Negative pressure biopsy needle

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to a negative pressure biopsy needle which comprises an inner needle rod and an outer needle rod, the outer needle rod is coaxially arranged on the outer side of the inner needle rod in a sleeving mode, the inner needle rod is configured to be of a non-through type hollow structure, the two ends of the outer side of the inner needle rod are provided with an adsorption hole and a communicating hole respectively, and the adsorption hole is communicated with the communicating hole. The adsorption holes are communicated with the communicating holes; the outer needle rod is configured to move in the direction away from the handle assembly along the axis of the inner needle rod in a rotating mode in the process that the biopsy device is converted from the to-be-fired state to the fired state. When the launching assembly is converted from a to-be-fired state to a release state, the outer needle rod cuts and samples focus tissue in a rotating mode under the cooperation of the outer needle base and the spiral guide groove, and meanwhile, negative pressure is formed in the first negative pressure channel and the second negative pressure channel at the same time through the negative pressure assembly, and a tissue sample is adsorbed.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to a negative pressure biopsy needle. Background Art

[0002] In the field of modern medical diagnosis, biopsy, also known as surgical pathological examination, is a technique in which diseased tissues are excised, forceps-extracted, or punctured from a patient's body for pathological examination as required for diagnosis and treatment. It is the most important part of diagnostic pathology, and for the vast majority of submitted cases, it can make a clear histopathological diagnosis and pathological analysis. Doctors can clarify the type and stage of the disease and formulate targeted treatment plans. There are various ways of biopsy sampling, and each method has its unique advantages and disadvantages.

[0003] Among them, the negative pressure columnar biopsy method is widely used in clinical practice. This method sucks tissues into a columnar needle tube through negative pressure to obtain relatively complete tissue samples, providing strong support for pathological diagnosis. However, there are still the following problems in the actual operation process of this technology:

[0004] First, in the tissue severance link, this technology has obvious deficiencies. When using a negative pressure columnar biopsy needle to obtain tissue samples, it often occurs that tissue severance is difficult, and the tissue is easily in a state of "connected by filaments". This not only affects the integrity of the obtained sample, making it difficult to accurately reflect the true situation of the diseased tissue in the subsequent pathological analysis process, which may interfere with the doctor's diagnosis result, but also may lead to multiple samplings, increasing the patient's pain and medical costs.

[0005] Second, there are also great risks during the extraction process after sample acquisition. Due to reasons such as insufficient negative pressure, the tissue sucked into the needle tube through negative pressure is very likely to fall off when the biopsy needle is withdrawn. Once the sample falls off, it not only means the failure of this biopsy operation and the need for re-sampling, delaying the diagnosis time, but also may cause additional harm to the patient, such as an increased incidence of complications such as bleeding and infection.

[0006] In summary, the problems of the existing negative pressure columnar biopsy technology in tissue severance and sample preservation seriously restrict its application effect in clinical diagnosis. Therefore, it is of great practical significance and clinical value to develop a new type of negative pressure biopsy needle that can effectively solve these problems. Summary of the Invention

[0007] The object of the present invention is to provide a negative pressure biopsy needle. When the firing assembly changes from the to-be-fired state to the released state, the outer needle rod cuts and samples the lesion tissue in a rotating manner under the cooperation of the outer needle base and the spiral guiding groove. At the same time, through the negative pressure assembly, negative pressure is formed inside both the first negative pressure channel and the second negative pressure channel to adsorb the tissue sample.

[0008] The technical solution adopted by the present invention is specifically as follows:

[0009] A negative pressure biopsy needle includes an inner needle rod and an outer needle rod, and the outer needle rod is coaxially sleeved outside the inner needle rod;

[0010] The inner needle rod is configured as a non-through hollow structure. Adsorption holes and communication holes are respectively opened at both ends outside the inner needle rod, and the adsorption holes and the communication holes are communicated with each other;

[0011] The outer needle rod is configured such that during the process of the biopsy device changing from the to-be-fired state to the fired state, the outer needle rod moves away from the handle assembly along the axis of the inner needle rod in a rotating manner;

[0012] It further includes:

[0013] A negative pressure assembly, which is connected between the negative pressure assembly and the inner needle rod and between the negative pressure assembly and the outer needle rod;

[0014] Wherein, when the outer needle rod moves away from the handle assembly, negative pressure is formed in the gap between the inner needle rod and the outer needle rod and inside the inner needle rod to adsorb the tissue sample into the outer needle rod.

[0015] In a preferred solution, a secondary adsorption end is opened at one end of the inner needle rod away from the handle assembly, and the secondary adsorption end is adapted to the adsorption hole. A piercing blade is opened at one end of the secondary adsorption end away from the handle assembly. A cutting blade is opened at one end of the outer needle rod away from the handle assembly, and the cutting blade is one of the following structural forms: a serrated blade edge, an inclined plane blade edge, a triangular prism blade edge.

[0016] In a preferred solution, an anti-slip surface is opened on the inner wall of the outer needle rod near the cutting blade, and a plurality of anti-slip lines are opened on the anti-slip surface.

[0017] In a preferred solution, the anti-slip lines are one or a combination of several of the following forms: spiral anti-slip lines, groove anti-slip lines, bump anti-slip lines.

[0018] In a preferred embodiment, the negative pressure assembly includes an inner needle base and an outer needle base. The inner needle base is fixed inside the handle assembly, and the inner needle base is fixedly connected to the inner needle rod. The outer needle base is slidably connected to the outside of the inner needle base, and the inner needle base is fixedly connected to the outer needle rod. A negative pressure chamber is formed between the inner needle base and the outer needle base. The negative pressure chamber is configured such that during the process of the biopsy device transitioning from the pre-firing state to the firing state, the gas pressure inside it is less than the external gas pressure.

[0019] In a preferred embodiment, a spiral guiding groove is provided on the outside of the outer needle base, and a guiding boss is provided inside the handle assembly, and the guiding boss is adapted to the spiral guiding groove.

[0020] In a preferred embodiment, the inner needle rod and the outer needle rod are slidably connected in a clearance fit manner. A first negative pressure channel is formed between the inner needle rod and the outer needle rod. The adsorption hole and the communication hole form a second negative pressure channel, and both the first negative pressure channel and the negative pressure chamber and the second negative pressure channel and the negative pressure chamber are in communication with each other.

[0021] In a preferred embodiment, the outer diameter of the inner needle rod is denoted as D1, and the outer diameter of the secondary adsorption end is denoted as D2, and D1 > D2.

[0022] In a preferred embodiment, the materials of the inner needle rod and the outer needle rod are one of the following materials: stainless steel, titanium alloy, nitinol alloy.

[0023] A handle assembly applicable to the negative pressure biopsy needle described in any one of the above, includes a handle housing. A winding wrench is rotatably connected to the outside of the handle housing. A firing assembly, a safety lock assembly, and a puncture depth adjustment assembly are fixed inside the handle housing, and the winding wrench and the firing assembly, and the firing assembly and the safety lock assembly are adapted to each other. A guiding boss is provided inside the handle housing, and the guiding boss is adapted to the spiral guiding groove.

[0024] The technical effects achieved by the present invention are:

[0025] When the firing assembly of the present invention changes from the pre-firing state to the firing state, the outer needle rod and the outer needle base are driven by the firing assembly to move towards the lesion tissue. The outer needle rod cuts and samples the lesion tissue. At the same time, through the negative pressure assembly, negative pressure is simultaneously formed inside the first negative pressure channel and the second negative pressure channel. Through the cooperation of the first negative pressure channel and the second negative pressure channel, the tissue sample is adsorbed, improving the adsorption effect of the device on the tissue sample and preventing the tissue sample from detaching from the inside of the outer needle rod;

[0026] The present invention forms multiple adsorption holes on the outer side of the secondary adsorption end. When the tissue sample is secondarily adsorbed through the second negative pressure channel, the multiple adsorption holes cooperate to form multi-point adsorption on the sample tissue, making the adsorption force acting on the tissue sample by the second negative pressure channel more uniform;

[0027] The present invention forms a spiral guiding groove on the outer side of the outer needle base. When the outer needle base drives the outer needle rod to cut and sample the lesion tissue, through the cooperation of the guiding rod and the spiral guiding groove, the outer needle rod enters the lesion tissue internally in a rotating manner and performs cutting, improving the cutting force of the outer needle rod on the lesion tissue and effectively solving the problem that it is difficult to disconnect the lesion tissue and the tissue sample;

[0028] The present invention provides a piercing end at one end of the inner needle rod. After the tissue sample enters the inner part of the outer needle rod under the action of negative pressure, the piercing end on the inner needle rod can pierce into the tissue sample. On the basis of the common adsorption of the tissue sample by the first negative pressure channel and the second negative pressure channel, the secondary adsorption end can fix the tissue sample again, further preventing the tissue sample from detaching from the inner part of the outer needle rod. Description of the Drawings

[0029] Figure 1 is a schematic structural diagram of the negative pressure biopsy needle in Embodiment 1 of the present invention;

[0030] Figure 2 is a structural sectional view of the negative pressure biopsy needle in Embodiment 1 of the present invention;

[0031] Figure 3 is a partial structural sectional view of the inner needle rod and the outer needle rod in Embodiment 1 of the present invention;

[0032] Figure 4 is an exploded schematic structural diagram of the negative pressure biopsy needle in Embodiment 1 of the present invention;

[0033] Figure 5 is a schematic structural diagram of the inner needle rod in Embodiment 1 of the present invention;

[0034] Figure 6 is a schematic structural diagram of the handle assembly in Embodiment 2 of the present invention;

[0035] Figure 7 is a bottom view of the handle assembly in Embodiment 2 of the present invention;

[0036] Figure 8 is a schematic structural diagram of the interior of the handle housing in Embodiment 2 of the present invention;

[0037] Figure 9 is a schematic structural diagram of the guiding boss in Embodiment 2 of the present invention;

[0038] Figure 10It is a schematic structural diagram of the negative pressure component in the third embodiment of the present invention;

[0039] Figure 11 It is a schematic structural diagram of the driving component in the fifth embodiment of the present invention.

[0040] In the drawings, the list of components represented by each label is as follows:

[0041] 10. Inner needle rod; 11. Outer needle rod; 12. Secondary adsorption end; 13. Adsorption hole; 14. Communication hole;

[0042] 21. Inner needle base; 22. Outer needle base; 23. Spiral guide groove; 24. Micro vacuum pump;

[0043] 30. Handle housing; 31. Winding wrench; 32. Launching component; 33. Safety lock component; 34. Puncture depth adjustment component;

[0044] 41. Driving motor; 42. Driving gear; 43. Driven gear ring. Specific Embodiments

[0045] To make the above objects, features, and advantages of the present invention more obvious and understandable, the following detailed description of the specific embodiments of the present invention will be given in conjunction with the accompanying drawings of the specification.

[0046] In the following description, many specific details are set forth to facilitate a full understanding of the present invention. However, the present invention may be implemented in other ways different from those described herein. Those skilled in the art can make similar extensions without departing from the connotation of the present invention. Therefore, the present invention is not limited by the specific embodiments disclosed below.

[0047] Secondly, the so-called "one embodiment" or "embodiment" herein refers to a specific feature, structure, or characteristic that may be included in at least one implementation manner of the present invention. The phrase "in a preferred embodiment" that appears in different places in this specification does not necessarily refer to the same embodiment, nor is it an individual or alternative embodiment that is mutually exclusive with other embodiments.

[0048] Furthermore, the present invention is described in detail in conjunction with the schematic diagrams. When detailing the embodiments of the present invention, for the sake of convenience of explanation, the cross-sectional views showing the device structure will be enlarged locally out of the general proportion, and the schematic diagrams are only examples and should not limit the scope of protection of the present invention herein. In addition, in actual production, three-dimensional spatial dimensions including length, width, and depth should be included.

[0049] Embodiment 1

[0050] Please refer to the attached Figures 1 to 6As shown in the figure, this is the first embodiment of the present invention. This embodiment provides a negative pressure biopsy needle, which includes an inner needle rod 10 and an outer needle rod 11. The outer needle rod 11 is coaxially sleeved outside the inner needle rod 10. One end of the inner needle rod 10 away from the handle assembly is provided with a secondary adsorption end 12. The inner needle rod 10 is configured as a non-through hollow structure. Both ends of the outer side of the inner needle rod 10 are respectively provided with a plurality of adsorption holes 13 and communication holes 14. The secondary adsorption end 12 is adapted to the adsorption holes 13, and the adsorption holes 13 and the communication holes 14 are interconnected;

[0051] The outer needle rod 11 is configured such that during the process of the biopsy device transitioning from the to-be-fired state to the fired state, the outer needle rod 11 moves away from the handle assembly along the axis of the inner needle rod 10 in a rotational manner;

[0052] It further includes:

[0053] A negative pressure assembly, which is connected between the negative pressure assembly and the inner needle rod 10 and between the negative pressure assembly and the outer needle rod 11. The negative pressure cavity is configured such that during the process of the biopsy device transitioning from the to-be-fired state to the fired state, the gas pressure inside it is less than the external gas pressure;

[0054] Wherein, when the outer needle rod 11 moves away from the handle assembly, a negative pressure is formed in the gap between the inner needle rod 10 and the outer needle rod 11 and inside the inner needle rod 10 through the negative pressure assembly, and the tissue sample is adsorbed into the inside of the outer needle rod 11 under the action of the negative pressure.

[0055] It should be noted that the biopsy device can perform biopsy sampling on the lesion tissue of the patient. It at least includes a handle assembly and a negative pressure biopsy needle, and the handle assembly is connected to the negative pressure biopsy needle. The handle assembly can drive the negative pressure biopsy needle into the lesion tissue and cut the lesion tissue through the negative pressure biopsy needle to achieve the purpose of tissue sampling. Among them, before the inner needle rod 10 penetrates into the patient's body, the biopsy device is in the to-be-fired state.

[0056] Furthermore, the materials of the inner needle rod 10 and the outer needle rod 11 are one of the following materials: stainless steel, titanium alloy, nitinol. Preferably, in this embodiment, the materials of the inner needle rod 10 and the outer needle rod 11 are stainless steel.

[0057] In this embodiment, when a biopsy sample needs to be taken from the lesion tissue of a patient, first, routine preparatory work such as draping, disinfecting, and anesthetizing the patient is carried out. Hold the handle assembly, and percutaneous puncture and deliver the inner needle rod 10 and the outer needle rod 11 to the edge of the lesion tissue. Start the biopsy device, so that the biopsy device changes from the state to be fired to the fired state. The outer needle rod 11 moves along the axis of the inner needle rod 10 in a rotating manner towards the direction close to the lesion tissue, and cuts the lesion tissue through the outer needle rod 11. At the same time, the air pressure inside the negative pressure assembly is less than the external gas pressure. Since the negative pressure assembly is connected to the inner needle rod 10 and the negative pressure assembly is also connected to the outer needle rod 11, a negative pressure is formed through the negative pressure assembly in the gap between the inner needle rod 10 and the outer needle rod 11 and inside the inner needle rod 10. The tissue sample is adsorbed into the inner part of the outer needle rod 11 under the action of the negative pressure. Withdraw the inner needle rod 10 and the outer needle rod 11 from the lesion tissue through the handle assembly to complete the biopsy sampling. In the above solution, the tissue sample is negatively adsorbed simultaneously through the gap between the inner needle rod 10 and the outer needle rod 11 and inside the inner needle rod 10, which improves the adsorption force of the device on the tissue sample, can effectively prevent the tissue sample from slipping out of the inner part of the outer needle rod 11. At the same time, the lesion tissue is cut by a rotating method, which can improve the cutting effect and avoid the situation that it is difficult to separate the lesion tissue and the tissue sample, effectively ensuring the integrity of the tissue sample.

[0058] Secondly, please refer to again Figure 4 and Figure 5 . A piercing edge is provided at one end of the secondary adsorption end 12 away from the handle assembly, and a cutting edge is provided at one end of the outer needle rod 11 away from the handle assembly. The cutting edge is one of the following structural forms: a serrated edge, an inclined plane edge, a triangular prism edge, or other structural forms with cutting ability. Preferably, in this embodiment, the structural form of the cutting edge is a triangular prism edge.

[0059] It should be noted that a blind hole is provided inside the inner needle rod 10, and the blind hole is opened from one end of the spiral guiding groove 23 away from the piercing edge and does not penetrate the piercing edge. The adsorption hole 13 and the communication hole 14 are communicated with each other through the blind hole.

[0060] Furthermore, when the biopsy device is in the state to be fired, the piercing edge on the inner needle rod 10 is located outside the outer needle rod 11 (that is, the piercing edge of the inner needle rod 10 slightly protrudes from the cutting edge), which is convenient for the inner needle rod 10 to puncture the subcutaneous tissue.

[0061] In this embodiment, the provision of the piercing edge facilitates puncturing the subcutaneous tissue when the inner needle rod 10 and the outer needle rod 11 are delivered to the edge of the lesion during the biopsy sampling process. The provision of the cutting edge facilitates cutting and separating the lesion tissue by the inner needle rod 10.

[0062] In a preferred embodiment, an anti-slip surface is provided on the inner wall of the outer needle rod 11 near one end of the cutting edge. A number of anti-slip lines are provided on the anti-slip surface, and the form of the anti-slip lines is one or a combination of several of the following forms: spiral anti-slip lines, groove anti-slip lines, bump anti-slip lines, or other anti-slip line forms with the function of increasing friction. In this embodiment, the form of the anti-slip lines is preferably bump anti-slip lines. By providing the anti-slip lines, the friction between the tissue sample and the outer needle rod 11 can be increased, further preventing the tissue sample from slipping inside the outer needle rod 11.

[0063] Next, please also refer to Figures 1 to 4 , the negative pressure assembly includes an inner needle base 21 and an outer needle base 22. The inner needle base 21 is fixed inside the handle assembly, and the inner needle base 21 is fixedly connected to the inner needle rod 10. The outer needle base 22 is slidably connected to the outside of the inner needle base 21, and the inner needle base 21 is fixedly connected to the outer needle rod 11. A sealing element is provided between the inner needle base 21 and the outer needle base 22, and a negative pressure chamber is formed between the inner needle base 21 and the outer needle base 22.

[0064] Furthermore, the inner needle rod 10 and the outer needle rod 11 are slidably connected in a clearance fit manner. A first negative pressure channel is formed between the inner needle rod 10 and the outer needle rod 11. The plurality of adsorption holes 13 and the communication holes 14 form a second negative pressure channel, and the first negative pressure channel, the negative pressure chamber, the second negative pressure channel, and the negative pressure chamber are all interconnected.

[0065] Furthermore, the plurality of adsorption holes 13 are evenly distributed in a ring shape outside the secondary adsorption end 12.

[0066] It should be noted that when the biopsy device changes from the to-be-fired state to the fired state, the outer needle base 22 moves away from the handle assembly, the internal volume of the negative pressure chamber increases, and the internal gas pressure is less than the external gas pressure.

[0067] In this embodiment, when taking a biopsy sample of the patient's diseased tissue, hold the handle assembly, insert the inner needle rod 10 and the outer needle rod 11 through the skin and transport them to the edge of the diseased tissue. Start the biopsy device, so that the biopsy device changes from the to-be-fired state to the fired state, causing the outer needle base 22 to move away from the handle assembly. The internal volume of the negative pressure chamber increases and generates negative pressure, and causes the first negative pressure channel and the second negative pressure channel to form negative pressure. The cut tissue sample is adsorbed through the cooperation of the first negative pressure channel and the second negative pressure channel, so that the tissue sample enters the inside of the outer needle rod 11. And by simultaneously adsorbing the tissue sample inside the outer needle rod 11 through the first negative pressure channel and the second negative pressure channel, the adsorption force of the device on the tissue sample can be effectively improved, preventing the tissue sample from slipping inside the outer needle rod 11. At the same time, the way the second negative pressure channel adsorbs the tissue sample is multi-point adsorption, making the adsorption force acting on the tissue sample by the second negative pressure channel more uniform.

[0068] Secondly, please refer to again Figure 1 and Figure 4 On the outer side of the outer needle base 22, a spiral guiding groove 23 is provided. Inside the handle assembly, a guiding boss is arranged, and the guiding boss is adapted to the spiral guiding groove 23.

[0069] In this embodiment, when holding the handle assembly to sample the lesion tissue, the biopsy device is activated, so that the biopsy device changes from the state to be fired to the fired state, causing the outer needle base 22 to move. At the same time, through the cooperation of the guiding boss and the spiral guiding groove 23, the outer needle base 22 drives the outer needle rod 11 to move towards the lesion tissue in a rotating manner, and then the outer needle rod 11 cuts and samples the lesion tissue in a rotating manner, improving the cutting effect, avoiding the situation that the lesion tissue and the tissue sample are difficult to be separated, and effectively ensuring the integrity of the tissue sample.

[0070] In a preferred embodiment, the outer diameter of the inner needle rod 10 is denoted as D1, and the outer diameter of the secondary adsorption end 12 is denoted as D2, and D1 > D2.

[0071] In this embodiment, through the above scheme, after the outer needle rod 11 cuts the sample of the lesion tissue, under the action of negative pressure, the tissue sample is sucked into the inside of the outer needle rod 11. At the same time, the secondary adsorption end 12 can penetrate into the tissue sample under the action of the piercing edge. On the basis of the common adsorption of the tissue sample by the first negative pressure channel and the second negative pressure channel, the secondary adsorption end 12 can fix the tissue sample inside the outer needle rod 11 again, further avoiding the tissue sample from detaching from the inside of the outer needle rod 11.

[0072] In a preferred embodiment, the inner diameter range of the outer needle rod 11 is 1 mm to 7 mm.

[0073] In this embodiment, when performing biopsy sampling on the lesion tissue, the diameter range of the tissue sample will vary due to different types, locations, sizes of the lesions and biopsy methods. For example: the sample diameter of the liver is 1 mm to 2 mm, and the sample diameter of the breast is 1.5 mm to 2.5 mm. Through the above scheme, the device can perform biopsy sampling on different tissues. Of course, when sampling different tissues, it is necessary to replace the outer needle rod 11 with different inner diameters according to the sampling requirements.

[0074] Embodiment Two

[0075] Please refer to the appendix Figures 6 to 9As shown, this embodiment provides a handle assembly, which is applicable to a negative pressure biopsy needle in any one of the first embodiment. The handle assembly includes a handle housing 30. A winding wrench 31 is rotatably connected to the outside of the handle housing 30. An ejection assembly 32, a safety lock assembly 33, and a puncture depth adjustment assembly 34 are assembled inside the handle housing 30. The winding wrench 31 and the ejection assembly 32, the ejection assembly 32 and the safety lock assembly 33, the ejection assembly 32 and the outer needle base 22, and the puncture depth adjustment assembly 34 and the outer needle base 22 are all adapted to each other. An activation button is assembled on the outside of the handle housing 30, and the activation button is connected to the ejection assembly 32. A guiding boss is fixed inside the handle housing 30, and the guiding boss is adapted to the spiral guiding groove 23.

[0076] Herein, the winding wrench 31 can drive the ejection assembly 32 to change from the fired state to the cocked state; the ejection assembly 32 can drive the outer needle rod 11 and the outer needle base 22 to move in the direction close to or away from the cutting edge; the activation button can start the operation of the ejection assembly 32 in the cocked state, so that the ejection assembly 32 changes from the cocked state to the fired state; the safety lock assembly 33 can form or release a limit on the ejection assembly 32 in the cocked state. After the safety lock assembly 33 forms a limit on the ejection assembly 32 in the cocked state, the ejection assembly 32 in the cocked state cannot change to the fired state; the puncture depth adjustment assembly 34 can adjust and limit the moving distance of the outer needle base 22 when the outer needle base 22 moves in the direction close to the cutting edge (that is, adjust the sampling depth of the outer needle rod 11). In this embodiment, the sampling depth of the outer needle rod 11 can be 13 mm, 23 mm, or 33 mm. Further, the winding wrench 31, the ejection assembly 32, the safety lock assembly 33, and the puncture depth adjustment assembly 34 are all existing mature applications and are widely used in biopsy devices. Their specific structures will not be further described herein.

[0077] In this embodiment, when a biopsy sample needs to be taken from the lesion tissue of a patient, the winding wrench 31 is rotated. By means of the winding wrench 31, the firing assembly 32 is changed from the fired state to the to-be-fired state, and the outer needle rod 11 and the outer needle base 22 are driven by the firing assembly 32 to move in a direction close to or away from the cutting edge. The safety lock assembly 33 can limit the firing assembly 32 in the to-be-fired state. According to the sampling requirement, the sampling depth of the outer needle rod 11 is adjusted by the puncture depth adjustment assembly 34. Then, the handle housing 30 is held, and the inner needle rod 10 and the outer needle rod 11 are percutaneously inserted and transported to the edge of the lesion tissue. The limit formed by the safety lock assembly 33 on the firing assembly 32 is released, and the firing assembly 32 is started by the firing key to be changed from the to-be-fired state to the fired state. The outer needle rod 11 and the outer needle base 22 are driven by the firing assembly 32 to move in a direction close to the lesion tissue, so that the outer needle rod 11 cuts the lesion tissue, and the tissue sample is adsorbed into the inner part of the outer needle rod 11 by the negative pressure assembly, completing the biopsy sampling.

[0078] Embodiment III

[0079] Please refer to Figure 10 As shown, this embodiment is a further adjustment based on Embodiment I and Embodiment II. Among them, the difference between this embodiment and Embodiment I is that: one end of the inner needle rod 10 away from the piercing edge penetrates through the inside of the inner needle base 21, and the second negative pressure channel and the negative pressure chamber are no longer in communication with each other. Specifically:

[0080] The negative pressure assembly further includes a micro vacuum pump 24. The micro vacuum pump 24 is fixed inside the handle housing 30, and the input end of the micro vacuum pump 24 and the communication hole 14 are connected by a pipeline. The second negative pressure channel is connected to the micro vacuum pump 24;

[0081] Here, a control circuit board is also fixed inside the handle housing 30, and the firing key, the control circuit board, the micro vacuum pump 24 and the control circuit board are all electrically connected by wires.

[0082] It should be noted that in this embodiment, when the firing key starts the firing assembly 32, it can also synchronously start the micro vacuum pump 24 through the control circuit board to ensure that negative pressure can be formed simultaneously inside the first negative pressure chamber and inside the second negative pressure chamber.

[0083] In this embodiment, when performing a biopsy sampling on the lesion tissue of a patient, after the inner needle rod 10 and the outer needle rod 11 are delivered to the edge of the lesion tissue, the limit on the firing assembly 32 formed by the safety lock assembly 33 is released. The micro vacuum pump 24 and the firing assembly 32 are simultaneously started by the activation key. The firing assembly 32 drives the outer needle base 22 and the outer needle rod 11 to move towards the lesion tissue. The outer needle rod 11 cuts the lesion tissue. At the same time, the volume inside the negative pressure chamber increases and the pressure decreases. A negative pressure is formed inside the first negative pressure channel through the negative pressure chamber. After the micro vacuum pump 24 operates, a negative pressure can be synchronously formed inside the second negative pressure channel. The tissue sample is adsorbed through the cooperation of the first negative pressure channel and the second negative pressure channel. With the above scheme, the first negative pressure channel and the second negative pressure channel can operate independently. When the first negative pressure channel or the second negative pressure channel cannot form a negative pressure due to uncontrollable factors (such as: the sealing element fails or the micro vacuum pump 24 cannot operate), the other negative pressure channel can operate independently to adsorb the tissue sample.

[0084] Embodiment Four

[0085] This embodiment is a further adjustment based on Embodiment Three. The difference between this embodiment and Embodiment Three is that: the micro vacuum pump 24 is no longer installed inside the handle housing 30. Specifically:

[0086] The negative pressure assembly further includes a negative pressure generating device. The control assembly is integrated inside the negative pressure generating device. The negative pressure generating device is arranged outside the handle housing 30. An air path connector is arranged on the outer side of the handle housing 30. The air path connector is connected to the inner needle rod 10 and the negative pressure generating device through pipelines respectively. Among them, after the negative pressure generating device operates, the negative pressure generating device can extract the gas inside the inner needle rod 10, so that a negative pressure is formed inside the second negative pressure channel.

[0087] It should be noted that the control circuit board and the negative pressure generating device are detachably electrically connected. When the activation key drives the firing assembly 32 to drive the outer needle base 22 and the outer needle rod 11 to move, the activation key can send an electrical signal to the control circuit board. After receiving the electrical signal, the control circuit board synchronously sends a start signal to the negative pressure generating device. The negative pressure generating device can operate synchronously and a negative pressure is formed inside the second negative pressure channel. Among them, in this embodiment, the specific ways of circuit connection and signal transmission are all existing mature applications, and their specific working principles will not be further elaborated here.

[0088] In this embodiment, a negative pressure generating device is used to replace the micro vacuum pump 24 in Embodiment 3. Relatively speaking, as a peripheral device, the negative pressure generating device is convenient for maintenance, while the micro vacuum pump 24 in Embodiment 3 is arranged inside the handle housing 30, which is not convenient for maintaining the micro vacuum pump 24. With the above arrangement, the device can operate stably for a long time.

[0089] Embodiment 5

[0090] Please refer to Figure 11 As shown, this embodiment is a further adjustment based on Embodiments 1 and 2. The differences between this embodiment, Embodiment 1, and Embodiment 2 are as follows: The spiral guiding groove 23 provided on the outer side of the outer needle base 22 is cancelled, and at the same time, the guiding boss provided inside the handle housing 30 is cancelled. Specifically:

[0091] A driving assembly is further assembled inside the handle housing 30. The driving assembly includes a driving motor 41, a driving gear 42, and a driven gear ring 43. The driving motor 41 is fixed inside the handle housing 30, the driving gear 42 is fixed to the output end of the driving motor 41, the driven gear ring 43 is fixed to the outer side of the outer needle base 22, and the driven gear ring 43 is meshed with the driving gear 42. Among them, the driving motor 41 is preferably a servo motor.

[0092] It should be noted that an integrated circuit board is also fixed inside the handle housing 30. The excitation key, the integrated circuit board, the driving motor 41, and the integrated circuit board are electrically connected through wires. When the excitation key drives the emission assembly 32 to operate, it can send a signal to the integrated circuit board, and the integrated circuit board controls the synchronous operation of the driving motor 41.

[0093] In this embodiment, when a biopsy sample is taken from a patient, the emission assembly 32 is driven by the excitation key to change from the to-be-fired state to the fired state. The outer needle base 22 and the outer needle rod 11 are driven by the emission assembly 32 to move synchronously in the direction close to the lesion tissue. At the same time, the driving motor 41 is started through the integrated circuit board, so that the output end of the driving motor 41 rotates. The driving motor 41 drives the driving gear 42 to rotate. Through the meshing connection between the driving gear 42 and the driven gear ring 43, the driving gear 42 drives the driven gear ring 43 and the outer needle base 22 to rotate synchronously (at the same time, relative sliding occurs between the driving gear 42 and the driven gear ring 43), and then the outer needle rod 11 cuts and samples the lesion tissue in a rotating manner.

[0094] It should be noted that in Embodiments 3 to 5, since the components involved in the modification are different, the space inside the handle housing 30 and the corresponding component layout can be adjusted and optimized according to the actual situation, and will not be listed one by one here.

[0095] The working principle of the present invention is:

[0096] When a biopsy sample needs to be taken from the lesion tissue of a patient, first perform routine preparations such as draping, disinfecting, and anesthetizing the patient. Rotate the winding wrench 31, so that the firing assembly 32 is changed from the fired state to the to-be-fired state through the winding wrench 31, and drive the outer needle rod 11 and the outer needle base 22 to move in the direction close to or away from the cutting edge through the firing assembly 32. The safety lock assembly 33 can limit the firing assembly 32 in the to-be-fired state. According to the sampling requirements, adjust the sampling depth of the outer needle rod 11 through the puncture depth adjustment assembly 34. Then, hold the handle housing 30, and percutaneous puncture and deliver the inner needle rod 10 and the outer needle rod 11 to the edge of the lesion tissue. Release the limit formed by the safety lock assembly 33 on the firing assembly 32, and start the firing assembly 32 to change from the to-be-fired state to the fired state through the activation key. Drive the outer needle rod 11 and the outer needle base 22 to move in the direction close to the lesion tissue through the firing assembly 32, so that the outer needle rod 11 cuts and samples the lesion tissue in a rotating manner. At the same time, form negative pressure inside both the first negative pressure channel and the second negative pressure channel through the negative pressure assembly, so that the tissue sample enters the inner part of the outer needle rod 11, and adsorb the tissue sample through the first negative pressure channel and the second negative pressure channel. Withdraw the inner needle rod 10 and the outer needle rod 11 from the lesion tissue through the handle assembly to complete the biopsy sampling.

[0097] The above is only the preferred embodiment of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle of the present invention, several improvements and refinements can be made, and these improvements and refinements should also be regarded as the protection scope of the present invention. The structures, devices, and operation methods not specifically described and explained in the present invention are implemented according to the conventional means in the art without special instructions and limitations.

Claims

1. A negative pressure biopsy needle, comprising an inner needle rod (10) and an outer needle rod (11), wherein the outer needle rod (11) is coaxially sleeved on the outer side of the inner needle rod (10), characterized in that: The inner needle rod (10) is configured as a non-through hollow structure, and the two ends of the outer side of the inner needle rod (10) are respectively provided with an adsorption hole (13) and a communication hole (14), and the adsorption hole (13) and the communication hole (14) are connected to each other; The outer needle rod (11) is configured to move in a rotational manner along the axis of the inner needle rod (10) in a direction away from the handle assembly when the biopsy device is transformed from a ready-to-fire state to a fired state; Also includes: A negative pressure assembly, wherein the negative pressure assembly and the inner needle rod (10) as well as the negative pressure assembly and the outer needle rod (11) are connected to each other; When the outer needle rod (11) moves in a direction away from the handle assembly, a negative pressure is formed in the gap between the inner needle rod (10) and the outer needle rod (11) and inside the inner needle rod (10), so as to absorb the tissue sample into the inside of the outer needle rod (11).

2. A negative pressure biopsy needle according to claim 1, characterized in that: The inner needle rod (10) is provided with a secondary adsorption end (12) at one end away from the handle assembly, and the secondary adsorption end (12) is matched with the adsorption hole (13), and the secondary adsorption end (12) is provided with a piercing blade at one end away from the handle assembly, and the outer needle rod (11) is provided with a cutting blade at one end away from the handle assembly, and the cutting blade is one of the following structural forms: a serrated blade edge, a bevel blade edge, and a triangular blade edge.

3. The negative pressure biopsy needle according to claim 1, characterized in that: The inner wall of the outer needle rod (11) close to one end of the cutting blade is provided with an anti-skid surface, and the anti-skid surface is provided with a plurality of anti-skid grooves.

4. A negative pressure biopsy needle according to claim 3, characterized in that: The anti-skid pattern is in the form of one or a combination of the following forms: spiral anti-skid pattern, groove anti-skid pattern, and convex anti-skid pattern.

5. The negative pressure biopsy needle according to claim 1, characterized in that: The negative pressure assembly comprises an inner needle base (21) and an outer needle base (22), wherein the inner needle base (21) is fixed inside the handle assembly, and the inner needle base (21) and the inner needle rod (10) are fixedly connected, the outer needle base (22) is slidably connected to the outer side of the inner needle base (21), and the inner needle base (21) and the outer needle rod (11) are fixedly connected, and a negative pressure chamber is formed between the inner needle base (21) and the outer needle base (22), and the negative pressure chamber is configured such that when the biopsy device is transformed from a ready-to-fire state to a firing state, the gas pressure inside the negative pressure chamber is lower than the external gas pressure.

6. A negative pressure biopsy needle according to claim 5, characterized in that: A spiral guide groove (23) is provided on the outer side of the outer needle base (22), a guide boss is provided inside the handle assembly, and the guide boss and the spiral guide groove (23) are matched.

7. The negative pressure biopsy needle according to claim 1, characterized in that: The inner needle rod (10) and the outer needle rod (11) are slidably connected in a clearance-fitting manner, a first negative pressure channel is formed between the inner needle rod (10) and the outer needle rod (11), the adsorption hole (13) and the connecting hole (14) form a second negative pressure channel, and the first negative pressure channel and the negative pressure chamber are connected to each other as are the second negative pressure channel and the negative pressure chamber.

8. The negative pressure biopsy needle according to claim 2, characterized in that: The outer diameter of the inner needle rod (10) is recorded as D1, and the outer diameter of the secondary adsorption end (12) is recorded as D2, and D1>D2.

9. The negative pressure biopsy needle according to claim 1, characterized in that: The material of the inner needle rod (10) and the outer needle rod (11) is one of the following materials: stainless steel, titanium alloy, and nickel-titanium alloy.

10. A handle assembly, suitable for a negative pressure biopsy needle according to any one of claims 1 to 9, characterized in that: The invention comprises a handle housing (30), the outer side of which is rotatably connected to a winding wrench (31), the interior of which is fixed a firing assembly (32), a safety lock assembly (33) and a puncture depth adjustment assembly (34), and the winding wrench (31) and the firing assembly (32) as well as the firing assembly (32) and the safety lock assembly (33) are mutually adapted, and a guide boss is arranged inside the handle housing (30), and the guide boss is adapted to a spiral guide groove (23).

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