Endoscopic puncture needle
By designing needle tips with specific angles and shapes, the puncture and recyclability of the puncture needle for endoscopy is enhanced, and the problem of difficult tissue recycling in the prior art is solved, achieving efficient tissue recovery effect.
Patent Information
- Application Number
- CN202080034272.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2019-05-17
- Filing Date
- 2020-05-15
- Publication Date
- 2025-08-08
- Estimated Expiration
- 2040-05-15
AI Technical Summary
It is difficult to efficiently recover tissue into the needle after the body tissue is cut off with an existing endoscopic puncture needle, and the puncture and recovery are insufficient.
A puncture needle for an endoscope is designed, with a needle tip of a specific angle and shape, including a first needle tip and a second needle tip. The blade surface is in communication with the inner space of the tubular part, and the blade surface normal is facing closer to the other blade surface than the orthogonal direction of the needle tip line, enhancing puncture and recyclability.
The puncture properties and tissue recovery efficiency of the puncture needle in the body tissue are improved, and the cut body tissue is easily recycled into the inside of the puncture needle.
Smart Images

Figure CN113795201B_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to an endoscope puncture needle. This application claims priority based on PCT application No. PCT / JP2019 / 019665 filed on May 17, 2019, the contents of which are incorporated herein by reference. Background Art
[0002] A biopsy is a well-known examination method that involves extracting a small amount of body tissue and observing it under a microscope. When extracting tissue from deep within organs, such as internal organs, observation using an optical endoscope is difficult. Therefore, endoscopic ultrasonography-assisted puncture and aspiration (EUS-FNA) is used. This involves obtaining an ultrasonic cross-sectional image of the organ using an ultrasound endoscope, inserting a tubular needle into the organ under ultrasonic observation, and extracting the tissue. EUS-FNA requires a needle that can extract a large amount of body tissue.
[0003] Patent Document 1 describes an endoscopic puncture needle device that takes in a tissue block and cuts it off from surrounding tissue. The puncture needle described in Patent Document 1, which has two sharp tips, can efficiently cut into body tissue.
[0004] Prior art literature
[0005] Patent Literature
[0006] Patent Document 1: Japanese Patent Application Laid-Open No. 2005-073798 Summary of the Invention
[0007] Problems to be solved by the invention
[0008] However, the puncture needle having two sharp tips described in Patent Document 1 can efficiently penetrate into body tissue, but does not exhibit a sufficient effect in recovering the cut body tissue into the interior of the puncture needle.
[0009] In view of the above circumstances, an object of the present invention is to provide an endoscope puncture needle having high punctureability into body tissue (the puncture needle easily penetrates into the body tissue) and easy recovery of the cut body tissue into the interior of the puncture needle.
[0010] Solutions for solving problems
[0011] In order to solve the above problems, the present invention proposes the following solutions.
[0012] The puncture needle for an endoscope of the first technical solution of the present invention includes: a tubular tubular portion; a first needle tip portion, which is arranged at the top end of the tubular portion, and has a first needle tip at the top end of the first needle tip portion; and a second needle tip portion, which is arranged at the top end of the tubular portion, and has a second needle tip at the top end of the second needle tip portion, the first needle tip portion has a first blade surface and a second blade surface extending toward the first needle tip, the second needle tip portion has a third blade surface and a fourth blade surface extending toward the second needle tip, the first blade surface, the second blade surface, the third blade surface and the fourth blade surface forming the edge of an opening connected to the internal space of the tubular portion, the first needle tip portion and the second needle tip portion include: a top area, which includes the first needle tip and the second needle tip ; the base end area of the first needle tip portion and the base end area of the second needle tip portion; and an intermediate area, which is located between the top end area and the base end area, in the main view observed from the direction along the axial direction of the tubular portion, the normal vector of the first blade surface in the top end area and the normal vector of the third blade surface are directed toward each other from one of the blade surfaces to the other blade surface compared with the direction perpendicular to the straight line passing through the first needle tip and the second needle tip, and in the main view, the normal vector of the second blade surface in the top end area and the normal vector of the fourth blade surface are directed toward each other from one of the blade surfaces to the other blade surface compared with the direction perpendicular to the straight line passing through the first needle tip and the second needle tip.
[0013] Effects of the Invention
[0014] The endoscopic puncture needle of the present invention can provide an endoscopic puncture needle having high punctureability into body tissue (the puncture needle easily penetrates into the body tissue) and easy recovery of the cut body tissue into the interior of the puncture needle. BRIEF DESCRIPTION OF THE DRAWINGS
[0015] Figure 1 This is an overall view of a biopsy system including the endoscopic puncture needle according to the first embodiment.
[0016] Figure 2 This is a perspective view of the endoscopic puncture needle according to the first embodiment.
[0017] Figure 3 This is a longitudinal sectional view showing a section along the longitudinal axis of the endoscopic puncture needle of the first embodiment, showing a distal end portion of the endoscopic puncture needle.
[0018] Figure 4 This is a perspective view of a needle tube included in the endoscopic puncture needle according to the first embodiment.
[0019] Figure 5 It is a side view of the needle tube of the first embodiment.
[0020] Figure 6 This is a front view of the needle tube of the first embodiment as viewed from the distal end in the axial direction, in which cross sections are arranged at equal intervals in the longitudinal axis direction and schematically illustrates changes in the orientation of the cross sections of each blade surface.
[0021] Figure 7 yes Figure 5 This is a cross-sectional view of the needle tube according to the first embodiment, taken along the XX section.
[0022] Figure 8 yes Figure 5 This is a cross-sectional view of the needle tube according to the first embodiment, taken along the YY cross section.
[0023] Figure 9 It is a diagram for explaining the operation of the endoscopic puncture needle according to the first embodiment.
[0024] Figure 10 This is a diagram showing the target tissue when the needle slider is advanced toward the distal end side of the operation portion.
[0025] Figure 11 This is a perspective view of a modified example of the endoscopic puncture needle of the first embodiment.
[0026] Figure 12 This is a perspective view of a modified example of the endoscopic puncture needle of the first embodiment.
[0027] Figure 13 This is a perspective view of a needle tube included in an endoscope puncture needle according to a second embodiment.
[0028] Figure 14 It is a side view of the needle tube of the second embodiment.
[0029] Figure 15 This is a front view of the needle tube of the second embodiment as viewed from the distal end in the axial direction, in which cross sections are arranged at equal intervals in the longitudinal axis direction and schematically illustrates changes in the orientation of the cross sections of each blade surface.
[0030] Figure 16 yes Figure 14 This is a cross-sectional view of the needle tube according to the second embodiment, taken along the XX section.
[0031] Figure 17 yes Figure 14 This is a cross-sectional view of the needle tube according to the second embodiment, taken along the YY cross section.
[0032] Figure 18 This is a perspective view of a needle tube included in an endoscope puncture needle according to a third embodiment.
[0033] Figure 19 It is a side view of the needle tube of the third embodiment.
[0034] Figure 20 The needle tube of the third embodiment is Figure 19 Cross-sectional view along the central axis viewed from the same direction.
[0035] Figure 21 This is a front view of the needle tube of the third embodiment as viewed from the distal end in the axial direction, in which cross sections are arranged at equal intervals in the longitudinal axis direction to schematically illustrate changes in the orientation of the cross sections of each blade face.
[0036] Figure 22 This is a plan view of the needle tube of the third embodiment as seen from a radial direction and in a direction parallel to the straight line V.
[0037] Figure 23 It is from Figure 22 Cross-sectional view along the central axis viewed from the same direction.
[0038] Figure 24 yes Figure 19 This is a cross-sectional view of the needle tube according to the third embodiment, taken along the ZZ cross section.
[0039] Figure 25 It is a perspective view showing a modified example of the sixth blade surface of the needle tube according to the third embodiment.
[0040] Figure 26 This is a perspective view of a needle tube included in an endoscope puncture needle according to a fourth embodiment.
[0041] Figure 27 It is a side view of the needle tube of the fourth embodiment.
[0042] Figure 28 The needle tube of the fourth embodiment is Figure 27 Cross-sectional view along the central axis viewed from the same direction.
[0043] Figure 29 This is a front view of the needle tube of the fourth embodiment as viewed from the distal end in the axial direction, in which cross sections are arranged at equal intervals in the longitudinal axis direction to schematically illustrate changes in the orientation of the cross sections of each blade face.
[0044] Figure 30 yes Figure 27 The cross-sectional view of the needle tube of the fourth embodiment along the line BB is Figure 29 An enlarged cross-sectional view of region S is shown.
[0045] Figure 31 This is a plan view of the needle tube of the fourth embodiment as seen from a radial direction and in a direction horizontal to the straight line V.
[0046] Figure 32It is from Figure 31 Cross-sectional view along the central axis viewed from the same direction.
[0047] Figure 33 yes Figure 27 A cross-sectional view of the needle tube according to the fourth embodiment is shown along the line AA.
[0048] Figure 34 yes Figure 27 A cross-sectional view taken along line BB of the needle tube according to the fourth embodiment is shown.
[0049] Figure 35 yes Figure 27 A cross-sectional view taken along line CC of the needle tube according to the fourth embodiment is shown.
[0050] Figure 36 It is aimed at Figure 29 The cross section perpendicular to the axial direction A is shown in the figure, in which the normal lines of the main first blade surface and the blade surface are indicated by arrows.
[0051] Figure 37 It is a perspective view of a needle tube included in an endoscope puncture needle according to a fifth embodiment.
[0052] Figure 38 It is a front view of the needle tube of the fifth embodiment.
[0053] Figure 39 It is a side view of the needle tube of the fifth embodiment.
[0054] Figure 40 The needle tube of the fifth embodiment is Figure 39 Cross-sectional view along the central axis viewed from the same direction.
[0055] Figure 41 This is a front view of the needle tube of the fifth embodiment as viewed from the distal end in the axial direction, in which cross sections are arranged at equal intervals in the longitudinal axis direction and schematically illustrates changes in the orientation of the cross sections of each blade face.
[0056] Figure 42 This is a plan view viewed from a direction horizontal to the straight line V.
[0057] Figure 43 It is from Figure 42 Cross-sectional view along the central axis viewed from the same direction.
[0058] Figure 44 yes Figure 39 A cross-sectional view taken along line DD of the needle tube according to the fifth embodiment is shown.
[0059] Figure 45 yes Figure 39A cross-sectional view taken along line EE of the needle tube according to the fifth embodiment is shown.
[0060] Figure 46 yes Figure 39 A cross-sectional view taken along line FF of the needle tube according to the fifth embodiment is shown.
[0061] Figure 47 yes Figure 39 A cross-sectional view taken along line GG of the needle tube according to the fifth embodiment is shown.
[0062] Figure 48 It is aimed at Figure 41 The cross section perpendicular to the axial direction is shown in the figure, in which the normal lines of the first blade surface and the like are indicated by arrows. DETAILED DESCRIPTION
[0063] (First embodiment)
[0064] Reference Figures 1 to 10 A biopsy system 150 including the endoscopic puncture needle 1 according to the first embodiment of the present invention will be described. Figure 1 This is an overall view of a biopsy system 150 including the endoscopic puncture needle 1 according to this embodiment.
[0065] [Biopsy system 150]
[0066] like Figure 1 As shown, the biopsy system 150 is a medical device used to extract body tissue required for biopsy. The biopsy system 150 includes an ultrasonic endoscope 100 and an endoscope puncture needle 1 (hereinafter referred to as "puncture needle 1").
[0067] [Ultrasonic endoscope 100]
[0068] like Figure 1 As shown, the ultrasonic endoscope 100 includes an insertion portion 101 inserted into the body from the top end, an operating portion 109 installed at the base end of the insertion portion 101, a universal cable 112 having one end connected to the side of the operating portion 109, a light source device 113 connected to the other end of the universal cable 112 by means of a branch cable 112a, an optical observation portion 114 connected to the other end of the universal cable 112 by means of a branch cable 112b, and an ultrasonic observation portion 115 connected to the other end of the universal cable 112 by means of a branch cable 112c.
[0069] The insertion portion 101 is provided with a distal hard portion 102 , an active bending portion 105 , and a flexible tube portion 106 in this order from the distal end side.
[0070] The distal rigid portion 102 includes an optical imaging mechanism 103 for optical observation and an ultrasonic scanning mechanism 104 for ultrasonic observation.
[0071] The optical imaging mechanism 103 includes an imaging optical system with a field of view facing obliquely forward of the distal rigid portion 102 , an image sensor such as a CCD or CMOS for detecting an image of a subject incident through the imaging optical system, and a CPU for controlling the operation of the image sensor.
[0072] The ultrasonic scanning mechanism 104 includes an ultrasonic transducer (not shown) for emitting and receiving ultrasonic waves. The ultrasonic transducer receives reflected waves generated by the ultrasonic transducer and reflected from the observation object, and outputs signals based on the received ultrasonic waves to the ultrasonic observation unit 115.
[0073] The active bending section 105 is a cylindrical member formed by connecting multiple joints arranged along the centerline of the insertion section 101. The active bending section 105 is bent in a predetermined direction by pulling an angle manipulation wire (not shown) through the manipulation section 109. The angle manipulation wire is fixed to the distal end of the active bending section 105 and extends to the manipulation section 109. The active bending section 105 of this embodiment is bendable in two directions along the scanning direction of ultrasound.
[0074] The flexible tubular portion 106 is a flexible cylindrical member formed to guide the distal rigid portion 102 to a desired position within the luminal tissue or body cavity. A channel 107 and a conduit (not shown) for air, water, and suction are provided within each of the active bending portion 105 and the flexible tubular portion 106.
[0075] like Figure 1 As shown, the channel 107 is a cylindrical portion through which the puncture needle 1 can pass. The distal end of the channel 107 opens at the distal end of the distal hard portion 102 , and the proximal end of the channel 107 opens at the side surface of the distal end side of the operating portion 109 .
[0076] like Figure 1 As shown, the operating unit 109 has an outer surface that is configured to be held by a surgeon using the ultrasonic endoscope 100. The operating unit 109 includes a bending operating mechanism 110 for bending the active bending portion 105 by pulling the angle operating wire or for moving the lifting platform 108 by pulling the lifting wire, and a plurality of switches 111 for supplying air, water, or suction via the tube.
[0077] The light source device 113 is a device for emitting illumination light for imaging by the optical imaging mechanism 103 .
[0078] The optical observation unit 114 is configured to project the image captured by the image sensor of the optical imaging mechanism 103 on the monitor 116 .
[0079] The ultrasonic observation unit 115 receives a signal output from the ultrasonic scanning mechanism 104 , generates an image based on the signal, and displays the image on the monitor 116 .
[0080] [Puncture needle 1]
[0081] Figure 2 It is a perspective view of the puncture needle 1. Figure 3 This is a longitudinal sectional view showing a section of the distal end portion of the puncture needle 1 along the longitudinal axis of the puncture needle 1 .
[0082] like Figure 2 As shown, the puncture needle 1 includes an insertion body 2 , an operating portion 8 , and a stylet 27 .
[0083] [Insert 2]
[0084] The insertion body 2 is an elongated member that can be inserted into the channel 107 of the ultrasonic endoscope 100. Figure 2 and Figure 3 As shown, the insertion body 2 includes a needle tube 3 and a sheath 7 .
[0085] Figure 4 It is a perspective view of the needle tube 3. Figure 5 It is a side view of the needle tube 3. Figure 6 This is a front view of the needle tube 3 as seen from the distal end in the axial direction A, in which cross sections are arranged at equal intervals in the longitudinal axis direction to schematically illustrate changes in the orientation of the cross sections of each blade face. Figure 6 The dashed lines shown indicate intersections of the first blade face 33 , the second blade face 34 , the third blade face 35 and the fourth blade face 36 with cross sections perpendicular to the axial direction A arranged at equal intervals in the axial direction A. Figure 7 It is needle 3 Figure 5 The sectional view of the X-X section is shown. Figure 8 It is needle 3 Figure 5 The cross-sectional view of the YY section is shown.
[0086] like Figure 4 As shown, the needle tube 3 includes a tubular portion 30, and a first needle tip portion 31 and a second needle tip portion 32 provided at the top of the tubular portion 30. The needle tube 3 can be moved forward and backward within the sheath 7 using an operating portion 8. An opening 4 is formed at the top of the needle tube 3. This opening 4 serves as an entrance for tissue pierced by the first needle tip portion 31 and the second needle tip portion 32 to enter the interior of the needle tube 3. The first needle tip portion 31 and the second needle tip portion 32 of the needle tube 3 can be extended or retracted relative to the opening at the top of the sheath 7.
[0087] The needle tube 3 is preferably made of a material that is flexible and has elasticity that allows it to easily return to a straight state even if bent by an external force. For example, alloy materials such as stainless steel alloy, nickel-titanium alloy, and cobalt-chromium alloy can be used as the material of the needle tube 3.
[0088] like Figures 4 to 6 As shown, the first needle tip portion 31 has a first blade surface 33 and a second blade surface 34, and the first blade surface 33 and the second blade surface 34 extend toward the sharp first needle tip 31a. Figure 6 As shown, the first blade surface 33 and the second blade surface 34 are symmetrical with respect to the straight line V passing through the first needle tip 31a and the second needle tip 32a. In addition, the first blade surface 33 and the second blade surface 34 may be flat or slightly curved.
[0089] The outer circumferential surface 31e of the first needle tip portion 31 is a curved surface that is continuous with the outer circumferential surface 30e of the tubular portion 30, and has the same diameter and curvature. Furthermore, the inner circumferential surface 31i of the first needle tip portion 31 is a curved surface that is continuous with the inner circumferential surface 30i of the tubular portion 30, and has the same diameter and curvature. The first blade surface 33 and the second blade surface 34 of the first needle tip portion 31 are formed by, for example, cutting away a portion of the tubular portion 30.
[0090] like Figures 4 to 6 As shown, the second needle tip portion 32 has a third blade surface 35 and a fourth blade surface 36, and the third blade surface 35 and the fourth blade surface 36 extend toward the sharp second needle tip 32a. The first needle tip 31a and the second needle tip 32a are arranged at positions symmetrical with respect to the central axis O extending along the axial direction A of the needle tube 3. In the front view viewed from the direction along the axial direction A of the needle tube 3, as shown in FIG. Figure 6 As shown, the third blade surface 35 and the fourth blade surface 36 are symmetrical with respect to the straight line V passing through the first needle tip 31a and the second needle tip 32a. In addition, the third blade surface 35 and the fourth blade surface 36 may be flat or slightly curved.
[0091] The outer circumferential surface 32e of the second needle tip portion 32 is a curved surface that is continuous with the outer circumferential surface 30e of the tubular portion 30, and has the same diameter and curvature. Furthermore, the inner circumferential surface 32i of the second needle tip portion 32 is a curved surface that is continuous with the inner circumferential surface 30i of the tubular portion 30, and has the same diameter and curvature. The third and fourth blade surfaces 35, 36 are formed in the second needle tip portion 32 by, for example, cutting away a portion of the tubular portion 30.
[0092] like Figure 4 and Figure 5As shown, the first needle tip portion 31 and the second needle tip portion 32 form an opening 4 surrounded by a first blade surface 33, a second blade surface 34, a third blade surface 35, and a fourth blade surface 36. The opening 4 communicates with the inner space of the tubular portion 30.
[0093] like Figures 4 to 6 As shown, the first blade surface 33 and the third blade surface 35 are connected at a first base end 38 of the edge of the opening 4. The second blade surface 34 and the fourth blade surface 36 are connected at a second base end 39 of the edge of the opening 4.
[0094] In the first needle tip portion 31 and the second needle tip portion 32, as shown in FIG. Figure 5 As shown, a top region Z1 including the first needle tip 31a and the second needle tip 32a, a base region Z3 including the first base end 38 and the second base end 39, and an intermediate region Z2 located between the top region Z1 and the base region Z3 and connected to the top region Z1 and the base region Z3 are defined.
[0095] (First blade surface 33 and second blade surface 34 of the first needle tip portion 31)
[0096] like Figure 4 and Figure 7 As shown, the intersection line (first inner intersection line 33c) of the first blade surface 33 and the inner peripheral surface 31i of the first needle tip portion 31 defines a portion of the outline of the opening 4. The intersection line (second inner intersection line 34c) of the second blade surface 34 and the inner peripheral surface 31i of the first needle tip portion 31 defines a portion of the outline of the opening 4.
[0097] like Figure 7 As shown, in the front view as viewed from the direction along the axial direction A of the needle tube 3 (tubular portion 30), the normal vector 33n of the first blade face 33 in the tip region Z1 is directed toward the third blade face 35 in the tip region Z1, compared to the direction perpendicular to the straight line V passing through the first needle tip 31a and the second needle tip 32a. Similarly, in the front view, the normal vector 34n of the second blade face 34 in the tip region Z1 is directed toward the fourth blade face 36 in the tip region Z1, compared to the direction perpendicular to the straight line V passing through the first needle tip 31a and the second needle tip 32a.
[0098] And, as Figure 8 As shown, the normal vector 33n of the first blade face 33 in the middle region Z2 is also directed toward the third blade face 35 in the middle region Z2 compared to the direction perpendicular to the straight line V, as in the top region Z1. Furthermore, the normal vector 34n of the second blade face 34 in the middle region Z2 is also directed toward the fourth blade face 36 in the middle region Z2 compared to the direction perpendicular to the straight line V, as in the top region Z1.
[0099] Preferably, if Figure 8As shown, the normal vector 33n of the first blade surface 33 in the intermediate region Z2 is oriented in a direction forming an acute angle with the straight line V connecting the first needle tip 31a and the second needle tip 32a. In addition, the normal vector 34n of the second blade surface 34 in the intermediate region Z2 is oriented in a direction forming an acute angle with the straight line V connecting the first needle tip 31a and the second needle tip 32a.
[0100] Preferably, if Figure 6 and Figure 7 As shown, the normal vector 33 n of the first blade surface 33 and the normal vector 34 n of the second blade surface 34 are oriented in the tip region Z1 toward a direction closer to the central axis O than the circumferential direction C of the tubular portion 30 .
[0101] like Figure 5 As shown, the intersection line of the first blade surface 33 and the second blade surface 34 (first tip intersection line 31b) extends from the tip of the inner peripheral surface 31i of the first needle tip portion 31 to the first needle tip 31a. In addition, it is preferable that the first tip intersection line 31b is located on the straight line V in the front view seen from the direction along the axial direction A of the needle tube 3.
[0102] The intersection line (first outer intersection line 33b) where the first blade surface 33 intersects the outer peripheral surface 31e is a first outer edge 33b having an edge in the circumferential direction of the tubular portion 30. Figures 6 to 8 As shown, in the main view observed from the direction along the axial direction A of the needle tube 3, the angle θ1 formed by the first blade surface 33 at the first outer edge 33b and the outer peripheral surface 31e is an acute angle in the top area Z1, and the closer to the middle area Z2, the larger the angle θ1 is, forming an obtuse angle in the middle area Z2.
[0103] The intersection line (first inner intersection line 33c) where the first blade surface 33 intersects the inner peripheral surface 31i is a first inner edge 33c having an edge in the circumferential direction of the tubular portion 30. Figure 7 and Figure 8 As shown, in the front view along the axial direction A of the needle tube 3, the angle θ2 formed by the first blade surface 33 at the first inner edge 33c and the inner peripheral surface 31i is an obtuse angle in the top area Z1 and an acute angle in the middle area Z2.
[0104] The intersection line (second outer intersection line 34b) where the second blade surface 34 intersects the outer peripheral surface 31e is a second outer edge 34b having an edge in the circumferential direction of the tubular portion 30. Figure 7 and Figure 8 As shown, in the main view observed from the direction along the axis of the needle tube 3, the angle θ3 formed by the second blade surface 34 at the second outer edge 34b and the outer peripheral surface 31e is an acute angle in the top area Z1, and the closer to the middle area Z2, the larger the angle θ3 is, forming an obtuse angle in the middle area Z2.
[0105] The intersection line (second inner intersection line 34c) where the second blade surface 34 intersects the inner peripheral surface 31i is a second inner edge 34c having an edge in the circumferential direction of the tubular portion 30. Figure 7 and Figure 8 As shown, in the front view along the axial direction A of the needle tube 3, the angle θ4 formed by the second blade surface 34 at the second inner edge 34c and the inner peripheral surface 31i is an obtuse angle in the distal region Z1 and an acute angle in the intermediate region Z2.
[0106] (Third cutting edge surface 35 and fourth cutting edge surface 36 of second needle tip portion 32)
[0107] like Figure 4 and Figure 7 As shown, the intersection line (third inner intersection line 35c) of the third blade surface 35 and the inner peripheral surface 32i of the second needle tip portion 32 defines a portion of the outline of the opening 4. The intersection line (fourth inner intersection line 36c) of the fourth blade surface 36 and the inner peripheral surface 32i of the second needle tip portion 32 defines a portion of the outline of the opening 4.
[0108] like Figure 7 As shown, in the front view as viewed from the direction along the axial direction A of the needle tube 3, the normal vector 35n of the third blade surface 35 in the tip region Z1 is directed toward the first blade surface 33 in the tip region Z1, compared to the direction perpendicular to the straight line V passing through the first needle tip 31a and the second needle tip 32a. Similarly, in this front view, the normal vector 36n of the fourth blade surface 36 in the tip region Z1 is directed toward the second blade surface 34 in the tip region Z1, compared to the direction perpendicular to the straight line V passing through the first needle tip 31a and the second needle tip 32a.
[0109] And, as Figure 8 As shown, the normal vector 35n of the third blade face 35 in the middle region Z2 is also directed toward the first blade face 33 in the middle region Z2 compared to the direction perpendicular to the straight line V, as in the top region Z1. Furthermore, the normal vector 36n of the fourth blade face 36 in the middle region Z2 is also directed toward the second blade face 34 in the middle region Z2 compared to the direction perpendicular to the straight line V, as in the top region Z1.
[0110] Preferably, if Figures 6 to 8 As shown, the normal vector 35n of the third blade face 35 in the middle region Z2 is oriented in a direction forming an acute angle with the straight line V connecting the first needle tip 31a and the second needle tip 32a. In addition, the normal vector 36n of the fourth blade face 36 in the middle region Z2 is oriented in a direction forming an acute angle with the straight line V connecting the first needle tip 31a and the second needle tip 32a.
[0111] Preferably, if Figure 6 and Figure 7As shown, the normal vector 35 n of the third blade face 35 and the normal vector 36 n of the fourth blade face 36 are oriented in the tip region Z1 toward a direction closer to the central axis O than the circumferential direction C of the tubular portion 30 .
[0112] like Figure 5 As shown, the intersection line of the third blade surface 35 and the fourth blade surface 36 (second tip intersection line 32b) extends from the tip of the inner peripheral surface 32i of the second needle tip portion 32 to the second needle tip 32a. In addition, it is preferable that the second tip intersection line 32b is located on the straight line V in the front view seen from the direction along the axial direction A of the needle tube 3.
[0113] The intersection line (third outer intersection line 35b) where the third blade surface 35 intersects the outer peripheral surface 32e is a third outer edge 35b having an edge in the circumferential direction of the tubular portion 30. Figures 6 to 8 As shown, in the main view observed from the direction along the axial direction A of the needle tube 3, the angle θ5 formed by the third blade surface 35 at the third outer edge 35b and the outer peripheral surface 32e is an acute angle in the top area Z1, and the closer to the middle area Z2, the larger the angle θ5 is, forming an obtuse angle in the middle area Z2.
[0114] The intersection line (third inner intersection line 35c) where the third blade surface 35 intersects the inner peripheral surface 32i is a third inner edge 35c having an edge in the circumferential direction of the tubular portion 30. Figure 7 and Figure 8 As shown, in the front view along the axial direction A of the needle tube 3, the angle θ6 formed by the third blade surface 35 at the third inner edge 35c and the inner peripheral surface 32i is an obtuse angle in the top area Z1 and an acute angle in the middle area Z2.
[0115] The intersection line (fourth outer intersection line 36b) where the fourth blade surface 36 intersects the outer peripheral surface 32e is a fourth outer edge 36b having an edge in the circumferential direction of the tubular portion 30. Figure 7 and Figure 8 As shown, in the main view observed from the direction along the axis of the needle tube 3, the angle θ7 formed by the fourth blade surface 36 at the fourth outer edge 36b and the outer peripheral surface 32e is an acute angle in the top area Z1, and the closer to the middle area Z2, the larger the angle θ7 is, forming an obtuse angle in the middle area Z2.
[0116] The intersection line (fourth inner intersection line 36c) where the fourth blade surface 36 intersects the inner peripheral surface 32i is a fourth inner edge 36c having an edge in the circumferential direction of the tubular portion 30. Figure 7 and Figure 8 As shown, in the front view along the axial direction A of the needle tube 3, the angle θ8 formed by the fourth blade surface 36 at the fourth inner edge 36c and the inner peripheral surface 32i is an obtuse angle in the top area Z1 and an acute angle in the middle area Z2.
[0117] like Figure 3 As shown, the sheath 7 preferably includes an outer sheath 71 and an inner sheath 74 .
[0118] The outer sheath 71 includes a coil body 72 formed by winding a metal wire into a coil shape with the longitudinal axis as the central axis, and a cylindrical distal end chip 73 fixed to the distal end of the coil body 72 .
[0119] The coil body 72 has a top end and a base end, and has an outer diameter between the top and base ends that allows insertion into the channel 107 and an inner space 72a extending along the longitudinal axis. The wire material constituting the coil body 72 can be selected from stainless steel, shape memory alloy, superelastic alloy, etc., and the shape can be selected from circular cross-section, rectangular cross-section, etc., with an eye on the bendability and restoring force of the coil body 72.
[0120] The distal tip 73 is a cylindrical member that is fixed to the distal end surface of the coil body 72 and has a through hole formed therein through which the needle tube 3 can pass.
[0121] The inner sheath 74 is a cylindrical member made of resin, for example, having a top end 74a and a base end. The inner sheath 74 is positioned approximately coaxially with the central axis of the coil body 72 within the internal space 72a of the coil body 72. Furthermore, the inner sheath 74 has an inner circumferential surface 74c and an outer circumferential surface 74d. The inner circumferential surface 74c forms a through-path for insertion of the needle tube 3, while the outer circumferential surface 74d is positioned within the internal space 72a of the coil body 72, between the top end 74a and the base end of the inner sheath 74, so as to span between adjacent wires of the coil body 72. The outer circumferential surface 74d covers the gap between the top end 74a and the base end of the inner sheath 74 from the inside of the coil body 72, which occurs when the coil body 72 bends. Therefore, the inner sheath 74 functions as a cover for the coil body 72. The top end 74a of the inner sheath 74 is fixed to the top end tip 73. The base end of the inner sheath 74 extends to the operating portion 109.
[0122] The inner sheath 74 is slidable relative to the outer sheath 71 at a position on the side of the fixed portion between the distal end 74 a of the inner sheath 74 and the distal end head 73 in the entire length of the inner sheath 74 .
[0123] The sheath 7 has a double-layer structure of a coil-shaped outer sheath 71 and a resin-made inner sheath 74 , but may be composed of only one of them.
[0124] [Operation unit 8]
[0125] like Figure 2 As shown, the operating portion 8 includes an operating body 9 provided at the proximal end of the sheath 7 , a mounting adapter 18 connected to the operating body 9 , and a needle slider 23 connected to the proximal end of the needle tube 3 on the proximal end side of the operating body 9 .
[0126] The operating body 9 has a lumen through which the needle tube 3 and sheath 7 can pass. A mounting adapter 18 is attached to the distal end of the operating body 9. The proximal end of the operating body 9 is inserted into a tubular needle slider 23. The operating body 9 and mounting adapter 18, as well as the operating body 9 and needle slider 23, engage with each other via grooves or protrusions (not shown) formed on their outer circumferential surfaces, thereby enabling axial sliding while preventing relative rotation about the axis.
[0127] The needle slider 23 is movable from a first position in which it is locked relative to the operating body 9 to a second position in which it abuts against a stopper 61, which abuts against the enlarged portion of the operating body 9. While the operator is moving the needle slider 23 between the first and second positions, the distal end of the needle tube 3 is configured to be able to protrude or retract relative to the distal end of the sheath 7.
[0128] The mounting adapter 18 is connected to the operating body 9 so as to be movable relative to the operating body 9, thereby adjusting the amount by which the sheath 7 protrudes from the distal end of the channel 107 of the ultrasonic endoscope 100. The distal end portion of the mounting adapter 18 is attachable to and detachable from the proximal end sleeve 107b of the ultrasonic endoscope 100.
[0129] The needle slider 23 is fixed to the base end of the needle tube 3. Furthermore, the needle slider 23 is connected to the operating body 9 so as to be movable relative to the operating body 9. Since the base end of the needle tube 3 is fixed to the needle slider 23 so as to protrude from the base end of the sheath 7, the needle tube 3 can be protruded or retracted relative to the tip of the sheath 7 by sliding the needle slider 23 relative to the operating body 9.
[0130] like Figure 2 As shown, the needle slider 23 is restricted in movement by the stopper 61, so that it can only advance relative to the operating body 9 to a position in contact with the stopper 61. By adjusting the fixed position of the stopper 61 relative to the operating body 9, the maximum protruding length of the needle tube 3 from the sheath 7 can be adjusted.
[0131] The state where the needle slider 23 is moved to the proximal end side of the operating body 9 to the limit is the initial state before the puncture needle 1 is used. In the initial state, the distal end of the needle tube 3 is inside the sheath 7.
[0132] [Style Needle 27]
[0133] The stylet 27 is attached to the base end of the needle slider 23. The stylet 27 is a needle-shaped member that penetrates the interior of the needle tube 3. The tip of the stylet 27 is not limited to a needle shape and may have an end surface that intersects the longitudinal axis of the stylet 27 or a curved surface such as a hemispherical surface.
[0134] Next, the operation of the biopsy system 150 according to this embodiment will be described. Figure 9 This figure is used to illustrate the function of the puncture needle 1. The following description uses as an example a biopsy procedure in which a lesion in the body is inserted into the needle tube 3 of the puncture needle 1 as the target tissue and the lesioned cells are recovered from the interior of the needle tube 3. The puncture needle 1 of the above embodiment is not limited to biopsy of the pancreatic head.
[0135] First, the operator will Figure 1 The insertion section 101 of the ultrasonic endoscope 100 shown is inserted into the body. The distal end of the insertion section 101 is guided into the vicinity of the target tissue (in this embodiment, the pancreatic head) while observation is performed using the optical imaging mechanism 103 and the active bending section 105 is appropriately bent. Following this introduction, the operator determines the biopsy site based on the observation results of the optical imaging mechanism 103 and the ultrasonic scanning mechanism 104. For example, when performing a biopsy of the pancreatic head, the insertion section 101 is moved while the active bending section 105 is bent, allowing the optical imaging mechanism 103 and ultrasonic scanning mechanism 104 provided in the insertion section 101 of the ultrasonic endoscope 100 to reach the duodenum.
[0136] When performing a biopsy of the pancreatic head using the ultrasonic endoscope 100, the active bending portion 105 needs to be bent in order to locate the puncture site of the puncture needle 1 within the field of view of the ultrasonic endoscope 100. In particular, when performing a biopsy of the pancreatic head as in the present embodiment, the active bending portion 105 is bent to a degree close to the performance limit of the active bending portion 105 of the ultrasonic endoscope 100.
[0137] Next, the operator inserts the insertion body 2 of the puncture needle 1 from the Figure 1 The base end sleeve 107b of the operating portion 109 of the ultrasonic endoscope 100 is inserted into the channel 107. The operator then connects the mounting adapter 18 of the operating portion 109 to the base end sleeve 107b. This secures the operating portion 8 of the puncture needle 1 to the ultrasonic endoscope 100 so that it does not rotate relative to the operating portion 109.
[0138] Next, the operator loosens the fixing screw 10 (see Figure 2), while observing the sheath 7 and the body using the optical imaging mechanism 103 and the ultrasonic scanning mechanism 104, the operator slides the mounting adapter 18 and the operating body 9 relative to each other, adjusting the amount of sheath 7 protruding from the tip of the insertion portion 101 of the ultrasonic endoscope 100 to an appropriate value. After adjustment, the operator tightens the fixing screw 10 to fix the protrusion of the sheath 7. At this point, the tip of the coil body 72 is within the observation field of the observation optical system of the ultrasonic endoscope 100, and the needle slider 23 has moved to the first position.
[0139] Next, the surgical operator advances the needle tube 3 relative to the coil body 72. At this time, the coil body 72 of the outer sheath 71 is in a state where the coil body 72 of the outer sheath 71 is bent by the active bending portion 105, and a gap is generated between the wires constituting the coil body 72. However, in this embodiment, the inner sheath 74 is arranged in the internal space of the coil body 72 of the outer sheath 71, and the gap between the wires of the coil body 72 is covered by the inner sheath 74 from the inside of the coil body 72. As a result, even if the insertion body 2 is bent at the position of the active bending portion 105, the needle tube 3 moving inside the inner sheath 74 is not easily stuck in the gap between the wires of the coil body 72.
[0140] Next, based on the observation results of the ultrasonic scanning mechanism 104 , the stopper 61 is moved in consideration of the distance to the target tissue T to be biopsied, and the stopper 61 is fixed to the operating body 9 at a desired position to adjust the maximum protruding length of the needle tube 3 from the sheath 7 .
[0141] Next, the operator moves the needle slider 23 forward toward the distal end of the operating portion 8. Figure 9 As shown, when the needle tube 3 protrudes from the sheath 7, the stylet 27 is pulled back into the needle tube 3. Thus, the needle tube 3 can be pierced into the tissue using its sharp needle tip (first needle tip 31a and second needle tip 32a).
[0142] Next, with the distal end of the sheath 7 in contact with the intestinal wall, the operator moves the needle slider 23 further toward the distal end of the operating portion 8, thereby Figure 9 As shown, the needle tips (first needle tip 31a and second needle tip 32a) of the needle tube 3 protrude from the distal end of the sheath 7, penetrate the tissue, and are advanced toward the target tissue T to be biopsied. At this time, the stylet 27 is disposed within the needle tube 3, preventing tissue not to be biopsied from entering the needle tube 3.
[0143] The surgeon can use the ultrasonic scanning mechanism 104 to obtain the position information of the distal end portion of the needle tube 3 inserted into the tissue. Figure 1The ultrasonic observation unit 115 shown observes an ultrasonic image acquired by the ultrasonic scanning mechanism 104, which shows the distal end portion of the needle tube 3. The operator refers to the image of the distal end portion of the needle tube 3 clearly projected in the ultrasonic observation unit 115 and brings the needle tip (first needle tip 31a and second needle tip 32a) of the needle tube 3 toward the target tissue T to be biopsied.
[0144] Figure 10 This diagram shows the target tissue T when the needle slider 23 is advanced toward the distal end of the operating portion 8. The normal vector 33n of the first blade surface 33 and the normal vector 34n of the second blade surface 34 are oriented closer to the central axis O than the circumferential direction C of the tubular portion 30 in the first needle tip 31a. Furthermore, the normal vector 35n of the third blade surface 35 and the normal vector 36n of the fourth blade surface 36 are oriented closer to the central axis O than the circumferential direction C of the tubular portion 30 in the second needle tip 32a. Therefore, the needle tube 3 can appropriately move the excised target tissue T into the interior of the needle tube 3.
[0145] When the operator further advances the needle slider 23 toward the distal end of the operating portion 8, the target tissue T is cut off by the first outer edge 33b, the second outer edge 34b, the third outer edge 35b, and the fourth outer edge 36b. In the distal region Z1, the first outer edge 33b, the second outer edge 34b, the third outer edge 35b, and the fourth outer edge 36b form acute angles, enabling the target tissue T to be appropriately cut off.
[0146] To aspirate tissue into the needle tube 3, the operator removes the stylet 27 from the insertion body 2 and the operating unit 8. This creates a through hole extending from the tip of the needle tube 3 to the base end of the needle slider 23. The operator connects a syringe or the like to a port at the base end of the needle slider 23 to aspirate the inside of the needle tube 3, aspirating and extracting cells, etc., of the target tissue T from the tip of the needle tube 3.
[0147] Once the desired amount of cells or the like has been extracted, the needle slider 23 is retracted toward the proximal end of the operating portion 8, thereby removing the needle tube 3 from the tissue and storing the distal end of the needle tube 3 within the sheath 7. Once the needle tube 3 has been removed from the tissue, the mounting adapter 18 is removed from the proximal end sleeve 107b of the operating portion 109 of the ultrasonic endoscope 100, and the puncture needle 1 is removed from the channel 107. Finally, the ultrasonic endoscope 100 is removed from the patient, completing the series of procedures.
[0148] The biopsy system 150 equipped with the puncture needle 1 of this embodiment has high penetrability into body tissue (the puncture needle 1 easily penetrates the body tissue), making it easy to recover the excised body tissue (the specimen required for diagnosis) within the puncture needle 1. The normal vector 33n of the first blade face 33 and the normal vector 34n of the second blade face 34 in the tip region Z1 are oriented toward the third blade face 35 and the fourth blade face 36 in the tip region Z1, respectively, relative to a direction perpendicular to the straight line V passing through the first and second needle tips 31a, 32a. Furthermore, in this front view, the normal vector 35n of the third blade face 35 and the normal vector 36n of the fourth blade face 36 in the tip region Z1 are oriented toward the first and second blade faces 33, 34 in the tip region Z1, relative to a direction perpendicular to the straight line V passing through the first and second needle tips 31a, 32a. Therefore, the puncture needle 1 can appropriately move the target tissue T into the interior of the needle tube 3.
[0149] Furthermore, the puncture needle 1 has acute angles in the distal region Z1 of the first, second, third, and fourth outer edges 33b, 34b, 35b, and 36b, so that the target tissue T can be appropriately cut when the operator advances the needle slider 23 further toward the distal end of the operating portion 8.
[0150] While the first embodiment of the present invention has been described in detail with reference to the accompanying drawings, the specific structure is not limited to this embodiment and includes design changes within the scope of the present invention. In addition, the components shown in the above-mentioned embodiments and modifications can be appropriately combined to form the present invention.
[0151] (Variation 1)
[0152] In the above embodiment, the outer peripheral surface 31e of the first needle tip portion 31 and the outer peripheral surface 32e of the second needle tip portion 32 are not processed, but the configurations of the first needle tip portion and the second needle tip portion are not limited thereto.
[0153] exist Figure 11 In the needle tube 3C shown as a modified example of the needle tube 3, the outer circumference of the first needle tip 31 and the outer circumference of the second needle tip 32 are subjected to a backcut process B. This allows the first and second needle tips 31, 32 to penetrate body tissue more easily. In other words, the needle tips 31a, 32a easily penetrate the surface of body tissue. Furthermore, the needle tips 31a, 32a of the needle tube 3C are less likely to contact the inner surface of the sheath 7, improving operability.
[0154] exist Figure 12In the needle tube 3D shown as a modified example of the needle tube 3, a cut surface M is applied to at least a portion of the outer circumference of the tip region Z1, formed by conical cutting centered on the inner circumference (31i, 32i). This allows the first and second needle tips 31a, 32 to penetrate body tissue more effectively. In other words, the needle tips 31a, 32a easily penetrate the surface of body tissue. Furthermore, the needle tips 31a, 32a of the needle tube 3D are less likely to contact the inner surface of the sheath 7, resulting in improved operability.
[0155] (Second embodiment)
[0156] Reference Figures 13 to 17 A biopsy system 150B including an endoscopic puncture needle 1B according to a second embodiment of the present invention will be described. In the following description, the same reference numerals are given to the same components as those already described, and duplicate descriptions will be omitted.
[0157] [Biopsy system 150B]
[0158] The biopsy system 150B is a medical device used to extract tissue from the body during a biopsy. The biopsy system 150B includes an ultrasonic endoscope 100 and an endoscope puncture needle 1B (hereinafter referred to as "puncture needle 1B"). The puncture needle 1B includes an insertion body 2B, an operating unit 8, and a stylet 27.
[0159] [Insert 2B]
[0160] The insertion body 2B is an elongated member that can be inserted into the channel 107 of the ultrasonic endoscope 100. The insertion body 2B includes a needle tube 3B and a sheath 7.
[0161] Figure 13 It is a perspective view of the needle tube 3B. Figure 14 It is a side view of the needle tube 3B. Figure 15 This is a front view of the needle tube 3B as viewed from the distal end in the axial direction A, in which cross sections are arranged at equal intervals in the longitudinal axis direction to schematically illustrate changes in the orientation of the cross sections of each blade surface. Figure 15 The dashed lines shown indicate intersections of the cross sections perpendicular to the axial direction A arranged at equal intervals in the axial direction A with the first blade face 33B, the second blade face 34B, the third blade face 35B, and the fourth blade face 36B. Figure 16 yes Figure 14 The needle tube 3B is shown in a cross-sectional view taken along the line XX. Figure 17 yes Figure 14 The needle tube 3B is shown in a cross-sectional view along the YY section.
[0162] like Figure 13As shown, the needle tube 3B includes a tubular portion 30, and a first needle tip portion 31B and a second needle tip portion 32B provided at the distal end of the tubular portion 30. The needle tube 3B can be advanced and retracted within the sheath 7 using the operating portion 8. An opening 4B is formed at the distal end of the needle tube 3B. This opening 4B serves as an entrance for tissue pierced by the first needle tip portion 31B and the second needle tip portion 32B to enter the interior of the needle tube 3B. The first needle tip portion 31B and the second needle tip portion 32B of the needle tube 3B can be extended or retracted relative to the opening at the distal end of the sheath 7.
[0163] like Figure 13 and Figure 15 As shown, the first needle tip portion 31B has a first blade surface 33B and a second blade surface 34B, and the first blade surface 33B and the second blade surface 34B extend toward the sharp first needle tip 31a. Figure 15 As shown, the first blade surface 33B and the second blade surface 34B are symmetrical with respect to the straight line V passing through the first needle tip 31a and the second needle tip 32a. In addition, the first blade surface 33B and the second blade surface 34B may be flat or slightly curved.
[0164] The outer circumferential surface 31e of the first needle tip portion 31B is a curved surface that is continuous with the outer circumferential surface 30e of the tubular portion 30, and has the same diameter and curvature. Furthermore, the inner circumferential surface 31i of the first needle tip portion 31B is a curved surface that is continuous with the inner circumferential surface 30i of the tubular portion 30, and has the same diameter and curvature. The first needle tip portion 31B is formed by, for example, cutting away a portion of the tubular portion 30 to form the first blade surface 33B and the second blade surface 34B.
[0165] like Figure 13 As shown, the second needle tip portion 32B has a third blade surface 35B and a fourth blade surface 36B, and the third blade surface 35B and the fourth blade surface 36B extend toward the sharp second needle tip 32a. The first needle tip 31a and the second needle tip 32a are arranged at positions symmetrical with respect to the central axis O extending along the axial direction A of the needle tube 3B. In the front view viewed from the direction along the axial direction A of the needle tube 3B, as shown in FIG. Figure 15 As shown, the third blade surface 35B and the fourth blade surface 36B are symmetrical with respect to the straight line V passing through the first needle tip 31a and the second needle tip 32a. In addition, the third blade surface 35B and the fourth blade surface 36B may be flat or slightly curved.
[0166] The outer circumferential surface 32e of the second needle tip portion 32B is a curved surface that is continuous with the outer circumferential surface 30e of the tubular portion 30, and has the same diameter and curvature. Furthermore, the inner circumferential surface 32i of the second needle tip portion 32B is a curved surface that is continuous with the inner circumferential surface 30i of the tubular portion 30, and has the same diameter and curvature. The third and fourth blade surfaces 35B and 36B of the second needle tip portion 32B are formed by, for example, cutting away a portion of the tubular portion 30.
[0167] like Figures 13 to 15 As shown, the first needle tip portion 31B and the second needle tip portion 32B form an opening 4B surrounded by the first blade surface 33B, the second blade surface 34B, the third blade surface 35B, and the fourth blade surface 36B. The opening 4B communicates with the inner space of the tubular portion 30 .
[0168] like Figures 13 to 15 As shown, the first blade surface 33B and the third blade surface 35B are connected at a first base end 38B of the opening 4B. The second blade surface 34B and the fourth blade surface 36B are connected at a second base end 39B of the opening 4B.
[0169] In the first needle tip portion 31B and the second needle tip portion 32B, as shown in FIG. Figure 14 As shown, a top region Z1 including the first needle tip 31a and the second needle tip 32a, a base region Z3 including the first base end 38B and the second base end 39B, and an intermediate region Z2 located between the top region Z1 and the base region Z3 and connected to the top region Z1 and the base region Z3 are defined.
[0170] (First blade surface 33B and second blade surface 34B of the first needle tip portion 31B)
[0171] like Figure 13 and Figure 16 As shown, the intersection line (first inner intersection line 33Bc) between the first blade surface 33B and the inner peripheral surface 31i of the first needle tip portion 31B defines a portion of the outline of the opening 4B. The intersection line (second inner intersection line 34Bc) between the second blade surface 34B and the inner peripheral surface 31i of the first needle tip portion 31B defines a portion of the outline of the opening 4B.
[0172] like Figure 16 As shown, in the front view as viewed from the direction along the axial direction A of the needle tube 3B, the normal vector 33Bn of the first blade surface 33B in the tip region Z1 is directed toward the third blade surface 35B in the tip region Z1, relative to the direction perpendicular to the straight line V passing through the first needle tip 31a and the second needle tip 32a. Similarly, in the front view, the normal vector 34Bn of the second blade surface 34B in the tip region Z1 is directed toward the fourth blade surface 36B in the tip region Z1, relative to the direction perpendicular to the straight line V passing through the first needle tip 31a and the second needle tip 32a.
[0173] And, as Figure 17As shown, the normal vector 33Bn of the first blade face 33B in the middle region Z2 is also directed toward the third blade face 35B in the middle region Z2 compared to the direction perpendicular to the straight line V, as in the top region Z1. Furthermore, the normal vector 34Bn of the second blade face 34B in the middle region Z2 is also directed toward the fourth blade face 36B in the middle region Z2 compared to the direction perpendicular to the straight line V, as in the top region Z1.
[0174] Preferably, if Figure 17 As shown, the normal vector 33Bn of the first blade surface 33B in the intermediate region Z2 is oriented in a direction forming an acute angle with the straight line V connecting the first needle tip 31a and the second needle tip 32a. In addition, the normal vector 34Bn of the second blade surface 34B in the intermediate region Z2 is oriented in a direction forming an acute angle with the straight line V connecting the first needle tip 31a and the second needle tip 32a.
[0175] Preferably, if Figure 15 and Figure 16 As shown, the normal vector 33Bn of the first blade surface 33B is oriented in a direction closer to the central axis O than the circumferential direction C of the tubular portion 30 in the tip region Z1 .
[0176] like Figure 14 As shown, the intersection line of the first blade surface 33B and the second blade surface 34B (first top intersection line 31b) extends from the top of the inner peripheral surface 31i of the first needle tip portion 31B to the first needle tip 31a. In addition, in the front view viewed from the direction along the axial direction A of the needle tube 3B, the first top intersection line 31b is located on the straight line V.
[0177] The first blade surface 33B further includes a first cutting edge surface 33C on the tip side in the tip region Z1. The normal vector of the first cutting edge surface 33C faces a direction forming an acute angle with the straight line V, and the normal vector 33Bn of the first blade surface 33B faces a direction forming an acute angle with respect to the straight line V smaller than the angle of the normal vector of the first cutting edge surface 33C with respect to the straight line V. Figures 13 to 16 As shown, the ridge line where the first blade surface 33B and the first cutting edge surface 33C intersect extends from the first top intersection line 31b toward the middle area Z2.
[0178] The second blade surface 34B further includes a second cutting blade surface 34C on the tip side in the tip region Z1. The normal vector of the second cutting blade surface 34C faces a direction forming an acute angle with the straight line V, and the normal vector 34Bn of the second blade surface 34B faces a direction forming an acute angle with respect to the straight line V smaller than the angle of the normal vector of the second cutting blade surface 34C with respect to the straight line V. Figures 13 to 16 As shown, the ridge line where the second blade surface 34B and the second cutting edge surface 34C intersect extends from the first top intersection line 31b toward the middle area Z2.
[0179] The intersection line (first outer intersection line 33Bb) where the first blade surface 33B intersects the outer peripheral surface 31e is a first outer edge 33Bb having an edge in the circumferential direction of the tubular portion 30. Figure 16 and Figure 17 As shown, in a front view along the axial direction A of the needle tube 3B, an angle θ1 formed between the first blade surface 33B at the first outer edge 33Bb and the outer peripheral surface 31e forms an acute angle in the distal region Z1 and the intermediate region Z2.
[0180] The intersection line (first inner intersection line 33Bc) where the first blade surface 33B intersects the inner peripheral surface 31i is a first inner edge 33Bc having an edge in the circumferential direction of the tubular portion 30. Figure 16 and Figure 17 As shown, the angle θ2 formed between the first blade surface 33B at the first inner edge 33Bc and the inner peripheral surface 31i forms an obtuse angle in the top region Z1 and the middle region Z2.
[0181] The intersection line (second outer intersection line 34Bb) where the second blade surface 34B intersects the outer peripheral surface 31e is a second outer edge 34Bb having an edge in the circumferential direction of the tubular portion 30. Figure 16 and Figure 17 As shown, the angle θ3 formed between the second blade surface 34B at the second outer edge 34Bb and the outer peripheral surface 31 e forms an acute angle in the tip region Z1 and the middle region Z2.
[0182] The intersection line (second inner intersection line 34Bc) where the second blade surface 34B intersects the inner peripheral surface 31i is a second inner edge 34Bc having an edge in the circumferential direction of the tubular portion 30. Figure 16 and Figure 17 As shown, the angle θ4 formed between the second blade surface 34B at the second inner edge 34Bc and the inner peripheral surface 31i forms an obtuse angle in the top region Z1 and the middle region Z2.
[0183] (Third cutting edge surface 35B and fourth cutting edge surface 36B of second needle tip portion 32B)
[0184] like Figure 13 and Figure 16 As shown, the intersection line (third inner intersection line 35Bc) between the third blade surface 35B and the inner peripheral surface 32i of the second needle tip portion 32B defines a portion of the outline of the opening 4B. The intersection line (fourth inner intersection line 36Bc) between the fourth blade surface 36B and the inner peripheral surface 32i of the second needle tip portion 32B defines a portion of the outline of the opening 4B.
[0185] In the front view as viewed from the direction along the axial direction A of the needle tube 3B, the normal vector 35Bn of the third blade surface 35B in the distal region Z1 is directed toward the first blade surface 33B in the distal region Z1, relative to the direction perpendicular to the straight line V passing through the first needle tip 31a and the second needle tip 32a. Similarly, in the front view, the normal vector 36Bn of the fourth blade surface 36B in the distal region Z1 is directed toward the second blade surface 34B in the distal region Z1, relative to the direction perpendicular to the straight line V passing through the first needle tip 31a and the second needle tip 32a.
[0186] Furthermore, the normal vector 35Bn of the third blade face 35B in the middle region Z2 is also directed toward the first blade face 33B in the middle region Z2 compared to the direction perpendicular to the straight line V, as in the top region Z1. Furthermore, the normal vector 36Bn of the fourth blade face 36B in the middle region Z2 is also directed toward the second blade face 34B in the middle region Z2 compared to the direction perpendicular to the straight line V, as in the top region Z1.
[0187] Preferably, if Figures 15 to 17 As shown, the normal vector 35Bn of the third blade face 35B in the intermediate region Z2 is oriented in a direction forming an acute angle with the straight line V connecting the first needle tip 31a and the second needle tip 32a. In addition, the normal vector 36Bn of the fourth blade face 36B in the intermediate region Z2 is oriented in a direction forming an acute angle with the straight line V connecting the first needle tip 31a and the second needle tip 32a.
[0188] Preferably, if Figure 15 and Figure 16 As shown, the normal vector 35Bn of the third blade surface 35B is directed in a direction closer to the central axis O than the circumferential direction C of the tubular portion 30 in the tip region Z1 .
[0189] like Figure 14 As shown, the intersection line of the third blade surface 35B and the fourth blade surface 36B (second top intersection line 32b) extends from the top of the inner peripheral surface 32i of the second needle tip portion 32B to the second needle tip 32a. In addition, in the front view observed from the direction along the axis of the needle tube 3B, the second top intersection line 32b is located on the straight line V.
[0190] The third blade surface 35B further includes a third cutting blade surface 35C on the tip side in the tip region Z1. The normal vector of the third cutting blade surface 35C faces a direction forming an acute angle with the straight line V, and the normal vector 35Bn of the third blade surface 35B faces a direction forming an acute angle with respect to the straight line V smaller than the angle of the normal vector of the third cutting blade surface 35C with respect to the straight line V. Figures 13 to 16 As shown, the ridge line where the third blade surface 35B and the third cutting edge surface 35C intersect extends from the second top intersection line 32b toward the middle area Z2.
[0191] The fourth blade surface 36B further includes a fourth cutting edge surface 36C on the tip side in the tip region Z1. The normal vector of the fourth cutting edge surface 36C faces a direction forming an acute angle with the straight line V, and the normal vector 36Bn of the fourth blade surface 36B faces a direction forming an acute angle smaller than the angle of the normal vector of the fourth cutting edge surface 36C with respect to the straight line V. Figures 13 to 16 As shown, the ridge line where the fourth blade surface 36B and the fourth cutting edge surface 36C intersect extends from the second top intersection line 32b toward the middle area Z2.
[0192] The intersection line (third outer intersection line 35Bb) where the third blade surface 35B intersects the outer peripheral surface 32e is a third outer edge 35Bb having an edge in the circumferential direction of the tubular portion 30. Figure 16 and Figure 17 As shown, the angle θ5 formed between the third blade surface 35B at the third outer edge 35Bb and the outer peripheral surface 32e forms an acute angle in the tip region Z1 and the middle region Z2.
[0193] The intersection line (third inner intersection line 35Bc) where the third blade surface 35B intersects the inner peripheral surface 32i is a third inner edge 35Bc having an edge in the circumferential direction of the tubular portion 30. Figure 16 and Figure 17 As shown, the angle θ6 formed between the third blade surface 35B at the third inner edge 35Bc and the inner peripheral surface 32i forms an obtuse angle in the tip region Z1 and the middle region Z2.
[0194] The intersection line (fourth outer intersection line 36Bb) where the fourth blade surface 36B intersects the outer peripheral surface 32e is a fourth outer edge 36Bb having an edge in the circumferential direction of the tubular portion 30. Figure 16 and Figure 17 As shown, the angle θ7 formed between the fourth blade surface 36B at the fourth outer edge 36Bb and the outer peripheral surface 32e forms an acute angle in the tip region Z1 and the middle region Z2.
[0195] The intersection line (fourth inner intersection line 36Bc) where the fourth blade surface 36B intersects the inner peripheral surface 32i is a fourth inner edge 36Bc having an edge in the circumferential direction of the tubular portion 30. Figure 16 and Figure 17 As shown, the angle θ8 formed between the fourth blade surface 36B at the fourth inner edge 36Bc and the inner peripheral surface 32i forms an obtuse angle in the top region Z1 and the middle region Z2.
[0196] Using a biopsy system 150B equipped with the puncture needle 1B of this embodiment, the puncture efficiency of body tissue is high (the puncture needle 1B easily penetrates the body tissue), making it easy to recover the excised body tissue (the specimen required for diagnosis) within the puncture needle 1B. The normal vector 33Bn of the first blade face 33B and the normal vector 34Bn of the second blade face 34B in the tip region Z1 are directed toward the third blade face 35B and the fourth blade face 36B in the tip region Z1, respectively, relative to a direction perpendicular to the straight line V passing through the first needle tip 31a and the second needle tip 32a. Furthermore, in this front view, the normal vector 35Bn of the third blade face 35B and the normal vector 36Bn of the fourth blade face 36B in the tip region Z1 are directed toward the first blade face 33B and the second blade face 34B in the tip region Z1, relative to a direction perpendicular to the straight line V passing through the first needle tip 31a and the second needle tip 32a. Therefore, the puncture needle 1B can appropriately move the excised target tissue T into the interior of the needle tube 3B.
[0197] Furthermore, the first outer edge 33Bb, the second outer edge 34Bb, the third outer edge 35Bb, and the fourth outer edge 36Bb of the puncture needle 1B in the distal region Z1 and the intermediate region Z2 are formed at acute angles, so that more target tissue T can be excised when the operator further advances the needle slider 23 toward the distal end of the operating portion 8.
[0198] The second embodiment of the present invention has been described in detail with reference to the accompanying drawings, but the specific structure is not limited to this embodiment and includes design changes within the scope of the present invention. In addition, the components shown in the above-mentioned embodiment and modification examples can be appropriately combined and configured.
[0199] (Third embodiment)
[0200] Reference Figures 18 to 22 A biopsy system 150E including an endoscopic puncture needle 1E according to a third embodiment of the present invention will be described. In the following description, components common to those already described will be denoted by the same reference numerals, and duplicate descriptions will be omitted. Compared to the endoscopic puncture needle 1 according to the first embodiment, the endoscopic puncture needle 1E further includes a fifth blade surface 41 and a sixth blade surface 42.
[0201] [Biopsy System 150E]
[0202] The biopsy system 150E is a medical device used to extract tissue from the body during a biopsy. The biopsy system 150E includes an ultrasonic endoscope 100 and an endoscope puncture needle 1E (hereinafter referred to as "puncture needle 1E"). The puncture needle 1E includes an insertion body 2E, an operating unit 8, and a stylet 27.
[0203] [Insert 2E]
[0204] The insertion body 2E is an elongated member that can be inserted into the channel 107 of the ultrasonic endoscope 100. The insertion body 2E includes a needle tube 3E and a sheath 7.
[0205] Figure 18 It is a perspective view of the needle tube 3E. Figure 19 It is a side view of the needle tube 3E. Figure 20 It is the needle tube 3E from and Figure 19 A cross-sectional view along the central axis O observed from the same direction, Figure 21 This is a front view of the needle tube 3E as viewed from the distal end in the axial direction A, in which cross sections are arranged at equal intervals in the longitudinal axis direction to schematically illustrate changes in the orientation of the cross sections of each blade surface. Figure 21 The single-dot chain line shown represents the intersection of the cross sections perpendicular to the axial direction A arranged at equal intervals in the axial direction A and the first blade face 33, the second blade face 34, the third blade face 35, the fourth blade face 36, the fifth blade face 41 and the sixth blade face 42. Figure 22 It is a plan view viewed from the radial direction R of the needle tube 3E and in a direction horizontal to the straight line V. Figure 23 It is from Figure 22 A cross-sectional view along the central axis O viewed from the same direction. Figure 24 yes Figure 19 The needle tube 3E is shown in a cross-sectional view taken along the ZZ section.
[0206] like Figure 18 As shown, the needle tube 3E includes a tubular portion 30, and a first needle tip portion 31E and a second needle tip portion 32E provided at the distal end of the tubular portion 30. The needle tube 3E can be advanced and retracted within the sheath 7 using an operating portion 8. An opening 4 is formed at the distal end of the needle tube 3E. This opening 4 serves as an entrance for tissue pierced through the first needle tip portion 31E and the second needle tip portion 32E to enter the interior of the needle tube 3E. The first needle tip portion 31E and the second needle tip portion 32E of the needle tube 3E can be extended or retracted relative to the opening at the distal end of the sheath 7.
[0207] like Figures 18 to 22 As shown, the first needle tip portion 31E has a first blade surface 33 and a second blade surface 34 , and the first blade surface 33 and the second blade surface 34 extend toward the sharp first needle tip 31 a .
[0208] The outer circumferential surface 31e of the first needle tip portion 31E is a curved surface that is continuous with the outer circumferential surface 30e of the tubular portion 30, and has the same diameter and curvature. Furthermore, the inner circumferential surface 31i of the first needle tip portion 31E is a curved surface that is continuous with the inner circumferential surface 30i of the tubular portion 30, and has the same diameter and curvature. The first needle tip portion 31E is formed by, for example, cutting away a portion of the tubular portion 30 to form the first blade surface 33 and the second blade surface 34.
[0209] like Figures 18 to 21 and Figure 23 As shown, the second needle tip portion 32E has a third blade surface 35 and a fourth blade surface 36, which extend toward the sharp second needle tip 32a. The first needle tip 31a and the second needle tip 32a are arranged at symmetrical positions relative to the central axis O extending along the axial direction A of the needle tube 3E.
[0210] The outer circumferential surface 32e of the second needle tip portion 32E is a curved surface that is continuous with the outer circumferential surface 30e of the tubular portion 30, and has the same diameter and curvature. Furthermore, the inner circumferential surface 32i of the second needle tip portion 32E is a curved surface that is continuous with the inner circumferential surface 30i of the tubular portion 30, and has the same diameter and curvature. The third and fourth blade surfaces 35, 36 are formed in the second needle tip portion 32E by, for example, cutting away a portion of the tubular portion 30.
[0211] like Figures 18 to 23 As shown, the first tip portion 31E and the second tip portion 32E form the edge of an opening 4 surrounded by the first blade surface 33, the second blade surface 34, the third blade surface 35, and the fourth blade surface 36. The opening 4 communicates with the inner space of the tubular portion 30.
[0212] like Figures 18 to 23 As shown, the first blade surface 33 and the third blade surface 35 are connected at a first base end 38 of the edge of the opening 4. The second blade surface 34 and the fourth blade surface 36 are connected at a second base end 39 of the edge of the opening 4.
[0213] In the first needle tip portion 31E and the second needle tip portion 32E, as shown in FIG. Figure 19 As shown, a tip region Z1 including the first needle tip 31a and the second needle tip 32a, a base region Z3 including the first base end 38 and the second base end 39, and an intermediate region Z2 located between and connected to the tip region Z1 and the base region Z3 are defined. Furthermore, a region of the base region Z3 located closer to the tip than the first base end 38 and the second base end 39 in the axial direction A is defined as a first base region Z31, and a region closer to the base than the first base end 38 and the second base end 39 is defined as a second base region Z32.
[0214] The first and second needle tip portions 31E and 32E have a fifth blade surface 41 and a sixth blade surface 42 on the outer peripheral surfaces 31e and 32e of the first and second needle tip portions 31E and 32E.
[0215] (Fifth blade surface 41 and sixth blade surface 42)
[0216] The fifth blade surface 41 is a blade surface formed on the outer peripheral surface 31e of the first needle tip portion 31E and the outer peripheral surface 32e of the second needle tip portion 32E. Figure 22 and Figure 23As shown, the fifth blade surface 41 is an inclined surface inclined relative to the central axis O. As the distance between the fifth blade surface 41 and the central axis O gradually decreases from the base end side of the needle tube 3E toward the first needle tip 31a and the second needle tip 32a. The fifth blade surface 41 has a first outer intersection point 33d (see FIG. 1 ) which is an intersection point with the first outer intersection line (first outer edge) 33b. Figure 22 ) and the third outer intersection point 35d (refer to Figure 23 ).like Figure 20 and Figure 22 As shown, the first outer intersection line 33b is an intersection line formed by the first blade surface 33 and the outer peripheral surface 31e of the first needle tip portion 31E. Figure 20 and Figure 23 As shown, the third outer intersection line 35b is the intersection line formed by the third blade surface 35 and the outer peripheral surface 32e of the second needle tip portion 32E. The fifth blade surface 41 intersects the first outer intersection line 33b at the first outer intersection point 33d, and the fifth blade surface 41 intersects the third outer intersection line 35b at the third outer intersection point 35d.
[0217] like Figure 24 As shown, the intersection line of the fifth blade surface 41 and the first blade surface 33 is defined as the first intermediate edge 33f. The intersection line of the fifth blade surface 41 and the third blade surface 35 is defined as the third intermediate edge 35f. Figure 20 As shown, the first intermediate edge 33 f and the third intermediate edge 35 f are connected at the first base end 38 .
[0218] like Figures 21 to 23 As shown, in the first base end region Z31, the thickness T1 between the fifth blade surface 41 and the inner peripheral surface 31i of the first needle tip portion 31E becomes thinner as it moves from the first outer intersection 33d toward the first base end 38. Furthermore, in the first base end region Z31, the thickness T1 between the fifth blade surface 41 and the inner peripheral surface 32i of the second needle tip portion 32E becomes thinner as it moves from the third outer intersection 35d toward the first base end 38.
[0219] like Figures 21 to 23 As shown, in the second proximal end region Z32, the thickness T1 between the fifth blade surface 41 and the inner circumferential surface 31i of the first needle tip portion 31E increases as it moves from the first proximal end 38 toward the proximal end of the needle tube 3E. Similarly, in the second proximal end region Z32, the thickness T1 between the fifth blade surface 41 and the inner circumferential surface 32i of the second needle tip portion 32E increases as it moves from the first proximal end 38 toward the proximal end of the needle tube 3E. In other words, the thickness T1 between the fifth blade surface 41 and the inner circumferential surfaces 31i, 32i decreases as it moves from the proximal end of the fifth blade surface 41 toward the first proximal end 38.
[0220] like Figure 20As shown, in a side view viewed from a direction perpendicular to the central axis O and the straight line V, the first outer intersection point 33d and the third outer intersection point 35d of the fifth blade surface 41 are formed at positions symmetrical with respect to the central axis O extending in the axial direction A of the needle tube 3E. Figure 22 and Figure 23 As shown, the first outer intersection point 33 d and the third outer intersection point 35 d are located at the top end of the fifth blade surface 41 .
[0221] The intersection line formed by the fifth blade surface 41 and the outer peripheral surface 31e of the first needle tip portion 31E is defined as a fifth intersection line 410. Figure 20 As shown, the interval between the first portion 411 in the fifth intersection line 410 connected to the first outer intersection point 33d and the third portion 412 in the fifth intersection line 410 connected to the third outer intersection point 35d gradually narrows as it goes from the top of the fifth blade surface 41 toward the base end.
[0222] like Figure 23 As shown, a first proximal edge 38e is formed in the second proximal region Z32, with the first proximal end 38 at its apex. The first proximal edge 38e is a sharp edge formed by the fifth blade face 41 and the inner circumferential surfaces 31i and 32i. By reducing the thickness T1 at the first proximal end 38, the resistance experienced by the first proximal end 38 from the tissue when the needle tube 3E is inserted into body tissue can be reduced. Furthermore, the first proximal edge 38e is formed by reducing the apical angle formed by the fifth blade face 41 and the inner circumferential surfaces 31i and 32i at the first proximal end 38.
[0223] The sixth blade surface 42 is a blade surface formed on the outer peripheral surface 31e of the first needle tip portion 31E and the outer peripheral surface 32e of the second needle tip portion 32E. Figure 22 and Figure 23 As shown, the sixth blade surface 42 is an inclined surface inclined relative to the central axis O. As the distance between the sixth blade surface 42 and the central axis O gradually decreases from the base end side of the needle tube 3E toward the first needle tip 31a and the second needle tip 32a. The sixth blade surface 42 has a second outer intersection point 34d (see Figure 22 ) and the fourth outer intersection point 36d (refer to Figure 23 ).like Figure 19 and Figure 22 As shown, the second outer intersection line 34b is the intersection line formed by the second blade surface 34 and the outer peripheral surface 31e of the first needle tip portion 31E. Figure 19 and Figure 23As shown, the fourth outer intersection line 36b is the intersection line formed by the fourth blade surface 36 and the outer peripheral surface 32e of the second needle tip portion 32E. The sixth blade surface 42 intersects the second outer intersection line 34b at the second outer intersection point 34d, and the sixth blade surface 42 intersects the fourth outer intersection line 36b at the fourth outer intersection point 36d.
[0224] like Figure 24 As shown, the intersection line of the sixth blade surface 42 and the first blade surface 33 is defined as the second intermediate edge 34f. The intersection line of the sixth blade surface 42 and the fourth blade surface 36 is defined as the fourth intermediate edge 36f. Figure 19 As shown, the second intermediate edge 34 f and the fourth intermediate edge 36 f are connected at the second base end 39 .
[0225] like Figures 21 to 23 As shown, in the first base end region Z31, the thickness T1 between the sixth blade surface 42 and the inner peripheral surface 31i of the first needle tip portion 31E becomes thinner as it moves from the second outer intersection point 34d toward the second base end 39. Similarly, in the first base end region Z31, the thickness T1 becomes thinner as it moves from the fourth outer intersection point 36d toward the second base end 39.
[0226] like Figures 21 to 23 As shown, in the second proximal end region Z32, the thickness T1 between the sixth blade surface 42 and the inner circumferential surface 31i of the first needle tip portion 31E increases as it moves from the second proximal end 39 toward the proximal side. Similarly, in the second proximal end region Z32, the thickness T1 between the sixth blade surface 42 and the inner circumferential surface 32i of the second needle tip portion 32E increases as it moves from the second proximal end 39 toward the proximal side. In other words, the thickness T1 between the sixth blade surface 42 and the inner circumferential surfaces 31i, 32i decreases as it moves from the proximal end of the sixth blade surface 42 toward the second proximal end 39.
[0227] like Figure 19 As shown, in a side view viewed from a direction perpendicular to the central axis O and the straight line V, the second outer intersection point 34d and the fourth outer intersection point 36d of the sixth blade surface 42 are formed at positions symmetrical with respect to the central axis O extending in the axial direction A of the needle tube 3E. Figure 22 and Figure 23 As shown, the first outer intersection point 33 d and the third outer intersection point 35 d are located at the top end of the sixth blade surface 42 .
[0228] The intersection line formed by the sixth blade surface 42 and the outer peripheral surface 31e of the first needle tip portion 31E is defined as a sixth intersection line 420. Figure 19 As shown, the interval between the second portion 421 connected to the second outer intersection point 34d in the sixth intersection line and the fourth portion 422 connected to the fourth outer intersection point 36d in the sixth intersection line gradually narrows as it goes from the top end of the sixth blade surface 42 toward the base end.
[0229] like Figure 23 As shown, a second proximal edge 39e is formed in the second proximal region Z32, with the second proximal end 39 as its apex. The second proximal edge 39e is a sharp edge formed by the sixth blade face 42 and the inner circumferential surfaces 31i and 32i. By reducing the thickness T1 at the second proximal end 39, the resistance experienced by the second proximal end 39 from the tissue when the needle tube 3E is inserted into body tissue can be reduced. Furthermore, the second proximal edge 39e is formed by reducing the apical angle formed by the sixth blade face 42 and the inner circumferential surfaces 31i and 32i at the second proximal end 39.
[0230] The fifth blade surface 41 and the sixth blade surface 42 are formed by, for example, cutting the outer peripheral surface 30e of the tubular portion 30 of the needle tube 3E. Figure 21 As shown, in a front view viewed from a direction along the axial direction A of the needle tube 3E (tubular portion 30), the first outer intersection point 33d and the second outer intersection point 34d are formed at positions symmetrical with respect to a straight line V passing through the first needle tip 31a and the second needle tip 32a. Furthermore, it is also preferable that, in the same front view, the third outer intersection point 35d and the fourth outer intersection point 36d are formed at positions symmetrical with respect to a straight line V passing through the first needle tip 31a and the second needle tip 32a.
[0231] Using the biopsy system 150E having the puncture needle 1E of this embodiment, not only the first outer edge 33b, the second outer edge 34b, the third outer edge 35b, and the fourth outer edge 36b, but also the first base end edge 38e and the second base end edge 39e cut into the body tissue, making it easy to extract the body tissue (the specimen required for diagnosis).
[0232] Biopsy system 150E equipped with puncture needle 1E of this embodiment has high penetrability into body tissue (puncture needle 1E easily penetrates body tissue), making it easy to retrieve excised body tissue (a specimen required for diagnosis) within puncture needle 1E. Needle tube 3E has thinner and sharper first and second proximal ends 38 and 39 than needle tube 3 of the first embodiment, thus improving both extraction and puncture performance.
[0233] The third embodiment of the present invention has been described in detail with reference to the accompanying drawings, but the specific structure is not limited to this embodiment and includes design changes within the scope of the present invention. In addition, the components shown in the above embodiments and modifications can be appropriately combined and configured.
[0234] (Variation)
[0235] In the above embodiment, the fifth blade surface 41 and the sixth blade surface 42 are formed as flat surfaces, but the fifth blade surface 41 and the sixth blade surface 42 are not limited thereto. Figure 25This is a perspective view showing a sixth blade face 42B as a modified example of the sixth blade face 42. The sixth blade face 42B is formed into a curved surface by machining with an end mill. As in the above-described embodiment, the provision of the sixth blade face 42B forms a second base end edge 39e with the second base end 39 at its apex. Furthermore, the thickness T1 between the sixth blade face 42B and the inner circumferential surface 31i of the first needle tip portion 31E increases in thickness as it moves from the second base end 39 toward the base end. The same applies to the fifth blade face 41.
[0236] (Fourth embodiment)
[0237] Reference Figures 26 to 35 A biopsy system 150F including an endoscopic puncture needle 1F according to a fourth embodiment of the present invention will be described. In the following description, components common to those already described will be denoted by the same reference numerals, and duplicate descriptions will be omitted. Compared to the endoscopic puncture needle 1 according to the first embodiment, the endoscopic puncture needle 1F further includes a seventh blade surface 43 and an eighth blade surface 44.
[0238] [Biopsy System 150F]
[0239] The biopsy system 150F is a medical device used to extract tissue from the body during a biopsy. The biopsy system 150F includes an ultrasonic endoscope 100 and an endoscope puncture needle 1F (hereinafter referred to as "puncture needle 1F"). The puncture needle 1F includes an insertion body 2F, an operating unit 8, and a stylet 27.
[0240] [Insert 2F]
[0241] The insertion body 2F is an elongated member that can be inserted into the channel 107 of the ultrasonic endoscope 100. The insertion body 2F includes a needle tube 3F and a sheath 7.
[0242] Figure 26 This is a perspective view of the needle tube 3F. Figure 27 It is a side view of the needle tube 3F. Figure 28 The needle tube 3F is from Figure 27 A cross-sectional view along the central axis O observed from the same direction, Figure 29 This is a front view of the needle tube 3F as viewed from the distal end in the axial direction A, in which cross sections are arranged at equal intervals in the longitudinal axis direction to schematically illustrate changes in the orientation of the cross sections of each blade surface. Figure 29 The single-dot chain line shown represents the intersection of the cross sections perpendicular to the axial direction A arranged at equal intervals in the axial direction A and the first blade face 33, the second blade face 34, the third blade face 35, the fourth blade face 36, the seventh blade face 43 and the eighth blade face 44. Figure 30 yes Figure 27 The cross-sectional view of the needle tube 3F along the line BB is Figure 29 An enlarged cross-sectional view of region S is shown. Figure 31It is a plan view viewed from the radial direction R of the needle tube 3F and in a direction horizontal to the straight line V. Figure 32 It is from Figure 31 A cross-sectional view along the central axis O viewed from the same direction.
[0243] Figure 33 yes Figure 27 The needle tube 3F is shown in a cross-sectional view taken along line AA. Figure 34 yes Figure 27 The needle tube 3F is shown in a cross-sectional view taken along line BB. Figure 35 yes Figure 27 The needle tube 3F is shown in a cross-sectional view along line CC. Line AA passes through the first inner intersection point 33e, the second inner intersection point 34e, the third inner intersection point 35e, and the fourth inner intersection point 36e, which will be described later. Line CC passes through the first proximal end 38 and the second proximal end 39.
[0244] like Figure 26 As shown, the needle tube 3F includes a tubular portion 30, and a first needle tip portion 31F and a second needle tip portion 32F provided at the distal end of the tubular portion 30. The needle tube 3F can be advanced and retracted within the sheath 7 using an operating portion 8. An opening 4 is formed at the distal end of the needle tube 3F. This opening 4 serves as an entrance for tissue pierced through the first needle tip portion 31F and the second needle tip portion 32F to enter the interior of the needle tube 3F. The first needle tip portion 31F and the second needle tip portion 32F of the needle tube 3F can be extended or retracted relative to the opening at the distal end of the sheath 7.
[0245] like Figures 26 to 31 As shown, the first needle tip portion 31F has a first blade surface 33 and a second blade surface 34 , and the first blade surface 33 and the second blade surface 34 extend toward the sharp first needle tip 31 a .
[0246] The outer circumferential surface 31e of the first needle tip portion 31F is a curved surface that is continuous with the outer circumferential surface 30e of the tubular portion 30, and has the same diameter and curvature. Furthermore, the inner circumferential surface 31i of the first needle tip portion 31F is a curved surface that is continuous with the inner circumferential surface 30i of the tubular portion 30, and has the same diameter and curvature. The first needle tip portion 31F is formed by, for example, cutting away a portion of the tubular portion 30 to form the first blade surface 33 and the second blade surface 34.
[0247] like Figures 26 to 29 and Figure 32 As shown, the second needle tip portion 32F has a third blade surface 35 and a fourth blade surface 36, which extend toward the sharp second needle tip 32a. The first needle tip 31a and the second needle tip 32a are arranged at symmetrical positions relative to the central axis O extending along the axial direction A of the needle tube 3F.
[0248] The outer circumferential surface 32e of the second needle tip portion 32F is a curved surface that is continuous with the outer circumferential surface 30e of the tubular portion 30, and has the same diameter and curvature. Furthermore, the inner circumferential surface 32i of the second needle tip portion 32F is a curved surface that is continuous with the inner circumferential surface 30i of the tubular portion 30, and has the same diameter and curvature. The third and fourth blade surfaces 35, 36 are formed in the second needle tip portion 32F by, for example, cutting away a portion of the tubular portion 30.
[0249] like Figures 26 to 32 As shown, the first tip portion 31F and the second tip portion 32F form the edge of an opening 4 surrounded by the first blade surface 33, the second blade surface 34, the third blade surface 35, and the fourth blade surface 36. The opening 4 communicates with the inner space of the tubular portion 30.
[0250] like Figures 26 to 32 As shown, the first blade surface 33 and the third blade surface 35 are connected at a first base end 38 at the edge of the opening 4. The second blade surface 34 and the fourth blade surface 36 are connected at a second base end 39 at the edge of the opening 4B.
[0251] In the first needle tip portion 31F and the second needle tip portion 32F, as shown in FIG. Figure 27 As shown, a tip region Z1 including the first needle tip 31a and the second needle tip 32a, a base region Z3 including the first base end 38 and the second base end 39, and an intermediate region Z2 located between and connected to the tip region Z1 and the base region Z3 are defined. Furthermore, a region of the base region Z3 located closer to the tip than the first base end 38 and the second base end 39 in the axial direction A is defined as a first base region Z31, and a region closer to the base than the first base end 38 and the second base end 39 is defined as a second base region Z32.
[0252] The first and second needle tip portions 31F and 32F have a seventh blade surface 43 and an eighth blade surface 44 on the inner circumferential surface 31i and the inner circumferential surface 32i of the first and second needle tip portions 31F and 32F. The first and second needle tip portions 31F and 32F may have the fifth and sixth blade surfaces 41 and 42 described in the third embodiment in addition to the seventh and eighth blade surfaces 43 and 44, or may have the seventh and eighth blade surfaces 43 and 44 instead of the fifth and sixth blade surfaces 41 and 42.
[0253] (Seventh blade surface 43 and eighth blade surface 44)
[0254] The seventh blade surface 43 is a blade surface formed on the inner peripheral surface 31i of the first needle tip portion 31F and the inner peripheral surface 32i of the second needle tip portion 32F. Figure 29 As shown, the seventh blade surface 43 has a first inner intersection point 33e (see FIG. 1 ) which is an intersection point with the first inner intersection line (first inner edge) 33c. Figure 31) and the third inner intersection point 35e (refer to Figure 32 ).like Figure 28 and Figure 31 As shown, the first inner intersection line 33c is an intersection line formed by the first blade surface 33 and the inner peripheral surface 31i of the first needle tip portion 31F. Figure 28 and Figure 32 As shown, the third inner intersection line 35c is the intersection line formed by the third blade surface 35 and the inner peripheral surface 32i of the second needle tip portion 32F. The seventh blade surface 43 intersects the first inner intersection line 33c at the first inner intersection point 33e, and the seventh blade surface 43 intersects the third inner intersection line 35c at the third inner intersection point 35e.
[0255] like Figures 33 to 35 As shown, the intersection line of the seventh blade surface 43 and the first blade surface 33 is defined as the first intermediate edge 33f. The intersection line of the seventh blade surface 43 and the third blade surface 35 is defined as the third intermediate edge 35f. The first intermediate edge 33f and the third intermediate edge 35f are connected at the first base end 38.
[0256] like Figure 29 and Figure 30 As shown, the angle 33k formed between the seventh blade surface 43 and the first blade surface 33 at the first intermediate edge 33f becomes smaller from the distal end toward the proximal end of the needle tube 3F.
[0257] like Figure 29 and Figure 34 As shown, the angle 35k formed between the seventh blade surface 43 at the third intermediate edge 35f and the third blade surface 35 becomes smaller from the top end toward the base end.
[0258] like Figure 29 As shown, in a cross section perpendicular to the axial direction A, the curvature of the curve formed by the first intermediate edge 33 f and the third intermediate edge 35 f is greater than the curvature of the inner peripheral surface 30 i of the tubular portion 30 .
[0259] like Figures 29 to 32 As shown, in the first base end region Z31, the thickness T2 between the seventh blade surface 43 and the outer peripheral surface 31e of the first needle tip portion 31F becomes thinner as it moves from the first inner intersection 33e toward the first base end 38. Similarly, in the first base end region Z31, the thickness T2 becomes thinner as it moves from the third inner intersection 35e toward the first base end 38.
[0260] like Figures 29 to 32As shown, in the second proximal end region Z32, the thickness T2 between the seventh blade surface 43 and the outer peripheral surface 31e of the first needle tip portion 31F increases as it moves from the first proximal end 38 toward the proximal end of the needle tube 3F. Similarly, in the second proximal end region Z32, the thickness T2 between the seventh blade surface 43 and the outer peripheral surface 32e of the second needle tip portion 32F increases as it moves from the first proximal end 38 toward the proximal end of the needle tube 3F. In other words, the thickness T1 between the seventh blade surface 43 and the outer peripheral surfaces 31e, 32e decreases as it moves from the proximal end of the seventh blade surface toward the first proximal end 38.
[0261] In a side view viewed from a direction perpendicular to the central axis O and the straight line V, the first inner intersection point 33e and the third inner intersection point 35e are formed at positions symmetrical with respect to the central axis O extending in the axial direction A of the needle tube 3F. Figure 31 and Figure 32 As shown, the first inner intersection point 33 e and the third inner intersection point 35 e are located at the top end of the seventh blade surface 43 .
[0262] The intersection line formed by the seventh blade surface 43 and the inner peripheral surface 31i of the first needle tip portion 31F is defined as a seventh intersection line 430. Figure 28 As shown, the interval between the first portion 431 connected to the inner circumferential surface 31i in the seventh intersection line 430 and the third portion 432 connected to the inner circumferential surface 32i in the seventh intersection line 430 gradually narrows as it goes from the top end of the seventh blade surface 43 toward the base end.
[0263] like Figure 32 As shown, a first proximal edge 38f is formed in the second proximal end region Z32, with the first proximal end 38 as its apex. The first proximal edge 38f is a sharp edge formed by the seventh blade surface 43 and the outer peripheral surfaces 31e and 32e. By reducing the thickness T2 at the first proximal end 38, the resistance experienced by the first proximal end 38 from the tissue when the needle tube 3F is inserted into body tissue can be reduced. Furthermore, the first proximal edge 38f is formed by reducing the apical angle formed by the seventh blade surface 43 and the outer peripheral surfaces 31e and 32e at the first proximal end 38.
[0264] The eighth blade surface 44 is a blade surface formed on the inner peripheral surface 31i of the first needle tip portion 31F and the inner peripheral surface 32i of the second needle tip portion 32E. Figure 29 As shown, the eighth blade surface 44 has a second inner intersection point 34e (see FIG. 1 ) which is an intersection point with the second inner intersection line (second inner edge) 34c. Figure 31 ) and the fourth inner intersection point 36e (refer to Figure 32 ).like Figure 27 and Figure 31 As shown, the second inner intersection line 34c is an intersection line formed by the second blade surface 34 and the inner peripheral surface 31i of the first needle tip portion 31F. Figure 27 and Figure 32 As shown, the fourth inner intersection line 36c is the intersection line formed by the fourth blade surface 36 and the inner peripheral surface 32i of the second needle tip portion 32F. The eighth blade surface 44 intersects the second inner intersection line 34c at the second inner intersection point 34e, and the eighth blade surface 44 intersects the fourth inner intersection line 36c at the fourth inner intersection point 36e.
[0265] like Figures 33 to 35 As shown, the intersection line of the eighth blade surface 44 and the second blade surface 34 is the second intermediate edge 34f. The intersection line of the eighth blade surface 44 and the fourth blade surface 36 is the fourth intermediate edge 36f. The second intermediate edge 34f and the fourth intermediate edge 36f are connected at the second base end 39.
[0266] like Figure 29 and Figure 34 As shown, the angle 34k formed between the eighth blade surface 44 and the second blade surface 34 at the second intermediate edge 34f becomes smaller from the distal end toward the proximal end of the needle tube 3F.
[0267] like Figure 29 and Figure 34 As shown, the angle 36k formed between the eighth blade surface 44 at the fourth intermediate edge 36f and the fourth blade surface 36 becomes smaller from the distal end toward the proximal end of the needle tube 3F.
[0268] like Figure 29 As shown, in a cross section perpendicular to the axial direction A, the curvature of the curve formed by the second middle edge 34 f and the fourth middle edge 36 f is greater than the curvature of the inner circumferential surface 30 i of the tubular portion 30 .
[0269] like Figures 29 to 32 As shown, in the first base end region Z31, the thickness T2 between the eighth blade surface 44 and the outer peripheral surface 31e of the first needle tip portion 31F becomes thinner as it moves from the second inner intersection 34e toward the second base end 39. Similarly, in the first base end region Z31, the thickness T2 becomes thinner as it moves from the fourth inner intersection 36e toward the second base end 39.
[0270] like Figures 29 to 32 As shown, in the second proximal end region Z32, the thickness T2 between the eighth blade surface 44 and the outer peripheral surface 31e of the first needle tip portion 31F increases as it moves from the second proximal end 39 toward the proximal end of the needle tube 3F. Similarly, the thickness T2 between the eighth blade surface 44 and the outer peripheral surface 32e of the second needle tip portion 32F increases as it moves from the second proximal end 39 toward the proximal end of the needle tube 3F. In other words, the thickness T1 between the eighth blade surface 44 and the outer peripheral surfaces 31e and 32e decreases as it moves from the proximal end of the eighth blade surface toward the second proximal end 39.
[0271] In a side view viewed from a direction perpendicular to the central axis O and the straight line V, the second inner intersection point 34e and the fourth inner intersection point 36e are formed at positions symmetrical with respect to the central axis O extending in the axial direction A of the needle tube 3F. Figure 31 and Figure 32 As shown, the second inner intersection point 34 e and the fourth inner intersection point 36 e are located at the top end of the eighth blade surface 44 .
[0272] The intersection line formed by the eighth blade surface 44 and the inner peripheral surface 31i of the first needle tip portion 31F is defined as an eighth intersection line 440. Figure 27 As shown, the interval between the first portion 441 connected to the inner circumferential surface 31i in the eighth intersection line 440 and the third portion 442 connected to the inner circumferential surface 32i in the eighth intersection line 440 gradually narrows as it goes from the top end of the eighth blade surface 44 toward the base end.
[0273] like Figure 32 As shown, a second proximal edge 39f is formed in the second proximal region Z32, with the second proximal end 39 as its apex. The second proximal edge 39f is a sharp edge formed by the eighth blade surface 44 and the outer peripheral surfaces 31e and 32e. By reducing the thickness T2 at the second proximal end 39, the resistance experienced by the second proximal end 39 from the tissue when the needle tube 3F is inserted into body tissue can be reduced. Furthermore, the second proximal edge 39f is formed by reducing the apical angle formed by the eighth blade surface 44 and the outer peripheral surfaces 31e and 32e at the second proximal end 39.
[0274] The seventh blade surface 43 and the eighth blade surface 44 are formed, for example, by cutting the inner peripheral surface 30i of the tubular portion 30 of the needle tube 3F. Figure 29 As shown, in a front view viewed from a direction along the axial direction A of the needle tube 3F (tubular portion 30), the first inner intersection point 33e and the second inner intersection point 34e are formed at positions symmetrical with respect to a straight line V passing through the first needle tip 31a and the second needle tip 32a. Furthermore, it is also preferable that, in the same front view, the third inner intersection point 35e and the fourth inner intersection point 36e are formed at positions symmetrical with respect to a straight line V passing through the first needle tip 31a and the second needle tip 32a.
[0275] Using the biopsy system 150F having the puncture needle 1F of this embodiment, not only the first outer edge 33b, the second outer edge 34b, the third outer edge 35b, and the fourth outer edge 36b, but also the first base end edge 38f and the second base end edge 39f cut into the body tissue, making it easy to extract the body tissue (the specimen required for diagnosis).
[0276] A biopsy system 150F equipped with the puncture needle 1F of this embodiment has high puncture performance for body tissue, making it easy to retrieve excised body tissue within the puncture needle 1F. Compared to the needle tube 3 of the first embodiment, the needle tube 3F has thinner and sharper first and second proximal ends 38 and 39, resulting in improved puncture performance in addition to extraction performance. As in the first embodiment, the normal vector 33n of the first blade face 33 and the normal vector 34n of the second blade face 34 in the tip region Z1 are oriented toward the third blade face 35 and the fourth blade face 36 in the tip region Z1, respectively, relative to a direction perpendicular to the line V passing through the first and second needle tips 31a and 32a. Furthermore, in this front view, the normal vector 35n of the third blade face 35 and the normal vector 36n of the fourth blade face 36 in the tip region Z1 are oriented toward the first and second blade faces 33 and 34 in the tip region Z1, relative to a direction perpendicular to the line V passing through the first and second needle tips 31a and 32a. Therefore, the puncture needle 1F can appropriately move the target tissue T into the interior of the needle tube 3 .
[0277] Figure 36 It is aimed at Figure 29 In the figure, arrows are used to indicate the normal lines of the main blade surfaces, such as the first blade surface 33, in a cross section perpendicular to the axial direction A. In the needle tube 3F, as the needle tube 3F moves from the distal end toward the proximal end, the normal lines of the blade surfaces are oriented in a direction closer to the central axis O than in the circumferential direction C of the tubular portion 30. As a result, the needle tube 3F has a higher extraction performance than the needle tube 3 of the first embodiment.
[0278] The fourth embodiment of the present invention has been described in detail with reference to the accompanying drawings, but the specific structure is not limited to this embodiment and includes design changes within the scope of the present invention. In addition, the components shown in the above-mentioned embodiments and modifications can be appropriately combined and configured.
[0279] (Fifth embodiment)
[0280] Reference Figures 37 to 48 A biopsy system 150G including an endoscopic puncture needle 1G according to a fifth embodiment of the present invention will be described. In the following description, components common to those already described will be denoted by the same reference numerals, and duplicate descriptions will be omitted. The endoscopic puncture needle 1G differs from the endoscopic puncture needle 1 according to the first embodiment in the shape of its blade surface.
[0281] [Biopsy System 150G]
[0282] The biopsy system 150G is a medical device used to extract tissue from the body during a biopsy. The biopsy system 150G includes an ultrasonic endoscope 100 and an endoscope puncture needle 1G (hereinafter referred to as "puncture needle 1G"). The puncture needle 1G includes an insertion body 2G, an operating unit 8, and a stylet 27.
[0283] [Insert 2G]
[0284] The insertion body 2G is an elongated member that can be inserted into the channel 107 of the ultrasonic endoscope 100. The insertion body 2G includes a needle tube 3G and a sheath 7.
[0285] Figure 37 This is a three-dimensional diagram of needle tube 3G. Figure 38 This is a front view of the needle tube 3G. Figure 39 It is a side view of needle tube 3G. Figure 40 The needle tube 3G is from Figure 39 A cross-sectional view along the central axis O viewed from the same direction. Figure 41 This is a front view of the needle tube 3G as viewed from the distal end in the axial direction A, in which cross sections are arranged at equal intervals in the longitudinal axis direction to schematically illustrate changes in the orientation of the cross sections of each blade surface. Figure 41 The dashed lines shown indicate intersections of the cross sections perpendicular to the axial direction A arranged at equal intervals in the axial direction A with the first blade face 33G, the second blade face 34G, the third blade face 35G, and the fourth blade face 36G. Figure 42 This is a plan view viewed from a direction horizontal to the straight line V. Figure 43 It is from Figure 42 A cross-sectional view along the central axis O viewed from the same direction.
[0286] Figure 44 yes Figure 39 The needle tube 3G is shown in a cross-sectional view taken along line DD. Figure 45 yes Figure 39 The needle tube 3G is shown in a cross-sectional view taken along line EE. Figure 46 yes Figure 39 The needle tube 3G is shown in a cross-sectional view taken along line FF. Line FF passes through a first proximal end 38G and a second proximal end 39G, which will be described later. Figure 47 yes Figure 39 A cross-sectional view of the needle tube 3G taken along line GG is shown.
[0287] like Figure 37 As shown, the needle tube 3G includes a tubular portion 30, and a first needle tip portion 31G and a second needle tip portion 32G provided at the distal end of the tubular portion 30. The needle tube 3G can be advanced and retracted within the sheath 7 using the operating portion 8. An opening 4G is formed at the distal end of the needle tube 3G. This opening 4G serves as an entrance for tissue pierced by the first needle tip portion 31G and the second needle tip portion 32G to enter the interior of the needle tube 3G. The first needle tip portion 31G and the second needle tip portion 32G of the needle tube 3G can be extended or retracted relative to the opening at the distal end of the sheath 7.
[0288] like Figures 37 to 43As shown, the first needle tip portion 31G has a first outer edge 33b and a second outer edge 34b formed along the outer peripheral surface 31e of the first needle tip portion 31G. The first outer edge 33b and the second outer edge 34b extend toward the sharp first needle tip 31a. In the front view viewed from the direction along the axial direction A of the needle tube 3G (tubular portion 30), as shown in FIG. Figure 38 As shown, the first outer edge 33b and the second outer edge 34b are symmetrical with respect to a straight line V passing through the first needle tip 31a and the second needle tip 32a. The first outer edge 33b and the second outer edge 34b are formed by, for example, cutting away a portion of the tubular portion 30.
[0289] The outer circumferential surface 31e of the first needle tip portion 31G is a curved surface continuous with the outer circumferential surface 30e of the tubular portion 30 and has the same diameter and curvature. Furthermore, the inner circumferential surface 31i of the first needle tip portion 31G is a curved surface continuous with the inner circumferential surface 30i of the tubular portion 30 and has the same diameter and curvature.
[0290] like Figures 37 to 43 As shown, the second needle tip portion 32G has a third outer edge 35b and a fourth outer edge 36b formed along the outer peripheral surface 31e of the first needle tip portion 31G. The third outer edge 35b and the fourth outer edge 36b extend toward the sharp second needle tip 32a. The first needle tip 31a and the second needle tip 32a are arranged at positions symmetrical with respect to the central axis O extending along the axial direction A of the needle tube 3G. In the front view viewed from the direction along the axial direction A of the needle tube 3G, as shown in FIG. Figure 38 As shown, the third outer edge 35b and the fourth outer edge 36b are symmetrical with respect to the straight line V passing through the first needle tip 31a and the second needle tip 32a. The third outer edge 35b and the fourth outer edge 36b are formed by, for example, cutting away a portion of the tubular portion 30.
[0291] The outer circumferential surface 32e of the second needle tip portion 32G is a curved surface continuous with the outer circumferential surface 30e of the tubular portion 30, and has the same diameter and curvature. The inner circumferential surface 32i of the second needle tip portion 32G is a curved surface continuous with the inner circumferential surface 30i of the tubular portion 30, and has the same diameter and curvature.
[0292] like Figures 37 to 43 As shown, the base end of the first outer edge 33b and the base end of the third outer edge 35b are connected at the first base end 38G. The base end of the second outer edge 34b and the base end of the fourth outer edge 36b are connected at the second base end 39G. Figure 39 and Figure 40 As shown, in a side view viewed from a direction perpendicular to the central axis O and the straight line V, the first base end 38G and the second base end 39G are formed at symmetrical positions with respect to the central axis O extending in the axial direction A of the needle tube 3G.
[0293] In the first needle tip portion 31G and the second needle tip portion 32G, as shown in FIG. Figure 39 and Figure 40 As shown, a tip region Z1 including the first needle tip 31a and the second needle tip 32a, a base region Z3 including the first base end 38G and the second base end 39G, and an intermediate region Z2 located between and connected to the tip region Z1 and the base region Z3 are defined. Furthermore, a region of the base region Z3 located closer to the tip than the first base end 38G and the second base end 39G in the axial direction A is defined as a first base region Z31, and a region closer to the base than the first base end 38G and the second base end 39G is defined as a second base region Z32.
[0294] (First continuous blade surface 401 and second continuous blade surface 402)
[0295] like Figure 37 and Figure 38 As shown, the first needle tip portion 31G and the second needle tip portion 32G have a first continuous blade surface 401 and a second continuous blade surface 402 .
[0296] The first continuous blade surface 401 is a continuous curved surface formed on the inner circumference 31i of the first needle tip portion 31G and the inner circumference 32i of the second needle tip portion 32G. The first continuous blade surface 401 extends between the first needle tip portion 31G and the second needle tip portion 32G. Figure 38 and Figure 40 As shown, the first continuous blade surface 401 extends from the first needle tip 31a toward the proximal end of the needle tube 3G. Furthermore, the first continuous blade surface 401 extends from the second needle tip 32a toward the proximal end of the needle tube 3G. The proximal end of the first continuous blade surface 401 is located closer to the proximal end of the needle tube 3G than the first proximal end 38G of the edge of the opening 4G.
[0297] like Figure 37 As shown, the first continuous blade surface 401 has a first continuous blade surface outer edge 401b, which is the intersection of the first continuous blade surface 401, the outer peripheral surface 31e of the first needle tip portion 31G, and the outer peripheral surface 32e of the second needle tip portion 32G. The base end of the first continuous blade surface outer edge 401b is consistent with the first base end 38G. Figure 40 and Figure 42 As shown, the thickness T3 between the first continuous blade surface 401 and the outer peripheral surface 31e of the first needle tip portion 31G becomes thinner as it approaches the first base end 38G from the base end of the first continuous blade surface inner edge 401c (the base end of the first continuous blade surface 401). Figure 40 and Figure 43As shown, the thickness T3 between the first continuous blade surface 401 and the outer peripheral surface 32e of the second needle tip portion 32G decreases as it moves from the base end of the first continuous blade surface inner edge 401c (the base end of the first continuous blade surface 401) toward the first base end 38G. Furthermore, the first continuous blade surface inner edge 401c is the intersection of the first continuous blade surface 401 and the inner peripheral surfaces 31i and 32i, and is located radially inward of the needle tube 3G relative to the first outer edge 33b and the third outer edge 35b.
[0298] like Figure 39 and Figure 40 As shown, in a side view viewed from a direction perpendicular to the central axis O and the straight line V, the first continuous blade surface inner edge 401c extends from the proximal end of the first tip intersection line 31b extending from the first needle tip 31a toward the proximal end of the needle tube 3G. Furthermore, the first continuous blade surface inner edge 401c extends from the proximal end of the second tip intersection line 32b extending from the second needle tip 32a toward the proximal end of the needle tube 3G. The proximal end of the first continuous blade surface inner edge 401c is located closer to the proximal end of the needle tube 3G than the first proximal end 38G. At the proximal end of the first continuous blade surface inner edge 401c, the portion extending from the proximal end of the first tip intersection line 31b toward the proximal end of the needle tube 3G is connected to the portion extending from the proximal end of the second tip intersection line 32b toward the proximal end of the needle tube 3G.
[0299] like Figure 40 As shown, the first continuous blade surface 401 includes a first blade surface 33G that is connected to the first outer edge 33b and is closer to the top end than the first base end 38G, a third blade surface 35G that is connected to the third outer edge 35b and is closer to the top end than the first base end 38G, and a seventh blade surface 43G that is closer to the base end than the first base end 38G. The first blade surface 33G and the seventh blade surface 43G are continuously connected curved surfaces, preferably without a height difference between the first blade surface 33G and the seventh blade surface 43G. The third blade surface 35G and the seventh blade surface 43G are continuously connected curved surfaces, preferably without a height difference between the third blade surface 35G and the seventh blade surface 43G.
[0300] The second continuous blade surface 402 is a continuous curved surface formed on the inner circumference 31i of the first needle tip portion 31G and the inner circumference 32i of the second needle tip portion 32G. The second continuous blade surface 402 extends between the first needle tip portion 31G and the second needle tip portion 32G. Figure 38 and Figure 39 As shown, the second continuous blade surface 402 extends from the first needle tip 31a toward the proximal end of the needle tube 3G. Furthermore, the second continuous blade surface 402 extends from the second needle tip 32a toward the proximal end of the needle tube 3G. The proximal end of the second continuous blade surface 402 is located closer to the proximal end of the needle tube 3G than the second proximal end 39G of the edge of the opening 4G.
[0301] like Figure 37As shown, the second continuous blade surface 402 has a second continuous blade surface outer edge 402b, which is the intersection of the second continuous blade surface 402, the outer peripheral surface 31e of the first needle tip portion 31G, and the outer peripheral surface 32e of the second needle tip portion 32G. The base end of the second continuous blade surface outer edge 402b is consistent with the second base end 39G. Figure 39 and Figure 42 As shown, the thickness T3 between the second continuous blade surface 402 and the outer peripheral surface 31e of the first needle tip portion 31G becomes thinner as it approaches the second base end 39G from the base end of the second continuous blade surface inner edge 402c (the base end of the second continuous blade surface 402). Figure 39 and Figure 43 As shown, the thickness T3 between the second continuous blade surface 402 and the outer peripheral surface 32e of the second needle tip portion 32G decreases as it moves from the base end of the second continuous blade surface inner edge 402c (the base end of the second continuous blade surface 402) toward the second base end 39G. Furthermore, the second continuous blade surface inner edge 402c is the intersection of the second continuous blade surface 402 and the inner peripheral surfaces 31i, 32i, and is located radially inward of the needle tube 3G relative to the second outer edge 34b and the fourth outer edge 36b.
[0302] like Figure 39 As shown, in a side view viewed from a direction perpendicular to the central axis O and the straight line V, the second continuous blade surface inner edge 402c extends from the proximal end of the first tip intersection line 31b extending from the first needle tip 31a toward the proximal end of the needle tube 3G. Furthermore, the second continuous blade surface inner edge 402c extends from the proximal end of the second tip intersection line 32b extending from the second needle tip 32a toward the proximal end of the needle tube 3G. The proximal end of the second continuous blade surface inner edge 402c is located closer to the proximal end of the needle tube 3G than the second proximal end 39G. At the proximal end of the second continuous blade surface inner edge 402c, the portion extending from the proximal end of the first tip intersection line 31b toward the proximal end of the needle tube 3G is connected to the portion extending from the proximal end of the second tip intersection line 32b toward the proximal end of the needle tube 3G.
[0303] like Figure 39 As shown, the second continuous blade surface 402 includes a second blade surface 34G that is connected to the second outer edge 34b and is closer to the top end than the second base end 39G, a fourth blade surface 36G that is connected to the fourth outer edge 36b and is closer to the top end than the second base end 39G, and an eighth blade surface 44G that is closer to the base end than the second base end 39G. The second blade surface 34G and the eighth blade surface 44G are continuously connected curved surfaces, preferably without a height difference between the second blade surface 34G and the eighth blade surface 44G. The fourth blade surface 36G and the eighth blade surface 44G are continuously connected curved surfaces, preferably without a height difference between the fourth blade surface 36G and the eighth blade surface 44G.
[0304] In the front view viewed from the direction along the axial direction A of the needle tube 3G, as shown in FIG. Figure 38 and Figure 41 As shown, the first continuous blade surface 401 and the second continuous blade surface 402 are symmetrical with respect to the straight line V.
[0305] like Figure 38 As shown, the intersection line of the first blade surface 33G and the second blade surface 34G (first tip intersection line 31b) extends from the tip of the inner peripheral surface 31i of the first needle tip portion 31G to the first needle tip 31a. In the front view viewed from the direction along the axial direction A of the needle tube 3G, the first tip intersection line 31b is located on the straight line V.
[0306] like Figure 38 As shown, the intersection line (second top intersection line 32b) of the third blade surface 35G and the fourth blade surface 36G extends from the top of the inner peripheral surface 31i of the second needle tip portion 32G to the first needle tip 31a. In the front view seen from the direction along the axial direction A of the needle tube 3G, the second top intersection line 32b is located on the straight line V.
[0307] like Figure 37 and Figure 41 As shown, the first needle tip portion 31G and the second needle tip portion 32G form an opening 4G surrounded by the first blade surface 33G, the second blade surface 34G, the third blade surface 35G, and the fourth blade surface 36G. The opening 4G communicates with the inner space of the tubular portion 30 .
[0308] like Figure 41 As shown, the first blade surface 33G, the second blade surface 34G, the third blade surface 35G, and the fourth blade surface 36G are curved surfaces, and the curvature of each curved surface is equal in a front view seen from the direction along the axial direction A of the needle tube 3G.
[0309] (First blade surface 33G)
[0310] The first blade surface 33G is formed into a curved surface. Figures 44 to 46 As shown, in a front view seen from the direction along the axial direction A of the needle tube 3G, the ridge line of the first blade surface 33G extends in an arc shape that is concave toward the outer peripheral surface 31e.
[0311] like Figure 44 As shown, in the main view observed from the direction along the axial direction A of the needle tube 3G, the normal vector 33n of the first blade surface 33G in the top area Z1 is directed toward the third blade surface 35G side in the top area Z1 compared to the direction orthogonal to the straight line V at any position on the curved surface.
[0312] like Figure 45 As shown, the normal vector 33n of the first blade surface 33G in the middle region Z2 is also directed toward the third blade surface 35G side in the middle region Z2 rather than the direction perpendicular to the straight line V as in the tip region Z1.
[0313] The first outer edge 33b is an intersection line (first outer intersection line 33b) where the first blade surface 33G (first continuous blade surface 401) intersects the outer peripheral surface 31e, and has an edge in the circumferential direction of the tubular portion 30. The first outer edge 33b is a portion of the first continuous blade surface outer edge 401b. Figures 44 to 46 As shown, in the main view observed from the direction along the axial direction A of the needle tube 3G, the angle θ1 formed by the first blade surface 33G (first continuous blade surface 401) at the first outer edge 33b (first continuous blade surface outer edge 401b) and the outer peripheral surface 31e is an acute angle from the top end area Z1 to the first base end area Z31 (the first base end 38G of the edge of the opening 4G).
[0314] The intersection line (first inner intersection line 33c) where the first blade surface 33G intersects the inner peripheral surface 31i is a first inner edge 33c having an edge in the circumferential direction of the tubular portion 30. The first inner edge 33c is a portion of the first continuous blade surface inner edge 401c. Figures 44 to 46 As shown, in the main view observed from the direction along the axial direction A of the needle tube 3G, the angle θ2 formed by the first blade surface 33G (first continuous blade surface 401) at the first inner edge 33c (first continuous blade surface inner edge 401c) and the inner peripheral surface 31i is an obtuse angle from the top end area Z1 to the first base end area Z31 (the first base end 38G of the edge of the opening 4G).
[0315] (Second blade surface 34G)
[0316] The second blade surface 34G is formed into a curved surface. Figures 44 to 46 As shown, in a front view seen from the direction along the axial direction A of the needle tube 3G, the ridge line of the second blade surface 34G extends in an arc shape that is concave toward the outer peripheral surface 31e.
[0317] like Figure 44 As shown, in the main view observed from the direction along the axial direction A of the needle tube 3G, the normal vector 34n of the second blade surface 34G in the top area Z1 is directed toward the side of the fourth blade surface 36G in the top area Z1 compared to the direction orthogonal to the straight line V at any position on the curved surface.
[0318] like Figure 45 As shown, the normal vector 34n of the second blade surface 34G in the middle region Z2 is also directed toward the fourth blade surface 36G side in the middle region Z2 rather than the direction perpendicular to the straight line V as in the tip region Z1.
[0319] The second outer edge 34b is an intersection line (second outer intersection line 34b) where the second blade surface 34G (second continuous blade surface 402) intersects the outer peripheral surface 31e, and has an edge in the circumferential direction of the tubular portion 30. The second outer edge 34b is a portion of the second continuous blade surface outer edge 402b. Figures 44 to 46As shown, in the main view observed from the direction along the axial direction of the needle tube 3G, the angle θ3 formed by the second blade surface 34G (second continuous blade surface 402) at the second outer edge 34b (second continuous blade surface outer edge 402b) and the outer peripheral surface 31e is an acute angle from the top end area Z1 to the first base end area Z31 (the second base end 39G of the edge of the opening 4G).
[0320] The intersection line (second inner intersection line 34c) where the second blade surface 34G intersects the inner peripheral surface 31i is a second inner edge 34c having an edge in the circumferential direction of the tubular portion 30. The second inner edge 34c is a portion of the second continuous blade surface inner edge 402c. Figures 44 to 46 As shown, in the main view observed from the direction along the axial direction A of the needle tube 3G, the angle θ4 formed by the second blade surface 34G (second continuous blade surface 402) at the second inner edge 34c (second continuous blade surface inner edge 402c) and the inner peripheral surface 31i is an obtuse angle from the top end area Z1 to the first base end area Z31 (the second base end 39G of the edge of the opening 4G).
[0321] (Third blade surface 35G)
[0322] The third blade surface 35G is formed into a curved surface. Figures 44 to 46 As shown, in a front view seen from the direction along the axial direction A of the needle tube 3G, the ridge line of the third blade surface 35G extends in an arc shape that is concave toward the outer peripheral surface 32e.
[0323] like Figure 44 As shown, in the main view observed from the direction along the axial direction A of the needle tube 3G, the normal vector 35n of the third blade surface 35G in the top area Z1 is directed toward the first blade surface 33G side in the top area Z1 compared to the direction orthogonal to the straight line V at any position on the curved surface.
[0324] like Figure 45 As shown, the normal vector 35n of the third blade surface 35G in the intermediate region Z2 is also directed toward the first blade surface 33G side in the intermediate region Z2 rather than the direction perpendicular to the straight line V as in the distal region Z1.
[0325] The third outer edge 35b is an intersection line (third outer intersection line 35b) where the third blade surface 35G (first continuous blade surface 401) intersects the outer peripheral surface 32e, and has an edge in the circumferential direction of the tubular portion 30. The third outer edge 35b is a portion of the first continuous blade surface outer edge 401b. Figures 44 to 46 As shown, in the main view observed from the direction along the axial direction A of the needle tube 3G, the angle θ5 formed by the third blade surface 35G (first continuous blade surface 401) at the third outer edge 35b (first continuous blade surface outer edge 401b) and the outer peripheral surface 32e is an acute angle from the top end area Z1 to the first base end area Z31 (the first base end 38G of the edge of the opening 4G).
[0326] The intersection line (third inner intersection line 35c) where the third blade surface 35G intersects the inner peripheral surface 32i is a third inner edge 35c having an edge in the circumferential direction of the tubular portion 30. The third inner edge 35c is a portion of the first continuous blade surface inner edge 401c. Figures 44 to 46 As shown, in the main view observed from the direction along the axial direction A of the needle tube 3G, the angle θ6 formed by the third blade surface 35G (first continuous blade surface 401) at the third inner edge 35c (first continuous blade surface inner edge 401c) and the inner peripheral surface 32i is an obtuse angle from the top end area Z1 to the first base end area Z31 (the first base end 38G of the edge of the opening 4G).
[0327] (Fourth blade surface 36G)
[0328] The fourth blade surface 36G is formed into a curved surface. Figures 44 to 46 As shown, in a front view seen from the direction along the axial direction A of the needle tube 3G, the ridge line of the fourth blade surface 36G extends in an arc shape that is concave toward the outer peripheral surface 32e.
[0329] like Figure 44 As shown, in the main view observed from the direction along the axial direction A of the needle tube 3G, the normal vector 36n of the fourth blade surface 36G in the top area Z1 is toward the side of the second blade surface 34G in the top area Z1 compared to the direction orthogonal to the straight line V at any position on the curved surface.
[0330] like Figure 45 As shown, the normal vector 36n of the fourth blade surface 36G in the middle region Z2 is also directed toward the second blade surface 34G side in the middle region Z2 rather than the direction perpendicular to the straight line V as in the tip region Z1.
[0331] The fourth outer edge 36b is an intersection line (fourth outer intersection line 36b) where the fourth blade surface 36G (second continuous blade surface 402) intersects the outer peripheral surface 32e, and has an edge in the circumferential direction of the tubular portion 30. The fourth outer edge 36b is a portion of the second continuous blade surface outer edge 402b. Figures 44 to 46 As shown, in the main view observed from the direction along the axial direction of the needle tube 3G, the angle θ7 formed by the fourth blade surface 36G (second continuous blade surface 402) at the fourth outer edge 36b (second continuous blade surface outer edge 402b) and the outer peripheral surface 32e is an acute angle from the top end area Z1 to the first base end area Z31 (the second base end 39G of the edge of the opening 4G).
[0332] The intersection line (fourth inner intersection line 36c) where the fourth blade surface 36G intersects the inner peripheral surface 32i is a fourth inner edge 36c having an edge in the circumferential direction of the tubular portion 30. The fourth inner edge 36c is a portion of the second continuous blade surface inner edge 402c. Figures 44 to 46As shown, in the main view observed from the direction along the axial direction A of the needle tube 3G, the angle θ8 formed by the fourth blade surface 36G (second continuous blade surface 402) at the fourth inner edge 36c (second continuous blade surface inner edge 402c) and the inner peripheral surface 32i is an obtuse angle from the top end area Z1 to the first base end area Z31 (the second base end 39G of the edge of the opening 4G).
[0333] (Seventh Blade 43G)
[0334] The seventh blade surface 43G is formed closer to the base end than the first base end 38G. The seventh blade surface 43G forms a portion of the inner circumferential surface 31i of the first needle tip portion 31G and the inner circumferential surface 32i of the second needle tip portion 32G. The seventh blade surface 43G is a curved surface shape that is continuously connected to the first blade surface 33G and the third blade surface 35G. It is preferably continuous without any height difference between the first blade surface 33G and the seventh blade surface 43G, and between the third blade surface 35G and the seventh blade surface 43G.
[0335] like Figure 39 and Figure 47 As shown, in the cross section perpendicular to the axial direction A, the curvature of the curve formed by the seventh blade surface 43G is greater than the curvature of the inner peripheral surface 30 i of the tubular portion 30 .
[0336] like Figure 42 As shown, the thickness T3 between the seventh blade surface 43G (first continuous blade surface 401) and the outer peripheral surface 31e of the first needle tip portion 31E becomes thinner as it moves from the base end of the seventh blade surface 43G (the base end of the first continuous blade surface 401) toward the first base end 38G. Figure 43 As shown, the thickness T3 between the seventh blade surface 43G (first continuous blade surface 401) and the outer peripheral surface 32e of the second needle tip portion 32E becomes thinner from the base end of the seventh blade surface 43G (the base end of the first continuous blade surface 401) toward the first base end 38G.
[0337] like Figure 42 and Figure 43 As shown, a first proximal edge 38g is formed in the second proximal region Z32, with the first proximal end 38G as its apex. The first proximal edge 38g is a sharp edge formed by the seventh blade surface 43G and the outer peripheral surfaces 31e and 32e. By reducing the thickness T3 at the first proximal end 38G, the resistance experienced by the first proximal end 38G from the tissue when the needle tube 3G is inserted into body tissue can be reduced. Furthermore, the first proximal edge 38g is formed by reducing the apical angle formed by the seventh blade surface 43G and the outer peripheral surfaces 31e and 32e at the first proximal end 38G.
[0338] (Eighth Blade Surface 44G)
[0339] The eighth blade surface 44G is formed closer to the base end than the second base end 39G. The eighth blade surface 44G forms a portion of the inner circumferential surface 31i of the first needle tip portion 31G and the inner circumferential surface 32i of the second needle tip portion 32G. The eighth blade surface 44G is a curved surface shape that is continuously connected to the second blade surface 34G and the fourth blade surface 36G. It is preferably continuous without any height difference between the second blade surface 34G and the eighth blade surface 44G, and between the fourth blade surface 36G and the eighth blade surface 44G.
[0340] like Figure 39 and Figure 47 As shown, in the cross section perpendicular to the axial direction A, the curvature of the curve formed by the eighth blade surface 44G is greater than the curvature of the inner peripheral surface 30 i of the tubular portion 30 .
[0341] like Figure 42 As shown, the thickness T3 between the eighth blade surface 44G (the second continuous blade surface 402) and the outer peripheral surface 31e of the first needle tip portion 31E becomes thinner as it moves from the base end of the eighth blade surface 44G (the base end of the second continuous blade surface 402) toward the second base end 39G. Figure 43 As shown, the thickness T3 between the eighth blade surface 44G (second continuous blade surface 402) and the outer peripheral surface 32e of the second needle tip portion 32E becomes thinner from the base end of the eighth blade surface 44G (the base end of the second continuous blade surface 402) toward the second base end 39G.
[0342] like Figure 42 and Figure 43 As shown, a second proximal end edge 39g is formed in the second proximal end region Z32, with the second proximal end 39G as its apex. The second proximal end edge 39g is a sharp edge formed by the eighth blade surface 44G and the outer peripheral surfaces 31e and 32e. By reducing the thickness T3 at the second proximal end 39G, the resistance experienced by the second proximal end 39G from the tissue when the needle tube 3G is inserted into body tissue can be reduced. Furthermore, the second proximal end edge 39g is formed by reducing the apical angle formed by the eighth blade surface 44G and the outer peripheral surfaces 31e and 32e at the second proximal end 39G.
[0343] Using the biopsy system 150G having the puncture needle 1G of this embodiment, not only the first outer edge 33b, the second outer edge 34b, the third outer edge 35b, and the fourth outer edge 36b, but also the first base end edge 38g and the second base end edge 39g cut into the body tissue, making it easy to extract the body tissue (the specimen required for diagnosis).
[0344] A biopsy system 150G equipped with the puncture needle 1G of this embodiment provides enhanced puncture performance for body tissue (the puncture needle 1G easily penetrates the body tissue), making it easier to retrieve excised body tissue (the specimen required for diagnosis) within the puncture needle 1G. Compared to the needle tube 3 of the first embodiment, the needle tube 3G has thinner and sharper first and second proximal ends 38G and 39G, resulting in enhanced puncture performance and retraction. Furthermore, the needle tube 3G has acute angles at the first, second, third, and fourth outer edges 33b, 34b, 35b, and 36b in the tip region Z1, the middle region Z2, and the first proximal region Z31, further enhancing puncture performance.
[0345] Figure 48 It is aimed at Figure 41 In the figure, arrows are used to indicate the normal lines of the first blade surface 33G and other blade surfaces in a cross section perpendicular to the axial direction A. As the needle tube 3G moves from the distal end toward the proximal end, the normal lines of the blade surfaces are oriented in a direction closer to the central axis O than in the circumferential direction C of the tubular portion 30. As a result, the needle tube 3G has a higher extraction performance than the needle tube 3 of the first embodiment.
[0346] The fifth embodiment of the present invention has been described in detail with reference to the accompanying drawings, but the specific structure is not limited to this embodiment and includes design changes within the scope of the present invention. In addition, the components shown in the above embodiments and modifications can be appropriately combined and configured.
[0347] Industrial applicability
[0348] The present invention can be applied to medical equipment having a puncture needle.
[0349] Description of Reference Numerals
[0350] 100. Ultrasonic endoscope; 1, 1B, 1E, 1F, 1G, puncture needle (endoscopic puncture needle); 2, 2B, 2E, 2F, 2G, insertion body; 3, 3B, 3C, 3D, 3E, 3F, 3G, needle tube; 30, tubular portion; 31, 31B, first needle tip; 31a, first needle tip; 32, 32B, second needle tip; 32a, second needle tip; 33, 33B, first blade surface; 33b, 33Bb, first outer edge; 33c, 33Bc, first inner edge; 33n, 33Bn, normal vector; 34, 34B, second blade surface; 34b, 34Bb, second outer edge; 34c, 34 Bc, second inner edge; 34n, 34Bn, normal vector; 35, 35B, third blade surface; 35b, 35Bb, third outer edge; 35c, 35Bc, third inner edge; 35n, 35Bn, normal vector; 36, 36B, fourth blade surface; 36b, 36Bb, fourth outer edge; 36c, 36Bc, fourth inner edge; 36n, 36Bn, normal vector; 38, 38B, first base end; 39, 39B, second base end; 41, fifth blade surface; 42, sixth blade surface; 43, 43G, seventh blade surface; 44, 44G, eighth blade surface; 4, 4B, 4G, opening; 7, sheath; 8, operating part.
Claims
1. An endoscope puncture needle, wherein: The endoscopic puncture needle includes: a tubular portion; a first needle tip portion, which is provided at the top end of the tubular portion and has a first needle tip at the top end of the first needle tip portion; and The second needle tip portion is provided at the top end of the tubular portion, and has a second needle tip at the top end of the second needle tip portion. The first needle tip portion has a first cutting edge surface and a second cutting edge surface extending toward the first needle tip, The second needle tip portion has a third cutting edge and a fourth cutting edge extending toward the second needle tip. The first blade surface, the second blade surface, the third blade surface, and the fourth blade surface form edges of an opening communicating with the inner space of the tubular portion. In a front view viewed from a direction along the axis of the tubular portion, a normal vector of the first blade surface and a normal vector of the third blade surface are directed toward each other from one of the blade surfaces toward the other blade surface, compared to a direction perpendicular to a straight line passing through the first needle tip and the second needle tip. In the front view, the normal vector of the second blade surface and the normal vector of the fourth blade surface are directed toward each other from one of the blade surfaces toward the other blade surface, compared to a direction perpendicular to a straight line passing through the first needle tip and the second needle tip. The first needle tip portion and the second needle tip portion have a fifth cutting edge surface and a sixth cutting edge surface, The fifth blade surface comprises: a first outer intersection point, which is an intersection point of a first outer edge formed by the first blade surface and the outer peripheral surface of the first needle tip portion and the fifth blade surface; and a third outer intersection point, which is an intersection point of a third outer edge formed by the third blade surface and the outer peripheral surface of the second needle tip portion and the fifth blade surface; The sixth blade surface comprises: a second outer intersection point, which is an intersection point of a second outer edge formed by the second blade surface and the outer peripheral surface of the first needle tip portion and the sixth blade surface; and The fourth outer intersection point is an intersection point between a fourth outer edge formed by the fourth blade surface and the outer peripheral surface of the second needle tip portion and the sixth blade surface.
2. The endoscopic puncture needle according to claim 1, wherein The first needle tip portion and the second needle tip portion include: a tip region comprising the first needle tip and the second needle tip, In the front view, the normal vector of the first blade surface and the normal vector of the third blade surface in the top region are directed toward each other from one of the blade surfaces toward the other blade surface, compared to a direction perpendicular to a straight line passing through the first needle tip and the second needle tip. In the front view, the normal vector of the second blade surface in the tip region and the normal vector of the fourth blade surface are directed toward each other from one of the blade surfaces toward the other blade surface, compared to a direction perpendicular to a straight line passing through the first needle tip and the second needle tip. The normal vector of the first blade surface and the normal vector of the second blade surface are directed in the tip region toward a direction closer to the central axis extending in the axial direction of the tubular portion than in the circumferential direction of the tubular portion. The normal vector of the third blade face and the normal vector of the fourth blade face are directed in the tip region toward a direction closer to the central axis extending in the axial direction of the tubular portion than in the circumferential direction of the tubular portion.
3. The endoscopic puncture needle according to claim 2, wherein: The first needle tip portion and the second needle tip portion further include: the base end region of the first needle tip portion and the base end region of the second needle tip portion; and A middle region is located between the top region and the base region.
4. The endoscopic puncture needle according to claim 3, wherein In the main view, The normal vector of the first blade surface and the normal vector of the third blade surface in the middle region are oriented in a direction forming an acute angle with the straight line passing through the first needle tip and the second needle tip, The normal vector of the second blade surface and the normal vector of the fourth blade surface in the intermediate region are oriented in a direction forming an acute angle with respect to a straight line passing through the first needle tip and the second needle tip.
5. The endoscopic puncture needle according to claim 3 or 4, wherein: The endoscopic puncture needle has a first outer edge formed by the first blade surface and the outer peripheral surface of the first needle tip portion, wherein the angle between the first blade surface and the outer peripheral surface of the first needle tip portion is an acute angle in the top region and an obtuse angle in the middle region. The endoscopic puncture needle has a second outer edge formed by the second blade surface and the outer peripheral surface of the first needle tip portion, wherein the angle between the second blade surface and the outer peripheral surface of the first needle tip portion is an acute angle in the top region and an obtuse angle in the middle region. The endoscopic puncture needle has a third outer edge formed by the third blade surface and the outer peripheral surface of the second needle tip portion, wherein the angle between the third blade surface and the outer peripheral surface of the second needle tip portion is an acute angle in the top region and an obtuse angle in the middle region. The endoscopic puncture needle has a fourth outer edge formed by the fourth blade surface and the outer peripheral surface of the second needle tip portion, wherein the angle between the fourth blade surface and the outer peripheral surface of the second needle tip portion is acute in the tip region and obtuse in the middle region.
6. The endoscopic puncture needle according to claim 2, wherein: The endoscopic puncture needle has a first inner edge formed by the first blade surface and the inner peripheral surface of the first needle tip portion, wherein the angle between the first blade surface and the inner peripheral surface of the first needle tip portion is an obtuse angle in the tip region. The endoscopic puncture needle has a second inner edge formed by the second blade surface and the inner peripheral surface of the first needle tip portion, wherein the angle between the second blade surface and the inner peripheral surface of the first needle tip portion is an obtuse angle in the tip region. The endoscopic puncture needle has a third inner edge formed by the third blade surface and the inner peripheral surface of the second needle tip portion, wherein the angle between the third blade surface and the inner peripheral surface of the second needle tip portion is an obtuse angle in the tip region. The endoscopic puncture needle has a fourth inner edge formed by the fourth blade surface and the inner peripheral surface of the second needle tip portion, and the angle between the fourth blade surface and the inner peripheral surface of the second needle tip portion is an obtuse angle in the distal end region.
7. The endoscopic puncture needle according to claim 3, wherein: The base end region has: A first base end where the first blade surface is connected to the third blade surface; and The second base end of the second blade surface is connected to the fourth blade surface, The normal vector of the first blade surface and the normal vector of the third blade surface are directed closer to the central axis extending in the axial direction of the tubular portion than in the circumferential direction of the tubular portion from the first needle tip to the first base end. The normal vector of the second blade face and the normal vector of the fourth blade face from the second needle tip to the second base end are directed closer to the central axis extending in the axial direction of the tubular portion than in the circumferential direction of the tubular portion.
8. The endoscopic puncture needle according to claim 3, wherein The endoscopic puncture needle has a first outer edge formed by the first blade surface and the outer peripheral surface of the first needle tip portion, wherein the angle between the first blade surface and the outer peripheral surface of the first needle tip portion is an acute angle in the middle region. The endoscopic puncture needle has a second outer edge formed by the second blade surface and the outer peripheral surface of the first needle tip portion, wherein the angle between the second blade surface and the outer peripheral surface of the first needle tip portion is an acute angle in the intermediate region. The endoscopic puncture needle has a third outer edge formed by the third blade surface and the outer peripheral surface of the second needle tip portion, wherein the angle between the third blade surface and the outer peripheral surface of the second needle tip portion is an acute angle in the middle region. The endoscopic puncture needle has a fourth outer edge formed by the fourth blade surface and the outer peripheral surface of the second needle tip portion, and the angle between the fourth blade surface and the outer peripheral surface of the second needle tip portion is an acute angle in the intermediate region.
9. The endoscopic puncture needle according to claim 3, wherein The endoscopic puncture needle has a first inner edge formed by the first blade surface and the inner peripheral surface of the first needle tip portion, wherein the angle between the first blade surface and the inner peripheral surface of the first needle tip portion is an obtuse angle in the intermediate region. The endoscopic puncture needle has a second inner edge formed by the second blade surface and the inner peripheral surface of the first needle tip portion, wherein the angle between the second blade surface and the inner peripheral surface of the first needle tip portion is an obtuse angle in the intermediate region. The endoscopic puncture needle has a third inner edge formed by the third blade surface and the inner peripheral surface of the second needle tip portion, wherein the angle between the third blade surface and the inner peripheral surface of the second needle tip portion is an obtuse angle in the intermediate region. The endoscopic puncture needle has a fourth inner edge formed by the fourth blade surface and the inner peripheral surface of the second needle tip portion, and the angle between the fourth blade surface and the inner peripheral surface of the second needle tip portion is an obtuse angle in the intermediate region.
10. The endoscopic puncture needle according to claim 1, wherein In the front view, the first needle tip and the second needle tip are arranged at positions symmetrical with respect to a central axis in the axial direction of the tubular portion.
11. The endoscopic puncture needle according to claim 1, wherein In the front view, the first blade surface and the second blade surface are symmetrical with respect to a straight line passing through the first needle tip and the second needle tip.
12. The endoscopic puncture needle according to claim 1, wherein In the front view, the third blade surface and the fourth blade surface have symmetrical shapes with respect to a straight line passing through the first needle tip and the second needle tip.
13. The endoscopic puncture needle according to claim 3, wherein The base end region has: A first base end where the first blade surface is connected to the third blade surface; and The second blade surface is connected to the second base end of the fourth blade surface.
14. The endoscopic puncture needle according to claim 13, wherein The fifth blade surface and the sixth blade surface are inclined surfaces inclined toward the central axis extending along the axial direction of the tubular portion, and the distance between the fifth blade surface and the sixth blade surface and the central axis becomes closer as they go from the base end side of the tubular portion toward the first needle tip and the second needle tip.
15. The endoscopic puncture needle according to claim 13, wherein The thickness between the fifth blade surface and the inner peripheral surface of the first needle tip portion becomes thinner as it moves from the base end of the fifth blade surface toward the first base end. The thickness between the fifth blade surface and the inner peripheral surface of the second needle tip portion becomes thinner as it goes from the base end of the fifth blade surface toward the first base end. The thickness between the sixth blade surface and the inner peripheral surface of the first needle tip portion becomes thinner as it goes from the base end of the sixth blade surface toward the second base end. The thickness between the sixth blade surface and the inner peripheral surface of the second needle tip portion decreases from the base end of the sixth blade surface toward the second base end.
16. The endoscopic puncture needle according to claim 3, wherein The base end region has: A first base end where the first blade surface is connected to the third blade surface; and The second base end of the second blade surface is connected to the fourth blade surface, The first needle tip portion and the second needle tip portion have a seventh cutting edge surface and an eighth cutting edge surface, The seventh blade surface has: a first inner intersection point, which is an intersection point of a first inner edge formed by the first blade surface and the inner peripheral surface of the first needle tip portion and the seventh blade surface; and a third inner intersection point, which is an intersection point of the third inner edge formed by the third blade surface and the inner peripheral surface of the second needle tip portion and the seventh blade surface; The eighth blade surface comprises: a second inner intersection point, which is an intersection point of a second inner edge formed by the second blade surface and the inner peripheral surface of the first needle tip portion and the eighth blade surface; and The fourth inner intersection point is an intersection point between a fourth inner edge formed by the fourth blade surface and the inner peripheral surface of the second needle tip portion and the eighth blade surface.
17. The endoscopic puncture needle according to claim 16, wherein: The seventh blade surface is a curved surface formed on the inner peripheral surface of the first needle tip portion and the inner peripheral surface of the second needle tip portion. The eighth blade surface is a curved surface formed on the inner peripheral surface of the first needle tip portion and the inner peripheral surface of the second needle tip portion.
18. The endoscopic puncture needle according to claim 16, wherein The thickness between the seventh blade surface and the outer peripheral surface of the first needle tip portion becomes thinner as it goes from the base end of the seventh blade surface toward the first base end. The thickness between the seventh blade surface and the outer peripheral surface of the second needle tip portion becomes thinner as it goes from the base end of the seventh blade surface toward the first base end. The thickness between the eighth blade surface and the outer peripheral surface of the first needle tip portion becomes thinner as it goes from the base end of the eighth blade surface toward the second base end. The thickness between the eighth blade surface and the outer peripheral surface of the second needle tip portion decreases from the base end of the eighth blade surface toward the second base end.
19. The endoscopic puncture needle according to claim 2, wherein The first continuous blade surface includes the first blade surface and the third blade surface, which continuously form a curved surface shape. The second continuous blade surface includes the second blade surface and the fourth blade surface, which continuously form a curved surface shape. The endoscopic puncture needle has: a first continuous blade surface outer edge, which is an intersection line between the first continuous blade surface and the outer peripheral surfaces of the first needle tip portion and the second needle tip portion; and a second continuous blade surface outer edge, which is an intersection line between the second continuous blade surface and the outer peripheral surface of the first needle tip portion and the outer peripheral surface of the second needle tip portion; At the outer edge of the first continuous blade surface, the angle formed between the first continuous blade surface and the outer peripheral surface of the first needle tip portion is an acute angle from the top region to the first base end of the edge of the opening. At the outer edge of the first continuous blade surface, the angle formed between the first continuous blade surface and the outer peripheral surface of the second needle tip portion is an acute angle from the top region to the first base end of the edge of the opening. At the outer edge of the second continuous blade surface, the angle formed between the second continuous blade surface and the outer peripheral surface of the first needle tip portion is an acute angle from the top region to the second base end of the edge of the opening. At the outer edge of the second continuous blade surface, the angle formed between the second continuous blade surface and the outer peripheral surface of the second needle tip portion is an acute angle from the tip region to the second base end of the edge of the opening.
20. The endoscopic puncture needle according to claim 19, wherein The thickness between the first continuous blade surface and the outer peripheral surface of the first needle tip portion becomes thinner as it approaches from the base end of the first continuous blade surface to the first base end. The thickness between the first continuous blade surface and the outer peripheral surface of the second needle tip portion becomes thinner as it approaches from the base end of the first continuous blade surface to the first base end. The thickness between the second continuous blade surface and the outer peripheral surface of the first needle tip portion becomes thinner as it approaches from the base end of the second continuous blade surface to the second base end. The thickness between the second continuous blade surface and the outer peripheral surface of the second needle tip portion decreases from the base end of the second continuous blade surface toward the second base end.
21. The endoscopic puncture needle according to claim 19, wherein In the front view, the first continuous blade surface and the second continuous blade surface are symmetrical with respect to a straight line passing through the first needle tip and the second needle tip.
22. The endoscopic puncture needle according to claim 19, wherein The first blade face, the second blade face, the third blade face, and the fourth blade face are curved surfaces, and in the front view, the curvatures of the curved surfaces are equal.
23. The endoscopic puncture needle according to claim 3, wherein In a front view of the intermediate region as viewed along the axial direction of the tubular portion, the angle formed between the first blade surface and the inner peripheral surface of the first needle tip portion is an acute angle, and the angle formed between the second blade surface and the inner peripheral surface of the first needle tip portion is an acute angle. In the front view of the middle region along the axial direction of the tubular portion, the angle formed by the third blade surface and the inner peripheral surface of the second needle tip portion is an acute angle, and the angle formed by the fourth blade surface and the inner peripheral surface of the second needle tip portion is an acute angle.
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