Biopsy needle and tissue collecting device

Abstract

Provided are a biopsy needle and a tissue collection device with which a biological tissue can be collected, with a simple structure and a simple operation, in an amount sufficient for performing a diagnosis for pathological confirmation. A biopsy needle to be inserted into a forceps channel of an endoscope is provided with a tube (54) comprising: a puncture part (56) that is provided to a distal end part (55) of the tube (54), and that has at least one cutting edge endpoint (62); a slit (58) that extends from a distal end opening part (50) of the tube (54) toward a base end opening part (54); and a tissue excision cutter (60) that is provided to a base end (58C) of the slit (58), and that is formed to be tapered from the base end (58C) of the slit (58) toward the distal end of the slit (58).

Description

Biopsy needle and tissue sampling device

[0001] The present invention relates to a biopsy needle and a tissue sampling device, and particularly to a biopsy needle and a tissue sampling device used for collecting a biological tissue.

[0002] In recent years, a needle tube is introduced into the body cavity through the treatment tool insertion channel of an ultrasonic endoscope, and under the observation of an ultrasonic tomographic image by the ultrasonic endoscope, the needle tube is guided to the observation site and pierced into the diseased tissue, and a pathological diagnosis is made by collecting the biological tissue.

[0003] As a tissue sampling device used for performing such a pathological diagnosis, for example, the one disclosed in Patent Document 1 is known. The tissue sampling device of Patent Document 1 includes a flexible sheath that can be inserted into the treatment tool insertion channel of an endoscope, a needle tube that is inserted into the sheath so as to be able to advance and retreat and is punctured into a biological tissue, an operation unit that is connected to the proximal end of the sheath and operates the advancement and retreat of the needle tube, and a syringe that is connected to the operation unit and applies negative pressure to the needle tube.

[0004] Further, the needle tube disclosed in Patent Document 1 is provided with a slit extending from the tip opening toward the proximal end side, and a step is formed between the first edge portion and the second edge portion by configuring the radius of curvature of the first edge portion provided on both sides of the slit to be larger than the radius of curvature of the second edge portion.

[0005] According to the tissue sampling device of Patent Document 1, after the needle tube is pierced into the diseased tissue, the needle tube is rotated, and the biological tissue is taken into the tip of the tube from the gap of the step, and then the needle tube is further rotated to cut the taken biological tissue by the edge of the slit. Thereby, a sufficient amount of biological tissue can be collected for performing a pathological diagnosis.

[0006] International Publication No. 2014 / 112518

[0007] However, the needle tube (hereinafter referred to as a biopsy needle) of Patent Document 1 has a complex structure having a first edge portion and a second edge portion with different radii of curvature, so there is a problem that it is difficult to manufacture a biopsy needle with a small diameter of, for example, 3 mm or less in outer diameter.

[0008] Furthermore, according to the tissue sampling device of Patent Document 1, when biological tissue is taken up and excised using a biopsy needle, the biopsy needle is rotated around its axis. However, in this case, the operating part must be rotated together with the syringe, which can be burdensome for the operator.

[0009] This invention has been made in view of these circumstances, and aims to provide a biopsy needle and tissue collection device that can collect a sufficient amount of biological tissue for definitive pathological diagnosis with a simple structure and simple operation.

[0010] To achieve the objectives of the present invention, the biopsy needle according to the present invention is a biopsy needle inserted into an endoscope forceps channel, comprising a hollow tube having a tip opening and a proximal opening, with the tip opening and the proximal opening communicating with each other, the tube comprising a puncture portion provided at the tip of the tube and having at least one blade tip point, a slit extending from the tip opening toward the proximal opening, and a tissue resection cutter provided at the proximal end of the slit and tapering toward the tip of the slit.

[0011] Furthermore, in one embodiment of the biopsy needle according to the present invention, it is preferable that the tissue excision cutter has at least one inclined blade surface that is inclined so as to approach the central axis of the tube from the base end of the slit to the tip of the slit.

[0012] Furthermore, in one embodiment of the biopsy needle according to the present invention, it is preferable that a sharp blade is formed on the inclined blade surface, and that the blade is formed in a position that does not protrude from the outer surface of the tube to the outside of the tube.

[0013] Furthermore, in the biopsy needle according to the present invention, when the tube is viewed from the axial direction of the tube, it is preferable that at least one cutting edge point and the slit are positioned opposite each other in the radial direction of the tube.

[0014] Furthermore, it is preferable that the biopsy needle according to the present invention has at least one cutting edge point that is a first cutting edge point formed on the tip side of the tube in the axial direction of the tube, relative to the slit.

[0015] Furthermore, the puncture portion of the biopsy needle according to the present invention has a first blade tip, a second blade tip, and a third blade tip, and the first blade tip, the second blade tip, and the third blade tip are each formed on the inner circumferential surface of the tube, and when the tube is viewed from a direction perpendicular to the axial direction of the tube, the first blade tip is formed closer to the tip of the tube than the second blade tip and the third blade tip, and when the tube is viewed from the axial direction of the tube, the first blade tip is positioned opposite the slit in the radial direction of the tube, and the second blade tip and the third blade tip are preferably positioned opposite each other with the slit in between.

[0016] Furthermore, it is preferable that the biopsy needle according to the present invention has a first cutting surface at the tip of the tube that connects the outer circumferential surface of the tube to the first cutting surface tip and the second cutting surface tip, and has a normal including a component directed radially outward of the tube and a component directed toward the tip of the tube, and a second cutting surface that connects the outer circumferential surface of the tube to the first cutting surface tip and the third cutting surface tip, and has a normal including a component directed radially outward of the tube and a component directed toward the tip of the tube.

[0017] Furthermore, in the biopsy needle according to the present invention, it is preferable that at least one cutting edge is formed on the inner circumferential surface of the tube.

[0018] Furthermore, in the biopsy needle according to the present invention, it is preferable that the length from the tip of the first blade to the tip of the tissue excision cutter in the axial direction of the tube is 0.5 mm or more and 25.0 mm or less.

[0019] Furthermore, in the biopsy needle according to the present invention, it is preferable that the width of the slit in the circumferential direction of the tube is smaller than the inner diameter of the tube.

[0020] Furthermore, the biopsy needle according to the present invention preferably has an outer diameter of 0.3 mm or more and 3.0 mm or less.

[0021] Furthermore, the biopsy needle according to the present invention preferably has an inner diameter of 0.1 mm or more and 2.5 mm or less.

[0022] Furthermore, it is preferable that the biopsy needle according to the present invention is equipped with an echo marker on the outer surface of the tube that allows the position of the tube to be visually indicated under an ultrasound image.

[0023] Furthermore, in the biopsy needle according to the present invention, it is preferable that the echo marker is provided only around the periphery including the proximal end of the slit.

[0024] Furthermore, in the biopsy needle according to the present invention, it is preferable that the echo marker is provided in the region on the tip side of the tube, starting from the area around the proximal end of the slit.

[0025] Furthermore, in the biopsy needle according to the present invention, it is preferable that the echo marker is provided in the region on the proximal end side of the tube, starting from the area around the proximal end of the slit.

[0026] Furthermore, in the biopsy needle according to the present invention, it is preferable that the echo marker is configured in an uneven shape.

[0027] Furthermore, the biopsy needle according to the present invention preferably has a tube made of stainless steel, nickel-titanium alloy, nickel-chromium alloy, or cobalt-chromium alloy.

[0028] To achieve the objectives of the present invention, the tissue sampling device according to the present invention comprises a biopsy needle and a suction member that communicates with the proximal end opening of the biopsy needle and creates a negative pressure inside the biopsy needle.

[0029] According to the present invention, a sufficient amount of biological tissue for making a definitive pathological diagnosis can be collected with a simple structure and simple operation.

[0030] Cross-sectional view of the main part showing the tissue sampling device as one embodiment of the present invention incorporated into an ultrasound endoscope. Cross-sectional view showing the overall configuration of the tissue sampling device. Cross-sectional view of the insertion part where the biopsy needle protrudes outward from the tip opening of the sheath. Cross-sectional view of the insertion part where the biopsy needle is immersed inside the sheath. Enlarged perspective view showing the configuration of the tip of the tube constituting the tissue sampling device. Enlarged perspective view showing the configuration of the tip of the tube constituting the tissue sampling device. Enlarged perspective view showing the configuration of the tip of the tube constituting the tissue sampling device. Explanatory diagram showing a method of collecting biological tissue using the tissue sampling device. Perspective view showing the tip of the tube relating to the modified example of the second perspective view Perspective view showing the tip of the tube relating to the modified example of the third perspective view Perspective view showing the tip of the tube relating to the modified example of the fourth perspective view Perspective view showing the tip of the tube relating to the modified example of the fifth perspective view Perspective view showing the tip of the tube relating to the modified example of the sixth perspective view Perspective view showing the tip of the tube relating to the modified example of the seventh perspective view Perspective view showing the tip of the tube relating to the modified example of the eighth perspective view Perspective view showing the first aspect of the echo marker Perspective view showing the second aspect of the echo marker Perspective view showing the third aspect of the echo marker Perspective view showing the fourth aspect of the echo marker

[0031] Preferred embodiments of the present invention will be described in detail below with reference to the attached drawings.

[0032] The tissue sampling device for puncture to which the present invention is applied is described as being configured to be inserted into a body cavity via a treatment instrument insertion channel formed in an ultrasound endoscope that performs electronic convex scanning. However, as a guide means for the tissue sampling device, an ultrasound endoscope with a different scanning method, a treatment instrument insertion channel of a normal endoscope without an ultrasound diagnostic mechanism, or a trocar can be used as a guide means. When inserted into a trocar, the entire device can be made of a rigid material.

[0033] First, Figure 1 shows the configuration of the tip portion of the ultrasound endoscope that guides the tissue sampling device. In the figure, reference numeral 10 denotes the insertion portion into the body cavity, and this insertion portion 10 consists of an angle portion 11 with a tip body 12 attached to the tip, and the tip body 12 is provided with an endoscope observation section 13 on the proximal end side and an ultrasound observation section 14 on the tip side. The endoscope observation section 13 is provided on the inclined portion 12a on the proximal end side of the tip body 12 and is configured to direct the observation field of view diagonally forward.

[0034] Figure 1 shows an illumination mechanism 15 equipped with a light guide that constitutes the endoscope observation section 13. An observation mechanism is provided adjacent to this illumination mechanism 15, but its illustration is omitted. A solid-state image sensor or an image guide can be used as the observation mechanism.

[0035] The ultrasonic observation unit 14 has an ultrasonic transducer unit 16 attached to an opening 12b provided at the tip of the tip body 12. This ultrasonic transducer unit 16 performs electronic convex scanning and is composed of a large number of strip-shaped ultrasonic transducers 17 arranged in an arc shape.

[0036] A treatment instrument outlet section 18 is formed between the endoscope observation section 13 and the ultrasound observation section 14. This treatment instrument outlet section 18 is a passage with a predetermined inner diameter drilled into the tip body 12, and a connecting pipe 19 is connected to this treatment instrument outlet section 18. This connecting pipe 19 is bent at a predetermined angle, and a flexible tube 20 is connected to its base end. Therefore, the treatment instrument insertion channel 21 is formed from the treatment instrument outlet section 18, the connecting pipe 19, and the flexible tube 20, the treatment instrument outlet section 18 extends diagonally forward with respect to the axis of the insertion section 10, the flexible tube 20 extends in the axial direction of the insertion section 10, and the middle portion of the connecting pipe 19 is bent by a predetermined angle.

[0037] Reference numeral 30 denotes a tissue sampling device of an embodiment, which is inserted into the instrument insertion channel 21 and can extend and retract from the instrument outlet 18. The tip body 12 is brought into contact with the inner wall S of the body cavity, the tissue sampling site T is brought into the ultrasound observation field using the ultrasound observation unit 14, the tip of the tissue sampling device 30 is inserted from the instrument outlet 18 through the inner wall S of the body cavity, and the tip is guided to the tissue sampling site T before the tissue can be collected.

[0038] Figure 2 is a cross-sectional view showing the overall configuration of the tissue sampling device 30. As is clear from the figure, the tissue sampling device 30 consists of an insertion section 31 and an operating section 32, and a syringe 33 is detachably connected to the base end of the operating section 32. This syringe 33 is an example of a suction member.

[0039] The insertion portion 31 is at least longer than the total length of the instrument insertion channel 21 and is composed of a double cylindrical member, as shown in Figures 3 and 4. In other words, the insertion portion 31 is composed of a sheath 34 and a biopsy needle 35 inserted into the inside of the sheath 34, from the outermost side. Figure 3 is a cross-sectional view of the insertion portion 31 showing the state in which the biopsy needle 35 is protruding outward from the tip opening 34A of the sheath 34, and Figure 4 is a cross-sectional view of the insertion portion 31 showing the state in which the biopsy needle 35 is retracted into the inside of the sheath 34.

[0040] The sheath 34 is inserted into the instrument insertion channel 21 of the endoscope and constitutes the outer casing of the insertion section 31. The sheath 34 is made of a flexible cylindrical member and is formed of a resin material such as polyethersulfone, Teflon (registered trademark), or polyetheretherketone (PEEK). The sheath 34 may also be made of a tightly packed coil or the like.

[0041] The biopsy needle 35 is for puncturing a living tissue to collect a lesion tissue or the like, and is inserted into the sheath 34 so as to be movable forward and backward. Although the detailed configuration of the biopsy needle 35 will be described later, the biopsy needle 35 has a tube 54. This tube 54 has a tip opening 50 and a base end opening 52 (see FIG. 2), and the tip opening 50 and the base end opening 52 are in communication. Further, as shown in FIGS. 3 and 4, a puncture portion 56, a slit 58, and a tissue excision cutter 60 are provided at the tip portion 55 of the tube 54.

[0042] Since the above-described tube 54 is inserted into the body, it must be made of a hard material. In addition, since the tube 54 is inserted into the treatment tool insertion channel 21, it passes through the bent connection pipe 19, and in order to be able to smoothly insert even when the angle portion 11 is bent, it must have flexibility in the bending direction. For this reason, the tube 54 is made of a stainless steel, nickel-titanium alloy, nickel-chromium alloy, or cobalt-chromium alloy having a small diameter and flexibility. Stainless steel is difficult to rust, nickel-titanium is a superelastic alloy and is difficult to get a bend even when inserted into the bent connection pipe 19, and nickel-chromium and cobalt-chromium have high hardness and can be easily inserted into the living tissue collection site T. Note that the biopsy needle 35 may be formed with a tip portion 55 including at least the puncture portion 56 by a hard pipe, and the portion other than the tip portion 55 may be constituted by a flexible soft tube.

[0043] The tube 54 is inserted into the sheath 34 so as to be movable forward and backward, and moves between a retracted position where the tube 54 is immersed in the sheath 34 (the position in FIG. 4) and an operating position where it protrudes from the tip opening 34A of the sheath 34 by a predetermined length (the position in FIG. 3).

[0044] For this purpose, the base end portion of the tube 54 is connected to the operation portion 32, and by operating this operation portion 32, the tube 54 appears and disappears from the tip opening 34A of the sheath 34. The specific configuration of the operation portion 32 is as shown in FIG. 2.

[0045] As shown in Figure 2, the operating section 32 includes a Luer lock operating section 39, a sheath position operating section 40, a tube position operating section 41, and a stopper ring 42. A stylet 36 is inserted inside the tube 35.

[0046] The Luer lock operating section 39 has a Luer lock portion 39A at its tip, which is used to fix the Luer lock portion 39A to the instrument entry port (not shown) of the ultrasound endoscope, and is detachably connected, for example, to a pair of Luer lock portions present in the instrument entry port. The Luer lock operating section 39 is inserted through a hole in the sheath position operating section 40, and the Luer lock operating section 39 and the sheath position operating section 40 are mounted so as to be slidable relative to each other along the axis P of the operating section 32. The Luer lock operating section 39 and the sheath position operating section 40 are fixed together by a screw 43 that is screwed in from the outer circumferential surface of the sheath position operating section 40 toward the outer circumferential surface of the Luer lock operating section 39.

[0047] Furthermore, a stopper ring 42 is slidably provided on the outer circumferential surface of the sheath position operating section 40 along the axis P, and the stopper ring 42 is fixed by a screw 44 that is screwed in from the outer circumferential surface of the stopper ring 42 toward the outer circumferential surface of the sheath position operating section 40. The sheath position operating section 40 is inserted through the hole of the tube position operating section 41, and the sheath position operating section 40 and the tube position operating section 41 are mounted so as to be slidable relative to each other along the axis P. The relative position of the sheath position operating section 40 and the tube position operating section 41 in the direction of the axis P is determined by the tip surface 41A of the tube position operating section 41 contacting the stopper ring 42.

[0048] With respect to the operation unit 32 configured as described above, in the sheath 34, the base side of the sheath 34 is inserted through the hole of the luer lock operation unit 39 into the hole of the sheath position operation unit 40 and fixed to the base end portion of the sheath position operation unit 40. As a result, the proximal end opening 34B of the sheath 34 is opened at the base end portion of the sheath position operation unit 40. Further, in the tube 54, the proximal end side of the tube 54 is inserted through the proximal end opening 34B of the sheath 34 into the hole of the tube position operation unit 41 and fixed to the base end portion of the tube position operation unit 41. As a result, the proximal end opening 52 of the tube 54 is opened at the base end portion of the tube position operation unit 41. Further, a luer lock portion 45 communicating with the proximal end opening 52 is provided at the base end portion of the tube position operation unit 41, and a stylet 36 is provided between the luer lock portion 45 and the position where it protrudes from the distal end opening 50 of the tube. The stylet 36 functions to protect the blade tip points 62, 64, 66, protect the sheath 34 from the blade tip points 62, 64, 66, and suppress the intrusion of foreign matter into the tube 34. When the stylet 36 protrudes from the distal end opening 50 of the tube, when the sheath 34 is formed in a curved shape forming a part of an arc, the distal end surface of the stylet 36 contacts the inner surface of the sheath 34 and the outer peripheral surface of the distal end opening of the tube. Further, the distal end surface of the stylet 36 is pressed from the inner surface of the sheath 34, and the distal end opening 50 of the tube is in a state of retreating to a position separated from the inner surface of the sheath 34. When the stylet 36 is completely removed from the luer lock portion 45 in the proximal end direction, a syringe 33 having a luer lock for suction and liquid pumping can be attached to and detached from the luer lock portion 45.

[0049] Next, a usage example of the tissue sampling device 30 shown in FIG. 2 will be described.

[0050] First, the sheath 34 through which the tube 35 is inserted is inserted into the treatment tool insertion channel 21 shown in FIG. 1 from the treatment tool inlet of the ultrasonic endoscope. For example, when the distal end portion of the sheath 34 is located near the distal end of the treatment tool outlet portion 18 in FIG. 1, the luer lock portion 39A of the luer lock operation unit 39 is fixed to the luer lock that is the pair of the treatment tool inlet.

[0051] Next, loosen the screw 43 and slide the sheath position operating part 40 along axis P in the direction of arrow Q relative to the Luer lock operating part 39. This causes the tip of the sheath 34 to protrude from the instrument outlet 18. After this, adjust the sliding position of the sheath position operating part 40 until the protruding length of the sheath 34 is appropriate, and then fix the sheath position operating part 40 to the Luer lock operating part 39 with the screw 43.

[0052] Next, the screw 44 is loosened, and the stopper ring 42 is slid along the axis P relative to the sheath position operating part 40 to adjust the position of the stopper ring 42 relative to the sheath position operating part 40. In other words, the length of the tube 54 protruding from the tip of the sheath 34 is adjusted. This adjustment can be done, for example, by looking at the scale printed on the outer surface of the sheath position operating part 40. After this, the stopper ring 42 is fixed to the sheath position operating part 40 with the screw 44.

[0053] Next, the stylet 36 protruding from the tip opening 50 is slightly withdrawn towards the proximal end and inserted about 5 mm to 10 mm into the tip opening 50 of the tube. This makes it easier for the blade tips 62, 64, and 66 to penetrate the tissue sampling site T.

[0054] Next, the tube positioning unit 41 is slid along axis P in the direction of arrow Q relative to the sheath positioning unit 40. This sliding motion causes the tip 55 of the tube 54 to protrude from the tip opening 34A of the sheath 34, and when the tip surface 41A of the tube positioning unit 41 comes into contact with the stopper ring 42, the tip 55 of the tube 54 is inserted into the biological tissue sampling site T (see Figure 1).

[0055] Next, the stylet 36 is withdrawn from the Luer lock section 45 and completely removed. After that, a syringe 33 can be attached to the Luer lock section 45 and aspirate can be performed. The above is an example of how to use the tissue sampling device 30.

[0056] Furthermore, tube 54 also functions as a fluid passage. This fluid passage acts as a suction passage for applying negative pressure and as a passage for pumping physiological saline to discharge the biological tissue collected inside tube 54.

[0057] Next, the configuration of the tip portion 55 of the tube 54 will be described.

[0058] Figure 5 is an enlarged perspective view showing the configuration of the tip portion 55 of the tube 54, and is a perspective view of one side of the tip portion 55 seen from the tip side of the tube 54. Figure 6 is a perspective view of the other side of the tip portion 55 seen from the tip side of the tube 54. Figure 7 is a front view of the tip portion 55 seen from the tip side of the tube 54.

[0059] In describing the configuration of the tip 55 of the tube 54 below, we will use a three-dimensional Cartesian coordinate system with X, Y, and Z axes. That is, when viewing the tip 55 of the tube 54 from the operating section 32 (see Figure 2), and considering the direction in which the slit 58 faces upward, the upward direction will be the Z(+) direction, and the opposite direction, downward, will be the Z(-) direction. Also, the direction to the right in this case will be the X(+) direction, and the direction to the left will be the X(-) direction. Furthermore, the direction towards the tip will be the Y(+) direction, and the direction towards the base will be the Y(-) direction.

[0060] As shown in Figures 5 to 7, the tip 55 of the tube 54 has the puncture portion 56 described above, a slit 58, and a tissue excision cutter 60.

[0061] As shown in Figure 5, the slit 58 is a linear, elongated through-hole that extends in the Y-direction from the tip opening 50 toward the proximal opening 52 (see Figure 2). During tissue collection, it functions as an intake port for taking in a large amount of biological tissue from the side of the tip 55 into the tube 54. This slit 58 is formed by the gap between a pair of wall portions 58A and 58B that face each other in the X direction and are aligned in the Y direction.

[0062] The tissue excision cutter 60 is provided at the proximal end 58C of the slit 58. This tissue excision cutter 60 is tapered from the proximal end 58C toward the tip (Y(+) side) of the slit 58. The tissue excision cutter 60 also has an inclined blade surface 60B that is inclined to approach the central axis 54C of the tube 54 from the proximal end 58C toward the tip (Y(+) side) of the slit 58. A sharp blade 60A is formed on this inclined blade surface 60B toward the tip (Y(+) side) of the slit 58, and this blade 60A is formed on the inner circumferential surface 54A of the tube 54. By providing such a tissue excision cutter 60 at the proximal end 58C of the slit 58, the biological tissue taken into the interior of the tip portion 55 through the slit 58 can be excised by operating the tube 54 in the Y(+) direction, that is, by operating the tube 54 in the same direction as the puncture direction of the tube 54 toward the biological tissue collection site T. Furthermore, since the tissue excision cutter 60 only needs to be formed in the tapered shape described above, the blade 60A does not necessarily need to be sharp, and only needs to be thin enough to have a cutting function.

[0063] The puncture portion 56 is the part that is inserted from the inner wall S of the body cavity (see Figure 1) into the tissue sampling site T (see Figure 1) when the tube 54 moves in the Y(+) direction, and is also the part that holds the tissue sampling site T. In this example, the puncture portion 56 has, as an example, a blade tip 62, a blade tip 64, and a blade tip 66. These blade tips 62, 64, and 66 are each formed to be sharp, gradually tapering towards the Y(+) direction. By configuring the puncture portion 56 with multiple blade tips 62, 64, and 66 in this way, the tissue sampling site T can be reliably held inside the tube 54 without escaping to the outside of the tube 54. Note that blade tip 62 is an example of a first blade tip, blade tip 64 is an example of a second blade tip, and blade tip 66 is an example of a third blade tip.

[0064] The cutting edge points 62, 64, and 66 are each formed on the inner circumferential surface 54A of the tube 54. The inner circumferential surface 54A refers to the surface (Z-X plane) perpendicular to the axial direction (Y direction) of the tube 54, where the normal direction is toward the central axis 54C of the tube 54. By forming the cutting edge points 62, 64, and 66 on this inner circumferential surface 54A, when the cutting edge points 62, 64, and 66 are viewed from the axial direction (Y direction) of the tube 54, they are formed in a position that overlaps with the inner circumferential surface 54A. As a result, when the tube 54 is inserted into or removed from the sheath 34, the cutting edge points 62, 64, and 66 do not come into contact with the inner surface of the sheath 34, making it possible to prevent damage to the sheath 34.

[0065] Furthermore, when viewing the tube 54 from a direction perpendicular to the axial direction (Y direction) of the tube 54 (X direction), the cutting edge point 62 is formed closer to the tip of the tube 54 than the cutting edge points 64 and 66. Also, when viewing the tube 54 from the axial direction (Y direction), the cutting edge point 62 is positioned opposite the slit 58 in the radial direction (Z direction) of the tube 54, and the cutting edge points 64 and 66 are positioned opposite each other in the X direction with the slit 58 in between. Note that when viewing the tube 54 from a direction perpendicular to the axial direction (Y direction) of the tube 54 (X direction), the cutting edge points 64 and 66 are formed at the same position in the axial direction (Y direction) of the tube 54, but this is just an example, and they may be formed at offset positions in the axial direction (Y direction) of the tube 54.

[0066] By forming these blade tip points 62, 64, and 66 on the tip portion 55, two blade surfaces 68 and 70 are formed on the tip portion 55 of the tube 54.

[0067] In other words, as shown in Figure 5, the cutting surface 68 is formed as a surface connecting the outer circumferential surface 54B of the tube 54 with the cutting tip point 62 and the cutting tip point 64. This cutting surface 68 has a normal that includes a component directed outward in the radial direction (X (-) direction) of the tube 54 and a component directed towards the tip (Y (+)) side of the tube 54. By forming such a cutting surface 68, a sharp cutting edge 68A is formed at the portion where the cutting surface 68 intersects with the inner circumferential surface 54A. Note that this cutting surface 68 is an example of a first cutting surface.

[0068] As shown in Figure 6, the cutting surface 70 is formed as a surface connecting the outer circumferential surface 54B of the tube 54 with the cutting tip point 62 and the cutting tip point 66. This cutting surface 70 has a normal that includes a component directed outward in the radial direction (X (+) direction) of the tube 54 and a component directed towards the tip (Y (+)) side of the tube 54. By forming such a cutting surface 70, a sharp cutting edge 70A is formed at the portion where the cutting surface 70 intersects with the inner circumferential surface 54A. Note that this cutting surface 70 is an example of a second cutting surface.

[0069] The above describes the configuration of the tip portion 55 of the tube 54. In this embodiment, the tube 54 is configured to have a symmetrical shape with respect to the Z-axis passing through the central axis 54C of the tube 54, as shown in Figure 7. However, it is not limited to this shape and may be configured to have an asymmetrical shape.

[0070] The embodiment is configured as described above, and next, an example of a method for collecting biological tissue using this tissue collection device 30 will be described.

[0071] First, as shown in Figure 1, the tip body 12 of the ultrasound endoscope is positioned at a predetermined location relative to the inner wall S of the body cavity. In this state, when the tissue sampling site T inside the body is located within the observation field of view of the ultrasound transducer unit 16 that constitutes the ultrasound observation unit 14, the insertion part 31 of the tissue sampling device 30 is inserted into the instrument insertion channel 21. At this stage, the sheath tip opening 34A is positioned so as not to protrude from the tip of the instrument outlet 18.

[0072] Next, the sheath positioning unit 40 is operated in the direction of arrow Q to make the sheath tip opening 34A protrude from the tip of the treatment instrument discharge unit 18, and the position is fixed with the screw 43 at a position suitable for puncture.

[0073] Here, before insertion into the body cavity wall S, the tip 55 of the tube 54 at the insertion section 31 is covered by the sheath 34 (see Figure 4). In this state, when the tube position manipulation section 41 (see Figure 2) is operated in the direction of arrow Q, the tip 55 of the tube 54 protrudes in the Y(+) direction from the tip opening 34A of the sheath 34, as shown in section 100a of Figure 8. Then, due to the continued protrusion of the tube 54 in the Y(+) direction, the puncture section 56 of the tip 55 penetrates the body cavity wall S (see Figure 1) into the tissue sampling site T, as shown in section 100b of Figure 8.

[0074] At this time, during step 100a in Figure 8, the stylet 36 (see Figure 2) is inserted about 5 mm to 10 mm from the tip opening 50, and then the tip of the tube 55 is extended, allowing the blade tip to be used to insert the stylet into the tissue sampling site T. Furthermore, after step 100b in Figure 8, the stylet 36 is extended again from the tip opening 50, allowing any stomach wall or other foreign matter that may be introduced during insertion to be expelled from the tube. This makes it possible to obtain only specimens suitable for pathological diagnosis.

[0075] Furthermore, the tip point 62, which is located closest to the tip among the tip points 62, 64, and 66, functions as the cutting edge that forms the starting point of insertion. Then, the tip points 64 and 66 that follow tip point 62 are guided by the preceding cutting surfaces 68 and 70 and are smoothly inserted from the inner wall S of the body cavity into the tissue sampling site T. In this embodiment, since the puncture section 56 is composed of multiple tip points 62, 64, and 66, the inserted tissue sampling site T can be securely held inside the tube 54 without escaping to the outside of the tube 54. In addition, since the insertion path of the tube 54 at this time can be captured within the ultrasound observation field, the insertion operation can be performed safely and the tissue sampling site T can be reliably targeted.

[0076] Next, as shown in section 100c of Figure 8, as the tube 54 continues to protrude in the Y(+) direction, the puncture section 56 penetrates the biological tissue (e.g., tumor) at the tissue sampling site T, causing a portion of the biological tissue to enter the tube 54 through the slit 58. Then, as the tube 54 protrudes further in the Y(+) direction, the biological tissue that has entered the tube 54 is excised by the blade 60A of the tissue excision cutter 60, and the excised biological tissue is collected inside the tube 54. This ensures that a sufficient amount of biological tissue for pathological diagnosis is collected by the tube 54.

[0077] Furthermore, by applying suction to the above procedure, it becomes possible to obtain a larger amount of biological tissue. There are mainly two methods for applying suction. The first is to use a syringe 33. After 100b in Figure 8, if the stylet 36 is completely removed from the Luer lock portion 45 towards the proximal end, and then the syringe 33 is attached to the Luer lock portion 45, and the procedure is performed while maintaining negative pressure inside the tube 54 by operating the syringe 33, suction will be generated in the slit 58, further increasing the amount of biological tissue that enters the slit 58. Also, if the tube 54 is moved back and forth inside the biological tissue while suction is generated in the slit 58, the biological tissue will continuously enter the inside of the tube 54 through the slit 58, making it possible to efficiently collect a larger amount of biological tissue.

[0078] The second suction method involves using a stylet 36. By slowly withdrawing the stylet 36 towards the proximal end of the Luer lock portion 45 while performing step 100c in Figure 8, a slight negative pressure can be applied inside the tube 54. This also makes it possible to obtain a large amount of biological tissue.

[0079] After collecting biological tissue with the insertion section 31 of the tissue collection device 30 as described above, the insertion section 31 is withdrawn from the instrument insertion channel 21. In this case, for example, as shown in the 100d section of Figure 8, the tube 54 may be moved in the Y(-) direction to immerse the tip 55 of the tube 54 inside the sheath 34, and then the insertion section 31 may be withdrawn from the instrument insertion channel 21 in this state.

[0080] After withdrawing the insertion part 31 from the instrument insertion channel 21, a syringe for pumping, for example, physiological saline is connected to the Luer lock part 45 in place of the aspiration syringe 33, and physiological saline is pumped into the tube 54 from this syringe. This allows the collected biological tissue to be transferred to a test tube or the like. Alternatively, the stylet 36 can be reinserted through the Luer lock part 45 and extended to the tube tip opening 50 to push out and discharge the biological tissue inside the tube.

[0081] As described above, according to the embodiment, in a tube 54 having a puncture portion 56 and a slit 58, a tissue excision cutter 60 is provided at the proximal end 58C of the slit 58, so that a sufficient amount of biological tissue for pathological definitive diagnosis can be collected with a simple structure. Furthermore, with the above configuration, biological tissue can be collected by moving the tube 54 in the Y(+) direction (operation in the same direction as the puncture direction of the tube 54 to the biological tissue), so that biological tissue can be collected with a simple operation compared to the tissue collection device of Patent Document 1, which rotates the tube when collecting biological tissue.

[0082] Therefore, according to the embodiment, a sufficient amount of biological tissue for making a definitive pathological diagnosis can be collected with a simple structure and simple operation.

[0083] Furthermore, according to this embodiment, since the blade 60A of the tissue excision cutter 60 is formed on the inner circumferential surface 54A of the tube 54, the blade 60A does not pierce or get caught on the inner circumferential surface or tip body 12 of the sheath 34, and the tube 54 can be smoothly moved forward and backward inside the sheath 34.

[0084] In this embodiment, an example was described in which the blade 60A is formed on the inner circumferential surface 54A of the tube 54. However, the blade 60A may be formed, for example, between the inner circumferential surface 54A and the outer circumferential surface 54B, or on the same plane as the outer circumferential surface 54B. The blade 60A may also be formed in a position that protrudes from the outer circumferential surface 54B to the outside of the tube 54. However, from the viewpoint of preventing the above-mentioned piercing and snagging, it is preferable to form the blade 60A in a position that does not protrude from the outer circumferential surface 54B to the outside of the tube 54.

[0085] Furthermore, in this embodiment, the tissue excision cutter 60 is equipped with the inclined blade surface 60B described above, so that the biological tissue excised by the blade 60A can be reliably cut from the tissue collection site T by the inclined blade surface 60B.

[0086] Furthermore, in this embodiment, the puncture portion 56 has multiple blade tip points 62, 64, and 66, which facilitates insertion of the puncture portion 56 into the tissue sampling site T, and ensures that the inserted tissue sampling site T is securely held without slipping out of the tube 54. In this embodiment, three blade tip points 62, 64, and 66 are exemplified, but at least one blade tip point is sufficient. However, it is preferable to have multiple blade tip points from the viewpoint of insertion and holding described above.

[0087] Furthermore, in this embodiment, the blade tip 62, which is furthest from the slit 58 in the Y direction, and the slit 58 are positioned opposite each other in the radial direction (Z direction) of the tube 54. That is, the blade tip 62 is inserted sufficiently into the tissue sampling site T, and then the slit 58 is brought into contact with the tissue, thereby enabling the appropriate collection of tissue.

[0088] Furthermore, in this embodiment, a configuration is adopted in which cutting surfaces 68 and 70 are formed on the tip 55 of the tube 54. That is, a configuration is adopted in which the inner circumferential surface 54A of the tube 54 always contacts the biological tissue collection site T before the outer circumferential surface 54B of the tube 54, so that biological tissue can be collected appropriately.

[0089] Furthermore, as shown in Figure 3, it is preferable that the length L from the tip point 62 to the blade 60A of the tissue excision cutter 60 in the axial direction (Y direction) of the tube 54 is 0.5 mm or more and 25.0 mm or less. This ensures that the starting point for insertion is reliably formed by the tip point 62, and that the entire length of the slit 58 is easily inserted into the tissue collection site T during the procedure, thereby enabling the appropriate collection of tissue.

[0090] Furthermore, as shown in Figure 7, it is preferable that the width B of the slit 58 in the circumferential direction of the tube 54 is smaller than the inner diameter ID of the tube 54. This makes it difficult for the biological tissue taken into the tip portion 55 to escape to the outside of the tip portion 55, thus enabling proper collection of biological tissue.

[0091] Furthermore, as shown in Figure 7, the outer diameter (OD) of the tube 54 is preferably 0.3 mm or more and 3.0 mm or less. This allows the tube 54 to be easily inserted into the sheath 34 and minimizes the invasiveness to the patient.

[0092] Furthermore, as shown in Figure 7, the inner diameter ID of the tube 54 is preferably 0.1 mm or more and 2.5 mm or less. This allows a large amount of biological tissue to be taken into the tube 54 while maintaining the strength of the tube 54.

[0093] The biopsy needle and tissue sampling device according to the present invention have been described in detail above. However, the present invention is not limited to the above examples, and various improvements and modifications may be made without departing from the spirit of the invention. Some modified examples will be described below. In describing the following modified examples, members that are the same as or similar to the tube 54 shown in Figures 3 to 7 will be denoted by the same reference numerals.

[0094] [First Modified Example] In the first modified example shown in Figure 9, a blade tip point 60C is formed on the blade 60A of the tissue excision cutter 60. This blade tip point 60C is formed on the blade 60A in the central part of the circumferential direction of the tube 54 and is sharply formed toward the tip of the slit 58.

[0095] According to the first modification, the blade tip 60C functions as a cutting edge that forms the starting point for insertion of biological tissue that has entered the inside of the tube 54 through the slit 58, so that the biological tissue can be smoothly cut by the blade 60A that follows the blade tip 60C. In the tissue excision cutter 60 shown in Figure 9, two inclined blade surfaces 60B, 60B are arranged in series on both sides in the X-axis direction with the blade tip 60C in between, but it is sufficient to have at least one of these inclined blade surfaces 60B.

[0096] [Second Modified Example] In the second modified example shown in Figure 10, the blade tip point 62 is formed at the same position as the blade tip points 64 and 66 in the axial direction (Y direction) of the tube 54. The other configurations are the same as those of the tube 54 shown in Figures 6 to 8.

[0097] In the second modified example, the blade tips 62, 64, and 66 are simultaneously inserted into the tissue sampling site T. Similar to the tube 54 shown in Figures 6 to 8, the inserted tissue sampling site T can be securely held inside the tube 54 without being released to the outside of the tube 54. The position of the blade tip 62 is not limited to the above position; the blade tip 62 may be formed closer to the proximal end of the tube 54 than the blade tips 64 and 66, as long as it is possible to prevent the tissue sampling site T from being released to the outside of the tube 54.

[0098] [Third Modification] In the third modification shown in Figure 11, the width B1 of the slit 58 is formed to be larger than the width B shown in Figure 7. Furthermore, the above width B1 is formed to be smaller than the inner diameter ID of the tube 54 (see Figure 7).

[0099] According to the third modification, since the width B1 of the slit 58 is large, it becomes possible to allow more biological tissue to penetrate into the interior of the tip portion 55.

[0100] [Fourth Modification] In the fourth modification shown in Figure 12, the width B2 of the slit 58 is formed to be smaller than the width B shown in Figure 7. Furthermore, the above width B2 is formed to be smaller than the inner diameter ID of the tube 54 (see Figure 7).

[0101] According to the fourth modification, when the syringe 33 is operated, a greater suction force is generated in the slit 58 than that of the width B, making it possible to introduce a sufficient amount of biological tissue into the tip 55.

[0102] [Fifth Modification] In the fifth modification shown in Figure 13, of the three blade tip points 62, 64, and 66 shown in Figures 5 to 7, only the blade tip point 62, which is formed closest to the tip, is formed on the tip portion 55. As described above, this blade tip point 62 is positioned opposite the slit 58 in the radial direction of the tube 54.

[0103] According to the fifth modification, when the blade tip 62 is inserted into the tissue collection site T, the blade tip 62 can hold the tissue collection site T, and it becomes possible to allow the tissue to enter the interior of the tip 55 through the slit 58.

[0104] [Sixth Modification] In the sixth modification shown in Figure 14, two cutting edge points 72 and 74 are formed at the tip 55 of the tube 54. The cutting edge points 72 and 74 are each formed on the extension line in the Y(+) direction of the inner circumferential surface 54A of the tube 54. When the tube 54 is viewed from a direction perpendicular to the axial direction (Y direction) of the tube 54 (X direction), the cutting edge points 72 and 74 are formed at the same position in the axial direction (Y direction) of the tube 54. When the tube 54 is viewed from the axial direction (Y direction) of the tube 54, the cutting edge points 72 and 74 are arranged opposite each other in the radial direction (Z direction) of the tube 54, but are not arranged opposite to the slit 58, and are formed with a 90-degree phase difference in the circumferential direction.

[0105] According to the sixth modification, when the blade tips 72 and 74 are inserted into the tissue collection site T, the blade tips 72 and 74 can securely hold the tissue collection site T, and it becomes possible to insert the tissue into the tip portion 55 through the slit 58.

[0106] [Seventh Modification] The seventh modification shown in Figure 15 is another modification in which the tube 54 has a blade tip 67, and this blade tip 67 is not positioned opposite the slit 58 in the radial direction of the tube 54. Figure 15, 200a is a perspective view of the tube 54, 200b is a side view of the tube 54 viewed from the X(-) direction, and 200c is a top view of the tube 54 viewed from the Z(+) direction.

[0107] According to the seventh modification, the cutting edge point 67 is formed on the tip side of the tube 54 in the axial direction (Y direction) of the tube 54, relative to the slit 58. Furthermore, the cutting edge point 67 is formed on the tip side of the cutting edge point 66 in the X direction, relative to the cutting edge point 64, and is formed at a position extending from the cutting edge point 66 toward the tip side of the tube 54 in the axial direction (Y direction) of the tube 54. Moreover, the cutting edge point 67 is formed on the tip side of the tube 54, relative to the cutting edge points 66 and 68.

[0108] According to the seventh modification, the blade tip 67 is inserted into the tissue collection site T before the blade tips 64 and 66, but since a tissue excision cutter 60 is provided at the base end 58C of the slit 58, a sufficient amount of tissue for pathological diagnosis can be collected with a simple structure, similar to the tube 54 shown in Figure 5.

[0109] [Eighth Modification] In the eighth modification shown in Figure 16, the tissue excision cutter 60 has an inclined blade surface 60D that is inclined away from the central axis 54C of the tube 54 from the base end 58C of the slit 58 toward the tip of the slit 58. In addition, the blade 60A is formed in a position that protrudes outward from the outer peripheral surface 54B of the tube 54.

[0110] According to the eighth modification, the biological tissue that has entered the interior of the tip 55 through the slit 58 can be cut by the blade 60A of the tissue excision cutter 60 by the Y(+) movement of the tube 54 and collected inside the tip 55. In this case, the inclined blade surface 60D functions as a guide surface for pushing the excised biological tissue into the interior of the tip 55.

[0111] Next, several embodiments of the echo marker provided on the outer circumferential surface 54B of the tube 54 will be described. An echo marker is a marker that allows the position of the tube 54 to be visually indicated under an ultrasound image. By confirming this echo marker under an ultrasound image, the position of the tip 55 of the tube 54 can be visually confirmed. In describing the following embodiments, components that are the same as or similar to the tube 54 shown in Figures 3 to 7 will be denoted by the same reference numerals.

[0112] As shown in Figures 17 to 20, the echo marker 76 provided on the outer circumferential surface 54B of the tube 54 is constructed by densely forming multiple small-diameter recesses 78 on the outer circumferential surface 54B. This creates an uneven surface on the outer circumferential surface 54B, which enhances ultrasonic visibility, allowing the position of the tip 55 of the tube 54 to be confirmed under an ultrasonic image.

[0113] [First Embodiment] First, in the first embodiment shown in Figure 17, the echo marker 76 is provided only around the base end 58C of the slit 58.

[0114] According to the first embodiment, the position of the proximal end 58C of the slit 58 can be easily confirmed by confirming the position of the echo marker 76 under ultrasound imaging. This makes it easy to confirm whether or not the entire length of the slit 58 is inserted into the biological tissue, thus enabling a safe and reliable procedure.

[0115] [Second Embodiment] In the second embodiment shown in Figure 18, the echo marker 76 is provided in the region of the tube 54 on the tip side (Y(+) direction side), starting from the area around the base end 58C of the slit 58. Specifically, the echo marker 76 is provided over the entire outer surface 54B of the tube 54 from the above starting point to the blade tip point 62. Although not shown in Figure 18, the echo marker 76 is also formed on the Z(-) side surface of the blade tip point 62.

[0116] According to the second embodiment, the position of the tip portion 55, including the blade tip point 62, can be easily confirmed by confirming the position of the tip portion of the echo marker 76 under ultrasound imaging. Furthermore, the position of the proximal end portion of the echo marker 76 can be easily confirmed by confirming the position of the proximal end 58C of the slit 58. This makes it easy to confirm whether the entire length of the slit 58 is inserted into the biological tissue, thus enabling a safe and reliable procedure.

[0117] [Third Embodiment] In the third embodiment shown in Figure 19, the echo marker 76 is provided in the region of the tube 54 on the tip side (Y(+) direction side), starting from the area including the base end 58C of the slit 58. Specifically, the echo marker 76 is provided over the entire outer surface 54B of the tube 54 from the above starting point to the blade tip points 64, 66.

[0118] According to the third embodiment, the position of the tip portion 55, including the blade tip points 64 and 66, can be easily confirmed by confirming the position of the tip portion of the echo marker 76 under ultrasonic imaging, and the position of the base end 58C of the slit 58 can be confirmed by confirming the position of the base end portion of the echo marker 76, thus achieving the same effects as in the second embodiment.

[0119] [Fourth Embodiment] In the fourth embodiment shown in Figure 20, the echo marker 76 is provided in the region of the tube 54 on the proximal end side (Y(-) direction side), starting from the area including the proximal end 58C of the slit 58.

[0120] According to the fourth embodiment, the position of the base end 58C of the slit 58 can be confirmed by confirming the position of the tip portion of the echo marker 76, so the same effect as in the first embodiment can be obtained.

[0121] Each of the echo markers 76 shown in Figures 17 to 20 is configured to allow confirmation of the position of the proximal end 58C of the slit 58, in particular, to confirm whether the entire length of the slit 58 is embedded in biological tissue. Such echo markers 76 may also be provided in the tubes 54 of the various modifications shown in Figures 9 to 15.

[0122] 10 Insertion section 11 Angle section 12 Tip section body 12a Inclined section 12b Opening 13 Endoscope observation section 14 Ultrasonic observation section 15 Illumination mechanism 16 Ultrasonic transducer unit 17 Ultrasonic transducer 18 Treatment instrument outlet section 19 Connecting pipe 20 Flexible tube 21 Treatment instrument insertion channel 30 Tissue sampling device 31 Insertion section 32 Operation section 33 Syringe 34 Sheath 34A Tip opening 35 Biopsy needle 36 Stylet 39 Luer lock operation section 39A Luer lock section 40 Sheath position operation section 41 Tube position operation section 41A Tip surface 42 Stopper ring 43 Screw 44 Screw 45 Luer lock section 50 Tip opening 52 Proximal opening 54 Tube 54A Inner surface 54B Outer surface 54C Central axis 55 Tip 56 Puncture part 58 Slit 58A Wall 58B Wall 58C Base 58A Wall 60 Tissue excision cutter 60A Blade 60B Inclined blade surface 60C Blade tip point 60D Inclined blade surface 62 Blade tip point 64 Blade tip point 66 Blade tip point 67 Blade tip point 68 Blade surface 68A Blade 70 Blade surface 70A Blade 72 Blade tip point 74 Blade tip point 76 Echo marker 78 Recess

Claims

1. A biopsy needle to be inserted into an endoscopic forceps channel, comprising a hollow tube having a distal opening and a proximal opening, the distal opening and the proximal opening being in communication with each other, the tube having: a puncture section provided at the distal end of the tube and having at least one blade tip point; a slit extending from the distal opening toward the proximal opening; and a tissue excision cutter provided at the proximal end of the slit and tapering from the proximal end of the slit toward the distal end of the slit.

2. The biopsy needle according to claim 1, wherein the tissue resection cutter has at least one inclined cutting edge that is inclined from the base end of the slit toward the tip end of the slit so as to approach the central axis of the tube.

3. The biopsy needle according to claim 2, wherein a sharp blade is formed on the inclined blade surface, and the blade is formed at a position that does not protrude outside the tube from the outer circumferential surface of the tube.

4. The biopsy needle according to any one of claims 1 to 3, wherein when the tube is viewed in the axial direction of the tube, the at least one blade tip point and the slit are arranged opposite each other in the radial direction of the tube.

5. A biopsy needle according to any one of claims 1 to 4, wherein the at least one cutting edge tip point has a first cutting edge tip point formed on the distal end side of the tube relative to the slit in the axial direction of the tube.

6. A biopsy needle according to any one of claims 1 to 3, wherein the puncture section has a first blade tip point, a second blade tip point, and a third blade tip point, and when the tube is viewed from a direction perpendicular to the axial direction of the tube, the first blade tip point is formed closer to the tip of the tube than the second blade tip point and the third blade tip point, and when the tube is viewed from the axial direction of the tube, the first blade tip point is positioned opposite the slit in the radial direction of the tube, and the second blade tip point and the third blade tip point are positioned opposite each other with the slit between them.

7. A biopsy needle according to claim 6, wherein the tip of the tube comprises: a first blade surface connecting the outer circumferential surface of the tube with the first blade tip point and the second blade tip point, the first blade surface having a normal including a component directed radially outward from the tube and a component directed toward the tip of the tube; and a second blade surface connecting the outer circumferential surface of the tube with the first blade tip point and the third blade tip point, the second blade surface having a normal including a component directed radially outward from the tube and a component directed toward the tip of the tube.

8. A biopsy needle according to any one of claims 1 to 7, wherein the at least one cutting edge point is formed on the inner circumferential surface of the tube.

9. The biopsy needle according to claim 6 or 7, wherein the length from the tip of the first blade to the tip of the tissue excision cutter in the axial direction of the tube is 0.5 mm or more and 25.0 mm or less.

10. A biopsy needle according to any one of claims 1 to 9, wherein the width of the slit in the circumferential direction of the tube is smaller than the inner diameter of the tube.

11. The biopsy needle according to any one of claims 1 to 10, wherein the outer diameter of the tube is 0.3 mm or more and 3.0 mm or less.

12. The biopsy needle according to any one of claims 1 to 11, wherein the inner diameter of the tube is 0.1 mm or more and 2.5 mm or less.

13. A biopsy needle according to any one of claims 1 to 12, wherein the outer surface of the tube is provided with an echo marker that can visually indicate the position of the tube under an ultrasound image.

14. The biopsy needle according to claim 13, wherein the echo marker is provided only around the periphery including the base end of the slit.

15. The biopsy needle according to claim 13, wherein the echo marker is provided in a region on the distal end side of the tube, starting from a periphery including the base end of the slit.

16. The biopsy needle according to claim 13, wherein the echo marker is provided in a region on the proximal side of the tube, starting from a periphery including the proximal end of the slit.

17. A biopsy needle according to any one of claims 13 to 16, wherein the echo marker is configured in an uneven shape.

18. A biopsy needle according to any one of claims 1 to 17, wherein the tube is made of stainless steel, nickel-titanium alloy, nickel-chromium alloy, or cobalt-chromium alloy.

19. A tissue sampling device comprising: a biopsy needle according to any one of claims 1 to 18; and a suction member that communicates with the base end opening of the biopsy needle and creates a negative pressure inside the biopsy needle.

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