Biopsy device

Abstract

A biopsy device (1) includes: a hollow needle (2); a wire (3) disposed inside the needle (2) along a length direction of the needle (2), having a spiral-shaped drill bit body (6) at a distal end of the wire (3); and a rotation mechanism (10, 11, 12) that moves the drill bit body (6) projecting from a distal end (2a) of the needle (2) and rotating around a length axis of the wire along the length direction. The drill bit body (6) has a predetermined pitch in the length direction, and the rotation mechanism (10, 11, 12) moves the rotating drill bit body (6) along the length direction by a lead equal to the predetermined pitch.

Description

Technical Field

[0001] (Mutual references between related applications)

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 189793, filed May 18, 2021, which is incorporated herein by reference in its entirety.

[0003] This invention relates to biopsy devices and methods for collecting samples. Background Technology

[0004] Previously, biopsy methods such as endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) or endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) were known, in which a hollow needle was inserted into biological tissue under ultrasound guidance to collect a portion of the tissue as a specimen (see, for example, Patent Documents 1 and 2). One problem with such biopsy methods is the amount of specimen collected. Because the needle inserted into the body through the endoscope's instrument channel is of a small diameter, it is difficult to collect a sufficient amount of specimen for diagnostic purposes. In Patent Documents 1 and 2, the amount of specimen collected is improved by forming the distal end of the needle into a spiral shape.

[0005] Existing technical documents

[0006] Patent documents

[0007] Patent Document 1: Japanese Patent No. 6430697

[0008] Patent Document 2: Japanese Patent Application Publication No. 2012-235878 Summary of the Invention

[0009] The problem the invention aims to solve

[0010] The distal end of the needle described in Patent Documents 1 and 2 penetrates biological tissue while rotating. If the needle rotation is improper, the spiral-shaped distal end will inappropriately penetrate the biological tissue, making it difficult to collect a sufficient amount of sample.

[0011] The present invention was made in view of the above circumstances, and its object is to provide a biopsy device and a biopsy collection method capable of reliably collecting a sufficient amount of specimen by properly inserting a spiral distal end into biological tissue.

[0012] Solution for solving the problem

[0013] One aspect of the present invention is a biopsy device comprising: a hollow needle; a filament disposed inside the needle along its length direction, the filament having a helical drill body at its distal end; and a rotation mechanism that moves the drill body, which protrudes from the distal end of the needle and rotates about the length axis of the filament, along the length direction, the drill body having a predetermined pitch in the length direction, the rotation mechanism causing the rotating drill body to move along the length direction with a lead equal to the predetermined pitch.

[0014] Another aspect of the present invention is a specimen collection method that uses a biopsy device to collect a specimen from biological tissue. The method involves inserting a drill body, located within a hollow needle of the biopsy device, into the biological tissue by rotating it about the length axis of the needle while moving it along the length direction of the needle with a lead equal to the pitch of the drill body. The needle is then inserted into the biological tissue by advancing it distally along the length direction. After penetrating a predetermined distance, the needle and the drill body are withdrawn together from the biological tissue.

[0015] The effects of the invention

[0016] According to the present invention, it is effective in reliably collecting a sufficient amount of specimen by properly inserting the distal end of the spiral-shaped probe into the biological tissue. Attached Figure Description

[0017] Figure 1A This is an overall structural diagram of the biopsy device according to the first embodiment, showing the state in which the threaded portion and the joint portion are disconnected.

[0018] Figure 1B It means Figure 1A The diagram shows the state in which the biopsy device is positioned by a positioning mechanism and the joint and threaded part are engaged.

[0019] Figure 2 It describes the drill bit body. Figure 1A An enlarged view of the distal portion of the biopsy device.

[0020] Figure 3 It describes the rotating mechanism. Figure 1A An enlarged view of the operating section of the biopsy device.

[0021] Figure 4 A flowchart of the specimen collection method of the first embodiment.

[0022] Figure 5A This is a diagram illustrating the operation of the biopsy device in step S1 of the specimen collection method.

[0023] Figure 5BThis is a diagram illustrating the operation of the biopsy device in step S2 of the specimen collection method.

[0024] Figure 5C This diagram illustrates the operation of the biopsy device in step S3 of the specimen collection method.

[0025] Figure 5D This diagram illustrates the operation of the biopsy device in step S4 of the specimen collection method.

[0026] Figure 5E This diagram illustrates the operation of the biopsy device in step S5 of the specimen collection method.

[0027] Figure 6 This is an overall structural diagram of the biopsy device according to the second embodiment, showing the state in which the joint and the threaded part are engaged by positioning the wire using a positioning mechanism.

[0028] Figure 7 This is a flowchart of the specimen collection method according to the second embodiment.

[0029] Figure 8A This is a diagram illustrating the operation of the biopsy device in step S11 of the specimen collection method.

[0030] Figure 8B This is a diagram illustrating the operation of the biopsy device in step S21 of the specimen collection method.

[0031] Figure 8C This is a diagram illustrating the operation of the biopsy device in step S31 of the specimen collection method.

[0032] Figure 8D This is a diagram illustrating the operation of the biopsy device in step S41 of the specimen collection method.

[0033] Figure 8E This is a diagram illustrating the operation of the biopsy device in step S42 of the specimen collection method.

[0034] Figure 8F This is a diagram illustrating the operation of the biopsy device in step S51 of the specimen collection method.

[0035] Figure 9A This is a diagram showing a structural example of a hollow drill bit body.

[0036] Figure 9B This is a diagram showing another structural example of a hollow drill bit body.

[0037] Figure 10 This is an overall structural diagram of a modified biopsy device.

[0038] Figure 11A This refers to step S11 of the sample collection method. Figure 10A diagram illustrating the operation of a biopsy device.

[0039] Figure 11B This refers to step S21 of the sample collection method. Figure 10 A diagram illustrating the operation of a biopsy device.

[0040] Figure 11C This refers to step S31 of the sample collection method. Figure 10 A diagram illustrating the operation of a biopsy device.

[0041] Figure 11D This refers to step S41 of the sample collection method. Figure 10 A diagram illustrating the operation of a biopsy device.

[0042] Figure 11E This refers to step S42 of the sample collection method. Figure 10 A diagram illustrating the operation of a biopsy device.

[0043] Figure 11F This refers to step S51 of the sample collection method. Figure 10 A diagram illustrating the operation of a biopsy device.

[0044] Figure 12 This is a partial structural diagram of the lines illustrating a modified example of the threaded section.

[0045] Figure 13 This is an overall structural diagram of another variation of the biopsy device.

[0046] Figure 14A This diagram illustrates the action of the joint performed by the second line.

[0047] Figure 14B This diagram illustrates the action of the joint performed by the second line. Detailed Implementation

[0048] (First Embodiment)

[0049] The biopsy device and specimen collection method of the first embodiment of the present invention are described with reference to the accompanying drawings.

[0050] like Figure 1A and Figure 1B As shown, the biopsy device 1 of this embodiment includes a hollow needle 2, a suture 3 disposed inside the needle 2, a longitudinal sheath 4 covering the needle 2, and an operating part 5 disposed on the proximal side of the needle 2, the suture 3 and the sheath 4.

[0051] The biopsy device 1 is used in combination with an ultrasonic endoscope. The needle 2, thread 3, and sheath 4 are inserted into the instrument channel of the ultrasonic endoscope, and the operating part 5 is positioned on the outside of the ultrasonic endoscope. The distal ends of the needle 2, thread 3, and sheath 4, protruding from the distal end of the ultrasonic endoscope, are positioned within the field of view of the ultrasonic endoscope and can be observed in the optical and ultrasonic images acquired by the ultrasonic endoscope.

[0052] The needle 2 and the sheath 4 are flexible tubular components with openings at both ends. The needle 2 has a pointed tip 2a at its distal end. The needle 2 is arranged within the sheath 4 along its length, and the flexible thread 3 is arranged within the needle 2 along its length. The needle 2, thread 3, and sheath 4 are movable relative to each other along their lengths, and the thread 3 is rotatable about its length axis A relative to the needle 2 and the sheath 4.

[0053] like Figure 2 As shown, line 3 has a helical drill body 6 at its distal end. The drill body 6 has a helical groove wound around the length axis A, with a predetermined pitch P1 in the length direction. To facilitate easy penetration into biological tissue, the distal end of the drill body 6 can also be a sharp point. The drill body 6 is formed, for example, by machining the helical groove on the outer circumferential surface of the cylindrical distal end of line 3. Because such a solid drill body 6 has high rigidity, it is not easily deformed when penetrating or withdrawing from biological tissue.

[0054] As described later, the thread 3 is rotated by operating the knob 9 of the operating unit 5, thereby rotating the drill body 6. To efficiently transmit rotation from the proximal end of the thread 3 to the drill body 6, the outer diameter of the thread 3 is preferably relatively large. On the other hand, to ensure space for the insertion of biological tissue within the needle 2, the thread 3 is preferably relatively thin. The outer diameter of the thread 3 is appropriately designed based on both the efficiency of rotation transmission and the volume of space within the needle 2.

[0055] The operating part 5 has a main body 7 that is fixed to the proximal end of the sheath 4, a slider 8 that is fixed to the proximal end of the needle 2, and a knob 9 that is fixed to the proximal end of the thread 3.

[0056] The main body 7 is a generally cylindrical component that extends coaxially with the sheath 4.

[0057] The slider 8 and the knob 9 are annular or cylindrical components disposed radially outside the body 7, supported on the body 7 in a manner that allows them to move along the length direction. Furthermore, the knob 9 is supported on the body 7 in a manner that allows it to rotate about the central axis of the body 7, which is aligned with the length axis A.

[0058] like Figure 1A As shown, when the slider 8 and knob 9 are in their initial positions, the needle tip 2a and drill body 6 are housed within the sheath 4. Figure 1B As shown, by pushing the slider 8 and knob 9 to the distal side, the operator can advance the needle 2 and thread 3 to the distal side, causing the needle tip 2a and drill body 6 to protrude from the distal end of the sheath 4. Furthermore, by pulling the slider 8 and knob 9 to the proximal side, the operator can retract the needle 2 and thread 3 to the proximal side.

[0059] like Figure 3 As shown, the biopsy device 1 also includes a rotation mechanism 10 that moves the drill body 6, which rotates about the length axis A, along the length direction; a release mechanism 13 that releases the engagement between the threaded portion 11 and the engagement portion 12 of the rotation mechanism 10; and a positioning mechanism 14 that positions the suture 3 relative to the needle 2 (see reference). Figure 1B ).

[0060] The rotating mechanism 10 is a mechanism that converts rotation about the length axis A into movement along the length axis A. Specifically, the rotating mechanism 10 includes a threaded portion 11 provided on the main body (peripheral member) 7 and a connecting portion 12 provided on the knob (line side member) 9 and engaged with the threaded portion 11.

[0061] The threaded portion 11 has a threaded groove formed on the outer peripheral surface of the body 7. The engaging portion 12 is a protrusion provided on the inner peripheral surface of the knob 9 and protruding radially inward, and may have thread teeth with a pitch equal to that of the threaded groove of the threaded portion 11.

[0062] The threaded portion 11 has a pitch P2 equal to the predetermined pitch P1 of the drill body 6. Therefore, by rotating the knob 9 with the engagement portion 12 engaged with the threaded groove of the threaded portion 11, the thread 3 moves along the length direction with a lead equal to the predetermined pitch P1. The lead is the amount of movement in the length direction per revolution.

[0063] exist Figure 3 In the diagram, the solid line at the joint 12 indicates the state where engagement with the threaded portion 11 has been released, while the double-dotted line at the joint 12 indicates the state where engagement with the threaded portion 11 has been achieved. The release mechanism 13 is constituted by the end of the knob 9 that has the joint 12 and is capable of displacement. By displacing the end of the knob 9, the joint 12 moves between a position engaged with the threaded portion 11 and a position where engagement with the threaded portion 11 has been released. For example, the displacement of the end of the knob 9 can be achieved by partial deformation of the knob 9.

[0064] like Figure 1A As shown, with the engagement between the joint 12 and the threaded portion 11 disengaged, the knob 9 and the wire 3 can move parallel to each other along the length direction relative to the body 7 and the sheath 4. Figure 1B As shown, with the joint 1 engaged with the threaded part 11, as described above, the knob 9 and the wire 3 can move along the length direction with a lead equal to the predetermined pitch P1 while rotating.

[0065] The positioning mechanism 14 consists of a sliding member 8 disposed on the distal side of the knob 9 and against which the knob 9 rests. That is, as... Figure 1B As shown, by abutting the knob 9 against the slider 8, the thread 3 is positioned relative to the needle 2 at a predetermined distance d protruding from the needle tip 2a at the distal end of the drill body 6. In this state, by rotating the knob 9, the needle 2 and the thread 3 move distally in conjunction. The predetermined distance d is the distance by which the drill body 6 partially protrudes from the needle tip 2a, for example, a few millimeters.

[0066] The structure of the positioning mechanism 14 described above is one example. Alternatively, any positioning mechanism with an arbitrary structure can be used to position the line 3 at a position on the far end of the drill body 6 that protrudes a predetermined distance d from the needle tip 2a.

[0067] Next, the sample collection method of this embodiment using biopsy device 1 will be described.

[0068] like Figure 4 As shown, the sample collection method includes steps S1 of inserting the biopsy device 1 into the body, S2 of positioning the needle tip 2a relative to the biological tissue T to be collected, S3 of positioning the drill body 6 relative to the needle 2 with the aid of the thread 3, S4 of piercing the drill body 6 and the needle 2 into the biological tissue T, S5 of pulling the needle 2 and the drill body 6 out of the biological tissue T together, and S6 of pulling the biopsy device 1 out of the body.

[0069] Before step S1, an ultrasound endoscope is inserted into the body cavity and positioned so that the biological tissue T to be observed can be positioned. For example, the biological tissue T to be observed is a lesion such as cancer in the pancreas, and the ultrasound endoscope is inserted from the mouth into the stomach or duodenum.

[0070] In step S1, the operator positions the slider 8 and knob 9 in their initial positions, confirms that the needle tip 2a and drill body 6 are housed within the sheath 4, and inserts the sheath 4 into the treatment instrument channel of the ultrasonic endoscope. Figure 5A As shown, the operator observes the optical or ultrasonic images of the ultrasound endoscope while positioning the distal end of the sheath 4 in the appropriate position relative to the biological tissue T to be treated.

[0071] Next, in step S2, with the engagement between the joint 12 and the threaded portion 11 disengaged, the operator observes the ultrasound image while simultaneously pushing the slider 8 and the knob 9 to advance the needle 2 and thread 3 simultaneously, positioning the needle tip 2a near the target biological tissue T. Figure 5B ).

[0072] Next, in step S3, the operator pushes the knob 9 until it abuts against the slider 8, and uses the line 3 to position the drill body 6 at a predetermined distance d protruding from the needle tip 2a. Figure 5C ).

[0073] Next, in step S4, the operator engages the engagement portion 12 with the threaded portion 11 and then rotates the knob 9, thereby advancing the drill body 6 along the length direction while simultaneously advancing the needle 2 along the length direction, thus simultaneously piercing the biological tissue T into the desired depth (predetermined distance) with both the drill body 6 and the needle 2. Figure 5D ).

[0074] At this time, utilizing the rotating mechanism 10 composed of the threaded portion 11 and the connecting portion 12, the drill body 6 rotates about the length axis A while advancing along the length direction with a lead equal to the predetermined pitch P1. Thus, the drill body 6 advances while drawing the biological tissue T into the spiral groove and cutting it in a spiral shape. The series of linear biological tissue T cut off is discharged along the spiral groove towards the proximal side and drawn into the needle 2.

[0075] Next, in step S5, the operator disengages the threaded portion 11 from the engagement portion 12, and then simultaneously pulls the slider 8 and the knob 9, thereby pulling the needle 2 and the drill body 6 out of the biological tissue T and completely retracting them into the sheath 4. Figure 5E ).

[0076] Next, in step S6, the operator removes the biopsy device 1 from the body by pulling out the sheath 4 containing the drill body 6 and the needle 2 from the treatment instrument channel. This allows the collection of biological tissue T, which has been placed within the spiral grooves of the drill body 6 and the needle 2, as a specimen.

[0077] Thus, according to this embodiment, the rotating drill body 6 advances with a lead equal to the pitch P1 of the drill body 6 using the rotating mechanism 10. Therefore, the drill body 6 can be appropriately inserted into the biological tissue T while simultaneously cutting it helically using the drill body 6. Consequently, the biological tissue T can be efficiently drawn into the helical groove and the needle 2, and a sufficient amount of sample can be reliably collected.

[0078] When the rotation is too slow relative to the forward movement of the drill body 6, the drill body 6 advances while pushing the biological tissue T forward. As a result, it is difficult to efficiently draw the biological tissue T into the spiral groove and to use the drill body 6 to cut the biological tissue T in a spiral shape.

[0079] When the drill body 6 rotates too fast relative to its forward movement, it advances while cutting the biological tissue T into thin sections. Consequently, it becomes difficult to cut the biological tissue T in a series of linear cuts and to retract the biological tissue T into the needle 2.

[0080] Furthermore, when the drill body 6 is pulled out from the biological tissue T, the biological tissue T that has entered the spiral groove is hooked onto the drill body 6, thereby preventing the biological tissue T, which was once drawn into the needle 2, from being pulled outwards from the needle 2. As a result, a sufficient amount of specimen can be reliably collected.

[0081] Furthermore, in step S4, with the thread 3 positioned relative to the needle 2 using the positioning mechanism 14, the needle 2 penetrates the biological tissue T at the same speed as the drill body 6. This allows for the efficient collection of the biological tissue T cut off by the drill body 6 and discharged proximally into the needle 2.

[0082] Furthermore, the engagement between the threaded portion 11 and the connecting portion 12 can be released using the release mechanism 13. Therefore, without needing to rotate the drill body 6 as in step S4, by releasing the engagement between the connecting portion 12 and the threaded portion 11, the wire 3 can be easily moved relative to the needle 2 along the length direction without needing to rotate the wire 3.

[0083] Furthermore, since the drill body 6 is exposed from the needle tip 2a after the biological tissue T is drawn into the needle 2, it is possible to use the same drill body 6 to collect samples from other locations within the biological tissue T. For example, the needle tip 2a can be positioned at multiple locations within the biological tissue T by the movement of the curved portion of the ultrasonic endoscope, allowing for fanning operations to collect samples from multiple locations.

[0084] (Second Implementation)

[0085] Next, the biopsy device and specimen collection method of the second embodiment of the present invention will be described with reference to the accompanying drawings.

[0086] In this embodiment, structures different from those in the first embodiment will be described, while structures identical to those in the first embodiment will be labeled with the same reference numerals and their descriptions will be omitted.

[0087] Figures 8A to 8F The operation of the biopsy device 100 in the specimen collection method of this embodiment is explained. In this embodiment, after the drill body 6 is inserted into the biological tissue T, the needle 2 is inserted into the biological tissue T along the line 3. The biopsy device 100 of this embodiment differs from the biopsy device 1 of the first embodiment in the amount d' of the drill body 6 protruding from the needle tip 2a.

[0088] like Figure 6 As shown, the biopsy device 100 of this embodiment includes a needle 2, a thread 3, a sheath 4, an operating part 5, a rotating mechanism 10, a releasing mechanism 13, and a positioning mechanism 14.

[0089] When the slider 8 and knob 9 are in their initial positions, the needle tip 2a and drill body 6 are housed within the sheath 4, just as in the first embodiment.

[0090] With the knob 9 abutting against the slider 8, the drill body 6 protrudes a predetermined distance d' from the needle tip 2a. The predetermined distance d' from the needle tip 2a to the distal end of the drill body 6 is preferably greater than or equal to the thickness of the target biological tissue T. For example, if the target biological tissue T is a pancreatic tumor, since the size of pancreatic tumors is mostly around 20 mm, the predetermined distance d' is preferably greater than or equal to 20 mm.

[0091] Next, the sample collection method of this embodiment will be described.

[0092] like Figure 7 As shown, the specimen collection method includes the following steps: Step S11, inserting the biopsy device 100 into the body; Step S21, positioning the needle tip 2a relative to the biological tissue T to be collected; Step S31, positioning the drill body 6 relative to the biological tissue T; Step S41, puncturing the biological tissue T while rotating the drill body 6; Step S42, puncturing the biological tissue T along the line 3 with the needle 2; Step S51, pulling the needle 2 and the drill body 6 out of the biological tissue T together; and Step S61, removing the biopsy device 100 from the body.

[0093] like Figure 8A As shown, the operator performs step S11 in the same manner as in the first embodiment.

[0094] Next, in step S21, with the engagement between the joint 12 and the threaded portion 11 disengaged, the operator, while observing the ultrasound image, pushes the slider 8 to advance the needle 2, positioning the needle tip 2a relative to the biological tissue T to be targeted. Figure 8B ).

[0095] Next, in step S31, the operator advances the wire 3 to the position where the distal end of the drill body 6 contacts the biological tissue T by pushing the knob 9, thereby positioning the drill body 6. Figure 8C ).

[0096] Next, in step S41, the operator engages the engagement portion 12 with the threaded portion 11, and then rotates the knob 9, thereby advancing the drill body 6 to penetrate the biological tissue T. Figure 8D At this time, using the rotating mechanism 10 consisting of the threaded portion 11 and the joint portion 12, the drill body 6 rotates about the length axis A and advances along the length direction with a lead equal to the predetermined pitch P1.

[0097] Next, in step S42, the operator advances the needle 2 by pushing the slider 8, piercing the biological tissue T to the desired depth (predetermined distance). Figure 8E Thus, the biological tissue T is drawn into the interior of needle 2.

[0098] Next, in step S51, the operator disengages the threaded portion 11 from the engagement portion 12, and then simultaneously pulls the slider 8 and the knob 9, thereby pulling the needle 2 and the drill body 6 out of the biological tissue T and completely retracting them into the sheath 4. Figure 8F ).

[0099] Next, in step S61, the operator removes the biopsy device 100 from the body by pulling out the sheath 4 containing the drill body 6 and the needle 2 from the treatment instrument channel. This allows the collection of biological tissue T, which has been placed inside the needle 2, as a specimen.

[0100] Thus, according to this embodiment, when the drill body 6 is punctured into the biological tissue T, the rotating drill body 6 advances with a lead equal to the pitch P1. Therefore, while efficiently drawing the biological tissue T into the helical groove of the drill body 6, the drill body 6 is properly inserted into the biological tissue T, fixing the drill body 6 relative to the biological tissue T and functioning as an anchor. By inserting the needle 2 into the biological tissue T in this state, it is possible to prevent the biological tissue T from being pushed and moved in the puncture direction by the needle 2, and a sufficient amount of biological tissue T is reliably drawn into the needle 2.

[0101] Furthermore, since only the drill body 6 of the needle 3 penetrates the biological tissue T, compared with the first embodiment, it is possible to collect a thicker columnar biological tissue T into the needle 2, and more specimens suitable for the diagnosis of biological tissue T can be collected.

[0102] Furthermore, when the needle 2 is withdrawn from the biological tissue T, the biological tissue T inside the needle 2 hooks onto the drill body 6, thereby preventing the biological tissue T, which was once drawn into the needle 2, from being pulled outwards. This allows for more reliable collection of a sufficient amount of sample.

[0103] In the first and second embodiments described above, the drill body 6 is solid, but it can also be replaced as follows: Figure 9A and Figure 9B The drill bit body 6 shown is hollow.

[0104] exist Figure 9A In this design, the drill body 6 is composed of fine threads wound into a spiral coil. Due to this structure, biological tissue T can also be drawn into the inside of the drill body 6 through the gaps between the threads and the opening at the distal end face, thus enabling the collection of more specimens.

[0105] exist Figure 9B In this structure, the cross-section of the thin wire constituting the drill body 6 is rectangular. According to this structure, since the thin wire forms a flat surface that is approximately perpendicular to the puncture direction of the wire 3, when the drill body 6 is pulled out from the biological tissue T in steps S5 and S51, the biological tissue T that has been drawn into the inner side of the drill body 6 is not easily detached, and a sufficient amount of specimen can be collected more reliably.

[0106] exist Figure 9A and Figure 9B In the modified example, the wall thickness, inner diameter, and pitch P1 of the drill body 6 are designed so that the drill body 6 has a rigidity that does not deform when puncturing into and pulling out of the biological tissue T.

[0107] In the first and second embodiments described above, the rotating mechanism 10 is provided in the operation section 5, but the rotating mechanism 10 may also be provided in other positions.

[0108] When the distance from the rotating mechanism 10 to the drill body 6 is relatively large, the lead of the drill body 6 may not accurately match the pitch P2 of the rotating mechanism 10 (i.e., the pitch P1 of the drill body 6) due to the influence of the rotational transmission between the rotating mechanism 10 and the drill body 6. To eliminate this undesirable situation, the rotating mechanism 10 is preferably located closer to the drill body 6.

[0109] Figure 10 An example is shown where the rotating mechanism 10 is located between the needle 2 and the thread 3. Figure 10 In the biopsy device, the rotating mechanism 10 has a threaded portion 11 formed by the drill body (wire-side member) 6 and a connecting portion 12 provided on the inner circumferential surface of the needle (peripheral member) 2 and engaging with the helical groove of the drill body 6. The sliding member 8 is provided with a locking portion 8a for fixing the sliding member 8 to the main body 7 and for releasing the fixing, and the knob 9 is provided with a locking portion 9a for fixing the knob 9 to the main body 7 and for releasing the fixing. Figure 10 In the diagram, the solid lines representing the locking parts 8a and 9a indicate the unlocked state, while the double-dotted lines representing the locking parts 8a and 9a indicate the fixed state.

[0110] like Figures 11A to 11F As shown, Figure 10 The biopsy device is used in the specimen collection method of the second embodiment.

[0111] exist Figure 11A After step S11 as shown, as Figure 11B As shown, with the locking parts 8a and 9a released from their fixed state, the slider 8 and the knob 9 are pushed simultaneously to make the needle 2 and the thread 3 move forward at the same time (step S21).

[0112] Next, as Figure 11C and Figure 11DAs shown, by using the locking part 8a to fix the sliding member 8, the knob 9 is rotated, thereby causing the drill body 6 to advance and puncture the biological tissue T (steps S31, S41).

[0113] Next, as Figure 11E As shown, the knob 9 is fixed by the locking part 9a and the sliding member 8 is released by the locking part 8a, causing the sliding member 8 to rotate, thereby advancing the needle 2 and piercing the biological tissue T to the desired depth (step S42).

[0114] Next, as Figure 11F As shown, the locking part 9a is used to release the knob 9 from its fixed position, and the sliding part 8 and the knob 9 are pulled at the same time, so that the needle 2 and the drill body 6 are pulled out from the biological tissue T together and completely stored in the sheath 4 (step S51).

[0115] exist Figure 10 In this design, a longer drill body 6 is used as the threaded portion 11, but it can also be replaced as follows: Figure 12 The line 3 shown has a threaded portion 11 that differs from that of the drill body 6. In this case, the threaded portion 11 can be provided at any position on the line 3 closer to the drill body 6 than the drill body 6. The position of the engagement portion 12 is also designed accordingly to correspond to the position of the threaded portion 11.

[0116] exist Figure 10 In the structure of the rotating mechanism 10, in order for the needle 2 and the thread 3 to move relative to each other along the length direction, either the needle 2 or the thread 3 must be rotated; the needle 2 and the thread 3 cannot move relative to each other in parallel along the length direction. Figure 13 The illustration shows a modified biopsy device that also includes a release mechanism 13 to enable the wire 3 and needle 2 to move in parallel relative to each other.

[0117] Figure 13 The biopsy device includes a second wire 15 inserted into the wire (first wire) 3 as a release mechanism 13. Therefore, the wire 3 is at least partially hollow. The rotating mechanism 10 has a connecting portion 12 provided on the first wire (wire-side member) 3 and a threaded portion 11 provided on the needle (peripheral member) 2. The connecting portion 12 is a protrusion extending from the outer peripheral surface of the first wire 3; the protrusion may also be a thread. The threaded portion 11 is an internally threaded portion having a threaded groove provided on the inner peripheral surface of the needle 2.

[0118] A second knob 16 is provided on knob 9, which is fixed to the proximal end of the second wire 15 and is used to move the second wire 15 along its length. The operator moves the second wire 15 forward or backward by pushing or pulling the second knob 16, thereby... Figure 14A and Figure 14B As shown, the engagement portion 12 can be moved between a position where it engages with the threaded portion 11 and a position where it is disengaged from the threaded portion 11.

[0119] Specifically, such as Figure 14B As shown, a portion of the sidewall of the first line 3 with a joint 12 is bent radially inward.

[0120] like Figure 14A As shown, when the second line 15 is inserted into the first line 3 to a position beyond the joint 12, the joint 12 is pushed radially outward by the second line 15 and engages with the threaded portion 11.

[0121] like Figure 14B As shown, the second line 15 is moved back until the distal end of the second line 15 is positioned closer to the position side than the joint 12. A portion of the sidewall of the first line 3 is bent radially inward, and the joint 12 moves inward toward the outer diameter of the first line 3, thereby disengaging the joint 12 from the threaded portion 11.

[0122] The various embodiments of the present invention have been described in detail above with reference to the accompanying drawings. However, the specific structure is not limited to the above embodiments, and may include design changes that do not depart from the spirit of the present invention.

[0123] In particular, expressions such as "equal pitch" and "equal lead" are not limited to being completely "equal," and the fact that they are substantially equal does not deviate from the main purpose of this invention, which is to reliably collect a sufficient amount of sample.

[0124] Furthermore, the constituent elements shown in the above embodiments and variations can be appropriately combined to form a configuration.

[0125] Explanation of reference numerals in the attached figures

[0126] 1. Biopsy device; 2. Needle; 3. Thread (first thread); 4. Sheath; 5. Operating part; 6. Drill body; 7. Main body (peripheral components); 8. Sliding part (positioning mechanism); 9. Knob (thread-side component, release mechanism); 10. Rotation mechanism; 11. Threaded part (rotation mechanism); 12. Connecting part (rotation mechanism); 13. Release mechanism; 14. Positioning mechanism; 15. Second thread (release mechanism); 16. Second knob; T, biological tissue; A, length axis.

Claims

1. A biopsy device, wherein, The biopsy device includes: Hollow needle; A thread, which is disposed inside the needle along the length direction of the needle, has a helical drill body at the distal end of the thread, the drill body having a predetermined pitch in the length direction; A rotating mechanism that moves the drill body, which protrudes from the distal end of the needle and rotates about the length axis of the line, along the length direction. A longitudinal sheath covering the needle, the needle and the thread being movable relative to the sheath along the length direction; and An operating part is located proximal to the needle, the thread, and the sheath. The operating unit has: The main body is fixed together with the proximal end of the sheath; A slider, fixed to the proximal end of the needle, is supported on the body in a manner that allows it to move along the length direction; and A knob, fixed to the proximal end of the line and located on the proximal side of the slider, is supported on the body in a manner that allows it to move along the length direction and rotate about the length axis. The rotating mechanism includes: A threaded portion, provided on the body, having a pitch equal to the predetermined pitch; and A connecting portion is provided on the knob, which engages with the threaded portion. The rotating mechanism causes the rotating drill body to move along the length direction with a lead equal to the predetermined pitch. When the knob moves toward the distal side by rotation while the engagement portion is engaged with the threaded portion, the knob abuts against the slider and moves toward the distal side in conjunction with the slider.

2. The biopsy device according to claim 1, wherein, The thread and the needle are capable of moving relative to each other along the length direction. The slider is a positioning mechanism that positions the line relative to the needle at a predetermined distance protruding from the distal end of the needle at the distal end of the drill body. When positioned using the positioning mechanism, the needle moves toward the distal side in conjunction with the movement of the thread toward the distal side.

3. The biopsy device according to claim 1, wherein, The biopsy device also includes a release mechanism for releasing the engagement between the threaded portion and the mating portion.

4. The biopsy device according to claim 1, wherein, The drill bit body is hollow.

5. The biopsy device according to claim 3, wherein, The release mechanism is formed by an end of the knob that has the engagement portion and is displaceable by partial deformation of the knob. By displacing the end of the knob, the engagement portion moves between a position engaged with the threaded portion and a position released from engagement with the threaded portion.

6. The biopsy device according to claim 4, wherein, The drill bit body is made of fine wire wound into a spiral coil shape.

7. The biopsy device according to claim 6, wherein, The cross-section of the thin lines that make up the drill bit body is rectangular.

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