Drug – bio-affecting and body treating compositions – Enzyme or coenzyme containing – Oxidoreductases
Reexamination Certificate
2001-05-03
2004-01-27
Weber, Jon P. (Department: 1651)
Drug, bio-affecting and body treating compositions
Enzyme or coenzyme containing
Oxidoreductases
C435S191000
Reexamination Certificate
active
06682732
ABSTRACT:
The invention relates to methods for the treatment, alleviation or prevention of lesions, especially ulcers, and in particular to means for use in any said method.
The term “lesion” is used herein to mean any interruption in the surface of the skin or in the surface of a membrane lining any cavity within the body, whether resulting from injury or disease. The term “ulcer” is used herein to refer to any breach on the surface of the skin or on the surface of a membrane lining any cavity within the body, which does not tend to heal quickly.
Human skin is a complex integration of different types of cells and tissues which form an organ. Skin is also the primary seat of the sense of touch and creates a covering for the protection of the deeper tissues. The skin also plays an important role in the regulation of body temperature and is also an excretory and absorbing organ. Skin consists primarily of a layer of vascular tissue and an external covering of epithelium known as the epidermis. Near the surface are the sensitive papillae, and alongside or imbedded beneath it are certain specialised organs, specifically the sweat glands, hair follicles, and sebaceous glands.
In order to protect the tissues below from trauma, the skin must be tough, flexible, and highly elastic. In the context of this function, injuries to the skin can occur. Wounds, which are caused by physical means, result in a disruption of the normal continuity of the structures of the skin. Examples of wounds include cuts, punctures, lacerations, etc. There are two types of healing processes:
(1) primary union or first intention healing and
(2) secondary union or second intention healing.
Primary union occurs when a clean wound with a minimal loss of tissue heals together cleanly. The process involves clotting and formation of a crust or scab to seal the wound; an acute inflammatory reaction, reepithelialization of the surface and fibrous bridging due to fibrin followed by complete sealing of the wound by an epithelial covering. Thereafter, hair follicles, sebaceous glands and sweat glands may subsequently regenerate. The process of second intention healing requires the removal of necrotic debris. The gap in the wound then fills in with fibrous materials. Second intention healing can be impaired by infection and by a restriction, for whatever reason, of the blood supply and therefore oxygenation status of the wound to give rise to ulcers. This invention is concerned, inter alia, with the treatment of those ulcers, which are exemplified by decubitus ulcers, described below.
In nursing homes, hospitals or in private homes where invalid patients with certain diseases and afflictions are bedridden, a problem arises from bed sores which these patients develop. These bed sores, which have a tendency to ulcerate and may also be known as decubitus ulcers, usually result from a loss of blood circulation caused by pressure on the skin, particularly pressure over a bony protuberance. Decubitus means ischaemic necrosis of the skin or subcutaneous tissue caused at a projected bone area due to continuous pressure. It is commonly developed in aged patients as a result of such patients being confined to their beds over long periods of time, and may also be developed on compression in plaster upon fracture.
Decubitus ulcers are defined by reference to four “Stages” according to severity: Stage I—Skin pink-mottled, the epidermis is damaged; Stage II—Skin is cracked, blistered and broken, the epidermis is destroyed; Stage III—Skin is broken with some tissue involvement, the sub-cutaneous skin is destroyed and there are decaying cells; Stage IV—Extensive penetration to muscle and bone, presence of necrotic tissue, and profuse drainage, structures are decayed. By stage III or IV, debridement is usually necessary.
The pressure on areas of support may exceed the mean capillary blood pressure, with the result that those areas are vulnerable to the formation of decubitus ulcers. Other factors which can contribute to formation of decubitus ulcers are lack of proper ventilation, moisture and diet. Additionally, the problem of bed wetting and the accumulation of urine in the bed contribute to the formation of bed sores since the moisture remains in the area of the patient's body. Attempts have been made to remedy these conditions and thereby prevent the decubitus ulcers. Some have involved merely the passing of air through the bed mattress which air is then allowed to pass upwardly around the patient's body. Other devices have had pulsatingly inflatable air mattresses which again merely allow the air to be circulated upwardly around the body of the patient. Those attempts have been relatively unsuccessful in practice.
Some supportive measures used for the prevention or alleviation of decubitus are: occupational therapy, physical therapy, and nutritional therapy. For example, it is the practice to change the position of a patient or to release one or more pressed areas of the patient from pressure so that his skin is protected from continuous compression. Typically, that involves a repositioning schedule every two hours, checking bony prominences for breakdown daily, keeping skin dry and clean, ambulating the patient as much as possible, forcing fluids, and using cornstarch to prevent friction. Other known practices are use of a special bed having a hygroscopic cushioning material and effecting rigorous skin cleaving and wiping, with the object of keeping the skin dry and thereby preventing secondary infection. Where the condition of decubitus is extremely serious, surgery is effected to resect the decubital part and then to restore the resulting lost part by sutured minification, adjacent flap, distant flap or the like.
There are many different products available for the care of decubitus ulcers, including solutions having antibacterial or antacid activity, water-repellent ointments, and dressings. For example, Betadine solution rinses are used for their antibacterial properties, but some allergic reactions can occur to the iodine, enhancing the skin problem. Uniwash and Uniderm treatments have to be done every eight hours or more frequently. Dressings are necessary and beneficial but sometimes tear the skin further. Medicated dressings such as Silvadene have to be changed also every eight hours. Domeboros Solution is used every four hours during the day. Antacids may be beneficial for superficial ulcers, but can hold in purlent matter and debris in the deep ulcer.
Patients particularly prone to formation of decubitis ulcers are cachetic patients (those in negative nitrogen balance), patients with congenital or acquired boney deformities, stroke patients who are immobile, paraplegics with uncontrollable muscle spasms, any spinal cord injury patient, incontinent patients, arthritic patients, those who are confused or comatose, nutritionally deficient patients, those with oedema or poor capillary refill, anyone who is on medications such as steroids, tranquilizers and analgesics, any geriatric patient, and anyone with pre-existing diseases. Decubiti in such patients may also result from or be exacerbated by friction, shearing force and pressure, which all hospital patients are exposed to while in bed. Usually, a combination of two of those forces will cause a pressure sore, which may appear within twelve hours. Friction can be from moving in bed, shearing can be from a position in bed, and pressure can be from gravity alone. A pressure of greater than 25 mm Hg. will occlude flow of blood to capillaries in soft tissues causing hypoxia and, if unrelieved, eventual necrosis which is manifested in decubitis ulcer formation.
Decubitus remains a skin disease which is difficult to prevent in patients who are immobile for a substantial length of time, even with intensive nursing attendance. Whilst the causes, observable symptoms and modes of treatment of ulcers in other membranes may differ substantially from those of decubitis, a common factor is the tendency of ulcers not to heal, or to heal only very slowly. Moreover, once ulceration has occu
Blake David Russell
Bodamyali Tulin
Eisenthal Robert
Harrison Roger
Kanczler Janos
Merchant & Gould P.C.
The University of Bath
Weber Jon P.
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