RU198693U1 - NEEDLE FOR ELECTRIC IMPACT ON TUMOR IN THE BODY OF A HUMAN OR ANIMAL - Google Patents

Abstract

The utility model relates to medical technology and can be used for electrical action on various, mainly malignant, tumors in the human body with the aim of killing tumor cells. As a result of using the proposed utility model, a technical result is achieved, which consists in creating a needle for electrical action only on a tumor in the human body and eliminating electrical effects on other tissues in the human body by isolating the spoke sections outside the active zone from other organs. The technical result is achieved by the fact that the needle for electrical action on the tumor in the human body is made in the form of a needle, on the surface of which an insulating coating of poly-para-xylylene with a thickness of 15 μm to 30 μm is applied, the needle is made with a sharpness at one end and has the shape a square bar at the other end, the diameter of the needle being from 0.6 mm to 1.5 mm, the length of the needle being in the range from 80 mm to 300 mm.

Description

The utility model relates to medical technology and can be used for electrical action on various, mainly malignant, tumors in the human body with the aim of killing tumor cells.

Modern medicine is committed to minimally invasive treatments.

Currently, the task is to conduct irreversible electroporation by electrical action on a tumor in the body of humans and animals with minimal surgical intervention and minimal trauma of operations.

Known needle for puncture morphological diagnosis of tumors [1]. The needle contains a tube with three internal channels, two of the three channels are equipped with plugs made of a material permeable to electromagnetic radiation, and the third channel is made through with the possibility of connecting to a syringe. The needle makes it possible to study the characteristics of pathological changes in tissues, but does not provide the possibility of electrical action on a tumor in the human body. The outer diameter of the needle, which is 1.5 mm, creates a corresponding hole in the human body during diagnostics and increases the invasiveness of the operation.

A biopsy needle is also known for biopsy of soft tissue tumors [2]. The needle provides the taking of biopsy material, but does not provide the possibility of electrical impact on the tumor in the human body.

Known needles (Kirschner pins) used in operations on bones when opening a pathological focus [3], [4].

The lack of a smooth insulating coating and the ability to connect to a source of electrical impact does not allow the use of these needles for electrical effects on a tumor in the human body during low-trauma operations.

Known protector to the Kirschner spoke, which is a metal cylinder, put on the ends of the Kirschner spoke [5]. The length of the inner clearance of the cylinder is 3-4 cm. The cylinder provides the ability to close the end part of the Kirschner wire.

The device according to the patent [5] does not provide the possibility of electrical action on a tumor in the human body by introducing a needle through soft tissues.

Known knitting needle for osteosynthesis in the form of a rod with a pointed end, which has a coating in contact with the tissues of the body, which has a developed surface relief, applied by the method of electrospark alloying [6]. For coating, electrodes are used selected from the groups of biocompatible materials: titanium and / or tantalum and / or molybdenum and / or niobium and / or silver. The absence of a thin, smooth insulating coating and elements for connecting to a source of electrical impact on the wire does not allow the wire to be used for electrical action on the tumor.

When conducting a patent search, a prototype of the proposed needle for the same purpose was not identified, namely: a needle for electrical action on a tumor in the human body by introducing a needle through soft tissues.

The problem solved by the utility model is to create a needle for electrical action only on a tumor in the human body and to exclude electrical action on other tissues in the human body by isolating other organs from the spokes outside the core.

To solve this problem, the needle for electrical action on a tumor in the human body is made in the form of a needle, on the surface of which an insulating coating of poly-para-xylylene with a thickness of 15 μm to 30 μm is applied, the needle is made with a sharpness at one end and has the shape of a square rod sections at the other end, the diameter of the needle being from 0.6 mm to 1.5 mm, the length of the needle being in the range from 80 mm to 300 mm, marking is made on the needle to determine the depth of immersion into the body.

The point at the end of the needle can be in the usual needle shape, as well as in the shape of a spear (trocar) or feather.

The essence of the utility model is illustrated by drawings, which show:

in fig. 1 is a side view of the needle;

in fig. 2 - view in section A-A;

in fig. 3 - view along arrow B;

in fig. 4 and 5 - options for sharpening the needle;

in fig. 6 is an example of connecting a needle to an electrical source used to conduct irreversible electroporation.

FIG. 1 are marked:

1 - spoke;

2 - coating on the surface of the spoke 1;

3 - sharpening at the end of the needle 1 for introduction into the tumor;

4 - a protrusion at the other end of the spoke 1 for connection to a source of electrical impact;

5 - marking the needle;

a - the length of the pointed needle 1;

b - the length of the non-insulated section of the spoke 1 from the tip 3 of the spoke 1 to the beginning of the section of the spoke 1, on which the insulating coating 2 is applied;

c - step of marking the needle;

d is the diameter of the needle;

Δ is the length of the active zone of the needle;

l - distance to the beginning of the marking;

L is the length of the needle.

FIG. 2 are marked:

1 - spoke in cross section;

2 - coating on the surface of the spoke 1 in cross section.

FIG. 3 are indicated:

1 - spoke;

2 - coating on the surface of the spoke 1;

4 - a protrusion at the other end of the spoke 1 for connection to a source of electrical impact;

δ is the thickness of the coating 2 on the surface of the spoke 1.

FIG. 4 are indicated:

1 - spoke;

6 - spear-shaped sharpening (trocar).

FIG. 5 indicate:

1 - spoke;

7 - feather-shaped sharpening.

FIG. 6 are marked:

1 - spoke;

2 - coating on the surface of the spoke 1;

3 - sharpening at one end of the needle 1 (inserted into the tumor);

5 - marking the needle;

8 - terminal device for connecting the spoke 1 to a source of electrical impact.

The proposed needle for electrical action on a tumor in the human body is made in the form of a wire 1 (Kirschner wire), on the surface of which an insulating coating 2 is applied (see Fig. 1, 2, 3, 6).

Spoke 1 is made of an elastic conductive material that is resistant to aggressive media, for example, stainless surgical steel in accordance with GOST R ISO 5838-3-2019.

Insulating coating 2 is made of poly-para-xylylene (OST V 107.460007.008-2000). Poly-para-xylylene is chemically inert, has good electrical insulating properties, high elasticity and biocompatibility. Coating 2 is applied to the entire surface of the spoke 1, with the exception of the active zone of length Δ and the projection 4, or only on that part of the spoke that should be electrically isolated from the body tissues when conducting an electrical effect on the tumor.

The coating 2 has a thickness δ of 15 μm to 30 μm. Such a thickness of the coating 2 provides the necessary electrical isolation of the wire 1 from the organs of the human body outside the active zone of electrical action on the tumor and minimal trauma during the operation.

The beginning of the marking 5 with a step c, for example equal to 10 mm, is located at a distance from the end of the tip 1, which can range from two to several centimeters (see Fig. 1). The transparency of the poly-para-xylylene coating 2 ensures good visibility of the markings 5 and other inscriptions on the spoke during operations.

The length L of the needle ranges from 80 mm to 300 mm (see Fig. 1). The specified range of needle lengths L allows reaching tumors in various parts of the human body. To reach tumors in different parts of the human body, it is recommended to have a set of needles, for example, with a length L equal to 80 mm, 100 mm, 150 mm, 200 mm, 250 mm and 300 mm. It is advisable to use needles with a minimum length L when the tumor is not deep from the surface of the human body. In this case, it is possible to influence the tumor with simpler and more accurate manipulations. If the tumor is at a greater distance, it is advisable to use needles with a longer length L.

The diameter d of the needle is between 0.6 mm and 1.5 mm. The specified range of diameters d, provides minimal damage to the human body when the needle is introduced into it and the necessary strength and flexibility of the needle.

The needle 1 at the end intended for introduction into the tumor is made with the usual needle point 3 (see Fig. 1). The sharpening at this end of the spoke 1 can be in the form of a spear (trocar) (see Fig. 4) or the shape of a feather (see Fig. 5).

A section of the spoke with a length equal to the sum of the length a of the tip of the spoke 1 and the length b of the uninsulated section of the spoke 1 from the tip 3 of the spoke 1 to the beginning of the section of the spoke 1, on which an insulating coating 2 is applied (see Fig. 1),

forms an active zone (see Fig. 6). The length Δ of the active zone depends on the requirements for the size of the active zone, determined by the dimensions of the area of influence on the tumor, and is usually from 10 mm to 50 mm.

At the other end of the spoke 1, intended for attachment to the terminal device 8, connected to the source of electrical action on the tumor, there is a protrusion 4, which has the shape of a rod of square cross-section (see Fig. 3). This shape of the protrusion 4 allows the needle to rotate when it is inserted into the patient's body and withdrawn after the end of the electrical action on the tumor. The length of the projection 4 usually does not exceed 50 mm.

A needle with specific dimensions a, b, c, d, Δ, L, δ can be made for a specific patient. In this case, the dimensions d, L, δ must satisfy the requirements specified for these dimensions in accordance with the proposed technical solution.

The proposed needle is made as follows.

First, a spoke 1 is made mechanically or otherwise with a tip 3 at one end of the spoke 1 and a protrusion 4 for attaching to a source of electrical impact at its other end. Then, markings 5 are applied to the spoke 1 to determine the depth of immersion in the human body. The markings are applied mechanically on a numerically controlled machine or using a laser installation. In the future, the spoke (s) 1 is cleaned of all contaminants in the cleaning fluids. The first stage of cleaning is carried out in specialized ultrasonic baths filled with isopril alcohol. The second step is washing in deionized water. The third stage is drying with a 60 ° C blowing in a heating cabinet. It is possible to clean the surface of the spoke 1 in a low-pressure plasma system.

After cleaning, the needles 1 are installed on a device for applying a poly-para-xylylene dielectric coating 2. The coating is produced by applying from a gaseous medium in a vacuum, followed by gas-phase pyrolysis polymerization of paracyclophane.

The technological process of obtaining and further deposition of the coating takes place in a special reactor and consists of three stages:

1.sublimation: sublimation of the dimer (di-para-xylene), vacuum 1 mm Hg, temperature 150 ° C;

2. pyrolysis: thermal decomposition, vacuum 0.5 mm Hg, temperature 680 ° C;

3. diffusion process of polymer deposition.

The diffusion process of deposition of the obtained poly-para-xylylene coating 2 onto the spoke 1 from the vapor phase in the form of a thin inert film with a high degree of conformity occurs under high vacuum conditions (vacuum 0.1 mm Hg) and at a temperature of 25 ° C. The process takes about 8-9 hours at a film deposition rate of 2-33 microns / hour.

The proposed needle is used to create non-thermal energy in the active zone in the form of short microsecond pulses of localized high-voltage electric fields. For this purpose, the needle is installed in the terminal device 8 (see Fig. 6), which is part of the apparatus for irreversible electroporation of soft tissues. The needle is invasively inserted into the tumor zone located in hard-to-reach places (pancreas and prostate glands, liver, kidneys, etc.). The needle is inserted percutaneously without opening the human body, ensuring minimal injury during the operation. The depth of immersion of the needle in the patient's body is monitored using marks 5 and / or using magnetic resonance imaging and / or an ultrasound diagnostic unit (US).

The impact of such energy on the cell leads to the creation of permanent nano-pores in the cell membrane of the tumor, and, as a consequence, to the disruption of cell homeostasis, which as a result leads to cell death by apoptosis. Cellular debris is removed by the lymphatic system as a result of a macrophage reaction.

After the operation, with the help of light rotational movements around the axis of the needle, it is removed. The use of poly-para-xylylene provides minimal friction and minimal trauma to the patient's body.

Thus, as a result of using the proposed utility model, a technical result is achieved, which consists in creating a needle for electrical action only on a tumor in the human body and eliminating electrical effects on other tissues in the human body by isolating the spoke sections outside the active zone from other organs.

The industrial applicability of the utility model is determined by the fact that the proposed needle can be made on the basis of the above description and drawings using known materials and used for electrical action on tumors in the human or animal body in order to kill tumor cells.

Sources of information:

1. RF patent No. 2098028 for the invention, MTZH A61V 17/34, A61M 5/32, publ. 10.12.1997

2. RF patent №2136236 for invention, IPC А61В 17/34, А61В 10/00, publ. 09/10/1999

3. RF patent 2307611 for invention, IPC А61В 17/56, publ. 10.10.2007

4. RF patent 2407471 for invention, IPC А61В 17/56, publ. 27.12.2010

5. RF patent 138963 for a useful model, IPC А61В 17/66, publ. 03/21/2013

6. RF patent 2358678 for invention, IPC А61В 17/58, publ. 06/20/2009

Claims (1)

A needle for electrical action on a tumor in the human body, characterized in that the needle is made in the form of a needle made of an electrically conductive material, an insulating poly-para-xylylene coating is applied to the surface of the needle with a thickness of 15 μm to 30 μm, the needle is made with a pointed one end and a protrusion at the other end, which has the shape of a square bar, while the diameter of the needle is from 0.6 mm to 1.5 mm, the length of the needle is in the range from 80 mm to 300 mm, the needle is made with markings for determining the depth dipping the needle into the body.

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