RU236117U1 - DEVICE FOR TAKING BIOPSY FROM THE WALLS OF THE VAGINA AND UTERUS - Google Patents

Abstract

The utility model relates to medical equipment, namely to a device for taking a biopsy from the walls of the vagina and uterus. The device for taking a biopsy from the walls of the vagina and uterus contains a container for taking biopsy material, fixed on a flange with a handle, to which endoscopic forceps and an optical laser with a light guide are attached. The container is provided with a casing, in which an outlet opening is made for the endoscopic forceps and the light guide, as well as an input and output opening for the coagulator electrode. The casing is made cylindrical with a rounded distal part. The container is made with the possibility of movement inside the casing. Use of the utility model allows for safe taking of a biopsy from the walls of the vagina and uterus. 1 Fig.

Description

Field of technology

The utility model relates to medicine, in particular to obstetrics and gynecology and surgery, and can be used to take (perform) a biopsy from the walls of the vagina and uterus.

State of the art

A device for intrauterine biopsy is known from the prior art (see https://www.sigma-med.ru/catalog/ginekologiia/ustroystvo_dlya_vnutrimatochnoy_biopsii_uvb_vektor/?ysclid=maw6qsnpbq462773200), which consists of a tube with a diameter of 3 mm and a length of 265 mm, having a side opening at the distal end, and a rod with a handle. The rod is placed inside the tube. At the distal end of the rod, located in the cavity of the distal end of the tube, there is an elastic scraper with the possibility of its exit beyond the contours of the tube through the side opening. The end of the distal end of the tube has a spherical atraumatic shape, and at its opposite end there is a sealing device (cuff). There is a limiter on the tube.

However, it should be noted that the atraumatic spherical end, although it reduces the risk of perforation, in cases of anatomical anomalies (e.g., saddle-shaped uterus or adhesions in the uterine cavity), the device may not provide sufficient maneuverability, which increases trauma, and due to the small diameter of the tube and the limited stroke of the scraper, there is a high probability of obtaining fragmented or insufficient tissue volume, which reduces the diagnostic value of the study, especially if focal pathologies are suspected (e.g., endometrial cancer). Also, despite the declared minimally invasiveness, the procedure using a mechanical scraper can be more painful compared to aspiration methods.

A cervical sampler is known (see patent RU 2307610, IPC A61B 17/42, published 10.10.2007), comprising a cavity for transporting biological material and a rod provided with a working element in the form of a folding diamond-shaped elastic element with working sides connected to a flexible working rod and covered with a sample-holding material. The sampler is provided with a piston fixed to the rod, installed in a cavity for transporting biological material, made in the form of a tube-container, wherein the free end of the flexible working rod is provided with a teardrop-shaped stopper, placed with the possibility of blocking the opening of the tube-container when the rod is moved, and the sample-holding material is made elastic and absorbent.

However, when using this device, instability of shape during deployment is possible, which reduces the efficiency of collecting material from uneven or hard-to-reach areas of the cervix. The elasticity of the element may be insufficient to adapt to anatomical features (e.g., with inflammation or cicatricial changes), which increases the risk of tissue injury. The mechanism for closing the hole in the container tube depends on the accuracy of the rod movement. Calibration errors can lead to incomplete closure, leakage of biomaterial or contamination of the sample, which is why the probability of the plug getting stuck in the hole due to deformation of the elastic material during repeated use. The elasticity of the material used by the authors does not guarantee reliable retention of tissue fragments or mucus, especially with active movement of the working organ.

A device is known for aspirating the contents of the cervical canal after endocervical curettage (see patent RU 2795079, IPC A61B 10/02, published 04/28/2023), comprising a hollow cylindrical body with a polymer piston installed inside, the distal end of which is narrowed and has an opening, wherein in the distal part of the body there is a lateral opening for collecting material. The opening for collecting material is made in the form of a cutout along the circumference of the tube and located at an angle relative to the plane of the circumference of the tube, wherein in the upper part along the entire cutout there is a protruding rib made of the same material as the material of the body, and the distal end of the device is sealed using a plug made with the possibility of its removal.

However, the angular cutout and the shape of the rib may result in uneven pressure distribution, which reduces the efficiency of aspiration in hard-to-reach areas of the canal. The shape of the rib may injure the walls of the cervical canal during active movement of the device, especially in patients with inflammation or cicatricial changes, and frequent removal of the plug increases the risk of contamination of the internal cavities. If the plug is reusable, its sterilization may be difficult due to the narrow gaps between the plug and the body. Therefore, compared to conventional syringes or vacuum systems, this device has a more complex design, which may be less reliable in emergency situations.

A device is known for taking samples from a body cavity, in particular for taking samples from the vagina and/or cervix (see patent RU 2546430, IPC A61B 10/02, published 10.04.2015), which comprises: a tube having an open proximal end of the tube and an open distal end of the tube; a sample-collecting element; a piston having a proximal end of the piston and a distal end of the piston; wherein the piston is inserted into the tube with the distal end of the piston protruding from the distal end of the tube and serves as a carrier of the sample-collecting element at the proximal end of the tube. Moreover, the piston is capable of moving in the proximal direction (P) inside the tube from a retracted insertion position to an extended sample-collecting position; wherein in the insertion position the sample-collecting element is located inside the tube and protrudes from the tube in the sample-collecting position; and said sampling device is provided with an extension limiter which determines a maximum extension value (Z) by which the sampling element can be extended from the proximal end of the tube; and wherein said extension limiter comprises an extension stop provided inside the tube which, when viewed in the axial direction of the piston, fixes the relative position of the piston relative to the tube at the maximum extension value (Z).

However, when using the developed device, there is a risk of insufficient material collection and difficulties with sterilization. In addition, the lack of smooth control of the advancement speed increases the risk of microtrauma, especially in patients with increased tissue vulnerability, which ensures potential trauma and low compatibility with modern diagnostic protocols.

Revealing the essence

The technical challenge is to develop a device designed to safely take biopsies from the walls of the vagina and uterus.

The technical result consists in anatomically and physiologically safe taking of biopsies from the walls of the vagina and uterus.

The technical result is achieved in that the device for taking a biopsy from the walls of the vagina and uterus, according to the solution, contains a container for taking biopsy material, fixed on a flange with a handle, to which endoscopic forceps and an optical laser with a light guide are attached, the body is provided with a casing, in which an outlet opening is made for the endoscopic forceps and the light guide, as well as an input and output opening for the coagulator electrode, wherein the casing and the container have a shape anatomically similar to the shape of the vagina, and the container is made with the possibility of movement inside the casing.

Brief description of the drawings

The utility model is illustrated by a drawing, which shows the claimed device.

The following positions are indicated on the drawing:

1. container for collecting biopsy material;

2. flange;

3. handle;

4. tip;

5. endoscopic forceps for taking biopsy;

6. optical laser;

7. light guide;

8. casing;

9. casing limiter;

10. outlet for endoscopic forceps and light guide;

11. input hole for the coagulator electrode;

12. outlet for the coagulator electrode;

13. coagulator electrode.

Implementation of a utility model

The device comprises a container for collecting biopsy material 1, secured to a flange 2 with a handle 3 using clips (not shown in the figure) on one side and having a tip 4 on the other side. Endoscopic forceps for taking a biopsy 5 and an optical laser 6 with a light guide 7 (intended for visualizing the walls of the vagina and uterus) located parallel to the endoscopic forceps 5, which extend beyond the container body through the tip 4, are fixedly attached to the flange 2. The container is provided with a casing 8 with a limiter 9, in which an outlet opening for the endoscopic forceps and the light guide 10 is made on the distal part, as well as an inlet 11 and an outlet 12 opening for the coagulator electrode 13. In this case, the container for collecting biopsy material 1 is designed with the possibility of moving inside the casing 8, performing the function of a piston.

The claimed device operates as follows.

The device is sterilized. AminoSorb gel of natural origin based on chitosan aminopolysaccharide is applied to the surface of the casing (15-30 ml of gel concentrate is preliminarily diluted in 100 ml of warm water). The device in the working position (with the forceps extended beyond the casing) is inserted into the patient's vaginal cavity with or without a gynecological speculum. After taking the sample, by pinching with forceps, the sample rolls into the container along the inner surface of the endoscopic forceps through the tip. The sampling site is cauterized with a coagulator electrode.

In this case, the sample taken does not roll out of the container into the tip or the inner surface of the forceps, since the biopsy material passes from the forceps into the container and is fixed inside the container due to the suction of the flange and the handle.

The procedure is performed with visualization of the vaginal and uterine walls using a light guide of an optical laser, activated by a power button located, for example, on the flange (not shown in the figure). Then the device is removed as a whole. To remove the material from the container, it is removed from the casing. It is detached from the flange by opening the clips. After the manipulation, the device is sent for sterilization.

The casing has a shape anatomically similar to the shape of the vagina - cylindrical with a rounded distal part. At the same time, the container has a shape similar to the shape of the casing.

Dimensions of the device elements: length of the biopsy material collection container - 20 cm, length of the casing - 20 cm. The casing and containers are made of medical polystyrene, which is lightweight and durable, quickly acquires body temperature, and has good optical transparency.

An example of application from surgical practice.

Patient: a 33-year-old woman with bleeding after intercourse was referred to the hospital to clarify the causes of non-menstrual bleeding that occurred after intercourse. It was decided that a biopsy of the vaginal and uterine walls was necessary. For this purpose, the cervix was cleaned of mucus with a swab previously moistened in a physiological solution of NaCL. Then, material was collected from the vaginal and uterine walls using endoscopic forceps for taking a biopsy, under the control of an optical laser for visualization of the walls of the uterus and vagina, activated by the power button located on the flange. The collection site was cauterized with a coagulator electrode. Then the claimed device was removed. The material was sent for biopsy, and the device was sent for sterilization.

The developed device combines minimal invasiveness and sampling accuracy, allowing for precise identification of pathological areas of the vaginal and uterine walls (e.g., erosions, ectopia, synechiae, neoplasms), eliminating blind biopsy. Coagulation of the biopsy site immediately after sampling minimizes the risk of intraoperative and postoperative bleeding, which ensures the safety of intrauterine and intravaginal manipulations and is especially important when examining pathologies of the cervix and vagina. Thus, the use of the developed device ensures effective sampling (material), reduced risk of complications and comfort for the patient due to the physiological shape of the developed device. At the same time, sufficiently high visualization allows local removal of pathological foci without disturbing the cellular structure of the surrounding tissues.

Additional advantages of the device: multiple use, compatibility with modern technologies - make the device a promising tool for a high degree of visualization of the pathological process in gynecological practice.

Claims (1)

A device for taking a biopsy from the walls of the vagina and uterus, comprising a container for taking biopsy material, secured to a flange with a handle, to which endoscopic forceps and an optical laser with a light guide are attached, the container is provided with a casing in which an outlet opening is made for the endoscopic forceps and the light guide, as well as an input and output opening for a coagulator electrode, wherein the casing is made cylindrical with a rounded distal part, and the container is made with the possibility of movement inside the casing.