A minimally invasive puncture biopsy and resection device for pulmonary nodules

Abstract

The present application relates to a minimally invasive puncture biopsy and excision device for lung nodules, and relates to the technical field of medical devices, which includes a mechanical arm electrically connected to a CT device, a navigation auxiliary device, a puncture assembly for puncturing human tissues detachably connected to the mechanical arm, a sampling assembly for sampling tissues at the nodules, and a marking assembly for marking the sampling site; the puncture assembly includes a mounting seat detachably connected to the mechanical arm, a puncture needle arranged on the mounting seat, and the end of the puncture needle is sharp; the puncture needle is hollow, and the sampling assembly includes a rotary cutting cylinder rotatably arranged in the puncture needle and a power member driving the rotary cutting cylinder to rotate, the puncture needle is provided with a first rotary cutting opening, and the rotary cutting cylinder is provided with a second rotary cutting opening, and the first rotary cutting opening corresponds to the second rotary cutting opening. The present application has the effect of facilitating the increase of the sampling amount of each biopsy sampling, reducing the number of puncture samplings and reducing the radiation dose.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and in particular to a device for minimally invasive puncture biopsy and resection of pulmonary nodules. Background Technology

[0002] Pulmonary nodules are round or irregular lesions less than 3 cm in diameter that appear in the lungs due to environmental factors, smoking, or occupational factors. In the early stages, pulmonary nodules may be small and not compress surrounding tissues, having little impact on lung structure and function, so they are often asymptomatic. However, pulmonary nodules are classified as benign or malignant. Benign pulmonary nodules can be treated conservatively with medication or observation, while malignant pulmonary nodules tend to grow significantly in a short period, compressing lung tissue and causing symptoms such as persistent cough, hemoptysis, and chest pain, which can subsequently affect the patient's lifespan. Since pulmonary nodules can only be observed via CT scans in the early stages, and it is difficult to directly determine their benign or malignant nature based on appearance alone, biopsies are usually performed to obtain samples for testing to determine the benign or malignant nature of the nodule, allowing for targeted treatment based on the results.

[0003] When performing biopsies on lung nodules, medical staff typically use biopsy needles. Common biopsy needles include puncture needles and sampling needles coaxially positioned within the puncture needle. The puncture needle has a sharp, open tip, while the sampling needle moves through the tip. The sidewall of the sampling needle is barbed. When sampling a lung nodule, the doctor first inserts the puncture needle into the body and uses a CT scan to determine if the needle tip has reached the nodule. Then, the technician slides the puncture needle to extend it beyond the needle tip, positioning the barbed portion at the nodule. The sampling needle is then withdrawn, at which point the barbed portion removes the tissue from the nodule and is retrieved from the cavity within the sampling needle, completing the sampling process.

[0004] Regarding the aforementioned techniques, since puncture is often performed manually by the doctor, it is difficult to locate small pulmonary nodules (<10 mm in diameter), pure ground-glass nodules, or subsolid nodules that are far from the visceral pleura (>15 mm) during surgery. Furthermore, it is difficult to accurately control the puncture angle during manual puncture. When performing puncture sampling, it is not easy to accurately sample tissue from the nodule through the sampling needle. Tissue sampled from the barb often involves normal tissue. If the nodule tissue does not meet the testing standards during subsequent testing, multiple punctures and samplings are required, which causes significant pain to the patient and can easily lead to pneumothorax and bleeding. Summary of the Invention

[0005] In order to facilitate increasing the sample volume of each biopsy, reduce the number of punctures, and reduce the radiation dose, this application provides a minimally invasive puncture biopsy resection device for lung nodules.

[0006] The minimally invasive puncture biopsy and resection device for lung nodules provided in this application adopts the following technical solution:

[0007] A minimally invasive puncture biopsy and resection device for pulmonary nodules includes a robotic arm electrically connected to a CT scanner, a puncture assembly detachably connected to the robotic arm for performing human tissue puncture, a sampling assembly for sampling tissue from the nodule, and a marking assembly for marking the sampling site. The puncture assembly includes a mounting base detachably connected to the robotic arm and a puncture needle mounted on the mounting base, the tip of which is pointed. The puncture needle is hollow. The sampling assembly includes a rotary cutting cylinder rotatably disposed within the puncture needle and a power component for driving the rotary cutting cylinder to rotate. The puncture needle has a first rotary incision, and the rotary cutting cylinder has a second rotary incision, with the first and second rotary incisions corresponding movably. The rotary cutting cylinder has a marking cavity containing a sealing material, and the rotary cutting cylinder also has a third connecting port, which corresponds movably to the first rotary incision. The second rotary incision, the third connecting port, and the first rotary incision can be selectively movably matched. The mounting base also has a switching component that allows the first rotary incision to be switched to the second rotary incision or the third connecting port.

[0008] By adopting the above technical solution, the navigation aid can be either an optical navigation aid or a magnetic navigation aid. When the navigation aid is a magnetic navigation aid, during the biopsy sampling of lung nodules, a magnetic pole marker is first properly placed on the patient's body surface as a spatial positioning reference point. Subsequently, a comprehensive scan of the human body is performed using computed tomography (CT) technology to obtain detailed anatomical image information. Based on this image data, computer-aided three-dimensional reconstruction technology and the magnetic navigation aid are used to accurately simulate and plan the puncture path required for nodule biopsy. In this process, the puncture needle is regarded as the probe element of the magnetic navigation system, and the robotic arm controls the mounting base and the puncture needle to perform guided puncture operations according to the pre-constructed puncture path.

[0009] When the navigation aid is an optical navigation aid, displacement sensors and optical sensors need to be installed on the robotic arm. First, a comprehensive scan of the human body is still performed using computed tomography (CT) technology to obtain detailed anatomical images. Based on these image data, the puncture path required for nodule biopsy is simulated and planned using computer-aided 3D reconstruction technology. Then, the travel path of the puncture needle is simulated using data transmitted from the displacement sensors and optical sensors on the robotic arm, and thus represented in the form of images.

[0010] This process requires ensuring that the puncture needle travels precisely along the planned path until its tip accurately reaches the target location of the lung nodule, thereby completing the precise execution of the biopsy. By combining the puncture needle with CT equipment, the puncture path can be made more precise, reducing human error.

[0011] It should be noted that, regardless of the navigation-assisted device used, when the puncture needle reaches near the nodule, the doctor needs to use a CT scanner to reconstruct the image and ask the patient to hold their breath to ensure the lungs remain relatively static before performing the final puncture and sampling, thus ensuring the accuracy of the puncture and sampling.

[0012] Driven by a power component, the rotary cutting cylinder rotates. Through the correspondence and separation of the first and second rotary cutting ports, human tissue, with its inherent elasticity, enters the first rotary cutting port of the puncture needle. The rotating cylinder then cuts and samples the tissue that has entered the first rotary cutting port. This rotary cutting sampling method improves sampling efficiency. When a large number of samples are needed, multiple needle insertions are not required, reducing the pain caused by multiple needle insertions.

[0013] Meanwhile, by using the marked cavity and the sealing material inside the marked cavity, after the tissue is excised and sampled, the sealing material is used to seal the tissue excision site, reducing the occurrence of pneumothorax and also reducing complications such as puncture bleeding and infection.

[0014] Furthermore, when it is necessary to seal the sampling site and puncture site, there is no need for a second needle insertion. The switching component connects the third connecting port with the first rotary incision, allowing the sealing material to enter the rotary incision from the first rotary incision for sealing. This reduces the complexity of puncture and sealing operations, thereby improving surgical efficiency.

[0015] Optionally, the power component includes a rotating cylinder disposed inside the puncture needle, the outer peripheral wall of the rotating cylinder having a wave-shaped groove, a limiting cylinder being rotatably and slidably disposed inside the puncture needle, the limiting cylinder being connected to the rotary cutting cylinder, a rotating output component being disposed on the mounting base and connected to the limiting cylinder, and a locking block being disposed on the inner peripheral wall of the limiting cylinder, the locking block being slidably adapted to the groove.

[0016] By adopting the above technical solution, a rotating output component drives the limiting cylinder to rotate, which in turn drives the rotary cutting cylinder to rotate, thus rotary cutting the tissue entering the first and second rotary cutting openings. Simultaneously, a wave-shaped groove is formed on the outer peripheral wall of the rotating cylinder. During the rotary cutting process, the rotary cutting cylinder both rotates and slides along the length of the puncture needle. When the locking block aligns with the trough of the groove, the first and second rotary cutting openings are perfectly aligned. When the locking block aligns with the trough of the groove, the first and second rotary cutting openings are not perfectly aligned. This facilitates subsequent aspiration of the cut tissue using negative pressure, while reducing the impact of negative pressure on the surrounding normal tissue and improving sampling accuracy.

[0017] Optionally, the mounting base is connected to a first negative pressure tube and a second positive pressure tube. A dividing tube is coaxially provided inside the rotating cylinder. The dividing tube divides the rotating cylinder into a first negative pressure cavity and a second positive pressure cavity. The first negative pressure tube is connected to the first negative pressure cavity, and the second positive pressure tube is connected to the second positive pressure cavity. The first negative pressure tube is used to provide negative pressure to the first negative pressure cavity, and the second positive pressure tube is used to provide positive pressure to the second positive pressure cavity. The second positive pressure cavity is located inside the dividing tube, and the first negative pressure cavity is located between the dividing tube and the rotating cylinder. The rotary cutting cylinder is provided with multiple sets of rotary cutting blades. The rotary cutting blades are spaced apart along the circumference of the rotary cutting cylinder. The cavity enclosed between two adjacent sets of rotary cutting blades is connected to the first negative pressure cavity. The end of the rotary cutting blade away from the mounting base and the puncture needle enclose a marking cavity. The sealing material is located in the marking cavity, and the marking cavity is connected to the second positive pressure cavity.

[0018] By adopting the above technical solution, through the first negative pressure cavity and the second negative pressure cavity, when tissue rotary cutting sampling is performed, the first negative pressure tube provides negative pressure towards the first negative pressure cavity. At this time, the rotary cutting blade cuts and samples the tissue entering the first rotary cutting opening relative to the side wall of the puncture needle. At the same time, during the process of the rotary cutting cylinder moving towards the mounting base, the second rotary cutting opening is not completely connected to the first rotary cutting opening. The negative pressure component in the first negative pressure tube collects the rotary-cut tissue under negative pressure, while reducing the impact of negative pressure on the surrounding normal tissue.

[0019] Meanwhile, by setting up multiple sets of rotary cutting blades, multiple samples can be taken with each rotation of the rotary cutting cylinder during the process of cutting the tissue, thereby improving sampling efficiency, shortening operation time, and reducing complications caused by operation time.

[0020] After the tissue biopsy is completed, the switching component slides the marking cavity to a position connected to the first rotary incision. At this time, positive pressure is generated in the second positive pressure cavity through the second positive pressure tube, which squeezes the sealing material in the marking cavity toward the position of the first rotary incision, thereby sealing the rotary incision site and the puncture site, thus achieving the effect of hemostasis and reducing pneumothorax.

[0021] Optionally, the sealing material is a medical polylactic acid ball, one end of which is connected to a marking line, which is a polydioxanone absorbable line. The marking cavity is also provided with a marker, which is a sac containing a fluorescent colorimetric agent. When the switching component is switched to the position where the third connecting hole corresponds to the first rotary incision, the sac ruptures, and the sealing material enters the sampling and resection site through the first rotary incision.

[0022] By adopting the above technical solution, and by setting the occlusion material as medical polylactic acid (PLA) balls, since there is little tissue fluid in lung cells, tissue fluid is only generated at the puncture site. Therefore, by utilizing the water-absorbing and swelling properties of PLA, when the occlusion material enters the puncture sampling site, it absorbs the surrounding tissue fluid and expands to seal the puncture site, reducing pneumothorax. At the same time, medical PLA balls are harmless to the human body, and compared with metal occlusion materials, they cause less burden and pain to the human body, improving patient comfort.

[0023] Meanwhile, since the tissue sample is taken for biopsy to determine whether the nodule is benign or malignant, and if it is malignant, subsequent surgery is required at the sampling site, the absorbable polydioxanone (PDX) marker attached to the marker will remain in the body and be completely absorbed after sampling, or will remain outside the lung through the puncture channel, facilitating subsequent endoscopic or robotic resection surgery guided by the marker. Furthermore, the marker is set to be an absorbable PDX line because the detection cycle is often 3-7 days, while the human body's absorption period for PDX and polylactic acid is longer than the detection cycle. This means that before the test results are available, the marker and occluder can perform normal marking and hemostasis functions.

[0024] If the test result is benign, setting the marker line to a polydioxanone absorbable line and the occlusive material to a polyemulsion form reduces the need for a second surgery to remove the occlusive material and marker line. The material is directly absorbed by the body, further reducing the risk of a second surgery and improving patient comfort.

[0025] Simultaneously, a pouch containing indocyanine green fluorescent dye is set up to mark and stain the excised tissue. Since there is relatively little lung fluid, the liquid in the pouch, which serves as a solvent for the fluorescent dye, absorbs and expands as polylactic acid. When switching to a site requiring sealing, the pouch ruptures, and the fluorescent dye forms a complex with the sealing material. This complex not only possesses the near-infrared fluorescence properties of ICG but also retains the biodegradability and biocompatibility of PLA, serving as a marker for secondary surgeries. Optionally, the extrusion from the first excision site under the positive pressure of the second positive pressure tube can also seal the excision site. The switching assembly includes a switching cylinder slidably disposed within the puncture needle, one end of which is connected to the rotating cylinder. The switching cylinder is equipped with a lever protruding from the mounting base.

[0026] By adopting the above technical solution, the position of the rotating cylinder inside the puncture needle can be adjusted by sliding the switching cylinder, thereby realizing the switching between the two functions of sampling and occlusion. The adjustment operation of the rotating cylinder is simplified by the toggle block set at the mounting base.

[0027] When this device is separated from the robotic arm, it simplifies the doctor's operation of switching between the two functions and improves the device's adaptability.

[0028] Optionally, a limiting rod is rotatably connected to the lever, one end of the limiting rod is in contact with the lever, and the other end of the limiting rod is provided with a limiting block. A limiting groove is opened on the switching cylinder, and the limiting block is movably engaged with the limiting groove.

[0029] By adopting the above technical solution, since both the rotary cutting needle and the puncture needle need to be removed from the human body after sampling, the limiting rod, the limiting block, and the limiting groove opened on the switching cylinder can be used to switch between the sampling and sealing functions. At this time, the technician does not operate the limiting rod. The limiting block is always engaged with the limiting groove. The technician slides the lever, which drives the switching cylinder to slide, thereby driving the rotating cylinder to slide, so as to realize the correspondence between the second rotary cutting port / third connecting port and the first rotary cutting port.

[0030] When it is necessary to remove the rotary cutting cylinder from the puncture needle, the technician presses the limiting rod to separate the limiting block from the limiting groove. At this time, the switching cylinder and the rotating cylinder can be smoothly removed from the puncture needle, which facilitates the operation after sampling. At the same time, during rotary cutting, the rotation of the switching cylinder and the rotating cylinder is further restricted by the set lever, making the rotation and sliding of the rotary cutting cylinder more stable and improving the stability of the rotary cutting operation.

[0031] Optionally, the end of the rotary cutter away from the mounting base is provided with a partition, the partition and the end side of the puncture needle forming a marking cavity, the sealing material is located on the side of the partition away from the mounting base, the partition is provided with a connecting hole that communicates with the second positive pressure cavity, the marking line is laid through the connecting hole, and when the third connecting port is laid opposite to the first rotary cut port, the partition is also provided with a clamping and conveying component for conveying the marking line.

[0032] By adopting the above technical solution, during the preparation work, in order to avoid the dislodgement of the sealing material, the polydioxanone absorbable line is often in a taut state, that is, the sealing material is located in the center of the partition. Moreover, when the sealing material needs to be squeezed out during sealing, the polydioxanone absorbable line needs to provide space for the sealing material to move. Therefore, when the sealing material needs to be squeezed into the rotary cutting area after sampling, the positive pressure in the connecting hole sends the sealing material to the rotary cutting area. At the same time, the set clamping and conveying component transports the marking line towards the second positive pressure cavity, improving the sealing efficiency of the sealing material. At the same time, the clamping and conveying component continuously transports the polydioxanone absorbable line towards the second positive pressure cavity, which facilitates the subsequent removal of the rotary cutting blade from the puncture needle and reduces the problem of pulling the polydioxanone absorbable line and the sealing material out of the rotary cutting position when the rotary cutting blade is removed.

[0033] Optionally, the clamping and conveying component includes a clamping rod rotatably mounted on the partition plate. The end of the clamping rod protrudes from the outer peripheral wall of the partition plate, and a baffle is provided on the inner peripheral wall of the puncture needle. The protruding end of the clamping rod is movably fitted with the baffle. An elastic return member is provided at the pivot of the clamping rod, and the size of the opening of the communicating hole is adjusted at the axis of the clamping rod near the partition plate.

[0034] By adopting the above technical solution, when the third connecting port slides to the position corresponding to the first rotary cutting port, the rotary cutting cylinder continues to rotate and slide under the action of power. During the rotation and sliding of the rotary cutting cylinder, the end of the clamping rod is pressed against the baffle, thereby causing the clamping rod to rotate on the partition and adjust the opening size of the connecting port, thereby clamping the polydioxanone absorbable line and conveying it towards the direction close to the tip of the puncture needle. At this time, due to the rotary cutting cylinder rotating and sliding forward or backward, when rotating and sliding forward, the end of the clamping rod is pressed against the baffle. When sliding to the limit position of the rotary cutting cylinder, the clamping rod just slides to the baffle. At the phase separation position, the clamping rod rebounds under the elastic force of the elastic restoring element, opening the communication port and thus relaxing the polydioxanone absorbable line. Therefore, when the rotary cutting cylinder retracts, the polydioxanone absorbable line will not move back with the rotary cutting cylinder, thus ensuring that the polydioxanone absorbable line is always delivered towards the tip of the puncture needle. Since the rotary cutting cylinder always rotates in one direction, when it slides towards the tip of the puncture needle again, the clamping rod rotates to a position where it is in contact with and pressed against the baffle, thus ensuring that the polydioxanone absorbable line is always delivered towards the tip of the puncture needle.

[0035] Optionally, an auxiliary plate is rotatably provided on the side of the partition near the tip of the puncture needle, and the tip of the puncture needle is provided with a limiting structure for rotating and limiting the auxiliary plate. The auxiliary plate is inclined toward the first rotary incision.

[0036] By adopting the above technical solution, when positive pressure is input into the second positive pressure cavity through the second positive pressure pipe, the auxiliary plate is always inclined towards the first rotary cutting opening, thereby guiding the sealing material and allowing it to be smoothly squeezed out from the first rotary cutting opening and enter the rotary cutting part to seal the rotary cutting part.

[0037] Optionally, the auxiliary plate is slidably and rotatably connected to the partition, the marker is embedded in the inner wall of the puncture needle, and the end of the auxiliary plate near the first rotary incision is movably fitted with the marker.

[0038] By adopting the above technical solution, when the first rotary cutting port corresponds to the third connecting port, the rotary cutting cylinder rotates and slides, causing the end side of the auxiliary plate to slide, thereby causing the tip of the auxiliary plate to slide against the capsule and puncture the capsule, thus facilitating the outflow of the fluorescent colorimetric agent and the combination of the fluorescent colorimetric agent with the polylactic acid spheres, achieving simultaneous marking and sealing.

[0039] In summary, this application includes at least one of the following beneficial technical effects:

[0040] 1. By setting a hollow puncture needle, rotating the cutting cylinder inside the puncture needle, opening a second cutting port and a third connecting port on the cutting cylinder, and a switching component, the puncture, sampling, and occlusion operations can be realized through a single device. At the same time, the amount of sample taken in a single puncture is increased, the pain caused to the patient by multiple needle insertions is reduced, and the switching component realizes the switching of functions, reducing the prolongation of operation time caused by multiple needle insertions, and further reducing the surgical risk.

[0041] 2. By setting up a first negative pressure tube, a second positive pressure tube, a first negative pressure cavity, and a second positive pressure cavity, stable collection of tissue samples can be achieved while the sealing material is stably extruded when switching between rotary cutting and sealing functions;

[0042] 3. By setting the occluder as a polylactic acid ball, the marking line as a polydioxanone absorbable line, and the marking agent as a capsule containing a fluorescent dye, when the test result is benign, there is no need for a second surgery to remove the occluder and marking line, reducing the risk and pain of a second surgery. At the same time, when the test result is malignant, the polylactic acid ball and the fluorescent dye mark the excision site, which facilitates subsequent surgical resection and improves the accuracy and efficiency of the subsequent resection surgery. Attached Figure Description

[0043] Figure 1 This is a schematic diagram of the overall structure of an embodiment of this application;

[0044] Figure 2 This is a schematic diagram of the connection structure of the puncture component and the sampling component in the embodiments of this application;

[0045] Figure 3 This is a schematic diagram of the connection structure of the puncture component and the sampling component;

[0046] Figure 4 This is a schematic diagram of the connection structure of the marking component and the switching component;

[0047] Figure 5 This is a schematic diagram of the connection structure between the handle and the mounting base;

[0048] Figure 6 yes Figure 5 A schematic diagram of the connection structure between parts A and B.

[0049] Reference numerals: 1. Puncture assembly; 11. Puncture needle; 12. Mounting base; 13. First rotary incision; 14. Power component; 141. Rotating cylinder; 142. Slot; 143. Limiting cylinder; 144. Locking block; 15. Robotic arm; 2. Sampling assembly; 21. Rotary cutting cylinder; 211. Rotary cutting blade; 22. Second rotary incision; 23. Third connecting port; 24. First negative pressure tube; 25. Second positive pressure tube; 26. First negative pressure cavity; 27. ... 28. Positive pressure cavity; 29. ​​Divider cylinder; 30. Collection cylinder; 31. Marking assembly; 32. Blocking material; 33. Marking line; 34. Marking object; 35. Marking cavity; 36. Partition plate; 37. Connecting hole; 38. Clamping and conveying component; 39. Clamping rod; 30. Baffle plate; 31. Elastic recovery component; 32. Auxiliary plate; 43. Switching assembly; 44. Switching cylinder; 45. Toggle block; 46. Limiting rod; 47. Limiting block; 48. Limiting groove. Detailed Implementation

[0050] The following is in conjunction with the appendix Figure 1-6 This application will be described in further detail.

[0051] This application discloses a minimally invasive puncture biopsy resection device for pulmonary nodules. (Refer to...) Figure 1 and Figure 2 A minimally invasive puncture biopsy resection device for lung nodules includes a robotic arm 15 electrically connected to a CT scanner and a puncture assembly 1 detachably connected to the robotic arm 15. In this application, the CT scanner is a conventional CT scanner, and the robotic arm 15 is a common six-axis robotic arm. The CT scanner is not shown in the figures. (Refer to...) Figure 1 In the enlarged portion of the diagram, the robotic arm 15 is equipped with a component for adjusting the switching assembly 4. The robotic arm 15 also has an auxiliary component for assisted positioning of the puncture site. (Refer to...) Figure 1 As can be seen, the auxiliary component includes an auxiliary plate mounted on the robotic arm 15 with six axes of rotation. The auxiliary plate has a positioning hole for the puncture needle 11 to pass through. During biopsy puncture, the robotic arm 15 first controls the auxiliary plate to move to the puncture position and rotates it to the optimal puncture angle during simulation. Then, the robotic arm 15 controls the puncture needle 11 to pass through the positioning hole for puncture, thereby performing biopsy sampling. The auxiliary component further enables precise positioning and control of the puncture angle and position.

[0052] The puncture assembly 1 includes a mounting base 12 that is detachably connected to the robotic arm 15. The detachable connection is secured by bolts. The mounting base 12 is provided with a puncture needle 11. The puncture needle 11 is hollow and has a sharp end. A first rotary cut 13 is provided on the side wall of the tip of the puncture needle 11.

[0053] The mounting base 12 is also provided with a sampling component 2 for taking tissue samples from the nodules. The sampling component 2 includes a rotary cutting cylinder 21 that is rotatably and slidably disposed inside the puncture needle 11. The mounting base 12 is provided with a power component 14 for driving the rotary cutting cylinder 21. A second rotary cutting opening 22 is opened on the rotary cutting cylinder 21. Multiple sets of rotary cutting blades 211 are fixedly connected to the rotary cutting cylinder 21. The multiple sets of rotary cutting blades 211 are arranged at intervals along the circumference of the rotary cutting cylinder 21. The rotary cutting blades 211 are movably fitted with the inner wall of the puncture needle 11, and the rotary cutting blades 211 are located at the second rotary cutting opening 22.

[0054] Reference Figure 1 and Figure 2 The power component 14 includes a rotating cylinder 141 coaxially disposed inside the puncture needle 11. The rotating cylinder 141 is not easily rotated relative to the puncture needle 11. A limiting cylinder 143 is connected to the rotary cutting cylinder 21. The limiting cylinder 143 is slidably and rotatably disposed inside the puncture needle 11. The mounting base 12 is provided with a rotating output component that drives the limiting cylinder 143 to rotate. A continuous and wavy groove 142 is opened on the outer peripheral wall of the rotating cylinder 141. A locking block 144 is fixedly connected to the inner peripheral wall of the limiting cylinder 143. The locking block 144 is slidably adapted to the groove 142.

[0055] When the rotating output component drives the limiting cylinder 143 to rotate, the limiting cylinder 143 rotates, and the locking block 144, under the limiting action of the locking groove 142, drives the rotary cutting cylinder 21 to rotate and slide. When the second rotary cutting opening 22 corresponds to the first rotary cutting opening 13, the rotary cutting blade 211 cuts the tissue that falls into the first rotary cutting opening 13 to complete the sampling. The multiple sets of rotary cutting blades 211 set up perform multiple samplings in one rotation, thereby increasing the sampling volume while reducing the number of needle insertions.

[0056] Meanwhile, since the sampling site may be missing after sampling, it is necessary to seal the sampling site to reduce the occurrence of pneumothorax. This requires sealing the sampling site. Furthermore, based on the post-sampling test results, it is necessary to determine whether the nodule requires surgery; therefore, the sampling site also needs to be marked. To address this issue, the mounting base 12 is also equipped with a marking component 3 for sealing and marking the sampling site, as shown in the reference... Figure 2 and Figure 3 A marking cavity 34 is left between the rotary cutting cylinder 21 and the end side of the puncture needle 11. The marking component 3 includes a sealing material 31 disposed in the marking cavity 34. A third connecting port 23 is provided on the rotary cutting cylinder 21. The third connecting port 23 is connected to the marking cavity 34 and is movably corresponding to the first rotary cutting port 13. The mounting base 12 is also provided with a switching component 4 for movably corresponding the first rotary cutting port 13 with the second rotary cutting port 22 / third connecting port 23.

[0057] The mounting base 12 is connected to a first negative pressure tube 24 and a second positive pressure tube 25. A partition tube 28 is coaxially arranged inside the limiting tube 143, dividing the inner cavity of the limiting tube 143 into a first negative pressure cavity 26 and a second positive pressure cavity 27. The end of the first negative pressure cavity 26 away from the puncture needle 11 is equipped with a filter screen to facilitate the reception and filtration of the cut tissue, reducing the problems caused by the tissue directly entering the negative pressure power component. The first negative pressure cavity 26 is located between the partition tube 28 and the limiting tube 143, and the second positive pressure cavity 27 is located inside the limiting tube 143. The axis of the cutting tube 21 is connected to the second positive pressure cavity 27. The first negative pressure cavity 26 is located between the limiting tube 143 and the partition tube 28, and the cavity between adjacent cutting blades 211 is connected to the first negative pressure cavity 26.

[0058] The first negative pressure tube 24 is connected to the first negative pressure cavity 26, and the first negative pressure tube 24 provides negative pressure to the first negative pressure cavity 26. The second positive pressure tube 25 is connected to the second positive pressure cavity 27, and the second positive pressure tube 25 provides positive pressure to the second positive pressure cavity 27. The second positive pressure cavity 27 is connected to the marking cavity 34. A collection cylinder 29 is connected to the first negative pressure tube 24. A filter screen is provided at the end of the collection cylinder 29 away from the puncture needle 11 for filtering and collecting tissue. The collection cylinder 29 is detachably mounted on the first negative pressure tube 24.

[0059] It should be noted that the sealing material 31 is a polylactic acid ball, and one end of the sealing plate is connected to a marking line 32. The marking line 32 is connected to the second positive pressure cavity 27. In this application, the marking line 32 is a polydioxanone absorbable line. At the same time, a marking material 33 is also embedded in the marking cavity 34. The marking material 33 is a capsule storing a fluorescent colorimetric agent. In this application, the fluorescent colorimetric agent is indocyanine green fluorescent colorimetric agent. When the switching component 4 switches the rotary cutting tube 21 from connecting the first rotary cutting port 13 and the second rotary cutting port 22 to connecting the first rotary cutting port 13 and the third connecting port 23, the capsule ruptures, and the sealing material 31 enters the sampling and resection site through the first rotary cutting port 13.

[0060] Since lung cells contain relatively little tissue fluid, tissue fluid is only generated at the puncture site. Therefore, by utilizing the water-absorbing and swelling properties of polylactic acid, when the sealing material 31 enters the puncture sampling site, it absorbs the surrounding tissue fluid and expands to seal the puncture site, reducing pneumothorax. At the same time, medical polylactic acid balls are harmless to the human body and, compared to metal sealing materials, cause less burden and pain to the human body, thus improving patient comfort.

[0061] Meanwhile, since the sampled tissue is used for biopsy to determine whether the nodule is benign or malignant, and if it is a malignant nodule, subsequent surgery is required at the sampling site, the marker line 32 connected to the marker 33 will remain outside the body along the puncture channel after sampling to facilitate subsequent CT equipment to perform secondary resection surgery under the guidance of the marker line 32. The marker line 32 is set to be a polydioxanone absorbable line. Since the detection cycle is often 3-7 days, and the human body's absorption cycle for polydioxanone absorbable lines and polylactic acid is longer than the detection cycle, the marker line 32 and the occluder 31 can achieve normal marking and occlusion hemostasis functions before the test results are available.

[0062] If the test result is benign, setting the marker line 32 to a polydioxanone absorbable line and setting the plugging material 31 to a polyemulsion form will reduce the need for a second surgery to remove the plugging material 31 and the marker line 32. They can be directly absorbed by the human body, further reducing the risk of a second surgery and improving patient comfort.

[0063] Simultaneously, a capsule containing fluorescent dye is set up to mark and stain the excised tissue. Since there is little lung tissue fluid, the liquid in the capsule, which serves as a solvent for the fluorescent dye, is absorbed and expanded by polylactic acid. When the switch is made to seal the excised area, the capsule ruptures, and the fluorescent dye and the sealing material 31 are squeezed out at the first excised opening 13 under the positive pressure of the second positive pressure tube 25 to seal the excised area.

[0064] A partition 35 is fixedly connected to the end of the rotary cutting cylinder 21 away from the mounting base 12. The partition 35 and the inner wall of the puncture needle 11 form a marking cavity 34. The marker 33 and the sealing material 31 are both located in the marking cavity 34.

[0065] When performing tissue rotary cutting sampling, the first negative pressure tube 24 provides negative pressure towards the first negative pressure cavity 26. At this time, the rotary cutting blade 211 cuts and samples the tissue entering the first rotary cutting port 13 relative to the side wall of the rotary cutting cylinder 21. Meanwhile, as the rotary cutting cylinder 21 moves towards the mounting base 12, the second rotary cutting port 22 is not completely connected to the first rotary cutting port 13. The negative pressure component in the first negative pressure tube 24 collects the rotary-cut tissue under negative pressure, while reducing the impact of negative pressure on the surrounding normal tissue.

[0066] After the tissue biopsy is completed, the switching component 4 slides the marking cavity 34 to a position connected to the first rotary incision 13. At this time, positive pressure is generated in the second positive pressure cavity 27 through the second positive pressure tube 25, which squeezes the sealing material 31 in the marking cavity 34 toward the position of the first rotary incision 13, thereby sealing the rotary incision site and the puncture site, thereby achieving the effect of hemostasis and reducing pneumothorax.

[0067] Reference Figure 4 and Figure 5 The switching assembly 4 includes a switching cylinder 41 slidably disposed inside the puncture needle 11. The switching cylinder 41 is sleeved on and detachably connected to the rotating cylinder 141. The sliding direction of the switching cylinder 41 is consistent with the length direction of the puncture needle 11. A lever 42 is slidably disposed on the switching cylinder 41. A switching groove is opened on the outer wall of the puncture needle 11. The lever 42 protrudes out of the switching groove. At the same time, a limiting rod 43 is rotatably connected to the switching cylinder 41. One end of the limiting rod 43 is located inside the puncture needle 11, and the other end of the limiting rod 43 is movably fitted with the lever 42. The end of the limiting rod 43 located inside the puncture needle 11 is fixedly connected to a limiting block 44. A limiting groove 45 is opened on the outer peripheral wall of the rotating cylinder 141. The limiting block 44 is movably engaged with the limiting groove 45.

[0068] Since both the rotary cutting needle and the puncture needle 11 need to be removed from the body after sampling, the limiting rod 43, the limiting block 44, and the limiting groove 45 on the switching cylinder 41 are set to allow the technician to switch between the sampling and sealing functions. At this time, the technician does not operate the limiting rod 43. The limiting block 44 is always engaged with the limiting groove 45. The technician slides the lever 42 to drive the switching cylinder 41 to slide, thereby driving the rotating cylinder 141 to slide, so as to realize the correspondence between the second rotary cutting port 22 / third connecting port 23 and the first rotary cutting port 13.

[0069] When it is necessary to remove the rotary cutting cylinder 21 from the puncture needle 11, the technician presses the limiting rod 43 to separate the limiting block 44 from the limiting groove 45. At this time, the switching cylinder 41 and the rotating cylinder 141 can be smoothly removed from the puncture needle 11, which facilitates the operation after sampling. At the same time, during rotary cutting, the rotation of the switching cylinder 41 and the rotating cylinder 141 is further restricted by the set lever 42, making the rotation and sliding of the rotary cutting cylinder 21 more stable and improving the stability of the rotary cutting operation.

[0070] If the rotary cutting cylinder 21 is removed and disassembled by the robotic arm 15 at this time, refer to Figure 1 The schematic diagram of the middle part shows that the limiting rod 43 is pressed by the structure set on the robotic arm 15, so that the limiting block 44 is separated from the limiting groove 45.

[0071] When switching between rotary cutting and sealing operations is performed by the robotic arm 15, the limiting rod 43 is directly moved by the structure set on the robotic arm 15, causing the switching cylinder 41 to slide, thereby driving the rotating cylinder 141 to slide, so as to realize the correspondence between the second rotary cutting port 22 / third connecting port 23 and the first rotary cutting port 13.

[0072] During preparation, to prevent the sealing material 31 from falling off, the absorbable line of polydioxanone is often taut, meaning the sealing material 31 is located at the center of the partition 35. Moreover, when the sealing material 31 needs to be squeezed out during sealing, the absorbable line of polydioxanone needs to provide space for the sealing material 31 to move. Therefore, to achieve this function, the partition 35 is provided with a connecting hole 36 that communicates with the second positive pressure cavity 27. At the same time, the partition 35 is also provided with a clamping and conveying component 37 for conveying the marking line 32 toward the tip of the puncture needle 11.

[0073] Reference Figure 3 The clamping and conveying component 37 includes a clamping rod 371 rotatably mounted on the partition 35. One end of the clamping rod 371 protrudes from the outer peripheral wall of the partition 35, and the other end of the clamping rod 371 is arc-shaped. The rotation axis of the clamping rod 371 is consistent with the axis of the partition 35. When the clamping rod 371 rotates, it adjusts the opening size of the connecting hole 36. A baffle 372 is fixedly connected to the inner wall of the puncture needle 11. The end of the clamping rod 371 is movably fitted and pressed against the baffle 372. An elastic return element 373 is provided at the rotation axis of the clamping rod 371. In this application, the elastic return element 373 can be a miniature torsion spring, or the clamping rod 371 itself can be made of an elastic material. The length of the baffle 372 is less than the sliding length of the rotary cutting cylinder 21.

[0074] When the third connecting port 23 slides to the position corresponding to the first rotary cutting port 13, the rotary cutting cylinder 21 continues to rotate and slide under the action of power. During the rotation and sliding of the rotary cutting cylinder 21, the end side of the clamping rod 371 is pressed against the baffle 372, so that the clamping rod 371 rotates on the partition 35 to adjust the opening size of the connecting port, thereby clamping the polydioxanone absorbable line and conveying it towards the direction close to the tip of the puncture needle 11.

[0075] When the rotary cutting cylinder 21 slides to its limit position, the clamping rod 371 slides to the position where it is separated from the baffle 372. Under the elastic force of the elastic return member 373, the clamping rod 371 rebounds and opens the communication port, thereby releasing the polydioxanone absorbable line. As a result, when the rotary cutting cylinder 21 retracts, the polydioxanone absorbable line will not move back with the rotary cutting cylinder 21, thus realizing the function of always delivering the polydioxanone absorbable line toward the tip of the puncture needle 11.

[0076] The rotary cutting cylinder 21 always rotates in one direction, so that when it slides toward the tip of the puncture needle 11 next time, the clamping rod 371 rotates to a position that fits and abuts against the baffle 372, thereby realizing the function of always delivering the polydioxanone absorbable line toward the tip of the puncture needle 11, thus facilitating the extrusion of the sealing material 31 toward the biopsy sampling site.

[0077] To further facilitate the extrusion of the sealing material 31, an auxiliary plate 38 is rotatably provided on the side of the partition 35 near the tip of the puncture needle 11. The auxiliary plate 38 is always inclined toward the first rotary cut 13, and a receiving groove for storing the marker 33 is provided on the inner wall of the puncture needle 11. The end of the auxiliary plate 38 near the first rotary cut 13 is sharp, and the sharp side of the auxiliary plate 38 is in contact with the marker 33.

[0078] When positive pressure is input into the second positive pressure cavity 27 through the second positive pressure pipe 25, the auxiliary plate 38 is always inclined toward the first rotary cutting opening 13, thereby guiding the sealing material 31 so that the sealing material 31 can be smoothly squeezed out from the first rotary cutting opening 13 and enter the rotary cutting part to seal the rotary cutting part.

[0079] When the first rotary cutting port 13 corresponds to the third connecting port 23, the rotary cutting cylinder 21 rotates and slides, causing the end side of the auxiliary plate 38 to slide, thereby causing the tip of the auxiliary plate 38 to slide against the capsule and puncture the capsule, thus facilitating the outflow of the fluorescent color developer and the combination of the fluorescent color developer with the polylactic acid spheres, achieving simultaneous marking and sealing.

[0080] Meanwhile, the inner wall of the puncture needle 11 is also provided with a limiting structure to restrict the rotation of the auxiliary plate 38. In this application, the limiting structure is a snap-fit ​​block provided on the inner wall of the tip of the puncture needle 11. The auxiliary plate 38 is provided with a snap-fit ​​groove, and the snap-fit ​​block and the snap-fit ​​groove are slidably adapted to each other.

[0081] It should be noted that when assembling the rotary cutting cylinder 21 and the puncture needle 11 before puncture, the first step is to install the lever 42. The limiting block 44 is always not protruding from the inner surface of the switching cylinder. At this time, the technician slides the rotary cutting cylinder 21, the rotating cylinder 141, and the limiting cylinder 143 into the puncture needle 11 until the auxiliary plate 38 slides past the position of the first rotary cutting port 13. At this time, the medical staff places the marker 33 into the inner wall of the puncture needle 11 through the first rotary cutting port 13.

[0082] The implementation principle of the minimally invasive puncture biopsy resection device for lung nodules in this application embodiment is as follows: When performing biopsy sampling on a patient, the human body is first scanned by a CT device, and then a puncture route is constructed by a computer. The robotic arm 15 controls the mounting base 12 and the puncture needle 11 to puncture according to the constructed puncture route until the first rotary incision 13 on the puncture needle 11 reaches the nodule.

[0083] At this time, the rotating output component works, driving the limiting cylinder 143 to rotate. The limiting cylinder 143 drives the rotary cutting cylinder 21 to rotate, performing rotary cutting on the tissue entering the first rotary cutting port 13 and the second rotary cutting port 22. At the same time, the wavy groove 142 opened on the outer peripheral wall of the rotating cylinder 141 allows the rotary cutting cylinder 21 to both rotate and slide along the length of the puncture needle 11 during the rotary cutting process. When the locking block 144 corresponds to the trough of the groove 142, the first rotary cutting port 13 and the second rotary cutting port 22 are completely aligned. When the locking block 144 corresponds to the trough of the groove 142, the first rotary cutting port 13 and the second rotary cutting port 22 are not completely aligned, which facilitates the subsequent suction of the cut tissue by negative pressure.

[0084] After sampling is completed, the technician slides the lever 42, which drives the switching cylinder 41 to slide, thereby driving the rotating cylinder 141 to slide, so that the third connecting port 23 corresponds to the first rotary cutting port 13. At this time, the rotating output component continues to work, driving the rotary cutting cylinder 21 to rotate. At the same time, the second positive pressure tube 25 outputs positive pressure into the second positive pressure cavity 27, squeezing out the sealing material 31 from the first rotary cutting port 13 to seal the tissue sampling site.

[0085] Meanwhile, as the rotary cutting cylinder 21 rotates and slides, the end of the clamping rod 371 is pressed against the baffle 372, thereby causing the clamping rod 371 to rotate on the partition 35, adjusting the size of the opening of the connecting port, thereby clamping the polydioxanone absorbable line and conveying it towards the tip of the puncture needle 11.

[0086] After sampling and sealing are completed, the technician presses the lever 42 and removes the mounting base 12, rotary cutting cylinder 21, limiting cylinder 143, and rotating cylinder 141 from the puncture needle 11. Finally, the puncture needle 11 is removed, and the marking line 32 remains outside the body through the first rotary cutting port 13. After the puncture needle 11 is removed, the marking line 32 is cut.

[0087] The above are all preferred embodiments of this application, and are not intended to limit the scope of protection of this application. Therefore, all equivalent changes made in accordance with the structure, shape and principle of this application should be covered within the scope of protection of this application.

Claims

1. A minimally invasive puncture biopsy and resection device for lung nodules, characterized by: The invention comprises a mechanical arm electrically connected to a CT device, a navigation auxiliary device, a puncture component (1) detachably connected to the mechanical arm for puncturing human tissue, a sampling component (2) for sampling tissue at a nodule, and a marking component (3) for marking the sampling site, wherein the navigation auxiliary device is one of an optical navigation auxiliary device and a magnetic navigation auxiliary device; The puncture assembly (1) comprises a mounting seat (12) detachably connected to the mechanical arm, and a puncture needle (11) disposed on the mounting seat (12), wherein the end of the puncture needle (11) is sharp; The puncture needle (11) is hollow, the sampling assembly (2) comprises a rotary cutting cylinder (21) rotatably arranged in the puncture needle (11) and a power member (14) driving the rotary cutting cylinder (21) to rotate, the puncture needle (11) is provided with a first rotary cutting opening (13), the rotary cutting cylinder (21) is provided with a second rotary cutting opening (22), and the first rotary cutting opening (13) and the second rotary cutting opening (22) are movably corresponding to each other; The rotary cutting cylinder (21) is provided with a marking cavity (34), a sealing object (31) is stored in the marking cavity (34), the rotary cutting cylinder (21) is also provided with a third communication port (23), the third communication port (23) is movably corresponding to the first rotary cutting port (13), and the second rotary cutting port (22) and the third communication port (23) are selectively movably corresponding to the first rotary cutting port (13), and the mounting seat (12) is also provided with a switching component (4) for switching the first rotary cutting port (13) with the second rotary cutting port (22) and the third communication port (23).

2. A minimally invasive puncture biopsy and resection device for pulmonary nodules according to claim 1, characterized in that: The power member (14) comprises a rotating cylinder (141) connected to the rotary cutting cylinder (21); the mounting seat (12) is provided with a rotating power member (14) connected to the rotating cylinder (141); a wave-shaped clamping groove (142) is provided on the outer peripheral wall of the rotating cylinder (141); a limiting cylinder (143) is slidably arranged in the puncture needle (11); a clamping block (144) is provided on the inner peripheral wall of the limiting cylinder (143); and the clamping block (144) is slidably matched with the clamping groove (142).

3. A minimally invasive puncture biopsy and resection device for pulmonary nodules according to claim 2, characterized in that: The mounting seat (12) is connected to a first negative pressure tube (24) and a second positive pressure tube (25); a separation tube (28) is coaxially provided in the rotating cylinder (141); the separation tube (28) divides the rotating cylinder (141) into a first negative pressure cavity (26) and a second positive pressure cavity (27); the first negative pressure tube (24) is connected to the first negative pressure cavity (26); the second positive pressure tube (25) is connected to the second positive pressure cavity (27); the first negative pressure tube (24) is used to provide negative pressure in the first negative pressure cavity (26); the second positive pressure tube (25) is used to provide positive pressure toward the second positive pressure cavity (27); the second positive pressure cavity (27) ) is located in the separation cylinder (28), the first negative pressure cavity (26) is located between the separation cylinder (28) and the rotating cylinder (141), a plurality of groups of rotary cutters (211) are provided in the rotary cut cylinder (21), the rotary cutters (211) are arranged at intervals along the circumference direction of the rotary cut cylinder (21), the cavity enclosed between two adjacent groups of rotary cutters (211) is connected to the first negative pressure cavity (26), one end of the rotary cutter (211) away from the mounting seat (12) and the puncture needle (11) enclose a marking cavity (34), the blocking object (31) is located in the marking cavity (34), and the marking cavity (34) is connected to the second positive pressure cavity (27).

4. A minimally invasive puncture biopsy and resection device for lung nodules according to claim 3, characterized in that: The plugging object (31) is a high-polylactic acid ball. One end of the plugging object (31) is connected to a marking line (32). The marking line (32) is a polydioxanone absorbable line. A marker (33) is also arranged in the marking cavity (34). The marker (33) is a bag storing a fluorescent color developer. When the switching component (4) is switched to the third connecting hole (36) corresponding to the first rotary incision (13), the bag ruptures and the plugging object (31) enters the sampling and resection site through the first rotary incision (13).

5. A minimally invasive puncture biopsy and resection device for lung nodules according to claim 4, characterized in that: The switching assembly (4) comprises a switching cylinder (41) slidably disposed in the puncture needle (11), one end of the switching cylinder (41) being connected to the rotating cylinder (141), and a shifting block (42) being provided on the switching cylinder (41), the shifting block (42) being arranged protruding from the mounting seat (12).

6. A minimally invasive puncture biopsy and resection device for lung nodules according to claim 5, characterized in that: The shift block (42) is rotatably connected to a limit rod (43), one end of the limit rod (43) is in contact with the shift block (42), the other end of the limit rod (43) is provided with a limit block (44), the switching cylinder (41) is provided with a limit groove (45), and the limit block (44) is movably engaged with the limit groove (45).

7. A minimally invasive puncture biopsy and resection device for lung nodules according to claim 6, characterized in that: A partition (35) is provided at one end of the rotary cutter (211) away from the mounting seat (12), and the partition (35) and the end side of the puncture needle (11) together form a marking cavity (34). The blocking object (31) is located on the side of the partition (35) away from the mounting seat (12). A connecting hole (36) connected to the second positive pressure cavity (27) is formed on the partition (35), and the marking line (32) is arranged through the connecting hole (36). When the third connecting port (23) and the first rotary cut port (13) are arranged opposite to each other, a clamping and conveying member (37) for conveying the marking line (32) is further provided on the partition (35).

8. The minimally invasive puncture biopsy and resection device for lung nodules according to claim 7, characterized in that: The clamping and conveying member (37) comprises a clamping rod (371) rotatably arranged on the partition (35), the end side of the clamping rod (371) protrudes from the outer peripheral wall of the partition (35), and a baffle (372) is provided on the inner peripheral wall of the puncture needle (11), the protruding end side of the clamping rod (371) is movably fitted with the baffle (372), an elastic return member (373) is provided at the rotating shaft of the clamping rod (371), and the clamping rod (371) is close to the axis of the partition (35) to adjust the opening size of the connecting hole (36).

9. The minimally invasive puncture biopsy and resection device for pulmonary nodules according to claim 8, characterized in that: An auxiliary plate (38) is provided on one side of the partition plate (35) close to the tip of the puncture needle (11), and the auxiliary plate (38) is arranged obliquely toward the first rotary cut (13).

10. The minimally invasive puncture biopsy and resection device for lung nodules according to claim 9, characterized in that: The auxiliary plate (38) is slidably and rotatably connected to the partition plate (35), the marker (33) is embedded in the inner wall of the puncture needle (11), and the end side of the auxiliary plate (38) close to the first rotary cut (13) is movably fitted with the marker (33).

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