Puncture device and puncture method thereof

Abstract

The invention discloses a puncture device and a puncture method thereof, and belongs to the technical field of medical instruments.In the puncture device, a limiting piece is arranged on a second component, and the limiting piece is used for limiting a first component, so that the first component can drive the second component to move towards a third component; the guide pipe is connected with the second component, so that the guide pipe can move along with the second component; the puncture needle can be connected with the first component, so that the first component drives the puncture needle to move when moving, the catheter can be driven to penetrate through the tissue together when the puncture needle punctures, the puncture needle can be withdrawn, the catheter is left in the tissue for subsequent operative treatment, and damage to the tissue in an operation is reduced.

Description

Technical Field

[0001] The present application belongs to the technical field of medical devices, and specifically relates to a puncture device and a puncture method thereof. Background Art

[0002] Biopsy puncture technology is a medical diagnostic method used to obtain tissue or cell samples from the patient's body for pathological examination. This technology uses a puncture device to puncture the tissue, accurately guide the needle tip to the lesion, and then collect tissue or cell samples. Biopsy puncture technology can be applied to lesions in different parts of the body, such as the lungs, liver, breast, thyroid, etc., and is widely used in clinical practice.

[0003] Conventional biopsy puncture technology directly obtains tissue through needle puncture and suction, and the amount of tissue that can be extracted is relatively limited. Other improved methods have emerged in clinical practice, such as biopsy with biopsy forceps under ultrasound guidance, or obtaining tissue with frozen bougies. However, it is usually necessary to cut the tissue before using biopsy forceps or frozen bougies, which causes great surgical trauma. Even if the biopsy forceps are directly inserted through the ultrasonic needle channel, due to the size limitation of the inner hole of the ultrasonic needle core, the small opening of the biopsy forceps and the small sampling volume have become a major obvious pain point. Summary of the invention

[0004] Purpose of the invention: An embodiment of the present application provides a puncture device, aiming to solve the technical problem of small sampling volume in the current method of obtaining tissue by biopsy forceps under the needle channel of an ultrasonic needle; another purpose of the embodiment of the present application is to provide a puncture method.

[0005] Technical solution: A puncture device described in an embodiment of the present application includes:

[0006] A handle mechanism is provided with a channel, the handle mechanism comprises a first member, a second member and a third member arranged in sequence in the length direction thereof, the channel penetrates the first member, the second member and the third member in the length direction; the second member is provided with a limiting member, the limiting member is configured to limit the first member, so that the first member can drive the second member to move toward the third member;

[0007] a conduit, disposed in the channel and connected to the second member, the conduit passing through the third member along the channel and extending outside the channel;

[0008] The puncture needle is configured to penetrate the channel and the catheter and to be connectable to the first member.

[0009] In some embodiments, the first member is provided with a first locking member, and the first locking member is configured to have an unlocked state and a locked state;

[0010] When in the unlocked state, the first member is movable relative to the second member;

[0011] When in the locked state, the first locking member can be locked to the second component to fix the first component to the second component.

[0012] In some embodiments, the second member is provided with a second locking member, and the second locking member is configured to be lockable to the third member to fix the second member to the third member;

[0013] The second locking element is further configured to be unlocked when pressed, so that the second component can move relative to the third component.

[0014] In some embodiments, the catheter comprises:

[0015] a main body section connected to the second member;

[0016] The tapered section is connected to one end of the main section away from the second component, and the outer diameter of the tapered section gradually decreases along the direction away from the main section.

[0017] In some embodiments, the inner diameter of the tapered section gradually decreases in a direction away from the main body section.

[0018] In some embodiments, the inner diameter of the tapered section at the minimum inner diameter is D1, and the outer diameter of the needle body of the puncture needle is D2, satisfying: 0.5≤D1 / D2≤10.

[0019] In some embodiments, the puncture device further satisfies: 0.3 mm ≤ D1 ≤ 3.6 mm.

[0020] In some embodiments, the puncture device further satisfies: 0.3 mm ≤ D1 ≤ 1.9 mm.

[0021] In some embodiments, the puncture needle is configured to contact the inner wall of the tapered section when piercing the catheter.

[0022] In some embodiments, the material of the catheter is an elastic material.

[0023] In some embodiments, the puncture device further comprises:

[0024] The developing part is arranged at an end of the guide tube away from the second member.

[0025] In some embodiments, the developing portion is disposed between an outer tube wall and an inner tube wall of the catheter.

[0026] In some embodiments, the conduit is provided with a receiving groove, and the developing portion is disposed in the receiving groove.

[0027] In some embodiments, the puncture needle comprises:

[0028] A needle body, configured to be able to penetrate the channel and the catheter;

[0029] A connector is connected to an end of the first component away from the second component and is connected to the needle body.

[0030] In some embodiments, the joint is detachably connected to the first member.

[0031] In some embodiments, a connecting portion is provided at one end of the first component away from the second component, and the joint is detachably connected to the connecting portion.

[0032] In some embodiments, the second member includes a first core rod, the first member and the limiting member are both disposed on the first core rod, and the limiting member is configured to have an open state and a closed state;

[0033] When in the open state, the limiting member can move on the first core rod along the length direction;

[0034] When in the closed state, the limiting member is fixed to the first core rod so as to limit the first component.

[0035] Accordingly, a puncture method according to an embodiment of the present application is applied to the puncture device according to any of the above embodiments, and the puncture method includes:

[0036] The first component is limited by the limiting piece, and the first component is moved to drive the second component to move toward the third component, and drive the puncture needle and the catheter to pierce the tissue together.

[0037] In some embodiments, the method further includes: after the puncture needle and the catheter penetrate the tissue together, separating the puncture needle from the first component to withdraw the puncture needle from the catheter and the channel, leaving the catheter in the tissue.

[0038] In some embodiments, the method further includes: moving the first component to drive the puncture needle to withdraw into the catheter, and passing a guide wire under the puncture needle.

[0039] In some embodiments, the method further includes: switching the first locking member on the first component to a locked state, moving the first component to drive the second component to move toward the third component, and driving the puncture needle and the catheter to penetrate the tissue together.

[0040] In some embodiments, the method further includes: switching the first locking member on the first member to a locked state, pressing the second locking member on the second member, moving the second member to drive the first member toward the third member, and driving the puncture needle and the catheter to penetrate the tissue together.

[0041] Beneficial effect: The puncture device provided in the embodiment of the present application includes: a handle mechanism, which is provided with a channel, and the handle mechanism includes a first component, a second component and a third component arranged in sequence in the length direction thereof, and the channel penetrates the first component, the second component and the third component in the length direction; the second component is provided with a limiter, and the limiter is configured to limit the first component so that the first component can drive the second component to move toward the third component; a catheter is arranged in the channel and connected to the second component, and the catheter passes through the third component along the channel and extends outside the channel; a puncture needle is configured to be able to penetrate the channel and the catheter, and can be connected to the first component. In the puncture device of the embodiment of the present application, a limiter is provided on the second component and the limiter is used to limit the first component, so that the first component can drive the second component to move toward the third component; the catheter is connected to the second component so that the catheter can move together with the second component; and the puncture needle can be connected to the first component so that the puncture needle is driven to move when the first component moves, so that the puncture needle can pass through the tissue together with the catheter during puncture, and then the puncture needle can be withdrawn and the catheter can be left in the tissue for subsequent surgical treatment. In this way, the biopsy forceps under the catheter can be used to increase the sampling amount and reduce damage to the tissue.

[0042] The puncture method of the embodiment of the present application is applied to the above-mentioned puncture device, and the puncture method includes: limiting the first component by the limiting member, moving the first component so that it drives the second component to move toward the third component, and drives the puncture needle and the catheter to pierce the tissue together. The catheter can be left in the tissue for subsequent surgical treatment, so that the biopsy forceps under the catheter can be used to increase the sampling volume and reduce damage to the tissue. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings required for use in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For those skilled in the art, other drawings can be obtained based on these drawings without creative work.

[0044] Figure 1 A perspective structural diagram of a puncture device provided in some embodiments of the present application;

[0045] Figure 2A schematic diagram of the structure of a puncture device provided in some embodiments of the present application;

[0046] Figure 3 A schematic diagram of the structure of a puncture device provided in some other embodiments of the present application;

[0047] Figure 4 for Figure 2 A schematic diagram of the local enlarged structure of the middle A area;

[0048] Figure 5 for Figure 2 A partial enlarged perspective structural diagram of the A area in the middle;

[0049] Figure 6 It is a schematic diagram of a partial cross-sectional structure of a needle body and a catheter in some embodiments of the present application;

[0050] Figure 7 Schematic diagram of partial cross-sectional structure of needle bodies and catheters in other embodiments of the present application;

[0051] Figure 8 Schematic diagram of partial cross-sectional structure of needle bodies and catheters in other embodiments of the present application;

[0052] Fig. 9 A schematic diagram of a puncture method provided in some embodiments of the present application;

[0053] Fig.10 A schematic diagram of the process of guiding the wire under the puncture device provided in some embodiments of the present application;

[0054] Fig.11 A cross-sectional schematic diagram of the puncture device provided in some embodiments of the present application when the guide wire is lowered;

[0055] Fig.12 A schematic diagram of a puncture method provided in some embodiments of the present application;

[0056] Figure markings: 100-handle mechanism; 101-channel; 110-first component; 111-first handle; 112-connecting part; 113-first locking member; 120-second component; 121-second handle; 122-first core rod; 123-second locking member; 130-third component; 131-connecting member; 132-second core rod; 140-limiting member; 150-support sleeve; 200-catheter; 210-main body; 220-tapered section; 230-outer tube wall; 240-inner tube wall; 250-accommodating groove; 300-puncture needle; 310-needle body; 320-connector; 400-probe assembly; 410-probe; 420-needle cap; 500-developing part; 600-guide wire; X-length direction. DETAILED DESCRIPTION

[0057] The technical solutions in the embodiments of the present application will be described clearly and completely below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work are within the scope of protection of the present application.

[0058] In the description of the present application, it should be understood that the terms "proximal end" and "distal end" are referenced to the surgical operator (doctor), wherein the "proximal end" is the end of the surgical tool closer to the operator, and the "distal end" is the end farther away from the operator relative to the "proximal end", that is, the end closer to the patient. The orientation or position relationship indicated by the terms "upper", "lower", "inner", "outer", etc. is based on the orientation or position relationship shown in the drawings, and is only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or device referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application. "Multiple" means two or more, and at least one means one, two or more, unless otherwise clearly and specifically defined. The terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be directly connected, or indirectly connected through an intermediate medium, it can be the internal connection of two devices or the interaction relationship between two devices, unless otherwise clearly and specifically defined. The terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features.

[0059] In the description of the present application, the length direction is introduced to facilitate the description of the relative positional relationship between the components in the puncture device. The length direction is the extension direction of the channel in the handle mechanism in the puncture device, and is also the direction of relative movement between the first component, the second component, and the third component in the handle mechanism. In the drawings of the present application, the length direction X is indicated by an arrow marked with X, and the length direction X can be the direction from the proximal end of the handle mechanism to the distal end of the handle mechanism.

[0060] Biopsy puncture technology can be applied to lesions in different parts, such as the lungs, liver, breast, thyroid, etc., and is widely used in clinical practice. For example, EBUS-TBNA (Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration), which combines endoscopy and ultrasound technology, can directly observe and guide the needle to puncture lung lesions through the ultrasound probe guided by the bronchoscope, so as to obtain tissue samples for cytology or histology examination; another example is digestive ultrasound endoscopic puncture, bile duct superselection, etc. In related technologies, the puncture device may cause damage to tissues or other instruments in actual applications. For example, when the guide wire is used under bile duct superselection, the guide wire will contact the distal blade of the needle when it moves, causing the guide wire skin to be scraped. In addition, if cryo-bougies or biopsy forceps are needed for extratracheal sampling or treatment in clinical practice, the trachea needs to be cut open with an electric knife, and then the cryo-bougies or biopsy forceps are inserted through the incision, which will cause greater damage to the tracheal tissue. Even if the biopsy forceps are inserted directly through the ultrasonic needle channel, the biopsy forceps opening is small due to the size limitation of the inner hole of the ultrasonic needle core, and the sampling volume is small.

[0061] In view of this, an embodiment of the present application provides a puncture device, which can be used for puncture sampling in ultrasonic endoscopy and ultrasonic bronchoendoscopic surgery to obtain tissue specimens from the target site. It is understandable that the puncture device can also be used in other minimally invasive surgeries, not limited to ultrasonic endoscopy and ultrasonic bronchoendoscopic surgery. Applying it to biliary superselection can reduce damage to the guide wire skin; applying it to extratracheal sampling or treatment, a catheter can be left in place, and a frozen bougie or biopsy forceps can be placed under the catheter to reduce damage to the tissue.

[0062] Please also read Figure 1 and Figure 2 The puncture device provided in the embodiment of the present application includes: a handle mechanism 100, a catheter 200 and a puncture needle 300.

[0063] The handle mechanism 100 is a control structure of the puncture device and is usually held by a doctor or an operator. The handle mechanism 100 is used to operate and control the catheter 200 and the puncture needle 300 to complete actions such as advancement, retraction, rotation and collection of tissue samples.

[0064] The handle mechanism 100 includes a first member 110, a second member 120, and a third member 130 arranged in sequence in the length direction X. The first member 110, the second member 120, and the third member 130 are arranged in sequence from the proximal end to the distal end of the handle mechanism 100 and are movably connected in sequence. Through operation, the first member 110 can be moved relative to the second member 120, and the second member 120 can also be moved relative to the third member 130.

[0065] The handle mechanism 100 is provided with a channel 101, which penetrates the first component 110, the second component 120 and the third component 130 in the length direction X. The channel 101 is used to lay the catheter 200 and pass the puncture needle 300. The catheter 200 and the puncture needle 300 are sent into the patient's body through the clamp channel of the endoscope by holding the handle mechanism 100. The connector 131 of the third component 130 can be used to connect with the clamp channel boss of the endoscope to be fixed on the endoscope. The support sleeve 150 provided at the distal end of the connector 131 is used to pass the catheter 200.

[0066] The second component 120 is provided with a limiting member 140 , and the limiting member 140 is configured to limit the first component 110 , so that the first component 110 can drive the second component 120 to move toward the third component 130 .

[0067] like Figure 1 As shown, in some embodiments, the stopper 140 can be fixed on the second member 120 so that its position on the second member 120 is fixed. When the first member 110 is controlled to move toward the second member 120 along the length direction X until it contacts the stopper 140, the first member 110 can apply a thrust to the stopper 140 along the length direction X toward the third member 130. When the second member 120 and the third member 130 are in a relatively active state, the stopper 140 can drive the second member 120 to move toward the third member 130 under the thrust of the first member 110; when the second member 120 and the third member 130 are in a relatively fixed state, the stopper 140 reacts to the first member 110 to limit the first member 110, so that the first member 110 moves to the stopper 140 and is blocked and stops moving toward the third member 130. In other words, the stopper 140 can limit the relative position of the first member 110 and the second member 120.

[0068] In some embodiments, the second member 120 includes a second handle 121 and a first core rod 122, the first core rod 122 is connected to one end of the second handle 121 close to the first handle 111, the first member 110 and the stopper 140 are both arranged on the first core rod 122 of the second member 120, and the stopper 140 is arranged to have an open state and a closed state; when in the open state, the stopper 140 can move along the length direction X on the first core rod 122; when in the closed state, the stopper 140 is fixed to the first core rod 122 to limit the first member 110. Thus, the puncture distance of the puncture needle 300 can be adjusted by adjusting the position of the stopper 140 on the first core rod 122. Among them, the stopper 140 can adopt a structure such as a clamp, a clamp, and a locking screw.

[0069] In some embodiments, the relative active state and the relative fixed state of the second member 120 and the third member 130 can be realized by the second locking member 123 of the second member 120. When the second locking member 123 is locked, the second member 120 is fixed to the third member 130, and the relative fixed state of the second member 120 and the third member 130 is realized; when the second locking member 123 is unlocked, the second member 120 can move relative to the third member 130, and the relative active state of the second member 120 and the third member 130 is realized. Optionally, the second locking member 123 can be a locking nut, which is sleeved on the distal end of the second handle 121 of the second member 120. When the second locking member 123 is tightened, the distal end of the second handle 121 is squeezed to clamp the second core rod 132 of the third member 130, and the locking is realized; when the second locking member 123 is loosened, the distal end of the second handle 121 is loosened, and the unlocking is realized. Optionally, the second locking member 123 can be a locking screw, which is assembled in the side wall mounting hole of the second handle 121. When the second locking member 123 is screwed in, its end can be pressed 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 be detached from the second core rod 132 of the third component 130 to achieve unlocking.

[0070] The second locking member 123 may also be implemented by other locking structures. In some embodiments, the second locking member 123 is configured to be locked to the third member 130 to fix the second member 120 to the third member 130; the second locking member 123 is also configured to be unlocked when pressed so that the second member 120 can move relative to the third member 130. For example, although not shown in the figure, it can be understood that: a tooth groove structure can be provided on the second core rod 132 of the third member 130, that is, a plurality of grooves are arranged at intervals on the outer peripheral surface of the second core rod 132 along the length direction X, and the grooves 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 assembled around the second core rod 132 and is fixedly connected to the second handle 121 of the second member 120. The base and the second handle 121 are configured to be movable along the second core rod 132 (that is, movable relative to the second core rod 132 in the length direction X), and an assembly hole is provided on the base. The pressing member is arranged in the assembly hole and connected to the base through the elastic member. The pressing member can move along the direction perpendicular to the length direction X, that is, along the extension direction of the groove, when the pressing force is applied. The pressing member is provided with a protrusion, which can be inserted into the groove of the tooth-groove structure so as to be able to cooperate with the groove to lock. In this way, when the pressing member is not pressed, the elastic member keeps the pressing member in the locking position, so that the protrusion of the pressing member is stuck in the groove of the tooth-groove structure, and the second locking member 123 cannot move relative to the third member 130 in the length direction X, thereby fixing the second member 120 on the third member 130. When a doctor or other operator applies pressure to the pressing member, the force is transmitted to the elastic member to cause it to produce elastic deformation, and then the pressing member can be pressed to move along the extension direction of the groove, driving its protrusion to move out of the groove, realizing unlocking, so that the second member 120 can move relative to the third member 130 in the length direction X. For another example, the second locking member 123 may include an elastic member and a snap-on member, wherein the middle portion of the snap-on member is hinged on the second handle 121, the elastic member is fixedly connected to the second handle 121, and the snap-on member is pressed in a locking position so that one end of the snap-on member can be snapped into the slot of the tooth-groove structure. A pressing structure is provided at the other end of the snap-on member, and when the doctor presses the pressing structure, the other end of the snap-on member is pressed, generating a seesaw effect, and can rotate around the hinge to resist the elastic force of the elastic member, so that the end of the snap-on member that is snapped into the slot is disengaged from the slot, thereby achieving unlocking.

[0071] The catheter 200 is disposed in the channel 101 and connected to the second member 120. The catheter 200 passes through the third member 130 along the channel 101 and extends to the outside of the channel 101. Specifically, the catheter 200 can be connected to the second member 120 at one end, and the other end can pass through the third member 130 along the channel 101 and extend to the outside of the channel 101, so that the catheter 200 can be driven to move by moving the second member 120. After the puncture device is installed in the endoscope, when the second member 120 and the third member 130 are in a relatively active state, the length of the catheter 200 extending out of the endoscope can be controlled by controlling the second member 120 to move relative to the third member 130.

[0072] The puncture needle 300 is configured to penetrate the channel 101 and the catheter 200, and can be connected to the first component 110. In other words, the puncture needle 300 can be connected to the first component 110, and can also be removed from the first component 110, that is, the two are detachably connected. By penetrating the puncture needle 300 in the channel 101 and the catheter 200, and connecting it to the first component 110, the first component 110 can drive the puncture needle 300 to move when it moves. Through the limiting effect of the limiting member 140, the relative position of the first component 110 and the second component 120 can be limited, so that the length of the puncture needle 300 extending out of the catheter 200 can be controlled.

[0073] In the puncture device of the embodiment of the present application, by setting a stopper 140 on the second member 120, the stopper 140 is used to limit the first member 110, so that the first member 110 can drive the second member 120 to move toward the third member 130. By connecting the catheter 200 with the second member 120, the catheter 200 can move with the second member 120. Therefore, after the puncture device is loaded into the endoscope, the position of the second member 120 is adjusted to control the length of the catheter 200 extending out of the endoscope. By connecting the puncture needle 300 with the first member 110, the puncture needle 300 is driven to move when the first member 110 moves to perform puncture. Therefore, the puncture needle 300 can pass through the tissue together with the catheter 200 during puncture. When the catheter 200 is observed to reach the outside of the tissue under ultrasound or other environments, the puncture needle 300 can be removed from the first member 110, and then the puncture needle 300 can be withdrawn to leave the catheter 200 in the tissue. The catheter 200 can be used as a pathway for subsequent treatments, for example, to deliver a cryo-bougie or biopsy forceps through the catheter 200 for sampling or other treatments, thereby increasing the amount of tissue extracted and also reducing damage to the tissue.

[0074] See also Figure 3In some embodiments, the first member 110 is provided with a first locking member 113, and the first locking member 113 is configured to have an unlocked state and a locked state; when in the unlocked state, the first member 110 can move relative to the second member 120; when in the locked state, the first member 110 is fixed to the second member 120 by the first locking member 113. In this embodiment, the first locking member 113 is set to the locked state, so that the first member 110 and the second member 120 can be fixedly connected, so that the two can act synchronously. When the second member 120 and the third member 130 are in a relatively active state, the first member 110 is operated to enable the puncture needle 300 and the catheter 200 to puncture the tissue together. By providing the first locking member 113 on the first member 110, the connection strength when the first member 110 and the second member 120 are fixedly connected can be improved, and the puncture needle 300 can be prevented from retracting when subjected to force. When the first locking member 113 is set to the unlocked state, the limiting member 140 can be used to limit the first component 110 to determine the puncture distance of the puncture needle 300. By utilizing the puncture sampling function of the puncture needle 300 itself, the puncture needle 300 can be controlled by the first component 110 to independently penetrate the tissue to achieve rapid puncture.

[0075] For the embodiment in which the second locking member 123 of the second member 120 is unlocked by pressing, by setting the first locking member 113 on the first member 110, it is more convenient for doctors to operate and it is easier to achieve the puncture needle 300 and the catheter 200 to puncture together. Specifically, after the first locking member 113 is set to the locked state, the first member 110 and the second member 120 are fixedly connected and can move synchronously in the length direction X. The doctor only needs to hold the second member 120 and press the second locking member 123, and move the second member 120 to drive the first member 110 to move together, so that the puncture needle 300 and the catheter 200 can be punctured together. In other words, the doctor only needs to hold the second member 120 with one hand to achieve the puncture operation together. Conversely, in the embodiment in which the second locking member 123 is unlocked by pressing, if the first locking member 113 is not set on the first member 110, the first member 110 is not locked and fixed by the first locking member 113, and is therefore movably set on the second member 120. When the doctor holds the second member 120 and presses the second locking member 123 to move the second member 120 toward the third member 130, the first member 110 may follow the second member 120, but when the puncture needle 300 encounters resistance when it hits the tissue, the puncture needle 300 and the first member 110 will retract due to the resistance. In this way, if the puncture needle 300 and the catheter 200 are to be punctured together, the doctor must use two hands to operate, one hand to hold the second member 120 and press to unlock the second locking member 123, and the other hand to hold the first member 110 to resist the resistance of the puncture needle 300, which increases the difficulty of operation.

[0076] Optionally, the first locking member 113 may be a locking nut, which is sleeved on the distal end of the first handle 111 of the first member 110. When the first locking member 113 is tightened, the distal end of the first handle 111 is squeezed to clamp the first core rod 122 of the second member 120 to achieve locking; when the first locking member 113 is loosened, the distal end of the first handle 111 is loosened to achieve unlocking. Optionally, the first locking member 113 may be a locking screw, which is assembled in the side wall mounting hole of the first handle 111. When the first locking member 113 is screwed in, its end can be pressed against the first core rod 122 of the second member 120 to achieve locking; when the first locking member 113 is screwed out, its end can be separated from the first core rod 122 of the second member 120 to achieve unlocking. It is understandable that the first locking member 113 may also be implemented by other locking structures, which are not limited here.

[0077] Please also read Figures 1 to 4 In some embodiments, the puncture needle 300 includes a needle body 310 and a connector 320. The needle body 310 is configured to be able to penetrate the channel 101 and the catheter 200. The connector 320 is connected to an end of the first component 110 away from the second component 120 and is connected to the needle body 310. By penetrating the needle body 310 through the channel 101 and the catheter 200 and connecting the connector 320 to the first component 110, the connection and assembly of the puncture needle 300 and the handle mechanism 100 can be completed.

[0078] In some embodiments, the connector 320 is detachably connected to the first member 110. By removing the connector 320 from the first member 110, the needle body 310 can be withdrawn from the channel 101 and the catheter 200, and the puncture needle 300 can be removed.

[0079] In some embodiments, a connection portion 112 is provided at one end of the first member 110 away from the second member 120, and the connector 320 is detachably connected to the connection portion 112. Optionally, the connection portion 112 may be a Luer connector, or may be a connection structure such as a thread or a buckle.

[0080] In some embodiments, the puncture device further comprises a probe assembly 400, wherein a probe 410 of the probe assembly 400 is inserted into the hole of the puncture needle 300, and a needle cap 420 of the probe assembly 400 is arranged at the proximal end of the puncture needle 300. The distal end of the probe assembly 400 is a round head, and when the probe assembly 400 and the puncture needle 300 are connected, the distal end of the probe assembly 400 will exceed the needle tip section. By arranging the probe assembly 400, the influence on the needle tip of the puncture needle 300 can be reduced when the puncture device is sent into the patient's body through the endoscope.

[0081] See also Figure 4In some embodiments, the catheter 200 includes a main body section 210 and a tapered section 220, wherein the main body section 210 is the main part of the catheter 200, the main body section 210 is connected to the second member 120, and extends along the channel 101 to the distal end of the puncture device. The tapered section 220 is connected to one end of the main body section 210 away from the second member 120, and the outer diameter D of the tapered section 220 gradually decreases along the direction away from the main body section 210. The direction away from the main body section 210 is the direction gradually away from the main body section 210 along the axis of the catheter 200. In this embodiment, the tapered section 220 is set to gradually decrease in outer diameter along the direction away from the main body section 210, that is, the distal end of the tapered section 220 is thinner, and the closer to the proximal end, the thicker it is, that is, the tapered section 220 is roughly conical, such a setting can reduce the resistance of the catheter 200 to penetrate the tissue, which helps the catheter 200 and the puncture needle 300 to penetrate the tissue together, reducing damage to the tissue.

[0082] Please also read Figure 4 and Figure 5 In some embodiments, the inner diameter d of the tapered section 220 gradually decreases in the direction away from the main section 210. As a result, the distal opening of the tapered section 220 is smaller, so that the gap between the catheter 200 and the puncture needle 300 at the distal opening is smaller, which can further reduce the resistance when piercing the tissue and reduce damage to the tissue. On the other hand, the distal opening of the tapered section 220 is smaller, so that the puncture needle 300 and the catheter 200 fit better, which is conducive to the generation of static friction between the two, and the puncture needle 300 is more likely to drive the catheter 200 to penetrate the tissue together when piercing the tissue. Furthermore, the inner diameter d of the tapered section 220 gradually decreases, so that the inner wall of the tapered section 220 forms a roughly conical guide surface, which can guide the puncture needle 300 and help improve the stability and accuracy of the puncture.

[0083] See also Figure 6, the inner diameter size at the minimum inner diameter of the tapered section 220 is D1, that is, the diameter of the distal opening of the catheter 200 is D1, and this size can be measured by measuring tools such as a vernier caliper and a micrometer. The outer diameter of the needle body 310 of the puncture needle 300 is D2, that is, the tube diameter of the needle body 310 of the puncture needle 300 is D2, and this size can be measured by measuring tools such as a vernier caliper and a micrometer, or determined according to the specifications of the needle, for example, for a 19G needle body 310, D2 is 1.1 mm. Optionally, it satisfies: 0.5≤D1 / D2≤10. Controlling D1 / D2 within the above range ensures that the gap between the puncture needle 300 and the catheter 200 at their distal openings is small enough to ensure the fit between the two, further reduce damage to the tissue, and further improve 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 a range between any two values.

[0084] Optionally, the inner diameter dimension D1 at the minimum inner diameter of the tapered section 220 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 a range value between any two values. Setting D1 within this range enables the catheter 200 to meet the application of EUS (Endoscopic Ultrasound).

[0085] Optionally, the inner diameter dimension D1 at the minimum inner diameter of the tapered section 220 satisfies: 0.3 mm ≤ D1 ≤ 1.9 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, or a range value between any two values. Setting D1 within this range enables the catheter 200 to meet the application of EBUS (Endobronchial Ultrasound).

[0086] In some embodiments, the puncture needle 300 is configured to contact the inner wall of the tapered section 220 when piercing the catheter 200. This can improve the fit between the puncture needle 300 and the catheter 200 at the opening of the catheter 200, so that when the two pierce the tissue together, the damage to the tissue can be further reduced.

[0087] Optionally, the material of the catheter 200 can be an elastic material, such as medical rubber, silicone, etc., so that the minimum inner diameter of the catheter 200 at the tapered section 220 can be smaller than the outer diameter of the puncture needle 300, and the puncture needle 300 can stretch it open, making the two directly combined more closely, improving the puncture effect together, and further reducing damage to the tissue.

[0088] Please also read Figure 6 , Figure 7 and Figure 8 In some embodiments, the puncture device further includes a developing unit 500, which can be configured to develop under ultrasound and / or X-ray conditions, and can be made of metal or other developing materials. The developing unit 500 is disposed at an end of the catheter 200 away from the second member 120, that is, the developing unit 500 is disposed at the distal end of the catheter 200. Therefore, after the puncture needle 300 is withdrawn, the position of the catheter 200 can still be accurately confirmed by ultrasound or other means.

[0089] Please refer again Figure 8 In some embodiments, the developing part 500 is disposed between the outer tube wall 230 and the inner tube wall 240 of the catheter 200, that is, the developing part 500 is disposed in the material of the catheter 200. This will not affect the smoothness of the outer tube wall 230 and the inner tube wall 240 of the catheter 200, and can avoid contact with the puncture needle 300, the forceps channel of the endoscope and the body tissue, thereby reducing the possibility of damaging other parts or tissues and improving the safety of the operation.

[0090] Please also read Figure 6 and Figure 7 In some embodiments, the catheter 200 is provided with a receiving groove 250, and the developing part 500 is disposed in the receiving groove 250. This can also prevent the developing part 500 from protruding, reduce the possibility of damaging other parts or tissues, and improve the safety of the operation. Optionally, the receiving groove 250 can be disposed on the outer wall of the catheter 200 (such as Figure 6 ), or may be disposed on the inner wall of the catheter 200 (as shown Figure 7 shown).

[0091] Accordingly, the present application also provides a puncture method for the puncture device of any of the above embodiments, see Fig. 9 , the puncture method includes:

[0092] The first member 110 is limited by the limiting member 140, and the first member 110 is moved, so that the second member 120 is driven to move toward the third member 130, and the puncture needle 300 and the catheter 200 are driven to penetrate the tissue together. This can reduce damage to the tissue and also allow the catheter 200 to be retained in the tissue for subsequent treatment.

[0093] In some embodiments, the puncture method further includes: after the puncture needle 300 and the catheter 200 are inserted into the tissue together, the puncture needle 300 is separated from the first component 110 to withdraw the puncture needle 300 from the catheter 200 and the channel 101. In this way, the catheter 200 can be left in the tissue, so that the catheter 200 and the channel 101 can form a passage, which can be used for subsequent surgical treatment, such as inserting a frozen bougie through the catheter 200 for sampling or other treatment, or removing a biopsy forceps from the catheter 200 and using the biopsy forceps to clamp a tissue sample. The inner channel size of the catheter 200 is larger than that of the puncture needle 300, which can effectively increase the sampling volume of the biopsy forceps.

[0094] Please also read Fig.10 and Fig.11 In some embodiments, the method further includes: moving the first member 110 to drive the puncture needle 300 to withdraw into the catheter 200, and passing the guide wire 600 through the puncture needle 300. Specifically, when performing intra-biliary superselection, the needle tip of the puncture needle 300 is withdrawn into the catheter 200, and the guide wire 600 is passed through the puncture needle 300. Since the guide wire 600 directly contacts the catheter 200, the guide wire skin is prevented from being cut by the needle tip of the puncture needle 300.

[0095] See also Fig.12 In some embodiments, when the first member 110 of the puncture device is provided with a first locking member 113, the puncture method further includes: switching the first locking member 113 on the first member 110 to a locked state, moving the first member 110 so that it drives the second member 120 to move toward the third member 130, and drives the puncture needle 300 and the catheter 200 to penetrate the tissue together. Specifically, when the first locking member 113 is locked, the first member 110 and the second member 120 are fixedly connected, so that the puncture needle 300 and the catheter 200 can be punctured together, and the puncture needle 300 will not retract when subjected to force. When the first locking member 113 is unlocked, the position of the upper limit member 140 on the first core rod 122 can be adjusted to determine the puncture distance of the puncture needle 300, and the puncture can still be performed quickly, retaining the puncture sampling function of the puncture needle 300 itself, at which time only the needle is punctured, and the catheter 200 does not enter together.

[0096] In some embodiments, when the first member 110 of the puncture device is provided with a first locking member 113, and the second locking member 123 provided with the second member 120 is locked by pressing, the puncture method further includes: switching the first locking member 113 on the first member 110 to a locked state, pressing the second locking member 123 on the second member 120, moving the second member 120 to drive the first member 110 to move toward the third member 130, and drive the puncture needle 300 and the catheter 200 to penetrate the tissue together. In this way, the doctor only needs to hold the second member 120 with one hand to perform the puncture operation together, which is convenient for the surgical operation.

[0097] In the above embodiments, the description of each embodiment has its own emphasis. For parts that are not described in detail in a certain embodiment, reference can be made to the relevant descriptions of other embodiments.

[0098] The puncture device and puncture method provided in the embodiments of the present application are introduced in detail above, and the principles and implementation methods of the present application are explained by using specific examples. The description of the above embodiments is only used to help understand the technical solution and its core idea of ​​the present application; ordinary technicians in this field should understand that they can still modify the technical solutions recorded in the aforementioned embodiments, or replace some of the technical features therein with equivalents; and these modifications or replacements do not make the essence of the corresponding technical solution deviate from the scope of the technical solution of the embodiments of the present application.

Claims

1. A puncture device, characterized in that: include: A handle mechanism is provided with a channel, the handle mechanism comprises a first member, a second member and a third member arranged in sequence in the length direction thereof, the channel penetrates the first member, the second member and the third member in the length direction; the second member is provided with a limiting member, the limiting member is configured to limit the first member, so that the first member can drive the second member to move toward the third member; a conduit, disposed in the channel and connected to the second member, the conduit passing through the third member along the channel and extending outside the channel; The puncture needle is configured to penetrate the channel and the catheter and to be connectable to the first member.

2. The puncture device according to claim 1, characterized in that: The first member is provided with a first locking member, and the first locking member is configured to have an unlocked state and a locked state; When in the unlocked state, the first member is movable relative to the second member; When in the locked state, the first locking member can be locked to the second component to fix the first component to the second component.

3. The puncture device according to claim 2, characterized in that: The second member is provided with a second locking member, and the second locking member is configured to be lockable to the third member so as to fix the second member to the third member; The second locking element is further configured to be unlocked when pressed, so that the second component can move relative to the third component.

4. The puncture device according to any one of claims 1 to 3, characterized in that: The catheter comprises: a main body section connected to the second member; The tapered section is connected to one end of the main section away from the second component, and the outer diameter of the tapered section gradually decreases along the direction away from the main section.

5. The puncture device according to claim 4, characterized in that: Along the direction away from the main body section, the inner diameter of the tapered section gradually decreases.

6. The puncture device according to claim 5, characterized in that: The inner diameter of the tapered section at the minimum inner diameter is D1, and the outer diameter of the needle body of the puncture needle is D2, satisfying: 0.5≤D1 / D2≤10.

7. The puncture device according to claim 6, characterized in that: The puncture device also satisfies: 0.3mm≤D1≤3.6mm.

8. The puncture device according to claim 7, characterized in that: The puncture device also satisfies: 0.3mm≤D1≤1.9mm.

9. The puncture device according to claim 4, characterized in that: The puncture needle is configured to be able to contact the inner wall of the tapered section when piercing the catheter.

10. The puncture device according to claim 9, characterized in that: The material of the catheter is elastic material.

11. The puncture device according to any one of claims 1 to 3, characterized in that: The puncture device also includes: The developing part is arranged at an end of the guide tube away from the second member.

12. The puncture device according to claim 11, characterized in that: The developing part is arranged between the outer tube wall and the inner tube wall of the conduit.

13. The puncture device according to claim 11, characterized in that: The guide tube is provided with a receiving groove, and the developing part is arranged in the receiving groove.

14. The puncture device according to any one of claims 1 to 3, characterized in that: The puncture needle comprises: A needle body, configured to be able to penetrate the channel and the catheter; A connector is connected to an end of the first component away from the second component and is connected to the needle body.

15. The puncture device according to claim 14, characterized in that: The joint is detachably connected to the first member.

16. The puncture device according to claim 15, characterized in that A connecting portion is provided at one end of the first component away from the second component, and the joint is detachably connected to the connecting portion.

17. The puncture device according to any one of claims 1 to 3, characterized in that: The second member includes a first core rod, the first member and the limiting member are both arranged on the first core rod, and the limiting member is arranged to have an open state and a closed state; When in the open state, the limiting member can move on the first core rod along the length direction; When in the closed state, the limiting member is fixed to the first core rod so as to limit the first component.

18. A puncture method, characterized in that: Applicable to the puncture device according to any one of claims 1 to 17, the puncture method comprising: The first component is limited by the limiting piece, and the first component is moved to drive the second component to move toward the third component, and drive the puncture needle and the catheter to pierce the tissue together.

19. The puncture method according to claim 18, characterized in that: Also includes: After the puncture needle and the catheter pierce the tissue together, the puncture needle is separated from the first component to withdraw the puncture needle from the catheter and the channel, so that the catheter remains in the tissue.

20. The puncture method according to claim 18, characterized in that: Also includes: The first component is moved to drive the puncture needle to withdraw into the catheter, and the guide wire is passed under the puncture needle.

21. The puncture method according to claim 18, characterized in that: Also includes: The first locking member on the first component is switched to a locked state, and the first component is moved to drive the second component to move toward the third component, and drive the puncture needle and the catheter to penetrate the tissue together.

22. The puncture method according to claim 18, characterized in that: Also includes: The first locking piece on the first component is switched to a locked state, and the second locking piece on the second component is pressed to move the second component to drive the first component to move toward the third component and drive the puncture needle and the catheter to penetrate the tissue together.

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