Mechanical cryo-rotating biopsy needle

Abstract

The application discloses a mechanical frozen rotary cutting biopsy needle, which is characterized in that a puncture needle is connected with a freezing mechanism, a rotary cutting needle tube is arranged on the puncture needle, a mechanical rotary cutting structure is connected with the rotary cutting needle tube, a limiting mechanism is arranged, the rotary cutting needle tube is limited at a proximal end position and a pre-stored mechanical energy is formed, a releasing mechanism is further arranged and connected with the freezing mechanism and the limiting mechanism, the releasing mechanism is arranged to open the freezing mechanism and release the pre-stored mechanical energy by releasing the limitation at a first releasing position and a second releasing position respectively, and then the releasing mechanism is pushed by single stroke to realize the freezing of the peripheral tissue of the puncture needle, the pre-stored mechanical energy output by the limiting mechanism is converted into the composite rotary cutting motion of the rotary cutting needle tube by the mechanical rotary cutting mechanism to realize the rotary cutting of the frozen tissue, and the rotary cutting sampling is completed, the whole process is mechanical, no additional electric power or pneumatic power is needed, the product is miniaturized as a whole, the weight can be effectively reduced, and the operation is facilitated.

Description

Technical Field

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

[0002] Biopsy or biopsy tissue examination is an important means of diagnosing the initial progression of cancerous masses and other pathological diagnoses. Among existing biopsy techniques, the method of using cryogenic biopsy needles to sample lesions is relatively common. This generally involves using a probe attached to a liquid refrigerant for rotating cutting and sampling. The purpose of cryogenic sampling is to freeze and adsorb the lesion onto the needle core before sampling, and then cut it through the needle tube. This allows for more complete and precise tissue cutting.

[0003] A smart controlled cryogenic biopsy device (patent number CN 114224399 A) discloses a smart controlled cryogenic biopsy device. By integrating the sampling needle as a separate consumable, the biopsy instrument is mounted on the outer shell through a mounting cavity. This allows for easy replacement of the biopsy needle. When multiple lesions need to be biopsied, there is no need to repeatedly disassemble and reassemble the shell, assemble the probe, and cut the cannula, saving time and simplifying operation for medical personnel. Furthermore, this technology uses a smart robotic arm to replace manual operation. Biopsy sampling can be performed through precise robotic control, eliminating the need for manual skill. The smart robot avoids vibrations that could lead to inaccurate sampling of lesions, perfectly replacing manual biopsy puncture and improving sampling efficiency. The smart robotic arm also improves accuracy and reduces labor intensity by replacing manual labor in cryogenic biopsy sampling.

[0004] The invention discloses a rotary biopsy needle and a cold-bonded core biopsy needle assembly (patent number CN116650030 A), which includes a needle tube, a guide, and a screw. The needle tube is a straight tube structure, and the screw is inserted and fixed in the outer circumferential direction of part of the needle tube. The outer side of the screw has threads, and the guide matches the thread of the screw. The guide is movably connected to the guide thread. A cold-bonded core biopsy needle assembly includes a rotary biopsy needle, a power unit, and a needle mounting body. The needle mounting body has a tubular structure with open ends and an internal mounting cavity. The power unit is installed inside the needle mounting body, and the rotary biopsy needle is installed inside the needle mounting body. The puncture end of the rotary biopsy needle extends out of the needle mounting body. The power unit has a preset stroke in the axial direction of the rotary biopsy needle. A screw is connected to the power unit for transmission. The needle mounting body has a fixing groove, and a guide is installed in the fixing groove. While the power unit drives the needle tube to move axially, the guide acts on the screw so that the screw and the needle tube can rotate together.

[0005] However, as disclosed above, existing cryoablation biopsy needles are usually driven by electric or pneumatic power to cut and sample tissue. They are relatively large (length*width*height: approximately 270mm*50mm*100mm, excluding carbon dioxide cylinders) and each product is heavy, making it difficult for doctors to operate. Summary of the Invention

[0006] The technical problem to be solved by the present invention is to provide a mechanical cryoablation biopsy needle to solve the problem that the existing cryoablation biopsy needles are large in size and heavy in weight, making them difficult to operate.

[0007] To solve the above problems, the technical solution of the present invention is as follows:

[0008] The present invention provides a mechanical cryoablation biopsy needle for switching between puncture, cryoablation, and ablation configurations, comprising:

[0009] A puncture needle is connected to a freezing mechanism and is configured to receive and expand the compressed medium output by the freezing mechanism when it is turned on.

[0010] A rotary cutting needle tube is coaxially sleeved on the puncture needle;

[0011] A mechanical rotary cutting mechanism, wherein the output end of the mechanical rotary cutting mechanism is connected to the rotary cutting needle tube, and the mechanical rotary cutting mechanism is configured to drive the rotary cutting needle tube to rotate and move from the proximal position to the distal position under the action of pre-stored mechanical energy, forming a compound rotary cutting motion.

[0012] A limiting mechanism is configured to cooperate with the mechanical rotary cutting mechanism to limit the position at the proximal end and form the pre-stored mechanical energy;

[0013] The release mechanism is linked to the freezing mechanism and the limiting mechanism respectively. The release stroke of the release mechanism includes a first release position and a second release position distributed from the proximal end to the distal end. The first release position is configured to open the freezing mechanism by the release mechanism, and the second release position is configured to release the limiting mechanism from the rotary cutting needle tube and release the pre-stored mechanical energy by the release mechanism.

[0014] In the puncture configuration, the rotary cutting needle is limited to the proximal position by the limiting mechanism, and the freezing mechanism is not activated. In the freezing configuration, the release mechanism moves to the first release position and activates the freezing mechanism to output a compressed medium. The puncture needle receives the compressed medium and expands to freeze the tissue surrounding the puncture needle. In the rotary cutting configuration, the release mechanism moves to the second release position and releases the limiting mechanism from limiting the mechanical rotary cutting mechanism. The output end of the mechanical rotary cutting mechanism, under the action of pre-stored mechanical energy, drives the rotary cutting needle to perform a compound rotary cutting motion.

[0015] The mechanical cryoablation biopsy needle of the present invention further includes a receiving shell and an outer shell;

[0016] The outer shell is fitted onto the receiving shell and forms a sliding chamber. The release mechanism is slidably connected to the sliding chamber. At least a portion of the release mechanism extends into the receiving shell and forms a first execution end and a second execution end corresponding to the first release position and the second release position, respectively. At least a portion of the release mechanism extends out of the outer shell to form a first operating end.

[0017] The receiving shell is fitted with and connected to the puncture needle. The mechanical rotary cutting mechanism and the limiting mechanism are arranged inside the receiving shell, and at least part of the freezing mechanism and the rotary cutting needle tube are arranged inside the receiving shell.

[0018] The mechanical cryoablation biopsy needle of the present invention has a first actuating end connected to the movable opening member of the cryoablation mechanism, and a second actuating end serving as a guide unlocking end for pushing the limiting mechanism to release its limit.

[0019] The mechanical cryoablation biopsy needle of the present invention includes a cryoablation mechanism comprising a medium channel, a first elastic element, a movable opening element, and a medium source;

[0020] The medium channel is provided with a first flow channel, a closing point and a second flow channel connected in sequence, and the proximal end of the puncture needle extends into and is sealed to the first flow channel;

[0021] The movable opening element is at least partially arranged in the first flow channel, and the protruding end of the movable opening element is connected to the release mechanism. The second end of the movable opening element is pressed against the closing point by the elastic force of the first elastic element to cut off the connection between the first flow channel and the second flow channel.

[0022] The medium source is connected to and sealed within the second flow channel.

[0023] The mechanical cryoablation biopsy needle of the present invention has a movable opening member having an opening facing the distal end, and the movable opening member having a medium opening connecting the opening member to the first flow channel; the proximal end of the puncture needle extends into and is sealed in the opening member.

[0024] The mechanical cryoablation biopsy needle of the present invention includes a media channel comprising a distal cylinder, an intermediate cylinder, a mating cylinder, a reset elastic element, a closing washer, and an intermediate tube;

[0025] The distal end cylinder extends into and is sealed to the distal end of the intermediate cylinder, and the distal end cavity of the distal end cylinder and the intermediate cavity of the intermediate cylinder cooperate to form the first flow channel; the movable opening member is sealed through the distal end cavity and extends into the intermediate cavity; the reset elastic member is arranged in the intermediate cavity, and its two ends are respectively connected to the distal end cylinder and the movable opening member; the proximal end of the intermediate cavity is provided with a first connecting hole, the closing washer is arranged in the proximal end of the intermediate cavity and surrounds the connecting hole, and the movable opening member is configured to abut against the closing washer under the elastic force of the reset elastic member and cut off the communication between the first connecting hole and the intermediate cavity;

[0026] The fitting sleeve extends into and is sealed to the proximal end of the intermediate sleeve, and the fitting sleeve is provided with a second connecting hole corresponding to the first connecting hole. The intermediate tube is embedded in the first connecting hole and the second connecting hole; wherein, the proximal end of the fitting sleeve is provided with a detachable connection end for connecting the medium source.

[0027] The mechanical cryoablation biopsy needle of the present invention uses a CO2 gas cylinder as the medium source.

[0028] The mechanical cryoablation biopsy needle of the present invention includes a limiting mechanism comprising a hook and a second elastic element.

[0029] The hook is arranged coaxially with the input end of the mechanical rotary cutting mechanism, and the hook is configured to abut against the input end of the mechanical rotary cutting mechanism in the rotary cutting configuration;

[0030] The two ends of the second elastic member are respectively connected to the hook member and the receiving shell, and the receiving shell is provided with a locking block located on the proximal side of the hook member. The hook member is configured to snap onto the locking block and compress the second elastic member to form the pre-stored mechanical energy.

[0031] The mechanical cryoablation biopsy needle of the present invention includes a first sleeve, a nut fixing member, and a threaded rod;

[0032] The first sleeve is fixed inside the housing, and the nut is fixed to the first sleeve. The threaded rod extends into the first sleeve and is threaded to the nut. The threaded rod is sleeved and fixedly connected to the rotary cutting needle tube. The proximal end of the threaded rod is used to abut against the hook.

[0033] The first sleeve has a first sliding groove for slidingly connecting the hook component.

[0034] The mechanical cryoablation biopsy needle of the present invention further includes a second sleeve and a pusher in the ablation mechanism;

[0035] The second sleeve is coaxially arranged at the far end of the first sleeve, and in the rotary cutting configuration, the threaded rod extends into the second sleeve;

[0036] The pusher is slidably connected to the second sleeve, and the sleeve is provided with a second sliding groove for the pusher to be slidably connected and extended. The pusher is located at the far end of the threaded rod.

[0037] It also includes a preparation mechanism, which is slidably connected to the sliding chamber and configured to be linked to the pusher to drive the threaded rod and the hook to move toward the proximal end.

[0038] The mechanical cryoablation biopsy needle of the present invention includes an upper shell and a lower shell that are snap-fitted together.

[0039] The mechanical cryoablation biopsy needle of the present invention includes a needle tip, an inner core tube, and a ventilation tube.

[0040] The needle is installed at the distal end of the inner core tube, and the vent tube extends coaxially into the inner core tube; the rear end of the inner core tube is sealed to the freezing mechanism, and a pressure relief hole communicating with the outside is provided on the inner core tube.

[0041] Because the present invention adopts the above technical solution, it has the following advantages and positive effects compared with the prior art:

[0042] In one embodiment of the present invention, a puncture needle is connected to a freezing mechanism, and a rotary cutting needle tube is sleeved on the puncture needle. A mechanical rotary cutting structure is linked with the rotary cutting needle tube, and a limiting mechanism is set to limit the rotary cutting needle tube to the proximal position and form a pre-stored mechanical energy. Furthermore, a release mechanism is set to be linked with the freezing mechanism and the limiting mechanism. The release mechanism is set to activate the freezing mechanism and release the limiting mechanism to release the pre-stored mechanical energy at the first release position and the second release position, respectively. Then, the single-stroke push of the release mechanism realizes the freezing of the tissue around the puncture needle. Then, the mechanical rotary cutting mechanism converts the pre-stored mechanical energy output by the limiting mechanism into a compound rotary cutting motion of the rotary cutting needle tube to realize the rotary cutting of the frozen tissue, thereby completing the rotary cutting sampling. The whole process is mechanical and does not require additional electric or pneumatic power. The product is miniaturized and the weight can be effectively reduced, making it easy to operate. Attached Figure Description

[0043] Figure 1 This is a front view of the mechanical cryoablation biopsy needle of the present invention;

[0044] Figure 2 This is a schematic diagram of the mechanical cryoablation biopsy needle of the present invention;

[0045] Figure 3 This is an exploded view of the mechanical cryoablation biopsy needle of the present invention;

[0046] Figure 4 This is another exploded view of the mechanical cryoablation biopsy needle of the present invention;

[0047] Figure 5 This is a cross-sectional view of the cryotherapy mechanism of the mechanical cryoablation biopsy needle of the present invention;

[0048] Figure 6 This is a cross-sectional view of the limiting mechanism and the mechanical cutting mechanism of the mechanical cryoablation biopsy needle of the present invention;

[0049] Figure 7 This is a schematic diagram of the puncture needle of the mechanical cryoablation biopsy needle of the present invention.

[0050] Explanation of reference numerals in the attached drawings: 1. Outer shell; 2. Upper shell; 3. Lower shell; 301. Locking block; 4. Puncture needle; 401. Triangular needle tip; 402. Inner core tube; 4021. Pressure relief hole; 403. Vent tube; 404. Sleeve; 5. Rotary cutting needle tube; 6. Freezing mechanism; 601. Distal cylinder; 602. Intermediate cylinder; 603. Mating cylinder; 604. Medium source; 605. Movable opening element; 606. Embedded tube; 6 7. Intermediate tube; 608. First elastic element; 609. Closing washer; 610. Sealed chamber; 7. Connector; 8. Limiting mechanism; 801. Hook; 802. Second elastic element; 9. Mechanical rotary cutting mechanism; 901. First sleeve; 902. Nut fixing element; 903. Threaded rod; 904. Second sleeve; 905. Push element; 10. Release push button; 11. Ready push button; 12. Safety switch. Detailed Implementation

[0051] The mechanical cryoablation biopsy needle of the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. The advantages and features of the present invention will become clearer from the following description.

[0052] See Figures 1 to 7 In one embodiment, a mechanical cryoablation biopsy needle for switching between a puncture configuration, a cryoablation configuration, and an ablation configuration includes a puncture needle 4, an ablation needle tube 5, a mechanical ablation mechanism 9, a limiting mechanism 8, and a release mechanism.

[0053] The puncture needle 4 is connected to the freezing mechanism 6, and is configured to receive the compressed medium output by the freezing mechanism 6 and expand it for cooling. The rotary cutting needle tube 5 is coaxially sleeved on the puncture needle 4.

[0054] The output end of the mechanical rotary cutting mechanism 9 is connected to the rotary cutting needle tube 5, and the mechanical rotary cutting mechanism 9 is configured to drive the rotary cutting needle tube 5 to rotate and move from the proximal position to the distal position under the action of pre-stored mechanical energy, forming a compound rotary cutting motion (the proximal position is the end closer to the operator, and the distal position is the end farther away from the operator). The limiting mechanism 8 is configured to cooperate with the mechanical rotary cutting mechanism 9 to limit it to the proximal position and form pre-stored mechanical energy.

[0055] The release mechanism is linked to the freezing mechanism 6 and the limiting mechanism 8 respectively. The release stroke of the release mechanism includes a first release position and a second release position distributed from the proximal end to the distal end. The first release position is configured to open the freezing mechanism 6 by the release mechanism, and the second release position is configured to release the limiting mechanism 8 from limiting the rotary cutting needle tube 5 and release the pre-stored mechanical energy by the release mechanism.

[0056] In the puncture configuration, the rotary cutting needle 5 is limited to the proximal position by the limiting mechanism 8, and the freezing mechanism 6 is not activated. In the freezing configuration, the release mechanism moves to the first release position and activates the freezing mechanism 6 to output the compressed medium. The puncture needle 4 receives the compressed medium and expands to freeze the tissue surrounding the puncture needle 4. In the rotary cutting configuration, the release mechanism moves to the second release position and releases the limiting mechanism 8 from the mechanical rotary cutting mechanism 9. The output end of the mechanical rotary cutting mechanism 9, under the action of pre-stored mechanical energy, drives the rotary cutting needle 5 to perform a compound rotary cutting motion.

[0057] In this embodiment, the puncture needle 4 is connected to the freezing mechanism 6, and a rotary cutting needle tube 5 is sleeved on the puncture needle 4. The mechanical rotary cutting structure is linked with the rotary cutting needle tube 5. A limiting mechanism 8 is set to limit the rotary cutting needle tube 5 to the proximal position and form a pre-stored mechanical energy. Furthermore, a release mechanism linked with the freezing mechanism 6 and the limiting mechanism 8 is set. The release mechanism is set to open the freezing mechanism 6 and release the limiting mechanism to release the pre-stored mechanical energy at the first release position and the second release position, respectively. Then, the single-stroke push of the release mechanism realizes the freezing of the tissue around the puncture needle 4. Then, the mechanical rotary cutting mechanism 9 converts the pre-stored mechanical energy output by the limiting mechanism 8 into the compound rotary cutting motion of the rotary cutting needle tube 5 to realize the rotary cutting of the frozen tissue, thereby completing the rotary cutting sampling. The whole process is mechanical and does not require additional electric or pneumatic power. The product is miniaturized and the weight can be effectively reduced, making it easy to operate.

[0058] The specific structure of the mechanical cryoablation biopsy needle in this embodiment will be further explained below:

[0059] In this embodiment, the mechanical cryoablation biopsy needle may further include a housing and an outer shell 1.

[0060] The outer shell 1 is fitted onto the receiving shell and forms a sliding chamber. The release mechanism is slidably connected to the sliding chamber. At least a portion of the release mechanism extends into the receiving shell and forms a first actuating end and a second actuating end corresponding to the first release position and the second release position, respectively. At least a portion of the release mechanism extends out of the outer shell 1 to form a first operating end. The receiving shell is fitted onto and connected to the puncture needle 4. The mechanical rotary cutting mechanism 9 and the limiting mechanism 8 are arranged inside the receiving shell. At least a portion of the freezing mechanism 6 and the rotary cutting needle tube 5 are arranged inside the receiving shell.

[0061] The accommodating shell mainly houses the puncture needle 4 and related structures for freezing and mechanical cutting, while the outer shell 1 is a sliding chamber fitted inside the accommodating cavity to form between the two (the sliding chamber can be formed by setting the top of the accommodating shell as a plane, and the gap between the plane and the outer shell 1). It is used to install a release mechanism for user operation. The release mechanism is linked with the freezing mechanism 6 and the limiting mechanism 8 in the sliding chamber, and the release mechanism also extends out of the outer shell 1 for easy operation.

[0062] Furthermore, the housing can be specifically divided into an upper shell 2 and a lower shell 3, which are connected by a snap-fit ​​mechanism. The upper shell 2 and the lower shell 3 are fixed to the outer shell 1 by several protrusions on their surfaces.

[0063] In this embodiment, the first actuating end is connected to the movable opening member 605 of the freezing mechanism 6, and the second actuating end is a guide unlocking end that pushes the limiting mechanism 8 to release the limit. Specifically, the release mechanism can be a release push button 10. The part of the release push button 10 located in the aforementioned sliding cavity can be configured to be directly connected to the opening end of the freezing mechanism 6, that is, when the release push button 10 slides, it directly drives the opening end of the freezing mechanism 6 to move forward; and the front end of the release push button 10 in the sliding cavity can be configured to have a guiding slope, which is used to press forward against the limiting mechanism 8 and push the limiting mechanism 8 to move or deform to both sides to release the limit.

[0064] In this embodiment, the aforementioned freezing mechanism 6 may specifically include a medium channel, a first elastic element 608 (specifically a spring), a movable opening element 605, and a medium source 604.

[0065] The medium channel is provided with a first flow channel, a closing point, and a second flow channel connected in sequence. The proximal end of the puncture needle 4 extends into and is sealed to the first flow channel. A movable opening member 605 is at least partially arranged in the first flow channel, and the protruding end of the movable opening member 605 is connected to a release mechanism (i.e., connected to the release push button 10). The second end of the movable opening member 605 is pressed against the closing point by the elastic force of the first elastic member 608 to cut off the connection between the first flow channel and the second flow channel (the elastic force applied by the first elastic member is directed towards the proximal end, opposite to the opening direction). The medium source 604 is connected to and sealed in the second flow channel, wherein the medium source 604 may specifically be a CO2 gas cylinder. In the closed state, the second flow channel is under high pressure. When the push button 10 is released, the movable opening part 605 overcomes the elastic force and moves away from the closed position, the first flow channel and the second flow channel are connected. The high-pressure CO2 can then enter the puncture needle 4 through the first flow channel. It rapidly expands and cools at the needle tip (Joule-Thomson effect), instantly freezing and fixing the target tissue into an "ice ball", while also stopping bleeding and reducing pain.

[0066] Furthermore, the movable opening member 605 has an opening facing the distal end, and the movable opening member 605 has a medium opening connecting the opening and the first flow channel. The proximal end of the puncture needle 4 extends into and is sealed in the opening. That is, the movable opening member 605 is a hollow tube with an opening at the front end (i.e., the opening is located at the distal end), and the medium opening is provided on the rear side wall of the hollow tube to communicate with the first flow channel (i.e., the medium opening is located at the proximal end), thereby allowing high-pressure CO2 to enter the opening of the movable opening member 605 and then enter the puncture needle 4.

[0067] Specifically, the aforementioned medium channel may include a distal cylinder 601, an intermediate cylinder 602, a mating cylinder 603, a reset elastic element, a closing washer 609 (which may specifically be an annular silicone segment), and an intermediate tube 607. The distal cylinder 601 extends into and is sealed to the distal end of the intermediate cylinder 602, and the distal inner cavity of the distal cylinder 601 and the intermediate inner cavity of the intermediate cylinder 602 cooperate to form a first flow channel. A movable opening element 605 is sealed through the distal inner cavity and extends into the intermediate inner cavity. The reset elastic element is arranged in the intermediate inner cavity, and its two ends are respectively connected to the distal cylinder 601 and the movable opening element 605 (the reset elastic element may specifically be a reset spring). A first connecting hole is provided at the proximal end of the intermediate inner cavity. The closing washer 609 is arranged at the proximal end of the intermediate inner cavity and surrounds the connecting hole. The movable opening element 605 is configured to abut against the closing washer 609 under the elastic force of the reset elastic element and cut off the communication between the first connecting hole and the intermediate inner cavity.

[0068] The mating cylinder 603 extends into and is sealed to the proximal end of the intermediate cylinder 602, and the mating cylinder 603 is provided with a second connecting hole corresponding to the first connecting hole. The intermediate tube 607 is embedded in the first connecting hole and the second connecting hole. The proximal end of the mating cylinder 603 is provided with a detachable connection end for connecting the medium source 604.

[0069] Furthermore, the proximal end of the distal cylinder 601 can be configured to be threaded to the distal end of the intermediate cylinder 602 via an external thread, and a sealing groove can be provided between the proximal stepped surface of the distal cylinder 601 and the distal end face of the intermediate cylinder 602, with a sealing ring installed in the sealing groove for sealing. Specifically, the distal end of the distal cylinder 601 can be expanded outward to form an installation groove based on the distal inner cavity, and further provided with an embedded tube 606, which is embedded in the installation groove. A sealing groove is provided between the outer ring of the embedded tube 606 and the inner wall of the installation groove, and a sealing ring is installed therein. A sealing groove is also provided on the inner ring of the embedded tube 606, with a sealing ring installed in the sealing groove, for sealing the embedded tube 606 and the inserted puncture needle 4.

[0070] Furthermore, the distal end of the embedded tube 606 can be configured to extend out of the mounting groove and be embedded into a connector 7, which is fixedly assembled to the lower shell 3 or the upper shell 2, and the connector 7 is provided with a clearance hole for the puncture needle 4, thereby fixing the relative position of the embedded tube 606 and the insertion of the puncture needle 4 during the production process.

[0071] Similarly, the distal end of the mating cylinder 603 can be configured to be threaded to the proximal end of the intermediate cylinder 602 via an external thread. A sealing groove can be provided between the distal end face of the distal cylinder 601 and the proximal end face of the intermediate cylinder 602, and a sealing ring is provided in the sealing groove for sealing. This connection forms a sealed chamber 610 located between the intermediate cylinder 602 and the distal end of the mating cylinder 603. The proximal end of the mating cylinder 603 can also be provided with an internal thread, and a sealing ring can be provided at the distal end of the internal thread for threaded installation of the medium source 604 and compression of the sealing ring to achieve sealing.

[0072] The intermediate tube 607 can be a copper tube, which is fixed to the second connecting hole of the mating cylinder 603 by welding. The distal end of the copper tube passes through the aforementioned sealed chamber 610 and extends into the first connecting hole.

[0073] In this embodiment, the aforementioned limiting mechanism 8 may specifically include a hook 801 and a second elastic element 802 (specifically, a spring). The hook 801 is coaxially arranged with the input end of the mechanical rotary cutting mechanism 9, and the hook 801 is configured to abut against the input end of the mechanical rotary cutting mechanism 9 in the rotary cutting configuration.

[0074] The two ends of the second elastic member 802 are respectively connected to the hook member 801 and the receiving shell, and the receiving shell is provided with a locking block 301 located on the proximal side of the hook member 801. The hook member 801 is configured to snap onto the locking block 301 and compress the second elastic member 802 to form pre-stored mechanical energy. Specifically, the hook member 801 may be provided with two hooks located on both sides, and the receiving shell may be provided with corresponding locking blocks 301. During the process of the hook engaging, the hook abuts against the locking block 301 through its engagement slope to form a force toward both sides, and moves or deforms to both sides and passes over the locking block 301, resets and completes the engagement. The locking block 301 may be specifically provided on the lower shell 3; when the limit is released, the aforementioned guide slope cooperates with the engagement slope on the locking block 301 to realize the outward movement of the locking block 301 toward both sides and the movement toward the far end.

[0075] In this embodiment, the mechanical rotary cutting mechanism 9 may specifically include a first sleeve 901, a nut fixing member 902, and a threaded rod 903. The first sleeve 901 is fixed inside the accommodating shell (specifically, this can be achieved by setting a rib on the outer ring of the first sleeve 901 and setting corresponding recesses on the inner wall surfaces of the upper shell 2 and the lower shell 3, thereby fixing the relative position of the first sleeve 901 through an embedded method), and the nut fixing member 902 is fixed to the first sleeve 901. The threaded rod 903 extends into the first sleeve 901 and is threadedly connected to the nut fixing member 902, and the threaded rod 903 is sleeved and fixedly connected to the rotary cutting needle tube 5. The proximal end of the threaded rod 903 is used to abut against the hook member 801. The first sleeve 901 has a first sliding groove for slidingly connecting the hook member 801, thereby realizing the internal embedment of the hook member 801 and shortening the overall length.

[0076] Furthermore, through the threaded engagement between the nut fixing part 902 and the threaded rod 903, the axial movement of the hook part 801 output to the threaded rod 903 can be transformed into a compound rotary cutting motion of the axial movement and circumferential rotation of the rotary cutting needle tube 5 on it.

[0077] In this embodiment, the rotary cutting mechanism further includes a second sleeve 904 and a pusher 905. The second sleeve 904 is coaxially arranged at the distal end of the first sleeve 901, and in the rotary cutting configuration, the threaded rod 903 extends into the second sleeve 904. The pusher 905 is slidably connected to the second sleeve 904, and the sleeve is provided with a second sliding groove for the pusher 905 to slide and extend. The pusher 905 is located at the distal end of the threaded rod 903.

[0078] By moving the pusher 905 toward the near end, the threaded rod 903 and the hook 801 can be moved toward the near end simultaneously, achieving a second limiting, i.e., resetting. The second sleeve 904 can also be fixed in relative position through its ribs and the recesses on the inner walls of the upper and lower shells.

[0079] It may also include a preparation mechanism slidably connected to the sliding chamber and configured to be linked to the pusher 905 to move the threaded rod 903 and the latch 801 toward the proximal end. This preparation mechanism may be a preparation push button 11, located at the distal end of the release push button 10, extending into and connected to the pusher 905. By pushing the preparation push button 11 backward, the operator can cause the latch 801 to be confined to the latch block 301, compressing and pre-storing the elastic force of the second elastic element 802 (i.e., achieving the winding operation).

[0080] In this embodiment, the puncture needle 4 may specifically include a needle tip, an inner core tube 402, and a vent tube 403. The needle tip is mounted at the distal end of the inner core tube 402, and the vent tube 403 extends coaxially into the inner core tube 402, forming an air vent gap between the vent tube 403 and the inner core tube 402. The rear end of the inner core tube 402 is sealed to the freezing mechanism 6, and a pressure relief hole 4021 communicating with the outside is provided on the inner core tube 402. The needle tip may be a triangular pillow, which is fixed to the inner core tube 402 by laser welding. The inner core tube 402 is fixed to the lower shell 3 by adhesive dispensing, and the rotary cutting needle tube 5 is fixed to the threaded rod 903 by adhesive dispensing or injection molding. A sleeve 404 may also be included, which is arranged between the inner core tube 402 and the rotary cutting needle tube 5 and fixed to the lower shell 3 by adhesive dispensing.

[0081] In this embodiment, a safety switch 12 may also be included. The safety switch 12 is movably mounted on the housing 1 and is used to limit the forward movement of the release push button 10. When a freeze-slicing operation is required, the safety switch 12 is opened first, and then the release push button 10 is pushed.

[0082] The working principle of the mechanical cryoablation biopsy needle in this embodiment is as follows: the compressed gas rapidly expands and cools at the needle tip (Joule-Thomson effect), instantly freezing and fixing the target tissue into an "ice ball", which also has the effects of hemostasis and pain reduction. Then, in the frozen and fixed state, the target tissue is completely and in large pieces cut off by the high-speed rotating sharp cutting needle tube 5 and safely removed.

[0083] The working process of the mechanical cryoablation biopsy needle in this embodiment is as follows:

[0084] 1. First, screw the CO2 cylinder into the fitting cylinder 603 until it reaches the bottom and can no longer be turned. The purpose is to open the mouth of the CO2 cylinder through the copper tube so that CO2 can enter the sealed chamber 610 mentioned above.

[0085] 2. Push the preparation button 11 backward until you hear a "click" sound. The purpose of this is to wind the syringe.

[0086] 3. Rotate the safety switch 12 clockwise to put the product into the safety position;

[0087] 4. Guided by ultrasound, X-ray, or other imaging techniques, the product is inserted into the target tissue.

[0088] 5. Turn on the safety switch 12 and slowly push the release button 10 forward until the needle is fired to cut the tissue. During the process of pushing the release button 10 forward, the release button 10 first opens the movable opening part 605, and CO2 is sent to the triangular needle tip 401 through the first connecting hole, the first flow channel, and the air tube 403, so that the tissue in contact with the needle tip is frozen quickly. The release button 10 continues to be pushed forward, and the hook part 801 is pushed open. Under the action of the spring, the rotary cutting needle 5 cuts and samples the target tissue.

[0089] 6. After the rotary cutting is completed, remove the entire product from the body and push the preparation button 11 backward to wind the needle. Since the tissue sample is frozen and fixed to the needle tip, the needle will not fall off during the winding process.

[0090] 7. Remove the obtained cylindrical frozen tissue sample from the needle, place it in the preservation solution, and send it for testing.

[0091] This embodiment of the mechanical cryoablation biopsy needle employs a mechanical winding and firing mechanism. The overall design is compact, and to achieve a CO2 gas seal, the CO2 sealing component is made of metal and sealed with a sealing ring. The overall size of the cryoablation biopsy needle is reduced, making it more convenient and easier for doctors to use. Furthermore, the product is more economical, with lower costs compared to electric / pneumatic solutions.

[0092] In other embodiments, the winding operation can also be carried out by adding a motor for electric winding, but this will increase the cost and size of the product accordingly.

[0093] The embodiments of the present invention have been described in detail above with reference to the accompanying drawings, but the present invention is not limited to the above embodiments. Even if various changes are made to the present invention, if these changes fall within the scope of the claims of the present invention and their equivalents, they shall still fall within the protection scope of the present invention.

Claims

1. A mechanical cryo-rotating biopsy needle, characterized in that, Used for switching between puncture, cryoablation, and rotary cutting configurations, including: A puncture needle is connected to a freezing mechanism and is configured to receive and expand the compressed medium output by the freezing mechanism when it is turned on. A rotary cutting needle tube is coaxially sleeved on the puncture needle; A mechanical rotary cutting mechanism, wherein the output end of the mechanical rotary cutting mechanism is connected to the rotary cutting needle tube, and the mechanical rotary cutting mechanism is configured to drive the rotary cutting needle tube to rotate and move from the proximal position to the distal position under the action of pre-stored mechanical energy, forming a compound rotary cutting motion. A limiting mechanism is configured to cooperate with the mechanical rotary cutting mechanism to limit the position at the proximal end and form the pre-stored mechanical energy; The release mechanism is linked to the freezing mechanism and the limiting mechanism respectively. The release stroke of the release mechanism includes a first release position and a second release position distributed from the proximal end to the distal end. The first release position is configured to open the freezing mechanism by the release mechanism, and the second release position is configured to release the limiting mechanism from the rotary cutting needle tube and release the pre-stored mechanical energy by the release mechanism. In the puncture configuration, the rotary cutting needle is limited to the proximal position by the limiting mechanism, and the freezing mechanism is not activated. In the freezing configuration, the release mechanism moves to the first release position and activates the freezing mechanism to output a compressed medium. The puncture needle receives the compressed medium and expands to freeze the tissue surrounding the puncture needle. In the rotary cutting configuration, the release mechanism moves to the second release position and releases the limiting mechanism from limiting the mechanical rotary cutting mechanism. The output end of the mechanical rotary cutting mechanism, under the action of pre-stored mechanical energy, drives the rotary cutting needle to perform a compound rotary cutting motion.

2. The mechanical cryoablation biopsy needle as described in claim 1, characterized in that, It also includes the housing and the outer shell; The outer shell is fitted onto the receiving shell and forms a sliding chamber. The release mechanism is slidably connected to the sliding chamber. At least a portion of the release mechanism extends into the receiving shell and forms a first execution end and a second execution end corresponding to the first release position and the second release position, respectively. At least a portion of the release mechanism extends out of the outer shell to form a first operating end. The receiving shell is fitted with and connected to the puncture needle. The mechanical rotary cutting mechanism and the limiting mechanism are arranged inside the receiving shell, and at least part of the freezing mechanism and the rotary cutting needle tube are arranged inside the receiving shell.

3. The mechanical refrigeration rotary biopsy needle of claim 2 wherein, The first actuator is connected to the movable opening component of the refrigeration mechanism, and the second actuator is a guide unlocking end that pushes the limiting mechanism to release its limit.

4. The mechanical refrigeration rotary biopsy needle of claim 1 wherein, The freezing mechanism includes a medium channel, a first elastic element, a movable opening element, and a medium source; The medium channel is provided with a first flow channel, a closing point and a second flow channel connected in sequence, and the proximal end of the puncture needle extends into and is sealed to the first flow channel; The movable opening element is at least partially arranged in the first flow channel, and the protruding end of the movable opening element is connected to the release mechanism. The second end of the movable opening element is pressed against the closing point by the elastic force of the first elastic element to cut off the connection between the first flow channel and the second flow channel. The medium source is connected to and sealed within the second flow channel.

5. The mechanical refrigeration rotary biopsy needle of claim 4 wherein, The movable opening member has an opening facing the distal end, and the movable opening member has a medium opening connecting the opening and the first flow channel; the proximal end of the puncture needle extends into and is sealed in the opening.

6. The mechanical refrigeration rotary biopsy needle of claim 4 wherein, The medium channel includes a distal cylinder, an intermediate cylinder, a mating cylinder, a reset elastic element, a closing washer, and an intermediate tube; The distal end cylinder extends into and is sealed to the distal end of the intermediate cylinder, and the distal end cavity of the distal end cylinder and the intermediate cavity of the intermediate cylinder cooperate to form the first flow channel; the movable opening member is sealed through the distal end cavity and extends into the intermediate cavity; the reset elastic member is arranged in the intermediate cavity, and its two ends are respectively connected to the distal end cylinder and the movable opening member; the proximal end of the intermediate cavity is provided with a first connecting hole, the closing washer is arranged in the proximal end of the intermediate cavity and surrounds the connecting hole, and the movable opening member is configured to abut against the closing washer under the elastic force of the reset elastic member and cut off the communication between the first connecting hole and the intermediate cavity; The fitting sleeve extends into and is sealed to the proximal end of the intermediate sleeve, and the fitting sleeve is provided with a second connecting hole corresponding to the first connecting hole. The intermediate tube is embedded in the first connecting hole and the second connecting hole; wherein, the proximal end of the fitting sleeve is provided with a detachable connection end for connecting the medium source.

7. The mechanical refrigeration rotary biopsy needle of claim 4 wherein, The medium source is a CO2 gas cylinder.

8. The mechanical cryoablation biopsy needle as described in claim 2, characterized in that, The limiting mechanism includes a hook and a second elastic element; The hook is arranged coaxially with the input end of the mechanical rotary cutting mechanism, and the hook is configured to abut against the input end of the mechanical rotary cutting mechanism in the rotary cutting configuration; The two ends of the second elastic member are respectively connected to the hook member and the receiving shell, and the receiving shell is provided with a locking block located on the proximal side of the hook member. The hook member is configured to snap onto the locking block and compress the second elastic member to form the pre-stored mechanical energy.

9. The mechanical refrigeration rotary biopsy needle of claim 8 wherein, The mechanical rotary cutting mechanism includes a first sleeve, a nut fixing component, and a threaded rod; The first sleeve is fixed inside the housing, and the nut is fixed to the first sleeve. The threaded rod extends into the first sleeve and is threaded to the nut. The threaded rod is sleeved and fixedly connected to the rotary cutting needle tube. The proximal end of the threaded rod is used to abut against the hook. The first sleeve has a first sliding groove for slidingly connecting the hook component.

10. The mechanical refrigeration rotary-cut biopsy needle of claim 9 wherein, The rotary cutting mechanism also includes a second sleeve and a pusher; The second sleeve is coaxially arranged at the far end of the first sleeve, and in the rotary cutting configuration, the threaded rod extends into the second sleeve; The pusher is slidably connected to the second sleeve, and the sleeve is provided with a second sliding groove for the pusher to be slidably connected and extended. The pusher is located at the far end of the threaded rod. It also includes a preparation mechanism, which is slidably connected to the sliding chamber and configured to be linked to the pusher to drive the threaded rod and the hook to move toward the proximal end.

11. The mechanical refrigeration rotary biopsy needle of claim 2 wherein, The housing includes an upper shell and a lower shell that are snap-fitted together.

12. The mechanical refrigeration rotary-cut biopsy needle of claim 1 wherein, The puncture needle includes a needle tip, an inner core tube, and a ventilation tube; The needle is installed at the distal end of the inner core tube, and the vent tube extends coaxially into the inner core tube; the rear end of the inner core tube is sealed to the freezing mechanism, and a pressure relief hole communicating with the outside is provided on the inner core tube.

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