JP7036313B2 - Biometer and biometer - Google Patents

Description

The present invention relates to a biopsy needle for puncturing a living tissue in a living body and collecting a part of the living tissue. The present invention also relates to a biopsy device including the biopsy meter.

Conventionally, a puncture needle device used for sampling a living tissue by an ultrasonic endoscopic puncture suction method (EUS-FNA) or the like is known (see, for example, Patent Document 1). The puncture needle device described in Patent Document 1 includes a puncture needle operating portion, a tubular sheath member (sheath) fixed to the tip of the puncture needle operating portion, and a tubular biopsy needle inserted into the inner peripheral side of the sheath member. It is equipped with a (needle tube). The biopsy needle is formed in an elongated cylindrical shape having a constant inner and outer diameters. In this puncture needle device, when a part of the biological tissue in the living body is collected, the biopsy needle is rotated while the tip (needle tip) of the biopsy needle is inserted into the living tissue, and the biopsy needle is rotated when the biopsy needle is rotated. The living tissue is cut at the tip of the body. Therefore, Patent Document 1 proposes a shape of a tip portion of a biopsy needle suitable for cutting a biological tissue by rotation of the biopsy needle (see FIGS. 5 to 8 of Patent Document 1).

In the biopsy needle described in Patent Document 1, for example, the tip of the biopsy needle is perpendicular to the axial direction of the biopsy needle, and the inner end of the tip of the biopsy needle is a cutting edge for cutting a living tissue (Patent). See FIG. 5 of Document 1). Further, for example, in the biopsy needle described in Patent Document 1, semicircular notches are formed at the tip of the biopsy needle at intervals of about 90 °, and the living tissue is cut into the semicircular notches. A blade surface (semicircular blade) is formed (see FIG. 8 (a) of Patent Document 1). Further, for example, in the biopsy needle described in Patent Document 1, acute-angled protrusions having an acute-angled tip are formed at the tip of the biopsy needle at equal intervals, and the cutting edge surface (sharp-angled protrusion blade) for cutting a living tissue is formed on the acute-angled protrusions. ) Is formed (see FIG. 8 (b) of Patent Document 1).

Japanese Unexamined Patent Publication No. 2005-137454

The inventor of the present application is studying the shape of the tip of a biopsy needle that easily cuts a living tissue when the biopsy needle is rotated. According to the study by the inventor of the present application, in the biopsy needle described in Patent Document 1, if the length of the acute-angled protrusion formed at the tip of the biopsy needle is lengthened and the inclination angle of the side surface of the acute-angled protrusion is made gentle, the acute-angled protrusion is formed. It was revealed that the edge formed on the side surface of the biopsy needle makes it easier to cut the living tissue when the biopsy needle is rotated. On the other hand, in the biopsy needle described in Patent Document 1, it is clear from the study of the inventor of the present application that if the length of the acute-angled protrusion is increased, the rigidity of the acute-angled protrusion constituting the tip of the biopsy needle may decrease. became. If the rigidity of the acute-angled protrusion is reduced, the acute-angled protrusion may be deformed when the living tissue is cut, and the living tissue may not be cut. Further, when the rigidity of the acute-angled protrusion is reduced, the risk of the acute-angled protrusion being damaged increases.

Further, since the biopsy needle described in Patent Document 1 is formed in an elongated cylindrical shape having a constant inner diameter, a portion of the biological tissue cut by the rotating biopsy needle, which is connected to the surrounding biological tissue. The area (the part where the tip of the biopsy needle is located at the end of cutting) is wide according to the inner diameter of the biopsy needle, and is relatively large. Therefore, in the case of the biopsy needle described in Patent Document 1, it is difficult to separate a part of the biological tissue cut by the biopsy needle from the surrounding biological tissue.

Therefore, a first object of the present invention is to provide a biopsy needle capable of ensuring the rigidity of the tip portion even if the biological tissue is easily cut when the biopsy needle is rotated. A second object of the present invention is to provide a biopsy needle capable of easily separating a part of the biological tissue cut by the rotating biopsy needle from the surrounding biological tissue. Another object of the present invention is to provide a biopsy device including such a biopsy meter.

In order to solve the above-mentioned first problem, the biopsy needle of the present invention has a tubular portion formed in a tubular shape in a biopsy needle for piercing a living body tissue in a living body and collecting a part of the living body tissue. It is provided with one needle tip portion connected to the tip of the tubular portion, and the tip of the needle tip portion is a needle tip formed by the line of intersection between the flat first inclined surface and the planar second inclined surface. The inclination angle of the first inclined surface with respect to the axis of the tubular portion when viewed from the first direction parallel to the first inclined surface is the axis when viewed from the second direction parallel to the second inclined surface. It is looser than the angle of inclination of the second inclined surface with respect to, and the inner end of the first inclined surface in the radial direction of the tubular part is a cutting edge for cutting the living tissue, and the needle tip has a tubular part. From the axial direction, a planar third inclined surface adjacent to the second inclined surface when viewed from the axial direction, and a planar fourth inclined surface adjacent to the third inclined surface when viewed from the axial direction. When viewed, a planar fifth inclined surface adjacent to the fourth inclined surface and adjacent to the first inclined surface is formed, and when viewed from a direction parallel to the third inclined surface, the third inclined surface is formed. When viewed from a direction parallel to the 4th inclined plane, the 4th inclined surface is inclined with respect to the axis, and when viewed from a direction parallel to the 5th inclined plane, the 4th inclined surface is inclined. 5 The inclined surface is inclined with respect to the axis, and the inner end in the radial direction of the intersection line between the second inclined surface and the third inclined surface is set as the first intersection, and the intersection line between the third inclined surface and the fourth inclined surface. The radial inner end of is the second intersection, the radial inner end of the line of intersection between the fourth inclined surface and the fifth inclined surface is the third intersection, and the intersection of the fifth inclined surface and the first inclined surface. The inner end in the radial direction is the fourth intersection, the distance between the needle tip and the first intersection in the axial direction is the first distance, the distance between the needle tip and the second intersection in the axial direction is the second distance, and the axial direction. Assuming that the distance between the needle tip and the third line of intersection is the third distance and the distance between the needle tip and the fourth line of intersection in the axial direction is the fourth distance, the fourth distance is longer than the first distance and the second distance. Is longer than the fourth distance, and the third distance is longer than the second distance .
Further, in order to solve the above-mentioned first problem, the biopsy needle of the present invention is a tubular portion formed in a tubular shape in a biopsy needle for piercing a living tissue in a living body and collecting a part of the living tissue. And one needle tip connected to the tip of the tubular portion, and the tip of the needle tip is a needle tip formed by the line of intersection between the flat first inclined surface and the planar second inclined surface. The angle of inclination of the first inclined surface with respect to the axis of the tubular portion when viewed from the first direction parallel to the first inclined surface is when viewed from the second direction parallel to the second inclined surface. It is looser than the angle of inclination of the second inclined surface with respect to the axis, and the inner end of the first inclined surface in the radial direction of the tubular part is a cutting edge for cutting the living tissue. A planar third inclined surface adjacent to the second inclined surface when viewed from the axial direction of the tubular portion, and a planar surface adjacent to the third inclined surface and adjacent to the first inclined surface when viewed from the axial direction. When viewed from a direction parallel to the third inclined surface, the third inclined surface is inclined with respect to the axis of alignment, and when viewed from a direction parallel to the fourth inclined surface. , The 4th inclined surface is inclined with respect to the axis, and the inner end in the radial direction of the line of intersection between the 2nd inclined surface and the 3rd inclined surface is set as the first intersection, and the third inclined surface and the 4th inclined surface are The radial inner end of the line of intersection is the second intersection, the radial inner end of the line of intersection between the fourth inclined surface and the first inclined surface is the fifth intersection, and the needle tip and the first intersection in the axial direction Assuming that the distance is the first distance, the distance between the needle tip and the second intersection in the axial direction is the second distance, and the distance between the needle tip and the fifth intersection in the axial direction is the fifth distance, the fifth distance is the fifth. It is characterized in that it is longer than one distance and the second distance is longer than the fifth distance.

In the biopsy needle of the present invention, the needle tip is formed by the line of intersection between the first inclined surface and the second inclined surface. Further, in the present invention, the inclination angle of the first inclined surface with respect to the axial center of the tubular portion when viewed from the first direction parallel to the first inclined surface is when viewed from the second direction parallel to the second inclined surface. It is looser than the inclination angle of the second inclined surface with respect to the axial center of the tubular portion, and the inner end of the first inclined surface in the radial direction of the tubular portion is a cutting edge for cutting the living tissue. That is, in the present invention, the radial inner end of the first inclined surface having a gentle inclination angle with respect to the axial center of the tubular portion is the cutting edge. Therefore, in the present invention, it becomes easy to cut the living tissue by the cutting edge when the biopsy needle is rotated.

Further, in the present invention, when the inclination angle of the second inclined surface with respect to the axial center of the tubular portion when viewed from the second direction parallel to the second inclined surface is viewed from the first direction parallel to the first inclined surface. It is larger than the inclination angle of the first inclined surface with respect to the axial center of the tubular portion. Therefore, in the present invention, the radial inner end of the first inclined surface having a gentle inclination angle with respect to the axial center of the tubular portion is the cutting edge, and the length of the cutting edge in the axial direction of the tubular portion is relatively long. Even if this is the case, it is possible to shorten the distance from the needle tip, which is one end of the second inclined surface, to the other end of the second inclined surface in the axial direction of the tubular portion. Therefore, in the present invention, it is possible to secure the rigidity of the tip portion of the biopsy needle. That is, in the present invention, it is possible to secure the rigidity of the tip portion of the biopsy needle even if the biological tissue is easily cut when the biopsy needle is rotated.

Further, in the present invention, the radial inner end of the first inclined surface having a gentle inclination angle with respect to the axial center of the tubular portion is the cutting edge, and the length of the cutting edge in the axial direction of the tubular portion is lengthened. Therefore, it is possible to increase the amount of cutting of living tissue when the biopsy needle makes one rotation. In the biopsy needle described in Patent Document 1, since a plurality of acute-angled protrusions are formed at equal intervals at the tip of the biopsy needle, the acute-angled protrusion blade formed on a certain acute-angled protrusion while rotating the biopsy needle. When trying to cut a living tissue, the acute-angled protrusions adjacent to the acute-angled protrusions may hinder the acute-angled protrusion blades from coming into contact with the living-body tissue. Therefore, the biopsy needle described in Patent Document 1 may be difficult to cut the living tissue. On the other hand, in the present invention, there is one needle tip portion connected to the tip of the tubular portion, and the tip of this needle tip portion is formed by the line of intersection between the first inclined surface and the second inclined surface. Therefore, when the biopsy needle is rotated, the cutting edge is easily brought into contact with the living tissue.

Further, in the present invention, the needle tip portion has a planar third inclined surface adjacent to the second inclined surface when viewed from the axial direction of the tubular portion and a third inclined surface when viewed from the axial direction. An adjacent planar fourth inclined surface and a planar fifth inclined surface adjacent to the fourth inclined surface and adjacent to the first inclined surface when viewed from the axial direction are formed, and the third inclined surface is formed. When viewed from a parallel direction, the third inclined surface is inclined with respect to the axis, and when viewed from a direction parallel to the fourth inclined surface, the fourth inclined surface is inclined with respect to the axis. When viewed from a direction parallel to the 5 inclined surfaces, the 5th inclined surface is inclined with respect to the axis, and the inner end in the radial direction of the line of intersection between the 2nd inclined surface and the 3rd inclined surface is set as the first intersection. The radial inner end of the line of intersection between the third inclined surface and the fourth inclined surface is defined as the second intersection, and the radial inner end of the intersection line between the fourth inclined surface and the fifth inclined surface is defined as the third intersection. , The inner end of the line of intersection between the 5th inclined surface and the 1st inclined surface is the 4th intersection, the distance between the needle tip in the axial direction and the 1st intersection is the 1st distance, and the needle tip in the axial direction. If the distance from the second intersection is the second distance, the distance between the needle tip and the third intersection in the axial direction is the third distance, and the distance between the needle tip and the fourth intersection in the axial direction is the fourth distance. The 4 distance is longer than the 1st distance, the 2nd distance is longer than the 4th distance, the 3rd distance is longer than the 2nd distance, or the needle tip is the axis of the tubular part. A planar third inclined surface adjacent to the second inclined surface when viewed from the direction, and a planar fourth inclined surface adjacent to the third inclined surface and adjacent to the first inclined surface when viewed from the axial direction. A surface is formed, the third inclined surface is inclined with respect to the axis when viewed from a direction parallel to the third inclined surface, and the fourth inclined surface is inclined when viewed from a direction parallel to the fourth inclined surface. The surface is inclined with respect to the axis, and the inner end in the radial direction of the line of intersection between the second inclined surface and the third inclined surface is set as the first intersection, and the diameter of the line of intersection between the third inclined surface and the fourth inclined surface. The inner end in the direction is the second intersection, the radial inner end of the line of intersection between the fourth inclined surface and the first inclined surface is the fifth intersection, and the distance between the needle tip and the first intersection in the axial direction is the first. Assuming that the distance is the distance between the needle tip and the second intersection in the axial direction as the second distance and the distance between the needle tip and the third intersection in the axial direction is the fifth distance, the fifth distance is larger than the first distance. Long, the second distance is longer than the fifth distance. Therefore, according to the study of the inventor of the present application, it becomes easy to form the needle tip portion so that the sharp protrusion protruding toward the needle tip side is not formed around the cutting edge. That is, it becomes possible to easily form a needle tip portion in which the cut edge easily comes into contact with the living tissue.

In the present invention, for example, the inclination angle of the first inclined plane with respect to the axis when viewed from the first direction is 1 ° to 5 °, and the second inclination with respect to the axis when viewed from the second direction. The inclination angle of the surface is 20 ° to 30 °, and the plane parallel to the plane orthogonal to the first inclined surface and passing through the axis is the first virtual plane and orthogonal to the second inclined surface. Assuming that the plane parallel to the plane and passing through the axis is the second virtual plane, the angle between the first virtual plane and the second virtual plane when viewed from the axial direction of the tubular portion is 150 °. It is ~ 180 °.

Further, in order to solve the above-mentioned second problem, the biopsy needle of the present invention is a tubular portion formed in a tubular shape in a biopsy needle for piercing a living body tissue in a living body and collecting a part of the living body tissue. And a needle tip portion connected to the tip of the tubular portion, and the needle tip portion has a radial outer surface and an inner surface surface of the tubular portion in the radial direction toward the needle tip formed at the tip of the needle tip portion. A tapered portion is formed that inclines toward the inside of the tape, and the tip of the tapered portion is a needle tip. When viewed from the axial direction of the tubular portion, cutting edges are formed on both sides of the needle tip in the circumferential direction of the tubular portion, and the needle tip portion has a flat first inclined surface and the tubular portion. A planar second inclined surface adjacent to the first inclined surface when viewed from the axial direction, and a planar third inclined surface adjacent to the second inclined surface when viewed from the axial direction, and from the axial direction. A planar fourth inclined surface adjacent to the third inclined surface when viewed, and a planar fifth inclined surface adjacent to the fourth inclined surface and adjacent to the first inclined surface when viewed from the axial direction. Is formed, and when viewed from a direction parallel to the first inclined surface, the first inclined surface is inclined with respect to the axial center of the tubular portion, and when viewed from a direction parallel to the second inclined surface, the second inclined surface is formed. When the inclined surface is inclined with respect to the axis and viewed from a direction parallel to the third inclined surface, the third inclined surface is inclined with respect to the axis and when viewed from a direction parallel to the fourth inclined surface. In addition, the 4th inclined surface is inclined with respect to the axis, and when viewed from a direction parallel to the 5th inclined surface, the 5th inclined surface is inclined with respect to the axis, and the 2nd inclined surface and the 3rd inclined surface are inclined. The intersection line with the surface is the needle tip, and the virtual line, which is an extension of the intersection line between the second inclined surface and the third inclined surface when viewed from the axial direction, passes through the axial center and is in the axial direction. When viewed from above, the first inclined plane and the fourth inclined plane are formed line-symmetrically with respect to the virtual line, and when viewed from the axial direction, the center of the fifth inclined surface in the circumferential direction of the tubular portion is a virtual line. Is characterized by passing through .

In the biopsy needle of the present invention, the tip of the tapered portion whose outer surface and inner surface in the radial direction of the tubular portion are inclined inward in the radial direction toward the needle tip formed at the tip of the needle tip is the needle tip. It has become. Further, in the present invention, at least the tip portion of the tapered portion, the end portion of the inner side surface in the radial direction is a cutting edge for cutting the living tissue. Therefore, in the present invention, the outer shape of the one end side portion of the living tissue cut by the rotating biopsy needle becomes a truncated cone shape in which the outer diameter gradually decreases toward one end of the living tissue. Therefore, in the present invention, it is possible to reduce the area of the portion of the biological tissue cut by the rotating biopsy needle, which is connected to the surrounding biological tissue (the portion where the needle tip of the biopsy needle is located at the end of cutting). .. As a result, in the present invention, it becomes possible to easily separate a part of the biological tissue cut by the rotating biopsy needle from the surrounding biological tissue.

Further, in the present invention , since the cutting edges are formed on both sides of the needle tip in the circumferential direction of the tubular portion when viewed from the axial direction of the tubular portion, the cutting edge is formed regardless of which direction the biopsy needle is rotated. Cuts the living tissue.

In the present invention, it is preferable that the entire axial direction of the end portion of the inner surface of the tapered portion in the radial direction is a cutting edge. With this configuration, it becomes possible to cut a living tissue in a wider range in the radial direction. Therefore, it is possible to increase the amount of living tissue that is cut and collected by a biopsy needle.

In the present invention, for example, the distance between the axial center of the tubular portion and the inner end of the needle tip in the radial direction when viewed from the axial direction of the tubular portion is 0.1 mm or less.

In the present invention, the inner peripheral surface of the tubular portion is formed with a recess that is recessed toward the outside in the radial direction of the tubular portion, and the side surface of the recess on the needle tip side is accommodated on the inner peripheral side of the tubular portion. It is preferable that it is a regulatory surface that regulates the movement of a part of the living tissue toward the needle tip side. With this configuration, it is possible to prevent a part of the biological tissue cut at the cutting edge and contained on the inner peripheral side of the tubular portion from coming out of the biopsy needle. Therefore, it becomes possible to reliably take out a part of the biological tissue contained in the inner peripheral side of the tubular portion.

In the present invention, the regulating surface is orthogonal to the inner peripheral surface of the tubular portion, and the side surface of the concave portion on the proximal end side of the tubular portion is an inclined surface inward in the radial direction toward the proximal end side of the tubular portion. When viewed from the axial direction of the tubular portion, the recess is preferably formed in an arc shape with the axial center of the tubular portion as the center of curvature. With this configuration, the side surface of the concave portion on the proximal end side of the tubular portion is an inclined surface that is radially inward toward the proximal end side of the tubular portion, so that the inner peripheral surface of the tubular portion is formed. Even if the concave portion is formed, the movement of the living tissue to the inner peripheral side of the tubular portion is less likely to be hindered by the concave portion.

In the present invention, the tubular portion is formed with a through hole penetrating the tubular portion in the radial direction of the tubular portion, and the side surface of the through hole on the needle tip side is a living tissue housed on the inner peripheral side of the tubular portion. It is preferable that it is a regulatory surface that regulates the movement of a part of the needle tip to the needle tip side. With this configuration, it is possible to prevent a part of the biological tissue cut at the cutting edge and contained on the inner peripheral side of the tubular portion from coming out of the biopsy needle. Therefore, it becomes possible to reliably take out a part of the biological tissue contained in the inner peripheral side of the tubular portion.

In the present invention, the through hole is formed in a substantially triangular shape having two first side surfaces and a regulating surface that approach each other and intersect each other from both ends of the regulating surface in the circumferential direction of the tubular portion toward the proximal end side of the tubular portion. Therefore, it is preferable that the regulation surface and the first side surface are inclined surfaces toward the needle tip portion toward the outer side in the radial direction. With this configuration, even if a through hole is formed in the tubular portion, the movement of the biological tissue to the inner peripheral side of the tubular portion is less likely to be hindered by the through hole.

In the present invention, it is preferable that the through holes are formed at a plurality of locations over the entire circumferential direction of the tubular portion. With such a configuration, it becomes possible to effectively prevent a part of the biological tissue cut at the cutting edge and contained on the inner peripheral side of the tubular portion from coming out of the biopsy needle by the plurality of through holes.

The biopsy needle of the present invention is formed in a tubular shape and has a sheath member on which the biopsy needle is arranged on the inner peripheral side, a gripping member to which the base end of the sheath member is fixed, and a gripping member that is rotatable and slidable. It can be used in a biopsy device including a needle operation member to be used. In this biopsy device, the base end of the tubular portion is connected to the needle operating member, and the biopsy needle can move in the axial direction of the tubular portion together with the needle operating member with respect to the gripping member. On the other hand, it can rotate in the circumferential direction of the tubular part together with the needle operating member. With this biopsy device, it is possible to secure the rigidity of the tip of the biopsy needle even if it is easy to cut the biological tissue when the biopsy needle rotates. In addition, this biopsy device makes it possible to easily separate a part of the biological tissue cut by the rotating biopsy needle from the surrounding biological tissue.

As described above, in the present invention, it is possible to secure the rigidity of the tip portion of the biopsy needle even if the biological tissue is easily cut when the biopsy needle is rotated. Further, in the present invention, it becomes possible to easily separate a part of the biological tissue cut by the rotating biopsy needle from the surrounding biological tissue.

It is a schematic diagram for demonstrating the structure of the bio-inspection apparatus which concerns on embodiment of this invention. It is a side view of the biopsy needle shown in FIG. It is a front view of the biopsy needle shown in FIG. (A) is a schematic view for explaining the inclination angle of the first inclined surface shown in FIG. 2, and (B) is a schematic view for explaining the inclination angle of the second inclined surface shown in FIG. be. It is a figure for demonstrating the manufacturing procedure of the biopsy needle shown in FIG. It is a front view of the state in the middle of manufacturing of the biopsy needle shown in FIG. 5 (B). It is a perspective view for demonstrating the modification of the biopsy needle shown in FIG. (A) and (B) are side views of the biopsy needle according to the second embodiment of the present invention, and (C) is a perspective view of the biopsy needle shown in (A) and (B). FIG. 8 is a front view of the biopsy needle shown in FIG. It is a figure for demonstrating the manufacturing procedure of the biopsy needle shown in FIG. It is a figure which shows an example of a part of the living tissue collected by the biopsy needle shown in FIG. (A) and (B) are side views of the biopsy needle according to another embodiment of the present invention, and (C) is a perspective view of the biopsy needle shown in (A) and (B). FIG. 12 is a front view of the biopsy needle shown in FIG. (A) and (B) are side views of the biopsy needle according to another embodiment of the present invention, and (C) is a perspective view of the biopsy needle shown in (A) and (B). FIG. 14 is a front view of the biopsy needle shown in FIG. (A) is an exploded perspective view of a part of the tubular part according to another embodiment of the present invention, and (B) and (C) are vertical sectional views of a part of the tubular part shown in (A). (D) is a cross-sectional view of a part of the tubular portion shown in (A). (A) is a perspective view of a part of the tubular part according to another embodiment of the present invention, (B) is a vertical sectional view of a part of the tubular part shown in (A), and (C). ) Is an enlarged view of the G portion of (B), and (D) is an enlarged view of the H portion of (B).

Hereinafter, embodiments of the present invention will be described with reference to the drawings.

[Embodiment 1]
(Approximate configuration of biometric device)
FIG. 1 is a schematic diagram for explaining the configuration of the biopsy device 3 according to the embodiment of the present invention. FIG. 2 is a side view of the biopsy needle 1 shown in FIG.

The biopsy needle 1 of this embodiment is used to puncture a living tissue in a living body and collect a part of the living tissue. Specifically, the biopsy needle 1 is used to puncture a living tissue while rotating and to collect a part of the living tissue. The biopsy needle 1 constitutes a part of the biopsy needle device 3 used in the collection of biological tissue by the ultrasonic endoscopic puncture suction method. The biopsy device 3 includes a biopsy needle 1, a sheath member 4 which is formed in a tubular shape and the biopsy needle 1 is arranged on the inner peripheral side, a grip member 5 to which the base end of the sheath member 4 is fixed, and a grip member. It is provided with a needle operating member 6 held by 5. The sheath member 4 is an elongated tube made of a flexible resin. The sheath member 4 is inserted into the inner peripheral side of the forceps channel of the ultrasonic endoscope. The needle operating member 6 is rotatably and slidably held by the gripping member 5. The gripping member 5 is gripped when operating the needle operating member 6.

The biopsy needle 1 is, for example, a steel pipe made of stainless steel. The outer diameter and inner diameter of the biopsy needle 1 are constant. The outer diameter of the biopsy needle 1 is, for example, 0.5 mm to 1.0 mm. The biopsy needle 1 is composed of a tubular portion 1a formed in a tubular shape and a single needle tip portion 1b connected to the tip of the tubular portion 1a. The tubular portion 1a is formed in a straight line. The proximal end of the tubular portion 1a (ie, the proximal end of the biopsy needle 1) is connected to the needle operating member 6. The biopsy needle 1 is movable in the axial direction of the tubular portion 1a together with the needle operating member 6 with respect to the gripping member 5, and the tubular portion 1a is movable together with the needle operating member 6 with respect to the gripping member 5. It can rotate in the circumferential direction. The biopsy needle 1 of this embodiment is suitable for collecting a relatively hard biological tissue.

When collecting a part of the biological tissue, as shown in FIG. 1B, the needle tip portion of the biopsy needle 1 is rotated from the tip of the sheath member 4 while rotating the needle operating member 6 with respect to the gripping member 5. The needle operating member 6 is moved in the direction in which 1b protrudes. At this time, the biopsy needle 1 moves while rotating together with the needle operating member 6. The biopsy device 3 is provided with a suction mechanism for sucking a part of the biological tissue cut by the cutting edge 1t, which will be described later, toward the inner peripheral side of the tubular portion 1a. Further, the needle operating member 6 includes a stopper 7 that regulates the slide amount of the needle operating member 6 with respect to the gripping member 5. Further, the operation of the needle operating member 6 may be performed manually or automatically. When the needle operation member 6 is automatically operated, the biopsy needle device 3 includes a rotation mechanism that automatically rotates the needle operation member 6 and a slide mechanism that automatically slides the needle operation member 6. ..

(Composition of biopsy needle)
FIG. 3 is a front view of the biopsy needle 1 shown in FIG. FIG. 4A is a schematic view for explaining the inclination angle θ1 of the first inclined surface 1c shown in FIG. 2, and FIG. 4B is an inclination angle θ2 of the second inclined surface 1d shown in FIG. It is a schematic diagram for demonstrating. FIG. 5 is a diagram for explaining the manufacturing procedure of the biopsy needle 1 shown in FIG. FIG. 6 is a front view of the biopsy needle 1 shown in FIG. 5B during the manufacturing process.

As described above, the biopsy needle 1 is composed of a tubular portion 1a and a single needle tip portion 1b connected to the tip of the tubular portion 1a. The tubular portion 1a is formed in an elongated cylindrical shape. The inner surface of the needle tip portion 1b in the radial direction of the tubular portion 1a (hereinafter, this direction is referred to as the “diameter direction”) is connected to the inner peripheral surface of the tubular portion 1a. As shown in FIGS. 2 and 3, the needle tip portion 1b is viewed from a planar first inclined surface 1c and an axial direction of the tubular portion 1a (hereinafter, this direction is referred to as an “axial direction”). Sometimes a planar second inclined surface 1d adjacent to the first inclined surface 1c and a planar third inclined surface 1e adjacent to the second inclined surface 1d when viewed from the axial direction, as seen from the axial direction. Sometimes a planar fourth inclined surface 1f adjacent to the third inclined surface 1e and a planar fifth inclined surface adjacent to the fourth inclined surface 1f and adjacent to the first inclined surface 1c when viewed from the axial direction. A surface of 1 g is formed.

When viewed from the first direction parallel to the first inclined surface 1c formed in a plane shape, the first inclined surface 1c is inclined with respect to the axial center 1h of the tubular portion 1a. When viewed from a second direction parallel to the second inclined surface 1d formed in a plane shape, the second inclined surface 1d is inclined with respect to the axial center 1h of the tubular portion 1a. Further, when viewed from a direction parallel to the third inclined surface 1e formed in a plane, the third inclined surface 1e is inclined with respect to the axis 1h and becomes a fourth inclined surface 1f formed in a plane. When viewed from a parallel direction, the 4th inclined surface 1f is inclined with respect to the axis 1h, and when viewed from a direction parallel to the 5th inclined surface 1g formed in a plane, the 5th inclined surface 1g Is inclined with respect to the axis 1h.

The tip of the needle tip portion 1b is the needle tip 1j formed by the line of intersection between the first inclined surface 1c and the second inclined surface 1d. The inclination angle θ1 of the first inclined surface 1c with respect to the axial center 1h when viewed from the first direction (see FIG. 4A) is the inclination of the second inclined surface 1d with respect to the axial center 1h when viewed from the second direction. It is looser than the angle θ2 (see FIG. 4B). In this embodiment, the inclination angle θ1 is 1 ° to 5 ° (1 ° or more and 5 ° or less), and the inclination angle θ2 is 20 ° to 30 °.

The radial inner end of the line of intersection between the second inclined surface 1d and the third inclined surface 1e is the first intersection point 1k, and the inner end of the intersection line between the third inclined surface 1e and the fourth inclined surface 1f is the radial inner end. The second intersection point 1n, the radial inner end of the line of intersection between the fourth inclined surface 1f and the fifth inclined surface 1g is the third intersection point 1p, and the intersection line between the fifth inclined surface 1g and the first inclined surface 1c. The inner end in the radial direction is the fourth intersection 1q, the distance between the needle tip 1j and the first intersection 1k in the axial direction is the first distance L1, and the distance between the needle tip 1j and the second intersection 1n in the axial direction is the second. Let the distance L2 be the distance between the needle tip 1j and the third intersection 1p in the axial direction be the third distance L3, and the distance between the needle tip 1j and the fourth intersection 1q in the axial direction be the fourth distance L4. As shown in A), the fourth distance L4 is longer than the first distance L1. Further, the second distance L2 is longer than the fourth distance L4, and the third distance L3 is longer than the second distance L2.

In this embodiment, the inner end of the first inclined surface 1c in the radial direction is a cutting edge (blade for cutting) 1t for cutting a living tissue. That is, the edge formed at the end of the first inclined surface 1c is the cutting edge 1t. Further, the radial inner end of the first inclined surface 1c, which is the cutting edge 1t, the radial inner end of the second inclined surface 1d, the radial inner end of the third inclined surface 1e, and the fourth inclined surface. The radial inner end of 1f and the radial inner end of the fifth inclined surface 1g define the contour of the opening formed on the tip end side of the needle tip portion 1b.

In this embodiment, the biopsy needle 1 is formed by grinding the tip of a tubular member formed in an elongated cylindrical shape having a constant outer diameter and inner diameter. Specifically, first, as shown in FIG. 5 (A), a first inclined surface 1c is formed on the tubular member by grinding, and then, as shown in FIG. 5 (B), a second inclined surface is formed. 1d is formed by grinding. After that, as shown in FIG. 5C, the third inclined surface 1e is formed by grinding, and then, as shown in FIG. 5D, the fourth inclined surface 1f is formed by grinding, and finally. The fifth inclined surface 1 g is formed by grinding. When the fifth inclined surface 1g is formed, the biopsy needle 1 is completed.

Further, in the present embodiment, the plane parallel to the plane orthogonal to the first inclined surface 1c and passing through the axis 1h is defined as the first virtual plane VP1, and the plane parallel to the plane orthogonal to the second inclined surface 1d. Assuming that the plane passing through the axis 1h is the second virtual plane VP2, as shown in FIG. 3, the angle θ3 formed by the first virtual plane VP1 and the second virtual plane VP2 when viewed from the axial direction is , 150 ° to 180 °. In the biopsy needle 1 at the stage after the second inclined surface 1d is formed, as shown in FIG. 6, the first virtual plane VP1 is in the circumferential direction of the tubular portion 1a (hereinafter referred to as this) when viewed from the axial direction. The direction is referred to as "circumferential direction"), and the second virtual plane VP2 passes through the center of the second inclined surface 1d in the circumferential direction.

(Main effect of this form)
As described above, in the present embodiment, the needle tip 1j is formed by the line of intersection between the first inclined surface 1c and the second inclined surface 1d. Further, in the present embodiment, the inclination angle θ1 of the first inclined surface 1c with respect to the axial center 1h of the tubular portion 1a is looser than the inclination angle θ2 of the second inclined surface 1d with respect to the axial center 1h, and the first in the radial direction. The inner end of the inclined surface 1c is a cutting edge 1t for cutting a living tissue. That is, in this embodiment, the radial inner end of the first inclined surface 1c having a gentle inclination angle θ1 with respect to the axial center 1h is the cutting edge 1t. Therefore, in this embodiment, when the biopsy needle 1 is rotated, the living tissue is easily cut by the cutting edge 1t.

Further, in the present embodiment, the inclination angle θ2 of the second inclined surface 1d with respect to the axis 1h is larger than the inclination angle θ1 of the first inclined surface 1c. Therefore, in the present embodiment, the radial inner end of the first inclined surface 1c having a gentle inclination angle θ1 with respect to the axial center 1h is the cutting edge 1t, and the length of the cutting edge 1t in the axial direction is relatively long. Even so, it is possible to shorten the distance from the needle tip 1j, which is one end of the second inclined surface 1d, to the other end of the second inclined surface 1d in the axial direction. That is, it is possible to shorten the first distance L1, which is the distance between the needle tip 1j and the first intersection 1k in the axial direction. Therefore, in this embodiment, it is possible to secure the rigidity of the tip portion (needle tip portion 1b) of the biopsy needle 1. That is, in this embodiment, it is possible to secure the rigidity of the tip portion of the biopsy needle 1 even if the biological tissue is easily cut when the biopsy needle 1 is rotated.

Further, in the present embodiment, the radial inner end of the first inclined surface 1c having a gentle inclination angle θ1 with respect to the axial center 1h is the cutting edge 1t, and the length of the cutting edge 1t in the axial direction can be lengthened. This makes it possible to increase the amount of tissue cut when the biopsy needle 1 makes one rotation.

In this embodiment, the needle tip 1j is formed at the tip and the number of needle tip portions 1b connected to the tip of the tubular portion 1a is one, and sharp protrusions protruding toward the needle tip 1j are formed around the cutting edge 1t. Not formed. Therefore, in this embodiment, when the biopsy needle 1 is rotated, the cutting edge 1t is easily brought into contact with the living tissue. Further, in the present embodiment, in addition to the first inclined surface 1c and the second inclined surface 1d, the third inclined surface 1e to the fifth inclined surface 1g are formed, and the first distance L1 to the fourth distance L4 are described above. Therefore, according to the study of the inventor of the present application, it becomes easy to form the needle tip portion 1b so that the sharp protrusion protruding toward the needle tip 1j side is not formed around the cutting edge 1t. That is, in this embodiment, it becomes possible to easily form the needle tip portion 1b in which the cutting edge 1t easily comes into contact with the living tissue.

(Deformation example of needle tip)
In the first embodiment, the fifth inclined surface 1g may not be formed on the needle tip portion 1b. In this case, when viewed from the axial direction, the fourth inclined surface 1f is adjacent to the third inclined surface 1e and adjacent to the first inclined surface 1c (see FIG. 5D). Further, as shown in FIG. 5D, the radial inner end of the line of intersection between the 4th inclined surface 1f and the 1st inclined surface 1c is set as the 5th intersection point 1v, and the needle tip 1j and the 5th intersection point in the axial direction. Assuming that the distance from 1v is the fifth distance L5, the fifth distance L5 is longer than the first distance L1, and the second distance L2 is longer than the fifth distance L5.

Even in this case, according to the study of the inventor of the present application, it becomes easy to form the needle tip portion 1b so that a sharp protrusion protruding toward the needle tip 1j side is not formed around the cutting edge 1t. That is, it becomes possible to easily form the needle tip portion 1b in which the cutting edge 1t easily comes into contact with the living tissue. However, when the 5th inclined surface 1g is not formed, a very small protrusion having the 5th intersection 1v as the apex is formed, so that it is preferable that the 5th inclined surface 1g is formed.

Further, in the first embodiment, the third inclined surface 1e, the fourth inclined surface 1f and the fifth inclined surface 1g may not be formed. In this case, for example, after the second inclined surface 1d is formed by grinding (see FIG. 5B), the needle tip portion 1b is formed by cutting the portion shown by the diagonal line in FIG. 7 by laser processing or the like. It is formed. However, if the third inclined surface 1e, the fourth inclined surface 1f, and the fifth inclined surface 1g are formed by grinding, the needle tip portion 1b can be formed more accurately.

[Embodiment 2]
(Composition of biopsy needle)
8 (A) and 8 (B) are side views of the biopsy needle 11 according to the second embodiment of the present invention, and FIG. 8 (C) shows the biopsy needle 11 shown in FIGS. 8 (A) and 8 (B). It is a perspective view of. FIG. 9 is a front view of the biopsy needle 11 shown in FIG. FIG. 10 is a diagram for explaining the manufacturing procedure of the biopsy needle 11 shown in FIG. FIG. 11 is a diagram showing an example of a part of the biological tissue collected by the biopsy needle 11 shown in FIG.

In the biopsy meter 3, the biopsy needle 11 may be used instead of the biopsy needle 1 of the first embodiment. Like the biopsy needle 1, the biopsy needle 11 of the present embodiment is, for example, a steel pipe made of stainless steel. The biopsy needle 11 is composed of a tubular portion 11a formed in a tubular shape and a needle tip portion 11b connected to the tip of the tubular portion 11a. The tubular portion 11a is formed in a straight line. The outer diameter of the tubular portion 11a is, for example, 0.5 mm to 1.0 mm. The inner surface of the needle tip portion 11b in the radial direction of the tubular portion 11a (hereinafter, this direction is referred to as the “diameter direction”) is connected to the inner peripheral surface of the tubular portion 11a.

The biopsy needle 1 of the first embodiment is formed by grinding the tip of a tubular member formed in an elongated cylindrical shape having a constant outer diameter and inner diameter. On the other hand, the biopsy needle 11 of the present embodiment is formed by grinding the tip of an elongated cylindrical tubular member (see FIG. 10A) whose tip has been drawn. .. Therefore, the needle tip portion 11b is formed with a tapered portion 11d in which the outer surface and the inner side surface in the radial direction are inclined inward in the radial direction toward the needle tip 11c formed at the tip of the needle tip portion 11b. ing.

The inclination angle of the outer surface of the tapered portion 11d in the radial direction and the inclination angle of the inner surface of the tapered portion 11d in the radial direction are substantially equal to each other. The inclination angle (gradient angle) θ4 of the tapered portion 11d with respect to the axial center 11e of the tubular portion 11a is about 10 ° to 15 °. Further, the wall thickness of the tubular portion 11a and the wall thickness of the tapered portion 11d are substantially equal to each other. The tip of the tapered portion 11d is the needle tip 11c.

The needle tip portion 11b is adjacent to the flat first inclined surface 11f and the first inclined surface 11f when viewed from the axial direction of the tubular portion 11a (hereinafter, this direction is referred to as "axial direction"). A planar second inclined surface 11g, a planar fourth inclined surface 11j adjacent to the second inclined surface 11g when viewed from the axial direction, and an adjacent fourth inclined surface 11j when viewed from the axial direction. In addition, a planar third inclined surface 11h adjacent to the first inclined surface 11f is formed.

When viewed from a direction parallel to the first inclined surface 11f formed in a plane, the first inclined surface 11f is inclined with respect to the axial center 11e of the tubular portion 11a, and the second inclined surface formed in a plane is formed. The second inclined surface 11g is inclined with respect to the axis 11e when viewed from a direction parallel to 11g, and the third inclined surface is inclined when viewed from a direction parallel to the third inclined surface 11h formed in a plane. The surface 11h is inclined with respect to the axis 11e, and the fourth inclined surface 11j is inclined with respect to the axis 11e when viewed from a direction parallel to the fourth inclined surface 11j formed in a plane. In this embodiment, the line of intersection between the first inclined surface 11f and the second inclined surface 11g is the needle tip 11c. Further, when viewed from the axial direction, the distance L10 (see FIG. 9) between the axial center 11e of the tubular portion 11a and the inner end of the needle tip 11c in the radial direction is 0.1 mm or less. However, the distance L10 may exceed 0.1 mm.

The radial inner end of the line of intersection between the second inclined surface 11g and the fourth inclined surface 11j is the first intersection point 11k, and the radial inner end of the intersection line between the fourth inclined surface 11j and the third inclined surface 11h is defined as the first intersection point 11k. The second intersection 11n, the radial inner end of the line of intersection between the third inclined surface 11h and the first inclined surface 11f is the third intersection 11p, and the distance between the needle tip 11c and the first intersection 11k in the axial direction is the first. Assuming that 1 distance L11, the distance between the needle tip 11c and the second intersection 11n in the axial direction is the second distance L12, and the distance between the needle tip 11c and the third intersection 11p in the axial direction is the third distance L13, FIG. As shown in (A), the first distance L11 is longer than the third distance L13, and the second distance L12 is longer than the first distance L11.

In the axial direction, the first intersection point 11k is arranged at a position closer to the needle tip 11c than the base end 11s of the tapered portion 11d. Further, in the axial direction, the second intersection 11n and the third intersection 11p are arranged slightly closer to the needle tip 11c than the base end 11s of the tapered portion 11d. A part of the third inclined surface 11h and a part of the fourth inclined surface 11j are arranged on the proximal end side of the biopsy needle 11 with respect to the proximal end 11s of the tapered portion 11d. Assuming that the radial outer end of the line of intersection between the third inclined surface 11h and the first inclined surface 11f is the fifth intersection 11r, the fifth intersection 11r is located at substantially the same position as the base end 11s of the tapered portion 11d in the axial direction. Is located in.

In the present embodiment, at least the tip portion of the tapered portion 11d, the end portion of the inner side surface in the radial direction is a cutting edge 11t for cutting the living tissue. Specifically, a portion of the inner end of the first inclined surface 11f in the radial direction and a part of the inner end of the third inclined surface 11h in the radial direction, which is closer to the needle tip 11c than the base end 11s of the tapered portion 11d. Is the cutting edge 11t. That is, the entire axial direction of the end portion of the inner surface of the tapered portion 11d in the radial direction is the cutting edge 11t. Further, when viewed from the axial direction, a cutting edge 11t is formed on one side of the needle tip 11c in the circumferential direction of the tubular portion 11a. Further, the portion of the edge formed at the end of the first inclined surface 11f and the edge formed at the end of the third inclined surface 11h on the needle tip 11c side of the base end 11s of the tapered portion 11d is cut. The edge is 11t.

Further, in the present embodiment, the radial inner end of the first inclined surface 11f forming a part of the cutting edge 11t, the radial inner end of the second inclined surface 11g, and the radial inner end of the fourth inclined surface 11j. The contour of the opening formed on the tip end side of the needle tip portion 11b is defined by the inner end and the radial inner end of the third inclined surface 11h.

As described above, in the present embodiment, the biopsy needle 11 is formed by grinding the tip of an elongated cylindrical tubular member (see FIG. 10A) whose tip has been drawn. Specifically, first, as shown in FIG. 10B, a first inclined surface 11f is formed on the tubular member by grinding, and then, as shown in FIGS. 10C and 10D, the first inclined surface 11f is formed by grinding. The second inclined surface 11g is formed by grinding. After that, as shown in FIGS. 10 (E) and 10 (F), the third inclined surface 11h is formed by grinding, and finally the fourth inclined surface 11j is formed by grinding. When the fourth inclined surface 11j is formed, the biopsy needle 11 is completed.

As shown in FIG. 11, the outer shape of one end portion BT1 of the living tissue cut by the rotating biopsy needle 11 becomes a truncated cone shape in which the outer diameter gradually decreases toward one end of the living tissue. That is, the outer shape of one end portion BT1 of a part of the living tissue collected by the biopsy needle 11 which is inserted into the living tissue while rotating becomes a truncated cone shape whose outer diameter gradually decreases toward one end of the living tissue. .. In addition, a part of the living tissue is spirally cut off by the biopsy needle 11 which is inserted into the living tissue while rotating. That is, as shown in FIG. 11B, a spiral notch BT2 is formed in a part of the living tissue collected by the biopsy needle 11 which is inserted into the living tissue while rotating.

(Main effect of this form)
As described above, in the present embodiment, the tip of the tapered portion 11d is the needle tip 11c, and the entire axial direction of the end of the inner side surface of the tapered portion 11d in the radial direction cuts the living tissue. The edge is 11t. Therefore, in the present embodiment, the outer shape of one end portion BT1 of the living tissue cut by the rotating biopsy needle 11 becomes a truncated cone shape whose outer diameter gradually decreases toward one end of the living tissue as described above. Therefore, in the present embodiment, it is possible to reduce the area of the portion of the biological tissue cut by the rotating biopsy needle 11 that is connected to the surrounding biological tissue (the portion where the needle tip 11c of the biopsy needle 11 is located at the end of cutting). It will be possible. As a result, in this embodiment, it becomes possible to easily separate a part of the biological tissue cut by the rotating biopsy needle 11 from the surrounding biological tissue.

Further, in the present embodiment, since the entire axial direction of the end portion of the inner side surface of the tapered portion 11d in the radial direction is the cutting edge 11t, the inner surface surface in the radial direction of a part of the tip end side of the tapered portion 11d. It is possible to cut a living tissue in a wider range in the radial direction as compared with the case where the end portion has a cutting edge 11t. Therefore, in this embodiment, it is possible to increase the amount of biological tissue cut and collected by the biopsy needle 11.

However, the end portion of the inner side surface in the radial direction of a part of the tapered portion 11d on the distal end side may be a cutting edge 11t. Even in this case, the outer shape of one end BT1 of the biological tissue cut by the rotating biopsy needle 11 becomes a truncated cone shape, and is connected to the surrounding biological tissue of the biological tissue cut by the biopsy needle 11. Since the area of the portion is small, it becomes possible to easily separate a part of the biological tissue cut by the rotating biopsy needle 11 from the surrounding biological tissue.

(Modification example 1 of the needle tip)
12 (A) and 12 (B) are side views of the biopsy needle 21 according to another embodiment of the present invention, and FIG. 12 (C) is a biopsy needle shown in FIGS. 12 (A) and 12 (B). 21 is a perspective view of 21. FIG. 13 is a front view of the biopsy needle 21 shown in FIG.

In the second embodiment, as shown in FIGS. 12 and 13, the first inclined surface 21f to the tip of an elongated cylindrical tubular member (see FIG. 10 (A)) whose tip has been drawn. The biopsy needle 21 may be formed by grinding the five inclined surfaces of the fifth inclined surface 21j. In this modification 1, the biopsy needle 21 is composed of a tubular portion 21a formed similarly to the tubular portion 11a and a needle tip portion 21b connected to the tip of the tubular portion 21a. The needle tip portion 21b is formed with a tapered portion 21d similar to the tapered portion 11d, and the tip of the tapered portion 21d is the needle tip 21c.

The needle tip portion 21b is adjacent to the first inclined surface 21f having a flat surface and the first inclined surface 21f when viewed from the axial direction of the tubular portion 21a (hereinafter, this direction is referred to as "axial direction"). A flat second inclined surface 21g, a planar third inclined surface 21h adjacent to the second inclined surface 21g when viewed from the axial direction, and an adjacent third inclined surface 21h when viewed from the axial direction. A planar fourth inclined surface 21i and a planar fifth inclined surface 21j adjacent to the fourth inclined surface 21i and adjacent to the first inclined surface 21f when viewed from the axial direction are formed.

When viewed from a direction parallel to the first inclined surface 21f, the first inclined surface 21f is inclined with respect to the axial center 21e of the tubular portion 21a, and when viewed from a direction parallel to the second inclined surface 21g, the first inclined surface 21f 2 The inclined surface 21g is inclined with respect to the axis 21e, and when viewed from a direction parallel to the third inclined surface 21h, the third inclined surface 21h is inclined with respect to the axis 21e and becomes the fourth inclined surface 21i. When viewed from a parallel direction, the fourth inclined surface 21i is inclined with respect to the axis 21e, and when viewed from a direction parallel to the fifth inclined surface 21j, the fifth inclined surface 21j is inclined with respect to the axis 21e. Is tilted.

In the first modification, the line of intersection between the second inclined surface 21g and the third inclined surface 21h is the needle tip 21c. Further, similarly to the biopsy needle 11, the distance between the axial center 21e and the inner end of the needle tip 21c in the radial direction when viewed from the axial direction is 0.1 mm or less. Further, in the first modification, the virtual line VL, which is an extension of the line of intersection (that is, the needle tip 21c) between the second inclined surface 21g and the third inclined surface 21h when viewed from the axial direction, is the axis 21e. Is passing through. Further, when viewed from the axial direction, the first inclined surface 21f and the fourth inclined surface 21i are formed line-symmetrically with respect to the virtual line VL, and the virtual line VL is the fifth in the circumferential direction of the tubular portion 21a. It passes through the center of the inclined surface 21j.

The radial inner end of the line of intersection between the first inclined surface 21f and the second inclined surface 21g is defined as the first intersection point 21k, and the radial inner end of the intersection line between the third inclined surface 21h and the fourth inclined surface 21i is defined as the first intersection point 21k. The second intersection 21n is defined as the radial inner end of the line of intersection between the fourth inclined surface 21i and the fifth inclined surface 21j, and the third intersection 21p is defined as the intersection of the fifth inclined surface 21j and the first inclined surface 21f. Assuming that the inner end in the radial direction is the fourth intersection 21q, the first intersection 21k and the second intersection 21n are arranged at the same position in the axial direction, and the third intersection 21p and the fourth intersection 21q are arranged at the same position. ing.

The distance between the first intersection 21k and the second intersection 21n in the axial direction and the needle tip 21c is shorter than the distance between the third intersection 21p and the fourth intersection 21q and the needle tip 21c in the axial direction. The third intersection 21p and the fourth intersection 21q are arranged at substantially the same positions as the base end 21s of the tapered portion 21d in the axial direction. A part of the first inclined surface 21f, a part of the fourth inclined surface 21i, and the whole of the fifth inclined surface 21j are arranged on the proximal end side of the biopsy needle 21 with respect to the proximal end 21s of the tapered portion 21d. The radial outer end of the line of intersection between the first inclined surface 21f and the second inclined surface 21g, and the radial outer end of the line of intersection between the third inclined surface 21h and the fourth inclined surface 21i are the fifth intersection 21r. Then, in the axial direction, the fifth intersection 21r is arranged on the distal end side of the biopsy needle 21 with respect to the proximal end 21s of the tapered portion 21d.

In the first modification, at least the tip of the tapered portion 21d, the end of the inner side surface in the radial direction is a cutting edge 21t for cutting the living tissue. Specifically, it is a part of the inner end of the second inclined surface 21g in the radial direction, the inner end of the third inclined surface 21h in the radial direction, and the inner end of the first inclined surface 21f in the radial direction, and is a tapered portion. The portion of the needle tip 21c side of the base end 21s of the 21d and the portion of the inner end of the fourth inclined surface 21i in the radial direction on the needle tip 21c side of the base end 21s of the tapered portion 21d are cut. The edge is 21t. That is, the entire axial direction of the end portion of the inner surface of the tapered portion 21d in the radial direction is the cutting edge 21t. Further, when viewed from the axial direction, cutting edges 21t are formed on both sides of the needle tip 21c in the circumferential direction of the tubular portion 21a.

Further, in the first modification, the radial inner end of the second inclined surface 21g forming a part of the cutting edge 21t, the radial inner end of the third inclined surface 21h, and the radial inner end of the first inclined surface 21f. The contour of the opening formed on the tip end side of the needle tip portion 21b is defined by the inner end, the radial inner end of the fourth inclined surface 21i, and the radial inner end of the fifth inclined surface 21j. .. Further, in the first modification, for example, a second inclined surface 21 g is first formed by grinding at the tip of an elongated cylindrical tubular member (see FIG. 10A) whose tip has been drawn. After that, the third inclined surface 21h is formed by grinding, then the first inclined surface 21f is formed by grinding, then the fourth inclined surface 21i is formed by grinding, and finally the fifth inclined surface 21j. Is formed by grinding.

Similar to the biopsy needle 11, the outer shape of one end portion BT1 of the living tissue cut by the rotating biopsy needle 21 becomes a truncated cone shape whose outer diameter gradually decreases toward one end of the living tissue. Further, a part of the living tissue is spirally cut off by the biopsy needle 21 which is inserted into the living tissue while rotating.

Also in the first modification, the same effect as that of the second embodiment described above can be obtained. Further, in the displacement example 1, since the cutting edges 21t are formed on both sides of the needle tip 21c in the circumferential direction of the tubular portion 21a when viewed from the axial direction, the biopsy needle 21 may be rotated in either direction. The living tissue is cut by the cutting edge 21t. The end of the inner side surface in the radial direction of a part of the tapered portion 21d on the tip end side may be a cutting edge 21t.

(Modification example 2 of the needle tip)
14 (A) and 14 (B) are side views of the biopsy needle 21 according to another embodiment of the present invention, and FIG. 14 (C) is a biopsy needle shown in FIGS. 14 (A) and 14 (B). 21 is a perspective view of 21. FIG. 15 is a front view of the biopsy needle 21 shown in FIG.

In the above-mentioned modification 1, as shown in FIG. 12, the needle tip portion 21b has a protrusion protruding toward the needle tip 21c with the third intersection 21p as the apex and a protrusion with the fourth intersection 21q as the apex toward the needle tip 21c. A protruding protrusion is formed, but as shown in FIG. 14, an elongated cylindrical shape whose tip is drawn so that a protrusion protruding toward the needle tip 21c is not formed on the needle tip 21b. The biopsy needle 21 may be formed by grinding five inclined surfaces of the first inclined surface 21f to the fifth inclined surface 21j at the tip of the tubular member (see FIG. 10A).

In FIGS. 14 and 15, the same reference numerals are given to the configurations corresponding to the configurations of the above-mentioned modification 1. In this modification 2, the third intersection 21p and the fourth intersection 21q are arranged closer to the base end of the biopsy needle 21 than the base end 21s of the tapered portion 21d, and the protrusion protruding toward the needle tip 21c is the needle tip. It is not formed in the portion 21b. In this modified example 2, the same effect as that of the modified example 1 can be obtained.

[Modification example 1 of tubular part]
16 (A) is an exploded perspective view of a part of the tubular portion 1a according to another embodiment of the present invention, and FIGS. 16 (B) and 16 (C) are tubular portions shown in FIG. 16 (A). It is a vertical cross-sectional view of a part of 1a, and FIG. 16 (D) is a cross-sectional view of a part of the tubular portion 1a shown in FIG. 16 (A). The X1 direction side in FIG. 16 is the tip end side (needle tip portion 1b side) of the biopsy needle 1, and the X2 direction side in FIG. 16 is the proximal end side of the biopsy needle 1.

In the first embodiment, a recess 1u recessed outward in the radial direction may be formed on the inner peripheral surface of the tubular portion 1a. Specifically, a plurality of recesses 1u may be formed on the inner peripheral surface of the tubular portion 1a with a predetermined interval in the axial direction. For example, three recesses 1u are formed on the inner peripheral surface of the tubular portion 1a. In this case, the tubular portion 1a is formed with an opening 1w for processing the concave portion 1u on the inner peripheral surface of the tubular portion 1a. The tubular portion 1a includes a cover 1x that closes the opening 1w.

When viewed from the axial direction, the recess 1u is formed in an arc shape having the axis 1h of the tubular portion 1a as the center of curvature. For example, the recess 1u is formed in a range of about 120 ° about the axis 1h when viewed from the axial direction. The side surface of the recess 1u on the needle tip portion 1b side is a regulatory surface 1u1 that restricts the movement of a part of the biological tissue housed on the inner peripheral side of the tubular portion 1a to the needle tip portion 1b side. The regulation surface 1u1 is orthogonal to the inner peripheral surface of the tubular portion 1a. The angle formed by the inner peripheral surface of the tubular portion 1a and the regulation surface 1u1 may be an acute angle or an obtuse angle having a relatively small angle.

The side surface of the recess 1u on the proximal end side of the tubular portion 1a is an inclined surface 1u2 that goes inward in the radial direction toward the proximal end side of the tubular portion 1a. The inclination angle θ5 of the inclined surface 1u2 with respect to the inner peripheral surface of the tubular portion 1a is about 10 °. The radial inner end of the regulation surface 1u1 and the end of the inclined surface 1u2 on the distal end side of the tubular portion 1a are connected by an arcuate surface 1u3 parallel to the inner peripheral surface of the tubular portion 1a.

When forming the concave portion 1u, first, the opening 1w is formed at a predetermined portion of the tubular portion 1a by laser processing or the like. After that, the concave portion 1u is formed by electrolytic laser combined processing, laser processing, cutting processing, or the like. After that, the opening 1w is closed with the cover 1x, and the cover 1x is fixed by adhesive, laser welding, or the like. Instead of closing the opening 1w with the cover 1x, the opening 1w may be closed with a heat-shrinkable tube. Further, the number of recesses 1u formed on the inner peripheral surface of the tubular portion 1a may be one.

In the modified example shown in FIG. 16, the side surface of the recess 1u on the needle tip portion 1b side regulates the movement of a part of the biological tissue contained in the inner peripheral side of the tubular portion 1a to the needle tip portion 1b side. Since the surface is 1u1, it is possible to prevent a part of the biological tissue cut by the cutting edge 1t and housed on the inner peripheral side of the tubular portion 1a from coming out of the biopsy needle 1. In particular, in this modification, when viewed from the axial direction, the recess 1u is formed in a range of about 120 ° centered on the axis 1h, and the regulation surface 1u1 is also 120 ° centered on the axis 1h. Since it is formed within a certain range, it is possible to effectively prevent a part of the biological tissue cut by the cutting edge 1t and contained in the inner peripheral side of the tubular portion 1a from coming out of the biopsy needle 1. Become. Therefore, it is possible to reliably take out a part of the biological tissue contained in the inner peripheral side of the tubular portion 1a.

Further, in this modification, the side surface of the concave portion 1u on the proximal end side of the tubular portion 1a is an inclined surface 1u2 that is radially inward toward the proximal end side of the tubular portion 1a, so that the tubular portion is formed. Even if the concave portion 1u is formed on the inner peripheral surface of 1a, the movement of the biological tissue cut by the cutting edge 1t toward the inner peripheral side of the tubular portion 1a is less likely to be hindered by the concave portion 1u. A recess similar to the recess 1u may be formed on the inner peripheral surface of the tubular portions 11a and 21a of the biopsy needles 11 and 21.

[Deformation example 2 of tubular part]
17 (A) is a perspective view of a part of the tubular portion 1a according to another embodiment of the present invention, and FIG. 17 (B) is a part of the tubular portion 1a shown in FIG. 17 (A). It is a vertical cross-sectional view, FIG. 17 (C) is an enlarged view of a portion G of FIG. 17 (B), and FIG. 17 (D) is an enlarged view of a portion H of FIG. 17 (B). The X1 direction side in FIG. 17 is the tip end side (needle tip portion 1b side) of the biopsy needle 1, and the X2 direction side in FIG. 17 is the proximal end side of the biopsy needle 1.

In the first embodiment, the tubular portion 1a may be formed with a through hole 1y that penetrates the tubular portion 1a in the radial direction. Specifically, through holes 1y may be formed at a plurality of locations over a predetermined range in the axial direction of the tubular portion 1a and over the entire circumferential direction of the tubular portion 1a. The through hole 1y is formed by electrolytic laser combined processing, laser processing, cutting processing, or the like. The through hole 1y may not be formed over the entire circumferential direction of the tubular portion 1a. Further, the number of through holes 1y formed in the tubular portion 1a may be one.

The side surface of the through hole 1y on the needle tip portion 1b side is a regulation surface 1y1 that regulates the movement of a part of the biological tissue contained in the inner peripheral side of the tubular portion 1a to the needle tip portion 1b side. .. The regulation surface 1y1 is a gently arcuate concave curved surface. The center of curvature of the regulation surface 1y1 is closer to the proximal end side of the tubular portion 1a than the regulation surface 1y1. Further, the through hole 1y has two first side surfaces 1y2 and a regulation surface 1y1 that approach each other and intersect each other from both ends of the regulation surface 1y1 in the circumferential direction of the tubular portion 1a toward the proximal end side of the tubular portion 1a. It is formed in a triangular shape.

The first side surface 1y2 is a gently arcuate convex curved surface. The center of curvature of the first side surface 1y2 is closer to the proximal end side of the tubular portion 1a than the first side surface 1y2. The regulation surface 1y1 and the first side surface 1y2 are inclined surfaces toward the needle tip portion 1b side toward the outside in the radial direction. That is, the angle θ6 formed by the inner peripheral surface of the tubular portion 1a and the regulation surface 1y1 is smaller than 90 °, and the angle θ7 formed by the inner peripheral surface of the tubular portion 1a and the first side surface 1y2 is 90 °. Is bigger than. The regulation surface 1y1 and the first side surface 1y2 may be formed in a plane. Further, the angle θ6 may be 90 ° or may be an obtuse angle having a relatively small angle.

In the modified example shown in FIG. 17, the side surface of the through hole 1y on the needle tip portion 1b side restricts the movement of a part of the biological tissue contained in the inner peripheral side of the tubular portion 1a to the needle tip portion 1b side. Since the regulation surface is 1y1, it is possible to prevent a part of the biological tissue cut by the cutting edge 1t and housed on the inner peripheral side of the tubular portion 1a from coming out of the biopsy needle 1. In particular, in this modification, since the through holes 1y are formed at a plurality of locations over the entire circumferential direction of the tubular portion 1a, the living body is cut at the cutting edge 1t and housed on the inner peripheral side of the tubular portion 1a. It is possible to effectively prevent a part of the tissue from coming out of the biopsy needle 1 by the plurality of through holes 1y. Therefore, it is possible to reliably take out a part of the biological tissue contained in the inner peripheral side of the tubular portion 1a.

Further, in this modification, the through hole 1y approaches and intersects with each other from both ends of the regulation surface 1y1 in the circumferential direction of the tubular portion 1a toward the proximal end side of the tubular portion 1a, and the regulation surface. Since it is formed in a substantially triangular shape having 1y1 and the first side surface 1y2 is an inclined surface toward the needle tip portion 1b side toward the outside in the radial direction, a through hole 1y is formed in the tubular portion 1a. Even if it is formed, the movement of the living tissue cut at the cutting edge 1t toward the inner peripheral side of the tubular portion 1a is less likely to be hindered by the through hole 1y. A through hole similar to the through hole 1y may be formed on the inner peripheral surfaces of the tubular portions 11a and 21a of the biopsy needles 11 and 21.

1 Biopsy needle 1a Tubular part 1b Needle tip 1c 1st inclined surface 1d 2nd inclined surface 1e 3rd inclined surface 1f 4th inclined surface 1g 5th inclined surface 1h Axial center (axial center of tubular part)
1j Needle tip 1k 1st intersection 1n 2nd intersection 1p 3rd intersection 1q 4th intersection 1t Cutting edge 1u Recess 1u1 Restriction surface 1u2 Inclined surface 1v 5th intersection 1y Through hole 1y1 Restriction surface 1y2 1st side 3 Biopsy device 4 Sheath Member 5 Grip member 6 Needle operation member 11 Biopsy needle 11a Tubular part 11b Needle tip 11c Needle tip 11d Tapered part 11e Axial center (axial center of tubular part)
11f 1st inclined surface 11g 2nd inclined surface 11h 3rd inclined surface 11j 4th inclined surface 11t Cutting edge 21 Biopsy needle 21a Tubular part 21b Needle tip 21c Needle tip 21d Tapered part 21e Axial center (axial center of tubular part)
21f 1st inclined surface 21g 2nd inclined surface 21h 3rd inclined surface 21i 4th inclined surface 21j 5th inclined surface 21t Cutting edge L1 1st distance L2 2nd distance L3 3rd distance L4 4th distance L5 5th distance L10 Tubular Distance between the axis of the part and the inner end of the needle tip in the radial direction VL virtual line VP1 1st virtual plane VP2 2nd virtual plane θ1 1st inclined surface tilt angle θ2 2nd tilted surface tilt angle θ3 1st virtual plane The angle between the second virtual plane and the second virtual plane

Claims (12)

In a biopsy needle for puncturing a living tissue in a living body and collecting a part of the living tissue.
It is provided with a tubular portion formed in a tubular shape and a needle tip portion connected to the tip of the tubular portion.
The tip of the needle tip portion is a needle tip formed by the line of intersection between the flat first inclined surface and the planar second inclined surface.
The inclination angle of the first inclined surface with respect to the axis of the tubular portion when viewed from the first direction parallel to the first inclined surface is the inclination angle of the first inclined surface when viewed from the second direction parallel to the second inclined surface. It is looser than the inclination angle of the second inclined surface with respect to the axis.
The inner end of the first inclined surface in the radial direction of the tubular portion is a cutting edge for cutting the living tissue .
The needle tip portion has a planar third inclined surface adjacent to the second inclined surface when viewed from the axial direction of the tubular portion and adjacent to the third inclined surface when viewed from the axial direction. A planar fourth inclined surface and a planar fifth inclined surface adjacent to the fourth inclined surface and adjacent to the first inclined surface when viewed from the axial direction are formed.
The third inclined surface is inclined with respect to the axis when viewed from a direction parallel to the third inclined surface, and the fourth inclined surface is inclined when viewed from a direction parallel to the fourth inclined surface. Is inclined with respect to the axis, and when viewed from a direction parallel to the fifth inclined surface, the fifth inclined surface is inclined with respect to the axis.
The radial inner end of the line of intersection between the second inclined surface and the third inclined surface is set as the first intersection, and the inner end in the radial direction of the intersection line between the third inclined surface and the fourth inclined surface. Is the second intersection, and the inner end in the radial direction of the intersection line between the fourth inclined surface and the fifth inclined surface is the third intersection, and the intersection line between the fifth inclined surface and the first inclined surface is defined as the third intersection. The inner end in the radial direction is the fourth intersection, the distance between the needle tip and the first intersection in the axial direction is the first distance, and the distance between the needle tip and the second intersection in the axial direction is the first. It is assumed that the distance between the needle tip and the third intersection in the axial direction is the third distance, and the distance between the needle tip and the fourth intersection in the axial direction is the fourth distance.
The fourth distance is longer than the first distance, the second distance is longer than the fourth distance, and the third distance is longer than the second distance. Meter reading. In a biopsy needle for puncturing a living tissue in a living body and collecting a part of the living tissue.
It is provided with a tubular portion formed in a tubular shape and a needle tip portion connected to the tip of the tubular portion.
The tip of the needle tip portion is a needle tip formed by the line of intersection between the flat first inclined surface and the planar second inclined surface.
The inclination angle of the first inclined surface with respect to the axis of the tubular portion when viewed from the first direction parallel to the first inclined surface is the inclination angle of the first inclined surface when viewed from the second direction parallel to the second inclined surface. It is looser than the inclination angle of the second inclined surface with respect to the axis.
The inner end of the first inclined surface in the radial direction of the tubular portion is a cutting edge for cutting the living tissue.
The needle tip portion has a planar third inclined surface adjacent to the second inclined surface when viewed from the axial direction of the tubular portion and adjacent to the third inclined surface when viewed from the axial direction. At the same time, a planar fourth inclined surface adjacent to the first inclined surface is formed.
The third inclined surface is inclined with respect to the axis when viewed from a direction parallel to the third inclined surface, and the fourth inclined surface is inclined when viewed from a direction parallel to the fourth inclined surface. Tilt with respect to the axis
The radial inner end of the line of intersection between the second inclined surface and the third inclined surface is set as the first intersection, and the inner end in the radial direction of the intersection line between the third inclined surface and the fourth inclined surface. Is the second intersection, the inner end in the radial direction of the line of intersection between the fourth inclined surface and the first inclined surface is the fifth intersection, and the distance between the needle tip and the first intersection in the axial direction is defined as the distance between the needle tip and the first intersection. Let the first distance be the distance between the needle tip and the second intersection in the axial direction be the second distance, and the distance between the needle tip and the fifth intersection in the axial direction be the fifth distance.
The biopsy needle, characterized in that the fifth distance is longer than the first distance and the second distance is longer than the fifth distance. The inclination angle of the first inclined surface with respect to the axis when viewed from the first direction is 1 ° to 5 °.
The inclination angle of the second inclined surface with respect to the axis when viewed from the second direction is 20 ° to 30 °.
The plane parallel to the plane orthogonal to the first inclined plane and passing through the axis is the first virtual plane, and the plane parallel to the plane orthogonal to the second inclined plane is the axis. If the plane that passes through is the second virtual plane,
The raw material according to claim 1 or 2 , wherein the angle between the first virtual surface and the second virtual surface when viewed from the axial direction of the tubular portion is 150 ° to 180 °. Meter reading. In a biopsy needle for puncturing a living tissue in a living body and collecting a part of the living tissue.
A tubular portion formed in a tubular shape and a needle tip portion connected to the tip of the tubular portion are provided.
The needle tip portion is formed with a tapered portion in which the outer surface and the inner surface surface of the tubular portion in the radial direction are inclined inward in the radial direction toward the needle tip formed at the tip of the needle tip portion. Being done
The tip of the tapered portion is the needle tip.
At least the tip of the tapered portion, the end of the inner side surface in the radial direction is a cutting edge for cutting the living tissue .
When viewed from the axial direction of the tubular portion, the cutting edges are formed on both sides of the needle tip in the circumferential direction of the tubular portion.
The needle tip portion has a planar first inclined surface, a planar second inclined surface adjacent to the first inclined surface when viewed from the axial direction of the tubular portion, and a planar second inclined surface viewed from the axial direction. Sometimes a planar third inclined surface adjacent to the second inclined surface, a planar fourth inclined surface adjacent to the third inclined surface when viewed from the axial direction, and a planar fourth inclined surface viewed from the axial direction. Occasionally, a planar fifth inclined surface adjacent to the fourth inclined surface and adjacent to the first inclined surface is formed.
When viewed from a direction parallel to the first inclined surface, the first inclined surface is inclined with respect to the axial center of the tubular portion, and when viewed from a direction parallel to the second inclined surface, the first inclined surface is said. The two inclined surfaces are inclined with respect to the axis, and when viewed from a direction parallel to the third inclined surface, the third inclined surface is inclined with respect to the axis and parallel to the fourth inclined surface. When viewed from a certain direction, the fourth inclined surface is inclined with respect to the axis, and when viewed from a direction parallel to the fifth inclined surface, the fifth inclined surface is inclined with respect to the axis. Tilt,
The line of intersection between the second inclined surface and the third inclined surface is the needle tip.
The imaginary line, which is an extension of the line of intersection between the second inclined surface and the third inclined surface when viewed from the axial direction, passes through the axial center.
When viewed from the axial direction, the first inclined surface and the fourth inclined surface are formed line-symmetrically with respect to the virtual line.
A biopsy needle, characterized in that the virtual line passes through the center of the fifth inclined surface in the circumferential direction of the tubular portion when viewed from the axial direction . The biopsy needle according to claim 4 , wherein the entire area of the inner side surface of the tapered portion in the radial direction is the cutting edge in the axial direction. The fourth or fifth aspect of the present invention, wherein the distance between the axial center of the tubular portion and the inner end of the needle tip in the radial direction when viewed from the axial direction of the tubular portion is 0.1 mm or less. Biopsy needle. A recess is formed on the inner peripheral surface of the tubular portion so as to be recessed toward the outside in the radial direction of the tubular portion.
The side surface of the recess on the needle tip side is a regulatory surface that restricts the movement of a part of the biological tissue contained in the inner peripheral side of the tubular portion to the needle tip side. The biopsy needle according to any one of claims 1 to 6 . The regulation surface is orthogonal to the inner peripheral surface of the tubular portion and is orthogonal to the inner peripheral surface.
The side surface of the concave portion on the proximal end side of the tubular portion is an inclined surface that is inclined inward in the radial direction toward the proximal end side of the tubular portion.
The biopsy needle according to claim 7 , wherein when viewed from the axial direction of the tubular portion, the concave portion is formed in an arc shape having the axial center of the tubular portion as the center of curvature. A through hole is formed in the tubular portion so as to penetrate the tubular portion in the radial direction of the tubular portion.
The side surface of the through hole on the needle tip side is a regulatory surface for restricting the movement of a part of the biological tissue contained in the inner peripheral side of the tubular portion to the needle tip side. The biopsy needle according to any one of claims 1 to 6 , characterized in that. The through hole has a substantially triangular shape having two first side surfaces and the restricting surface that approach each other and intersect each other from both ends of the restricting surface in the circumferential direction of the tubular portion toward the proximal end side of the tubular portion. Formed,
The biopsy needle according to claim 9 , wherein the regulation surface and the first side surface are inclined surfaces toward the needle tip portion side toward the outside in the radial direction. The biopsy needle according to claim 9 or 10 , wherein the through holes are formed at a plurality of locations over the entire circumferential direction of the tubular portion. The biopsy needle according to any one of claims 1 to 11 , a sheath member formed in a tubular shape and the biopsy needle is arranged on the inner peripheral side, and a gripping member to which the base end of the sheath member is fixed. The gripping member is provided with a needle operating member that is rotatably and slidably held.
The base end of the tubular portion is connected to the needle operating member,
The biopsy needle is movable in the axial direction of the tubular portion together with the needle operating member with respect to the gripping member, and is of the tubular portion together with the needle operating member with respect to the gripping member. A biopsy device characterized by being rotatable in the circumferential direction.

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