Noninvasive Transcervical Tubal Occlusion (Sterilization) in Women
In 1985, Platia and Krudy reported the first successful transcervical catheterization of one obstructed fallopian tube in a woman with bilateral tubal obstruction. Since then a number of reports have documented successful retrograde tubal cannulation. From this preliminary work, the concept of a safe, cost effective, outpatient method of achieving tubal catheterization and intentionally causing obstruction has been developed.
A team of investigators at Dartmouth -Hitchcock Medical Center, Lebanon N.H. have developed an applicator designed to produce tubal occulsions in women for the purpose of sterilization (<500,000 sterilizations are performed annually). The reasons for pursuing new sterilization techniques for women are: 1) so that they can be performed in an outpatient setting with little or no morbidity, 2) eliminate the need for a general anesthetic, 3) no post operative recovery, 4) no incisions, 5) be cost effective, 6) be simple and easy to perform, and 7) assure reliable contraception.
The applicator is designed so that it can be inserted retrograde into the fallopian tube transvaginally/transcervically either under flouroscopic guidance, or endoscopically. The tubal occlusion would be characterized by complete fibrosis and blockage of the fallopian tube lumen with retention of the integrity of the outer layers of the tube. Success of the occlusive procedure could be documented by hysterosalpingoraphy (HSP).
Preliminary animal testing using our original prototype applicator has shown successful occlusions, however, some continued testing and development of the applicator will be necessary to optimize its performance. The information we have accrued so far will constitute a portion of that necessary for FDA approval of device usage in human patients. Based on our current data, an institutional device exemption (IDE) for preliminary clinical trials could likely be obtained within a year.
Therefore, we feel that this device offers true potential for an inexpensive (it appears that the system and professional fees would cost the patient in the range of $1500-2000.00; compared with laparoscopic tubal ligations costing the patient $2500-3000.00), easy and highly consistent method of female sterilization.
This technology is claimed in the United States Patent No. 6,485,486. We are seeking an industrial partner for the continued development and commercialization of this technology. (Ref: J41)
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