Mechanical cryo-rotating biopsy needle

Abstract

This invention relates to the field of medical device technology, and more particularly to a mechanical cryoablation biopsy needle, comprising a housing; a needle assembly including a puncture needle and an ablation tube; a cryo-mechanism disposed within the housing and communicating with the puncture needle; a mechanical ablation mechanism disposed within the housing and linked to the ablation tube, the mechanical ablation mechanism having an energy storage state and an energy release state, storing mechanical energy in the energy storage state and releasing mechanical energy in the energy release state to drive the ablation tube to perform a ablation action; a limiting mechanism for locking the mechanical ablation mechanism and holding it in the energy storage state; and a release mechanism movably disposed within the housing, the release mechanism having a first trigger position and a second trigger position arranged sequentially along its direction of movement; the release mechanism is configured to sequentially reach the first trigger position and the second trigger position during a single movement, triggering the cryo-mechanism to cool the puncture needle upon reaching the first trigger position, and triggering the limiting mechanism to unlock the mechanical ablation mechanism upon reaching the second trigger position.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a mechanical cryoablation biopsy needle. Background Technology

[0002] Biopsy is an important means of obtaining pathological tissue samples in clinical practice. Traditional biopsy needles often face problems such as tissue slippage, sample breakage, and incomplete sampling during the puncture and sampling process. Especially when targeting lesions with soft texture or rich blood supply, the tissue is prone to displacement when the puncture needle cuts, resulting in sampling failure or poor sample quality, thus affecting the accuracy of pathological diagnosis.

[0003] In recent years, cryobiopsy technology has gradually attracted attention. This technology utilizes the Joule-Thomson effect, where high-pressure gas is suddenly throttled through a micro-orifice, causing a sharp drop in pressure and rapid gas expansion, resulting in a rapid cooling of the probe tip. The frozen tissue is solidified and adheres to the needle tip, effectively suppressing tissue displacement at the moment of cutting and improving sample formation and integrity.

[0004] However, most existing cryobiopsy devices are complex in structure, partially relying on electric or pneumatic power sources, making operation cumbersome and costly. In some devices, the activation of the freezing function and the triggering of the cutting function are independent, requiring the operator to perform multiple steps separately, which not only increases the operation time but also raises the complexity and risk of errors. In addition, the timing coordination between the freezing and cutting mechanisms in existing devices is often not precise enough, making it difficult to guarantee the ideal "freeze first, then cut" sequence.

[0005] Therefore, there is a need for a mechanical cryo-excision biopsy needle that is simple in structure, easy to operate, and capable of sequentially linking freezing and excision through a single operation. Summary of the Invention

[0006] The purpose of this invention is to overcome the shortcomings of existing technologies and to provide a mechanical cryoablation biopsy needle, comprising: shell; A needle assembly is disposed within the housing, the needle assembly comprising a puncture needle and a rotary cutting needle tube; A freezing mechanism is disposed within the housing and communicates with the puncture needle, the freezing mechanism being configured to cool the puncture needle; A mechanical rotary cutting mechanism is disposed inside the housing and linked with the rotary cutting needle tube. The mechanical rotary cutting mechanism has an energy storage state and an energy release state. In the energy storage state, mechanical energy is stored, and in the energy release state, the mechanical energy is released to drive the rotary cutting needle tube to perform a rotary cutting action. A limiting mechanism is used to lock and maintain the mechanical rotary cutting mechanism in the energy storage state; A release mechanism is movably disposed in the housing, the release mechanism having a first trigger position and a second trigger position arranged sequentially along its moving direction; The release mechanism is configured to sequentially reach the first trigger position and the second trigger position during a single movement, and trigger the freezing mechanism to cool the puncture needle when reaching the first trigger position, and trigger the limiting mechanism to unlock the mechanical rotary cutting mechanism when reaching the second trigger position, so that the triggering of the freezing mechanism precedes the unlocking of the mechanical rotary cutting mechanism.

[0007] Furthermore, the housing is provided with mutually spaced needle mounting area and gas cylinder mounting area, the needle assembly and the mechanical rotary cutting mechanism are disposed in the needle mounting area, and at least a portion of the freezing mechanism is disposed in the gas cylinder mounting area; The outer shell includes an upper shell and a lower shell arranged symmetrically. Each of the upper shell and the lower shell includes half of the needle mounting area and half of the gas cylinder mounting area. The upper shell and the lower shell are structurally symmetrical and together enclose a complete installation space.

[0008] Furthermore, the outer shell is also provided with a cover, which includes an upper cover and a lower cover arranged symmetrically to each other. The cover is divided into a driven area and a driving area along the axial direction, wherein the driven area is closer to the distal end and the driving area is closer to the proximal end. A front sleeve and a rear sleeve are fixedly provided in the driven area. A first guide groove is provided on the front sleeve from the driving area to the driven area, and a second guide groove is provided on the rear sleeve from the driving area to the driven area. A limit plate is provided at the junction of the driving area and the driven area. The limit plate is configured to cooperate with the limiting mechanism to limit the mechanical rotary cutting mechanism.

[0009] Furthermore, the mechanical rotary cutting mechanism includes: A small pusher is slidably sleeved around the periphery of the puncture needle located in the front sleeve area, and the small pusher is slidably connected to the first guide groove; A threaded component is fixedly connected to the periphery of the rotary cutting needle tube located in the rear sleeve area, and the threaded component has external threads; A nut fastener is fixedly disposed on the side of the rear sleeve near the driven area, and the nut fastener has an internal thread hole at its center that mates with the external thread of the threaded component; An elastic element is sleeved around the periphery of the rotary cutting needle tube, with one end of the elastic element abutting against the limiting mechanism and the other end abutting against the proximal end of the cover; The threaded component is configured to rotate axially along the rotary cutting needle tube and move distally when the mechanical energy is released, pushing the small pusher and causing the rotary cutting needle tube to perform a compound rotary cutting motion of rotation and axial movement.

[0010] Furthermore, the limiting mechanism includes: A hook is slidably fitted onto the proximal region of the rotary cutting needle tube located in the rear sleeve, the hook having a limiting hook formed by extending outward from both sides of the mounting base and bending towards the distal end; The limiting hook is configured to hook the limiting plate when the limiting mechanism is in the limiting state, so that the elastic element is kept in a compressed state to store the mechanical energy.

[0011] Furthermore, the release mechanism includes a push button, which is slidably disposed between the outer casing and the cover, and the push button has: An unlocking part is provided at one end of the push button near the proximal end. The unlocking part is configured to cooperate with the limiting hook and push the limiting hook outward to disengage from the limiting plate when the push button slides to the second trigger position in the distal direction. The first linkage is located on the side of the push button near the gas cylinder installation area. The first linkage is configured to activate the refrigeration mechanism when the push button slides to the first trigger position in the distal direction.

[0012] Furthermore, the push button also has a second linkage part, which is disposed at one end of the push button near the distal end and is configured to push the small pusher to move in the proximal direction when the push button slides in the proximal direction, so as to drive the threaded part to rotate and reset and make the limiting hook re-hook the limiting plate, so as to re-compress the elastic element.

[0013] Furthermore, the refrigeration mechanism includes: A gas cylinder is located within the gas cylinder installation area, and the gas cylinder is used to contain a compressed medium. An active switch is provided on the airflow passage between the gas cylinder and the puncture needle. The active switch has a closed position that closes the air passage and an open position that opens the air passage. A rotating stop is rotatably disposed in the gas cylinder installation area. One end of the rotating stop abuts against the movable switch, and the other end abuts against the first linkage part of the push button when the push button is in the first trigger position. When the push button slides to the distal end, the first linkage part drives the rotating block to rotate, and the rotating block pushes the movable switch from the closed position to the open position, so that the compressed medium is delivered to the puncture needle through the airflow passage.

[0014] Furthermore, the needle assembly also includes a copper tube, one end of which is connected to the puncture needle, and the other end is inserted into the airflow passage within the gas cylinder installation area, through which the compressed medium is delivered to the puncture needle.

[0015] Furthermore, it also includes a safety switch operably disposed in the housing, the safety switch having a locked position and an unlocked position. In the locked position, the safety switch constrains the limiting mechanism to remain locked, and in the unlocked position, the safety switch releases the constraint on the limiting mechanism, allowing the release mechanism to trigger unlocking.

[0016] Furthermore, the safety switch has an inner mounting arc surface, a middle limiting arc surface, and an outer control arc surface arranged in an approximately concentric arc surface. The inner mounting arc surface is disposed between the outer shell and the cover. The middle limiting arc surface is attached to the outer periphery of the outer shell. The middle limiting arc surface is provided with protrusions. The outer shell is provided with a first limiting groove and a second limiting groove in sequence along the sliding direction of the safety switch. In the locked position, the protrusion is located in the first limiting groove, and the inner mounting arc surface abuts against the hook to prevent the limiting hook from disengaging from the limiting plate; in the unlocked position, the protrusion is located in the second limiting groove, and the inner mounting arc surface disengages from the hook, allowing the unlocking part of the push button to push the limiting hook away from the limiting plate.

[0017] The present invention also provides a biopsy system, comprising: the above-described mechanical cryoablation biopsy needle; and a guide sheath that cooperates with the biopsy needle; The guide sheath has an axially extending guide channel, the inner diameter of which is adapted to the outer diameter of the biopsy needle, and the biopsy needle is slidably inserted into the guide channel.

[0018] Compared with the prior art, the beneficial effects of the present invention are: 1. This invention sets up a release mechanism, which sequentially reaches the first trigger position and the second trigger position during a single movement, respectively triggering the freezing mechanism to cool the puncture needle and triggering the limit mechanism to unlock the mechanical cutting mechanism. This achieves timing control of the freezing mechanism opening first and the mechanical cutting mechanism releasing later. The operator only needs to perform a single operation to complete the sampling process of freezing first and then cutting, which is simple to operate.

[0019] 2. This invention accumulates mechanical energy through a mechanical rotary cutting mechanism and drives the rotary cutting needle to perform rotary cutting action when released. It does not require an additional external electric or pneumatic power source, and the overall structure is simple and the cost is low.

[0020] 3. By setting a safety switch, the limit mechanism cannot be unlocked if the safety switch is not released, thus preventing accidental triggering and improving operational safety.

[0021] 4. By fixing the threaded part to the rotary cutting needle tube, and cooperating with the small pusher sleeved on the rotary cutting needle tube and the fixed guide structure, when the elastic element releases mechanical energy, the threaded part rotates and moves axially, thereby directly driving the rotary cutting needle tube to rotate and move axially synchronously, while the small pusher only slides along the guide structure to maintain the direction of movement, thus improving the stability and reliability of the rotary cutting action. Attached Figure Description

[0022] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are provided to further illustrate the invention and form part of the specification. They are used together with the embodiments of the invention to explain the invention and do not constitute a limitation thereof. In the drawings: Figure 1 This is a schematic diagram of the structure of a mechanical cryoablation biopsy needle according to the present invention; Figure 2 This is an exploded view of a mechanical cryoablation biopsy needle according to the present invention; Figure 3 This is a schematic diagram of the cap structure of a mechanical cryoablation biopsy needle according to the present invention; Figure 4 This is a schematic diagram of the outer shell structure of a mechanical cryoablation biopsy needle according to the present invention; Figure 5 This is a schematic diagram of the sleeve structure of a mechanical cryoablation biopsy needle according to the present invention; Figure 6 This is a schematic diagram of the needle assembly structure of a mechanical cryoablation biopsy needle according to the present invention; Figure 7 This is a structural diagram of the motion conversion component of a mechanical cryoablation biopsy needle according to the present invention; Figure 8 This is a cross-sectional view of the motion conversion component of a mechanical cryoablation biopsy needle according to the present invention; Figure 9 This is an exploded view of the motion conversion component of a mechanical cryoablation biopsy needle according to the present invention; Figure 10 This is an overall cross-sectional view of a mechanical cryoablation biopsy needle according to the present invention; Figure 11 This is a schematic diagram of a safety switch for a mechanical cryoablation biopsy needle according to the present invention; Figure 12 This is a first-view schematic diagram of the safety switch of a mechanical cryoablation biopsy needle of the present invention when it is unlocked; Figure 13 This is a second-view schematic diagram of the safety switch of a mechanical cryoablation biopsy needle of the present invention when it is unlocked; Figure 14 This is a first-view schematic diagram of the safety switch of a mechanical cryoablation biopsy needle of the present invention when it is locked. Figure 15 This is a second-view schematic diagram of the safety switch of a mechanical cryoablation biopsy needle of the present invention when it is locked. Figure 16 This is a cross-sectional view of the internal structure of the cap of a mechanical cryoablation biopsy needle according to the present invention; Figure 17 This is a cross-sectional view of the tail end of the needle assembly of a mechanical cryoablation biopsy needle according to the present invention; Figure 18 This is a schematic diagram showing the connection between the push button and the upper outer shell of a mechanical cryoablation biopsy needle according to the present invention.

[0023] Figure Labels 1: Outer shell; 11: Upper housing; 12: Lower housing; 13: Needle mounting area; 14: Gas cylinder mounting area; 15: First through groove; 16: Opening groove; 17: First limiting groove; 18: Second limiting groove; 2: Cover; 21: Upper cover; 22: Lower cover; 23: Driven area; 24: Driven area; 25: Guide platform; 26: Second through slot; 3: Needle assembly; 31: Puncture needle; 32: Rotary cutting needle tube; 33: Copper tube; 311: Inner core; 312: Sleeve; 313: Triangular needle tip; 314: Vent tube; 4: Front sleeve; 41: First guide groove; 5: Rear sleeve; 51: Second guide groove; 6: Small pusher parts; 61: Guide wing; 7: Nut fastener; 71: Internal threaded hole; 8: Threaded parts; 9: Hook; 91: Mounting base; 92: Limiting wing; 93: Limiting hook; 94: Sleeve; 10: Limit plate; 101: Through hole; 102: Guide surface; 20: Receiving frame; 201: Sleeve receiving area; 30: Elastic component; 40: Push button; 401: Arc-shaped mounting plate; 402: Push handle; 403: Third guide groove; 404: Unlock hook; 405: Limiting eaves; 406: Protruding brace; 50: Safety switch; 501: Inner mounting arc surface; 502: Middle limiting arc surface; 503: Outer control arc surface; 504: Protrusion; 60: Rotary stop; 70: Intermediate cylinder; 701: Receiving cavity; 702: Copper pipe installation passage; 80: CO2 gas cylinder with matching sleeve; 90: CO2 gas cylinder; 100: Connector; 110: Round silicone pad; 120: Active switch; 121: Abutment post; 122: Conical post; 123: Guide post; 130: Return spring; 140: Axis; 150: Torsion spring. Detailed Implementation

[0024] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

[0025] To keep the drawings concise, only the parts relevant to the invention are shown schematically in each figure, and they do not represent the actual structure of the product. Furthermore, for ease of understanding, in some figures, only one of components with the same structure or function is shown schematically, or only one is labeled. In this document, "one" can mean not only "only one" but also "more than one".

[0026] First Embodiment Please see Figures 1-18 The technical solution of the mechanical cryoablation biopsy needle provided in this embodiment includes the following: 1. Outer shell, 2. Cover body disposed inside the outer shell, 3. Needle assembly disposed inside the cover body, 4. Freezing mechanism, mechanical cutting mechanism, limiting mechanism and release mechanism.

[0027] Specifically, such as Figure 2As shown, the outer casing 1 includes an upper casing 11 and a lower casing 12 arranged symmetrically. A needle mounting area 13 and a gas cylinder mounting area 14 are formed within the outer casing 1, spaced apart from each other. Each of the upper casing 11 and the lower casing 12 includes half of the needle mounting area 13 and half of the gas cylinder mounting area 14. The upper casing 11 and the lower casing 12 are structurally symmetrical, together enclosing a complete mounting space. The needle assembly 3 and the mechanical rotary cutting mechanism are disposed within the needle mounting area 13, and at least a portion of the freezing mechanism is disposed within the gas cylinder mounting area 14.

[0028] Self-attached on the upper shell 11 Figure 2 Two first through slots 15 are symmetrically opened from the left to the right to expose the push button 40 of the release mechanism. The arc-shaped structure between the two first through slots 15 forms a slide, which cooperates with the third guide slot 403 of the push button 40 below for guidance. On the side of the lower housing 12 away from the gas cylinder installation area 14, an opening slot 16, a first limiting slot 17 and a second limiting slot 18 are opened sequentially along the arc surface for installing the safety switch 50.

[0029] For details, see attached. Figure 3 As shown, the cover 2 includes an upper cover 21 and a lower cover 22 arranged symmetrically. The cover 2 is axially divided into a driven area 23 and a driving area 24. The driven area 23 is located near the puncture end of the needle assembly 3, i.e., attached to... Figure 3 The distal left end, driving area 24 is far from the puncture end, i.e., the appendix Figure 3 The right proximal end. The upper cover 21 and the lower cover 22 are fixed together by a snap fastener, as shown in the attached figure. Figure 3 and attached Figure 4 As shown, the cover 2 is fixed in the groove of the outer shell 1 by protrusions on the outer wall.

[0030] As attached Figure 5 As shown, the left ends of the upper cover 21 and the lower cover 22 are protruding surfaces, the outer diameter of which is larger than the outer diameter of the upper cover 21 or the lower cover 22 body, serving as sliding limiting surfaces. The top of the upper cover 21 is provided with a guide platform 25 near the left side along the direction, which is used to fit and fix with the groove of the inner wall of the slide of the upper housing 11 and support the slide.

[0031] A limiting plate 10, i.e., a limiting structure, is provided at the junction of the driving area 24 and the driven area 23 of the cover 2. The limiting plate 10 has a through hole 101 in the middle for mounting the needle assembly 3. The left side wall edge of the limiting plate 10 has a guide surface 102 facing outward to facilitate the limiting hook 93 of the hook 9 to smoothly pass over the limiting plate 10 during energy storage. The right side area of ​​the limiting plate 10 also has a receiving frame 20 with an opening on the left side, and a sleeve receiving area 201 is formed inside the receiving frame 20.

[0032] In specific implementation, as shown in the appendix Figure 5As shown, the driven area 23 inside the cover 2 is fixedly installed with a front sleeve 4 and a rear sleeve 5 arranged sequentially from left to right. The front sleeve 4 and the rear sleeve 5 are fixed in the cover 2 by ribs.

[0033] The front sleeve 4 has a first guide groove 41, and the rear sleeve 5 has a second guide groove 51. Both the first guide groove 41 and the second guide groove 51 extend from the right end face of their respective sleeves to the left, but do not connect to the left end face. The first guide groove 41 of the front sleeve 4 is a guide structure fixedly installed inside the outer shell according to the present invention.

[0034] Specifically, the needle assembly 3 is housed in the inner cavity of the cover 2, and its left side extends through the front sleeve 4 and the rear sleeve 5 before exiting the left side of the cover 2.

[0035] like Figure 6 As shown, the needle assembly 3 includes a puncture needle 31 and a rotary cutting needle tube 32 coaxially sleeved on the outside of the puncture needle 31. The puncture needle 31 includes an inner core 311, a sleeve 312 sleeved around the inner core 311, and a triangular needle tip 313 located at the puncture end of the inner core; wherein, the triangular needle tip 313 is fixed to the inner core 311 by laser welding, and the inner core 311 and the sleeve 312 are fixed in the lower cover by adhesive dispensing, and the rotary cutting needle tube 32 and the outer wall of the sleeve 312 can rotate relative to each other.

[0036] The inner cavity of the inner core 311 is provided with a venting capillary 314, which is connected to the airflow passage of the freezing mechanism. The venting capillary 314 is used to receive the compressed medium and expand it for cooling, so as to freeze and fix the surrounding target object. The rotary cutting needle tube 32 is used to perform a rotary cutting action to cut the target under the drive of the mechanical rotary cutting mechanism.

[0037] A copper tube 33 is connected to the right side of the needle assembly 3, and the other side of the copper tube 33 is inserted into the copper tube installation passage 702 in the gas cylinder installation area 14 to form a complete airflow passage.

[0038] In specific implementation, as shown in the appendix Figure 7 As shown, the mechanical rotary cutting mechanism includes an elastic element 30 and a motion conversion component.

[0039] The motion conversion assembly includes a threaded part 8 and a nut fixing part 7 with threaded engagement, a guide structure fixedly installed in the housing, namely the first guide groove 41 of the front sleeve 4, and a small pusher 6 sleeved on the rotary cutting needle tube 32.

[0040] The small pusher 6 is sleeved around the periphery of the front sleeve 4 region of the rotary cutting needle tube 32. The right side wall of the small pusher 6 abuts against the left side wall of the threaded part 8. Guide wings 61 are provided on both sides of the small pusher 6, and the guide wings 61 are slidably connected to the first guide groove 41. The small pusher 6 and the rotary cutting needle tube 32 are sleeved together. The small pusher 6 does not rotate with the rotary cutting needle tube 32, but only slides axially along the first guide groove 41. The small pusher 6 guides the radial direction of the threaded part 8 on the periphery of the rotary cutting needle tube 32 through the slidable engagement of its guide wings 61 with the first guide groove 41.

[0041] The nut fastener 7 is fixedly installed on the side of the rear sleeve 5 near the driven area 23, and the nut fastener 7 has an internal thread hole 71 at its center.

[0042] The threaded component 8 is fixedly connected to the outer periphery of the rotary cutting needle tube 32 located in the area of ​​the rear sleeve 5. The threaded component 8 has an external thread that mates with the internal threaded hole 71 of the nut fixing component 7. The threaded component 8 is fixedly connected to the rotary cutting needle tube 32 so that the rotary cutting needle tube 32 moves synchronously when the threaded component 8 rotates and moves axially.

[0043] In this embodiment, the elastic element 30 can preferably be a needle tube spring, which is sleeved around the periphery of the rotary cutting needle tube 32, or more specifically, located around the sleeve 94 of the hook 9 itself. The elastic element 30 undergoes elastic deformation to store mechanical energy when the mechanical rotary cutting mechanism accumulates mechanical energy.

[0044] Driven by the elastic element 30, the threaded component 8 rotates axially along the rotary cutting needle tube 32 and moves towards the driven zone 23 through its threaded engagement with the nut fixing component 7. Since the threaded component 8 is fixedly connected to the rotary cutting needle tube 32, the rotary cutting needle tube 32 rotates synchronously with the threaded component 8 and moves axially, thus performing a compound rotary cutting action of rotational and axial motion. The small pusher 6 slides along the guide structure under the thrust of the threaded component 8, guiding the direction of the rotary cutting needle tube 32.

[0045] In specific implementation, as shown in the appendix Figure 7 As shown, the limiting mechanism includes a radially deflectable hook, namely hook 9, which engages with a limiting structure, namely limiting plate 10, disposed within the housing 1.

[0046] The hook 9 is slidably fitted onto the right side of the rotary cutting needle tube 32 located in the rear sleeve 5. The hook 9 has a limiting wing 92 that extends outward from both sides of the mounting base 91 and bends towards the drive area 24. The right end of the limiting wing bends inward towards the cavity to form a limiting hook 93. The limiting wing 92 is slidably connected to the second guide groove 51 on the side near the driven area 23.

[0047] In the locked state, i.e. the energy storage state, the limiting hook 93 of the hook 9 is hooked onto the limiting plate 10, and the elastic element 30 is compressed between the mounting base 91 of the hook 9 and the right side plate of the receiving frame 20, so that mechanical energy can be stored.

[0048] When the release mechanism reaches the second trigger position, the limiting hook 93 of the push hook 9 is radially deflected, causing the limiting hook 93 to disengage from the limiting plate 10, the limiting mechanism is unlocked, and the elastic element 30 releases mechanical energy.

[0049] In specific implementation, as shown in the appendix Figure 2 As shown, the release mechanism is a push button 40. The push button 40 is movably disposed between the outer casing 1 and the cover 2.

[0050] The push button 40 includes an arc-shaped mounting plate (composed of two symmetrical arc-shaped mounting pieces 401) and a push handle 402 disposed on the arc-shaped mounting plate. The spacing between the two arc-shaped mounting pieces 401 matches the remaining structure between the two first through slots 15 of the upper housing 11. A third guide groove 403 is provided on the lower end face of the push handle 402, and the third guide groove 403 matches the slide table.

[0051] The arc-shaped mounting plate 401 of the push button 40 is installed between the upper housing 11 and the upper cover 21, and the push handle 402 is located outside the upper housing 11. The push button 40 has an unlocking part, namely the unlocking hook 404, at one end near the drive area 24. The inner tangent of the unlocking hook 404 matches the right end face of the limiting hook 93 of the hook 9.

[0052] The push button 40 has a first trigger position and a second trigger position in sequence along its moving direction.

[0053] When the push button 40 slides towards the driven area 23 to the first trigger position, the push button 40 triggers the freezing mechanism to cool the puncture needle 31. When the push button 40 continues to slide towards the driven area 23 to the second trigger position, the unlocking hook 404 of the push button 40 engages with the limiting hook 93 and pushes the limiting hook 93 outward, causing the limiting hook 93 to disengage from the limiting plate 10. The limiting mechanism is unlocked, and the elastic element 30 releases mechanical energy to drive the rotary cutting needle tube 32 to perform a rotary cutting action.

[0054] During a single movement, the push button 40 sequentially reaches the first trigger position and the second trigger position, thus enabling the freezing mechanism to be triggered before the mechanical slicing mechanism is unlocked.

[0055] Specifically, the push button 40 is provided with a second linkage part, namely a limiting eave 405, at the end facing the driven area 23. The limiting eave 405 and the guide wings 61 on both sides of the small pusher 6 are on the same path. When re-energy storage is required, the push button 40 is slid towards the drive area 24, the limiting eave 405 pushes the small pusher 6 to move towards the drive area 24, the small pusher 6 pushes the threaded part 8 to rotate and reset, and the limiting hook 93 re-hooks the limiting plate 10, and the elastic part 30 is re-compressed.

[0056] The push button 40 has a first linkage part, namely the protrusion 406, on the side near the gas cylinder installation area 14, which is used to link the opening of the refrigeration mechanism.

[0057] In specific implementation, as shown in the appendix Figure 8 Appendix Figure 9 and attached Figure 10 As shown, the refrigeration mechanism is located in the gas cylinder installation area 14 and mainly includes a rotating stop block 60, an intermediate cylinder 70, a CO2 gas cylinder matching cylinder 80, a CO2 gas cylinder 90 (i.e., a compressed medium container), a connector 100, a circular silicone pad 110, an active switch 120 (i.e., a valve assembly), and a return spring 130.

[0058] A rotating stop 60 is rotatably connected to the lower housing 12 via a shaft 140 and a torsion spring 150, and is located in the gas cylinder mounting area 14 near the left side. An intermediate cylinder 70 is located in the right side region of the gas cylinder mounting area 14. A CO2 cylinder mating cylinder 80 is threadedly connected to the right inner wall of the intermediate cylinder 70, and a CO2 cylinder 90 is threadedly connected to the right end face of the CO2 cylinder mating cylinder 80. A connector 100 and a circular silicone pad 110 are sequentially provided between the CO2 cylinder mating cylinder 80 and the CO2 cylinder 90. The right conical surface of the connector 100 is inserted into the circular silicone pad 110, and a through hole for CO2 flow is provided between the connector 100 and the circular silicone pad 110.

[0059] The right side of the interior of the intermediate cylinder 70 has a receiving cavity 701, and the left side of the intermediate cylinder 70 near the needle mounting area 13 has a copper tube mounting passage 702.

[0060] The movable switch 120 is inserted into the intermediate cylinder 70 and includes an abutment post 121 that extends to the left through the intermediate cylinder 70 (the through portion forming a flow path and communicating with the copper pipe installation passage 702) and abuts against the lower side of the rotating stop block 60; a conical post 122 disposed to the right of the abutment post 121; and a guide post 123 disposed to the right of the conical post 122. The conical surface of the conical post 122 abuts against the inner wall of the left flow path of the receiving cavity 701 of the intermediate cylinder 70. The movable switch 120 has a closed position for closing the air passage and an open position for opening the air passage.

[0061] The reset spring 130 is disposed in the receiving cavity 701 of the intermediate cylinder 70. One end of the reset spring 130 abuts against the connector 100, and the other end is sleeved on the periphery of the guide post 123 and abuts against the flat end of the tapered post 122.

[0062] In actual use, to further ensure the sealing of the refrigeration mechanism, an O-ring is provided between the left end of the abutment column 121 and the flow path, an O-ring is provided between the CO2 cylinder mating cylinder 80 and the intermediate cylinder 70, a small silicone gasket is provided between the conical column 122 and the right end of the flow path, and an O-ring is provided between the connector 100 and the CO2 cylinder mating cylinder 80. The CO2 cylinder mating cylinder 80, connector 100, circular silicone gasket 110, and small silicone gasket are all connected and fixed to their respective areas with adhesive.

[0063] In the normal state (i.e., the refrigeration mechanism is not turned on), under the elastic force of the reset spring 130, the conical column 122 of the active switch 120 is pressed tightly against the left side of the receiving cavity 701 of the intermediate cylinder 70, the active switch 120 is in the closed position, and the air passage is in the closed state.

[0064] When the push button 40 slides towards the driven area 23 to the first trigger position, the protrusion 406 of the push button 40 drives the rotating stop 60 to rotate counterclockwise. The end of the rotating stop 60 that abuts against the movable switch 120 pushes the movable switch 120 to move towards the compression return spring 130. The conical column 122 leaves the left side of the inner cavity of the intermediate cylinder 70, and the movable switch 120 switches to the open position. The gas path is opened, and compressed CO2 gas is delivered from the flow path through the copper tube installation passage 702 and the copper tube 33 to the puncture needle 31. The puncture needle 31 utilizes the Joule-Thomson effect expansion cooling, that is, the high-pressure gas is suddenly throttled through the micro-orifice, the pressure drops sharply, the gas expands rapidly, and the tip of the probe cools down rapidly, achieving the freezing and fixation of the surrounding target object.

[0065] In specific implementation, as shown in the appendix Figure 11 To be continued Figure 15 As shown, the safety switch 50 is operably mounted on the housing 1, located between the lower housing 12 and the lower cover 22. The lower housing 12, on the side away from the gas cylinder mounting area 14, has an opening groove 16, a first limiting groove 17, and a second limiting groove 18 sequentially formed along its arc surface. The lower cover 22 also has a second through groove 26 in the area corresponding to the opening groove 16.

[0066] The safety switch 50 has an inner mounting arc surface 501, a middle limiting arc surface 502, and an outer control arc surface 503 arranged in an approximately concentric arc surface. The lower end of the outer control arc surface 503 extends downward and then bends to form an arc-shaped component of the same circle as the outer control arc surface 503, forming the inner mounting arc surface 501. The middle limiting arc surface 502 is provided between the inner mounting arc surface 501 and the outer control arc surface 503. The middle limiting arc surface 502 also includes an arc-shaped component and a connecting platform that connects with the outer control arc surface 503.

[0067] An inner mounting arc surface 501 is disposed between the lower housing 12 and the lower cover 22, and a middle limiting arc surface 502 is fitted to the outer periphery of the lower housing 12. A protrusion 504 is provided on the inner wall of the middle limiting arc surface 502 on the side away from the connecting platform.

[0068] Specifically, the safety switch 50 has a locked position and an unlocked position.

[0069] As attached Figure 14 and attached Figure 15As shown, in the locked position, the protrusion 504 is located in the first limiting groove 17. At this time, the side of the inner mounting arc surface 501 away from the opening section presses against the hook 9 in the second through groove 26 of the lower cover 22. The safety switch 50 constrains the limiting mechanism to keep it locked, and the limiting hook 93 of the hook 9 cannot disengage from the limiting plate 10, thus achieving safety locking.

[0070] As attached Figure 12 and attached Figure 13 As shown, in the unlocked position, when the safety switch 50 is pushed, the protrusion 504 leaves the first limiting groove 17 and enters the second limiting groove 18. At this time, the side of the inner mounting arc surface 501 away from the opening end leaves the second through groove 26 of the lower cover 22. The safety switch 50 releases the constraint on the limiting mechanism, and the hook 9 can be lifted by the unlocking hook 404 of the push button 40 and disengage from the limiting plate 10, allowing the release mechanism to trigger unlocking.

[0071] The connecting section between the inner mounting arc surface 501 and the outer control arc surface 503 of the safety switch 50 is slidably disposed in the opening slot 16 of the lower housing 12.

[0072] Second Embodiment The present invention also provides the working principle or process of the mechanical cryoablation biopsy needle in the first embodiment: Initial state: The rotary cutting needle 32 is locked in the proximal position (i.e., the side closest to the drive end) by the limiting hook 93 of the hook 9, which is hooked into the limiting plate 10. The elastic element 30 is in a compressed state and accumulates mechanical energy. The freezing mechanism is not turned on, and the conical column 122 of the active switch 120 closes the air passage. At this time, the operator can insert the biopsy needle to the target location.

[0073] Freezing Stage: The operator pushes the push button 40 towards the driven area 23. The push button 40 first reaches the first trigger position; specifically, the protrusion 406 of the push button 40 drives the rotating stop 60 to rotate, and the rotating stop 60 pushes the movable switch 120 to the right. The conical surface of the conical column 122 leaves the left side of the inner cavity of the intermediate cylinder 70, and the movable switch 120 switches to the open position. The gas path is opened, and compressed CO2 gas is delivered to the puncture needle 31 through the airflow passage and copper tube 33. The puncture needle 31 rapidly expands and cools using the Joule-Thomson effect, and the needle tip temperature drops sharply, producing a freezing and adhesion effect on the surrounding target object, freezing and fixing the target object to the needle tip.

[0074] During the rotary cutting stage: Push button 40 continues to move towards the driven zone 23 to the second trigger position; specifically: the unlocking hook 404 of push button 40 cooperates with the right end face of the limiting hook 93 of hook 9, pushing the limiting hook 93 outward to deflect and lift it, so that it is separated from the limiting plate 10, releasing the limiting mechanism from limiting the rotary cutting needle tube 32. The elastic element 30 releases mechanical energy, pushing the hook 9 as a whole to move towards the driven zone 23, and the hook 9 pushes the threaded part 8 to move. With the cooperation of the internal thread hole 71 of the nut fixing part 7, the threaded part 8 rotates along the axial direction of the rotary cutting needle tube 32 and moves towards the driven zone 23. Since the threaded part 8 is fixedly connected to the rotary cutting needle tube 32, the rotary cutting needle tube 32 rotates synchronously and moves axially, performing a compound rotary cutting motion of rotation and axial movement to rotary cut and sample the frozen and fixed target object.

[0075] During a single movement, the push button 40 sequentially reaches the first trigger position and the second trigger position, thus enabling the freezing mechanism to be triggered before the mechanical slicing mechanism is unlocked.

[0076] Reset / Energy Storage: After sampling, the operator slides the push button 40 towards the drive zone 24, i.e., towards the proximal end. The limiting edge 405 of the push button 40 pushes the small pusher 6 towards the drive zone 24. The small pusher 6 pushes the threaded part 8 to rotate and move to the right. Since the left side of the limiting plate 10 has a guide surface 102, the right side of the limiting hook 93 of the hook 9 can cross the limiting plate 10 along the guide surface 102 and re-hook the right side of the limiting plate 10. The elastic element 30 is recompressed, completing energy storage. The device returns to its initial state and can be operated again.

[0077] Throughout the process, when the safety switch 50 is in the unlocked position, the push button 40 can push the limit hook 93 to disengage from the limit plate 10; if the safety switch 50 is in the locked position, the limit hook 93 is pressed by the inner mounting arc surface 501 of the safety switch 50 and cannot be lifted by the push button 40, effectively preventing accidental triggering.

[0078] Third Embodiment This embodiment provides a biopsy system, including a mechanical cryoablation biopsy needle as described in the first embodiment, and a guide sheath that cooperates with the biopsy needle.

[0079] The guide sheath is a slender, hollow tubular structure with an axially extending guide channel. The inner diameter of the guide channel is matched to the outer diameter of the biopsy needle, allowing the needle to slide through the channel. The proximal end of the guide sheath has a sheath seat for easy gripping by the operator; the distal end is rounded to minimize damage to surrounding tissues. The outer wall of the guide sheath has axial depth markings to indicate the insertion depth.

[0080] In use, the operator first inserts the guide sheath near the target location, then inserts the biopsy needle through the guide channel from the proximal end of the guide sheath. The biopsy needle slides along the guide channel to the distal end and extends out, precisely reaching the target location under the guidance of the guide sheath. The biopsy needle is then operated as described in the first embodiment to complete the sampling. After sampling, the biopsy needle is withdrawn from the guide channel, and the guide sheath can be left in the body for subsequent sampling.

[0081] Finally, it should be noted that the above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A mechanical cryoablation biopsy needle, characterized in that, include: shell; A needle assembly is disposed within the housing, the needle assembly comprising a puncture needle and a rotary cutting needle tube; A freezing mechanism is disposed within the housing and communicates with the puncture needle, the freezing mechanism being configured to cool the puncture needle; A mechanical rotary cutting mechanism is disposed inside the housing and linked with the rotary cutting needle tube. The mechanical rotary cutting mechanism has an energy storage state and an energy release state. In the energy storage state, mechanical energy is stored, and in the energy release state, the mechanical energy is released to drive the rotary cutting needle tube to perform a rotary cutting action. A limiting mechanism is used to lock and maintain the mechanical rotary cutting mechanism in the energy storage state; A release mechanism is movably disposed in the housing, the release mechanism having a first trigger position and a second trigger position arranged sequentially along its moving direction; The release mechanism is configured to sequentially reach the first trigger position and the second trigger position during a single movement, and trigger the freezing mechanism to cool the puncture needle when reaching the first trigger position, and trigger the limiting mechanism to unlock the mechanical rotary cutting mechanism when reaching the second trigger position, so that the triggering of the freezing mechanism precedes the unlocking of the mechanical rotary cutting mechanism.

2. The mechanical cryoablation biopsy needle according to claim 1, characterized in that, The outer casing has a spaced-apart needle mounting area and a gas cylinder mounting area. The needle assembly and the mechanical rotary cutting mechanism are disposed in the needle mounting area, and at least a portion of the freezing mechanism is disposed in the gas cylinder mounting area. The outer shell includes an upper shell and a lower shell arranged symmetrically. Each of the upper shell and the lower shell includes half of the needle mounting area and half of the gas cylinder mounting area. The upper shell and the lower shell are structurally symmetrical and together enclose a complete installation space.

3. The mechanical cryoablation biopsy needle according to claim 2, characterized in that, The outer shell is also provided with a cover, which includes an upper cover and a lower cover arranged symmetrically to each other. The cover is divided into a driven area and a driving area along the axial direction, wherein the driven area is closer to the distal end and the driving area is closer to the proximal end. A front sleeve and a rear sleeve are fixedly provided in the driven area. A first guide groove is provided on the front sleeve from the driving area to the driven area, and a second guide groove is provided on the rear sleeve from the driving area to the driven area. A limit plate is provided at the junction of the driving area and the driven area. The limit plate is configured to cooperate with the limiting mechanism to limit the mechanical rotary cutting mechanism.

4. The mechanical cryoablation biopsy needle according to claim 3, characterized in that, The mechanical rotary cutting mechanism includes: A small pusher is slidably sleeved around the periphery of the puncture needle located in the front sleeve area, and the small pusher is slidably connected to the first guide groove; A threaded component is fixedly connected to the periphery of the rotary cutting needle tube located in the rear sleeve area, and the threaded component has external threads; A nut fastener is fixedly disposed on the side of the rear sleeve near the driven area, and the nut fastener has an internal thread hole at its center that mates with the external thread of the threaded component; An elastic element is sleeved around the periphery of the rotary cutting needle tube, with one end of the elastic element abutting against the limiting mechanism and the other end abutting against the proximal end of the cover; The threaded component is configured to rotate axially along the rotary cutting needle tube and move distally when the mechanical energy is released, pushing the small pusher and causing the rotary cutting needle tube to perform a compound rotary cutting motion of rotation and axial movement.

5. The mechanical cryoablation biopsy needle according to claim 4, characterized in that, The limiting mechanism includes: A hook is slidably fitted onto the proximal region of the rotary cutting needle tube located in the rear sleeve, the hook having a limiting hook formed by extending outward from both sides of the mounting base and bending towards the distal end; The limiting hook is configured to hook the limiting plate when the limiting mechanism is in the limiting state, so that the elastic element is kept in a compressed state to store the mechanical energy.

6. The mechanical cryoablation biopsy needle according to claim 5, characterized in that, The release mechanism includes a push button, which is slidably disposed between the outer shell and the cover, and the push button has: An unlocking part is provided at one end of the push button near the proximal end. The unlocking part is configured to cooperate with the limiting hook and push the limiting hook outward to disengage from the limiting plate when the push button slides to the second trigger position in the distal direction. The first linkage is located on the side of the push button near the gas cylinder installation area. The first linkage is configured to activate the refrigeration mechanism when the push button slides to the first trigger position in the distal direction.

7. The mechanical cryoablation biopsy needle according to claim 6, characterized in that, The push button also has a second linkage part, which is located at the end of the push button near the far end. The second linkage part is configured to push the small pusher to move towards the near end when the push button slides towards the near end, so as to drive the threaded part to rotate and reset and make the limiting hook re-hook the limiting plate, so as to re-compress the elastic part.

8. The mechanical cryoablation biopsy needle according to claim 6, characterized in that, The refrigeration mechanism includes: A gas cylinder is located within the gas cylinder installation area, and the gas cylinder is used to contain a compressed medium. An active switch is provided on the airflow passage between the gas cylinder and the puncture needle. The active switch has a closed position that closes the air passage and an open position that opens the air passage. A rotating stop is rotatably disposed in the gas cylinder installation area. One end of the rotating stop abuts against the movable switch, and the other end abuts against the first linkage part of the push button when the push button is in the first trigger position. When the push button slides to the distal end, the first linkage part drives the rotating block to rotate, and the rotating block pushes the movable switch from the closed position to the open position, so that the compressed medium is delivered to the puncture needle through the airflow passage.

9. The mechanical cryoablation biopsy needle according to claim 8, characterized in that, The needle assembly also includes a copper tube, one end of which is connected to the puncture needle, and the other end is inserted into the airflow passage in the gas cylinder installation area. The compressed medium is delivered to the puncture needle through the copper tube.

10. The mechanical cryoablation biopsy needle according to claim 6, characterized in that, It also includes a safety switch operably disposed in the housing, the safety switch having a locked position and an unlocked position. In the locked position, the safety switch constrains the limiting mechanism to remain locked, and in the unlocked position, the safety switch releases the constraint on the limiting mechanism, allowing the release mechanism to trigger unlocking.

11. The mechanical cryoablation biopsy needle according to claim 10, characterized in that, The safety switch has an inner mounting arc surface, a middle limiting arc surface, and an outer control arc surface arranged in an approximately concentric arc surface. The inner mounting arc surface is disposed between the outer shell and the cover, and the middle limiting arc surface is attached to the outer periphery of the outer shell. The middle limiting arc surface is provided with protrusions. The outer casing is provided with a first limiting groove and a second limiting groove in sequence along the sliding direction of the safety switch; In the locked position, the protrusion is located in the first limiting groove, and the inner mounting arc surface abuts against the hook to prevent the limiting hook from disengaging from the limiting plate; in the unlocked position, the protrusion is located in the second limiting groove, and the inner mounting arc surface disengages from the hook, allowing the unlocking part of the push button to push the limiting hook away from the limiting plate.

12. A biopsy system, characterized in that, include: Mechanical cryoablation biopsy needle as described in any one of claims 1-11; And a guide sheath that mates with the biopsy needle; The guide sheath has an axially extending guide channel, the inner diameter of which is adapted to the outer diameter of the biopsy needle, and the biopsy needle is slidably inserted into the guide channel.

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