A surgical bone grafting method and cleaning apparatus suitable for 3D printing

Abstract

The application discloses a surgical bone grafting method and cleaning equipment suitable for 3D printing, which comprises a shell, a rotating disc, a cleaning brush assembly and a control assembly, a motor is fixedly installed in the shell; the rotating disc is fixedly installed on the output shaft of the motor, at least three movable grooves are formed in the upper surface of the rotating disc in a radial distribution mode, a bidirectional threaded rod is installed in each movable groove, respectively, the first end of the bidirectional threaded rod extends to the central region of the rotating disc and is connected with a clamping piece, the second end of the bidirectional threaded rod extends to the periphery of the rotating disc and is connected with an adjusting piece, the cleaning brush assembly is arranged above the rotating disc; the control assembly is used for rotating the adjusting piece to synchronously move a plurality of clamping pieces to the central direction of the rotating disc, thereby realizing the central clamping of the 3D printing bone grafting support, and the application has the characteristics of simple structure, convenient operation, good cleaning effect and high bone grafting efficiency.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a surgical bone grafting method and cleaning equipment suitable for 3D printing. Background Technology

[0002] Bone defects are a common orthopedic condition caused by factors such as infection, trauma, and resection of malignant tumors. Treatment is often lengthy and repair is challenging. While autologous bone grafting is considered the "gold standard" for treating bone defects, it suffers from limitations in autologous bone sources, significant trauma, and high infection risks. 3D printing technology demonstrates unique advantages in bone tissue engineering, enabling the customization of bone graft scaffolds based on the individual morphology of the patient's bone defect, achieving precise matching of the defect site. However, existing 3D-printed bone graft scaffolds still face the following technical challenges in practical applications: The complex three-dimensional porous structure of 3D-printed bone graft scaffolds makes it difficult to remove residual free powder from the printing process. While commonly used methods such as high-pressure water jet cleaning and ultrasonic vibration cleaning are employed, the fixation mechanisms are often rudimentary, frequently only allowing for unilateral or localized treatment of the scaffold. Cleaning is challenging, as the scaffold is difficult to keep centered during cleaning, easily creating blind spots and affecting the thoroughness of the cleaning. After implanting the 3D-printed bone graft scaffold into the bone defect site, there is a lack of standardized technical solutions for how to stably inject the bone graft material and how to ensure that the material and the scaffold are fully integrated, resulting in significant individual differences in surgical outcomes. In existing technologies, the 3D-printed bone graft scaffold is directly filled with bone graft material after cleaning, which leads to problems such as uneven injection and material loss. Existing cleaning equipment generally uses complex clamping mechanisms and transmission structures, which not only have high manufacturing and maintenance costs, but are also inconvenient for rapid use and sterilization in actual clinical operations. For example, some equipment uses multi-motor drives or multi-stage transmission systems, which are structurally redundant and have complex assembly processes, making it difficult to quickly produce physical prototypes and apply them clinically. Summary of the Invention

[0003] To address the shortcomings of existing technologies, this invention provides a surgical bone grafting method and cleaning equipment suitable for 3D printing, which features a simplified structure, easy operation, good cleaning effect, and high bone grafting efficiency.

[0004] A surgical bone grafting method and cleaning device suitable for 3D printing includes: a housing, a turntable, a cleaning brush assembly, and a control assembly. A motor is fixedly installed inside the housing. The turntable is fixedly installed on the output shaft of the motor. The upper surface of the turntable has at least three radially distributed movable slots. A bidirectional threaded rod is installed in each movable slot. The first end of the bidirectional threaded rod extends to the center area of ​​the turntable and is connected to a clamping component. The second end of the bidirectional threaded rod extends to the periphery of the turntable and is connected to an adjusting component. The cleaning brush assembly is located above the turntable. The control assembly moves multiple clamping components synchronously towards the center of the turntable by rotating the adjusting component, thereby achieving centered clamping of the 3D printed bone graft scaffold.

[0005] Furthermore, the cleaning brush assembly includes: a lifting base slidably mounted on the inner wall of the housing, a drive motor mounted on the lifting base, and a cleaning brush head connected to the output end of the drive motor. The cleaning brush head has a concave brush surface that matches the contour of the outer wall of the 3D-printed bone graft scaffold.

[0006] Furthermore, the inner wall of the housing is provided with a lifting guide rail, the lifting seat is slidably disposed on the lifting guide rail, and is driven by a lifting drive mechanism installed on the housing.

[0007] Furthermore, the cleaning equipment also includes a spraying mechanism disposed on the inner wall of the housing. The spraying mechanism has multiple spray nozzles arranged around the turntable, and the exit angle of each spray nozzle is adjustable for spraying cleaning fluid toward the porous surface of the 3D printed bone graft scaffold.

[0008] Furthermore, the bottom of the housing is provided with a drain port, and a filter and a recovery liquid tank are connected in sequence downstream of the drain port for recovering and filtering the cleaning liquid.

[0009] Furthermore, the control component includes a control panel disposed on the outer wall of the housing, and a controller electrically connected to the control panel, the controller being electrically connected to the motor, the drive motor, the lifting drive mechanism, and the spraying mechanism, respectively.

[0010] The surgical bone grafting method for 3D printing provided by this invention uses the aforementioned cleaning equipment to clean the 3D-printed bone graft scaffold, and then performs the following steps: (1) Place the 3D printed bone graft scaffold on the turntable and rotate the adjusting component to clamp and fix the scaffold in the center position of the turntable; (2) Start the drive motor to drive the cleaning brush head to rotate, and start the lifting drive mechanism to move the cleaning brush head from top to bottom along the outer wall of the bracket to clean the outer wall of the bracket. (3) Start the spraying mechanism so that multiple spray nozzles spray cleaning liquid toward the porous structure of the support from different angles; (4) After cleaning, remove the 3D printed bone graft scaffold and dry and sterilize it; (5) The dried and sterilized 3D-printed bone graft scaffold is implanted into the patient's bone defect site; (6) The bone graft material is injected into the porous structure of the 3D printed bone graft scaffold through the injection device, so that the bone graft material fills the internal cavity of the scaffold. (7) After the perfusion is completed, a bioabsorbable membrane is covered on the outer surface of the 3D printed bone graft scaffold to maintain the distribution of the bone graft material in the scaffold.

[0011] Furthermore, the bone graft material described in step (6) is selected from one or more of autologous bone, allogeneic bone, and artificial bone substitute materials, or a mixture thereof. Although autologous bone transplantation is considered the gold standard, its sources are limited; artificial bone substitute materials such as calcium phosphate bone cement and hydroxyapatite have good osteoconductivity and biocompatibility. This protocol allows for flexible selection of material combinations according to clinical needs.

[0012] Furthermore, in step (6), the infusion pressure is controlled at 0.1 to 0.3 MPa, the infusion rate is 2 to 5 mL / min, and the infusion volume is controlled at 90% to 100% of the pore volume of the stent.

[0013] Further, the bioabsorbable membrane mentioned in step (7) is a collagen membrane or a polylactic acid membrane.

[0014] By employing the aforementioned technical solutions, this invention, compared to existing technologies, utilizes a radially arranged bidirectional threaded rod linkage system to ensure the scaffold is clamped at the center of the turntable. Combined with a height-adjustable cleaning brush head and a multi-angle spray mechanism, it achieves comprehensive cleaning of the scaffold's outer wall and porous structure, eliminating blind spots. The equipment structure is streamlined, and the assembly process is simple, allowing clinical personnel to quickly learn and operate it without complex training. Covering the scaffold with a bioabsorbable membrane effectively maintains the distribution of bone graft material within the scaffold's porous structure, preventing material loss during implantation or early postoperative periods and improving bone graft stability. This solution provides a complete standardized operating procedure from scaffold cleaning, disinfection, and implantation to material perfusion, reducing reliance on individual physician experience and improving the predictability of surgical outcomes. The bone grafting method provided by this invention has a high degree of standardization, is simple and reliable to operate, and can be widely applied in clinical fields involving bone defect repair, such as orthopedics, oral and maxillofacial surgery, and neurosurgery, demonstrating excellent industrial practicality and promotional application value. Attached Figure Description

[0015] Figure 1 This is a schematic diagram of the overall structure of the cleaning equipment of the present invention; Figure 2 This is a top view of the turntable, showing the layout of the radial movable grooves and the bidirectional threaded rod; Figure 3 This is a schematic diagram of the cleaning brush assembly. Detailed Implementation

[0016] To make the technical means, creative features, objectives, and effects of this invention easier to understand, the invention is further described below in conjunction with specific embodiments: Example 1

[0017] See Figures 1 to 3A surgical bone graft cleaning device suitable for 3D printing includes a housing 1, a motor disposed on the bottom surface inside the housing 1, a turntable 2 fixed to the output shaft of the motor, a cleaning brush assembly 3 disposed above the turntable 2, and a control assembly 5.

[0018] The shell 1 is a sealed container made of stainless steel. The front of the shell 1 is equipped with an openable and closable sealing door for easy placement and removal of the bone graft stent. The bottom of the shell 1 is equipped with a drain port, and a filter and a recovery liquid tank are connected downstream of the drain port for recycling and filtering the cleaning liquid.

[0019] The turntable 2 has a diameter of 15-25cm and at least three radially evenly distributed movable slots on its upper surface, preferably four movable slots arranged in a cross pattern. Each movable slot is provided with a bidirectional threaded rod. The first end of the bidirectional threaded rod extends to the center area of ​​the turntable and is connected to an arc-shaped clamping member. The surface of the clamping member that contacts the bone graft scaffold is provided with a silicone buffer layer. The second end of the bidirectional threaded rod extends to the periphery of the turntable and is connected to an adjustment knob. By rotating the adjustment knob, multiple clamping members can move synchronously along the movable slots towards the center of the turntable to achieve centered clamping of the bone graft scaffold.

[0020] The cleaning brush assembly 3 includes: a lifting seat that is slidably mounted on the inner wall of the housing 1, a drive motor mounted on the lifting seat, and a cleaning brush head connected to the output end of the drive motor. The cleaning brush head has a concave brush surface that matches the contour of the outer wall of the bone graft support. The brush surface material is medical-grade nylon bristles. The inner wall of the housing 1 is provided with a vertical lifting guide rail. The lifting seat is slidably mounted on the lifting guide rail and is driven to lift by an electric push rod mounted on the top of the housing 1.

[0021] The spraying mechanism 4 includes a ring-shaped main pipeline and 6 to 8 spray nozzles evenly distributed on the ring-shaped main pipeline. The spraying angle of each spray nozzle can be adjusted manually or automatically, ranging from 30° to 150°. It is used to spray cleaning fluid toward the porous surface of the bone graft scaffold. The spraying mechanism 4 is connected to an external cleaning fluid supply system through pipelines.

[0022] The control component 5 includes a touch control panel disposed on the outer wall of the housing 1, and a PLC controller electrically connected to the control panel. The controller is electrically connected to the motor, the drive motor, the electric push rod and the solenoid valve of the spray mechanism. Example 2

[0023] The cleaning equipment described in Example 1 is used to clean the 3D-printed bone graft scaffold, specifically including the following steps: (a) Cleaning process (1) Place the 3D printed personalized bone graft scaffold on turntable 2, and rotate each adjustment knob to make the four arc-shaped clamping parts clamp and fix the scaffold in the center of the turntable. (2) Start the cleaning program through the control panel: the drive motor drives the cleaning brush head to rotate at a speed of 200-500 r / min, and the electric push rod drives the cleaning brush head to move from top to bottom along the outer wall of the bracket at a speed of 5-10 mm / s to clean the outer wall of the bracket. (3) Simultaneously start the spraying mechanism 4. The six spray nozzles spray cleaning liquid from different angles (alternating between 45° and 90° incident angles) toward the porous structure of the support. The spraying pressure is 0.3 to 0.5 MPa and the spraying time is 3 to 5 minutes. (4) After cleaning, drain the cleaning solution, start the hot air drying system (temperature 40-60℃) set in the shell 1 to dry the bracket, and then take out the bracket and perform ethylene oxide sterilization or low temperature plasma sterilization.

[0024] (II) Implantation Procedure (5) The dried and sterilized 3D printed bone graft scaffold is implanted into the bone defect site of the patient and fixed by conventional orthopedic surgery (such as screws, plates or Kirschner wires); (6) The bone graft material is injected into the porous structure of the 3D printed bone graft scaffold through an injection device (such as a medical syringe or a special injection gun). The injection material is a mixture of calcium phosphate bone cement and autologous bone particles (volume ratio 2:1). The injection pressure is controlled at 0.2MPa, the injection speed is 3mL / min, and the injection volume is controlled at 95% of the pore volume of the scaffold to ensure that the bone graft material fills the internal cavity of the scaffold. (7) After the perfusion is completed, a bioabsorbable collagen membrane is covered on the outer surface of the 3D printed bone graft scaffold. The size of the collagen membrane is slightly larger than the outer contour of the scaffold (5-10 mm beyond the periphery). The membrane is fixed to the surrounding normal periosteum with medical sutures or tissue glue to maintain the distribution of the bone graft material in the scaffold and prevent the loss of bone graft material during or early after the operation. Example 3

[0025] Ten patients with bone defects (3-8 cm in length) were treated according to the method described in Example 2. A 6-month follow-up observation showed that all patients had good bone graft fusion. CT images showed that the bone graft material was evenly distributed within the scaffold, with no significant absorption or displacement. New bone formation was observed at the interface between the scaffold and the host bone. Postoperative X-rays showed uniform bone density in the graft area, without radiolucent lines or gaps. No complications related to the bone graft material (such as infection, immune rejection, or nonunion) occurred. Compared with existing conventional methods that rely solely on simple preoperative cleaning and direct postoperative filling with bone graft material, the method of this invention improved the uniformity of bone graft material distribution within the scaffold by approximately 28%, and increased the area of ​​newly formed bone by approximately 22% at 3 months postoperatively.

[0026] Furthermore, compared to the existing technology patent number CN202321745505.1, patent title "A 3D Printed Polydopamine Artificial Bone Auxiliary Cleaning Device," the existing technology uses a clamping method where two moving blocks on both sides converge towards the center via a bidirectional threaded rod. This results in limited clamping points and makes it difficult to ensure the centered positioning of irregular supports. The present invention uses no fewer than three sets of radially distributed clamping members that move synchronously towards the center, achieving centered clamping of the support from multiple directions, effectively solving the problem of centered fixation of irregular supports. The existing technology only uses a rotating turntable in conjunction with a fixed brush for cleaning, which limits the cleaning coverage. The present invention uses a liftable cleaning brush head that moves from top to bottom along the support axis for brushing, combined with multi-angle spraying, to achieve multi-dimensional and all-round coverage. The existing technology only focuses on the cleaning process and does not involve the overall planning of subsequent bone grafting operations. The present invention organically combines the cleaning equipment with the bone grafting method to form a standard process from support post-processing to clinical application. The present invention integrates the linkage clamping system and the brushing system into the same turntable assembly, reducing redundant transmission components and lowering manufacturing and maintenance costs.

[0027] The present invention has been described in detail above. However, modifications or improvements can be made to it, which will be obvious to those skilled in the art. Therefore, any modifications or improvements that do not depart from the spirit of the present invention are within the scope of protection of the present invention.

Claims

1. A surgical bone grafting method and cleaning equipment suitable for 3D printing, characterized in that, include: The device comprises a housing (1), a turntable (2), a cleaning brush assembly (3), and a control assembly (5). A motor is fixedly installed inside the housing (1). The turntable (2) is fixedly installed on the output shaft of the motor. At least three radially distributed movable slots are opened on the upper surface of the turntable (2). A bidirectional threaded rod is installed in each movable slot. The first end of the bidirectional threaded rod extends to the center area of ​​the turntable and is connected to a clamping component. The second end of the bidirectional threaded rod extends to the periphery of the turntable and is connected to an adjusting component. The cleaning brush assembly (3) is located above the turntable (2). The control assembly (5) moves multiple clamping components synchronously toward the center of the turntable by rotating the adjusting component.

2. The surgical bone grafting method and cleaning equipment suitable for 3D printing according to claim 1, characterized in that: The cleaning brush assembly (3) includes: a lifting seat that is slidably mounted on the inner wall of the housing (1), a drive motor mounted on the lifting seat, and a cleaning brush head connected to the output end of the drive motor, the cleaning brush head having a concave brush surface that matches the contour of the outer wall of the 3D printed bone graft scaffold.

3. The surgical bone graft cleaning device suitable for 3D printing according to claim 2, characterized in that, The inner wall of the housing (1) is provided with a lifting guide rail, and the lifting seat is slidably disposed on the lifting guide rail and driven by a lifting drive mechanism installed on the housing (1).

4. The surgical bone graft cleaning device suitable for 3D printing according to claim 1, characterized in that, It also includes a spray mechanism (4) disposed on the inner wall of the housing (1), the spray mechanism (4) having a plurality of spray nozzles arranged around the turntable (2).

5. The surgical bone graft cleaning device suitable for 3D printing according to claim 4, characterized in that, The bottom of the housing (1) has a drain port, and a filter and a recovery tank are connected downstream of the drain port in sequence.

6. The surgical bone graft cleaning device suitable for 3D printing according to claim 1, characterized in that, The control component (5) includes a control panel disposed on the outer wall of the housing (1) and a controller electrically connected to the control panel. The controller is electrically connected to the motor, the drive motor, the lifting drive mechanism and the spraying mechanism respectively.

7. A surgical bone grafting method suitable for 3D printing, employing the cleaning equipment described in any one of claims 1 to 6, characterized in that, Includes the following steps: (1) Place the 3D printed bone graft scaffold on the turntable (2) and use the adjusting parts to clamp and fix the scaffold in the center position of the turntable; (2) Start the cleaning brush assembly (3) Clean the outer wall of the bracket, and at the same time start the spray mechanism (4) Spray cleaning liquid towards the porous structure of the bracket from multiple angles; (3) After cleaning, remove the 3D printed bone graft scaffold and dry and sterilize it; (4) The dried and sterilized 3D-printed bone graft scaffold is implanted into the patient's bone defect site; (5) The bone graft material is injected into the porous structure of the 3D printed bone graft scaffold; (6) After the perfusion is completed, a bioabsorbable membrane is covered on the outer surface of the 3D printed bone graft scaffold.

8. The surgical bone grafting method suitable for 3D printing according to claim 7, characterized in that, The bone graft material mentioned in step (5) is selected from one or more of autologous bone, allogeneic bone, and artificial bone substitute materials, or a mixture thereof.

9. The surgical bone grafting method suitable for 3D printing according to claim 7, characterized in that, In step (5), the infusion pressure is controlled at 0.1 to 0.3 MPa, the infusion rate is 2 to 5 mL / min, and the infusion volume is controlled at 90% to 100% of the pore volume of the stent.

10. The surgical bone grafting method suitable for 3D printing according to claim 7, characterized in that, The bioabsorbable membrane mentioned in step (6) is a collagen membrane or a polylactic acid membrane.

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