DEVICE FOR CARRYING OUT ECHO-HYSTEROSALPINGOGRAPHY (ECHO-HYSTEROPROBE)

Abstract

The utility model relates to medicine, namely to auxiliary devices for echohysterosalpingography (EchoHSG) and echohysterography, and can be used to diagnose uterine and tubal factors of female infertility. The device is designed as a hollow plastic tube (1) with two unconnected channels (2, 3) in the proximal section, equipped with connectors (4, 5) for syringes. A movable limiting clamp (7) is mounted on the tube and can be fixed at the required distance from the distal end. A triangular latex balloon (6) is located at the distal end, simulating the anatomy of the lower third of the uterine cavity. The balloon is inflated with saline solution through channel (3), and a contrast medium is introduced through the through channel (2).The use of the device allows for minimizing pain (46% reduction according to VAS), eliminating contrast backflow, creating optimal pressure for assessing the patency of the fallopian tubes, and increasing the information content of echo-HSG.

Description

[0001] The utility model relates to the field of medicine, namely to auxiliary medical devices (products) for use in the clinical practice of a gynecologist and an ultrasound diagnostic physician performing echohysterosalpingography (EchoHSG), echohysterography, and can be used to introduce a contrast solution into the uterine cavity and fallopian tubes for the purpose of diagnosing uterine and / or tubal factors of female infertility during an ultrasound examination of the pelvic organs.

[0002] Uterine cavity pathology and tubal factors are the most common causes of female infertility. Modern diagnostic standards include X-ray hysterosalpingography, echohysterosalpingography, and chromohydrotubation. EchoHSG using contrast agents (HyCoSy) has high sensitivity (94%) and is readily available, making it a routine method for assessing tubal patency.

[0003] Various types of devices for hysterosalpingography are known: metal (Schulze device, traumatic) and polymer balloon catheters. The closest analogue (prototype) is the device patented by RU2363503, published on August 10, 2009, which contains an elastic catheter with two channels, a cylindrical cuff, and a limiter. However, these known solutions have drawbacks: the spherical or cylindrical shape of the balloon causes excessive distension of the uterine cavity, discomfort for the patient, insufficient sealing, and a risk of catheter displacement.

[0004] Problem of the utility model

[0005] Elimination of the shortcomings of the prototype and known solutions, namely: ensuring reliable fixation, sealing the uterine cavity, creating optimal pressure for the passage of contrast, reducing discomfort for the patient.

[0006] Technical results: increasing the reliability of the echohysteroprobe fixation, ensuring reliable sealing of the uterine cavity, creating optimal pressure for the passage of contrast through the fallopian tubes, reducing the level of discomfort for the patient (by at least 46% on the visual analogue scale) and increasing the diagnostic accuracy of the EchoHSG method.

[0007] Brief description of drawings

[0008] Fig. 1 shows the assembled device of the utility model.

[0009] Figure 2 shows the echohysteroprobe device installed in the uterine cavity and the principle of its use.

[0010] Example 1:

[0011] Fig. 3 - Uterine cavity. 3D RealisticVue visualization mode. Coronal section.

[0012] Fig. 4 - Contrasting the uterine cavity with sodium chloride solution using an echohysteroprobe. The echohysteroprobe is inserted into the cervical canal.

[0013] Fig. 5 - Endometrial polyp. Contrast of the uterine cavity with sodium chloride solution. 2D EchoHSG color Doppler imaging mode. Transverse scanning of the uterine cavity.

[0014] Fig. 6 - Visualization of both patency of fallopian tubes. 3D EchoHSG Contrast visualization mode, using the RealisticVue module.

[0015] Example 2:

[0016] Fig. 7 - Uterine cavity. 3D visualization mode. Coronal section.

[0017] Fig. 8 - Contrast enhancement of the uterine cavity with sodium chloride solution using an echohysteroprobe. The echohysteroprobe is inserted into the uterine cavity at the level of the internal os. A - sagittal section, B - coronal section.

[0018] Fig. 9 - Intrauterine adhesion. Contrast of the uterine cavity with sodium chloride solution using an echohysteroprobe. The echohysteroprobe is inserted into the uterine cavity at the level of the internal os. Coronal section.

[0019] Fig. 10 - Visualization of a patent right fallopian tube. The left fallopian tube is obstructed at the interstitial level. 3D EchoHSG Contrast visualization mode.

[0020] Fig. 11 - Visualization of contrast in the periovarian space: A - accumulation of contrast periovarian on the right, B - no accumulation of contrast periovarian on the left. 2D EchoHSG Contrast visualization mode.

[0021] List of main elements of the device (in Fig.1-3): 1 - hollow tube made of hard plastic; 2 - channel for introducing contrast medium into the uterine cavity (through); 3 - channel for inflating the balloon; 4 - connector with valve for a syringe with contrast solution; 5 - connector with valve for a syringe with saline solution for inflating the balloon; 6 - triangular latex balloon; 7 - limiting retainer (movable, disc-shaped).

[0022] Implementation of a utility model

[0023] The device according to the utility model (see Fig. 1) is a hollow tube (1) made of hard plastic, with two unconnected channels (2, 3) in the proximal section, equipped with connectors (4, 5) for connection with syringes. At the distal end of the echohysteroprobe, a triangular-shaped latex balloon (6) is placed, inflated with a physiological sodium chloride solution supplied with a syringe through one of the channels (3). The other channel (2) (through) is used to introduce a contrast medium into the uterine cavity. For fixation, the echohysteroprobe is equipped with a movable limiting clamp (7), mounted on the tube with the ability to fix at the required distance from the distal end.

[0024] The new feature is the triangular shape of the balloon (6), with its apex directed toward the internal os, mimicking the anatomical shape of the lower third of the uterine cavity (see Fig. 2). The triangular balloon, inflated at the level of the lower third of the uterine cavity, and the disc-shaped limiting retainer (7) positioned at the external os, provide secure fixation, preventing displacement toward the fundus of the uterus or into the cervical canal.

[0025] Experimental studies have shown that the echohysteroprobe can be manufactured with a central hollow tube diameter of 5F and 8F and a triangular balloon volume of 1.5 ml and 2.0 ml, respectively. To diagnose the condition of the lower third of the uterine cavity and cervical canal, the balloon must be deflated at the end of the examination.

[0026] The triangular balloon follows the anatomical shape of the lower third of the uterine cavity. This ensures:

[0027] minimization of excessive stretching of the uterine walls → reduction of pain;

[0028] uniform adherence of the balloon to the walls of the uterine cavity → reliable sealing;

[0029] the ability to maintain stable pressure when introducing contrast → reliable assessment of tubal patency.

[0030] The movable limiting clamp is installed at the level of the external os and, together with the inflated triangular balloon (fixed at the level of the internal os), creates bilateral fixation of the device. This prevents:

[0031] displacement of the probe towards the fundus of the uterus (prevents trauma);

[0032] extending the probe into the cervical canal or vagina (maintains tightness and position).

[0033] The hollow tube made of hard plastic and the presence of two independent channels ensures:

[0034] sufficient rigidity to pass through the cervical canal even with cicatricial changes;

[0035] Separate supply of balloon inflation fluid and contrast agent (functional reliability).

[0036] Thus, the combination of features “triangular cylinder + limiting clamp + hard plastic tube with two channels” ensures the achievement of the stated technical result.

[0037] Algorithm for performing EchoHSG using the device:

[0038] Overview transvaginal ultrasound of the pelvic organs.

[0039] Installation of a disposable gynecological speculum according to Cusco, treatment with an antiseptic.

[0040] Passing an echohysteroprobe through the cervical canal and installing it at the level of the lower third of the uterine cavity, sealing it by inflating the balloon.

[0041] Fixing the catheter with a limiting clamp at the level of the external os.

[0042] Introduction of contrast solution into the uterine cavity, assessment of intrauterine pathology, archiving.

[0043] Evaluation of contrast passage through the fallopian tubes in 2D / 3D mode, archiving.

[0044] Balloon deflation for evaluation of the lower third of the uterine cavity and cervical canal, archiving.

[0045] Removal of the catheter.

[0046] Registration of the conclusion.

[0047] Clinical Cases

[0048] Example 1

[0049] Patient K., 34, consulted an obstetrician / gynecologist in the Center's Consultative and Diagnostic Department complaining of a three-year marriage without pregnancy. Her gynecological history is unremarkable. Parity is 0.

[0050] The patient was offered a plan for clinical and instrumental examination for pre-gravid preparation, which included contrast echohysterosalpingography to assess the condition of the uterine cavity and the patency of the fallopian tubes.

[0051] On December 13, 2024, a contrast echohysterosalpingography was performed using a balloon echohysteroprobe, which resulted in data on the presence of intrauterine pathology (endometrial polyp) and freely passable both fallopian tubes.

[0052] Premedication: tab. No-shpa

[0053] The study was conducted in a manipulation room.

[0054] Before the start of the study, the results of a smear test for the degree of purity of the vagina (2nd degree of purity) and a blood test for syphilis, hepatitis B and C, HIV infection (negative) were obtained.

[0055] Research progress

[0056] A 2D / 3D ultrasound examination of the pelvic organs was performed with the patient lying supine. No pelvic pathology was detected. Photo and video files have been archived (Fig. 3).

[0057] Treatment of the external genitalia with an antiseptic solution (Octenisept) and insertion of a disposable Cusco speculum with a fixator (registration certificate No. 2018 / 7077) to expose the cervix. The vagina and cervix are treated with an antiseptic solution (Octenisept).

[0058] Ultrasound-guided probing of the cervical canal with a Sims probe. The cervical canal is patent and 4.0 cm long.

[0059] Under ultrasound guidance, an echohysteroprobe was inserted into the uterine cavity at the level of the internal os and secured by inflating the balloon and positioning a movable stop at the level of the external os. The balloon was inflated by injecting 1.5 ml of 0.9% sodium chloride solution through a dedicated channel on the echohysteroprobe, which was equipped with a connector for connection to a syringe.

[0060] Removal of the Cusco gynecological speculum with a retainer (registration certificate No. 2018 / 7077) and installation of a transvaginal ultrasound sensor into the vagina.

[0061] Through the second dedicated channel of the echohysteroprobe, equipped with a connector for connection to a syringe, a 0.9% sodium chloride solution in a volume of 3.5 ml was introduced into the uterine cavity, which made it possible to achieve a divergence of the anterior and posterior layers of the endometrium by 1.0 cm for reliable contrasting of the uterine cavity in order to assess intrauterine pathology (Fig. 4).

[0062] In the projection of the left uterine angle, a polyp-like structure of 0.7 cm in diameter with a blood flow locus was detected in the color Doppler imaging mode (Fig. 5).

[0063] No backflow of contrast solution from the uterine cavity into the cervical canal was observed.

[0064] Archiving photo and video files.

[0065] After assessing the condition of the uterine cavity using a 0.9% sodium chloride solution, an echo-positive contrast solution “Sonovue” (Bracco, Italy) was introduced into the same channel of the echohysteroprobe at a rate of 1.5 ml of the prepared “Sonovue” solution in 15.0 ml of saline.

[0066] The interstitial sections of both fallopian tubes were unremarkable. Contrast flow through the left and right fallopian tubes was clearly visible as a hyperintense substance moving from the uterine cavity into the fallopian tubes, filling their lumen (approximately 1 mm wide in the isthmic section and up to 10-12 mm wide in the ampullar section) (Fig. 6).

[0067] Accumulation of contrast was noted periovarianly on the right and left and in the retrouterine space.

[0068] Archiving photo and video files.

[0069] Release the balloon contents, remove the catheter from the uterine cavity and the transvaginal ultrasound probe from the vagina.

[0070] The total volume of contrast injected is 18.5 ml

[0071] No blood loss.

[0072] Study duration 30 min.

[0073] Consultation with a gynecologist-surgeon is recommended.

[0074] Example 2

[0075] Patient N., 27, consulted an obstetrician / gynecologist in the Center's Consultative and Diagnostic Department complaining of a two-year marriage without pregnancy. Her medical history included separate diagnostic curettage of the cervical cavity and canal for a missed abortion at 6 weeks. Parity: 1.

[0076] The patient was offered a plan for clinical and instrumental examination for pre-gravid preparation, which included contrast echohysterosalpingography to assess the condition of the uterine cavity and the patency of the fallopian tubes.

[0077] On December 21, 2024, a contrast-enhanced echohysterosalpingography (EEG) was performed using a balloon echohysteroprobe. This revealed intrauterine adhesions and an obstructed left fallopian tube at the interstitial level. The right fallopian tube is patent for contrast.

[0078] Premedication: tab. No-shpa

[0079] The study was conducted in a manipulation room.

[0080] Before the start of the study, the results of a smear test for the degree of purity of the vagina (grade 2 purity) and a blood test for syphilis, hepatitis B and C, HIV infection (negative) were obtained.

[0081] Research Progress

[0082] A 2D / 3D pelvic ultrasound was performed with the patient in the supine position. A suspected intrauterine adhesion was identified in the left uterine angle.

[0083] Archiving photo and video files (Fig. 7).

[0084] Treatment of the external genitalia with an antiseptic solution (Octenisept) and insertion of a disposable Cusco speculum with a fixator (registration certificate No. 2018 / 7077) to expose the cervix. The vagina and cervix are treated with an antiseptic solution (Octenisept).

[0085] Ultrasound-guided probing of the cervical canal with a Sims probe. The cervical canal is patent and 4.0 cm long.

[0086] Under ultrasound guidance, an echohysteroprobe was inserted into the uterine cavity at the level of the internal os and secured by inflating the balloon and positioning a movable stop at the level of the external os. The balloon was inflated by injecting 1.5 ml of 0.9% sodium chloride solution through a dedicated channel of the echohysteroprobe, equipped with a connector for connection to a syringe (Fig. 8).

[0087] Removal of the Cusco gynecological speculum with a retainer (registration certificate No. 2018 / 7077) and installation of a transvaginal ultrasound sensor into the vagina.

[0088] Through the second dedicated channel of the echohysteroprobe, equipped with a connector for connection to a syringe, a 0.9% sodium chloride solution in a volume of 2.5 ml was introduced into the uterine cavity, which made it possible to achieve a divergence of the anterior and posterior layers of the endometrium by 1.0 cm for reliable contrasting of the uterine cavity in order to assess intrauterine pathology.

[0089] Intrauterine adhesion with a thickness of 0.2 cm was detected in the projection of the left uterine angle.

[0090] No backflow of contrast solution from the uterine cavity into the cervical canal was observed.

[0091] Archiving photo and video files (Fig. 9).

[0092] After assessing the condition of the uterine cavity using a 0.9% sodium chloride solution, the echo-positive contrast solution “Sonovue” (Bracco, Italy) was introduced into the same channel of the echohysteroprobe at a rate of 1.0 ml of the prepared “Sonovue” solution in 10.0 ml of saline.

[0093] The interstitial part of the right fallopian tube is unremarkable; on the left, it is not clearly visualized (Fig. 10).

[0094] Contrast flow through the right fallopian tube was clearly visible as a hyperintense substance moving from the uterine cavity, filling the lumen of the tube (approximately 1 mm wide in the isthmic region and up to 10-12 mm wide in the ampullar region). Contrast flow through the left fallopian tube was not detectable from the level of the interstitial region.

[0095] Contrast accumulation was noted periovarianly on the right (Fig. 11) and in the retrouterine space. Contrast was not detected periovarianally on the left.

[0096] Archiving photo and video files.

[0097] Release the balloon contents, remove the catheter from the uterine cavity and the transvaginal ultrasound probe from the vagina.

[0098] The total volume of contrast injected is 12.5 ml

[0099] No blood loss.

[0100] Study duration 30 min.

[0101] Consultation with a gynecologist-surgeon is recommended.

[0102] The echohysteroprobe was tested empirically during clinical studies on 128 patients and showed good results compared to the use of a standard balloon catheter: reliable fixation, sealing, creation of the necessary pressure, a reduction in discomfort by 46% (according to the visual analogue scale), and an increase in diagnostic accuracy were ensured.

Claims

A device for performing echohysterosalpingography, which is a hollow tube made of hard plastic, with two channels in the proximal section that are not connected to each other, equipped with connectors for connection with syringes, on the tube with the possibility of fixing at the required distance from the distal end, a movable limiting clamp is installed, characterized in that at the distal end there is a latex balloon of a triangular shape, simulating the anatomical shape of the lower third of the uterine cavity, inflated with a physiological solution of sodium chloride, supplied through one of the channels, while the other channel is through and serves to introduce a contrast medium into the uterine cavity.

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