Skull fixing device and brain micro-infusion system thereof

Abstract

The utility model discloses a skull fixing device and a brain micro-infusion system thereof, the skull fixing device comprises a base part and a first opening, and the first opening is arranged in the base part; the first groove is formed in one side in the base part; the second groove is positioned on the other side of the base part; and the clamping hook is connected with the second groove. Through close cooperation of the base part, the first groove, the second groove and the clamping hook, a stable fixing effect is provided for the brain micro-drug infusion tube, it is ensured that the infusion tube can be accurately positioned to a target brain area, and therefore accurate injection is achieved.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, specifically a skull fixation device and its brain micro-infusion system. Background Technology

[0002] With the development and application of gene therapy, cell therapy, and molecular biological drug therapy for neurological diseases, an increasing number of refractory neurological diseases require precise drug delivery to target areas within the brain. Therefore, a head fixation system in conjunction with a brain micro-infusion drug delivery system is needed clinically. Currently, gene therapy, cell therapy, and molecular biological drug therapy for neurological diseases using intracranial targeted drug injection are mainly focused on preclinical research, and widespread clinical application is imminent. However, a safe and convenient head fixation system is still lacking in clinical practice.

[0003] Currently, there is no skull fixation device for intracerebral microdrug infusion tubing. Intracerebral microdrug injection requires a stable fixation of the infusion tubing to ensure accurate positioning of the tubing to the target brain region, thus achieving precise injection. Therefore, there is an urgent clinical need for a skull fixation device for intracerebral microdrug infusion tubing. Utility Model Content

[0004] To solve or partially solve the above problems, this application provides a skull fixation device. It includes: a base; a first opening disposed within the base; a first groove disposed on one side of the base; a second groove located on the other side of the base; and a hook connected to the second groove.

[0005] The skull fixation device provided in this application further includes a skull fixation component, the base of which is located inside the skull fixation component.

[0006] The skull fixation device provided in this application further includes the fixation cover, which is connected to one end of the skull fixation component.

[0007] A skull fixation device provided in this application: one end of the skull fixation component is provided with a third groove for accommodating the base.

[0008] The skull fixation device provided in this application has a threaded connection at one end of the skull fixation component for connecting the skull fixation component to the patient's skull.

[0009] A skull fixation device provided in this application: the fixation cover is provided with a second opening, the second opening being used to accommodate a drainage tube through which it passes.

[0010] The skull fixation device provided in this application has an anti-slip texture on the surface of the fixation cover to increase the stability when holding it during use.

[0011] This application provides a skull fixation device: the skull fixation component is made of polymer material or titanium alloy.

[0012] Secondly, this application also provides a brain micro-infusion system, characterized in that it includes a skull fixation device and a brain micro-infusion device that cooperates with it. Beneficial effects

[0013] 1. This application provides a stable fixation effect for the brain micro-drug infusion tube through the tight cooperation of the base, the first groove, the second groove and the hook, ensuring that the infusion tube can be accurately positioned to the target brain region, reducing the risk of movement during the operation, and thus achieving precise injection.

[0014] 2. The design of the fixed cap can be used to protect or seal the connection between the base and the infusion tube, preventing external factors from damaging the infusion system.

[0015] 3. The design of the third groove ensures precise alignment and stable connection between the base and the skull fixation component, improving the overall stability of the device, simplifying the installation process, and enabling doctors to fix the device more quickly.

[0016] 4. A thread is provided at one end of the skull fixation component to connect the skull fixation component to the patient's skull, ensuring that the skull fixation component can be firmly fixed to the skull. Moreover, the thread design allows doctors to make fine adjustments according to the shape and size of the patient's skull, improving the accuracy of fixation. Attached Figure Description

[0017] Figure 1 An exploded view of a skull fixation device provided in an embodiment of this application;

[0018] Figure 2 A partially enlarged view of a skull fixation device provided in an embodiment of this application;

[0019] Figure 3 An external view of a skull fixation device provided in an embodiment of this application;

[0020] Figure 4 This is an external structural diagram of a brain micro-infusion device according to this application;

[0021] Figure 5 This is a three-dimensional schematic diagram of the hollow support tube of a brain micro-infusion device according to the present application in the inserted state;

[0022] Figure 6This is an exploded schematic diagram of the hollow support tube structure of a brain micro-infusion device according to this application;

[0023] Figure 7 This is a three-dimensional schematic diagram of the side hole support tube of a brain micro-infusion device according to the present application in the inserted state;

[0024] Figure 8 This is an exploded schematic diagram of the side hole support tube structure of a brain micro-infusion device according to this application;

[0025] 1. Cavity fixing device; 10. Base; 101. First opening; 102. First groove; 103. Second groove; 11. Fixing cap; 111. Second opening;

[0026] 2. Hook;

[0027] 3. Skull fixation component; 30. Third groove; 31. Thread;

[0028] 4. Filter;

[0029] 5. Extension tube;

[0030] 6. Filter connection device; 61. Contraction nut; 62. Contraction bracket; 63. Drainage tube contraction body;

[0031] 7. Brain infusion puncture assembly; 71. Drainage tube body; 72. Hollow support tube; 721. Third opening; 73. Outer soft tube; 74. Puncture head; 75. Support tube fixing cap; Detailed Implementation

[0032] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present utility model. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments.

[0033] Example 1

[0034] The applicant has discovered that existing technologies lack a skull fixation device for intracerebral microdrug infusion tubes. Intracerebral microdrug injection requires a stable fixation of the infusion tube to ensure accurate positioning of the tube to the target brain region, thereby achieving precise injection. Therefore, there is an urgent clinical need for a skull fixation device for intracerebral microdrug infusion tubes.

[0035] In view of this, in order to solve the above problems, the applicant has proposed a skull fixation device, please refer to [link to relevant documentation]. Figure 2 , Figure 2 This is a partially enlarged view of a skull fixation device provided in an embodiment of this application. The skull fixation device of the brain micro-infusion system includes: a base 10, a first opening 101, a first groove 102, a second groove 103, and a hook 2.

[0036] The base 10 has a first opening 101 located inside it, and a first groove 102 is provided on one side of the base 10. A second groove 103 is located on the other side of the base 10, and a hook 2 is provided inside the second groove 103 to secure the drug infusion tube stably, so as to ensure that the drug infusion tube will not move easily inside the skull.

[0037] The above-mentioned contents also include the skull fixation component 3, the base 10 can be disposed inside the skull fixation component 3. The arrangement of the skull fixation component 3 not only enhances the stability of the entire device, but also ensures that the base 10 can fit tightly and accurately on the skull fixation component 3.

[0038] In addition, it may include a fixing cover 11, which is connected to one end of the skull fixation component 3 with a third groove 30. The fixing cover 11 can also be connected to the skull fixation component 3 by a thread 31. The thread 31 connection design not only ensures that the fixing cover 11 can fit tightly on the skull fixation component 3, but also provides adjustable tightness so that doctors can make fine adjustments according to the needs of the surgery.

[0039] Meanwhile, the tight fit between the fixing cap 11 and the skull fixation component 3 further enhances the stability and reliability of the entire device, providing a more stable and safe support environment for brain micro-infusion operations. This not only simplifies the surgical procedure but also improves the precision of the surgery and the patient's recovery outcome.

[0040] One end of the skull fixation component 3 may be provided with a third groove 30 to accommodate the base 10, which can achieve a tight connection between the base 10 and the skull fixation component 3, improve the stability of the entire device, simplify the installation process, and allow doctors to fix the device more quickly. In addition, the inside of the skull fixation component 3 may be a soft hollow tube, preferably made of silicone resin, to allow the drug infusion tube to pass through without kinking.

[0041] See Figure 3 , Figure 3 This is an external view of a skull fixation device provided in an embodiment of this application. The other end of the skull fixation component 3 is provided with a threaded loop 31, which is used to match the threaded hole 31 on the patient's surface. By rotating the skull fixation component 3, its threaded loop 31 is tightly engaged with the threaded hole 31 on the patient's skull, which can effectively prevent any accidental loosening or displacement and ensure that the skull fixation component 3 can be firmly fixed to the patient's skull. This design not only provides stable support for subsequent operations such as brain micro-infusion, but also enhances the safety of the operation and the patient's comfort.

[0042] In order to accommodate the drainage tube and ensure the continuity and stability of the infusion system, a second opening 111 can be provided on the fixed cover 11, which allows the drainage tube to pass through the fixed cover 11 without obstruction, effectively preventing the drainage tube from shifting or falling off during the operation, thereby ensuring the stability of the entire infusion system.

[0043] Meanwhile, the surface of the fixation cover 11 is textured with anti-slip material, increasing the stability for the surgeon when it is closed. This ensures the surgeon can firmly grip the cover, allowing for accurate and rapid operations, improving surgical safety, reducing errors caused by hand slippage, and thus increasing overall surgical efficiency. It also effectively increases the friction between the fixation cover 11 and the surgeon's hand, ensuring a stable grip even when the surgeon's hands are sweaty or other lubricants are present during surgery.

[0044] In this embodiment, the cranial fixation component 3 can be made of polymer materials or titanium alloys. Polymer materials are favored for their lightweight, corrosion resistance, and good biocompatibility. They can effectively reduce the burden on patients, while minimizing postoperative rejection and promoting faster recovery. Furthermore, polymer materials have excellent processing properties, allowing for customization into fixation components of various shapes and sizes to meet different surgical needs. Titanium alloys, on the other hand, are another important choice for the cranial fixation component 3 due to their high strength, wear resistance, and corrosion resistance. The robustness of titanium alloys ensures the stability and reliability of the fixation component during surgery, preventing deformation or damage. Simultaneously, their good biocompatibility guarantees postoperative safety for patients.

[0045] Working principle: During use, we first use a positioning and guidance device, combined with high-precision image-guided technology, such as a stereotactic frame, neuronavigation system, or advanced surgical robot arm, to accurately determine the target location on the head. Then, we select a suitable drilling kit to perform a meticulous skull drilling operation. Next, the skull fixation component 3, with a thread 31 at one end, is precisely placed on the patient's skull, and under the precise guidance of the positioning device, the skull fixation component 3 is firmly screwed onto the skull.

[0046] With the precise assistance of a positioning and guiding device and a stereotactic instrument or surgical robot arm, we accurately insert the brain micro-injection catheter into the brain to the preset target location through the positioning and guiding device and the skull fixation device. At this point, we place the base 10 into the third groove 30 of the skull fixation component 3 and securely position the injection catheter in the first opening 101. Next, by manually or using a tool, we gently move the hook 2 to allow it to smoothly enter the second groove 103, thereby firmly clamping the drug infusion tube and ensuring its stability. Finally, we cover it with the fixing cap 11 to ensure that the brain micro-injection catheter smoothly exits from the second opening 111. This effectively prevents the brain micro-injection catheter from shifting during use, ensuring the accuracy and safety of the surgery.

[0047] Example 2

[0048] This application also provides a brain micro-infusion system, including a skull fixation device and a brain micro-infusion device similar to those described in the above embodiments. The brain micro-infusion device works in conjunction with the skull fixation device to address the current clinical predicament of not having a brain micro-drug infusion system.

[0049] The inventors of this application have discovered that existing drug injection systems are mainly used in animal brain experiments, and the equipment is crude and cannot be used in the human brain. A few drug injection systems used in human brain research are "pieced together" instruments, which are cumbersome in structure, require frequent disassembly during the tube fixing process, are prone to gas in the drug infusion tube leading to inaccurate injection volume, and are prone to drug leakage and loss during the frequent disassembly process. Moreover, they are prone to contamination of surgical instruments or brain surgical areas, causing damage. At the same time, it is difficult to implement multi-target injection in the brain, cannot provide effective treatment, and cannot meet the needs of clinical use. In view of this, this application provides a brain micro-infusion device.

[0050] The brain micro-drug infusion device includes a filter 4, an extension tube 5, a filter connection device 6, a lumen fixation device 1, a skull fixation component 3, and a brain infusion puncture assembly 7.

[0051] One end of the extension tube 5 is connected to the filter 4, the filter connecting device 6 is connected to the other end of the extension tube 5, the lumen fixing device 1 is connected to the filter connecting device 6, the skull fixing component 3 is connected to the lumen fixing device 1, and the brain infusion puncture assembly 7 is connected to the filter connecting device 6, the lumen fixing device 1, and the skull fixing component 3 as a whole.

[0052] As described above, by setting up filter 4 and filter connection device 6, impurities and particles in the drug can be effectively removed, ensuring that the drug will not leak or be contaminated by external sources during infusion. Furthermore, by providing a thread 31 at the end of the skull fixation component 3 away from the base 10, the skull fixation component 3 can be connected to the patient's skull, ensuring that the system is firmly fixed to the patient's skull, reducing the risk of movement or detachment during use, thereby ensuring the accuracy and safety of the infusion. Moreover, the brain infusion puncture assembly 7 is connected to the filter connection device 6, the lumen fixation device 1, and the skull fixation component 3 as a single unit. This integrated design simplifies the operation process, making the structure simpler, and allowing drug infusion to be completed without disassembling the tubing, saving time and improving work efficiency.

[0053] First, refer to Figure 8 The brain infusion puncture assembly 7 comprises a drainage tube body 71, a hollow support tube 72, an outer flexible tube 73, a puncture head 74, and a support tube fixing cap 75. The support tube fixing cap 75 is located on the upper part of the hollow support tube 72, the drainage tube body 71 is placed inside the hollow support tube 72, and the hollow support tube 72 is located inside the outer flexible tube 73. Specifically, the outer flexible tube 73 can be 240-260 mm long, preferably 250 mm, and its diameter can be 2.0-5.0 mm; the drainage tube body 71 can be 500 mm long and its diameter can be 0.2-0.5 mm. The end of the intracranial drainage tube 71 away from the skull fixation component 3 and the end of the outer soft tube 73 away from the skull fixation component 3 form a puncture head 74. The diameter of this puncture head 74 transitions from large to small in a conical shape and can be made of polymer material or ceramic material. This design enables the puncture head 74 to maintain extremely high stability and accuracy during puncture, and can easily penetrate brain tissue, providing a strong guarantee for the smooth insertion of the drainage tube 71.

[0054] Meanwhile, the sharpness and sturdiness of the puncture tip 74 can greatly reduce resistance during the puncture process, improve puncture efficiency, and alleviate patient pain. Moreover, the conical shape of the puncture tip 74 can prevent the infused drug fluid from flowing backward along the tip of the drainage catheter.

[0055] To prevent leakage or external contamination of the drug during infusion, this application also includes a filter 4 and a filter connection device 6. The filter connection device 6 consists of a shrink nut 61, a shrink bracket 62, and a drainage tube shrink body 63. The shrink nut 61 can be tightly fitted onto the outside of the shrink bracket 62. By rotating the shrink nut 61, the shrink bracket 62 can be firmly fixed in position, preventing loosening or displacement during infusion. The shrink bracket 62 is fitted onto the outside of the drainage tube shrink body 63. Both are designed with concentric through holes, the size of which is sufficient to allow the drainage tube body 71 to pass through, thus ensuring a smooth infusion channel.

[0056] The filter connection device 6 is detachable. Specifically, the drainage tube constriction body 63 has a groove or thread 31. When connecting the filter connection device 6 to the extension tube 5, simply align one end of the extension tube 5 with the corresponding groove or thread 31 on the drainage tube constriction body 63, and then rotate or push the extension tube 5. This allows the snap-fit ​​or thread 31 at one end of the extension tube 5 to engage with the groove or thread 31 on the drainage tube constriction body 63, thus tightly connecting the filter connection device 6 and the extension tube 5. When disassembling the filter connection device 6 and the extension tube 5, simply reverse the operation steps—rotating or pulling the unlocking mechanism—to easily separate them without additional tools or complex operations.

[0057] Furthermore, during the drilling and fixation of the skull, the target point on the head is first determined using a positioning and guiding device combined with an image-guided framed stereotactic instrument, a neuronavigation system, or a surgical robot arm. A drilling kit is then used to drill the skull, ensuring accuracy and safety. An electrocoagulation needle is used to perforate the dura mater, and the skull fixation component 3 is installed under the guidance of the positioning device. The end of the skull fixation component 3 furthest from the base 10 has a thread 31, allowing it to connect to the patient's skull, ensuring the stability and safety of the entire infusion system.

[0058] In addition, the lumen fixation device 1 may include a base 10 and a fixation cap 11. The base 10 is located inside the fixation cap 11, and the fixation cap 11 is connected to the end of the skull fixation component 3 away from the puncture head 74. This ensures the continuity and stability of the entire infusion system and allows the drainage tube 71 to be accurately positioned at the preset target location, thereby greatly improving the accuracy and safety of the infusion. Moreover, a second opening 111 is provided on one side of the fixation cap 11 to prevent the drainage tube 71 from shifting or falling off during use, and also to maximize the stability of the drainage tube 71.

[0059] Meanwhile, a first opening 101 can be provided inside the base 10. The first opening 101 is located on the outside of the drainage tube body 71 near the fixed cover 11. When the hook 2 is moved to clamp the drainage tube body 71, the hook 2 located at the first opening 101 will firmly clamp the drainage tube body 71, thereby further improving the stability of the drainage tube body 71.

[0060] Furthermore, an annular cavity can be formed between the drainage tube body 71 and the outer flexible tube 73, which accommodates a retractable hollow support tube 72. This support tube can be 300 mm long and 1.5–4.5 mm in diameter, and can be made of polymer materials or ceramics. Its retractable design allows medical personnel to adjust the position and length of the support tube as needed to adapt to different surgical requirements. A third opening 721 is provided at the end of the hollow support tube 72 near the support tube fixing cap 75. The third opening 721 allows the drainage tube body 71 to pass through, and the drainage tube body 71 can be separated from the hollow support tube 72 through the third opening 721. The design of the third opening 721 makes the operation simpler and faster, allowing medical personnel to quickly separate the drainage tube body 71 from the hollow support tube 72.

[0061] Its working principle is as follows: First, a positioning and guiding device, combined with image-guided framed technology such as a framed stereotactic instrument, neuronavigation system, or surgical robot arm, is used to precisely determine the target location on the head. Then, a suitable hole is drilled in the skull using a specialized drilling kit. Next, an electrocautery needle is inserted through the dura mater, and the head and skull fixation component 3 is installed under the guidance of the positioning device, ensuring its stability. Then, one end of the filter connection device 6 is connected to the drainage tube body 71, and the other end is connected to the filter 4 with an extension tube 5. The distal end of the extension tube 5 is connected to the drug injector, forming a complete infusion system. To ensure the smoothness and sterility of the infusion system, a micropump is used to purge air from the infusion tubing system. Then, with the assistance of the positioning and guiding device and stereotactic instrument or surgical robot arm, the puncture head 74 is precisely inserted into the brain to the target point through the positioning and guiding device and the head and skull fixation component 3. The skull fixation component 3 is tightened, the hollow support tube 72 is withdrawn, and the drainage tube body 71 is removed from the third opening 721 and separated from the outer tubing 73. Finally, place the base 10 between the skull fixation component 3 and the fixation cover 11. After the skull fixation component 3 and the fixation cover 11 are connected, rotate clockwise to fix them. The brain micro-injection system can then infuse drugs into the brain.

[0062] Example 3:

[0063] In this utility model, see also Figure 6 As shown, the hollow support tube 72 can be separated without the need for a third opening 721. The specific method is as follows:

[0064] An annular cavity can be formed between the drainage tube body 71 and the outer flexible tube 73, which can accommodate a retractable hollow support tube 72 with a length of 300 mm and a diameter of 2 mm, and can be made of polymer material or ceramic.

[0065] In use, the target location on the head is first precisely determined using a positioning and guiding device combined with image-guided framed technology, such as a framed stereotactic instrument, neuronavigation system, or surgical robot arm. Then, a suitable hole is drilled in the skull using a specialized drilling kit. Next, the dura mater is penetrated through an electrocautery needle, and the head and skull fixation component 3 is installed under the guidance of the positioning device, ensuring its stability. Next, one end of the filter connection device 6 is connected to the drainage tube body 71, and the other end is connected to the filter 4 with an extension tube 5. The distal end of the extension tube 5 is connected to the drug injector, forming a complete infusion system. To ensure the smoothness and sterility of the infusion system, a micropump is used to purge air from the infusion tubing system. Then, with the assistance of the positioning and guiding device and stereotactic instrument or surgical robot arm, the puncture head 74 is precisely inserted into the brain to the target location through the positioning and guiding device and the head and skull fixation component 3. Tighten the skull fixation component 3, and pull the hollow support tube 72 directly out from the annular cavity formed between the drainage tube body 71 and the outer soft tube 73. Finally, place the base 10 between the skull fixation component 3 and the fixation cover 11. After the skull fixation component 3 and the fixation cover 11 are connected, rotate clockwise to fix them. The brain micro-injection system can then infuse drugs into the brain.

[0066] The foregoing has shown and described the basic principles, main features, and advantages of this utility model. It will be apparent to those skilled in the art that this utility model is not limited to the details of the exemplary embodiments described above, and that it can be implemented in other specific forms without departing from the spirit or basic characteristics of this utility model. Therefore, the embodiments should be considered exemplary and non-limiting in all respects. The scope of this utility model is defined by the appended claims rather than the foregoing description, and thus all variations falling within the meaning and scope of equivalents of the claims are intended to be included within this utility model. No reference numerals in the claims should be construed as limiting the scope of the claims.

[0067] Furthermore, it should be understood that although this specification describes embodiments, not every embodiment contains only one independent technical solution. This narrative style is merely for clarity. Those skilled in the art should consider the specification as a whole, and the technical solutions in each embodiment can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.

[0068] The foregoing has shown and described the basic principles, main features, and advantages of this utility model. It will be apparent to those skilled in the art that this utility model is not limited to the details of the exemplary embodiments described above, and that it can be implemented in other specific forms without departing from the spirit or basic characteristics of this utility model. Therefore, the embodiments should be considered exemplary and non-limiting in all respects. The scope of this utility model is defined by the appended claims rather than the foregoing description, and thus all variations falling within the meaning and scope of equivalents of the claims are intended to be included within this utility model. No reference numerals in the claims should be construed as limiting the scope of the claims.

[0069] Furthermore, it should be understood that although this specification describes embodiments, not every embodiment contains only one independent technical solution. This narrative style is merely for clarity. Those skilled in the art should consider the specification as a whole, and the technical solutions in each embodiment can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.

Claims

1. A skull fixation device, characterized in that, include: base The device includes a skull fixation component, wherein the base is located inside the skull fixation component, one end of the skull fixation component is provided with a third groove for accommodating the base, and the other end of the skull fixation component is provided with a thread for connecting the skull fixation component to the patient's skull. A first opening is provided within the base; The first groove is provided on one side of the base; A second groove, the second groove being located on the other side of the base; The hook is connected to the second groove.

2. The skull fixation device according to claim 1, characterized in that, It also includes a fixing cap, which is connected to one end of the skull fixing component.

3. The skull fixation device according to claim 2, characterized in that, The fixing cover is provided with a second opening, which is used to accommodate the drainage tube body through which it passes.

4. The skull fixation device according to claim 3, characterized in that, The surface of the fixed cover is provided with an anti-slip texture to increase the stability of the grip during use.

5. A skull fixation device according to claim 1, characterized in that, The skull fixation component is made of polymer material or titanium alloy.

6. A brain micro-infusion system, characterized in that, It includes the skull fixation device as described in any one of claims 1-5, and the brain microinfusion device that works in conjunction with it.

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