Bone cement injection guiding device for vertebroplasty

Abstract

The invention relates to the technical field of medical instruments, in particular to a bone cement injection guiding device for vertebroplasty, which comprises a negative pressure suction guiding device and a bone cement injector, the negative pressure suction guiding device comprises a negative pressure tank, a guiding pipe and a connecting hose connecting the negative pressure tank and the guiding pipe, and a plurality of side holes used for forming a negative pressure area in the vertebral body are formed in the side wall of the guiding pipe. The bone cement injector comprises a working sleeve, a needle tube and a push rod, bone cement is contained in the needle tube, through the synergistic effect of integration of negative pressure suction and bone cement injection, the safety and effectiveness of an operation are remarkably improved, firstly, a controllable negative pressure environment is continuously created in a vertebral body before and in the bone cement injection process, and the bone cement is continuously injected into the vertebral body; and bone marrow, fat and blood stasis in the vertebral body can be effectively sucked and removed, and the risk of embolism caused by the fact that fat drops or blood stasis blocks enter a circulatory system due to pressure in the operation is greatly reduced.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a bone cement injection guide device for vertebroplasty. Background Technology

[0002] Vertebral compression fractures are a common condition in elderly patients with osteoporosis. Percutaneous vertebroplasty, which involves injecting bone cement into the affected vertebra, can quickly stabilize the vertebra and relieve pain, and has become a mainstream minimally invasive treatment method. The core of this surgery lies in accurately, controllably, and evenly injecting the viscous bone cement into the vertebral body.

[0003] Currently, the most common method of bone cement injection in clinical practice is manual injection. The surgeon uses a syringe or a special plunger to inject bone cement directly into the cancellous bone of the vertebral body through a puncture cannula. The injection process depends on the surgeon's experience and feel, and the diffusion of cement is monitored in real time through X-ray imaging.

[0004] However, existing injection techniques have significant limitations. First, direct injection can easily create localized high pressure within the vertebral body, causing bone cement to leak along the path of least resistance (such as fracture fissures or venous access), leading to serious complications such as nerve compression or pulmonary embolism. Second, the polymerization reaction of bone cement generates heat and toxic monomers, which, if present directly within the vertebral body, may damage surrounding tissues. Furthermore, bone marrow and blood stasis within the vertebral body can affect the uniformity of bone cement distribution and may enter the circulatory system during surgery due to pressure. Summary of the Invention

[0005] The purpose of this invention is to provide a bone cement injection guide device for vertebroplasty to solve the problems mentioned in the background art.

[0006] The objective of this invention can be achieved through the following technical solutions: A bone cement injection guiding device for vertebroplasty includes a negative pressure suction guiding device and a bone cement injector; The negative pressure suction guiding device includes a negative pressure tank, a guide tube, and a connecting hose connecting the negative pressure tank and the guide tube. The guide tube has several side holes on its side wall for forming a negative pressure zone in the vertebral body. The bone cement injector includes: a working sleeve, a needle tube, and a push rod. The needle tube contains bone cement and has an opening at its front end for discharging the bone cement. The push rod is slidably disposed inside the needle tube for discharging the bone cement. During the surgery, the guide tube and working cannula are respectively inserted into the vertebral body of the affected vertebra. The needle is located inside the working cannula with its front opening extending out of the working cannula. The side holes of the guide tube are set towards the center of the vertebral body to guide the bone cement to diffuse towards the central area of ​​the vertebral body.

[0007] Preferably, the end of the negative pressure tank away from the guide tube can be connected to a central negative pressure device, and the negative pressure tank is provided with a negative pressure adjustment knob for adjusting the suction force.

[0008] Preferably, the negative pressure tank includes a tank body with an air inlet and an air outlet. The air inlet is connected to a guide pipe via a connecting hose, and the air outlet is adapted to be connected to a central negative pressure device via another connecting hose. A negative pressure adjustment knob is installed at the air outlet.

[0009] Preferably, the tank body is provided with a multi-stage diversion baffle to prevent the backflow of the sucked liquid. The multi-stage diversion baffle includes a first diversion baffle, a second diversion baffle, and a third diversion baffle that are vertically arranged in sequence from the air inlet to the air outlet. The upper ends of the first and third diversion baffles are connected to the top wall of the tank, and the lower ends are separated from the bottom wall of the tank by a first gap (b) and a second gap. The lower end of the second drainage baffle is connected to the bottom wall of the tank, and a gap is left between the upper end and the top wall of the tank. The gap 'a' between the third diversion baffle and the tank wall on the same side is smaller than the gap 'b' between the first diversion baffle and the tank wall on the same side, so as to form a tortuous path to prevent liquid backflow.

[0010] Preferably, it also includes a negative pressure adjustment component for testing the patency and pressure value of the negative pressure system during surgery; the negative pressure adjustment component includes a negative pressure adjustment bag containing a test solution and can be detachably connected to the working sleeve.

[0011] Preferably, at least a portion of the inner wall or the drainage baffle of the negative pressure vessel is coated with a detection coating, the component of which is at least one of iodine and heparin, used to generate a color reaction with the test solution and prevent blood clotting.

[0012] Preferably, the test solution is a starch-based solution that changes color upon contact with iodine.

[0013] Preferably, the end of the syringe has a grip portion that facilitates the operator's gripping and rotation, and the grip portion is marked with the direction of the opening at the front end of the syringe; the end of the plunger has a handle that facilitates injection.

[0014] Preferably, the working cannula and the guide tube have a rigidity and shape suitable for pedicle puncture into the vertebral body under image guidance; the guide tube is placed in the posterior 1 / 2 to posterior 1 / 3 region of the vertebral body, and the working cannula is placed in the anterior 1 / 2 to anterior 1 / 3 region of the vertebral body.

[0015] Preferably, the method for performing vertebroplasty using a guiding device includes the following steps: S1. Insert the working sleeve and guide tube into the predetermined position within the vertebral body of the affected vertebra; S2. Connect and start the negative pressure suction guide device, and adjust the negative pressure to continuously suction the fluid in the vertebral body; S3. By using negative pressure suction, bone marrow, fat, and blood stasis are removed from the vertebral body; S4. Insert the bone cement injector containing bone cement into the working sleeve, and inject bone cement into the vertebral body while maintaining negative pressure. S5. After the bone cement has hardened, remove all instruments.

[0016] Preferably, step S2 further includes a step of using a negative pressure adjustment bag to perform system testing: connecting the negative pressure adjustment bag containing the test solution to the system, adjusting the negative pressure adjustment knob until the test solution is drawn into the negative pressure tank and comes into contact with the detection coating to develop color, and recording the knob position at this time as the target negative pressure value for surgery.

[0017] The beneficial effects of this invention are: The bone cement injection guidance device for vertebroplasty provided by this invention significantly improves the safety and effectiveness of the surgery by integrating negative pressure suction and bone cement injection. First, a controllable negative pressure environment is continuously created within the vertebral body before and during bone cement injection, which can effectively aspirate and remove bone marrow, fat, and blood clots from the vertebral body, greatly reducing the risk of embolism (such as pulmonary embolism) caused by fat droplets or blood clots entering the circulatory system due to pressure during the operation. At the same time, this continuous negative pressure can actively guide the bone cement to diffuse towards the central area of ​​the vertebral body, making its distribution more uniform and reasonable. This not only reduces complications such as bone cement leakage along fracture gaps or venous plexuses, but also helps to better restore and maintain vertebral height and spinal alignment, optimizing the final mechanical support effect.

[0018] The bone cement injection guidance device for vertebroplasty provided by this invention can continuously remove the heat and toxic volatile monomers generated by the polymerization reaction of bone cement from the surgical area during the operation, thereby significantly reducing the thermal and chemical toxic damage to important nerves and blood vessels around the vertebral body. This transforms the traditional passive bone cement filling into an active and controllable guided distribution, achieving the dual goals of reducing surgical risks and improving surgical quality, and has important clinical application value. Attached Figure Description

[0019] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, for those skilled in the art, other drawings can be obtained based on these drawings without creative effort. Figure 1 This is a schematic diagram of the overall structure of the present invention; Figure 2 This is a schematic diagram of the state during the debugging process of the present invention using a negative pressure debugging bag; Figure 3 This is the present invention. Figure 1 A schematic diagram of the structure of a medium-pressure tank.

[0020] The attached figures are labeled as follows: 1. Vertebrae; 2. Working sleeve; 3. Needle; 4. Push rod; 5. Negative pressure tank; 6. Guide tube; 7. Side hole; 8. Connecting hose; 9. Negative pressure adjustment knob; 10. Air inlet; 11. Exhaust outlet; 12. Negative pressure adjustment bag; 13. Detection coating; 14. First drainage baffle; 15. Second drainage baffle; 16. Third drainage baffle. Detailed Implementation

[0021] 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.

[0022] See Figure 1 A bone cement injection guiding device for vertebroplasty, comprising a negative pressure suction guiding device and a bone cement injector; The bone cement injector is used to inject bone cement into the vertebral body. It includes a working sleeve 2, a needle tube 3, and a push rod 4. The needle tube 3 has a cavity for accommodating bone cement and is open at the front. The end of the push rod 4 is slidably connected to the needle tube 3 through a piston. The needle tube 3 is located in the working sleeve 2. The push rod 4 moves within the needle tube 3, which pushes the bone cement into the vertebral body 1 at the treatment position, achieving the purpose of rapid pain relief and effective and stable treatment.

[0023] The main function of the negative pressure suction guiding device is to create a negative pressure environment within the vertebral body 1, reducing surgical risks. Its structure specifically includes: a negative pressure tank 5, a guide tube 6, and a connecting hose 8 connecting the negative pressure tank 5 and the guide tube 6. Several side holes 7 are provided on the side wall of the guide tube 6 to quickly create a stable negative pressure environment within the vertebral body 1. An air inlet 10 and an exhaust outlet 11 are respectively provided at the front and rear ends of the negative pressure tank 5. The air inlet 10 is connected to the guide tube 6 via the connecting hose 8, and the exhaust outlet 11 is connected to an external central negative pressure device via another connecting hose. The external central negative pressure device can be any device capable of generating negative pressure, such as a vacuum pump.

[0024] In order to adjust the negative pressure, a negative pressure adjustment knob 9 is installed at the exhaust port 11. The adjustment knob 9 is existing technology and will not be described in detail here. By rotating the negative pressure adjustment knob 9, the opening and closing size of the exhaust port 11 can be controlled to achieve negative pressure adjustment.

[0025] When performing vertebroplasty procedures such as PVP or PKP vertebral body surgery, such as Figure 1 and Figure 2 As shown, the guide tube 6 and the working sleeve 2 are respectively guided by the guide needle to enter the lesion location in the vertebral body through the pedicle. The working sleeve 2 is placed between the anterior 1 / 2 and anterior 1 / 3 of the vertebral body 1, and the guide tube 6 is placed between the posterior 1 / 2 and posterior 1 / 3 of the vertebral body 1.

[0026] It should be noted that the side hole 7 of the guide tube 6 faces the center of the vertebral body 1, and the needle tube 3 is positioned inside the working sleeve 2 with its front opening extending out of the working sleeve 2 to inject bone cement into the vertebral body 1. For ease of operation, as follows... Figure 1 As shown, a gripping part is formed at the tail end of the needle tube 3, and the opening direction of the front opening is marked, so that the doctor can rotate the needle tube to adjust the orientation of the front opening according to the needs of the operation.

[0027] To adjust the negative pressure of the bone cement injection device to a suitable range, and simultaneously check whether the guide tube 6 and the working sleeve 2 are properly connected (in the correct position), such as... Figure 2 As shown, the present invention also includes a negative pressure adjustment bag 12, which is connected to the working sleeve 2 and contains a test solution. When the negative pressure can smoothly draw the test solution in the negative pressure adjustment bag 12 into the negative pressure tank 5, it indicates that the negative pressure has reached the ideal value and the positions of the guide tube 6 and the working sleeve 2 are appropriate. Record the scale of the negative pressure adjustment knob 9 at this time. Continue to draw and rinse with negative pressure until the solution in the negative pressure tank 5 reaches 50ml-80ml, washing out bone marrow fat and blood stasis, and then turn off the negative pressure adjustment knob 9.

[0028] Furthermore, to prevent backflow of the aspirated fluid (bone marrow, blood clots, or test solutions, etc.) inside the negative pressure tank 5, several drainage baffles are also installed inside the negative pressure tank 5. For example... Figure 3 As shown, the flow diversion baffle includes a first flow diversion baffle 14, a second flow diversion baffle 15, and a third flow diversion baffle 16, which are arranged vertically from the air inlet 10 to the exhaust outlet 11. The first flow diversion baffle 14 and the third flow diversion baffle 16 are connected to the top wall of the negative pressure tank 5 and have a gap between them and the bottom wall of the negative pressure tank 5. The second flow diversion baffle 15 is connected to the bottom wall of the negative pressure tank 5 and has a gap between it and the top wall of the negative pressure tank 5. The gap a between the third flow diversion baffle 16 and the tank wall on the same side is smaller than the gap b between the first flow diversion baffle 14 and the tank wall on the same side. This achieves the best backflow prevention effect.

[0029] To facilitate more intuitive observation, a detection coating 13 should be applied to at least the inner wall of the negative pressure tank 5. Alternatively, the detection coating 13 can be applied to one or more surfaces of the first drainage baffle 14, the second drainage baffle 15, and the third drainage baffle 16. The detection coating 13 will change color upon contact with the test solution. The test solution in the negative pressure adjustment bag 12 should be a harmless surgical rehydration solution, such as a starch-based solution that turns blue upon contact with iodine; hydroxyethyl starch solution is a suitable option, but not limited to. Therefore, the detection coating 13 is an iodine coating and a heparin coating. The iodine coating tests whether the negative pressure is sufficient to draw the test solution from the negative pressure adjustment bag 12 into the negative pressure tank 5, while the heparin coating prevents the blood aspirated during surgery from clotting and affecting observation. It should be noted that the choice of coating 13 and test solution is not limited to this embodiment; other substances that change color upon contact can also be used, as long as the purpose of intuitive monitoring is achieved.

[0030] To better understand and implement this technology, the surgical procedure for vertebroplasty using the bone cement injection device is briefly described below: First, under X-ray guidance, the working sleeve 2 and the guide tube 6 are inserted into the vertebral body 1 of the affected vertebra, with the side hole 7 of the guide tube 6 facing the center of the vertebral body 1. Then, the negative pressure adjustment bag 12 is connected to the working sleeve 2, the negative pressure suction guiding device is activated, and the negative pressure adjustment knob 9 is adjusted until bloody fluid flows continuously and slowly from the guide tube 6 into the negative pressure tank 5. Then, the test solution in the negative pressure adjustment bag 12 slowly enters the negative pressure tank 5 (the detection coating 13 changes color). The scale position of the negative pressure adjustment knob 9 at this time is recorded as the target position. The irrigation continues until the solution in the negative pressure tank 5 reaches 50ml-80ml, washing out bone marrow fat and blood stasis. The negative pressure adjustment knob 9 is then turned off. Next, remove the negative pressure adjustment bag 12, insert the bone cement injector into the working sleeve 2, so that the front opening of the needle 3 extends out of the front end of the working sleeve 2, check the direction of the front opening marked on the handle, turn the negative pressure adjustment knob 9 to the target position, and slowly inject bone cement under X-ray monitoring to complete the PVP or PKP vertebral body surgery.

[0031] In summary, this bone cement injection device is suitable for PVP or PKP vertebral body surgery. The direction of the needle tube 3's opening can be adjusted by rotating it, thus controlling the injection direction of the bone cement. By applying a central negative pressure device to the guide tube 6 with side holes, negative pressure is created in the center of the vertebral body 1, guiding the bone cement to disperse within the vertebral body 1, reducing the risk of bone cement leakage, promoting diffusion within the vertebral body, resulting in a more uniform distribution, and significantly optimizing surgical quality and outcome. In addition, by using a negative pressure suction guide device, fat and blood clots in the vertebral body 1 can be aspirated before surgery to prevent fat and blood clots from entering blood vessels during the operation and causing possible vascular embolism, such as pulmonary embolism. Through continuous suction, harmful and toxic substances released during the chemical reaction of bone cement can also be removed, reducing their adverse effects on the body by entering the blood and tissues. Heat released during the chemical reaction of bone cement can also be removed, reducing the risk of thermal damage to nearby important tissues caused by bone cement.

[0032] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely illustrative of the principles of the invention. Various changes and modifications can be made to the invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the claimed invention.

Claims

1. A bone cement injection guiding device for vertebroplasty, comprising a negative pressure suction guiding device and a bone cement injector, characterized in that: The negative pressure suction guiding device includes a negative pressure tank (5), a guide tube (6) and a connecting hose (8) connecting the negative pressure tank (5) and the guide tube (6). The guide tube (6) has several side holes (7) on its side wall for forming a negative pressure zone in the vertebral body (1). The bone cement injector includes: a working sleeve (2), a needle tube (3) and a push rod (4). The needle tube (3) contains bone cement and has an opening at its front end for discharging bone cement. The push rod (4) is slidably disposed inside the needle tube (3) for discharging bone cement. During the operation, the guide tube (6) and the working sleeve (2) are respectively inserted into the vertebral body (1) of the diseased vertebra. The needle tube (3) is located inside the working sleeve (2) and its front end opening extends out of the working sleeve (2). The side hole (7) of the guide tube (6) is set towards the center of the vertebral body (1) to guide the bone cement to diffuse towards the central area of ​​the vertebral body.

2. The bone cement injection guide device for vertebroplasty according to claim 1, characterized in that, The negative pressure tank (5) has one end away from the guide tube (6) that can be connected to a central negative pressure device, and the negative pressure tank (5) is provided with a negative pressure adjustment knob (9) for adjusting the suction force. The negative pressure adjustment knob (9) is installed at the exhaust port (11). The negative pressure tank (5) includes a tank body with an air inlet (10) and an exhaust port (11). The air inlet (10) is connected to the guide pipe (6) via a connecting hose (8), and the exhaust port (11) is adapted to be connected to the central negative pressure device via another connecting hose.

3. The bone cement injection guide device for vertebroplasty according to claim 2, characterized in that, The tank body is provided with a multi-stage drainage baffle to prevent the backflow of the sucked liquid. The multi-stage drainage baffle includes a first drainage baffle (14), a second drainage baffle (15) and a third drainage baffle (16) arranged vertically in sequence from the air inlet (10) to the exhaust outlet (11). The upper ends of the first drainage baffle (14) and the third drainage baffle (16) are connected to the top wall of the tank, and the lower ends are separated from the bottom wall of the tank by a first gap (b) and a second gap. The lower end of the second drainage baffle (15) is connected to the bottom wall of the tank, and the upper end is separated from the top wall of the tank. Among them, the gap a between the third diversion baffle (16) and the tank wall on the same side is smaller than the gap b between the first diversion baffle (14) and the tank wall on the same side, so as to form a tortuous path to prevent liquid backflow.

4. The bone cement injection guide device for vertebroplasty according to claim 1, characterized in that, It also includes a negative pressure adjustment assembly for testing the patency and pressure of the negative pressure system during surgery; the negative pressure adjustment assembly includes a negative pressure adjustment bag (12) containing a test solution and detachably connected to the working sleeve (2).

5. The bone cement injection guide device for vertebroplasty according to claim 4, characterized in that, The inner wall or drainage baffle of the negative pressure tank (5) is coated with a detection coating (13), the components of which are at least one of iodine and heparin, and are used to react with the test solution to produce a colorimetric reaction and to prevent blood clotting.

6. The bone cement injection guide device for vertebroplasty according to claim 5, characterized in that, The test solution is a starch-based solution that changes color upon contact with iodine.

7. The bone cement injection guide device for vertebroplasty according to claim 1, characterized in that, The end of the needle (3) is formed with a grip part that is easy for the operator to hold and rotate, and the direction of the opening of the front end of the needle (3) is marked on the grip part; the end of the push rod (4) is formed with a handle that is easy to push injection.

8. The bone cement injection guide device for vertebroplasty according to claim 1, characterized in that, The working sleeve (2) and the guide tube (6) have a rigidity and shape suitable for pedicle puncture into the vertebral body (1) under image guidance; the guide tube (6) is inserted into the posterior 1 / 2 to posterior 1 / 3 region of the vertebral body (1), and the working sleeve (2) is inserted into the anterior 1 / 2 to anterior 1 / 3 region of the vertebral body (1).

9. A method for performing vertebroplasty using the guiding device according to any one of claims 1-8, characterized in that, Includes the following steps: S1. Insert the working sleeve (2) and the guide tube (6) into the predetermined position inside the vertebral body (1) of the diseased vertebra; S2. Connect and start the negative pressure suction guide device, and adjust the negative pressure to continuously suction the fluid in the vertebral body; S3. Remove bone marrow, fat and blood stasis from the vertebral body (1) by negative pressure suction; S4. Insert the bone cement injector containing bone cement into the working sleeve (2), and inject bone cement into the vertebral body (1) while maintaining negative pressure. S5. After the bone cement has hardened, remove all instruments.

10. A bone cement injection guide device for vertebroplasty according to claim 9, characterized in that, In step S2, the system test is also performed using a negative pressure adjustment bag (12): the negative pressure adjustment bag (12) containing the test solution is connected to the system, the negative pressure adjustment knob (9) is adjusted until the test solution is drawn into the negative pressure tank (5) and comes into contact with the detection coating (13) and develops color, and the position of the knob at this time is recorded as the target negative pressure value for the operation.

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