Needle tube set module, puncture actuator and surgical robot

Abstract

The invention discloses a needle tube set module, a puncture actuator and a surgical robot, and the needle tube set module is suitable for retinal blood vessel injection and retinal sublayer injection of fundus microsurgery. The inner tube is connected with the needle tip, a bent section is arranged at the joint of the inner tube and the needle tip, the inner tube is made of a shape memory material and is provided with a pre-bending angle, and a medicine injection channel is arranged in the needle tip and the inner tube; at least part of the inner tube is connected into the outer tube in a sliding mode, the needle tip and the inner tube can do telescopic motion in the outer tube, and the needle tip, the inner tube and the outer tube can do rotary motion; and the force sensing element is arranged on the outer pipe. The problem of adjusting the angle of puncturing the retina is solved, the high-precision intraocular flexible arm and the force sensing element can be integrated at the same time, the depth can be accurately sensed through the force sensing element in the retina sublayer injection operation puncturing process, the puncturing path can be prolonged, medicine backflow can be avoided, and therefore the operation success rate is increased.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a needle tube assembly module, a puncture actuator and a surgical robot. Background Art

[0002] Subretinal injection (SI) is a minimally invasive treatment method that directly injects drugs, gene vectors, or stem cells into the potential space between the retina and the retinal pigment epithelium (RPE). This area, known as the subretinal space, is a key lesion site for many retinal diseases.

[0003] The retina is a highly stratified layer of neural tissue located at the back of the eyeball. From the outside in, it primarily comprises the retinal pigment epithelium (RPE), photoreceptor layer, bipolar cell layer, and ganglion cell layer. The potential space between the RPE and the outer segments of the photoreceptors is the target area for subretinal injections. This structure is crucial for supporting the metabolism of photoreceptors and maintaining visual function. Damage to it can cause irreversible vision loss.

[0004] The injection is typically performed around the fovea, the area of ​​greatest visual acuity. The surgeon selects a puncture point through the vitreous cavity using micromanipulation. Using a microinjection needle, the surgeon penetrates the neural retina and slowly injects fluid, creating a localized retinal bulge (bleb). This precisely delivers the therapeutic substance into the subretinal space. The depth of the puncture and the injection rate must be carefully controlled to prevent retinal tears or tissue damage.

[0005] Subretinal injections are widely used in the treatment and research of the following diseases: inherited retinal diseases (such as Leber congenital amaurosis and retinitis pigmentosa): injection of gene therapy vectors (such as AAV vectors); age-related macular degeneration (AMD): delivery of anti-angiogenic drugs or stem cells to promote visual function repair; diabetic retinopathy: achieve targeted local drug delivery and reduce systemic side effects; experimental animal studies: used for disease model establishment or new therapy verification.

[0006] Existing retinal injectors, such as the retinal vascular injector and injection method for an ophthalmic surgical robot disclosed in the Chinese patent document with publication number CN110368184A previously applied by the inventor, use a needle assembly module to control the horizontal release of the needle tip, a feeding module to advance the needle tip, and a rotation module to rotate the needle tip. Driven by the robotic arm of the ophthalmic surgical robot, the needle tip can also be moved up and down, increasing the efficiency of retinal vascular positioning by more than 30% and making vascular positioning more precise. However, during the process of puncturing the retinal blood vessels, the precise adjustment of the bending angle is limited because the curved portion of the needle tip is pre-bent in a shorter area and the extended length of the needle tip corresponds to the angle.

[0007] In addition, because retinal vascular injection is different from subretinal injection, before subretinal injection, the intraocular instrument needs to pass through a 23G or higher scleral cannula (inner diameter 0.52mm) into the vitreous cavity. The intraocular instrument is then moved further, gradually approaching the retina for surgical operation. Limited by the size of the scleral minimally invasive opening, the intraocular instrument cannot simultaneously integrate the intraocular flexible arm and the force sensing element, resulting in the inability to perform tactile perception during subretinal injection, and the retina can only be punctured at a fixed, approximately vertical angle, which can easily cause problems such as excessive puncture and reflux during drug injection.

[0008] In summary, existing retinal vascular injectors are unable to simultaneously integrate high-precision intraocular flexible arms and force sensing elements, resulting in an inability to sense depth and extend the puncture path during subretinal injection surgery, leading to drug reflux and a reduced success rate of the surgery. Summary of the Invention

[0009] The purpose of the present invention is to provide a needle and tube assembly module, a puncture actuator and a surgical robot suitable for retinal vascular injection and subretinal injection in fundus microsurgery, so as to solve the problem that the existing retinal vascular injector cannot simultaneously integrate a high-precision intraocular flexible arm and a force sensing element, resulting in the inability to perceive the depth during the subretinal injection surgical puncture and the inability to extend the puncture path, leading to drug reflux and reducing the success rate of the operation.

[0010] In a first aspect, the present invention provides a needle tube assembly module, the needle tube assembly module comprising:

[0011] needle tip;

[0012] An inner tube connected to the needle tip and configured as a curved section at the connection, the inner tube being made of a shape memory material and having a pre-bent angle, and a drug injection channel being configured inside the needle tip and the inner tube;

[0013] an outer tube, wherein at least a portion of the inner tube is slidably connected to the outer tube, the needle tip and the inner tube are capable of telescopic movement within the outer tube, and the needle tip, the inner tube, and the outer tube are capable of rotational movement;

[0014] The force sensing element is mounted on the outer tube.

[0015] In one embodiment of the present invention, the needle tip and the inner tube are an integrated structure, the needle tip is provided with a sharp tip, and the needle tip is made of a shape memory material.

[0016] In one embodiment of the present invention, a drug injection tube is further included, which is connected to the inner tube and communicated with the drug injection channel.

[0017] In one embodiment of the present invention, a plurality of the force sensing elements are fixed to the outer wall of the outer tube near the needle tip in a circular array.

[0018] In one embodiment of the present invention, the force sensing element is a Bragg fiber grating sensor.

[0019] In a second aspect, the present invention provides a puncture actuator, comprising the needle tube assembly module, and further comprising:

[0020] An inner tube feeding module, connected to the inner tube, for driving the inner tube and the needle tip to perform telescopic motion within the outer tube;

[0021] The rotating module is connected to the inner tube feeding module and is used to drive the inner tube feeding module and the needle tube group module connected to the inner tube feeding module to rotate, so that the needle tip, the inner tube and the outer tube perform rotational motion.

[0022] In one embodiment of the present invention, the needle tube assembly module further includes a mounting frame, the mounting frame is mounted on the rotating module, the rotating module is used to drive the mounting frame to rotate, and the outer tube is inserted into the mounting frame.

[0023] In one embodiment of the present invention, the inner tube feeding module includes a power drive unit, a screw, a screw nut, an inner tube connecting piece and a slide rail, and the slide rail is installed on the mounting frame; one end of the screw is rotatably installed on the mounting frame, and the other end is connected to the power drive unit installed on the mounting frame, the screw nut is installed on the screw, and the slide rail is arranged parallel to the screw; the inner tube connecting piece is slidably installed on the slide rail and is connected to the screw nut, the inner tube connecting piece is connected to the inner tube, and the inner tube connecting piece moves linearly along the slide rail under the drive of the screw nut to drive the inner tube to perform telescopic movement in the outer tube; the power drive unit includes a first driving mechanism, a first pulley connected to the first driving mechanism, a second pulley connected to the first pulley through a conveyor belt, and the second pulley is connected to the screw.

[0024] In one embodiment of the present invention, the rotation module includes a second driving mechanism, which is installed on the actuator fixing seat. The output shaft of the second driving mechanism is equipped with a rotating fastening nut, which is connected to the mounting bracket. The second driving mechanism drives the mounting bracket to rotate through the rotating fastening nut.

[0025] In a third aspect, the present invention provides a surgical robot comprising the puncture actuator and a linear guide rail module, wherein the puncture actuator is mounted on the linear guide rail module, and the linear guide rail module is used to drive the puncture actuator to move.

[0026] Beneficial effects of the present invention:

[0027] The present invention can directly inject drugs into the subretinal layer of tiny lesions, successfully breaking through the physiological limits of human hands and achieving the purpose of treatment. The needle tube group module uses a concentric tube structure to flexibly adjust the puncture angle, while ensuring the accuracy and stability of the puncture trajectory during the puncture process, as well as the stability of the overall structure. The needle tube group module makes the needle tip and the inner tube into an integral structure, so that the needle tip and the inner tube can be rotated at the same angle at the same time, thereby adjusting the direction of puncture into the blood vessel. In addition, the needle tube group module presets a bending curvature for the curved section of the needle tip and the inner tube in the outer tube, and the curvature is constant. Based on the working principle of the concentric tube, during the extension process of the needle tip and the inner tube, as the extended length increases, the needle tip and the inner tube that leak out of the outer tube are equivalent to the flexible arm gradually changing from a straight line to a curved state, thereby ensuring the precise adjustment of the bending angle of the needle tube group module, and performing force sensing through the force sensing element, thereby achieving precise retinal puncture injection.

[0028] When not in use, the needle tip of the needle-tube module of the present invention can be retracted into the outer tube along with the inner tube, reducing the overall diameter to less than 0.52 mm, allowing smooth passage through a 23G scleral cannula. This not only helps ensure needle tip hygiene but also protects the needle tip from external forces, preventing subsequent surgical hazards caused by changes in needle tip curvature after contact. Furthermore, it protects the needle tip before entering the eye. Therefore, the needle-tube module solves the size issue of intraocular instruments with integrated force sensing elements and concentric tube principle flexible arms, enabling them to enter the eye through a medical 23G scleral cannula.

[0029] The needle tip and inner tube of the needle tube assembly module of the present invention adopt an integrated design, which can effectively ensure the reliability of the connection between the needle tip and inner tube, without relying on welding or bonding. In addition, the integrated processing method of the needle tip and inner tube can also be used on straight rigid needles, so that the part entering the eye has a coarse and fine structure, ensuring overall rigidity. The needle tube assembly module integrates the needle with the intraocular flexible arm based on the concentric tube principle, solving the reliability problems of welding or gluing the connection between the needle and the concentric tube.

[0030] The present invention integrates a force sensing element, namely a Bragg fiber grating sensor, and has an overall diameter of less than 0.5 mm. It can use a 23G medical scleral cannula to enter the eye, ensuring the reliability of the integrated needle tip, and is particularly suitable for subretinal injection.

[0031] In summary, the present invention solves the problem of adjusting the angle of retinal puncture and can simultaneously integrate a high-precision intraocular flexible arm and a force sensing element. During the subretinal injection surgical puncture process, the force sensing element can accurately sense the depth, extend the puncture path, avoid drug reflux, and thus improve the success rate of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 It is a three-dimensional diagram of the puncture actuator provided by the present invention.

[0033] Figure 2 This is a front view of the puncture actuator provided by the present invention.

[0034] Figure 3 It is a side view of the puncture actuator provided by the present invention.

[0035] Figure 4 It is a top view of the puncture actuator provided by the present invention.

[0036] Figure 5 This is a partial effect diagram of the present invention controlling the pre-bending angle of the inner tube by extending the needle tip.

[0037] Figure 6 This is a rendering of the puncture actuator provided by the present invention installed on a surgical robot.

[0038] Figure 7 It is a schematic structural diagram of the present invention when the needle tip and the inner tube do not extend out of the outer tube.

[0039] Figure 8 It is a schematic diagram of the process of the needle tip and the inner tube extending out of the outer tube of the present invention.

[0040] Figure 9 It is a schematic diagram of the needle tip and the inner tube of the present invention rotating in the outer tube.

[0041] Figure 10 It is a schematic diagram of the overall structure of the outer tube and the force sensing element of the present invention.

[0042] Figure 11 yes Figure 10 Cross-sectional view along AA.

[0043] In the figure: 1. Needle tube assembly module; 1-1. Needle tip; 1-2. Inner tube; 1-3. Outer tube; 1-4. Force sensing element; 1-5. Injection microtube; 1-6. Mounting frame; 2. Inner tube feeding module; 2-1. First driving mechanism; 2-2. First pulley; 2-3. Conveyor belt; 2-4. Second pulley; 2-5. Screw; 2-6. Screw nut; 2-7. Inner tube connector; 2-8. Slide rail; 2-9. Tensioner; 3. Rotation module; 3-1. Bearing; 3-2. Rotation fastening nut; 3-3. Second driving mechanism; 4. Actuator fixing seat; 5. Linear guide module; 5-1. Sliding platform; 5-2. Linear guide; 5-3. Third driving mechanism. DETAILED DESCRIPTION

[0044] The technical solution of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the embodiments described are only some embodiments of the present invention, not all embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention.

[0045] In the description of the present invention, it should be noted that the terms "center," "up," "down," "left," "right," "vertical," "horizontal," "inside," and "outside" and the like, indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings and are intended only to facilitate the description of the present invention and simplify the description. They do not indicate or imply that the devices or components referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on the present invention. Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance. The terms "first position" and "second position" refer to two different positions.

[0046] In the description of the present invention, it should be noted that, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "connected" should be understood broadly. For example, they may refer to fixed or detachable connections; mechanical or electrical connections; direct or indirect connections through an intermediary; and connections within two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention.

[0047] An embodiment of the present invention provides a needle and tube assembly module, a puncture actuator, and a surgical robot, which are suitable for retinal vascular injection and subretinal injection in fundus microsurgery. The puncture actuator is an end effector adapted for an ophthalmic surgical robot, which is used to deliver therapeutic agents directly under the retinal layer to achieve subretinal injection. At the same time, it can also be used for injection into retinal blood vessels, which helps to fundamentally treat diseases.

[0048] Please refer to Figures 1 to 11 An embodiment of the present invention provides a needle tube group module, the needle tube group module 1 includes a needle tip 1-1, an inner tube 1-2, an outer tube 1-3, a force sensing element 1-4, an injection microtube 1-5 and a mounting frame 1-6, the outer tube 1-3 is inserted into the front end of the mounting frame 1-6, at least part of the inner tube 1-2 is slidably connected to the outer tube 1-3, and the inner tube 1-2 is concentrically constrained by the outer tube 1-3 during the extension process. The needle tip 1-1 and the inner tube 1-2 are concentrically arranged and integrally formed. The connection between the needle tip 1-1 and the inner tube 1-2 is a curved section. At least one force sensing element 1-4 is installed on the outer tube 1-3. The needle tip 1-1 and the inner tube 1-2 are provided with injection channels. The base of the inner tube 1-2 is connected to the injection microtube 1-5, and the other end of the injection microtube 1-5 is connected to an external syringe, so that manual injection can be performed.

[0049] In this embodiment, the needle tip 1-1 and inner tube 1-2 are integrally formed, resulting in a robust structure that avoids gluing marks, loose glue, and uneven overall stiffness of the inner tube 1-2. This facilitates installation and adjustment of the pre-bend angle of the inner tube 1-2. The needle tip 1-1 and inner tube 1-2 can slide relative to each other along the inner wall of the outer tube 1-3, facilitating release of the needle tip. The inner diameter of the injection channel can be selected to be 0.06 mm.

[0050] Optionally, the needle tip 1-1 and the inner tube 1-2 are made of shape memory material, preferably nickel-titanium alloy.

[0051] Optionally, a plurality of force sensing elements 1-4 are fixed to the outer wall of the outer tube 1-3 near the needle tip 1-1 in a circular array. Figure 11For example, this embodiment uses three force sensing elements 1-4 bonded to the outer tube 1-3 in a circular array, with the angle between adjacent force sensing elements 1-4 being 120 degrees. The force sensing elements 1-4 can be selected as fiber Bragg grating sensors. The needle tube assembly module 1 integrates force sensing elements 1-4 with force sensing, and the overall diameter is less than 0.5 mm. A 23G medical scleral cannula can be used for intraocular access, ensuring the reliability of the integrated needle tip, making it particularly suitable for subretinal injection.

[0052] Optionally, the manufacturing process of the needle tube group module 1 can be as follows: first, on the 0.2 mm diameter nickel-titanium tube (inner tube 1-2), by removing part of the nickel-titanium material, the diameter of a part of the nickel-titanium tube is reduced to 0.1 mm (needle tip 1-1), and then the part of the nickel-titanium tube with a diameter of 0.2 mm (inner tube 1-2) is pre-bent on a customized mold and heated to shape.

[0053] Therefore, the needle tip 1-1 and inner tube 1-2 of the needle tube assembly module 1 adopt an integrated design, which can effectively ensure the reliability of the connection between the needle tip 1-1 and the inner tube 1-2, without relying on welding or gluing. In addition, the integrated processing method of the needle tip 1-1 and the inner tube 1-2 can also be used on straight rigid needles, so that the part entering the eye is thicker and thinner, ensuring overall rigidity. The needle tube assembly module 1 integrates the needle and the intraocular flexible arm based on the concentric tube principle, solving the reliability problems existing in the connection methods such as welding or gluing between the needle and the concentric tube.

[0054] When not in use, the needle tip 1-1 of the needle tube assembly module 1 can be retracted into the outer tube 1-3 along with the inner tube 1-2, reducing the overall diameter to less than 0.52 mm, allowing it to pass smoothly through a 23G scleral cannula. This not only helps ensure the hygiene of the needle tip 1-1, but also ensures that the needle tip 1-1 is not touched by external forces, preventing subsequent surgical risks caused by changes in the curvature of the needle tip 1-1 after being touched, and can also protect the needle tip 1-1 before entering the eye. Therefore, the needle tube assembly module 1 solves the size problem of intraocular instruments with integrated force sensing elements and concentric tube principle flexible arms, enabling them to enter the eye through a medical 23G scleral cannula.

[0055] Among them, the bending angle of the needle tip 1-1 is divided into the following steps: before entering the 23G scleral cannula, the inner tube 1-2 is completely retracted into the outer tube 1-3, and after entering the eye, the inner tube 1-2 extends from the outer tube 1-3. Since a part of the inner tube 1-2 is pre-bent, as the extended length increases, the angle of the front needle tip 1-1 relative to the outer tube 1-3 gradually increases. In addition to adjusting the bending angle of the needle tip 1-1, the inner tube 1-2 and the outer tube 1-3 can also be rotated at the same time to adjust the direction.

[0056] In some embodiments, the curvature of the inner tube 1-2 end of the needle tube assembly module 1 is controllable and can be adjusted by pre-bending the angle. The diameter of the needle tip 1-1 is 0.1 mm, the diameter of the inner tube 1-2 is 0.2 mm, and the connection between the inner tube 1-2 and the needle tip 1-1 is configured as a 0.2 mm curved section. The needle tip 1-1 is ground, and the diameter of the curved section at the connection between the needle tip 1-1 and the inner tube 1-2 transitions from 0.2 mm to 0.1 mm.

[0057] Preferably, the insertion end of the needle tip 1 - 1 is processed into a sharp tip by laser processing and fine grinding.

[0058] In this embodiment, the end of the needle tip 1-1 has a sharp tip. During surgery, the inner tube 1-2 is first retracted into the outer tube 1-3 and enters the eye. After entering the eye, the bending angle of the needle tip 1-1 is adjusted according to the position of the blood vessels and the retina, and the angle between the needle tip 1-1 and the retina is further adjusted. During puncture, the puncture actuator is installed on the telecentric motion (RCM) mechanism of the fundus surgery robot and all joints on the actuator drive unit move in coordination, and puncture is performed at a small angle in the direction of the needle tip, achieving precise tilted insertion into the blood vessels or under the retinal layer, improving the adjustment of the accuracy of the retinal puncture angle.

[0059] It should be noted that the needle tip 1 - 1 of the needle tube module 1 generally needs to be inserted at a certain angle when inserted into the blood vessel. If it is inserted vertically into the blood vessel, it is very easy to puncture the entire blood vessel.

[0060] The needle and tube module 1 provided by the present invention can directly inject drugs into the subretinal layer of tiny lesions, successfully breaking through the physiological limits of human hands and achieving the purpose of treatment. The needle and tube module 1 uses a concentric tube structure to flexibly adjust the puncture angle, while ensuring the accuracy and stability of the puncture trajectory during the insertion process, as well as the stability of the overall structure. The needle and tube module 1 also forms an integral structure with the needle tip 1-1 and the inner tube 1-2, allowing the needle tip 1-1 and the inner tube 1-2 to rotate simultaneously and at the same angle, thereby adjusting the direction of insertion into the blood vessel. In addition, the needle tip 1-1 and the curved section of the inner tube 1-2 in the outer tube 1-3 of the needle tube group module 1 have a preset curvature, and the curvature is constant. Based on the working principle of concentric tubes, during the extension process of the needle tip 1-1 and the inner tube 1-2, as the extended length increases, the needle tip 1-1 and the inner tube 1-2 leaking out of the outer tube 1-3 are equivalent to the flexible arm gradually changing from a straight line to a curved state, thereby ensuring the precise adjustment of the bending angle of the needle tube group module 1, and performing force sensing through the force sensing element 1-4, thereby achieving precise retinal puncture injection.

[0061] For example, the inventor's previous Chinese patent application, CN110368184A, discloses a retinal vascular injector and injection method for an ophthalmic surgical robot. However, the angle adjustment of the front needle tip is imprecise, and the reliability of the needle tip adhering to the inner tube is very low, making it very prone to leakage and needle drop. The needle tube assembly module 1 provided by the present invention solves the problem of adjusting the angle for retinal puncture. It can simultaneously integrate a high-precision intraocular flexible arm and a force sensing element. During subretinal injection surgery, the force sensing elements 1-4 accurately sense the depth, extending the puncture path, preventing drug backflow, and thus improving the success rate of the surgery.

[0062] Compared with the existing syringe device, the needle tip bending angle of the needle tube group module 1 provided by the present invention can be adjusted in two ways: the first is by adjusting the pre-bending degree of the inner tube 1-2 itself, and the second is by constraining the length of the inner tube 1-2 extending out of the outer tube 1-3, wherein the pre-bending degree is determined in advance, and the bending angle is determined by the extension length and the pre-bending degree.

[0063] In addition, please refer to Figure 1 、 Figure 2 、 Figure 3 and Figure 4 An embodiment of the present invention also provides a puncture actuator with force perception, including the above-mentioned needle tube group module 1, and also including an inner tube feeding module 2, a rotating module 3 and an actuator fixing seat 4, the mounting frame 1-6 is installed at the front end of the rotating module 3, the base of the inner tube 1-2 is installed at the front end of the inner tube feeding module 2, the needle tube group module 1 is installed on the inner tube feeding module 2 and is fed under the drive of the inner tube feeding module 2, the inner tube feeding module 2 is installed at the front of the rotating module 3, the needle tube group module 1 and the inner tube feeding module 2 are rotated under the drive of the rotating module 3, and the rotating module 3 is installed on the actuator fixing seat 4 located at the rear of the inner tube feeding module 2.

[0064] In some embodiments, the inner tube feeding module 2 includes a power drive unit, a screw 2-5, a screw nut 2-6, an inner tube connector 2-7 and a slide rail 2-8. The slide rail 2-8 is installed on the mounting frame 1-6. One end of the screw 2-5 is rotatably installed on the front of the mounting frame 1-6. The other end of the screw 2-5 is connected to the power drive unit installed on the mounting frame 1-6. The screw nut 2-6 is installed on the screw 2-5. The slide rail 2-8 is arranged parallel to the screw 2-5. The lower part of the inner tube connector 2-7 is slidably installed on the slide rail 2-8, and the side of the inner tube connector 2-7 is connected to the screw nut 2-6. The inner tube connector 2-7 is connected to the inner tube 1-2. The inner tube connector 2-7 moves linearly along the slide rail 2-8 driven by the screw nut 2-6, thereby driving the extension and contraction of the inner tube 1-2.

[0065] With such arrangement, the inner tube connector 2-7 connects the inner tube 1-2, the lead screw nut 2-6 and the slide rail 2-8, so that the inner tube 1-2 can extend and retract relative to the outer tube 1-3 along the slide rail 2-8.

[0066] Optionally, the power drive unit includes a first drive mechanism 2-1, a first pulley 2-2 drivingly connected to the first drive mechanism 2-1, a second pulley 2-4 connected to the first pulley 2-2 via a conveyor belt 2-3, and the second pulley 2-4 is connected to the screw 2-5.

[0067] In this embodiment, the first pulley 2-2 is connected to the output shaft of the first drive mechanism 2-1. The first drive mechanism 2-1 is used to drive the first pulley 2-2 to rotate. The first pulley 2-2 drives the second pulley 2-4 to rotate via the transmission belt 2-3. The second pulley 2-4 drives the lead screw 2-5 to rotate, thereby causing the lead screw nut 2-6 to move up and down. Thus, the first drive mechanism 2-1 transmits motion to the lead screw 2-5 via the timing belt 2-3. The motion is then transmitted to the inner tube 1-2 via the lead screw 2-5, the lead screw nut 2-6, and the inner tube connector 2-7, causing it to extend and retract relative to the outer tube 1-3. The first drive mechanism 2-1 can be equipped with an AC servo motor.

[0068] Optionally, it also includes a tensioning member 2-9 installed at the rear of the mounting frame 1-6, the first driving mechanism 2-1 is installed on the tensioning member 2-9, and the second pulley 2-4 is installed at the other end of the screw 2-5; the tensioning member 2-9 is formed by two long strips of plates that are buckled together, and two hollow shafts are provided at the buckling part, each hollow shaft is embedded with a spring, and the release force of the spring pushes the first pulley 2-2 outward, thereby achieving tensioning of the conveyor belt 2-3.

[0069] In this arrangement, the tensioning member 2-9 and the mounting frame 1-6 of this embodiment are connected to form a whole, and two springs are installed in the two hollow shafts at the connection position to provide tension to the conveyor belt 2-3.

[0070] In some embodiments, the rotation module 3 includes a second drive mechanism 3-3, which is installed on the actuator fixing seat 4. The output shaft of the second drive mechanism 3-3 is installed with a rotating fastening nut 3-2, and the rotating fastening nut 3-2 is connected to the mounting frame 1-6. The second drive mechanism 3-3 drives the mounting frame 1-6 to rotate through the rotating fastening nut 3-2.

[0071] In this embodiment, the second drive mechanism 3-3 is connected to the needle assembly module 1 and the inner tube feeding module 2 via the mounting bracket 1-6, thereby driving the needle assembly module 1 and the inner tube feeding module 2 to rotate, thereby adjusting the orientation of the needle tip 1-1 so that the needle tip 1-1 and the target blood vessel are aligned in the same plane. An AC servo motor can be used for the second drive mechanism 3-3.

[0072] Optionally, the rotating module 3 further includes a bearing 3 - 1 , which is sleeved on the rotating shaft at the connection between the mounting bracket 1 - 6 and the actuator fixing seat 4 .

[0073] With this arrangement, since the AC servo motor has poor ability to withstand non-working loads, the bearing 3-1 is used to support the entire actuator, which greatly reduces the non-working load on the second drive mechanism 3-3.

[0074] To meet the precision requirements of the inner tube feed module 2 and the rotation module 3, each is equipped with an AC servo motor. Compared to conventional motors, AC servo motors can directly drive components at low speeds, unlike traditional fixed-power motors that require speed control mechanisms such as speed reducers. Consequently, they offer higher precision. In the stationary state, without current flowing, the motors self-lock through friction. High-precision optical encoders achieve micron-level accuracy and provide position information for the surgical robot's speed control, motion compensation, and other functions.

[0075] The inner tube feed module 2 has an accuracy of 1-2μm, while the rotation module 3 has a 270-degree travel range and an end-of-swing accuracy of 2-3μm. As a high-precision surgical instrument, deformation caused by the inherent rigidity of the components cannot be ignored. Therefore, the actuator minimizes bonding and assembly. For example, the mounting bracket 1-6 is a custom, one-piece 1060 aluminum alloy component, ensuring both rigidity and lightweight. The integrated machining of the needle tip 1-1 and inner tube 1-2 facilitates installation and replacement, and ensures uniform overall rigidity during the feeding of the inner tube 1-2.

[0076] At the same time, because the tissue contact stress between the needle and the subretinal insertion point is much greater than the operating force during the intubation process, the developed force sensing elements 1-4 must be integrated into the human eye. The present invention uses a fiber Bragg grating sensor for micro-force sensing. It is not affected by electrical noise, is easy to sterilize, and has good biocompatibility. Using an adaptive compensation algorithm, it can accurately obtain the value of the micro-force, thereby achieving two-dimensional force sensing.

[0077] The overall design distribution of the puncture actuator takes into account the center of gravity position and is continuously optimized to make the center of gravity close to the central axis position. This ensures that when the end rotates, no additional torque will be generated due to the deviation of the center of gravity, and the overall operation will be more stable.

[0078] In addition, please refer to Figure 6An embodiment of the present invention further provides a surgical robot, comprising the above-mentioned puncture actuator, and also comprising a linear guide rail module 5, wherein the actuator fixing seat 4 is mounted on the linear guide rail module 5, and the linear guide rail module 5 is connected to the telecentric motion (RCM) mechanism of the ophthalmic surgical robot, and the linear guide rail module 5 is used to drive the actuator fixing seat 4 to move, thereby driving the entire puncture actuator to move through the linear guide rail module 5.

[0079] In some embodiments, the linear guide module 5 includes a sliding platform 5-1, a linear guide 5-2, and a third drive mechanism 5-3. The actuator mount 4 is mounted on the sliding platform 5-1, which is slidably mounted on the linear guide 5-2 via bolts. The third drive mechanism 5-3 is connected to the linear guide 5-2. The third drive mechanism 5-3 propels the actuator mount 4 and its components for precise movement. A stepper motor can be used for the third drive mechanism 5-3.

[0080] The working principle of the present invention is:

[0081] The needle assembly module 1 is inserted into the patient's eyeball by the movement of the surgical robot's operating arm. The needle is then delivered to the vicinity of the target to be punctured by the robot's remote centripetal motion (RCM) mechanism to complete the rough positioning.

[0082] At this time, the first drive mechanism 2-1 starts to move and releases the needle tip 1-1, and then through the joint action of the linear guide module 5 and the second drive mechanism 3-3, an angle between 20-90 degrees can be formed, which is adjusted by the doctor.

[0083] Execute the subretinal layer or retinal blood vessel puncture program in the host computer, control the movement of the linear guide module 5 and the robot operating arm, and realize the coordinated movement of all joints on the robot's telecentric motion (RCM) mechanism and the drive unit on the actuator to realize the linear guide module 5 to puncture the subretinal layer or retinal blood vessels along the direction of the needle tip 1-1. At the same time, the force sensing element 1-4 on the outer tube 1-3 detects the puncture force. When the force reaches a preset value, the puncture is stopped and then the injection is performed.

[0084] The present invention ensures a secure connection through the integrated design of the needle tip 1-1 and the inner tube 1-2. Furthermore, the present invention eliminates one degree of freedom of longitudinal advancement of the actuator itself. In the prior art, the actuator has one linear degree of freedom, the guide rail provides another linear degree of freedom, and the motor that feeds the inner tube 1-2 provides another longitudinal degree of freedom. The present invention eliminates the intermediate rotational feed degree of freedom, retaining only two longitudinal degrees of freedom: one for the feed of the first drive mechanism 2-1 and the other for the longitudinal feed provided by the linear guide rail module 5.

[0085] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit the same. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. These modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the various embodiments of the present invention, and should all be included in the scope of protection of the present invention.

Claims

1. A needle tube assembly module, characterized in that: The needle tube assembly module (1) comprises: Needle tip (1-1); An inner tube (1-2) is connected to the needle tip (1-1) and is configured as a curved section at the connection; the inner tube (1-2) is made of a shape memory material and is configured with a pre-bending angle; and a drug injection channel is configured inside the needle tip (1-1) and the inner tube (1-2); An outer tube (1-3), at least a portion of the inner tube (1-2) is slidably connected inside the outer tube (1-3), the needle tip (1-1) and the inner tube (1-2) can perform telescopic movement inside the outer tube (1-3), and the needle tip (1-1), the inner tube (1-2) and the outer tube (1-3) can perform rotational movement; A force sensing element (1-4) is installed on the outer tube (1-3).

2. The needle tube assembly module according to claim 1, characterized in that: The needle tip (1-1) and the inner tube (1-2) are an integrated structure; the needle tip (1-1) is provided with a sharp tip; and the needle tip (1-1) is made of a shape memory material.

3. The needle tube assembly module according to claim 1, characterized in that: It also includes a drug injection tube (1-5), which is connected to the inner tube (1-2) and communicates with the drug injection channel.

4. The needle tube assembly module according to claim 1, characterized in that: A plurality of force sensing elements (1-4) are fixed in a circular array to the outer wall of the outer tube (1-3) at one end close to the needle tip (1-1).

5. The needle tube assembly module according to claim 1, characterized in that: The force sensing element (1-4) is a Bragg fiber grating sensor.

6. A puncture actuator, characterized in that: The needle tube assembly module (1) according to any one of claims 1 to 5 further comprises: An inner tube feeding module (2) is connected to the inner tube (1-2) and is used to drive the inner tube (1-2) and the needle tip (1-1) to perform telescopic movement within the outer tube (1-3); A rotating module (3) is connected to the inner tube feeding module (2) and is used to drive the inner tube feeding module (2) and the needle tube assembly module (1) connected to the inner tube feeding module (2) to rotate, so as to make the needle tip (1-1), the inner tube (1-2) and the outer tube (1-3) perform a rotational motion.

7. The puncture actuator according to claim 6, characterized in that: The needle tube assembly module (1) further comprises a mounting frame (1-6), wherein the mounting frame (1-6) is mounted on the rotating module (3), and the rotating module (3) is used to drive the mounting frame (1-6) to rotate, and the outer tube (1-3) is inserted into the mounting frame (1-6).

8. The puncture actuator according to claim 7, characterized in that: The inner tube feeding module (2) comprises a power drive unit, a lead screw (2-5), a lead screw nut (2-6), an inner tube connector (2-7) and a slide rail (2-8), wherein the slide rail (2-8) is mounted on the mounting frame (1-6); one end of the lead screw (2-5) is rotatably mounted on the mounting frame (1-6), and the other end is connected to the power drive unit mounted on the mounting frame (1-6); the lead screw nut (2-6) is mounted on the lead screw (2-5), and the slide rail (2-8) is arranged in parallel with the lead screw (2-5); the inner tube connector (2-7) is slidably mounted on the slide rail (2-8) and is in contact with the lead screw nut. The inner tube connector (2-7) is connected to the inner tube (1-2), and the inner tube connector (2-7) is connected to the inner tube (1-2). Driven by the lead screw nut (2-6), the inner tube connector (2-7) moves linearly along the slide rail (2-8) to drive the inner tube (1-2) to perform telescopic movement in the outer tube (1-3); the power drive unit includes a first driving mechanism (2-1), a first pulley (2-2) drivingly connected to the first driving mechanism (2-1), and a second pulley (2-4) connected to the first pulley (2-2) through a conveyor belt (2-3), and the second pulley (2-4) is connected to the lead screw (2-5).

9. The puncture actuator according to claim 7, characterized in that: The rotation module (3) includes a second drive mechanism (3-3), the second drive mechanism (3-3) is mounted on the actuator fixing seat (4), the output shaft of the second drive mechanism (3-3) is mounted with a rotating fastening nut (3-2), the rotating fastening nut (3-2) is connected to the mounting frame (1-6), and the second drive mechanism (3-3) drives the mounting frame (1-6) to rotate through the rotating fastening nut (3-2).

10. A surgical robot, characterized in that: The puncture actuator comprises the puncture actuator according to any one of claims 6 to 9, and further comprises a linear guide module (5), wherein the puncture actuator is mounted on the linear guide module (5), and the linear guide module (5) is used to drive the puncture actuator to move.

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