A rotary biopsy needle
By designing the structure and operation mode of the rotary biopsy needle, the problems of low sampling efficiency and poor sample quality of traditional biopsy needles are solved, and efficient tissue sampling and simple operation are achieved.
Patent Information
- Application Number
- CN202411344583.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2024-09-25
- Publication Date
- 2025-10-21
- Estimated Expiration
- 2044-09-25
Smart Images
Figure CN119318516B_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of medical devices, and in particular to a rotary biopsy needle. Background Art
[0002] Biopsy, short for "live tissue examination," also known as surgical pathology, is a group of medical diagnostic tests used to determine the structure and composition of tissues or cells. During a biopsy, cells or tissues are sampled from an organ or other body part and sent to the pathology department. Standardized pathological sections are then made and observed under a microscope for changes in morphology and structure. Ultimately, a clear pathological diagnosis can be made, guiding targeted clinical treatment. Typically, if an abnormality is detected through superficial examinations such as palpation or radiographic imaging, a biopsy can be performed to determine the nature of the suspected abnormality.
[0003] Endoscopic ultrasound-guided transbronchial needle aspiration biopsy is a minimally invasive technique for biopsy of the lungs, peripulmonary tissues, and lymph nodes under real-time ultrasound guidance. Its advantages include avoiding vital areas such as large blood vessels and nerves while minimizing the risk of major bleeding and improving sample collection accuracy. It is also minimally invasive, simple, and relatively safe.
[0004] Traditional endoscopic ultrasound biopsy needles require repeated punctures for sampling, resulting in poor tissue integrity, resulting in low sampling efficiency and poor sample quality. Unlike traditional biopsy needles, rotary biopsy needles feature a rotary cutting blade that is driven by a motor. This rotary cutting method replaces traditional reciprocating puncture sampling, improving sampling efficiency and sample quality.
[0005] For example, when sampling a lung nodule, a biopsy needle is passed through an endoscope to the bronchus near the nodule. The needle then punctures the bronchial wall to reach the sampling location. The bronchial wall is relatively hard, making penetration difficult. Since the biopsy blade itself cannot penetrate the bronchial wall, a puncture needle is needed to guide the biopsy blade to achieve this puncture.
[0006] However, the puncture needle of the current rotary biopsy needle is a nickel-titanium wire (also called a guide wire, which realizes the function of the puncture needle) located inside the rotary cutter. During puncture breakthrough, the nickel-titanium wire can puncture the tissue wall, but the rotary cutter cannot puncture and is blocked outside the tissue wall, unable to reach the sampling position, thereby causing puncture failure. Summary of the Invention
[0007] In order to solve the above technical problems, the present invention provides a rotary biopsy needle, including a distal pipeline part, which includes an outer sheath, a puncture needle tube and a rotary cutting knife tube from the outside to the inside. Before puncture, the distal end of the puncture needle tube is located in the outer sheath, and the distal end of the rotary cutting knife tube is located in the puncture needle tube; during puncture, the puncture needle tube and the rotary cutting knife tube are protruded from the distal end of the outer sheath together to puncture the tissue, and during the puncture process, the distal end of the rotary cutting knife tube is always located in the puncture needle tube; after the puncture is completed, the rotary cutting knife tube extends from the distal end of the puncture needle tube to perform rotary cutting sampling on the tissue.
[0008] Preferably, an endoscope fixing part is also provided on the outer sheath tube, and the endoscope fixing part includes a locking sleeve and a locking part. The locking sleeve includes an integral connecting part and a locking part. The connecting part is used to be fixedly connected to the endoscope. The locking part is movably sleeved on the outer sheath tube and can slide axially on the outer sheath tube, and the locking part can be locked at any position of the outer sheath tube by the locking part.
[0009] Preferably, the connecting portion is a first Luer connector, and the proximal end of the working channel of the endoscope is provided with a second Luer connector adapted to the first Luer connector, and the first Luer connector and the second Luer connector are cooperatively connected; the locking portion is located at the proximal end of the intermediate connecting sleeve, and the locking portion is provided with an external thread, and the locking piece is a locking cap, and a threaded hole adapted to the external thread of the locking portion is provided in the locking cap, and the locking cap is tightened on the locking portion so that the locking portion is clamped and fixed to the outer sheath.
[0010] Preferably, the apparatus further comprises a proximal handheld portion, the proximal handheld portion comprising a proximal housing and a puncture depth adjustment mechanism, the puncture depth adjustment mechanism comprising a sheath seat and a sheath seat locking member, the sheath seat being fixed to the proximal end of the outer sheath tube, and the proximal housing being axially movable relative to the sheath seat;
[0011] The puncture needle tube and the rotary cutter tube are respectively connected to the proximal shell. During puncture, the proximal shell is pushed toward the distal end, so that the puncture needle tube and the rotary cutter tube pass through the distal end of the outer sheath tube together and puncture the tissue. After the puncture is completed, the proximal shell is locked with the sheath seat through the sheath seat locking piece.
[0012] Preferably, the sheath seat is a sleeve structure, the distal end of the sheath seat is fixedly connected to the proximal end of the outer sheath tube, and the proximal end of the sheath seat is movablely sheathed on the proximal end shell;
[0013] An external thread is provided on the proximal outer wall of the sheath seat, and the sheath seat locking piece is a locking cap, and an internal threaded hole is provided in the locking cap that is adapted to the external thread of the sheath seat, and the sheath seat is clamped to the proximal shell by tightening the internal threaded hole of the locking cap onto the external thread of the sheath seat; or, a threaded hole is provided on one side wall of the sheath seat, and the sheath seat locking piece is a threaded fastener adapted to the threaded hole, one end of the threaded fastener passes through the threaded hole into the sheath seat, and by tightening the threaded fastener, the end of the threaded fastener is pressed against the proximal shell.
[0014] Preferably, the proximal handheld portion further includes a puncture needle tube adjusting mechanism, through which the puncture needle tube is installed in the proximal housing, and the puncture needle tube is axially moved by the puncture needle tube adjusting mechanism.
[0015] Preferably, the puncture needle tube adjustment mechanism includes a puncture needle tube sleeve and an elastic locking structure, the puncture needle tube sleeve is located in the proximal shell and is fixedly sleeved on the puncture needle tube; the elastic locking structure is provided on at least one outer side of the puncture needle tube sleeve, and a puncture needle tube adjustment groove is axially opened on at least one side of the tube wall of the proximal shell, and the elastic locking structure passes through the puncture needle tube adjustment groove; the elastic locking structure includes an integrally arranged button and at least one limiting column, and a plurality of limiting slots are spaced apart on at least one side of the groove wall of the puncture needle tube adjustment groove. In a natural state, the limiting column is located in the limiting slot, and by pressing the button, the limiting column is disengaged from the limiting slot to the proximal shell, thereby enabling the puncture needle tube to follow the button and move axially along the puncture needle tube adjustment groove.
[0016] Preferably, a mounting hole is provided in the axial direction at the center of the puncture needle tube sleeve, and the puncture needle tube passes through the mounting hole and is fixed to the mounting hole; a hollow area is provided at the proximal end of the tube wall of at least one side of the puncture needle tube sleeve located at the mounting hole, and an elastic strip is provided on the outside of the hollow area, and the elastic strip is arranged along the axial direction of the puncture needle tube sleeve, and the distal end of the elastic strip is fixedly connected to the puncture needle tube sleeve, and the elastic locking structure is fixed to the proximal end of the elastic strip, and when the button is pressed, the limit column follows the proximal end of the elastic strip to move toward the hollow area, so that the limit column disengages from the limit slot.
[0017] Preferably, the proximal handheld portion further comprises a rotary cutter tube transmission assembly, the rotary cutter tube is connected to the proximal housing via the rotary cutter tube transmission assembly, and the rotary cutter tube is driven to perform rotary cutting on the tissue by driving the rotary cutter tube transmission assembly.
[0018] Preferably, the rotary cutter tube transmission assembly includes a circumferential rotation transmission mechanism and an axial movement transmission mechanism. By driving the circumferential rotation transmission mechanism, the rotary cutter tube is driven to rotate, so that the rotary cutter tube cuts the tissue; by driving the axial movement transmission mechanism, the rotary cutter tube is driven to move axially to adjust the cutting depth of the rotary cutter tube.
[0019] Preferably, the circumferential rotation transmission mechanism includes a core shaft assembly and a rotating sleeve located in the proximal housing, the core shaft assembly is fixedly sleeved on the rotary cutter tube, the rotating sleeve is sleeved on the core shaft assembly, and is slidably connected to the core shaft assembly in the axial direction and relatively fixedly connected in the circumferential direction; a rotating gear is coaxially fixedly connected to the rotating sleeve, and the rotating gear is driven by a rotary drive motor, so that the rotating gear drives the rotating sleeve to rotate;
[0020] The axial movement transmission mechanism includes a screw sleeve and a transmission screw, the screw sleeve is rotatably arranged in the proximal housing and is threadably engaged with the transmission screw for transmission; the screw sleeve is coaxially fixedly connected to a travel gear, the travel gear is driven to rotate by a travel drive motor, the travel gear drives the screw sleeve to rotate, and the rotational motion of the screw sleeve is converted into axial movement of the transmission screw;
[0021] The transmission screw is externally mounted on the rotating sleeve and is relatively fixed to the core shaft assembly in the axial direction and is connected to rotate relative to the core shaft assembly in the circumferential direction.
[0022] Preferably, the spindle assembly includes a fixed tube and an inner cutter sleeve, the fixed tube is fixedly sleeved on the rotary cutter tube, the inner cutter sleeve is fixedly sleeved on the fixed tube, the rotating sleeve is sleeved on the inner cutter sleeve, and the rotating sleeve and the inner cutter sleeve are connected by an axial protrusion inserted into an axial guide groove to achieve axial sliding connection and circumferential fixed connection;
[0023] The inner cutter sleeve and the transmission screw are connected in a circumferential rotation direction and fixedly connected in an axial direction by inserting an annular limiting clamping piece provided circumferentially into an annular limiting clamping groove.
[0024] Preferably, a guide rail is further provided on the inner wall of the proximal shell, and the transmission screw is slidably arranged on the guide rail.
[0025] Preferably, the proximal handheld portion further includes a motor handle, the rotation drive motor and the stroke drive motor are both installed in the motor handle, and the motor handle is fixedly connected to the proximal housing.
[0026] Preferably, the rotary cutting knife tube includes a distal metal tube, a metal wire spring tube, a proximal metal tube and a polymer sealing tube, the distal end of the distal metal tube is an annular blade, and the proximal end face of the distal metal tube is fixedly connected to the distal end face of the metal wire spring tube; the polymer sealing tube is at least sealed on the metal wire spring tube and at the connection between the metal wire spring tube and the distal metal tube; the proximal metal tube is fixedly sleeved on the proximal end of the polymer sealing tube.
[0027] Compared with the prior art, the technical solution of the embodiment of the present invention has the following beneficial effects:
[0028] 1. The rotary biopsy needle provided by the present invention includes a distal tubing portion, which includes, from the outside to the inside, an outer sheath, a puncture needle tube, and a rotary cutter tube. Before puncture, the distal end of the puncture needle tube is located within the outer sheath, and the distal end of the rotary cutter tube is located within the puncture needle tube. During puncture, the puncture needle tube and the rotary cutter tube are protruded from the distal end of the outer sheath to puncture the tissue, and during the puncture process, the distal end of the rotary cutter tube is always located within the puncture needle tube. After the puncture is completed, the rotary cutter tube extends from the distal end of the puncture needle tube to sample the tissue by rotary cutting. Since the distal end of the rotary cutter tube is located within the puncture needle tube during puncture, the rotary cutter tube can penetrate the human tissue together with the puncture needle tube, ensuring the smoothness of the outer surface of the puncture needle tube and making it easier to puncture and penetrate.
[0029] 2. In the present invention, the outer sheath serves as the outermost layer of the distal tubing portion of the biopsy needle, and its inner cavity can completely accommodate the puncture needle tube and the rotary cutter tube. Therefore, before puncture, the distal end of the puncture needle tube is placed in the outer sheath, and the distal end of the rotary cutter tube is placed in the puncture needle tube. During the process of transporting the outer sheath into the working channel of the endoscope, the puncture needle or the rotary cutter is prevented from damaging the endoscope.
[0030] 3. To achieve flexible rotation of the rotary cutter tube, the rotary cutter tube uses a flexible rotary cutter shaft of a wire spring tube to achieve flexible transmission of torque and speed. However, without rigid support, the wire spring tube is very prone to shaking, affecting the sampling effect. In the present invention, the puncture needle tube is sheathed outside the rotary cutter tube. The inner diameter of the puncture needle tube is slightly larger than the outer diameter of the rotary cutter tube. Therefore, the puncture needle tube can act like a sliding bearing. When the rotary cutter tube rotates, the rotary cutter tube rotates within the inner cavity of the puncture needle tube, preventing the rotary cutter tube from shaking, thereby providing rigid support for the rotary cutter tube and improving the stability of the rotary cutter tube during rotation.
[0031] 4. Traditional biopsy needles are usually fixed by the proximal housing and the endoscope, and are uniformly operated by the endoscope operator. However, since the rotary biopsy needle is equipped with a motor, the weight of the motor handle and the proximal housing after assembly is relatively large. If the traditional fixing method is adopted, the difficulty of moving the endoscope and operating the endoscope will be greatly increased after the proximal housing and the endoscope are fixed. The present invention directly fixes the outer sheath to the endoscope through the endoscope fixing part on the outer sheath, and the proximal housing and the motor handle are held and operated by another special operator. The doctor moves the endoscope and cooperates with the sampling to avoid the motor handle and the consumable handle being too heavy, which affects the operation. Therefore, the hand-holding and operation of the endoscope are distinguished from the hand-holding and operation of the proximal housing, which reduces the difficulty of operation and increases the adjustment range of the outer sheath intervention depth.
[0032] Of course, any product implementing the present invention does not necessarily need to achieve all of the advantages described above at the same time. BRIEF DESCRIPTION OF THE DRAWINGS
[0033] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.
[0034] Figure 1 A schematic structural diagram of a rotary biopsy needle provided in one embodiment of the present invention;
[0035] Figure 2 A schematic structural diagram of a distal pipeline portion provided by an embodiment of the present invention;
[0036] Figure 3 A schematic diagram of the structure of a rotary biopsy needle before puncture provided by an embodiment of the present invention;
[0037] Figure 4 A schematic diagram of the structure of the rotary biopsy needle provided in one embodiment of the present invention after puncture is completed;
[0038] Figure 5 A schematic structural diagram of an endoscope fixing member provided in one embodiment of the present invention;
[0039] Figure 6 A schematic structural diagram of a puncture needle tube provided in one embodiment of the present invention;
[0040] Figure 7 An axial diagram of a puncture needle tube adjustment mechanism provided in one embodiment of the present invention;
[0041] Figure 8 An end view of a puncture needle tube adjustment mechanism provided in one embodiment of the present invention;
[0042] Figure 9 A schematic structural diagram of a rotary cutting blade tube with an outer cutting edge provided by one embodiment of the present invention;
[0043] Figure 10 A schematic structural diagram of a rotary cutting blade tube with an inner cutting edge provided by one embodiment of the present invention;
[0044] Figure 11 A schematic structural diagram of a rotary cutting blade tube provided in one embodiment of the present invention;
[0045] Figure 12 A schematic structural diagram of a rotary cutter tube transmission assembly provided in one embodiment of the present invention;
[0046] Figure 13 A schematic diagram of the positions of the outer sheath, puncture needle tube, and rotary cutting knife tube before puncture provided in one embodiment of the present invention;
[0047] Figure 14 A schematic diagram showing the positions of the outer sheath, puncture needle, and rotary cutting blade during puncture according to one embodiment of the present invention;
[0048] Figure 15 This is a schematic diagram of the positions of the outer sheath tube, puncture needle tube and rotary cutting knife tube during sampling provided by one embodiment of the present invention. DETAILED DESCRIPTION
[0049] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.
[0050] The terms "first", "second", "third", "fourth", etc. (if any) in the description and claims of the present invention and the above-mentioned drawings are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that the numbers used in this way are interchangeable where appropriate, so that the embodiments of the invention described herein can be implemented in an order other than those illustrated or described herein. In addition, the terms "including" and "having" and any variations thereof are intended to cover non-exclusive inclusions, for example, a process, method, system, product or device that includes a series of steps or units is not necessarily limited to those steps or units clearly listed, but may include other steps or units that are not clearly listed or inherent to these processes, methods, products or devices. The terms "on" and "above" and any variations thereof are intended to describe positional relationships and do not represent a relationship of direct contact between the described objects.
[0051] As described in the background technology, the puncture needle of the current rotary biopsy needle is a nickel-titanium wire (also called a guide wire, which realizes the function of the puncture needle) located inside the rotary cutter. During puncture breakthrough, the nickel-titanium wire can puncture the tissue wall, but the rotary cutter cannot puncture and is blocked outside the tissue wall, unable to reach the sampling position, thereby causing puncture failure.
[0052] To solve the above technical problems, please refer to Figure 1 and Figure 2 The present invention provides a rotary biopsy needle, comprising a distal pipeline part 1, which comprises an outer sheath 101, a puncture needle tube 102 and a rotary cutter tube 103 from the outside to the inside. Before puncture, the distal end of the puncture needle tube 102 is located in the outer sheath 101, and the distal end of the rotary cutter tube 103 is located in the puncture needle tube 102; during puncture, the puncture needle tube 102 and the rotary cutter tube 103 pass through the distal end of the outer sheath 101 together to puncture the tissue, and during the puncture process, the distal end of the rotary cutter tube 103 is always located in the puncture needle tube 102; after the puncture is completed, the rotary cutter tube 103 extends from the distal end of the puncture needle tube 102 to collect samples by rotary cutting the tissue.
[0053] Since the distal end of the rotary cutter tube 103 is located inside the puncture needle tube 102 during puncture, the rotary cutter tube 103 can penetrate the human tissue together with the puncture needle tube 102, ensuring the smoothness of the outer surface of the puncture needle tube and making puncture easier.
[0054] In the present invention, the outer sheath 101 serves as the outermost layer of the distal tubing portion of the biopsy needle, and its inner cavity can completely accommodate the puncture needle tube 102 and the rotary cutter tube 103. Therefore, before puncture, the distal end of the puncture needle tube 102 is placed in the outer sheath 101, and the distal end of the rotary cutter tube 103 is placed in the puncture needle tube 102. During the process of transporting the outer sheath 101 into the working channel of the endoscope, the puncture needle or the rotary cutter is prevented from damaging the endoscope.
[0055] As an embodiment, the rotary biopsy needle further comprises a proximal handheld portion, which comprises a proximal housing 4 and a puncture depth adjustment mechanism 3, see Figure 3 The puncture depth adjustment mechanism 3 includes a sheath seat 301 and a sheath seat locking piece 302. The sheath seat 301 is fixed to the proximal end of the outer sheath tube 101. The proximal shell 4 can move axially relative to the sheath seat 301. The sheath seat 301 can be locked with the proximal shell 4 through the sheath seat locking piece 302.
[0056] The puncture needle tube 102 and the rotary cutter tube 103 are respectively connected to the proximal housing 4. Before puncture, the distal end of the puncture needle tube 102 is located in the outer sheath tube 101, and the distal end of the rotary cutter tube 103 is located in the puncture needle tube 102; during puncture, the sheath seat locking member 302 does not lock the sheath seat 301 and the proximal housing 4, and by pushing the proximal housing 4 toward the distal end, the puncture needle tube 102 and the rotary cutter tube 103 are passed through the distal end of the outer sheath tube 101 and puncture the tissue. Please refer to Figure 4 During the puncture process, the distal end of the rotary cutter tube 103 is always located inside the puncture needle tube 102. Therefore, the rotary cutter tube 103 can penetrate the human tissue together with the puncture needle tube 102, ensuring the smoothness of the outer surface of the puncture needle tube 102 and making it easier to puncture and break through.
[0057] The present invention does not impose any restrictions on the material of the outer sheath 101 , and preferably a smooth polymer material such as PTFE, PEEK, etc. is used to prevent damage to the endoscope during the passage through the working channel of the endoscope and ensure its delivery performance.
[0058] Traditional biopsy needles are typically secured to the endoscope via a proximal housing and operated by the endoscope operator. However, because rotary biopsy needles incorporate a motor, the motor handle and proximal housing are relatively heavy when assembled. Using traditional securing methods, securing the proximal housing to the endoscope significantly increases the difficulty for the endoscope operator in manipulating the needle and operating the needle.
[0059] In order to solve the above technical problems, the present invention directly fixes the outer sheath 101 to the endoscope through the endoscope fixing piece 2 on the outer sheath 101, and the proximal housing and motor handle are held and operated by another dedicated operator. The doctor moves the endoscope and cooperates with sampling to avoid the motor handle and consumable handle being too heavy and affecting the operation. Therefore, the hand-holding and operation of the endoscope are distinguished from the hand-holding and operation of the proximal housing, which reduces the difficulty of operation and increases the adjustment range of the intervention depth of the outer sheath 101.
[0060] As an example, please refer to Figure 5 The endoscope fixing member 2 includes a locking member 202 and a locking sleeve 201. The locking sleeve 201 is provided with a connecting portion 2011 fixedly connected to the endoscope and a locking portion 2013 movably sleeved on the outer sheath tube 101. The locking portion 2013 can move axially relative to the outer sheath tube 101, and the locking portion 2013 can be locked at any position of the outer sheath tube 101 through the locking member 202.
[0061] This embodiment does not impose any specific restrictions on the manner in which the connection portion 2011 is fixedly connected to the endoscope, and for example, a threaded connection, a clamping connection, or other detachable fixed connection methods may be used. Furthermore, this embodiment does not impose any specific restrictions on the manner in which the locking member 202 locks the locking portion 2013 to the outer sheath 101, and for example, a nut or a locking screw may be used for locking.
[0062] As an embodiment, the connecting portion 2011 is a first Luer connector, and the proximal end of the working channel of the endoscope is provided with a second Luer connector adapted to the first Luer connector, and the first Luer connector and the second Luer connector are cooperatively connected.
[0063] In a specific embodiment, the connecting portion 2011 and the locking portion 2013 are coaxially fixedly connected through an intermediate connecting sleeve 2012, and the connecting portion 2011 and the intermediate connecting sleeve 2012 are both movably sleeved on the outer sheath 101, and the connecting portion 2011 is located at the distal end of the intermediate connecting sleeve 2012, and an internal threaded joint is provided on the connecting portion 2011, and an external threaded joint adapted to the internal threaded joint is provided at the proximal end of the working channel of the endoscope, and the internal threaded joint and the external threaded joint are fastened by threads; the locking portion 2013 is located at the proximal end of the intermediate connecting sleeve 2012, and an external thread is provided on the locking portion 2013, and the locking piece 202 is a first locking cap, and a threaded hole adapted to the external thread of the locking portion 2013 is provided in the first locking cap, and the first locking cap is tightened on the locking portion 2013, so that the locking portion 2013 clamps the outer sheath 101.
[0064] The locking portion 2013 may be an elastic member such as a silicone structure, and the first locking cap squeezes the elastic member to enhance the fixing effect. A plurality of pressure strips may be spaced apart at the proximal end of the locking portion 2013, and the pressure strips are movably positioned over the outer sheath 101. The first locking cap is designed to have a tapered structure that gradually tapers from the distal end to the proximal end. When the first locking cap is tightened with the locking portion 2013, the pressure strips are contracted and clamped to the outer sheath 101, thereby achieving a fixed connection between the outer sheath 101 and the endoscope.
[0065] During transport, the endoscope is fixedly connected to the connecting portion 2011, and the first locking cap is loosened, allowing the endoscope to be moved freely to adjust the relative position of the outer sheath 101 and the endoscope. When the endoscope reaches the designated position, the adjustment is completed and the first locking cap is locked. At this time, the locking portion 2013 will contract as the first locking cap is locked to clamp the outer sheath 101, thereby securing the outer sheath 101 and the endoscope.
[0066] Since the locking portion 2013 can move axially relative to the outer sheath 101 , the endoscope fixture 2 can be locked at any position of the outer sheath 101 , thereby expanding the intervention length adjustment range of the outer sheath 101 .
[0067] Since the technical solution of adjusting and locking the two components by cooperating with the locking sleeve 201 through the locking member 202 is a relatively mature technology in the mechanical field, all technical solutions of adjusting and locking the outer sheath 101 and the endoscope by cooperating with the locking sleeve 201 through the locking member 202 are within the scope of protection of the present invention.
[0068] Similarly, since the sheath seat 301 and the sheath seat locking piece 302 of the puncture depth adjustment mechanism 3 are also a technical solution for adjusting and locking the two components through cooperation, this technical solution is a relatively mature technology in the mechanical field. Therefore, the present invention does not limit the specific structure of the sheath seat 301 and the sheath seat locking piece 302. Any technical solution for adjusting and locking the outer sheath tube 101 and the proximal shell 4 through the sheath seat 301 and the sheath seat locking piece 302 is within the protection scope of the present invention.
[0069] As an embodiment, the sheath seat 301 is a sleeve structure, the distal end of the sheath seat 301 is coaxially fixedly connected to the proximal end of the outer sheath tube 101, and the proximal movable outer sleeve of the sheath seat 301 is on the proximal shell 4; the proximal outer wall of the sheath seat 301 is provided with an external thread, and the sheath seat locking piece 302 is a second locking cap, and the second locking cap is provided with a threaded hole adapted to the external thread of the sheath seat 301. By tightening the second locking cap on the sheath seat 301, the sheath seat 301 clamps the proximal shell 4.
[0070] The proximal end of the sheath seat 301 can be an elastic member, such as a silicone structure, and the second locking cap squeezes the elastic member to enhance the fixation effect. The proximal end of the sheath seat 301 is not limited to an elastic member. A plurality of beadings can also be provided at intervals. These beadings are movably mounted on the proximal housing 4. The second locking cap is designed to have a tapered structure that gradually tapers from the distal end to the proximal end. When the second locking cap is tightened with the sheath seat 301, the beadings are contracted and clamped to the proximal housing 4, achieving a locked connection between the sheath seat 301 and the proximal housing 4.
[0071] In the initial state before puncture, the distal end of the puncture needle tube 102 is located inside the outer sheath tube 101, and the distal end of the rotary cutter tube 103 is located inside the puncture needle tube 102, and the outer sheath tube 101 is transported into the working channel of the endoscope. When the outer sheath tube 101 reaches the designated position and is fixed, puncture breakthrough can be performed. At this time, the puncture depth adjustment mechanism 3 is adjusted according to the required puncture depth. Specifically, the second locking cap is loosened, the sheath seat 301 is held, and the proximal shell 4 is quickly pushed toward the distal end. The proximal shell 4 will drive the distal ends of the puncture needle tube 102 and the rotary cutter tube 103 to pass out of the outer sheath tube 101 and puncture obstructive tissue such as the bronchial wall. After the puncture is completed, the second locking cap is locked.
[0072] When the proximal housing 4 is pushed quickly toward the distal end, an annular protrusion 401 is provided on the outer side of the proximal housing 4 to facilitate manual operation of the proximal housing 4. By pushing the annular protrusion 401, the proximal housing 4 can be pushed quickly toward the distal end.
[0073] In order to identify the puncture depth, a puncture depth scale is provided on the proximal housing 4 .
[0074] Of course, the sheath seat locking member 302 of the present invention is not limited to a locking cap structure, and can also be a threaded fastener. Specifically, a threaded hole is provided on one side wall of the sheath seat 301, and the sheath seat locking member 302 is a threaded fastener adapted to the threaded hole. The first end of the threaded fastener passes through the threaded hole into the sheath seat, and the second end is located outside the sheath seat 301. The threaded fastener is tightened by manually tightening the second end of the threaded fastener so that the first end of the threaded fastener abuts against the proximal housing 4, thereby fixing the proximal housing 4 to the sheath seat 301. The threaded fastener is a structure such as a locking screw.
[0075] The puncture needle tube 102 is the middle layer of the distal tubing of the biopsy needle and is made of metal material, such as 304L, 316L and other stainless steel materials. The thickness of the puncture needle should be as low as possible, usually less than 0.1mm, to increase its inner cavity to accommodate the cutting knife tube. Figure 6 The puncture needle tube 102 has a needle tip 1021, through which puncture breakthrough can be achieved.
[0076] The main body of the puncture needle tube 102 is provided with a hollow structure 1022, the purpose of which is to reduce the hardness of the puncture needle tube 102 at a local position without sacrificing the puncture effect, thereby improving the performance of the biopsy needle passing through the working channel of the endoscope in a bent state.
[0077] To enhance ultrasound imaging and facilitate visualization of the position of the puncture needle 102, a first ultrasound-reflecting region is provided on the outer surface of the puncture needle 102 near its needle tip 1021. The first ultrasound-reflecting region is required to have an uneven texture. The present invention does not impose any specific restrictions on the shape of the texture in the first ultrasound-reflecting region. For example, the outer surface of the puncture needle 102 may be roughened by processes such as threading or dotting to enhance ultrasound imaging of the puncture needle 102.
[0078] In the present invention, the proximal handheld part also includes a puncture needle tube adjustment mechanism 6, and the puncture needle tube 102 is installed in the proximal shell 4 through the puncture needle tube adjustment mechanism 6. The puncture needle tube 102 is axially moved by the puncture needle tube adjustment mechanism 6, that is, the puncture needle tube 102 can be moved toward the distal end or toward the proximal end through the puncture needle tube adjustment mechanism 6.
[0079] As an example, please refer to Figure 7 and Figure 8 The puncture needle tube adjustment mechanism 6 includes a puncture needle tube sleeve 602 and an elastic locking structure 601. The puncture needle tube sleeve 602 is located in the proximal shell 4 and is fixedly mounted on the proximal end of the puncture needle tube 102; at least one outer side of the puncture needle tube sleeve 602 is provided with the elastic locking structure 601, and at least one side of the tube wall of the proximal shell 4 is axially provided with a puncture needle tube adjustment groove, and the elastic locking structure 601 passes through the puncture needle tube adjustment groove; the elastic locking structure The structure 601 includes an integrally arranged button 6011 and at least one limiting column 6012. A plurality of limiting slots are spaced apart on at least one side wall of the puncture needle tube adjustment slot. In a natural state, the limiting column 6012 is located in the limiting slot. By pressing the button 6011, the limiting column 6012 is disengaged from the limiting slot to the proximal shell 4, thereby enabling the puncture needle tube 102 to follow the button 6011 and move axially along the puncture needle tube adjustment slot.
[0080] In this embodiment, when the button 6011 is pressed, the limiting post 6012 disengages from the limiting slot, and the puncture needle tube 102 can follow the button 6011 and move freely in the axial direction along the puncture needle tube adjustment slot, thereby adjusting the axial position of the puncture needle tube 102. When the button is released, the button returns to its original position under the action of elasticity, and the limiting post 6012 inserts into the limiting slot of the puncture needle tube adjustment slot, thereby fixing the puncture needle tube 102.
[0081] In one embodiment, after the puncture is completed, the puncture needle tube 102 is retracted through the puncture needle tube adjustment mechanism 6, so that the distal end of the rotary cutter tube 103 extends from the distal end of the puncture needle tube 102, and the rotary cutter tube 103 begins to perform rotary cutting. Of course, the method of making the distal end of the rotary cutter tube 103 extend from the distal end of the puncture needle is not limited to retracting the puncture needle tube 102. The distal end of the rotary cutter tube 103 can also be directly extended from the distal end of the puncture needle tube 102. In one embodiment, the distal end of the rotary cutter tube 103 is extended from the distal end of the puncture needle tube 102 by driving the rotary cutter tube transmission assembly 7.
[0082] In order to identify the retraction distance of the puncture needle tube 102, an adjustment scale is provided on the outside of the puncture needle tube adjustment groove.
[0083] To facilitate manual operation, it is preferred that an elastic retaining structure 601 is provided on each of the two corresponding outer sides of the puncture needle tube sleeve 602, and the elastic retaining structure 601 is provided along the radial direction of the puncture needle tube sleeve 602. A puncture needle tube adjustment groove is provided along the axial direction on each of the two corresponding sides of the tube wall of the proximal housing 4, and the two elastic retaining structures 601 respectively penetrate a puncture needle tube adjustment groove. A plurality of limit slots are provided on the groove walls on both sides of the puncture needle tube adjustment groove, and correspondingly, a limit post 6012 is provided on each side of the button 6011. The button 6011 and the limit posts 6012 on both sides thereof are provided along the circumference of the puncture needle tube sleeve 602. In the natural state, the limit posts 6012 on both sides of the button 6011 are respectively located in a limit slot on the groove walls on both sides of the puncture needle tube adjustment groove. When it is necessary to press the button 6011, the operator presses the two buttons 6011 with two fingers at the same time to disengage the limit column 6012 from the limit slot, and then pushes the button 6011 to adjust the position of the puncture needle tube 102.
[0084] In one embodiment, a mounting hole 6021 is axially provided at the center of the puncture needle tube sleeve 602, and the puncture needle tube 102 passes through the mounting hole 6021 and is fixed to the mounting hole 6021; a hollow area 6022 is provided at the proximal end of the tube wall of at least one side of the mounting hole 6021 of the puncture needle tube sleeve 602, and an elastic pressure strip 6013 is provided on the outside of the hollow area 6022. The elastic pressure strip 6013 is arranged along the axial direction of the puncture needle tube sleeve 602, and the distal end of the elastic pressure strip 6013 is fixedly connected to the puncture needle tube sleeve 602, and the elastic locking structure 601 is fixed to the proximal end of the elastic pressure strip 6013. When the button 6011 is pressed, the limiting column 6012 follows the proximal end of the elastic pressure strip 6013 to move toward the hollow area 6022, so that the limiting column 6012 disengages from the limiting slot.
[0085] The rotary cutting blade 103 is a tubular structure that forms the innermost layer of the distal tubing of the biopsy needle. The distal end of the rotary cutting blade 103 includes an annular blade that ensures smooth tissue incision. The annular blade preferably has a flat edge to ensure the integrity of the tissue after rotary cutting, preventing it from being crushed and affecting pathological analysis.
[0086] As an example, please refer to Figure 9 The annular blade at the distal end of the rotary cutter tube 103 is an outer blade edge 1031 formed by removing the inner corners of the distal end surface of the rotary cutter tube 103 . The outer blade edge 1031 is used for cutting low-density tissue.
[0087] As another example, please refer to Figure 10 The annular blade at the distal end of the rotary cutter tube 103 is an inner blade edge 1031 ′ formed by removing outer edges and corners from the distal end surface of the rotary cutter tube 103 . The inner blade edge 1031 ′ is used for cutting high-density tissue.
[0088] In a specific embodiment, please refer to Figure 11 The rotary cutter tube 103 includes a distal metal tube 1032, a wire spring tube 1033, a proximal metal tube 1035, and a polymer sealing tube 1034. Both the distal metal tube 1032 and the proximal metal tube 1035 are metal tubes, such as stainless steel tubes. The distal end of the distal metal tube 1032 is an annular blade. The metal structure of the distal metal tube 1032 ensures that the rotary cutter tube 1033 can smoothly cut tissue. The metal structure of the proximal metal tube 1035 facilitates assembly and fixation. The wire spring tube 1033 is a hollow tube woven from stainless steel or nickel-titanium wire. When bent, the wire spring tube 1033 can flexibly transmit rotational speed and torque, effectively reducing vibration. The proximal end of the distal metal tube 1032 and the distal end of the wire spring tube 1033 are connected by end-face welding to ensure that the outer diameter and inner diameter of the distal metal tube 1032 and the wire spring tube 1033 are substantially consistent.
[0089] A thin-walled polymer sealing tube 1034, such as a thin-walled heat-shrink tubing, is attached to the outside of the rotary cutter tube 103 via a heat-shrink process. This seals the rotary cutter tube 103, allowing the internal cavity to transmit negative or positive pressure, preventing leakage at welds and gaps between braided tubes. Furthermore, the thin-walled heat-shrink tubing reduces friction between the rotary cutter tube and the puncture needle during rotation, preventing wear of the braided wire of the rotary cutter tube.
[0090] The proximal metal tube 1035 is wrapped around the proximal outer side of the polymer sealing tube 1034, and can be fixed to the proximal metal tube 1035 and the polymer sealing tube 1034 by bonding or other means. In this way, a sealed tube cavity with only two outlets can be formed inside the rotary cutter tube.
[0091] As an embodiment, the metal wire spring tube 1033 , the polymer sealing tube 1034 and the proximal metal tube 1035 are flush at the proximal end surface.
[0092] In the art, in order to achieve flexible rotation of the rotary cutter tube 103, the rotary cutter tube 103 uses a flexible rotary cutter shaft of a wire spring tube 1033 to achieve flexible transmission of torque and speed. However, without rigid support, the wire spring tube 1033 is very prone to shaking, affecting the sampling effect. In the present invention, the puncture needle tube 102 is sheathed outside the rotary cutter tube 103. The inner diameter of the puncture needle tube 102 is slightly larger than the outer diameter of the rotary cutter tube 103. Therefore, the puncture needle tube 102 can play a role similar to a sliding bearing. When the rotary cutter tube 103 rotates, the rotary cutter tube 103 rotates within the inner cavity of the puncture needle tube 102, preventing the rotary cutter tube 103 from shaking, thereby providing rigid support for the rotary cutter tube 103 and improving the stability of the rotary cutter tube 103 during rotation.
[0093] The outer surface of the rotary cutter tube 103 is covered with a polymer sealing tube 1034 . The polymer sealing tube 1034 is at least sealed on the metal wire spring tube 1033 and at the connection between the metal wire spring tube 1033 and the distal metal tube 1032 .
[0094] In order to reduce the friction between the rotary cutter tube 103 and the puncture needle tube 102 during rotation and avoid wear of the braided metal wire of the rotary cutter tube 103, the polymer sealing tube 1034 is a heat shrink tube formed by fixing a polymer tube to the outer surface of the rotary cutter tube 103 through a heat shrink process. The heat shrink tube can also improve the torsional performance and sealing performance of the metal wire spring tube 103 without losing the bending performance.
[0095] In order to increase the adhesion strength of the tissue after cutting and prevent the tissue from falling off after cutting and sampling, the inner wall surface of the rotary cutting blade tube 103 is provided with a rough surface that increases the friction coefficient, such as a threaded surface.
[0096] In order to improve the effect of ultrasonic imaging, a second ultrasonic reflection area is provided on the outer surface of the distal metal tube 1032. The second ultrasonic reflection area is required to be an uneven texture. As for the texture shape of the second ultrasonic reflection area, the present invention does not impose any specific restrictions. For example, the roughness of the outer surface of the distal metal tube 1032 can be increased through processes such as threading and dotting to improve the imaging effect of the rotary cutting tube 103 under ultrasound.
[0097] In this invention, please refer to Figure 3 The proximal handheld part also includes a rotary cutter tube transmission assembly 7, which is installed in the proximal shell 4. The rotary cutter tube transmission assembly 7 is connected to the rotary cutter tube 103. The rotary cutter tube 103 is driven by the rotary cutter tube transmission assembly 7 to perform rotary cutting on the tissue.
[0098] By driving the peeling blade tube transmission assembly 7, the peeling blade tube transmission assembly 7 drives the peeling blade tube 103 to perform peeling, which is a mature technology in this field. Therefore, the present invention does not limit the specific structure of the peeling blade tube transmission assembly 7. Any technical solution that can drive the peeling blade tube transmission assembly 7 to drive the peeling blade tube 103 to perform peeling is applicable to the present invention.
[0099] The rotary cutter tube transmission assembly 7 can not only drive the rotary cutter tube 103 to rotate and cut tissue, but also adjust the axial stroke of the rotary cutter tube 103 to adjust the cutting depth of the rotary cutter tube 103. In one embodiment, the rotary cutter tube transmission assembly 7 includes a circumferential rotation transmission mechanism and an axial movement transmission mechanism, both of which are connected to the rotary cutter tube 103. The circumferential rotation transmission mechanism drives the rotary cutter tube 103 to rotate, causing the rotary cutter tube 103 to cut tissue; the axial movement transmission mechanism drives the rotary cutter tube 103 to move axially, thereby adjusting the axial stroke of the rotary cutter tube 103 and, in turn, the cutting depth of the rotary cutter tube 103.
[0100] As an example, please refer to Figure 12 The circumferential rotation transmission mechanism includes a core shaft assembly and a rotating sleeve 702 located in the proximal shell 4. The core shaft assembly is fixedly sleeved on the rotary cutter tube 103, and the rotating sleeve 702 is sleeved on the core shaft assembly and is slidably connected to the core shaft assembly in the axial direction and relatively fixedly connected in the circumferential direction; a rotating gear 701 is coaxially fixedly connected to the rotating sleeve 702, and the rotating gear 701 is driven by a rotary drive motor, so that the rotating gear 701 drives the rotating sleeve 702 to rotate.
[0101] Since the mutually sleeved rotating sleeve 702 and the core shaft assembly are slidably connected in the axial direction and relatively fixedly connected in the circumferential direction, it is a conventional technical means in the mechanical field. Therefore, the present invention does not limit the specific connection structure of the rotating sleeve 702 and the core shaft assembly.
[0102] As an embodiment, the core shaft assembly includes a fixed tube 708 and an inner knife sleeve 706, the fixed tube 708 is fixedly outer-circuited on the rotary cutting knife tube 103, the inner knife sleeve 706 is fixedly outer-circuited on the fixed tube 708, the rotating sleeve 702 is outer-circuited on the inner knife sleeve 706, and the rotating sleeve 702 and the inner knife sleeve 706 are connected by sliding in the axial direction and fixedly connected in the circumferential direction by inserting an axial protrusion into an axial guide groove.
[0103] In one specific implementation, the inner wall of the rotating sleeve 702 is provided with a plurality of protrusions spaced circumferentially, each of which is arranged axially along the rotating sleeve 702. The outer wall of the inner blade sleeve 706 is provided with a plurality of guide grooves spaced circumferentially, each of which is adapted to mate with the protrusions. These guide grooves are also arranged axially along the inner blade sleeve 706. By inserting the protrusions into the guide grooves, the rotating sleeve 702 and the inner blade sleeve 706 are both axially slidably connected and circumferentially fixedly connected. This means that the rotating sleeve 702 and the inner blade sleeve 706 can both slide relative to each other axially and rotate synchronously circumferentially. Alternatively, the protrusions can be provided on the outer wall of the inner blade sleeve 706, and the guide grooves can be provided on the inner wall of the rotating sleeve 702. This embodiment does not impose any specific limitations on this.
[0104] The axial movement transmission mechanism includes a screw sleeve 703 and a transmission screw 704. The screw sleeve 703 is mounted on the transmission screw 704 and is threadedly engaged with the transmission screw 704 for transmission. The screw sleeve 703 is coaxially fixedly connected to a travel gear 709. The travel gear 709 is driven by a travel drive motor to rotate. The travel gear 709 drives the screw sleeve 703 to rotate, and the rotational movement of the screw sleeve 703 is converted into axial movement of the transmission screw 704. The transmission screw 704 is mounted on the rotating sleeve 702 and is relatively fixed to the core shaft assembly in the axial direction and is connected to the core shaft assembly for relative rotation in the circumferential direction.
[0105] As an embodiment, the proximal handheld portion further includes a motor handle 5, in which the rotation drive motor and the stroke drive motor are both mounted, and the motor handle 5 is fixedly connected to the proximal housing 4. The rotation drive motor and the stroke drive motor respectively control the rotation gear 701 and the stroke gear 709 directly or through a gear transmission, thereby achieving rotation and forward and backward movement of the rotary cutter tube 103.
[0106] The screw sleeve 703 only rotates within the proximal housing 4 and does not move axially. To limit axial movement of the screw sleeve 703 within the proximal housing 4, positioning baffles are provided at the proximal and distal ends of the screw sleeve 703 and the proximal housing 4. The purpose is to confine the screw sleeve 703 between the two positioning baffles to prevent it from moving axially.
[0107] In this embodiment, the transmission screw 704 is sleeved on the rotating sleeve 702 and is relatively fixedly connected to the core shaft assembly in the axial direction and relatively rotatably connected in the circumferential direction.
[0108] As an embodiment, the inner knife sleeve 706 and the transmission screw 704 are connected in a circumferential rotational direction and fixedly connected in an axial direction by inserting a circumferentially arranged annular limiting clamp into an annular limiting groove.
[0109] In one specific implementation, an annular limiting groove 7061 is provided on the outer circumference of the inner blade sleeve 706, and an annular limiting clamp 705 is provided on the inner circumference of the drive screw 704, which is adapted to the annular limiting groove 7061. The annular limiting clamp 705 is inserted into the annular limiting groove 7061 to achieve a circumferential rotational connection between the drive screw 704 and the inner blade sleeve 706, and an axially fixed connection, that is, the inner blade sleeve 706 and the drive screw 704 can rotate relative to each other but cannot produce relative displacement in the axial direction. Of course, the annular limiting groove can also be provided on the inner circumference of the drive screw 704, and the annular limiting clamp adapted to the annular limiting groove is provided on the outer circumference of the inner blade sleeve 706. This embodiment does not impose specific limitations on this.
[0110] A guide rail 8 is axially provided on the inner wall of the proximal shell 4, and the transmission screw 704 is slidably set on the guide rail 8. By driving the screw sleeve 703 to rotate, the transmission screw 704 moves along the guide rail 8, so as to limit the axial movement distance of the transmission screw 704.
[0111] Working principle of rotary biopsy needle:
[0112] Please refer to Figure 13 Before puncture, the distal end of the puncture needle tube 102 is located inside the outer sheath tube 101, and the distal end of the rotary cutter tube 103 is located inside the puncture needle tube 102. The outer sheath tube 101 is transported into the working channel of the endoscope. When the outer sheath tube 101 reaches the designated position, the outer sheath tube 101 is fixed to the endoscope through the endoscope fixing member 2.
[0113] During puncture, the sheath seat locking member 302 does not lock the sheath seat 301 and the proximal shell 4. By pushing the proximal shell 4 toward the distal end, the puncture needle tube 102 and the rotary cutter tube 103 pass through the distal end of the outer sheath tube 101 and puncture the tissue. Please refer to Figure 14 During the puncture process, the distal end of the rotary cutter tube 103 is always located in the puncture needle tube 102. After the puncture is completed, the sheath seat 301 and the proximal housing 4 are locked by the sheath seat locking member 302.
[0114] After the puncture is completed, the puncture needle tube 102 is withdrawn through the puncture needle tube adjustment mechanism 6, the distal end of the puncture needle tube 102 is withdrawn, and the rotary cutter tube 103 is left, so that the distal end of the rotary cutter tube 103 extends from the distal end of the puncture needle tube 102. At this time, the metal wire spring tube 1033 of the rotary cutter tube 103 is completely located in the puncture needle tube 102, and the distal end of the puncture needle tube 102 is located in front of the outer sheath tube 101 and between the proximal and distal ends of the distal metal tube 1032 of the rotary cutter tube 103. Please refer to Figure 15 The rotary cutting blade tube 103 is driven by the rotary cutting blade tube transmission assembly 7 to perform rotary cutting and sampling on the tissue.
[0115] Although the present invention is disclosed as above, the present invention is not limited thereto. Any person skilled in the art can make various changes and modifications without departing from the spirit and scope of the present invention. Therefore, the scope of protection of the present invention should be based on the scope defined by the claims.
Claims
1. A rotary biopsy needle, characterized in that: The device comprises a distal tubing portion and a proximal handheld portion, wherein the distal tubing portion comprises an outer sheath, a puncture needle tube, and a rotary cutter tube in sequence from the outside to the inside. Before puncture, the distal end of the puncture needle tube is located within the outer sheath, and the distal end of the rotary cutter tube is located within the puncture needle tube. During puncture, the puncture needle tube and the rotary cutter tube are protruded from the distal end of the outer sheath together to puncture the tissue, and during the puncture process, the distal end of the rotary cutter tube is always located within the puncture needle tube. After the puncture is completed, the rotary cutter tube extends from the distal end of the puncture needle tube to perform rotary cutting and sampling on the tissue. The proximal handheld portion includes a proximal housing and a puncture depth adjustment mechanism, the puncture depth adjustment mechanism includes a sheath seat and a sheath seat locking piece, the sheath seat is fixed to the proximal end of the outer sheath tube, and the proximal housing can move axially relative to the sheath seat; The puncture needle tube and the rotary cutter tube are respectively connected to the proximal shell. During puncture, the proximal shell is pushed toward the distal end, so that the puncture needle tube and the rotary cutter tube pass through the distal end of the outer sheath tube and puncture the tissue. After the puncture is completed, the proximal shell is locked with the sheath seat through the sheath seat locking piece. The rotary cutting knife tube includes a distal metal tube, a metal wire spring tube, a proximal metal tube and a polymer sealing tube. The distal end of the distal metal tube is an annular blade, and the proximal end face of the distal metal tube is fixedly connected to the distal end face of the metal wire spring tube; the polymer sealing tube is at least sealed on the metal wire spring tube and at the connection between the metal wire spring tube and the distal metal tube; the proximal metal tube is fixedly sleeved on the proximal end of the polymer sealing tube.
2. The rotary biopsy needle according to claim 1, characterized in that: An endoscope fixing part is also provided on the outer sheath tube, and the endoscope fixing part includes a locking sleeve and a locking part. The locking sleeve includes an integral connecting part and a locking part. The connecting part is used to be fixedly connected to the endoscope. The locking part is movably sleeved on the outer sheath tube and can slide axially on the outer sheath tube. The locking part can be locked at any position of the outer sheath tube through the locking part.
3. The rotary biopsy needle according to claim 2, characterized in that: The connecting part is a first Luer connector, and the proximal end of the working channel of the endoscope is provided with a second Luer connector adapted to the first Luer connector, and the first Luer connector and the second Luer connector are cooperatively connected; the locking part is provided with an external thread, and the locking piece is a locking cap, and a threaded hole adapted to the external thread of the locking part is provided in the locking cap, and the locking cap is tightened on the locking part so that the locking part is clamped and fixed on the outer sheath.
4. The rotary biopsy needle according to claim 1, characterized in that: The sheath seat is a sleeve structure, the distal end of the sheath seat is fixedly connected to the proximal end of the outer sheath tube, and the proximal end movable sleeve of the sheath seat is on the proximal end shell; An external thread is provided on the proximal outer wall of the sheath seat, and the sheath seat locking piece is a locking cap, and an internal threaded hole is provided in the locking cap that is adapted to the external thread of the sheath seat, and the sheath seat is clamped to the proximal shell by tightening the internal threaded hole of the locking cap onto the external thread of the sheath seat; or, a threaded hole is provided on one side wall of the sheath seat, and the sheath seat locking piece is a threaded fastener adapted to the threaded hole, one end of the threaded fastener passes through the threaded hole into the sheath seat, and by tightening the threaded fastener, the end of the threaded fastener is pressed against the proximal shell.
5. The rotary biopsy needle according to claim 1, characterized in that: The proximal handheld portion further comprises a puncture needle tube adjusting mechanism, through which the puncture needle tube is installed in the proximal housing, and the puncture needle tube is axially moved by the puncture needle tube adjusting mechanism.
6. The rotary biopsy needle according to claim 5, characterized in that: The puncture needle tube adjustment mechanism includes a puncture needle tube sleeve and an elastic locking structure, wherein the puncture needle tube sleeve is located in the proximal shell and is fixedly sleeved on the puncture needle tube; the elastic locking structure is provided on at least one outer side of the puncture needle tube sleeve, and a puncture needle tube adjustment groove is axially opened on at least one side of the tube wall of the proximal shell, and the elastic locking structure passes through the puncture needle tube adjustment groove; the elastic locking structure includes an integrally arranged button and at least one limiting column, and a plurality of limiting slots are spaced apart on at least one side groove wall of the puncture needle tube adjustment groove. In a natural state, the limiting column is located in the limiting slot, and by pressing the button, the limiting column is disengaged from the limiting slot to the proximal shell, thereby enabling the puncture needle tube to follow the button and move axially along the puncture needle tube adjustment slot.
7. The rotary biopsy needle according to claim 6, characterized in that: A mounting hole is axially provided at the center of the puncture needle tube sleeve, and the puncture needle tube passes through the mounting hole and is fixed to the mounting hole; a hollow area is provided at the proximal end of the tube wall of at least one side of the puncture needle tube sleeve located at the mounting hole, and an elastic strip is provided on the outside of the hollow area, and the elastic strip is arranged along the axial direction of the puncture needle tube sleeve, and the distal end of the elastic strip is fixedly connected to the puncture needle tube sleeve, and the elastic locking structure is fixed to the proximal end of the elastic strip, and when the button is pressed, the limit column follows the proximal end of the elastic strip to move toward the hollow area, so that the limit column disengages from the limit slot.
8. The rotary biopsy needle according to claim 1, characterized in that: The proximal handheld part also includes a rotary cutter tube transmission assembly, and the rotary cutter tube is connected to the proximal housing through the rotary cutter tube transmission assembly. By driving the rotary cutter tube transmission assembly, the rotary cutter tube is driven to perform rotary cutting on the tissue.
9. The rotary biopsy needle according to claim 8, characterized in that: The rotary cutter tube transmission assembly includes a circumferential rotation transmission mechanism and an axial movement transmission mechanism. By driving the circumferential rotation transmission mechanism, the rotary cutter tube is driven to rotate, so that the rotary cutter tube cuts the tissue; by driving the axial movement transmission mechanism, the rotary cutter tube is driven to move axially, so as to adjust the cutting depth of the rotary cutter tube.
10. The rotary biopsy needle according to claim 9, characterized in that: The circumferential rotation transmission mechanism includes a core shaft assembly and a rotating sleeve located in the proximal housing, the core shaft assembly is fixedly sleeved on the rotary cutter tube, the rotating sleeve is sleeved on the core shaft assembly, and is slidably connected to the core shaft assembly in the axial direction and relatively fixedly connected in the circumferential direction; a rotating gear is coaxially fixedly connected to the rotating sleeve, and the rotating gear is driven by a rotary drive motor so that the rotating gear drives the rotating sleeve to rotate; The axial movement transmission mechanism includes a screw sleeve and a transmission screw, the screw sleeve is rotatably arranged in the proximal housing and is threadably engaged with the transmission screw for transmission; the screw sleeve is coaxially fixedly connected to a travel gear, the travel gear is driven to rotate by a travel drive motor, the travel gear drives the screw sleeve to rotate, and the rotational motion of the screw sleeve is converted into axial movement of the transmission screw; The transmission screw is externally mounted on the rotating sleeve and is relatively fixed to the core shaft assembly in the axial direction and is connected to rotate relative to the core shaft assembly in the circumferential direction.
11. The rotary biopsy needle according to claim 10, characterized in that: The core shaft assembly includes a fixed tube and an inner knife sleeve, the fixed tube is fixedly outer-circuited on the rotary cutter tube, the inner knife sleeve is fixedly outer-circuited on the fixed tube, the rotating sleeve is outer-circuited on the inner knife sleeve, and the rotating sleeve and the inner knife sleeve are connected in an axial sliding manner by inserting an axial protrusion into an axial guide groove, and are fixedly connected in the circumferential direction; The inner cutter sleeve and the transmission screw are connected in a circumferential rotation direction and fixedly connected in an axial direction by inserting an annular limiting clamping piece provided circumferentially into an annular limiting clamping groove.
12. The rotary biopsy needle according to claim 11, characterized in that: A guide rail is further provided on the inner wall of the proximal shell, and the transmission screw is slidably arranged on the guide rail.
13. The rotary biopsy needle according to claim 10, characterized in that: The proximal handheld portion further comprises a motor handle, in which both the rotation drive motor and the stroke drive motor are mounted, and the motor handle is fixedly connected to the proximal housing.
Citation Information
Patent Citations
Closed continuous sampling breast rotary cutting biopsy needle
CN116831643A
Tissue biopsy device
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