Biopsy puncture device

Abstract

The utility model discloses a biopsy puncture device, and belongs to the technical field of medical instruments.In the biopsy 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can be driven to penetrate through the tissue together when the puncture needle punctures, the puncture needle can be withdrawn, the catheter is left in the tissue for subsequent operative treatment, and damage to the tissue in an operation is reduced.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 application belongs to the technical field of medical devices, and particularly relates to a biopsy puncture device. BACKGROUND

[0002] Biopsy puncture technology is a medical diagnosis and treatment technology, which is used for obtaining tissue or cell samples in a patient's body for pathological examination, or for constructing a treatment path required by drug intervention, particle implantation, etc. The technology uses a puncture device to accurately guide the needle tip to the lesion site through puncture of the tissue, and then collects tissue or cell samples or gives corresponding treatment. Biopsy puncture technology can be applied to lesions in different parts, such as the lung, liver, breast, thyroid, etc., and is widely used in clinical practice.

[0003] At present, the puncture device used in biopsy puncture technology is usually composed of a thin needle, a catheter or a needle knife, etc., and has different sizes and designs, but the obtained tissue is obtained by thin needle aspiration, so not only the amount of tissue is extremely limited, but also the quality of the specimen is poor due to excessive bleeding and broken structure in the specimen, resulting in poor pathological diagnosis efficiency, and it is more difficult to perform modern molecular pathological diagnosis and other examinations. In order to obtain more and more complete high-quality tissue specimens, at present, other equipment or consumables need to be used in addition to the use of the puncture needle, and the operation is difficult and the patient's trauma is large. CONTENT OF THE UTILITY MODEL

[0004] The utility model aims to provide a biopsy puncture device, which aims to solve the technical problem that the current technology for obtaining more and more complete high-quality tissue specimens has a large trauma to the patient.

[0005] Technical scheme: The biopsy puncture device provided in the embodiments of the application comprises:

[0006] A hand-held mechanism comprising a first component, a second component and a third component arranged and connected in sequence in the length direction thereof, wherein the second component is provided with a limiting piece, and the limiting piece is arranged to be capable of limiting the first component, so that the first component can drive the second component to move towards the third component;

[0007] A catheter connected to the second component at one end and extending to the outside of the hand-held mechanism along the length direction through the third component at the other end;

[0008] A puncture needle arranged to be capable of penetrating through the hand-held mechanism and the catheter and capable of being connected to the first component.

[0009] In some embodiments, the first component is provided with a first locking piece arranged 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 member is fixed to the second member by the first locking member.

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

[0013] The second locking member is further configured to be unlockable when pressed to allow the second member to be movable relative to the third member.

[0014] In some embodiments, the catheter comprises:

[0015] a body segment connected to the second member;

[0016] a tapered segment connected to one end of the body segment away from the second member, and gradually decreasing in outer diameter along a direction away from the body segment.

[0017] In some embodiments, the inner diameter of the tapered segment gradually decreases along the direction away from the body segment.

[0018] In some embodiments, the inner diameter size at the smallest inner diameter of the tapered segment is L1, and the outer diameter of the needle body of the puncture needle is L2, satisfying: 0.5≤L1 / L2≤10.

[0019] In some embodiments, the biopsy puncture device satisfies: 0.3mm≤L1≤1.9mm.

[0020] In some embodiments, the puncture needle is configured to be in contact with the inner wall of the tapered segment when penetrating the catheter.

[0021] In some embodiments, the biopsy puncture device further comprises:

[0022] a developing portion provided at one end of the catheter away from the second member.

[0023] In some embodiments, the developing portion is provided between the outer tube wall and the inner tube wall of the catheter.

[0024] In some embodiments, the catheter is provided with a receiving groove, and the developing portion is provided in the receiving groove.

[0025] In some embodiments, the puncture needle comprises:

[0026] a needle body configured to penetrate the hand-held mechanism and the catheter;

[0027] a joint connected to one end of the first member away from the second member and connected to the needle body.

[0028] In some embodiments, the joint is detachably connected to the first member.

[0029] In some embodiments, one end of the first member away from the second member is provided with a connecting portion, and the joint is detachably connected to the connecting portion.

[0030] In some embodiments, the second member comprises a first core rod, and the first member and the limiting member are arranged on the first core rod, and the limiting member is arranged to have an open state and a closed state.

[0031] When in the open state, the limiting member can move on the first core rod in the length direction.

[0032] When in the closed state, the limiting member is fixed to the first core rod to be able to limit the first member.

[0033] Beneficial effects: The biopsy puncture device provided by the embodiments of the present application comprises: a handheld mechanism comprising a first member, a second member and a third member arranged and connected in sequence in the length direction thereof, the second member being provided with a limiting member arranged to be able to limit the first member and limit the moving distance of the first member, while also enabling the first member to drive the second member to move towards the third member; a catheter connected to the second member at one end and extending to the outside of the handheld mechanism along the length direction through the third member; and a puncture needle arranged to be able to pass through the handheld mechanism and the catheter and connected to the first member. In the biopsy puncture device of the embodiments of the present application, the limiting member is arranged on the second member to limit the first member, limit the moving distance of the first member, and also enable the first member to drive the second member to move towards the third member; the catheter is connected to the second member to enable the catheter to move together with the second member; and the puncture needle is connected to the first member to enable the first member to drive the puncture needle to move when the first member moves, so that the puncture needle can pass through the tissue together with the catheter when puncturing, and then the puncture needle can be withdrawn and the catheter can be left in the tissue for subsequent surgical treatment, reducing the damage to the tissue, obtaining more and more complete high-quality tissue specimens, and reducing the trauma to the patient. BRIEF DESCRIPTION OF DRAWINGS

[0034] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings needed to be used in the embodiments description will be briefly introduced. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without any creative effort based on these drawings.

[0035] Figure 1 A perspective structural schematic view of the biopsy puncture device provided by some embodiments of the present application;

[0036] Figure 2 A structural schematic view of the biopsy puncture device provided by some embodiments of the present application;

[0037] Figure 3 A structural schematic view of the biopsy puncture device provided by some embodiments of the present application;

[0038] Figure 4 A partial enlarged structural schematic view of region A in FIG. 1; Figure 2

[0039] A partial enlarged perspective structural schematic view of region A in FIG. 1; Figure 5 Figure 2 A partial sectional structural schematic view of the needle and the catheter of some embodiments of the present application;

[0040] Figure 6 A partial sectional structural schematic view of the needle and the catheter of some embodiments of the present application;

[0041] Figure 7 A partial sectional structural schematic view of the needle and the catheter of some embodiments of the present application;

[0042] Figure 8 A flowchart of the puncture method provided by some embodiments of the present application;

[0043] Figure 9 A flowchart of the puncture method provided by some embodiments of the present application;

[0044] Figure 10 A flowchart of the puncture method provided by some embodiments of the present application;

[0045] ​100 - hand-held mechanism; 101 - channel; 110 - first member; 111 - first handle; 112 - connecting portion; 113 - first locking member; 120 - second member; 121 - second handle; 122 - first core rod; 123 - second locking member; 130 - third member; 131 - connecting member; 132 - second core rod; 140 - limiting member; 150 - support sleeve; 200 - catheter; 210 - main body section; 220 - tapered section; 230 - outer tube wall; 240 - inner tube wall; 250 - accommodating groove; 300 - puncture needle; 310 - needle body; 320 - joint; 400 - probe assembly; 410 - probe; 420 - needle cap; 500 - developing portion; 600 - guide wire; X - length direction. DETAILED DESCRIPTION

[0046] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, but not all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work fall within the scope of protection of the present application.

[0047] In the description of the present application, it should be understood that the terms "proximal end" and "distal end" are with reference 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, i.e., the end closer to the patient. The terms "upper", "lower", "inner", "outer" and the like indicate the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the devices or instruments must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the present application. The meaning of "a plurality of" is two or more, and at least one of them can be one, two or more, unless otherwise explicitly specified. The terms "mounting", "connecting", "connecting" should be understood broadly, for example, it can be fixedly connected, or detachably connected, or integrally connected; it can be directly connected, or indirectly connected through an intermediate medium; it can be the internal communication of two devices or the interaction relationship between two devices, unless otherwise explicitly specified. The terms "first" and "second" are only for the purpose of description, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features limited by "first" and "second" can explicitly or implicitly include one or more of the features.

[0048] In the description of the present application, the length direction is introduced to facilitate the explanation of the relative position relationship between the components in the biopsy puncture device. The length direction is the extension direction of the channel in the hand-held mechanism of the biopsy puncture device, and is also the direction of the relative movement between the first component, the second component and the third component in the hand-held mechanism. In the drawings of the present application, the length direction X is indicated by an arrow marked X. The length direction X can be a direction from the proximal end of the hand-held mechanism to the distal end of the hand-held mechanism.

[0049] Endobronchial Ultrasound (EBUS) is a medical examination device that combines an ultrasound probe with a bronchoscope. Through the ultrasound probe guided by the bronchoscope, the lung lesions can be directly observed and the needle puncture is guided to obtain tissue samples for cytological or histological examination. For the diagnosis of tracheal wall and extramural lesions, including mediastinal space-occupying and cysts, the current common methods are: 1. EBUS-TBNA (EndoBronchial UltraSound-Guided TransBronchial Needle Aspiration): The material extracted by needle aspiration is relatively limited, and if there is no appropriate histopathological evaluation, the uncertainty of diagnosis still exists; 2. EBUS+IFB (Intranodal Forceps Biopsy): Under the guidance of ultrasound, biopsy is performed using biopsy forceps. Although the positive rate is high, the current technology is to enter the biopsy forceps after cutting the airway wall under the monitoring of ultrasound, which has large surgical trauma and high surgical risk. 3. EBUS+TBCB (Transbronchial Cryobiopsy): Under the guidance of ultrasound, biopsy is performed using a cryoprobe. Although the positive rate of cryobiopsy is high, the current technology is to enter the cryoprobe after cutting the airway wall under the monitoring of ultrasound, which has large surgical trauma and high surgical risk.

[0050] In the related art, the material extracted by the biopsy puncture device is relatively limited, and if there is no appropriate histopathological evaluation, the uncertainty of diagnosis still exists. In recent years, we have combined biopsy forceps biopsy, cryobiopsy and puncture biopsy to significantly improve the diagnostic positive rate of biopsy specimens, and the obtained tissue specimens are sufficient to meet the modern molecular pathological diagnosis and other examinations. Before performing biopsy forceps biopsy, cryobiopsy and other operations, we need to establish a biopsy channel, and insert biopsy forceps, cryoprobe and other equipment through the channel to perform biopsy sampling or corresponding treatment in the target lesion. The commonly used methods at present include high-frequency needle knife, laser, needle puncture expansion and the like to establish the channel, but the above-mentioned technologies all need to use other equipment or consumables on the basis of using the puncture needle, and the operation difficulty is high and the patient trauma is large.

[0051] To this end, we designed a puncture needle that can be separated from the sheath, i.e., the biopsy puncture device provided in the embodiments of the present application. The puncture needle can both puncture biopsy and establish a channel between the target lesion and the outside world through the puncture needle sheath tube for biopsy and treatment. In particular, the biopsy puncture device can be used for puncture sampling in an ultrasound bronchoscopy (EBUS) operation, i.e., EBUS-TBNA, to obtain tissue specimens from the target site. It can be understood that the biopsy puncture device can also be applied in other minimally invasive surgeries and is not limited to EBUS-TNBA. When applied to tracheal sampling or treatment, a catheter can be left in place, and a biopsy forceps or a cryoprobe is used for biopsy, reducing damage to the tissue.

[0052] For a better understanding of the present application, reference will be made by way of example to the accompanying drawings in which: Figure 1 and Figure 2 The biopsy puncture device provided in the embodiments of the present application includes a hand-held mechanism 100, a catheter 200, and a puncture needle 300.

[0053] The hand-held mechanism 100 is a control structure of the biopsy puncture device, which is usually held by a doctor or operator. The hand-held 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.

[0054] The hand-held mechanism 100 includes a first member 110, a second member 120, and a third member 130 arranged in sequence in the length direction X of the hand-held mechanism 100. 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 hand-held 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.

[0055] The second member 120 is provided with a limiting piece 140, which is arranged to limit the movement of the first member 110. The limiting piece 140 can limit the movement distance of the first member 110, or can enable the first member 110 to move the second member 120 towards the third member 130.

[0056] As Figure 1As shown, in some embodiments, the limiting member 140 can be fixed on the second member 120, and its position on the second member 120 is fixed. When the first member 110 is controlled to move along the length direction X to the second member 120 to contact the limiting member 140, the first member 110 can exert a pushing force on the limiting member 140 along the length direction X towards the third member 130. When the second member 120 and the third member 130 are in the relative active state, the limiting member 140 can be driven by the pushing force of the first member 110 to move the second member 120 towards the third member 130; when the second member 120 and the third member 130 are in the relative fixed state, the limiting member 140 reacts on the first member 110 to limit the first member 110, so that the first member 110 is stopped by the limiting member 140 and cannot move towards the third member 130. That is, the limiting member 140 can limit the relative position of the first member 110 and the second member 120.

[0057] In some embodiments, the second member 120 comprises a second handle 121 and a first core rod 122, the first core rod 122 is connected to the second handle 121 at one end close to the first handle 111, and the first member 110 and the limiting member 140 are arranged on the first core rod 122 of the second member 120. The limiting member 140 is arranged to have an open state and a closed state. When in the open state, the limiting member 140 can move on the first core rod 122 along the length direction X; when in the closed state, the limiting member 140 is fixed on 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 limiting member 140 on the first core rod 122. The limiting member 140 can adopt structures such as a hoop, a clasp, a locking screw, etc.

[0058] In some embodiments, the relative active state and the relative fixed state of the second member 120 and the third member 130 can be achieved by a 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, achieving the relative fixed state of the second member 120 and the third member 130; when the second locking member 123 is unlocked, the second member 120 can move relative to the third member 130, achieving the relative active state of the second member 120 and the third member 130. 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 screwed, it presses the distal end of the second handle 121, so that the second handle 121 clamps the second core rod 132 of the third member 130, achieving locking; when the second locking member 123 is unscrewed, 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 assembled in the side wall mounting hole of the second handle 121. When the second locking member 123 is screwed in, the end thereof can abut against the second core rod 132 of the third member 130, achieving locking; when the second locking member 123 is unscrewed, the end thereof can be separated from the second core rod 132 of the third member 130, achieving unlocking.

[0059] The second locking member 123 can also be implemented in other locking structures. In some embodiments, the second locking member 123 is arranged to be locked to the third member 130 to fix the second member 120 to the third member 130, and is arranged to be unlocked when pressed to allow the second member 120 to move relative to the third member 130. For example, although not shown, it can be understood that a toothed groove structure can be arranged on the second core rod 132 of the third member 130, i.e. a plurality of grooves are arranged on the outer circumferential surface of the second core rod 132 along the length direction X, and the grooves extend along a direction perpendicular to the length direction X. The second locking member 123 comprises a base, a pressing member and an elastic member. The base is fitted 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 arranged to be movable along the second core rod 132 (i.e. movable relative to the second core rod 132 along the length direction X), and the base is provided with a fitting hole. The pressing member is fitted in the fitting hole and is connected to the base by the elastic member. The pressing member is movable along a direction perpendicular to the length direction X (i.e. along the extension direction of the grooves) under a pressing force. The pressing member is provided with a protrusion which can be clamped into the grooves of the toothed groove structure to be locked with the grooves. In this way, when the pressing member is not pressed, the elastic member keeps the pressing member in the locked position, so that the protrusion of the pressing member is clamped in the grooves of the toothed groove structure, the second locking member 123 cannot move relative to the third member 130 along the length direction X, and the second member 120 is fixed to the third member 130. When a doctor or other operator applies a pressure to the pressing member, the force is transmitted to the elastic member to cause elastic deformation of the elastic member, and the pressing member can then move along the extension direction of the grooves under the pressure, and the protrusion of the pressing member is moved out of the grooves to be unlocked, so that the second member 120 can move relative to the third member 130 along the length direction X. For another example, the second locking member 123 can comprise an elastic member and a clamping member, wherein the middle part of the clamping member is hinged to the second handle 121, the elastic member is fixedly connected to the second handle 121 and presses the clamping member to the locked position, and one end of the clamping member can be clamped into the grooves of the above-mentioned toothed groove structure. The other end of the clamping member is provided with a pressing structure. When a doctor presses the pressing structure, the other end of the clamping member is pressed by the pressure, and a seesaw action is caused to allow the other end of the clamping member to rotate around the hinge to resist the elastic force of the elastic member, so that the end of the clamping member clamped into the grooves is moved out of the grooves to be unlocked.

[0060] The catheter 200 is connected to the second member 120 at one end and extends through the third member 130 along the length direction X and out of the hand-held mechanism 100 at the other end. The puncture needle 300 is arranged to pass through the hand-held mechanism 100 and the catheter 200 and is connected to the first member 110.

[0061] In some embodiments, the hand-held mechanism 100 is provided with a channel 101 which penetrates the first member 110, the second member 120 and the third member 130 in the length direction X, and which is used for arranging the catheter 200 and for the puncture needle 300 to pass through. By operating the hand-held mechanism 100 to send the catheter 200 and the puncture needle 300 into the patient's body through the channel of the endoscope, the connecting member 131 of the third member 130 can be used to connect with the channel boss of the endoscope to be fixed on the endoscope, and the support sleeve 150 arranged at the distal end of the connecting member 131 is used for the catheter 200 to pass through.

[0062] The catheter 200 is arranged in the channel 101 and is connected with the second member 120, and the catheter 200 penetrates the third member 130 along the channel 101 and extends out of the channel 101. Specifically, the catheter 200 can be connected with the second member 120 at one end thereof, and the other end thereof penetrates the third member 130 along the channel 101 and extends out of the channel 101, so that the catheter 200 can be moved by moving the second member 120. After the biopsy puncture device is installed in the endoscope, when the second member 120 and the third member 130 are in a relative active state, the length of the catheter 200 extending out of the endoscope can be controlled by controlling the movement of the second member 120 relative to the third member 130.

[0063] The puncture needle 300 is arranged to be able to pass through the channel 101 and the catheter 200, and is able to be connected with the first member 110. That is, the puncture needle 300 can be connected with the first member 110, and can also be detached from the first member 110, that is, the two are detachably connected. By arranging the puncture needle 300 to pass through the channel 101 and the catheter 200 and connecting it with the first member 110, the first member 110 can drive the puncture needle 300 to move when the first member 110 moves. By limiting the relative position of the first member 110 and the second member 120 through the limiting action of the limiting member 140, the length of the puncture needle 300 extending out of the catheter 200 can be controlled.

[0064] In the biopsy puncture device of the embodiment of the present application, the first member 110 is limited by the limiting member 140 provided on the second member 120, so that the first member 110 can drive the second member 120 to move towards the third member 130. The catheter 200 is connected with the second member 120, so that the catheter 200 can move together with the second member 120. Thus, after the biopsy puncture device is loaded into the endoscope, the length of the catheter 200 extending out of the endoscope can be controlled by adjusting the position of the second member 120. The puncture needle 300 is connected with the first member 110, so that the puncture needle 300 can move when the first member 110 moves, and puncture. Thus, the puncture needle 300 can puncture together with the catheter 200 through the tissue. When the catheter 200 reaches outside the tissue in the environment of ultrasound, etc., the puncture needle 300 can be removed from the first member 110, and then the puncture needle 300 can be withdrawn, and the catheter 200 can be left in the tissue. The catheter 200 can be used as a channel for subsequent treatment, so as to be used for subsequent surgical treatment, such as sending a biopsy forceps or a cryoprobe through the catheter 200 to sample or other treatment, to improve the amount of extracted tissue, and also to reduce the damage to the tissue.

[0065] Please refer to Figure 3 In some embodiments, the first member 110 is provided with a first locking member 113, which is provided with 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 on the second member 120 by the first locking member 113. In the embodiment, the first locking member 113 is set to the locked state, so as to realize the fixed connection between the first member 110 and the second member 120, and thus the two can move synchronously. When the second member 120 and the third member 130 are in the relative active state, the first member 110 is operated, so as to realize that the puncture needle 300 and the catheter 200 puncture the tissue together. By providing the first locking member 113 on the first member 110, the connection strength of the fixed connection between the first member 110 and the second member 120 can be improved, so as to avoid that the puncture needle 300 is retracted backwards when subjected to force. When the first locking member 113 is set to the unlocked state, the first member 110 can be limited by the limiting member 140, so as to determine the puncture distance of the puncture needle 300, and the puncture sampling function of the puncture needle 300 itself is used to realize rapid puncture by controlling the puncture needle 300 to independently puncture the tissue by the first member 110.

[0066] For the embodiment that the second locking member 123 of the second member 120 is unlocked by pressing, the first locking member 113 is arranged on the first member 110, which can make the operation of the doctor more convenient and make the puncture needle 300 and the catheter 200 puncture together more easily. Specifically, when the first locking member 113 is arranged in 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 then move the second member 120 to drive the first member 110 to move, so that the puncture needle 300 and the catheter 200 can puncture together. That is to say, the doctor only needs to hold the second member 120 with one hand, and then the puncture operation can be realized. Conversely, in the embodiment that the second locking member 123 is unlocked by pressing, if the first locking member 113 is not arranged on the first member 110, the first member 110 is not fixedly locked by the first locking member 113 and is movably arranged 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 towards the third member 130, the first member 110 can also move with the second member 120, but when the puncture needle 300 encounters resistance due to the tissue, the puncture needle 300 and the first member 110 will be retracted due to the resistance. Therefore, if the puncture needle 300 and the catheter 200 are to be punctured together, the doctor must use both hands to operate, one hand holding the second member 120 and pressing the second locking member 123, and the other hand holding the first member 110 to resist the resistance of the puncture needle 300, which increases the operation difficulty.

[0067] Optionally, the first locking member 113 can 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 screwed, the distal end of the first handle 111 is pressed to clamp the first core rod 122 of the second member 120, so that the locking is realized. When the first locking member 113 is loosened, the distal end of the first handle 111 is relaxed, so that the unlocking is realized. Optionally, the first locking member 113 can 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, the end thereof can abut against the first core rod 122 of the second member 120, so that the locking is realized. When the first locking member 113 is screwed out, the end thereof can be separated from the first core rod 122 of the second member 120, so that the unlocking is realized. It can be understood that the first locking member 113 can also adopt other locking structures, which are not limited herein.

[0068] Please refer to Figures 1 to 4In some embodiments, the puncture needle 300 comprises a needle body 310 and a connector 320, the needle body 310 is arranged to be capable of being disposed in the channel 101 of the hand-held mechanism 100 and the catheter 200, and the connector 320 is connected to the first member 110 at the end away from the second member 120 and connected with the needle body 310. By disposing the needle body 310 in the channel 101 and the catheter 200 and connecting the connector 320 with the first member 110, the connection and assembly of the puncture needle 300 and the hand-held mechanism 100 can be completed.

[0069] In some embodiments, the connector 320 is detachably connected with the first member 110. By detaching 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.

[0070] In some embodiments, the end of the first member 110 away from the second member 120 is provided with a connecting portion 112, and the connector 320 is detachably connected with the connecting portion 112. Alternatively, the connecting portion 112 can be a luer connector, or a threaded connection, a buckle connection or the like.

[0071] In some embodiments, the biopsy puncture device further comprises a probe assembly 400, a probe 410 of the probe assembly 400 is disposed in the channel 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 is connected with the puncture needle 300, the distal end of the probe assembly 400 will protrude beyond 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 biopsy puncture device is sent into the patient's body through an endoscope.

[0072] Please refer to Figure 4 In some embodiments, the catheter 200 comprises 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 with the second member 120 and extends along the channel 101 to the distal end of the biopsy puncture device. The tapered section 220 is connected to the 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 in 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 arranged to gradually decrease in 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, that is, the tapered section 220 is roughly conical. Such an arrangement can reduce the resistance of the catheter 200 to the tissue, which helps the catheter 200 and the puncture needle 300 to penetrate the tissue together and reduce the damage to the tissue.

[0073] Please refer to Figure 4 andFigure 5 In some embodiments, the inner diameter d of the tapered section 220 gradually decreases along a direction away from the body section 210. Thus, the distal end opening of the tapered section 220 is smaller, so that the gap between the catheter 200 and the puncture needle 300 at the distal end opening is smaller, which can further reduce the resistance when the tissue is punctured and reduce the damage to the tissue. On the other hand, the smaller distal end opening of the tapered section 220 makes the puncture needle 300 and the catheter 200 more closely fitted, which is conducive to generating static friction between the two, and the puncture needle 300 is more likely to drive the catheter 200 to puncture the tissue together. Furthermore, the gradual decrease of the inner diameter d of the tapered section 220 makes the inner wall of the tapered section 220 form a generally conical guide surface, which can guide the puncture needle 300 and help improve the stability and accuracy of puncture.

[0074] Please refer to Figure 6 The inner diameter size L1 at the smallest inner diameter of the tapered section 220, i.e., the diameter of the distal end opening of the catheter 200, can be measured by a vernier caliper, a micrometer, or the like. The outer diameter L2 of the needle body 310 of the puncture needle 300, i.e., the tube diameter of the needle body 310 of the puncture needle 300, can be measured by a vernier caliper, a micrometer, or the like, or determined according to the needle specification, for example, the needle body 310 of a 19G needle has an L2 of 1.1mm. Optionally, 0.5≤L1 / L2≤10. Controlling L1 / L2 within the above range ensures that the gap between the puncture needle 300 and the catheter 200 at the distal end opening thereof is small enough, ensuring the fit of the two, further reducing damage to the tissue, and further improving the stability and accuracy of puncture. Optionally, L1 / L2 can be any of 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 value between any two of them.

[0075] Optionally, the inner diameter size L1 at the smallest inner diameter of the tapered section 220 satisfies 0.3mm≤L1≤1.9mm. For example, D1 can be any of 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 of them. Setting D1 within this range makes the catheter 200 meet the application of EBUS (Endobronchial Ultrasound).

[0076] In some embodiments, the puncture needle 300 is arranged to be in contact with the inner wall of the tapered section 220 when the catheter 200 is inserted. This can improve the fit between the puncture needle 300 and the catheter 200 at the opening of the catheter 200, so that the tissue damage can be further reduced when the two are inserted into the tissue together.

[0077] Optionally, the material of the catheter 200 can be an elastic material, such as medical rubber, silicone, etc. In this way, 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, so that the puncture needle 300 can be expanded to make the two more closely combined, improve the puncture effect, and further reduce the damage to the tissue.

[0078] Please refer to Figure 6 、 Figure 7 and Figure 8 In some embodiments, the biopsy puncture device further comprises a developing part 500, which can be arranged to develop under ultrasonic and / or X-ray conditions. The developing part 500 can be made of metal or other developing materials. The developing part 500 is arranged at the end of the catheter 200 away from the second member 120, i.e. the developing part 500 is arranged at the distal end of the catheter 200. Thus, after the puncture needle 300 is withdrawn, the position of the catheter 200 can still be accurately determined by ultrasonic and other means.

[0079] Please refer to Figure 8 In some embodiments, the developing part 500 is arranged between the outer tube wall 230 and the inner tube wall 240 of the catheter 200, i.e. the developing part 500 is arranged in the material of the catheter 200. In this way, the smoothness of the outer tube wall 230 and the inner tube wall 240 of the catheter 200 will not be affected, which can avoid contact with the puncture needle 300, the forceps channel of the endoscope, and the tissue in the body, reduce the possibility of damaging other components or tissues, and improve the safety of the operation.

[0080] Please refer to Figure 6 and Figure 7 In some embodiments, the catheter 200 is provided with a receiving groove 250, and the developing part 500 is arranged in the receiving groove 250. In this way, the developing part 500 can also be avoided from protruding, which can reduce the possibility of damaging other components or tissues, and improve the safety of the operation. Optionally, the receiving groove 250 can be arranged on the outer tube wall of the catheter 200 (as shown in Figure 6 ), or on the inner tube wall of the catheter 200 (as shown in Figure 7 ).

[0081] Correspondingly, the application also provides a puncture method applied to the biopsy puncture device of any of the above embodiments. Please refer to Figure 9 The puncture method comprises:

[0082] The first member 110 is limited by the limiting member 140, and the first member 110 is moved to drive the second member 120 to move towards the third member 130, and the puncture needle 300 and the catheter 200 are simultaneously punctured into the tissue. In this way, the damage to the tissue can be reduced, and the catheter 200 can be left in the tissue for subsequent treatment.

[0083] In some embodiments, the puncture method further comprises: after the puncture needle 300 and the catheter 200 are simultaneously punctured into the tissue, the puncture needle 300 is separated from the first member 110 to withdraw the puncture needle 300 from the catheter 200 and the channel 101. Thus, the catheter 200 can be left in the tissue, and the catheter 200 and the channel 101 can form a passage, which can be used for subsequent surgical treatment, such as sampling or other treatment by a cold biopsy probe through the catheter 200, or biopsy forceps are lowered from the catheter 200 to clamp tissue samples.

[0084] Please refer to Figure 10 In some embodiments, when the first member 110 of the biopsy puncture device is provided with the first locking member 113, the puncture method further comprises: switching the first locking member 113 on the first member 110 to a locked state, moving the first member 110 to drive the second member 120 to move towards the third member 130, and driving the puncture needle 300 and the catheter 200 to be simultaneously punctured into the tissue. 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 simultaneously punctured, and the puncture needle 300 will not be retracted backward under stress. When the first locking member 113 is unlocked, the position of the limiting member 140 on the first core rod 122 can be adjusted to determine the puncture distance of the puncture needle 300, and the puncture needle 300 can still be quickly punctured to retain the puncture sampling function of the puncture needle 300 itself. At this time, only the needle is punctured, and the catheter 200 does not enter together.

[0085] In some embodiments, when the first member 110 of the puncture device is provided with the first locking member 113, and the second locking member 123 provided on the second member 120 is locked in a pressing manner, the puncture method further comprises: 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 towards the third member 130, and driving the puncture needle 300 and the catheter 200 to be simultaneously punctured into the tissue. In this way, the doctor only needs to hold the second member 120 with one hand to realize the simultaneous puncture operation, which is convenient for surgical operation.

[0086] In the above embodiments, the description of each embodiment has its own emphasis, and the parts not described in detail in a certain embodiment can be referred to the related description of other embodiments.

[0087] The biopsy puncture device provided by the embodiments of the present application is described in detail above, and the principles and implementation manners of the present application are described by using specific examples. The above embodiment descriptions are only used to help understand the technical solutions of the present application and the core ideas thereof. Those skilled in the art should understand that the technical solutions recorded in the foregoing embodiments can still be modified, or some technical features thereof can be replaced equivalently; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present application.

Claims

1. A biopsy puncture device, characterized by, The application relates to a biopsy puncture device. The device comprises: a hand-held mechanism, which comprises a first component, a second component and a third component connected in sequence along a length direction of the hand-held mechanism, the second component is provided with a limiting member, the limiting member is arranged to limit the first component, and the first component can drive the second component to move towards the third component; a catheter, one end of which is connected to the second component, and the other end of which penetrates through the third component along the length direction and extends out of the hand-held mechanism; 2. The biopsy punch device of claim 1, wherein, a puncture needle, which is arranged to penetrate through the hand-held mechanism and the catheter and is connected to the first component. The first component is provided with a first locking member, which is arranged to have an unlocked state and a locked state; when in the unlocked state, the first component can move relative to the second component; 3. The biopsy punch device of claim 2, wherein, when in the locked state, the first component is fixed on the second component by the first locking member. The second component is provided with a second locking member, which is arranged to be locked on the third component to fix the second component on the third component; 4. The biopsy punch device according to any one of claims 1 to 3, characterized in that the second locking member is also arranged to be unlocked when pressed to enable the second component to move relative to the third component. The catheter comprises: a main body segment connected to the second component; 5. The biopsy punch device of claim 4, wherein, a tapered segment connected to one end of the main body segment away from the second component, and gradually reducing in outer diameter along a direction away from the main body segment.

6. The biopsy punch device of claim 5, wherein, The inner diameter of the tapered segment gradually reduces along the direction away from the main body segment.

7. The biopsy punch device of claim 6, wherein, The inner diameter size at the smallest inner diameter of the tapered segment is L1, and the outer diameter of the needle body of the puncture needle is L2, satisfying 0.5<=L1 / L2<=10.

8. The biopsy punch device of claim 4, wherein, The biopsy puncture device satisfies 0.3mm<=L1<=1.9mm.

9. The biopsy punch device according to any one of claims 1 to 3, characterized in that The puncture needle is arranged to be in contact with the inner wall of the tapered segment when penetrating through the catheter. The biopsy puncture device further comprises:

10. The biopsy punch device of claim 9, wherein, a developing part arranged at one end of the catheter away from the second component.

11. The biopsy punch device of claim 9, wherein, The developing part is arranged between the outer tube wall and the inner tube wall of the catheter.

12. The biopsy punch device according to any one of claims 1 to 3, characterized in that The catheter is provided with a receiving groove, and the developing part is arranged in the receiving groove. The puncture needle comprises: a needle body arranged to penetrate through the hand-held mechanism and the catheter; 13. The biopsy punch device of claim 12, wherein, a connector connected to one end of the first component away from the second component and connected to the needle body.

14. The biopsy punch device of claim 13, wherein, The connector is detachably connected to the first component.

15. The biopsy punch device according to any one of claims 1 to 3, characterized in that One end of the first component away from the second component is provided with a connecting part, and the connector is detachably connected to the connecting part. The second component comprises a first core rod, the first component and the limiting member are 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 along the length direction on the first core rod; when in the closed state, the limiting member is fixed on the first core rod to limit the first component.

Images