Microneedle implantation apparatus and methods

Abstract

The application discloses a kind of microneedle implantation equipment and method, the microneedle implantation equipment includes microneedle clamping module, microneedle cutting module, blood vessel imaging module and mechanical arm, microneedle clamping module is used to clamp, release, microneedle cutting module is used to cut the microneedle body of microneedle, mechanical arm is detachably connected with microneedle clamping module, mechanical arm is used to drive microneedle to move in cutting and implantation process, blood vessel imaging module is detachably connected with mechanical arm.The microneedle implantation equipment of the application can be automatically completed accurate implantation of microneedle under the assistance of navigation tracking system by automatic mechanical arm, and in the case where there is risk of microneedle body to pierce blood vessel, utilize microneedle cutting module to cut ahead of time microneedle body in specific area, avoid blood vessel, to guarantee that microneedle is implanted into intracranial designated area quickly, accurately, safely.This microneedle implantation equipment is simple to operate, and implantation precision is high, safety is high, and practicality is strong.

Description

Technical Field

[0001] This invention relates to the field of brain-computer interface medical devices, and more particularly to a microneedle implantation device and method. Background Technology

[0002] Microneedles, with their numerous signal contact points, can simultaneously acquire large amounts of data from different brain regions, making them a promising candidate for various applications. Currently, in the field of brain-computer interfaces, invasive brain-computer interface research requires the implantation of microneedle electrodes into the cranium to more directly acquire brain signals for research and treatment.

[0003] Surgical robots are increasingly used in the field of neurosurgery, playing an important role in procedures such as brain biopsy / drainage, SEEG (stereoscopic electroencephalography), and DBS (deep brain stimulation). Compared with traditional surgery, they can quickly locate lesions and perform navigation and orientation with an accuracy of up to 0.5 mm, greatly improving surgical precision and success rate.

[0004] Microneedles need to be implanted in specific brain regions to function. Based on the requirements of the microneedle product and its functions, the requirements for the implantation site are as follows:

[0005] For small-sized microneedles, such as single-needle bodies or single-row needle bodies, it is necessary to collect the electrical signal activity of neurons in a specific region, which requires particularly high implantation accuracy, with a deviation of ≤0.1mm.

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

[0007] Currently available neurosurgical robots are not compatible with microneedles, and their precision is insufficient for implantation, making it impossible to 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 this invention is implemented as follows: a microneedle implantation device, comprising:

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

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

[0012] A robotic arm connected to a microneedle gripping module is used to move the microneedles during the cutting and implantation 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, the vascular imaging module being detachably connected to a robotic arm, the robotic arm being detachably connected to a microneedle clamping module; the vascular imaging module is electrically connected to a 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. Both the second and third connecting devices include connecting plates. The connecting plates of the second and third connecting devices are provided with connecting posts. The sidewalls of the connecting posts are provided with grooves. The connecting plate of the second connecting device is provided with a first connector for connecting with the microneedle clamping module, and the connecting plate of the third connecting device is provided with a second connector for connecting with the vascular imaging module.

[0016] Furthermore, the first connecting device includes a base, a locking member for engaging with a groove in the connecting post, and a locking adjustment handle for driving the locking member to move. The side wall of the base is provided with a hinge groove, and a portion of the locking adjustment handle is located in the hinge groove of the base. The locking adjustment handle is hinged to the base via a pin. The base is provided with a connecting hole for connecting to the end of the robotic arm. The base is also provided with a mating hole for engaging with the connecting post of the second connecting device. The side wall of the mating hole is provided with a mounting hole for mounting the locking member. One end of the mounting hole communicates with the mating hole, and the other end of the mounting hole communicates with the hinge groove. The locking member is loosely fitted in the mounting hole. The base is provided with a return spring for allowing the locking member to return to its original position.

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

[0018] Furthermore, the microneedle clamping module includes a connecting part and a gripping component. The gripping component includes a gripper head for gripping or releasing the microneedle and a drive member for controlling the movement of the gripper head. The gripper head is connected to one end of the connecting part, and the drive member is disposed on the connecting part.

[0019] Furthermore, the robotic arm adopts a 6-DOF (degrees of freedom) design;

[0020] or / and,

[0021] An angle sensor is built into each joint of the robotic arm;

[0022] or / and,

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

[0024] Furthermore, the microneedle implantation device of the present invention also includes a marker kit for placement around the craniotomy window. The marker kit includes a reticle with a hollow area in the middle corresponding to the craniotomy window. The reticle has a first scale extending in a first direction and a second scale extending in a second direction, wherein the first direction is 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 placed 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 the 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 installed on the fixing device. The cutting tool is provided with a cutting action part for cutting microneedles. The cutting tool is provided with parallel tooth-like parts on both sides of the cutting action part. There is a gap between adjacent tooth-like parts for the microneedle body to extend into.

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

[0028] And / or,

[0029] The robotic 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] This 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] Acquire vascular data of the microneedle implantation area, and determine the microneedle cutting area and plan based on the 3D model and vascular data;

[0036] If there are unavoidable blood vessels 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 of interference with the blood vessel on the microneedle cutting module.

[0037] The microneedle implantation procedure is initiated, and the robotic arm is controlled to move the microneedle along the planned path to the predetermined area. After fixation, the microneedle is released to complete the implantation.

[0038] The microneedle implantation method of the present invention further includes the following steps: installing a marker kit at 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 to perform vascular imaging, performing local registration of the vascular image with the three-dimensional model, and determining the microneedle cutting area and scheme.

[0039] The microneedle implantation method of the present invention further includes the following steps: registering and calibrating the positions of the robotic arm, the patient, and the surgical instruments 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 this invention can automatically and precisely implant microneedles with the assistance of an automated robotic arm and a navigation tracking system. Furthermore, in cases where there is a risk of the microneedle puncturing a blood vessel, a microneedle cutting module pre-cuts the microneedle in a specific area to avoid blood vessels, thereby ensuring rapid, accurate, and safe implantation of the microneedle into the designated intracranial region. This invention utilizes an automated robotic arm to implant microneedles with high precision into the target brain region and effectively avoids bleeding during the implantation process.

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

[0043] Simple to operate: This microneedle implantation device adopts an integrated module approach, and doctors can automatically complete the entire microneedle implantation process with one click by controlling the host computer software.

[0044] High implantation precision: This microneedle implantation device uses a fully automated module, achieving implantation precision down to the micrometer level, far exceeding the precision of manual implantation by doctors. Furthermore, this invention installs a high-precision reticle at the craniotomy window for intraoperative high-precision local imaging. After fusion with the preoperative model, implantation precision can be further improved to 100μm, enabling the microneedles to be precisely implanted into designated areas to collect specific neuronal signals.

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

[0046] Highly practical: This microneedle implantation device provides a standardized microneedle implantation method, so that microneedle implantation surgery no longer relies mainly on the doctor's experience, reducing the difficulty of the surgery. Attached Figure Description

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

[0048] Figure 2 This is a structural schematic diagram of the first connecting device provided in an embodiment of the present invention from a first perspective;

[0049] Figure 3 This is a structural schematic diagram of the first connecting device provided in an embodiment of the present invention from a second perspective;

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

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

[0052] Figure 6 This is a schematic diagram of the structure of the reticle provided in an embodiment of the present invention;

[0053] Figure 7 This is a schematic diagram illustrating a usage scenario of the vascular imaging module provided in an embodiment of the present invention;

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

[0055] Figure 9 This is a schematic diagram of the structure of the cutting tool provided in an embodiment of the present invention;

[0056] Figure 10 for Figure 9 Enlarged view of part P;

[0057] Figure 11 This is a schematic diagram of the structure of a 32×32 area array microneedle provided in an embodiment of the present invention;

[0058] Figure 12This is a schematic diagram of the structure of the 32×32 area array microneedles provided in an embodiment of the present invention;

[0059] Figure 13 This is a schematic diagram illustrating the matching of the implantation area and vascular information provided in an embodiment of the present invention;

[0060] Figure 14 This is a schematic diagram illustrating the interaction between the pre-cutting tool and the microneedle provided in an embodiment of the present invention.

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

[0062] Figure 16 A schematic diagram of the cutting process provided in an embodiment of the present invention;

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

[0064] Figure 18 This is a schematic diagram of the microneedle clamping module provided in an embodiment of the present invention;

[0065] Figure 19 A first-view schematic diagram of a microneedle clamping module provided for an embodiment of the present invention (schematic diagram of clamping and grasping of 32×32 area array microneedles);

[0066] Figure 20 A second-view schematic diagram of a microneedle clamping module provided for an embodiment of the present invention (schematic diagram of clamping and grasping of 32×32 area array microneedles);

[0067] Figure 21 for Figure 20 A schematic diagram of its vertical cross-section;

[0068] Figure 22 A first-view schematic diagram of a microneedle clamping module provided in an embodiment of the present invention (a schematic diagram of the adsorption gripping of 32×32 area array microneedles);

[0069] Figure 23 A second-view schematic diagram of a microneedle clamping module provided in an embodiment of the present invention (a schematic diagram of the adsorption gripping of 32×32 area array microneedles);

[0070] Figure 24 for Figure 23 A schematic diagram of its vertical cross-section;

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

[0072] Figure 26A schematic diagram of the structure of the robotic arm provided in an embodiment of the present invention;

[0073] Figure 27 A flowchart illustrating the microneedle implantation procedure provided in this embodiment of the invention.

[0074] In the attached diagram, 1 is the robotic arm, 11 is the pressure sensor, 12 is the first connecting device, 121 is the base, 1211 is the hinge groove, 1212 is the connecting hole, 1213 is the mating hole, 122 is the locking adjustment handle, 123 is the locking element, 124 is the positioning pin, 125 is the pin shaft, 2 is the microneedle gripping module, 201 is the connecting part, 2010 is the housing, 2011 is the inner cavity, 202 is the gripper 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 plane, 205 is the locking knob, 206 is the adapter, 207 is the screw, 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 board, 213 is the slider, 214 is... 3 is a 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 part, 314 is a mounting and fixing part, 32 is a fixing device, 4 is a blood vessel 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 base, 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 post of the second connecting device, 913 is a first connector, 92 is a third connecting device, 921 is a connecting plate of the third connecting device, 922 is a connecting post of the third connecting device, 923 is a second connector, 10 is a marker kit, 101 is a reticle, 102 is a hollow area, 103 is a first scale, and 104 is a second scale. Detailed Implementation

[0075] To enable those skilled in the art to better understand the technical solutions of the present invention, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0076] See Figures 1 to 26 This invention discloses a microneedle implantation device, comprising:

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

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

[0079] Robotic arm 1, which is connected to microneedle clamping module 2, is used to move microneedles 8 during cutting and implantation.

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

[0081] In some embodiments, both the robotic arm 1 and the microneedle cutting module 3 are mounted on a support base 7. The support base 7 is provided with rollers. The support base 7 is provided with an electrical mounting cavity, and the control module is disposed within the electrical mounting cavity of the support base 7.

[0082] Furthermore, the microneedle implantation device of the present invention also includes 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 is a human-computer interaction module, which can be a touch screen.

[0083] Display module 6 provides doctors with a visual display of surgical planning and operation control, which helps doctors operate conveniently during the operation and improves surgical efficiency.

[0084] The control module can 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 robotic arm 1, and the robotic arm 1 is detachably connected to the microneedle clamping module 2. The robotic arm 1 is used to receive vascular imaging commands output by the control module, and the robotic 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 commands.

[0087] Furthermore, the vascular imaging module 4 employs a near-infrared vascular imaging module 4. This module utilizes the differences in absorption of near-infrared light (wavelength 700-970nm) by human tissue and hemoglobin to generate vascular data and images. This helps doctors determine the course of blood vessels in the patient's brain before surgery and develop a microneedle 8 implantation plan. Simultaneously, it can also help doctors confirm the microneedle 8 implantation location during surgery, addressing the potential problem of puncturing large blood vessels during microneedle 8 implantation.

[0088] The near-infrared vascular imaging module 4 includes a near-infrared emitting light source 41, an optical lens 42, and a camera 43. 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. In one embodiment, the near-infrared emitting light source 41 used in the vascular imaging module 4 can emit infrared light with a wavelength of 850–940 nm towards the target area. After absorption and reflection by the cerebral cortex, the light is focused by the optical lens 42 and captured by the camera 43 to obtain an image of the cerebral cortex vessels. In addition to capturing images of the vessels in the craniotomy area, the camera 43 used in this vascular imaging module 4 can also capture images of the scale (scale spacing 0.1 mm, scale line width 0.05 mm) on the scale of the reticle 101 fixed around the craniotomy window.

[0089] The vascular imaging module 4 is used to acquire vascular images of the target area and transmit the vascular images of the target area to the control module. The control module determines whether there are target blood vessels that the microneedle 8 cannot avoid in the implantation area based on the vascular images. When there are target blood vessels that the microneedle 8 cannot avoid in the implantation area, the microneedle 8 cutting area and microneedle 8 cutting scheme are obtained based on the location of the target blood vessels.

[0090] The control module controls the robotic arm 1 to perform microneedle 8 cutting operations based on the microneedle 8 cutting area and microneedle 8 cutting scheme.

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

[0092] A first connecting device 12 is provided at the end of the robotic arm 1, allowing the microneedle clamping module 2 or the vascular imaging module 4 to be quickly attached and detached from the end of the robotic arm 1. This facilitates the installation of different devices at the end of the robotic arm 1 to achieve different functions. For example, the vascular imaging module 4 can be installed to take pictures of blood vessels in a specific brain region, and the microneedle clamping module 2 can be installed to enable the rapid implantation of microneedles 8. The structure of the first connecting device 12 is as follows: Figure 3 As shown. The structure of the second connecting device 91 is as follows. Figure 18 As shown. The structure of the third connecting device is as follows. Figure 5 As shown.

[0093] Further, the first connecting device 12 includes a base 121, a locking member 123 for engaging with a groove in the connecting post, 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, and a portion of the locking adjustment handle 122 is located in the hinge groove 1211 of the base 121. The locking adjustment handle 122 is hinged to the base 121 via a pin 125. The base 121 is provided with a connecting hole 1212 for connecting to the end of the robotic arm 1. 1212 is a stepped through hole. One side of the base 121 is provided with a mating hole 1213 (the mating hole 1213 is a blind hole) for engaging with the connecting post of the second connecting device 91. The side wall of the mating hole 1213 is provided with a mounting hole for installing the locking member 123. One end of the mounting hole communicates with the mating hole 1213, and the other end of the mounting hole communicates with the hinge groove 1211. The locking member 123 is fitted with the mounting hole with clearance. The base is provided with a return spring for the locking member to return to its original position. The locking member 123 has a large diameter section and a small diameter section, forming a stepped shape. The return spring is sleeved on the small diameter section of the locking member 123.

[0094] After the connecting post of the second connecting device 91 extends into the mating hole 1213 of the base 121, the locking member 123 is driven to extend into the groove of the connecting post of the second connecting device 91 by the locking adjustment handle 122. The locking adjustment handle 122 is positioned so that the second connecting device 91 is connected 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 positioning between the base 121 and the robotic 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, with the positioning pin 124 and the positioning hole having a clearance fit.

[0097] The microneedle clamping module 2 can be a surface array spring slider clamping assembly.

[0098] Furthermore, the microneedle clamping module 2 includes a connecting part and a gripping assembly. The gripping assembly includes a gripper head for gripping or releasing the microneedle 8 and a drive member for controlling the movement of the gripper head. The gripper head is connected to one end of the connecting part, and the drive member is disposed on the connecting part. The connecting part 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 with the second connecting device 91.

[0100] As in one embodiment, the connection structure includes a locking knob 205 and an adapter 216, wherein the locking knob 205 locks the first connector of the second connection device 91 to the adapter 216, and the adapter 216 is mounted on the connection portion 201.

[0101] There are two implementation methods for grasping: one is clamping grasping, and the other is suction grasping. The two specific grasping methods are detailed below.

[0102] Please see Figures 19 to 21 The gripper 202 includes a first clamping block 2020 and a second clamping block 2021 disposed opposite to each other. The space between the first clamping block 2020 and the second clamping block 2021 forms a clamping area for holding the microneedles 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 area. In this embodiment, a gripping method is used to grasp the microneedles 8. This gripping method is most suitable for grasping area array microneedles 8. Of course, by controlling the precision of the gripping method, it can also be used for single needles, such as small animal microneedles 8, large animal microneedles 8, etc. Furthermore, by designing anti-slip and anti-damage structures, the safe clamping of single needles can be ensured. Anti-slip and anti-damage can be achieved, for example, by using rubber gripping surfaces. Specifically, the first clamping block 2020 and the second clamping block 2021 cooperate to clamp the microneedles 8, and when they cooperate, there is a clamping area between them. The first clamping block 2020 and the second clamping block 2021 can be driven by a driving component. One of the clamping blocks can move, or both can move. This embodiment does not limit this. The purpose is to change the size of the clamping range in order to clamp or release the microneedle 8.

[0103] To further optimize the above solution, the driving component includes a push rod 203 for driving the first clamping block 2020 closer to or further away from the second clamping block 2021, and the push rod 203 is movably disposed on the connecting part 201. In this embodiment, a push rod 203 can be used to drive the first clamping block 2020 closer to or further away from the second clamping block 2021. The pushing direction of the push rod 203 can be set in various ways. Its pushing direction can be consistent with the moving direction of the first clamping block 2020 or perpendicular to it. When the directions are consistent, the pushing direction of the push rod 203, the first clamping block 2020, and the second clamping block 2021 are on a straight line. At this time, the push rod 203 can be placed outside the connecting part 201, and the push rod 203 can be fixedly installed with the first clamping block 2020. In this way, the push rod 203 can push or retract the first clamping block 2020. When pushing the first clamping block 2020, the microneedle 8 is clamped (grabbed); when retracting the first clamping block 2020, the microneedle 8 is released. When the direction is perpendicular, the push rod 203... The surface in contact with the first clamping block is an inclined plane 204, and the pushing direction of the push rod 203 is perpendicular to the moving direction of the first clamping block. A first return spring is installed on the first clamping block. The inclined plane 204 decomposes the direction of the driving force, so that the moving direction of the first clamping block can be perpendicular to the pushing direction of the push rod 203. Thus, the push rod 203 can be placed inside the connecting part 201. At this time, because the force is decomposed by the inclined plane 204, the push rod 203 cannot be fixed to the first clamping block. Otherwise, there would be no relative sliding between the two, and the first clamping block could not be pushed. Therefore, the first return spring can be used to reset the first clamping block. When the first return spring is compressed, the microneedle 8 is clamped (grabbed). When the first return spring is reset, the microneedle 8 is released. Preferably, a guide rod 210 is provided to assist the movement of the first clamping block. The guiding direction of the guide rod 210 is consistent with the moving direction of the first clamping block. The first return spring is sleeved on the guide rod 210.

[0104] As an optimized solution for an embodiment of the present invention, please refer to Figures 19 to 21 The driving component further includes a control button movably sleeved on the connecting part 201 and a connecting rod disposed on the push rod 203, the connecting rod being 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 threaded onto the connecting part 201, so that the control button can be turned to adjust its up and down movement, thereby driving the push rod 203 to move via the connecting rod. The connecting rod can be a screw 207, and a threaded hole is provided on the push rod 203 for the screw 207 to be installed.

[0105] As an optimized solution for an embodiment of the present invention, please refer to Figures 19 to 21A 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 reset of the push rod 203. For example, after the force pressing the push rod 203 is removed (i.e. the control button is turned up), 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 move away from the second clamping block under the action of the first return spring.

[0106] Please see Figures 22 to 25 The gripper 202 can be a suction nozzle 2022, and the driving component can be a negative pressure mechanism that provides suction to the suction nozzle 2022. In this embodiment, the suction nozzle 2022 and the negative pressure mechanism can be used together to achieve the adsorption of the microneedles 8. This adsorption is suitable not only for single needles and multi-needles, but also for array microneedles 8.

[0107] For further optimization of the above solution, please refer to [link / reference]. Figures 22 to 25 The negative pressure mechanism includes an air tube disposed on the connecting part 201 and a negative pressure generating device 209 for providing negative pressure. The two ends of the air tube are respectively connected to the suction nozzle 2022 and the negative pressure generating device 209. In this embodiment, the negative pressure mechanism can be further refined into an air tube and a negative pressure generating device 209. The air tube can be built into the connecting part 201 or laid outside the connecting part 201; either is acceptable, and this embodiment does not limit this. The purpose of the air tube is to provide negative pressure, therefore its two ends need to be connected to the suction nozzle 2022 and the negative pressure generating device 209 respectively. The suction nozzle 2022 is threaded onto the air tube. The negative pressure generating device 209 can be a separate component or a component fixedly installed on the connecting part 201.

[0108] As an optimized solution for an embodiment of the present invention, please refer to Figure 25 The suction nozzle is a surface array suction nozzle. Since the surface array microneedles 8 are a single plate, only adsorption points need to be designed on both sides to adsorb the entire surface array microneedles 8. Preferably, the suction nozzle includes a suction block 2023 with built-in air channels. The suction block has adsorption points that communicate with the air channels. The suction nozzle can be refined into a suction block with air channels inside and adsorption points on the bottom surface, thus allowing the microneedles 8 to be adsorbed.

[0109] As an optimized 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 makes the microneedle clamping module 2 more compact and also protects the driving member.

[0110] As an optimized embodiment of the present invention, the microneedle clamping module 2 further includes a camera 211 for observing the implantation status of the microneedle 8. In this embodiment, the camera 211 is designed to observe the implantation status of the microneedle 8, and the observed image can be exported and stored, allowing people to observe the implantation image in real time. The camera 211 can be a macro camera 211, which also has characteristics such as supplementary lighting, high resolution, and small size. Of course, the supplementary lighting characteristic can also be achieved using a separate supplementary lighting structure, and this embodiment does not limit this. Preferably, the camera 211 is mounted on the connecting part 201.

[0111] As an optimized 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 from the first end to the last end of the connecting portion 201. A gripper head 202 for gripping the microneedle 8 is provided at the end of the connecting portion 201. A PCB board that can be disposed on the microneedle 8 is mounted on the PCB adapter plate 212. In this embodiment, the sliding docking of the PCB adapter plate 212 on the connecting portion 201 with the PCB board allows for precise docking of the PCB board, stable docking of the microneedle 8, without affecting the already implanted microneedle 8, thus improving the reliability of the microneedle 8.

[0112] To further optimize the above technical solution, the PCB adapter board 212 is slidably mounted on the connecting part 201 via a slider 213. The sliding direction of the slider 213 is consistent with the direction from the first end to the last end of the connecting part 201. In this embodiment, the PCB board and the micro-needle 8 can be docked and installed by sliding the slider 213. Preferably, the slider 213 is fixed to the connecting part 201 by a locking structure. The slider 213 can be fixed to the connecting part 201 by the locking structure, so that the micro-needle 8 can be implanted first, and then the docking and installation of the PCB board and the micro-needle 8 can be achieved.

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

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

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

[0116] Specifically, the robotic arm 1 uses servo motors to drive the movement of six joints to achieve precise control of the end effector position. Each joint of the robotic arm 1 has a built-in angle sensor, which accurately identifies the position of the robotic arm 1 and, in conjunction with the control system, compensates and adjusts it, achieving a repeatability accuracy of 0.01mm at the end effector tool. A pressure sensor 11 is installed at the end effector joint of the robotic arm 1, capable of distinguishing force differences as small as 0.01N. This sensor can detect the reverse resistance generated by brain tissue during the implantation of the microneedles 8, thereby achieving precise control of the implantation.

[0117] Furthermore, the microneedle implantation device of the present invention also includes a marker kit 10 for placement around the craniotomy window. The marker kit 10 includes a reticle 101 with a hollowed-out area 102 in the middle corresponding to the craniotomy window. The reticle 101 has a first scale 103 extending along a first direction and a second scale 104 extending along a second direction, the first direction being perpendicular to the second direction. The craniotomy window is located within the hollowed-out area 102 of the reticle 101. Preferably, the reticle 101 is a rectangular frame.

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

[0119] Specifically, the tracking and positioning module 5 includes a light emitting device, a light receiving device, and a light reflecting device for placement on the target. The light emitting device emits a light beam, the light reflecting device reflects the light beam back to the light receiving device, and the light receiving device receives the light signal reflected back from the light reflecting device, obtaining the target position information based on the light signal. The tracking and positioning module 5 is electrically connected to the control module, and it transmits 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 that supports movement and multi-directional adjustment 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 installed on the fixing device 32. The cutting tool 31 is provided with a cutting action part 311 for cutting microneedles 8. The cutting tool 31 has parallel tooth-like parts 312 on both sides of the cutting action part 311 to form a cutting comb part 313. There is a gap between adjacent tooth-like parts 312 for microneedles 8 to extend into. The gap spacing matches the spacing of microneedles 8 and is on the micrometer level.

[0122] The cutting tool 31 is sheet-shaped. The thickness of the cutting tool 31 can be set as needed.

[0123] Preferably, the cutting action part 311 is located in the middle of the cutting tool 31. The fixing device 32 has a hollowed-out portion, and both 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 hollowed-out portion of the fixing device 32. The cutting tool 31 has mounting and fixing parts 314 at both ends of the cutting comb part 313.

[0124] The microneedle cutting module 3 mainly cuts the microneedle 8 in areas where it may puncture large blood vessels, thus solving the problem of potential puncture of large blood vessels during microneedle 8 implantation. After the robotic arm 1 holding the microneedle 8 moves above the cutting tool 31, it extends vertically downward into the gap between the comb teeth, and then cuts off the microneedle 8 in the designated area through relative motion.

[0125] The microneedle implantation device of the present invention can automatically complete the precise implantation of microneedles 8 with the assistance of an automated robotic arm 1 and a navigation tracking system. In the event that there is a risk of the microneedle body 81 puncturing blood vessels, the microneedle body 81 in a specific area can be pre-cut to avoid blood vessels, thereby ensuring that the microneedle 8 is quickly, accurately and safely implanted into the designated area of ​​the intracranial cavity.

[0126] This invention provides a standardized microneedle implantation device, suitable for the standard implantation of microneedles 8 in various specifications / models / shapes.

[0127] Based on the above microneedle implantation devices, see [link / reference]. Figure 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. The vascular imaging module is used to image the cerebral blood vessels at the craniotomy site to clarify the vascular data near the microneedle implantation. Based on the three-dimensional model and vascular data, the microneedle cutting area and plan are determined.

[0131] A microneedle gripping module is installed at the end of the robotic arm to fix the selected microneedle in the corresponding position of the microneedle gripping module and lock it in place;

[0132] If there are unavoidable blood vessels 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 of interference with the blood vessel on the microneedle cutting module.

[0133] Initiate the microneedle implantation procedure (e.g., initiate the microneedle 8 implantation procedure on the software of the display and control module). The robotic arm drives the microneedle to the predetermined area along the planned path, fixes it, and then releases the microneedle to complete the implantation.

[0134] The microneedle implantation method of the present invention further includes the following steps: installing a marker kit at 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 to perform vascular imaging, performing local registration of the vascular image with the three-dimensional model, and determining the microneedle cutting area and scheme.

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

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

[0137] Based on various imaging data acquired from the patient before surgery, this invention uses surgical software to create a 3D model, determine the implantation area of ​​the microneedle 8, clarify the vascular data near the microneedle 8 implantation, and determine the microneedle 8 cutting area and plan. After fixing the patient on the operating table, the positions of the robotic arm 1, the patient, and the surgical instruments are registered and calibrated through a tracking and positioning module.

[0138] The robotic arm is controlled to move the microneedle to the microneedle cutting module to complete the cutting of the needle body at the location where it interferes with the blood vessel. Specifically, the robotic arm 1 moves the microneedle 8 to the top of the cutting module, performs 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 image to the software system to compare the microneedle 8 cutting results for pre-implantation confirmation.

[0140] It is understood that the above embodiments are merely exemplary embodiments used to illustrate the principles of the present invention, and the present invention is not limited thereto. For those skilled 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 implant device, characterized by, include: A microneedle clamping module, which is used to clamp and release microneedles; A microneedle cutting module, which is used to cut the microneedle body of the microneedle; A robotic arm, which is connected to a microneedle clamping module, is used to move the microneedles during cutting and implantation, and is electrically connected to a control module. A marker kit is disposed around the craniotomy window. The marker kit includes a reticle with a cutout area in the middle corresponding to the craniotomy window. The reticle has a first scale extending in a first direction and a second scale extending in a second direction, wherein the first direction is perpendicular to the second direction. A vascular imaging module is used to acquire vascular data of a target area. The vascular imaging module is detachably connected to a robotic arm, the robotic arm is detachably connected to a microneedle clamping module, and the vascular imaging module is electrically connected to a control module. 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 control module is used to acquire image data, perform 3D modeling, determine the microneedle implantation area, and when the vascular imaging module is installed at the end of the robotic arm, control the vascular imaging module to move to the marker kit to perform vascular imaging, receive the vascular data of the microneedle implantation area acquired by the vascular imaging module, perform local registration of the vascular image with the 3D model, and determine the microneedle cutting area and scheme. If there are unavoidable blood vessels 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 of interference with the blood vessel on the microneedle cutting module. The microneedle implantation procedure is initiated, and the robotic arm is controlled to move the microneedle along the planned path to the predetermined area. After fixation, the microneedle is released to complete the implantation.

2. The microneedle implant device of claim 1, wherein: Both the second and third connecting devices include a connecting plate. The connecting plates of the second and third connecting devices are provided with connecting posts. The sidewalls of the connecting posts are provided with grooves. The connecting plate of the second connecting device is provided with a first connecting member for connecting with the microneedle clamping module. The connecting plate of the third connecting device is provided with a second connecting member for connecting with the vascular imaging module.

3. The microneedle implant device of claim 2, wherein: The first connecting device includes a base, a locking member for engaging with a groove in a connecting post, and a locking adjustment handle for driving the locking member to move. The side wall of the base is provided with a hinge groove, and a portion of the locking adjustment handle is located in the hinge groove of the base. The locking adjustment handle is hinged to the base via a pin. The base is provided with a connecting hole for connecting to the end of a robotic arm. The base is also provided with a mating hole for engaging with a connecting post in the second connecting device. The side wall of the mating hole is provided with a mounting hole for mounting the locking member. One end of the mounting hole communicates with the mating hole, and the other end of the mounting hole communicates with the hinge groove. The locking member is loosely fitted in the mounting hole. The base is provided with a return spring for allowing the locking member to return to its original position. The base is provided with a positioning pin or a positioning hole, and the connecting plate is provided with a positioning hole or a positioning pin, with the positioning pin and the positioning hole having a clearance fit.

4. The microneedle implant device of claim 2, wherein: The microneedle clamping module includes a connecting part and a gripping component. The gripping component includes a gripper head for gripping or releasing the microneedle and a drive member for controlling the movement of the gripper head. The gripper head is connected to one end of the connecting part, and the drive member is disposed on the connecting part.

5. The microneedle implant device of claim 1, wherein: The robotic arm is a 6-DOF robotic arm; or / and, An angle sensor is built into each joint of the robotic arm; or / and, A pressure sensor is installed at the end joint of the robotic arm.

6. The microneedle implant device of claim 1, wherein: 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 placed 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 the light signal reflected back by the light reflecting device, and obtain the target position information based on the light signal.

7. The microneedle implant device of claim 1, wherein: The robotic arm and the microneedle cutting module are both mounted on the support base; And / or, It also includes a human-computer interaction module, which is electrically connected to the control module.

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