Multi-component bone cement loading, mixing, injection and delivery device

Abstract

The application belongs to the technical field of medical materials and orthopedic surgical instruments, and particularly discloses a multi-component bone cement loading, mixing and injecting integrated device. The device comprises a first solid material cavity, a second solid material cavity and a liquid material cavity, which are used for respectively storing first solid-phase powder, second solid-phase powder and liquid-phase components. Each cavity is independently and long-term sealed by a sealing cover to avoid the solid-phase powder from being damp and the liquid-phase components from being volatilized. The first solid material cavity and the second solid material cavity are detachably connected through a powder connecting port to realize the pre-mixing of various solid-phase powders. The solid material cavity and the liquid material cavity are connected through a solid-liquid connecting port to realize the uniform mixing of solid-liquid components. After mixing, the liquid material cavity is connected to an injection connector, and the mixed bone cement slurry is injected into a surgical treatment site by a driving rod pushing a piston. The device can realize the orderly loading, mixing and injecting of multi-component bone cement in a closed system, and is simple to operate, uniform in mixing, high in safety and suitable for the clinical application of multi-component bone cement.

Description

Technical Field

[0001] This invention relates to the field of medical materials and orthopedic surgical instruments, specifically to an integrated device for loading, mixing, and injecting multi-component bone cement. Background Technology

[0002] Bone cement is widely used in orthopedic surgery, playing a crucial role, especially in vertebral body shaping, joint replacement, and bone defect repair. Current bone cements typically consist of solid powder and liquid monomers, mixed on-site before clinical use. With the continuous development of bone cement formulations, some bone cement systems now include two or more solid powder components with different particle sizes, functions, or reactivity characteristics. However, most existing bone cement mixing devices are designed only for systems with a single solid and liquid phase, and lack sufficient support for systems where multiple solid powders and liquid phases coexist.

[0003] The following problems usually exist in the practical application of existing multi-component bone cement: (1) Multiple solid powders need to be pre-mixed manually, the operation steps are complicated and easy to introduce pollution; (2) It is difficult to achieve long-term independent sealed storage of multi-component materials in the same system; (3) The mixing process is mostly open or semi-open, which has the problems of liquid evaporation, solid moisture and safety hazards; (4) The mixing sequence is difficult to control, which can easily lead to uneven mixing, thus affecting the performance of bone cement; (5) Some mixing devices have complex structures or are inconvenient to clinical operation, which is not conducive to promotion and application. Summary of the Invention

[0004] The purpose of this invention is to provide a multi-component bone cement loading, mixing, and injection integrated device to solve the problem that existing bone cement mixing devices are unable to achieve orderly and closed mixing of multiple solid-phase powders and liquid-phase components. This device can realize the independent storage, stepwise mixing, and final injection of multi-component materials within the same system, thereby improving the uniformity of bone cement mixing and the safety of clinical use.

[0005] To achieve the above objectives, the present invention provides the following technical solution: a multi-component bone cement loading, mixing, and injection integrated device, comprising a first solid material chamber, a second solid material chamber, a liquid material chamber, and a solid-liquid interface. The first solid material chamber is provided with a space for storing a first solid phase powder, the second solid material chamber is provided with a space for storing a second solid phase powder, and the liquid material chamber is provided with a space for storing liquid phase components. The first and second solid material chambers are connected by a detachable powder interface, the solid-liquid interface is located between the liquid material chamber and either the first or second solid material chamber, and the liquid material chamber is connected to a detachable injection connector.

[0006] Preferably, the first solid material chamber, the second solid material chamber, and the liquid material chamber have the same structure, each including a central cylinder and side cylinders respectively disposed at both ends of the central cylinder; the central cylinder is a hollow cylindrical structure with both ends through, the side cylinder is a hollow cylindrical structure with both ends through, and the diameter of the side cylinder is smaller than that of the central cylinder; the central cylinder and the side cylinder are integrally formed and smoothly transitioned, and the outer surface of the side cylinder is provided with an external thread structure.

[0007] Using the above technical solution, different components of bone cement can be stored through the No. 1 solid material chamber, the No. 2 solid material chamber, and the liquid material chamber.

[0008] Preferably, the powder interface is located between the first solid material chamber and the second solid material chamber.

[0009] Using the above technical solution, the connection between the No. 1 solid material chamber and the No. 2 solid material chamber can be realized through the powder interface.

[0010] Preferably, the powder interface includes a powder mixing section and powder connecting sections respectively disposed at both ends of the powder mixing section. The powder mixing section is a hollow cylindrical structure with both ends connected. The inner wall of the powder mixing section is provided with an internal thread structure, and the powder connecting section matches the external thread structure of the side cylinder.

[0011] Using the above technical solution, the mixing of solid powders can be achieved through the powder interface.

[0012] Preferably, the powder mixing section is provided with a dividing plate, which is a grid structure.

[0013] By adopting the above technical solution, the dividing plate can prevent powder from agglomerating.

[0014] Preferably, the solid-liquid interface is located between the liquid material chamber and the first solid material chamber or the second solid material chamber.

[0015] Using the above technical solution, the liquid material chamber can be connected to the second solid material chamber or the first solid phase chamber through the solid-liquid interface.

[0016] Preferably, the solid-liquid interface includes a solid-liquid mixing section and solid-liquid connecting sections respectively disposed at both ends of the solid-liquid mixing section, wherein the solid-liquid mixing section and the solid-liquid connecting sections form an hourglass-shaped structure with both ends connected.

[0017] Using the above technical solution, the mixing of liquid components and solid mixtures can be achieved through the solid-liquid interface.

[0018] Preferably, the inner wall of the solid-liquid mixing section is provided with a spiral guide groove, and at least one flow-dispersing rod is provided in the solid-liquid mixing section.

[0019] By adopting the above technical solution, the uniformity of mixing can be increased through the guide channel and the turbulence bar.

[0020] Preferably, each end of the first solid material chamber, the second solid material chamber, and the liquid material chamber is provided with a sealing cap, and each sealing cap is provided with a sealing gasket; each chamber is provided with a piston that can move axially, and the piston is connected to a drive rod.

[0021] By adopting the above technical solution, the material can be stored in a sealed manner through the sealing cap.

[0022] Preferably, both the powder interface and the solid-liquid interface are provided with detachable sealing blocks at their ends.

[0023] By adopting the above technical solution, the powder interface and the solid-liquid interface can be protected by the sealing block.

[0024] Preferably, the injection connector consists of a base and an injection interface. The base has the same structure as the sealing cap, except for the central hole that communicates with the injection interface. The injection interface is a hollow conical tube structure that can be connected to a universal syringe needle or catheter.

[0025] Using the above technical solution, the mixed bone cement slurry is injected into the desired treatment site through the injection connector.

[0026] Compared with the prior art, the beneficial effects of the present invention are: the multi-component bone cement loading and mixing integrated device: 1. The present invention is provided with three independent material chambers: a first solid material chamber, a second solid material chamber, and a liquid material chamber. These chambers are sealed by connecting a sealing cap, which can store different components of bone cement materials separately. This allows for long-term independent and sealed storage of materials, preventing premature reaction of components and preventing the solid powder from getting damp and the liquid components from volatilizing. Furthermore, the No. 1 solid material chamber and the No. 2 solid material chamber can be connected through the powder interface to achieve the pre-mixing of the first solid phase powder and the second solid phase powder. Similarly, the solid-liquid interface connects the liquid material chamber to the No. 2 solid material chamber or the No. 1 solid material chamber to achieve the mixing of the solid phase mixture and the liquid phase component. This allows for precise control of the mixing sequence of the bone cement components, improves the uniformity and stability of the bone cement mixture, and avoids the deterioration of bone cement performance caused by disordered mixing sequence. The mixing process is completed within a closed system, reducing the risk of contamination and improving the safety of clinical use. The modular structure of each material chamber, standardized interfaces, simplified structure, and unified size and shape facilitate large-scale production and widespread application. The flexible assembly method facilitates rapid clinical operation. The same device has loading, mixing and injection functions, which can reduce the frequency of instrument replacement.

[0027] 2. In this invention, a square grid structure dividing plate is set inside the powder interface. When the first solid powder and the second solid powder pass through, the dividing plate divides the solid powder, avoiding the agglomeration of solid powder caused by long-term storage, and initially achieving uniform mixing. The solid-liquid interface is a transverse hourglass-shaped structure. Its inner wall is provided with a spiral guide groove and a staggered hollow cross frame structure of turbulence rods, which can make the liquid component and the solid mixture form a spiral flow during the flow process. At the same time, the blocking and diversion effect of the turbulence rods breaks the laminar flow state of the fluid, so that the components are fully mixed, avoiding local agglomeration and ensuring the mechanical properties of the bone cement after curing. 3. After the solid-liquid phase mixing is completed, the material chamber can be used for injection by changing the injection connector. The injection connector consists of a connecting base and an injection interface. A universal injection needle or catheter can be connected through the injection connector to realize the need to inject the mixed bone cement slurry into the required treatment site. Attached Figure Description

[0028] Figure 1 This is a schematic diagram of the connection structure between the first and second solid material cavities of the present invention; Figure 2 This is a schematic diagram of the internal structure of the first and second solid material cavities of the present invention; Figure 3 This is a schematic diagram of the connection structure between the solid material chamber and the liquid material chamber of the present invention; Figure 4 This is a schematic diagram of the internal structure of the No. 2 solid material chamber and liquid material chamber of the present invention; Figure 5 This is a schematic diagram of the No. 1 solid-phase cavity structure of the present invention; Figure 6 This is a schematic diagram of the piston mounting structure of the present invention; Figure 7 This is a schematic diagram of the powder connection port structure of the present invention; Figure 8 This is a schematic diagram of the segmented plate mounting structure of the present invention; Figure 9 This is a schematic diagram of the solid-liquid connection structure of the present invention; Figure 10 This is a schematic diagram of the spoiler rod installation structure of the present invention; Figure 11 This is a schematic diagram of the injection connector structure of the present invention.

[0029] In the diagram: 1. Solid material chamber 1; 2. Solid material chamber 2; 3. Liquid material chamber; 4. Powder connection port; 401. Powder mixing section; 402. Powder connection section; 403. Dividing plate; 5. Solid-liquid connection port; 501. Solid-liquid mixing section; 502. Solid-liquid connection section; 503. Guide channel; 504. Baffle rod; 6. Sealing cap; 7. Sealing gasket; 8. Sealing block; 9. Piston; 10. Drive rod; 11. Base; 12. Injection port. Detailed Implementation

[0030] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0031] Please see Figures 1-11 The present invention provides a technical solution: a multi-component bone cement loading and mixing integrated device, comprising a first solid material chamber 1, a second solid material chamber 2, a liquid material chamber 3, a powder connection port 4, a powder mixing section 401, a powder connection section 402, a dividing plate 403, a solid-liquid connection port 5, a solid-liquid mixing section 501, a solid-liquid connection section 502, a guide channel 503, a turbulence rod 504, a sealing cover 6, a sealing gasket 7, a sealing block 8, a piston 9, a drive rod 10, a base 11, and an injection interface 12. Solid material chamber 1 has a storage space for storing a first solid phase powder, solid material chamber 2 has a storage space for storing a second solid phase powder, and liquid material chamber 3 has a storage space for storing liquid phase components. Solid material chamber 1 and solid material chamber 2 are detachably connected via a powder connection port 4, and solid material chamber 2 and liquid material chamber 3 are connected via a detachable solid-liquid connection port 5. Solid material chamber 1, solid material chamber 2, and liquid material chamber 3 have the same structure, each including a middle cylinder and... Side cylinders are respectively set at both ends of the middle cylinder; the middle cylinder is a hollow cylindrical structure with both ends through, and the side cylinders are hollow cylindrical structures with both ends through, and the diameter of the side cylinders is smaller than that of the middle cylinder; the middle cylinder and the side cylinders are integrally formed and smoothly transitioned, and the outer surface of the side cylinders is provided with an external thread structure; both ends of the first solid material cavity 1, the second solid material cavity 2 and the liquid material cavity 3 are provided with sealing caps 6, and each sealing cap 6 is provided with a sealing gasket 7; each cavity is provided with a piston 9 that can move along the axial direction, and the piston 9 is connected to the drive rod 10; like Figure 5 and Figure 6 As shown, rotate the sealing cap 6 at one end of the first solid material chamber 1 to inject the first solid powder from the side cylinder at the end of the first solid material chamber 1 away from the piston 9. Rotate the sealing cap 6 to make the internal thread of the sealing cap 6 tightly connected with the external thread of the side cylinder of the first solid material chamber 1. At this time, the sealing is achieved by the annular sealing gasket 7 inside the sealing cap 6 to prevent the first solid powder from getting damp. Similarly, by rotating the sealing cap 6 at one end of the second solid material chamber 2, the second solid powder is injected from the side cylinder at the end of the second solid material chamber 2 away from the piston 9. Rotating the sealing cap 6 makes the internal thread of the sealing cap 6 tightly connected with the external thread of the side cylinder of the second solid material chamber 2, thus completing the storage of the second solid powder. Rotate the sealing cap 6 at one end of the liquid material chamber 3 to inject the liquid phase component from the side cylinder at the end of the liquid material chamber 3 away from the piston 9. Rotate the sealing cap 6 to make the internal thread of the sealing cap 6 tightly connected with the external thread of the side cylinder of the liquid material chamber 3, thus completing the storage of the liquid phase component. At this time, the first solid phase powder, the second solid phase powder and the liquid phase component are stored separately, and the two ends of the powder connection port 4 are sealed by the sealing block 8, and the two ends of the solid-liquid connection port 5 are sealed by the sealing block 8.

[0032] The powder connection port 4 is located between the first solid material chamber 1 and the second solid material chamber 2; the powder connection port 4 includes a powder mixing section 401 and powder connecting sections 402 respectively located at both ends of the powder mixing section 401. The powder mixing section 401 is a hollow cylindrical structure with both ends through; the inner wall of the powder mixing section 401 is provided with an internal thread structure, and the powder connecting section 402 matches the external thread structure of the side cylinder; the powder mixing section 401 is provided with a dividing plate 403, which is a grid structure; like Figure 1 , Figure 2 , Figure 7 and Figure 8 As shown, when using this device, the first solid powder and the second solid powder are pre-mixed. The sealing blocks 8 at both ends of the powder connection port 4 are removed. The sealing cap 6 on the side of the first solid chamber 1 away from the piston 9 is removed. The external thread on this side of the first solid chamber 1 is threaded to the powder connection section 402 on the side of the powder connection port 4. Similarly, the sealing cap 6 on the side of the second solid chamber 2 away from the piston 9 is removed. The external thread on this side of the second solid chamber 2 is threaded to the powder connection section 402 on the other side of the powder connection port 4. At this time, the first solid chamber 1, the powder connection port 4 and the second solid chamber 2 are internally connected. Remove the sealing caps 6 on the other side of the first solid material chamber 1 and the second solid material chamber 2 respectively, exposing the piston 9. Fix the drive rod 10 to the piston 9 in the first solid material chamber 1 and the second solid material chamber 2 respectively through the threaded connection hole. Push the drive rods 10 on both sides in sequence. The drive rods 10 are driven to move towards the powder connection port 4, so that the first solid phase powder and the second solid phase powder enter the powder mixing section 401 of the powder connection port 4 from their respective material chambers. When the powder flows in the powder mixing section 401, it passes through the square grid structure dividing plate 403 fixed on the inner wall. The dividing plate 403 divides and breaks up the clumped solid powder, and at the same time guides the two powders to mix alternately, thus initially achieving mixing. The piston 9 is continuously pushed alternately until the two solid powders completely enter the same material chamber. The second solid material chamber 2 is selected as the subsequent mixing chamber. After the premixing is completed, the powder connection port 4 is separated from the second solid material chamber 2.

[0033] The solid-liquid connection port 5 is located between the liquid material chamber 3 and either the first solid material chamber 1 or the second solid material chamber 2; the solid-liquid connection port 5 includes a solid-liquid mixing section 501 and solid-liquid connecting sections 502 respectively located at both ends of the solid-liquid mixing section 501, the solid-liquid mixing section 501 and the solid-liquid connecting sections 502 form an hourglass-shaped structure with both ends connected; the inner wall of the solid-liquid mixing section 501 is provided with a spiral guide groove 503, and at least one baffle rod 504 is provided inside the solid-liquid mixing section 501; both the powder connection port 4 and the solid-liquid connection port 5 are provided with detachable sealing blocks 8 at their ends; like Figure 3 , Figure 4 , Figure 9 and Figure 10 As shown, remove the sealing blocks 8 at both ends of the solid-liquid connection port 5, and thread the external thread of the open end of the second solid material chamber 2 to the solid-liquid connection section 502 at one end of the solid-liquid connection port 5. At this time, remove the sealing cover 6 on one side of the liquid material chamber 3, and thread the external thread inside the liquid material chamber 3 on this side to the solid-liquid connection section 502 at the other end of the solid-liquid connection port 5. At this time, the liquid material chamber 3, the solid-liquid connection port 5, and the interior of the second solid material chamber 2 are connected. Remove the sealing cover 6 on the other side of the liquid material chamber 3, and the piston 9 inside is exposed. Take the driving rod 10 and thread it to the piston 9. Similarly, alternately push the piston inside the liquid material chamber 3. Drive rod 10 and drive rod 10 inside solid material chamber 2 push the premixed solid mixture from solid material chamber 2 into solid-liquid connection port 5. Liquid components enter solid-liquid connection port 5 from liquid material chamber 3. In solid-liquid mixing section 501, spiral guide channel 503 guides the material to form spiral flow, increasing the solid-liquid contact area. At the same time, the turbulence bar 504 on the inner wall can break the laminar flow state of the fluid, divert the material, and avoid local agglomeration. The material is fully mixed and uniform after being guided by guide channel 503 and turbulence bar 504, and finally forms qualified bone cement. The injection connector consists of a base 11 and an injection port 12. The base 11 has the same structure as the sealing cap 6, except that it has a central hole that connects to the injection port 12. The injection port 12 has a hollow conical tube structure and can be connected to a universal syringe needle or tubing. After the final mixing is completed, rotate to remove the solid-liquid connection port 5, select the liquid material chamber 3 as the injection chamber, thread the end of the liquid material chamber 3 away from the drive rod 10 to the base 11 in the injection connector, connect the injection interface 12 to the universal syringe needle or catheter, push the drive rod 10, the piston 9 of the drive rod 10 moves to push the bone cement through the injection interface 12 to the surgical site for orthopedic surgery.

[0034] Working principle: The sealing cap 6 and sealing gasket 7 seal the first solid material chamber 1, the second solid material chamber 2, and the liquid material chamber 3 respectively, thereby independently storing the first solid phase powder, the second solid phase powder, and the liquid phase component, achieving material sealing, moisture prevention, and anti-evaporation. The sealing block 8 seals the powder connection port 4 and the solid-liquid connection port 5 respectively. After removing the sealing block 8 and the sealing cap 6, the powder connection port 4 is used to connect the first solid material chamber 1 and the second solid material chamber 2. The drive rod 10 pushes the piston 9, causing the solid phase powder to be mixed alternately by the dividing plate 403 in the powder mixing section 401, completing the process. After premixing, the powder is separated at the connection port 4. The solid-liquid connection port 5 is used to connect the second solid chamber 2 and the liquid chamber 3. Similarly, the solid-liquid mixture and the liquid components are brought into the solid-liquid mixing section 501 by the drive rod 10 and the piston 9. The mixture is guided by the spiral guide groove 503 and then stirred by the staggered turbulence rod 504 to achieve thorough mixing. The solid-liquid connection port 5 is removed, and the liquid chamber 3 is connected to the injection connector composed of the base 11 and the injection interface 12. The drive rod 10 is pushed to drive the piston 9, and the mixed bone cement is pushed out through the injection interface 12 for use in surgery.

[0035] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention.

Claims

1. A multi-component bone cement loading, mixing, and injection integrated device, comprising a first solid material chamber (1), a second solid material chamber (2), a liquid material chamber (3), and a solid-liquid interface (5), characterized in that: The first solid material chamber (1) has a space for storing a first solid phase powder, the second solid material chamber (2) has a space for storing a second solid phase powder, and the liquid material chamber (3) has a space for storing a liquid phase component; the first solid material chamber (1) and the second solid material chamber (2) are connected by a detachable powder interface (4), and the solid-liquid interface (5) is located between the liquid material chamber (3) and the first solid material chamber (1) or the second solid material chamber (2); the liquid material chamber is connected to a detachable injection... The joint connection is as follows: the No. 1 solid material chamber (1), the No. 2 solid material chamber (2) and the liquid material chamber (3) have the same structure, each including a middle cylinder and side cylinders respectively set at both ends of the middle cylinder; the middle cylinder is a hollow cylindrical structure with both ends through, the side cylinder is a hollow cylindrical structure with both ends through, and the diameter of the side cylinder is smaller than that of the middle cylinder; the middle cylinder and the side cylinder are integrally formed and smoothly transitioned, the outer surface of the side cylinder is provided with an external thread structure, and the powder interface (4) is set between the No. 1 solid material chamber (1) and the No. 2 solid material chamber (2).

2. The multi-component bone cement loading, mixing, and injection integrated device according to claim 1, characterized in that: The powder interface (4) includes a powder mixing section (401) and powder connecting sections (402) respectively disposed at both ends of the powder mixing section (401). The powder mixing section (401) is a hollow cylindrical structure with both ends connected. The inner wall of the powder mixing section (401) is provided with an internal thread structure. The powder connecting section (402) matches the external thread structure of the side cylinder.

3. The multi-component bone cement loading, mixing, and injection integrated device according to claim 2, characterized in that: The powder mixing section (401) is provided with a dividing plate (403), which is a grid structure.

4. The multi-component bone cement loading, mixing, and injection integrated device according to claim 1, characterized in that: The solid-liquid interface (5) includes a solid-liquid mixing section (501) and solid-liquid connecting sections (502) respectively disposed at both ends of the solid-liquid mixing section (501). The solid-liquid mixing section (501) and the solid-liquid connecting section (502) form an hourglass-shaped structure with both ends connected.

5. The multi-component bone cement loading, mixing, and injection integrated device according to claim 4, characterized in that: The inner wall of the solid-liquid mixing section (501) is provided with a spiral guide groove (503), and at least one baffle rod (504) is provided in the solid-liquid mixing section (501).

6. The multi-component bone cement loading, mixing, and injection integrated device according to claim 1, characterized in that: The first solid material chamber (1), the second solid material chamber (2) and the liquid material chamber (3) are all provided with sealing caps (6) at both ends, and each sealing cap (6) is provided with a sealing gasket (7); each chamber is provided with a piston (9) that can move along the axial direction, and the piston (9) is connected to the drive rod (10).

7. The multi-component bone cement loading, mixing, and injection integrated device according to claim 1, characterized in that: Both the powder interface (4) and the solid-liquid interface (5) are provided with removable sealing blocks (8) at their ends.

8. The multi-component bone cement loading, mixing, and injection integrated device according to claim 6, characterized in that: The injection connector consists of a base (11) and an injection interface (12). The base (11) has the same structure as the sealing cap (6), except that it has a central hole that connects to the injection interface (12). The injection interface (12) is a hollow conical tube structure that can be connected to a universal syringe needle or catheter.

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