RU2785353C1 - Device for perforating human or animal skin biopsy - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: invention relates to medical equipment, namely to a device for perforating human or animal skin biopsy. The device for perforating human or animal skin biopsy contains a handle and a hollow metal cylinder with a cutting working end. The cylinder has a vertical slot for its entire length. One edge of the slot protrudes 0.5 mm and has an angle of 45°. The non-working end of the cylinder is soldered into the handle.

EFFECT: use of the invention makes it possible to reduce the traumatism of the biopsy and improve the quality of the biopsy.

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Description

The present invention relates to medicine, namely to dermatology, cosmetology, plastic surgery, pathological physiology, pathological anatomy, morphology (histology), veterinary medicine.

Histological examination of the skin is one of the most reliable, informative and visual diagnostic methods in demand in many areas of medicine and veterinary medicine.

Some dermatological problems are diagnosed only with the help of a biopsy, and if tumors are detected, a biopsy allows not only to make a reliable diagnosis, but also to choose the optimal chemotherapy regimen or irradiation of a person or animal.

The biopsy provides information about the nature of the abnormality and distinguishes between infections, allergic skin diseases, autoimmune skin diseases and tumors - benign or malignant. By determining the nature of the anomaly, it is possible to determine the most appropriate treatment for this disease. A skin biopsy provides valuable information about the type of cells in an abnormal area of the skin or skin tumor, and it can help determine whether the inflammation poses a serious threat to human or animal health.

The main indications for a biopsy are: inflammatory and precancerous pathologies, non-healing ulcers, inflammatory processes and abscesses, neoplasms, seals, tissue structure disorders.

Currently, the following skin biopsy techniques are used: incisional, excisional, shaver, curettage, excision of a pedicle, perforation (Practitioner's Handbook, translated from English by A.N. Redkin - M.: Litterra, 2005).

The main disadvantage of the above methods, with the exception of perforation biopsy, is the traumatic nature of material sampling, and, as a rule, a noticeable residual cosmetic defect, often unacceptable for the patient, for example, when it comes to facial skin, which significantly limits the use of these diagnostic methods.

Various devices for skin biopsy are known, consisting of a handle and a metal part (dermo-punch) that acts as a cutting element.

It is known, for example, a device for incisional skin biopsy, including a nozzle and a scalpel handle made integral with the nozzle retainer, while the nozzle at the working end has a U-shape, the size of the faces is 3.5 ± 0.5 mm and the protrusions limiting the depth of the injection into the skin, and its upper edge is a cutting element (patent RU 244486 U1, publ. 27.03.2005).

A disadvantage of the known device is the crumpling/deformation of the edges of a part of the obtained biopsy due to the implementation of pressure on the device, which significantly reduces the reliability and accuracy of the subsequent pathomorphological study of the obtained biopsy.

A device for perforating skin biopsy is known, which contains a coaxial outer cannula, an inner stylet with a recess for biopsy, a handle and a trigger located in it. The biopsy cavity is a quarter cylinder. The stylet has a non-working end bent at a right angle and is located inside a hollow cylindrical body and a handle telescopically connected to it with the possibility of reciprocating movement relative to the cannula, which is detachably fixed on the body. A cylindrical stop is installed inside the body. The handle is made in the form of a hollow rod-holder, provided with a removable handle with a ring fixed at its opposite end by a spring placed inside the body coaxially with the stylet, two ring limiters and a slot. The trigger mechanism consists of a button with a blind channel for fixing the curved end of the stylet and a spring element with three protrusions. One interacts with the handle, the second goes around the curved end of the stylet, the third is located in the slot of the holding rod (patent RU 2087130 C1, publ. 1997).

The disadvantages of the known device are the lack of control and dosing of the force of insertion of the internal stylet, which complicates the prognosis for obtaining an intact biopsy.

A device for targeted skin biopsy is known, containing a cylinder consisting of two threaded parts, screwed one into the other; inside one (upper) part, a mechanism is installed containing a movable mirror and a lens (prism), the optical center of which is aligned with the bracket of the digital dermatoscope, mounted at an angle of 45 degrees; the upper part of the tube also has an ultrasound probe holder, which ensures the central position of the probe; the other (lower) part of the cylinder, facing the area under study on the human skin, is an insert with markings and control holes corresponding to the aperture size of the ultrasound sensor (patent RU 205326 U1, publ. 08.07.2021).

The disadvantages of the known device are its high cost and the need for comparison with the ultrasound sensor, which increases both the time of the procedure and the cost of the procedure for the patient.

Closest to the claimed prototype is a device for perforating skin biopsy of humans and laboratory animals, containing a hollow metal cylinder with an inner diameter of 2 mm, the working end of which is sharpened from the side of the lumen with the formation of an internal bevel of the section of the cylinder wall and has eight notches along the perimeter on equal distance from each other. The notches are made to enhance the cutting ability of the edge when performing rotational movements during tissue sampling. The cylinder is fixed on a plastic handle and equipped with a plastic restrictive cuff. The cuff is fixed on the handle in such a way that in the sagittal projection the cylinder protrudes from the cuff by 4-5 mm (patent RU 2468756 C1, publ. 10.12.2012).

The disadvantages of the known device are:

- the device does not provide a skin biopsy that is uniform in area, due to the lack of control over the uniformity of the pressure force to obtain a biopsy;

- low quality of the resulting biopsy specimen, associated with crumpling/deformation of its edges during the biopsy, which greatly complicates the diagnosis, especially if it is necessary to determine the boundaries of healthy and pathological tissue.

The objective of the invention is to develop a device for perforating skin biopsy, easy to manufacture, easy to use, allowing to perform manipulation quickly, with little trauma, with maximum preservation of all parts of the resulting biopsy intact, and also with the possibility of macromorphological evaluation before placing the biopsy in fixative fluids.

EFFECT: reduced biopsy traumatism and improved biopsy quality.

The task is achieved by the proposed device.

In FIG. 1 shows a general side view of the device.

In FIG. 2 shows a view of the metal part of the device (perforator) in the form of a cylinder from the front.

In FIG. 3 is a top view of the cylinder.

The device consists of two rigidly connected parts: a handle made in the form of a pencil (1) and a metal part (perforator), which is a hollow regular cylinder (2), having a vertical slot (3) for the entire length of the cylinder, with one edge of the slot ( 4) protrudes by 0.5 mm and has an angle of 45°. The slot width is 2 mm. The inner diameter of the cylinder bore can be from 1 mm to 12 mm (in 1 mm increments), depending on the purpose of the biopsy. The cylinder (2), made of stainless steel or alloy, has a length of 10-15 mm, and the length of the working (outer) part of the cylinder (perforator) (5) is 4-9 mm, depending on the purpose of the biopsy. The submersible non-working end of the cylinder (6), 6 mm long, is soldered into the handle, providing a strong connection.

The handle (1) provides the most convenient use of the instrument and is the location of the hands of the person performing the manipulation of obtaining and extracting a biopsy. The handle can be made of plastic, plastic or metal.

The proposed design of the device makes it possible to insert the instrument like the first puncture with a longer sharp edge of the slot (which reduces the pressure exerted on the skin and, as a result, keeps the biopsy specimen as intact as possible) and to carry out a corkscrew-like movement of the entire metal part (which allows you to keep the borders adjacent to the metal part as intact as possible). edges of the obtained biopsy). The presence of a slot for the entire length of the perforator allows a preliminary macromorphological assessment of the obtained biopsy material before its placement in fixing media and, if necessary, repeat tissue sampling by adjusting the sampling area.

The device works as follows. After skin treatment and local anesthesia, the device is installed by the handle (1) exactly along the boundaries of the intended sampling volume, perpendicular to the skin surface, then with a sharp elongated edge (4) of the slot (3), the cylinder (2) is corkscrewed into the skin surface until it stops, without pressure, clockwise for the entire length of the metal part, followed by removal of the device along with the resulting biopsy. Then the handle is slightly tilted by about 45° - due to the presence of a sharp elongated edge of the slot, the cylindrical biopsy specimen is cut off from the underlying tissue and is easily removed along with the instrument itself. Due to the presence of a slot for the entire length of the perforator, it is possible to immediately conduct a macromorphological assessment of the resulting biopsy specimen on the spot and then place it in a fixative solution.

The proposed device allows to obtain an intact cylindrical skin sample from the epidermis to the subcutaneous fat (including it), suitable for all types of histological studies. The skin defect formed as a result of taking the material with the proposed device heals on its own, does not need suturing or additional exposure to reduce the area of the defect, forming an inconspicuous normotrophic scar and does not lead to the formation of any noticeable cosmetic skin defect two months after the manipulation.

The defining differences of the proposed device, compared with the prototype, are:

- the device is made with a vertical slot in the cylinder, which allows you to check the adequacy of the obtained material before placing it in fixing media (make its macromorphological assessment), as well as quickly remove it from the device without using additional tools and without causing a traumatic effect on the biopsy itself;

- one edge of the slot protrudes by 0.5 mm and has an angle of 45°, which enhances its cutting ability and allows the sharp edge of the slot to corkscrew the instrument into the skin, without pressure, which reduces damage to the resulting biopsy specimens;

- the absence of sharpened with a decrease in the diameter of the boundaries of the cylinder itself, as in the prototype, allows you to keep the most intact borders of the biopsy adjacent to the walls of the inner diameter of the cylinder.

The invention is illustrated by the following examples of specific application of the device.

Example 1

Patient N. was admitted to the clinic with a suspected 4 mm oval pathological focus in the area of the forearm. For skin biopsy, the inventive device was used with a pencil-shaped handle made of plastic, 80 mm long and 8 mm in diameter, and with a perforating cylinder made of stainless steel, with a cylinder wall thickness of 0.5 mm, having a working length of 7 mm, and the inner diameter of the cylinder bore is 6 mm. The manipulation field was processed according to the clinic method: the sampling area was treated with an aqueous solution of 0.05% solution of chlorhexidine bigluconate and the sharp end (4) of the slot (3) of the proposed device, corkscrew-like screwing into the skin surface until it stops, the material taken for biopsy was separated by cylindrical walls of a metal parts (2) of the device from the surrounding tissues in the horizontal plane from the epidermis to the subcutaneous fat. As a result, an intact trepanation cylindrical skin biopsy was obtained, suitable for all types of histological studies. For the purpose of fixation, the biopsy was placed in a 10% formalin solution and sent to the histological laboratory. Based on subsequent histological studies of the obtained biopsy, the diagnosis was correctly determined and the treatment was adjusted.

Example 2

A skin biopsy was performed on the back of a male Wistar breed, which has a pathological formation of a round shape with a diameter of 1.5 mm. For skin biopsy, the inventive device was used with a pencil-shaped handle made of plastic, with a length of 80 mm and a diameter of 6 mm, and with a perforating cylinder made of stainless steel, with a cylinder wall thickness of 0.1 mm, having a working length of 4 mm , and the inner diameter of the cylinder bore is 2 mm.

The skin of the back of a male Wistar breed, weighing 260 g, was depilated, treated with an aqueous solution of 0.05% solution of chlorhexidine bigluconate, and the sharp end (4) of the proposed device was corkscrewed into the skin surface until it stops, which was accompanied by the separation of the material taken for biopsy by the cylindrical walls of the metal part of the device from the surrounding tissues in a horizontal plane from the epidermis to the subcutaneous fat. As a result, an intact trepanation cylindrical skin biopsy was obtained, suitable for all types of histological studies.

Example 3

A skin biopsy was performed on the front right paw of a cat that had a pathological formation of a round shape with a diameter of 2 mm. For skin biopsy, the inventive device was used with a handle, in the form of a pencil, made of plastic, with a length of 80 mm and a diameter of 6 mm, and with a perforating cylinder made of an alloy of biocompatible titanium with an ultra-low impurity content, with a cylinder wall thickness of 0.1 mm , having a length of 6 mm, and the inner diameter of the cylinder bore is 4 mm.

The skin of the front right paw of a female Felis catus breed (cats), weighing 3260 g, was depilated, treated with an aqueous solution of 0.05% solution of chlorhexidine bigluconate, and the cylinder (2) was corkscrewed into the skin surface with the sharp end (4) of the proposed device until it stops, which was accompanied by separating the material taken for biopsy by the cylindrical walls of the metal part (2) of the device from the surrounding tissues in the horizontal plane from the epidermis to the subcutaneous fat. As a result, an intact trepanation cylindrical skin biopsy was obtained, suitable for all types of histological studies.

The use of the proposed device will allow you to perform a biopsy quickly, less traumatically, with maximum safety of both the biopsy itself and its edges, uniform due to the absence of manual pressure on the skin, with the formation of a minor cosmetic defect.

Claims (3)

1. A device for perforating human or animal skin biopsy, containing a handle and a hollow metal cylinder with a cutting working end, characterized in that the cylinder has a vertical slot for its entire length, while one edge of the slot protrudes by 0.5 mm and has an angle of 45 °, and the non-working end of the cylinder is soldered into the handle. 2. Device according to claim. 1, characterized in that the inner diameter of the cylinder bore is from 1 mm to 12 mm. 3. The device according to claim 1, characterized in that the cylinder has a length of 10-15 mm, and the length of the working part of the cylinder is 4-9 mm.

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