Puncture biopsy device

Abstract

The application discloses a puncture biopsy device and belongs to the technical field of medical devices. In the puncture biopsy device, a positioning assembly is arranged, the relative positions of a first component and a second component can be positioned by the positioning assembly, the first component and the second component can move towards a third component together, a sheath tube is connected with the second component, the sheath tube can move together with the second component, and a puncture needle can be connected with the first component, so that the first component can drive the puncture needle to move when the first component moves, the puncture needle can drive the sheath tube to pass through tissues when the puncture needle punctures, the puncture needle can be withdrawn, and the sheath tube can be left in the tissues, so that subsequent surgical treatment can be performed, and damage to the tissues is reduced.

Description

Technical Field

[0001] This application belongs to the field of medical device technology, specifically relating to a puncture biopsy device. Background Technology

[0002] Endoscopic ultrasound (EUS) is a medical examination technique that combines endoscopy and ultrasound imaging to observe and diagnose diseases of the digestive tract and surrounding tissues. EUS can be used to diagnose and evaluate a variety of diseases, including gastrointestinal tumors, pancreatic diseases, biliary tract diseases, liver lesions, and enlarged lymph nodes. Furthermore, EUS can guide other treatment procedures, such as guided biopsies, guided puncture for fluid aspiration or cyst fluid removal, and stent placement.

[0003] For the diagnosis of lesions in and outside the digestive tract, including lesions and cysts in the liver, pancreas, and adrenal glands, EUS-TTNB (EUS-guided through-the-needle biopsy) can achieve rapid diagnosis. EUS-TTNB combines the technical advantages of endoscopic ultrasound (EUS) and biopsy forceps. Under the guidance of endoscopic ultrasound, doctors can accurately locate the lesion and use a fine needle to puncture the lesion area. Subsequently, a biopsy forceps is inserted through the fine needle to collect a tissue sample from the lesion for subsequent pathological analysis. The commonly used instrument is a 19G ultrasonic needle (0.9mm inner diameter) combined with an ultrafine biopsy forceps (0.8mm diameter), but the small opening of this biopsy forceps and the small sample volume are significant drawbacks. Utility Model Content

[0004] Purpose of the utility model: This application provides a puncture biopsy device, which aims to solve the technical problems of small biopsy channels and small sample volume in the puncture needles of current puncture biopsy devices in practical applications.

[0005] Technical solution: A puncture biopsy device according to an embodiment of this application includes:

[0006] A handle assembly having a proximal side and a distal side disposed opposite to each other in its length direction, the handle assembly including a first member, a second member and a third member arranged sequentially from the proximal side to the distal side, the first member being movably disposed on the second member, and the second member being movably disposed on the third member;

[0007] A positioning component is disposed on the handle assembly, the positioning component being used to position the relative positions of the first component and the second component so that the first component and the second component can move together toward the third component;

[0008] The sheath has one end connected to the second component and the other end extending along the length direction and penetrating to the outside of the third component;

[0009] The puncture needle is configured to pass through the handle assembly and the sheath, and to be connected to the first component.

[0010] In some embodiments, the positioning component includes:

[0011] A first locking element is disposed on the first component, and the first locking element is configured to have an unlocked state and a locked state;

[0012] When in the unlocked state, the first component is able to move relative to the second component in the length direction;

[0013] When in the locked state, the first locking member can lock onto the second member to fix the first member onto the second member.

[0014] In some embodiments, the second component is provided with a second locking member, which is configured to lock onto the third component to fix the second component onto the third component;

[0015] The second locking element is also configured to unlock when pressed, so that the second member can move relative to the third member in the length direction.

[0016] In some embodiments, the positioning component further includes:

[0017] A limiting member is disposed on the second component, and the limiting member is configured to have an open state and a closed state;

[0018] When in the open state, the limiting member is movable relative to the second member in the length direction;

[0019] When in the closed state, the limiting member is fixed to the second component to limit the first component.

[0020] In some embodiments, the sheath includes:

[0021] The main body segment is connected to the second component;

[0022] A tapering section is connected to the end of the main body segment away from the second member, and the outer diameter of the tapering section gradually decreases along the direction away from the main body segment.

[0023] In some embodiments, the inner diameter of the tapering segment gradually decreases along a direction away from the main body segment.

[0024] In some embodiments, the inner diameter dimension at the minimum inner diameter of the tapered section is D1, and the outer diameter of the needle body of the puncture needle is D2, satisfying: 0.5 ≤ D1 / D2 ≤ 10;

[0025] When D1 < D2, the tapered section is configured to be elastically deformed under the extrusion of the needle body.

[0026] In some embodiments, the puncture biopsy device further satisfies: 0.3 mm ≤ D1 ≤ 3.6 mm.

[0027] In some embodiments, the puncture needle is configured to be in contact with the inner wall of the tapered section when passing through the sheath.

[0028] In some embodiments, the puncture biopsy device further includes:

[0029] A visualization portion provided at an end of the sheath away from the second member.

[0030] In some embodiments, the visualization portion is provided between the outer tube wall and the inner tube wall of the sheath.

[0031] In some embodiments, the sheath is provided with a receiving groove, and the visualization portion is provided in the receiving groove.

[0032] In some embodiments, the puncture needle includes:

[0033] A connector provided proximally of the handle assembly and connected to the first member;

[0034] A needle body connected to the connector and capable of passing through the handle assembly and the sheath.

[0035] In some embodiments, the connector is detachably connected to the first member.

[0036] In some embodiments, a connecting portion is provided at an end of the first member away from the second member, and the connector is detachably connected to the connecting portion.

[0037] Beneficial Effects: The biopsy device provided in this application includes: a handle assembly having a proximal side and a distal side disposed opposite to each other in its length direction; the handle assembly includes a first component, a second component, and a third component arranged sequentially from the proximal side to the distal side; the first component is movably disposed on the second component; the second component is movably disposed on the third component; a positioning component disposed on the handle assembly; the positioning component is used to position the relative position of the first component and the second component so that the first component and the second component can move together toward the third component; a sheath, one end of which is connected to the second component, and the other end extends along the length direction and penetrates to the outside of the third component; and a puncture needle configured to pass through the handle assembly and the sheath, and to be connected to the first component. In the biopsy device of this application embodiment, by setting a positioning component, the puncture depth during rapid puncture of the puncture needle can be controlled by the positioning component, and the relative positions of the first component and the second component can be positioned so that the first component and the second component can move together toward the third component; by connecting the sheath to the second component, the sheath can move together with the second component; and the puncture needle can be connected to the first component so that the movement of the first component drives the movement of the puncture needle, thereby enabling the puncture needle to drive the sheath through the tissue during puncture, and then the puncture needle can be withdrawn, leaving the sheath in the tissue, leaving a larger channel for subsequent surgical treatment, such as increasing the amount of tissue sample by using a larger biopsy forceps. Attached Figure Description

[0038] To more clearly illustrate the technical solutions in the embodiments of this application, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0039] Figure 1 This is a schematic diagram of the structure of a puncture biopsy device provided in some embodiments of this application;

[0040] Figure 2 Schematic diagrams of the puncture biopsy device provided in other embodiments of this application;

[0041] Figure 3 This is a perspective view of the biopsy device provided in some other embodiments of this application;

[0042] Figure 4 for Figure 2 A magnified schematic diagram of a portion of region A in the middle;

[0043] Figure 5 for Figure 2 A magnified perspective view of a portion of region A in the middle;

[0044] Figure 6 This is a partial cross-sectional structural diagram of the needle body and sheath in some embodiments of this application;

[0045] Figure 7 This is a partial cross-sectional structural diagram of the needle body and sheath in some other embodiments of this application;

[0046] Figure 8 This is a partial cross-sectional structural diagram of the needle body and sheath in some other embodiments of this application;

[0047] Figure 9 A schematic flowchart illustrating the puncture method provided in some embodiments of this application;

[0048] Figure 10 A schematic diagram illustrating the process of the guidewire in a puncture biopsy device provided in some embodiments of this application;

[0049] Figure 11 A cross-sectional schematic diagram of the use state of the puncture biopsy device under the guidewire in some embodiments of this application;

[0050] Figure 12 A schematic flowchart illustrating the puncture method provided in some embodiments of this application;

[0051] Reference numerals: 100-Handle assembly; 101-Proximal; 102-Distal; 103-Channel; 110-First component; 111-First handle; 112-Connector; 120-Second component; 121-Second handle; 122-First core rod; 123-Second locking element; 130-Third component; 131-Connector; 132-Second core rod; 140-Support sleeve; 200-Positioning assembly; 210-First locking element; 220-Limiting element; 300-Sheath; 310-Main body segment; 320-Gradual section; 330-Outer wall; 340-Inner wall; 350-Receiving groove; 400-Punch needle; 410-Needle body; 420-Connector; 500-Probe assembly; 510-Probe; 520-Needle cap; 600-Illuminating section; 700-Guidewire; X-Length direction. Detailed Implementation

[0052] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of them. All other embodiments obtained by those skilled in the art based on the embodiments of this application without creative effort are within the scope of protection of this application.

[0053] In the description of this application, it should be understood that the terms "proximal" and "distal" are used with the surgical operator (doctor) as the reference point. "Proximal" refers to the end of the surgical instrument closer to the operator, and "distal" refers to the end further away from the operator relative to the "proximal," i.e., closer to the patient. The terms "upper," "lower," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or apparatus referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application. "Multiple" means two or more, and "at least one" can mean one, two, or more, unless otherwise explicitly specified. The terms "installed," "connected," and "linked" should be interpreted broadly, for example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two devices or the interaction between two devices, unless otherwise explicitly specified. The terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature.

[0054] In the description of this application, the length direction is introduced to facilitate the explanation of the relative positional relationships between the components of the biopsy device. The length direction refers to the direction corresponding to the proximal and distal sides of the handle assembly in the biopsy device, the extension direction of the channel in the handle assembly, and also the arrangement direction of the first, second, and third components in the handle assembly and the direction of their relative movement. In the accompanying drawings of this application, the length direction X is indicated by an arrow marked X, which can be the direction from the proximal side of the handle assembly to the distal side of the handle assembly.

[0055] Biopsy techniques can be applied to lesions in various locations, such as the lungs, liver, breast, and thyroid, and are widely used in clinical practice. For example, EUS (Endoscopic Ultrasound) is a diagnostic and therapeutic tool combining endoscopy and ultrasound technology. It provides high-resolution images of internal organs and allows for real-time ultrasound-guided biopsy. Endoscopic ultrasound biopsy involves obtaining tissue samples for pathological examination through ultrasound-guided puncture. This technique is commonly used for the diagnosis and evaluation of lesions in internal organs such as the digestive tract, liver, and pancreas. However, it involves obtaining relatively small samples. EUS-TTNB, or Endoscopic Ultrasound Guided Through-the-Needle Biopsy, combines the advantages of endoscopic ultrasound (EUS) and biopsy forceps. Under the guidance of endoscopic ultrasound, doctors can precisely locate lesions and use a fine needle to puncture and access the lesion area. Subsequently, a biopsy forceps is inserted through a fine needle to collect tissue samples from the lesion for subsequent pathological analysis.

[0056] In related technologies, puncture biopsy devices can cause damage to tissues or other instruments in practical applications. For example, when using a guidewire under superselective bile duct manipulation, the guidewire may come into contact with the distal edge of the needle during movement, causing the guidewire skin to be scratched. Additionally, in EUS-TTNB procedures, a 19G ultrasonic needle (0.9mm core diameter) is used in conjunction with ultrafine biopsy forceps (0.8mm diameter). However, the small opening of these forceps and the limited sample volume are significant drawbacks.

[0057] In view of this, embodiments of this application provide a puncture biopsy device capable of being used for puncture sampling during endoscopic ultrasound (EUS) surgery to obtain tissue specimens from a target site. A channel can be left in place after puncture during EUS, allowing the use of larger biopsy forceps to complete EUS-TTNB procedures. It is understood that this puncture biopsy device can also be applied to other minimally invasive surgeries, and is not limited to endoscopic ultrasound. Its application to bile duct superselective biliary tract surgery can reduce damage to the guidewire skin.

[0058] Please refer to the following: Figure 1 and Figure 2 The puncture biopsy device provided in this application includes: a handle assembly 100, a positioning assembly 200, a sheath 300, and a puncture needle 400.

[0059] The handle assembly 100 is the control structure of the puncture biopsy device, which is usually held by the doctor or operator. The handle assembly 100 is used to operate and control the sheath 300 and the puncture needle 400 to perform actions such as advancing, retracting, rotating and collecting tissue samples.

[0060] The handle assembly 100 has a proximal side 101 and a distal side 102 disposed opposite to each other in its length direction X. It is understood that the proximal side 101 and the distal side 102 are opposite sides of the handle assembly 100 in the length direction X, with the proximal side 101 closer to the proximal end of the biopsy device and the distal side 102 closer to the distal end of the biopsy device relative to the proximal side 101. The handle assembly 100 includes a first member 110, a second member 120, and a third member 130 arranged sequentially from the proximal side 101 to the distal side 102. The first member 110, the second member 120, and the third member 130 are arranged sequentially along the length direction X and are movably connected in sequence. The first member 110 is movably disposed on the second member 120, and the second member 120 is movably disposed on the third member 130. Through operation, the first member 110 can be moved relative to the second member 120 in the length direction X, and the second member 120 can also be moved relative to the third member 130 in the length direction X.

[0061] A positioning component 200 is disposed on the handle assembly 100. The positioning component 200 is used to position the relative positions of the first component 110 and the second component 120 so that the first component 110 and the second component 120 can move together toward the third component 130. That is, by providing the positioning component 200 on the handle assembly 100, the positioning component 200 can at least fix the relative positions of the first component 110 and the second component 120 when moving toward the third component 130. The positioning component 200 may include a first locking member 210 disposed on the first component 110, which can fix the first component 110 onto the second component 120 so that the first component 110 and the second component 120 can move together toward the third component 130; the positioning component 200 may also include a limiting member 220 disposed on the second component 120, which limits the first component 110 and can control the puncture depth when the puncture needle 400 punctures rapidly.

[0062] One end of the sheath 300 is connected to the second component 120, and the other end extends along the length direction X and passes through the third component 130; the puncture needle 400 is configured to pass through the handle assembly 100 and the sheath 300, and can be connected to the first component 110.

[0063] In some embodiments, the handle assembly 100 is provided with a channel 103 that extends through the first member 110, the second member 120, and the third member 130 in the longitudinal direction X. The channel 103 is used for laying the sheath 300 and for the puncture needle 400 to pass through. By manipulating the handle assembly 100, the sheath 300 and the puncture needle 400 are inserted into the patient's body through the endoscope's channel. The connector 131 of the third member 130 can be used to connect with the protrusion of the endoscope's channel to fix it to the endoscope. A support sleeve 150 provided at the distal end of the connector 131 is used for passing the sheath 300.

[0064] A sheath 300 is disposed in the channel 103 and connected to the second component 120. The sheath 300 passes through the third component 130 along the channel 103 and extends outside the channel 103. Specifically, the sheath 300 can be connected to the second component 120 at one end, and its other end can pass through the third component 130 along the channel 103 and extend outside the channel 103, so that the sheath 300 can be moved by moving the second component 120. After the puncture biopsy device is inserted into the endoscope, when the second component 120 and the third component 130 are in a relatively active state, the length of the sheath 300 extending out of the endoscope can be controlled by controlling the movement of the second component 120 relative to the third component 130.

[0065] The puncture needle 400 is configured to pass through the channel 103 and the sheath 300, and can be connected to the first component 110. That is, the puncture needle 400 can be connected to and detached from the first component 110; the two are detachably connected. By inserting the puncture needle 400 into the channel 103 and the sheath 300, and connecting it to the first component 110, the first component 110 can move the puncture needle 400 when it moves. The limiting member 220 limits the relative position of the first component 110 and the second component 120, thereby controlling the length of the puncture needle 400 extending out of the sheath 300.

[0066] In the puncture biopsy device of this application embodiment, by setting the positioning component 200, the relative positions of the first component 110 and the second component 120 can be positioned, so that the first component 110 and the second component 120 can move together toward the third component 130; by connecting the sheath 300 to the second component 120, the sheath 300 can move together with the second component 120; and the puncture needle 400 can be connected to the first component 110, so that when the first component 110 moves, it drives the puncture needle 400 to move, thereby enabling the puncture needle 400 and the sheath 300 to pass through the tissue together when puncturing, and then the puncture needle 400 can be withdrawn, leaving the sheath 300 in the tissue, leaving a larger channel for subsequent surgical treatment, such as increasing the amount of tissue sample by using a larger biopsy forceps.

[0067] Please see Figure 1 In some embodiments, the positioning component 200 includes a first locking member 210, which is disposed on the first component 110 and configured to have an unlocked state and a locked state. When in the unlocked state, the first component 110 can move relative to the second component 120; when in the locked state, the first component 110 is fixed to the second component 120 by the first locking member 210. In this embodiment, setting the first locking member 210 to the locked state enables a fixed connection between the first component 110 and the second component 120, allowing them to move synchronously. When the second component 120 and the third component 130 are in a relatively fixed state, operating the first component 110 or the second component 120 enables the puncture needle 400 and the sheath 300 to puncture tissue together. By providing the first locking member 210 on the first component 110, the connection strength when the first component 110 and the second component 120 are fixedly connected can be improved, preventing the puncture needle 400 from retracting under force.

[0068] Optionally, the first locking member 210 can be a locking nut, sleeved on the distal end of the first handle 111 of the first component 110. When the first locking member 210 is tightened, it squeezes the distal end of the first handle 111, causing it to clamp the first core rod 122 of the second component 120, thus locking. When the first locking member 210 is loosened, the distal end of the first handle 111 relaxes, thus unlocking. Optionally, the first locking member 210 can be a locking screw, fitted into the mounting hole on the side wall of the first handle 111. When the first locking member 210 is screwed in, its end can press against the first core rod 122 of the second component 120, thus locking. When the first locking member 210 is screwed out, its end can disengage from the first core rod 122 of the second component 120, thus unlocking. It is understood that the first locking member 210 can also be implemented using other locking structures, which are not limited here.

[0069] In some embodiments, the relative active and relative fixed states of the second component 120 and the third component 130 can be achieved by the second locking member 123 of the second component 120. When the second locking member 123 is locked, the second component 120 is fixed to the third component 130, achieving a relative fixed state between the second component 120 and the third component 130; when the second locking member 123 is unlocked, the second component 120 can move relative to the third component 130, achieving a relative active state between the second component 120 and the third component 130. Optionally, the second locking member 123 can be a locking nut, sleeved on the distal end of the second handle 121 of the second component 120. When the second locking member 123 is tightened, it squeezes the distal end of the second handle 121, causing it to clamp the second core rod 132 of the third component 130, achieving locking; when the second locking member 123 is loosened, the distal end of the second handle 121 is released, achieving unlocking. Optionally, the second locking member 123 can be a locking screw, which is installed in the mounting hole on the side wall of the second handle 121. When the second locking member 123 is screwed in, its end can press against the second core rod 132 of the third component 130 to achieve locking; when the second locking member 123 is screwed out, its end can disengage from the second core rod 132 of the third component 130 to achieve unlocking.

[0070] The second locking member 123 can also be implemented using other locking structures. In some embodiments, the second locking member 123 is configured to lock onto the third member 130 to fix the second member 120 onto the third member 130. The second locking member 123 is also configured to unlock when pressed, so that the second member 120 can move relative to the third member 130. For example, although not shown, it can be understood that a toothed structure can be provided on the second core rod 132 of the third member 130, that is, multiple slots are arranged at intervals along the length direction X on the outer peripheral surface of the second core rod 132, and the slots extend in a direction perpendicular to the length direction X. The second locking member 123 includes a base, a pressing member, and an elastic member. The base is circumferentially mounted on the second core rod 132 and fixedly connected to the second handle 121 of the second member 120. The base and the second handle 121 are configured to move along the second core rod 132 (i.e., move relative to the second core rod 132 in the length direction X), and the base is provided with mounting holes. The pressing element passes through the mounting hole and is connected to the base via an elastic element. When pressed, the pressing element can move in a direction perpendicular to the length direction X, i.e., along the extension direction of the groove. The pressing element has a protrusion that can engage with the groove of the toothed structure for locking. Thus, when the pressing element is not pressed, the elastic element holds it in the locked position, causing the protrusion to engage within the groove of the toothed structure. The second locking element 123 cannot move relative to the third component 130 in the length direction X, thereby fixing the second component 120 to the third component 130. When a doctor or other operator applies pressure to the pressing element, the force is transmitted to the elastic element, causing it to deform elastically. This allows the pressing element to move along the extension direction of the groove, causing its protrusion to move out of the groove, unlocking the pressing element and allowing the second component 120 to move relative to the third component 130 in the length direction X. For example, the second locking member 123 may include an elastic member and a locking member. The middle part of the locking member is hinged to the second handle 121, and the elastic member is fixedly connected to the second handle 121, pressing the locking member into the locked position so that one end of the locking member can be engaged into the groove of the aforementioned toothed structure. The other end of the locking member is provided with a pressing structure. When the doctor presses the pressing structure, the other end of the locking member is subjected to pressing force, generating a seesaw effect, which allows it to rotate around the hinge to resist the elastic force of the elastic member, causing the end engaged in the groove to disengage from the groove, thereby achieving unlocking.

[0071] In the embodiment where the second locking member 123 of the aforementioned second component 120 is unlocked by pressing, by providing the first locking member 210 on the first component 110, it is easier for the doctor to operate and to achieve simultaneous puncture of the puncture needle 400 and the sheath 300. Specifically, after the first locking member 210 is set to the locked state, the first component 110 and the second component 120 are fixedly connected and can move synchronously in the length direction X. The doctor only needs to hold the second component 120 and press the second locking member 123 to move the second component 120, thereby enabling the puncture needle 400 and the sheath 300 to be punctured together. That is to say, the doctor only needs to hold the second component 120 with one hand to achieve the simultaneous puncture operation. Conversely, in the embodiment where the second locking member 123 is unlocked by pressing, if the first locking member 210 is not provided on the first component 110, then the first component 110 is not locked and fixed by the first locking member 210, and is therefore movably provided on the second component 120. When the doctor holds the second component 120 and presses the second locking member 123, moving the second component 120 toward the third component 130, the first component 110 may also follow the second component 120. However, when the puncture needle 400 encounters resistance from the tissue, both the puncture needle 400 and the first component 110 will retract due to the resistance. Therefore, to achieve simultaneous puncture of the puncture needle 400 and the sheath 300, the doctor must use both hands: one hand to hold the second component 120 and press to unlock the second locking member 123, and the other hand to hold the first component 110 to resist the resistance encountered by the puncture needle 400, increasing the difficulty of the operation.

[0072] Please refer to the following: Figures 1 to 3 In some embodiments, the positioning component 200 includes a limiting member 220, which is disposed on the second component 120. The limiting member 220 is configured to limit the first component 110, control the puncture depth when the puncture needle 400 punctures quickly, and enable the first component 110 to drive the second component 120 to move toward the third component 130.

[0073] Specifically, the limiting member 220 can be fixed to the second member 120, thus fixing its position on the second member 120. When the first member 110 moves along the length direction X towards the second member 120 until it contacts the limiting member 220, the first member 110 can apply a pushing force along the length direction X towards the third member 130 to the limiting member 220. When the second member 120 and the third member 130 are in a relatively movable state, the limiting member 220, under the pushing force of the first member 110, can drive the second member 120 to move towards the third member 130. When the second member 120 and the third member 130 are in a relatively fixed state, the limiting member 220 reacts to the first member 110 to limit the first member 110, causing the first member 110 to stop moving towards the third member 130 at the limiting member 220. In other words, the limiting member 220 can limit the relative position of the first member 110 and the second member 120.

[0074] It is understandable that by setting a limiting member 220 on the second component 120, the first component 110 is limited by the limiting member 220, allowing the first component 110 to drive the second component 120 to move towards the third component 130. By connecting the sheath 300 to the second component 120, the sheath 300 can move together with the second component 120. Thus, after the puncture biopsy device is inserted into the endoscope, adjusting the position of the second component 120 can control the length of the sheath 300 extending out of the endoscope. By connecting the puncture needle 400 to the first component 110, the movement of the first component 110 drives the puncture needle 400 to move, performing puncture. Thus, the puncture needle 400 can drive the sheath 300 through the tissue during puncture. When the sheath 300 reaches outside the tissue under ultrasound or other conditions, the puncture needle 400 can be removed from the first component 110, and then withdrawn, leaving the sheath 300 in the tissue. The sheath 300 can be used as a pathway for subsequent treatments, such as inserting biopsy forceps through the sheath 300 for sampling or other treatments, reducing tissue damage and increasing the sample volume.

[0075] In some embodiments, the first core rod 122 is connected to the end of the second handle 121 near the first handle 111. The first component 110 and the limiting member 220 are both disposed on the first core rod 122 of the second component 120. The limiting member 220 is configured to have an open state and a closed state. When in the open state, the limiting member 220 can move along the length direction X on the first core rod 122. When in the closed state, the limiting member 220 is fixed to the first core rod 122 to limit the first component 110. Thus, the puncture distance of the puncture needle 400 can be adjusted by adjusting the position of the limiting member 220 on the first core rod 122. The limiting member 220 can be a clamp, a clip, a locking screw, or a similar structure.

[0076] Please see Figure 1 In some embodiments, the positioning component 200 includes the first locking member 210 and the limiting member 220 described above. When the first locking member 210 is set to the unlocked state, the limiting member 220 can be used to limit the first component 110, determine the puncture distance of the puncture needle 400, and use the puncture sampling function of the puncture needle 400 itself to control the puncture needle 400 to independently puncture the tissue to achieve rapid puncture.

[0077] Please refer to the following: Figures 1 to 4 In some embodiments, the puncture needle 400 includes a needle body 410 and a connector 420. The needle body 410 is configured to pass through the channel 103 and the sheath 300. The connector 420 is connected to the end of the first component 110 away from the second component 120 and is connected to the needle body 410. By passing the needle body 410 through the channel 103 and the sheath 300 and connecting the connector 420 to the first component 110, the connection and assembly of the puncture needle 400 and the handle assembly 100 can be completed.

[0078] In some embodiments, the connector 420 is detachably connected to the first member 110. By removing the connector 420 from the first member 110, the needle body 410 can be withdrawn from the channel 103 and the sheath 300, and the puncture needle 400 can be removed.

[0079] In some embodiments, the end of the first component 110 away from the second component 120 is provided with a connecting portion 112, and the connector 420 is detachably connected to the connecting portion 112. Optionally, the connecting portion 112 can be a Luer connector, or it can adopt a threaded, snap-fit, or other connection structure.

[0080] In some embodiments, the biopsy device further includes a probe assembly 500, wherein a probe 510 of the probe assembly 500 passes through the channel of the puncture needle 400, and a needle cap 520 of the probe assembly 500 is disposed at the proximal end of the puncture needle 400. The distal end of the probe assembly 500 is rounded, and when the probe assembly 500 and the puncture needle 400 are connected, the distal end of the probe assembly 500 extends beyond the needle tip. By configuring the probe assembly 500, the impact of the needle tip of the puncture needle 400 on the forceps channel can be reduced when the biopsy device is inserted into the patient's body via an endoscope.

[0081] Please see Figure 4In some embodiments, the sheath 300 includes a main body segment 310 and a tapering segment 320. The main body segment 310 is the main portion of the sheath 300, connected to the second member 120, and extends along the channel 103 toward the distal end of the biopsy device. The tapering segment 320 is connected to the end of the main body segment 310 away from the second member 120, and its outer diameter D gradually decreases along the direction away from the main body segment 310. The direction away from the main body segment 310 is the direction along the axis of the sheath 300 that gradually moves away from the main body segment 310. In this embodiment, the tapering segment 320 is configured such that its outer diameter gradually decreases along the direction away from the main body segment 310; that is, the distal end of the tapering segment 320 is thinner, and it becomes thicker as it approaches the proximal end, i.e., the tapering segment 320 is approximately conical. This configuration reduces the resistance of the sheath 300 when it penetrates the tissue, facilitating the insertion of the sheath 300 and the puncture needle 400 into the tissue together, thus reducing tissue damage.

[0082] Please refer to the following: Figure 4 and Figure 5 In some embodiments, the inner diameter d of the tapered section 320 gradually decreases along the direction away from the main body section 310. This results in a smaller distal opening of the tapered section 320, leading to a smaller gap between the sheath 300 and the puncture needle 400 at the distal opening, further reducing resistance during tissue insertion and minimizing tissue damage. Furthermore, the smaller distal opening of the tapered section 320 allows for a closer fit between the puncture needle 400 and the sheath 300, facilitating static friction and making it easier for the puncture needle 400 to guide the sheath 300 into the tissue. Moreover, the gradually decreasing inner diameter d of the tapered section 320 creates a roughly conical guide surface on its inner wall, which guides the puncture needle 400, contributing to improved stability and accuracy of the puncture.

[0083] Please see Figure 6, the inner diameter dimension at the minimum inner diameter of the tapered section 320 is D1, that is, the diameter of the distal opening of the sheath 300 is D1, and this dimension can be measured by measuring tools such as vernier calipers and micrometers. The outer diameter of the needle body 410 of the puncture needle 400 is D2, that is, the pipe diameter of the needle body 410 of the puncture needle 400 is D2, and this dimension can be measured by measuring tools such as vernier calipers and micrometers, or determined according to the specification of the needle. For example, for the needle body 410 of 20G, D2 is 0.9 mm. Optionally, it satisfies: 0.5 ≤ D1 / D2 ≤ 10. Controlling D1 / D2 within the above range ensures that the gap between the puncture needle 400 and the sheath 300 at its distal opening is small enough, ensuring the fit between the two, further reducing the damage to tissues, and further improving the stability and accuracy of the puncture. Optionally, D1 / D2 can be any value among 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10 or the range value between any two values.

[0084] Optionally, the inner diameter dimension D1 at the minimum inner diameter of the tapered section 320 satisfies: 0.3 mm ≤ D1 ≤ 3.6 mm. For example, the value of D1 can be any value among 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6 or the range value between any two values. Setting D1 within this range enables the sheath 300 to meet the application of EUS (Endoscopic Ultrasound).

[0085] In some embodiments, the puncture needle 400 is arranged to be in contact with the inner wall of the tapered section 320 when penetrating the sheath 300. This can improve the fit between the puncture needle 400 and the sheath 300 at the opening of the sheath 300, and further reduce the damage to tissues when the two penetrate into tissues together.

[0086] Optionally, when D1 < D2, the tapered section 320 is arranged to be able to generate elastic deformation and expand outward under the extrusion of the needle body 410. Specifically, the material of the sheath 300 can be an elastic material, such as medical rubber, silica gel, etc. In this way, the minimum inner diameter of the sheath 300 at the tapered section 320 can be smaller than the outer diameter of the puncture needle 400, and the puncture needle 400 can expand it, making the direct combination of the two closer, improving the co-puncture effect, and further reducing the damage to tissues.

[0087] Please refer to Figure 6 and Figure 7 and Figure 8 In some embodiments, the biopsy device further includes a imaging section 600, which can be configured to develop images under ultrasound and / or X-ray conditions. The imaging section 600 can be made of metal or other imaging materials. The imaging section 600 is located at the end of the sheath 300 away from the second member 120, that is, at the distal end of the sheath 300. This allows for accurate confirmation of the position of the sheath 300 by means of ultrasound or other methods even after the puncture needle 400 is withdrawn.

[0088] Please refer to it again. Figure 8 In some embodiments, the imaging section 600 is disposed between the outer tube wall 330 and the inner tube wall 340 of the sheath 300, that is, the imaging section 600 is disposed within the material of the sheath 300. This does not affect the smoothness of the outer tube wall 330 and the inner tube wall 340 of the sheath 300, and can avoid contact with the puncture needle 400, the forceps channel of the endoscope and the internal tissue, reducing the possibility of damage to other components or tissues and improving the safety of the operation.

[0089] Please refer to it again. Figure 6 and Figure 7 In some embodiments, the sheath 300 has a receiving groove 350, and the imaging part 600 is disposed within the receiving groove 350. This also prevents the imaging part 600 from protruding, reducing the possibility of damage to other components or tissues and improving the safety of the surgery. Optionally, the receiving groove 350 can be disposed on the outer wall of the sheath 300 (e.g., Figure 6 As shown), it can also be installed on the inner wall of the sheath 300 (e.g. Figure 7 (As shown).

[0090] Accordingly, this application also provides a puncture method for the puncture biopsy device applied to any of the above embodiments. Please refer to [link to relevant documentation]. Figure 9 The puncture method includes:

[0091] The first component 110 is limited by the limiting member 220. Moving the first component 110 causes the second component 120 to move toward the third component 130, and also causes the puncture needle 400 and sheath 300 to be inserted into the tissue together. This can reduce damage to the tissue and also leave the sheath 300 in the tissue for subsequent treatment.

[0092] In some embodiments, the puncture method further includes: after the puncture needle 400 and sheath 300 are inserted into the tissue together, separating the puncture needle 400 from the first member 110 to withdraw the puncture needle 400 from the sheath 300 and the channel 103. This allows the sheath 300 to remain in the tissue, enabling the sheath 300 and channel 103 to form a pathway for subsequent surgical treatment, such as inserting a biopsy forceps through the sheath 300 to obtain tissue samples. The internal channel size of the sheath 300 is relatively larger than that of the puncture needle 400, effectively increasing the sample volume that can be obtained with the biopsy forceps.

[0093] Please refer to the following: Figure 10 and Figure 11 In some embodiments, the method further includes: moving the first component 110 to retract the puncture needle 400 into the sheath 300, and then lowering the guide wire 700 through the puncture needle 400. Specifically, during intraductal superselection, the tip of the puncture needle 400 is retracted into the sheath 300, and the guide wire 700 is lowered from the puncture needle 400. Since the guide wire 700 directly contacts the sheath 300, the guide wire skin is prevented from being cut by the tip of the puncture needle 400.

[0094] Please see Figure 12 In some embodiments, when the first component 110 of the biopsy device is equipped with a first locking member 210, the puncture method further includes: switching the first locking member 210 on the first component 110 to a locked state, moving the first component 110 so that it drives the second component 120 to move toward the third component 130, and driving the puncture needle 400 and the sheath 300 to puncture the tissue together. Specifically, when the first locking member 210 is locked, the first component 110 and the second component 120 are fixedly connected, allowing the puncture needle 400 and the sheath 300 to puncture together, and the puncture needle 400 will not retract when force is applied. When the first locking member 210 is unlocked, the position of the upper limit member 220 of the first core rod 122 can be adjusted to determine the puncture distance of the puncture needle 400, allowing for rapid puncture and retaining the puncture and sampling function of the puncture needle 400 itself. At this time, only the needle punctures, and the sheath 300 does not enter along with it.

[0095] In some embodiments, when the first component 110 of the biopsy device is provided with a first locking member 210 and the second locking member 123 of the second component 120 is locked by pressing, the puncture method further includes: switching the first locking member 210 on the first component 110 to a locked state, pressing the second locking member 123 on the second component 120, moving the second component 120 to move the first component 110 toward the third component 130, and causing the puncture needle 400 and sheath 300 to be inserted into the tissue together. This allows the doctor to perform the puncture operation by holding the second component 120 with only one hand, facilitating the surgical procedure.

[0096] In the above embodiments, the descriptions of each embodiment have different focuses. For parts not described in detail in a certain embodiment, please refer to the relevant descriptions in other embodiments.

[0097] The above provides a detailed description of the puncture biopsy device provided in the embodiments of this application, and uses specific examples to illustrate the principles and implementation methods of this application. The description of the above embodiments is only for the purpose of helping to understand the technical solutions and core ideas of this application. Those skilled in the art should understand that they can still modify the technical solutions described in the foregoing embodiments, or make equivalent substitutions for some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this application.

Claims

1. A puncture biopsy device, characterized in that, Comprising: A handle assembly having a proximal side and a distal side oppositely disposed in its longitudinal direction, the handle assembly including a first member, a second member, and a third member arranged in sequence from the proximal side to the distal side, the first member being movably disposed on the second member, and the second member being movably disposed on the third member; A positioning assembly disposed on the handle assembly, the positioning assembly being configured to position the relative positions of the first member and the second member so that the first member and the second member can move together towards the third member; A sheath tube, one end of which is connected within the second member, and the other end extends along the longitudinal direction and penetrates to the outside of the third member; A puncture needle configured to penetrate the handle assembly and the sheath tube and be connected to the first member.

2. The biopsy device according to claim 1, characterized in that, The positioning assembly includes: A first locking member disposed on the first member, the first locking member being configured to have an unlocked state and a locked state; When in the unlocked state, the first member can move relative to the second member in the longitudinal direction; When in the locked state, the first locking member can be locked to the second member to fix the first member to the second member.

3. The biopsy device according to claim 2, characterized in that, The second member is provided with a second locking member, the second locking member being configured to be locked to the third member to fix the second member to the third member; The second locking member is further configured to be unlocked when pressed so that the second member can move relative to the third member in the longitudinal direction.

4. The biopsy device according to claim 2, characterized in that, The positioning assembly further includes: A limiting member disposed on the second member, the limiting member being configured to have an open state and a closed state; When in the open state, the limiting member can move relative to the second member in the longitudinal direction; When in the closed state, the limiting member is fixed to the second member to be able to limit the first member.

5. The biopsy device according to any one of claims 1 to 4, characterized in that, The sheath tube includes: A main body section connected to the second member; A tapered section connected to one end of the main body section away from the second member, and along the direction away from the main body section, the outer diameter of the tapered section gradually decreases.

6. The biopsy device according to claim 5, characterized in that, Along the direction away from the main body section, the inner diameter of the tapered section gradually decreases.

7. The biopsy device according to claim 6, characterized in that, The inner diameter dimension at the minimum inner diameter of the tapered section is D1, and the outer diameter of the needle body of the puncture needle is D2, satisfying: 0.5 ≤ D1 / D2 ≤ 10; In the case where D1 < D2, the tapered section is configured to be able to elastically deform under the extrusion of the needle body.

8. The biopsy device according to claim 7, characterized in that, The puncture biopsy device further satisfies: 0.3 mm ≤ D1 ≤ 3.6 mm.

9. The biopsy device according to claim 5, characterized in that, The puncture needle is configured to be able to contact the inner wall of the tapered section when penetrating the sheath tube.

10. The biopsy device according to any one of claims 1 to 4, characterized in that, The puncture biopsy device further includes: A developing portion disposed at one end of the sheath tube away from the second member.

11. The biopsy device according to claim 10, characterized in that, The developing portion is disposed between the outer tube wall and the inner tube wall of the sheath tube.

12. The biopsy device according to claim 10, characterized in that, The sheath tube is provided with a receiving groove, and the developing portion is disposed in the receiving groove.

13. The biopsy device according to any one of claims 1 to 4, characterized in that, The puncture needle includes: A connector disposed at the proximal side of the handle assembly and connected to the first member; The needle body is connected to the connector and can be inserted into the handle assembly and the sheath.

14. The biopsy device according to claim 13, characterized in that, The connector is detachably connected to the first component.

15. The biopsy device according to claim 14, characterized in that, The first component has a connecting part at the end away from the second component, and the connector is detachably connected to the connecting part.

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