Vagina cleaning system for preventing pregnancy and sexually...

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

Reexamination Certificate

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C604S036000, C604S515000, C604S257000, C604S275000, C600S220000, C600S210000

Reexamination Certificate

active

06447490

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to an improved vagina cleaning system to be used for removing unwanted substances from a woman's vagina. The vagina cleaning system of the present invention includes an improved vagina opener, a simplified vagina-cleaning device and a multi-functional vagina cleaning solution. A device used to introduce health-promoting probiotic bacteria into the vagina may also be used as part of the system. Also included is a method of using the vagina cleaning system of the present invention.
2. Description of the Related Arts
The incidence of sexually transmitted diseases, including human immunodeficiency virus (HIV) infection, is increasing in children, adolescents, young adults, as well as others who are sexually active. It has been reported that approximately 50% of American adolescents are sexually active by age 16 years (Committee on Infectious Diseases, American Academy of Pediatrics: 1994 Red Book, Report of the Committee on Infectious Diseases, 23rd edition, G. Peter, N. A. Halsey, E. K. Marcuse & L. K. Pickering, eds. p. 103, American Academy of Pediatrics, 1994, Elk Grove Village, Ill.). Sexually experienced adolescents have the highest rate of sexually transmitted diseases as compared to any age group. Being pregnant is not the desired consequence of sexual activity for most adolescent girls.
The American Academy of Pediatrics reported that traditional sexually transmitted diseases, including syphilis, gonorrhea, chancroid, and lymphogranuloma venereum, are still prevalent today. Currently, HIV, hepatitis B virus and Chlamydia trachomatis are major pathogens of sexually transmitted diseases (Committee on Infectious Diseases, American Academy of Pediatrics: 1994 Red Book. Report of the Committee on Infectious Diseases, 23rd edition, G. Peter, N. A. Halsey, E. K. Marcuse & L. K. Pickering, eds. pp. 104-106, American Academy of Pediatrics, 1994, Elk Grove Village, Ill.). Although certain sexually transmitted diseases are treatable, some of those caused by Candida albicans, cytomegalovirus, HIV, and Herpes simplex types 1 and 2, lack effective and/or inexpensive treatment methods.
Major results of sexually transmitted diseases in childbearing women include HIV infection, chronic hepatitis, salpingitis, ectopic pregnancies, and infertility. Carcinoma of the cervix is also related to sexually transmitted diseases (X. Castellsague et al., Prevalence of Penile Human Papillomavirus DNA in Husbands of Women with and Without Cervical Neoplasis: a Study in Spain and Colombia,
The Journal of Infectious Diseases
, 176, pp. 353-361, 1997). Furthermore, sexually transmitted diseases cause neonatal infections, such as HIV, hepatitis B virus, and Herpes simplex (R. C. Hershow et al., Increased Vertical Transmission of Human Immunodeficiency Virus from Hepatitis C Virus Co-Infected Mothers, The Journal of Infectious Diseases, 176, pp. 414-420, 1997). Sexually transmitted diseases also cause premature delivery, a significant problem in the neonatal care area (Committee on Infectious Diseases, American Academy of Pediatrics, 1994 Red Book: Report of the Committee on Infectious Diseases, 23rd edition, G. Peter, N. A. Halsey, E. K. Marcuse & L. K. Pickering, eds. pp. 104-106, American Academy of Pediatrics, 1994, Elk Grove Village, Ill.). Urinary tract infections among females are often acute and recurring. Sex partners have been identified to be the pathogen carriers (B. Foxman et al., Transmission of Uropathogens Between Sex Partners, The Journal of Infectious Diseases, 173, pp. 989-992, 1997).
Worldwide sexually transmitted diseases cause serious health problems. Those diseases not only decrease the quality of a patients' life, but also lead to harmful effects for the next generation. Therefore, a simple and effective method for preventing sexually transmitted diseases is needed.
Condom use has been recognized as the most effective method in preventing many kinds of sexually transmitted diseases. However, condom use has many problems. First, for many people using a condom results in reduced sensation or decreased sexual pleasure. Second, the condom may break or slip off during intercourse (M. Steiner et al., Can Condom Users Likely to Experience Condom Failure be Identified?
Fam
-
Plann
-
Perspect
., 25(5), pp. 620-223 & 226,1993). Third, using a condom sends unwanted messages to one's partner that the user might have a sexually transmitted disease, especially HIV infection. Fourth, frequently buying condoms is an embarrassment for the frequent condom user (W. R. Grady et al., Condom Characteristics: The Perceptions and Preferences of Men in the United States,
Fam
-
Plann
-
Perspect
., 25(2), pp. 67-73, 1993). Thus, there is a need for a new method of preventing sexually transmitted diseases.
Men, to clean their penises for preventing sexually transmitted diseases, have used soap and water (N. O'Farrell, Soap and Water Prophylaxis for Limiting Genital Ulcer Diseases and HIV-1 Infection in Men in Sub-Saharan Africa,
Genitourin
-
Med
, 69(4), pp. 297-300, 1993). However, this method is not as easy for women to clean the vaginal cavity due to practical reasons.
Many methods can be used to prevent pregnancy. The use of a condom is one of the most common and effective methods to prevent unwanted pregnancy. However, due to many reasons, as stated in the above paragraphs, people do not want to use a condom. For adolescents, the rate of condom use is lower than adults, due to many known and unknown reasons. Since teenage pregnancy is one of the most unwanted consequences of the sexual activity, it is necessary to have some alternative methods to prevent unwanted pregnancy. The significant removal of semen from the vagina can largely reduce the chance of pregnancy.
Several instruments have been invented for washing the vagina. William Sims introduced a vagina washing system that included water as a washing solution, a washing device and a vagina opener with a solid wall (U.S. Pat. No. 258,140, May 16, 1882). The use of this system cannot effectively clean the vaginal cavity due to the fact that the vagina opener creates a dead space between the outside wall of the opener and the vaginal cavity, in which the washing solution cannot reach. The second problem associated with the Sims' vaginal washing system is that it is very inconvenient to carry this system when the user is traveling. Also, a more efficient vagina washing solution, rather than just water, is needed. Therefore, there is a need to improve the Sims system. Anthony E. Magoris invented a spectrum-like tool for cleaning the vagina (U.S. Pat. No. 471,647, Mar. 29, 1892). Edward B. Cantor (U.S. Pat. No. 2,792,003, May 4, 1957), John R. Lane (U.S. Pat. No. 735,276, Aug. 4, 1903), and Arthur E. Wilde (U.S. Pat. No. 1,080,395, Feb. 19, 1913), all invented a syringe-like tool for cleaning the vagina. All of the above devices have the same problem in that a dead space is created between the wall of the vagina opener and the vaginal cavity, and the washing solution cannot reach that dead space. Henricus W. Westlake created a vaginal irrigator (U.S. Pat. No. 693,358, Feb. 11, 1902). Four disadvantages exist in Westlake's system: (1) it is relatively difficult to manufacture Westlakes' device; (2) the device is not easy to use by the individual; (3) it is expensive to purchase the whole device; and (4) the system creates a dead space between the outside wall of the device and the vaginal cavity. Lucie et al. designed a fluid dispensing device for introducing therapeutical liquid into the vagina (U.S. Pat. No. 3,010,454, Nov. 28, 1961). Ellis presented a disposable douche syringe for feminine hygiene (U.S. Pat. No. 3,144,866, Aug. 18, 1964). Like the other tools mentioned above, Lucies' and Ellis' devices could not create a space between the surface of the vaginal cavity and the outside wall of the devices. All of the introduced liquid would flow out of the vagina under pressure. The lower part of the vaginal

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