Fetal intrauterine congenital heart disease interventional operation robot and use method thereof

Abstract

The invention provides a fetal intrauterine congenital heart disease interventional operation robot and a using method, concentric tubes of the robot comprise N nickel-titanium alloy tubes which are sequentially nested, and the N nickel-titanium alloy tubes are sequentially an outermost tube, at least one middle tube and an innermost tube from outside to inside; wherein the middle pipe and the innermost pipe have hyperelasticity and memorability and are pre-bent by a set angle, and the bending angle of the middle pipe is smaller than that of the innermost pipe and is within the range of 10-30 degrees; the bending angle of the innermost pipe is at least 30 degrees; wherein the outermost pipe is not pre-bent and is a straight pipe; the numerical error of the concentricity of the outermost pipe, the central pipe and the innermost pipe is within 1%, the thicknesses of the pipe walls are sequentially reduced from outside to inside, and the distance of 0.05 m or above is reserved between the radiuses of every two adjacent pipes; and the rear end driving device is connected with the concentric pipe, controls the outermost pipe to stretch out and draw back, and controls the middle pipe and the innermost pipe to stretch out and draw back and rotate. According to the invention, the pre-bent concentric tube and the multi-degree-of-freedom rear-end driving device are combined, so that the focus can be accurately positioned.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular, to a fetal intrauterine congenital heart disease interventional surgery robot and a method of using the same. Background Art

[0002] Fetal cardiac intervention (FCI) is currently in its developmental stages in clinical practice. With only a little over 400 FCI surgeries worldwide, few institutions in China are capable of performing FCI, and most rely on experienced specialists. With the gradual development of modern surgery, challenges and bottlenecks in FCI surgery have gradually emerged:

[0003] The most important issue is the difficulty in positioning the fetus during FCI surgery. During FCI surgery, doctors typically insert a needle directly into the fetal heart. Fetal position completely determines whether the needle can penetrate the heart. Therefore, during conventional manual FCI surgery, it is often necessary to wait until the fetus reaches the appropriate position. Furthermore, the straight-rod nature of the needle severely impacts surgical efficiency and outcomes.

[0004] Secondly, passive interventional devices are difficult to operate. Lesions are located in different locations across different CHD patients. If the puncture needle cannot reach the designated location, the treatment becomes significantly more difficult. Passive puncture needles and interventional guidewires lack active control technology, making FCI procedures highly dependent on the surgeon's personal experience and intuition, significantly increasing the difficulty and uncertainty of the procedure.

[0005] Furthermore, the surgical precision is limited. During FCI surgery, the diameter of the puncture needle is usually around 17G (1.4mm). The surgeon's hands will inevitably tremble during the procedure, and even small movements can cause puncture errors. Furthermore, the fetal heart is small and fragile, making complications more likely.

[0006] Based on existing research, and on the research of concentric tube interventional robots and magnetically controlled guidewires, the development of an intrauterine congenital heart disease interventional surgical robot has important practicality and clinical value.

[0007] A search of prior art revealed a Chinese invention patent, CN202410053006.9, titled "A Concentric Tube Robot for Natural Orifice Surgery," which is capable of performing complex minimally invasive surgeries within natural orifices. However, its limitation is that it can only be used within natural orifices and cannot perform complex intrauterine interventional procedures.

[0008] Further research revealed a Chinese invention patent, CN118697390A, titled "An Active Biopsy Mechanism Based on a Concentric Tube Robot," which enables precise biopsy diagnosis with minimal tissue damage. However, its shortcomings lie in its design principles, which only cover the design of the puncture needle, without addressing the back-end driver. This makes the operation inconsistent with human behavior, prone to errors, and unable to perform biopsy procedures with high sensitivity. Summary of the Invention

[0009] In response to one of the defects in the prior art, the purpose of this application is to provide a fetal intrauterine congenital heart disease interventional surgery robot and its use method.

[0010] In a first aspect, the present application provides a fetal intrauterine congenital heart disease interventional surgery robot, comprising:

[0011] The concentric tubes include N nickel-titanium alloy tubes nested in sequence, which are, from the outside to the inside, an outermost tube, at least one intermediate tube, and an innermost tube;

[0012] The intermediate tube and the innermost tube both have superelasticity and memory and are pre-bent at set angles. The set angle of the intermediate tube is smaller than the set angle of the innermost tube and is within a range of 10°-30°. The set angle of the innermost tube is at least 30°.

[0013] Wherein, the outermost tube is not pre-bent and is a straight tube;

[0014] The numerical error of the concentricity of the outermost tube, the central tube, and the innermost tube is within 1%, and the rigidity of the tubes decreases from the outside to the inside, and a radius of more than 0.05 mm is reserved between adjacent tubes;

[0015] The rear end driving device is connected to the concentric tubes, controls the extension and contraction of the outermost tube, and controls the extension and rotation of the middle tube and the innermost tube.

[0016] Optionally, the outermost tube has an outer diameter of 2.80 mm, an inner diameter of 2.20 mm, a wall thickness of 0.30 mm, and a total length of 120 mm;

[0017] The intermediate tube has an outer diameter of 2.10 mm, an inner diameter of 1.60 mm, a wall thickness of 0.25 mm, a pre-bent arc length of 70 mm, a straight section length of 220 mm, a curvature radius of 90 mm, and a bending arc of

[0018] The innermost tube has an outer diameter of 1.40 mm, an inner diameter of 1.10 mm, a pre-bend length of 40 mm, a straight section length of 320 mm, a curvature radius of 30 mm, and a bending arc of above.

[0019] Optionally, the rear-end driving device includes:

[0020] The base plate is used to place the motor controller and is located at the bottom of the entire device;

[0021] Fixed plates, N+1 of which are arranged in parallel and fixed on the bottom plate;

[0022] Moving plates, N moving plates are located in the N intervals formed by the fixed plates, and the N moving plates sequentially clamp the outermost tube, the middle tube, and the innermost tube;

[0023] Ball screw motors, wherein N ball screw motors are respectively mounted on N fixed plates farther away from the concentric tubes, with their ball screws passing through the two fixed plates in front of them, and their guide blocks connected to the movable plate between the two fixed plates;

[0024] Rotating motors, N-1 rotating motors are fixed horizontally in parallel on a fixed plate farthest from the concentric tube;

[0025] Rotating shafts, N-1 rotating shafts are respectively connected to the rotating motors and pass through all the fixed plates and the movable plates;

[0026] The transmission element is provided on each of the movable plates, connects the rotating shaft and the intermediate tube and the innermost tube, and transmits the rotational kinetic energy from the rotating shaft to the intermediate tube or the innermost tube.

[0027] Optionally, the movable plate controls the movement of the corresponding outermost tube, the middle tube and the innermost tube; the rotating shaft drives the rotation of the corresponding middle tube and the innermost tube; and all degrees of freedom are independent of each other.

[0028] Optionally, the fixed plate is provided with N horizontally arranged through holes, into which N bearings are embedded respectively; the inner holes of N-1 bearings are square holes, through which the rotating shaft passes; the diameter of the inner hole of the middle bearing should be 0.05mm-0.10mm larger than the diameter of the fixed concentric tube to ensure concentricity, through which the concentric tube passes.

[0029] Optionally, the conductive member is provided on the movable plate and includes:

[0030] Bearings, N bearings are horizontally and side by side embedded in the movable plate; the rotating shaft, the middle tube or the innermost tube passes through them respectively;

[0031] Gears are matched and covered on the bearings corresponding to the rotating shaft and the concentric tubes; the rotating shaft, the middle tube or the innermost tube respectively pass through them; the inner hole of the gear is square, and the rotating shaft is square;

[0032] The clamping piece is fixed on the gear corresponding to the intermediate tube or the innermost tube, and clamps the intermediate tube or the innermost tube passing therethrough.

[0033] Optionally, the clamping member is a vertically symmetrical structure.

[0034] A second aspect of the present application provides a method for using a fetal intrauterine congenital heart disease interventional surgery robot, comprising:

[0035] Control the rear end drive device so that the outermost tube extends;

[0036] Control the rear end drive device, the middle tube extends from the outermost tube and bends;

[0037] Control the rear-end drive device to rotate the middle tube and change the direction of the puncture needle;

[0038] To control the rear end drive unit, the innermost tube extends from the middle tube and bends;

[0039] Control the rear-end drive device to rotate the innermost tube and locate it at the destination point;

[0040] After positioning or puncture is completed, the magnetically controlled guide wire passes through the inner diameter of the concentric tube, and the magnetic response of the electromagnet to the magnetically controlled guide wire is used to realize the navigation function of the fetal heart disease focus, so that the magnetically controlled guide wire reaches the target position.

[0041] Optionally, the magnetically controlled guidewire includes a magnetic segment, an embedded segment, and a non-magnetic segment;

[0042] The magnetic segment is made of a mixture of polydimethylsiloxane particles and micron-sized neodymium iron boron particles, with a mass ratio of 1.8 to 4.0;

[0043] The embedded section is an overlapping portion of a non-magnetic section embedded in a magnetic section, or a polytetrafluoroethylene tube is used to nest the magnetic section and the non-magnetic section, and glue is used to connect the embedded section;

[0044] Wherein, the non-magnetic segment is a nickel-titanium alloy guide wire.

[0045] A third aspect of the present application provides a method for preparing a magnetically controlled guide wire for use in any one of the fetal intrauterine congenital heart disease interventional surgery robots, comprising:

[0046] Mix polydimethylsiloxane particles and micron-sized neodymium iron boron particles in a mass ratio of 1.8-4.0, stir evenly, and evacuate for more than 40 minutes until there are no obvious bubbles in the mixed liquid;

[0047] The coating on the front end of the nickel-titanium alloy wire is peeled off, and the front end is embedded in the mold tube;

[0048] The mixed liquid is injected into the mold tube with a pressurized syringe. After injection, the mixed liquid is accelerated by irradiating with an ultraviolet lamp and roasting the mold head with a high-temperature gun. The mixture is gravity cured for more than 24 hours.

[0049] After solidification, the mold tube is peeled off and the inner core is taken out to obtain the unmagnetized magnetic control guide wire;

[0050] Magnetizing the unmagnetized magnetic control wire in a direction parallel to the magnetic field to obtain a magnetized magnetic control wire with one end as an N pole and the other end as an S pole;

[0051] After obtaining the magnetized magnetron guide wire, methacrylated gelatin, photoinitiator and deionized water are mixed in a mass ratio of 1:0.25:10 to form a hydrogel, which is evenly coated on the surface of the magnetron guide wire and cured under ultraviolet light.

[0052] The fetal intrauterine congenital heart disease interventional surgical robot provided in this application adopts a technical means combining a pre-bent concentric tube and a rear-end drive device with multiple degrees of freedom, which brings the technical effect of accurately locating the lesion.

[0053] Other technical effects brought about by the additional features will be further explained in the corresponding embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0054] Other features, objects and advantages of the present application will become more apparent upon reading the detailed description of non-limiting embodiments with reference to the following drawings:

[0055] Figure 1 FIG1 is a side view of a robot for intrauterine congenital heart disease interventional surgery according to an exemplary embodiment;

[0056] Figure 2 FIG1 is a top view of a robot for intrauterine congenital heart disease interventional surgery according to an exemplary embodiment;

[0057] Figure 3 FIG1 is a top view of a robot for intrauterine congenital heart disease interventional surgery according to an exemplary embodiment;

[0058] Figure 4 is a diagram showing a movable plate according to an exemplary embodiment;

[0059] Figure 5 1 is a schematic diagram of the overall assembly of a robot for intrauterine congenital heart disease interventional surgery according to an exemplary embodiment;

[0060] Figure 6 is a schematic diagram of an electromagnet according to an exemplary embodiment;

[0061] Figure 7 This is a flow chart showing a method for using a robot for intrauterine congenital heart disease interventional surgery according to an exemplary embodiment;

[0062] Figure 8 The present invention is a flow chart of a method for preparing a magnetically controlled guidewire according to an exemplary embodiment.

[0063] In the figure, 1- overall housing of the mechanism, 2- moving plate, 3- ball screw motor, 4- rotating motor, 5- bottom plate, 6- concentric tube;

[0064] 11-first fixing plate, 12-second fixing plate, 13-third fixing plate, 14-fourth fixing plate;

[0065] 21-first movable plate, 22-second movable plate, 23-third movable plate;

[0066] 31-first ball screw motor, 32-second ball screw motor, 33-third ball screw motor;

[0067] 41 - first rotating motor, 42 - second rotating motor, 43 - first rotating shaft, 44 - second rotating shaft, 221 - first gear, 222 - second gear;

[0068] 61-outermost tube (one-stage tube), 62-middle tube (two-stage tube), 63-innermost tube (three-stage tube). DETAILED DESCRIPTION

[0069] The present application is described in detail below with reference to specific embodiments. The following examples will help those skilled in the art to further understand the present application, but are not intended to limit the present application in any form. It should be noted that, without departing from the concept of the present application, a number of variations and improvements may be made by those skilled in the art, and these all fall within the scope of protection of the present application. Parts not described in detail in the following examples may be implemented using existing technologies.

[0070] During FCI surgery, doctors typically use a puncture needle to directly puncture the fetal heart. The fetal position completely determines whether the puncture needle can puncture the fetal heart. Therefore, in conventional manual FCI surgery, it is often necessary to wait until the fetus reaches the appropriate position before proceeding. The puncture needle itself is a straight rod, which seriously affects the fetal position and efficiency of the surgery. To address the above issues, embodiments of the present application provide a fetal intrauterine congenital heart disease interventional surgery robot to address these existing problems.

[0071] Reference Figure 1-Figure 5 As shown, in one embodiment of the present application, a fetal intrauterine congenital heart disease interventional surgery robot includes a concentric tube 6 and a rear end drive device.

[0072] The concentric tubes comprise N nested nickel-titanium alloy tubes, which, from the outside inward, consist of an outermost tube 61, at least one intermediate tube 62, and an innermost tube 63. The intermediate tubes 62 and innermost tube 63 exhibit superelasticity and memory properties, and are pre-bent at set angles. The intermediate tubes have a smaller bending angle than the innermost tube, ranging from 10° to 30°. The innermost tube has a bending angle of at least 30°. The outermost tube is not pre-bent and is straight.

[0073] Specifically, the concentric tubes in this application refer to the outermost tube, the middle tube, and the innermost tube that are nested together, that is, Figure 1 The entire device is shown with the protruding tubular portion on the left.

[0074] Specifically, the superelasticity of the middle tube 62 and innermost tube 63 refers to the material's presence of an elastic potential energy function, a scalar function of the strain tensor whose derivative with respect to the strain component is the corresponding stress component. This phenomenon allows the strain to recover automatically upon unloading. Memory refers to the property of a material that, after undergoing physical deformation (such as stretching, compression, bending, etc.), can spontaneously return to its original shape when the external force is removed or specific conditions (such as temperature changes, light exposure, electric fields, etc.) are met.

[0075] The superelasticity and memory of the present application are obtained by the following method: heating the nickel-titanium alloy tube at a high temperature of 550° C. for 30 minutes.

[0076] The numerical error of the concentricity of the outermost tube 61, the central tube 62 and the innermost tube 63 is within 1%, and the tube wall thickness decreases from the outside to the inside. The radius between two adjacent tubes is reserved for a distance of more than 0.05 mm.

[0077] Specifically, the concentricity error between the outermost, middle, and innermost tubes is within 1%, and a minimum radius of 0.05mm is reserved between adjacent tubes. This high concentricity ensures the stability of each layer of tubes during expansion and contraction, avoiding mutual interference and enabling more precise operation. Appropriate radial spacing ensures the relative independence of each tube while preventing excessive gaps that could compromise the overall structure, ensuring the reliability of the instrument during surgery.

[0078] The tube wall thickness decreases sequentially, ensuring the inner tube yields to the outer tube's rigidity. Due to the shape memory and superelasticity of nickel-titanium alloy, the inner tube can extend from the outer tube and restore its pre-bent shape at high temperatures. This means that through the inter-nesting and expansion of the tubes, the inner tube can be completely contracted within the outer tube and can also be fully extended to restore its original pre-bent shape, thus enabling multiple punctures and post-puncture direction changes. A certain spatial distance is maintained to ensure that the concentric tubes have the ability to expand and contract and rotate with each other.

[0079] The rear end driving device is connected to the concentric tubes 6 to control the extension and contraction of the outermost tube 61 and the extension and rotation of the middle tube 62 and the innermost tube 63.

[0080] In the embodiments of the present application, the design of the concentric tube structure allows for puncture of the fetal heart even when the fetal position has not reached the ideal position. During the puncture operation, since the outermost tube is a straight tube, while the middle tube and the innermost tube are pre-bent and have different bending angles, the rigidity of the tube gradually decreases from the outside to the inside. This type of design enables the robot to operate more precisely in accordance with the shape and position of the heart and other organs in the complex environment of the fetus in the uterus. For example, the combination of the smaller preset bending angle of the middle tube and the larger preset bending angle of the innermost tube allows the instrument to first avoid the surrounding tissue with a smaller bend and then accurately reach the site of the heart lesion; the gradual decrease in rigidity ensures that the innermost tube has higher flexibility when approaching the diseased tissue, thereby reducing potential damage to the fetal heart tissue.

[0081] It's worth noting that due to the small size of the fetal heart, only one intermediate tube is used in this application. If other interventional procedures with larger operating spaces are required, multiple intermediate tubes can be used to meet spatial steering and depth requirements. Therefore, the robot in the above-mentioned embodiment of this application covers a variety of intrauterine interventional procedures, enabling the delivery of magnetically controlled guidewires, intrauterine endoscopic delivery, and other surgical scenarios.

[0082] When N=3, the concentric tubes include three nested nickel-titanium alloy tubes. In order to obtain the optimal size setting, in some preferred embodiments of the present application, the outermost tube has an outer diameter of 2.80 mm, an inner diameter of 2.20 mm, a wall thickness of 0.30 mm, and a total length of 120 mm; the middle tube has an outer diameter of 2.10 mm, an inner diameter of 1.60 mm, a wall thickness of 0.25 mm, a pre-bend length of 70 mm, a straight section length of 220 mm, a curvature radius of 90 mm, and a bending arc of The outer diameter of the innermost tube is 1.40mm, the inner diameter is 1.10mm, the pre-bend arc length is 40mm, the straight section length is 320mm, the curvature radius is 30mm, and the bending arc is above.

[0083] Note that the length of the straight line segment here refers to the sum of the length of the portion extending into the outermost tube and the length of the portion clamped by the movable plate. The value of π here is 180 degrees.

[0084] This application implements detailed dimensional parameters for the outermost, middle, and innermost tubes, such as outer diameter, inner diameter, wall thickness, and pre-bend arc length. These precise parameters are specifically designed based on the fetal intrauterine environment and surgical requirements. For example, the appropriate tube diameter ensures sufficient strength for operation while minimizing trauma to the fetus; the specific pre-bend arc length and curvature radius allow the device to better adapt to the fetal heart anatomy, improving the safety and effectiveness of the procedure.

[0085] In order to achieve precise operation of the concentric tubes, in some specific embodiments of the present application, the rear-end drive device is composed of an overall housing 1 of the mechanism, a movable plate 2, a ball screw motor 3, a rotary motor 4, a base plate 5 and a rotating shaft. The base plate 5 is used to place the motor controller and is located at the bottom of the entire device. The overall housing 1 of the mechanism includes N+1 fixed plates (note that N here is the number of nickel-titanium alloy tubes nested in the concentric tubes), which are arranged in parallel and fixed on the base plate. The N movable plates 2 are respectively located in the N intervals formed by the fixed plates. The N ball screw motors 3 are respectively mounted on N fixed plates farther away from the nickel-titanium alloy concentric tubes, and their ball screws pass through the two fixed plates in front of them, and their guide blocks are connected to the movable plates. The N-1 rotary motors 4 are horizontally fixed in parallel on a fixed plate farthest from the nickel-titanium alloy concentric tubes. N-1 rotating shafts are respectively connected to the rotating motors and pass through all the fixed plates and movable plates; the nickel-titanium alloy concentric tubes pass through all the fixed plates and movable plates; the conductive parts connect the rotating shafts and the nickel-titanium alloy concentric tubes to transfer the rotational kinetic energy from the rotating shafts to the nickel-titanium alloy concentric tubes, specifically the middle tube 62 or the innermost tube 63.

[0086] Specifically, such as Figure 1-Figure 5 As shown, the first fixing plate 11 , the second fixing plate 12 , the third fixing plate 13 , and the fourth fixing plate 14 are arranged from left to right and are vertically fixed on the bottom plate 5 .

[0087] For example, the first fixing plate 11 is rectangular. The second and third fixing plates 12 and 13 are convex, with a protruding top for mounting a ball screw motor, saving design space. The fourth fixing plate 14 is a double-layered plate structure, facilitating the installation of the rotating shaft and rotating motor.

[0088] Specifically, the first movable plate 21 , the second movable plate 22 , and the third movable plate 23 are respectively disposed in adjacent intervals of the four fixed plates.

[0089] For example, the first movable plate 21 and the third movable plate 23 are shaped like an inverted "convex" structure. The second movable plate 22 is also shaped like a "convex" structure, similar to the second fixed plate 12 and the third fixed plate 13. This type of structural design provides space for the installation of the ball screw motor.

[0090] Specifically, the first ball screw motor 31 is fixed to the right side of the second fixed plate 12, and its lead screw passes through the second fixed plate 12 and the first fixed plate 11 on its left side, and its guide block is connected to the first movable plate 21. Of course, a bearing connection is used at the contact point between the fixed plate and the lead screw. The first ball screw motor 31 is started and the lead screw rotates. Since the first movable plate 21 is restricted in rotation by the rotating shaft and the concentric tube, the guide block drives the first movable block 21 to move on the lead screw. Similarly, the second ball screw motor 32 and the third ball screw motor 33 also have the same installation method and principle. The second ball screw motor 32 corresponds to the second fixed plate 12, the third fixed plate 13 and the second movable plate 22; the third ball screw motor 33 corresponds to the third fixed plate 13, the fourth fixed plate 14 and the third movable plate 23.

[0091] It's worth noting that all movable and fixed plates feature three horizontally aligned through-holes. Bearings extend through the two side holes to ensure the shaft's rotation is unaffected. The center hole also features a bearing, allowing the outermost, middle, and innermost tubes to pass through. The center bearing of the first movable plate 21 extends through the outermost tube 61. The center bearing of the second movable plate 22 extends through the middle tube 62. The center bearing of the third movable plate 23 extends through the innermost tube 63.

[0092] Specifically, the first rotary motor 41 and the second rotary motor 42 are fixed on the fourth fixing plate 14 , and the output shafts thereof are connected to the first rotary shaft 43 and the second rotary shaft 44 via connectors.

[0093] In the above embodiment of the present application, the driving device is composed of 5 servo motors, including 2 rotary motors and 3 ball screw motors. The device has a compact structure and is lightweight. All driving devices are located at the rear end of the concentric tube and do not occupy the front end space. At the same time, the robot body is composed of only a few thin tubes. The movement of all mechanisms is concentrated on the flexible concentric tube at the front end. There is no need for a large incision, the tissue damage is small, and the safety of minimally invasive surgery is higher.

[0094] The drive device adopts a multi-axis independent control structure. Each set of motors controls one rod, that is, the five degrees of freedom are completely decoupled, and rotation and feeding can be performed completely independently, improving the overall response speed and control accuracy of the device.

[0095] In order to drive the concentric tubes to rotate more sensitively and quickly, in some specific embodiments of the present application, such as Figure 4 As shown, the second movable plate 22 and the third movable plate 23 are each equipped with 3 bearings and 2 gears. The inner hole of the gear is square, and the rear roller of the gear is fixed to the inner ring of the bearing.

[0096] In order to achieve more sensitive and rapid rotation of the concentric tube, in some specific embodiments of the present application, the following is adopted: Figure 4The structural design shown is as follows: 3 bearings and 2 gears are respectively arranged on the second movable plate 22 and the third movable plate 23, wherein the 3 bearings are horizontally embedded side by side in the movable plate, for the rotating shaft, the middle tube or the innermost tube to pass through respectively. The inner diameter of the middle bearing should be 0.05mm-0.10mm larger than the diameter of the fixed concentric tube to ensure concentricity, through which the concentric tube passes. The rollers of the first gear 221 and the second gear 222 are respectively interference fit with the inner rings of the bearings corresponding to the rotating shaft and the concentric tube, so that the gears can rotate freely and be fixed to the movable plate. The inner hole of the first gear 221 is designed to be square and is mounted on the square rotating shaft, so that the first gear 221 can rotate synchronously with the rotating shaft. The second gear 222 clamps the middle tube or the innermost tube through upper and lower symmetrical clamps. The clamps are fixed to the second gear 222 through threaded holes.

[0097] During operation, the square rotating shaft drives the first gear 221 to rotate. The first gear 221 drives the second gear 222 to rotate, and the second gear 222 transmits the rotational motion synchronously to the concentric tube through the clamping member. The corresponding bearings ensure transmission stability and low friction resistance.

[0098] It's worth noting that to allow the gears to slide freely on the first and second rotating shafts 43 and 44, corresponding sliders are provided, fixed to the inner races of the bearings. The sliders here are cylindrical and have a square-shaped inner hole that fits within the inner races of the bearings. This allows the movable plate to slide on the square shaft and helps to keep the square shaft parallel to the entire device.

[0099] The above-mentioned embodiment of the present application utilizes a gear transmission design to facilitate transmission of motor torque to the concentric tubes, thereby mitigating friction between the tubes. The support structure is robust and provides high-precision guidance. Each shaft is supported by multiple plates, ensuring concentricity during feeding and rotation of the concentric tubes and reducing vibration.

[0100] The drive also supports closed-loop control system integration. The driver supports high-precision encoding, facilitating the design of high-precision closed-loop control systems and helping to achieve precise puncture paths through integrated navigation and puncture. The overall device design is compact and small, making it ideal for miniaturization of medical equipment.

[0101] Based on the same technical concept, in other embodiments of the present application, a method for using a fetal intrauterine congenital heart disease interventional surgery robot is provided, such as Figure 7 Shown, including:

[0102] Step 1: Control the rear end drive device to extend the outermost tube;

[0103] Step 2: Control the rear end drive device so that the middle tube extends from the outermost tube and bends;

[0104] Step 3: Control the rear end drive device to rotate the middle tube to change the direction of the puncture needle;

[0105] Step 4: Control the rear end drive device so that the innermost tube extends from the middle tube and bends;

[0106] Step 5: Control the rear end drive device to rotate the innermost tube and locate it at the destination point;

[0107] Step 6: After positioning or puncture is completed, the magnetically controlled guide wire passes through the inner diameter of the concentric tube, and the magnetic response of the electromagnet to the guide wire is used to achieve the navigation function of the fetal heart disease focus. After the magnetically controlled guide wire reaches the lesion, the corresponding FCI treatment is then performed.

[0108] In the above-mentioned embodiment of the present application, the inner tube can be completely retracted within the outer tube by means of the inter-nesting and telescopic tubes, and the inner tube can also be fully extended to restore its original pre-bent shape, thereby achieving multi-stage puncture and changing direction after puncture. Even when the fetus is not in the standard position, puncture can still be performed to the fetal heart.

[0109] Specifically, the doctor first secures the device to a bracket and completes disinfection. Using ultrasound, the doctor determines the fetal position within the maneuverable range of the concentric tube interventional robot and determines the puncture point. The doctor then uses an assistant to control the puncture needle: first, using a traditional straight-tube puncture, the original puncture needle (the outermost tube of the concentric tube) pierces the mother's uterus.

[0110] Then, after one section of the tube (the outermost tube) enters the amniotic fluid, the fetal position is observed according to the ultrasound image, and the bending function of the second section of the tube (the middle tube) is used to achieve a certain angle of bending, that is, the second section of the tube realizes the change of direction of the puncture needle.

[0111] Then, based on the ultrasound image, the three-section tube (the innermost tube) is pushed to accurately locate the fetal heart according to the actual situation, and then puncture is performed by an internal needle or with the three-section tube.

[0112] Finally, after positioning or puncture is completed, the magnetically controlled guide wire passes through the inner diameter of the concentric tube, and the magnetic response of the electromagnet to the guide wire is used to realize the navigation function of the fetal heart disease lesion. After the magnetically controlled guide wire reaches the lesion, the corresponding FCI treatment is then performed.

[0113] Specifically, such as Figure 6 A schematic diagram of an electromagnet. The electromagnet guides the magnetically controlled wire through the concentric tubes and adjusts the strength of the magnetic force to achieve angular bending of the wire. The diameter of the magnetically controlled wire ranges from 0.1 to 0.8 mm, sufficient to pass through the innermost diameter of the concentric tubes. The electromagnet is responsible for guiding the magnetically controlled wire.

[0114] In some specific embodiments, the magnetically controlled guide wire includes a magnetic segment, an embedded segment, and a non-magnetic segment; wherein the magnetic segment is made of a mixture of polydimethylsiloxane particles and micron-sized neodymium iron boron particles with a mass ratio of 1.8 to 4.0; wherein the embedded segment is the overlapping part of the non-magnetic segment embedded in the magnetic segment, or the magnetic segment and the non-magnetic segment are nested in a polytetrafluoroethylene tube, and glue is used to connect the embedded part; wherein the non-magnetic segment is a nickel-titanium alloy guide wire.

[0115] Based on the same technical concept, in some specific embodiments of the present application, a method for preparing a magnetically controlled guide wire for any fetal intrauterine congenital heart disease interventional surgery robot is provided, such as Figure 8 Shown, including:

[0116] S100, polydimethylsiloxane particles and micron-sized neodymium iron boron particles are mixed in a mass ratio of 1.8-4.0, stirred evenly, and vacuumed for more than 40 minutes until no obvious bubbles are left in the mixed liquid.

[0117] Specifically, polydimethylsiloxane (PDMS) serves as a flexible matrix, mixed with NdFeB particles to form a "soft magnetic composite material." The elasticity of PDMS imparts flexibility to the guidewire while simultaneously encapsulating the NdFeB particles to prevent oxidation and shedding. Vacuuming eliminates bubbles in the mixture, preventing the formation of pores within the cured material. This ensures the mechanical strength (such as bending resistance) and uniform magnetic permeability of the guidewire matrix, preventing bubbles from affecting magnetic field conduction efficiency.

[0118] S200, the coating on the front end of the nickel-titanium alloy wire is peeled off and the front end is embedded in the mold tube.

[0119] Specifically, nickel-titanium alloy wire has a shape memory effect and serves as the mechanical support skeleton of the guidewire. Peeling off the front coating (such as the insulating layer or oxide layer) can expose the metal surface, enhance the physical intercalation and chemical bonding with the PDMS mixture, and avoid interface shedding after subsequent curing. The embedded mold tube can accurately control the position of the nickel-titanium wire in the guidewire, ensuring the overall axial symmetry of the guidewire, laying the foundation for the stability of subsequent magnetic control guidance.

[0120] S300: inject the mixed liquid into the mold tube with a pressurized syringe, and then irradiate the mold head with an ultraviolet lamp and a high-temperature gun to accelerate the curing of the mixed liquid. The mixture is gravity cured for more than 24 hours.

[0121] Specifically, ultraviolet irradiation and high-temperature gun baking can accelerate the cross-linking reaction of PDMS (such as the formation of silicon-oxygen bonds), so that the material at the head of the mold solidifies first, preventing the mixed liquid from leaking from the mold opening, and fixing the front end position of the nickel-titanium wire.

[0122] Gravity curing for more than 24 hours ensures that the mixed liquid solidifies gradually and evenly from the head to the tail of the mold. Gravity is used to promote the sedimentation and distribution of NdFeB particles, reduce shrinkage stress during the curing process, avoid deformation of the guide wire or internal cracking, and improve structural integrity.

[0123] S400, after solidification, the mold tube is peeled off and the inner core is taken out to obtain an unmagnetized magnetic control guide wire.

[0124] S500, magnetizing in a magnetic field direction parallel to the unmagnetized magnetron guide wire to obtain a magnetized magnetron guide wire with one end as an N pole and the other end as an S pole.

[0125] Specifically, under the action of an external parallel magnetic field, the magnetic domains of the NdFeB particles are uniformly oriented to form a dipole magnetic field (NS pole) along the axial direction of the guide wire, which makes the guide wire magnetically responsive and can be controlled to deflect or move in the external magnetic field, realizing the "magnetic control guidance" function.

[0126] S600, after obtaining the magnetized magnetron guide wire, methacrylated gelatin, photoinitiator, and deionized water are mixed in a mass ratio of 1:0.25:10 to form a hydrogel, which is evenly coated on the surface of the magnetron guide wire and cured under ultraviolet light.

[0127] Specifically, gelatin methacrylate (GelMA) hydrogel has good cell affinity and biodegradability. The coating can reduce the stimulation of the guide wire to biological tissues and is suitable for minimally invasive surgical scenarios in vivo. At the same time, the hydrophilicity of the hydrogel can reduce the friction resistance of the guide wire in body fluids, making it easier to operate.

[0128] UV curing cross-links the GelMA molecules to form a network structure, tightly wrapping the surface of the guide wire, protecting the internal PDMS and NdFeB materials, and preventing erosion by body fluids.

[0129] The magnetically controlled guide wire prepared in the above embodiment of the present application cooperates with the concentric tube interventional robot. The innermost tube of the concentric tube can be used for the magnetically controlled guide wire to pass through. The concentric tube is bent at a large angle to realize the puncture bending process of intrauterine interventional surgery. The magnetically controlled guide wire penetrates the inner diameter of the concentric tube and shuttles into the uterus to realize precise guidance and positioning.

[0130] In the description of the embodiments of the present application, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "bottom", "inside", "outside", "clockwise", "counterclockwise", etc., indicating the orientation or position relationship, are based on the orientation or position relationship shown in the accompanying drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply 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 a limitation on the present application.

[0131] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be understood to indicate or imply relative importance or to implicitly indicate the quantity of the technical features indicated. Thus, a feature specified as "first" or "second" may explicitly or implicitly include one or more of the features.

[0132] In the description of the embodiments of the present application, the meaning of "multiple" is two or more, unless otherwise clearly specified and specifically defined. In the present application, unless otherwise clearly specified and defined, the terms "installed", "connected", "connected", "fixed" and the like 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 or an electrical connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be a communication between the internal parts of two components. For those of ordinary skill in the art, the specific meanings of the above terms in the present application can be understood according to the specific circumstances.

[0133] In the embodiments of the present application, the terms "including" and "having" and any variations thereof are intended to cover non-exclusive inclusions. For example, a process, method, system, product, or apparatus comprising a series of steps or units is not limited to the listed steps or units, but may optionally include steps or units not listed, or may optionally include other steps or units inherent to the process, method, product, or apparatus.

[0134] The above describes some specific embodiments of the present application. It should be understood that the present application is not limited to the specific embodiments described above, and those skilled in the art may make various variations or modifications within the scope of the claims, which do not affect the substantive content of the present application. The above preferred features may be used in any combination as long as they do not conflict with each other.

Claims

1. A fetal intrauterine congenital heart disease interventional surgery robot, characterized in that: include: The concentric tubes include N nickel-titanium alloy tubes nested in sequence, which are, from the outside to the inside, an outermost tube, at least one intermediate tube, and an innermost tube; The intermediate tube and the innermost tube both have superelasticity and memory and are pre-bent at set angles. The set angle of the intermediate tube is smaller than the set angle of the innermost tube and is within a range of 10°-30°. The set angle of the innermost tube is at least 30°. Wherein, the outermost tube is not pre-bent and is a straight tube; The numerical error of the concentricity of the outermost tube, the central tube, and the innermost tube is within 1%, and the rigidity of the tubes decreases from the outside to the inside. A radius of more than 0.05 mm is reserved between adjacent tubes. The rear end driving device is connected to the concentric tubes, controls the extension and contraction of the outermost tube, and controls the extension and rotation of the middle tube and the innermost tube.

2. The intrauterine congenital heart disease interventional surgery robot according to claim 1, characterized in that: The outermost tube has an outer diameter of 2.80 mm, an inner diameter of 2.20 mm, a wall thickness of 0.30 mm, and a total length of 120 mm; The intermediate tube has an outer diameter of 2.10 mm, an inner diameter of 1.60 mm, a wall thickness of 0.25 mm, a pre-bent arc length of 70 mm, a straight section length of 220 mm, a curvature radius of 90 mm, and a bending arc of The innermost tube has an outer diameter of 1.40 mm, an inner diameter of 1.10 mm, a pre-bend length of 40 mm, a straight section length of 320 mm, a curvature radius of 30 mm, and a bending arc of above.

3. The intrauterine congenital heart disease interventional surgery robot according to claim 1, characterized in that: The rear end driving device comprises: The base plate is used to place the motor controller and is located at the bottom of the entire device; Fixed plates, N+1 of which are arranged in parallel and fixed on the bottom plate; Moving plates, N moving plates are located in the N intervals formed by the fixed plates, and the N moving plates sequentially clamp the outermost tube, the middle tube, and the innermost tube; Ball screw motors, wherein N ball screw motors are respectively mounted on N fixed plates farther away from the concentric tubes, with their ball screws passing through the two fixed plates in front of them, and their guide blocks connected to the movable plate between the two fixed plates; Rotating motors, N-1 rotating motors are fixed horizontally in parallel on a fixed plate farthest from the concentric tube; Rotating shafts, N-1 rotating shafts are respectively connected to the rotating motors and pass through all the fixed plates and the movable plates; The transmission element is provided on each of the movable plates, connects the rotating shaft and the intermediate tube and the innermost tube, and transmits the rotational kinetic energy from the rotating shaft to the intermediate tube or the innermost tube.

4. The intrauterine congenital heart disease interventional surgery robot according to claim 3, characterized in that: The movable plate controls the movement of the corresponding outermost tube, the middle tube and the innermost tube; the rotating shaft drives the rotation of the corresponding middle tube and the innermost tube; and all degrees of freedom are independent of each other.

5. The intrauterine congenital heart disease interventional surgery robot according to claim 3, characterized in that: The fixed plate is provided with N horizontally arranged through holes, into which N bearings are embedded respectively; the inner holes of the N-1 bearings are square holes, through which the rotating shaft passes; the inner hole diameter of the middle bearing should be 0.05mm-0.10mm larger than the diameter of the fixed concentric tube to ensure concentricity, through which the concentric tube passes.

6. The intrauterine congenital heart disease interventional surgery robot according to claim 3, characterized in that: The conductive member is provided on the movable plate and includes: Bearings, N bearings are horizontally and side by side embedded in the movable plate; the rotating shaft, the middle tube or the innermost tube passes through them respectively; Gears are matched and covered on the bearings corresponding to the rotating shaft and the concentric tubes; the rotating shaft, the middle tube or the innermost tube respectively pass through them; the inner hole of the gear is square, and the rotating shaft is square; The clamping piece is fixed on the gear corresponding to the intermediate tube or the innermost tube, and clamps the intermediate tube or the innermost tube passing therethrough.

7. The intrauterine congenital heart disease interventional surgery robot according to claim 6, characterized in that: The clamping piece is a vertically symmetrical structure.

8. A method for using a fetal intrauterine congenital heart disease interventional surgery robot, characterized in that: include: Control the rear end drive device so that the outermost tube extends; Control the rear end drive device, the middle tube extends from the outermost tube and bends; Control the rear-end drive device to rotate the middle tube and change the direction of the puncture needle; To control the rear end drive unit, the innermost tube extends from the middle tube and bends; Control the rear-end drive device to rotate the innermost tube and locate it at the destination point; After positioning or puncture is completed, the magnetically controlled guide wire passes through the inner diameter of the concentric tube, and the magnetic response of the electromagnet to the magnetically controlled guide wire is used to realize the navigation function of the fetal heart disease focus, so that the magnetically controlled guide wire reaches the target position.

9. The method for using a fetal intrauterine congenital heart disease interventional surgery robot according to claim 8, characterized in that: The magnetically controlled guide wire comprises a magnetic section, an embedded section, and a non-magnetic section; The magnetic segment is made of a mixture of polydimethylsiloxane particles and micron-sized neodymium iron boron particles, with a mass ratio of 1.8 to 4.0; The embedded section is an overlapping portion of a non-magnetic section embedded in a magnetic section, or a polytetrafluoroethylene tube is used to nest the magnetic section and the non-magnetic section, and glue is used to connect the embedded section; Wherein, the non-magnetic segment is a nickel-titanium alloy guide wire.

10. A method for preparing a magnetically controlled guide wire for use in a fetal intrauterine congenital heart disease interventional surgery robot according to any one of claims 1 to 7, characterized in that: include: Mix polydimethylsiloxane particles and micron-sized neodymium iron boron particles in a mass ratio of 1.8-4.0, stir evenly, and evacuate for more than 40 minutes until there are no obvious bubbles in the mixed liquid; The coating on the front end of the nickel-titanium alloy wire is peeled off, and the front end is embedded in the mold tube; The mixed liquid is injected into the mold tube with a pressurized syringe. After injection, the mixed liquid is accelerated by irradiating with an ultraviolet lamp and roasting the mold head with a high-temperature gun. The mixture is gravity cured for more than 24 hours. After solidification, the mold tube is peeled off and the inner core is taken out to obtain the unmagnetized magnetic control guide wire; Magnetizing the unmagnetized magnetic control wire in a direction parallel to the magnetic field to obtain a magnetized magnetic control wire with one end being an N pole and the other end being an S pole; After obtaining the magnetized magnetron guide wire, methacrylated gelatin, photoinitiator and deionized water are mixed in a mass ratio of 1:0.25:10 to form a hydrogel, which is evenly coated on the surface of the magnetron guide wire and cured under ultraviolet light.

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