Orbital tissue needle biopsy equipment and system

Abstract

The invention discloses orbital tissue needle biopsy equipment and system. The orbital tissue needle biopsy equipment comprises a controllable sleeve, a plurality of driving components and a needle biopsy needle. Wherein the controllable sleeve comprises a sleeve body and a traction rope, and a plurality of groove groups are formed in the surface of the sleeve body; the traction rope in the casing pipe body penetrates through the whole length of the casing pipe body from the interior of the traction rope channel, and the driving component pulls the traction rope to control the bending direction and / or angle of the controllable casing pipe. The orbital tissue needle biopsy system comprises the needle biopsy equipment, a mechanical arm and B-ultrasonic equipment, under the guidance of the B-ultrasonic equipment, the mechanical arm is used for controlling the movement of the controllable sleeve and / or the needle biopsy needle, the driving component is used for controlling the bending direction and / or angle of the controllable sleeve, and the controllable sleeve and / or the needle biopsy needle are / is driven by the driving component. The needle biopsy needle can bypass an eyeball to directly reach a focus, and the minimally invasive property, accuracy and safety of biopsy are improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an orbital tissue puncture biopsy device and system. Background Art

[0002] Orbital tissue biopsy plays a vital role in the diagnosis and treatment of orbital diseases. It not only helps to diagnose orbital diseases, but also is a key method to determine whether orbital tumors are benign or malignant. However, current technical methods have some challenges and limitations:

[0003] (1) The currently commonly used surgical biopsy method is high-risk. The surgical biopsy method usually requires a large incision in the lesion area to remove samples for diagnosis of the disease. If general anesthesia is required during the process, complications such as diplopia may occur. In addition, in many cases, especially for inflammatory lesions, surgical biopsy is not necessary, and blind surgical biopsy increases the possibility that patients will be exposed to unnecessary surgical risks.

[0004] (2) Fine needle aspiration biopsy is a relatively safe alternative method due to its minimally invasive nature. However, current fine needle aspiration biopsy is only suitable for superficial, easily accessible lesions. As for lesions located deep in the orbit behind the eyeball, there is currently a lack of effective techniques and equipment specifically for orbital puncture biopsy, as the orbital space is small and complex, and contains a variety of important tissues. Existing puncture biopsy needles for liver, kidney and other parts are mostly rigid straight needles, which can meet the needs of puncture biopsy of organs in the abdominal cavity and other parts, but it is difficult to bypass the eyeball and enter the deep orbit, so it is difficult to use in orbital puncture biopsy surgery. Although flexible twisting needles have appeared, they can be turned by uneven force on the oblique needle tip at the distal end. This device can bypass the eyeball to reach the lesions deep in the orbit, but because its turning depends on the interaction between the needle tip and the tissue, it may cause damage to normal tissues; and because its turning requires twisting the entire needle body, nonlinear deformation such as needle body distortion may occur, making accurate turning operations difficult.

[0005] (3) Traditional clinical and imaging examinations, such as CT scans (Computed Tomography) or MRI (Magnetic Resonance Imaging), can detect masses or irregular tissues, but they cannot distinguish between cancerous cells and non-cancerous cells. This results in a relatively low diagnostic accuracy rate and increases the risk of misdiagnosis, which in turn affects the patient's treatment plan and prognosis.

[0006] Therefore, the current puncture biopsy of orbital lesion tissue has defects such as high invasiveness and the inability of the needle to accurately turn, which leads to an increase in the risk of puncture biopsy surgery and a decrease in diagnostic accuracy. Summary of the invention

[0007] The purpose of the present invention is to provide an efficient, safe and accurate puncture biopsy device and system for diagnosing and treating orbital lesions, which allows precise positioning of the needle and real-time tracking of the operation during puncture biopsy.

[0008] In order to achieve the above-mentioned object, the present invention provides an orbital tissue puncture biopsy device, comprising a manipulable cannula, a plurality of driving components, and a puncture biopsy needle;

[0009] The manipulable sleeve comprises a sleeve body and a traction rope. The surface of the sleeve body is provided with a plurality of groove groups, each of the groove groups comprises two mirror-symmetrical grooves, and the opening directions of adjacent groove groups are perpendicular to each other. At least three traction rope channels are provided in the sleeve body, and the traction rope channels extend along the axial direction of the sleeve body. The traction rope passes through the entire length of the sleeve body from the traction rope channels, the distal end of the traction rope is fixed to the distal end of the sleeve body, and the proximal end of the traction rope is led out from the proximal end of the sleeve body.

[0010] The driving component is connected to the proximal end of the traction rope, and the driving component controls the bending direction and / or angle of the steerable sleeve by pulling the traction rope;

[0011] The needle tip of the puncture biopsy needle is beveled; the puncture biopsy needle is provided with a biopsy groove at the distal end, and the biopsy groove is used to cut the biopsy sample; the puncture biopsy needle can slide in the steerable sleeve, and at least part of it can extend out of the steerable sleeve from the distal end of the steerable sleeve.

[0012] Furthermore, the groove groups are distributed at equal intervals in the axial direction of the sleeve body.

[0013] Furthermore, the traction rope channels are distributed at equal intervals in the circumferential direction of the sleeve body.

[0014] Furthermore, the steerable sleeve also includes a hose, and the hose is adhered to the inner tube wall of the sleeve body.

[0015] Furthermore, the distal end of the maneuverable sleeve is in a beveled shape to match the needle tip of the puncture biopsy needle.

[0016] Furthermore, the puncture biopsy needle and the sleeve body are both made of nickel-titanium alloy material.

[0017] Furthermore, the puncture biopsy needle includes an optical fiber assembly for optical coherence tomography to locate the needle body.

[0018] Furthermore, a plurality of optical fibers are embedded in the hose, and the optical fibers extend along the axial direction of the hose; a fiber grating sensor is installed outside the proximal end of the manipulable sleeve, and the fiber grating sensor is connected to the optical fibers in the hose.

[0019] The present invention also provides an orbital puncture biopsy system, comprising:

[0020] The orbital tissue puncture biopsy device as described above,

[0021] A robotic arm, wherein the distal end of the robotic arm comprises a plurality of interfaces, wherein the interfaces are used to respectively connect and fix the proximal end of the manipulable cannula and the proximal end of the puncture biopsy needle to transport the manipulable cannula and the puncture biopsy needle to a designated position, and to control the manipulable cannula and / or the puncture biopsy needle to move toward the proximal end or the distal end;

[0022] The B-ultrasound device comprises a B-ultrasound probe, a signal processing module, and a B-ultrasound imaging display screen. The B-ultrasound probe and the B-ultrasound imaging display screen are electrically / signally connected. After the B-ultrasound probe transmits an ultrasonic signal into the orbital tissue, it receives an echo signal, and the echo signal is transmitted to the signal processing module. The signal processing module performs a logical operation based on the received echo signal, converts it into a B-ultrasound image and presents it on the B-ultrasound imaging display screen. According to the B-ultrasound image, the movement of the steerable cannula and / or the puncture biopsy needle is controlled by the robotic arm.

[0023] Furthermore, the bending direction and / or angle of the steerable sleeve is controlled by the driving component according to the B-ultrasound image.

[0024] Compared with the prior art, the beneficial effects of the present invention at least include:

[0025] (1) In the orbital tissue puncture biopsy device provided by the present invention, a plurality of grooves are provided on the surface of the cannula body of the manipulable cannula. The design of the grooves reduces the amount of material of the cannula body used to resist bending, thereby reducing the axial stiffness of the manipulable cannula and increasing its flexibility, so that the manipulable cannula is more likely to bend when subjected to force, which facilitates force control; a traction rope is inserted into the cannula body along the axial direction of the cannula body, and the proximal end of the traction rope is connected to the driving component. By pulling the traction rope, the manipulable cannula can bend in a preset direction and accurately bypass the eyeball, thereby improving the accuracy of the operation.

[0026] (2) In the orbital tissue puncture biopsy system provided by the present invention, the manipulable cannula, puncture biopsy needle, driving component, mechanical arm, and B-ultrasound equipment cooperate to complete the puncture biopsy operation of the orbital tissue, greatly improving the operation accuracy during the puncture biopsy operation. First, the bending direction and / or angle of the manipulable cannula is accurately controlled by pulling the traction rope by the driving component, so that the internal cavity of the manipulable cannula forms an effective biopsy channel for the movement of the puncture biopsy needle; second, the manipulable cannula and puncture biopsy needle can be transmitted to the accurate orbital position by the mechanical arm, and the manipulable cannula and / or puncture biopsy needle can be moved forward and backward by the mechanical arm, further improving the accuracy of the operation. At the same time, the use of the mechanical arm can avoid the error caused by physiological tremor when the human hand holds the puncture biopsy needle, thereby improving the safety of the operation; third, the orbital tissue is monitored in real time by the B-ultrasound equipment, allowing the doctor to accurately locate the position of the manipulable cannula and puncture biopsy needle when manipulating the orbital tissue puncture biopsy system, and track the operation in real time, ensuring the accuracy and safety of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 It is a schematic diagram of the structure of the maneuverable sleeve of the present invention; wherein, the traction rope and the hose are not shown in the figure.

[0028] Figure 2 FIG. 4 is a cross-sectional view of a steerable sleeve of the present invention; wherein the shaded area represents the traction rope.

[0029] Figure 3 It is a schematic structural diagram of the puncture biopsy needle of the present invention.

[0030] Figure ID:

[0031] A manipulable sleeve 10, a sleeve body 11, a traction rope 12, a groove 13, a traction rope channel 14, a hose 15,

[0032] Puncture biopsy needle 20, biopsy groove 21. DETAILED DESCRIPTION

[0033] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0034] In the description of the present invention, it should be noted that the terms "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance.

[0035] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0036] The “proximal end” described herein refers to a direction close to an operator, and the “distal end” described herein refers to a direction close to the inside of the patient's orbital tissue.

[0037] The "axial direction" described herein refers to a direction parallel to the axis of the steerable sleeve.

[0038] As described in the background technology, the space inside the orbit is small and complex in structure, and contains a variety of important tissues. The existing puncture biopsy needles used for orbital puncture biopsy cannot meet the requirements of precise and safe steering operations, which makes it very easy to cause damage to normal orbital tissues during the puncture process, increasing the risk of surgery.

[0039] In order to solve the problem that the currently used rigid needle is difficult to reach the back of the eyeball and difficult to control its direction, the present invention provides an orbital tissue puncture biopsy device and system, which includes a manipulable cannula 10, a puncture biopsy needle 20, a number of driving components (not shown in the figure), and a mechanical arm (not shown in the figure). The mechanical arm carries the manipulable cannula 10 and the puncture biopsy needle 20 to the patient's orbital puncture position, which can ensure the accuracy of the puncture position and effectively avoid the tremor that may be caused by the doctor's manual operation, thereby ensuring the stability of the puncture process; The driving component is connected to the steerable cannula 10, and can accurately control the bending direction and / or angle of the steerable cannula 10, so that the steerable cannula 10 bypasses the eyeball and accurately turns to locate the lesion; the robotic arm is used to control the steerable cannula 10 and / or the puncture biopsy needle 20 to move proximally or distally, so that the puncture biopsy needle 20 extends out of the steerable cannula 10 along the internal cavity portion of the steerable cannula 10, and cooperates with the steerable cannula 10 to complete the shearing of the biopsy sample, thereby improving the minimally invasiveness, accuracy and safety of the puncture biopsy.

[0040] The present invention provides an orbital tissue puncture biopsy device, which includes a manipulable cannula 10, a puncture biopsy needle 20, and a plurality of driving components (not shown in the figure), which are described in detail below.

[0041] The structural schematic diagram of the steerable sleeve 10 is as follows Figure 1As shown. The manipulable sleeve 10 includes a sleeve body 11 and a traction rope 12. The internal cavity of the manipulable sleeve 10 forms a biopsy channel for the movement of the puncture biopsy needle 20. A plurality of groove groups are provided on the surface of the sleeve body 11, each of the groove groups includes two mirror-symmetrical grooves 13, and the opening directions of adjacent groove groups are perpendicular to each other. In this embodiment, the portion of the sleeve body 11 where the groove groups need to be cut is divided into ten sections at equal intervals. The groove groups of the first section and the second section are taken as examples to illustrate the opening method of the groove groups in this embodiment: the groove groups of the first section are cut on the surface of the sleeve body 11 along the horizontal plane direction using a laser, and the groove groups of the second section are cut on the surface of the sleeve body 11 along the direction perpendicular to the horizontal plane using a laser, so that the cross section of the groove group of the first section is perpendicular to the cross section of the groove group of the second section, and the opening of the groove groups of the third to tenth sections is cyclic in this opening method. The provision of the grooves 13 reduces the solid part of the sleeve body 11, thereby reducing the amount of material resisting bending, reducing the axial rigidity of the steerable sleeve 10, and increasing the flexibility of the steerable sleeve 10, which makes it easier for the steerable sleeve 10 to bend when subjected to the same force. Designing the opening directions of adjacent groove groups to be perpendicular to each other is conducive to the steerable sleeve 10 to achieve a balance between flexibility and axial rigidity, and is conducive to the steerable sleeve 10 being subjected to uniform force, avoiding the steerable sleeve 10 being too soft due to only opening groove groups in the same direction, thereby failing to effectively control the bending direction and / or angle of the steerable sleeve 10.

[0042] In order to achieve precise control of the bending direction and angle of the manipulable sleeve 10, the present invention provides at least three traction rope channels 14 in the sleeve body 11, and the traction rope channels 14 extend along the axial direction of the sleeve body 11; the traction rope 12 passes through the entire length of the sleeve body 11 along the traction rope channels 14, the distal end of the traction rope 12 is fixed to the distal end of the sleeve body 11, and the proximal end of the traction rope 12 is exposed from the proximal end of the sleeve body 11. When the traction rope 12 passes through the entire length of the sleeve body 11, part of the length of the traction rope 12 is exposed between the two sides of the groove 13, providing certain support for the two sides of the groove 13. The proximal end of each traction rope 12 in the steerable sleeve 10 is respectively connected to the driving component, and each traction rope 12 can be individually controlled by the driving component. When a traction rope 12 is pulled toward the proximal end by the driving component, the traction rope 12 can drive the steerable sleeve 10 to bend in the direction of its force, thereby realizing the control of the bending direction of the steerable sleeve 10; when the pulling force of pulling the traction rope 12 toward the proximal end is controlled by the driving component, the bending angle of the steerable sleeve 10 can be controlled.

[0043] In this embodiment, the steerable sleeve 10 includes three traction ropes 12, such as Figure 2 In the cross-sectional view of the steerable sleeve 10 shown, three traction ropes 12 ( Figure 3 The traction ropes 12 are evenly spaced in the circumferential direction of the sleeve body 11. The traction ropes 12 are evenly spaced to ensure that each traction rope 12 evenly shares the load when subjected to the pulling force of the driving component, thereby avoiding structural weaknesses caused by uneven force. The traction ropes 12 include but are not limited to steel wire ropes, polypropylene ropes, nylon ropes, and polyester fiber ropes. The traction ropes 12 in this embodiment are steel wire ropes.

[0044] In this embodiment, continue to see Figure 1 The longitudinal section of the groove 13 is rectangular and the cross section is semicircular. The depth of a single cut groove 13 is 0.4 mm and the width is 1.2 mm. It can be understood that the cutting length, width and opening angle of the groove 13 can be optimized to ensure that the steerable sleeve 10 can achieve a good balance between flexibility and axial rigidity.

[0045] In this embodiment, the cannula body 11 of the manipulable cannula 10 is made of a thin-walled nickel-titanium alloy tube, and its distal end is beveled to match the needle tip of the puncture biopsy needle 20. The beveled shape is conducive to reducing the puncture resistance of the manipulable cannula 10 and is conducive to the smooth extension of the puncture biopsy needle 20 to successfully complete the shearing operation of the pathological tissue. The cannula body 11 has a length of 30 mm, an inner diameter of 1.2 mm, and an outer diameter of 2 mm.

[0046] In this embodiment, a hose 15 (such as Figure 2As shown in the figure, the internal cavity of the hose 15 forms a biopsy channel for the movement (sliding) of the puncture biopsy needle 20. The length of the hose 15 is 30 mm, the inner diameter is 1.1 mm, and the outer diameter is 1.2 mm. The hose 15 is used to prevent the biopsy sample obtained from leaking out from the hollow part of the bottom surface of the groove 13 when the puncture biopsy needle 20 slides, and is also used to ensure that a safe and stable biopsy channel is formed to prevent the puncture biopsy needle 20 from leaking out from the hollow part of the bottom surface of the groove 13. Preferably, the hose 15 is composited with three layers of materials, including an inner layer, a middle layer and an outer layer of materials. The inner layer material is an ultra-high molecular weight polyethylene coating, which is generated on the inner surface of the middle layer material by plasma-assisted chemical vapor deposition technology to isolate the cavity inside the hose 15 and the tissue outside the manipulable sleeve 10. The middle layer material is a braided reinforced polyurethane tube, which is made of fine polyamide fibers interwoven at a specific braiding angle to provide radial support for the hose 15. The outer layer material is a hydrophilic polyacrylamide gel coating, which is generated on the outer surface of the middle layer material by ultraviolet light-induced polymerization reaction to play a lubricating role and reduce the puncture resistance of the steerable sleeve 10 .

[0047] In some embodiments, the steerable sleeve 10 may also integrate optical fiber pressure sensing technology to monitor the bending state and stress of the steerable sleeve 10 in real time. The optical fiber pressure sensing technology mainly detects pressure by changing the propagation characteristics of light in the optical fiber. Its basic principle is to use the optical fiber as a sensitive element. When the optical fiber is subjected to external pressure, the shape, size or refractive index of the optical fiber changes. These changes will affect the propagation characteristics of light in the optical fiber, such as light intensity, phase, wavelength, polarization, etc., thereby realizing the detection of pressure. In this embodiment, a fiber grating strain sensor (not shown) is installed on the outer tube wall of the proximal end of the steerable sleeve 10, and a plurality of optical fibers are embedded in the hose 15. The optical fibers extend along the axial direction of the hose 15. The fiber grating strain sensor is connected to the optical fiber. The fiber grating strain sensor transmits an optical signal to the optical fiber and receives a reflected optical signal. By measuring the wavelength changes of the emitted light and the reflected light, the bending state and stress of the steerable sleeve 10 are accurately detected.

[0048] The driving component includes but is not limited to a DC motor, an AC motor, a stepper motor and a servo motor. The connection method between the driving component and the proximal end of the traction rope 12 includes but is not limited to direct connection, belt connection, and chain connection. In the present embodiment, the driving component is a stepper motor, and the stepper motor includes a rotating shaft. After receiving a digital control signal (electric pulse signal) transmitted from the outside, the stepper motor can convert it into an angular displacement instruction corresponding thereto, so as to achieve precise control of the rotation angle of the rotating shaft. In the present embodiment, the three traction ropes 12 are directly connected to the rotating shafts of the three stepper motors respectively, and the proximal ends of the traction ropes 12 are fixed on the rotating shaft. When the rotating shaft is controlled to rotate a certain angle, the traction rope 12 gradually wraps around the rotating shaft to a certain length and bears the corresponding tension. The longer the length of the traction rope 12 wrapped around the rotating shaft, the greater the tension it is subjected to. By pulling different traction ropes 12 with different stepper motors, the bending direction of the controllable sleeve 10 can be controlled; by accurately controlling the rotation angle of the rotating shaft of the stepper motor, the force degree of the traction rope 12 in the axial direction of the controllable sleeve 10 can be accurately controlled, thereby achieving precise control of the bending angle of the controllable sleeve 10.

[0049] The structural schematic diagram of the puncture biopsy needle 20 is as follows Figure 3 As shown. The needle tip of the puncture biopsy needle 20 is beveled to facilitate puncture action and precise orientation. The puncture biopsy needle 20 is provided with a biopsy groove 21 at the distal end, and the biopsy groove 21 is used to cut the biopsy sample (biopsy tissue). When the puncture biopsy operation is performed, the biopsy groove 21 can extend from the internal cavity of the manipulable sleeve 10. Preferably, the wall surface of the biopsy groove 21 is made into a micro-tooth structure using electric spark machining technology, which is conducive to improving the collection efficiency of biopsy samples. Preferably, the puncture biopsy needle 20 is made of superelastic nickel-titanium alloy wire, and the needle body is made of heat treatment technology to achieve a gradient change in elastic modulus. The proximal end of the puncture biopsy needle 20 is harder to provide a thrust so that the distal end of the puncture biopsy needle 20 extends from the distal end of the manipulable sleeve 10; the distal end of the puncture biopsy needle 20 is softer to reduce damage to the surrounding healthy orbital tissue during the puncture process.

[0050] In this embodiment, the puncture biopsy needle 20 has a length of 50 mm, an inner diameter of 0.65 mm, and an outer diameter of 0.8 mm. The length of the puncture biopsy needle 20 is greater than the length of the steerable cannula 10, so that when the puncture biopsy needle 20 is pushed to partially extend out of the steerable cannula 10, the biopsy groove 21 can be exposed outside the steerable cannula 10. The puncture biopsy needle 20 is also provided with a depth mark on the needle body to facilitate the doctor to observe and control its puncture depth.

[0051] In some embodiments, the puncture biopsy needle 20 can also integrate optical coherence tomography technology to monitor the position information of the puncture biopsy needle 20 in real time. The optical coherence tomography technology is based on the principle of optical coherence. By recording the reflection or scattering signal of the sample to be tested (orbital tissue) to the incident light, a two-dimensional or three-dimensional structural image of the sample to be tested can be obtained by scanning technology. In this embodiment, the interior of the puncture biopsy needle 20 is used for optical coherence tomography to locate the optical fiber assembly (not shown in the figure). The optical fiber assembly includes a micro-optical fiber and a detector. The micro-optical fiber transmits the incident light to the orbital tissue, and then the detector collects and transmits the light signal reflected or scattered from the orbital tissue to achieve real-time imaging, determine the position of the puncture biopsy needle 20 inside the orbital tissue, and provide more accurate guidance for the doctor's surgical operation.

[0052] The present invention also provides an orbital tissue puncture biopsy system, which includes a robotic arm, a B-ultrasound device, and the puncture biopsy device described above, which is described in detail below.

[0053] The distal end of the manipulator is equipped with several quick-change interfaces, which are fixedly connected to the proximal end of the manipulable sleeve 10 and the proximal end of the puncture biopsy needle 20. The manipulable sleeve 10 and the puncture biopsy needle 20 can be transferred to the patient's eye socket position by the manipulator, and the puncture biopsy needle 20 and the manipulable sleeve 10 can be respectively controlled by the manipulator to move toward the proximal end or the distal end. When the biopsy sampling operation is not performed, the puncture biopsy needle 20 is retracted into the internal cavity of the manipulable sleeve 10 by the manipulator; when the biopsy sampling operation is performed, the puncture biopsy needle 20 is pushed out of the internal cavity of the manipulable sleeve 10 by the manipulator, so that the biopsy groove 21 of the puncture biopsy needle 20 pierces the pathological tissue, and then the manipulable sleeve 10 is pushed toward the distal end along the puncture biopsy needle 20 by the manipulator to shear a small amount of pathological tissue in the biopsy groove 21.

[0054] In this embodiment, the robotic arm is a four-degree-of-freedom serial robotic arm, consisting of two mutually perpendicular translation joints and two mutually parallel rotation joints. The translation joint adopts high-precision ball screw transmission, combined with linear guide rails, to achieve precise linear motion; the rotation joint uses a harmonic reducer, which has the characteristics of high precision, low backlash and high rigidity. All joints of the robotic arm use high-resolution encoders and high-precision torque sensors to achieve closed-loop control of position and force. The robotic arm material is selected from aviation-grade aluminum alloy, and through topological optimization design, the weight is minimized while ensuring rigidity. The joint drive of the robotic arm adopts a brushless DC motor, which has high efficiency and low noise characteristics. The entire robotic arm integrates active anti-seismic technology, which can compensate for external vibrations in real time and further improve the accuracy of puncture biopsy operations. This design enables the robotic arm to cooperate in completing the puncture biopsy, and the robotic arm accurately adjusts the manipulable cannula 10 and the puncture biopsy needle 20 connected thereto to be positioned just above the eyeball, and the robotic arm accurately pushes the distal ends of the manipulable cannula 10 and the puncture biopsy needle 20 to reach the pathological tissue. The robotic arm not only ensures the stability and accuracy of the puncture process, but also effectively avoids the tremor caused by physiological fatigue of the doctor, significantly improving the safety and success rate of the operation.

[0055] In some embodiments, the robotic arm may be the MOTOMAN-GP series of YASKAWA, the MOTOMAN-HC series of YASKAWA, the LBR iiwa of KUKA, the KR4AGILUS of KUKA, the LR Mate 200iD of FANUC, the Robot M-10iA series of FANUC, the IRB 120, the IRB 2600 of ABB, etc.

[0056] The B-ultrasound (B-ultrasound) device is used to provide real-time images of the orbital tissue before and during the operation, so as to identify, locate and plan the lesion path before the operation. The B-ultrasound device includes a B-ultrasound probe, a signal processing module, and a B-ultrasound imaging display screen, and the B-ultrasound probe is electrically / signally connected to the B-ultrasound imaging display screen. After the B-ultrasound probe transmits an ultrasonic signal into the orbital tissue, it receives an echo signal, which is transmitted to the signal processing module. The signal processing module performs a logical operation based on the received echo signal and converts it into a two-dimensional B-ultrasound image presented on the B-ultrasound imaging display screen. During the operation, on the one hand, the B-ultrasound guides the manipulable cannula 10 and the puncture biopsy needle 20 inside it to bypass important tissues such as the eyeball to reach the lesion area and complete the biopsy. The resolution imaging of the B-ultrasound can display structures such as the eyeball, bones and eye muscles, helping doctors to accurately identify the target area for puncture. The real-time imaging function of the B-ultrasound device allows doctors to monitor the dynamic changes of the orbital tissue during the puncture process to ensure the accuracy of the operation. On the other hand, B-ultrasound supports multi-plane and multi-angle imaging, providing a more comprehensive perspective to adapt to the complex anatomical structure of the orbit, and enhancing the effect of puncture guidance. The radiation-free feature makes B-ultrasound safer for patients in long-term or repeated monitoring. On the other hand, B-ultrasound's good imaging effect on soft tissue is particularly suitable for evaluating soft tissue lesions in the orbit, such as masses or cysts, which helps doctors to perform more accurate positioning and puncture.

[0057] In some embodiments, the B-ultrasound device can be Sequoia from Siemens, E20 from GE Healthcare, EPIQ from Philips, Helix 880 from Fuji, Apollo i900 from Canon, Nuwa series from Mindray, P60 from Kaili, etc.

[0058] In this embodiment, the specific operation steps of the orbital tissue puncture biopsy system guided by B-ultrasound include:

[0059] Step 1, preoperative preparation: B-ultrasound imaging positioning. Before performing a puncture biopsy, B-ultrasound imaging is first performed to obtain high-resolution images of the orbital tissue. The doctor slides the B-ultrasound probe over the patient's orbital area and observes and records the image of the internal structure of the orbit through the B-ultrasound imaging display to ensure that the target tissue, abnormalities or lesions are clearly seen.

[0060] Step 2: Plan the puncture path. Under the guidance of B-ultrasound images, the doctor determines the puncture location and plans a reasonable puncture path to avoid damaging important tissues in the orbit. The real-time image of B-ultrasound provides accurate guidance information, allowing the doctor to determine the best puncture point and depth.

[0061] Step 3, insert the manipulable cannula according to the planned puncture path. After determining the puncture position, the doctor manipulates the orbital tissue puncture biopsy system and inserts the manipulable cannula into the orbital tissue according to the planned puncture path. First, the manipulable cannula and the puncture biopsy needle are conveyed close to the patient's eye socket by the robotic arm. After the robotic arm is adjusted to reach the predetermined position, the puncture biopsy device starts working. According to the lesion position located before the operation and the planned path, the manipulable cannula and the puncture biopsy needle are pushed to the far end by the robotic arm into the orbital tissue. During the process, the doctor tracks the operation in real time under the feedback of the B-ultrasound image, controls the insertion of the manipulable cannula and / or the puncture biopsy needle through the robotic arm according to the B-ultrasound image, and controls the bending direction and / or angle of the manipulable cannula by pulling the traction rope through the driving component, so as to ensure that the manipulable cannula can bypass the eyeball based on the preoperatively planned path and reach the lesion area at the far end, avoid damaging important tissues, and ensure the accuracy and safety of the puncture.

[0062] Step 4, biopsy sampling operation. After the distal end of the manipulable cannula reaches the target position, the doctor uses the robotic arm to control the puncture biopsy needle to perform the biopsy operation. Under the feedback of the B-ultrasound image, the doctor uses the robotic arm to control the puncture biopsy needle to extend out of the manipulable cannula along the internal cavity of the manipulable cannula and pierce the tissue in the lesion area. Then the doctor uses the robotic arm to control the manipulable cannula to move toward the distal end along the puncture biopsy needle, shear a small amount of pathological tissue in the biopsy groove at the distal end of the puncture biopsy needle, and isolate it from normal tissue. After completion, withdraw the puncture biopsy needle and take out the biopsy sample, which will be sent to the laboratory for detailed pathological examination.

[0063] In summary, the present invention provides an orbital tissue puncture biopsy device and system, which significantly improves the accuracy and safety of orbital puncture biopsy through the coordinated work of a manipulable cannula, a puncture biopsy needle, a driving component and a robotic arm. The system controls the traction rope in the tube body of the manipulable cannula through a driving component, thereby achieving precise control of the manipulable cannula, making it more flexible during the puncture process and easy to bypass sensitive areas. The system is also equipped with a robotic arm to stably transmit the manipulable cannula and the puncture biopsy needle to the target position, and the biopsy sampling is completed by the robotic arm, reducing the risk of human tremor. In addition, the integrated B-ultrasound device provides real-time high-resolution imaging, ensuring that the doctor can accurately monitor the entire biopsy process, thereby improving the accuracy and safety of the operation. The orbital tissue puncture biopsy system of the present invention is expected to be widely applicable to the clinical diagnosis and treatment of various orbital diseases, such as tumors, cysts and infections, and become an indispensable and important tool in ophthalmology and orbital surgery.

[0064] Although the content of the present invention has been described in detail through the above preferred embodiments, it should be appreciated that the above description should not be considered as a limitation of the present invention. After reading the above content, it will be apparent to those skilled in the art that various modifications and substitutions of the present invention will occur. Therefore, the protection scope of the present invention should be limited by the appended claims.

Claims

1. An orbital tissue puncture biopsy device, characterized in that: It includes a manipulable cannula, several driving components, and a puncture biopsy needle; The manipulable sleeve comprises a sleeve body and a traction rope. The surface of the sleeve body is provided with a plurality of groove groups, each of the groove groups comprises two mirror-symmetrical grooves, and the opening directions of adjacent groove groups are perpendicular to each other. At least three traction rope channels are provided in the sleeve body, and the traction rope channels extend along the axial direction of the sleeve body. The traction rope passes through the entire length of the sleeve body from the traction rope channels, the distal end of the traction rope is fixed to the distal end of the sleeve body, and the proximal end of the traction rope is led out from the proximal end of the sleeve body. The driving component is connected to the proximal end of the traction rope, and the driving component controls the bending direction and / or angle of the steerable sleeve by pulling the traction rope; The needle tip of the puncture biopsy needle is beveled; the puncture biopsy needle is provided with a biopsy groove at the distal end, and the biopsy groove is used to cut the biopsy sample; the puncture biopsy needle can slide in the steerable sleeve, and at least part of it can extend out of the steerable sleeve from the distal end of the steerable sleeve.

2. The orbital tissue puncture biopsy device according to claim 1, characterized in that: The groove groups are distributed at equal intervals in the axial direction of the sleeve body.

3. The orbital tissue puncture biopsy device according to claim 1, characterized in that: The traction rope channels are distributed at equal intervals in the circumferential direction of the sleeve body.

4. The orbital tissue puncture biopsy device according to claim 1, characterized in that: The steerable cannula further includes a hose adhered to the inner tube wall of the cannula body.

5. The orbital tissue puncture biopsy device according to claim 1, characterized in that: The distal end of the maneuverable sleeve is in a beveled shape and is adapted to the needle tip of the puncture biopsy needle.

6. The orbital tissue puncture biopsy device according to claim 1, characterized in that: The puncture biopsy needle and the sleeve body are both made of nickel-titanium alloy.

7. The orbital tissue puncture biopsy device according to claim 1, characterized in that: The biopsy needle includes a fiber optic assembly for optical coherence tomography to locate the needle body.

8. The orbital tissue puncture biopsy device according to claim 4, characterized in that: A plurality of optical fibers are embedded in the hose, and the optical fibers extend along the axial direction of the hose; a fiber grating sensor is installed outside the proximal end of the manipulable sleeve, and the fiber grating sensor is connected to the optical fibers in the hose.

9. An orbital puncture biopsy system, characterized in that: Include: The orbital tissue puncture biopsy device according to any one of claims 1 to 8, A robotic arm, wherein the distal end of the robotic arm comprises a plurality of interfaces, wherein the interfaces are used to respectively connect and fix the proximal end of the manipulable cannula and the proximal end of the puncture biopsy needle to transport the manipulable cannula and the puncture biopsy needle to a designated position, and to control the manipulable cannula and / or the puncture biopsy needle to move toward the proximal end or the distal end; The B-ultrasound device comprises a B-ultrasound probe, a signal processing module, and a B-ultrasound imaging display screen. The B-ultrasound probe and the B-ultrasound imaging display screen are electrically / signally connected. After the B-ultrasound probe transmits an ultrasonic signal into the orbital tissue, it receives an echo signal, and the echo signal is transmitted to the signal processing module. The signal processing module performs a logical operation based on the received echo signal, converts it into a B-ultrasound image and presents it on the B-ultrasound imaging display screen. According to the B-ultrasound image, the movement of the steerable cannula and / or the puncture biopsy needle is controlled by the robotic arm.

10. The orbital puncture biopsy system according to claim 9, characterized in that: The bending direction and / or angle of the steerable sleeve is controlled by the driving component according to the B-ultrasound image.

Images