Method of sterilizing females

Surgery – Female reproductory tract shields – supports – or birth...

Reexamination Certificate

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C128S831000

Reexamination Certificate

active

06378524

ABSTRACT:

TECHNICAL FIELD
This invention relates to a method of irreversibly sterilizing females through laser radiation therapy.
BACKGROUND OF THE INVENTION
It is often necessary or desirous for a female to become sterile in order to prevent pregnancy. Tubal sterilization remains the most common method of sterilization in the world. It is estimated that this procedure is done more than 10 million times annually throughout the world.
In the past, a common method of tubal sterilization has been by tubal occlusion, which itself may be accomplished in several different manners. One manner of accomplishing this has been to position a blocking agent within the fallopian tube to prevent the passage of eggs therethrough. The blocking agent may be in the form of a glue, a plug or a coil. Another manner of accomplishing tubal occlusion has been to place chemicals within the tube which cause injury to the fallopian tube cells which in turn results in the production of scar tissue which occludes the tubes. Similarly, electrodes may be placed within, or about, the fallopian tube which causes a current to be passed between the electrodes which injure the fallopian tube cells. Lastly, occlusion may be performed by restricting the fallopian tube with an externally mounted fallopian ring.
Despite the effectiveness of laparoscopic tubal occlusion, problems associated with these procedures still exists. One problem has been the expense associated with these procedures since they require operating room facilities as well as a general or regional anesthetic. These requirements have been the principle limitation on the availability of this procedure in third-world countries and less affluent segments of our society. Another problem has been a well defined morbidity associated with this procedure, even though such is relatively low. Also, because of the complexity of the procedure, the effectiveness or success rate of the procedure is relative to the experience of the surgeon conducting the procedure.
Another method of tubal sterilization has been to surgically sever or tie off the fallopian tube. This procedure is typically accomplished by grasping the fallopian tube and pulling upon it to form a loop or sharp bend. The bent fallopian tube is either tied off and physically severed or tied off tightly to prevent the flow of blood through the bight area of the bend resulting in necrosis of the bight area. This procedure however has many of the same economic and physical limitation previously discussed, as well as being more physically invasive than the previous procedure. Furthermore, the severed tube may reconnect itself through re-anastomosis resulting in the ultimate failure of the procedure.
Another recent method of sterilization has been attempted which utilizes a laser positioned within the uterus. The laser is oriented to direct a destructive light at the utero-tubal ostium, the opening between the fallopian tube and the uterus, in an attempt to cause damage to the area of the uterus about the utero-tubal ostium. The damaged area of the uterus is intended to heal with a resulting closing of the utero-tubal ostium. This method has proven to be very unreliable because of tissue revitalization.
Accordingly, it is seen that a need remains for a method of sterilizing women in an economic and effective manner with minimum morbidity. It is to the provision of such therefore that the present invention is primarily directed.
SUMMARY OF THE INVENTION
In a preferred form of the invention a method of sterilizing a female is preformed wherein the interior of the fallopian tube is ablated with energy sufficient to cause necrosis of a length of the fallopian tube so as to causes fibrosis of the length of the necrotic area.


REFERENCES:
patent: 5323778 (1994-06-01), Kandarpa et al.
patent: 5382247 (1995-01-01), Cimino et al.
patent: 5549600 (1996-08-01), Cho
patent: 5607420 (1997-03-01), Schuman
patent: 5695493 (1997-12-01), Nakajima et al.
patent: 5743900 (1998-04-01), Hara
patent: 5755850 (1998-05-01), Martin et al.
patent: 6112747 (2000-09-01), Jones
Transcervical sterilization with use of methyl 2-cyanoacrylate and a newer delivery system (the FEMCEPT device); Jack Shuber, M.D., pp. 887-889.
A multi-centre collaborative study into the treatment of menorrhagia by Nd-YAG laser ablation of the endometrium; Dr. Ray Garry, et al., pp. 357-362.
Transcervical sterilization in the human female by hysteroscopic application of hydrogelic occlusive devices into the intramural parts of the Fallopian tubes: 10 years experience of the P-block; Jan Brudin, pp. 41-49.
American Association of Gynecologic Laparoscopists' 1998 membership survey on laparoscopic sterilization; Dr. Jaroslav Hulka, et al., pp. 584-586.
Method failures of laparoscopic tubal sterilization in residency training program. A comparison of the tubal ring and spring-loaded clip; Dr. Thomas Stovall, et al., pp. 283-286.
Female sterilizations in the United States, 1987; Dana Schwartz, et al., pp. 209-212, Oct. 1989.
Attempted transcervical occlusion of the fallopian tube with the ND:YAG laser; Dr. John Brumsted, et al., pp. 327-328.
Falloposcopy: a microendoscopic technique for visual exploration of the human fallopian tube from the uterotubal ostium to the fimbria using a transvaginal approach; Dr. Kerin, et al., pp. 390-400.

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