RU160731U1 - DEVICE FOR BIOPSY - Google Patents

Abstract

A device for biopsy of biological tissues, consisting of a cylindrical tube with a handle and the presence of a cutting edge with a biopsy gripping mechanism, characterized in that a rod with a similar handle is located inside the tube with a cross handle, on the distal end of which there are two side grooves 2 in length -3 cm with round extensions lying at a distance of 5 mm from each other, which fix two needles, equipped with burrs on the outer ends and holes on the extended proximal wow ends.

Description

The device relates to medicine and is applicable in anatomical studies and clinical practice.

A puncture biopsy is a valuable diagnostic method that allows in most cases to establish the correct diagnosis, determine the most effective further tactics of surgical treatment, chemotherapy and radiation therapy (MF Maksudov, 2010. The leading factors in ensuring the effectiveness and safety of a puncture biopsy are careful adherence to the technique punctures, the right choice of instruments (Yu.E. Chirkov, RP Fedorshin, 2012). Puncture biopsy in anatomical, pathoanatomical and forensic studies It is an important methodological technique for obtaining biological material for cytological and histological studies.

State of the art

To perform a biopsy, the modified suction needles used have a cannula with sharpened sharp edges and tips of various shapes and are designed to take cytological and histological samples (V.G. Ieshin, S.A. Larin, Yu.G. Andreev / Comparative analysis of the safety and effectiveness of needles for aspiration liver biopsy. An experimental study. - Bulletin of new medical technologies. - 2009 - T. XVI, No. 4 - p. 178-182). In the study of the piercing ability of needles, the authors found that the puncture strength of the liver capsule depends on the shape of the sharpening needle. The best stitching ability was noted on a pencil-sharpened needle. The worst stitching ability are needles with trihedral and dihedral sharpening. A single-pointed sharpening needle is intermediate. Applying a grindstone to the edges of a cut of a standard needle does not improve its stitching properties.

These patterns are noted in the study of needles with different diameters. Regardless of the shape of the sharpening of the distal end, an increase in the diameter of the needle leads to a deterioration in its piercing ability. Needles with a diameter of 0.8 mm are most easily pierced by a liver capsule. Cell damage is present at all sharpening angles of the needle.

An aspiration biopsy with a small-diameter cutting needle, using automatic biopsy devices, less damages surrounding tissues and allows obtaining samples for histological examination. (A.O. Kozlov, V.G. Sapozhnikov, D.V. Khaleev, N.N. Khaleeva / Prognostic value of a fine-needle aspiration biopsy with a cutting needle for suspected breast cancer.- Bulletin of new medical technologies. - 2007 - T. XIV, No. 4 - p. 95-98.). A cutting needle biopsy is performed using an automatic Magnum biopsy device (BARD, USA). Special needles for cutting biopsy (BARD, USA) 14G are used, which allow obtaining tissue samples sufficient for histological examination. To obtain material for cytological examination, 2-3 aspirations were performed. Aspiration stops when blood appears in the syringe, since the admixture of blood cells makes cytological examination difficult. Despite the minimal invasiveness of a fine-needle aspiration biopsy with a cutting needle, the obtained biopsy does not allow us to evaluate the anatomical structure of the tissue under study, the spatial structure of the constituent elements and give their morphometric characteristics. A small amount of material obtained is sufficient only for cytological examination.

To perform a biopsy, there are manual and automatic needles of industrial production for trepanbiopsies with a cutting mechanism for obtaining materials of different sizes - 14G, 16G, 17G, 18G and 181 (with an elongated notch) (Yu.E. Chirkov, RP Fedorshin / Needle selection for puncture biopsy under ultrasound monitoring for diffuse glomerulopathy in children / DODATOK. Ukrainian Journal of Nephrology and Dialysis No. 1 (33) 2012. - No. 1. - pp. 58-61.). The diameter of the biopsy needles is divided into needles of small caliber - 25-21 Gauge (0.51-0.82 mm), medium caliber - 20-18

Gauge (0.95-1.25 mm) and large caliber 16-14 Gauge (2.0-1.65 mm). The needle-trepan is represented by two elements - a retractable stylet with a longitudinal recess, and an external hollow needle in which it is located, with a pointed distal part. The process of sampling the material consists in extending the stylet into a biological tissue or organ, after which the hollow needle advances, moving into the stylet and cutting off with a sharp edge tissue that remains trapped in the recess of the stylet. The cavity of the recess is a truncated cylinder, the basis of which is a truncated circle (with the exception of the segment, which falls on the thin part of the stylet). The differences of the needles, first of all, are the differences in the diameters of their stylets, on which the diameter of the biopsy channel depends. The diameters of the stylet differ by 0.5 mm. When using automatic needles, the automatic extension of the stylet of the automatic needle along with the described disadvantages predisposes to more frequent development of hemorrhagic complications. No statistically significant differences were found in the effectiveness and safety of manual and automatic needles.

The volume of the material obtained depends on the length of the notch, the diameter of the stylet and the height of its thin part, the elastic qualities of the layers and structures of the tissue under study. Significant trauma and deformation of the biopsy tissue are observed.

The use of a trocan trepan biopsy followed by cytological and histological examination of the material is of greater diagnostic significance in the verification of pathological processes compared to fine-needle aspiration biopsy (Yu.A. Ragulin, V. S. Usachev. Transthoracic biopsy in the diagnosis of pulmonary masses / Siberian Oncology Journal, 2011. - Appendix No. 1. - p. 96-97.).

Semi-automatic cutting needles of the True-Cut type (caliber 14G) with a harpoon-type mandrel, which allow you to get fabric columns up to 2 cm long and up to 1.2 mm thick. (A.K. Vdovin, S.V. Akulenko, D.V. Safonov. Percutaneous puncture core biopsy of the kidney in diffuse diseases / Clinical Medicine. - 2013 - Volume 5, No. 3. - S. 39-44). The device fixes the captured fabric, equipped with a depth limiter for maximum immersion. However, their design allows a biopsy of only soft, elastic tissues with pronounced turgor.

Closest to the proposed device is a Jamshidi needle for bone biopsies (A.Yu. Mushkin et al. Percutaneous puncture trepanobiopsy for lesions of the spine in children / Spinal Surgery. - 2/2009 - p. 62-67). Jamshidi needles for bone biopsies have three sizes, varying in diameter and length. The features of the Jamshidi biopsy needle are as follows:

the presence of a pointed mandrel, facilitating the introduction of the needle into the bone to the required depth until it stops directly against the needle itself; cross section of the sharpened tip, preventing its deformation;

the presence of a massive transverse handle, convenient for positioning in the surgeon's hand and allowing you to create sufficient axial and rotational force;

narrowed for 7-10 mm from the tip of the needle its inner lumen;

the presence of an ejector that extrudes the biopsy material from the needle.

In addition, in the latest generation of Jamshidi needles, there are through lateral openings in the tip of the needle, which allow, on the one hand, to stick the biopsy material more firmly during manipulation, and on the other hand, when it is pushed out, it is possible to partially separate (squeeze out) the soft tissue component of the contents.

The disadvantages of devices with cutting properties are as follows. In practice, the notch of the stylet is not always entirely filled with material. The degree of filling depends on the type of needle, the skill of the operator, possibly on the properties of the punctured fabric. It is usually necessary to obtain several biopsies in the organ or biological tissue under study. Therefore, it is impossible to obtain biopsy specimens of the same size and volume. This significantly affects the subsequent study of biological material, since a complete morphological analysis requires light-optical with staining according to different methods, immunohistochemical and electron-microscopic studies, which require a sufficient amount of material obtained from trepanbiopsy. It is relevant to ensure a uniform shape and size of the obtained biopsy specimens for their comparative characterization in serial biopsies, to determine the spatial structure of anatomical structures, and their position in the human body.

The objective of the proposal is to create a device for biopsy of biological tissues of any density, providing multiple sampling of the material, obtaining the selected material of a certain volume and shape while maintaining its spatial orientation when removed from the device.

The novelty of the utility model lies in the fact that a device for biopsy of biological tissues is proposed, the design of which provides a biopsy sample in the form of a cylinder of a given length. The device allows for multiple sampling of material from biological tissues of small thickness while maintaining the mutual spatial orientation of the collected biopsy specimens.

Disclosure of the invention:

A device for biopsy of biological tissues, consisting of a cylindrical tube with a handle and the presence of a cutting or sawing edge with a biopsy gripping mechanism, characterized in that a rod with a similar handle is located inside the tube with a cross-shaped handle, on the distal end of which there are two side grooves in accordance with the handle 2-3 cm long with round extensions lying at a distance of 5 mm from each other, which fix two needles, equipped with burrs on the outer ends and holes on the extended proximal ends.

The device consists of a cylindrical tube (Fig. 1, pos. 1) with a cross-shaped handle fixed at one end (Fig. 1, pos. 3), and a working part in the form of a pointed (cutting) edge or gear (sawing) (Fig. 1 , item 2). Inside the tube is a locking rod (Fig. 1, item 5). At the proximal end of the rod there is a cruciform handle (Fig. 1, item 4), compatible with the handle on the tube, which allows you to orient the rod in relation to the tube. At the distal end of the rod, in accordance with the two transverse crossbars of its handle, there are lateral longitudinal grooves 2-3 cm long with round extensions alternating through 5 mm (Fig. 1, item 6). Before work, fixing needles are installed in the grooves (Fig. 1, item 7), on the distal (working) ends of which there are burrs of the “fishing hook” type, which allow holding the biopsy. At the proximal ends of the needles, there are extensions, in diameter corresponding to the extensions in the grooves of the rod, ensuring the fixation of the needle in the groove to a predetermined depth. Holes were made in the center of the needle extensions for subsequent threading through the biopsy sample.

The penetration of the device through tissues of different densities is due to the cutting or sawing edges of the tool and the presence of a handle for applying pressure and rotation of the tube. In this case, the needle of the rod penetrates into the biopsy specimen to a predetermined depth. The rod with needles during rotational movements of the tube retains its position by holding it by the researcher in a certain direction of its handle and fixing it with needles. The collected material has a cylindrical shape and a predetermined length. This is achieved by the diameter of the cutting tube and the device of the side grooves of the rod for fixing different lengths of the protrusion of the needles. The burrs of the needles hold the biopsy and facilitate its extraction by tearing it from the underlying tissues. Repeated sampling of the material allows one-dimensional material to be sequentially accumulated on the needles, and when removing biopsy samples from the device, fix it with threads inserted into the holes of the needles. Preservation of the spatial orientation of the rod handle and the angle of inclination of the device to the surface of the test tissue during repeated trepanobiopsy ensures the fixation of all biopsy samples of the same size on two strands in a certain spatial position. This makes it possible to produce histological preparations of biopsy samples or histotopograms with their identical sequential position on one slide and a certain spatial position. Histological processing of all biopsy specimens takes place simultaneously under the same technological conditions. Preservation of the orientation of the material being taken with respect to the human body and the possibility of determining the spatial position of the studied object on histotopographic preparations allows us to study its topography.

The method is as follows.

The rod with needles is removed from the tube, the needles are installed in the longitudinal lateral grooves of the rod for a certain protrusion length from the end of the rod. The rod is inserted into the tube. The device is installed perpendicular to the surface of the test tissue, organ or body. The rod handle is fixed in a predetermined direction relative to the position of the organ or body to maintain the spatial orientation of the biopsy. By pressure and rotation of the handle of the tube, the device is immersed until it stops in the test tissue to a depth equal to the distance between the ends of the tube and the shorter shaft. The needles hold the biopsy sample and, when the device is removed, tear it away from the underlying tissue. If the length of the biopsy is less than the length of the protruding needles, a second biotrepanation of the next tissue site is possible. During biotrepanation of film, lamellar or thin tissues with underlying loose tissue (skin, stomach, intestine, etc.), repeated repeated biotrepanation of tissues becomes possible.

The technical result is ensured by the ability of the biopsy device to reliably extract the test material from the tissue, to obtain one or more biopsy samples of the same geometry, fixed on two strands while maintaining the spatial position of the studied anatomical object.

Application example

1. A single biotrepanation of the sphenoid sinus, hip joint. For biotrepanation of tissues with different densities, a device with a cutting edge of the tube body in the form of pointed teeth is used (Fig. 2). Cartilage and bone tissue are sawn through simultaneous pressure and rotation of the handle of the body-cutter (Fig. 3). In the process of through cutting of the bone, a round sawdust is formed, which makes it possible to separate the biopsy specimen from the surrounding tissues, and the fixing needles ensure its extraction (Fig. 4). When removing the needles, yarns are held in their place to preserve the spatial orientation of the object in the process of further processing and research.

2. Repeated serial biopsy of the skin of the perineum, small intestine. During biopsy of soft multilayer tissues, the pointed edge of the tube-case without teeth is used (Fig. 5). Penetration of retaining needles through the test tissue (skin, intestinal wall) ensures the extraction of the biopsy specimen and its fixation on the needles. A repeated biopsy of other areas of the investigated object is performed. The number of repeated biopsies is determined by the set length of the needles on which the extracted biopsies are sequentially placed. When removing the needles, yarns are held in their place to preserve the spatial orientation of the objects in the process of further processing and research.

Thus, all biopsy specimens of the same shape and size are sequentially located on two strands. This ensures their simultaneous processing in the manufacture of histotopographic preparations, the placement of all identically stained sections of biopsy specimens on one glass while maintaining their ordinal and spatial location.

The developed device for biopsy of biological tissues of any density provides multiple sampling of the material, allows you to get the selected material of a certain volume and shape while maintaining its spatial orientation when removed from the device, simplifies the subsequent histological examination of the collected material.

Literature

M.F. Maksudov. Information and safety of a transthoracic biopsy of the volumetric formations of the chest organs performed under the control of computed tomography / Medical Imaging, 2010. - No. 2. - from. 33-38.

V.G. Ivshin, S.A. Larin, Yu.G. Andreev / Comparative analysis of the safety and effectiveness of needles for aspiration liver biopsy. Experimental study. - Bulletin of new medical technologies. - 2009 - T. XVI, No. 4 - p. 178-182.

A.O. Kozlov, V.G. Sapozhnikov, D.V. Khaleev, N.N. Khaleeva / Prognostic value of a fine-needle aspiration biopsy with a cutting needle for suspected breast cancer. - Bulletin of new medical technologies. - 2007 - T. XIV, No. 4 - p. 95-98.

Yu.E. Chirkov, R.P. Fedorshin / Selection of a needle for a biopsy under ultrasound guidance for diffuse glomerulopathies in children / DODATOK. Ukrainian Journal of Nephrology and Dialysis No. 1 (33) 2012. - No. 1. - from. 58-61.

Yu.A. Ragulin, V.S. Usachev. Transthoracic biopsy in the diagnosis of lung masses / Siberian Oncology Journal, 2011. - Appendix No. 1. - from. 96-97.

A.K. Vdovin, S.V. Akulenko, D.V. Safonov. Percutaneous puncture core biopsy of the kidney in diffuse diseases / Clinical medicine. - 2013 - Volume 5, No. 3. - from. 39-44.

A.Yu. Mushkin et al. Percutaneous puncture trepanobiopsy for lesions of the spine in children / Spinal surgery. - 2/2009. - from. 62-67.

Claims (1)

A device for biopsy of biological tissues, consisting of a cylindrical tube with a handle and the presence of a cutting edge with a biopsy gripping mechanism, characterized in that a rod with a similar handle is located inside the tube with a cross handle, on the distal end of which there are two side grooves with a length of 2 -3 cm with round extensions lying at a distance of 5 mm from each other, which fix two needles, equipped with burrs on the outer ends and holes on the extended proximal wow ends.

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