Pressure ulcers, also known as decubitus ulcers or bedsores, are a common problem in any situation where patients are compromised because of immobility, nutrition, incontinence, or age. Each year, more than 2.5 million people in the United States develop pressure ulcers, which cost approximately $10 billion or between $20,000 and $150,000 to treat per wound dependent upon the severity. Further, these wounds are very painful, are the subject of 17,000 law suits annually and are considered preventable.

The formation of a pressure ulcer or deep tissue injury starts when tissue is deprived of oxygen and nutrients, this normally occurs immediately adjacent to a bony prominence and can be seen ultrasonically as the formation of fluid in the subcutaneous tissue. This is followed by dermal and sub-epidermal edema as the injury progresses.

The EPISCAN's ability to visualize down to the bony prominence and detect these subtle changes prior to any alteration to the skin’s surface being seen is used in the early detection of deep tissue injury. This ability enables clinicians to initiate earlier intervention, greatly improving the chances that the injury will be resolved without an open wound developing. By scanning a patient on admission, the clinician can also better document any anatomical sites at risk of breakdown at the time of admission.

EPISCAN being used to scan a heel

Stage 3 and 4 pressure ulcers are one of the conditions that CMS now classify as never events, meaning they should never happen. CMS announced in 2007 that certain hospital-acquired conditions would no longer be covered by Medicare ad Medicaid.  One of these conditions is pressure ulcers.  This rule change is forcing clinicians to put greater emphasis on pressure ulcer prevention in hospitals. In this regard, the EPISCAN can help hospitals in two ways; it can determine if the patient has come into the hospital with a pre-existing condition such as deep tissue injury, and in circumstances where the injury originates in the hospital, it provides a means of earlier detection leading to prevention.

The FY 2014 hospital payment rule finalizes the general framework for the Hospital-Acquired Condition (HAC) Reduction Program for the FY 2015 implementation.  Section 3008 of the Affordable Care Act requires CMS to establish a program for IPPS hospitals to improve patient safety, by imposing financial penalties on hospitals that perform poorly with regard to hospital-acquired conditions. 

Patient care suffers from incomplete, inaccessible and inconsistent use of pressure ulcer assessment and treatment plans. The ruling will serve to improve patient care and communication among health care providers.  This can also provide transparency and needed information for patients and caregivers. An additional benefit to the health system is an avenue to develop quality surveillance and initiatives.

The EPISCAN can be used to improve communications between the clinical team and the patient and / or their relatives. With abnormality found presented together with the plan being implemented to prevent the condition worsening, such communications have been found to reduce the risk of future litigation.

Tissue damage caused by friction or pressure can be readily separated, with the former starting at the epidermis and the latter deep as shown below.

The EPISCAN can be a valuable tool in the assessment of all types of chronic wounds and can be used in the following ways:

Visualization of tissue beneath the wound and edema

Up until now the caregiver could only visually assess the surface of a wound. The EPISCAN allows the user to look at tissue beneath the wound to see what is occurring. It can aid treatment decisions by helping to determine how deep the wound penetrates, the quality of the tissue beneath the wound, and visualize edema which can be a prime reason for slow healing. The EPISCAN is the perfect tool to monitor changes to tissue structure and the effectiveness of treatments.

Visualization of wound undermining and tract formation

It is common for wounds to undermine under the skin expanding much wider than the wound surface. The EPISCAN allows the user to image the peri-wound area to see if undermining is occurring. This can change the treatment regime and require more aggressive debridement or packing of the wound. The EPISCAN can also visualize sinus tracts whose presence may necessitate more aggressive treatments. This may also alert the healthcare provider to the possibility of ostoemyelitis which may warrant further diagnostic testing.

Wound Image showing Tracking Down to the Bone

Visualization of foreign bodies

There are times where there are foreign bodies within the wound tissue. This could be suture or various other structures. Examining the wound with the EPISCAN could help identify these foreign bodies and also help navigate the clinician to the exact location to aid in their removal.

Documentation of effectiveness of wound treatments

It is extremely important to document wound appearance, treatment, and outcome as documentation aides in appropriate continuity of care and positive clinical outcomes. The EPISCAN is an excellent assessment tool for this documentation.

The above image sequence shows the healing of a chronic wound. “Wound Day 1” shows the wound at its worst and by “2 months” the tissue is returning to a condition approaching “Normal”.

HRUS Image of Normal Skin

The EPISCAN produces high resolution images of the skin and superficial soft tissue to a vertical resolution of about 40 microns. The different layers of the epidermis and dermis can be visualized and distinguished. Subcutaneous structures can be identified and structures like tendon, blood vessels and ligaments are seen at a microscopic level. Each tissue has its own reflective quality giving it its unique appearance on the screen. Pathology such as edema and foreign bodies are of a different reflective quality, separating them from the surrounding tissue.

The scans should be read from the top down. They should be pictured as a non-invasive biopsy starting from the surface of the skin and continuing down to the selected depth. The intensity of the reflections is an indication of the density of the tissue. The intensity will also be affected by the reflective quality of the surrounding tissue. In other words if there is fluid above a structure the reflection off that tissue will be greater than if there were more dense tissue above it. The top reflection or entrance reflection is always intense because of the contrast between it and the ultrasound gel.

Skin

Ultrasound image of the skin exhibits very characteristic patterns. The top reflection off the epidermis is a strong reflection. This represents the stratum corneum. Directly beneath this hard reflection is a very much less reflective are that represents the stratum malpighii or area of living cells of the epidermis. Directly beneath this is the papillary layer of the dermis. This shows a homogenous pattern of moderately dense structure. The reticular layer of dermis is beneath the papillary layer. It has a slightly greater density with small highly reflective strips throughout. The dermis may have several lucent areas passing through it. These represent hair follicles or glandular structures.

Image of Abdomen

Directly below the dermis is a hard reflection that represents the dermal-hypodermal boundary. This reflection will be greater in thin skin than in thicker skin. The reason for that is that thicker skin is less mobile and is more firmly attached to the hypodermal tissue making this interface more gradual and therefore acoustically less distinct.

Subcutaneous tissue (Hypodermis): The reflective patterns of the deeper tissue will vary by the anatomy found in the imaged area. Structures such as blood vessels, glands, fascia and adipose tissue can be identified. Generally the deep fascia can be identified below a layer of subcutaneous tissue.

Deeper Tissue

Many structures can be identified in the deeper tissue. Tendons and ligaments can be imaged in both longitudinal and cross section. Nerves can also be distinguished as well as blood vessels. The bone/soft tissue interface can also be seen. Edema is easy to distinguish from normal tissue because of the marked difference in reflective quality of fluid with normal tissue.

EPISCAN Images showing a Tendon and Blood Vessels

The EPISCAN is finding use in a wide range of research, testing and product validation activities not only in the wound and dermatology applications described but also in many other fields. The skin is not only impacted directly by many conditions, diseases and injuries but as the body's largest organ the skin is often an early indicator of other issuers. For example preliminary links has been shown between the skin thickness and bone fracture risk, both being impacted by collagen density, between wound healing rates and psychological  stress and the impact of HRT being reflected in skin thickness changes for women. The skin can also be effected by medications directed at other regions of the body, for example steroids thin the skin.

Research with the EPISCAN has been conducted on humans in vitro and in vivo and with a variety of animals ranging from mice right up to horses.

Human Skin	Pig Skin	Mouse Skin

 The above of images of human, pig, and mouse skin captured with a 35MHz probe show the similarities and differences in their skin. Note there is no measurable subcutaneous tissue (fat) in the pig skin below the dermis which goes to about the 4mm depth marker; while the mouse dermis is about half the thickness.

Image Analysis

The EPISCAN offers a range of tools to assess images captured.  Simple linear measurements can be performed as illustrated immediately below, which shows the increased dermal thickness around a filler.

The EPISCAN allows the user to view and export any A-scan line from the normally viewed B-scan image. This is illustrated below with the A-Scan associated with the line marked A on the image below being shown to the right.

The EPISCAN also provides the user with the means to compare the makeup of the reflected signals that is used to create the images.

Intensity distribution plots for a dermal filler (blue line) and adjacent normal tissue (pink line) are shown in the figure to the right. The plot for the filler shows more of the signal having higher intensity; suggesting that the filler is denser and /or less homogeneous than normal tissue.

As the filler dissipates the distribution plot would be expected to progress towards that for the normal tissue.

It is further possible to determine numerical values from the intensity distribution graphs. From the two plots shown on the previous slide the following values were obtained.

In the example below the same analysis is performed on a skin lesion and an adjacent area of normal tissue as marked on the image, the analysis is shown on the plots to the right below.

Unlike tissue damaging biopsies HRUS can capture a series of images from the same location thus changes in tissue characteristic with time can be monitored. This ability has been used to assess the effectiveness of wound healing dressings and therapies and aesthetic procedures.

The above image sequence shows the healing of a chronic wound. “Wound Day 1” shows the wound at its worst and by “2 months” the tissue is returning to a condition approaching “Normal”. Using the ability to capture a series of images from the same location the impact of wound healing products can be assessed.

Chronic Wounds are a major worldwide health care problem, in the US they affect 2% of the population, are reported to cost $50 billion per annum, and give rise to a great deal of suffering. With many of the factors that influence the various wound types (diabetes, aging population, obesity, etc.) impacting a growing percentage of the population, the expectancy is that wounds will become an even greater problem in the future.

The EPISCAN is a valuable tool in the prevention and assessment of chronic wounds. It allows the user to look beneath the surface of both existing wounds and at risk intact skin to visualize subtle changes in soft tissue that cannot be seen by visual assessment. This HRUS data, when combined with visual assessment and patient history information can lead to better and earlier assessment of a wound or potential wound.

The EPISCAN can also be used as a powerful communications tool to patients and their relatives, resulting in better compliance and appreciation of their condition and the treatment being provided.

Importantly the EPISCAN can be used to monitor the progression of wounds and the impact a treatment modality by repeat scanning and this ability also enables patient specific treatments to be developed.

The above EPISCAN image sequence shows the healing of a chronic wound. “Wound Day 1” shows the wound at its worst and by “2 months” the tissue is returning to a condition approaching “Normal”

In addition to the assessment and prevention of chronic wounds the EPISCAN can also be used to assess acute wounds including burns and the effectiveness of treatment on scars.

EPISCAN image of Skin showing Hair Follicles

High frequency ultrasound can provide both qualitative and quantitative data in the whole arena of aesthetics and plastic surgery.  Tests have shown that the impact of treatment such as laser skin rejuvenation can be detected earlier with ultrasound, and the technology can validate new devices and treatments.  The EPISCAN enables clinicians and patients to see the impact of treatments often before visual signs are apparent.  Further, Longport’s scanner can be a powerful marketing tool for any aesthetics center, as they are able to show the impact of treatments in a new way and retain records for future visits.

Tracking and analyzing the effects of skin care products and procedures through high-resolution digital ultrasound imaging of the human skin is an exciting and dynamic technology that promises to transform the skin care industry!

Cosmeceuticals

The demand for cosmeceuticals in the US will increase 7.4 percent annually through 2016, driven by an aging population seeking to maintain the appearance of youth. Antioxidants will remain the largest chemical category while botanicals and enzymes stay among the best opportunities. Injectables and skin care products will register the fastest growth.

These images, which show changes resulting from an interdermal injection, help to monitor the effectiveness of therapy and provide evidence to the client the impact the procedure had on their skin. When such treatments are in the form of injectables, the EPISCAN can guide the clinician to the targeted dermal plane.

HRUS can similarly image fillers and implants.

Cellulite

Cellulite is fatty deposit causing a dimpled or uneven appearance, as around the thighs and buttocks. It occurs almost exclusively in women.

High Frequency Ultrasound
Image of Cellulite

While harmless, the dimpled appearance is a cause of concern for some people. The cosmetics industry claims to offer many of what it calls remedies. Remedies include various applications of lotions, laser and other light treatments, radio frequency energy, liposuction as well as diet and exercise; all which act on fatty and connective tissue. All methods require continual follow-up to maintain reduced levels of cellulite.

The EPISCAN can image cellulite and monitor the effectiveness of treatments.

Chemical Peels, Facials and Electrotherapeutic procedures

The EPISCAN is currently being used to evaluate the impact of various skin rejuvenating treatments.

Collagen formation, an important aspect of anti-wrinkle treatments, can be visualized at an early stage (prior to visual indications) following treatment, and fat thickness can be measured quickly and accurately. HRUS can visually scan, track, and prove a product’s ability to penetrate into the dermal layers of the skin.  The ultrasound scan can provide an image that reveals an increase in hydration, fiber plumpness, and progressive activation in collagen production.

Note the increase thickness of the dermis in the sun exposed image also, the reduced intensity of reflections from the upper, papillary, region of the dermis in the sun exposed area, indicating a weaker collagen structure.

Image Analysis

In addition to providing clinicians with clear high resolution images of the skin Longport is developing algorithms to numerically represent changes in skin structure. These techniques are described more fully in the Research section of this site.

		No Sun	Sun Exposed
	Median Intensity	24	14
	Mean	0.314	0.179
	Variance	0.126	0.072
	Relative Dispersion (%)	88.55	66.62

High resolution ultrasound can be used to image scars, acne and other skin conditions such as eczema and psoriasis and the impact of treatments.  These are also discussed in the Dermatology section of this site.

Image of skin through to muscle

The EPISCAN is able to image the human skin to very high resolution and to differentiate between subtle changes in tissue structure. Such information is only obtained otherwise by tissue damaging biopsies. Thus the EPISCAN is an ideal tool for dermatologists to assess various conditions and diseases, determine the effectiveness of treatments, and to help plan surgery.

High resolution image of dermis, showing hair follicles

Skin Cancers

Images of different skin lesions

High frequency ultrasound (HRUS) can be used to map and determine margins of skin lesions; providing input into surgical planning.  This can be utilized in two ways; when applied to Mohs surgery, it can be used to reduce the number of surgical sections needed to clear the margins of a lesion, leading to better utilization of clinician’s time and facilities, reduce costs and lessen patient discomfort. When applied to conventional surgery, it will increase the probability that lesion margins are cleared, thus reducing the probability of tumor reoccurrence. Dependent upon the tumor size and type, the probability of a lesion reoccurring at an excision site is between 50 and 90% within a five year period.

The ability of the EPISCAN to better determine margin can also help optimize the parameters for non-surgical interventions such as photo dynamic therapy (PDT) and radiation treatments.

HRUS can also be used following all procedures to verify the lesion has been cleared.

Lesion imaged with depth measured

One determining factor on whether or not a pigmented feature is potentially malignant melanoma or merely a superficial skin discoloration is its depth of penetration. HRUS can accurately map skin lesions, including their depth. Therefore HRUS can provide dermatologists with a rapid non invasive screening tool for the early assessment of pigmented features and lessen the incidence of unnecessary biopsies.

Other Skin Conditions

The EPISCAN can image many other skin disorders such as psoriasis, eczema and acne and the effectiveness of treatments. Similarly, scars including keloids, can be imaged and the impact of treatments assessed.

Surgical scar

Stretch mark

In addition to imaging the skin high frequency ultrasound can be used to image nails and nail beds.

The skin although subject to many diseases, conditions and injuries has not been well catered for by imaging technology, beyond tissue damaging biopsies and subsequent histology. The EPISCAN is allowing clinicians and researchers working in applications such as wound care and prevention, aesthetics and dermatology to non-invasively image soft tissue structures with the resolution and ease of use needed in a clinical environment.

Above Left: Conventional Ultrasound Image of Fetus

Above Right: EPISCAN Image of the Skin

The dotted lines between the images show the comparative zoom factor between the images, with 5mm being the smallest marked distance on the conventional image, but is the whole EPISCAN image. (Note that these images are not of the same subject).

The EPISCAN is an ultrasound imaging tool, but is differentiated from conventional ultrasound systems by its resolution. We can image a hair follicle within the human skin while conventional ultrasound often can't see the skin at all.

The EPISCAN cannot image as deep as conventional ultrasound and is designed to image the first 15mm or so of soft tissue. This region accounts for some $55 billion of expenditure in the USA alone each year.

The imaging capability of the EPISCAN is finding application in:

• Wounds (Assessment and Prevention)
• Dermatology
• Aesthetics
• And a broad range of Research activities

Ultrasound has been utilized in medicine since the 1950’s with the range of applications for this modality significantly expanding as improved image quality, faster data processing and system miniaturization have been utilized. The evolution of ultrasound imaging and the introduction of other imaging technologies have, however, not addressed the imaging requirements of the surface of the body, despite this region being the subject of many diseases, injuries and procedures that cost $55 billion in the USA alone each year. For the skin and immediately underlying soft tissue a combination of very high resolution imaging and the ability to see subtle changes in soft tissue characteristics is required. Systems addressing this need also have to be affordable to the clinical groupings associated with dermatology, wound care, aesthetics, etc. and be user friendly.

The EPISCAN System

Longport has developed an ultrasound imaging technology to addresses these requirements: the EPISCAN I-200.

This EPISCAN utilizes broadband ultrasound at frequencies from 20 to 50MHz to image the skin and underlying soft tissue. The system is primarily digital in design, enabling flexible and cost effective data processing and presentation. The ultrasound data is digitalized in real time at rates up to 200MSPS (200 million samples per second) allowing the capture of the maximum amount of information. A series of interchangeable probes provide the user with a range of imaging options. These probes provide the user with a range of imaging depths and resolutions.

Longport's software operates under a Windows environment providing the user with a comprehensive, but user friendly interface.

EPISCAN Screen showing two images of skin lesions

Features of the EPISCAN's software include:

• Multiple images can be tiled on the scanner screen allowing the progression of conditions or different scan sites to be readily compared;
• Measurements, including linear and area measurements can be performed and stored onto images.
• Image assessment techniques such as pixel intensity distribution can be undertake;
• A-Scans can be viewed and exported;
• A range of palettes - grey scale and color can be applied to the images;
• An integrated relational database enables images and other data, including digital photographs, to be stored and retrieved in a patient-orientated manner;
• When scanning, the images are retained in "memory loop" enabling the user to review a series of images at the conclusion of the scanning process and to select what images should be stored.

The probe is the principle component of the scanner as it both produces and receives the sound waves. Ultrasound probes come in a variety of frequencies which is measured in megahertz (MHz). The higher the frequency, the higher the image resolution is achieved. However, the higher the frequency the less penetration of tissue is achieved. The ideal situation therefore is to use the highest frequency possible to achieve penetration to the area of interest. Typical diagnostic ultrasound for fetal imaging is around 3.5 to 7 MHz, while the EPISCAN uses probes in the range 20 to 50MHz.

This high frequency ultrasound used and resultant high resolution images enables Longport to designate the EPISCAN as a high resolution ultrasound system or HRUS, thus enabling the detail imaging of the layers of the skin and subcutaneous tissue, as shown on the right.

The processed images are displayed onto the EPISCAN's monitor. Different palettes can be used to maximize the information on the screen. Once displayed, items of interest can be labeled and measured and the image stored for future reference.

The EPISCAN can be connected to a network via cable or wireless means enabling data captured to be backed-up or shared with other clinicians within the facility or remotely. Thus the EPISCAN is compatible with telemedicine use including DICOM configured systems. A DVD ROM also enables data to be backed-up or transferred as does access to USB ports.

The EPISCAN can be readily taken to the patient's bedside via an optional cart. An optional medical grade UPS enables the system to remain powered up when being transferred between patients beds, thus optimizing system utilization.

A full system specification is available from the downloads section of this website.

The EPISCAN is a high resolution ultrasound (HRUS) imaging system that utilizes ultrasound at frequencies as high as 50 MHz to image the skin and underlying soft tissue. The system has been designed to provide users with images of very high resolution and clarity and offers a user friendly interface enabling the EPISCAN to be utilized in broad range of clinical applications as well as in research and development. The EPISCAN enables the examination of tissue at a microscopic level without the need to perform damaging biopsies.

The high imaging resolution of the EPISCAN differentiates it from main stream ultrasound imaging systems, which offer deeper imaging capability, but substantially less resolving capability than the EPISCAN. Subtle changes in thickness, density and fluid content can be clearly appreciated. This information can be utilized for a number of reasons. The human skin is the largest organ of the body. Pathology like chronic wounds, burns, skin cancers and skin lesions are very common. Also, the skin is affected by a number of systemic diseases making it a great indicator of these afflictions. High resolution ultrasound images provide the clinician with detailed anatomical information that can lead to better and more accurate treatments.

The EPISCAN has gained FDA marketing clearance and a CE mark. Our FDA clearance K062571 is summarized by the following statement.

The EPISCAN I-200 high-resolution ultrasound system is a specialized system for imaging the skin and underlying soft tissue. It is intended for use by clinicians, or under the direction of physicians for imaging and analysis in research environments as well as clinical settings including medical / surgical dermatology assessment and diagnosis (aesthetic and therapeutic), plastic / reconstructive surgical planning, wound assessment and management, skin assessment for pressure ulcer detection and prevention and superficial musculoskeletal diagnosis.

For more specific information on the EPISCAN I-200 and accessories, view our Technology.

Reimbursement for Hospital-Acquired Pressure Ulcers to Cease

CMS Ruling

On August 1, 2007, the Department of Health & Human Services, Centers for Medicare & Medicaid Services (CMS), announced a series of changes to the hospital inpatient prospective payment system (IPPS). These included identifying seven hospital-acquired conditions that Medicare and Medicaid will no longer pay for. One of these conditions is pressure ulcers. This rule change will take effect beginning October, 2008.

Significance to Longport

These changes have been widely reported in the media and are expected to benefit Longport’s efforts in getting the Company’s EPISCAN I-200 ultrasound scanner accepted in hospitals for use in pressure ulcer prevention. In an announcement dated September 20, 2007, Paul Wilson, President of Longport, Inc. commented, “This rule change is forcing clinicians to put greater emphasis on pressure ulcer prevention in hospitals and is expected to open up major new opportunities for Longport’s EPISCAN ultrasound scanner. In this regard, the EPISCAN can help hospitals in two ways; it can determine if the patient has come into the hospital with a pre-existing condition such as deep tissue injury, and in circumstances where the injury originates in the hospital, it provides a means of earlier detection leading to prevention.”

Media Coverage

The CMS ruling has attracted broad media coverage:

On September 5, 2007, the Wall Street Journal posted an article stating “Hospitals Combat Dangerous Bedsores”.  This article explains how “Hospitals around the country are scrambling to put in place new programs to prevent pressure ulcers” as a result of the CMS rule change. The article identifies ultrasound as a new technique to help assess skin for underlying tissue damage. The articles goes on to state that 60,000 deaths occur annually as a result of hospital-acquired pressure ulcers and that 2.5 million people are treated each year with this condition. The annual cost of treating pressure ulcers is put as high as $11 billion annually in this article.

Longport has prepared a short handout explaining how its technology can impact pressure ulcers in hospitals.