Bone cement delivery tube and pedicle screw installation kit

Abstract

The present invention provides a bone cement delivery tube, comprising: a tube body, the tube body being hollow and configured to deliver bone cement, the tube body having an inlet end disposed at one end and an outlet end disposed at the other end; a first breaking portion disposed within the tube body and proximate the outlet end, the first breaking portion comprising a plurality of first breaking plates radially extending inward from the inner wall of the tube body, the plurality of first breaking plates being arranged circumferentially, with adjacent first breaking plates spaced apart. The bone cement delivery tube and pedicle screw installation kit of the present invention, by providing the first breaking portion, ensure that the bone cement column breaks in a designated area, making it easier to break, thereby improving crushing and cutting efficiency, reducing debris generated during the breaking process, and lowering operational difficulty.

Description

Technical Field

[0001] The invention relates to an installation kit for a bone cement delivery tube and a pedicle screw. Background Art

[0002] Osteoporosis often causes serious complications, among which osteoporotic fractures are the most common, and the spine is one of the high-incidence sites.

[0003] Currently, vertebral augmentation is the most effective treatment for spinal fractures, represented by percutaneous vertebroplasty (PVP) and percutaneous kyphoplasty (PKP). The core operation of both procedures is to inject bone cement into the anterior column of the vertebra to enhance vertebral strength and relieve pain. However, these treatment options have exposed some problems that cannot be ignored in clinical application. On the one hand, the risk of bone cement leakage always exists; on the other hand, after bone cement injection, a harder reinforced area and a relatively weaker non-reinforced area are formed within the vertebral body. This structural difference leads to uneven stress distribution within the vertebral body, greatly increasing the probability of secondary middle column fractures.

[0004] To address this challenge, in 2019, Cianfoni et al. innovatively proposed a minimally invasive augmentation method called stent-screw-assisted internal fixation for the treatment of severe spinal osteoporotic fractures. The key to this technology is the use of a hollow pedicle screw device.

[0005] When injecting bone cement into a hollow pedicle screw using a traditional pedicle screw installation kit, there's a risk of cement leakage at the posterior margin of the vertebral body due to its fluidity. After injection, the cement solidifies into a cement rod within the channel. The rod needs to be broken, but the current method involves tapping the end of the pedicle screw with a specialized tool. This force is difficult to precisely control, and the injection process can create bubbles, which in turn can release air during solidification, leading to random fracture locations. Overall, the traditional fracture process for cement rods is difficult to predict. Furthermore, the fracture process produces debris, which, if it falls into the vertebral body, can directly compress peripheral nerves. If the debris leaks into the spinal canal and compresses the spinal cord or nerve roots, it can cause increased localized pain, numbness and tingling in the limbs, severely impair motor function, and even lead to lower limb paralysis. If the debris leaks into blood vessels, it can block them, leading to insufficient blood supply to local tissues, or damage the vessel walls, causing rupture and bleeding, forming a hematoma and further compressing surrounding tissues.

[0006] In view of this, it is necessary to improve the existing bone cement delivery tube to solve the above problems. Summary of the Invention

[0007] The object of the present invention is to provide a bone cement delivery tube to solve the problem that the bone cement column injected by the existing installation kit breaks off at random positions and easily generates debris.

[0008] To achieve the above object, the present invention provides a bone cement delivery tube, the bone cement delivery tube comprising:

[0009] A tube body, wherein the tube body is hollow and is used to convey bone cement, and the tube body has an inlet end provided at one end and an outlet end provided at the other end;

[0010] The first breaking portion is arranged in the tube body and close to the outlet end. The first breaking portion includes a plurality of first breaking plates protruding radially inward from the inner wall of the tube body. The plurality of first breaking plates are arranged along the circumferential direction, and two adjacent first breaking plates are spaced apart.

[0011] As a further improvement of the present invention, the first breaking plate extends obliquely toward the inlet end away from one end of the tube body.

[0012] As a further improvement of the present invention, the thickness of the first breaking plate gradually becomes thinner along the radial direction from the tube body.

[0013] As a further improvement of the present invention, the bone cement delivery tube also includes a second breaking portion, which is located on the side of the first breaking portion away from the outlet end. The second breaking portion includes a plurality of second breaking plates protruding radially inward from the inner wall of the tube body. The plurality of second breaking plates are arranged in a circumferential direction, and two adjacent second breaking plates are spaced apart.

[0014] As a further improvement of the present invention, the second breaking plate extends obliquely toward the inlet end away from one end of the tube body, and the inclination angle of the second breaking plate relative to the axis is greater than the inclination angle of the first breaking plate relative to the axis.

[0015] As a further improvement of the present invention, the number of the first breaking plates and the second breaking plates are the same, and both are arranged in an array along the circumferential direction.

[0016] As a further improvement of the present invention, when viewed along the axial direction, the first breaking plates and the second breaking plates are alternately arranged in the circumferential direction.

[0017] As a further improvement of the present invention, the radial length of the second breaking plate is smaller than the radial length of the first breaking plate.

[0018] As a further improvement of the present invention, the bone cement delivery tube also includes a check portion, which is located between the outlet end and the first broken portion. The check portion includes a plurality of check heads protruding radially inward from the inner wall of the tube body. The plurality of check heads are arranged in a circumferential direction, and two adjacent check heads are spaced apart. The check heads extend obliquely toward the outlet end away from one end of the tube body.

[0019] As a further improvement of the present invention, the radial length of the check head is equal to the radius of the tube body.

[0020] As a further improvement of the present invention, the number of the check heads is greater than the number of the first breaking plates, and the interval between two adjacent check heads is smaller than the distance between two adjacent first breaking plates.

[0021] As a further improvement of the present invention, the tube body includes a transfer tube and a breaking head arranged at one end of the transfer tube, the breaking head is located at the outlet end of the tube body, and the diameter of the breaking head is smaller than the diameter of the transfer tube.

[0022] As a further improvement of the present invention, the breaking head is divided into a rotating area and a fixed area that can be rotatably connected along the axial direction. The first breaking part and the second breaking part are arranged in the rotating area, and the non-return part is arranged in the fixed area. The rotating area and the fixed area can rotate relative to each other along the circumferential direction.

[0023] The present invention also provides a pedicle screw installation kit, which includes a handle outer sleeve, a handle inner sleeve inserted into the handle outer sleeve, and a bone cement delivery tube as described above, wherein the bone cement delivery tube is inserted into the handle inner sleeve.

[0024] The beneficial effects of the present invention are as follows: the bone cement delivery tube and pedicle screw installation kit of the present invention, by providing a first breaking portion, ensures that the bone cement column breaks in a designated area and breaks more easily, thereby improving the crushing and cutting efficiency, reducing the debris generated during the breaking process, and reducing the difficulty of operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The drawings described herein are used to provide a further understanding of the present application and constitute a part of the present application. The illustrative embodiments of the present application and their descriptions are used to explain the present application and do not constitute an improper limitation on the present application. In the drawings:

[0026] Figure 1 It is a schematic cross-sectional view of the pedicle screw installation kit of the present invention for installing the pedicle screw;

[0027] Figure 2 It is a side structural schematic diagram of the pedicle screw installation kit of the present invention;

[0028] Figure 3It is a structural schematic diagram of the outer sleeve of the handle of the pedicle screw installation kit of the present invention;

[0029] Figure 4 It is a schematic structural diagram of the inner sleeve of the handle of the pedicle screw installation kit of the present invention;

[0030] Figure 5 1 is a schematic cross-sectional view of the bone cement delivery tube of the present invention;

[0031] Figure 6 yes Figure 5 Schematic diagram of the structure of the middle area A;

[0032] Figure 7 It is a schematic top view of the structure of the broken end of the bone cement delivery tube of the present invention without a check valve;

[0033] Figure 8 The figure is a schematic top view of the structure of the broken head of the bone cement delivery tube provided with a check valve according to the present invention. DETAILED DESCRIPTION

[0034] The technical solution of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the embodiments described are only some embodiments of the present invention, not all embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention.

[0035] In the description of the present invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings and are intended solely to facilitate and simplify the description of the present invention. They are not intended to indicate or imply that the devices or components referred to must have, be constructed, or operate in a specific orientation, and therefore should not be construed as limitations on the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0036] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be internal communication between two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances. In addition, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0037] like Figures 1 to 8 As shown, the pedicle screw installation kit 100 of the present invention includes a handle outer sleeve 1 , a handle inner sleeve 2 inserted into the handle outer sleeve 1 , and a bone cement delivery tube 3 .

[0038] The handle outer sleeve 1 has a rotating handle 11 at one end away from the pedicle screw 200, and a fixing buckle 12 at the end closer to the pedicle screw 200. The rotating handle 11 is used to rotate the pedicle screw installation kit 100, and the fixing buckle 12 is circumferentially fixed to the pedicle screw 200 to prevent the pedicle screw 200 from rotating relative to the handle outer sleeve 1 during implantation.

[0039] The end of the handle inner sleeve 2 away from the pedicle screw 200 is provided with a rotating head 21, and the end close to the pedicle screw 200 is provided with a fixing thread 22. The pedicle screw 200 can be fixed by twisting the rotating head 21.

[0040] The bone cement delivery tube 3 is inserted into the inner sleeve 2 of the handle.

[0041] like Figures 6 to 8 As shown, the bone cement delivery tube 3 includes a tube body 31 , a first breaking portion 32 , a second breaking portion 33 and a non-return portion 34 .

[0042] The tube body 31 is hollow and is used to convey bone cement. The tube body 31 has an inlet end 314 at one end and an outlet end 315 at the other end.

[0043] The tube body 31 includes a transfer tube 311, a snap-off head 313 at one end of the transfer tube 311, and a Luer connector 312 at the other end of the transfer tube 311. The snap-off head 313 is located at the outlet end 315 of the tube body 31. The Luer connector 312 is located at the inlet end 314 and is used to connect to a bone cement syringe. The Luer connector 312 is a common connector in the medical field.

[0044] Bone cement enters the delivery tube 311 from the Luer connector 312 , then passes through the snap-off head 313 , and enters the pedicle screw 200 from the outlet end 315 .

[0045] In this embodiment, the first breaking portion 32, the second breaking portion 33, and the non-return portion 34 are all disposed within the breaking head 313. The diameter of the breaking head 313 is smaller than that of the transfer tube 311. The larger diameter of the transfer tube 311 improves the efficiency of bone cement delivery, while the smaller diameter of the breaking head 313 facilitates the breaking of bone cement.

[0046] The first breaking portion 32 is arranged in the tube body 31. Specifically, the first breaking portion 32 is located in the breaking head 313 and is arranged near the outlet end 315. The first breaking portion 32 includes a plurality of first breaking plates 321 protruding radially inward from the inner wall of the tube body 31. The plurality of first breaking plates 321 are arranged in a circumferential direction, and two adjacent first breaking plates 321 are spaced apart so that bone cement can pass through smoothly.

[0047] In this embodiment, since the first breaking portion 32 is provided, the first breaking portion 32 occupies a part of the volume in the breaking head 313, so that there is less bone cement there and it is easier to break, so less debris is generated during breaking.

[0048] The first break plate 321 extends obliquely from the end of the tube 31 toward the inlet end 314. This design increases the contact area with the bone cement and reduces the strength of the bone cement at the break. Furthermore, the oblique direction aligns with the direction of cement injection, enhancing the grip of the first break plate 321 on the bone cement. This arrangement makes it easier for the break to occur between the first break portion 32 and the outlet end 315.

[0049] The thickness of the first breaking plate 321 gradually decreases radially from the tube body 31. The end close to the tube body 31 is thicker to improve strength, and the end close to the middle is thinner to minimize the impact on flow velocity.

[0050] The bone cement delivery tube 3 also includes a second breaking portion 33, which is located on the side of the first breaking portion 32 away from the outlet end 315. The second breaking portion 33 includes a plurality of second breaking plates 331 protruding radially inward from the inner wall of the tube body 31. The plurality of second breaking plates 331 are arranged in a circumferential direction, and adjacent two second breaking plates 331 are spaced apart.

[0051] In this embodiment, the second breaking portion 33 is provided, and the multi-layer breaking heads 313 cooperate with each other to enhance the holding force between the breaking heads 313 and the bone cement rod, and can further reduce the strength of the bone cement column in the breaking heads 313 .

[0052] The second breaking plate 331 extends obliquely from the end of the tube 31 away from the inlet end 314, and the angle of inclination of the second breaking plate 331 relative to the axis is greater than the angle of inclination of the first breaking plate 321 relative to the axis. In other words, in this embodiment, the first breaking plate 321 is tilted more sharply, and the second breaking portion 33 is located closer to the inlet end 314, making it easier for bone cement to break between the first breaking portion 32 and the outlet end 315. The difference in inclination angle between the first breaking plate 321 and the second breaking plate 331 is between 40-50 degrees.

[0053] The first and second breaking plates 321 and 331 are arranged in an array along the circumference of the circumference. In this embodiment, there are six of each. Of course, in other embodiments, the number of the first and second breaking plates 321 and 331 may vary. The axial projections of the first and second breaking plates 321 and 331 are both smaller than the radius of the breaking head 313, leaving more space in the middle to ensure smooth flow of bone cement.

[0054] The radial length of the second breaking plate 331 is less than or equal to the radial length of the first breaking plate 321. This ensures that the average stress in the bone cement rod gradually increases as the second breaking plate 331 moves along the first breaking plate 321, with the maximum stress region occurring near the outlet of the first breaking plate 321. Because the contact area with the bone cement rod is smaller, the corresponding stress concentration area is also smaller, resulting in lower average stress. Therefore, the bone cement rod is less likely to break at the first and second breaking plates 321, 331, but is more likely to break at the outlet of the first breaking plate 321.

[0055] When viewed along the axial direction, the first breaking plates 321 and the second breaking plates 331 are alternately arranged in the circumferential direction, thereby increasing the contact area between the first breaking plates 321 and the second breaking plates 331 and the bone cement rod, thereby increasing the holding force. The alternating arrangement reduces stress concentration in the contact area, thereby preventing the cement rod from randomly breaking in the contact area and generating more debris.

[0056] In addition, the circumferential alternating arrangement also optimizes the flow path of bone cement, where the bone cement flows more evenly, avoiding the formation of cavities after solidification due to bubbles contained during flow, thereby ensuring that the fracture position is precisely controllable.

[0057] The check portion 34 is located between the outlet end 315 and the first break portion 32. The check portion 34 includes a plurality of check heads 341 that protrude radially inward from the inner wall of the tube body 31. The check heads 341 are arranged circumferentially, with adjacent check heads 341 spaced apart to leave gaps for bone cement to pass through. The radial length of the check heads 341 is equal to the radius of the tube body 31. The term "equal" is sufficient to achieve an equal effect, not an absolute value, to ensure that the check heads 341 converge in the middle.

[0058] In this embodiment, multiple check heads 341 converge in the middle, and the bone cement fracture is located between the check portion 34 and the first breaking portion 32. The check portion 34 can prevent cement debris from entering the human body, thereby improving the safety and reliability of the operation.

[0059] The check head 341 extends obliquely toward the outlet end 315 from one end of the tube body 31. The oblique direction of the check head 341 is consistent with the direction of bone cement injection, allowing bone cement to flow out of the check portion 34 in a laminar flow during injection. However, if the bone cement flows back, the angle of the check head 341 is opposite to the flow direction of the bone cement, and because of the gap before the check head 341 and the shape of the check portion 34, the bone cement flows back in a turbulent state. The bone cement will first contact the middle tip area of ​​the check portion 34 and flow to both sides, which will hinder other reverse-flowing bone cement, thereby preventing backflow. In this embodiment, the angle between the check head 341 and the axis is between 30 and 60 degrees.

[0060] In addition, in this embodiment, the anti-return head 341 also generates a holding force on the bone cement column, and the inclination direction is opposite to the inclination direction of the first breaking plate 321. The middle area of ​​the anti-return head 341 and the first breaking plate 321 forms a stress-weak area without holding force, and the breaking position is in this stress-weak area.

[0061] In a preferred embodiment, the breaking head 313 is divided into a rotating area 3131 and a fixed area 3132 that are rotatably connected along the axial direction, wherein the first breaking portion 32 and the second breaking portion 33 are arranged in the rotating area 3131, and the non-return portion 34 is arranged in the fixed area. The rotating area 3131 and the fixed area 3132 can rotate relative to each other in the circumferential direction but will not separate from each other, for example, the two are connected by a threaded connection. The tube body 31 is fixedly connected to the rotating area 3131 of the breaking head 313. When the tube body 31 rotates, it can drive the rotating area 3131 to rotate, while the fixed area 3132 remains stationary, thereby achieving the effect of breaking the bone cement.

[0062] After the bone cement solidifies, twisting the bone cement delivery tube 3 causes the first and second breaking plates 321 and 331 to rotate. Because the check portion 34 has rotational freedom, the check portion 34 is fixed after the bone cement solidifies, generating a holding force opposite to that of the first and second breaking plates 321 and 331. The two work together to ensure that the breaking area is between the check portion 34 and the first breaking portion 32. The cement rod in the unchecked area breaks naturally, generating larger debris, which is blocked by the check portion 34 to prevent it from falling into the body.

[0063] The number of the check heads 341 is greater than the number of the first breaking plates 321, and the distance between two adjacent check heads 341 is less than the distance between two adjacent first breaking plates 321. In this embodiment, the number of check heads 341 is 8 to 10, and each check head 341 has an inclination angle of 45° at the axial position. A larger number of check heads 341 can provide a better filtering effect, and the bone cement column closer to the check heads 341 is weaker and more likely to break.

[0064] When the bone cement column is broken, the pedicle screw installation kit 100 is lifted upwards, and the non-return portion 34 can be separated from the bone cement column, while taking out the debris at the broken part.

[0065] The bone cement delivery tube 3 and the pedicle screw installation kit 100 of the present invention, by providing a first breaking portion 32, ensure that the bone cement column breaks in a designated area and breaks more easily, thereby improving the crushing and cutting efficiency, reducing the debris generated during the breaking process, and reducing the difficulty of operation; by providing a check portion 34, on the one hand, the breaking effect can be improved, and on the other hand, the risk of debris scattering can be reduced, and the backflow of bone cement can be avoided.

[0066] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0067] The above-described embodiments merely illustrate several implementations of the present invention, and while their descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the patent for this invention shall be determined by the appended claims.

Claims

1. A bone cement delivery tube, characterized in that: The bone cement delivery tube comprises: A tube body, wherein the tube body is hollow and is used to convey bone cement, and the tube body has an inlet end provided at one end and an outlet end provided at the other end; a first breaking portion, the first breaking portion being disposed in the tube body and near the outlet end, the first breaking portion comprising a plurality of first breaking plates radially protruding inwardly from the inner wall of the tube body, the plurality of first breaking plates being arranged in a circumferential direction, with adjacent two first breaking plates being spaced apart; a second breaking portion, the second breaking portion being located on a side of the first breaking portion away from the outlet end, the second breaking portion comprising a plurality of second breaking plates radially protruding inwardly from the inner wall of the tube body, the plurality of second breaking plates being arranged in a circumferential direction, with adjacent second breaking plates spaced apart; a check portion, the check portion being located between the outlet end and the first breaking portion, the check portion comprising a plurality of check heads protruding radially inward from the inner wall of the tube body, the plurality of check heads being arranged in a circumferential direction, with adjacent two check heads spaced apart, and the check heads extending obliquely toward the outlet end away from one end of the tube body; A transfer tube and a breaking head arranged at one end of the transfer tube, the breaking head is located at the outlet end of the tube body, the diameter of the breaking head is smaller than the diameter of the transfer tube, the breaking head is divided into a rotating area and a fixed area that are rotatably connected along the axial direction, the first breaking portion and the second breaking portion are arranged in the rotating area, and the non-return portion is arranged in the fixed area, and the rotating area and the fixed area can rotate relative to each other along the circumferential direction.

2. The bone cement delivery tube according to claim 1, characterized in that: The first breaking plate extends obliquely toward the inlet end from one end of the tube body.

3. The bone cement delivery tube according to claim 2, characterized in that: The thickness of the first breaking plate gradually becomes thinner along the radial direction from the tube body.

4. The bone cement delivery tube according to claim 1, characterized in that: The second breaking plate extends obliquely toward the inlet end away from one end of the tube body, and an inclination angle of the second breaking plate relative to the axis is greater than an inclination angle of the first breaking plate relative to the axis.

5. The bone cement delivery tube according to claim 4, characterized in that: The number of the first breaking plates and the second breaking plates is the same, and both are arranged in an array along the circumferential direction.

6. The bone cement delivery tube according to claim 5, characterized in that: When viewed in the axial direction, the first breaking plates and the second breaking plates are alternately arranged in the circumferential direction.

7. The bone cement delivery tube according to claim 4, characterized in that: The length of the second breaking plate in the radial direction is smaller than the length of the first breaking plate in the radial direction.

8. The bone cement delivery tube according to claim 1, characterized in that: The length of the check head in the radial direction is equal to the radius of the tube body.

9. The bone cement delivery tube according to claim 1, characterized in that: The number of the check heads is greater than the number of the first breaking plates, and the interval between two adjacent check heads is smaller than the distance between two adjacent first breaking plates.

10. A pedicle screw installation kit, characterized by: The pedicle screw installation kit includes a handle outer sleeve, a handle inner sleeve inserted into the handle outer sleeve, and a bone cement delivery tube according to any one of claims 1 to 9, wherein the bone cement delivery tube is inserted into the handle inner sleeve.

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