KR100295212B1 - Preparation method of expanding device for expanding stenosis part of human body by shape memory alloy and expanding device made by the same method - Google Patents

Abstract

PURPOSE: Provided are preparation method of expanding device for expanding stenosis part of human body by shape memory alloy and expanding device made by this method, which cures almost permanently the stenosis of the blood vessel, esophagus by cancer mass, biliary tract and urethra by expanding the narrowed part by the spherical empty net made by shape memory alloy unlike the balloon treatment which needs re-treatment. CONSTITUTION: The treatment device comprises: an empty cylindrical body(3) made of super tensile string of shape memory alloy material(1) with 0.1-0.5mm diameter by inter twining the string up and down, wherein the diameter of the above empty cylindrical body is 10-30% larger than the diameter of the stenosis vessel of human body to be treated; a diamond shape empty part and curvature shape inserting terminal(4) and discharging terminal(5) at both ends being shaped in one body with the above cylindrical body(3); welded both ends(6,7) of the shape memory alloy material(1) in the interior of the above empty cylindrical body(3). The empty cylindrical body(3) with different diameters is also made and the smaller one is inserted into the larger one and formed into one body.

Description

Method for manufacturing expansion mechanism for expanding stenosis of body using shape memory alloy and expansion mechanism manufactured thereby

The present invention relates to a method for manufacturing an expansion mechanism for expanding the stenosis of the body by using a shape memory alloy, and to an expansion mechanism manufactured by the same, and more specifically, to the blood vessels as well as narrowing the blood vessels by blood clots By using shape memory alloy to widen the passage of stenosis or stenosis by installing on a series of body adsorption progression or adsorption site such as stricture of esophagus, biliary stricture, ureter stricture and artificial passage between intravenous intrahepatic portal The present invention relates to a method for manufacturing an expansion mechanism for expanding a constriction part of the body and an expansion mechanism manufactured by the same.

In general, blood vessels cause various diseases by blocking or adsorbing blood vessels by presence, arteriosclerosis, and the like.

When the adsorption progression or adsorption of such blood vessels occurs, artificial blood vessel replacement or bypass composition is used in the above-described areas mainly through surgical operations.

However, such a surgical operation is required to resecrate the body of the lesion, so that the area is very large, leaving a large scar, and also requires a lot of nursing period, and the surgical effect is not very high.

In particular, in the case of such vascular diseases, hypertension, heart disease, etc. appear in most cases, the operation itself is impossible in this case patients.

In order to overcome this problem, a small hole is made in the femoral artery recently, and a balloon catheter tube is inserted into the blood vessel from the outside of the human body through the hole. It is using angioplasty to inflate the balloon.

However, such an angioplasty usually occurs 3 to 4 months after restenosis occurs and should be repeatedly performed, so there is a disadvantage in that the patient suffers from regular pain as well as economic burden.

In addition to these vascular diseases, if the esophagus is blocked or progressed by cancerous tissues, it is impossible for food to be taken into the mouth. Is giving mental stigma.

In addition to the biliary stricture, narrowing of the urethra, the artificial passage between the intravenous hepatic portal, as well as other organ obstruction or stenosis occurs in the same manner as described above.

Even in these cases, mental and economic burdens are becoming more of a problem for the patients and their families than for the effects of treatment.

In addition, Japanese Utility Model Publication No. Hei 4-377445 provides an expansion mechanism for vascular expansion as described above.

The expansion mechanism is made of a cylindrical pipe made of a material of tungsten or stainless steel, which does not have self-resilience, which is obtained by using an ultrasonic lamp to form a diamond shape and the remaining part is made of wire only. It provides an extension mechanism of how to have it.

Since these expansion mechanisms do not have restoring force, a separate expansion mechanism such as a balloon (henceforth referred to as "winding art") is inserted into the manufactured expansion mechanism to inflate air by inflating the balloon. By expanding the vessel expansion mechanism by force to insert the stenosis projecting into the blood vessel inside the body.

At the end, a method of manufacturing a wound protection member made of a separate wire and bonding it to the expansion device is used to prevent damage to the blood vessel wall when the expansion device is inserted into the vessel.

Since this technique is forcibly expanding the manufactured expansion mechanism, the space in the shape of the rhombus is increased in such a way that deformation is applied to the junction part constituting the expansion mechanism, that is, the corner portion constituting the rhombus shape. Afterwards, the expansion mechanism cannot withstand the regenerating lesions (for example, lesions that undergo stenosis at the site where the procedure is performed). Therefore, the expansion mechanism must be removed and reoperation is performed with a new expansion mechanism. Since the same mechanism is added to the inside of the expansion mechanism forcibly increasing the expansion mechanism, there is a drawback that it is impossible to use the thin vessel.

And international publication WO 92/19310.

This is the same technique as Japanese Utility Model Publication No. Hei 4-377445, which also manufactures an expansion mechanism by cutting a cylindrical pipe having a material such as stainless steel into a rhombus shape by ultrasonic waves.

Since the expansion mechanism manufactured by this method also does not have self-resilience, the expansion mechanism is expanded by forcibly increasing the expansion mechanism by inserting a balloon-like mechanism inside the expansion mechanism and inflating the balloon. have.

Since the expansion mechanism does not have self-resilience after the conventional method, there is a disadvantage in that it must be re-shrinked by external conditions after a certain period of time. Increasing the expansion mechanism by forcing the use of thin blood vessels are disadvantages that can not be used.

The present invention has been made to solve the above problems, and constitutes a hollow cylindrical body having a certain length by a method of crossing a superelastic shape memory alloy having a predetermined length at different positions. However, the cross section has a plurality of rhombus-shaped spaces, and both ends are provided with an expansion mechanism by a method of bending to have a curved shape to reduce the rhombic space during the procedure to reduce the volume of the hollow cylindrical body After significantly reduced, and installed in the lesion site through the auxiliary device to push the lesion site outwards to expand the blood vessels, etc. to be used semi-permanently as a procedure.

1 is a reference perspective view of the expansion mechanism according to the present invention.

2 is of FIG. 1; Floor plan,

3 is a cross-sectional view taken along the line A-A of FIG.

4 to 6 is a state diagram used in the expansion mechanism according to the present invention.

〈Description of the symbols for the main parts of the drawings〉

1: Super elastic shape memory alloy material 2: Rhombic space part

3: hollow cylinder body 4: insertion end

5: discharge unit 8: expansion mechanism

Hereinafter, the present invention will be described in detail.

The material used in the present invention is a metal that is known to be harmless to the human body. For example, a metal having a predetermined shape is manufactured using a metal to be used, and then heat-treated to produce a metal that can be returned to the shape prepared before the heat treatment. use.

However, in case of stainless steel, it is harmless to human body, and it is selected and used as a material for manufacturing various medical equipments. However, it is not suitable because it is easily cut when repeating or folding the bending part due to lack of elasticity. In the present invention, a nickel-titanium (Ni-Ti) based alloy having high elasticity is used.

Such nickel-titanium (Ni-Ti) -based alloys are generally known as shape memory alloys and are widely used throughout the industry. By using such shape memory alloys, products having a certain shape are manufactured, and then the shapes are subjected to heat treatment. After the form is memorized, it has a characteristic of returning to the original shape originally produced when the temperature is constant.

In particular, in the case of nickel-titanium (Ni-Ti) -based alloys, superelasticity is maintained, and the effect of memorizing the shape is excellent, which is most suitable for realizing the present invention.

The superelastic shape memory alloy is selected as the material of the present invention, and the expansion mechanism of the present invention is manufactured using one thin wire having a diameter of 0.1 to 0.5 mm.

Thus, a hollow cylindrical body is formed by interweaving a superelastic shape memory alloy material having a diameter of 0.1 to 0.5 mm up and down at different positions, and a plurality of rhombic spaces are formed in the cylindrical body. The parts and both ends are curved and bent to form a curved structure to be memorized by heat treatment.

In this way, the shape of the hollow cylindrical body is memorized, and then connected to the method of welding both ends of the superelastic shape memory alloy material, thereby producing the expansion mechanism according to the present invention.

At this time, both ends of the super-elastic shape memory alloy material is placed inside the cylindrical body to adopt a welding method.

In the present invention, after the hollow cylindrical body is configured, heat treatment is performed by a conventional method to store the shape at a temperature such that the elasticity of the material is not lost.

At this time, the heat treatment temperature is most preferably performed at 350 to 600 ° C. for 8 to 30 minutes. When the heat treatment time is more than 30 minutes, the elasticity is remarkably decreased, which may be due to the characteristics of the superelastic shape memory alloy material.

On the other hand, when the diameter of the super-elastic shape memory alloy material used in the present invention has an ultrafine diameter of 0.1 mm or less, the self-elastic force is remarkably weak so that the adsorption site can be sufficiently expanded even after the expansion mechanism according to the present invention is manufactured. It was impossible to predict the effect, and when using a superelastic shape memory alloy material having a diameter of 0.5 mm or more, the volume of the hollow cylindrical body cannot be greatly reduced when it is not used because it does not have a sufficient rhombic space. There are disadvantages.

In addition, it is necessary that the curved shapes formed at both ends of the hollow cylindrical body described above should not be more than 12, which means that the number is large regardless of the diameter of the superelastic shape memory alloy material used. This is because it is possible to reduce the area of the above-mentioned rhombic space part so that the volume can not be reduced as much as used below.

However, if the number is three or less, the volume can be remarkably reduced when used, but at least three or more must be maintained because the resilience may be reduced even if the volume is returned to the stored shape.

In addition, when the both ends of the superelastic shape memory alloy material after the hollow cylindrical body is formed in the cylindrical body to be welded, the welding part may prevent the formation of oxides harmful to the human body, as well as the hollow. The deformation of the cylindrical body should also be prevented.

Therefore, at this time, ultra-precision welding by a silver welding or a laser is used, and if necessary, a Tig welding and a Mig welding method are also possible.

In addition, in the present invention, the rhombic space portion formed in the hollow cylindrical body, in particular, in the case of blood vessels or biliary tracts, because it has a curved portion that is structurally much curved, as well as its own flexibility and input into the interior thereof. To minimize the volume of the city itself.

In other words, the above-mentioned rhombic space part copes with this sufficiently because one side of the rhombic space that is installed when it is installed in a curved vessel or biliary tract becomes narrow.

In addition, both ends of the hollow cylindrical body are bent to have a plurality of curved shapes at regular intervals, which will be described below, but will not damage the inner wall of the blood vessel when inserted into the blood vessel or removed after insertion. This is to avoid.

The expansion mechanism according to the present invention is to be manufactured to be less than 10%, largely 30% larger than the diameter of the lesion, such as blood vessels, esophagus, biliary tract to be installed to ensure a sufficient internal diameter at the lesion site and At the same time, it is not to be moved by its own elastic force after installation.

Based on the accompanying drawings of the present invention having such characteristics will be described in detail with reference to FIGS.

Hollow cylindrical body having a certain length so as to have a plurality of rhombic space portions 2 by weaving one superelastic shape memory alloy material 1 having a diameter of 0.1 to 0.5 mm at different positions. 3) but the opposite ends form an insertion end (4) and discharge end (5) having a plurality of curved shapes at regular intervals,

Both ends 6 and 7 of the superelastic shape memory alloy material 1 after the hollow cylindrical body 3 having the predetermined length are formed of the hollow cylindrical body 3. It is located inside and welded to provide an expansion mechanism 8 according to the invention.

In the present invention, after the hollow cylindrical body 3 is formed, the conventional method is used for 8 to 30 minutes at 350 to 600 ° C., which is known as a temperature at which the material elasticity of the superelastic shape memory alloy is not lost. Heat treatment to store the shape.

In addition, it is necessary to prevent the insertion end 4 and the discharge end 5 having the curved shape from being 12 or more, respectively, regardless of the diameter of the one superelastic shape memory alloy material 1 described above. The large number is because the space of the above-mentioned rhombic space 2 is reduced, so that the volume cannot be reduced as much as it is used as described below.

In addition, both ends 6 and 7 of the superelastic shape memory alloy material 1 are placed inside the hollow cylindrical body 3 and welded thereto.

The expansion mechanism 8 of the present invention is inserted into the blood vessel 12 according to the accompanying drawings, and the effects thereof, according to the accompanying drawings. It will be described in detail by the use example.

First, the position of the lesion site 11 in the blood vessel 12, the size of the lesion site 11, and the internal diameter of the lesion site 11 are examined with a fluoroscopic apparatus using an angioplasty. Anesthetize part.

In this state, the expansion mechanism 8 according to the present invention having a diameter longer than the length of the lesion part 11 and 10-30% larger than the inner diameter of the blood vessel 12 is selected and used.

In this state, the guide tube 10 is inserted into the lesion site 11 within the blood vessel 12 while checking the movement of the guide tube 10 by angioplasty until the guide tube 10 reaches.

When the lesion site 11 in the blood vessel 12 is reached by this method, the expansion mechanism 8 according to the present invention is inserted into the guide tube 10.

At this time, the guide tube 10 has a small diameter, while the expansion mechanism 8 of the present invention has a large diameter, and when the inner tube is crushed inward, one superelastic shape memory alloy material 1 is located at different positions. Since the plurality of rhombic spaces 2 are formed to be intertwined and interwoven, the volume of the hollow cylindrical body 3 is significantly reduced. do.

In other words, in this state, the hollow cylindrical body 3 maintains a long rod shape composed of only the superelastic shape memory alloy material 1.

In such a state, it is inserted into the guide tube 10 and pushed to the lesion site 11 using a pusher catheter 13, or, if necessary, crushed into a long rod shape as described above. After completely removing the property to return to the original form by immersing in cold saline solution, it is inserted into the guide tube (10) and pushed to the lesion site (11) by using a pusher catheter (13). The tube 10 is discharged from the vessel 12 to the outside.

Thus, the expansion mechanism 8 of the present invention located at the lesion site 11 pushes the lesion site 11 located in the blood vessel 12 outward while returning to the shape having the original size while exiting the guide tube 10. It expands the blood vessel 12.

At this time, since the expansion mechanism 8 has a diameter of about 10 to 30% larger than the inner diameter of the blood vessel 12, the lesion 11 is pushed outward without moving the position by the elastic force. While maintaining the expansion of the blood vessel 12.

On the other hand, while the expansion mechanism 8 of the present invention can directly touch the inside of the blood vessel 12 while exiting the guide tube 10, the insertion end 4 which is one end of the expansion mechanism 8 of the present invention described above. ) Is composed of a plurality of curved shapes at regular intervals and is inserted into the blood vessel 12 without damaging the inner wall of the blood vessel 12 is positioned.

Similarly, when the expansion mechanism 8 of the present invention is installed and then removed, the discharge end 5 is formed in a plurality of curved shapes at regular intervals, and thus, without damage to the inner wall of the blood vessel 12, the vessel ( 12) to be inserted into the guide tube 10 from the inside to be discharged to the outside through the guide tube (10).

In addition, both ends 6 and 7 of the superelastic shape memory alloy material 1 are to be placed inside the hollow cylindrical body 3 to be welded. This is to prevent the possibility of coming into direct contact with the inside of the utmost.

On the other hand, as described above, if the diameter of the superelastic shape memory alloy material 1 is 5 mm or more, the reduction in volume does not occur as described above, as well as the insertion into the guide tube 10. Even if inserted, the disadvantage that cannot be pushed into the pusher catheter 14 to the lesion site 11 of the blood vessel 12 occurs.

Similarly, as described above, the insertion end 4 and the discharge end 5 having the curved shape need to be not more than 12, respectively, which is one superelastic shape memory alloy material 1 described above. Regardless of the diameter, the number of the particles may reduce the width of the rhombic space 2 so that the volume cannot be largely reduced during use. In order to prevent the disadvantage that can not be pushed to the pusher catheter 14 to the lesion site 11 of the blood vessel 12.

However, if the number is three or less, the volume can be remarkably reduced when used, but at least three or more must be maintained because the resilience may be reduced even if the volume is returned to the stored shape.

Particularly, in the present invention, the rhombic space portion 2 formed in the hollow cylindrical body 3 has its own flexibility because it has structurally many curved portions in the case of blood vessels or biliary tracts. When the above-mentioned rhombic space 2 is installed in a curved blood vessel or biliary tract, if one of the installed rhombic spaces 2 is narrowed, the other rhombus located on the opposite side Since the space 2 is widened, the vessel 12 can be expanded while fully coping with the space 2.

In the present invention, when the size of the lesion is large, if a considerable elastic force is required, the diameter of the hollow cylindrical body 3 according to the present invention is different from each other to form a large hollow type. The hollow cylindrical body 3 having a small diameter may be inserted into the cylindrical body 3 to be used integrally.

Likewise, it is possible to widen the passage of stenosis or stenosis by installing it on a series of body adsorption progression or adsorption sites such as narrowing of esophagus due to lumps, narrowing of the biliary tract, narrowing of the urethra and installation of artificial passage between intra-vein intrahepatic portals. .

As described in detail above, according to the present invention, a hollow cylindrical body having a certain length is formed to have a plurality of rhombic spaces by weaving superelastic shape memory alloys at different positions by selecting materials. However, both ends are provided with an expansion mechanism bent to have a plurality of curved shapes at regular intervals to reduce the volume of the hollow cylindrical body by significantly reducing the space of the plurality of rhombus shape during the procedure , It is installed on the lesion site through the assistive device to push the lesion outwards to expand the vessels, etc. In one procedure, not only narrowing of blood vessels by blood clots, but also narrowing of the esophagus by lumps, biliary narrowing, Narrowing through a series of body adsorption processes or adsorption sites, such as the establishment of artificial passages between the narrowing and intravenous intrahepatic portals The procedure of the progression or stenosis can not only be performed by a relatively easy method, but also semi-permanently maintained by a single procedure because of the use of metal, which can free mental and economic pain from patients and their families. It is obvious that the invention creates a very useful effect.

Claims (4)

In the manufacture of artificial implants for the treatment of occlusion, stenosis or dilatation of organs in the human body, A hollow cylindrical body having a certain length is formed by weaving one super-elastic shape memory alloy material having a diameter of 0.1 to 0.5 mm while intersecting them at different positions up and down. The hollow cylindrical body has a plurality of rhombus-shaped space portions and curved ends of a plurality of rhombus shapes by weaving while intersecting the superelastic shape memory alloy material up and down at different positions, The shape-memory alloy is characterized in that the hollow cylindrical body is heat-treated to memorize its shape and then connected to each other by welding both ends of the superelastic shape-memory alloy material in the hollow cylindrical body. Method of manufacturing an expansion mechanism for expanding the stenosis of the body by. In the artificial implant for the treatment of obstruction, stenosis or stenosis of organs in the human body, A hollow cylindrical body 3 having a certain length is formed by weaving a row of superelastic shape memory alloy materials 1 having a diameter of 0.1 to 0.5 mm by intersecting them at different positions from top to bottom. The hollow cylindrical body 3 has a rhombic space portion and both ends integrally configured to have an insertion end 4 and an outlet end 5 having a curved shape, and the superelastic shape memory alloy material ( Both ends (6) and (7) of 1) to expand the narrowing part of the body using a shape memory alloy, characterized in that the structure consisting of a welded connection in the interior of the hollow cylindrical body (3) For expansion mechanism. The method of claim 2, The diameter of the hollow cylindrical body 3 is 10-30% larger than the internal diameter of the blockage, stenosis progression or stenosis of the organs in the human body to be treated. Expansion mechanism for expanding the narrowing area. The method of claim 2, By configuring the diameter of the hollow cylindrical body (3) different from each other by inserting the hollow hollow cylindrical body (3) with a small diameter inside the large hollow cylindrical body (3) An expansion mechanism for expanding the constriction of the body by using the shape memory alloy, characterized in that the integral configuration.