WO2017171180A1 - Biopsy blade - Google Patents

Abstract

The present invention relates to a blade connected to a distal end of a biopsy needle assembly. In order to realize a biopsy blade which is coupled to a circular end of a biopsy needle, sharpened as if the blade is formed on a flat member, and reduced in the total length of the blade, thereby allowing for various types of procedures, the present invention relates to a biopsy blade, manufactured by sintering, a metal injection molding (MIM) method, etc., having a tip which is sharp and V-shaped when viewed from the front and gradually increases in size as if forming into an arc symmetrically in a plan view, and having a step so as to be smoothly coupled to the circular end of the biopsy needle, wherein four side surfaces of a V-shape from the distal end are polished with a tool having a diameter of 10 mm or less.

Description

Biopsy blade

The present invention relates to a biopsy blade, more particularly coupled to the needle tip of a biopsy needle assembly, without the need for a large amount of force and without preliminary biopsy of the tissue prior to insertion of the blade into the living body. It is a blade configured to penetrate and penetrate tissue, and is inserted into the affected part and relates to a biopsy blade for cutting out biological tissue.

For the examination of biological tissues, a needle assembly, which has a sharp blade at the tip of a needle, has been used to insert a portion of a living tissue to cut out a portion of the biological tissue or to cut out the affected tissue.

Hereinafter, the prior art will be described with reference to three gist of the prior art.

As a first prior art, reference is made to what is described in International Publication No. WO / 2012/166336, published December 6, 2012. 1 illustrates a conventional exemplary biopsy device 10 as corresponding to FIG. 2 of the first prior art. The biopsy device 10 includes a probe 20 and a holster 30. The probe 20 includes a needle assembly 100 extending at least partially distal from the casing of the probe 20, the needle assembly 100 being insertable into the patient's tissue to obtain biological tissue samples. . The biopsy device 10 further includes a tissue sample holder 40 to which tissue samples extracted from the needle assembly 100 are adsorbed. In such a biopsy device, the needle assembly 100 combines a sharp blade 200 at the end of the needle to insert a puncture of the biological tissue with a sharp edge without having to puncture the biological tissue in advance, thereby removing the biological tissue. .

2 is an exploded view of a blade 200 assembly having a first engagement member 350, a second engagement member 400, and a blade 210 corresponding to FIG. 7 of the first prior art. Using such a substantially flat blade may be desirable in certain situations to reduce the impact of inserting the biopsy needle into the patient. However, for very small needles, it may be difficult to properly fit a small flat blade to the needle. In some cases, the plastic molding may be formed around the blade through holes in the blade and bonded to the needle. However, attachment to the needle may be limited due to the bonding of the plastic to the metal needle. Providing metal to the metal contact area between the blade assembly and the needle may cause the blade assembly to be welded to the needle, thereby providing a stronger bond between the blade assembly and the needle. As described above, a complicated working process is involved while engaging a flat blade at the end of a circular needle.

As described in the second prior art published WO 13/2013/085938 published June 13, 2013, FIG. 3 corresponds to FIG. 11 of the second prior art and is an enlarged perspective view of a blade assembly as an example. In this example, the blade 360 is configured to snap onto the nose cone 370 through the elastic notched end 368. The nose cone 370 also includes a slot 372 configured to receive the blade 360 such that the elastic notched end 368 can snap into the proximal recess 374 formed in the nose cone 370.

The blade 360 includes a planar metal blade having a pair of first polishing surfaces 362 and a second polishing surface 364 that meet at a pair of sharp edges forming an acute blade tip. Even in this example, a combination of flat blades involves a complex work process.

As described in the third prior art published WO 09/2012/018461 published February 09, 2012, FIG. 4 corresponds to FIG. 13 of the third prior art and is a perspective view of an exemplary alternative needle portion. The unitary piercing tip 1102 of the present example compresses and flattens the distal end of the cannula 1108 and then polishes the top layer of flattened material (leave only one wall thickness of the material), followed by the remaining flattened material. It is formed by grinding the blade to form a blade (blade). Thus, the integral piercing tip 1102 and the cannula 1108 are formed by a homogeneous continuum of material in this example, rather than separately formed materials being later associated together. The blade of the integral piercing tip 1102 is defined by two sharp edges 1104 that converge at the sharp point 1103. Of course, the blades of the integral piercing tip 1102 may alternatively take various shapes. This example is a structure that compresses the end of the needle, which inevitably has a problem that the distance between the end point of the blade and the biological suction opening 1105 is followed by constraints during surgery.

Summarizing the gist of the three prior art citations as above,

In order to couple a flat blade to the end of a circular needle, it is the structure containing the member of a 1st, 2nd coupling member or a nose cone, or a structure which crimps the end of a needle (cannula). For this reason, there is a problem inevitably involving a complicated process.

The present invention is to solve the above problems, is coupled to the circular end of the biopsy needle, sharply polished as if the blade is ground by grinding on a flat member, and various types of treatment by reducing the total length of the blade The purpose is to implement a simplified biopsy blade for the manufacturing process, so that it can be done.

In order to achieve the above object, the blade of the present invention is coupled to the biopsy needle assembly, a pointed tip is formed in the forward direction to insert and pierce the biological tissue, the other side can be combined with other parts A biopsy blade having a body in the shape of a circle, ellipse, or polygon in cross section,

A concave blade surface having a wider width in the direction from the tip to the body part and formed to face each other, and an edge of the two sides in the direction from the tip to the body part, and having a concave shape in the blade center direction. It characterized in that it comprises two blades provided.

In addition, the blade of the present invention, the width between the two sides is gradually widened in the direction from the tip to the body and concave toward the center of the blade,

The concave blade surface from the tip portion to the body portion has a shape in which the V-shape has fallen to the right and its shape angle is an acute angle.

The vertical section of the concave blade surface is an arc shape having a diameter of 10 mm or less, or a part of an ellipse, streamline, or polygon having a maximum length of 10 mm or less in the longitudinal direction from the tip to the body;

The concave blade surface is characterized in that one side of the cross section is formed in contact with the center line between the two sides and the other side is in contact with the side.

In addition, the blade of the present invention is the vertical cross section of all the concave blade surface is an arc and has a larger arc size on the body side than the tip side,

The concave blade surfaces are formed symmetrically with arcs of the same size in two lateral directions from the center line,

The shape angle of the blade is 51 to 53 degrees,

The polished angle of the blade is 22 to 36 degrees, and

The diameter forming the arc of the concave blade surface is characterized in that 5 ~ 10 mm.

And, the blade is processed by grinding,

Made by sintering or metal injection molding process, or

The tip and both sides are subjected to the first process by sintering or metal injection molding, and the concave blades are sharply processed using a polishing tool having a diameter of 10 mm or less to make the blade and the pointed tip. do.

The biopsy needle assembly including the biopsy blade according to the present invention is a blade having a structure having a sharp edge, easy to manufacture the blade, due to the sharp blade to minimize the wound during the procedure to relieve pain It has the advantage of quick recovery and minimal fabrication process by minimizing wounds.

In addition, the blade according to the present invention has an advantage that can be easily performed by providing a surface portion of the concave blade having a concave section.

1 is a perspective view showing a conventional biopsy device.

2 is an exploded isometric view of a conventional biopsy blade assembly.

Figure 3 is another enlarged perspective view (blade) assembly of the prior art.

4 is a perspective view of another conventional needle part.

5 is a perspective view showing a needle assembly for biopsy as an example in which the blade of the present invention is used.

6 is a cross-sectional view showing a needle assembly for biopsy as an example in which the blade of the present invention is used.

7 is a three side view and an isometric perspective view of another conventional blade.

8 is a three-dimensional and isometric perspective view of the blade with the side of the present invention formed.

9 is a view showing a method of forming an example of a preferred concave blade surface of the present invention.

10 is a three-sided and isometric view of a blade with one concave blade surface completed in the manner described in FIG.

11 is a three side and isometric view of the blade of the present invention completed in the manner of FIGS. 9 and 10.

12 is a three-sided view and an isometric perspective view ground by the processing method in a conventional manner for reference.

13 is a three-sided view and an isometric perspective view polished by another conventional method of processing as a reference.

14 is a drawing of a preferred blade according to the present invention.

The blade of the biopsy needle assembly of the present invention includes a holster 30 for controlling a motor and a vacuum pressure, a probe 20 assembly for extending vacuum pressure and rotational power, and a biopsy needle extending to the end of the probe assembly. As part of a biopsy device 10 composed of an assembly 100, the biopsy needle assembly includes a blade portion, a needle portion to which the blade portion and one side thereof are coupled, and a cutter portion, and the needle assembly 100 The sharp blade 200 is coupled to the end of the needle to puncture the biological tissue without having to puncture the biological tissue in advance, and serves to detach the biological tissue.

The present invention relates to a structure and method in the blade (200) used in the needle assembly for biopsy, the sharp blade (5) can be processed so that the needle assembly can be easily inserted into the affected part.

Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings.

The structure of the blade 200 of the present invention is to minimize the total length (L) of the blade, to minimize the polished angle (A1) of the blade (5), the purpose is to implement a sharp blade (5).

5 and 6 are views of the biopsy needle assembly to which the blade of the present invention can be applied.

As shown in the figure, the needle assembly for biopsy comprises a blade 200, the needle portion 22, the cutter portion 23. The blade 200 is to allow the needle assembly to be inserted by puncturing the biological tissue through the skin, the blade 200 having the concave blade surface 1 is coupled to the needle portion 22, the suction groove 27 is formed so that the biological tissue to be cut into the needle portion 22 to be inhaled or pushed in close to the blade 200 side. The cutter portion 23 has a tube shape or a hollow cylindrical shape, and the cutter edge 231 polished inward is formed, and the cutter portion 23 is inserted into the needle portion 22 and is connected to an external vacuum device therein. It may be to suck the biological tissue to be cut out into the suction groove 27 to cut out to the cutter edge 231 and discharge to the outside.

The blade shown in Figure 5 has a concave blade surface (1) and two side surfaces (2), which are a total of four blade surfaces has a structure that can easily cut and insert the biological tissue while minimizing its length. Referring to the upper side with the suction groove 27 in Figure 5, the width of the main body (9) to the body (7) with two side surfaces (2) on the left and right sides with a wide area of the base side blades It is formed so that it may become wider. The two side surfaces 2 are formed with a width t of a predetermined thickness with respect to the tactile portion 9, and the concave shape is concave around the reference line in the vertical direction in the vertical direction of the two side surfaces 2. The blade surface 1 is formed in left and right. Thus, the concave blade surfaces 1 are formed one by one on the basis of the center in two directions, and four concave blade surfaces 1 are formed.

FIG. 7 is a drawing of a blade for comparison with the blade of the present invention, showing a shape processed by a general planar grinding method, and four machining surfaces centered on the pointed tip 9 in the center of the blade in the direction of travel, such as arrowheads. They all consist of flat, flat surfaces to form a shape. Thus, it is a view showing the shape of an image in which the shape angle A2 of the blade viewed from the front of the blade and the size of the polished angle A1 viewed in the plane are the same. Such a blade having a blade structure of FIG. 7 is disadvantageous for being easily cut and inserted into biological tissues. In particular, as shown in FIG. 1, the blade is coupled to the needle part 22 and inserted into the living body to the suction groove 27. In order to inhale the living body, the shorter the length of the blade in the advancing direction is preferable in the structure of inhaling the living body. Therefore, the blade structure of the structure as shown in Figure 7 has a small number of blade surfaces, even if workability may be advantageous, cutting the blade sharply disadvantageous.

Thus, the structure of the blade 200 of the present invention shown in Figure 5 will be described in more detail with reference to Figures 8 to 11, it is preferable to have a blade structure manufactured by the present description as a blade for biopsy. Do.

FIG. 8 is a three shaving and isometric perspective view of the blade of the present invention with the side face formed, FIG. 9 is a view showing a method of forming an example of the preferred concave blade surface 1 of the present invention, and FIG. 3 is a isometric and isometric view of a blade with one concave blade surface 1 completed in the manner described, and FIG. 11 is a bone completed by polishing four concave blade surfaces 1 in the manner of FIGS. 9 and 10. It is a three side view and an isometric perspective view of the blade of this invention.

This will be described with reference to FIGS. 8 to 11. First, the blade in FIG. 8 is represented by an isometric perspective view (a), a top view (b), a front view (c), and a left side view (d). In the front view (c), the sharp V-shape is a shape that falls to the right. As shown in (b), a symmetrical arc is formed to form a two-sided (2) that grows symmetrically and a jaw-shaped coupling portion 8 to be smoothly coupled to the circular end of the biopsy needle, and a conventional complicated assembly process. For simplicity, the shape can be formed into a simplified structure by using sintering or metal injection molding (MIM).

8 is a view showing a state in which two side surfaces are made in the shape of the blade primarily produced by the sintering or MIM method, and the like. FIG. 8 (a) is a perspective view showing that the pre-polishing tip 9a has a width t of a predetermined thickness and is gradually widened and extended from the pre-polishing tip 9a to the body 7. have. 8 (b) is a plan view, in which the tip portion 9a has a width t of a predetermined thickness, and the two side surfaces 2 opposed to the center line 5a are opened at a predetermined angle toward the body 7. The thing formed as a surface is shown. 8 (c) is a front view, and shows that the shape angle A2 of the blade is determined according to the total length L1 from the tip portion 9a to the end 6, and the shape angle A2 of the blade is It is preferable to have an acute angle. And it is preferable that the line along the blade shape angle A2 of the side surface 2 is vertically symmetrical as shown by a straight line. It is preferable that the straight line length L1 from the end 6 to the tip 9a is as short as possible. However, if too short, the shape angle (A2) of the blade is large, it will not implement a sharp blade. Fig. 8 (d) shows a left side view in which the side surfaces 2 are symmetrically formed from side to side, and the two side surfaces 2 at the tips 9a have a width t of a predetermined thickness. In the front view, the upper and lower surface of the side surface 2 shows a state in which the blade surface is not formed yet with only the portion corresponding to the shape angle A2 of the blade of the side surface 2 removed from the shape of the body. Thus, the two side surfaces (2) to be opposed to the main blade side of the primary process of the present invention is a process such as sintering or MIM method.

In more detail, the width between the two sides 2 widens in the direction of the body 7 but it may be straight or curved, but as in the direction of the blade center in a straight line reference as in the plan view of FIG. The more concave curvilinear form may be more advantageous when considering surface tension during biodissection. This side surface 2 may be straight or slightly more convex in shape and may also be formed as a plurality of processing surfaces rather than one single processing surface. It is preferable that the blade surface of a knife blade for use for a living body normally has the same surface as the single grinding | polishing process surface concave like the top view of FIG.8 (b).

And the shape angle of the blade of the two side surfaces (2) is represented by A2, and about 51 to 53 degrees is preferable for biopsy, and as described later, it is made of a straight inclination angle, which is determined at this stage. desirable.

The blade 200 in the state of FIG. 8 may be injected by sintering or MIM (Metal Injection Molding) method as described above, or may be made by grinding a general material. For the convenience of the process, it is convenient to inject by sintering or MIM (Metal Injection Molding) method. The centerline portion 5a of the shape angle A2 of the blades of the upper and lower portions of the side blades 2 illustrated in FIG. 8 is a state where the blades are to be formed and will not be processed yet, and will be described below with additional drawings. .

Figure 9 illustrates a preferred embodiment of forming the most important upper lower blade in the blade of the present invention.

First, FIG. 9 (a) is rotated in a clockwise direction so that the line according to the shape of the upper blade in the front view of FIG. 8 (c) is horizontal as the center line 5a. FIG. 9B is a left side view of FIG. 9A, and FIG. 9C is a plan view of FIG. 9A. That is, the front view (a), the left side view (b), the top view (c) which looked at the perpendicular | vertical surface of the said centerline 5a according to the upper shape of the side which faces the body 7 at the tip part 9a as a reference plane. to be.

The circle dotted line 15a in Fig. 9B is for explaining the cross-sectional arc of the concave blade surface 1 which is the most important in the structure of the blade of the present invention. Such concave blade surface 1 is circular in cross section and the outer surface of the circular abrasive tool 15a is disposed parallel to the center line 5a according to the upper shape of the side facing the body 7 at the tip 9a end point, The shape of the concave blade surface 1 is determined by the surface produced by contacting the center line 5a with the outer surface of the circular polishing tool 15a. At this time, the diameter of the circular grinding tool is preferably set to a circular cross section of 10 mm or less.

The grinding tool setting angle A3 between the tangent 5c of the outer diameter of the grinding tool 15a and the center line 5a between the two side surfaces 2 is the polished angle of the blade of the concave blade surface 1 produced by grinding. (A1) is determined.

FIG. 10 shows that one concave blade surface 1 is formed on the upper right side according to the method of FIG. 9.

FIG. 10 (a) is a perspective view showing that the concave blade surface 1 is completed only on the upper portion of the blade surfaces on the right side of the two side surfaces 2. FIG. 10B is a plan view, in which the center line 5a described in FIG. 9 is clearly formed by the formation of the concave blade surface 1. Fig. 10 (c) is a front view showing that the blade of the concave blade surface 1 is inclined by the set angle A3 of the polishing tool of Fig. 9 and along the cylindrical surface. 10 (d) is a left side view, in which a concave blade surface 1 is formed on the upper right side of the side surface 2. It is shown that the width t portion on the right side of the central tip portion 9a is inclined downward on the formation of the concave blade surface 1.

In the same manner as in the method of forming the concave blade surface 1 of FIG. 9, it may be symmetrically formed on the upper left side between the two sides, and may be formed in the same manner so as to be symmetrical to the two concave blade surfaces 1 downward.

As such, four concave blade surfaces 1 are formed to complete the blade of the present invention as shown in FIG. 11.

Preferred completed blades of the present invention are described with reference to FIG.

Fig. 11 (a) is a perspective view showing the concave blade surface 1 completed on the upper and lower sides of the right side. Fig. 11 (b) is a plan view, in which the center line 5a, which was virtually explained in Fig. 9, is completed as the blade 5 by the formation of the upper two concave blade surfaces 1, and is clearly shown. Fig. 11 (c) is a front view showing that the blade of the concave blade surface 1 is vertically machined by the set angle A3 of the grinding tool of Fig. 9 and in accordance with the outer diameter of the circular grinding tool 15a. FIG. 11 (d) is a left side view, in which four concave blade surfaces 1 are formed on the left and right upper and lower sides of the side surface 2. The pointed part 9 was made by completion of the concave blade surface 1 in the width | variety t part in the center part 9. As shown in FIG. The width t of the ridge 9a made in the basic side of FIG. 8 changes like a sharp window edge by the completion of the concave blade surface 1, and finally the angle A1 of the blade is made.

Thus, finally, the size of the edge A1 of the edge is determined by the crossing angle of the center line 5a and the tangent of the polishing tool 5c, and the crossing angle is called the set angle A3 of the polishing angle.

Accordingly, while operating the polishing tool to the injection-only member of FIG. 8, the contact point where the tangent line and the radius of the polishing tool cross vertically is gradually polished and coincided with the center line 5a, so that the left side (b) of FIG. The part X1 to be polished is polished to realize the shape of the polished upper right surface 1 of FIG. 10.

The concave blade surface 1 formed by Figs. 9 and 10 has different sizes of arcs on the body 9 and the body 9 as shown. That is, the circular arc size of the concave blade surface 1 is larger on the body side than on the tip portion 9 side. This is due to the relationship that the width is widened from the tip portion 9a to the body 7 side as shown in FIG.

It can be seen from the plan view (b) of FIG. 11 that the polished angle A1 is considerably smaller than the shape angle A2 of the blade. Since the polishing tool is brought into contact with the center line 5a in a horizontal manner, the polishing tool is smoothly polished without a jaw. This is a structure that is inserted into the body while being punctured smoothly without insertion.

According to the method of the present invention, when polishing with a cutting tool having a diameter of 10 mm or less, there is an advantage of reducing the surface tension generated between the biological tissue and the polishing surface generated when the polishing surface is to cut the biological tissue in the shape of an arc.

12 is a structure of a blade to be compared with the blade of the present invention as shown in Figure 9 in the state having the side of FIG. 8, not a cylindrical concave arc-shaped concave surface as shown in Figure 9, the general of the surface such as the width of the concave blade surface It is a figure which shows the blade surface provided in the plane, for example with the blade surface grind | polished by the smoothing. Fig. 12A is a perspective view showing the completion of the flat blade surface 1p at the upper and lower portions of the right side. FIG. 12 (b) is a plan view, and the center line 5a, which has been virtually described in FIG. 9 by the formation of the upper two flat blade surfaces 1p, is clearly shown as a blade. Fig. 12 (c) is a front view showing that the blade of the flat blade surface 1p is vertically processed. FIG. 12 (d) is a left side view, in which four flat blade surfaces 1p are formed on the left and right upper and lower sides of the side surface 2.

It can be seen that the polished angle A1 of the blade polished in the blade of FIG. 12 is similar to the side blade shape angle A2, and is considerably larger than the polished angle A1 of the blade of FIG.

Figure 13 is a structure of the blade for comparison with the blade of the present invention in the state having the side of Figure 8 made a flat blade instead of the concave blade surface as shown in Figure 12 and the difference between the structure of the blade of Figure 12 is polished of the blade In order to make angle A1 similar to the polished angle A1 of the blade of FIG. 11, the flat tool surface was made small the grinding | polishing tool set angle A3. That is, in the state of the blade of Fig. 8, it is processed by artificially reducing the angle (A1) polished by general smoothing, invading the body side end 6 and the needle coupling portion 8 of the blade compared with Fig. You can check the polished shape.

Accordingly, as shown in FIGS. 12 and 13, it is possible to confirm that a sharp shape as shown in FIG. 11 can not be realized in the case of a general planar blade.

The concave blade surface 1 of the blade of the present invention preferably has a circular cross section, but in the case of using a method such as firing or other manufacturing method other than grinding, polygons (the more angles, the easier the sharp blades are produced) or It may have a shape such as an elliptic streamline. 12 and 13, it is possible to reduce the surface tension compared to the straight line, it is advantageous to implement a sharp blade.

14 is a perspective view of a blade as a preferred example of the present invention. As shown, the concave blade surface 1 is characterized by being provided at a predetermined angle to the left and right sides, respectively. The blade according to the present invention can be made by processing such as polishing and can be made by the injection method such as the sintering or metal injection molding (MIM) method described above for convenience, preferably the side (2) and the blade of Figure 8 Up to the shape step is made by injection method, and then forming the concave blade surface 1 shown in FIG. 9 is to make the concave blade surface 1 finally by grinding in the manner described in FIG. 9 with a cylindrical polishing rod.

The blade of the present invention is suitable for the construction of a blade for use in the biopsy assembly of FIG. When used for biopsy, the length of the blade according to the present invention preferably has a length (L1) = 5 ~ 8 mm as a whole. For use in such a blade it is preferable that the body 7 has a cylindrical or polygonal cross section, and based on the circular cross section, the body side diameter preferably has a range of 3 to 7 mm.

The concave cross section of the concave blade surface 1 is in the form of a window arc and preferably has a diameter of 5 to 10 mm for forming the arc. And it is preferable that the range of the width | variety t of FIG. 8 is 0.3-0.5 mm. The concave cross section may have a concave cross section of another shape, such as an ellipse or streamline, but an arc shape is preferable in consideration of workability or insertion of a blade. If the ellipse or streamline is produced, the shape can be produced by a conventional polishing method.

Since the polished angle A1 of the blade is preferably formed at 22 to 36 degrees, the polished angle of the desired blade is adjusted by adjusting the tangential angle A3 for forming the blade angle A1 of the concave blade surface 1 accordingly. What is necessary is to determine (A1) by considering durability and tissue dissection performance.

It is preferable to use the blade shape angle A2 as 51 to 53 degrees. However, if the blade shape angle is reduced, the total length L1 of the blade becomes long.

In particular, in the case of making the concave blade surface (1) is made, care should be taken in the following description when setting the tool.

In order to artificially modify the polishing tool setting angle A3 in order to reduce the polished angle A1 of the blade, as shown in the example of FIG. 13, the tip 6 of the blade and the engaging jaw 8 of the needle are invaded. Cause problems. In addition, even when the cutting tool is larger than 10 mm in diameter, as in the embodiment of Fig. 12 or 13, the tip 6 of the blade and the engaging jaw 8 of the needle are invaded, or the polished angle A1 of the blade is increased. There is this.

As described above, in the detailed description of the present invention, specific embodiments have been described, but various modifications are possible without departing from the scope of the present invention. Therefore, the scope of the present invention should not be limited to the described embodiments, but should be defined by the claims below and equivalents thereof.

The blade for a biopsy needle assembly of the present invention can be mainly used as a medical device and can be used in other similar related industries. That is, the incision inserted into the object and the suction part can be used in industrial parts that require cutting and discharging.

Claims (4)

A biopsy in which a sharp tip 9 is formed in the forward direction to insert and insert a living tissue, and a body 7 having a cross section in a circle, an ellipse, or a polygonal shape on the opposite side to be joined with other components. As a dragon blade, Two side surfaces 2 which are wider in the direction from the tip portion 9 to the body portion 7 and are opposed to each other, and Two blades 5 formed on the edge side of the two side surfaces 2 in the direction from the tip 9 to the body 7 and having a concave blade surface 1 having a concave cross section in the blade center direction. Blade for biopsy, characterized in that it comprises a). The method of claim 1, The width between the two sides 2 widens in the direction of the tip portion 9 in the direction of the body portion 7 and concave in the direction of the blade center, The blade 5 of the concave blade surface 1 from the tip portion 9 to the body portion 7 has a shape in which the V-shape has fallen to the right and its shape angle A2 is an acute angle. The vertical cross section of the concave blade surface 1 is an ellipse, a streamline, or an arc shape having a diameter of 10 mm or less or a maximum length of 10 mm or less in the longitudinal direction from the tip portion 9 to the body 7 portion as an axis. Part of the polygon, and The concave blade surface (1) is a blade for biopsy, characterized in that one side of the cross-section is in contact with the center line (5a) between the two side (2) and the other side is in contact with the side (2). The method of claim 2, The vertical cross section of all the concave blade surfaces 1 is an arc and has a larger arc size on the body 7 side than on the tip 9 side, The concave blade surfaces 1 are formed symmetrically with circular arcs of the same size in the direction of the two sides 2 from the center line 5a, The shape angle A2 of the blade is 51 to 53 degrees, The polished angle (A1) of the blade is 22 to 36 degrees, and Biopsy blade, characterized in that the diameter forming the arc of the concave blade surface (1) is 5 ~ 10 mm. The method according to any one of claims 1 to 3, The blade is processed by grinding, Made by sintering or metal injection molding process, or The tip 9 and both sides 2 are subjected to the first process by sintering or metal injection molding, and the concave blade surfaces 1 are sharply processed using a polishing tool having a diameter of 10 mm or less. Blade for biopsy, characterized in that the blade (5) and the sharp point (9) to make.

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