KR100731169B1 - Biocompatible elastic alloy microspikes and method of manufacturing the same - Google Patents

Abstract

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a microspike made of a superelastic alloy material as a biopsy apparatus used for collecting tissue for biopsy. More specifically, the present invention is a micro-spike made of a nickel-titanium alloy, there is no breakage and biocompatible characteristics due to the superelastic effect during the biopsy, and the minimum invasion during tissue collection is sufficient to minimize the pain of the examinee The present invention relates to a micro-spike made of a superelastic alloy material capable of collecting a sheep tissue.

In the present invention, a micro spike having a concave-convex structure capable of extracting a sufficient amount of tissue specimens to be examined by a simple process of inserting and extracting a tissue using a bio-compatible, superelastic nickel-titanium alloy with a simple process of extracting the tissue. Provides a method of manufacturing the wire by using a wire discharge discharge (WEDM: Wire Electro Discharge Micrmachining) method.

The superelastic alloy biopsy tool provided by the present invention is not broken and biocompatible when collecting tissue, and minimally invasive to minimize the pain and risk of the examinee, as well as surgical instruments such as endoscopes used in conventional biopsy And it can be easily combined or detached with mounting mechanisms, such as forceps.

Superelastic alloy, nickel-titanium alloy, superelastic effect, biocompatibility, wire discharge machining, micro spikes, irregularities, texture extraction

Description

Biocompatible micro spikes made of superelastic alloy and its manufacturing method {Biocompatible elastic alloy microspikes and method of manufacturing the same}

Figure 1 shows the microneedle (biopsy forcep) used in the conventional sampling of tissue specimens.

Figure 2 shows the external configuration of the microspikes (microspikes) of the superelastic alloy material according to the present invention.

Figure 3 shows in detail the multi-stage shape extension and the wing-like protrusion of the super-elastic alloy micro spike according to the present invention.

4A is a superelastic alloy micro spike having a wing-shaped protrusion formed on a straight extension of the present invention.

Figure 4b shows in detail the extensions and protrusions of the superelastic alloy micro spikes in which the wing-like protrusions are formed in the straight extension of the present invention.

4C is a superelastic alloy micro spike having a wing-shaped protrusion formed on the curved extension of the present invention.

Figure 4d shows in detail the extensions and protrusions of the superelastic alloy micro spikes formed with wing-like protrusions in the curved extension of the present invention.

5A illustrates a superelastic alloy micro spike having a rectangular protrusion formed in an extension of a multistage shape of the present invention.

5B illustrates a superelastic alloy micro spike having a rectangular protrusion formed on a straight extension of the present invention.

Figure 5c shows a superelastic alloy micro spike formed with a rectangular protrusion on the curved extension of the present invention.

6A illustrates a superelastic alloy micro spike with semicircular protrusions formed in accordance with the present invention.

Figure 6b shows a superelastic alloy micro spikes formed with triangular protrusions in accordance with the present invention.

Figures 7a and 7b shows a sample of tissue samples using the superelastic alloy micro spike of the present invention.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a microspike made of a superelastic alloy material as a biopsy apparatus used for collecting tissue for biopsy. More specifically, the present invention is a micro-spike made of a nickel-titanium alloy, there is no breakage and biocompatible characteristics due to the superelastic effect during the biopsy, and the minimum invasion during tissue collection is sufficient to minimize the pain of the examinee The present invention relates to a micro-spike made of super-elastic alloy material capable of collecting sheep tissue and a method of manufacturing the same.

Pathology examination, which removes tissue from patients for the diagnosis of disease, is a very important process in the diagnosis and treatment of disease. However, since the conventional biopsy apparatus has a relatively large size, when the tissue is collected, the amount of tissue collected is unnecessarily large, and a large amount of reagents are required to analyze the sampled tissue, and the patient is required to perform the procedure. You must bear the pain and risk that comes with it.

As a method for solving such a problem, microbiological inspection / precision cutting devices having a relatively small size have been proposed by applying a microprocess and a precision process. However, since these small biopsy instruments or precision cutting instruments have a complicated structure in most cases, it is difficult to operate the instruments when performing the biopsy and requires the skill of the operator.

FIG. 1 shows a catheter 200 used for collecting a conventional tissue specimen, and as shown, includes a forceps jaw 202, a microneedle 204, a body 201, and the like.

In the catheter 200 of FIG. 1, the microneedle 204 which has an uneven structure is mounted in the center, and the forceps jaw 202 is attached to both sides. In the catheter 200 of FIG. 1, when the tissue 500 is pierced and pulled by the microneedle 204, the surface of the tissue is stretched, and the tissue is collected by the forceps jaw 202. This has the advantage of ensuring accurate sampling amount during tissue collection.

However, when the tissue is collected using the catheter 200 of FIG. 1, the examinee goes through two steps of inserting the microneedle 204 into the tissue and two steps of the forceps jaw 202 picking up and removing the tissue. It has the disadvantage of aggravating pain. There is also the hassle of manipulating the movement of the forceps jaw 202 to remove the tissue again while pulling the tissue with the microneedle 204.

In addition, in the catheter 200 of FIG. 1, since the body portion 201, the microneedle 204, and the forceps structure 202 are manufactured in one piece, the microneedle 204 and the forceps structure are used once after being used for tissue collection. Body portion 201 as well as (202) had to be disposed of together. That is, the conventional catheter can not only be used for one-time use, it is not preferable in terms of efficient utilization of resources.

On the other hand, as a method for manufacturing a microbiological tool, methods using a substrate bonding, a LIGA (Lithographie, Galvanoformung, Abformung) process, laser micromachining, or silicon micromachining are known. A brief description of each is as follows.

First, a substrate bonding method is a method of forming a three-dimensional structure by forming a structure on each of the two substrates, and then bonding the two substrates in the last step. This method is complicated by the complicated bonding process and is likely to deform into the structure due to the stress between the two substrates.

In the LIGA process, a photolithography process is performed on a thick photoresist using ion beams such as ultraviolet rays or X-rays emitted from a particle accelerator, and the gap between the photoresists remaining after development is filled with electroplating. After casting, it is a method of making a metal mold for molding.

The 3D LIGA process is a method of manufacturing a 3D structure by exposing the ion beam while rotating in various directions. This method has a disadvantage that it is difficult to obtain easily because the particle accelerator that can expose the ion beam is very expensive equipment. In addition, the three-dimensional structure made by the LIGA process is difficult to make a mold frame because it is difficult to plate the photosensitive material structure after exposure, and the three-dimensional structure of the biopsy device composed of the photosensitive material only has a very low durability, so the actual biopsy It is not suitable to use for such purposes.

The laser micromachining method is a method of scanning and cutting a shape by using a laser, which is very difficult to control the processing conditions when processing a precise metal shape. For example, increasing the energy to increase the cutting force of the workpiece increases the laser line width, which not only reduces the precision of the workpiece, but also melts or thermally deforms the periphery of the shape, and reducing the energy reduces the line width of the laser, thereby improving the precision. This decreases the production time. In addition, the thermal deformation caused along the cutting surface during laser processing changes the properties of the metal to be harmful to the living body. The cost of laser precision machining equipment is generally high and it is difficult to mass-produce.

Silicon micromachining is a method of making three-dimensional structures using silicon, and it is possible to process structures with high precision of tens of micrometers. However, due to the nature of the silicone material, when subjected to a force higher than the elastic limit, it is destroyed without permanent deformation, or some of them cause permanent deformation, which is not suitable for tissue collection. In addition, the micro spikes made of single crystal silicon may use a biocompatible organic thin film such as a parylene thin film, or a silicon silicon oxide film, silicon nitride film, gold, or aluminum to improve biocompatibility and strength. There is a disadvantage that the surface should be coated.

As described above, the manufacturing methods of the micro tools conventionally used have manufacturing difficulties such as complexity of the manufacturing process, expensive manufacturing equipment requirements, low durability of the micro tools, and bending and breaking. Therefore, there is a need for a method for manufacturing a robust biopsy apparatus that is easy to manufacture, biocompatible and free from breakage. In addition, as described above, there is a need for a biopsy apparatus that minimizes the risk of tissue collection and pain of the examinee and is easy to operate.

In order to solve the above problems, the present invention, using a bio-compatible and super-elastic nickel-titanium alloy can be collected in a sufficient amount of tissue specimens to be examined by a simple process of inserting and extracting the tissue during tissue collection. The present invention provides a micro spike having a concave-convex structure and a wire electro discharge micromachining (WEDM) method.

Wire discharge machining can easily process very hard materials with high thermal energy due to electric discharge, and it can be processed without mechanical stress and the workpiece is safe from residual stress, and can be processed into precise and complex shapes depending on wire diameter. In addition, it is connected to a computer numerical controller (CNC) and can be mass-produced by programming and automating the process. Therefore, it is most suitable as a method for processing super-elastic alloys.

Micro-spike of the present invention for achieving the above object, the body portion of the super-elastic alloy material that can be inserted into the surgical instrument for collecting a tissue sample; An extension part formed integrally with the body part on one side of the body part as a part inserted into the tissue when the tissue sample is collected; And a protrusion formed integrally with one or more sides of the extension part and inserted into the tissue together with the extension part to collect a tissue sample when the biological tissue sample is collected.

In the present invention, the superelastic alloy material is preferably a nickel-titanium alloy. In the nickel-titanium alloy, the shape recovery temperature varies depending on the weight composition ratio of nickel and titanium. For example, if the shape recovery temperature is higher than room temperature (about 20 ° C), the shape memory effect appears at room temperature. If the shape recovery temperature is lower than room temperature (about 20 ° C), the super elastic effect is at room temperature. effect).

The superelastic alloy is deformed by applying a large deformation force such that it is a plastic deformation of ordinary metal material, and is restored to its original shape like rubber when the deformation force is removed. Therefore, there is a characteristic of maintaining the original shape even after collection without deformation or breakage due to the force to be collected at the time of tissue collection is safe.

In order for the nickel-titanium alloy to exhibit a superelastic effect, the atomic composition ratio of nickel and titanium is preferably 50:50 to 99: 1 (in terms of weight composition ratio, 55:45 to 99: 1). Preferably, nickel and titanium are formulated to have an atomic ratio of 50:50 to 60:40.
In addition, the nickel-titanium alloy may further include iron, and may further include any one of cobalt, chromium, and copper.

In addition, the manufacturing method of the super-elastic alloy micro spike of the present invention for achieving the above object, by vacuum arc melting of the nickel and titanium composition of the weight composition ratio which can adjust the shape recovery temperature of the alloy to room temperature or less so as to exhibit a super-elastic effect Dissolving into a melt at; Solidifying the nickel-titanium melt obtained in the above step into a sheet shape; And wire discharge machining the nickel-titanium plate using a wire having an appropriate wire diameter to form a micro spike shape.

Hereinafter, with reference to the accompanying drawings will be described in detail the configuration and manufacturing method of the micro-spike (hereinafter referred to as "super-elastic alloy micro spike") of the superelastic alloy material according to the present invention.

Figure 2 shows the external configuration of the super-elastic alloy micro spikes according to the present invention. As shown in FIG. 2, the superelastic alloy micro spike 100 according to the present invention may include a body 110, an extension 120, and a protrusion 130. In addition, the super-elastic alloy micro spike according to the present invention, the body portion 110, the extension portion 120 and the protrusion 130 may be composed of a material of an integral nickel-titanium alloy formed of a single material. The atomic ratio of nickel and titanium in the alloy is in the range of 50:50 to 99: 1.

The body portion 110 is configured to be easily coupled with the mounting mechanism, such as surgical instruments and forceps, such as conventional endoscopes. For example, it is possible to easily combine or detach the existing surgical instrument and the superelastic alloy micro spike 100 of the present invention simply by forming a groove into which the body portion 110 can be inserted into the existing surgical instrument.

One or more extension parts 120 are formed on one side of the body part 110. In relation to the number of extensions 120, in the embodiment of FIG. 2, two extensions are formed on one side of the body part 110, but the number of extensions may be variously adjusted as necessary. For example, if more tissue samples are needed, the number of extensions may be three or more. Preferably, the number of the extension may be configured as one or more than 10 each on one side of the body portion (110).

When the biopsy using the super-elastic alloy micro spike of the present invention, the extension portion 120 is a portion inserted into the tissue. Therefore, the tip portion 121 of the extension portion 120 is preferably configured in a form that can be easily inserted into biological tissue, for example, a pointed form.

In relation to the shape of the extension part 120, the width of the extension part 120 shown in FIG. 2 is a multi-stage shape including a section S that gradually narrows from the body part 110 to the tip part 121. . In the case of collecting a tissue sample through the superelastic alloy micro spike 100 having the multi-stage extension part 120 having such a shape, when inserting the extension part 120 into the target tissue and removing it, the minimal invasion occurs. While easily acquiring tissue specimens, the tissue specimens can be safely collected without bending or breaking by minimizing the stress caused by the extension.

The multi-stage shape of the extension may adjust the number of stages as needed. For example, when a safer and easier procedure is required, the number of steps may be implemented in three or more in the extension shape. Preferably, the number of stages in the extension portion may be configured to one or more than 10 each along the extension direction.

On the other hand, the size of the instrument to be inserted into the living body, the size is preferably limited to within a certain range. From this point of view, it is preferable that the length L of the extension part 120 is determined in a range longer than 10 μm and shorter than 10 mm, and the left and right spacing d of the extension part 120 is greater than 5 μm. It is preferred to be determined in a long and shorter range than 5 mm.

The protrusion 130 induces the separation of the tissue during tissue collection and performs a function of fixing the separated tissue. The protrusion 130 may protrude from the side of the extension portion 120 at an arbitrary interval. Regarding the number of the protrusions 130, four protrusions are formed in each of the extension parts 120 in FIG. 2, but it is natural that the number of protrusions 130 may be smaller or larger than necessary. In addition, although the protrusions are formed only on one side of each of the extensions 120 facing each other, it is also possible to form protrusions on both sides or all sides of each extension 120 as necessary.

In relation to the shape of the protrusion 130, the protrusion 130 shown in FIG. 2 includes both the wing shape toward the tip portion 121 inclined in the opposite direction to that inclined in the forward direction with respect to the longitudinal direction of the extension. . In the case of collecting a tissue sample through the superelastic alloy micro spike 100 having the wing-like protrusion 130 having the shape as described above, when the extension 120 is inserted into and removed from the target tissue, the wing-like protrusion 130 is removed. ) Tissues are caught and escaped together, so tissue samples can be easily collected.

Figure 3 shows in detail the extension portion 120 and the protrusion 130 of the superelastic alloy micro spike according to the present invention. Regarding the size of the protrusions, the width W of the protrusion 130, the distance D between each protrusion, and the height H of each protrusion are respectively higher than 5 μm and higher than 5 mm due to the characteristics of the mechanism to be inserted into the living body. It is preferred to be determined in the low range.

As the shape of the extension portion, in addition to the above-described multistage shape, various shapes can be adopted. For example, a linear extension 122 may be formed as shown in FIGS. 4A and 4B, or a curved extension 123 may be formed as illustrated in FIGS. 4C and 4D. Features such as the size and number of the extension are the same as the multi-stage shape described above.

Figure 4a shows a superelastic alloy micro spikes formed with a straight extension in accordance with the present invention, Figure 4b shows in detail the extensions and protrusions of the superelastic alloy micro spikes formed with a straight extension.

Figure 4c shows a superelastic alloy micro spike formed with a curved extension in accordance with the present invention, Figure 4d shows the extension and protrusions of the superelastic alloy micro spike formed with a curved extension.

FIG. 5A illustrates a superelastic alloy micro spike with square protrusions 134 in multistage extension 124 in accordance with the present invention. 5B illustrates a superelastic alloy micro spike having a rectangular protrusion 135 on a straight extension 125 in accordance with the present invention. 5C shows a superelastic alloy micro spike with a curved protrusion 136 on a curved extension 126 in accordance with the present invention. Also in the case of the protrusions 131 of FIGS. 5A, 5B, and 5C, the number of protrusions may be variously formed as necessary, the protrusions may be formed on both sides or all sides of the extension, and the protrusions may be formed. The width W, the distance D between each protrusion, the range of the height H of each protrusion, and the like are the same as those of the wing-shaped protrusion 130 described above.

As the shape of the protruding portion, various shapes other than the above-described wing shape and rectangular shape can be adopted. For example, as illustrated in FIGS. 6A and 6B, a semicircular protrusion 132 and a triangular protrusion 133 may be formed. Features such as size, spacing and number of protrusions are the same as those of the wing shape or the square shape described above. FIG. 6A illustrates a superelastic alloy micro spike having a semicircular protrusion formed according to the present invention, and FIG. 6B illustrates a superelastic alloy micro spike having a triangular protrusion formed according to the present invention.

Figures 7a and 7b shows a sample of tissue samples using the superelastic alloy micro spike of the present invention. According to the present invention, the tissue can be simply collected by simply inserting and extending the extension portion 120 of the superelastic alloy micro spike into the tissue portion to be sampled. If this is explained in more detail as follows.

For tissue collection, first, the extension 120 of the superelastic alloy micro spike according to the present invention is inserted into the tissue site 500. After inserting the extension part 120, the superelastic alloy micro spike is pulled out again from the tissue part 500, and in this process, the tissue specimen 501 is formed on the protrusion 130 formed on the side of the extension part 120. This will catch you and get out together. Therefore, it is possible to extract a sufficient amount of tissue specimens to be examined only by inserting and removing the extension 120 of the superelastic alloy micro spike into the tissue site.

Figure 8b shows the tissue sample 501 is fixed between the left extension and the right extension when the superelastic alloy micro spikes according to the present invention is taken out from the tissue. As described above, the superelastic alloy micro spike according to the present invention has a tissue caught in the space between the left and right extension parts 120 and 120 ', and is capable of collecting a sufficient amount of tissue samples for examination.

As described above, in the case of biopsy using the superelastic alloy micro spike of the present invention, the tissue can be collected by a simple process of inserting the superelastic alloy micro spike into the tissue and again removing the superelastic alloy micro spike from the tissue. Do. In addition, compared with the conventional forceps-type biopsy tool, a larger amount of tissue can be collected while alleviating the pain of the examinee.

Hereinafter, a method of manufacturing micro spikes according to the present invention will be described.

The micro spikes according to the present invention can be produced by applying a wire discharge machining (WEDM) method to a nickel-titanium alloy substrate prepared by melting.

The nickel-titanium alloy substrate has a shape recovery temperature that varies depending on the weight composition ratio, but when the shape recovery temperature is higher than the room temperature, a shape memory effect appears. When the shape recovery temperature is lower than the room temperature, the superelastic effect is obtained. effect).

Superelastic alloys are alloys that restore to their original state, like rubber, when they are deformed by applying a large deformation force such that plastic deformation is usually a metal material and removing the deformation force. Therefore, there is a characteristic that does not cause deformation or breakage due to the force collected during tissue collection and maintains its original shape even after the sample is collected.

First, a nickel and titanium composition (e.g., a nickel and titanium composition having an atomic composition ratio of 50:50 to 99: 1) in which the shape recovery temperature of the alloy can be adjusted to room temperature or less so as to exhibit a superelastic effect is vacuum arced. Dissolve as a melt in the furnace. Thereafter, the nickel-titanium melt is solidified into a plate shape. Thereafter, the nickel-titanium plate is wire discharged using a wire having an appropriate wire diameter, and processed into a micro spike shape to produce a micro spike according to the present invention.

The wire electric discharge machining technology is a method of processing a thin wire of 0.05mm ~ 0.25mm in diameter by using copper or brass as an electrode and discharging the workpiece in one direction while transferring the workpiece in one direction. It is a suitable technique for manufacturing precise microstructures. The shape and thickness of the micro spikes can be defined by controlling the plate thickness and width using a dissolution method.

The superelastic alloy micro spike according to the present invention is made of a nickel-titanium alloy, which is a superelastic alloy, so that it is more robust and durable than the structure by other methods. The process method can be applied to produce micro spikes with precise shapes.

The superelastic alloy micro spikes manufactured as described above are more resistant to breakage than conventional silicon micro spikes, are about 10 times better in elasticity than stainless steel, are not only biocompatible without special surface treatment, but also sufficient for tissue biopsy. Has a harvest In addition, it is possible to miniaturize by wire discharge processing, to enable microscopic biopsy of tissues, and to minimize invasion of the biopsy tool to the patient. As described above, the superelastic alloy micro spike of the present invention can be manufactured in a structure capable of collecting a sufficient amount of tissue with minimal invasiveness while having no breakage and excellent biocompatibility in material properties.

While specific embodiments of the present invention have been illustrated and described, the technical spirit of the present invention is not limited to the accompanying drawings and the above description, and various modifications can be made without departing from the spirit of the present invention. It is self-evident to those who have the common knowledge of.

Claims (15)

A body portion that can be inserted into a surgical tool for collecting a biological tissue sample; An extension part integrally extended with the body part on one side of the body part as a part inserted into the tissue when the tissue sample is collected; And Is formed integrally protruding on one or more sides of the extension to include a protrusion to be inserted into the tissue with the extension when collecting the biological tissue sample to collect a tissue sample, Super-elastic alloy micro spike made of a material of nickel-titanium alloy, characterized in that it is elastic. The super-elastic alloy micro spikes according to claim 1, wherein the atomic composition ratios of nickel and titanium in the nickel-titanium alloy are in the range of 50:50 to 99: 1. The super-elastic alloy micro spikes according to claim 2, wherein the atomic ratio of nickel and titanium is in the range of 50:50 to 60:40. 3. The super-elastic alloy micro spikes of claim 2, wherein the nickel-titanium alloy further comprises iron and further comprises any one of cobalt, chromium and copper. The super-elastic alloy micro spikes according to claim 1 or 2, wherein each of the protrusions is formed on at least one side face between the extension portions facing each other. The superelastic alloy micro spike according to claim 1 or 2, wherein the protrusion has a wing shape, a square shape, a semicircle shape, or a triangular shape. The said protrusion part has the width | variety W of 5 micrometers or more and 5 mm or less, the space | interval D is 5 micrometers or more and 5 mm or less, The height H is 5 micrometers or more and 5 mm. A superelastic alloy micro spike, characterized by the following. The super-elastic alloy micro spikes according to claim 1 or 2, wherein the extension part is formed in one or more parts on each side of the body part. 3. The super-elastic alloy micro spikes according to claim 1 or 2, wherein the extension part has an angular shape, a curved shape, a multistage shape or a straight shape. The superelastic alloy micro spike according to claim 9, wherein the extension part has a multistage shape, and the number of steps in the extension part is one or more and ten or less in the extension part direction. The superelastic alloy micro spike according to claim 1 or 2, wherein the shape recovery temperature of the nickel-titanium alloy is 20 ° C or less. The super-elastic alloy micro spike according to claim 1 or 2, wherein the body portion, the extension portion, and the protrusion portion are integrally formed entirely of the nickel-titanium alloy material. Dissolving a composition comprising nickel and titanium as a melt in a vacuum arc melting furnace (a); (B) solidifying the nickel-titanium melt obtained in the above step into a sheet shape; And The method of manufacturing a super-elastic alloy micro spikes according to claim 1 or 2, characterized in that it comprises a step (c) of processing the nickel-titanium plate using a wire discharge to a micro spike shape. Way. The method of claim 13, wherein the atomic composition ratio of nickel and titanium in step (a) is in the range of 50:50 to 99: 1. 15. The method of claim 14, wherein the atomic ratio of nickel and titanium is in the range of 50:50 to 60:40.

Images