Orientation-controllable bone cement filler

Abstract

The utility model discloses a directional controllable bone cement filler which comprises an injection rod and a volumetric tube. The injection rod comprises a rod body and an injection rod handle mounted at the tail part of the rod body; the volume tube comprises an inner tube and an outer tube tightly sleeved on the inner tube, an inner tube handle is mounted at the tail of the inner tube, an injection hole communicated with the inner tube is arranged in the middle of the tail of the inner tube handle, the head of the inner tube and the head of the outer tube are sealed, and an inner tube outflow hole is arranged on the inner tube close to the head. An outer pipe outflow hole is formed in the position, close to the head, of the outer pipe, the inner pipe outflow hole and the outer pipe outflow hole are matched in a crossed mode to form a bone cement outflow hole, and the size of the bone cement outflow hole can be controlled by rotating the outer pipe. And the injection rod is inserted into the inner tube of the volumetric tube and is used for applying pressure to enable the bone cement to flow out through the bone cement outflow hole. The bone cement injection device can control the dispersion direction of bone cement and the injection outflow amount, accurately injects the bone cement in a directional mode, shortens the operation time and the perspective frequency, and improves the treatment effect of a patient.

Description

Technical Field

[0001] This utility model relates to a directional controllable bone cement filler, belonging to the field of medical device technology. Background Technology

[0002] Osteoporosis is a systemic skeletal disease characterized by decreased bone mass, degeneration of trabeculae and microstructures, and increased bone fragility. Vertebral fractures resulting from osteoporosis severely impact the quality of life of the elderly. Conservative treatment requires prolonged bed rest, which can easily lead to serious complications and even death. Currently, surgical treatments primarily involve percutaneous vertebroplasty (PVP) and percutaneous kyphoplasty (PKP), performed under image-guided guidance, percutaneously injecting filler into the affected vertebra. These procedures strengthen and fix the fracture site, restoring vertebral stability and reducing pain. In addition to pain relief and functional improvement, the injected filler also shows satisfactory results in restoring vertebral height, improving kyphosis angle, and enhancing lung function.

[0003] Currently, bone cement leakage is a major and insurmountable complication of PKP and PVP. Once bone cement leaks into the intervertebral foramen or invades the spinal canal, it can cause neurological damage symptoms and even paraplegia. If bone cement leaks into the paravertebral veins, it can cause pulmonary embolism, potentially leading to patient death. This has a significant negative impact on patient treatment satisfaction and quality of life. Traditional bone cement placement pushers cannot achieve precise directional injection of bone cement, nor can they control the outflow of bone cement. They mainly rely on the natural diffusion of bone cement after accumulation within the vertebral body, and this uncontrollability greatly increases the risk of surgical leakage, the number of intraoperative fluoroscopy sessions, and the occurrence of postoperative complications. Summary of the Invention

[0004] To address the problems existing in the prior art, this utility model provides a directional controllable bone cement filler that can control the diffusion direction and outflow of bone cement, and precisely inject bone cement in a directional manner.

[0005] To achieve the above objectives, this utility model employs a directional controllable bone cement filler, comprising an injection rod and a volume tube;

[0006] The injection rod includes a rod body and an injection rod handle installed at the tail of the rod body;

[0007] The capacity tube includes an inner tube and an outer tube tightly fitted onto the inner tube. An inner tube handle is installed at the tail end of the inner tube, and an injection hole communicating with the inner tube is provided at the middle of the tail end of the inner tube handle. The heads of both the inner tube and the outer tube are sealed. An inner tube outlet hole is provided near the head of the inner tube, and an outer tube outlet hole is provided near the head of the outer tube. The inner tube outlet hole and the outer tube outlet hole intersect to form a bone cement outlet hole. Rotating the outer tube can control the size of the bone cement outlet hole.

[0008] The injection rod is inserted into the inner tube of the volume tube to apply pressure so that the bone cement flows out through the bone cement outlet hole.

[0009] Preferably, the injection rod handle is fan-shaped and has anti-slip texture.

[0010] Preferably, the inner tube outlet hole is arranged along the circumference of the inner tube, and the outer tube outlet hole is arranged along the circumference of the outer tube.

[0011] Preferably, the inner tube has two outlet holes, symmetrically arranged in the circumference of the inner tube, and the outer tube has two outlet holes, symmetrically arranged in the circumference of the outer tube.

[0012] Preferably, the inner tube handle is provided with an indicator arrow for indicating the direction of the inner tube outflow hole.

[0013] Preferably, the inner tube handle is provided with anti-slip texture.

[0014] Preferably, the inner tube and the outer tube are provided with a rotating structure near the head; the rotating structure includes a concave rotating groove on the inner tube and a rotating convex ring in the outer tube.

[0015] Preferably, a limiting structure is also included, installed between the inner tube and the outer tube, to restrict the rotation of the outer tube.

[0016] Preferably, the limiting structure includes a first limiting tooth and a second limiting tooth installed at the head of the inner tube handle, and an outer tube tooth installed at the tail of the outer tube. When the outer tube tooth contacts the first limiting tooth, the bone cement outflow hole is in its minimum state, and when the outer tube tooth contacts the second limiting tooth, the bone cement outflow hole is in its maximum state.

[0017] Preferably, the rod body and the injection rod handle are integrated, and the inner tube and the inner tube handle are integrated.

[0018] Compared with existing technologies, the directional controllable bone cement filler of this invention can control the direction of bone cement injection based on imaging fluoroscopy results, ensuring uniform dispersion. This reduces the difference in spinal stress gradient caused by uneven distribution of bone cement and effectively avoids bone cement infiltration into the posterior edge of the vertebral body, which could lead to intraspinal occupancy or leakage outside the vertebral body. It effectively reduces the risk of bone cement leakage and ensures full anchorage between the bone cement and the trabeculae, restoring vertebral height and stability, shortening surgical time and the number of fluoroscopy sessions, thereby improving the patient's treatment outcome. Attached Figure Description

[0019] Figure 1 This is a front view of the directional controllable bone cement filler of this utility model;

[0020] Figure 2 for Figure 1 The left view;

[0021] Figure 3 This is a three-dimensional structural diagram of the directional controllable bone cement filler of this utility model;

[0022] Figure 4 This is a three-dimensional structural diagram of the injection rod of this utility model;

[0023] Figure 5 This is a three-dimensional structural diagram of the inner tube of this utility model;

[0024] Figure 6 This is a three-dimensional structural diagram of the outer tube of this utility model;

[0025] Figure 7 This is a three-dimensional structural diagram of the inner tube handle of this utility model;

[0026] In the diagram: 1. Injector rod, 1-1. Injector rod handle, 1-2. Injector rod anti-slip texture, 1-3. Rod body;

[0027] 2. Capacity tube, 2-1. Injection hole, 2-2. Inner tube handle, 2-3. Anti-slip texture of inner tube handle, 2-4. First limit tooth, 2-5. Outer tube tooth, 2-6. Second limit tooth, 2-7. Outer tube, 2-8. Outer tube outlet hole, 2-9. Inner tube, 2-10. Inner tube outlet hole, 2-11. Rotary chute, 2-12. Indicator arrow. Detailed Implementation

[0028] The present invention will be further described below with reference to the accompanying drawings.

[0029] like Figures 1-7 As shown, a directional controllable bone cement filler includes an injection rod 1 and a volume tube 2;

[0030] The injection rod 1 includes a rod body 1-3 and an injection rod handle 1-1 installed at the tail of the rod body 1-3;

[0031] The capacity tube 2 includes an inner tube 2-9 and an outer tube 2-7 tightly fitted onto the inner tube 2-9. An inner tube handle 2-2 is installed at the tail end of the inner tube 2-9. An injection hole 2-1 communicating with the inner tube 2-9 is located at the middle of the tail end of the inner tube handle 2-2. Bone cement can be injected into the inner tube 2-9 through the injection hole 2-1, which also facilitates the insertion of the injection rod 1 into the inner tube 2-9. The heads of both the inner tube 2-9 and the outer tube 2-7 are sealed. Near the head of the inner tube 2-9... An inner tube outlet hole 2-10 is provided, and an outer tube outlet hole 2-8 is provided on the outer tube 2-7 near the head. This ensures that bone cement can only flow out from the inner tube outlet hole 2-10 and the outer tube outlet hole 2-8, which facilitates the control of the outflow direction of bone cement. The inner tube outlet hole 2-10 and the outer tube outlet hole 2-8 are cross-fitted to form a bone cement outlet hole. Rotating the outer tube 2-7 can control the size of the bone cement outlet hole. By changing the size of the bone cement outlet hole, the outflow amount of bone cement can be controlled.

[0032] The injection rod 1 is inserted into the inner tube 2-9 of the capacity tube 2. By pushing the injection rod 1, pressure is applied to make the bone cement flow out of the bone cement outflow hole into the vertebral body.

[0033] As a preferred embodiment, such as Figure 1 , Figure 3 and Figure 5 As shown, the injection rod handle 1-1 is fan-shaped and has anti-slip texture 1-2. The fan-shaped injection rod handle 1-1 is more ergonomic, and the anti-slip texture 1-2 increases the friction, making it easier and less strenuous to operate the injection rod handle 1-1.

[0034] As a preferred embodiment, such as Figure 5 As shown, the inner tube outlet holes 2-10 are arranged circumferentially along the inner tube 2-9, as follows: Figure 6 As shown, the outer tube outflow holes 2-8 are arranged circumferentially along the outer tube 2-7. This circumferential arrangement facilitates the formation of bone cement outflow holes by the intersection of the inner tube outflow holes 2-10 and the outer tube outflow holes 2-8. It also allows for adjustment of the size of the bone cement outflow holes by rotating the outer tube 2-7, thus controlling the amount of bone cement flowing out. Furthermore, there are two inner tube outflow holes 2-10, symmetrically arranged circumferentially on the inner tube 2-9, and two outer tube outflow holes 2-8, symmetrically arranged circumferentially on the outer tube 2-7. The two inner tube outflow holes 2-10 and two outer tube outflow holes 2-8 cooperate to form two symmetrically arranged bone cement outflow holes, allowing bone cement to flow out from two directions simultaneously, improving efficiency. It should be noted that the dimensions of the inner tube outflow holes 2-10 and the outer tube outflow holes 2-8 can be the same.

[0035] As a preferred embodiment, such as Figure 7 As shown, the inner tube handle 2-2 is provided with an indicator arrow 2-12 for indicating the direction of the inner tube outflow hole 2-10. The outflow direction of bone cement can be easily determined by the indicator arrow 2-12.

[0036] As a preferred embodiment, such as Figure 1 , Figure 3 and Figure 5 As shown, the inner tube handle 2-2 is provided with anti-slip texture 2-3, which improves the friction and makes it more convenient and less strenuous to operate the inner tube handle 2-2.

[0037] As a preferred embodiment, such as Figure 5 As shown, the inner tube 2-9 and the outer tube 2-7 are also provided with a rotating structure near the head; the rotating structure includes a concave rotating groove 2-11 on the inner tube 2-9 and a rotating convex ring in the outer tube 2-7. The rotating groove 2-11 and the rotating convex ring cooperate to limit and fix the inner tube 2-9 and the outer tube 2-7 to prevent them from separating, and to ensure that the outflow holes on the inner tube 2-9 and the outer tube 2-7 are kept at the same horizontal line, so that there will be no inconsistency in height.

[0038] As a preferred embodiment, it also includes a limiting structure installed between the inner tube 2-9 and the outer tube 2-7 to restrict the rotation of the outer tube 2-7. When the inner tube 2-9 is rotated, the limiting structure can ensure that the outer tube 2-7 will not rotate relative to the inner tube 2-9, thereby ensuring that the inner tube 2-9 and the outer tube 2-7 rotate synchronously, so as to realize the directional injection of bone cement into the vertebral body.

[0039] The limiting structure includes a first limiting tooth 2-4 and a second limiting tooth 2-6 installed at the head of the inner tube handle 2-2, and an outer tube tooth 2-5 installed at the tail of the outer tube 2-7. When the outer tube tooth 2-5 contacts the first limiting tooth 2-4, the bone cement outflow hole is in its minimum state, and when the outer tube tooth 2-5 contacts the second limiting tooth 2-6, the bone cement outflow hole is in its maximum state.

[0040] In a preferred embodiment, the rod body 1-3 and the push rod handle 1-1 are integrated, which facilitates the control of the push rod 1 to perform push and pull actions through the push rod handle 1-1; the inner tube 2-9 and the inner tube handle 2-2 are integrated, which facilitates the inner tube 2-9 to rotate accordingly through the inner tube handle 2-2.

[0041] In use, first, the outer tube 2-7 is fitted onto the inner tube 2-9, and at the same time, the outer tube retaining tooth 2-5 is in contact with the second limiting retaining tooth 2-6. At this time, the crossover rate of the outer tube outflow hole 2-8 and the inner tube outflow hole 2-10 is the largest, and the bone cement outflow hole is in the maximum state (the bone cement outflow is the largest). Then, bone cement is injected into the inner tube 2-9 through the injection hole 2-1. Then, the injection rod 1 is extended into the inner tube 2-9 through the injection hole 2-1. By pushing the injection rod 1, the bone cement flows out into the vertebral body through the bone cement outflow hole.

[0042] When it is necessary to change the outflow of bone cement, rotate the outer tube 2-7. When the outer tube retaining tooth 2-5 contacts the first limiting retaining tooth 2-4, the overlap rate of the outer tube outflow hole 2-8 and the inner tube outflow hole 2-10 is minimal, and the bone cement outflow hole is in its minimum state (the outflow of bone cement is minimal). When it is necessary to change the outflow direction of bone cement, rotate the inner tube handle 2-2 to drive the inner tube 2-9 and the outer tube 2-7 to rotate synchronously (to avoid the outer tube 2-7 rotating out of sync, you can hold the outer tube 2-7 with your hand to fix it to the inner tube 2-9). Relying on the indicator arrow 2-12, ensure that the inner tube 2-9 and the outer tube 2-7 are rotated to the required direction, and then bone cement can be injected into the vertebral body.

[0043] When treating vertebral hemangiomas, traditional bone cement fillers cannot accurately inject bone cement in the direction of the hemangioma. Once the channel is inserted, the direction cannot be changed. If the hemangioma is small or near the edge, the puncture channel through the pedicle is difficult to reach. Sufficient bone cement must be injected to accumulate and diffuse within the vertebral body to the location of the hemangioma to achieve the surgical goal. This significantly increases the number of intraoperative fluoroscopy sessions and the surgeon's operational difficulty. Furthermore, the more bone cement injected, the more complications may arise, and the risk of bone cement leakage also increases. However, using the directional controllable bone cement filler of this invention, after the puncture channel enters the vertebral body, the location of the hemangioma is shown on intraoperative fluoroscopy. The inner tube handle 2-2 is rotated, and the direction of bone cement outflow is determined by the indicator arrow 2-12 on the inner tube handle 2-2, directly reaching the lesion. The size of the outflow orifice can be controlled by rotating the outer tube 2-7 according to the size of the hemangioma, with the outflow orifices on the inner tube 2-9 and outer tube 2-7 intersecting. This controls the amount of bone cement outflow, greatly reducing surgical time and the amount of bone cement injected.

[0044] When treating vertebral compression fractures, traditional straight-opening fillers accumulate within the vertebral body and then randomly diffuse as the injected volume increases. The degree and direction of diffusion depend on the hardening state of the bone cement and the degree of change in the trabecular bone structure within the vertebral body after the fracture, making this process highly uncertain. However, using the directional controllable bone cement filler of this invention, when treating vertebral compression fractures, the inner tube handle 2-2 can be directly rotated. Following the guidance of the indicator arrow 2-12, the bone cement outlet is directed towards the upper and lower endplates of the vertebral body, thereby controlling the diffusion of bone cement from the injection rod 1 towards the upper and lower endplates. If the compression is still manageable and there is no significant peripheral wall damage, the outer tube 2-7 can be rotated to appropriately enlarge the bone cement outlet, allowing the bone cement to reach the endplate as quickly as possible. If the cement diffusion deviates, the inner tube handle 2-2 can be rotated to control the direction of the outlet to the ideal area before continuing to inject bone cement.

[0045] Bilateral pedicle screw fixation is a classic procedure for treating vertebral fractures, but postoperative pain relief, vertebral height recovery, and related indications are not significantly different from the unilateral pedicle screw fixation approach. However, bilateral procedures significantly increase operative time, cement injection volume, and the risk of leakage. In recent years, the number of surgeons performing unilateral vertebral fracture treatment has gradually increased. However, to achieve sufficient and uniform dispersion of the cement within the vertebral body, achieving biomechanical stability, and eliminating significant lateral stress differences, the puncture channel must be placed at the midline of the vertebral body before injection. This requires increasing the inward tilt angle of the puncture, increasing the risk of the channel entering the spinal canal. The directional controllable cement filler of this invention can achieve the desired therapeutic effect of unilateral procedures without deliberately increasing the inward tilt angle. This involves rotating the inner tube handle 2-2 laterally to align the cement outflow hole laterally, allowing the cement to diffuse laterally during injection, achieving directional midline spread and establishing a uniform lateral stress gradient within the vertebral body.

[0046] The above descriptions are merely embodiments of this utility model, and common technical solutions and / or characteristics known in the scheme are not described in detail here. It should be noted that those skilled in the art can make various modifications, improvements, or equivalent substitutions without departing from the technical solution of this utility model, and all such modifications, improvements, or equivalent substitutions should be covered within the scope of the claims of this utility model. The scope of protection claimed in this application should be determined by the content of its claims, and the detailed descriptions of the embodiments can be used to interpret the content of the claims.

Claims

1. A directionally controllable bone cement filler, characterized in that, The injection rod (1) and the volume tube (2) are included. The injection rod (1) includes a rod body (1-3) and an injection rod handle (1-1) installed at the tail of the rod body (1-3). The volume tube (2) includes an inner tube (2-9) and an outer tube (2-7) tightly sleeved on the inner tube (2-9), the tail of the inner tube (2-9) is provided with an inner tube handle (2-2), the middle of the tail of the inner tube handle (2-2) is provided with an injection hole (2-1) in communication with the inner tube (2-9), the heads of the inner tube (2-9) and the outer tube (2-7) are sealed, the inner tube (2-9) is provided with an inner tube outflow hole (2-10) near the head, the outer tube (2-7) is provided with an outer tube outflow hole (2-8) near the head, the inner tube outflow hole (2-10) and the outer tube outflow hole (2-8) cross and match to form a bone cement outflow hole, and the size of the bone cement outflow hole can be controlled by rotating the outer tube (2-7). The injection rod (1) is inserted into the inner tube (2-9) of the volume tube (2) to apply pressure to make the bone cement flow out through the bone cement outflow hole.

2. A controllably directed bone cement filler according to claim 1, wherein, The injection rod handle (1-1) is fan-shaped, and the injection rod handle (1-1) is provided with an injection rod anti-skid pattern (1-2).

3. The controllably directed bone cement filler of claim 1, wherein, The inner tube outflow hole (2-10) is arranged along the circumference of the inner tube (2-9), and the outer tube outflow hole (2-8) is arranged along the circumference of the outer tube (2-7).

4. A controllably directed bone cement filler according to claim 3, wherein, The inner tube outflow hole (2-10) is provided with two holes symmetrically arranged on the circumference of the inner tube (2-9), and the outer tube outflow hole (2-8) is provided with two holes symmetrically arranged on the circumference of the outer tube (2-7).

5. The controllably directed bone cement filler of claim 1, wherein, The inner tube handle (2-2) is provided with an indicating arrow (2-12) for indicating the direction of the inner tube outflow hole (2-10).

6. A controllably directable bone cement filler according to claim 1 or 5, wherein, The inner tube handle (2-2) is provided with an inner tube handle anti-skid pattern (2-3).

7. The controllably directed bone cement filler of claim 1, wherein, The inner tube (2-9) and the outer tube (2-7) are further provided with a rotating structure near the head. The rotating structure includes an inner concave rotating sliding groove (2-11) arranged on the inner tube (2-9) and a rotating convex ring arranged in the inner tube (2-7).

8. The controllably directed bone cement filler of claim 1, wherein, Further including a limiting structure installed between the inner tube (2-9) and the outer tube (2-7) for limiting the rotation of the outer tube (2-7).

9. A controllably directed bone cement filler according to claim 8, wherein, The limiting structure includes a first limiting tooth (2-4) and a second limiting tooth (2-6) installed at the head of the inner tube handle (2-2), and an outer tube tooth (2-5) installed at the tail of the outer tube (2-7). When the outer tube tooth (2-5) is in contact with the first limiting tooth (2-4), the bone cement outflow hole is in the minimum state, and when the outer tube tooth (2-5) is in contact with the second limiting tooth (2-6), the bone cement outflow hole is in the maximum state.

10. The controllably directed bone cement filler of claim 1, wherein, The rod body (1-3) and the injection rod handle (1-1) are integrated, and the inner tube (2-9) and the inner tube handle (2-2) are integrated.

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