A multi-well array needle guide and fixation device and system for use in puncture procedures

Abstract

The application discloses a multi-hole array needle guide and fixing device for puncture surgery, which comprises a needle guide assembly, a plurality of needle guide holes arranged in an array and having parallel axes are formed in the needle guide assembly, the spacing between adjacent needle guide holes is uniform, and the spacing is used for limiting the puncture path of a puncture needle. A support positioning assembly is connected with the needle guide assembly and is used for positioning the needle guide assembly above a target object. A needle fixing assembly is arranged on the support positioning assembly and is used for clamping and limiting the puncture needle after the puncture needle is punctured in place. The application has low cost and is portable: compared with an expensive mechanical arm surgical robot, the application has a simple structure, low manufacturing cost and is easy to popularize and generalize in primary hospitals. The application has strong versatility: the application is suitable for various puncture scenes, including biopsy, ablation, nerve block, intervertebral disc puncture and the like, and can be used in cooperation with various imaging devices such as ultrasound, CT, DSA and the like.

Description

Technical Field

[0001] This invention belongs to the field of medical devices, and in particular relates to a multi-hole array needle guide and fixation device and system for puncture surgery. Background Technology

[0002] In modern cancer diagnosis and treatment, minimally invasive interventional procedures have been widely used as a treatment method, including techniques such as needle biopsy, microwave / radiofrequency ablation, cryoablation, and irreversible electroporation (NanoKnife) ablation. These techniques usually require precise insertion of a thin needle into the lesion site under CT or ultrasound guidance; for large tumors or multifocal lesions, multiple needles are often needed to cover the entire treatment area.

[0003] However, existing manual puncture techniques face numerous challenges: For surgeries requiring the implantation of multiple needles (such as ablation therapy for large tumors), surgeons must perform repeated, independent punctures, making it difficult to ensure that all needles are parallel. Non-parallelism directly affects treatment outcomes. For example, in irreversible electroporation ablation, the angular deviation between the NanoKnife probes must not exceed 10 degrees, a precision requirement difficult to meet manually. Secondly, the depth and angle of manual punctures rely on the surgeon's experience and feel, leading to significant subjective errors and increasing the risk of vascular and nerve damage, as well as tumor metastasis along the needle tract.

[0004] Although existing technologies exist for fixing needles, their functions are limited and they cannot provide precise guidance and fixation during the puncture process, nor can they be integrated with robotic arms to fix the needle after the puncture is completed. For example, in the ablation of soft tissues such as brain tumors, after the puncture, the doctor generally needs to hold the ablation needle and keep it stable to prevent the needle from moving axially and piercing the brain. This method is not only unstable, but also significantly increases the physical burden on the surgeon and the surgical risk due to prolonged operation.

[0005] Therefore, there is an urgent clinical need for a multi-needle implantation auxiliary device that integrates preoperative planning, precise intraoperative guidance, and reliable fixation after insertion. This device can ensure the parallelism and spatial positioning accuracy of the multiple needles while reducing human error and the risk of complications, thereby significantly improving the efficiency, safety, and repeatability of minimally invasive interventional treatment for tumors. Summary of the Invention

[0006] The technical objective of this invention is to provide a multi-hole array needle guide and fixation device and system for puncture surgery, so as to solve the technical problem of lack of multi-needle parallel layout puncture.

[0007] To solve the above problems, the technical solution of the present invention is as follows: A multi-hole array needle guide and fixation device for puncture surgery includes: The needle guide assembly has several needle guide holes arranged in an array and with parallel axes. The spacing between adjacent needle guide holes is consistent, which is used to define the puncture path of the puncture needle. A support positioning component, connected to the needle guide component, is used to position the needle guide component above the target object; The needle fixing component, located on the support and positioning component, is used to clamp and limit the needle after it has been inserted into place.

[0008] The needle guide assembly includes a porous guide plate housing, with several needle guide holes arranged regularly in the horizontal and vertical directions on the porous guide plate housing and extending through the upper and lower end faces of the porous guide plate housing.

[0009] Specifically, the diameter of the needle guide hole matches the puncture needle, and the surface of its hole wall is smooth.

[0010] More preferably, the needle guide assembly further includes a micro-navigation module, a communication module, and a toggle switch. The micro-navigation module is integrated into the porous guide plate housing and is used to detect the tilt angle of the needle guide assembly in real time. The communication module is integrated inside the porous guide plate housing and is used to transmit the detected tilt angle to the outside in real time; The toggle switch is mounted on the housing of the perforated guide plate and is electrically connected to the micro-navigation module and the communication module. It is used to control the power supply to and from the micro-navigation module and the communication module.

[0011] Among them, the end of the porous guide plate shell that is connected to the support and positioning component is the connection end, and the connection end is provided with an interface structure that is connected to the support and positioning component; or, the connection end is provided with an initialization connection block that is connected to an external registration block.

[0012] The porous guide plate shell is made of medical polymer material that can transmit X-rays, CT or MRI.

[0013] The support and positioning component is a robotic arm assembly, which includes: Electromagnetic mount: The electromagnetic mount is used to magnetically attach to external instruments, thereby fixing the robotic arm assembly to the external instruments. The support arm assembly has at least two connected support arms, one end of which is connected to the electromagnetic base. A hydraulic adjustment joint is also provided between the connected support arms. By controlling the hydraulic adjustment joint, the support arm assembly can be kept fixed. The functional arm, connected to the other end of the support arm assembly, is used to secure the needle guide assembly and the needle fixing assembly.

[0014] Specifically, the needle fixation assembly includes: Adjusting bolts are installed on the functional arm; The adjusting nut is threadedly connected to the adjusting bolt. The needle clamping plate is fixedly connected to the adjusting nut. The adjustment nut is rotated to raise and lower the plate itself, thereby driving the needle clamping plate to rise and fall. The needle clamping plate has several needle clamping slots and a moving slot. The needle clamping slots and the moving slot are arranged parallel to each other. The adjusting bolt is slidably connected in the moving slot. The needle clamping plate can be moved horizontally by adjusting the position of the adjusting nut in the moving slot. By translating the needle clamping plate, the puncture needle after puncture is confined within the corresponding needle clamping groove, thereby fixing the puncture needle.

[0015] A guide system for a multi-hole array needle for puncture surgery, employing the aforementioned multi-hole array needle guide and fixation device for puncture surgery, further includes: The planning and navigation module is used to acquire medical image data of the target object, plan the puncture path based on the lesion location and the puncture needle insertion point, and generate the planning spatial angle parameters and puncture depth of the puncture path in a fixed reference frame. The coordinate registration module is fixedly set at a predetermined position that has a defined spatial correspondence with the coordinate system of the imaging device, and is used to provide a spatial registration reference; The attitude monitoring and communication module is connected to the guidance and fixing device to collect the spatial attitude angle data of the guidance and fixing device in real time and transmit it to the planning and navigation module. Before use, the guiding and fixing device is initialized and calibrated in conjunction with the coordinate registration module to establish the correspondence between the guiding and fixing device's own coordinate system and the fixed reference system, and to determine the current spatial attitude at the time of initialization as the attitude reference, so that the planned spatial angle parameters and spatial attitude angle data are under the same reference system. The planning and navigation module is also used to compare the real-time acquired spatial attitude angle data with the planned spatial angle parameters in the same reference system after the initial calibration is completed, and output guidance information according to the comparison results to guide the puncture needle to perform puncture and needle insertion along the guide and fixation device, and control the needle insertion according to the puncture depth.

[0016] Because the present invention adopts the above technical solution, it has the following advantages and positive effects compared with the prior art: This invention is inexpensive and portable: compared to expensive robotic surgical robots, this invention has a simple structure, low manufacturing cost, and is easy to promote and popularize in primary hospitals.

[0017] High versatility: It is suitable for various puncture scenarios (biopsy, ablation, nerve block, intervertebral disc puncture, etc.) and can be used in conjunction with various imaging equipment such as ultrasound, CT, and DSA. Attached Figure Description

[0018] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are for illustrative purposes only and are not intended to limit the invention.

[0019] Figure 1 This is a schematic diagram of the overall structure of a multi-hole array needle guide and fixation device for puncture surgery according to the present invention; Figure 2 This is a schematic diagram of the specific structure of the needle guide assembly of the present invention; Figure 3 These are schematic diagrams of the needle fixing assembly of the present invention from different perspectives; Figure 4 This is a schematic diagram of the specific structure of the support and positioning component of the present invention.

[0020] Explanation of reference numerals in the attached figures 1: Needle guide assembly; 1.1: Perforated guide plate housing; 1.2: Toggle switch; 1.3: Needle guide hole; 1.4: Initialization connecting block; 2: Needle fixing assembly; 2.1: Needle clamping plate; 2.2: Adjusting bolt; 2.3: Adjusting nut; 3: Support positioning assembly; 3.1: Functional arm; 3.2: Support arm assembly; 3.3: Hydraulic adjusting joint; 3.4: Electromagnetic base. Detailed Implementation

[0021] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the specific implementation methods of the present invention will be described below with reference to the accompanying drawings. Obviously, the drawings described below are merely some embodiments of the present invention. For those skilled in the art, other drawings and other implementation methods can be obtained based on these drawings without any creative effort.

[0022] To keep the drawings concise, only the parts relevant to the invention are shown schematically in each figure, and they do not represent the actual structure of the product. Furthermore, for ease of understanding, in some figures, only one of components with the same structure or function is shown schematically, or only one is labeled. In this document, "one" can mean not only "only one" but also "more than one".

[0023] The following detailed description, in conjunction with the accompanying drawings and specific embodiments, provides a multi-hole array needle guiding and fixing device and system for puncture surgery according to the present invention. The advantages and features of the present invention will become more apparent from the following description and claims.

[0024] Example 1

[0025] See Figures 1 to 4This embodiment provides a multi-hole array needle guide and fixation device for puncture surgery, which mainly includes: needle guide component 1, support and positioning component 3 and needle fixation component 2.

[0026] Specifically, such as Figure 1 and Figure 2 As shown, in this embodiment, the needle guide assembly 1 includes a porous guide plate housing 1.1. Preferably, the porous guide plate housing 1.1 is a flat cuboid structure, and its external dimensions are designed in various specifications according to different surgical sites (such as the thoracic cavity, abdominal cavity, and pelvic cavity) to adapt to the operating space requirements of different surgeries. Optionally, the porous guide plate housing 1.1 is made of a medical polymer material that can transmit X-rays, CT, or MRI to ensure that the positional relationship between the puncture needle and the lesion can be clearly observed under image guidance. Then, multiple needle guide holes 1.3 are provided on the porous guide plate housing 1.1 in an array and with parallel axes, penetrating the upper and lower end faces of the porous guide plate housing 1.1. That is, they are arranged regularly in the horizontal and vertical directions on the porous guide plate housing 1.1, and the spacing between the holes is consistent. The guide holes are used to limit the parallel puncture paths of multiple puncture needles. Specifically, the diameter of the needle guide hole 1.3 matches the puncture needle, and its hole wall surface is a smooth surface to reduce the resistance when the puncture needle passes through.

[0027] Preferably, the end of the porous guide plate housing 1.1 connected to the support and positioning component 3 is used as the connection end, and the connection end is provided with an interface structure for connecting to the support and positioning component 3; alternatively, an initialization connection block 1.4 connected to an external registration block can also be provided on the connection end. The initialization connection block 1.4 is used for aseptic isolation during product initialization. It can be understood that the initialization registration function block is a reference component fixed on medical imaging equipment such as CT, and the initialization connection block 1.4 is a matching accessory of this device. One end of it is connected to the porous guide plate housing 1.1 of this embodiment, and the other end is connected to the registration function block. Since the registration function block is located in a sterile environment, the initialization connection block 1.4, as a disposable aseptic isolation connector, realizes a non-contact connection between the device body and the sterile registration block during the preoperative registration process, thereby achieving the effect of aseptic isolation; after registration is completed, the initialization connection block 1.4 can be disassembled and discarded.

[0028] Preferably, the needle guide assembly 1 also includes a micro-navigation module, a communication module, and a toggle switch 1.2. The micro-navigation module is integrated within the porous guide plate housing 1.1 and is used to detect the tilt angle of the needle guide assembly 1 in real time. The communication module (in the form of a communication module circuit board) is integrated within the porous guide plate housing 1.1 and is used to transmit the detected tilt angle to the outside in real time. The toggle switch 1.2 is mounted on the porous guide plate housing 1.1, has a built-in power supply and IMU chip, and is electrically connected to the micro-navigation module and the communication module. The toggle switch 1.2 controls the power supply to and from the micro-navigation module and the communication module. Furthermore, since the IMU chip (inertial measurement unit) moves synchronously with the needle, its sensed local coordinate system is the actual spatial coordinate system of the needle guide component 1. This eliminates the multi-level transmission and calibration errors from "external base station - spatial mapping - surgical instrument" in traditional external navigation systems from a physical source. It eliminates the need to maintain the line-of-sight connection or electromagnetic field constraint between the external base station and the instrument during surgery. This makes this embodiment not only small in size and extremely low in cost, but also fundamentally eliminates the complex preoperative registration process of external optical or electromagnetic base stations, providing a technical basis for disposable consumables.

[0029] Specifically, such as Figure 1 and Figure 4 As shown, in this embodiment, the support positioning component 3 is connected to the needle guide component 1 and is used to position the needle guide component 1 above the target object. The support positioning component 3 is a robotic arm assembly, which includes: an electromagnetic base 3.4, a support arm assembly 3.2, a hydraulic adjustment joint 3.3, and a functional arm 3.1. The electromagnetic base 3.4 is magnetically attached to an external instrument, thereby fixing the robotic arm assembly to the instrument. The support arm assembly 3.2 includes at least two connected support arms, one end of which is connected to the electromagnetic base 3.4, and the other end is connected to the functional arm 3.1. The hydraulic adjustment joint 3.3 is disposed between the connected support arms, and by controlling the hydraulic adjustment joint 3.3, the support arm assembly 3.2 is kept fixed. The functional arm 3.1 is used to fix the needle guide component 1 and the needle fixing component 2.

[0030] Specifically, such as Figure 1 and Figure 3As shown, the needle fixing assembly 2 is mounted on the support and positioning assembly 3, specifically on the functional arm 3.1, and is used to clamp and limit the needle after it has been inserted into place. The needle fixing assembly 2 includes: an adjusting bolt 2.2, an adjusting nut 2.3, and a needle clamping plate 2.1. The adjusting bolt 2.2 is mounted on the functional arm 3.1, and the adjusting nut 2.3 is threadedly connected to the adjusting bolt 2.2. The needle clamping plate 2.1 is fixedly connected to the adjusting nut 2.3. Rotating the adjusting nut 2.3 raises and lowers the plate, thereby raising and lowering the needle clamping plate 2.1. The needle clamping plate 2.1 has multiple needle clamping slots and a moving slot, which are parallel to each other. The adjusting bolt 2.2 is slidably connected to the moving slot, and the adjusting nut 2.3 slides within the moving slot to allow the needle clamping plate 2.1 to move back and forth. By moving the needle clamping plate 2.1, the inserted needle is confined within the corresponding needle clamping slot, thus fixing the needle in place.

[0031] The usage steps are now described in conjunction with this embodiment: First, place the support positioning component 3 in a suitable position on the patient side of the CT bed. Rotate the knob of the electromagnetic base 3.4 to generate magnetic force and firmly attach it to the CT bed. Then, initialize the guide needle assembly using the initialization connection block 1.4 to align the spatial coordinate system with the CT equipment. Next, remove the initialization connection block 1.4 and connect the guide needle assembly to the functional arm 3.1”. Adjust the tilt angle of the guide needle assembly to match the angle planned by the micro-navigation module. Rotate the knob on the hydraulic adjustment joint 3.3 to fix the entire device under hydraulic pressure. Insert the required puncture needle through the needle guide hole 1.3 until it reaches the lesion. Then, rotate the adjusting nut 2.3 on the adjusting bolt 2.2 to adjust the height of the needle clamping plate 2.1 until the lower end of the needle handle is reached. Slide the needle clamping plate 2.1 to hold the needle in place, and rotate the adjusting nut 2.3 to tighten the needle clamping plate 2.1. At this point, the needle is fixed, and the ablation procedure is complete.

[0032] Example 2

[0033] This embodiment provides a guiding system for a multi-hole array needle for puncture surgery, including: the multi-hole array needle guiding and fixing device for puncture surgery as described in Embodiment 1, a planning and navigation module, a coordinate registration module, and an attitude monitoring and communication module. The planning and navigation module acquires medical image data of the target object, plans the puncture path based on the lesion location and the puncture insertion point location, and generates the planned spatial angle parameters and puncture depth of the puncture path in a fixed reference frame. The medical image data can be from CT, CBCT, DSA, MRI, ultrasound, or other imaging devices capable of characterizing the lesion location and the puncture insertion point location. In this embodiment, CT image data is preferably used. The physician can select the lesion location and the puncture insertion point location in the display and planning software corresponding to the planning and navigation module, and plan the puncture path based on these two parameters.

[0034] The coordinate registration module is fixedly installed at a predetermined position that has a defined spatial correspondence with the imaging equipment coordinate system, providing a spatial registration reference. This predetermined position can be a CT bed, imaging equipment gantry, operating table mounting location, or other positions that maintain a stable spatial pose relative to the imaging equipment coordinate system after installation. By fixing the coordinate registration module at the aforementioned predetermined position, a defined spatial correspondence can be established between it and the imaging equipment coordinate system after a single installation and configuration, thus providing a unified and reusable fixed reference reference for initial calibration in subsequent procedures.

[0035] The attitude monitoring and communication module is integrated into the guide and fixation device to collect the spatial attitude angle data of the puncture guide component in real time and transmit it to the planning and navigation module. The attitude monitoring and communication module can be integrated into the needle guide component of the guide and fixation device, or it can be installed in the connection part or the bearing part of the needle guide component.

[0036] The embodiments of the present invention have been described in detail above with reference to the accompanying drawings, but the present invention is not limited to the above embodiments. Even if various changes are made to the present invention, if these changes fall within the scope of the claims of the present invention and their equivalents, they shall still fall within the protection scope of the present invention.

Claims

1. A multi-hole array needle guide and fixation device for puncture surgery, characterized in that, include: A needle guide assembly has a plurality of needle guide holes arranged in an array and with parallel axes. The spacing between adjacent needle guide holes is consistent, which is used to define the puncture path of the puncture needle. A support positioning component, connected to the needle guide component, is used to position the needle guide component above the target object; A needle fixing component is disposed on the support and positioning component and is used to clamp and limit the needle after it has been inserted into place.

2. The multi-hole array needle guide and fixation device for puncture surgery according to claim 1, characterized in that, The needle guide assembly includes a porous guide plate housing, and a plurality of needle guide holes are arranged in a regular manner in the horizontal and vertical directions on the porous guide plate housing, and are disposed through the upper and lower end faces of the porous guide plate housing.

3. The multi-hole array needle guide and fixation device for puncture surgery according to claim 2, characterized in that, The diameter of the needle guide hole matches the puncture needle, and the surface of its hole wall is smooth.

4. The multi-hole array needle guide and fixation device for puncture surgery according to claim 2, characterized in that, The needle guide assembly also includes a micro-navigation module, a communication module, and a toggle switch. The micro-navigation module is integrated inside the porous guide plate housing and is used to detect the tilt angle of the needle guide assembly in real time. The communication module is integrated inside the porous guide plate housing and is used to transmit the detected tilt angle to the outside in real time. The toggle switch is mounted on the housing of the porous guide plate and is electrically connected to the micro-navigation module and the communication module, and is used to control the power supply to and from the micro-navigation module and the communication module through the toggle switch.

5. The multi-hole array needle guide and fixation device for puncture surgery according to claim 2, characterized in that, The connection end of the porous guide plate shell connected to the support and positioning component is used as the connection end, and the connection end is provided with an interface structure for connecting to the support and positioning component; or, the connection end is provided with an initialization connection block for connecting to an external registration block.

6. The multi-hole array needle guide and fixation device for puncture surgery according to claim 2, characterized in that, The porous guide plate shell is made of a medical polymer material that can transmit X-rays, CT, or MRI.

7. The multi-hole array needle for puncture surgery according to claim 1 It has a guiding and fixing device, characterized in that, The support and positioning component is a robotic arm assembly, which includes: An electromagnetic base is used to magnetically attach the robotic arm assembly to an external instrument, thereby fixing the robotic arm assembly to the external instrument. A support arm assembly is provided, wherein at least two connected support arms are provided in the support arm assembly, one end of the support arm assembly is connected to the electromagnetic base; a hydraulic adjustment joint is also provided between the connected support arms, and the support arm assembly is kept fixed by controlling the hydraulic adjustment joint. A functional arm, connected to the other end of the support arm assembly, is used to fix the needle guide assembly and the needle fixing assembly.

8. The multi-hole array needle for puncture surgery according to claim 7 It has a guiding and fixing device, characterized in that, The needle fixation assembly includes: An adjusting bolt, which is mounted on the functional arm; An adjusting nut is threadedly connected to the adjusting bolt. The needle clamping plate is fixedly connected to the adjusting nut. By rotating the adjusting nut, it can raise and lower itself, thereby driving the needle clamping plate to raise and lower. The needle clamping plate has several needle clamping slots and a moving slot. The several needle clamping slots and the moving slot are arranged parallel to each other. The adjusting bolt is slidably connected in the moving slot. The needle clamping plate can be translated by adjusting the position of the adjusting nut in the moving slot. By translating the needle clamping plate, the puncture needle after puncture is confined within the corresponding needle clamping groove, thereby fixing the puncture needle.

9. A guide system for a multi-hole array needle for puncture surgery, employing the multi-hole array needle for puncture surgery as described in any one of claims 1 to 8. It has a guiding and fixing device, characterized in that, Also includes: The planning and navigation module is used to acquire medical image data of the target object, plan the puncture path based on the lesion location and the puncture needle insertion point, and generate the planning spatial angle parameters and puncture depth of the puncture path in a fixed reference frame. The coordinate registration module is fixedly set at a predetermined position that has a defined spatial correspondence with the coordinate system of the imaging device, and is used to provide a spatial registration reference; An attitude monitoring and communication module, connected to the guiding and fixing device, is used to collect the spatial attitude angle data of the guiding and fixing device in real time and transmit it to the planning and navigation module. Before use, the guiding and fixing device is initialized and calibrated in conjunction with the coordinate registration module to establish the correspondence between the coordinate system of the guiding and fixing device and the fixed reference system, and to determine the current spatial attitude at the time of initialization as the attitude reference, so that the planned spatial angle parameters and the spatial attitude angle data are under the same reference system. The planning and navigation module is also used to compare the real-time acquired spatial attitude angle data with the planned spatial angle parameters in the same reference system after the initialization calibration is completed, and output guidance information according to the comparison result to guide the puncture needle to perform puncture and needle insertion along the guide and fixation device, and control the needle insertion according to the puncture depth.

Images