Patent Application
20100288291
1. Field of the Invention
This invention relates to the field of wound care, prevention and treatment for pressure sores.
2. Prior Art
Pressure ulcers, pressure sores, decubitus ulcers, bed sores (herein referred to collectively as “pressure sores”) are the bane of the bedridden and the wheelchair bound, and of their caregivers. For those hospitalized people who would otherwise be on the road to recovery from an illness or injury, the onset of pressure sores can increase hospital stays by as much as 50%, or more. For those residing in nursing homes, pressure sores can complicate what should be a restful experience into a punishing stay. For those required to use a wheelchair to get around, pressure sores can add severe pain to the inconvenience already being suffered. All pressure sore sufferers are at an increased risk of infection. Pressure sores can even lead to sepsis and/or to early death.
Pressure sores are lesions which can start off about a half inch across and can become as large as the size of a palm of a hand, or even larger. Surface size is only one measure of the extent of a pressure sore. A pressure sore typically starts at the surface of the skin. If left untreated, over time (and sometimes that time is very short) a pressure sore can extend deep into muscle and/or bone.
Pressure sores are classified into stages. The stages are generally described as follows:
People with reduced ability to move are the most susceptible to pressure sores. It is believed that pressure sores are the result of continuous pressure and/or friction at a particular area of skin, particularly an area of skin close to bone or cartilage, such as the spine, knees, ankles, heels, back, hips, and coccyx (tailbone).
Estimates are that more than one million people suffer from pressure sores in America alone. The numbers of people who will be at risk of suffering pressure sores is likely to increase dramatically because (i) older people are more likely to be involuntarily immobile, (ii) the skin of people tends to thin as they age, and (iii) a large cohort of people are about to start leaving middle age.
Treatment of pressure sores with prior art methods, even if treatment starts when a pressure sore is in an early stage, usually requires weeks for a successful resolution to be obtained, if one can be obtained at all.
One basic measure for treatment and/or prevention of pressure sores requires frequent turning by a caregiver of an immobile patient. To some extent, a wheelchair bound person may be able to move potentially affected portions of his own body himself. The turning is recommended at least once every two hours. Each time the body is turned, pressure is at least temporarily relieved from the areas previously under pressure and allows them to be air-cooled.
Additional treatment measures include administering oral antibiotics, cleaning the pressure sore and the area around it, including removing any dead tissue, applying topical antibiotics and/or other salves and dressings such as available under David Dixon Dermawound brand, 3M's Tegaderm brand, Convatec Inc.'s DuoDerm brand, Coloplast's Contreet brand, and King Pharmaceuticals' Silvadene brand.
Dressings and salves do reduce friction and further skin breakdown, and they help reduce the risk that an affected area would be contaminated by the results of bowel and/or urinary incontinence suffered by some patients. However, healing still is uncertain and takes weeks.
Other measures for preventing and/or treating pressure sores include having the patient rest on an alternating pressure mattress and/or on an air mattress having an air-permeable surface. The purposes of such mattresses are to temporarily transfer pressure from the pressure sore to nearby parts of the body and to provide airflow to the pressure sore, which among other things, could allow for cooling of the affected tissue. Even when mattresses are efficacious, they are expensive to buy and expensive to operate and maintain.
To prevent or alleviate pressure sores, various cushions and pads have been used, such as those disclosed in U.S. Pat. No. 3,721,232. Some are made of foam or of gel, and some are filled with air or water. These cushions and pads have a body-contacting surface area which is intended to distribute the pressure which results from lying on a bed or sitting in a chair away from the pressure sore lesion to other parts of the body. Some of these pads and cushions are formed with a void, with the pressure sore to be positioned over the void. Some of the voids are formed by having the pad or cushion shaped as a donut or ring.
The efficacy of the cushions and pads used in the prior art treatments still leaves much to be desired.
The invention is a method for treating or preventing pressure sores. It comprises (i.e., includes but is not limited to) the following steps: applying a cushion in indirect contact or in direct contact with substantially the entire surface of a pressure sore area, and applying pressure against the pressure sore area through the cushion. The cushion is preferably circular in shape (although it may have other shapes) with its diameter between about 1.5 and about 6 times its height, and preferably between about 3 and about 4 times its height. In the preferred embodiment, the cushion has a silicone elastomeric shell, with the portion of the shell intended to be in occlusive contact with the pressure sore having a smooth outer surface. In the preferred embodiment, the cushion is only partially filled, and the fill material is silicone gel. The cushion may be held in place by means of a strap, wrap, bandage or similar device.
In accordance with present invention, and contrary to prior art methods, increased pressure is applied locally to the pressure sore area.
The preferred embodiments of the invention are described herein, with the benefit of the illustrations the attached drawings which are referred to herein. The same reference numeral will be used to identify identical elements throughout the drawings.
When a person is found to have a pressure sore, or complains of pain at an area of bony prominence or a nerve ending, it is preferred that the pressure sore or the area of pain, and the area around it, be cleaned and any dead tissue should be gently removed. For purposes of convenience, the term “pressure sore area” is used herein to refer to both a pressure sore and to an area of pain that may lead to a pressure sore.
Preferably after the pressure sore area has been cleaned, the invented steps should be performed.
That is, an appropriately shaped and sized cushion, such as cushion 4, 24 or 34 shown in
As shown in
In
The cushion would typically be put in position by a caregiver, although some patients would have the ability to put the cushion in position themselves. With the cushion held in place, the patient is rolled back into normal resting position (i.e., supine). As a result, as illustrated in
As shown in
A cushion used in the invented method is illustrated in
Shell 5 is formed of a flexible material, preferably an elastomeric material. The material used should be formed so that it is substantially impermeable to fluids. Polyurethane or rubber could be used to form the shell. The most preferred material is elastomeric silicone. The outer surface of the shell may be textured or smooth. In the preferred embodiment the outer surface is smooth. The goal is to reduce as much as possible the friction which would be created between the shell and the skin of the patient when the cushion is in actual use.
In the preferred embodiment, the shell is filled substantially completely with liquid and/or gel, with no gaseous substance (for example, air) being present within the shell, or as little gaseous substance as practicable being present.
The shell could be filled to its capacity, such as the case with cushion 24 shown in
In the preferred embodiment of the invention, the cushion is selected for a particular pressure sore such that the perimeter of the cushion extends slightly beyond the perimeter of the lesion, as shown in
As shown in
When the cushion is circular, its diameter D when it is placed on a flat surface, with no external pressure applied, is between about 1.5 and about 6 times its height H as shown in
Those in the medical field will recognize the cushion used in the invented method as being the same as, or similar to, breast implants. It follows that makers of breast implants would have the know-how to make the cushions described herein.
In connection with the invented method, the cushion will transmit significant pressure against the pressure sore area.
While this is contrary to the typical recommendation that pressure be removed from the pressure sore as much as possible, this application of positive pressure through the cushion to the pressure sore area is an intended result of the invented method.
In addition, the specific heat index of the cushion is relatively high. As a result, a cushion at room temperature can be placed against a patient without causing a feeling of chill, yet for between one and three hours the cushion would draw heat away from the pressure sore area. This is an intended result of the invented method and in this regard treatment with the cushion is consistent with the typical recommendation that heat be removed from a pressure sore. When a cushion is first put into position, its temperature should be less than 96° F., and it is preferred that its temperature be room temperature or less.
To the extent that the patient makes small shifts relative to the mattress, friction is almost completely eliminated at the pressure sore area and the area immediately around it. That is because almost all the movement, and any friction associated with it, relative to the mattress is absorbed by the cushion, and the upper surface of the cushion would not move much, if at all, relative to the pressure sore area (or relative to a dressing if a dressing is used). To the extent, if any, that the pressure sore area does move relative to the upper surface of the cushion, the friction between the pressure sore area (or a dressing) and the upper surface of the cushion is very low.
Another advantage provided by the use of the invented method relates to a patient lying supine on a mattress. Using the invented method, the pressure sore area is lifted above the surface of the mattress, substantially reducing the risk that the pressure sore area would be contaminated by the results of any bowel and/or urinary incontinence.
After about an hour or two the cushion should be replaced with another cushion. The replacement cushion should be about room temperature. However, the replacement cushion could be cooled beforehand, which may provide further relief from discomfort for the patient over a longer period of time. Of course, in the case of a cooled cushion, the patient would be warned to expect an “initial contact” chill.
When the cushion is being replaced, the patient may be turned. If a dressing (such as Tegaderm brand transparent dressing) is used, it may be changed as needed, with the pressure sore area cleaned as is done in typical basic care. In addition, antibiotics or other salves may be administered to the pressure sore area.
Before positioning a cushion against a pressure sore area (or against a dressing in occlusive relationship with the pressure sore area), the cushion should be cleaned with a mild soap or an antibacterial soap, and fully rinsed and dried with a, preferably, lint free cloth.
When a pressure sore area is on the part of a body vertically above the resting surface (e.g., a pressure sore near a patient's coccyx when the patient lies supine), the pressure exerted through the cushion against the lesion actually comes from the body weight. For pressure sore areas located where body weight cannot provide the pressure, or for applying a cushion to pressure sore areas on particular parts of a body which might roll off of a cushion, or for accommodation of a patient in a wheel chair, a cushion may be held in position against a pressure sore area with a bandage, strap, belt, wrap or other device. Such a device will be referred to as a “harness” herein. In addition, the bottom surface of the cushion (i.e., the portion of the cushion that would face away from the patient (i.e., the portion with the fill hole)), may be fitted with fastening material which would help hold the cushion in place on a surface.
For example, for a pressure sore area located at a patient's heel bone, a cushion could be held in place with the harness illustrated in
Other examples of harnesses, such as an elastic bandage wrapped around the foot and lower portion of the leg, would be obvious to those skilled in the medical art.
The method described herein for treating pressure sores can also be used to prevent them by the occasional use of a cushion at any spot where a pressure sore is expected to occur.
By way of summary, the invented method for treating or preventing pressure sores comprises (i.e., includes but is not limited to) the following steps: applying a cushion in occlusive contact with substantially the entire surface of a pressure sore area, and applying pressure on the pressure sore area through the cushion. The cushion is preferably circular in shape (although it may have other shapes) with its diameter between about 1.5 and about 6 times its height, and preferably between about 3 and about 4 times its height. In the preferred embodiment, the cushion has a silicone elastomeric shell, with the portion of the shell which is intended to be in occlusive contact with the pressure sore area having a smooth outer surface. In the preferred embodiment, the cushion is only partially filled, and the fill material is silicone gel. The cushion may be held in place by means of a harness. Further, rather than having the cushion in direct contact with the pressure sore area, a dressing may be put in direct, preferably occlusive, contact with the pressure sore area, and the cushion would be disposed in contact with the dressing. In other words, the cushion would be in indirect contact with the pressure sore area. Pressure would be applied against the pressure sore area through the cushion and dressing.
It will be understood that various changes of the details, materials, steps, arrangement of steps and uses which have been herein described and illustrated in order to explain the nature of the invention will occur to and may be made by those skilled in the art, and such changes are intended to be included within the scope of this invention.
