the patient's sacrum if the delta value exceeds the threshold, and making a plurality of SEM measurements every two hours if the delta value exceeds the threshold.
  • a plurality of SEM measurements are made at least once an hour or at least once every half an hour if the delta value exceeds the threshold.
  • a predetermined scale may range from 0 to 20, such as from 0 to 1, from 0 to 2, from 0 to 3, from 0 to 4, from 0 to 5, from 0 to 6, from 0 to 7, from 0 to 8, from 0 to 9, from 0 to 10, from 0 to 11, from 0 to 12, from 0 to 13, from 0 to 14, from 0 to 15, from 0 to 16, from 0 to 17, from 0 to 18, from 0 to 19.
  • a predetermined scale can be scaled by a factor or a multiple based on the values provided herein.
  • the present disclosure further provides for, and includes, providing targeted treatment to an anatomical location of a patient identified as being damaged by a combination of a visual assessment and SEM scan measurements.
  • a targeted treatment is provided to a common site for pressure ulcers selected from the group consisting of: toes, heels, a sacrum, a spine, an elbows, shoulder blades, occiput, and ischial tuberosity.
  • a targeted treatment is concurrently provided to a second common site for pressure ulcers selected from the group consisting of: toes, heels, a sacrum, a spine, an elbows, shoulder blades, occiput, and ischial tuberosity.
  • a first site receiving a targeted treatment is known to cause a development of pressure ulcer at a second site.
  • Example 3 Identifying a Patient in Need of a Level-0 Intervention at Sacrum
  • a patient was subjected to multiple SEM measurements at and around the boney prominence of the sacrum using an apparatus capable of measuring SEM measurements. Prior to performing the measurements, surface moisture and matter above the patient's skin surface were removed. An electrode of the apparatus was applied to the patient's skin with sufficient pressure to ensure complete contact for approximately one second to obtain each SEM measurement.
  • FIG. 2A is a sample visual assessment of healthy tissue.
  • FIG. 2B is a corresponding plot of the averages of SEM measurements taken at each location.
  • a threshold of 0.5 was chosen.
  • a delta value was calculated as the difference between the maximum average SEM value and the minimum average SEM value, which was determined to be less than 0.5. Because the SEM delta value was below the threshold value, the patient was identified to be in need of a level-0 intervention. Accordingly, the patient was placed on a standard mattress, and was turned every 24 hours.
  • Example 4 Identifying a Patient in Need of a Level-n Intervention at Sacrum
  • a patient was subjected to multiple SEM measurements taken on a straight line across the sacrum in accordance with the same procedure as described in Example 3.
  • FIG. 3A is a sample visual assessment of damaged tissue.
  • FIG. 3B is a corresponding plot of the averages of SEM measurements taken at each location.
  • a threshold of 0.5 was chosen.
  • a delta value was calculated as the difference between the maximum average SEM value and the minimum average SEM value, which was determined to be above 0.5. Because the SEM delta value was more than 200% over the threshold value, the patient was identified to be in need of a level-8 intervention. Accordingly, the patient was placed on a silicone pad and monitored on an hourly basis until a SEM delta value of less than 170% of the threshold value was observed, at which point, the patient was switched to a level-7 intervention.
  • Example 5 Example Process for Selecting a Level of Intervention and Monitoring
  • FIG. 4 is an illustration of a process 400 for selecting a level of intervention and monitoring based on the amount by which a delta value derived from SEM measurements exceeds a threshold value.
  • a caregiver took a plurality of SEM measurements at a location on the skin of a patient using a SEM Scanner in step 402 , where each measurement generated a SEM value.
  • a delta value “a” was calculated in step 404 .
  • the delta value was calculated by subtracting the smallest SEM value from the largest SEM value generated from the plurality of SEM measurements.
  • step 406 The calculated delta value was compared to a threshold value “T” in step 406 . If the delta value was less than or equal to the threshold value, step 408 was executed and the caregiver waited until the monitoring interval associated with the current level of care transpires, then repeated the SEM measurements in step 402 . If the delta value was greater than the threshold value, the amount by which the delta value exceeded the threshold value was compared to a cascading series of difference values.
  • the delta value was positive and the comparison executed by subtracting the threshold value from the delta value, which produced a positive difference, and then a determination was made regarding whether the difference exceeded the first difference D 1 in step 410 . If the difference was less than D 1 , the process branched to step 412 and then step 414 to implement an intervention and measurement interval, respectively, associated with level-N+1. In this example, N had a value of zero or greater.
  • the delta value was negative, for example if the SEM measurement at the center position of the data in FIG. 3B is subtracted from an average of the SEM values from the leftmost and rightmost locations in FIG. 3B .
  • the differences D 1 , D 2 through Dn was selected to have negative values that could have different absolute values than the corresponding difference values D 1 , D 2 through Dn used for a positive delta value.
  • the comparisons in steps 410 , 420 , and 430 were changed to “ ⁇ ” in place of the “ ⁇ ” shown in FIG. 4 .
  • FIG. 5 is an example of a workflow guidance matrix 500 where the current level of intervention 502 and the new delta value 504 are used to select the new level of intervention 506 .
  • a caregiver monitored the condition of a patient by periodically taking a plurality of SEM measurements at one or more locations on the patient's skin. At the time of these measurements, the patient received care associated with a level of intervention and monitoring.
  • level-0 zero
  • level-0 was associated with a patient who was not considered to be at significant risk for development of a pressure ulcer.
  • Higher levels of intervention and monitoring were identified with the gradations of intervention ranked, for example, according to cost, difficulty to implement, or other parameter identified by the care facility.
  • the values of the new levels of intervention in the cells 506 were similar from row to row. In some instances, the values of the new levels of intervention in adjacent cells 506 differed by a single level or by more than one level. In some instances, the values of the new levels of intervention in adjacent cells 506 were the same in adjacent cells.
  • FIGS. 6A, 6B, and 6C depict an illustrative non-limiting example of a progression over time of the tissue condition leading to a pressure ulcer.
  • FIG. 6A depicts a cross-section of healthy tissue 600 , including the stratum corneum 602 and healthy cells 604 in the epidermis/dermis.
  • the center electrode 606 and the toroidal electrode 608 of a SEM scanner are shown in cross-section in contact with the stratum corneum 602 .
  • An illustrative indication of the sensitive region of the SEM Scanner is shown as the oval region 610 .
  • the region 610 has a depth of sensitivity. In some instances, the depth of sensitivity is in the range of 0.14 0.16 inches. In some instances, the depth of sensitivity is less than 0.16 inches.
  • FIG. 6B is an illustrative cross-section of slightly damaged tissue 620 .
  • Cellular damage for example resulting from long-term application of low-level pressure has affected the tissue. Without being limited by theory, some of the cells 622 have ruptured, releasing the fluid contents into an intercellular space 624 . Alternatively, and without being limited by theory, an inflammatory reaction has caused fluid to migrate into the intercellular space 624 . This damage is not visible on the skin surface.
  • FIG. 6C is an illustrative cross-section 640 of a more advanced level of damage.
  • the tissue is now mostly ruptured cells 622 , which can provide little mechanical structure to carry the continued applied pressure.
  • the tissue thickness is reduced, with the bone 642 now closer to the skin surface.
  • the ruptured cells 622 and intercellular space 624 are compressed, expelling the fluid 644 out of the local tissue as indicated by arrows 646 .
  • FIG. 6D shows an illustrative plot 660 of a delta value for a single patient at a single location where a pressure ulcer develops.
  • the SEM values were measured by a SEM scanner.
  • a delta value was generated from sets of SEM measurements taken at incremental times.
  • point 674 Another set of SEM measurements was made and the associated delta value was indicated at point 674 . This delta value was below the threshold 662 and, therefore, there was no indication of significant sub-surface damage.
  • the damage progressed and the delta value 676 was greater than the threshold 662 , indicating that there was significant damage. This damage was still not visible on the skin. Nonetheless, a delta value greater than the threshold 662 indicated that there was cellular damage at a depth less than the sensitive depth of the SEM scanner.
  • time t 4 the damage progressed to the point where it was visible on the skin surface, as shown in FIG. 3A .
  • time t 4 may occur before one or both of t 2 and t 3 .
  • time t 4 may occur after the delta value has reached zero again along curve 670 after time t 3 and before t 5 .
  • Arrow 665 indicates that after time t 4 , the damage remained visible.
  • the tissue may be considered to be a “stage 1” pressure ulcer after time t 4 .
  • the damage progressed to the point where sufficient fluid had been expelled from the local tissue that the SEM value of a measurement made over the damaged area was lower than the SEM value of healthy tissue.
  • the delta value 680 being negative, as shown in FIG. 3B .
  • the negative delta would indicate that the tissue is seriously damaged.
  • the negative delta would indicate that a portion of the tissue at the location of the lowest SEM value is necrotic.
  • FIG. 7A is an example of a method of mapping an area of possible damage.
  • the area of damage 700 was surrounded by healthy tissue 708 .
  • the center area 730 was significantly damaged.
  • the first surrounding area 720 was less damaged, and the second surrounding area 710 was less damaged but still not healthy tissue.
  • the skin over all of these areas had the same appearance and texture, with no indication of the subsurface damage.
  • the series of dashed-line circles 740 , 742 , 744 , 746 , 748 , and 750 indicate an example set of location where SEM measurements were taken.
  • SEM measurements taken at locations 740 , 742 , and 750 generally produced a SEM value associated with healthy tissue, identified within this example as “H.”
  • SEM measurements taken at locations 744 and 748 generally produced a SEM value “J” that is slightly higher than H.
  • a SEM measurement taken at location 746 generally produced a SEM value “P” that is greater than J. All of these measurements were considered to be taken at a single “location” on the patient's body, for example the sacrum, even though the individual locations were spatially dispersed over this location.
  • the delta was the difference between the highest SEM value, which likely occurred at location 746 , and the lowest SEM value, which likely occurred at one of locations 740 , 742 , and 750 , within this set. If the delta was greater than a threshold value “T,” this was an indication that there is significant damage at this location. The exact location of the greatest damage was likely to be proximate to the measurement location 746 where the greatest SEM value was produced.
  • FIG. 7B depicts a second example of mapping an area of possible damage.
  • the approximate location of the greatest damage was known, for example from prior application of the method illustrated in FIG. 7A .
  • the intent of this method was to map the boundary between area 710 and area 720 to determine the extent of the damage.
  • the SEM values produced by measurements in each area were the same and the SEM values increased from area 710 to area 720 and then to area 730 .
  • the first SEM measurement was taken at location 760 , which was known to be the approximate location of the greatest damage.
  • Subsequent measurements were taken at locations 762 , 764 , 766 , and 768 in the order indicated by path 780 .
  • the SEM value produced at location 764 was slightly higher than the SEM values produced at locations 762 and 766 , indicating that location 764 was partially within the area 720 while locations 762 and 766 were fully within the lesser-damaged area 710 .
  • the boundary could be approximated by interpolating between the various measurement locations.
  • the SEM value produced at location 770 was high enough to suggest that it is fully within the area 720 and therefore did not help identify the boundary between areas 710 and 720 .
  • the subsequent location 772 was therefore directly away from the starting location 760 .
  • location 760 in this example, was now fully within area 710 , the boundary between areas 710 and 720 could be interpolated to be between locations 770 and 772 .
  • the SEM value produced from a measurement at location 774 was similar to the SEM value from location 770 and it could be sufficient to identify the boundary as outside the location 774 without taking another measurement at a location corresponding to location 772 .
  • This set of measurements enabled the creation of a map of a certain level of damage, for example the area 720 . Repeating this mapping process at regular time intervals would provide an indication of whether the area 720 is growing, which may indicate that an increased level of intervention is appropriate, or shrinking, which may indicate that the current level of intervention is allowing the damage to heal.
  • Example 10 Treatment Decision Pathway for Stratifying Patients and Providing Appropriate Treatments
  • FIG. 8A outlines a currently recommended treatment decision pathway for preventing pressure ulcers in hospital patients as presented by The National Institute for Health and Care Excellence (NICE) in their clinical guideline Pressure ulcers: prevention and management , published 23 Apr. 2014.
  • the guidelines recommend that a risk analysis be performed for every patient admitted to a care facility that exhibits one or more risk factors such as significantly limited mobility, a significant loss of sensation, a previous or current pressure ulcer, a nutritional deficiency, an inability to reposition themselves, or a significant cognitive impairment.
  • Risk assessment is commonly done using a scored checklist, such as the Braden Scale, that assesses the severity of specific risk factors.
  • the patient Upon completion of the risk assessment, the patient is identified as (i) having a low risk of developing a pressure ulcer, (ii) being at risk of developing a pressure ulcer, or (iii) being at high risk of developing a pressure ulcer. Depending on the level of risk the patient is classified as having, the patient undergoes different sequences of treatment and evaluation by visual assessment.
  • stage-1 Pressure ulcers are categorized as stage-1 through stage-4, with stage-1 being the lowest condition.
  • the National Pressure Ulcer Advisory Panel (NPUAP) has defined a “stage-1” ulcer as intact skin with a localized area of non-blanchable erythema, where “blanchable” indicates that the tissue loses all redness when pressed and “non-blanchable” tissue remains red when pressed due to the presence of red blood cells outside of blood vessels (extravasation).
  • blanchable erythema or changes in sensation, temperature, or firmness may precede visual changes.
  • VSA Visual skin assessment
  • a patient is identified as having a low risk of developing a pressure ulcer, the patient is simply monitored for a change in clinical status such as undergoing surgery, worsening of an underlying condition, or a change in mobility.
  • a patient who uses a wheelchair or sits for prolonged periods may be provided with a high-specification foam cushion or equivalent pressure-distributing cushion. If there is no change in clinical status, a low-risk patient will not be reassessed under this set of guidelines and stays within the same treatment and evaluation pathway until he or she is discharged from the care facility.
  • a patient If a patient is identified as being at risk of developing a pressure ulcer, the patient will be scheduled to be turned, or “rounded,” every 6 hours. As with the low-risk patient, a high-spec foam cushion may be provided if the patient uses a wheelchair or sits for prolonged periods of time. No other monitoring or intervention is recommended by the NICE guidelines.
  • a high-risk patient receives a high-spec foam mattress as a preventative measure, provided with a high-spec cushion if they are in a wheelchair or sit for prolonged periods of time, and will be turned every 4 hours.
  • the patient will receive a daily VSA for all areas of the body. If an area is found to have non-blanchable erythema, an appropriate intervention will be implemented and that area re-checked by VSA every 2 hours. Areas that do not exhibit non-blanchable erythema are re-checked daily by VSA.
  • a personalized care plan will be developed for each high-risk patient.
  • FIG. 8B is an example of a current augmented treatment decision pathway for preventing pressure ulcers as currently implemented at some health care facilities.
  • the augmented pathway adds monitoring steps to both the at-risk and the low-risk paths.
  • a low-risk patient received a weekly risk assessment, for example completion of the Braden Scale assessment.
  • a patient identified as at-risk in the initial assessment will receive a high-spec foam mattress as a preventative measure and will be evaluated daily by VSA.
  • a care plan will be developed for the monitoring and treatment of the at-risk patient. No change is made in the care if a high-risk patient.
  • the augmented plan has the benefit of providing basic monitoring of all patients for pressure ulcers.
  • the additional steps require additional time, however, either by adding staff or further burdening the existing staff.
  • the care pathway of FIG. 8B requires more resources and still suffers from the limitation that a patient must develop a stage-1 ulcer before VSA identifies the damage.
  • FIG. 9 is an example flowchart of how a SEM Scanner may be used in a stand-alone process to prevent pressure ulcers, in accordance with the present disclosure.
  • Every incoming patient receives a complete SEM scanner assessment of all body locations that are selected for monitoring. These selected locations may include areas recommended in the Instructions For Use (IFU) of the SEM scanner, such as the sacrum and the heels. Additional locations may be identified by the hospital and integrated into their in-house practice. Multiple SEM measurements are taken at and around each body location at positions that are separated from each other, although this is generally referred to as taking multiple measurements at the body location.
  • the SEM scanner calculates a “delta” value for each location from the set of measurements taken at and around that location. The delta value is then compared to one or more threshold values to categorize a patient. In this example, the patient is assigned to one of two risk categories: low-risk and at-risk.
  • the clinician will perform an SEM scan of a body location identified as having possible damage in the initial SEM scan at a first time interval.
  • the clinician will also perform an SEM scan of all other body locations selected for monitoring at a second time interval that is longer than the first time interval.
  • the values of the first and second time intervals are different depending on the risk category to which the patient has been assigned. For example, a high-risk patient will have a first time interval of 4 hours and a second time interval of 1 day while an at-risk patient will have a first time interval of 1 day and a second time interval of 1 week.
  • the time interval may be event-based, for example upon a change of attending staff or shift change, rather than strictly based on time.
  • body locations that have elevated delta values are scanned more often than other body locations that are monitored but having normal delta values in previous SEM scans.
  • the interval at which an SEM scan is performed is determined by the delta values from the prior SEM scan. For example, an SEM scan of a body location that had a delta value greater than or equal to a first threshold in a previous SEM scan is performed at a first time interval, while an SEM scan is performed at a second time interval that is shorter than the first time interval when the prior SEM scan of a body location had a delta value greater than or equal to a second threshold that is higher than the first threshold.
  • low-risk patients receive a weekly SEM scan of all body locations that are selected for monitoring. This is a small effort that provides basic protection for even the healthiest patients, as a weekly SEM scan is likely to detect tissue damage before it becomes visible to VSA.
  • At-risk patients which will include patients that would be identified as high-risk in the current care pathways of FIGS. 8A and 8B , will receive specialized care based on the body location that exhibits a delta value above a threshold. For example, if the sacrum body location has a delta value above a threshold, the patient will be repositioned every 6 hours and receive a SEM scan of the sacrum every day and an SEM scan of the other body locations every week.
  • FIG. 10 is an example flowchart of how a SEM Scanner may be used as an adjunct to further improve the augmented treatment decision pathway of FIG. 8B , in accordance with the present disclosure.
  • An incoming patient receives both a risk assessment and an SEM scan of all body locations identified by the hospital for monitoring and the assignment of a patient to a risk category is based partially on the risk assessment and partially on the SEM scan results.
  • An initial delta value that is greater than a threshold is an indication that there is possible damage at that body location.
  • the assignment is based solely on the largest initial delta value found during the initial SEM scan.
  • a decision whether to implement an intervention is currently based on the VSA and risk assessment despite the uncertainty of whether there is early stage damage below the skin.
  • the decision to implement an intervention for a particular body site, or a general intervention such as a high-spec mattress is based on the delta value found for that site in the SEM scan. If the delta value is less than a predetermined threshold, no intervention is required. If the delta value is greater than the predetermined threshold, then an intervention is selected and implemented based partially on the body location and partially on the delta value for that body location.
  • the predetermined threshold for whether or not to select and implement an intervention may be higher or lower than the threshold for determination that there is possible damage at the body location.
  • FIGS. 8A, 8B, 9, and 10 A comparison of the costs of provided the care pathways of FIGS. 8A, 8B, 9, and 10 reveals one of the benefits of utilizing the SEM scanner to monitor patients. Note that the costs cited herein are for patients who do not have or develop pressure ulcers, in which case the estimated treatment cost jumps to $2000 for a stage-1 ulcer.
  • the baseline for this comparison is the augmented current practice of FIG. 8B , which represents a current “best practice” for hospitals striving to reduce the incidence rate of pressure ulcers.
  • Providing the care of the low-risk care pathway is expected to cost an average of $26 per patient for the average hospital stay of 5.6 days, the care for an at-risk patient is estimated to cost an average of $121, and a high-risk patient is expected to cost $165. All of the care pathways rely on a VSA to detect a pressure ulcer and are otherwise implementing interventions based on “typical” patient progression rather than the particular patient's condition.
  • Integrating the SEM scanner into the current “best practice” workflow, as shown in FIG. 10 does not lower the cost of any of the care pathways as no work element is being eliminated.
  • the benefit is in the ability to detect tissue damage at an earlier stage at a minimal incremental cost.
  • the incremental cost of adding a SEM scan to the no-risk care pathway is $2, raising the cost from approximately $26 to $28.
  • the expected cost of caring for an at-risk patient who does not have an elevated SEM scan delta value i.e. does not have subepidermal tissue damage, is also increased by only $2. If an at-risk patient is found to have an elevated SEM scan delta value, however, the patient is escalated to the high-risk category, where the expected cost of care increases from $165 to $169. While this may seem like an additional cost at first glance, it represents an increase in the level of protection provided to at-risk patients.
  • FIG. 9 represents an example workflow that relies solely on an SEM scanner to monitor patients and forgoes the routine VSA.
  • the expected cost of preventative care for a low-risk patient is $4, compared to the $28 cost for the integrated low-risk care pathway of FIG. 10 .
  • the expected cost is $97, compared to the $123-$169 costs for the at-risk and high-risk patients of the integrated care pathway of FIG. 10 .
  • FIG. 11 illustrates the concept of providing a continuity of care across multiple care settings, in accordance with the present disclosure.
  • This example shows a care pathway 1100 for a patient being sequentially cared for in a plurality of care settings, starting from a home care setting 1110 .
  • a decision is made to transfer the patient to a hospital 1150 where the patient is initially admitted to a medical/surgical (med/surg) unit 1120 .
  • the patient is transferred to a long-term care unit 1130 within the same hospital 1150 .
  • the patient is discharged from the hospital 1150 to a skilled nursing facility 1140 .
  • care pathway 1100 is not limited to this sample sequence and combination of care settings.
  • care pathway 1100 may also involve a discharge of a patient back to the home care setting.
  • a central “registry” or database 1160 is established to aggregate data from all care settings as well as the condition of the patient at the time of transfer between care settings.
  • the health information may include the results of examinations or tests, observations, measurements, treatments, the implementation of interventions that are intended to prevent the development of pressure ulcers, dietary notations, and other records related to the condition and treatment of the patient.
  • a data record from a care setting may include one or more of a patient identifier, a data element from the group of nutritional information, an implemented intervention, a risk assessment, a visual skin assessment, a care plan, a doctor's note, lean event, a vital sign, a “measure of health” such as skin redness or an indication of mobility or a measure of cognition, a body weight, and a lab result, and a date/time associated with the data element.
  • Data records may vary in structure and content.
  • a data record reported to the database may contain one of more of the following data elements:
  • a transfer record 1114 is created and reported to the database 1160 . Transferring information regarding risk and health information related to pressure ulcers will improve the care provided in the new care setting.
  • the transfer record 1114 comprises a patient assessment performed at the “from” care site after the decision to transfer the patient has been made.
  • the assessment comprises an SEM scan of at least one body location, wherein the SEM scan comprises a plurality of SEM values measured at a single body location and calculation of a delta value from the plurality of SEM values.
  • the transfer record contains a history of prior SEM values and/or delta values while in the “from” care setting.
  • the transfer record contains one or more of a VSA, a risk analysis, and other health data.
  • a transfer record may contain one of more of the following data elements:
  • a patient may move periodically from a primary care setting, for example a home care setting 1110 , to an advanced care setting, for example a long-term acute care unit 1130 , where the patient will undergo an “episode of care” by doctors or other skilled professionals.
  • Data records of the assessments and care provided in the advanced care setting are reported to the database 1160 .
  • data records containing care instructions, prescriptions, and other guidance for care in the home setting 1110 Upon discharge from the long-term acute care setting 1130 to the home setting 1110 , data records containing care instructions, prescriptions, and other guidance for care in the home setting 1110 .
  • a query is structured to determine whether instructions from monitoring and/or treatment of a patient are being followed.
  • a query is structured to determine whether a treatment of a patient is effective.
  • a query is structured to determine whether an outcome of a patient is related to one or more of the data elements reported to the database 1160 .
  • a query is structured to retrieve one or more measures of health along with delta values to evaluate possible linkages between the retrieved measures of health and the development of a pressure ulcer or other outcomes (development of other health con.
  • the delta values are plotted against the date/time of measurement to form a time history of the delta values for a body location.
  • the dealt values are analyzed to determine one or more of a slope, an acceleration, a curve shape and associated characteristics, and a time-to-intercept of a selected threshold value. In an aspect, these analytical results can be used to implement the methods and processes of FIGS. 1 and 4 .

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