Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Nitrogen containing other than solely as a nitrogen in an...
Reexamination Certificate
1999-10-01
2002-03-05
Bawa, Raj (Department: 1619)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Nitrogen containing other than solely as a nitrogen in an...
C514S937000, C514S944000, C424S078020
Reexamination Certificate
active
06353028
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
Applicant's invention relates to medicaments and treatment procedures relating to connective tissue disorders manifested by sub-dermal plaque accumulations as well as to fibrosis of muscle tissues, some example of which result in total or partial erectile dysfunction. Representative examples of such sub-dermal plaque accumulation disorders include Peyronie's Disease, Ledderhose Fibrosis, Dupuytren's contracture of the hand and certain forms of erectile dysfunction.
2. Background Information
A. Peyronie's Disease
An initial focus of the present invention—Peyronie's disease—has likely plagued men for time immemorial, but has been recognized as a distinct malady for no less than 400 years. Peyronie's disease was first described in 1743 by a French surgeon, Francois de la Peyronie. The disease was written about as early as 1687 and was oftentimes associated with impotence.
As with the other plaque manifested disorders to which the present invention relates, the symptoms of Peyronie's disease and of its severity vary to some degree. The most common manifestation of Peyronie's disease is in the form of a “lump,” “plaque” or “hard” area in the non-erect penis. With or without these palpable symptoms, painful erections and penile disfigurement are often associated with the malady.
The pain and disfigurement associated with Peyronie's disease relate to the physical structure of the penis in which is found two erectile rods, called the corpora cavernosa, a conduit (the urethra) through which urine flows from the bladder, and the tunica which separates the cavernosa from the outer layers of skin of the penis. A person exhibiting Peyronie's disease will have formation(s) of plaque or scar tissue between the tunica and these outer layers of the skin (referred to as “sub-dermal” in this application). The scaning or plaque accumulation of the tunica reduces its elasticity causes such that, in the affected area, it will not stretch to the same degree (if at all) as the surrounding, unaffected tissues. Thus, the erect penis bends in the direction of the scar or plaque accumulation, often with associated pain of some degree.
Peyronie's disease often occurs in a mild form and heals spontaneously in 6 to 15 months. However, in severe cases, the hardened plaque substantially reduces penile flexibility and causes excruciating pain as the penis is forced into a highly arcuate or even serpentine configuration. A plaque on the top of the shaft (most common) causes the penis to bed upward; a plaque on the underside causes it to bend downward. In some cases, the plague develops on both top and bottom, leading to indentation and shortening of the penis.
In all but minor manifestations of Peyronie's disease, the victim has some degree of sexual dysfunction. In more severe cases, sexual intercourse is either impossible, or is so painful as to be effectively prohibitive.
While plaque of Peyronie's disease is itself benign, or noncancerous, this is of little solace to sufferers of the disease.
Empirical evidence indicates an incidence of Peyronie's disease in approximately one percent of the male population. Although the disease occurs mostly in middle-aged men, younger and older men can acquire it. About 30 percent of men with Peyronie's disease also develop fibrosis (hardened cells) in other elastic tissues of the body, such as on the hand or foot. Common example of such other conditions include Dupuytren's contracture of the hand and Ledderhose Fibrosis of the foot.
Many researchers believe the plaque of Peyronie's disease develops following trauma to the penis (hitting or bending) that causes localized bleeding inside the penis. If the penis is abnormally bumped or bent, an area where the septum attaches to the elastic fibers surrounding the corpora cavernosa may stretch beyond its normal limit, injuring the lining of the erectile chamber and, for example, rupturing small blood vessels. Also, as a result of aging, diminished elasticity near the point of attachment to the septum may tend to increase the chances of injury of this nature.
Such a damaged area may heal slowly or abnormally because of repeated trauma to the same area and/or because of the natural, minimal amount of blood-flow in the sheath-like fibers of the elastic structures of the penis. In cases of Peyronie's disease which tend to heal within about a year, the plaque does not tend to advance beyond an initial inflammatory phase. In cases that persist for longer periods, the plaque typically undergoes fibrosis, or the formation of tough fibrous tissue, and even calcification, or the formation of calcium deposits.
While trauma might explain acute cases of Peyronie's disease, it does not explain why most cases develop slowly and with no apparent traumatic event. It also does not explain why some cases disappear quickly, and why similar conditions, such as Dupuytren's contracture, do not seem to result from severe trauma.
In some cases, men who are related by blood tend to develop Peyronie's disease, which suggests a possible genetic predisposition to Peyronie's disease.
B. Present Treatment of Peyronie's Disease
Because the cause(s) and development of Peyronie's disease are not well understood, physicians to this day treat the disease with a largely experimental approach—they discontinue anything which lacks apparent efficacy, and continue anything that seems to help.
Surgery is the only approach to treating Peyronie's disease which appears to have predictably repeatable efficacy. Surgery is usually only indicated in long-term cases where the disease is stabilized and the deformity prevents intercourse and/or causes extreme pain. However, complications can develop from surgery, including a permanent shortening of the penis.
Attempts at simple plaque excision were described in the 19th century by MaClellan, Regnoli and Huitfield, but by the early 20th century most authors described this technique as disastrous. For this reason Young developed a procedure that simply “freed” the plaque from the tunica albuginea in order to improve erectile dynamics. Lowsely and Boyce then re-explored the technique of simple plaque excision by adding the interposition of a “pat-pad” graft into the defect. Although many others continued to report success with this technique, it failed to gain general acceptance as the treatment of choice.
In 1995 Nesbit described the correction of congenital penile curvature with multiple elliptical excisions of the corporeal tunica. To this day, many surgeons prefer this technique for the correction of the Peyronie's bend. However, the inevitable penile shortening led Devine and Horton (1974) to experiment with further grafting procedures. Having experimented with fascial, arterial and venous patches in dogs, they came to the conclusion that dermal grafts were the least likely to “contract” and so reproduce the defect. To this day, many other grafting materials have been tried including autologous vein, temporoparietal fascia, tunica vaginalis, gortex and dacron.
The cost of the various surgical approaches to Peyronie's disease (no less than around $6,500) is, alone, often a deterrent to many Peyronie's disease sufferers in adopting this particular approach to treatment. While surgical intervention was, prior to the present invention, the most likely effective treatment in any given case of Peyronie's disease, the condition does often reappear, even after surgery.
The other, presently known, non-surgical approaches to Peyronie's disease treatment are many and varied, although they are all largely ineffective. Attempts to dissolve the plaque by direct intra-lesional injections have been tried since the late 19th century. Walsham and Spencer injected both mercury and iodide and intra-lesional injections of fibrinolysins were used in the 1820's. Teasley introduced the concept of intra-lesional steroid injections in 1954, alth
Bawa Raj
Henry David G.
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