Bone cement targeted plugging secondary injection method for vertebral body edge rupture
A targeted filling and dual-injection technique for bone cement in vertebral augmentation procedures addresses the challenge of leakage by sealing fractures with initial plastic-phase cement and subsequent uniform distribution, improving surgical efficacy and reducing complications.
Patent Information
- Application Number
- CN202410649160.2
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-05-24
- Publication Date
- 2025-07-15
AI Technical Summary
In vertebroplasty, the problem of bone cement leakage, especially in patients whose fracture lines involve the edge of the vertebral body, is difficult for the prior art to reduce the occurrence of leakage while ensuring that the bone cement is fully diffused.
The bone cement targeted sealing and filling secondary bolus injection technology is adopted, including preoperative evaluation and path planning. The characteristics of bone cement at different solidification periods are used to perform bone cement bolus injection in batches. The fracture cracks are blocked for the first time during the dough period, and the bone cement diffusion is completed in the second time during the drawing period. The second bolus injection is performed by adjusting the position of the working casing.
It effectively reduces bone cement leakage, ensures uniform strengthening of the vertebrae, reduces surgical risks, and improves surgical results and patient rehabilitation quality.
Smart Images
Figure CN120304937A_ABST
Abstract
Description
Technical Field
[0001] The invention relates to the field of medical technology, and in particular to a bone cement targeted blocking and secondary push injection method for fractured vertebral edge rupture during vertebroplasty. Background Art
[0002] Vertebroplasty is a commonly used minimally invasive surgical method for osteoporotic vertebral compression fractures in the elderly. It is widely used in spinal surgery and has become the preferred method for treating such fractures. However, during the operation, there are risks such as bone cement leakage, which seriously affects the safety of patients. Bone cement leakage occurs mostly because the fracture line involves the edge of the vertebral body, and the bone cement flows out along the cracks at the edge of the vertebral body.
[0003] During the preparation process, bone cement gradually transitions from a thin paste to a hardened state. Early push injections can fully disperse the bone cement, but bone cement leakage is also likely to occur, especially for patients with fractures involving the vertebral margins. Push injections in the late stage of bone cement solidification can reduce the risk of bone cement leakage, but since bone cement hardens quickly during this period, the push injection time window is short and the amount of bone cement that can be injected is limited. At present, the push injection of bone cement at home and abroad is basically completed by a one-time push injection. This method inevitably has the contradiction between bone cement dispersion and leakage.
[0004] How to reduce the occurrence of bone cement leakage as much as possible while ensuring sufficient diffusion of bone cement is an urgent problem to be solved. Summary of the invention
[0005] 1. Technical issues to be resolved The purpose of the present invention is to provide a bone cement targeted filling secondary push injection technology for patients whose fracture lines involve the vertebral edge to solve the above problems. Through technical breakthroughs, the present invention has completed the technical details of ① preoperative evaluation and path planning ② bone cement targeted filling of vertebral edge cracks ③ secondary adjustment and push injection of bone cement push rod, improved the push injection method of bone cement, reduced the risk of bone cement leakage, and improved the surgical effect and the patient's rehabilitation quality.
[0006] (II) Technical solution To achieve the above object, the present invention adopts the following technical scheme: a bone cement targeted filling and secondary push injection technology, comprising the following steps: Indication selection The patients selected for this technical invention scheme are patients with vertebral edge rupture based on preoperative CT and other imaging assessments, including patients with fracture lines involving the anterior wall of the vertebral body, fracture lines involving the upper endplate or lower endplate.
[0007] Preoperative assessment and path planning Before vertebroplasty, the specific location of the vertebral fracture rupture is determined based on preoperative imaging examinations such as CT, and the direction of the bone cement pusher during the first injection is planned so that the end of the bone cement pusher is near the fracture rupture during the operation.
[0008] Coagulation process of bone cement During the preparation process, bone cement gradually transitions from a thin paste state to a hardened state. This process can be artificially divided into 4 periods: wet sand period (thin paste state), wire-drawing period (toothpaste state), dough period (dough state), and hardening period. The wet sand period is about 5 minutes, and the bone cement is in a thin paste state. It is very easy for bone cement leakage to occur during injection in this period. It enters the wire-drawing period at 6 - 9 minutes, and at this time the bone cement is in a toothpaste state. Currently, most domestic and foreign scholars recommend injecting bone cement in this period to make the bone cement fully disperse. At 10 - 12 minutes, the bone cement is in a dough state, starts to heat up, and hardens into the hardening period in a short time. In the hardening period, the bone cement further heats up and hardens, and at this time injection is no longer possible.
[0009] Targeted filling of bone cement at the edge fissure of the vertebra The patient lies prone on the operating table, adjusts the position of the operating table or the C-arm X-ray machine to obtain the standard anteroposterior and lateral images of the injured vertebra, marks the projection of the surgical vertebra and the pedicle, marks the puncture point position according to the pre-planned targeted puncture route, performs routine disinfection and draping, and infiltrates the skin and subcutaneous tissue with 2% lidocaine for local anesthesia. Puncture the puncture needle at the marked point to the bone surface. The anteroposterior fluoroscopy shows that it is located at the outer edge of the pedicle projection. Then, according to the position of the rupture and the planned route, adjust the needle insertion direction on the lateral image. When reaching the target position at the anterior edge of the vertebra or the upper and lower vertebral laminae, replace the working cannula and establish a working channel. Divide the bone cement into three equal parts. First, take 1 / 3 of the bone cement for preparation. After the bone cement passes through the low-viscosity "wire-drawing period" and enters the high-viscosity "dough period", inject the bone cement near the edge of the vertebra where the fracture line involves, and "targetedly" block the fracture crack. The injection volume is about 0.5 - 1.5 ml.
[0010] Secondary adjustment and injection of the bone cement pusher After the targeted filling injection is completed, withdraw the working cannula to the pedicle position, adjust the cannula position and then perform secondary injection. During the secondary injection, prepare the remaining 2 / 3 of the bone cement and inject it during the low-viscosity "wire-drawing period". The injection volume is about 2.5 ml - 3.5 ml, with the standard that the bone cement covers the fracture area or reaches the upper and lower endplates.
[0011] Treatment after completion of injection After the injection is completed, end the operation and cover it with a sterile dressing. Get out of bed and move around wearing a waist circumference the next day after the operation.
[0012] (III) Invention effects By implementing the above technical solutions, the present invention has the following advantages: (1) Through the targeted filling technology, the occurrence of bone cement leakage is reduced. Since the bone cement used in the targeted filling stage is in the doughy stage, the viscosity of the bone cement at this stage is high, and it is not easy to disperse and leak. Although the injection time window is very narrow, because we only target the rupture for plugging, the amount of bone cement required is very small, only 0.5 - 1.5 ml is enough. Therefore, there is sufficient injection time. After the rupture is plugged, during the secondary preparation of the bone cement, the bone cement at the plugging port has hardened, making the vertebral body into a closed cavity, providing a good space for the secondary injection. (2) The secondary injection technology enables the bone cement to be fully dispersed and the vertebral body to be uniformly strengthened, reducing the surgical risks such as uneven distribution of bone cement and excessive injection pressure. (3) In terms of long-term effects, due to the reduction of vertebral bone cement leakage and good dispersion of the vertebral body, the risk of adjacent vertebral body degeneration and fracture is reduced. (4) Although this technology has been tentatively tried in some domestic and foreign hospitals, it is not standardized. Our team has conducted systematic research and solved key technologies such as the determination of the targeted site, the timing of bone cement injection, the amount of bone cement injection, and the method of secondary adjustment of the push rod. This makes the technology innovative, standardized, and feasible. The advantages of this technology are obvious and it has strong replicability. Our team has taken the lead in publishing relevant academic reports and applying for relevant patents to provide a basis for the next step of technology promotion. BRIEF DESCRIPTION OF THE DRAWINGS
[0013] Figure 1 is a schematic flow chart of the secondary injection of bone cement targeted filling of the present invention Figure 2 is a schematic diagram of pre-operative evaluation of the location of vertebral body rupture of the present invention Figure 3 is a schematic diagram of bone cement targeted filling of the rupture of the present invention Figure 4 is a schematic diagram of the secondary injection of bone cement of the present invention In the figure: 10. Pre-operative evaluation link; 11. Imaging data; 12. Those with vertebral edge rupture; 13. Determine the targeted plugging site; 14. Determine the injection direction of the push rod; 20. First injection flow chart; 21. Establish the working channel; 22. Bone cement targeted filling; 23. Closure of vertebral body rupture; 30. Secondary injection flow chart; 31. Adjust the working channel; 32. Secondary injection of bone cement; 33. Bone cement fills the vertebral body; 40. Rupture of the anterior upper wall of the vertebral body; 50. Bone cement targeted plugging of the rupture; 60. The bone cement push rod points to and the end is near the target position; 70. Secondary adjustment of the working channel; 80. Bone cement covers the fracture area. DETAILED DESCRIPTION OF THE EMBODIMENTS
[0014] The present invention will be described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be understood that the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. The specific embodiments described herein are only used to explain the present application and are not used to limit the present application. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts belong to the scope of protection of the present invention.
[0015] Please refer to Figure 1 , the present invention provides a surgical method for the secondary injection of bone cement for targeted filling, and the process includes: a preoperative evaluation link 10; a first injection process 20; a secondary injection process 30.
[0016] The preoperative evaluation link includes: imaging data 11; those with vertebral body edge rupture 12; determining the targeted occlusion site 13; determining the injection direction of the push rod 14. Specifically: Before the operation, relevant examinations of imaging data 11 such as CT and X-ray need to be completed. According to the sagittal CT images, the integrity of the anterior wall and the upper and lower end plates of the vertebral body is evaluated. For those with rupture of the anterior wall and / or vertebral end plates 11, during the injection of bone cement, bone cement leakage is very likely to occur. Therefore, this part of patients is suitable for the method of the present invention.
[0017] Figure 2 This is a schematic diagram of the position of the vertebral body rupture opening evaluated before the operation of the present invention. 40. Rupture of the anterior upper wall of the vertebral body. According to the sagittal CT images, the targeted occlusion site 13 is determined. The position of the puncture point and the direction of the puncture needle need to be planned before the operation so that the injection direction of the push rod 14 points to the target, and the end of the bone cement push rod is just near the vertebral body rupture opening.
[0018] The first injection process 20 of bone cement includes: establishing a working channel 21; targeted occlusion of bone cement 22; closing the vertebral body rupture opening 23. At the same time, in combination with Figure 3 , during the operation, the patient is in the prone position, routinely disinfected and draped, and local infiltration anesthesia of the skin and subcutaneous tissue is performed with 2% lidocaine. The puncture needle is punctured at the marked point to the bone surface. The anteroposterior fluoroscopy shows that it is located at the outer edge of the pedicle projection, and then the injection direction is adjusted according to the position of the rupture opening and the planned line on the lateral image. When reaching the target position of the anterior edge of the vertebral body or the upper and lower vertebral laminae, the working cannula is replaced to establish a working channel 21. The bone cement is divided into three equal parts. First, 1 / 3 of the bone cement is taken for preparation. After the bone cement passes through the low-viscosity "wire-drawing period" and enters the high-viscosity "dough period", the bone cement is injected near the edge of the vertebral body affected by the fracture line to target the occlusion 22 of the fracture crack, and the injection volume is about 0.5 - 1.5 ml. In this embodiment, when the puncture needle reaches the target position of the anterior upper edge of the vertebral body, the working cannula is replaced to establish a working channel 21. 1 / 3 of the bone cement is taken for preparation. After the bone cement enters the high-viscosity "dough period", the bone cement is injected to target the occlusion 22 of the fracture crack, so that the vertebral body rupture opening is closed 23.
[0019] Combined with Figure 4 and Figure 1 With the secondary injection process 30, we retract the puncture needle to the pedicle level, then adjust the working channel 31, and make a secondary adjustment through the working channel 70 for the secondary injection of bone cement. During the secondary injection, the remaining 2 / 3 of the bone cement is prepared and injected during the low-viscosity "stringy stage", with an injection volume of approximately 2.5 ml to 3.5 ml, so that the bone cement covers the entire fracture area 80.
[0020] In the embodiment of the present application, the vertebral body rupture opening is located in the anterior upper wall. In addition, the fracture rupture opening may also be located in the upper end plate, lower end plate, anterior lower wall, anterior wall, and may involve the upper and lower end plates simultaneously, etc. It can be understood that in addition to applying this technique to the anterior upper wall, this technique can also be applied to the fracture rupture openings in other areas except the posterior wall of the vertebral body.
[0021] The above has introduced in detail the method for secondary injection of targeted bone cement filling in the embodiments of the present application. Specific examples are used herein to elaborate on the principle and implementation manner of the present application. The description of the above embodiments is only used to help understand the technical solution and its core idea of the present application; those of ordinary skill in the art should understand that they can still modify the technical solutions recorded in the foregoing embodiments, or perform equivalent replacements on some of the technical features; and these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present application.
Claims
1. A method for secondary injection of targeted bone cement plugging for vertebral edge rupture, characterized in that It includes the following steps: Preoperative assessment and path planning: Before vertebroplasty, determine the specific location of the vertebral fracture rupture opening based on preoperative imaging examinations such as CT, and plan the direction of the bone cement pusher during the first injection so that the end of the bone cement pusher is near the fracture rupture opening during the operation. Targeted filling of the vertebral edge fissure with bone cement: The patient lies prone on the operating table, adjust the position of the operating table or the C-arm X-ray machine to obtain standard anteroposterior and lateral images of the injured vertebra, mark the projection of the surgical vertebra and the pedicle, mark the puncture point position according to the pre-planned targeted puncture route, disinfect and drape routinely, and perform local infiltration anesthesia of the skin and subcutaneous tissue with 2% lidocaine. Puncture the puncture needle at the marked point to the bone surface. In the anteroposterior view, it is located at the outer edge of the pedicle projection, and then adjust the needle insertion direction according to the rupture opening position and the planned route in the lateral view. When reaching the anterior edge of the vertebra or the target position of the upper and lower vertebral laminae, replace the working cannula and establish a working channel. Divide the bone cement into three equal parts, first take 1 / 3 of the bone cement for preparation. After the bone cement passes through the low-viscosity "wire-drawing stage" and enters the high-viscosity "dough stage", inject the bone cement near the edge of the vertebral body affected by the fracture line to "targetedly" block the fracture crack, and the injection volume is about 0.5 - 1.5 ml. Secondary adjustment and injection of the bone cement pusher: After the targeted filling injection is completed, withdraw the working cannula to the pedicle position, adjust the cannula position and then perform secondary injection. During the secondary injection, prepare the remaining 2 / 3 of the bone cement and inject it during the low-viscosity "wire-drawing stage", and the injection volume is about 2.5 ml - 3.5 ml, with the standard of covering the fracture area with bone cement or reaching the upper and lower endplates. Post-injection treatment: After the injection is completed, end the operation and cover it with a sterile dressing. Get out of bed and move around wearing a waist belt the next day after the operation.
2. According to the bone cement targeted plugging and secondary injection technique described in claim 1, in the selection of indications, the patients selected in this technical solution are those with vertebral edge ruptures evaluated by preoperative imaging such as CT, including patients with fracture lines involving the anterior wall of the vertebra, fracture lines involving the upper endplate or the lower endplate.
3. According to the bone cement targeted plugging and secondary injection technique described in claim 1, during the preparation process of the bone cement, it gradually transitions from a thin paste state to a hardened state, and this process can be artificially divided into 4 periods: wet sand period (thin paste state), wire-drawing period (toothpaste state), dough period (dough state), and hardening period. The wet sand period is about 5 minutes, and the bone cement is in a thin paste state. It enters the wire-drawing period at 6 - 9 minutes, at this time the bone cement is in a toothpaste state, at 10 - 12 minutes the bone cement is in a dough state, starts to heat up and hardens into the hardening period in a short time. During the hardening period, the bone cement further heats up and hardens, and at this time it is no longer possible to perform injection.
4. The bone cement targeted plugging secondary injection technique according to claim 1, characterized in that, Through the targeted plugging of bone cement, the occurrence of bone cement leakage is reduced. Through secondary injection, it can ensure the uniform distribution of bone cement and prevent the occurrence of insufficient injection.
5. The bone cement targeted plugging secondary injection technique according to claims 1 to 3, characterized in that The surgical complications are reduced and the surgical effect is improved.