Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-10-27
2004-02-17
Look, Edward K. (Department: 3745)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S329000, C604S402000
Reexamination Certificate
active
06692480
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a method and apparatus for treating and preventing urinary tract infections. More particularly, the present invention relates to a method and apparatus for treating and preventing urinary tract infections in females.
BACKGROUND
FIGS. 1 and 2
illustrate a urinary system
20
that helps maintain proper water and salt balance throughout a female
30
. Two kidneys
22
are located on each side of the body to help filter waste products, water, and salts from the blood to form urine
36
. Urine
36
passes from each kidney
22
to the bladder
26
through thin tubes referred to herein as ureters
24
. Bladder
26
stores urine
36
, which is then eliminated from the body via another tube called a urethra
28
. One major problem that occurs within urinary system
20
is a urinary tract infection. A urinary tract infection is an infection in urinary system
20
caused by microorganisms such as bacteria, viruses, and fungi.
The human body has many defenses to urinary tract infections. For example, urine is normally sterile, that is free of bacteria, viruses, and fungi that can cause urinary tract infections. In fact, urine functions as an antiseptic, washing potentially harmful microorganisms out of the body to help prevent urinary tract infections. Additionally, ureters
24
, which are used to carry urine from the kidneys
22
to the bladder
26
, are designed at their distal end to prevent urine from backing up into the kidney
22
. In females, the urethral gland secretes infection-fighting substances that help prevent urinary tract infections. Moreover, the immune system in a female continuously fights microorganisms.
Nevertheless, urinary tract infections are the second most common of all infections and can occur throughout the lifetime of an individual. On average, 10% to 20% of all women will develop a urinary tract infection at some time in their lives, and women are up to 30 times more likely to have urinary tract infections than men. Urinary tract infections are predominantly bacterial infections. The bacteria
Escherichia coli
is responsible for up to 85-90% of urinary tract infections.
Staphylococcus saprophyticus
is the second major bacterial culprit, causing 5% to 15% of cases in women. Other species of bacteria responsible for urinary tract infections include, Klebsiella,
Proteus mirabilis
, Pseudomanas,
Ureaplasma urealyticum
, and Enterococci. In most cases of urinary tract infections,
E. coli
, which originates as a harmless microorganism in the intestines, spreads to the vaginal passage where it invades and colonizes the urinary tract. In some cases, bacteria come from the uterus during menstruation or from unprotected sexual intercourse. In recurrent urinary tract infections, later infections are often caused by bacteria that are different from those that caused a previous or first infection; even if the later bacteria is still
E. coli
, it may be a different strain from that causing the previous infection.
The most common type of urinary tract infection is cystitis. Cystitis is an infection that occurs in the lower urinary tract, affecting the bladder and urethra and almost always occurs in women. Bacteria from fecal matter are easily transferred to the vagina and the urethra. In most cases, the infection is brief and acute and only the surface of the bladder is infected. Deeper layers of the bladder may be harmed if the infection becomes persistent, or chronic, or if the urinary tract is structurally abnormal. When infection is limited only to the urethra, the infection is known as urethritis, which is a common sexually transmitted disease in men. A urinary tract infection can also spread to the upper tract, that is, the ureters and kidneys, and is then referred to as pyelonephritis. As many as 10-20% of all women with cystitis may have pyelonephritis at the same time as cystitis.
Often, after a first episode of a urinary tract infection, a second urinary tract infection occurs a few months later. If three or more urinary tract infections occur over a two year period, the condition is referred to as a recurrent urinary tract infection. Recurrent urinary tract infections in certain women may be due to an increase in pH levels within the vagina. In normally fertile women
30
, a vagina
32
is colonized by lactobacilli, microorganisms that maintain a highly acidic environment, that is, an environment with a low pH of between about 4 and about 5, that is hostile to other bacteria. In addition, lactobacilli produce hydrogen peroxide, which helps eliminate bacteria and reduces the ability of
E. coli
to adhere to vaginal cells. When there is an increase in the pH level in vagina
32
, bacterial growth becomes prevalent and the risk of urinary tract infection is increased.
Vaginal wetting, the introduction of urine
36
into vagina
32
, may occur in some females during urination. Since urine
36
maintains a rather high pH of between about
6
and about
7
, vaginal wetting can increase the pH level in the vagina to between about
7
and
9
. The increased pH level caused by vaginal wetting may encourage bacterial growth and increase the risk of urinary tract infections, including recurrent urinary tract infections. Vaginal wetting may be caused by a number of factors, such as, but not limited to, large labia, structural abnormalities in urethra
28
, and swelling or scarring of tissue
34
surrounding urethra
28
. Some times, recurrent urinary tract infections lead to structural abnormalities in the female urethra called fibrosis. Fibrosis is a swelling or scarring of tissue
34
surrounding vagina
32
that the causes urethra
28
to shorten and point downwards into vagina
32
, as illustrated in FIG.
3
. Fibrosis may be caused by other factors as well, not just recurrent urinary tract infections. Females with fibrosis have an increased chance of a urinary tract infection since there is a greater chance for urine
36
to enter vagina
32
when urethra
28
is shortened and points downwards into the vagina
32
.
Symptoms arising from urinary tract infections, such as pain and bladder spasms, may be treated using drugs such as phenazopyridine, methenamine, flavoxate, or methylene. However, these drugs have side effects such as headaches, allergic reactions, upset stomachs, and may turn urine a blue or orange color, which can discolor and stain fabric. Moreover, these drugs treat only the symptoms and do not cure a urinary tract infection. For people with recurrent or severe urinary tract infections antibiotic treatments are available. Oral antibiotic or antimicrobial treatment of urinary tract infections, such as cystitis, results in about an 85% initial success rate, although the rate of recurrence remains high. Additionally, antibiotic drug combinations, such as trimethoprim/sulfamethoxazole, commonly called TMP-SMX, trimethoprin (PROLOPRIM, TRIMPEX) or sulfamethoxazole (THIOSULFIL, FORTE) used alone or with the anti-microbial nitrofurantoin (FURADANTIN, MACRODANTIN), may be used to treat urinary tract infections. Other antibiotics, in addition to the ones listed above, may also be used to treat urinary tract infections.
As with any drug, there are side effects and the antibiotic drugs only treat a single occurrence of urinary tract infection, and do not prevent recurrent urinary tract infections. The rate of recurrent urinary tract infections does not seem to be affected by even successful treatments. Furthermore, the repeated use of antibiotic drugs increases the chance of bacterial resistance in the person taking the antibiotics. Bacterial resistance to antibiotics is becoming a serious problem. About one third of the bacterial strains causing UTI have become resistant to the penicillin and sulfa drugs that were once commonly used for treatment. Resistance as high as 20% has also been found with two other commonly prescribed drugs, nitrofurantoin and nalidixic acid (NEGGRAM). As bacterial resistance to antibiotics increases, the effectiveness of antibiotic treatment is decreased. Accordingly, advan
Bush Irving M.
Look Edward K.
McCoy Kimya N
Sonnenschein Nath & Rosenthal LLP
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