Patent Description:
In recent years, in order to make a diagnosis, a needle tube has been introduced into a body cavity through a treatment tool-insertion channel of an ultrasonic endoscope, the needle tube has been guided to a portion to be observed and been inserted into lesional tissue under the observation of an ultrasonic tomographic image obtained performed by the ultrasonic endoscope, and biological tissue has been collected to confirm pathology.

For example, a tissue collecting device disclosed in <CIT> is known as a tissue collecting device used to make such a pathological confirmation diagnosis. The tissue collecting device disclosed in <CIT> comprises a flexible sheath that is freely inserted into a treatment tool-insertion channel of an endoscope, a needle tube that is inserted into the sheath to freely advance and retreat and punctures biological tissue, an operation unit that is connected to the proximal end portion of the sheath and allows the needle tube to advance and retreat, and a syringe that is connected to the operation unit and applies negative pressure to the needle tube.

Further, the needle tube disclosed in <CIT> comprises a slit that extends toward a proximal end side from a distal end opening thereof and the curvature radius of a first edge portion provided on both sides of the slit is adapted to be larger than the curvature radius of a second edge portion so that a step is formed between the first edge portion and the second edge portion.

According to the tissue collecting device disclosed in <CIT>, the needle tube is inserted into lesional tissue and is then rotated to take biological tissue into the distal end portion of the tube from the gap of the step. Then, the needle tube is further rotated to excise the taken biological tissue by the edge portion of the slit. Accordingly, it is possible to collect the amount of biological tissue enough to make a pathological confirmation diagnosis. <CIT> discloses a needle for tissue collection in an endoscopic procedure. <CIT> discloses an endoscopic tri-point biopsy needle.

However, the needle tube disclosed in <CIT> (hereinafter, referred to as a biopsy needle) has a complicated structure that includes the first and second edge portions having curvature radii different from each other. For this reason, there is a problem that it is difficult to manufacture a small-diameter biopsy needle having an outer diameter of, for example, <NUM> or less.

Further, according to the tissue collecting device disclosed in <CIT>, the biopsy needle is to be rotated about the axis of the biopsy needle in a case where biological tissue is to be taken in and excised by the biopsy needle. However, since the operation unit should be rotated together with the syringe in this case, an operator may be burdened.

The present invention has been made in consideration of the above-mentioned circumstances, and an object of the present invention is to provide a biopsy needle and a tissue collecting device that can collect the amount of biological tissue enough to make a pathological confirmation diagnosis with a simple structure and a simple operation.

In order to achieve the object of the present invention, a biopsy needle according to an aspect of the present invention is a biopsy needle that is to be inserted into an endoscope forceps channel. The biopsy needle comprises a hollow tube which includes a distal end opening portion and a proximal end opening portion and of which the distal end opening portion and the proximal end opening portion communicate with each other. The tube includes a puncture portion that is provided at a distal end portion of the tube and has at least one blade distal end point, a slit that extends toward the proximal end opening portion from the distal end opening portion, and a tissue excision cutter that is provided at a proximal end of the slit and is formed in a shape tapered toward a distal end of the slit from the proximal end of the slit. The puncture portion of the biopsy needle includes a first blade distal end point, a second blade distal end point, and a third blade distal end point. In a case where the tube is viewed in a direction orthogonal to an axial direction of the tube, the first blade distal end point is formed closer to a distal end side of the tube than the second blade distal end point and the third blade distal end point, and in a case where the tube is viewed in the axial direction of the tube, the first blade distal end point is disposed to face the slit in a radial direction of the tube and the second blade distal end point and the third blade distal end point are disposed to face each other with the slit interposed therebetween. The slit is an elongated through-hole that is formed in the shape of a line extending in the axial direction of the tube.

Further, in the biopsy needle according to the aspect of the present invention, it is preferable that the elongated through-hole is formed between a pair of wall portions facing each other in the direction orthogonal to the axial direction of the tube.

Further, in the biopsy needle according to the aspect of the present invention, it is preferable that the tissue excision cutter includes at least one inclined blade surface that is inclined to approach a central axis of the tube toward the distal end of the slit from the proximal end of the slit.

Furthermore, in the biopsy needle according to the aspect of the present invention, it is preferable that a sharp blade is formed on the inclined blade surface and the blade is formed at a position where the blade does not protrude to an outside of the tube from an outer peripheral surface of the tube.

Further, in the biopsy needle according to the aspect of the present invention, it is preferable that the inclined blade surface has a shape like a rounded chisel.

Moreover, in the biopsy needle according to the aspect of the present invention, it is preferable that the distal end portion of the tube includes a first blade surface that connects an outer peripheral surface of the tube to the first and second blade distal end points and has a normal line including a component toward an outside in the radial direction of the tube and a component toward the distal end side of the tube, and a second blade surface that connects the outer peripheral surface of the tube to the first and third blade distal end points and has a normal line including a component toward the outside in the radial direction of the tube and a component toward the distal end side of the tube.

Further, in the biopsy needle according to the aspect of the present invention, it is preferable that the at least one blade distal end point is formed on an inner peripheral surface of the tube.

Furthermore, in the biopsy needle according to the aspect of the present invention, it is preferable that a length between the first blade distal end point and a distal end of the tissue excision cutter in the axial direction of the tube is in a range of <NUM> to <NUM>.

Moreover, in the biopsy needle according to the aspect of the present invention, it is preferable that a width of the slit in a circumferential direction of the tube is smaller than an inner diameter of the tube.

Further, in the biopsy needle according to the aspect of the present invention, it is preferable that an outer diameter of the tube is in a range of <NUM> to <NUM>.

Furthermore, in the biopsy needle according to the aspect of the present invention, it is preferable that an inner diameter of the tube is in a range of <NUM> to <NUM>.

Moreover, in the biopsy needle according to the aspect of the present invention, it is preferable that an echo marker, which allows a position of the tube to be visually displayed in an ultrasound image, is provided on an outer peripheral surface of the tube.

Further, in the biopsy needle according to the aspect of the present invention, it is preferable that the echo marker is provided only around a periphery including the proximal end of the slit.

Furthermore, in the biopsy needle according to the aspect of the present invention, it is preferable that the echo marker is provided in a region extending toward a distal end side of the tube from a periphery, which includes the proximal end of the slit, as a starting point.

Moreover, in the biopsy needle according to the aspect of the present invention, it is preferable that the echo marker is provided in a region extending toward a proximal end side of the tube from a periphery, which includes the proximal end of the slit, as a starting point.

Further, in the biopsy needle according to the aspect of the present invention, it is preferable that the echo marker is formed in an uneven shape.

Furthermore, in the biopsy needle according to the aspect of the present invention, it is preferable that the tube is made of stainless steel, a nickel-titanium alloy, a nickel-chromium alloy, or a cobalt-chromium alloy.

In order to achieve the object of the present invention, a tissue collecting device according to another aspect of the present invention comprises the biopsy needle according to the aspect of the present invention and a suction member that communicates with the proximal end opening portion of the biopsy needle and generates negative pressure in the biopsy needle.

According to the present invention, it is possible to collect the amount of biological tissue enough to make a pathological confirmation diagnosis with a simple structure and a simple operation.

Preferred embodiments of the present invention will be described in detail below with reference to the accompanying drawings.

A tissue collecting device for puncture to which the present invention is applied will be described as being adapted to be inserted into a body cavity through a treatment tool-insertion channel formed in an ultrasonic endoscope for performing electronic convex scanning, but a treatment tool-insertion channel of a scanning type ultrasonic endoscope or a normal endoscope, which does not comprise an ultrasound diagnosis mechanism, other than this ultrasonic endoscope, a trocar, and the like can be used as a guide unit of the tissue collecting device. In a case where the tissue collecting device is inserted into a trocar, the whole tissue collecting device can also be formed of a hard member.

First, the configuration of a distal end portion of an ultrasonic endoscope that guides a tissue collecting device is shown in <FIG>. In <FIG>, reference numeral <NUM> denotes an insertion unit to be inserted into a body cavity, the insertion unit <NUM> is adapted so that a distal end portion body <NUM> is connected to a distal end of an angle part <NUM>, and the distal end portion body <NUM> is provided with an endoscope observation part <NUM> on the proximal end side thereof and is provided with an ultrasonic observation part <NUM> on the distal end side thereof. The endoscope observation part <NUM> is provided in an inclined portion 12a provided on the proximal end side of the distal end portion body <NUM>, and is adapted so that an observation field of view faces obliquely forward.

In <FIG>, an illumination mechanism <NUM> comprising a light guide of the endoscope observation part <NUM> is shown and an observation mechanism is provided adjacent to this illumination mechanism <NUM> but this observation mechanism is not shown. A solid-state imaging element or an image guide can be used as the observation mechanism.

The ultrasonic observation part <NUM> includes an ultrasonic transducer unit <NUM> that is mounted on an opening portion 12b provided at the distal end of the distal end portion body <NUM>. The ultrasonic transducer unit <NUM> is to perform electronic convex scanning, and includes a plurality of striped ultrasonic oscillators <NUM> that are arranged in an arc shape.

A treatment tool outlet portion <NUM> is formed at a position between the endoscope observation part <NUM> and the ultrasonic observation part <NUM>. This treatment tool outlet portion <NUM> is a passage that is formed through the distal end portion body <NUM> and has a predetermined inner diameter, and a connection pipe <NUM> is connected to the treatment tool outlet portion <NUM>. This connection pipe <NUM> is bent at a predetermined angle, and a flexible tube <NUM> is connected to the proximal end portion of the connection pipe <NUM>. Accordingly, a treatment tool-insertion channel <NUM> includes the treatment tool outlet portion <NUM>, the connection pipe <NUM>, and the flexible tube <NUM>, the treatment tool outlet portion <NUM> extends obliquely forward with respect to the axis of the insertion unit <NUM>, the flexible tube <NUM> extends in the axial direction of the insertion unit <NUM>, and the middle portion of the connection pipe <NUM> is bent by a predetermined angle.

Reference numeral <NUM> denotes a tissue collecting device according to an embodiment, and the tissue collecting device <NUM> is inserted into the treatment tool-insertion channel <NUM> and is adapted to be capable of appearing and disappearing from the treatment tool outlet portion <NUM>. Further, the distal end portion body <NUM> is allowed to be in contact with an inner wall S of the body cavity, a biological tissue collection point T is positioned in the ultrasonic observation field of view by the ultrasonic observation part <NUM>, a distal end portion of the tissue collecting device <NUM> is inserted into the inner wall S of the body cavity from the treatment tool outlet portion <NUM>, and biological tissue can be collected after the distal end portion is guided up to the tissue collection point T.

<FIG> is a cross-sectional view showing the overall configuration of the tissue collecting device <NUM>. As apparent from <FIG>, the tissue collecting device <NUM> includes an insertion unit <NUM> and an operation unit <NUM> and a syringe <NUM> is attachably and detachably connected to the proximal end portion of the operation unit <NUM>. The syringe <NUM> is an example of a suction member.

The insertion unit <NUM> has a length longer than the total length of at least the treatment tool-insertion channel <NUM>, and is formed of a double tubular member as shown in <FIG>. That is, the insertion unit <NUM> includes a sheath <NUM> and a biopsy needle <NUM> inserted into the sheath <NUM> that are arranged in this order from the outermost peripheral side. Further, <FIG> is a cross-sectional view of the insertion unit <NUM> showing a state where the biopsy needle <NUM> protrudes outward from a distal end opening 34A of the sheath <NUM>, and <FIG> is a cross-sectional view of the insertion unit <NUM> showing a state where the biopsy needle <NUM> is retracted into the sheath <NUM>.

The sheath <NUM> is inserted into the treatment tool-insertion channel <NUM> of an endoscope and forms the exterior of the insertion unit <NUM>. The sheath <NUM> consists of a tubular member having flexibility, and is formed of a resin member made of, for example, polyethersulfone, Teflon (registered trademark), or polyetheretherketone (PEEK). The sheath <NUM> may be formed of a contact coil or the like.

The biopsy needle <NUM> is used to puncture biological tissue to collect lesional tissue and the like, and is inserted into the sheath <NUM> to freely advance and retreat. The detailed configuration of the biopsy needle <NUM> will be described later, but the biopsy needle <NUM> includes a tube <NUM>. The tube <NUM> includes a distal end opening portion <NUM> and a proximal end opening portion <NUM> (see <FIG>), and the distal end opening portion <NUM> and the proximal end opening portion <NUM> communicate with each other. Further, as shown in <FIG>, a distal end portion <NUM> of the tube <NUM> is provided with a puncture portion <NUM>, a slit <NUM>, and a tissue excision cutter <NUM>.

Since the tube <NUM> is to be inserted into the body, the tube should be hard. Further, since the tube <NUM> is to be inserted into the treatment tool-insertion channel <NUM>, the tube <NUM> should have flexibility in a bending direction so that the tube <NUM> can pass through the bent connection pipe <NUM> and be smoothly inserted into the angle part <NUM> even in a state where the angle part <NUM> is curved. For this reason, the tube <NUM> is made of stainless steel, a nickel-titanium alloy, a nickel-chromium alloy, or a cobalt-chromium alloy having a small diameter and flexibility. Stainless steel is hard to rust, nickel-titanium alloy hardly has a bending habit even though being inserted into the bent connection pipe <NUM> since being a superelastic alloy, and nickel-chromium alloy and cobalt-chromium alloy can be easily inserted into the biological tissue collection point T since having a high hardness. At least the distal end portion <NUM>, which includes the puncture portion <NUM>, of the biopsy needle <NUM> may be formed of a hard pipe, and a portion of the biopsy needle <NUM> other than the distal end portion <NUM> may be formed of a soft tube having flexibility.

The tube <NUM> is inserted into and disposed in the sheath <NUM> to freely advance and retreat, and is moved to a retreat position (a position shown in <FIG>) where the tube <NUM> is retracted into the sheath <NUM> and an operating position (a position shown in <FIG>) where the tube <NUM> protrudes from the distal end opening 34A of the sheath <NUM> by a predetermined length.

For this purpose, the proximal end portion of the tube <NUM> is connected to the operation unit <NUM> and the tube <NUM> is adapted to appear and disappear from the distal end opening 34A of the sheath <NUM> by the operation of the operation unit <NUM>. The specific configuration of the operation unit <NUM> is shown in <FIG>.

As shown in <FIG>, the operation unit <NUM> includes a luer lock-operation part <NUM>, a sheath position-operation part <NUM>, a tube position-operation part <NUM>, and a stopper ring <NUM>. Further, a stylet <NUM> is inserted into the tube <NUM>.

A luer lock portion 39A is formed at the distal end portion of the luer lock-operation part <NUM>, and the luer lock portion 39Ais used to be fixed to a treatment tool inlet port (not shown) of the ultrasonic endoscope and is attachably and detachably connected to, for example, a pair of luer lock portions that are present at the treatment tool inlet port. The luer lock-operation part <NUM> is inserted into a hole portion of the sheath position-operation part <NUM>, and the luer lock-operation part <NUM> and the sheath position-operation part <NUM> are mounted to be relatively slidable along an axis P of the operation unit <NUM>. The luer lock-operation part <NUM> and the sheath position-operation part <NUM> are fixed to each other by a screw <NUM> that is screwed toward the outer peripheral surface of the luer lock-operation part <NUM> from the outer peripheral surface of the sheath position-operation part <NUM>.

Further, the stopper ring <NUM> is provided on the outer peripheral surface of the sheath position-operation part <NUM> to be slidable along the axis P, and the stopper ring <NUM> is fixed by a screw <NUM> that is screwed toward the outer peripheral surface of the sheath position-operation part <NUM> from the outer peripheral surface of the stopper ring <NUM>. The sheath position-operation part <NUM> is inserted into a hole portion of the tube position-operation part <NUM>, and the sheath position-operation part <NUM> and the tube position-operation part <NUM> are mounted to be relatively slidable along the axis P. The relative positions of the sheath position-operation part <NUM> and the tube position-operation part <NUM> in the direction of the axis P are determined in a case where a distal end surface 41A of the tube position-operation part <NUM> is in contact with the stopper ring <NUM>.

In the operation unit <NUM> having the above-mentioned configuration, with regard to the sheath <NUM>, the proximal portion side of the sheath <NUM> is inserted into the hole portion of the sheath position-operation part <NUM> from the hole portion of the luer lock-operation part <NUM> and is fixed to the proximal end portion of the sheath position-operation part <NUM>. Accordingly, a proximal end opening 34B of the sheath <NUM> is opened to the proximal end portion of the sheath position-operation part <NUM>. Further, with regard to the tube <NUM>, the proximal end side of the tube <NUM> is inserted into the hole portion of the tube position-operation part <NUM> from the proximal end opening 34B of the sheath <NUM> and is fixed to the proximal end portion of the tube position-operation part <NUM>. Therefore, a proximal end opening portion <NUM> of the tube <NUM> is opened to the proximal end portion of the tube position-operation part <NUM>. Furthermore, the proximal end portion of the tube position-operation part <NUM> is provided with a luer lock portion <NUM> communicating with the proximal end opening portion <NUM>, and the stylet <NUM> is provided between the luer lock portion <NUM> and a position protruding from the tube distal end opening portion <NUM>. The stylet <NUM> functions to protect blade distal end points <NUM>, <NUM>, and <NUM>, to protect the sheath <NUM> from the blade distal end points <NUM>, <NUM>, and <NUM>, and to suppress the entrance of foreign substances into the tube <NUM>. In a case where the stylet <NUM> protrudes from the tube distal end opening portion <NUM> and the sheath <NUM> is bent in a curved shape to form a part of an arc, the distal end surface of the stylet <NUM> and the outer peripheral surface of the tube distal end opening portion are in contact with the inner surface of the sheath <NUM>. In addition, the distal end surface of the stylet <NUM> is pressed from the inner surface of the sheath <NUM>, so that the tube distal end opening portion <NUM> is in a state where the distal end opening portion <NUM> retreats to a position away from the inner surface of the sheath <NUM>. In a case where the stylet <NUM> is completely removed from the luer lock portion <NUM> in a proximal direction, the syringe <NUM>, which includes a pair of luer locks for suction and liquid pumping, can be detached from the luer lock portion <NUM>.

Next, the usage example of the tissue collecting device <NUM> shown in <FIG> will be described.

First, the sheath <NUM> into which the tube <NUM> is inserted is inserted into the treatment tool-insertion channel <NUM> shown in <FIG> from the treatment tool inlet port of the ultrasonic endoscope, and the luer lock portion 39A of the luer lock-operation part <NUM> is fixed to a pair of luer locks of the treatment tool inlet port in a case where, for example, the distal end portion of the sheath <NUM> is positioned near the distal end of the treatment tool outlet portion <NUM> shown in <FIG>.

Then, the screw <NUM> is loosened, and the sheath position-operation part <NUM> is allowed to slide with respect to the luer lock-operation part <NUM> in the direction of an arrow Q along the axis P. Accordingly, the distal end portion of the sheath <NUM> protrudes from the treatment tool outlet portion <NUM>. After that, the slide position of the sheath position-operation part <NUM> is adjusted, and the sheath position-operation part <NUM> is fixed to the luer lock-operation part <NUM> by the screw <NUM> in a case where the protruding length of the sheath <NUM> is an appropriate length.

Then, the screw <NUM> is loosened, the stopper ring <NUM> is allowed to slide with respect to the sheath position-operation part <NUM> along the axis P, and the position of the stopper ring <NUM> with respect to the sheath position-operation part <NUM> is adjusted. That is, the protruding length of the tube <NUM> from the distal end portion of the sheath <NUM> is adjusted. A user can make this adjustment while looking at, for example, gradations printed on the outer peripheral surface of the sheath position-operation part <NUM>. After that, the stopper ring <NUM> is fixed to the sheath position-operation part <NUM> by the screw <NUM>.

Then, the stylet <NUM> protruding from the distal end opening portion <NUM> is slightly pulled toward the proximal end side and is retracted from the distal end opening portion <NUM> of the tube by a length in a range of about <NUM> to <NUM>. Accordingly, the blade distal end points <NUM>, <NUM>, and <NUM> are likely to be inserted into the biological tissue collection point T.

After that, the tube position-operation part <NUM> is allowed to slide with respect to the sheath position-operation part <NUM> in the direction of the arrow Q along the axis P. The distal end portion <NUM> of the tube <NUM> protrudes from the distal end opening 34A of the sheath <NUM> due to this slide operation, and the distal end portion <NUM> of the tube <NUM> is inserted into the biological tissue collection point T (see <FIG>) in a case where the distal end surface 41A of the tube position-operation part <NUM> is in contact with the stopper ring <NUM>.

Then, the stylet <NUM> is pulled out from the luer lock portion <NUM> and is completely removed. After that, the syringe <NUM> is mounted on the luer lock portion <NUM> and suction can be performed. The above is the usage example of the tissue collecting device <NUM>.

Further, the tube <NUM> also functions as a fluid passage. This fluid passage acts as a suction passage that applies a negative pressure and a passage that pumps normal saline to discharge biological tissue collected in the tube <NUM>.

Next, the configuration of the distal end portion <NUM> of the tube <NUM> will be described.

<FIG> is an enlarged perspective view showing the configuration of the distal end portion <NUM> of the tube <NUM>, and is a perspective view of one side surface of the distal end portion <NUM> viewed from the distal end side of the tube <NUM>. <FIG> is a perspective view of the other side surface of the distal end portion <NUM> viewed from the distal end side of the tube <NUM>. Further, <FIG> is a front view of the distal end portion <NUM> viewed from the distal end side of the tube <NUM>.

A description will be made below using a three dimensional Cartesian coordinate system of an X axis, a Y axis, and a Z axis the description of the configuration of the distal end portion <NUM> of the tube <NUM>. That is, in a case where a direction where the slit <NUM> faces is defined as an upward direction as the distal end portion <NUM> of the tube <NUM> is viewed from the operation unit <NUM> (see <FIG>), the upward direction is referred to as a Z(+) direction and a downward direction, which is a direction opposite to the upward direction, is referred to as a Z(-) direction. Further, a right direction in this case is referred to as an X(+) direction and a left direction is referred to as an X(-) direction. Furthermore, a direction toward the distal end side in this case is referred to as a Y(+) direction and a direction toward the proximal end side is referred to as a Y(-) direction.

As shown in <FIG>, the distal end portion <NUM> of the tube <NUM> includes the puncture portion <NUM>, the slit <NUM>, and the tissue excision cutter <NUM> described above.

As shown in <FIG>, the slit <NUM> is an elongated through-hole that is formed in the shape of a line extending in the Y(-) direction toward the proximal end opening portion <NUM> (see <FIG>) from the distal end opening portion <NUM>, and functions as an intake port that is used to take a large amount of biological tissue into the tube <NUM> from the side surface of the distal end portion <NUM> during the collection of tissue. The slit <NUM> is formed of a gap between a pair of wall portions 58A and 58B facing each other in the X direction and extending in the Y direction.

The tissue excision cutter <NUM> is provided at a proximal end 58C of the slit <NUM>. The tissue excision cutter <NUM> is formed in a shape tapered toward the distal end of the slit <NUM> (Y(+) side) from the proximal end 58C. Further, the tissue excision cutter <NUM> includes an inclined blade surface 60B that is inclined to approach a central axis 54C of the tube <NUM> toward the distal end of the slit <NUM> (Y(+) side) from the proximal end 58C of the slit <NUM>. A sharp blade 60Ais formed toward the distal end of the slit <NUM> (Y(+) side) on the inclined blade surface 60B, and this blade 60A is formed on an inner peripheral surface 54A of the tube <NUM>. Since this tissue excision cutter <NUM> is provided at the proximal end 58C of the slit <NUM>, biological tissue taken into the distal end portion <NUM> through the slit <NUM> can be excised by the operation of the tube <NUM> in the Y(+) direction, that is, the operation of the tube <NUM> in the same direction as a puncture direction with respect to the biological tissue collection point T. Since the tissue excision cutter <NUM> may be formed in a tapered shape as described above, the blade 60A does not necessarily need to be sharp and has only to be thin enough to have a cutter function.

The puncture portion <NUM> is a portion that is to be inserted into the biological tissue collection point T (see <FIG>) from the inner wall S of the body cavity (see <FIG>) in a case where the tube <NUM> is operated in the Y(+) direction, and is a portion that holds the biological tissue collection point T. The puncture portion <NUM> of this example includes, for example, the blade distal end point <NUM>, the blade distal end point <NUM>, and the blade distal end point <NUM>. Each of these blade distal end points <NUM>, <NUM>, and <NUM> is sharply formed so that distal ends thereof gradually become thinner toward the Y(+) direction. Since the puncture portion <NUM> includes the plurality of blade distal end points <NUM>, <NUM>, and <NUM> as described above, the biological tissue collection point T can be reliably held inside the tube <NUM> without escaping to the outside of the tube <NUM>. The blade distal end point <NUM> is an example of a first blade distal end point, the blade distal end point <NUM> is an example of a second blade distal end point, and the blade distal end point <NUM> is an example of a third blade distal end point.

Each of the blade distal end points <NUM>, <NUM>, and <NUM> is formed on the inner peripheral surface 54A of the tube <NUM>. The inner peripheral surface 54A refers to a surface of which the normal line direction faces the central axis 54C of the tube <NUM> in a plane (Z-X plane) orthogonal to the axial direction (Y direction) of the tube <NUM>. Since the respective blade distal end points <NUM>, <NUM>, and <NUM> are formed on this inner peripheral surface 54A, the blade distal end points <NUM>, <NUM>, and <NUM> are formed at positions overlapping with the inner peripheral surface 54A in a case where the blade distal end points <NUM>, <NUM>, and <NUM> are viewed in the axial direction of the tube <NUM> (Y direction). Accordingly, in a case where the tube <NUM> is inserted into and removed from the sheath <NUM>, the blade distal end points <NUM>, <NUM>, and <NUM> do not come in contact with the inner surface of the sheath <NUM> and damage to the sheath <NUM> can be prevented.

Further, in a case where the tube <NUM> is viewed in a direction (X direction) orthogonal to the axial direction of the tube <NUM> (Y direction), the blade distal end point <NUM> is formed closer to the distal end side of the tube <NUM> than the blade distal end points <NUM> and <NUM>. Furthermore, in a case where the tube <NUM> is viewed in the axial direction of the tube <NUM> (Y direction), the blade distal end point <NUM> is disposed to face the slit <NUM> in the radial direction of the tube <NUM> (Z direction) and the blade distal end points <NUM> and <NUM> are disposed to face each other in the X direction with the slit <NUM> interposed therebetween. In a case where the tube <NUM> is viewed in the direction (X direction) orthogonal to the axial direction of the tube <NUM> (Y direction), the blade distal end points <NUM> and <NUM> are formed at the same position in the axial direction of the tube <NUM> (Y direction). However, this is an example, and the blade distal end points <NUM> and <NUM> may be formed at positions shifted from each other in the axial direction of the tube <NUM> (Y direction).

Such these blade distal end points <NUM>, <NUM>, and <NUM> are formed at the distal end portion <NUM>, so that two blade surfaces <NUM> and <NUM> are formed at the distal end portion <NUM> of the tube <NUM>.

That is, as shown in <FIG>, the blade surface <NUM> is formed as a surface that connects an outer peripheral surface 54B of the tube <NUM> to the blade distal end points <NUM> and <NUM>. The blade surface <NUM> has a normal line that includes a component toward the outside in the radial direction of the tube <NUM> (X(-) direction) and a component toward the distal end side of the tube <NUM> (Y(+) side). Since this blade surface <NUM> is formed, a sharp blade 68A is formed at a portion where the blade surface <NUM> and the inner peripheral surface 54A intersect with each other. This blade surface <NUM> is an example of a first blade surface.

As shown in <FIG>, the blade surface <NUM> is formed as a surface that connects the outer peripheral surface 54B of the tube <NUM> to the blade distal end points <NUM> and <NUM>. The blade surface <NUM> has a normal line that includes a component toward the outside in the radial direction of the tube <NUM> (X(+) direction) and a component toward the distal end side of the tube <NUM> (Y(+) side). Since this blade surface <NUM> is formed, a sharp blade 70A is formed at a portion where the blade surface <NUM> and the inner peripheral surface 54A intersect with each other. This blade surface <NUM> is an example of a second blade surface.

The above is the configuration of the distal end portion <NUM> of the tube <NUM>. As shown in <FIG>, the tube <NUM> of the embodiment is formed in a shape symmetric with respect to a Z axis, which passes through the central axis 54C of the tube <NUM>, as the axis of symmetry, but is not limited to this shape. The tube <NUM> may be formed in an asymmetric shape.

The embodiment is configured as described above. Next, an example of a method of collecting biological tissue using this tissue collecting device <NUM> will be described.

First, as shown in <FIG>, the distal end portion body <NUM> of the ultrasonic endoscope is disposed at a predetermined position on the inner wall S of the body cavity. In this state, in a case where the tissue collection point T in the body is captured in the observation field of view of the ultrasonic transducer unit <NUM> included in the ultrasonic observation part <NUM>, the insertion unit <NUM> of the tissue collecting device <NUM> is inserted into the treatment tool-insertion channel <NUM>. In this step, the sheath distal end opening 34A is in a position where the distal end opening 34A of the sheath does not protrude from the distal end of the treatment tool outlet portion <NUM>.

Then, the sheath position-operation part <NUM> is operated in the direction of the arrow Q to make the sheath distal end opening 34A protrude from the distal end of the treatment tool outlet portion <NUM>, and the position of the sheath position-operation part <NUM> is fixed at a position appropriate for puncture by the screw <NUM>.

Here, in a state where the insertion unit <NUM> is not yet inserted into the inner wall S of the body cavity, the distal end portion <NUM> of the tube <NUM> of the insertion unit <NUM> is covered with the sheath <NUM> (see <FIG>). In a case where the tube position-operation part <NUM> (see <FIG>) is operated in the direction of the arrow Q in this state, the distal end portion <NUM> of the tube <NUM> protrudes in the Y(+) direction from the distal end opening 34A of the sheath <NUM> as shown in a portion 100a of <FIG>. Then, due to the continuous protruding operation of the tube <NUM> in the Y(+) direction, the puncture portion <NUM> of the distal end portion <NUM> is inserted into the tissue collection point T from the inner wall S of the body cavity (see <FIG>) as shown in a portion 100b of <FIG>.

At this time, the stylet <NUM> (see <FIG>) is retracted from the distal end opening portion <NUM> by a length in a range of about <NUM> to <NUM> at the time of 100a of <FIG> and the tube distal end portion <NUM> is then allowed to protrude, so that the blade distal end points can be inserted into the tissue collection point T. Further, after 100b of <FIG>, the stylet <NUM> is allowed to protrude from the tube distal end opening portion <NUM> again, so that a stomach wall and other foreign substances mixed in at the time of insertion can be discharged to the outside of the tube. Accordingly, only a specimen more appropriate for pathological diagnosis can be obtained.

Further, the blade distal end point <NUM>, which is positioned closest to the distal end side, among the blade distal end points <NUM>, <NUM>, and <NUM> functions as a blade edge that forms the starting point of insertion. Furthermore, the blade distal end points <NUM> and <NUM> following the blade distal end point <NUM> are smoothly inserted into the tissue collection point T from the inner wall S of the body cavity while being guided by the blade surfaces <NUM> and <NUM> preceding the blade distal end points <NUM> and <NUM>. Here, since the puncture portion <NUM> includes the plurality of blade distal end points <NUM>, <NUM>, and <NUM> in the embodiment, the tissue collection point T into which the puncture portion <NUM> is inserted can be reliably held inside the tube <NUM> without escaping to the outside of the tube <NUM>. Further, since the insertion path of the tube <NUM> at this time is captured in the ultrasonic observation field of view, it is possible to safely perform an operation for inserting the tube <NUM> and to reliably hit the tissue collection point T.

After that, in a case where the puncture portion <NUM> is inserted into the biological tissue (for example, a tumor) of the biological tissue collection point T as shown in a portion 100c of <FIG> due to the continuous protruding operation of the tube <NUM> in the Y(+) direction, a part of the biological tissue enters the tube <NUM> from the slit <NUM>. Then, in a case where the tube <NUM> further protrudes in the Y(+) direction in this state, the biological tissue entering the tube <NUM> is excised by the blade 60A of the tissue excision cutter <NUM> and the excised biological tissue is collected in the tube <NUM>. Accordingly, the amount of biological tissue enough to make a pathological confirmation diagnosis is collected by the tube <NUM>.

It is possible to obtain larger biological tissue by applying a suction force to the above-mentioned procedure. There are mainly following two types of methods of applying a suction force. The first method is a method using the syringe <NUM>. In a case where the stylet <NUM> is completely removed from the luer lock portion <NUM> in the proximal direction after 100b of <FIG>, the syringe <NUM> is then mounted on the luer lock portion <NUM>, and the inside of the tube <NUM> is maintained under negative pressure by the operation of the syringe <NUM>, a suction force is generated in the slit <NUM>. Accordingly, the amount of biological tissue entering the slit <NUM> is further increased. Further, in a case where the tube <NUM> is reciprocated in the biological tissue in a state where a suction force is generated in the slit <NUM>, the biological tissue continuously enters the tube <NUM> through the slit <NUM>. Accordingly, more biological tissue can be efficiently collected.

The second suction method is a method using the stylet <NUM>. In a case where 100c of <FIG> is performed while the stylet <NUM> is slowly removed in the proximal direction of the luer lock portion <NUM>, slight negative pressure can be applied to the inside of the tube <NUM>. This also makes it possible to obtain large biological tissue.

After biological tissue is collected by the insertion unit <NUM> of the tissue collecting device <NUM> as described above, the insertion unit <NUM> is taken out from the treatment tool-insertion channel <NUM>. In this case, for example, after the tube <NUM> is moved in the Y(-) direction to retract the distal end portion <NUM> of the tube <NUM> into the sheath <NUM> as shown in a portion 100d of <FIG>, the insertion unit <NUM> may be taken out from the treatment tool-insertion channel <NUM> in this state.

After the insertion unit <NUM> is taken out from the treatment tool-insertion channel <NUM>, for example, a syringe for pumping normal saline is connected to the luer lock portion <NUM> instead of the syringe <NUM> for suction and normal saline is pumped into the tube <NUM> from this syringe. Accordingly, the collected biological tissue can be transferred to a test tube or the like. Alternatively, the stylet <NUM> can also be reinserted from the luer lock portion <NUM> and be allowed to protrude up to the tube distal end opening portion <NUM> to push out and discharge the biological tissue present in the tube.

According to the embodiment, as described above, the tube <NUM> including the puncture portion <NUM> and the slit <NUM> employs a configuration in which the tissue excision cutter <NUM> is provided at the proximal end 58C of the slit <NUM>. Accordingly, it is possible to collect the amount of biological tissue enough to make a pathological confirmation diagnosis with a simple structure. Further, according to the above-mentioned configuration, it is possible to collect biological tissue by an operation for moving the tube <NUM> in the Y(+) direction (the operation of the tube <NUM> in the same direction as a puncture direction with respect to biological tissue). Accordingly, it is possible to collect biological tissue by a simple operation as compared to the tissue collecting device disclosed in <CIT> of which the tube is to be rotated at the time of collection of biological tissue.

Therefore, according to the embodiment, it is possible to collect the amount of biological tissue enough to make a pathological confirmation diagnosis with a simple structure and a simple operation.

Further, according to the embodiment, since the blade 60A of the tissue excision cutter <NUM> is formed on the inner peripheral surface 54A of the tube <NUM>, the blade 60A does not pierce or is not caught by the inner peripheral surface of the sheath <NUM> or the distal end portion body <NUM> and the tube <NUM> can be smoothly operated to advance and retreat in the sheath <NUM>.

An example in which the blade 60A is formed on the inner peripheral surface 54A of the tube <NUM> has been described in the embodiment, but the blade 60A may be formed, for example, between the inner peripheral surface 54A and the outer peripheral surface 54B or may be formed on the same surface as the outer peripheral surface 54B. Further, the blade 60Amay be formed at a position where the blade protrudes to the outside of the tube <NUM> from the outer peripheral surface 54B. However, in terms of preventing the above-mentioned piercing and catching, it is preferable that the blade 60A is formed at a position where the blade does not protrude to the outside of the tube <NUM> from the outer peripheral surface 54B of the tube <NUM>.

Furthermore, since the tissue excision cutter <NUM> includes the inclined blade surface 60B in the embodiment, the biological tissue excised by the blade 60A can be reliably cut from the tissue collection point T by the inclined blade surface 60B.

Further, since the puncture portion <NUM> includes the plurality of blade distal end points <NUM>, <NUM>, and <NUM> in the embodiment, the puncture portion <NUM> is easily inserted into the biological tissue collection point T and the biological tissue collection point T into which the puncture portion <NUM> is inserted can be reliably held without escaping to the outside of the tube <NUM>. The three blade distal end points <NUM>, <NUM>, and <NUM> have been exemplified in the embodiment, but the puncture portion <NUM> has only to include at least one blade distal end point. However, it is preferable in terms of the above-mentioned insertion and holding that the puncture portion <NUM> includes a plurality of blade distal end points.

Furthermore, a configuration in which the blade distal end point <NUM> farthest from the slit <NUM> in the Y direction and the slit <NUM> are disposed to face each other in the radial direction of the tube <NUM> (Z direction) has been employed in the embodiment. That is, since a configuration in which the slit <NUM> comes into contact with biological tissue after the blade distal end point <NUM> is sufficiently inserted into the biological tissue collection point T has been employed, the biological tissue can be appropriately collected.

Further, a configuration in which the blade surfaces <NUM> and <NUM> are formed on the distal end portion <NUM> of the tube <NUM> has been employed in the embodiment. That is, since a configuration in which the inner peripheral surface 54A of the tube <NUM> always comes into contact with the biological tissue collection point T prior to the outer peripheral surface 54B of the tube <NUM> is employed, the biological tissue can be appropriately collected.

Furthermore, it is preferable that a length L between the blade distal end point <NUM> and the blade 60A of the tissue excision cutter <NUM> in the axial direction of the tube <NUM> (Y direction) is in a range of <NUM> to <NUM> as shown in <FIG>. Accordingly, since the starting point of insertion can be reliably formed by the blade distal end point <NUM>, and the slit <NUM> can be easily inserted into the biological tissue collection point T by the total length thereof during the procedure, the biological tissue can be appropriately collected.

Further, it is preferable that a width B of the slit <NUM> in the circumferential direction of the tube <NUM> is smaller than the inner diameter ID of the tube <NUM> as shown in <FIG>. Accordingly, since it is difficult for biological tissue, which is taken into the distal end portion <NUM>, to escape to the outside of the distal end portion <NUM>, the biological tissue can be appropriately collected.

Furthermore, it is preferable that the outer diameter OD of the tube <NUM> is in a range of <NUM> to <NUM> as shown in <FIG>. Accordingly, the tube <NUM> can be satisfactorily inserted into the sheath <NUM> and the degree of invasion to a patient can be suppressed.

Further, it is preferable that the inner diameter ID of the tube <NUM> is in a range of <NUM> to <NUM> as shown in <FIG>. Accordingly, a large amount of biological tissue can be taken into the tube <NUM> while the strength of the tube <NUM> is maintained.

The biopsy needle and the tissue collecting device according to the embodiment of the present invention have been described in detail above, but it is natural that the present invention is not limited to the above-mentioned examples and may have various improvements and modifications without departing from the scope of the present invention. Some modification examples will be described below. In the description of the following modification examples, the same members as or members similar to those of the tube <NUM> shown in <FIG> will be denoted by the same reference numerals as those of the tube <NUM>.

In a first modification example shown in <FIG>, a blade distal end point 60C is formed on the blade 60A of the tissue excision cutter <NUM>. The blade distal end point 60C is formed in the middle portion of the blade 60A in the circumferential direction of the tube <NUM> and is formed to be sharp toward the distal end of the slit <NUM>.

According to the first modification example, since the blade distal end point 60C functions as a blade edge that forms the starting point of insertion on biological tissue entering the tube <NUM> through the slit <NUM>, the biological tissue can be smoothly excised by the blade 60A following the blade distal end point 60C. The tissue excision cutter <NUM> shown in <FIG> includes two inclined blade surfaces 60B and 60B connected on both sides in the direction of the X axis with the blade distal end point 60C interposed therebetween, but may include at least one inclined blade surface 60B.

In a second modification example shown in <FIG> and not falling under the scope of protection of the claims, the blade distal end point <NUM> is formed at the same position as the blade distal end points <NUM> and <NUM> in the axial direction of the tube <NUM> (Y direction). Other configuration is the same as that of the tube <NUM> shown in <FIG>.

According to the second modification example, the blade distal end points <NUM>, <NUM>, and <NUM> are simultaneously inserted into the biological tissue collection point T, but the tissue collection point T into which the blade distal end points <NUM>, <NUM>, and <NUM> are inserted can be reliably held inside the tube <NUM> without escaping to the outside of the tube <NUM> as in the tube <NUM> shown in <FIG>. The position of the blade distal end point <NUM> is not limited to the above-mentioned position, and the blade distal end point <NUM> may be formed closer to the proximal end side of the tube <NUM> than the blade distal end points <NUM> and <NUM> as long as it is possible to prevent the tissue collection point T from escaping to the outside of the tube <NUM>.

In a third modification example shown in <FIG> and not falling under the scope of protection of the claims, a width B1 of the slit <NUM> is larger than the width B shown in <FIG>. Further, the width B1 is smaller than the inner diameter ID (see <FIG>) of the tube <NUM>.

According to the third modification example, since the width B1 of the slit <NUM> is large, more biological tissue can be allowed to enter the distal end portion <NUM>.

In a fourth modification example shown in <FIG>, a width B2 of the slit <NUM> is smaller than the width B shown in <FIG>. Further, the width B2 is smaller than the inner diameter ID (see <FIG>) of the tube <NUM>.

According to the fourth modification example, since a suction force larger than that in the case of the width B is generated in the slit <NUM> in a case where the syringe <NUM> is operated, a sufficient amount of biological tissue can be allowed to enter the distal end portion <NUM>.

In a fifth modification example shown in <FIG> and not falling under the scope of protection of the claims, among the three blade distal end points <NUM>, <NUM>, and <NUM> shown in <FIG>, only the blade distal end point <NUM> formed closest to the distal end side is formed on the distal end portion <NUM>. This blade distal end point <NUM> is disposed to face the slit <NUM> in the radial direction of the tube <NUM> as described above.

According to the fifth modification example, in a case where the blade distal end point <NUM> is inserted into the biological tissue collection point T, the biological tissue collection point T can be held by the blade distal end point <NUM> and biological tissue can be allowed to enter the distal end portion <NUM> through the slit <NUM>.

In a sixth modification example shown in <FIG> and not falling under the scope of protection of the claims, two blade distal end points <NUM> and <NUM> are formed at the distal end portion <NUM> of the tube <NUM>. The blade distal end points <NUM> and <NUM> are formed on the extension lines of the inner peripheral surface 54A of the tube <NUM> in the Y(+) direction, respectively. Further, in a case where the tube <NUM> is viewed in a direction (X direction) orthogonal to the axial direction of the tube <NUM> (Y direction), the blade distal end points <NUM> and <NUM> are formed at the same position in the axial direction of the tube <NUM> (Y direction). Furthermore, in a case where the tube <NUM> is viewed in the axial direction of the tube <NUM> (Y direction), the blade distal end points <NUM> and <NUM> are disposed to face each other in the radial direction of the tube <NUM> (Z direction) but are disposed not to face the slit <NUM> and are formed to have a phase difference of <NUM>° in the circumferential direction.

According to the sixth modification example, in a case where the blade distal end points <NUM> and <NUM> are inserted into the biological tissue collection point T, the biological tissue collection point T can be reliably held by the blade distal end points <NUM> and <NUM> and biological tissue can be allowed to enter the distal end portion <NUM> through the slit <NUM>.

A seventh modification example shown in <FIG> is another modification example not falling under the scope of protection of the claims, in which a blade distal end point <NUM> is provided and is disposed not to face the slit <NUM> in the radial direction of the tube <NUM>. 200a of <FIG> is a perspective view of the tube <NUM>, 200b of <FIG> is a side view of the tube <NUM> in a case where the tube <NUM> is viewed from an X(-) side, and 200c of <FIG> is a top view of the tube <NUM> in a case where the tube <NUM> is viewed from a Z(+) side.

According to the seventh modification example, the blade distal end point <NUM> is formed closer to the distal end side of the tube <NUM> than the slit <NUM> in the axial direction of the tube <NUM> (Y direction). Further, the blade distal end point <NUM> is formed closer to the blade distal end point <NUM> than the blade distal end point <NUM> in the X direction and is formed at a portion of the tube <NUM> extending toward the distal end side from the blade distal end point <NUM> in the axial direction of the tube <NUM> (Y direction). Furthermore, the blade distal end point <NUM> is formed closer to the distal end side of the tube <NUM> than the blade distal end points <NUM> and <NUM>.

According to the seventh modification example, the blade distal end point <NUM> is inserted into the biological tissue collection point T prior to the blade distal end points <NUM> and <NUM>. However, since the tissue excision cutter <NUM> is provided at the proximal end 58C of the slit <NUM>, it is possible to collect the amount of biological tissue enough to make a pathological confirmation diagnosis with a simple structure as in the case of the tube <NUM> shown in <FIG>.

In an eighth modification example shown in <FIG>, the tissue excision cutter <NUM> includes an inclined blade surface 60D that is inclined to be away from the central axis 54C of the tube <NUM> toward the distal end of the slit <NUM> from the proximal end 58C of the slit <NUM>. Further, a blade 60A is formed at a portion of the tube <NUM> that protrudes outward from the outer peripheral surface 54B of the tube <NUM>.

According to the eighth modification example, as the tube <NUM> is operated in the Y(+) direction, biological tissue entering the distal end portion <NUM> through the slit <NUM> can be excised by the blade 60A of the tissue excision cutter <NUM> and be collected in the distal end portion <NUM>. In this case, the inclined blade surface 60D functions as a guide surface for pushing the excised biological tissue into the distal end portion <NUM>.

Next, some aspects of an echo marker including the outer peripheral surface 54B of the tube <NUM> will be described. The echo marker is a marker that can allow the position of the tube <NUM> to be visually displayed in an ultrasound image. It is possible to visually confirm the position of the distal end portion <NUM> of the tube <NUM> by confirming the echo marker in the ultrasound image. In the description of the following aspects, the same members as or members similar to those of the tube <NUM> shown in <FIG> will be denoted by the same reference numerals as those of the tube <NUM>.

As shown in <FIG>, an echo marker <NUM> provided on the outer peripheral surface 54B of the tube <NUM> is formed of a plurality of small-diameter recessed portions <NUM> that are densely formed on the outer peripheral surface 54B. Accordingly, unevenness is formed on the outer peripheral surface 54B and ultrasonic visibility is enhanced by the unevenness, so that the position of the distal end portion <NUM> of the tube <NUM> can be confirmed in the ultrasound image.

First, in a first aspect shown in <FIG>, the echo marker <NUM> is provided only around a periphery including the proximal end 58C of the slit <NUM>.

According to the first aspect, it is possible to easily confirm the position of the proximal end 58C of the slit <NUM> by confirming the position of the echo marker <NUM> in the ultrasound image. Accordingly, since it is possible to easily confirm whether or not the slit <NUM> is inserted into the biological tissue by the total length thereof, it is possible to realize a safe and reliable procedure.

In a second aspect shown in <FIG>, the echo marker <NUM> is provided in a region extending toward the distal end side of the tube <NUM> (Y(+) side) from a periphery, which includes the proximal end 58C of the slit <NUM>, as a starting point. Specifically, the echo marker <NUM> is provided on the entire outer peripheral surface 54B of the tube <NUM> between the starting point and the blade distal end point <NUM>. Although not shown in <FIG>, the echo marker <NUM> is formed up to the surface of the blade distal end point <NUM> corresponding to a Z(-) side.

According to the second aspect, it is possible to easily confirm the position of the distal end portion <NUM>, which includes the blade distal end point <NUM>, by confirming the position of the distal end portion of the echo marker <NUM> in the ultrasound image. Further, it is possible to easily confirm the position of the proximal end 58C of the slit <NUM> by confirming the position of the proximal end portion of the echo marker <NUM>. Accordingly, since it is possible to easily confirm whether or not the slit <NUM> is inserted into the biological tissue by the total length thereof, it is possible to realize a safe and reliable procedure.

In a third aspect shown in <FIG>, the echo marker <NUM> is provided in a region extending toward the distal end side of the tube <NUM> (Y(+) side) from a periphery, which includes the proximal end 58C of the slit <NUM>, as a starting point. Specifically, the echo marker <NUM> is provided on the entire outer peripheral surface 54B of the tube <NUM> between the starting point and the blade distal end points <NUM> and <NUM>.

According to the third aspect, it is possible to easily confirm the position of the distal end portion <NUM>, which includes the blade distal end points <NUM> and <NUM>, by confirming the position of the distal end portion of the echo marker <NUM> in the ultrasound image and to confirm the position of the proximal end 58C of the slit <NUM> by confirming the position of the proximal end portion of the echo marker <NUM>. Accordingly, the same effects as those of the second aspect can be obtained.

In a fourth aspect shown in <FIG>, the echo marker <NUM> is provided in a region extending toward the proximal end side of the tube <NUM> (Y(-) side) from a periphery, which includes the proximal end 58C of the slit <NUM>, as a starting point.

According to the fourth aspect, since it is possible to confirm the position of the proximal end 58C of the slit <NUM> by confirming the position of the distal end portion of the echo marker <NUM>, the same effects as those of the first aspect can be obtained.

Claim 1:
A biopsy needle (<NUM>) that is to be inserted into an endoscope forceps channel, the biopsy needle comprising:
a hollow tube (<NUM>) which includes a distal end opening portion (<NUM>) and a proximal end opening portion (<NUM>) and of which the distal end opening portion and the proximal end opening portion communicate with each other,
wherein the tube includes a puncture portion (<NUM>) that is provided at a distal end portion (<NUM>) of the tube and has a plurality of blade distal end points, a slit (<NUM>) that extends toward the proximal end opening portion (<NUM>) from the distal end opening portion (<NUM>), and a tissue excision cutter (<NUM>) that is provided at a proximal end of the slit (58C) and is formed in a shape tapered toward a distal end of the slit from the proximal end of the slit,
wherein the puncture portion includes a first blade distal end point (<NUM>), a second blade distal end point (<NUM>), and a third blade distal end point (<NUM>),
in a case where the tube is viewed in a direction orthogonal to an axial direction of the tube, the first blade distal end point (<NUM>) is formed closer to a distal end side of the tube than the second blade distal end point (<NUM>) and the third blade distal end point (<NUM>), and
in a case where the tube is viewed in the axial direction of the tube, the first blade distal end point (<NUM>) is disposed to face the slit (<NUM>) in a radial direction of the tube, and the second blade distal end point (<NUM>) and the third blade distal end point (<NUM>) are disposed to face each other with the slit interposed therebetween,
characterized in that
the slit is an elongated through-hole that is formed in the shape of a line extending in the axial direction of the tube (<NUM>).