Ultrasound imaging

Abstract

To provide methods and apparatus for evaluating a tissue structure in damaged or healing tissue.SOLUTION: The present disclosure provides methods of identifying a patient at the onset of risk of a pressure ulcer or at risk of the onset of a pressure ulcer, and treating the patient with anatomy-specific clinical intervention selected based on a number of sonographic characteristics. The present disclosure also provides methods of stratifying groups of patients based on risk of wound development, and methods of reducing incidence of tissue damage in a care facility. The present disclosure also provides methods of analyzing trends of sonographic characteristics to detect tissue damage before it is visible, and methods of comparing bisymmetric sonographic characteristics to identify damaged tissue.SELECTED DRAWING: Figure 3

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 935,635, filed November 14, 2019, and U.S. Provisional Patent Application No. 63 / 108,627, filed November 2, 2020, the entire contents of each of which are incorporated herein by reference.

[0002] The present disclosure provides methods and devices for assessing tissue structure in damaged or healing tissue. The present disclosure also provides methods for identifying patients at risk for developing or at risk for developing pressure sores and treating patients with selected anatomy-specific clinical interventions based on specific ultrasound echo characteristics. The present disclosure also provides methods for stratifying patient groups based on risk for developing wounds and for reducing the incidence or severity of tissue damage in institutionalized patients. The present disclosure also provides methods for detecting tissue damage before it is visible on the patient's skin. [Background technology]

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

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

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

[0006] It is desirable for patients as well as society to detect tissue damage before the skin breaks and to intervene with appropriate therapy to prevent further deterioration of the underlying tissue. The cost of treating pressure injuries averages around $2,000 for the earliest visible signs (stage 1 ulcers) but rises to $129,000 for ulcers deep enough to expose muscle or bone (stage 4 ulcers). See, for example, Brem, H. et al. (2010). High Cost of Stage IV Pressure Ulcers. Am. J. Surg. Oct; 200(4): 473-477. Currently, patients generally receive universal prevention of pressure ulcers, which means that the prevention is not targeted to a specific anatomical site. Patients do not receive targeted, localized treatment for ulcers until the ulcer has progressed to a point where it can be identified by visual assessment. The current standard for detecting pressure ulcers is by visual inspection, which is subjective, unreliable, premature, and lacking specificity. See, for example, Pancorbo-Hidalgo P. et al. (2006). Risk assessment scales for pressure ulcer prevention: a systematic review. Journal of Advanced Nursing, 54, 94-110 and Garcia-Fernandez, FP (2014). Predictive Capacity of Risk Assessment Scales and Clinical Judgment for Pressure Ulcers: A Meta-analysis. Journal of wound, Ostomy and Continence Nursing 41, 24-34. Thus, even if patients suffer from skin inflammation that is a precursor to the development of an ulcer, they do not receive localized treatments that target the developed ulcer. Instead, the inflammation progresses further and further until it becomes a full-blown ulcer.

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

[0008] Ultrasound involves sound waves with frequencies above the upper limit of human hearing. Ultrasound imaging (or medical echo) uses frequencies from 20 kHz to several gigahertz to provide non-invasive images (or sonographs) of tissue structures. An ultrasound imaging probe sends sound waves that travel through a patient's skin, bounce off tissues with different reflective properties, and produce images that are recorded and displayed in real time.

[0009] Unlike other common imaging methods, ultrasound devices are portable and can be brought to the bedside. They do not involve the use of harmful ionizing radiation. It is a convenient and cost-effective imaging diagnostic technique. Trained professionals can evaluate and interpret sonograms obtained by ultrasound imaging. Summary of the Invention

[0010] Non-invasive, objective measurements provide a systematic method for identifying the onset of pressure ulcer risk before visible skin breakdown occurs and then delivering tailored interventions to specific anatomical structures.Non-invasive, objective measurements also provide a systematic method for identifying the onset of pressure ulcer before visible skin breakdown occurs and then delivering tailored interventions to specific anatomical structures.Methods for monitoring wound healing progress and consistency of intervention compliance are further provided.

[0011] In one aspect, the present disclosure provides and encompasses an apparatus for generating an acoustic echo image of tissue beneath intact skin of a patient, the apparatus comprising: an emitter configured to emit acoustic waves at an intermediate frequency of approximately 10 MHz when activated; a receiver configured to receive vibrations of the returning acoustic waves and convert the vibrations into electrical pulses; and a processor coupled to the receiver. In one aspect, the processor is configured to receive the electrical pulses from the receiver, determine the length of time the acoustic waves return, determine the intensity of the returning acoustic waves, and generate an acoustic echo image. In one aspect, the apparatus further comprises a display configured to receive the acoustic echo image and provide the acoustic echo image.

[0012] In one aspect, the present disclosure provides and encompasses a method of evaluating sonic echo characteristics in tissue beneath intact skin of a patient, the method including emitting a sonic wave into the patient's skin at a first location, receiving a portion of the returning sonic wave that has reflected from the tissue, determining the length of time the sonic wave returns, determining the intensity of the returning sonic wave, generating a sonic echo image, acquiring the sonic echo image, and acquiring the number and type of one or more sonic echo characteristics. In one aspect, the one or more sonic echo characteristics are selected from the group consisting of smeared layered structures, hypoechoic lesions, fascial disruptions, and heterogeneous hypoechoic areas.

[0013] In one aspect, the disclosure provides and encompasses a method of reducing the incidence of wound development in patients admitted to a healthcare facility, comprising: assessing the patient for risk of tissue damage upon admission to the healthcare facility, implementing a level 0 intervention if the number of sonic echo signatures present is less than or equal to a first threshold, and implementing a level N intervention if the number of sonic echo signatures present is greater than the first threshold, where N is an integer equal to or greater than 1. In one aspect, the assessing step includes obtaining sonic echo images of the patient at one or more body locations at risk of wound development, and determining the number of sonic echo signatures of tissue damage present in the sonic echo images.

[0014] In one embodiment, the sonic echo characteristic is selected from the group consisting of smeared lamination, hypoechoic lesion, fascial disruption, and heterogeneous hypoechoic area. In one embodiment, the sonic echo characteristic is smeared lamination. In one embodiment, the sonic echo characteristic is hypoechoic lesion. In one embodiment, the sonic echo characteristic is fascial disruption. In one embodiment, the sonic echo characteristic is heterogeneous hypoechoic area. In one embodiment, the wound is selected from the group consisting of pressure sores, diabetic foot ulcers, deep tissue injuries, vascular ulcers, and burns.

[0015] In one embodiment, the one or more body locations at risk for wound development are selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on bony prominences of the patient. In one embodiment, the one or more body locations at risk for wound development include anatomical sites that are in prolonged contact with medical devices. In one embodiment, the one or more body locations at risk for wound development are selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen. In one embodiment, the Level N intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shockwave therapy, 30 degree wedges, composite dressings, hybrid mattresses, dynamic mattresses, support surfaces, silicone pads, low friction seat covers, and low friction padded mattress surfaces.

[0016] In one aspect, the disclosure provides and encompasses a method for stratifying a plurality of patients in a medical care facility based on medical care level, the method including the steps of obtaining an echo image of one of the plurality of patients at one or more body locations selected for monitoring; determining whether an echo signature of tissue damage is present in the echo image; determining a level of medical care among N levels of medical care corresponding to the number and type of echo signatures present; assigning a level of medical care to the patient based on the preceding steps; and placing the patient among the plurality of patients into a group based on the level of medical care assigned to the patient.

[0017] In one embodiment, the echo characteristic is selected from the group consisting of fuzzy lamellar structures, hypoechoic lesions, fascial disruptions, and heterogeneous hypoechoic areas. In one embodiment, the echo characteristic is fascial disruptions. In one embodiment, the one or more body locations are selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on bony prominences of the patient. In one embodiment, the one or more body locations include anatomical sites that are in prolonged contact with medical devices. In one embodiment, the one or more body locations are selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen. In one embodiment, the step of assigning a level of medical care to the patient is based on the presence or absence of fascial disruptions. In one embodiment, the step of assigning a level of medical care to the patient is based on a change in the presence of fuzzy lamellar structures over a two-week period.

[0018] In one aspect, the present disclosure provides and encompasses a method of identifying and providing an appropriate level of medical care to a patient in a medical care facility, the method including the steps of obtaining a plurality of sonic echo images of a patient at one or more body locations; determining whether sonic echo signatures of tissue damage are present in the plurality of sonic echo images; providing one or more anatomical structure-specific interventions based on the presence or absence of the sonic echo signatures in the preceding steps; increasing the level of anatomical structure-specific intervention based on an increase in the number of sonic echo signatures; and decreasing the level of anatomical structure-specific intervention based on a decrease in the number of sonic echo signatures.

[0019] In one embodiment, the echo characteristic is selected from the group consisting of a smeared layered structure, a hypoechoic lesion, a fascial break, and a non-uniform hypoechoic area. In one embodiment, the echo characteristic is a fascial break. In one embodiment, the echo characteristic is a smeared layered structure. In one embodiment, the one or more body sites are selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on bony prominences of the patient. In one embodiment, the one or more body sites include anatomical sites that are in prolonged contact with medical devices. In one embodiment, the one or more body sites are selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen.

[0020] In one embodiment, the anatomy-specific intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shockwave therapy, 30 degree wedges, composite dressings, hybrid mattresses, dynamic mattresses, support surfaces, silicone pads, low friction seat covers, and low friction padded mattress surfaces. In one embodiment, the level of anatomy-specific intervention is increased when the number of sonic echo signatures exceeds a first threshold. In one embodiment, the level of anatomy-specific intervention is decreased when the number of sonic echo signatures falls below a second threshold.

[0021] In one aspect, the disclosure provides and encompasses a method of assigning a patient in a healthcare facility to a risk category selected from a plurality of risk categories, the method including the steps of obtaining a plurality of initial ultrasound echo images of the patient at one or more body locations selected for monitoring, determining whether an ultrasound echo signature is present in the plurality of ultrasound echo images, and assigning the patient to a risk category selected from a plurality of risk categories based in part on the presence or absence of the ultrasound echo signature in the preceding steps.

[0022] In one embodiment, the echo characteristic is selected from the group consisting of a smeared layer structure, a hypoechoic lesion, a fascial break, and a non-uniform hypoechoic area. In one embodiment, the echo characteristic is a fascial break. In one embodiment, the echo characteristic is a smeared layer structure. In one embodiment, the one or more body sites selected for monitoring are selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on bony prominences of the patient. In one embodiment, the one or more body sites selected for monitoring include anatomical sites that are in prolonged contact with medical devices. In one embodiment, the one or more body sites selected for monitoring are selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen.

[0023] In one aspect, the disclosure provides and encompasses a method of managing medical care of a patient in a medical care facility, the method including the steps of acquiring a plurality of first ultrasonic echo images of the patient at one or more body locations selected for monitoring upon admission to the medical care facility, determining whether an ultrasonic echo characteristic is present in the plurality of first ultrasonic echo images, and if the number of ultrasonic echo characteristics present exceeds a first threshold, setting an intervention level N=1, and implementing a level N intervention for each of the one or more body locations where a number of ultrasonic echo characteristics is present that exceeds the first threshold, acquiring a plurality of subsequent ultrasonic echo images at each of the one or more body locations with a frequency of level N, and determining whether a new ultrasonic echo characteristic is present in the plurality of subsequent ultrasonic echo images.

[0024] In one embodiment, the echo characteristic is selected from the group consisting of a smeared layered structure, a hypoechoic lesion, a fascial break, and a non-uniform hypoechoic area. In one embodiment, the echo characteristic is a fascial break. In one embodiment, the echo characteristic is a smeared layered structure. In one embodiment, the body location selected for monitoring is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on bony prominences of the patient. In one embodiment, the body location selected for monitoring includes anatomical sites that are in chronic contact with medical devices. In one embodiment, the body location selected for monitoring is selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen.

[0025] In one embodiment, the Level N intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, a 30 degree wedge, composite dressings, hybrid mattresses, dynamic mattresses, support surfaces, silicone pads, low friction seat covers, and low friction padded mattress surfaces.

[0026] In one aspect, the disclosure provides and encompasses a method of identifying and treating a patient at risk for tissue damage, comprising: assessing a patient for risk of tissue damage upon admission to a healthcare facility, implementing a first intervention at level 0 if a first number of sonic echo characteristics present is less than or equal to a first threshold, and implementing a first intervention at level N (N is an integer equal to or greater than 1) if the first number of sonic echo characteristics present is greater than the first threshold. In one aspect, the assessing step includes obtaining a first plurality of sonic echo images of the patient and determining a first number of sonic echo characteristics present in the first plurality of sonic echo images.

[0027] In one aspect, the method further includes acquiring a second plurality of ultrasonic echo images of the patient at a first predetermined frequency corresponding to a level of intervention performed; determining a second number of ultrasonic echo characteristics present in the second plurality of ultrasonic echo images; determining whether the second number of ultrasonic echo characteristics exceeds a second threshold; continuing to perform the first intervention if the second number of ultrasonic echo characteristics present does not exceed the second threshold; continuing to acquire the plurality of ultrasonic echo images at the first predetermined frequency if the second number of ultrasonic echo characteristics present does not exceed the second threshold; implementing a second intervention at level M, where M is an integer greater than N, if the second number of ultrasonic echo characteristics present exceeds the second threshold; and acquiring a third plurality of ultrasonic echo images at a predetermined frequency corresponding to level M if the second number of ultrasonic echo characteristics present exceeds the second threshold.

[0028] In one aspect, the method further includes determining whether a second number of sonic echo characteristics present is less than or equal to a third threshold; continuing to perform the first intervention if the second number of sonic echo characteristics present is greater than or equal to the third threshold; continuing to acquire multiple sonic echo images at a first predetermined frequency if the second number of sonic echo characteristics present is greater than or equal to the third threshold; performing a third intervention at level L (L is an integer less than N) if the second number of sonic echo characteristics present is less than the third threshold and the first intervention is not level 0; and acquiring multiple sonic echo images at a predetermined frequency corresponding to level L if the second number of sonic echo characteristics present is less than the third threshold.

[0029] In one embodiment, the first intervention at Level N is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, 30 degree wedges, composite dressings, hybrid mattresses, dynamic mattresses, support surfaces, silicone pads, low friction sheet covers, and low friction padded mattress surfaces. In one embodiment, the second intervention at Level M is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, 30 degree wedges, composite dressings, hybrid mattresses, dynamic mattresses, support surfaces, silicone pads, low friction sheet covers, and low friction padded mattress surfaces. In one embodiment, the third intervention at Level L is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, 30 degree wedges, composite dressings, hybrid mattresses, dynamic mattresses, support surfaces, silicone pads, low friction sheet covers, and low friction padded mattress surfaces.

[0030] In one embodiment, the echo characteristic is selected from the group consisting of smeared laminae, hypoechoic lesions, fascial disruptions, and heterogeneous hypoechoic areas. In one embodiment, the echo characteristic is fascial disruptions. In one embodiment, the echo characteristic is smeared laminae.

[0031] In one embodiment, the first plurality of ultrasonic echo images are acquired at or around one or more body locations selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on the patient's bony prominences. In one embodiment, the first plurality of ultrasonic echo images are acquired at or around an anatomical site that is in chronic contact with the medical device. In one embodiment, the first plurality of ultrasonic echo images are acquired at or around one or more body locations selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen.

[0032] In one aspect, the disclosure provides and encompasses a method of slowing progression of skin and tissue damage in a patient in need thereof, comprising the steps of identifying a current level K intervention for the patient to receive; acquiring a plurality of ultrasonic echo images of the patient; identifying an ultrasonic echo characteristic in the plurality of ultrasonic echo images; determining a first number of ultrasonic echo characteristics present in the plurality of ultrasonic echo images; continuing to implement the current level K intervention if the first number of ultrasonic echo characteristics is less than or equal to a first threshold; continuing to acquire a plurality of ultrasonic echo images at a predetermined frequency corresponding to level K if the first number of ultrasonic echo characteristics is less than or equal to the first threshold; implementing a new level N intervention (N greater than K) if the number of ultrasonic echo characteristics exceeds the first threshold; and acquiring a plurality of ultrasonic echo images at a predetermined frequency corresponding to level N if the number of ultrasonic echo characteristics exceeds the first threshold.

[0033] In one aspect, the method further includes determining whether a first number of acoustic echo characteristics present is less than a second threshold, performing an intervention of level L (L being a non-negative value less than K) if the first number of acoustic echo characteristics is less than the second threshold, and acquiring a plurality of acoustic echo images at a predetermined frequency corresponding to level L if the first number of acoustic echo characteristics is less than the second threshold.

[0034] In one embodiment, the sonic echo characteristic is selected from the group consisting of a smeared layered structure, a hypoechoic lesion, a fascial disruption, and a heterogeneous hypoechoic area. In one embodiment, the sonic echo characteristic is a fascial disruption. In one embodiment, the sonic echo characteristic is a smeared layered structure. In one embodiment, the sonic echo characteristic is a hypoechoic lesion. In one embodiment, the sonic echo characteristic is a heterogeneous hypoechoic area.

[0035] In one embodiment, the multiple ultrasound echo images are acquired at or around one or more body locations selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on bony prominences of the patient. In one embodiment, the multiple ultrasound echo images are acquired at or around an anatomical site that is in chronic contact with the medical device. In one embodiment, the multiple ultrasound echo images are acquired at or around one or more body locations selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen.

[0036] In one aspect, the disclosure provides and encompasses a method of identifying and treating a patient requiring an intervention, the method including the steps of acquiring a plurality of ultrasonic echo images at an anatomical location of the patient, identifying ultrasonic echo characteristics in the plurality of ultrasonic echo images, determining a number of ultrasonic echo characteristics from the plurality of ultrasonic echo images, determining whether the number of ultrasonic echo characteristics exceeds a threshold corresponding to a level N, where N is 2 or greater, and performing an intervention at the anatomical location if the number of ultrasonic echo characteristics exceeds the threshold, and acquiring a plurality of ultrasonic echo images every two hours if the number of ultrasonic echo characteristics exceeds the threshold.

[0037] In one embodiment, the echogenic feature is selected from the group consisting of a poorly defined layered structure, a hypoechoic lesion, a fascial break, and a heterogeneous hypoechoic area. In one embodiment, the echogenic feature is a hypoechoic lesion. In one embodiment, the anatomical site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues over a bony prominence of the patient. In one embodiment, the intervention is selected from the group consisting of a heel boot, a barrier cream, neuromuscular stimulation, a topical cream, ultrasound therapy, shockwave therapy, a 30 degree wedge, a composite dressing, a hybrid mattress, a dynamic mattress, a support surface, a silicone pad, a low friction seat cover, and a mattress surface with a low friction pad.

[0038] In one aspect, the present disclosure provides and encompasses a method of identifying damaged tissue, the method including the steps of obtaining a first acoustic echo image from a first location on a patient's skin, obtaining a second acoustic echo image from a second location symmetrical to the first location, identifying acoustic echo features in each of the first and second acoustic echo images, determining a number of acoustic echo features from each of the first and second acoustic echo images, determining a difference in the number of acoustic echo features between the first and second acoustic echo images, and determining that tissue damage is present at the first or second location if the difference in the number of acoustic echo features between the first and second acoustic echo images exceeds a threshold.

[0039] In one embodiment, the echogenic feature is selected from the group consisting of a smeared layered structure, a hypoechoic lesion, a fascial break, and a non-uniform hypoechoic area. In one embodiment, the echogenic feature is a fascial break. In one embodiment, the location is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on bony prominences of the patient.

[0040] In one aspect, the present disclosure provides and encompasses a method of detecting tissue damage before it becomes visible on a patient's skin, the method including the steps of acquiring multiple time-staggered acoustic echo images at a single location, identifying an acoustic echo feature in each of the multiple acoustic echo images, determining a number of acoustic echo features from each of the multiple acoustic echo images, calculating a slope between the most recent number of acoustic echo features and the immediately preceding number of acoustic echo features, comparing the slope to a threshold, and determining that tissue damage is present if the slope exceeds the threshold.

[0041] In one embodiment, the echogenic feature is selected from the group consisting of a smeared layered structure, a hypoechoic lesion, a fascial break, and a non-uniform hypoechoic area. In one embodiment, the echogenic feature is a fascial break. In one embodiment, the location is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on bony prominences of the patient.

[0042] In one aspect, the present disclosure provides and encompasses a method of detecting tissue damage before it becomes visible on a patient's skin, the method including the steps of acquiring multiple acoustic echo images at a single location with time differences, identifying acoustic echo features in each of the multiple acoustic echo images, determining a number of acoustic echo features from each of the multiple acoustic echo images, calculating a difference value of a maximum number of acoustic echo features and a minimum number of acoustic echo features for each time difference, calculating a derivative with respect to time of the difference value, comparing the derivative to a threshold, and determining that tissue damage is present if the derivative exceeds the threshold.

[0043] In one embodiment, the echogenic feature is selected from the group consisting of a smeared layered structure, a hypoechoic lesion, a fascial break, and a non-uniform hypoechoic area. In one embodiment, the echogenic feature is a fascial break. In one embodiment, the location is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on bony prominences of the patient.

[0044] In one aspect, the present disclosure provides and encompasses a method for detecting tissue damage before it becomes visible on a patient's skin, the method including the steps of acquiring multiple acoustic echo images at a single location with time differences, identifying acoustic echo features in each of the multiple acoustic echo images, determining a number of acoustic echo features from each of the multiple acoustic echo images, calculating difference values ​​of a maximum number of acoustic echo features and a minimum number of acoustic echo features for each time difference, fitting a curve to a predetermined number of most recent difference values, calculating a curvature of the fitted curve, comparing the curvature to a threshold value, and determining that tissue damage is present if the curvature exceeds the threshold value.

[0045] In one embodiment, the echogenic feature is selected from the group consisting of a smeared layered structure, a hypoechoic lesion, a fascial break, and a non-uniform hypoechoic area. In one embodiment, the echogenic feature is a fascial break. In one embodiment, the location is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on bony prominences of the patient.

[0046] Aspects of the present disclosure are described herein, by way of example only, with reference to the accompanying drawings. Referring now in detail to the drawings, it is emphasized that the particulars shown are by way of example and are for purposes of illustrating aspects of the present disclosure. In this regard, the specification and drawings, considered separately and together, will make apparent to one skilled in the art how aspects of the present disclosure may be practiced. [Brief description of the drawings]

[0047] [Figure 1A] FIG. 1 shows an example of a currently recommended treatment decision pathway for preventing pressure ulcers in hospitalized patients using a combination of risk assessment and visual assessment. [Figure 1B] FIG. 1 illustrates an example of a current expanded treatment decision pathway for pressure ulcer prevention currently implemented in some healthcare facilities. [Diagram 2] 1 is an exemplary flow chart of a method in which a device for evaluating sonic echo properties of tissue beneath a patient's skin may be used in a stand-alone process of preventing bedsores according to the present disclosure. [Diagram 3] 1C is an exemplary flowchart of a method in which an apparatus for evaluating sonic echo characteristics of tissue beneath a patient's skin may be used as an aid to further refine the extended treatment decision pathway of FIG. 1B in accordance with the present disclosure. [Figure 4A] FIG. 2 illustrates an example of a pair of symmetrical locations on the sacral region in accordance with the present disclosure. [Figure 4B] FIG. 2 is a diagram illustrating an example of a pair of symmetrical locations on the bottom surfaces of both feet according to the present disclosure. [Figure 4C] 1 is a diagram showing an example of a pair of symmetrical locations on the sides and soles of both feet according to the present disclosure. FIG. [Figure 5A] FIG. 1 illustrates locations on left and right feet for acoustic echo imaging in accordance with the present disclosure. [Figure 5B] FIG. 13 is a plot of a number of acoustic echo signatures associated with known relative locations for identifying symmetrical locations in accordance with the present disclosure. [Figure 6] FIG. 1 illustrates an integrated system for measuring, evaluating, storing, and transmitting acoustic echo images in accordance with the present disclosure. [Figure 7A] FIG. 1 illustrates various pressure points on a patient's body in various positions. [Figure 7B] FIG. 1 illustrates various pressure points on a patient's body in various positions. [Figure 7C] FIG. 1 illustrates various pressure points on a patient's body in various positions. [Figure 7D] FIG. 1 illustrates various pressure points on a patient's body in various positions. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0048] This specification is not intended to be a detailed catalog of all the different ways in which the disclosure may be implemented or all the features that may be added to the disclosure. For example, features illustrated with respect to one embodiment may be incorporated into other embodiments, and features illustrated with respect to a particular embodiment may be deleted from that embodiment. Thus, the disclosure contemplates that in some of its embodiments, any feature or combination of features shown herein may be excluded or omitted. Also, numerous modifications and additions to the various embodiments proposed herein will become apparent to those skilled in the art in light of this disclosure without departing from the disclosure. In other instances, well-known structures, interfaces, and processes have not been shown in detail so as not to unnecessarily obscure the invention. It is intended that no part of this specification be construed as denying any portion of the full scope of the invention. Thus, the following description is intended to describe some specific embodiments of the disclosure, and is not intended to exhaustively specify all permutations, combinations, and variations thereof.

[0049] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. The terminology used herein of the present disclosure is for the purpose of describing particular aspects or embodiments only and is not intended to be limiting of the disclosure.

[0050] All publications, patent applications, patents, and other references cited herein are incorporated by reference in their entirety for the teachings relevant to the sentence and / or paragraph in which the reference is presented. References to technology employed herein are intended to represent the technology as commonly understood in the art, including variations of the technology or equivalent technology substitutes that would be apparent to one of ordinary skill in the art.

[0051] Unless the context indicates otherwise, it is expressly intended that the various features of the present disclosure described herein may be used in any combination. Moreover, the present disclosure contemplates that in some embodiments thereof, any feature or combination of features set forth herein may be excluded or omitted.

[0052] The methods disclosed herein include and cover one or more steps or actions for achieving the described method. These method steps and / or actions may be interchanged with one another without departing from the scope of the present disclosure. In other words, if a specific order of steps or actions is not required for the proper operation of an embodiment, the order and / or use of specific steps and / or actions may be modified without departing from the scope of the present disclosure.

[0053] As used in the specification of this disclosure and the appended claims, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise.

[0054] As used herein, "and / or" denotes and covers all possible combinations of one or more of the associated listed items, as well as the exclusion of combinations when interpreted as an alternative ("or").

[0055] As used herein, the terms "about" and "approximately" when describing a measurable value, such as a length, frequency, or measurement, are intended to cover variations of ±20%, ±10%, ±5%, ±1%, ±0.5%, or ±0.1% of the stated value.

[0056] As used herein, phrases such as "between X and Y" and "between about X and Y" are to be interpreted to include X and Y. As used herein, 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."

[0057] As used herein, the term "exemplary" is used to mean serving as an example, instance, or illustration. Any embodiment or aspect described as "exemplary" is not necessarily construed as preferred or advantageous over other embodiments or aspects, and is not intended to exclude equivalent structures and techniques known to those skilled in the art. Rather, use of the term exemplary is intended to present concepts in a concrete manner, and the disclosed subject matter is not limited by such examples.

[0058] As used herein, the term "patient" includes both human and animal subjects.

[0059] As used herein, the term "skin" refers to the surface of a patient's body.

[0060] As used herein, the term "tissue" refers to a collection of similar cells of the same origin and their respective extracellular matrices that together perform a specific function. In some embodiments, tissue includes multiple layers of a patient's body, starting with the stratum corneum and including additional deep structures such as the epidermis, dermis, and parts of the deep tissues that contain blood vessels. In one embodiment, tissue does not include the stratum corneum.

[0061] As used herein, the term "wound" refers to damaged or injured tissue, which may or may not be visible on the surface of the skin. Wounds may be open or closed. Wounds may result from surgery. Wounds may be burns. In one embodiment, the wound is a pressure ulcer. In another embodiment, the pressure ulcer is subcutaneous. In one embodiment, the pressure ulcer is a pressure ulcer resulting from prolonged use of a medical device, such as a mask, tubing, or strap. In one embodiment, the wound is a diabetic foot ulcer. In one embodiment, the wound is a vascular ulcer.

[0062] As used herein, "tissue biocapacitance" refers to a biophysical marker that detects early tissue damage based on an increase in the level of fluid accumulated in the interstitial space. Without being bound by theory, the greater the fluid content in the tissue, the higher the biocapacitance value. In some embodiments, the methods described herein include measuring tissue biocapacitance. In some embodiments, the methods described herein include measuring skin biocapacitance.

[0063] As used herein, the term "time delta" refers to the difference calculated between two values ​​derived from measurements taken from a subject at different times. In one embodiment, each of the two values ​​is an average value calculated from measurements taken at approximately the same time. In one embodiment, each of the two values ​​is a sum value calculated from measurements taken at approximately the same time. In one embodiment, two measurements are taken at approximately the same time (approximately 10 hours or less, approximately 8 hours or less, approximately 6 hours or less, approximately 5 hours or less, approximately 4 hours or less, approximately 3 hours or less, approximately 2 hours or less, or approximately 1 hour or less difference).

[0064] As used herein, the variables "K", "L", "M", and "N" are non-negative integers.

[0065] As used herein, the term "anatomy-specific" refers to the application of a clinical intervention to the same location where a particular ultrasound echo image was acquired.

[0066] As used herein, a "system" may be a collection of devices in wired or wireless communication with each other.

[0067] As used herein, "bisymmetric" refers to a pair of locations that are approximately equidistant from a line of symmetry.

[0068] As used herein, the terms "sonography," "ultrasonography," "ultrasound scanner," "ultrasound device," "ultrasound imager," or "scanner" include any method or device that produces images using sound waves. In one embodiment, the ultrasound scanner is capable of producing two-dimensional images. In one embodiment, the ultrasound scanner is capable of producing three-dimensional images. In one embodiment, the ultrasound scanner emits and collects pulsed sound waves. In one embodiment, the ultrasound scanner emits and collects continuous sound waves. In one embodiment, the ultrasound scanner is portable. In one embodiment, the ultrasound scanner is handheld. In one embodiment, the ultrasound scanner comprises a probe. In one embodiment, the ultrasound scanner comprises a transducer. In one embodiment, the ultrasound scanner comprises a display configured to display the acquired images.

[0069] As used herein, the term "sound wave" refers to energy propagating as an acoustic wave with a frequency of 20 kHz or greater. Without being bound by theory, the resolution of features in an ultrasound image is determined by the wavelength (or frequency) of the sound waves emitted by the ultrasound device. In one embodiment, an ultrasound device uses sound waves greater than 20 kHz. In one embodiment, an ultrasound device uses sound waves greater than 20 kHz. In one embodiment, an ultrasound device uses sound waves greater than 20 MHz. In one embodiment, an ultrasound device uses sound waves greater than 3 GHz.

[0070] As used herein, wavelengths and frequencies of sound are uniquely related, so identifying a sound as having a particular wavelength is equivalent to identifying that sound as having a particular frequency, and references to the frequency of a sound are considered equivalent and interchangeable with references to the wavelength of the same sound.

[0071] As used herein, the term "method" includes a sequence of operations (e.g., steps). In certain embodiments, the steps may be performed in a particular order, while in other embodiments, the sequence of operations may be interchanged. A "method" is considered equivalent to and interchangeable with a "process." In certain embodiments, one or more disclosed steps are omitted.

[0072] Apparatus and method for acoustic echo imaging and evaluation of acoustic echo characteristics - Patents.com In one aspect, the present disclosure provides an apparatus for generating an acoustic echo image of tissue beneath intact skin of a patient, the apparatus comprising: an emitter configured to emit acoustic waves at an intermediate frequency of approximately 10 MHz when activated, a receiver configured to receive vibrations of the returning acoustic waves and convert the vibrations into electrical pulses, and a processor coupled to the receiver and configured to receive the electrical pulses from the receiver, determine a length of time for the acoustic waves to return, determine an intensity of the returning acoustic waves, and generate an acoustic echo image. In one aspect, the apparatus further comprises a display configured to receive the acoustic echo image and provide the acoustic echo image.

[0073] In one aspect, the present disclosure provides a method of evaluating sonic echo characteristics in tissue beneath intact skin of a patient, the method including emitting sonic waves into the patient's skin at a first location, receiving a portion of the returning sonic waves that have reflected from the tissue, determining the length of time the sonic waves return, determining the intensity of the returning sonic waves, generating a sonic echo image, acquiring the sonic echo image, and acquiring the number and type of one or more sonic echo characteristics.

[0074] In one embodiment, the one or more echo characteristics are selected from the group consisting of fuzzy lamination, hypoechoic lesions, fascial breaks, and heterogeneous hypoechoic areas. Without being bound by theory, deep tissue injury associated with pressure sores can be visualized by echo. See, for example, Aoi et al., Plast. Reconstr. Surg., 124(2):540-50 (2009). Deep tissue injury is characterized by four types of abnormal signs specific to ultrasound echoes: fuzzy lamination, hypoechoic lesions, fascial breaks, and heterogeneous hypoechoic areas. In one embodiment, fuzzy lamination does not show clear laminations such as subcutaneous fat layer, superficial fascia, deep fascia, muscle layer, bursa, and bone in a sonogram. In one embodiment, fuzzy lamination is an area that appears foggy in a sonogram due to low contrast and coarse resolution. In one aspect, a hypoechoic lesion is a body tissue that is denser or harder than normal tissue as visualized by sound wave echoes. In one aspect, a hypoechoic lesion is less echogenic and appears darker than the surrounding tissue in a sonogram. In one aspect, a fascial interruption is a blocked high signal line on a sonogram, corresponding to the superficial or deep fascia. In one aspect, a heterogeneous hypoechoic area has a widening border in a sonogram.

[0075] In one embodiment, the sonic echo scan includes acquiring a sonic echo image at a single location on the patient's skin. In one embodiment, the sonic echo scan includes acquiring a sonic echo image at multiple locations on the patient's skin. In one embodiment, the sonic echo scan includes acquiring a plurality of sonic echo images at multiple locations on the patient's skin. In one embodiment, evaluating the patient includes acquiring sonic echo images of the patient at one or more body locations. In one embodiment, evaluating the patient includes determining a number of sonic echo features present in the sonic echo image. In one embodiment, evaluating the patient includes determining a number of sonic echo features present in the plurality of sonic echo images.

[0076] In one embodiment, the average number of acoustic echo features at a location is determined from 2, 3, 4, 5, 6, 7, 8, 9, 10, or 10 or more acoustic echo images acquired at the location. In one embodiment, a first difference in the number of acoustic echo features is determined by the difference between the number of acoustic echo features from measurements acquired at two symmetrical locations about the centerline.

[0077] In one embodiment, the number of sonic echo features may be determined in the methods disclosed herein from a plurality of sonic echo images taken at or in close proximity to a particular location. In one embodiment, a plurality of sonic echo images are taken in a predetermined pattern on the skin. In one embodiment, a plurality of sonic echo images are taken in a predetermined pattern on the skin, and the number of sonic echo features is determined from sonic echo images taken at predetermined locations within the pattern. In one embodiment, the number of sonic echo features is determined from a portion or subset of the plurality of sonic echo images taken. In one embodiment, the number of sonic echo features at a location is the average number of sonic echo features in the plurality of images taken at the location. In one embodiment, the number of sonic echo features at a location is the maximum number of sonic echo features in the plurality of images taken at the location. In one embodiment, the number of sonic echo features at a location is the median number of sonic echo features in the plurality of images taken at the location. In one embodiment, the number of sonic echo features at a location is the most frequent number of sonic echo features in the plurality of images taken at the location.

[0078] Methods for reducing the incidence of wound development using acoustic echo characteristics - Patents.com In one aspect, the disclosure provides a method for reducing the incidence of wound development in patients admitted to a healthcare facility, comprising the steps of: assessing the patient for risk of tissue damage upon admission to the healthcare facility; and implementing a level 0 intervention if the number of sonic echo signatures present is less than or equal to a first threshold; and implementing a level N intervention if the number of sonic echo signatures present is greater than the first threshold, where N is an integer equal to or greater than 1, and the assessing step comprises obtaining sonic echo images of the patient at one or more body locations at risk of wound development; and determining the number of sonic echo signatures of tissue damage present in the sonic echo images.

[0079] In one embodiment, the wound is a pressure sore. In one embodiment, the pressure sore is a pressure sore resulting from prolonged use of a medical device, such as a mask, tubing, or strap. In one embodiment, the wound is a diabetic foot ulcer. In one embodiment, the wound is a vascular ulcer. In one embodiment, the wound is a burn.

[0080] In one embodiment, the incidence of ulcers in patients in a healthcare 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.

[0081] In one embodiment, the healthcare facility is selected from the group consisting of a hospital, a recovery facility, an assisted living facility, a residential healthcare facility, a nursing home, a long-term care facility, a continuing care community, and an independent living community. In one embodiment, the healthcare facility may be the patient's home or other residence, in which case the "entry" step is an initial assessment in the patient's home by a nurse or other caregiver. In one embodiment, the schedule of interventions and assessment intervals used in the home environment may differ from the corresponding interventions and intervals used in the hospital.

[0082] In one embodiment, the method disclosed herein includes assessing a newly admitted patient for risk of tissue damage. In one embodiment, assessing the patient includes performing a visual assessment. In one embodiment, the visual assessment is performed according to the guidance of the National Pressure Ulcer Advisory Panel (NPUAP).

[0083] In one embodiment, evaluating the patient includes performing a risk assessment. In one embodiment, the risk assessment is performed according to a test selected from the group consisting of the Braden Scale, the Gosnell Scale, the Norton Scale, and the Waterlow Scale. In one embodiment, evaluating the patient further includes performing an assessment using one or more objective measurements selected from the group consisting of subepidermal water, bioimpedance, blood perfusion, biocapacitance, blood oxygenation, pressure measurement, capillary pressure, magnetic resonance imaging, PET imaging, infrared imaging, spectral imaging, transepidermal water loss, and detecting the presence of interleukin-1 alpha at one or more anatomical sites of interest.

[0084] 7A-7D show the location of risk of tissue injury of the patient in various locations as circles. In one embodiment, the one or more body locations at risk of developing pressure injury are selected from the group consisting of the back of the head, shoulders, base of the spine, buttocks, heels, feet, elbows, ears, lower back, thighs, legs, rib cage, and knees. In one embodiment, the one or more body locations at risk of developing tissue injury are selected from the group consisting of the sternum, sacrum, heels, os latum scapularum, elbows, ears, and other fleshy tissues on the patient's bony prominences.

[0085] In one embodiment, a newly admitted patient undergoes an intake assessment that includes one or more of a visual inspection of a portion of the patient's skin, completion of at least a portion of a risk assessment protocol that evaluates one or more of nutrition, movement, physical activity, strength, and communication skills, and an ultrasonic echo image is acquired at one or more locations on the patient's skin. In one embodiment, the ultrasonic echo scan may include acquiring multiple ultrasonic echo images at a single "location" on the patient's skin. In one embodiment, a "location" is considered an area rather than a single point such that ultrasonic echo images may be created at spatially separated points within the location. For example, a "heel" location includes the inner, outer, and posterior surfaces of the heel surrounding the foot, as well as the posterior portion of the sole of the foot. In one embodiment, the ultrasonic echo scan includes acquiring ultrasonic echo images at a single location on the patient's skin. In one embodiment, the ultrasonic echo scan includes acquiring ultrasonic echo images at multiple locations on the patient's skin. In one embodiment, the ultrasonic echo scan includes acquiring multiple ultrasonic echo images at multiple locations on the patient's skin. In one aspect, evaluating the patient includes determining a number of sonic echo features in the sonic echo images. In one aspect, evaluating the patient includes determining an average number of sonic echo features in the plurality of sonic echo images.

[0086] In one embodiment, once the assessment steps are completed, a determination is made as to whether the patient's measurements are abnormal, i.e., whether the combination of results of the various elements of the assessment indicates that the patient has or is at risk for developing another injury to the wound tissue. Each element of the assessment may have individual criteria for the level of risk (e.g., a scoring system with a threshold that indicates an unacceptable risk). In one embodiment, a protocol exists in which the combination of criteria produces a composite parameter that can be used to select a level of intervention.

[0087] In one embodiment, if the number of sonic echo signatures present is less than or equal to the first threshold, a level 0 intervention is implemented. In one embodiment, if the number of sonic echo signatures present is greater than the first threshold, a level N intervention is implemented. In one embodiment, the first threshold is approximately 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 3.10, 3.11, 3.12, 3.13, 3.14, 3.15, 3.16, 3.17, 3.18, 3.19, 3.20, 3.21, 3.22, 3.23, 3.24, 3.25, 3.26, 3.27, 3.28, 3.29, 3.30, 3.31, 3.32, 3.33, 3.34, 3.35, 3.36, 3.37, 3.38, 3.39, 3.40, 3.41, 3.42, 3.43, 3.44, 3.45 It may be 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, or 7.5. In one embodiment, the threshold value may be in the range of 0.1 to 8.0 (such as 0.1 to 1.0, 1.1 to 2.0, 2.1 to 3.0, 3.1 to 4.0, 4.1 to 5.0, 5.1 to 6.0, 6.1 to 7.0, 7.1 to 8.0, 0.1 to 7.5, 0.5 to 8.0, 1.0 to 7.0, 1.5 to 6.5, 2.0 to 6.0, 3.0 to 5.5, 3.5 to 5.0, or 4.0 to 4.5). In one embodiment, the threshold value may be scaled by a factor or multiple based on the values ​​given herein. It is understood that the threshold value is not constrained by design, but rather, one of skill in the art may select a predetermined value. In one embodiment, the threshold values ​​of the present disclosure are modified according to the particular part of the patient's body on which the measurement is being taken, or one or more characteristics of the patient, such as age, height, weight, family history, ethnicity, and other physical characteristics or medical conditions.

[0088] In one embodiment, if the patient is determined to be at an acceptable risk level, a minimum level of intervention, designated herein as "Level Zero" or "Level 0," will be implemented and the patient will be re-evaluated using at least an echocardiographic imaging protocol at the frequency (or conversely, time interval) associated with Level 0. In one embodiment, a Level 0 intervention is implemented if the number of echocardiographic features present is below a threshold value.

[0089] In one embodiment, the number of sonic echo signatures above a first threshold is indicative of a patient at risk for developing a pressure sore or tissue damage.

[0090] In one embodiment, if the patient is determined to have an abnormal measurement, a higher level of intervention is implemented. In one embodiment, a hierarchy of intervention levels is defined where each level implements a stronger intervention than the level below it. Also, in one embodiment, each level is defined with a monitoring interval or frequency indicating how often a set of sonic echo images should be created, generally shorter intervals for higher levels. In one embodiment, the process is defined at this point by the hospital or other governing body to move up to Level 1 intervention. In another embodiment, Level 2 or higher levels of intervention may be implemented. The process now enters a new loop where the patient is monitored at a frequency of Level N, where N ranges from 1 to n, where n is the highest defined level of intervention and monitoring. In one embodiment, if the number of sonic echo characteristics is above a threshold, Level N intervention is implemented. In one embodiment, Level N intervention is anatomical specific.

[0091] In one embodiment, sonic echo images of body locations identified in an initial set of sonic echo images as having possible damage are acquired at a first time interval. In one embodiment, sonic echo images of all other body locations selected for monitoring are acquired at a second time interval that is longer than the first time interval. In one embodiment, the values ​​of the first and second time intervals vary depending on the risk category to which the patient is assigned. For example, a high-risk patient may have a first time interval of 4 hours and a second time interval of 1 day, while a low-risk patient may have a first time interval of 1 day and a second time interval of 1 week. In one embodiment, the time intervals may be event-based (e.g., staff or shift change-based) rather than strictly based on time. Generally, body locations with a greater number of sonic echo features are scanned more frequently than body locations that are monitored but have few (or no) sonic echo features in previous sonic echo imaging sessions.

[0092] In one embodiment, the interval at which the acoustic echo images are acquired is determined by the number of acoustic echo features from a prior acoustic echo imaging session, for example, a body location where the number of acoustic echo features in a prior imaging session was equal to or greater than a first threshold is subjected to acoustic echo imaging for a first time interval, while a body location where the prior number of acoustic echo features was equal to or greater than a second threshold is subjected to acoustic echo imaging for a second time interval that is shorter than the first time interval.

[0093] How to assign patients to risk categories In one aspect, the disclosure provides a method for assigning a patient in a healthcare facility to a risk category selected from a plurality of risk categories, the method comprising the steps of obtaining a plurality of initial ultrasound echo images of the patient at one or more body locations selected for monitoring, determining whether an ultrasound echo signature is present in the plurality of ultrasound echo images, and assigning the patient to a risk category selected from a plurality of risk categories based in part on the presence or absence of the ultrasound echo signature in the preceding steps.

[0094] In one embodiment, the patient's risk level is determined entirely by echocardiography. In one embodiment, the patient's risk level is determined entirely by visual inspection of the patient. In one embodiment, the patient's risk level is determined entirely by administration of a risk assessment protocol to the patient. In one embodiment, the patient's risk level is determined by echocardiography and visual inspection of the patient. In one embodiment, the patient's risk level is determined by administration of a risk assessment protocol to the patient and visual inspection of the patient. In one embodiment, the patient's risk level is determined by echocardiography and administration of a risk assessment protocol to the patient. In one embodiment, the patient's risk level is determined by echocardiography, administration of a risk assessment protocol to the patient, and visual inspection of the patient. In one embodiment, there is a protocol where a combination of criteria produces a composite parameter that may be used to select a level of intervention.

[0095] In one embodiment, the patient is assigned to a risk category selected from a plurality of risk categories. In one embodiment, the risk categories include a positive risk category and a high risk category. In one embodiment, the risk categories include a low risk category and a high risk category. In one embodiment, the risk categories include a low risk category, a positive risk category, and a high risk category. In one embodiment, there are 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 risk categories. In one embodiment, the risk categories are associated with a corresponding level of medical care. In one embodiment, the risk categories are associated with a corresponding level of intervention. In one embodiment, the risk categories are associated with a corresponding frequency of subsequent ultrasound echo imaging.

[0096] In one embodiment, a patient is assigned to a risk category based on the number of sonic echo features. In one embodiment, a patient is assigned to a risk category by comparison of the number of sonic echo features to a threshold. In one embodiment, a patient is assigned to a risk category by comparison of the number of sonic echo features to a maximum number of sonic echo features. In one embodiment, the assignment is based solely on an initial maximum number of sonic echo features found during an initial sonic echo imaging scan.

[0097] Methods for assigning patients to levels of care and intervention In one aspect, the disclosure provides a method for stratifying a plurality of patients in a medical care facility based on medical care level, the method comprising the steps of obtaining an echo image of one of the plurality of patients at one or more body locations selected for monitoring; determining whether an echo signature of tissue damage is present in the echo image; determining a level of medical care among N levels of medical care corresponding to the number and type of echo signatures present; assigning a level of medical care to the patient based on the preceding steps; and placing the patient of the plurality of patients into a group based on the level of medical care assigned to the patient.

[0098] In one embodiment, a patient is assigned to a level of care based on the number of sonic echo characteristics. In one embodiment, a patient is assigned to a level of care out of N levels of care that corresponds to the number of sonic echo characteristics. In one embodiment, there are 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 levels of care. In one embodiment, each of the N levels of care corresponds to a range of numbers of sonic echo characteristics. In one embodiment, a level of care is associated with a corresponding level of intervention. In one embodiment, a level of care is associated with a corresponding frequency of subsequent sonic echo imaging. In one embodiment, a plurality of patients are grouped and arranged according to their assigned level of care. In one embodiment, a plurality of patients are grouped such that patients within a group are assigned to the same level of care. In one embodiment, a plurality of patients are grouped such that patients within a group are provided with the same intervention.

[0099] In one aspect, the present disclosure provides a method of identifying and providing an appropriate level of medical care to a patient in a medical-care facility, the method comprising the steps of obtaining a plurality of sonic echo images of the patient at one or more body locations; determining whether sonic echo signatures of tissue damage are present in the plurality of sonic echo images; providing one or more anatomical structure-specific interventions based on the presence or absence of the sonic echo signatures in the preceding steps; increasing the level of anatomical structure-specific intervention based on an increase in the number of sonic echo signatures; and decreasing the level of anatomical structure-specific intervention based on a decrease in the number of sonic echo signatures.

[0100] In one embodiment, a patient is assigned to a medical care level based on the number of sonic echo characteristics. In one embodiment, a patient is assigned to a medical care level out of N medical care levels that corresponds to the number of sonic echo characteristics. In one embodiment, there are 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 medical care levels. In one embodiment, each of the N medical care levels corresponds to a range of numbers of sonic echo characteristics. In one embodiment, a medical care level is associated with a corresponding level of intervention. In one embodiment, a medical care level is associated with a corresponding frequency of subsequent sonic echo imaging.

[0101] In one aspect, the patient history is evaluated to determine if the patient's condition is improving. If the patient's condition is improving, for example, as evidenced by a decrease in the number of sonic echo features present, the level of intervention is decreased. In one aspect, the current level of intervention is continued until the number of sonic echo features falls below a threshold. In one aspect, if the number of sonic echo features is decreasing, the level of intervention may be decreased based on the magnitude of the number of sonic echo features. If the patient's condition is worsening, for example, as evidenced by an increase in the number of sonic echo features, the level of intervention is increased. In one aspect, the current level of intervention is continued until the number of sonic echo features exceeds a threshold. In one aspect, if the number of sonic echo features is increasing, the level of intervention may be increased based on the magnitude of the number of sonic echo features.

[0102] In one aspect, if the patient does not show improvement, the process branches to an increased level of intervention, assuming the skin has not been broken down, i.e., no open wounds have developed. If an open wound has developed, sonic echo imaging will be performed around the open wound to map inflammation or other precursors to wound expansion. The open wound itself is treated and its perimeter is monitored until the wound closes.

[0103] In one aspect, the anatomy-specific intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, a 30 degree wedge, a composite dressing, a hybrid mattress, a dynamic mattress, a support surface, a silicone pad, a low friction seat cover, and a low friction padded mattress surface.

[0104] In one embodiment, the decision to perform an intervention on a particular body part or a general intervention such as a smart mattress is based on the number of sonic echo signatures found at that part in the echo imaging scan. If the number of sonic echo signatures is less than a predetermined threshold, no intervention is required. If the number of sonic echo signatures is greater than a predetermined threshold, an intervention is selected and performed based in part on the body part and the number of sonic echo signatures at that body part. The predetermined threshold for selecting and performing an intervention may be higher or lower than the threshold for determining that damage may be present at that body part.

[0105] How to Manage Healthcare Care In one aspect, the disclosure provides and encompasses a method of managing medical care of a patient in a medical care facility, the method including the steps of acquiring a plurality of first ultrasonic echo images of the patient at one or more body locations selected for monitoring upon admission to the medical care facility, determining whether an ultrasonic echo characteristic is present in the plurality of first ultrasonic echo images, and if the number of ultrasonic echo characteristics present exceeds a first threshold, setting an intervention level N=1, and implementing a level N intervention for each of the one or more body locations where a number of ultrasonic echo characteristics is present that exceeds the first threshold, acquiring a plurality of subsequent ultrasonic echo images at each of the one or more body locations with a frequency of level N, and determining whether a new ultrasonic echo characteristic is present in the plurality of subsequent ultrasonic echo images.

[0106] In one embodiment, the first threshold is approximately 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, It may be 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, or 7.5. In one embodiment, the first threshold value may be in the range of 0.1 to 8.0 (such as 0.1 to 1.0, 1.1 to 2.0, 2.1 to 3.0, 3.1 to 4.0, 4.1 to 5.0, 5.1 to 6.0, 6.1 to 7.0, 7.1 to 8.0, 0.1 to 7.5, 0.5 to 8.0, 1.0 to 7.0, 1.5 to 6.5, 2.0 to 6.0, 3.0 to 5.5, 3.5 to 5.0, or 4.0 to 4.5). In one embodiment, the first threshold value may be scaled by a factor or multiple based on the values ​​given herein. It is understood that the threshold value is not constrained by design, but rather, one of ordinary skill in the art may select a predetermined value based on the given units of the sonic echo characteristic. In one embodiment, the thresholds of the present disclosure are modified according to the particular part of the patient's body where the measurement is being taken, or according to one or more characteristics of the patient, such as age, height, weight, family history, ethnicity, and other physical characteristics or medical conditions.

[0107] In one embodiment, N ranges from 1 to 50 (e.g., 1 to 2, 1 to 3, 1 to 4, 1 to 5, 1 to 6, 1 to 7, 1 to 8, 1 to 9, 1 to 10, 1 to 15, 1 to 20, 1 to 25, 1 to 30, 1 to 35, 1 to 40, or 1 to 45). In one embodiment, N is determined by the amount by which the number of sonic echo signatures exceeds a first threshold. In one embodiment, a level N intervention corresponds to a range of numbers of sonic echo signatures. In one embodiment, a level N intervention is associated with a corresponding anatomical structure specific intervention. In one embodiment, a level N intervention is associated with a corresponding frequency of subsequent sonic echo imaging. In one embodiment, a level N intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, 30 degree wedges, composite dressings, hybrid mattresses, dynamic mattresses, support surfaces, silicone pads, low friction seat covers, and low friction padded mattress surfaces.

[0108] In one embodiment, the medical care of the patient is discharged or transferred from a medical care facility. In one embodiment, the patient's condition upon discharge or transfer is documented. In one embodiment, a final set of sonic echo images at one or more locations on the patient's body is acquired prior to discharge or transfer. In one embodiment, a final set of sonic echo images at one or more locations on the patient's body is created. In one embodiment, these locations are one or more body locations selected for monitoring. In one embodiment, these locations include areas that have not received intervention and areas that have not been previously identified as risk. In one embodiment, this information is provided to the receiving medical caregiver.

[0109] Methods for identifying and treating patients at risk for tissue injury 7A-7D show the location of tissue injury risk of the patient in various locations as circles. In one embodiment, the first plurality of sonic echo images are acquired at or around one or more body locations selected from the group consisting of sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue on the patient's bony prominence. In one embodiment, the first plurality of sonic echo images are acquired at and around one or more anatomical locations that are in chronic contact with the medical device, the anatomical locations being selected from the group consisting of cheek, nose, chest, stomach, and lower abdomen. In one embodiment, the first plurality of sonic echo images are separated into subgroups for analysis based on the approximate location where the measurements are obtained. In one embodiment, the number of sonic echo features is determined by a subset of the first plurality of sonic echo images. In one embodiment, the first plurality of sonic echo images are acquired at one or more concentric circular locations centered on the anatomical location. In one embodiment, the first plurality of sonic echo images are acquired at linear locations approximately equidistant from the anatomical location.

[0110] In one embodiment, the number of sonic echo features may be determined in the methods disclosed herein from a plurality of sonic echo images taken at or in close proximity to a particular location. In one embodiment, a plurality of sonic echo images are taken in a predetermined pattern on the skin. In one embodiment, a plurality of sonic echo images are taken in a predetermined pattern on the skin, and the number of sonic echo features is determined from a plurality of sonic echo images taken at a predetermined location within the pattern. In one embodiment, the number of sonic echo features is determined from a portion or subset of the plurality of sonic echo images taken. In one embodiment, the number of sonic echo features at a location is the average number of sonic echo features in the plurality of images taken at the location. In one embodiment, the number of sonic echo features at a location is the maximum number of sonic echo features in the plurality of images taken at the location. In one embodiment, the number of sonic echo features at a location is the median number of sonic echo features in the plurality of images taken at the location. In one embodiment, the number of sonic echo features at a location is the most frequent number of sonic echo features in the plurality of images taken at the location.

[0111] In one embodiment, N ranges from 1 to 50 (such as 1 to 2, 1 to 3, 1 to 4, 1 to 5, 1 to 6, 1 to 7, 1 to 8, 1 to 9, 1 to 10, 1 to 15, 1 to 20, 1 to 25, 1 to 30, 1 to 35, 1 to 40, or 1 to 45).

[0112] In one embodiment, N is determined by the amount by which a first number of sonic echo characteristics exceed a first threshold. In one embodiment, the amount by which the threshold established for (N+1) exceeds the first threshold is greater than the amount by which the threshold established for N exceeds the first threshold. In one embodiment, the amount by which the threshold established for (N-1) exceeds the first threshold is less than the amount by which the threshold established for N exceeds the first threshold. In one embodiment, the threshold established for (N+1) is greater than the threshold established for N. In one embodiment, the threshold established for N is greater than the threshold established for (N-1).

[0113] Choosing the level of intervention In one embodiment, Level 1 (N=1) intervention is applied to patients where the number of sonic echo features above the threshold is 100% or less of the threshold (such as 95% or less, 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less of the threshold). In one embodiment, Level 1 intervention is applied where measurements were taken.

[0114] In one embodiment, Level 2 (N=2) intervention is applied to patients where the number of sonic echo features above the threshold is 150% or less of the threshold (such as 145% or less, 140% or less, 135% or less, 130% or less, 125% or less, 120% or less, 115% or less, 110% or less, 100% or less, 95% or less, 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less of the threshold). In one embodiment, Level 2 intervention is applied where measurements were taken.

[0115] In one aspect, a level 3 (N=3) intervention is applied to patients where the number of sonic echo features exceeding the threshold is 200% or less than the threshold (such as 195% or less, 190% or less, 185% or less, 180% or less, 175% or less, 170% or less, 165% or less, 160% or less, 155% or less, 150% or less, 145% or less, 140% or less, 135% or less, 130% or less, 125% or less, 120% or less, 115% or less, 110% or less, 100% or less, 95% or less, 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less of the threshold). In one embodiment, a level 3 intervention is applied where the measurement was taken.

[0116] In one embodiment, the number of sonic echo features exceeding the threshold is 250% or less of the threshold (245% or less of the threshold, 240% or less, 235% or less, 230% or less, 225% or less, 220% or less, 215% or less, 210% or less, 205% or less, 200% or less, 195% or less, 190% or less, 185% or less, 180% or less, 175% or less, 170% or less, 165% or less, 160% or less, 155% or less, 150% or less, 145% or less, 140% or less, Level 4 (N=4) intervention is applied to patients with a mean saturation of 135% or less, 130% or less, 125% or less, 120% or less, 115% or less, 110% or less, 100% or less, 95% or less, 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less, etc. In one embodiment, level 4 intervention is applied to the location where the measurement was taken.

[0117] In one embodiment, the number of sonic echo features exceeding the threshold is 300% or less of the threshold (295% or less of the threshold, 290% or less, 285% or less, 280% or less, 275% or less, 270% or less, 265% or less, 260% or less, 255% or less, 250% or less, 245% or less, 240% or less, 235% or less, 230% or less, 225% or less, 220% or less, 215% or less, 210% or less, 205% or less, 200% or less, 195% or less, 190% or less, 185% or less, 180% or less, 175% or less, 170% or less, 165% or less, Level 5 (N=5) intervention is applied to patients with a mean saturation of 160% or less, 155% or less, 150% or less, 145% or less, 140% or less, 135% or less, 130% or less, 125% or less, 120% or less, 115% or less, 110% or less, 100% or less, 95% or less, 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less, etc. In one embodiment, level 5 intervention is applied to the site where the measurement was taken.

[0118] In one embodiment, the number of sonic echo features exceeding the threshold is 350% or less of the threshold (345% or less of the threshold, 340% or less, 335% or less, 330% or less, 325% or less, 320% or less, 315% or less, 310% or less, 305% or less, 300% or less, 295% or less, 290% or less, 285% or less, 280% or less, 275% or less, 270% or less, 265% or less, 260% or less, 255% or less, 250% or less, 245% or less, 240% or less, 235% or less, 230% or less, 225% or less, 220% or less, 215% or less, 210% or less, 205% or less, 200% or less, 195% or less, 190% or less, Level 6 (N=6) intervention is applied to patients with a mean saturation of 185% or less, 180% or less, 175% or less, 170% or less, 165% or less, 160% or less, 155% or less, 150% or less, 145% or less, 140% or less, 135% or less, 130% or less, 125% or less, 120% or less, 115% or less, 110% or less, 100% or less, 95% or less, 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less, etc. In one embodiment, level 6 intervention is applied to the site where the measurement was taken.

[0119] In one embodiment, the number of sonic echo features exceeding the threshold is 400% or less of the threshold (395% or less, 390% or less, 385% or less, 380% or less, 375% or less, 370% or less, 365% or less, 360% or less, 355% or less, 350% or less, 345% or less, 340% or less, 335% or less, 330% or less, 325% or less, 320% or less, 315% or less, 310% or less, 305% or less, 300% or less, 295% or less, 290% or less, 285% or less, 280% or less, 275% or less, 270% or less, 265% or less, 260% or less, 255% or less, 250% or less, 245% or less, 240% or less, 235% or less, 230% or less, 225% or less, 220% or less, 215% or less of the threshold, Level 7 (N=7) interventions would be applied to patients with a mean CI of 210% or less, 205% or less, 200% or less, 195% or less, 190% or less, 185% or less, 180% or less, 175% or less, 170% or less, 165% or less, 160% or less, 155% or less, 150% or less, 145% or less, 140% or less, 135% or less, 130% or less, 125% or less, 120% or less, 115% or less, 110% or less, 100% or less, 95% or less, 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less). In one embodiment, a level 7 intervention is applied where the measurement was taken.

[0120] In one embodiment, the number of sonic echo features exceeding the threshold is 450% or less of the threshold (445% or less of the threshold, 440% or less, 435% or less, 430% or less, 425% or less, 420% or less, 415% or less, 410% or less, 405% or less, 400% or less, 395% or less, 390% or less, 385% or less, 380% or less, 375% or less, 370% or less, 365% or less, 360% or less, 3 ...). 5% or less, 350% or less, 345% or less, 340% or less, 335% or less, 330% or less, 325% or less, 320% or less, 315% or less, 310% or less, 305% or less, 300% or less, 2 95% or less, 290% or less, 285% or less, 280% or less, 275% or less, 270% or less, 265% or less, 260% or less, 255% or less, 250% or less, 245% or less, 240% or less, 235% or less, 230% or less, 225% or less, 220% or less, 215% or less, 210% or less, 205% or less, 200% or less, 195% or less, 190% or less, 185% or less, 180% or less Lower, 175% or less, 170% or less, 165% or less, 160% or less, 155% or less, 150% or less, 145% or less, 140% or less, 135% or less, 130% or less, 125% or less, 120% Level 8 (N=8) intervention is applied to patients with a mean of 100% or less, 95% or less, 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less). In one embodiment, level 8 intervention is applied to where measurements were taken.

[0121] In one embodiment, the number of sonic echo features exceeding the threshold is 500% or less of the threshold (495% or less, 490% or less, 485% or less, 480% or less, 475% or less, 470% or less, 465% or less, 460% or less, 455% or less, 450% or less, 445% or less, 440% or less, 435% or less, 430% or less, 425% or less, 420% or less, 415% or less, 410% or less, 405% or less, 400% or less, 395% or less of the threshold). , 390% or less, 385% or less, 380% or less, 375% or less, 370% or less, 365% or less, 360% or less, 355% or less, 350% or less, 345% or less, 340% or less, 335% or less, 330% or less , 325% or less, 320% or less, 315% or less, 310% or less, 305% or less, 300% or less, 295% or less, 290% or less, 285% or less, 280% or less, 275% or less, 270% or less, 265% or less, 260% or less, 255% or less, 250% or less, 245% or less, 240% or less, 235% or less, 230% or less, 225% or less, 220% or less, 215% or less, 210% or less, 205% or less, 200% or less, 195% or less, 190% or less, 185% or less, 180% or less, 175% or less, 170% or less, 165% or less, 160% or less, 155% or less, 150% or less, 145% or less, 140% or less, 135% or less, 1 Level 9 (N=9) intervention is applied to patients with a mean saturation of 30% or less, 125% or less, 120% or less, 115% or less, 110% or less, 100% or less, 95% or less, 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less, etc. In one embodiment, level 9 intervention is applied to the location where the measurement was taken.

[0122] In one embodiment, the number of sonic echo features exceeding the threshold is 550% or less of the threshold (545% or less, 540% or less, 535% or less, 530% or less, 525% or less, 520% ​​or less, 515% or less, 510% or less, 505% or less, 500% or less, 495% or less, 490% or less, 485% or less, 480% or less, 475% or less, 470% or less, 465% or less, 460% or less, 455% or less, 450% or less, 445% or less, 440% or less, 435% or less, 43 ... % or less, 425% or less, 420% or less, 415% or less, 410% or less, 405% or less, 400% or less, 395% or less, 390% or less, 385% or less, 380% or less, 375% or less, 370% or less, 365% or less, 360% or less Lower, 355% or less, 350% or less, 345% or less, 340% or less, 335% or less, 330% or less, 325% or less, 320% or less, 315% or less, 310% or less, 305% or less, 300% or less, 295% or less, 290% or less, 2 85% or less, 280% or less, 275% or less, 270% or less, 265% or less, 260% or less, 255% or less, 250% or less, 245% or less, 240% or less, 235% or less, 230% or less, 225% or less, 220% or less, 215 % or less, 210% or less, 205% or less, 200% or less, 195% or less, 190% or less, 185% or less, 180% or less, 175% or less, 170% or less, 165% or less, 160% or less, 155% or less, 150% or less, 145% or less , 140% or less, 135% or less, 130% or less, 125% or less, 120% or less, 115% or less, 110% or less, 100% or less, 95% or less, 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less, etc.). In one embodiment, a level 10 intervention is applied to where measurements were taken.

[0123] In one embodiment, level N intervention is stronger than level 0 intervention. In one embodiment, level (N+1) intervention is stronger than level N intervention. In one embodiment, level (N-1) intervention is weaker than level N intervention.

[0124] Methods for identifying and treating patients at risk for tissue damage (subsequent imaging) In one aspect, the disclosure further provides and encompasses the steps of acquiring a second plurality of ultrasonic echo images of the patient at a first predetermined frequency corresponding to a level of intervention performed, determining a second number of ultrasonic echo characteristics present in the second plurality of ultrasonic echo images, determining whether the second number of ultrasonic echo characteristics exceeds a second threshold, continuing to perform the first intervention if the second number of ultrasonic echo characteristics present does not exceed the second threshold, continuing to acquire the plurality of ultrasonic echo images at the first predetermined frequency if the second number of ultrasonic echo characteristics present does not exceed the second threshold, implementing a second intervention at level M (M is an integer greater than N) if the second number of ultrasonic echo characteristics present exceeds the second threshold, and acquiring a third plurality of ultrasonic echo images at a predetermined frequency corresponding to level M if the second number of ultrasonic echo characteristics present exceeds the second threshold.

[0125] In one embodiment, the predetermined frequency is selected from the group consisting of at least once every 72 hours, at least once every 48 hours, at least once every 24 hours, at least once every 12 hours, at least once every 8 hours, at least once every 6 hours, at least once every 4 hours, at least once every 3 hours, at least once every 2 hours, at least once every hour, and at least once every half hour.

[0126] In one embodiment, the second plurality of sonic echo images are acquired at or around one or more body locations selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on the patient's bony prominences. In one embodiment, the second plurality of sonic echo images are acquired at and around one or more anatomical locations in chronic contact with the medical device, the anatomical locations being selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen. In one embodiment, the second plurality of sonic echo images are separated into subgroups for analysis based on the approximate locations where the measurements are obtained. In one embodiment, the second number of sonic echo characteristics is determined by a subset of the second plurality of sonic echo images. In one embodiment, the second plurality of sonic echo images are acquired at one or more concentric circular locations centered on the anatomical location. In one embodiment, the second plurality of sonic echo images are acquired at linear locations approximately equidistant from the anatomical location.

[0127] In one embodiment, the second number of sonic echo features may be determined by a second plurality of sonic echo images made at or in close proximity to a particular location in the methods disclosed herein. In one embodiment, the second plurality of sonic echo images are made in a predetermined pattern on the skin. In one embodiment, the second plurality of sonic echo images are made in a predetermined pattern on the skin, and the second number of sonic echo features is determined at a predetermined location in the pattern. In one embodiment, the second number of sonic echo features is determined by a portion or subset of the second plurality of sonic echo images acquired. In one embodiment, the second number of sonic echo features at a location is the average number of sonic echo features in the plurality of images acquired at the location. In one embodiment, the second number of sonic echo features at a location is the maximum number of sonic echo features in the second plurality of images acquired at the location. In one embodiment, the second number of sonic echo features at a location is the median number of sonic echo features in the second plurality of images acquired at the location. In one embodiment, the second number of acoustic echo features at a location is the most frequent number of acoustic echo features in a second plurality of images acquired at the location.

[0128] In one embodiment, the second plurality of acoustic echo images are created at the same location where the first plurality of acoustic echo images were acquired. In one embodiment, the second plurality of acoustic echo images are created at a portion of the same location where the first plurality of acoustic echo images were acquired. In one embodiment, the second plurality of acoustic echo images are created near the location where the first plurality of acoustic echo images were acquired. In one embodiment, the second plurality of acoustic echo images are created at a different location than where the first plurality of acoustic echo images were acquired.

[0129] In one embodiment, the second threshold is approximately 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, It may be 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, or 7.5. In one embodiment, the second threshold may be in the range of 0.1 to 8.0 (0.1 to 1.0, 1.1 to 2.0, 2.1 to 3.0, 3.1 to 4.0, 4.1 to 5.0, 5.1 to 6.0, 6.1 to 7.0, 7.1 to 8.0, 0.1 to 7.5, 0.5 to 8.0, 1.0 to 7.0, 1.5 to 6.5, 2.0 to 6.0, 3.0 to 5.5, 3.5 to 5.0, or 4.0 to 4.5, etc.). In one embodiment, the second threshold may be scaled by a factor or multiple based on the values ​​given herein. In one embodiment, the second threshold may be the same as the first threshold. In one embodiment, the second threshold may be greater than the first threshold. In one embodiment, the second threshold may be less than the first threshold.

[0130] In one embodiment, the second number of the sonic echo characteristic may be 0.1 to 99.5% of the second threshold (0.1 to 1%, 0.1 to 5%, 1 to 5%, 5 to 15%, 10 to 20%, 15 to 25%, 20 to 30%, 25 to 35%, 30 to 40%, 35 to 45%, 40 to 50%, 0.1 to 25%, 15 to 35%, Possible ranges are 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%, etc.

[0131] In one embodiment, the range of M is 2 to 50 (such as 2 to 3, 2 to 4, 2 to 5, 2 to 6, 2 to 7, 2 to 8, 2 to 9, 2 to 10, 2 to 15, 2 to 20, 2 to 25, 2 to 30, 2 to 35, 2 to 40, or 2 to 45).

[0132] In one embodiment, M is determined by the amount by which a second number of the sonic echo characteristics exceed a second threshold. In one embodiment, the amount by which the threshold established for (M+1) exceeds the second threshold is greater than the amount by which the threshold established for N exceeds the second threshold. In one embodiment, the amount by which the threshold established for (M-1) exceeds the second threshold is less than the amount by which the threshold established for M exceeds the second threshold. In one embodiment, the threshold established for (M+1) is greater than the threshold established for M. In one embodiment, the threshold established for M is greater than the threshold established for (M-1).

[0133] In one embodiment, level M of intervention is selected according to the above "Selecting a Level of Intervention" of this disclosure, substituting M for N.

[0134] In one aspect, the present disclosure further provides and includes the steps of determining whether a second number of sonic echo characteristics present is less than or equal to a third threshold, continuing to perform the first intervention if the second number of sonic echo characteristics present is greater than or equal to the third threshold, continuing to acquire multiple sonic echo images at a first predetermined frequency if the second number of sonic echo characteristics present is greater than or equal to the third threshold, performing a third intervention at level L (L is an integer less than N) if the second number of sonic echo characteristics present is less than the third threshold and the first intervention is not level 0, and acquiring multiple sonic echo images at a predetermined frequency corresponding to level L if the second number of sonic echo characteristics present is less than the third threshold.

[0135] In one embodiment, the range of L is 0 to 50 (0 to 3, 0 to 4, 0 to 5, 0 to 6, 0 to 7, 0 to 8, 0 to 9, 0 to 10, 0 to 15, 0 to 20, 0 to 25, 0 to 30, 0 to 35, 0 to 40, or 0 to 45, etc.).

[0136] In one embodiment, L is determined by the amount by which the number of sonic echo features falls below a third threshold. In one embodiment, the amount by which the threshold established for (L-1) falls below the third threshold is greater than the amount by which the threshold established for L falls below the third threshold. In one embodiment, the amount by which the threshold established for (L+1) falls below the third threshold is less than the amount by which the threshold established for L falls below the third threshold. In one embodiment, the threshold established for (L+1) is greater than the threshold established for L. In one embodiment, the threshold established for L is greater than the threshold established for (L-1).

[0137] In one embodiment, the third threshold is approximately 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, It may be 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, or 7.5. In one embodiment, the third threshold may be in the range of 0.1 to 8.0 (0.1 to 1.0, 1.1 to 2.0, 2.1 to 3.0, 3.1 to 4.0, 4.1 to 5.0, 5.1 to 6.0, 6.1 to 7.0, 7.1 to 8.0, 0.1 to 7.5, 0.5 to 8.0, 1.0 to 7.0, 1.5 to 6.5, 2.0 to 6.0, 3.0 to 5.5, 3.5 to 5.0, or 4.0 to 4.5, etc.). In one embodiment, the third threshold may be scaled by a factor or multiple based on the values ​​given herein. In one embodiment, the third threshold may be equal to the second threshold. In one embodiment, the third threshold may be greater than the second threshold. In one embodiment, the third threshold may be less than the second threshold. In one embodiment, the third threshold may be the same as the first threshold. In one embodiment, the third threshold is equal to the first threshold. In one embodiment, the third threshold can be greater than the first threshold. In one embodiment, the third threshold can be less than the first threshold.

[0138] In one embodiment, the second number of the sonic echo characteristic is 0.1 to 99.5% of the third threshold value (0.1 to 1%, 0.1 to 5%, 1 to 5%, 5 to 15%, 10 to 20%, 15 to 25%, 20 to 30%, 25 to 35%, 30 to 40%, 35 to 45%, 40 to 50%, 0.1 to 25%, 15 to 35%, Possible ranges are 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%, etc.

[0139] In one embodiment, level L of intervention is selected according to the above "Selection of Intervention Level" of this disclosure, substituting L for N.

[0140] In one embodiment, the level N intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, 30 degree wedges, composite dressings, hybrid mattresses, dynamic mattresses, support surfaces, silicone pads, low friction sheet covers, and low friction padded mattress surfaces. In one embodiment, the level M intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, 30 degree wedges, composite dressings, hybrid mattresses, dynamic mattresses, support surfaces, silicone pads, low friction sheet covers, and low friction padded mattress surfaces. In one embodiment, the level L intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, 30 degree wedges, composite dressings, hybrid mattresses, dynamic mattresses, support surfaces, silicone pads, low friction sheet covers, and low friction padded mattress surfaces.

[0141] Methods for slowing the progression of skin and tissue damage In one aspect, the present disclosure provides and encompasses a method of slowing progression of skin and tissue damage in a patient in need thereof, comprising the steps of acquiring a plurality of ultrasonic echo images of the patient, identifying ultrasonic echo characteristics in the plurality of ultrasonic echo images, determining a first number of ultrasonic echo characteristics present in the plurality of ultrasonic echo images, continuing to implement a current level K intervention if the first number of ultrasonic echo characteristics is equal to or less than a first threshold, continuing to acquire the plurality of ultrasonic echo images at a predetermined frequency corresponding to level K if the first number of ultrasonic echo characteristics is equal to or less than the first threshold, implementing a new level N intervention (N greater than K) if the number of ultrasonic echo characteristics exceeds the first threshold, and acquiring the plurality of ultrasonic echo images at a predetermined frequency corresponding to level N if the number of ultrasonic echo characteristics exceeds the first threshold.

[0142] In one embodiment, the patient in need is a patient experiencing a change in medical care, a change in mobility, a change in nutrition, a change in sensation, or a combination thereof. In one embodiment, the patient in need is a patient who has developed an open wound. In one embodiment, the patient in need is a patient who has healed from an open wound. In one embodiment, the patient in need is a patient undergoing surgery. In one embodiment, the patient in need is a patient recovering from surgery. In one embodiment, the patient in need is a patient who receives spinal or sacral analgesia during surgery. In one embodiment, the patient in need is a patient undergoing surgery for a duration of 4 hours or more (such as 5 hours or more, 6 hours or more, 7 hours or more, 8 hours or more, 9 hours or more, 10 hours or more, 11 hours or more, or 12 hours or more). In one embodiment, the duration of the surgery is 1 hour or more (such as 2 hours or more or 3 hours or more).

[0143] In one embodiment, the plurality of ultrasonic echo images are acquired at or around one or more body locations selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on bony prominences of the patient. In one embodiment, the plurality of ultrasonic echo images are acquired at and around one or more anatomical locations in chronic contact with the medical device, the anatomical locations being selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen. In one embodiment, the plurality of ultrasonic echo images are separated into subgroups for analysis based on the approximate location where the measurements are obtained. In one embodiment, a first number of ultrasonic echo characteristics is determined by a subset of the plurality of ultrasonic echo images. In one embodiment, the plurality of ultrasonic echo images are acquired at one or more concentric circular locations centered on the anatomical location. In one embodiment, the plurality of ultrasonic echo images are acquired at linear locations approximately equidistant from the anatomical location.

[0144] In one embodiment, the first number of sonic echo features may be determined in a number of ways from a number of sonic echo images created at or in close proximity to a particular location. In one embodiment, a number of sonic echo images are created in a predetermined pattern on the skin. In one embodiment, a number of sonic echo images are created in a predetermined pattern on the skin, and the first number of sonic echo features is determined at a predetermined location within the pattern. In one embodiment, the first number of sonic echo features is determined from a portion or subset of the plurality of sonic echo images acquired. In one embodiment, the first number of sonic echo features at a location is the average number of sonic echo features in the plurality of images acquired at the location. In one embodiment, the first number of sonic echo features at a location is the maximum number of sonic echo features in the plurality of images acquired at the location. In one embodiment, the first number of sonic echo features at a location is the median number of sonic echo features in the plurality of images acquired at the location. In one embodiment, the first number of sonic echo features at a location is the most frequent number of sonic echo features in the plurality of images acquired at the location.

[0145] In one embodiment, the first threshold is approximately 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, It may be 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, or 7.5. In one embodiment, the first threshold may be in the range of 0.1 to 8.0 (0.1 to 1.0, 1.1 to 2.0, 2.1 to 3.0, 3.1 to 4.0, 4.1 to 5.0, 5.1 to 6.0, 6.1 to 7.0, 7.1 to 8.0, 0.1 to 7.5, 0.5 to 8.0, 1.0 to 7.0, 1.5 to 6.5, 2.0 to 6.0, 3.0 to 5.5, 3.5 to 5.0, or 4.0 to 4.5, etc.). In one embodiment, the first threshold may be scaled by a factor or multiple based on the values ​​given herein.

[0146] In one embodiment, K ranges from 2 to 50 (such as 2 to 3, 2 to 4, 2 to 5, 2 to 6, 2 to 7, 2 to 8, 2 to 9, 2 to 10, 2 to 15, 2 to 20, 2 to 25, 2 to 30, 2 to 35, 2 to 40, or 2 to 45).

[0147] In one embodiment, K is determined by the amount by which the number of sonic echo characteristics exceeds a threshold. In one embodiment, the amount by which the number of sonic echo characteristics exceeds a threshold defined for (K+1) is greater than the amount by which the number of sonic echo characteristics exceeds a threshold defined for K. In one embodiment, the amount by which the number of sonic echo characteristics exceeds a threshold defined for (K-1) is less than the amount by which the number of sonic echo characteristics exceeds a threshold defined for K.

[0148] In one embodiment, level K of intervention is selected according to the above "Selecting Intervention Level" of this disclosure, substituting K for N.

[0149] In one aspect, the present disclosure further provides and encompasses the steps of determining whether a first number of acoustic echo characteristics present is less than a second threshold, and if the first number of acoustic echo characteristics is less than the second threshold, performing an intervention of level L, where L is a non-negative value less than K, and if the first number of acoustic echo characteristics is less than the second threshold, acquiring a plurality of acoustic echo images at a predetermined frequency corresponding to level L.

[0150] In one embodiment, the second threshold is equal to the first threshold. In one embodiment, the second threshold is approximately 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, It may be 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, or 7.5. In one embodiment, the second threshold may be in the range of 0.1 to 8.0 (0.1 to 1.0, 1.1 to 2.0, 2.1 to 3.0, 3.1 to 4.0, 4.1 to 5.0, 5.1 to 6.0, 6.1 to 7.0, 7.1 to 8.0, 0.1 to 7.5, 0.5 to 8.0, 1.0 to 7.0, 1.5 to 6.5, 2.0 to 6.0, 3.0 to 5.5, 3.5 to 5.0, or 4.0 to 4.5, etc.). In one embodiment, the second threshold may be scaled by a factor or multiple based on values ​​given herein. In one embodiment, the second threshold is equal to the first threshold. In one embodiment, the second threshold may be greater than the first threshold. In one embodiment, the second threshold may be less than the first threshold.

[0151] In one embodiment, L can be K-1, K-2, K-3, K-4, K-5, K-6, K-7, K-8, K-9, or K-10. In one embodiment, L is K-1 when the number of sonic echo characteristics is 90-99.5% of the second threshold (e.g., 90-95%, 91-96%, 92-97%, 93-98%, 94-99%, or 95-99.5% of the second threshold), except when K-1 is less than 0 (in which case L is 0). In one embodiment, when the number of sonic echo characteristics is 80-89.9% of the second threshold (e.g., 80-85%, 81-86%, 82-87%, 83-88%, 84-89%, or 85-89.9% of the second threshold), L is K-2, except when K-2 is less than 0 (in which case L is 0). In one embodiment, when the number of sonic echo characteristics is 70-79.9% of the second threshold (e.g., 70-75%, 71-76%, 72-77%, 73-78%, 74-79%, or 75-79.9% of the second threshold), L is K-3, except when K-3 is less than 0 (in which case L is 0). In one embodiment, when the number of sonic echo characteristics is 60-69.9% of the second threshold (e.g., 60-65%, 61-66%, 62-67%, 63-68%, 64-69%, or 65-69.9% of the second threshold), L is K-4, except when K-4 is less than 0 (in which case L is 0). In one embodiment, when the number of sonic echo characteristics is 50-59.9% of the second threshold (e.g., 50-55%, 51-56%, 52-57%, 53-58%, 54-59%, or 55-59.9% of the second threshold), L is K-5, except when K-5 is less than 0 (in which case L is 0). In one embodiment, when the number of sonic echo characteristics is 40-49.9% of the second threshold (40-45%, 41-46%, 42-47%, 43-48%, 44-49%, or 45-49.9% of the second threshold, etc.), L is K-6, except when K-6 is less than 0 (in which case L is 0). In one embodiment, when the number of sonic echo characteristics is 30-39.9% of the second threshold (30-35%, 31-36%, 32-37%, 33-38%, 34-39%, or 35-39.9% of the second threshold, etc.), L is K-7, except when K-7 is less than 0 (in which case L is 0).In one embodiment, when the number of sonic echo characteristics is 20-29.9% of the second threshold (e.g., 20-25%, 21-26%, 22-27%, 23-28%, 24-29%, or 25-29.9% of the second threshold), L is K-8, except when K-8 is less than 0 (in which case L is 0). In one embodiment, when the number of sonic echo characteristics is 10-19.9% ​​of the second threshold (e.g., 10-15%, 11-16%, 12-17%, 13-18%, 14-19%, or 15-19.9% ​​of the second threshold), L is K-9, except when K-9 is less than 0 (in which case L is 0). In one aspect, if the number of sonic echo features is between 0.1 and 9.9% of the second threshold (e.g., between 0.1 and 5%, 1 and 6%, 2 and 7%, 3 and 8%, 4 and 9%, or 5 and 9.9% of the second threshold), then L is K-10, except when K-10 is less than 0 (in which case L is 0).

[0152] How to identify and treat patients who need pressure ulcer intervention In one aspect, the disclosure provides and encompasses a method of identifying and treating a patient requiring an intervention, the method including the steps of acquiring a plurality of ultrasonic echo images at an anatomical location of the patient, identifying ultrasonic echo characteristics in the plurality of ultrasonic echo images, determining a number of ultrasonic echo characteristics from the plurality of ultrasonic echo images, determining whether the number of ultrasonic echo characteristics exceeds a threshold corresponding to a level N, where N is 2 or greater, and performing an intervention at the anatomical location if the number of ultrasonic echo characteristics exceeds the threshold, and acquiring a plurality of ultrasonic echo images every two hours if the number of ultrasonic echo characteristics exceeds the threshold.

[0153] In one embodiment, the anatomical site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on bony prominences of the patient.

[0154] In one aspect, the intervention for the pressure ulcer is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, 30 degree wedges, composite dressings, hybrid mattresses, dynamic mattresses, support surfaces, silicone pads, low friction seat covers, and low friction padded mattress surfaces.

[0155] In one aspect, the disclosure provides and encompasses 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 acquiring a plurality of sonic echo images at the patient's heel, identifying sonic echo signatures in the plurality of sonic echo images, determining a number of sonic echo signatures from the plurality of sonic echo images, determining whether the number of sonic echo signatures exceeds a threshold corresponding to a level N, where N is 2 or greater, applying a barrier cream to the heel if the number of sonic echo signatures exceeds the threshold, and acquiring a plurality of sonic echo images every two hours if the number of sonic echo signatures exceeds the threshold. In one aspect, if the number of sonic echo signatures exceeds the threshold, a plurality of sonic echo images are generated at least hourly or at least half-hourly.

[0156] In one aspect, the disclosure provides and encompasses a method of identifying and treating a patient in need of application of neuromuscular stimulation to the patient's heel, the method including the steps of acquiring a plurality of sonic echo images at the patient's heel, identifying sonic echo characteristics in the plurality of sonic echo images, determining a number of sonic echo characteristics from the plurality of sonic echo images, determining whether the number of sonic echo characteristics exceeds a threshold corresponding to a level N, where N is 2 or greater, applying neuromuscular stimulation to the heel if the number of sonic echo characteristics exceeds the threshold, and acquiring a plurality of sonic echo images every hour if the number of sonic echo characteristics exceeds the threshold. In one aspect, if the number of sonic echo characteristics exceeds the threshold, a plurality of sonic echo images are generated at least hourly or at least half-hourly.

[0157] In one aspect, the present disclosure provides and encompasses a method of identifying and treating a patient in need of application of a topical cream to the patient's heel, the method including the steps of acquiring a plurality of sonic echo images of the patient's heel, identifying sonic echo characteristics in the plurality of sonic echo images, determining a number of sonic echo characteristics from the plurality of sonic echo images, determining whether the number of sonic echo characteristics exceeds a threshold corresponding to a level N (N is 2 or greater), applying the topical cream to the heel if the number of sonic echo characteristics exceeds the threshold, and acquiring a plurality of sonic echo images every half hour if the number of sonic echo characteristics exceeds the threshold.

[0158] In one aspect, the disclosure provides and encompasses a method of identifying and treating a patient in need of application of a heel boot to the patient's heel, the method including the steps of obtaining a plurality of ultrasonic echo images at the patient's heel, identifying ultrasonic echo characteristics in the plurality of ultrasonic echo images, determining a number of ultrasonic echo characteristics from the plurality of ultrasonic echo images, determining whether the number of ultrasonic echo characteristics exceeds a threshold corresponding to a level N, N being 2 or greater, and if the number of ultrasonic echo characteristics exceeds the threshold, applying the heel boot to the heel; and obtaining a plurality of ultrasonic echo images every 10 hours if the number of ultrasonic echo characteristics exceeds the threshold.

[0159] In one aspect, the disclosure provides and encompasses a method of identifying and treating a patient in need of application of a barrier cream to the patient's sacrum, comprising the steps of acquiring a plurality of ultrasonic echo images at the patient's sacrum, identifying ultrasonic echo signatures in the plurality of ultrasonic echo images, determining a number of ultrasonic echo signatures from the plurality of ultrasonic echo images, determining whether the number of ultrasonic echo signatures exceeds a threshold corresponding to a level N, where N is 2 or greater, and if the number of ultrasonic echo signatures exceeds the threshold, applying a barrier cream to the sacrum, and if the number of ultrasonic echo signatures exceeds the threshold, acquiring a plurality of ultrasonic echo images every 6 hours. In one aspect, if the number of ultrasonic echo signatures exceeds the threshold, a plurality of ultrasonic echo images are generated at least once every 4 hours, at least once every 3 hours, at least once every 2 hours, at least once every hour, or at least once every half hour.

[0160] In one aspect, the disclosure provides and encompasses a method of identifying and treating a patient in need of application of neuromuscular stimulation to the patient's sacrum, comprising the steps of acquiring a plurality of ultrasonic echo images at the patient's sacrum, identifying ultrasonic echo characteristics in the plurality of ultrasonic echo images, determining a number of ultrasonic echo characteristics from the plurality of ultrasonic echo images, determining whether the number of ultrasonic echo characteristics exceeds a threshold corresponding to a level N, where N is 2 or greater, applying neuromuscular stimulation to the sacrum if the number of ultrasonic echo characteristics exceeds the threshold, and acquiring a plurality of ultrasonic echo images every four hours if the number of ultrasonic echo characteristics exceeds the threshold. In one aspect, if the number of ultrasonic echo characteristics exceeds the threshold, a plurality of ultrasonic echo images are generated at least once every three hours, at least once every two hours, at least once every hour, or at least once every half hour.

[0161] In one aspect, the present disclosure provides and encompasses a method of identifying and treating a patient in need of application of a topical cream to the patient's sacrum, comprising the steps of acquiring a plurality of ultrasonic echo images at the patient's sacrum, identifying ultrasonic echo characteristics in the plurality of ultrasonic echo images, determining a number of ultrasonic echo characteristics from the plurality of ultrasonic echo images, determining whether the number of ultrasonic echo characteristics exceeds a threshold corresponding to a level N (N is 2 or greater), applying the topical cream to the sacrum if the number of ultrasonic echo characteristics exceeds the threshold, and acquiring a plurality of ultrasonic echo images every two hours if the number of ultrasonic echo characteristics exceeds the threshold. In one aspect, if the number of ultrasonic echo characteristics exceeds the threshold, a plurality of ultrasonic echo images are produced at least once an hour or at least once a half hour.

[0162] In one aspect, the present disclosure provides and encompasses a method of identifying and treating a patient in need of application of ultrasound therapy, comprising the steps of acquiring a plurality of ultrasound echo images at an anatomical site of the patient, identifying an ultrasound echo signature in the plurality of ultrasound echo images, determining a number of ultrasound echo signatures from the plurality of ultrasound echo images, determining whether the number of ultrasound echo signatures exceeds a threshold corresponding to a level N (N is 2 or greater), administering ultrasound therapy to the anatomical site if the number of ultrasound echo signatures exceeds the threshold, and acquiring a plurality of ultrasound echo images every two hours if the number of ultrasound echo signatures exceeds the threshold. In one aspect, the anatomical site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on a bony prominence of the patient.

[0163] In one aspect, the present disclosure provides and encompasses a method for identifying and treating a patient in need of shockwave therapy, comprising the steps of: acquiring a plurality of sonic echo images at an anatomical site of the patient; identifying sonic echo characteristics in the plurality of sonic echo images; determining the number of sonic echo characteristics from the plurality of sonic echo images; determining whether the number of sonic echo characteristics exceeds a threshold corresponding to a level N (N is 2 or more); administering shockwave therapy to the anatomical site if the number of sonic echo characteristics exceeds the threshold; acquiring a plurality of sonic echo images every two hours if the number of sonic echo characteristics exceeds the threshold. In one aspect, the anatomical site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on the patient's bony prominences. In one aspect, the shockwave therapy is provided by electromagnetic pulses or pressurized air.

[0164] In one aspect, the disclosure provides and encompasses a method of identifying and treating a patient in need of application of a 30 degree wedge, comprising the steps of acquiring a plurality of sonic echo images at an anatomical site of the patient, identifying sonic echo characteristics in the plurality of sonic echo images, determining a number of sonic echo characteristics from the plurality of sonic echo images, determining whether the number of sonic echo characteristics exceeds a threshold corresponding to a level N (N is 2 or greater), performing a 30 degree wedge at the anatomical site if the number of sonic echo characteristics exceeds the threshold, and acquiring a plurality of sonic echo images every two hours if the number of sonic echo characteristics exceeds the threshold. In one aspect, the anatomical site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on a bony prominence of the patient.

[0165] In one aspect, the disclosure provides and encompasses a method of identifying and treating a patient requiring application of a composite dressing, comprising the steps of acquiring a plurality of sonic echo images at an anatomical site of the patient, identifying sonic echo signatures in the plurality of sonic echo images, determining a number of sonic echo signatures from the plurality of sonic echo images, determining whether the number of sonic echo signatures exceeds a threshold corresponding to a level N, where N is 2 or greater, administering the composite dressing to the anatomical site if the number of sonic echo signatures exceeds the threshold, and acquiring a plurality of sonic echo images every two hours if the number of sonic echo signatures exceeds the threshold. In one aspect, the anatomical site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on bony prominences of the patient.

[0166] In one aspect, the disclosure provides and encompasses a method of identifying and treating a patient in need of a hybrid mattress, comprising the steps of acquiring a plurality of sonic echo images at an anatomical site of the patient, identifying sonic echo characteristics in the plurality of sonic echo images, determining a number of sonic echo characteristics from the plurality of sonic echo images, determining if the number of sonic echo characteristics exceeds a threshold corresponding to a level N, where N is 2 or greater, applying the hybrid mattress to the anatomical site if the number of sonic echo characteristics exceeds the threshold, and acquiring a plurality of sonic echo images every two hours if the number of sonic echo characteristics exceeds the threshold. In one aspect, the anatomical site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on bony prominences of the patient.

[0167] In one aspect, the disclosure provides and encompasses a method of identifying and treating a patient in need of a dynamic mattress, comprising the steps of acquiring a plurality of sonic echo images at an anatomical site of the patient, identifying sonic echo characteristics in the plurality of sonic echo images, determining a number of sonic echo characteristics from the plurality of sonic echo images, determining if the number of sonic echo characteristics exceeds a threshold corresponding to a level N, where N is 2 or greater, applying a dynamic mattress to the anatomical site if the number of sonic echo characteristics exceeds the threshold, and acquiring a plurality of sonic echo images every two hours if the number of sonic echo characteristics exceeds the threshold. In one aspect, the anatomical site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on a bony prominence of the patient.

[0168] In one aspect, the disclosure provides and encompasses a method for identifying and ambulating a bedridden patient in need, the method including the steps of providing a movement sensor with an accelerometer and gyro sensor, monitoring the frequency and extent of patient movement, providing an alert if the movement sensor does not detect movement of more than a quarter turn for a specified period of time, and ambulating the patient upon the alert.

[0169] In one aspect, the disclosure further provides and encompasses the step of providing anatomy-specific intervention to a patient's anatomical site identified as damaged by a combination of visual assessment and sonic echo imaging. In one aspect, the anatomy-specific intervention is provided to a common site of wound development selected from the group consisting of the foot, heel, sacrum, spine, elbow, scapula, occipital region, and ischial tuberosity. In one aspect, the anatomy-specific intervention is also simultaneously provided to a second common site of wound development selected from the group consisting of the foot, heel, sacrum, spine, elbow, scapula, occipital region, and ischial tuberosity. In one aspect, the first site receiving the anatomy-specific intervention is known to be responsible for the development of wounds at the second site.

[0170] Identification of damaged tissue by comparing bilateral echograms In one aspect, the present disclosure provides and encompasses a method of identifying damaged tissue, the method including the steps of obtaining a first acoustic echo image from a first location on a patient's skin, obtaining a second acoustic echo image from a second location symmetrical to the first location, identifying acoustic echo features in each of the first and second acoustic echo images, determining a number of acoustic echo features from each of the first and second acoustic echo images, determining a difference in the number of acoustic echo features between the first and second acoustic echo images, and determining that tissue damage is present at the first or second location if the difference in the number of acoustic echo features between the first and second acoustic echo images exceeds a threshold.

[0171] 4A shows the sacral region of the back of a patient 410. A line of symmetry 412 can be drawn down the center of the back to divide the back into left and right mirror images. Point 414 is approximately the same distance and approximately the same height from line of symmetry 412 and is therefore considered to be the left and right mirror image of the back of patient 410.

[0172] 4B shows the left foot 420L and right foot 420R of patient 410 as they would appear if the patient 410 were lying on their back on a bed (not shown) with an observer standing at the foot of the bed. On the undersides 422L and 422R of feet 420L and 420R, locations 424L and 424R are at approximately equivalent locations (e.g., the same distance from the rear or heel and the same distance from the medial side of each foot 420L or 420R) and are considered symmetrical locations.

[0173] 4C illustrates additional exemplary symmetrical locations 432L and 432R located on the sides of the feet 420L and 420R, and symmetrical locations 434L and 434R located on the undersides 422L and 422R of the feet 420L and 420R, respectively. In one aspect, the locations 432R and 430R are considered symmetrical with respect to the foot 420R when considered alone without reference to the foot 420L.

[0174] Without being limited to a particular theory, comparison of echo images obtained at symmetrical locations can compensate for offsets of measurements on a particular patient from the patient population. For example, a patient may be dehydrated on a particular day when measurements are taken. Comparison of the number of echo signatures of healthy tissues of the same patient in a dehydrated state may be offset from the number of echo signatures of the same tissue at the same location when the patient is fully hydrated. If tissue at one location is healthy while tissue at the symmetrical location is damaged, comparison of measurements obtained at symmetrical locations will more reliably indicate that tissue at one location is damaged, excluding the "common mode" effect of variations in dehydration at both locations.

[0175] Measurements at multiple locations (e.g., a first measurement at a first location and a second measurement at a second location symmetrical to the first location) may be performed using an acoustic echo imaging device 600 as shown in Figure 6. In one embodiment, the device 600 includes a processor that may be configured by instructions stored on a non-transitory computer-readable medium to determine a characteristic of the measurements taken at the multiple locations or a parameter associated with or derived from the measurements (e.g., one or more of the difference in the number of acoustic echo characteristics determined by the multiple measurements). In one embodiment, the device 600 includes a display configured to display one or more parameters associated with the measurements (e.g., the difference in the number of acoustic echo characteristics determined by acoustic echo imaging taken at two symmetrical locations).

[0176] In one embodiment, a number of sonic echo features is determined, with a number exceeding a predetermined threshold indicating tissue damage at one of the locations where a corresponding sonic echo image was acquired. In one embodiment, the number of sonic echo features acquired at each symmetrical location is determined and compared. In one embodiment, a median or mode of the number of sonic echo features acquired at each symmetrical location is determined and compared. In one embodiment, damage is indicated at a location associated with a larger number of sonic echo features. In one embodiment, damage is indicated at a location associated with a smaller number of sonic echo features. In one embodiment, determining whether tissue damage is present includes one or more of comparing the individual numbers of sonic echo features to one or more predetermined ranges or thresholds and comparing the difference to one or more predetermined ranges or thresholds. In one embodiment, the predetermined range may be 0.1 to 8.0 (0.1 to 1.0, 1.1 to 2.0, 2.1 to 3.0, 3.1 to 4.0, 4.1 to 5.0, 5.1 to 6.0, 6.1 to 7.0, 7.1 to 8.0, 0.1 to 7.5, 0.5 to 8.0, 1.0 to 7.0, 1.5 to 6.5, 2.0 to 6.0, 3.0 to 5.5, 3.5 to 5.0, or 4.0 to 4.5, etc.). In one embodiment, the predetermined range may be 0.1 to 4.0 (0.5 to 4.0, 0.1 to 3.5, 1.0 to 3.5, 1.5 to 4.0, 1.5 to 3.5, 2.0 to 4.0, 2.5 to 3.5, 2.0 to 3.0, 2.0 to 2.5, or 2.5 to 3.0, etc.). In one embodiment, the predetermined range may be 4.1 to 8.0 (4.5 to 8.0, 4.1 to 7.5, 5.0 to 7.5, 5.5 to 7.0, 5.5 to 7.5, 6.0 to 8.0, 6.5 to 7.5, 6.0 to 7.0, 6.0 to 6.5, or 6.5 to 7.0, etc.).In one embodiment, the predetermined threshold is approximately 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, It may be 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, or 7.5. In one embodiment, the predetermined threshold may be in the range of 0.1 to 8.0 (such as 0.1 to 1.0, 1.1 to 2.0, 2.1 to 3.0, 3.1 to 4.0, 4.1 to 5.0, 5.1 to 6.0, 6.1 to 7.0, 7.1 to 8.0, 0.1 to 7.5, 0.5 to 8.0, 1.0 to 7.0, 1.5 to 6.5, 2.0 to 6.0, 3.0 to 5.5, 3.5 to 5.0, or 4.0 to 4.5). In one embodiment, the predetermined range or threshold may be scaled by a factor or multiple based on the values ​​provided herein. It is understood that the predetermined value is not constrained by design, but rather, one of ordinary skill in the art may select the predetermined value. In one aspect, the ranges and thresholds of the present disclosure are modified according to the particular bilateral location, the part of the patient's body where the measurement is being taken, or one or more characteristics of the patient, such as age, height, weight, family history, ethnicity, and other physical characteristics or medical conditions.

[0177] One or more regions of the body may be defined. In one embodiment, measurements made within a region may be considered comparable to one another. A region may be defined as an area on the skin of the body within which measurements may be taken at any point. In one embodiment, the region corresponds to an anatomical region (e.g., heel, ankle, lower back). In one embodiment, a region may be defined as a set of two or more specific points relative to an anatomical feature at which measurements are only taken. In one embodiment, the region may include multiple discontinuous regions on the body. In one embodiment, a set of specific locations may include points in multiple discontinuous areas.

[0178] In one embodiment, the region is defined by a surface area. In one embodiment, the region is defined by a surface area, for example, between 5 and 200 cm. 2 , 5~100cm 2 , 5~50cm 2 , 10~50cm 2 , 10~25cm 2 , or 5 to 25 cm 2 may be also possible.

[0179] In one embodiment, measurements may be taken in a specific pattern or a portion thereof. In one embodiment, the pattern of measurements is configured in a pattern centered around the area of ​​interest. In one embodiment, measurements are taken in one or more circular patterns of varying sizes, T-shaped patterns, a set of specific locations, or random traversal of the tissue or area. In one embodiment, the pattern may be positioned on the body by defining a first measurement location of the pattern relative to an anatomical feature and defining other measurement locations of the pattern as offsets from the first measurement location.

[0180] In one embodiment, the sonic echo measuring device of the present disclosure may further comprise a plurality of contact sensors surrounding the receivers in the same plane as each of the receivers, thereby bringing the device into full contact with the skin surface. The plurality of contact sensors may be a plurality of pressure sensors, a plurality of light sensors, a plurality of temperature sensors, a plurality of pH sensors, a plurality of sweat sensors, a plurality of ultrasound sensors, a plurality of bone growth promotion sensors, or a combination of a plurality of these. In one embodiment, the plurality of contact sensors may include 4, 5, 6, 7, 8, 9, 10 or more contact sensors.

[0181] 5A and 5B illustrate an example of how symmetrical locations can be identified by comparing the number of sonic echo characteristics associated with measurements at known relative locations according to the present disclosure. In this example, sonic echo measuring device 630 is shown across contact area 502R (e.g., 420R in FIG. 4C) on the right foot at non-overlapping locations marked "A" through "H" in FIG. 5A. The number of sonic echo characteristics measured at each location is plotted in the graph of FIG. 5B. In this example, the number of sonic echo characteristics at locations "A" and "H" is low or zero, reflecting that sonic echo measuring device 630 does not overlap contact area 502R at these locations. The number of sonic echo characteristics associated with locations "B" and "G" is high because sonic echo measuring device 630 overlaps a portion of contact area 502R at these locations. The number of sonic echo characteristics at locations C, D, E, and F are numerous and, in this example, substantially the same, indicating that the sonic echo measuring device 630 is entirely within the contact area 502R at these locations. In one embodiment, a sonic echo measuring device such as the sonic echo measuring device 630 may determine that certain locations (e.g., locations "C" and "F") are symmetrical about the centerline 504R of the right foot 420R. In one embodiment, if a similar set of measurements were taken at locations A'-H' on the left foot 420L, the locations on each foot 420L and 420R (e.g., locations E and E') may be determined to be substantially symmetrical.

[0182] FIG. 6 is a schematic diagram of an integrated system 600 for measuring, evaluating, storing, and transferring sonic echo images according to the present disclosure. In this example, the system 600 includes a sonic echo measuring device 630 capable of wireless communication with a Wi-Fi access point 610. The sonic echo measuring device 630 communicates with one or more of a sonic echo imaging application running on a server 650, a laptop computer 620, a smart phone 640, or an application running on another digital device. In one embodiment, the laptop computer 620 and the smart phone 640 are carried by a user of the sonic echo measuring device 630 (e.g., a nurse), and the application provides feedback and information to the user. In one embodiment, the patient's information received from the sonic echo measuring device 630 is stored in a database 660. In one embodiment, the information received from the sonic echo measuring device 630 is transferred via a network 655 to another server 680, which stores a portion of the information in the patient's electronic medical record (EMR) 670. In one embodiment, information from the ultrasonic echo measuring device 630 or information read from the database 660 or EMR 670 is transferred to an external server 690 and then to a computer 695 (e.g., a computer in a doctor's office providing medical care to the patient).

[0183] How to detect tissue damage before it becomes visible In one aspect, the present disclosure provides and encompasses a method of detecting tissue damage before it becomes visible on a patient's skin, the method including the steps of acquiring multiple time-staggered acoustic echo images at a single location, identifying an acoustic echo feature in each of the multiple acoustic echo images, determining a number of acoustic echo features from each of the multiple acoustic echo images, calculating a slope between the most recent number of acoustic echo features and the immediately preceding number of acoustic echo features, comparing the slope to a threshold, and determining that tissue damage is present if the slope exceeds the threshold.

[0184] In one aspect, a slope between the most recent number of sonic echo signatures and the number of sonic echo signatures immediately preceding the current number indicates tissue damage. In one aspect, a positive slope between the most recent number of sonic echo signatures and the number of sonic echo signatures immediately preceding the current number indicates worsening tissue damage. In one aspect, a positive slope between the most recent number of sonic echo signatures and the number of sonic echo signatures immediately preceding the current number indicates the formation of a pressure sore.

[0185] In one aspect, the present disclosure provides and encompasses a method of detecting tissue damage before it becomes visible on a patient's skin, the method including the steps of acquiring multiple acoustic echo images at a single location with time differences, identifying acoustic echo features in each of the multiple acoustic echo images, determining a number of acoustic echo features from each of the multiple acoustic echo images, calculating a difference value of a maximum number of acoustic echo features and a minimum number of acoustic echo features for each time difference, calculating a derivative with respect to time of the difference value, comparing the derivative to a threshold, and determining that tissue damage is present if the derivative exceeds the threshold.

[0186] In one embodiment, the difference value of the maximum number of sonic echo features and the minimum number of sonic echo features per time indicates tissue damage. In one embodiment, the derivative of the difference value with respect to time is calculated from two different times. In one embodiment, the derivative of the difference value with respect to time is calculated from the two most recent difference values. In one embodiment, the derivative of the difference value with respect to time is calculated from difference values ​​measured at two consecutive time points. In one embodiment, the derivative of the difference value with respect to time is calculated from difference values ​​measured at two non-consecutive time points. In one embodiment, a positive derivative indicates worsening of tissue damage. In one embodiment, a positive derivative indicates the formation of a bedsore.

[0187] In one aspect, the present disclosure provides and encompasses a method for detecting tissue damage before it becomes visible on a patient's skin, the method including the steps of acquiring multiple acoustic echo images at a single location with time differences, identifying acoustic echo features in each of the multiple acoustic echo images, determining a number of acoustic echo features from each of the multiple acoustic echo images, calculating difference values ​​of a maximum number of acoustic echo features and a minimum number of acoustic echo features for each time difference, fitting a curve to a predetermined number of most recent difference values, calculating a curvature of the fitted curve, comparing the curvature to a threshold value, and determining that tissue damage is present if the curvature exceeds the threshold value.

[0188] In one embodiment, the curvature of the fitted curve of the difference values ​​over time is indicative of tissue damage. In one embodiment, an increase in the curvature of the fitted curve of the difference values ​​over time is indicative of worsening tissue damage. In one embodiment, an increase in the curvature of the fitted curve of the difference values ​​over time is indicative of the formation of a pressure sore.

[0189] In one embodiment, a plurality of sonic echo images are acquired at a time difference, which may be approximately once every second, approximately once every 15 seconds, approximately once every 30 seconds, approximately once every minute, approximately once every 10 minutes, approximately once every 15 minutes, approximately once every 30 minutes, approximately once every hour, approximately once every 2 hours, approximately once every 3 hours, approximately once every 4 hours, approximately once every 6 hours, approximately once every 12 hours, approximately once every 24 hours, approximately once every day, approximately once every 2 days, approximately once every 3 days, approximately once every 4 days, approximately once every 5 days, approximately once every 6 days, approximately once every 7 days, approximately once every 8 days, approximately once every 9 days, approximately once every 10 days.

[0190] In one embodiment, the thresholds are approximately 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, 3.10, 3.11, 3.12, 3.13, 3.14, 3.15, 3.16, 3.17, 3.18, 3.19, 3.20, 3.21, 3.22, 3.23, 3.24, 3.25, 3.26, 3.27, 3.28, 3.29, 3.30, 3.31, 3.32, 3.33, 3.34, 3.35, 3.36, 3.37, 3.38, 3.39, 3.40, 3.41, 3.42, 3.43, 3.44, 3.45, 3.46, 3.47, 3.48, 3.49, 3.50, 3.51, 3.52, 3.53, 3.54, 3.55 It may be 4, 3.5, 3.6, 3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.0, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.1, 7.2, 7.3, 7.4, or 7.5. In one embodiment, the threshold value may be in the range of 0.1 to 8.0 (such as 0.1 to 1.0, 1.1 to 2.0, 2.1 to 3.0, 3.1 to 4.0, 4.1 to 5.0, 5.1 to 6.0, 6.1 to 7.0, 7.1 to 8.0, 0.1 to 7.5, 0.5 to 8.0, 1.0 to 7.0, 1.5 to 6.5, 2.0 to 6.0, 3.0 to 5.5, 3.5 to 5.0, or 4.0 to 4.5). In one embodiment, the threshold value may be scaled by a factor or multiple based on the values ​​given herein. It is understood that the threshold value is not constrained by design, but rather, one of skill in the art may select a predetermined value. In one embodiment, the threshold values ​​of the present disclosure are modified according to the particular part of the patient's body on which the measurement is being taken, or one or more characteristics of the patient, such as age, height, weight, family history, ethnicity, and other physical characteristics or medical conditions.

[0191] In one embodiment, the number of sonic echo signatures above a predefined threshold indicates epidermal damage that may lead to bed sores. The time interval between the first time the number of sonic echo signatures is above this threshold and the occurrence of visible symptoms of bed sores may be a first duration during which the number of sonic echo signatures increases linearly. The first duration may be 5 days or more (6 days or more, 7 days or more, 8 days or more, 9 days or more, or 10 days or more).

[0192] In another embodiment, if a plot of the number of sonic echo features over time shows an upward curvature or other deviation from a linear progression, visible symptoms may appear within a shorter time period (e.g., 2-3 days, 1-4 days, 1-3 days, 1-2 days, or 2-4 days). The number of these sonic echo feature values ​​is tracked and the trend of the number of sonic echo feature values, i.e., the slope and curvature of the curve connecting the number of these sonic echo feature values, is analyzed. In one embodiment, the amount by which the number of increments of the sonic echo feature exceeds a linear prediction based on the previous number of sonic echo features is compared to a predetermined threshold. In one embodiment, the amount by which the number of increments of the sonic echo feature exceeds the most recent previous number of sonic echo features is compared to a predetermined threshold. In one embodiment, the curvature of a best fit curve fitted to a predetermined number of the most recent number of sonic echo features is compared to a predetermined threshold. In one embodiment, the number of consecutive sonic echo features that exceed a predetermined threshold is compared to a measurement count threshold. In each of these embodiments, the sonic echo imaging scanner notifies the user when the comparison parameter exceeds each threshold.

[0193] In one aspect, the trend analysis may ignore the number of single acoustic echo characteristic values ​​below a threshold if both the preceding and subsequent numbers of the acoustic echo characteristic are above the threshold.

[0194] In one aspect, the trend curve for the number of acoustic echo features is a straight line connection between the points. In one aspect, the trend curve is a best fit curve fitted to the number of acoustic echo features. In one aspect, the fit curve is required to intersect the most recent number of acoustic echo features.

[0195] Having now generally described the invention, the same will be more readily understood by reference to the following examples, which are provided for illustrative purposes and are not intended to limit the disclosure unless otherwise specified. EXAMPLES

[0196] Example 1: Intervention Levels for Treating Pressure Ulcers on the Heel

[0197] Subjects identified as being at risk for heel ulcers are treated according to the following scheme.

[0198] One or more sonic echo images of the patient at the heel are obtained. A number of sonic echo features are determined. The patient is assigned an intervention level based on the number of sonic echo features compared to a threshold, as shown in Table 1. An appropriate intervention corresponding to the assigned intervention level is implemented. Subsequent sonic echo imaging is performed at a frequency determined by the assigned intervention level. The patient's assigned intervention level may be changed (either up or down) or may remain the same depending on the number of sonic echo features of subsequent measurements.

[0199] [Table 1]

[0200] Example 2: Intervention Levels for Treating Sacral Pressure Ulcers

[0201] Subjects identified as being at risk for sacral pressure ulcers are treated according to the following scheme.

[0202] One or more echo images of the patient at the sacrum are obtained. The number of echo features is determined. The patient is assigned an intervention level based on the number of echo features compared to a threshold, as shown in Table 2. An appropriate intervention corresponding to the assigned intervention level is performed at the sacrum. Subsequent echo imaging is performed at a frequency determined by the assigned intervention level. The patient's assigned intervention level may be changed (either up or down) or may remain the same depending on the number of echo features of subsequent measurements.

[0203] [Table 2]

[0204] Example 3: Treatment decision pathways to stratify patients and provide appropriate treatment

[0205] Pressure ulcers are classified as stages 1 through 4, with stage 1 being the least severe. The National Pressure Ulcer Advisory Panel (NPUAP) defines a stage 1 ulcer as a localized nonblanching erythema on intact skin. Erythema (redness of the superficial layer of skin) is "blanchable" if it blanches when pressed, and "non-blanchable" if it remains red when pressed, possibly due to the presence of red blood cells outside of blood vessels (extravasation). In some patients, blanching erythema or changes in sensation, temperature, or consistency may precede visual changes. Although all patients are potentially at risk, pressure ulcers are more likely to develop in patients who are seriously ill or who have neurological disorders, movement disorders, nutritional disorders, poor posture, or deformities.

[0206] Currently, visual skin assessment (VSA) is the method of identifying pressure ulcers: trained healthcare professionals visually and tactilely assess the appearance of the skin to look for changes in redness or tissue firmness, tissue temperature, or moisture.

[0207] Figure 1A outlines the currently recommended treatment decision pathway for preventing pressure ulcers in hospitalized patients, as presented in the clinical guideline "Pressure ulcers: prevention and management" published on 23 April 2014 by the UK National Institute for Health and Care Excellence (NICE). These guidelines recommend that a risk analysis be performed for all patients admitted to a care facility, indicating one or more risk factors, such as significantly restricted mobility, significant loss of sensation, past or current pressure ulcers, nutritional deficiencies, lack of ability to self-position, or significant cognitive impairment. Risk assessment is typically performed using a scored checklist, such as the Braden Scale, which assesses the severity of specific risk factors. See, for example, Bergstrom et al., Nurs Res,,36(4):205-210 (1987). This scale consists of six subscales reflecting sensation, skin moisture, activity, movement, friction and shear, and nutritional status.

[0208] The risk assessment identifies patients as being at (i) low risk of developing a pressure ulcer, (ii) at risk of developing a pressure ulcer, or (iii) at high risk of developing a pressure ulcer. Depending on the level of risk they are classified as, they undergo different sequences of treatments and follow-up evaluation with visual assessment.

[0209] If a patient is identified as being at low risk for developing a pressure ulcer, they are simply monitored for changes in clinical status (e.g., events such as surgery, worsening of underlying disease, changes in mobility). Patients who use wheelchairs or sit for long periods of time may be provided with high performance foam chair cushions or equivalent pressure-relieving cushions. If there is no change in clinical status, low-risk patients will not be reassessed under this set of guidelines and will remain in the same treatment and evaluation pathway until discharge from the care facility.

[0210] If patients are identified as at risk for developing pressure ulcers, they will be scheduled for repositioning, or "rounding," every six hours. As with low-risk patients, patients may be provided with high-performance foam chair cushions if they use a wheelchair or sit for long periods of time. No other monitoring or interventions are recommended, according to the NICE guidelines.

[0211] If patients are identified as at high risk for developing pressure ulcers, they will receive a high-performance foam mattress as a preventative measure, or a high-performance chair cushion if they use a wheelchair or sit for long periods of time. Patients will also be repositioned every four hours. Patients will undergo daily VSAs of all areas of the body. If an area shows non-blanching erythema, appropriate interventions will be implemented and the area will be rechecked with a VSA every two hours. Areas not showing non-blanching erythema will be rechecked daily with a VSA. An individualized medical care plan will be developed for each high-risk patient.

[0212] This flow chart (Figure 1A) shows that caregivers spend the majority of their time with high-risk patients. While this may be appropriate, it is possible that at-risk patients may be left unmonitored and develop a stage 1 ulcer before the condition is detected by the caregiver. Furthermore, relying on VSA to detect a problem necessarily means that patients will develop a stage 1 ulcer before an intervention can be selected or implemented. By the time damage has progressed to stage 1, intervention will likely result in the skin breaking down and developing a stage 2 ulcer. There is a clear need for early detection of tissue damage so that intervention can prevent subepidermal damage from progressing beyond stage 1.

[0213] Figure 1B is an example of an enhanced treatment decision pathway for pressure ulcer prevention currently implemented in several healthcare facilities. The enhanced pathway adds a monitoring step to both the at-risk and low-risk pathways. Low-risk patients undergo a weekly risk assessment (e.g., completing a Braden Scale assessment). At-risk patients receive a high-performance foam mattress as a preventative measure and will be evaluated daily with a VSA. A medical care plan will be developed to monitor and treat at-risk patients. There is no change in the medical care of high-risk patients.

[0214] This expanded plan has the advantage of providing baseline monitoring of pressure ulcers for all patients. However, these additional steps would require additional time due to increased staffing or increased strain on existing staff. Although the care pathway in Figure 1B is superior to the recommended care pathway in Figure 1A, it requires more resources and still suffers from the limitation that patients must have stage 1 ulcers before the VSA can identify the injury.

[0215] Different hospitals and healthcare facilities use different numbers of risk categories. These range from two categories (low risk and high risk) to four or more categories, with additional categories such as “very high risk” to those shown in the example in Figure 1B. Patients are assigned to various categories based on the results of an initial risk assessment.

[0216] FIG. 2 is an exemplary flow chart of a method in which a device for evaluating sonic echo images of tissues beneath a patient's skin may be used in an independent process to prevent bedsores according to the present disclosure. All patient visits undergo a complete sonic echo evaluation of all body locations selected for monitoring. These selected locations may include areas recommended in the instructions for use (IFU) of the sonic echo imager, such as the sacrum and heels. Additional locations may be identified by hospitals and incorporated into their in-house practice. Multiple sonic echo images are acquired at and around each body location at spatially distinct locations. A set of measurements determines the sonic echo signature of each location at and around the location. The number of sonic echo signatures is then compared to one or more thresholds to classify the patient.

[0217] In this example, patients are assigned to one of two risk categories: low risk and high risk. Low-risk patients undergo weekly echocardiography of all body locations selected for monitoring. This is a low-cost procedure that can benefit even the healthiest patients, as weekly echocardiography scans increase the likelihood of detecting tissue damage before it becomes visible on the VSA.

[0218] At-risk patients, which would include those identified as high risk in the current care pathway of Figures 1A and 1B, would receive specialized care based on the body location that exhibits a number of echo signatures above a threshold. For example, if the number of echo signatures of the sacrum is above a threshold, the patient would be repositioned every six hours and would receive daily echo imaging of the sacrum, while other body locations, such as the heels, would receive weekly echo imaging.

[0219] 3 is a flow chart of a method in which an apparatus for sonic echo imaging of tissue beneath a patient's skin may be used as an aid to further refine the extended treatment decision pathway of FIG. 1B in accordance with the present disclosure. An incoming patient undergoes both a risk assessment and a sonic echo imaging scan of all body locations identified by the hospital for monitoring, with the patient's assignment to a risk category based in part on the results of the risk assessment and the sonic echo imaging scan. An initial number of sonic echo signatures greater than a threshold indicates the likelihood of damage being present at that body location.

[0220] The decision to perform an intervention (e.g., repositioning the patient at the first interval) is currently based on the VSA and risk assessment, even though it is unknown whether early stage damage exists under the skin. However, when echocardiography is used as an adjunct to an extended treatment decision pathway as shown in FIG. 3, the decision to perform an intervention at a particular body location or a general intervention such as a high performance mattress is based on the number of echo signatures found at that location in the echocardiography scan. If the number of echo signatures is less than a predetermined threshold, no intervention is required. If the number of echo signatures is greater than a predetermined threshold, an intervention is selected and performed based in part on the body location and the number of echo signatures at that body location, respectively. The predetermined threshold for selecting and performing an intervention may be higher or lower than the threshold for determining that damage may exist at that body location.

[0221] A comparison of the costs of providing the care pathways of Figures 1A, 1B, 2, and 3 highlights one of the advantages of using an echocardiographic device to monitor a patient, although the costs quoted herein are for patients who do not have or develop a pressure ulcer, with estimated treatment costs rising to $2000 for a stage 1 ulcer.

[0222] The basis for this comparison is the expanded current approach in Figure 1B, which represents the current "best practice" for hospitals striving to reduce the incidence of pressure ulcers. Low-risk care pathway care delivery is expected to cost an average of $26 per patient with an average stay of 5.6 days, while care for at-risk patients is expected to cost an average of $121 and care for high-risk patients is expected to cost $165. All current care pathways rely on VSA to detect pressure ulcers and otherwise base interventions on a "typical" patient trajectory rather than a specific patient condition.

[0223] As shown in Figure 3, incorporating an echocardiogram into the current “best practice” workflow would not reduce the cost of either pathway since no work element is removed. However, the benefit is early detection of tissue damage at minimal incremental cost. The incremental cost of adding an echocardiogram scan to the low-risk pathway is $2, increasing the cost from approximately $26 to $28. The expected cost of care for at-risk patients who do not have an increased number of echocardiograms, i.e., no subepidermal tissue damage, would also increase by $2. However, if an at-risk patient were found to have an increased number of echocardiograms, the patient would be elevated to the high-risk category, increasing the expected cost of care from $165 to $169. This represents a small additional cost relative to the benefit of early detection of tissue damage in low-risk and at-risk patients.

[0224] Figure 2 illustrates an exemplary workflow that does not use conventional VSA and relies solely on echocardiography for patient monitoring. The expected cost of preventive care for low-risk patients is $4 using echocardiography alone, compared to $28 using the integrated low-risk care pathway of Figure 3. As shown in Figure 2, for at-risk patients using echocardiography alone, the expected cost is $97, compared to $123-169 for at-risk and high-risk patients using the integrated care pathway of Figure 3.

[0225] Example 4: Risk levels based on the number of sonic echo signatures

[0226] Subjects identified as being at risk for pressure ulcers are treated according to the following scheme.

[0227] One or more echo images of the patient at one or more target body locations are acquired. For each scanned body location, the number of echo features is determined. The number of echo features at various body locations of many patients with and without barotrauma has been acquired in the past and used to construct a histogram of the number of echo features. As shown in Table 3, patients with fewer than three echo features are assigned to risk level 0. Patients with three or more but fewer than ten echo features are assigned to risk level 1. Patients with ten or more echo features are assigned to risk level 2. An appropriate intervention is implemented corresponding to the assigned risk level. Subsequent echo imaging is performed at a frequency determined by the assigned intervention level. The patient's assigned intervention level may be changed (either up or down) or may remain the same depending on the number of echo features of the subsequent measurements.

[0228] [Table 3]

[0229] From the above, it will be appreciated that the present invention can be embodied in a variety of forms, including but not limited to the following.

[0230] Embodiment 1. An apparatus for generating an acoustic echo image of tissue beneath intact skin of a patient, the apparatus comprising: (a) an emitter configured to emit acoustic waves at an intermediate frequency of approximately 10 MHz when activated; (b) a receiver configured to receive vibrations of the returning acoustic waves and convert the vibrations into electrical pulses; and (c) a processor coupled to the receiver and configured to: (i) receive the electrical pulses from the receiver; (ii) determine the length of time the acoustic waves return; (iii) determine the intensity of the returning acoustic waves; and (iv) generate an acoustic echo image.

[0231] Embodiment 2. The device of embodiment 1, further comprising a display configured to receive the sonic echo image and provide the sonic echo image.

[0232] Embodiment 3. A method for evaluating sonic echo characteristics in tissue beneath intact skin of a patient, comprising the steps of: (a) emitting sonic waves into the patient's skin at a first location; (b) receiving a portion of the returning sonic waves that have reflected from the tissue; (c) determining the length of time it takes for the sonic waves to return; (d) determining the intensity of the returning sonic waves; (e) generating a sonic echo image; (f) acquiring the sonic echo image; and (g) acquiring the number and type of one or more sonic echo characteristics.

[0233] Embodiment 4. The method of embodiment 3, wherein the one or more echo characteristics are selected from the group consisting of poorly defined layered structures, hypoechoic lesions, fascial disruptions, and heterogeneous hypoechoic areas.

[0234] Embodiment 5. A method for reducing the incidence of wound development in patients admitted to a healthcare facility, comprising: (a) assessing the patient for risk of tissue damage upon admission to the healthcare facility, comprising: (i) obtaining an echo image of the patient at one or more body locations at risk of wound development; and (ii) determining the number of echo signatures of tissue damage present in the echo image; (b) implementing a level 0 intervention if the number of echo signatures present is less than or equal to a first threshold; and (c) implementing a level N intervention, where N is an integer greater than or equal to 1, if the number of echo signatures present exceeds the first threshold.

[0235] Embodiment 6. The method of embodiment 5, wherein the echo characteristics are selected from the group consisting of poorly defined layered structures, hypoechoic lesions, fascial disruptions, and heterogeneous hypoechoic areas.

[0236] Embodiment 7. The method of embodiment 5, wherein the acoustic echo characteristic is a smeared layered structure.

[0237] Embodiment 8. The method of embodiment 5, wherein the sonic echo characteristic is a hypoechoic lesion.

[0238] Embodiment 9. The method of embodiment 5, wherein the sonic echo characteristic is fascial disruption.

[0239] Embodiment 10. The method of embodiment 5, wherein the acoustic echo characteristic is a heterogeneous hypoechoic region.

[0240] Embodiment 11. The method of any one of embodiments 5-10, wherein the wound is selected from the group consisting of a pressure ulcer, a diabetic foot ulcer, a deep tissue injury, a vascular ulcer, and a burn.

[0241] Embodiment 12. The method of any one of embodiments 5 to 11, wherein the one or more body locations at risk of developing a wound are selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues over bony prominences of the patient.

[0242] Embodiment 13. The method of any one of embodiments 5 to 12, wherein the one or more body locations at risk for wound development include anatomical sites that are in prolonged contact with a medical device.

[0243] Embodiment 14. The method of any one of embodiments 5 to 13, wherein the one or more body locations at risk of developing wounds are selected from the group consisting of the cheeks, nose, chest, stomach, and lower abdomen.

[0244] Embodiment 15. The method of any one of embodiments 5 to 14, wherein the Level N intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, 30 degree wedges, composite dressings, hybrid mattresses, dynamic mattresses, support surfaces, silicone pads, low friction seat covers, and low friction padded mattress surfaces.

[0245] Embodiment 16. A method for stratifying a plurality of patients in a medical care facility based on medical care level, comprising: (a) obtaining an echo image of one of the plurality of patients at one or more body locations selected for monitoring; (b) determining whether an echo characteristic of tissue damage is present in the echo image; (c) determining a level of medical care among N levels of medical care corresponding to the number and type of echo characteristics present; (d) assigning a level of medical care to the patient based on step (c); and (e) placing the patient among the plurality of patients into a group based on the level of medical care assigned to the patient.

[0246] Embodiment 17. The method of embodiment 16, wherein the echo characteristics are selected from the group consisting of poorly defined layered structures, hypoechoic lesions, fascial disruptions, and heterogeneous hypoechoic areas.

[0247] Embodiment 18. The method of embodiment 16 or 17, wherein the sonic echo characteristic is fascial disruption.

[0248] Embodiment 19. The method of any one of embodiments 16-18, wherein the one or more body locations are selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on bony prominences of the patient.

[0249] Embodiment 20. The method of any one of embodiments 16-19, wherein the one or more body locations include anatomical sites that are in chronic contact with a medical device.

[0250] Embodiment 21. The method of any one of embodiments 16-20, wherein the one or more body sites are selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen.

[0251] Embodiment 22. The method of any one of embodiments 16 to 21, wherein the step of assigning a level of medical care to the patient is based on the presence or absence of fascial disruption.

[0252] Embodiment 23. The method of any one of embodiments 16 to 22, wherein the step of assigning a level of medical care to the patient is based on a change in the presence of smeared lamellar structures over a two-week period.

[0253] Embodiment 24. A method for identifying and providing an appropriate level of medical care to a patient in a medical care facility, comprising the steps of: (a) obtaining a plurality of ultrasonic echo images of a patient at one or more body locations; (b) determining whether ultrasonic echo signatures of tissue damage are present in the plurality of ultrasonic echo images; (c) providing one or more anatomical structure-specific interventions based on the presence or absence of the ultrasonic echo signatures in step (b); (d) increasing the level of anatomical structure-specific intervention based on an increase in the number of ultrasonic echo signatures; and (e) decreasing the level of anatomical structure-specific intervention based on a decrease in the number of ultrasonic echo signatures.

[0254] Embodiment 25. The method of embodiment 24, wherein the echo characteristics are selected from the group consisting of unclear layered structures, hypoechoic lesions, fascial disruptions, and heterogeneous hypoechoic areas.

[0255] Embodiment 26 The method of embodiment 24 or 25, wherein the sonic echo characteristic is fascial disruption.

[0256] Embodiment 27. The method of embodiment 24 or 25, wherein the acoustic echo characteristic is a smeared layered structure.

[0257] Embodiment 28. The method of any one of embodiments 24 to 27, wherein the one or more body locations are selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on bony prominences of the patient.

[0258] Embodiment 29. The method of any one of embodiments 24 to 28, wherein the one or more body locations include anatomical sites that are in chronic contact with a medical device.

[0259] Embodiment 30. The method of any one of embodiments 24-29, wherein the one or more body sites are selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen.

[0260] Embodiment 31. The method of any one of embodiments 24 to 30, wherein the anatomy-specific intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, 30 degree wedges, composite dressings, hybrid mattresses, dynamic mattresses, support surfaces, silicone pads, low friction seat covers, and low friction padded mattress surfaces.

[0261] Embodiment 32. The method of any one of embodiments 24 to 31, wherein the level of anatomy-specific intervention is increased if the number of acoustic echo characteristics exceeds a first threshold.

[0262] Embodiment 33. The method of any one of embodiments 24 to 32, wherein the level of anatomy-specific intervention is reduced if the number of acoustic echo characteristics falls below a second threshold.

[0263] Embodiment 34. A method for assigning a patient in a medical care facility to one risk category selected from a plurality of risk categories, comprising: (a) obtaining a plurality of initial ultrasound echo images of the patient at one or more body locations selected for monitoring; (b) determining whether an ultrasound echo characteristic is present in the plurality of ultrasound echo images; and (c) assigning the patient to one risk category selected from a plurality of risk categories based in part on the presence or absence of the ultrasound echo characteristic in step (b).

[0264] Embodiment 35. The method of embodiment 34, wherein the echo characteristics are selected from the group consisting of unclear layered structures, hypoechoic lesions, fascial disruptions, and heterogeneous hypoechoic areas.

[0265] Embodiment 36 The method of embodiment 34 or 35, wherein the sonic echo characteristic is fascial disruption.

[0266] Embodiment 37. The method of embodiment 34 or 35, wherein the acoustic echo characteristic is a smeared layered structure.

[0267] Embodiment 38. The method of any one of embodiments 34 to 37, wherein the one or more body locations selected for monitoring are selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on bony prominences of the patient.

[0268] Embodiment 39. The method of any one of embodiments 34 to 38, wherein the one or more body locations selected for monitoring include anatomical sites in chronic contact with a medical device.

[0269] Embodiment 40. The method of any one of embodiments 34 to 39, wherein the one or more body sites selected for monitoring are selected from the group consisting of cheek, nose, chest, stomach, and lower abdomen.

[0270] Embodiment 41. A method for managing medical care of a patient in a medical care facility, comprising: (a) acquiring a plurality of first ultrasonic echo images of the patient at one or more body locations selected for monitoring upon admission to the medical care facility; (b) determining whether an ultrasonic echo characteristic is present in the plurality of first ultrasonic echo images; (c) setting an intervention level N=1 if the number of ultrasonic echo characteristics present exceeds a first threshold; (d) implementing level N of intervention for each of the one or more body locations at which the number of ultrasonic echo characteristics present exceeds the first threshold; (e) acquiring a plurality of subsequent ultrasonic echo images at each of the one or more body locations with a frequency of level N; and (f) determining whether a new ultrasonic echo characteristic is present in the plurality of subsequent ultrasonic echo images.

[0271] Embodiment 42. The method of embodiment 41, wherein the sonic echo characteristic is selected from the group consisting of unclear layered structures, hypoechoic lesions, fascial disruptions, and heterogeneous hypoechoic areas.

[0272] Embodiment 43. The method of embodiment 41 or 42, wherein the sonic echo characteristic is fascial disruption.

[0273] Embodiment 44. The method of embodiment 41 or 42, wherein the acoustic echo characteristic is a smeared layered structure.

[0274] Embodiment 45. The method of any one of embodiments 41 to 44, wherein the body location selected for monitoring is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on bony prominences of the patient.

[0275] Embodiment 46. The method of any one of embodiments 41 to 45, wherein the body location selected for monitoring includes an anatomical site in chronic contact with a medical device.

[0276] Embodiment 47. The method of any one of embodiments 41 to 46, wherein the body site selected for monitoring is selected from the group consisting of cheek, nose, chest, stomach, and lower abdomen.

[0277] Embodiment 48. The method of any one of embodiments 41 to 47, wherein the Level N intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, 30 degree wedges, composite dressings, hybrid mattresses, dynamic mattresses, support surfaces, silicone pads, low friction seat covers, and low friction padded mattress surfaces.

[0278] Embodiment 49. A method for identifying and treating a patient at risk of tissue damage, comprising: (a) assessing a patient for risk of tissue damage upon admission to a medical care facility, the step including: (i) acquiring a first plurality of ultrasonic echo images of the patient; and (ii) determining a first number of ultrasonic echo characteristics present in the first plurality of ultrasonic echo images; (b) implementing a first intervention at level 0 if the first number of ultrasonic echo characteristics present is less than or equal to a first threshold; and (c) implementing a first intervention at level N (N is an integer greater than or equal to 1) if the first number of ultrasonic echo characteristics present is greater than the first threshold.

[0279] Embodiment 50. The method of embodiment 49, further comprising: (a) acquiring a second plurality of ultrasonic echo images of the patient at a first predetermined frequency corresponding to the intervention level performed; (b) determining a second number of ultrasonic echo characteristics present in the second plurality of ultrasonic echo images; (c) determining whether the second number of ultrasonic echo characteristics exceeds a second threshold; (d) continuing to perform the first intervention if the second number of ultrasonic echo characteristics present does not exceed the second threshold; (e) continuing to acquire a plurality of ultrasonic echo images at the first predetermined frequency if the second number of ultrasonic echo characteristics present does not exceed the second threshold; (f) implementing a second intervention of level M, where M is an integer greater than N, if the second number of ultrasonic echo characteristics present exceeds the second threshold; and (g) acquiring a third plurality of ultrasonic echo images at a predetermined frequency corresponding to level M if the second number of ultrasonic echo characteristics present exceeds the second threshold.

[0280] Embodiment 51. The method of embodiment 49 or 50, further comprising: (a) determining whether the second number of sonic echo characteristics present is less than or equal to a third threshold; (b) continuing to perform the first intervention if the second number of sonic echo characteristics present is greater than or equal to the third threshold; (c) continuing to acquire multiple sonic echo images at a first predetermined frequency if the second number of sonic echo characteristics present is greater than or equal to the third threshold; (d) performing a third intervention at level L (L is an integer less than N) if the second number of sonic echo characteristics present is less than the third threshold and the first intervention is not level 0; and (e) acquiring multiple sonic echo images at a predetermined frequency corresponding to level L if the second number of sonic echo characteristics present is less than the third threshold.

[0281] Embodiment 52. The method of any one of embodiments 49 to 51, wherein the first intervention at level N is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, 30 degree wedges, composite dressings, hybrid mattresses, dynamic mattresses, support surfaces, silicone pads, low friction seat covers, and low friction padded mattress surfaces.

[0282] Embodiment 53. The method of any one of embodiments 50 to 52, wherein the Level M second intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, 30 degree wedges, composite dressings, hybrid mattresses, dynamic mattresses, support surfaces, silicone pads, low friction seat covers, and low friction padded mattress surfaces.

[0283] Embodiment 54. The method of any one of embodiments 51 to 53, wherein the third intervention of level L is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, 30 degree wedges, composite dressings, hybrid mattresses, dynamic mattresses, support surfaces, silicone pads, low friction seat covers, and low friction padded mattress surfaces.

[0284] Embodiment 55. The method of any one of embodiments 49 to 54, wherein the sonic echo characteristic is selected from the group consisting of unclear layered structures, hypoechoic lesions, fascial disruptions, and heterogeneous hypoechoic areas.

[0285] Embodiment 56. The method of any one of embodiments 49 to 55, wherein the sonic echo characteristic is fascial disruption.

[0286] Embodiment 57. The method of any one of embodiments 49 to 55, wherein the acoustic echo characteristic is a smeared layered structure.

[0287] Embodiment 58. The method of any one of embodiments 49 to 57, wherein the first plurality of ultrasonic echo images are obtained at or around one or more body locations selected from the group consisting of the sternum, sacrum, heel, scapularum, elbow, ear, and other fleshy tissues on bony prominences of the patient.

[0288] Embodiment 59. A method as described in any one of embodiments 49 to 58, wherein a first plurality of ultrasonic echo images are acquired at or around an anatomical site in chronic contact with the medical device.

[0289] Embodiment 60. The method of any one of embodiments 49 to 59, wherein the first plurality of ultrasonic echo images are acquired at or around one or more body locations selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen.

[0290] Embodiment 61. A method for slowing the progression of skin and tissue damage in a patient in need thereof, comprising: (a) identifying a current level K intervention to be received by the patient; (b) acquiring a plurality of ultrasonic echo images of the patient; (c) identifying ultrasonic echo characteristics in the plurality of ultrasonic echo images; (d) determining a first number of ultrasonic echo characteristics present in the plurality of ultrasonic echo images; (e) continuing to implement the current level K intervention if the first number of ultrasonic echo characteristics is less than or equal to a first threshold; (f) continuing to acquire a plurality of ultrasonic echo images at a predetermined frequency corresponding to level K if the first number of ultrasonic echo characteristics is less than or equal to the first threshold; (g) implementing a new level N intervention, where N is greater than K, if the number of ultrasonic echo characteristics exceeds the first threshold; and (h) acquiring a plurality of ultrasonic echo images at a predetermined frequency corresponding to level N if the number of ultrasonic echo characteristics exceeds the first threshold.

[0291] Embodiment 62. The method of embodiment 61, further comprising: (a) determining whether a first number of acoustic echo characteristics present is less than a second threshold; (b) performing an intervention of level L (L is a non-negative value less than K) if the first number of acoustic echo characteristics is less than the second threshold; and (c) acquiring multiple acoustic echo images at a predetermined frequency corresponding to level L if the first number of acoustic echo characteristics is less than the second threshold.

[0292] Embodiment 63. The method of embodiment 61 or 62, wherein the sonic echo characteristic is selected from the group consisting of unclear layered structures, hypoechoic lesions, fascial disruptions, and heterogeneous hypoechoic areas.

[0293] Embodiment 64. The method of embodiment 61 or 62, wherein the sonic echo characteristic is fascial disruption.

[0294] Embodiment 65. The method of embodiment 61 or 62, wherein the acoustic echo characteristic is a smeared layered structure.

[0295] Embodiment 66 The method of embodiment 61 or 62, wherein the sonic echo characteristic is a hypoechoic lesion.

[0296] Embodiment 67. The method of embodiment 61 or 62, wherein the acoustic echo characteristic is a heterogeneous hypoechoic region.

[0297] Embodiment 68. The method of any one of embodiments 61 to 67, wherein a plurality of ultrasonic echo images are obtained at or around one or more body locations selected from the group consisting of the sternum, sacrum, heel, scapularum, elbow, ear, and other fleshy tissues on bony prominences of the patient.

[0298] Embodiment 69. The method of any one of embodiments 61 to 68, wherein multiple ultrasonic echo images are acquired at or around an anatomical site in chronic contact with the medical device.

[0299] Embodiment 70. The method of any one of embodiments 61 to 69, wherein multiple ultrasonic echo images are obtained at or around one or more body locations selected from the group consisting of the cheek, nose, chest, stomach, and lower abdomen.

[0300] Embodiment 71. A method for identifying and treating a patient requiring intervention, comprising: (a) acquiring a plurality of ultrasonic echo images at an anatomical location of the patient; (b) identifying ultrasonic echo characteristics in the plurality of ultrasonic echo images; (c) determining a number of ultrasonic echo characteristics from the plurality of ultrasonic echo images; (d) determining whether the number of ultrasonic echo characteristics exceeds a threshold corresponding to a level N (N is 2 or greater); (e) performing an intervention at the anatomical location if the number of ultrasonic echo characteristics exceeds the threshold; and (f) acquiring a plurality of ultrasonic echo images every two hours if the number of ultrasonic echo characteristics exceeds the threshold.

[0301] Embodiment 72. The method of embodiment 71, wherein the sonic echo characteristic is selected from the group consisting of unclear layered structures, hypoechoic lesions, fascial disruptions, and heterogeneous hypoechoic areas.

[0302] Embodiment 73. The method of embodiment 71 or 72, wherein the sonic echo characteristic is a hypoechoic lesion.

[0303] Embodiment 74. The method of any one of embodiments 71-73, wherein the anatomical site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on bony prominences of the patient.

[0304] Embodiment 75. The method of any one of embodiments 71 to 74, wherein the intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, 30 degree wedges, composite dressings, hybrid mattresses, dynamic mattresses, support surfaces, silicone pads, low friction seat covers, and low friction padded mattress surfaces.

[0305] Embodiment 76. A method for identifying damaged tissue, comprising: (a) acquiring a first ultrasonic echo image from a first location on a patient's skin; (b) acquiring a second ultrasonic echo image from a second location symmetrical to the first location; (c) identifying ultrasonic echo features in each of the first and second ultrasonic echo images; (d) determining a number of ultrasonic echo features from each of the first and second ultrasonic echo images; (e) determining a difference in the number of ultrasonic echo features between the first and second ultrasonic echo images; and (f) determining that tissue damage is present at the first or second location if the difference in the number of ultrasonic echo features between the first and second ultrasonic echo images exceeds a threshold value.

[0306] Embodiment 77. The method of embodiment 76, wherein the sonic echo characteristic is selected from the group consisting of unclear layered structures, hypoechoic lesions, fascial disruptions, and heterogeneous hypoechoic areas.

[0307] Embodiment 78. The method of embodiment 76 or 77, wherein the sonic echo characteristic is fascial disruption.

[0308] Embodiment 79. The method of any one of embodiments 76 to 78, wherein the site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on bony prominences of the patient.

[0309] Embodiment 80. A method for detecting tissue damage before it becomes visible on a patient's skin, comprising the steps of: (a) acquiring multiple ultrasonic echo images at a single location with time differences; (b) identifying ultrasonic echo features in each of the multiple ultrasonic echo images; (c) determining a number of ultrasonic echo features from each of the multiple ultrasonic echo images; (d) calculating a slope between the most recent number of ultrasonic echo features and the immediately preceding number of ultrasonic echo features; (e) comparing the slope to a threshold; and (f) determining that tissue damage is present if the slope exceeds the threshold.

[0310] Embodiment 81. The method of embodiment 80, wherein the sonic echo characteristic is selected from the group consisting of unclear layered structures, hypoechoic lesions, fascial disruptions, and heterogeneous hypoechoic areas.

[0311] Embodiment 82. The method of embodiment 80 or 81, wherein the sonic echo characteristic is fascial disruption.

[0312] Embodiment 83. The method of any one of embodiments 80 to 82, wherein the site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on bony prominences of the patient.

[0313] Embodiment 84. A method for detecting tissue damage before it becomes visible on a patient's skin, comprising the steps of: (a) acquiring multiple ultrasonic echo images at a single location with time differences; (b) identifying ultrasonic echo features in each of the multiple ultrasonic echo images; (c) determining a number of ultrasonic echo features from each of the multiple ultrasonic echo images; (d) calculating a difference value of the maximum number of ultrasonic echo features and the minimum number of ultrasonic echo features for each time difference; (e) calculating a derivative with respect to time of the difference value; (f) comparing the derivative with a threshold; and (g) determining that tissue damage is present if the derivative exceeds the threshold.

[0314] Embodiment 85. The method of embodiment 84, wherein the sonic echo characteristic is selected from the group consisting of unclear layered structures, hypoechoic lesions, fascial disruptions, and heterogeneous hypoechoic areas.

[0315] Embodiment 86. The method of embodiment 84 or 85, wherein the sonic echo characteristic is fascial disruption.

[0316] Embodiment 87. The method of any one of embodiments 84 to 86, wherein the site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on bony prominences of the patient.

[0317] Embodiment 88. A method for detecting tissue damage before it becomes visible on a patient's skin, comprising the steps of: (a) acquiring multiple ultrasonic echo images at a single location with time differences; (b) identifying ultrasonic echo features in each of the multiple ultrasonic echo images; (c) determining a number of ultrasonic echo features from each of the multiple ultrasonic echo images; (d) calculating difference values ​​of a maximum number of ultrasonic echo features and a minimum number of ultrasonic echo features for each time difference; (e) fitting a curve to a predetermined number of most recent difference values; (f) calculating the curvature of the fitted curve; (g) comparing the curvature to a threshold; and (h) determining that tissue damage is present if the curvature exceeds the threshold.

[0318] Embodiment 89. The method of embodiment 88, wherein the sonic echo characteristic is selected from the group consisting of unclear layered structures, hypoechoic lesions, fascial disruptions, and heterogeneous hypoechoic areas.

[0319] Embodiment 90. The method of embodiment 88 or 89, wherein the sonic echo characteristic is fascial disruption.

[0320] Embodiment 91. The method of any one of embodiments 88 to 90, wherein the site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissues on bony prominences of the patient.

[0321] Although the present invention has been described with reference to specific embodiments, those skilled in the art will recognize that various modifications may be made without departing from the scope of the invention and that equivalents may be substituted for its elements. Furthermore, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from its scope. It is therefore intended that the invention not be limited to the particular embodiments disclosed, but rather to include all embodiments coming within the scope and spirit of the appended claims.

Claims

1. 1. An apparatus for producing an acoustic echo image of tissue beneath intact skin of a patient, comprising: a. an emitter configured to emit acoustic waves at an intermediate frequency of approximately 10 MHz when activated; b. a receiver configured to receive returning acoustic vibrations and convert said vibrations into electrical pulses; c. coupled to the receiver; i. receiving an electrical pulse from the receiver; ii. determining the length of time it takes for the sound waves to return; iii. determining the intensity of the returning sound waves; iv. Producing an echo image; A processor configured to: An apparatus comprising:

2. The apparatus of claim 1 , further comprising a display configured to receive the acoustic echo image and present the acoustic echo image.

3. 1. A method for evaluating acoustic echo signatures in tissue beneath intact skin of a patient, comprising: a. emitting acoustic waves into the skin of the patient at a first location; b. receiving a portion of the returning acoustic waves reflected from the tissue; c. determining the length of time it takes for the sound waves to return; d. determining the intensity of the returning sound waves; e. Producing an acoustic echo image; f. acquiring said acoustic echo image; g. obtaining the number and type of one or more acoustic echo characteristics; A method comprising:

4. The method of claim 3 , wherein the one or more echo characteristics are selected from the group consisting of poorly defined laminar structures, hypoechoic lesions, fascial disruptions, and heterogeneous hypoechoic areas.

5. 1. A method for reducing the incidence of wound development in patients admitted to a healthcare facility, comprising: a. assessing a patient for risk of tissue injury upon admission to the healthcare facility; i. acquiring sonic echo images of the patient at one or more body locations at risk for wound development; ii. determining the number of sonic signatures of tissue damage present in the sonic image; and b. implementing a level 0 intervention if the number of acoustic echo signatures present is less than or equal to a first threshold; c. implementing a level N intervention if the number of acoustic echo characteristics present exceeds the first threshold, where N is an integer greater than or equal to 1; A method comprising:

6. The method of claim 5 , wherein the echo characteristics are selected from the group consisting of poorly defined laminar structures, hypoechoic lesions, fascial disruptions, and heterogeneous hypoechoic areas.

7. The method of claim 5 , wherein the acoustic echo characteristic is a smeared layer structure.

8. The method of claim 5 , wherein the sonic echo characteristic is a hypoechoic lesion.

9. The method of claim 5 , wherein the sonic echo characteristic is a fascial disruption.

10. The method of claim 5 , wherein the acoustic echo characteristic is a non-uniform hypoechoic region.

11. The method of any one of claims 5 to 10, wherein the wound is selected from the group consisting of a pressure ulcer, a diabetic foot ulcer, a deep tissue injury, a vascular ulcer, and a burn.

12. 12. The method of any one of claims 5 to 11, wherein the one or more body locations at risk of developing a wound are selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear and other fleshy tissues on bony prominences of a patient.

13. The method of any one of claims 5 to 12, wherein the one or more body locations at risk of developing a wound comprise anatomical sites in prolonged contact with a medical device.

14. The method according to any one of claims 5 to 13, wherein the one or more body areas at risk of developing wounds are selected from the group consisting of the cheeks, nose, chest, stomach and lower abdomen.

15. 15. The method of any one of claims 5 to 14, wherein the Level N intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, a 30 degree wedge, composite dressings, hybrid mattresses, dynamic mattresses, support surfaces, silicone pads, low friction seat covers, and low friction padded mattress surfaces.

16. 1. A method of stratifying a plurality of patients at a healthcare facility based on a level of healthcare care, comprising: a. acquiring an ultrasonic echo image of one of the plurality of patients at one or more body locations selected for monitoring; b. determining whether sonic echo characteristic of tissue damage is present in the sonic echo image; c. determining a level of medical care among the N levels of medical care that corresponds to the number and type of acoustic echo signatures present; d. assigning said level of care to said patient based on step (c); e. placing the patient of the plurality of patients into a group based on a level of medical care assigned to the patient; A method comprising:

17. 17. The method of claim 16, wherein the echo characteristics are selected from the group consisting of poorly defined laminar structures, hypoechoic lesions, fascial disruptions, and heterogeneous hypoechoic areas.

18. 18. The method of claim 16 or 17, wherein the sonic echo characteristic is a fascial disruption.

19. 19. The method of any one of claims 16 to 18, wherein the one or more body locations are selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue on a bony prominence of a patient.

20. The method of any one of claims 16 to 19, wherein the one or more body locations include anatomical sites in chronic contact with a medical device.

21. The method of any one of claims 16 to 20, wherein the one or more body locations are selected from the group consisting of cheek, nose, chest, stomach, and lower abdomen.

22. The method of any one of claims 16 to 21, wherein the step of assigning a level of medical care to the patient is based on the presence or absence of a fascial disruption.

23. 23. The method of any one of claims 16 to 22, wherein the step of assigning a level of medical care to the patient is based on a change in the presence of blurred lamellar structures over a two week period.

24. 1. A method for identifying and providing an appropriate level of medical care to a patient in a medical care facility, comprising: a. acquiring a plurality of ultrasonic echo images of the patient at one or more body locations; b. determining whether sonic echo characteristic of tissue damage is present in said plurality of sonic echo images; c. providing one or more anatomical specific interventions based on the presence or absence of the acoustic echo signature in step (b); d. increasing the level of anatomical specific intervention based on an increasing number of acoustic echo signatures; e. decreasing the level of anatomical specific intervention based on the reduced number of acoustic echo signatures; A method comprising:

25. 25. The method of claim 24, wherein the echo characteristics are selected from the group consisting of poorly defined laminar structures, hypoechoic lesions, fascial disruptions, and heterogeneous hypoechoic areas.

26. 26. The method of claim 24 or 25, wherein the sonic echo characteristic is a fascial disruption.

27. 26. The method of claim 24 or 25, wherein the acoustic echo characteristic is a smeared layered structure.

28. 28. The method of any one of claims 24 to 27, wherein the one or more body locations are selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue on a bony prominence of a patient.

29. The method of any one of claims 24 to 28, wherein the one or more body locations include anatomical sites in chronic contact with a medical device.

30. 30. The method of any one of claims 24 to 29, wherein the one or more body locations are selected from the group consisting of cheek, nose, chest, stomach, and lower abdomen.

31. 31. The method of any one of claims 24 to 30, wherein the anatomical specific intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, a 30 degree wedge, composite dressings, hybrid mattresses, dynamic mattresses, support surfaces, silicone pads, low friction seat covers, and low friction padded mattress surfaces.

32. The method according to any one of claims 24 to 31, wherein the level of anatomical specific intervention is increased if the number of acoustic echo characteristics exceeds a first threshold.

33. The method of any one of claims 24 to 32, wherein the level of anatomical specific intervention is reduced if the number of acoustic echo characteristics falls below a second threshold.

34. 1. A method for assigning a patient of a healthcare facility to a risk category selected from a plurality of risk categories, comprising: a. acquiring a plurality of initial ultrasonic echo images of the patient at one or more body locations selected for monitoring; b. determining whether an acoustic echo signature is present in the plurality of acoustic echo images; c. assigning the patient to a risk category selected from the plurality of risk categories based in part on the presence or absence of an echo signature in step (b); A method comprising:

35. 35. The method of claim 34, wherein the echo characteristics are selected from the group consisting of poorly defined laminar structures, hypoechoic lesions, fascial disruptions, and heterogeneous hypoechoic areas.

36. 36. The method of claim 34 or 35, wherein the sonic echo characteristic is a fascial disruption.

37. 36. The method of claim 34 or 35, wherein the acoustic echo characteristic is a smeared layered structure.

38. 38. The method of any one of claims 34 to 37, wherein the one or more body locations selected for monitoring are selected from the group consisting of: sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue on a bony prominence of a patient.

39. The method of any one of claims 34 to 38, wherein the one or more body locations selected for monitoring include anatomical sites in chronic contact with a medical device.

40. 40. The method of any one of claims 34 to 39, wherein the one or more body locations selected for monitoring are selected from the group consisting of cheek, nose, chest, stomach, and lower abdomen.

41. 1. A method of managing medical care for a patient in a medical care facility, comprising: a. acquiring a plurality of first ultrasonic echo images of the patient upon admission to a healthcare facility at one or more body locations selected for monitoring; b. determining whether an acoustic echo characteristic is present in the first plurality of acoustic echo images; c. if the number of acoustic echo characteristics present exceeds a first threshold, setting an intervention level N=1; d. performing a level N intervention for each of the one or more body locations where a number of acoustic echo characteristics exists above the first threshold; e. acquiring a plurality of subsequent ultrasonic echo images at each of said one or more body locations at a frequency level N; f. determining whether new acoustic echo features are present in said plurality of subsequent acoustic echo images; A method comprising:

42. 42. The method of claim 41, wherein the echo characteristics are selected from the group consisting of poorly defined laminar structures, hypoechoic lesions, fascial disruptions, and heterogeneous hypoechoic areas.

43. 43. The method of claim 41 or 42, wherein the sonic echo characteristic is a fascial disruption.

44. 43. The method of claim 41 or 42, wherein the acoustic echo characteristic is a smeared layered structure.

45. 45. The method of any one of claims 41 to 44, wherein the body locations selected for monitoring are selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue on bony prominences of the patient.

46. The method of any one of claims 41 to 45, wherein the body locations selected for monitoring include anatomical sites in chronic contact with a medical device.

47. The method of any one of claims 41 to 46, wherein the body locations selected for monitoring are selected from the group consisting of cheek, nose, chest, stomach, and lower abdomen.

48. 48. The method of any one of claims 41 to 47, wherein the Level N intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, a 30 degree wedge, a composite dressing, a hybrid mattress, a dynamic mattress, a support surface, a silicone pad, a low friction seat cover, and a low friction padded mattress surface.

49. 1. A method for identifying and treating a patient at risk for tissue damage, comprising: a. assessing a patient for risk of tissue injury upon admission to a healthcare facility; i. acquiring a first plurality of ultrasonic echo images of the patient; ii. determining a first number of acoustic echo features present in the first plurality of acoustic echo images; and b. performing a first intervention at level 0 if the first number of present acoustic echo signatures is less than or equal to a first threshold; c. performing a first intervention of level N, where N is an integer equal to or greater than 1, if the first number of present acoustic echo characteristics exceeds the first threshold; A method comprising:

50. acquiring a second plurality of ultrasonic echo images of the patient at a first predetermined frequency corresponding to the level of intervention performed; b. determining a second number of acoustic echo features present in the second plurality of acoustic echo images; c. determining whether a second number of the acoustic echo characteristics exceeds a second threshold; d. continuing to perform the first intervention if the second number of present acoustic echo characteristics does not exceed the second threshold; e. continuing to acquire a plurality of acoustic echo images at the first predetermined frequency if the second number of acoustic echo characteristics present does not exceed the second threshold; f. performing a second intervention at level M, where M is an integer greater than N, if the second number of acoustic echo characteristics present exceeds the second threshold; g. acquiring a third plurality of acoustic echo images at a predetermined frequency corresponding to a level M if the second number of acoustic echo characteristics present exceeds the second threshold; 50. The method of claim 49, further comprising:

51. determining whether a second number of the acoustic echo features present is less than or equal to a third threshold; b. continuing to perform the first intervention if the second number of present acoustic echo signatures is greater than or equal to a third threshold; c) continuing to acquire a plurality of acoustic echo images at the first predetermined frequency if the second number of acoustic echo characteristics present is greater than or equal to the third threshold; d. performing a third intervention of level L, where L is an integer less than N, if the second number of acoustic echo characteristics present is less than the third threshold and the first intervention is not level 0; e. if the second number of acoustic echo characteristics present is less than a third threshold, acquiring a plurality of acoustic echo images at a predetermined frequency corresponding to a level L; 51. The method of claim 49 or 50, further comprising:

52. 52. The method of any one of claims 49 to 51, wherein the Level N first intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, a 30 degree wedge, a composite dressing, a hybrid mattress, a dynamic mattress, a support surface, a silicone pad, a low friction seat cover, and a low friction padded mattress surface.

53. 53. The method of any one of claims 50 to 52, wherein the Level M second intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, a 30 degree wedge, a composite dressing, a hybrid mattress, a dynamic mattress, a support surface, a silicone pad, a low friction seat cover, and a low friction padded mattress surface.

54. 54. The method of any one of claims 51 to 53, wherein the level L tertiary intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, a 30 degree wedge, a composite dressing, a hybrid mattress, a dynamic mattress, a support surface, a silicone pad, a low friction seat cover, and a low friction padded mattress surface.

55. 55. The method of any one of claims 49 to 54, wherein the sonic echo characteristic is selected from the group consisting of poorly defined layered structures, hypoechoic lesions, fascial disruptions, and heterogeneous hypoechoic areas.

56. 56. The method of any one of claims 49 to 55, wherein the sonic echo characteristic is fascial disruption.

57. A method according to any one of claims 49 to 55, wherein the acoustic echo characteristic is a smeared layered structure.

58. 58. The method of any one of claims 49-57, wherein the first plurality of ultrasonic echo images are acquired at or about one or more body locations selected from the group consisting of: sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue on a bony prominence of a patient.

59. 59. The method of any one of claims 49 to 58, wherein the first plurality of acoustic echo images are acquired at or about an anatomical site in chronic contact with a medical device.

60. 60. The method of any one of claims 49 to 59, wherein the first plurality of ultrasonic echo images are acquired at or about one or more body locations selected from the group consisting of cheek, nose, chest, stomach, and lower abdomen.

61. 1. A method of slowing the progression of skin and tissue damage in a patient in need thereof, comprising: a. identifying a current level K intervention to be received by said patient; b. acquiring a plurality of ultrasonic echo images of the patient; c. identifying acoustic echo characteristics in the plurality of acoustic echo images; d. determining a first number of acoustic echo features present in the plurality of acoustic echo images; e. continuing to implement the current level K intervention if the first number of acoustic echo characteristics is less than or equal to a first threshold; f. if the first number of the acoustic echo characteristics is less than or equal to the first threshold, continuing to acquire a plurality of acoustic echo images at a predetermined frequency corresponding to a level K; g. implementing a new level N of intervention if the number of acoustic echo characteristics exceeds the first threshold, N being greater than K; h) acquiring a plurality of acoustic echo images at a predetermined frequency corresponding to a level N if the number of acoustic echo characteristics exceeds the first threshold; A method comprising:

62. a. determining whether a first number of the acoustic echo characteristics present is less than a second threshold; b. performing an intervention of level L, where L is a non-negative value less than K, if the first number of acoustic echo characteristics is less than a second threshold; c) acquiring a plurality of acoustic echo images at a predetermined frequency corresponding to a level L if the first number of the acoustic echo characteristics is less than the second threshold value; 62. The method of claim 61, further comprising:

63. 63. The method of claim 61 or 62, wherein the echo characteristics are selected from the group consisting of unclear layered structures, hypoechoic lesions, fascial disruptions, and heterogeneous hypoechoic areas.

64. 63. The method of claim 61 or 62, wherein the sonic echo characteristic is a fascial disruption.

65. 63. The method of claim 61 or 62, wherein the acoustic echo characteristic is a smeared layered structure.

66. 63. The method of claim 61 or 62, wherein the sonic echo characteristic is a hypoechoic lesion.

67. 63. The method of claim 61 or 62, wherein the acoustic echo characteristic is a heterogeneous hypoechoic region.

68. 68. The method of any one of claims 61-67, wherein the plurality of ultrasonic echo images are acquired at or around one or more body locations selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue on a bony prominence of a patient.

69. 69. The method of any one of claims 61 to 68, wherein the plurality of ultrasonic echo images are acquired at or about an anatomical site in chronic contact with a medical device.

70. 70. The method of any one of claims 61 to 69, wherein the plurality of ultrasonic echo images are acquired at or about one or more body locations selected from the group consisting of cheek, nose, chest, stomach, and lower abdomen.

71. 1. A method for identifying and treating a patient in need of an intervention, comprising: a. acquiring a plurality of ultrasonic echo images at an anatomical location on the patient; b. identifying acoustic echo characteristics in the plurality of acoustic echo images; c. determining a number of acoustic echo features from the plurality of acoustic echo images; d. determining whether the number of acoustic echo characteristics exceeds a threshold corresponding to a level N, where N is 2 or greater; e. performing the intervention at the anatomical site if the number of acoustic echo signatures exceeds the threshold; f. if the number of said sonic echo features exceeds said threshold, acquiring a plurality of sonic echo images every two hours; A method comprising:

72. 72. The method of claim 71, wherein the echo characteristics are selected from the group consisting of unclear layered structures, hypoechoic lesions, fascial disruptions, and heterogeneous hypoechoic areas.

73. 73. The method of claim 71 or 72, wherein the sonic echo characteristic is a hypoechoic lesion.

74. 74. The method of any one of claims 71-73, wherein the anatomical site is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue over a bony prominence of a patient.

75. 75. The method of any one of claims 71 to 74, wherein the intervention is selected from the group consisting of heel boots, barrier creams, neuromuscular stimulation, topical creams, ultrasound therapy, shock wave therapy, a 30 degree wedge, a composite dressing, a hybrid mattress, a dynamic mattress, a support surface, a silicone pad, a low friction seat cover, and a low friction padded mattress surface.

76. 1. A method for identifying damaged tissue, comprising: a. acquiring a first acoustic echo image from a first location on the patient's skin; b. acquiring a second acoustic echo image from a second location that is bilaterally symmetrical to the first location; c. identifying acoustic echo characteristics in each of the first and second acoustic echo images; d. determining a number of acoustic echo features from each of the first and second acoustic echo images; e. determining a difference in a number of acoustic echo features between the first acoustic echo image and the second acoustic echo image; f. determining that tissue damage is present at the first location or the second location if a difference in a number of acoustic echo features between the first acoustic echo image and the second acoustic echo image exceeds a threshold; A method comprising:

77. 77. The method of claim 76, wherein the echo characteristics are selected from the group consisting of poorly defined layered structures, hypoechoic lesions, fascial disruptions, and heterogeneous hypoechoic areas.

78. 78. The method of claim 76 or 77, wherein the sonic echo characteristic is a fascial disruption.

79. 79. The method of any one of claims 76-78, wherein the location is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue on a bony prominence of the patient.

80. 1. A method for detecting tissue damage before it becomes visible on a patient's skin, comprising: a. acquiring multiple time-staggered acoustic echo images at a single location; b. identifying acoustic echo characteristics in each of the plurality of acoustic echo images; c. determining a number of acoustic echo features from each of the plurality of acoustic echo images; d. calculating a slope between the most recent number of acoustic echo characteristics and the immediately preceding number of acoustic echo characteristics; e. comparing the slope to a threshold; f. determining that tissue damage is present if the slope exceeds the threshold; A method comprising:

81. 81. The method of claim 80, wherein the echo characteristics are selected from the group consisting of unclear layered structures, hypoechoic lesions, fascial disruptions, and heterogeneous hypoechoic areas.

82. 82. The method of claim 80 or 81, wherein the sonic echo characteristic is a fascial disruption.

83. 83. The method of any one of claims 80-82, wherein the location is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue on a bony prominence of the patient.

84. 1. A method for detecting tissue damage before it becomes visible on a patient's skin, comprising: a. acquiring multiple time-staggered acoustic echo images at a single location; b. identifying acoustic echo characteristics in each of the plurality of acoustic echo images; c. determining a number of acoustic echo features from each of the plurality of acoustic echo images; d. calculating a difference value between the maximum number of sonic echo features and the minimum number of sonic echo features for each time difference; e) calculating the derivative with respect to time of said difference value; f. comparing said derivative to a threshold; g. determining that tissue damage is present if the derivative exceeds the threshold; A method comprising:

85. 85. The method of claim 84, wherein the sonic echo characteristic is selected from the group consisting of poorly defined layered structures, hypoechoic lesions, fascial disruptions, and heterogeneous hypoechoic areas.

86. 86. The method of claim 84 or 85, wherein the sonic echo characteristic is a fascial disruption.

87. 87. The method of any one of claims 84-86, wherein the location is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue on a bony prominence of the patient.

88. 1. A method for detecting tissue damage before it becomes visible on a patient's skin, comprising: a. acquiring multiple time-staggered acoustic echo images at a single location; b. identifying acoustic echo characteristics in each of the plurality of acoustic echo images; c. determining a number of acoustic echo features from each of the plurality of acoustic echo images; d. calculating a difference value between the maximum number of sonic echo features and the minimum number of sonic echo features for each time difference; e. fitting a curve to a predetermined number of most recent difference values; f. Calculating the curvature of the fitted curve; g. comparing said curvature to a threshold; h. determining that tissue damage is present if the curvature exceeds the threshold; A method comprising:

89. 90. The method of claim 88, wherein the sonic echo characteristic is selected from the group consisting of poorly defined layered structures, hypoechoic lesions, fascial disruptions, and heterogeneous hypoechoic areas.

90. 90. The method of claim 88 or 89, wherein the sonic echo characteristic is a fascial disruption.

91. 91. The method of any one of claims 88-90, wherein the location is selected from the group consisting of the sternum, sacrum, heel, os latum scapularum, elbow, ear, and other fleshy tissue on a bony prominence of the patient.

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