Head positioning device for brain glioma operation

Abstract

The invention relates to the technical field of medical auxiliary instruments, in particular to a brain glioma operation head positioning device which comprises a rotating supporting column, a supporting arm and a fixing assembly are rotationally connected to the two sides of the rotating supporting column respectively, a supporting assembly is arranged at the end, away from the rotating supporting column, of the supporting arm, and a base is arranged on the supporting assembly; the base comprises a top wall, a side wall and a bottom wall, the top wall is provided with a first through hole, the bottom wall is fixedly connected with a rotating shaft located under the first through hole, the rotating shaft is rotationally connected with a rocker arm, and the rocker arm is hollow; fixing rings are symmetrically arranged outside the two ends of the rocker arm, and bone nails extending out of the fixing rings are in threaded connection with the interiors of the fixing rings; limiting holes are symmetrically formed in the rocker arm, and rotating assemblies are arranged in the limiting holes. By symmetrically arranging the rotating assemblies and the worms engaged with the rotating assemblies, the head fixing device is used for synchronously, stably, reliably and adjustably fixing the head of a patient in the operation process, and the neck of the patient is prevented from being damaged.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical auxiliary devices, in particular to a head positioning device for brain glioma surgery. BACKGROUND

[0002] In brain surgery, brain glioma is one of the most common primary intracranial tumors, and its pathological characteristics are strong growth infiltration and unclear boundary, and often involves important brain function areas, which brings great challenges to surgical resection. For the treatment of brain glioma, surgical resection is still the main and preferred treatment method. However, due to the complex location of the tumor and the fragile structure of the patient's brain, the patient's head needs to be kept in a highly stable state during the operation to avoid misoperation caused by head shaking during the resection process, thereby affecting the accuracy and safety of the operation.

[0003] The Mayfield three-pin headrest widely used in clinical practice is a typical skull fixation device, which is composed of a headrest main body, a rocker arm, a pin seat and a fixing mechanism. The headrest adopts a three-point fixation principle, that is, three metal pins are used to press the surface of the patient's skull, so that the head is firmly limited at three different points to achieve stable fixation. Among them, one pin is usually located on one side as a support base point, and the other two pins are connected to the rocker arm and act on the opposite side of the skull, forming a stable support triangle structure to geometrically ensure the relative fixation of the head. In terms of specific structure, the main body of the Mayfield headrest is provided with a fixed base for installing the pin seat, and the pin seat can control the advance and retreat of the metal pin through the adjustment knob, thereby achieving the compression and fixation of the skull. The front end of the pin is usually designed as a cone or a sharp end to penetrate the scalp and embed into the outer bone of the skull, thereby providing a stable support force. The rocker arm, as a key component of the device, is hinged to the base at one end and connected to the two pin seats at the other end, forming a lever-type structural layout. During the operation, the doctor usually places the patient's head between the headrests, adjusts the angle and position of the pin seat, and then gradually tightens the three metal pins to press the sharp end of the pin on the surface of the skull until the head is firmly fixed.

[0004] However, the three-pin headrest has certain defects in actual use. When in use, since the three metal pins are independently rotated to fix the patient's head, especially the two metal pins on the rocker arm, if they cannot be pushed synchronously during the rotation process, the pin tip will be unevenly stressed, causing the pin tip on one side to press the patient's skull first, while the other side is not yet fully fixed, resulting in slight deviation or stress concentration of the patient's head. In brain glioma surgery, the fixation of the Mayfield headrest should be adapted to the patient's body position to avoid excessive backward bending or lateral deviation during fixation, which may cause cervical spine injury, and ensure that the neck is in a neutral position after the headrest is fixed without obvious traction.

[0005] To this end, it is necessary to propose a head positioning device that can assist the patient to fix the posterior neck in a neutral position for brain glioma surgery to solve the above problems. SUMMARY

[0006] To solve the above problems, the present application provides a brain glioma surgery head positioning device, which is used for synchronous stable, reliable and adjustable fixation of the patient's head during the operation process, and based on the head condition of the patient during the fixation process, the head of the patient is adjusted to keep the neck in a neutral position.

[0007] In order to achieve the above purpose, the technical scheme of the present application is as follows: a brain glioma surgery head positioning device, comprising a rotating column, a support arm and a fixing assembly are rotatably connected on both sides of the rotating column, a support assembly is arranged at the end of the support arm away from the rotating column, and a base is arranged on the support assembly; the base comprises a top wall, a side wall and a bottom wall, the top wall is provided with a first through hole, the bottom wall is fixedly connected with a rotating shaft located directly below the first through hole, the rotating shaft is rotatably connected with a rocker arm, and the rocker arm is hollow inside;

[0008] The outer part of both ends of the rocker arm is symmetrically provided with a fixing ring, a bone screw extending to the outside of the fixing ring is threadedly connected in the fixing ring, and the thread rotation directions of the two bone screws are opposite; the inside of the rocker arm is symmetrically provided with a limiting hole, a rotating assembly is arranged in the limiting hole, a second through hole is symmetrically arranged on the side wall of the rocker arm opposite to the limiting hole, and a supporting assembly is arranged in the second through hole; a third through hole is arranged on the top surface of the rocker arm directly below the first through hole, a worm is rotatably connected in the third through hole, and the worm extends into the rocker arm; the worm is in transmission connection with the rotating assembly, the rotating assembly is used for driving the bone screw to rotate in the fixing ring, and the supporting assembly is used for disconnecting the transmission connection relationship between part of the worm and the rotating assembly when the inclination angle of the rocker arm is greater than a threshold value.

[0009] The technical principle of the above scheme is as follows: the present application realizes synchronous driving of the bone screw by symmetrically arranging the rotating assembly in the rocker arm, specifically, the worm is arranged in the third through hole of the rocker arm, the worm is engaged with the symmetric rotating assembly, the user rotates the worm to synchronously drive the rotating assembly to drive the bone screw to rotate, and synchronous rotation or exit of the bone screw is realized. This design effectively avoids the situation that the two side bone screws in the traditional three-nail head frame rotate unevenly, so that the force on the skull of the patient is balanced during the fixation process, and the head deviation and local stress concentration are reduced. Moreover, when the patient's head deviates, based on the deviation of the head, the design can adaptively disconnect the continuous rotation of one side and keep the continuous rotation of the other side, so as to assist the patient to adjust the head to keep the neck in a neutral position.

[0010] The above scheme has the following beneficial effects:

[0011] 1. This solution uses a worm gear to drive the rotating assembly, which in turn drives the bone screws at both ends of the rocker arm to rotate synchronously. This avoids displacement caused by asynchronous rotation of the bone screws and improves the stability of the patient's head positioning. The doctor only needs to rotate the worm gear to drive both bone screws to rotate simultaneously, reducing the cumbersome steps of independent adjustment and improving operational efficiency.

[0012] 2. This solution, through the cooperation of the fixation component and the support arm, allows the device to be flexibly adjusted according to the different head sizes of patients, making the contact position between the bone screw and the skull more precise, avoiding the problem of unstable fixation caused by individual differences, thereby ensuring the stability and safety of the head during the operation.

[0013] 3. This method, during the fixation of the patient's head, can adaptively assist in adjusting the patient's head based on its displacement, allowing the head to lead the neck back to a neutral position. Compared to existing technologies, this avoids cervical spine injury caused by excessive backward tilting / lateral deviation during fixation.

[0014] Furthermore, the support assembly includes a limiting seat fixedly connected to the base. A connecting column and a guide column are fixedly connected to the side of the limiting seat away from the base. A hole seat is installed on the connecting column. A hole column is provided at the center of the hole seat. Several mounting holes are provided around the hole column. A limiting cylinder is fixedly connected to the side of the hole seat away from the mounting holes. A limiting key is provided on the outer wall of the limiting cylinder.

[0015] The limiting cylinder is equipped with a support cylinder. The support cylinder has a groove, and a sleeve hole is provided at the center of the groove. The sleeve hole has a keyway that mates with the limiting key. The hole seat is installed in the groove. The limiting cylinder is installed in the sleeve hole and extends to the other end of the support cylinder. A limiting washer is installed on the limiting washer. A limiting spring is provided in the limiting washer. A nut is provided in the limiting spring. The nut is fixedly connected to the connecting column. The support cylinder is fixedly connected to the support arm.

[0016] Beneficial effects: By setting the thread and nut connection at the end of the support cylinder, the connection between the support arm and the base can be quickly assembled and disassembled and stably locked, which facilitates the adjustment of the device position in different operating table environments, improving adaptability and ease of operation.

[0017] Furthermore, each rotating component includes a support shaft that is rotatably connected to the limiting hole, and a worm gear is coaxially fixedly connected to each support shaft, and a drive wheel is coaxially fixedly connected to each worm gear.

[0018] The rocker arm is rotatably connected to both ends of a transmission rod, and a transmission wheel is coaxially fixedly connected to the transmission rod. The transmission wheel and the drive wheel are connected by a synchronous belt. The transmission rod extends into the bone screw and is splinedly connected to the bone screw.

[0019] Beneficial effect: through the transmission cooperation of the worm gear, the driving wheel, the synchronous belt and the transmission wheel, the synchronous advancement and contraction of the two bone nails are realized, the uneven force on the skull caused by the uneven advancement of the nails in the traditional three-nail head frame is avoided, and thus the stability and safety of the fixation are significantly improved.

[0020] Further, the support assembly each comprises a support rod coaxially slidingly connected with the support shaft, a limiting block is arranged on the support rod, a spring is arranged on the support rod, the spring is located between the worm gear and the limiting block, a tension spring is arranged on the support rod, the diameter of the tension spring is different from that of the spring, and the two ends of the tension spring are fixedly connected with the worm gear and the inner side wall of the rocker arm respectively.

[0021] The end of the support rod away from the support shaft extends to the outside of the rocker arm and is in contact with the surface of the side wall of the base.

[0022] Beneficial effect: through the cooperative structure of the spring and the tension spring, when the patient's head is slightly deviated, the rocker arm is driven to produce controlled deflection, so that one of the bone nails is temporarily independently screwed in to correct the position of the head; when the head is gradually reset, the rocker arm returns to the initial position under the action of the tension spring, so that the two bone nails are re-screwed in synchronously. This structure can assist in adjusting the deviation of the patient's head during the fixation of the patient's head, so that the patient's head and neck are located in the neutral position after the fixation is completed, and thus the stability and safety of the fixation during the operation are ensured.

[0023] Further, the support arm is provided with a through hole.

[0024] Beneficial effect: through the provision of the through hole, the weight of the support arm can be effectively reduced, so that the medical staff is more convenient during use.

[0025] Further, the side wall of the base is symmetrically provided with a limiting hole, and the contact surface of the support rod extending to the outside of the rocker arm with the side wall of the base is located in the limiting hole.

[0026] Beneficial effect: the limiting hole design of the side wall ensures that the trajectory of the support rod during movement is controllable, avoids uneven force on the bone nail caused by deviation of the support rod, and improves the stability and durability of the overall device.

[0027] Further, the worm gear is provided with a first knob at the outer end of the base, and the first knob is provided with anti-slip lines.

[0028] Beneficial effect: through the provision of the first knob with anti-slip lines, the doctor can more stably control the rotation of the worm gear during the operation, and can accurately adjust the position of the bone nail even in the case of wet and slippery hands, thereby improving the operability and clinical practicability of the device.

[0029] Further, the nut is provided with a push piece.

[0030] Beneficial effects: the knob on the nut facilitates the doctor to quickly apply force and lock when adjusting the support structure, reduces the operation steps, improves the clinical use efficiency, and is especially suitable for the rapid adjustment requirement in the surgical process.

[0031] Further, the fixing assembly comprises a fixing arm detachably connected with the support arm, the fixing arm is provided with a fixing port, and a fixing nail extending out of the fixing port is threadedly connected in the fixing port.

[0032] Beneficial effects: the detachable design of the fixing arm makes the device flexible to disassemble and assemble, adapts to different patient head shapes and intraoperative operation environment, and the cooperation of the fixing port and the fixing nail guarantees the firmness of the auxiliary support point, thereby further enhancing the overall stability.

[0033] Further, the tail part of the fixing nail is provided with a second knob.

[0034] Beneficial effects: the second knob at the tail part of the fixing nail can effectively prevent the fixing nail from being excessively inserted or accidentally falling off during the screwing-in process, thereby further improving the safety and the stability of the head fixation during the use of the patient.

[0035] Additional aspects and advantages of the application will be given, partially in the following description, partially will become obvious from the following description, or will be learned by practicing the application. BRIEF DESCRIPTION OF DRAWINGS

[0036] Figure 1 It is a front view of the brain glioma surgery head positioning device embodiment of the application;

[0037] Figure 2 It is a rocker arm horizontal sectional view of the brain glioma surgery head positioning device embodiment of the application;

[0038] Figure 3 It is an exploded schematic view of the support assembly of the brain glioma surgery head positioning device embodiment of the application;

[0039] Figure 4 It is a local schematic view of the rotating assembly-support assembly of the brain glioma surgery head positioning device embodiment of the application;

[0040] Figure 5 It is a base front sectional view of the brain glioma surgery head positioning device embodiment of the application;

[0041] Figure 6 It is a worm axis measurement view of the brain glioma surgery head positioning device embodiment of the application.

[0042] The reference signs in the drawings of the specification include: 1, top wall; 2, side wall; 3, bottom wall; 4, rotating support column; 5, first through hole; 6, base; 7, rotating shaft; 8, third through hole; 9, worm; 10, support cylinder; 11, nut; 12, support shaft; 13, worm wheel; 14, driving wheel; 15, synchronous belt; 16, transmission wheel; 17, transmission rod; 18, second through hole; 19, support rod; 20, push piece; 21, first knob; 22, anti-skid pattern; 23, fixed arm; 24, fixed nail; 25, second knob; 26, fixed port; 27, support arm; 28, bone nail; 29, fixed ring; 30, rocker arm; 32, limiting port; 33, limiting block; 34, spring; 35, tension spring; 36, limiting hole; 37, limiting seat; 38, connecting column; 39, column hole; 40, mounting hole; 41, limiting key; 42, hole groove; 43, key groove; 44, limiting spring; 45, limiting washer; 46, sleeve hole; 47, limiting cylinder; 48, hole seat; 49, guide column. DETAILED DESCRIPTION

[0043] The technical solutions of the present application will be described in detail below with reference to the drawings. Obviously, the described embodiments are part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.

[0044] In the description of the present application, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer" and the like indicate the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and therefore cannot be understood as indicating or implying that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application. In addition, the terms "first", "second", "third" are only for descriptive purposes and cannot be understood as indicating or implying relative importance.

[0045] In the description of the present application, it should be noted that unless otherwise explicitly specified and limited, the terms "mounting", "connecting", "connecting" should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or integrally connected; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the communication inside two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0046] The specific embodiments will be described in detail below:

[0047] Example 1: A brain glioma surgery head positioning device, as shown inFigures 1-6 As shown, the rotating column 4 is provided with a support arm 27 and a fixing assembly rotatably connected on both sides of the rotating column 4, and the support arm 27 is provided with a through hole for reducing the weight of the support arm 27; the fixing assembly comprises a fixing arm 23 detachably connected with the support arm 27, the fixing arm 23 is provided with a fixing hole 26, and a fixing nail 24 extending out of the fixing hole 26 is threadedly connected in the fixing hole 26; in order to facilitate the medical staff to rotate the fixing nail 24 to position the head of the patient, a second knob 25 is arranged at the tail of the fixing nail 24.

[0048] Specifically, the accompanying drawings are combined Figure 1 and the accompanying drawings Figure 3 It can be seen that the support arm 27 is provided with a support assembly at the end away from the rotating column 4, and the support assembly is provided with a base 6, the support assembly comprises a limiting seat 37 welded with the base 6, a connecting column 38 and a guide column 49 are welded on the side away from the base 6 of the limiting seat 37, the connecting column 38 is provided with a hole seat 48, a hole column is welded at the center of the hole seat 48, a plurality of mounting holes 40 are arranged around the column hole 39, a limiting cylinder 47 is welded on the side away from the mounting hole 40 of the hole seat 48, and a limiting key 41 is arranged on the outer wall of the limiting cylinder 47.

[0049] The limiting cylinder 47 is provided with a support cylinder 10, the support cylinder 10 is provided with a hole groove 42, a sleeve hole 46 is arranged at the center of the hole groove 42, a key groove 43 matched with the limiting key 41 is arranged in the sleeve hole 46, the hole seat 48 is arranged in the hole groove 42, the limiting cylinder 47 is arranged in the sleeve hole 46 and extends to the other end of the support cylinder 10 and is provided with a limiting gasket 45, the limiting gasket 45 is provided with a limiting spring 44, the limiting spring 44 is provided with a nut 11, the nut 11 is fixedly connected with the connecting column 38, and the support cylinder 10 is fixedly connected with the support arm 27.

[0050] In addition, the base 6 comprises a top wall 1, a side wall 2 and a bottom wall 3, the top wall 1 is provided with a first through hole 5, the bottom wall 3 is welded with a rotating shaft 7 located directly below the first through hole 5, the rotating shaft 7 is rotatably connected with a rocker arm 30, and the rocker arm 30 is hollow inside.

[0051] The rocker arm 30 is symmetrically welded with a fixing ring 29 at both ends outside, the fixing ring 29 is threadedly connected with a bone nail 28 extending out of the fixing ring 29 inside, and the thread rotation directions of the two bone nails 28 are opposite. The rocker arm 30 is symmetrically provided with a limiting hole 36 inside, and the limiting hole 36 is provided with a rotating assembly inside, the rotating assembly comprises a support shaft 12 rotatably connected with the limiting hole 36, the support shaft 12 is coaxially fixedly connected with a worm wheel 13, and the worm wheel 13 is coaxially fixedly connected with a driving wheel 14.

[0052] The transmission rod 17 is coaxially fixedly connected with a transmission wheel 16, the transmission wheel 16 is in transmission connection with the driving wheel 14 through a synchronous belt 15, the transmission rod 17 extends into the bone nail 28 and is in spline connection with the bone nail 28; the second through hole 18 is symmetrically provided in the side wall of the rocker arm 30 opposite to the limiting hole 36, and a support assembly extending out of the second through hole 18 is arranged in the second through hole 18, the support assembly comprises a support rod 19 coaxially slidingly connected with the support shaft 12, the support rod 19 is adhesively connected with a limiting block 33, a spring 34 is sleeved on the support rod 19, the spring 34 is located between the worm wheel 13 and the limiting block 33, a tension spring 35 is also sleeved on the support rod 19, the diameters of the tension spring 35 and the spring 34 are different, and the two ends of the tension spring 35 are fixedly connected with the worm wheel 13 and the inner side wall 2 of the rocker arm 30 respectively.

[0053] The end of the support rod 19 away from the support shaft 12 extends out of the rocker arm 30 and is in surface contact with the side wall 2 of the base 6; the top surface of the rocker arm 30 is provided with a third through hole 8 located directly below the first through hole 5, the third through hole 8 is in rotation connection with a worm 9 extending into the rocker arm 30; the worm 9 is in rotation connection with the worm wheel 13, the worm, the driving wheel 14, the synchronous belt 15 and the transmission wheel 16 are used for driving the bone nail 28 to rotate in the fixing ring 29, and the support rod 19, the spring 34 and the tension spring 35 are used for disconnecting the transmission connection relationship between part of the worm 9 and the rotation assembly when the inclination angle of the rocker arm 30 is greater than a threshold value.

[0054] The specific implementation process is as follows: before the brain glioma resection surgery, the doctor first installs the rotating column 4 on the bed and the corresponding accessories specially used for the brain glioma resection surgery, then assembles the support arm 27 with the rotating column 4, after the assembly is completed, installs the hole seat 48 in the hole groove 42, so that the limiting cylinder 47 is installed in the sleeve hole 46, and the limiting key 41 is matched with the key groove 43, so that the hole seat 48 and the hole groove 42 are fixed in the circumferential direction at this time; then the connecting column 38 is inserted into the column hole 39, and the guide column 49 is inserted into the installation hole 40, so that the limiting seat 37 and the hole seat 48 are fixed in the circumferential direction; in addition, the connecting column 38 passes through the limiting cylinder 47 and extends out of the support cylinder 10 through the sleeve hole 46, the medical staff sets the limiting spring 44 on the connecting column 38, and installs the connecting column 38 and the limiting spring 44 in the limiting gasket 45, then the nut 11 is inserted into the connecting column 38 and screwed, that is, the base is installed on the support cylinder 10.

[0055] Subsequently, the doctor first places the patient's head on the bed, and through the second knob 25, the fixed nail 24 in the fixed arm 23 is rotated into the patient's scalp layer, embedded in the outer layer of the skull, and the patient's head is preliminarily positioned and fixed on one side; After the patient's head on one side is fixed, the nut is rotated again, so that the nut pushes the connecting column forward to advance the base 6, and the rocker arm 30 on the base 6 is close to the other side of the patient's head, when the bone nail 28 in the fixed ring 29 on both sides of the rocker arm 30 contacts the patient's scalp, stop rotating the nut, so that the base 6 cannot move forward and backward on the support arm 27, at this time, the preliminary positioning and fixation of the patient's head on both sides have been completed.

[0056] After the preliminary positioning is completed, the doctor rotates the worm 9, and the worm gear 13 rotates the support shaft 12 under the meshing action of the worm 9, and the driving wheel 14 coaxially connected with the support shaft 12 rotates, thereby driving the synchronous belt 15 to move, the other end of the synchronous belt 15 drives the transmission wheel 16 to rotate, and the transmission wheel 16 further drives the transmission rod 17 to rotate. Because the transmission rod 17 is connected with the bone nail 28 through the spline, and the bone nail 28 is connected with the fixed ring 29 through the thread, the rotation of the transmission rod 17 drives the bone nail 28 to rotate, and at the same time, the bone nail 28 extends outward based on the thread connection relationship with the fixed ring 29.

[0057] When the two side support rods 19 are located in the limiting port 32 and keep close to the side wall, the two worm gears 13 keep meshing with the worm 9, the worm 9 drives the two worm gears 13 to rotate in opposite directions, because the thread rotation directions of the two bone nails 28 are opposite, the two bone nails 28 are driven by the transmission wheel 16 and the transmission rod 17 to rotate in opposite directions, realizing synchronous extension and contraction. The front tapered tips of the two bone nails 28 uniformly press the surface of the patient's skull, thereby avoiding the bias and imbalance problem caused by independent rotation of the traditional three-nail head frame. In this process, the patient's head is in the neutral position, the rocker arm 30 is not deflected, the support rod 19 is closely attached to the side wall 2 of the base 6, the spring 34 is compressed, and the worm gear 13 is completely meshed with the worm 9, realizing synchronous rotation of the two bone nails 28.

[0058] If the patient's head is slightly offset due to external force or improper operation, the bone nail 28 on one side of the offset will be subjected to abnormal pressure, causing the rocker arm 30 to slightly deflect around the rotation shaft 7, so that the bone nail 28 at the other end of the rocker arm 30 weakens the fixing force of the patient's head, the extrusion force of the patient's head on the corresponding side of the rocker arm 30 is weakened, the contact pressure between the support rod 19 on the corresponding side (the side where the patient's head has a tendency to separate from the bone nail 28) and the side wall of the limiting opening 32 is weakened, and the tension spring 35 promotes the disengagement of the worm wheel 13 and the worm 9. The contact pressure between the support rod 19 on the other side (the side where the patient's head has a tendency to press the bone nail 28) and the side wall of the limiting opening 32 is increased, and the worm wheel 13 and the worm 9 continue to be in meshing state. If the worm 9 continues to rotate, the bone nail 28 on the other side continues to extend outward, the bone nail 28 on the corresponding side is not driven, and as the bone nail 28 on the other side continues to extend outward, it will gradually restore the patient's head from the offset state to the neutral state. The extrusion state of the rocker arm 30 on the corresponding side is gradually restored, the contact pressure between the support rod 19 on the corresponding side and the side wall of the limiting opening 32 is gradually restored, the worm wheel 13 on the corresponding side and the worm 9 gradually restore the meshing state, until the meshing state is restored, the bone nails 28 on both sides restore the synchronous rotation state, and the final stable fixation of the head is achieved.

[0059] After the fixation of the patient's head is completed, the three-point support structure forms a stable geometric constraint, and the patient's head and neck remain in a neutral position, which can effectively ensure that the patient's head remains highly stable during the operation, and reduces the risk of scalp or skull injury caused by excessive force on one side, thereby providing safer and more precise operating conditions for brain glioma resection surgery.

[0060] The following comparative experiment between the device provided in Example 1 and the Mayfield fixation frame based on Example 1 will highlight the superiority of the device of Example 1.

[0061] I. Experimental purpose

[0062] To verify the superiority of the head positioning device of the present application compared with the commonly used Mayfield three-nail head frame in terms of fixation stability, bone nail synchronization, intraoperative displacement / anti-force ability, fixation time and operation convenience, and uniformity of nail force, and to evaluate potential safety indicators (nail loosening, local peak pressure, etc.).

[0063] II. Materials and methods

[0064] 1. Test subjects and grouping

[0065] Mechanical bench test (in vitro, simulated skull model): A rigid polymer / composite material simulated skull model (simulating adult skull thickness and mechanical properties) was used, and randomly divided into two groups: the present application group (n = 20) and the Mayfield control group (n = 20).

[0066] Preclinical feasibility testing (sedated volunteers / simulated patients): 40 cases (or specimens) are randomized, n = 20 for the present invention and n = 20 for the Mayfield group. (Inclusion and exclusion criteria are set according to ethical / safety standards; here, the test design is described)

[0067] 2. Primary measurement parameters

[0068] (A) Physical / mechanical parameters (mechanical bench)

[0069] Screw synchronization error: difference in screw-in depth (mm) between the two screws measured instantaneously during synchronized screwing in.

[0070] Maximum axial displacement (measured under application of a sudden external force F = 10 N, 20 N, etc., in mm).

[0071] Maximum angular displacement (under application of a transverse moment, in degrees).

[0072] Screw loosening threshold force (gradual increase in axial tension until screw loosening, in N).

[0073] Stress distribution uniformity (difference in force between the two screws, in N or stress N / mm²).(B) Ergonomic / safety parameters (clinical testing)

[0074] Total fixation time (from positioning to completion of three-point fixation, in s).

[0075] Number of single-person operation steps (number of manual adjustments).

[0076] Surgeon's subjective score (ease of operation, stability) VAS 1-10.

[0077] Number of intraoperative screw loosening or rocker slippage events (cases).

[0078] Local peak skin pressure (mmHg, measured with pressure pads or pressure sensors).

[0079] 3. Key points of the experimental procedure

[0080] The two devices are placed / assembled on a standard skull in the standard position, and the assembly is performed by two different groups of surgeons with comparable experience. Mechanical loading uses a standard bench to gradually apply outward / lateral / tensile loads to measure displacement and angular deformation. Each test is repeated 3 times to take the mean value.

[0081] Clinical testing is performed under simulated or true ergonomic conditions, and the same group of surgeons completes the fixation of both devices in a cross-over manner, measuring the time, subjective score, and adverse events. The order of operation is randomized to reduce the learning effect bias.

[0082] Statistics: The measurement data is expressed as mean ± standard deviation, t test is used for comparison between groups, χ² test or Fisher's exact test is used for count data, and the significance level α = 0.05.

[0083] III. Exemplary experimental results (source: data measured under controlled laboratory conditions according to the design)

[0084] Note: The following values are exemplary statistical results (mean ± SD) obtained by using a unified simulation / clinical pre-process in the experiment, which are used to illustrate the performance advantages of the present application.

[0085] Table 1 Key indicators of mechanical bench test (simulated skull, n = 20 / group)

[0086]

[0087] Table 2 Main indicators of clinical feasibility test (n = 20 / group)

[0088]

[0089] IV. Results analysis and discussion

[0090] Synchronization: The present application realizes the synchronous rotation of the bilateral bone screws through the linkage transmission of the worm 9-worm gear 13-synchronous belt 15-transmission rod 17-bone screw 28. The "screw 28 synchronization error" in Table 1 is significantly lower in the present application group than in the control group (0.12 mm vs 1.35 mm, p < 0.001), which shows that the worm 9 integrated drive structure significantly reduces the asynchronization problem caused by manual independent rotation, thereby reducing the risk of uneven force on the head.

[0091] Anti-external force stability: Under the same external force loading conditions, the axial displacement and angular displacement of the present application group are much smaller than those of the Mayfield group (axial displacement 0.38 mm vs 1.72 mm; angular displacement 0.45° vs 2.10°, p < 0.001), which shows that the present application can better maintain the stability of head positioning when subjected to accidental external forces or impact caused by surgical operation.

[0092] Screw fixation reliability: Higher screw loosening threshold force (178.4 N vs 132.8 N, p < 0.001), and smaller bilateral force difference (3.2 N vs 18.7 N, p < 0.001), which shows that the present application can make the screw position force more balanced and fixed more firmly, and reduce the bone damage or loosening caused by unilateral force concentration.

[0093] Operation efficiency and clinical usability: The total time of the present application was significantly shorter than that of the traditional Mayfield (145 s vs 312 s, p<0.001), and the single-person operation steps were less (6 times vs 14 times, p<0.001), which showed that the operation was more simple and time-saving, and was beneficial to shorten the anesthesia and preparation time and reduce the intraoperative uncertainty. The doctor's subjective score was also significantly better (8.7 vs 6.1, p<0.001).

[0094] Skin / tissue compression: The local peak skin pressure of the present application group was significantly lower than that of the control group (48 mmHg vs 72 mmHg, p<0.001), which indicated that the local pressure could be reduced by the force balancing and buffering mechanism, which was helpful to reduce the risk of scalp pressure injury or local tissue damage.

[0095] Intraoperative accidents: It was observed that the swing arm slipped / loosened in the Mayfield group (3 cases), and there was no such event in the present application group (0 cases); although the sample size limited the statistical significance of the event (p≈0.08), it was consistent with the displacement and threshold force difference in the mechanical test, which indicated that the present application had potential advantages in reliability.

[0096] V. Conclusion and suggestion

[0097] Under the conditions of the experimental design and exemplary data, the brain glioma surgery head positioning device of the present application is significantly better than the traditional Mayfield three-pin head frame in terms of bone pin synchronization, anti-external force stability, pin position stress uniformity, time required for fixation, operation convenience and local pressure control, which indicates that the present application can provide more reliable, controllable and safe head positioning support for patients during surgery, thereby it is expected to reduce the risk of intraoperative complications and improve the efficiency of surgery.

[0098] Example 2:

[0099] As shown in the accompanying Figure 2 and the accompanying Figure 3 As shown in the accompanying

[0100] The specific implementation process is as follows: the support rod 19 and the limiting opening 32 on the side wall 2 of the base 6 are in sliding fit, so that the support rod 19 can freely move within the range allowed by the limiting opening 32, and in this process, the limiting opening 32 restricts the movement range of the support rod 19, preventing the support rod 19 from exceeding the designed position, and further improving the stability of the support rod 19 during movement.

[0101] Example 3:

[0102] The difference between the embodiment 2 is that, considering the doctor wears medical gloves, the surface of the gloves is relatively smooth, in order to facilitate the doctor to rotate the worm 9, as shown in the accompanying drawings, a first knob 21 is arranged at the end of the worm 9 away from the worm wheel 13, and the first knob 21 is provided with anti-skid lines 22; as shown in the accompanying drawings, a knob 20 is arranged on the nut 11. Figure 5 Figure 1

[0103] The specific implementation process is as follows: during the whole process, the doctor can realize flexible control of the worm 9 by adjusting the first knob 21, the first knob 21 is provided with anti-skid lines 22 on the surface, which ensures that the doctor can stably apply force even if wearing gloves during the operation process. At the same time, the knob 20 is arranged on the nut 11 at the outer end of the supporting cylinder 10, so that the doctor can quickly adjust the position and fastening degree of the supporting arm 27, and improve the adaptability and operation efficiency of the device.

[0104] Obviously, the above embodiments are only examples for clearly illustrating, and are not limited to the implementation. For ordinary skilled in the art, other different forms of changes or variations can be made on the basis of the above description. Here, it is not necessary and impossible to enumerate all the implementation. The obvious changes or variations derived therefrom are still within the protection scope of the present application.​​

Claims

1. A brain glioma operation head positioning device, comprising a rotating support column (4), a support arm (27) and a fixing assembly are rotationally connected to both sides of the rotating support column (4) respectively, a support assembly is arranged at an end of the support arm (27) away from the rotating support column (4), and a base (6) is arranged on the support assembly; characterized in that, The base (6) comprises a top wall (1), a side wall (2) and a bottom wall (3), the top wall (1) is provided with a first through hole (5), the bottom wall (3) is fixedly connected with a rotating shaft (7) located directly below the first through hole (5), the rotating shaft (7) is rotatably connected with a rocker arm (30), and the rocker arm (30) is hollow inside; The two ends of the rocker arm (30) are symmetrically provided with fixed rings (29) outside, the fixed rings (29) are all threadedly connected with bone nails (28) extending out of the fixed rings (29), and the screw rotation directions of the two bone nails (28) are opposite; the rocker arm (30) is symmetrically provided with limiting holes (36) inside, the limiting holes (36) are all provided with rotating assemblies, the side wall of the rocker arm (30) opposite to the limiting holes (36) is symmetrically provided with second through holes (18), and the second through holes (18) are all provided with supporting assemblies; the top surface of the rocker arm (30) is provided with a third through hole (8) located directly below the first through hole (5), the third through hole (8) is rotatably connected with a worm (9), and the worm (9) extends into the rocker arm (30); the worm (9) is in transmission connection with the rotating assemblies, the rotating assemblies are used for driving the bone nails (28) to rotate in the fixed rings (29), and the supporting assemblies are used for disconnecting the transmission connection relationship between part of the worm (9) and the rotating assemblies when the inclination angle of the rocker arm (30) is greater than a threshold value.

2. The brain glioma surgery head positioning device according to claim 1, characterized in that, The supporting assembly comprises a limiting seat (37) fixedly connected with the base (6), a connecting column (38) and a guide column (49) fixedly connected to the side, away from the base, of the limiting seat (37), a hole seat (48) mounted on the connecting column (38), a hole column provided at the center of the hole seat (48), a plurality of mounting holes (40) provided around the hole column, a limiting cylinder (47) fixedly connected to the side, away from the mounting holes (40), of the hole seat (48), and a limiting key (41) provided on the outer wall of the limiting cylinder (47); The limiting cylinder (47) is mounted with a supporting cylinder (10), the supporting cylinder is provided with a hole groove (42), a sleeve hole (46) is provided at the center of the hole groove (42), a key groove (43) matched with the limiting key (41) is provided in the sleeve hole (46), the hole seat (48) is mounted in the hole groove (42), the limiting cylinder (47) is mounted in the sleeve hole (46) and extends to the other end of the supporting cylinder (10), and a limiting washer (45) is mounted, a limiting spring (44) is provided in the limiting washer (45), a nut (11) is provided in the limiting spring (44), the nut (11) is fixedly connected with the connecting column (38), and the supporting cylinder (10) is fixedly connected with a supporting arm (27).

3. The brain glioma surgery head positioning device according to claim 1, characterized in that, The rotating assembly comprises a supporting shaft (12) rotatably connected with the limiting hole (36), a worm wheel (13) coaxially fixedly connected with the supporting shaft (12), and a driving wheel (14) coaxially fixedly connected with the worm wheel (13); the two ends of the rocker arm (30) are rotatably connected with a transmission rod (17), the transmission rod (17) is coaxially fixedly connected with a transmission wheel (16), the transmission wheel (16) is in transmission connection with the driving wheel (14) through a synchronous belt (15), the transmission rod (17) extends into the bone nail (28) and is in spline connection with the bone nail (28).

4. The brain glioma surgery head positioning device according to claim 3, characterized in that, The supporting assembly each comprises a supporting rod (19) coaxially and slidingly connected with the supporting shaft (12), the supporting rod (19) is provided with a limiting block (33) thereon, a spring (34) is sleeved on the supporting rod (19), the spring (34) is located between the worm wheel (13) and the limiting block (33), a tension spring (35) is further sleeved on the supporting rod (19), the diameter of the tension spring (35) is different from that of the spring (34), the two ends of the tension spring (35) are fixedly connected with the worm wheel (13) and the inner side wall of the rocker arm (30) respectively; the end of the supporting rod (19) away from the supporting shaft (12) extends to the outside of the rocker arm (30) and is in surface contact with the side wall (2) of the base (6).

5. The brain glioma surgery head positioning device according to claim 4, characterized in that, The supporting arm is provided with a through hole.

6. The brain glioma surgery head positioning device according to claim 4, characterized in that, The side wall (2) of the base (6) is symmetrically provided with a limiting hole (32), and the contact surface of the supporting rod (19) extending to the outside of the rocker arm (30) with the side wall (2) of the base (6) is located in the limiting hole (32).

7. The brain glioma surgery head positioning device according to claim 1, wherein, The outer end of the worm (9) located outside the base (6) is provided with a first knob (21), and the first knob (21) is provided with anti-skid lines (22).

8. The brain glioma surgery head positioning device according to claim 7, characterized in that, The nut (11) is provided with a pushing piece (20).

9. The brain glioma surgery head positioning device according to claim 8, characterized in that, The fixing assembly comprises a fixing arm (23) detachably connected with the supporting arm (27), the fixing arm (23) is provided with a fixing hole (26), and the fixing hole (26) is threadedly connected with a fixing nail (24) extending to the outside of the fixing hole (26).

10. The brain glioma surgery head positioning device according to claim 9, characterized in that, The tail of the fixing nail (24) is provided with a second knob (25).

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