Female tubal factors are by far the largest group causing 25-35% of all infertility cases, thus 2/3 of all non conceiving couples will undergo an investigation that includes tubal imaging, 10% of whom will be candidates for tubal recanalization.
As for contraceptive methods; tubal ligation is one of the leading methods, being chosen by 15% of women in reproductive age in the
Summary of invention:
The Fallopian Tube Manipulator Device (FTM) is a steerable catheter that is introduced through the vagina, for easy access into the fallopian tubes. It can be used to image the fallopian tube and treat a blocked tube immediately and without reapplication of a different device.
It can also be used to deliver different methods of blocking the fallopian tube for means of sterilization, for example: biological glue, heating (for ablation).
Recanalization
Sterilization thru tube blockage.
Possible market size:
66% of all couples having troubles to conceive will need to undergo tubal imaging, 10% will need tubal recanalization.
As for means of contraceptives, some 10,000,000 women (15% of women in reproductive age) are choosing the method of tubal ligation.
Current solutions:
Currently there are different catheters for accessing the tubes all of which have non steerable with fixed angle. Therefore currently numerous tools are being used.
For tubal ligation a hysteroscopy is done, which does not give immediate information regarding whether a blockage was effectively done or not. Thus, 3 month after the procedure x-ray is done in order to reassure blockage.
Patent & regulatory status:
US Provisional patent application to be filled on December 2008 on behalf of
Dr. Daniel Tugendreich, Gynecology department - Belinson medical center, specialized in fallopian tube imaging and treatment
(assisted by Dr. Oz Gavish, Gynecology department - Belinson medical center).
Device expected to receive 510K clarification.
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