WO2012030251A1

WO2012030251A1 - Embryo implanter

Info

Publication number: WO2012030251A1
Application number: PCT/RU2011/000520
Authority: WO
Inventors: Михаил Григорьевич ШНЕЙДЕРМАН; Лев Львович КОЛЕСНИКОВ
Original assignee: Shnejjderman Mikhail Grigor Evich; Kolesnikov Lev L Vovich
Priority date: 2010-09-03
Filing date: 2011-07-15
Publication date: 2012-03-08

Abstract

The utility model relates to auxiliary instruments in the field of medicine and can be used in the process of in vitro fertilization (IVF) for improving attachment of an embryo to the endometrium of the uterine body. The technical result of this solution is a device which makes it possible to implement better "adhesion" of an embryo being transferred into the uterine cavity to the predecidual endometrium, which is a very important moment in the process of in vitro fertilization. The claimed technical result is achieved by producing a minimal pressure in the uterine cavity by the introduction of compressed sterile air (89% oxygen + 11% nitrogen) into the latter from a cylinder with a special plastic uterine nozzle. Stronger adherence of the embryo to the mucous membrane of the uterine cavity makes it possible to produce a greater probability of implantation of the embryo and a better final result in the process of in vitro fertilization (IVF).

Description

EMBRYO IMPLANTER

DESCRIPTION

The device relates to auxiliary tools in medicine and can be used to increase the possibility of implantation of embryos in the uterine mucosa during the artificial insemination (IVF) procedure.

Currently, more and more women suffer from infertility, due to many reasons - untimely treatment of gynecological diseases, hereditary factors, genetic abnormalities, poor living and nutrition conditions, underdevelopment of the uterine body, adhesions in the pelvic cavity, etc.

One of the methods for treating infertility is the currently widely used method of in vitro fertilization (IVF) [1-7].

In vitro fertilization is fertilization outside the human body. After ovulation stimulation is carried out, one or several eggs are obtained by puncture, which are fertilized under laboratory conditions

sperm cells with subsequent transfer of the resulting embryos into the uterus of a woman.

The prior art method of in vitro fertilization (patent RU2181581), including ovulation stimulation, controlled by ultrasound and hormonal testing, in vitro fertilization and transfer of embryos into the uterine cavity, characterized in that the ultrasound method determines the location of the dominant ovary, percutaneous stimulation areas of the BM-147 reflex point on the same side, after which the woman is placed on the corresponding side and the embryos are transferred into the uterine cavity on side of the endometrium, ipsilateral dominant ovary.

Also known from the prior art is a method of conducting extracorporeal

fertilization (patent RU2190978) by preliminary induction of superovulation and transfer of embryos into the uterine cavity, characterized in that at the time of follicular puncture, separate preovulatory oocytes and follicular fluid are aspirated from the right and left ovaries, the activity is determined in it proteolytic enzymes - acid peptide hydrolases and transfer of embryos into the uterine cavity are carried out on the side of the endometrium, ipsilateral to the ovary, where the activity of peptide hydrolases exceeded by 20 mg / ml for 1 h or more the corresponding indicator of another ovary.

The transfer of embryos into the uterine cavity takes place on a gynecological chair using a special plastic catheter, without expanding the cervix and other traumatic procedures (see solutions W09937348, US6010448, US6610005, WO2009104093, US2009299129; these methods were selected as prototypes). After the embryo transfer, the woman is in the clinic for 3 hours and then continues to be observed by the doctor with a successful pregnancy. All stages of artificial insemination - stimulation of the ovaries, ovarian puncture, embryological selection of the obtained eggs, joint cultivation of eggs and sperm in the laboratory for fertilization and development of the embryo, transfer of embryos into the uterine cavity are under the direct supervision of a doctor.

However, after the transfer of embryos into the uterine cavity of a woman, the process of implantation (engraftment) of fertilized eggs to the endometrium is not controlled and does not respond to the manipulations of a doctor. In this regard, the possibility of successful implantation is 5-7%, which, of course, is very small.

The technical result of this solution is to increase the possibility of successful implantation of the embryo to the endometrium with its subsequent development.

Those. provides improved "adhesion" of the embryo transferred to the uterine cavity with pre-caecum endometrium, which is a very important point in the process of in vitro fertilization.

The claimed technical result of improving blastocyst implantation to the endometrium is achieved by creating air pressure in the uterine body cavity, due to which close contact and fusion of the blastocyst with

endometrium and subsequent implantation.

The embryo implant is made up of a container with a compressed sterile air mixture and a disposable sterile plastic uterine

the tip, which is made with the possibility of mounting on the cylinder head, and in the distal part of the uterine tip is a protective mesh-divider, made with the possibility of preventing the exit of a direct stream of air.

The composition of the air mixture is selected from a ratio of 89% oxygen and 11% nitrogen.

Brief Description of the Drawings

In FIG. 1 shows a structural device for an embryo implant (side view) (a) a device for a disposable sterile plastic tip (b) for introducing implantable embryos into the cervix, where 1 is a balloon with a compressed sterile air mixture (composition: 89% oxygen + 11% nitrogen) designed for 1-2 injections (under a pressure of 1 atmosphere), 2 - a plastic tip for spraying an air stream, 3 - a protective mesh-divider, having the form of a cap

fixed on the distal part of the uterine tip, 4 - the lever for discharging the mixture from the balloon, 5 - the end, sitting on the nose of the balloon, 6 - the end having a cone-shaped expansion, pressed against the external opening of the cervical canal of the cervix, 7 - an opening in the conical end, 8 - nozzles-splitters jets of the air mixture in a protective mesh.

In FIG. 2 shows the position of the embryo in the uterine cavity after administration through the catheter, where 9 are the mucous membranes of the uterus, 10 is the embryo.

In FIG. 3 shows the insertion of the implant tip into the uterine cavity through the cervix and injection of the air mixture, where 11 is the cervix.

The embryo implant (Fig. 1) consists of a balloon (1) with compressed sterile air (composition: 89% oxygen + 11% nitrogen), designed for 1-2 air injections into the uterine cavity. A special disposable sterile plastic uterine tip (2) is attached to the cylinder, which is mounted on the cylinder head with a tubular end (5). On the distal part of the uterine tip is a protective mesh-divider (3), which prevents a direct stream of air from entering the uterine cavity and helps to create uniform pressure in the uterine cavity.

The composition of the air mixture is selected empirically from a ratio of 89% oxygen and 11% nitrogen. This composition of the mixture provides minimal harm to the embryo.

However, the composition of the mixture may be different. It does not significantly affect the embryo. The principle of operation of the device is as follows.

After successful in vitro fertilization and transfer of embryos into the uterine cavity (Fig. 2), the implant tip (2) is inserted into the uterus through the cervix (11), pressing against

the external opening of the cervical canal of the cervix with a conical tip (6), which helps to keep the air mixture from escaping through the cervix (11) and ensures the formation of air pressure in the uterine cavity.

Then, acting on the lever (4), the air mixture is injected from the balloon (1) through the tip (2) into the uterine cavity (Fig. 3), where it is uniformly blown into the cavity through the dissecting mesh (3) and creates air pressure, which contributes to that the embryo is slightly pressed against the mucous cavity (9) of the uterus and is more successfully fixed on the mucosa.

Since the pressure in the uterine cavity (see Fig. 3) promotes closer adhesion of the embryo (10) to the mucous cavity (9) of the uterus, this allows a higher probability of implantation of the embryo and a better end result in the process of artificial insemination (IVF).

The mucous membrane of the endometrium (9) of the uterine cavity, to which the blastocyst is implanted in women of the reproductive period, consists of 2 layers: the basal, 1-1.5 cm thick, located on the inner layer of the myometrium and

functional layer, the thickness of which varies from the day of the menstrual cycle from 1 mm to 8 mm. In the phase of secretion, under the influence of edema of the endometrium, the argyrophilic fibers of the reticular fibrous structure of the endometrium move apart and are densely located around the vessels and glands. Under normal conditions, branching of the glands does not occur, but in the phase of secretion in the functional layer, a deep spongy layer forms, where the glands are more closely located and the surface compact layer, in which the cytogenic stroma predominates. The surface epithelium in the proliferation phase is functionally and morphologically similar to the glandular epithelium. But with the onset of the secretion phase, changes occur in it that contribute to easier adhesion of the blastocyst with the endometrium and subsequent implantation and development of the embryo.

The most vulnerable stage of the in vitro fertilization (IVF) program at the moment is the period of transfer of the embryo into the uterine cavity with

its subsequent implantation (see [1-7] and Fig. 2). Reasons for Impossibility embryo implantations are numerous (from embryo abnormalities to endometrial abnormalities) and are described in scientific works of various authors [1-7], but no one

such an important factor is noted as the initial close mechanical adhesion of the blastocyst with endometrium and its subsequent implantation.

Successful in vitro fertilization and transfer of embryos into the uterine cavity does not always end with the onset of a desired pregnancy (successful result from 4 to 15%). And, of course, one of the many factors of failure may be the absence at the initial stage of close contact of the implantable embryo with the pre-caecum endometrium.

This device solves the problem of closer adhesion of the embryo with

endometrium.

Information sources:

1. Khondrikov N.I. (1989) Biopsy in gynecological practice. Obstetrics and

gynecology, 4; 68-74

2. Nakajima S.T., Molley M.N., Oi R.H., Ohlson K.A., Arevedo S.A., Boyers S.P. (1994) Clinical evaluation of luteal function. Obstetrics # Gynecology 84 (2); 219-221

3. Bonhoff A., Naether 0., Johannison E., Bohnet H.J. (1993) Morphometry

characteristics of endometrial biopsies after different types of ovarion stimulation for infertility treatment. Fertility # Sterility, 59 (3); 560-566

4. Nikitin A.I. Failure factors in an assisted reproduction program.

Reproduction Problems, 1995. - N22. - from. 36-43

5. Klentzoris L.D., Li T.S., Doekeryet A. Endometrial morphology: a predictive factor of pregnancy rate in infertile women. Hum. Reprat. - 1990. - Suppl. 1. - p. 52-66

6. Anshina M.B., Zdanovsky B.M. If you need a baby. M., 1998, 32s.

7. In vitro fertilization and its new directions in treatment

Female Infertility (Theoretical and Practical Approaches): A Guide for Physicians / Edited by V.I. Kulakova, B.I. Leonova - M., 2001, 782 p.

Claims

FORMULA

The embryo implant is made up of a container with a compressed sterile air mixture and a disposable sterile plastic uterine tip, which is designed to fit onto the cylinder head, and in the distal part of the uterine tip there is a protective mesh-divider, made with the possibility of preventing the direct air stream.

The embryo implant according to claim 1, characterized in that the composition of the air mixture in the balloon is selected from a ratio of 89% oxygen and 11% nitrogen.