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).
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.
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.