Micro-needle implantation equipment and method

Abstract

The invention discloses a microneedle implantation device and method.The microneedle implantation device comprises a microneedle clamping module, a microneedle cutting module, an angiography module and a mechanical arm, the microneedle clamping module is used for clamping and releasing a microneedle, the microneedle cutting module is used for cutting a microneedle body of the microneedle, and the angiography module is used for carrying out angiography on the microneedle body of the microneedle; the mechanical arm is detachably connected with the microneedle clamping module, the mechanical arm is used for driving the microneedle to move in the cutting and implanting process, and the blood vessel imaging module is detachably connected with the mechanical arm. The micro-needle implanting equipment can automatically complete accurate implantation of the micro-needle through the automatic mechanical arm under the assistance of the navigation tracking system, and under the condition that the micro-needle body has the risk of puncturing a blood vessel, the micro-needle cutting module is used for cutting the micro-needle body in a specific area in advance to avoid the blood vessel, so that the blood vessel puncturing risk is reduced, and the blood vessel puncturing risk is reduced. Therefore, it is guaranteed that the microneedle is rapidly, accurately and safely implanted into a designated intracranial area. The micro-needle implanting equipment is simple to operate, high in implanting precision, high in safety and high in practicability.

Description

Technical Field

[0001] The present invention relates to the field of brain-computer interface medical devices, and in particular to a microneedle implantation device and method. Background Art

[0002] Microneedles have many signal contact points and can simultaneously obtain a large amount of data from the brain, which has a broad application prospect. At present, in the field of brain-computer interface, invasive brain-computer interface research requires the implantation of microneedle electrodes into the skull in order to more directly obtain brain signals for research and treatment.

[0003] Surgical robots are increasingly used in neurosurgery. They play an important role in operations such as brain biopsy / drainage, SEEG (stereo-electroencephalogram) and DBS (deep brain stimulation). Compared with traditional operations, they can quickly locate the lesion and perform navigation with an accuracy of up to 0.5mm, which greatly improves surgical accuracy and increases the success rate of operations.

[0004] Microneedles need to be implanted in specific brain areas to exert their functions. According to the microneedle products and functional requirements, the requirements for implantation sites are as follows:

[0005] For small-sized microneedles, such as single needles / single-row needles, it is necessary to collect the electrical signal activity of neurons in a specific area, and the implantation accuracy requirements are particularly high, with the deviation required to be ≤0.1mm.

[0006] For large-sized microneedles, it is necessary to avoid blood vessels with a diameter ≥ 0.5 mm in the implantation area to avoid heavy bleeding during the implantation process.

[0007] Currently, the neurosurgical robots on the market cannot be adapted to microneedles, their accuracy cannot meet the implantation requirements, and they cannot effectively avoid large blood vessels. Summary of the invention

[0008] The present invention aims to solve at least one of the technical problems existing in the prior art, and proposes a microneedle implantation device and method.

[0009] The technical solution of the present invention is implemented as follows: a microneedle implantation device, comprising:

[0010] A microneedle clamping module, which is used to clamp and release the microneedle;

[0011] A microneedle cutting module, wherein the microneedle cutting module is used to cut the microneedle body of the microneedle;

[0012] A robotic arm is connected to the microneedle clamping module and is used to drive the microneedles to move during the cutting and implanting process.

[0013] Furthermore, the microneedle implantation device of the present invention also includes a vascular imaging module for acquiring vascular data of the target area, wherein the vascular imaging module is detachably connected to the robotic arm, and the robotic arm is detachably connected to the microneedle clamping module; the vascular imaging module is electrically connected to the control module.

[0014] Furthermore, the vascular imaging module adopts a near-infrared vascular imaging module, which includes a near-infrared emitting light source, an optical lens and a camera, the optical lens is connected between the near-infrared emitting light source and the camera, and the camera is connected to the first connecting device.

[0015] Furthermore, the end of the robotic arm is provided with a first connecting device for detachably connecting a microneedle clamping module or a vascular imaging module, the microneedle clamping module is provided with a second connecting device for cooperating with the first connecting device, and the vascular imaging module is provided with a third connecting device for cooperating with the first connecting device, the second connecting device and the third connecting device both include a connecting plate, the connecting plates of the second connecting device and the third connecting device are provided with connecting columns, the side walls of the connecting columns are provided with grooves, the connecting plate of the second connecting device is provided with a first connecting piece for connecting to the microneedle clamping module, and the connecting plate of the third connecting device is provided with a second connecting piece for connecting to the vascular imaging module.

[0016] Further, the first connecting device comprises a base, a locking piece for cooperating with a groove of a connecting column, and a locking adjustment handle for driving the locking piece to move, a side wall of the base is provided with a hinge groove, a part of the locking adjustment handle is located in the hinge groove of the base, the locking adjustment handle is hinged to the base through a pin shaft, a connecting hole for connecting with the end of the mechanical arm is provided on the base, a matching hole for cooperating with a connecting column of the second connecting device is also provided on the base, a mounting hole for installing the locking piece is provided on the side wall of the matching hole, one end of the mounting hole is communicated with the matching hole, the other end of the mounting hole is communicated with the hinge groove, the locking piece is loosely fitted in the mounting hole, and a return spring for returning the locking piece is provided in the base;

[0017] The base is provided with a positioning pin or a positioning hole, the connecting plate is provided with a positioning hole or a positioning pin, and the positioning pin and the positioning hole are in clearance fit.

[0018] Furthermore, the microneedle clamping module includes a connecting portion and a grasping component, the grasping component includes a grasping head for grasping or releasing the microneedle and a driving member for controlling the movement of the grasping head, the grasping head is connected to one end of the connecting portion, and the driving member is arranged on the connecting portion.

[0019] Furthermore, the robotic arm adopts a 6-degree-of-freedom robotic arm;

[0020] or / and,

[0021] Angle sensors are built into each joint of the robotic arm;

[0022] or / and,

[0023] A pressure sensor is arranged at the end joint of the robotic arm.

[0024] Furthermore, the microneedle implantation device of the present invention also includes a marker kit for being arranged around the craniotomy window, the marker kit including a graticule, a hollow area corresponding to the craniotomy window being provided in the middle of the graticule, a first ruler extending along a first direction and a second ruler extending along a second direction being provided on the graticule, the first direction being perpendicular to the second direction.

[0025] Furthermore, the microneedle implantation device of the present invention also includes a tracking and positioning module, which includes a light emitting device, a light receiving device and a light reflecting device for being set on the target, the light emitting device is used to emit a light beam, the light reflecting device is used to reflect the light beam back to the light receiving device, and the light receiving device is used to receive a light signal reflected back by the light reflecting device, and obtain the target position information based on the light signal.

[0026] Furthermore, the microneedle cutting module includes a cutting tool and a fixing device, the cutting tool is fixedly mounted on the fixing device, the cutting tool is provided with a cutting action part for cutting microneedles, the cutting tool is provided with parallel arranged toothed parts on both sides of the cutting action part, and there is a gap between adjacent toothed parts for the microneedle body of the microneedle to extend into.

[0027] Furthermore, the mechanical arm and the microneedle cutting module are both mounted on a support seat;

[0028] and / or,

[0029] The mechanical arm is electrically connected to the control module;

[0030] and / or,

[0031] It also includes a human-computer interaction module, which is electrically connected to the control module.

[0032] The present invention also discloses a microneedle implantation method, comprising the following steps:

[0033] Acquire image data and perform 3D modeling;

[0034] Determine the microneedle implantation area;

[0035] Obtain blood vessel data of the microneedle implantation area, and determine the microneedle cutting area and plan based on the three-dimensional model and blood vessel data;

[0036] If there are blood vessels that cannot be avoided in the microneedle implantation area, the cutting program is started according to the microneedle cutting area and plan, and the robotic arm is controlled to drive the microneedle to complete the cutting of the needle body at the position interfering with the blood vessel on the microneedle cutting module;

[0037] Start the microneedle implantation program, control the robotic arm to drive the microneedle to the predetermined area along the planned path, and release the microneedle after fixation to complete the implantation.

[0038] The microneedle implantation method of the present invention also includes the following steps: installing a marker kit on the craniotomy window, installing a vascular imaging module at the end of the robotic arm, controlling the vascular imaging module to move to the marker kit for vascular imaging, locally aligning the vascular image with the three-dimensional model, and determining the microneedle cutting area and plan.

[0039] The microneedle implantation method of the present invention further comprises the following steps: registering and calibrating the positions of the robot arm, the patient, and the surgical instrument through a tracking and positioning module.

[0040] Compared with the prior art, the present invention has the following beneficial effects:

[0041] The microneedle implantation device of the present invention can automatically complete the precise implantation of microneedles through an automated robotic arm with the assistance of a navigation and tracking system, and in the case where the microneedle body has the risk of puncturing a blood vessel, the microneedle body in a specific area can be cut in advance by a microneedle cutting module to avoid blood vessels, thereby ensuring that the microneedle is implanted quickly, accurately and safely into a designated area within the skull. The present invention uses an automated robotic arm to implant microneedles into a target brain area within the skull with high precision, and effectively avoids the problem of bleeding during the implantation process.

[0042] The microneedle implantation device of the present invention has the following advantages:

[0043] Simple operation: This microneedle implantation device adopts the method of integrating various modules. The doctor can automatically complete the entire microneedle implantation process with one click by controlling the host computer software.

[0044] High implantation accuracy: This microneedle implantation device adopts a fully automated module, and the implantation accuracy can reach micron level, which is much higher than the manual implantation accuracy of doctors. In addition, the present invention installs a high-precision graticule at the craniotomy window to perform local high-precision imaging during the operation. After fusion with the preoperative model, the implantation accuracy can be improved to 100μm, so that the microneedle can be accurately implanted in the designated area to collect specific neuronal signals.

[0045] High safety: This microneedle implantation device is equipped with a vascular imaging module and a microneedle cutting module. The microneedle implantation device uses the vascular imaging module installed at the end of the robotic arm to accurately image the blood vessels of brain tissue in the craniotomy area, conduct an evaluation before implantation, and combine with the microneedle cutting device to cut the needle body that may puncture large blood vessels, thereby avoiding puncturing large blood vessels during the subsequent implantation process, thereby improving the safety of the surgical process.

[0046] Strong practicality: This microneedle implantation device provides a standardized microneedle implantation method, so that the microneedle implantation surgery no longer relies mainly on the doctor's experience, reducing the difficulty of the surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0047] Figure 1 A schematic diagram of the structure of a microneedle implantation device provided in an embodiment of the present invention;

[0048] Figure 2 A schematic structural diagram of a first connection device from a first perspective provided by an embodiment of the present invention;

[0049] Figure 3 A schematic structural diagram of a first connecting device from a second viewing angle provided by an embodiment of the present invention;

[0050] Figure 4 A schematic diagram of the cooperation between the locking member and the locking adjustment handle of the first connecting device provided by an embodiment of the present invention;

[0051] Figure 5 A schematic diagram of the structure of a near-infrared vascular imaging module provided by an embodiment of the present invention;

[0052] Figure 6 A schematic diagram of the structure of a graticule provided in an embodiment of the present invention;

[0053] Figure 7 A schematic diagram of a use scenario of a vascular imaging module provided in an embodiment of the present invention;

[0054] Figure 8 A schematic diagram of the structure of a microneedle cutting module provided in an embodiment of the present invention;

[0055] Fig. 9 A schematic diagram of the structure of a cutting tool provided by an embodiment of the present invention;

[0056] Fig.10 for Fig. 9 A magnified view of the P part;

[0057] Fig.11 A schematic diagram of the structure of a 32×32 array microneedle provided in an embodiment of the present invention;

[0058] Fig.12A schematic diagram of the structure of a microneedle body of a 32×32 array microneedle provided in an embodiment of the present invention;

[0059] Fig.13 A schematic diagram of matching implantation area and blood vessel information provided by an embodiment of the present invention;

[0060] Fig.14 A schematic diagram of the cooperation between the cutting tool and the microneedle before cutting provided by an embodiment of the present invention;

[0061] Fig.15 for Fig.14 Enlarged view of the Q part;

[0062] Fig.16 A schematic diagram of a cutting process provided by an embodiment of the present invention;

[0063] Fig.17 A schematic diagram of a microneedle body after cutting provided in an embodiment of the present invention (front view in the direction of the needle tip);

[0064] Fig.18 A schematic diagram of the structure of a microneedle clamping module provided in an embodiment of the present invention;

[0065] Fig.19 A schematic diagram of a microneedle clamping module provided by an embodiment of the present invention from a first viewing angle (a schematic diagram of clamping-type grasping of 32×32 array microneedles);

[0066] Fig. 20 A schematic diagram of a microneedle clamping module provided by an embodiment of the present invention from a second viewing angle (a schematic diagram of clamping-type grasping of 32×32 array microneedles);

[0067] Fig.21 for Fig. 20 Schematic diagram of vertical section;

[0068] Fig. 22 A schematic diagram of a microneedle clamping module provided in an embodiment of the present invention from a first viewing angle (a schematic diagram of adsorption-type grasping of 32×32 array microneedles);

[0069] Fig.23 A schematic diagram of a microneedle clamping module provided by an embodiment of the present invention from a second viewing angle (a schematic diagram of adsorption-type grasping of 32×32 array microneedles);

[0070] Fig.24 for Fig.23 Schematic diagram of vertical section;

[0071] Fig.25 A schematic diagram of a nozzle of a microneedle clamping module provided in an embodiment of the present invention (area array nozzle);

[0072] Fig.26A schematic diagram of the structure of a mechanical arm provided by an embodiment of the present invention;

[0073] Fig. 27 Flow chart of the operation method of microneedle implantation provided in an embodiment of the present invention.

[0074] In the accompanying drawings, 1 is a mechanical arm, 11 is a pressure sensor, 12 is a first connecting device, 121 is a base, 1211 is a hinge groove, 1212 is a connecting hole, 1213 is a matching hole, 122 is a locking adjustment handle, 123 is a locking member, 124 is a positioning pin, 125 is a pin shaft, 2 is a microneedle clamping module, 201 is a connecting part, 2010 is a shell, 2011 is an inner cavity, 202 is a grasping head, 202 0 is the first clamping block, 2021 is the second clamping block, 2022 is the suction nozzle, 2023 is the suction block, 2024 is the suction point, 203 is the push rod, 204 is the inclined surface, 205 is the locking knob, 206 is the adapter, 207 is the screw rod, 208 is the second return spring, 209 is the negative pressure generating device, 210 is the guide rod, 211 is the camera, 212 is the PCB adapter plate, 213 is the slider, 214 is Spring clip, 3 is a microneedle cutting module, 31 is a cutting tool, 311 is a cutting action part, 312 is a toothed part, 313 is a cutting comb tooth part, 314 is a mounting and fixing part, 32 is a fixing device, 4 is a vascular imaging module, 41 is a near-infrared emitting light source, 42 is an optical lens, 43 is a camera, 5 is a tracking and positioning module, 6 is a display module, 7 is a support seat, 8 is a microneedle, 81 is a microneedle body, 91 is a second connecting device, 911 is a connecting plate of the second connecting device, 912 is a connecting column of the second connecting device, 913 is a first connecting piece, 92 is a third connecting device, 921 is a connecting plate of the third connecting device, 922 is a connecting column of the third connecting device, 923 is a second connecting piece, 10 is a marker kit, 101 is a dividing plate, 102 is a hollow area, 103 is a first ruler, and 104 is a second ruler. DETAILED DESCRIPTION

[0075] In order to enable those skilled in the art to better understand the technical solution of the present invention, the technical solution in the embodiment of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiment of the present invention. Obviously, the described embodiment is a part of the embodiment of the present invention, not all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0076] See also Figures 1 to 26 , the embodiment of the present invention discloses a microneedle implantation device, comprising:

[0077] A microneedle clamping module 2, the microneedle clamping module 2 is used to clamp and release the microneedle 8;

[0078] A microneedle cutting module 3, wherein the microneedle cutting module 3 is used to cut the microneedle body 81 of the microneedle 8;

[0079] A robotic arm 1 is connected to a microneedle clamping module 2 and is used to drive the microneedles 8 to move during cutting and implanting.

[0080] Furthermore, the robotic arm 1 is connected to the control module, and is used to receive the microneedle 8 cutting instructions and the microneedle 8 implantation instructions output by the control module, and according to the microneedle 8 cutting instructions and the microneedle 8 implantation instructions, respectively realize the motion control and positioning of the microneedle 8 during the cutting and implantation processes.

[0081] In some embodiments, the mechanical arm 1 and the microneedle cutting module 3 are both mounted on a support seat 7. The support seat 7 is provided with a roller. The support seat 7 is provided with an electrical installation cavity, and the control module is arranged in the electrical installation cavity of the support seat 7.

[0082] Furthermore, the microneedle implantation device of the present invention is further provided with a display module 6, which is connected to the control module. The display module 6 is also supported on the support base 7. Preferably, the display module 6 adopts a human-computer interaction module, which can be a touch screen.

[0083] The display module 6 provides the doctor with a visualized surgical planning and surgical operation control display, which helps the doctor to operate conveniently during the operation and improve the surgical efficiency.

[0084] The control module may be, but is not limited to, a host computer.

[0085] In some embodiments, the microneedle implantation device of the present invention further includes a vascular imaging module 4 for acquiring vascular data of a target area.

[0086] The vascular imaging module 4 is detachably connected to the mechanical arm 1, and the mechanical arm 1 is detachably connected to the microneedle clamping module 2. The mechanical arm 1 is used to receive the vascular imaging instruction output by the control module, and the mechanical arm 1 is used to realize the motion control and positioning of the vascular imaging module 4 during the vascular imaging process according to the vascular imaging instruction.

[0087] Furthermore, the vascular imaging module 4 adopts a near-infrared vascular imaging module 4. The near-infrared vascular imaging module 4 uses the difference in absorption of near-infrared light (wavelength 700-970nm) by human tissue and hemoglobin to generate vascular data and images to help doctors determine the direction of the patient's brain blood vessels before surgery and formulate a plan for implanting microneedles 8. It can also help doctors confirm the implantation position of microneedles 8 during surgery to solve the problem of possible puncture of large blood vessels during the implantation of microneedles 8.

[0088] The near-infrared vascular imaging module 4 includes a near-infrared emitting light source 41, an optical lens 42 and a camera 43, wherein the optical lens 42 is connected between the near-infrared emitting light source 41 and the camera 43, and the camera 43 is connected to the first connecting device 12. The near-infrared emitting light source 41 used in the vascular imaging module 4 of one embodiment can emit infrared light with a wavelength of 850 to 940 nm to the target area, which is absorbed and reflected by the cerebral cortex, converged by the optical lens 42 and photographed by the camera 43 to obtain a cerebral cortical vascular image. In addition to photographing the blood vessels in the craniotomy area, the camera 43 used in the vascular imaging module 4 can also photograph the scales (scale spacing 0.1 mm, scale line width 0.05 mm) on the scale plate 101 fixed around the craniotomy window.

[0089] The vascular imaging module 4 is used to obtain the vascular image of the target area and transmit the vascular image of the target area to the control module. The control module determines whether there is a target blood vessel that the microneedle 8 cannot avoid in the microneedle 8 implantation area based on the vascular image. When there is a target blood vessel that the microneedle 8 cannot avoid in the microneedle 8 implantation area, the microneedle 8 cutting area and the microneedle 8 cutting plan are obtained according to the position of the target blood vessel.

[0090] The control module controls the robot arm 1 to perform the microneedle 8 cutting operation according to the microneedle 8 cutting area and the microneedle 8 cutting plan.

[0091] In some embodiments, the end of the robotic arm 1 is provided with a first connecting device 12 for detachably connecting the microneedle clamping module 2 or the vascular imaging module 4, the microneedle clamping module 2 is provided with a second connecting device 91 for cooperating with the first connecting device 12, and the vascular imaging module 4 is provided with a third connecting device for cooperating with the first connecting device 12, the second connecting device 91 and the third connecting device both include a connecting plate, a connecting column 912 is provided on the connecting plate 911 of the second connecting device 91, a connecting column 922 is provided on the connecting plate 921 of the third connecting device 92, the side walls of the connecting columns 912 and 922 are provided with grooves, a first connecting piece 913 for connecting to the microneedle clamping module 2 is provided on the connecting plate 911 of the second connecting device 91, and a second connecting piece 923 for connecting to the vascular imaging module 4 is provided on the connecting plate of the third connecting device.

[0092] A first connecting device 12 is provided at the end of the robot arm 1, so that the microneedle clamping module 2 or the vascular imaging module 4 can be quickly assembled and disassembled from the end of the robot arm 1, thereby facilitating the installation of different devices at the end of the robot arm 1 to achieve different functions. For example, installing the vascular imaging module 4 can achieve the photography of blood vessels in a specific brain area, and installing the microneedle clamping module 2 can achieve the rapid implantation of the microneedle 8. The structure of the first connecting device 12 is as follows: Figure 3 The structure of the second connecting device 91 is as shown. Fig.18 The structure of the third connecting device is as shown. Figure 5 shown.

[0093] Further, the first connecting device 12 includes a base 121, a locking member 123 for cooperating with the groove of the connecting column, and a locking adjustment handle 122 for driving the locking member 123 to move. The side wall of the base 121 is provided with a hinge groove 1211, a part of the locking adjustment handle 122 is located in the hinge groove 1211 of the base 121, and the locking adjustment handle 122 is hinged to the base 121 through a pin 125. The base 121 is provided with a connecting hole 1212 (connection hole) for connecting to the end of the robot arm 1. 1212 is a stepped through hole), one side of the base 121 is provided with a matching hole 1213 (matching hole 1213 is a blind hole) for matching with the connecting column of the second connecting device 91, and the side wall of the matching hole 1213 is provided with a mounting hole for mounting the locking member 123, one end of the mounting hole is connected with the matching hole 1213, and the other end of the mounting hole is connected with the hinge groove 1211, and the locking member 123 is loosely fitted in the mounting hole, and a return spring for returning the locking member is provided in the base. The locking member 123 is provided with a large diameter section and a small diameter section to form a stepped shape, and the small diameter section of the locking member 123, and the return spring is sleeved on the small diameter section of the locking member 123.

[0094] After the connecting column of the second connecting device 91 is inserted into the matching hole 1213 of the base 121, the locking member 123 is driven by the locking adjustment handle 122 to extend into the groove of the connecting column of the second connecting device 91, and the locking adjustment handle 122 is positioned to connect the second connecting device 91 to the first connecting device 12.

[0095] The other side of the base 121 is provided with a step and a positioning pin 124 for achieving positioning between the base 121 and the robot arm 1 .

[0096] The base 121 is provided with a positioning pin 124 or a positioning hole, and the connecting plate is provided with a positioning hole or a positioning pin 124 , and the positioning pin 124 is loosely matched with the positioning hole.

[0097] The microneedle clamping module 2 may adopt a planar array spring slider clamping assembly.

[0098] Furthermore, the microneedle clamping module 2 includes a connecting portion and a grabbing assembly, the grabbing assembly includes a grabbing head for grabbing or releasing the microneedle 8 and a driving member for controlling the movement of the grabbing head, the grabbing head is connected to one end of the connecting portion, and the driving member is arranged on the connecting portion. The connecting portion of the microneedle clamping module 2 is connected to the first connecting member of the second connecting device 91.

[0099] Furthermore, the other end of the connecting portion is provided with a connecting structure for connecting to the second connecting device 91 .

[0100] As an embodiment, the connection structure includes a locking knob 205 and an adapter 216 , wherein the locking knob 205 locks the first connection member of the second connection device 91 with the adapter 216 , and the adapter 216 is installed on the connection portion 201 .

[0101] There are two ways to grab, one is the clamping grabbing method; the other is the adsorption grabbing method. The two specific grabbing methods are detailed below.

[0102] See also Figures 19 to 21 The gripping head 202 includes a first clamping block 2020 and a second clamping block 2021 that are arranged opposite to each other. The first clamping block 2020 and the second clamping block 2021 are between a clamping interval for clamping the microneedle 8. The driving member drives the first clamping block 2020 and / or the second clamping block 2021 to move to adjust the size of the clamping interval. In this embodiment, the microneedle 8 is grasped by clamping. This grasping method is most suitable for grasping the surface array microneedle 8. Of course, by controlling the accuracy of the clamping method, it can also be used for the clamping of a single needle, such as the small animal microneedle 8, the large animal microneedle 8, etc., and the anti-slip structure, anti-damage structure, etc. are designed to ensure the safe clamping of the single needle. For example, rubber surface clamping can be used for anti-slip and anti-damage. Specifically, the first clamping block 2020 and the second clamping block 2021 are used to clamp the microneedle 8. When the two cooperate, there is a clamping interval between them. The first clamp 2020 and the second clamp 2021 can be driven by a driving member. One of the clamps can move, or both can move. This embodiment does not limit this. The purpose is to change the size of the clamping interval to clamp or release the microneedle 8.

[0103] To further optimize the above solution, the driving member includes a push rod 203 for driving the first clamping block 2020 to approach or move away from the second clamping block 2021 , and the push rod 203 is movably disposed on the connecting portion 201 . In this embodiment, the push rod 203 can be used to drive the first clamp 2020 to approach or move away from the second clamp 2021. The pushing direction of the push rod 203 can be set in multiple ways. Its pushing direction can be consistent with the moving direction of the first clamp 2020, or it can be vertical. When the directions are consistent, the pushing direction of the push rod 203, the first clamp 2020 and the second clamp 2021 are in a straight line. At this time, the push rod 203 can be placed outside the connecting portion 201. At this time, the push rod 203 and the first clamp 2020 can be fixedly installed, so that the push rod 203 can push or retract the first clamp 2020. When the first clamp 2020 is pushed, the microneedle 8 is clamped (grasped), and when the first clamp 2020 is retracted, the microneedle 8 is released; when the direction is vertical, the push rod 203 The surface in contact with the first clamping block is an inclined surface 204, and the pushing direction of the push rod 203 is perpendicular to the moving direction of the first clamping block. The first clamping block is provided with a first reset spring, and the direction of the driving force is decomposed by the inclined surface 204, so that the moving direction of the first clamping block can be perpendicular to the pushing direction of the push rod 203. In this way, the push rod 203 can be placed in the connecting part 201. At this time, since the force is decomposed by the inclined surface 204, the push rod 203 cannot be fixed to the first clamping block, otherwise there will be no relative sliding between the two, and the first clamping block cannot be pushed. Then, the first reset spring can be used to achieve the reset of the first clamping block. When the first reset spring is compressed, the microneedle 8 is clamped (grasped), and when the first reset spring is reset, the microneedle 8 is released. Preferably, a guide rod 210 is provided to assist the movement of the first clamping block, and the guiding direction of the guide rod 210 is consistent with the moving direction of the first clamping block. The first reset spring is sleeved on the guide rod 210.

[0104] As an optimization solution of the embodiment of the present invention, please refer to Figures 19 to 21 The driving member further comprises a control button movably mounted on the connecting portion 201 and a connecting rod mounted on the push rod 203, wherein the connecting rod is fixed to the control button. In this embodiment, the push rod 203 can be driven to move by the cooperation of the control button and the connecting rod. The control button can be mounted on the connecting portion 201 in a threaded manner, so that the control button can be screwed to adjust the up and down movement of the control button, thereby driving the push rod 203 to move through the connecting rod. The connecting rod can be a screw rod 207, and a threaded hole is provided on the push rod 203 for the screw rod 207 to be installed.

[0105] As an optimization solution of the embodiment of the present invention, please refer to Figures 19 to 21, a second return spring 208 is installed on the push rod 203. In this embodiment, the second return spring 208 can be used to realize the automatic return of the push rod 203. For example, after the pressing force on the push rod 203 is removed (i.e., the control button is turned upward), the push rod 203 can move upward under the action of the second return spring, thereby removing the pressure on the first clamping block, and the first clamping block can be moved away from the second clamping block under the action of the first return spring.

[0106] See also Figure 22 to Figure 25 The gripping head 202 may be a suction nozzle 2022, and the driving member may be a negative pressure mechanism that provides suction force for the suction nozzle 2022. In this embodiment, the suction nozzle 2022 and the negative pressure mechanism may be used to achieve adsorption of the microneedle 8, and this adsorption is not only suitable for single needles and multiple needles, but also for area array microneedles 8.

[0107] To further optimize the above solution, please refer to Figure 22 to Figure 25 , the negative pressure mechanism includes an air pipe arranged on the connecting portion 201 and a negative pressure generating device 209 for providing negative pressure, and the two ends of the air pipe are respectively connected to the suction nozzle 2022 and the negative pressure generating device 209. In this embodiment, the above-mentioned negative pressure mechanism can be refined into an air pipe and a negative pressure generating device 209. The air pipe can be built into the connecting portion 201 or laid outside the connecting portion 201, and this is not limited in this embodiment. The purpose of the air pipe is to provide negative pressure, so its two ends need to be respectively connected to the suction nozzle 2022 and the negative pressure generating device 209. The suction nozzle 2022 is threadedly connected to the air pipe. The negative pressure generating device 209 can be a separate component or a component fixedly mounted on the connecting portion 201.

[0108] As an optimization solution of the embodiment of the present invention, please refer to Fig.25 , the suction nozzle is a surface array suction nozzle. Since the surface array microneedles 8 are in the shape of a whole plate, it is only necessary to design adsorption points on both sides to adsorb the entire surface array microneedles 8. Preferably, the suction nozzle includes a suction block 2023 with a built-in airway, and the suction block has adsorption points, and the adsorption points are connected to the airway. The suction nozzle can be refined into a suction block, and the suction block has an airway and adsorption points are provided on the bottom surface, so that the microneedles 8 can be adsorbed.

[0109] As an optimization solution of the embodiment of the present invention, the connecting part 201 has an inner cavity 2011, and the driving member is disposed in the inner cavity 2011. In this embodiment, the connecting part 201 may include a housing 2010 having an inner cavity 2011, and the driving member may be hidden in the inner cavity 2011, which can make the microneedle clamping module 2 more compact and can also protect the driving member.

[0110] As an optimization scheme of an embodiment of the present invention, the microneedle clamping module 2 also includes a camera 211 for observing the implantation state of the microneedle 8. In this embodiment, the implantation state of the microneedle 8 can be observed by designing the camera 211, and the observation picture can be exported and stored, and people can also observe the implantation picture in real time. The camera 211 can adopt a macro camera 211, which also has the characteristics of fill light, high pixel, small size, etc. Of course, the fill light characteristic can also adopt a separate fill light structure for fill light, and this embodiment does not limit this. Preferably, the camera 211 is installed on the connecting portion 201.

[0111] As an optimization scheme of the embodiment of the present invention, the microneedle clamping module 2 includes a connecting portion 201 and a PCB adapter plate 212 that can slide on the connecting portion 201, the sliding direction of the PCB adapter plate 212 is the direction from the head end to the tail end of the connecting portion 201, the end of the connecting portion 201 is provided with a gripper 202 for grabbing the microneedle 8, and the PCB adapter plate 212 is provided with a PCB board that can be arranged on the microneedle 8. In this embodiment, the PCB adapter plate 212 is used to slide and dock with the PCB board on the connecting portion 201, so that the docking PCB board can be refined, the docking microneedle 8 can be stably docked, the implanted microneedle 8 is not affected, and the reliability of the microneedle 8 is improved.

[0112] To further optimize the above technical solution, the PCB adapter plate 212 is slidably arranged on the connecting portion 201 through a slider 213, and the sliding direction of the slider 213 is consistent with the direction from the head end to the tail end of the connecting portion 201. In this embodiment, the sliding of the slider 213 can be used to complete the docking installation of the PCB board and the microneedle 8. Preferably, the slider 213 is fixed to the connecting portion 201 through a locking structure, and the slider 213 can be fixed to the connecting portion 201 through the locking structure, so that the microneedle 8 can be implanted first, and then the PCB board and the microneedle 8 can be docked.

[0113] As an optimization solution of the embodiment of the present invention, the PCB adapter plate 212 is mounted on a spring clip 214, and the spring clip 214 is fixed on the slider 213. In this embodiment, the PCB adapter plate 212 can be fixed by the spring clip 214.

[0114] Furthermore, the microneedle clamping module 2 mainly realizes the clamping of the microneedle 8 array and the rapid release of the microneedle 8 after the implantation is completed. The microneedle clamping module 2 is used to connect the end of the robot arm 1 and the microneedle 8, and a second connecting device 91 is provided at one end, which can form a rapid and stable connection with the first connecting device 12 at the end of the robot arm 1, and a clamping mechanism is provided at the other end, which can quickly clamp and release the microneedle 8.

[0115] Furthermore, the robot arm 1 is an automated robot arm 1. The robot arm 1 uses a 6-DOF robot arm 1 to achieve spatial movement and positioning, thereby achieving precise motion control and positioning of the microneedle 8 during the cutting and implantation process.

[0116] Specifically, the robot arm 1 is driven by a servo motor to move six joints to achieve precise control of the position of the end of the robot arm 1. An angle sensor is built into each joint of the robot arm 1, which can accurately identify the position of the robot arm 1 and cooperate with the control system to make compensation adjustments, so that the repeat positioning accuracy of the end tool can reach 0.01mm. A pressure sensor 11 is set at the end joint of the robot arm 1, which can distinguish a force difference of 0.01N and can sense the reverse resistance generated by the brain tissue during the implantation of the microneedle 8, thereby achieving precise control of the implantation.

[0117] Furthermore, the microneedle implantation device of the present invention further includes a marker kit 10 for being arranged around the craniotomy window, the marker kit 10 including a graticule 101, a hollow area 102 corresponding to the craniotomy window is provided in the middle of the graticule 101, and a first ruler 103 extending along a first direction and a second ruler 104 extending along a second direction are provided on the graticule 101, and the first direction is perpendicular to the second direction. The craniotomy window is located in the hollow area 102 of the graticule 101. Preferably, the graticule 101 is a rectangular frame.

[0118] Furthermore, the microneedle implantation device of the present invention also includes a tracking and positioning module 5, which uses optical positioning to track the precise positions of the robotic arm 1, surgical instruments and the patient during the operation in real time to assist the doctor and the robotic arm 1 to complete the corresponding actions.

[0119] Specifically, the tracking and positioning module 5 includes a light emitting device and a light receiving device and a light reflecting device for being set on the target, wherein the light emitting device is used to emit a light beam, the light reflecting device is used to reflect the light beam back to the light receiving device, and the light receiving device is used to receive the light signal reflected back by the light reflecting device, and obtain the target position information according to the light signal. The tracking and positioning module 5 is electrically connected to the control module, and the tracking and positioning module 5 is used to transmit the collected target position information to the control module in real time.

[0120] The light emitting device and the light receiving device are fixedly mounted on a bracket, which can support movement and multi-directional adjustment so as to quickly determine the tracking area before surgery.

[0121] Furthermore, the microneedle cutting module 3 includes a cutting tool 31 and a fixing device 32, the cutting tool 31 is fixedly mounted on the fixing device 32, the cutting tool 31 is provided with a cutting action portion 311 for cutting the microneedles 8, the cutting tool 31 is provided with parallelly arranged tooth portions 312 on both sides of the cutting action portion 311, forming a cutting comb tooth portion 313, and there is a gap between adjacent tooth portions 312 for the microneedles 8 to extend into, and the gap spacing matches the spacing of the microneedles 8 and is in the micron level.

[0122] The cutting tool 31 is in the form of a sheet, and the thickness of the cutting tool 31 can be set as required.

[0123] Preferably, the cutting action part 311 is located in the middle of the cutting tool 31. The fixing device 32 is provided with a hollow part, and the two ends of the cutting tool 31 are respectively supported on the fixing device 32. The cutting action part 311 of the cutting tool 31 corresponds to the hollow part of the fixing device 32. The two ends of the cutting comb part 313 of the cutting tool 31 are respectively provided with mounting fixing parts 314.

[0124] The microneedle cutting module 3 is mainly used to cut the microneedle 8 body in the area where the microneedle 8 may puncture the large blood vessels, so as to solve the problem that the microneedle 8 may puncture the large blood vessels during implantation. After the mechanical arm 1 holding the microneedle 8 moves above the cutting tool 31, it vertically extends downward into the gap between the comb teeth, and then cuts the needle body in the designated area of ​​the microneedle 8 through relative movement.

[0125] The microneedle implantation device of the present invention can automatically complete the precise implantation of the microneedle 8 through the automated robotic arm 1 with the assistance of a navigation and tracking system, and when there is a risk of the microneedle body 81 puncturing a blood vessel, the microneedle body 81 in a specific area can be cut in advance to avoid the blood vessel, thereby ensuring that the microneedle 8 is implanted quickly, accurately and safely into the designated area within the skull.

[0126] The present invention provides a standardized microneedle implantation device, which is suitable for standard implantation of microneedles 8 of various specifications / models / forms.

[0127] Based on the above microneedle implantation device, see Fig. 27 The present invention also provides a microneedle implantation method, comprising the following steps:

[0128] Acquire image data and perform 3D modeling;

[0129] Determine the microneedle implantation area;

[0130] A vascular imaging module is installed at the end of the robotic arm to image the cerebral blood vessels at the craniotomy site, clarify the blood vessel data near the microneedle implantation, and determine the microneedle cutting area and plan based on the three-dimensional model and blood vessel data;

[0131] A microneedle clamping module is installed at the end of the robotic arm, and the selected microneedle is fixed at the corresponding position of the microneedle clamping module and locked;

[0132] If there are blood vessels that cannot be avoided in the microneedle implantation area, the cutting program is started according to the microneedle cutting area and plan, and the robotic arm is controlled to drive the microneedle to complete the cutting of the needle body at the position interfering with the blood vessel on the microneedle cutting module;

[0133] The microneedle implantation program is started (for example, the microneedle 8 implantation program is started on the software of the display and control module), and the robotic arm drives the microneedle to the predetermined area according to the planned path, and releases the microneedle after fixation to complete the implantation.

[0134] The microneedle implantation method of the present invention also includes the following steps: installing a marker kit on the craniotomy window, installing a vascular imaging module at the end of the robotic arm, controlling the vascular imaging module to move to the marker kit for vascular imaging, locally aligning the vascular image with the three-dimensional model, and determining the microneedle cutting area and plan.

[0135] The microneedle implantation method of the present invention also includes the following steps: determining the type of implanted microneedles, selecting a microneedle clamping module of a corresponding model, installing it at the end of a mechanical arm, and fixing the array microneedles on the microneedle clamping module.

[0136] The microneedle implantation method of the present invention further comprises the following steps: registering and calibrating the positions of the robot arm, the patient, and the surgical instrument through a tracking and positioning module.

[0137] Based on various imaging data obtained from the patient before the operation, the present invention uses surgical software to perform three-dimensional modeling to determine the implantation area of ​​the microneedle 8, clarify the blood vessel data near the implantation of the microneedle 8, and determine the cutting area and plan of the microneedle 8. After the patient is fixed on the operating table, the position of the robot arm 1, the patient, and the surgical instrument are registered and calibrated through the tracking and positioning module.

[0138] Control the robotic arm to drive the microneedle to complete the cutting of the needle body at the position interfering with the blood vessel on the microneedle cutting module, specifically including: the robotic arm 1 moves with the microneedle 8 to the top of the cutting module, executes the microneedle 8 cutting action, and moves to a safe area to wait after completing the cutting of the microneedle 8 in the designated area.

[0139] The present invention can also use the near-infrared vascular imaging module 4 to image the cerebral blood vessels at the craniotomy site of the patient, and transmit the images to the software system to compare the cutting results of the microneedles 8 for confirmation before implantation.

[0140] It is to be understood that the above embodiments are merely exemplary embodiments used to illustrate the principles of the present invention, but the present invention is not limited thereto. For those of ordinary skill in the art, various modifications and improvements can be made without departing from the spirit and essence of the present invention, and these modifications and improvements are also considered to be within the scope of protection of the present invention.

Claims

1. A microneedle implantation device, characterized in that: include: A microneedle clamping module, which is used to clamp and release the microneedle; A microneedle cutting module, wherein the microneedle cutting module is used to cut the microneedle body of the microneedle; A robotic arm is connected to the microneedle clamping module and is used to drive the microneedles to move during the cutting and implanting process.

2. The microneedle implantation device according to claim 1, characterized in that: It also includes a vascular imaging module for acquiring vascular data of the target area, wherein the vascular imaging module is detachably connected to the mechanical arm, and the mechanical arm is detachably connected to the microneedle clamping module; the vascular imaging module is electrically connected to the control module.

3. The microneedle implantation device according to claim 2, characterized in that: A first connecting device for detachably connecting a microneedle clamping module or a vascular imaging module is provided at the end of the robotic arm, the microneedle clamping module is provided with a second connecting device for cooperating with the first connecting device, the vascular imaging module is provided with a third connecting device for cooperating with the first connecting device, the second connecting device and the third connecting device both include connecting plates, connecting columns are provided on the connecting plates of the second connecting device and the third connecting device, the side walls of the connecting columns are provided with grooves, the connecting plate of the second connecting device is provided with a first connecting piece for connecting to the microneedle clamping module, and the connecting plate of the third connecting device is provided with a second connecting piece for connecting to the vascular imaging module.

4. The microneedle implantation device according to claim 3, characterized in that: The first connecting device comprises a base, a locking piece for cooperating with a groove of a connecting column, and a locking adjustment handle for driving the locking piece to move, a side wall of the base is provided with a hinge groove, a part of the locking adjustment handle is located in the hinge groove of the base, the locking adjustment handle is hinged to the base through a pin shaft, a connecting hole for connecting with the end of the mechanical arm is provided on the base, a matching hole for cooperating with a connecting column of the second connecting device is also provided on the base, a mounting hole for installing the locking piece is provided on the side wall of the matching hole, one end of the mounting hole is communicated with the matching hole, and the other end of the mounting hole is communicated with the hinge groove, the locking piece is loosely fitted in the mounting hole, and a return spring for returning the locking piece is provided in the base; The base is provided with a positioning pin or a positioning hole, the connecting plate is provided with a positioning hole or a positioning pin, and the positioning pin and the positioning hole are in clearance fit.

5. The microneedle implantation device according to claim 3, characterized in that: The microneedle clamping module includes a connecting part and a grabbing component, the grabbing component includes a grabbing head for grabbing or releasing the microneedle and a driving member for controlling the movement of the grabbing head, the grabbing head is connected to one end of the connecting part, and the driving member is arranged on the connecting part.

6. The microneedle implantation device according to claim 1, characterized in that: The robotic arm adopts a 6-degree-of-freedom robotic arm; or / and, Angle sensors are built into each joint of the robotic arm; or / and, A pressure sensor is arranged at the end joint of the robotic arm.

7. The microneedle implantation device according to claim 1, characterized in that: It also includes a marker kit for setting around the craniotomy window, the marker kit includes a graticule, a hollow area corresponding to the craniotomy window is provided in the middle of the graticule, a first ruler extending along a first direction and a second ruler extending along a second direction are provided on the graticule, and the first direction is perpendicular to the second direction.

8. The microneedle implantation device according to claim 1, characterized in that: It also includes a tracking and positioning module, which is connected to the control module. The tracking and positioning module includes a light emitting device, a light receiving device and a light reflecting device for being set on the target. The light emitting device is used to emit a light beam, and the light reflecting device is used to reflect the light beam back to the light receiving device. The light receiving device is used to receive a light signal reflected by the light reflecting device, and obtain the target position information according to the light signal.

9. The microneedle implantation device according to claim 1, characterized in that: The mechanical arm and the microneedle cutting module are both installed on a support seat; and / or, The mechanical arm is electrically connected to the control module; and / or, It also includes a human-computer interaction module, which is electrically connected to the control module.

10. A microneedle implantation method, characterized in that: The steps include: Acquire image data and perform 3D modeling; Determine the microneedle implantation area; Obtain blood vessel data of the microneedle implantation area, and determine the microneedle cutting area and plan based on the three-dimensional model and blood vessel data; If there are blood vessels that cannot be avoided in the microneedle implantation area, the cutting program is started according to the microneedle cutting area and plan, and the robotic arm is controlled to drive the microneedle to complete the cutting of the needle body at the position interfering with the blood vessel on the microneedle cutting module; Start the microneedle implantation program, control the robotic arm to drive the microneedle to the predetermined area along the planned path, and release the microneedle after fixation to complete the implantation.

Images