Monday, January 23, 2017

Oh, patents! Femasys (1)

Copyright © Françoise Herrmann

Another woman on fire!...

Kathy Lee Sepsick, President, CEO and Founder of a company called Femasys Inc., is an inventor, with at least 50 patents awarded. Femasys Inc. is a company “committed to transforming women’s healthcare worldwide by expanding options for women with innovative medical devices and next-generation advancements” (Femasys). Accordingly, the company has invented, developed, tested, and successfully marketed a series of products specifically targeting women’s reproductive health.

Femasys’ first flagship product is called FemVue. It is used in conjunction with SONOHsg (sonographic hysterosalpingography) procedures to assist with the evaluation of tubal patency and the condition of the uterus. The central innovation of the Femvue / SonoHsg system is that it offers an office procedure where the previous state of the art in Fluoroscopic Hsg and the gold standard Laparoscopic chromopertubation (LC) required hospitalization, surgery and very expensive equipment.

Another important aspect of this invention is that Femvue delivers a flow of saline solution and micro air bubbles to the uterus and Falopian tubes, instead of traditional and potentially allergenic contrast media and dyes. Thus, FemVue delivers a natural contrast solution consisting of micro air bubbles and saline solution to enhance visualization with sonography, for the purposes of detecting tubal obstructions and conditions of the uterus -- in an office setting, within the context of fertility or other sorts of reproductive health evaluations.

A saline solution with "tiny bubbles", used as a contrast agent to enhance visualization with sonography, sounds easy enough, although nothing is farther from the truth! That is to say, how do you produce small enough bubbles that will stay dispersed in a liquid, instead of coalescing into one larger bubble within the liquid? How do you keep  tiny (2 to 5 micron) bubbles stable long enough for them to actually reach their target location within the body where they can support visualization of an organ cavity or duct?  Coalescence and stability of the microbubbles, without the use of stabilizers or other surfactants, in addition to costs and availability of the system, are some of the issues addressed in just one of the approximately 50 patents connected to this system, and others under development at FemaSys.

US US2010086492 titled Methods and devices for sonographic imaging, also published as WO2010040046 titled Contrast medium device for sonographic imaging, and CA2770504 titled Contrast medium for sonographic imaging, are the patents reciting the contrast media invention connected to the FemaVue device.

Below, the abstract for US US2010086492 titled Methods and devices for sonographic imaging, is included.  An image of the device generating the contrast media, extracted from the patent, and an image of the marketed embodiment are also included.
The present invention comprises methods and devices for providing contrast medium for sonography of structures such as ducts and cavities. The invention provides for creation of detectable acoustic variations between two generated phases of a gas and a liquid to make a contrast medium. Sonography is the primary means of imaging but other conventional detection means may also be employed with the present invention.


Femasys is also in the process of developing the FemBloc solution of permanent contraception. This is a female sterilization option involving Fallopian tube occlusion using a biopolymer. FemBloc is expected to be a safer option than traditional methods of tubal ligation, since it is an office procedure that requires no surgical intervention. FemBloc was cleared for clinical testing against traditional surgical methods of tubal ligation and is not yet commercially available.

Rhiana D. Saunders, M.D., James M. Shwayder, M.D., J.D., and Steven T. Nakajima, M.D (2011) Current methods of tubal patency assessment. Fertility and Sterility, 2011, 95:2171–79.

Caterina Exacoustos, MD., Errico Zupi, MD., Claudia Carusotti, MD., Giulio Lanzi, MD., Daniela Marconi, MD., and Domenico Arduini, M.D. (2003) Hysterosalpingo-Contrast Sonography Compared with Hysterosalpingography and Laparoscopic Dye Pertubation to Evaluate Tubal Patency. The Journal of the American Association of Gynecologic Laparoscopists. 2003;10(3):367-372.

No comments: