Surgery – Diagnostic testing – Monitoring fertility cycle
Reexamination Certificate
2002-04-24
2003-12-30
Hindenburg, Max F. (Department: 3736)
Surgery
Diagnostic testing
Monitoring fertility cycle
C128S920000, C340S309200, C368S012000
Reexamination Certificate
active
06669650
ABSTRACT:
BACKGROUND OF THE INVENTION
(a) Field of the Invention
This invention relates to a device used as a prompter of a user of the device to take steps to perform a self-examination of her body and more particularly, but not by way of limitation, to a self-examination prompter device used for alerting the user of the device it is time to examine her breasts in the interest of early detection of any irregularities, i.e. tumors occurring in the user's breast.
(b) Discussion of Prior Art
In U.S. Pat. No. 5,657,753 and U.S. Des. Pat. No. 377,832 to Jacober et al., a home Breast Self Examination system is disclosed which can be used in a shower for monthly exams. The system includes prompt signals which are predetermined and programmed into the system by the user based on a women's individual menstrual cycle. This type of self-examination system is based on a programmable timer which is regulated by the user and signaling the user that a desired timing interval has expired. In U.S. Pat. Nos. 5,494,442 to Hecht and 5,207,582 to Michelson, two different breast recording systems are described for manually recording information related to home self examinations. Also, U.S. Pat. No. 5,474,064 to Rohrberg discloses a breast floatation system for self-examination. None of the above mentioned patents disclose the unique features, structure, objects, simplicity and advantages of the subject invention for providing a breast self-examination prompter device to help a person in the early detection of a mass, tumor, or other irregularity in the breast.
Breast cancer is the most common cancer among women, other than skin cancer. It is the second leading cause of cancer death in women, after lung cancer. The American Cancer Society predicts several hundred thousand new cases of breast cancer each year with some forty thousand deaths resulting from the disease. Breast cancer also occurs in men, although much less often.
The earlier breast cancer is found, the better the chances for successful treatment. Because early breast cancer does not produce symptoms, it's important for all women to follow the guidelines for finding breast cancer early. These include the following:
1. A mammogram and a breast exam by a doctor or nurse (clinical breast examination) every year for women over the age of 40.
2. Between the ages of 20 and 39, women should have a clinical breast exam every 3 years
3. All women over 20 should do breast self-examination (BSE) every month.
Together, these methods offer the best chance of finding breast cancer early.
With the above in mind, when is the best time for a women to do a self breast examination? This is all dependent upon a woman's menstrual cycle. The average woman's cycle is 28 days. Day one of a woman's menstrual cycle being the first day of menstrual bleeding. The end of the cycle being the first day of the next menstrual cycle. It is recommended by the medical community that a woman conduct a breast self-examination about one week after the start of the menstrual cycle or in other words days 7-10. The timing is crucial as hormone levels in a woman's body are lower at this time. This means, a woman's breasts will be less tender and less swollen. Therefore, less discomfort for the woman then facilitates a more thorough and complete exam.
But all menstrual cycles are not created equal. Women and their menstrual cycles or lack of menstrual cycles are categorized below.
1. Women with “regular” or predictable menstrual cycles.
2. Women with “irregular” or unpredictable menstrual cycles. These women having sometimes no idea when the start of their next menstrual cycle might be.
3. Women using birth control pills. These women have menstrual cycles that are dictated by the hormones in the pills. These women experience regular menstrual cycles each being 28 days.
4. Women that have no menstrual cycle which can occur for a variety of reasons:
A. Post Hysterectomy
B. Post Menopause, “The Change”
C. Hormone Therapy
D. Pregnancy
E. Vigorous or Excessive Exercise
In an effort to facilitate the practice of monthly breast self examinations, the subject device described herein has taken into account all of the above scenarios.
Women with “regular” or predictable menstrual cycles will benefit from using the 7 day timer mode as described. On day one of the menstrual cycle, the start button is depressed and automatically 7 days later the device will prompt the woman, with an audible alarm and a flashing light, to do her breast self-examination.
Women with irregular or unpredictable menstrual cycles will benefit from using the 7 day timer as well. Even though irregular, when the menstrual cycle begins the woman can depress the start button and the device will prompt her to do the breast self-examination on day 7.
For the woman using birth control pins, the subject invention has a 28 day clock (or timer). These women have very predictable menstrual cycles every 28 days. Therefore, the invention prompts the woman to do her breast self-examination every 28 days. In this mode, it is not necessary to depress the start button. The clock will automatically time out every 28 days.
The subject invention described herein also offers a 30 day clock which prompts the user to do the breast self-examination every 30 days or once a month. This mode is for all those not experiencing menstrual cycles. It should be noted too that men can benefit from using this mode as well. Here again, in the 30 day mode, it is not necessary to depress the start button. The clock will automatically time out every 30 days.
In situations where individuals have very infrequent menstrual cycles, it may be deemed more important to do a regular monthly exam rather than waiting for the menstrual cycle to actually start and then doing the exam one week later.
SUMMARY OF THE INVENTION
In view of the foregoing, it is a primary objective of the subject invention to provide a prompter device to prompt a user of the device that it is time to conduct a breast self-examination on a routine or monthly basis. The prompter device can also be used as a reminder to the user for periodically doing a self-examination for other medical conditions that need to be monitored on a regular basis.
A feature of the prompter device is that the device can be set to accommodate individual uniqueness as it pertains to signaling the user of a timing interval of 7 days, 28 days or 30 days. Pressing of a button will allow the user to choose between the three settings. The device is designed for use by pre-menopausal women with regular or irregular cycles, women using birth control pills, and the various groups of women that experience no menstrual cycle as a result of post hysterectomy, post menopause, hormone therapy, pregnancy, and a vigorous or excessive exercise. Monthly breast self-examination for men would be included here as well.
Still another feature of the invention is that the device is adapted for use in a bathtub setting or a shower stall, thus encouraging the user to perform the breast self-examination while the body is wet as suggested by the medical community. Further, performing the breast self-examination while bathing or showering allows the user privacy and convenience.
The breast self-examination device includes a micro-controller timer capable of timing a timing interval of 7 days, 28 days or 30 days. The micro-controller may comprise a microprocessor. For women that experience regular or irregular menstrual cycles there is a 7 day timer. For women using Birth Control Pills, there is a 28 day timer. For women who have non-menstrual cycles and men, there is a 30 day timer.
The breast self-examination prompter device also includes a motion sensor. The motion sensor is able to detect if a person is located near the breast self-examination device. The device also includes a micro-controller that serves multiple functions which includes the timer function, control logic and power control for the system, command for the motion sensor and audio/visual components. The micro-controller is connected to the
Anker Denise M.
Odefey Marvin L.
Astorino Michael
Hindenburg Max F.
Leyendecker Kurt
Leyendecker Law Offices
LandOfFree
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