Pressure-guided bone cement injection device and method of operation

Abstract

To provide a safe and effective method for injecting bone cement, which can overcome the potential occurrence of overflow during the injection process. [Solution] The present invention provides a method and device for pressure-guided bone cement injection, which includes an algorithm capable of sensing at least one environmental parameter. The pressure-guided bone cement injection method includes the following steps: (a) setting an initial pressure output value; (b) receiving at least one environmental parameter sensed by a sensing unit; (c) acquiring data through a calculation process based on the at least one environmental parameter; (d) continuing or stopping the injection of bone cement according to data comparison and adjusting the pressure output value of the pressure unit; and (e) adjusting the pressure output value to occupy the entire internal volume of the vertebral body with bone cement, so as to reduce the risk of bone cement leakage.

Description

[Technical Field]

[0001] The present invention injects bone cement into the vertebral body. Device , in particular, utilizes an algorithm that controls the pressure output value for guiding the injection of bone cement. Pressure-guided bone cement injection device and method of operation to provide. [Background technology]

[0002] Since the late 20th century, the use of bone cement in the treatment of patients with spinal vascular malformations has increased significantly, highlighting the growing importance of bone fillers in orthopedic treatment. Of particular note is the application of bone fillers in vertebral support and shaping to prevent spinal nerve compression, providing an alternative to traditional nerve decompression surgery or a combination of traditional spinal fusion procedures to address nerve compression. Minimally invasive vertebral shaping procedures are performed percutaneously within the vertebrae, involving the placement of synthetic bone cement (polymethyl methacrylate, PMMA) or other bone filler materials into the damaged vertebrae. This enhances vertebral strength and stability and relieves chronic pain caused by vertebral injury. To facilitate smooth insertion of bone filler into the damaged vertebrae, implantation instruments for bone fillers are important. The stability of injection rate, applied force, convenience, and compatibility with other instruments are all intricately related to ease of operation and affect surgical outcomes.

[0003] Most existing devices for bone cement injection utilize a syringe or specially designed injector to deliver bone cement into the fractured vertebral body. However, factors such as osteoporosis, fracture, or excessive injection pressure applied by the operator can create situations where the bone cement leaks outside the vertebral body, potentially leading to safety concerns. Summary of the Invention [Problem to be solved by the invention]

[0004] The main challenge faced during bone cement injection is the occurrence of overflow throughout the injection process. "Decompressive Percutaneous Vertebroplasty: A Fixed Bone Cement Delivery Procedure for Vertebral Augmentation in Osteoporotic Compression Fractures" (JINJ-5173; page 6) discloses a bone cement injection method that applies constant, continuous suction pressure to the opposite side of the vertebral body during cement injection to reduce the possibility of leakage during the bone cement injection process. This can be considered a safer and more effective option for bone cement injection. However, this injection method relies on the physician's experience to control the injection conditions and can only deal with blockage or overflow situations that may occur during the bone cement injection process. For example, as the bone cement gradually fills the inside of the vertebral body, continuous injection of the bone cement may pose a risk of leakage into the surrounding cavities or veins, leading to leakage during the bone cement injection process and potentially causing complications such as nerve compression or pulmonary embolism in patients.

[0005] Therefore, providing a safe and effective bone cement injection method that can overcome the potential occurrence of overflow during the injection process has become an important issue that related industries need to urgently address.

[0010] In one aspect The present invention , Shii Algorithm-controlled bone cement injection reduces overflow during surgery Pressure-guided bone cement injection device to provide. [Means for solving the problem]

[0012] The present invention teeth, A pressure-guided bone cement injection device is provided, the pressure-guided bone cement injection device including: A pressure unit that introduces pressure. A propulsion unit that propels the injection of bone cement into the vertebral body. At least one environmental parameter is detected and monitor the monitored pressure value from the pressure unit. At least one sensing unit. a control unit connecting the pressure unit, the propulsion unit and the sensing unit and comprising an algorithm module; The algorithm module includes the following steps (a) to (e). (a) Setting the initial pressure output value. (b) at least one environmental parameter sensed by the sensing unit; and monitored pressure values receiving the signal. (c) at least one environmental parameter and monitored pressure values and obtaining data through a calculation process based on the (d) Data comparison process By 、 Continue or stop the injection of bone cement, And if bone cement injection is continued Modifying the pressure output value of the pressure unit 。 The calculation process is Includes: Calculating the saturation level of the injected bone cement by dividing the monitored pressure value by the pressure output value. Multiplying the pressure output by the manual setting parameter and subtracting the pressure output from the result to determine the saturation range of the bone cement; and Calculating the rate of change of pressure using differential or derivative methods. The data comparison process includes: Comparing the rate of change of pressure to a default pressure change threshold, and commanding the pressure unit to increase the pressure output value if the rate of change of pressure is less than the default pressure change threshold. comparing the monitored pressure value with a saturation range, and if the monitored pressure value is less than the saturation range, instructing the sensing unit to re-monitor the pressure value and repeating steps (a) through (d) until the pressure output value reaches a maximum pressure output value; and If the pressure value monitored during step (d) exceeds a saturation range, commanding the propulsion unit to stop injecting the bone cement.

[0013] The present invention also provides a method of operating a pressure-guided bone cement injection device, the method comprising the steps of: (a) providing a pressure-guided bone cement injection device to a patient; (a) Setting the initial pressure output value. (b) receiving at least one environmental parameter sensed by the sensing unit and a monitored pressure value; (c) obtaining data through a calculation process based on at least one environmental parameter and the monitored pressure value; (d) continuing or stopping the injection of bone cement through the data comparison process and modifying the pressure output value of the pressure unit if the injection of bone cement is to continue. The calculation process includes: Calculating the saturation level of the injected bone cement by dividing the monitored pressure value by the pressure output value. Multiplying the pressure output by the manual setting parameter and subtracting the pressure output from the result to determine the saturation range of the bone cement; and Calculating the rate of change of pressure using differential or derivative methods. The data comparison process includes: Comparing the rate of change of pressure to a default pressure change threshold, and commanding the pressure unit to increase the pressure output value if the rate of change of pressure is less than the default pressure change threshold. comparing the monitored pressure value with a saturation range, and if the monitored pressure value is less than the saturation range, instructing the sensing unit to re-monitor the pressure value and repeating steps (a) through (d) until the pressure output value reaches a maximum pressure output value; and If the pressure value monitored during step (d) exceeds a saturation range, commanding the propulsion unit to stop injecting the bone cement.

[0014] In order to provide examiners with a more detailed understanding and appreciation of the features and effects achieved by the present invention, a detailed description accompanied by preferred embodiments is provided herein. In the present invention, a novel algorithm for controlling pressure-guided bone cement injection is proposed, addressing the limitations of existing bone cement injection devices in responding to unknown filling conditions of bone cement within a vertebral body, which can result in bone cement leakage and affect patient safety. This method enables real-time calculation of the bone cement injection condition within a patient's vertebral body and provides a feedback signal to a control unit, thereby achieving the purpose of real-time feedback control.

[0015] The algorithm-controlled pressure-guided bone cement injection method provided by the present invention can fill the entire affected area uniformly during the bone cement injection process through pressure guidance, thereby reducing the risk of bone cement leakage.

[0016] Therefore, the present invention provides a novel algorithmically controlled pressure-guided bone cement injection method, which includes sensing at least one environmental parameter and transmitting the at least one environmental parameter to a control unit, which, in turn, further controls the injection of bone cement into a vertebral body through algorithmic calculation.

[0017] In accordance with the above principles, the components, characteristics, combinations thereof, and their interaction relationships included in the algorithm-controlled, pressure-guided bone cement injection method and apparatus provided by the present invention will be further described below. Referring to FIG. 1 , a system block diagram for an algorithm-controlled, pressure-guided bone cement injection apparatus provided by the present invention according to a preferred embodiment is shown. As shown, the algorithm-controlled, pressure-guided bone cement injection apparatus 10 provided by the present invention includes a pressure unit 11, a propulsion unit 12, a control unit 13, and at least one sensing unit 14. The control unit 13 includes an algorithm module 131 and is connected to the pressure unit 11 and the propulsion unit 12. After the control unit 13 obtains at least one sensing parameter from the at least one sensing unit 14, the algorithm module 131 of the control unit 13 calculates a required pressure output value and controls the bone cement injection conditions by the pressure unit 11.

[0018] The present invention provides an algorithm-controlled pressure-guided bone cement injection method. When at least one sensing unit 14 located at any position on the pressure unit 11 detects at least one environmental parameter, it transmits the at least one environmental parameter to the control unit 13. The algorithm module 131 of the control unit 13 then processes the content of the at least one environmental parameter, compares it with a preset ideal value, and uses the resulting difference value as a reference for controlling the pressure output value provided by the pressure unit 11. This establishes a self-feedback system mechanism. Through this self-feedback system mechanism, the algorithm-controlled pressure-guided bone cement injection device 10 provided by the present invention provides a convenient operating mode. Compared with the current situation in which operators rely solely on tactile sensation to determine and control the pressure output value, this system provides higher operational stability and more accurate and consistent operational response.

[0019] Based on the above-described embodiment, the present invention provides an algorithmically controlled pressure-guided bone cement injection device 10. From the observations of at least one sensing unit 14, a user or control unit 13 can more accurately understand the operating conditions, environmental conditions, and real-time changes in the pressure output value of the pressure unit 11. Furthermore, by indirectly obtaining this information, the state of bone cement delivery by the propulsion unit 12 can be inferred and corresponding adjustments can be made to the pressure output value. Compared to other types of bone cement injectors in the prior art, including bone cement injection systems that have pressure guidance but lack a sensing device, the pressure-guided bone cement injection method provided by the present invention allows for more precise control during the injection process. This allows for adjustments based on the effect of the pressure provided to the injection target area, making the injection process smoother and avoiding the high risk of leakage due to improper pressure application. Furthermore, sensing and adjusting the pressure intensity indirectly affects the bone cement injection parameters, allowing for relatively fine adjustments even if there are significant changes. On the other hand, when the sensing location is far from the actual injection end of the bone cement, changes in environmental parameters are relatively simple, and the obtained measurements are more accurate. Therefore, a more accurate feedback value can be obtained for adjusting the pressure output value, and the convenience of operating the injection system is improved.

[0020] Specifically, the bone cement injection method provided by the present invention is designed to address challenges associated with the gradual solidification of bone cement material during the injection process. As a result, placing a pressure sensor inside the bone cement injector is not feasible. In a preferred embodiment of the present invention, the sensing unit 14 is located between the propulsion unit 12 and the bone cement injection device 10. In this configuration, as the pressure inside the bone cement injection device 10 increases, resistance increases and the force applied by the propulsion unit rises. This results in an increase in pressure sensed by the pressure sensor, providing an estimate of the bone cement injection pressure. The method includes monitoring initial, intermediate, and maximum pressure values. Through the calculation and feedback control mechanism of the algorithm module, the method accurately assesses the rate and saturation level of pressure increase in the injection target area during the iterative process of continuous bone cement injection and solidification. This enables effective evaluation and feedback regarding the amount of bone cement injected into the target area and when to stop injection. The described approach effectively avoids the high risk of leakage due to inappropriate pressure application. Furthermore, since bone cement may solidify within the vertebral body or between pipelines during the suction process, it is important to know the pressure difference applied to the ends of the vertebral body. The sensing unit 14 disposed on the pressure unit 11 provides clear sensing data and offers higher detection accuracy compared to the prior art. Based on the aforementioned information, at least one sensing unit 14 in the present invention senses at least one environmental parameter, including the pressure within the target site.

[0021] See Figure 2 in the drawings associated with the present invention, which shows another preferred embodiment of an algorithm-controlled, pressure-guided bone cement injection method. When a clinician begins treatment, they can preset a variable initial pressure output value in the control unit 13. The sensing unit 14 then monitors the pressure value of the pressure unit 11. As the propulsion unit 12 begins to inject bone cement, the algorithm module 131 calculates the pressure change rate. After a period of measurement and evaluation, the algorithm commands the pressure unit 11 to increase the pressure output value until the intermediate pressure output value reaches a maximum output value, at which point the device stops injecting bone cement. Taking Figure 2 as an example, the initial pressure output value may be set to 400 mmHg. If the pressure is measured at 400 mmHg and the bone cement cannot move, the algorithm increases the intermediate pressure output value to 500 mmHg. The pressure output value is then increased to 500 mmHg, and so on, until the maximum output value is reached. In this example, the maximum output value is 680 mmHg. The algorithm determines that the injection of bone cement should be stopped at this point.

[0022] FIG. 3 shows a detailed example of the control algorithm S101, where the algorithm module 131 includes an exemplary pressure control algorithm S101. As described, the pressure control algorithm S101 includes monitoring certain parameters (such as the rate of pressure change and the saturation level of bone cement within the vertebral body). These parameters may be monitored continuously or periodically. The pressure control algorithm S101 checks the monitored parameters against a predetermined parameter profile to determine whether the individual or combined parameters fall within the specified range of the predetermined parameter profile. If the monitored parameters are within the specified range of the predetermined parameter profile, a command to output pressure can continue the injection of bone cement. If the monitored parameters are outside the specified range of the predetermined parameter profile, the algorithm 131 adjusts the command for pressure output accordingly or terminates the pressure output. The following is a non-exhaustive list of circumstances in which the algorithm 131 may adjust, terminate, or interrupt the command for pressure output: (1) The measured pressure change rate exceeds the default pressure change threshold. (2) The output pressure value exceeds the maximum pressure output value. (3) The pressure change rate is less than the default pressure change threshold. (4) The bone cement within the vertebral body approaches saturation.

[0023] In the algorithm flowchart, the processing blocks are as follows: S102: Set a variable initial pressure output value in the control unit 13. The initial pressure value can be manually set to, for example, 400 mmHg. S104: Calculate the saturation range of bone cement in the vertebral body, and subtract the pressure output value from the value obtained by multiplying the pressure output value by a parameter, where the parameter can be set manually. S106: Monitor or read the pressure value of the pressure unit 11 via the sensing unit 14. S108: The propulsion unit 12 is used to start injecting bone cement into the vertebral body. S110: Calculate the pressure change rate using the differential or derivative method. S112: Compare the pressure change rate with the pressure change threshold and calculate the saturation level of the bone cement, and use the monitored pressure value divided by the pressure output value to calculate the saturation level. If the pressure change rate is less than the pressure change threshold, proceed to S114. S114: Command the control system 13 to increase the pressure output value. In this example, the initial pressure value is increased from 400 mmHg to an intermediate pressure value of 500 mmHg. S116: Compare the pressure value with the saturation range of the bone cement. If the pressure value is less than the saturation range of the bone cement, return to S106 and re-monitor the pressure value. Then repeat the process from S102 to S116 until the pressure value reaches the maximum output value, in this example 680 mmHg. During S116, if the pressure value is greater than the saturation range of the bone cement, proceed to S118. S118: Command the propulsion unit 12 to stop injecting the bone cement.

[0024] For example, when the pressure continuously increases during the injection process and reaches the injection measurement threshold due to the cavity filling, it indicates that the bone cement filling at the surgical site is complete. Alternatively, if there is an obstruction of the operating environment that is inappropriate for bone cement injection, connecting the pressure unit will result in a rapidly measured pressure change that indicates an inappropriate operating state. Therefore, through the above-mentioned design, a bone cement injection system having a feedback mechanism that provides rapid feedback in real time during the operating process is obtained, providing excellent feedback on how the system selects to start and complete the operation.

[0025] In the above-described embodiments, the at least one environmental parameter provided by the present invention includes the pressure in the propulsion unit, the pressure in the pressure unit, or the pressure at the target site.

[0026] In summary, the present invention actually provides a system for algorithmically controlled pressure-guided bone cement injection. The system can dynamically observe environmental parameters within its operating system, including the pressure at the application site of the pressure-guided bone cement injection device. The observed data is transmitted to the control unit of the pressure-guided bone cement injection system. The system adapts injection conditions based on differences in bone cement saturation within the vertebral body, overcoming problems such as blockage and leakage commonly associated with bone cement injection in existing technologies. This effectively improves the injection efficiency and safety of bone cement injection. [Brief explanation of the drawings]

[0027] [Figure 1] 1 is a preferred embodiment of a pressure-guided bone cement injection device of the present invention, shown as a system block diagram. [Figure 2] 1 is a preferred embodiment of a system flow chart for the pressure-guided bone cement injection method of the present invention. [Figure 3] 1 is a diagram of a preferred embodiment of the pressure-guided bone cement injection method of the present invention. [Figure 4] 1 is a diagram of a preferred embodiment of the pressure-guided bone cement injection method of the present invention. [Figure 5] 1 is a diagram of a preferred embodiment of the pressure-guided bone cement injection method of the present invention. [Figure 6] 1 is a diagram of a preferred embodiment of the pressure-guided bone cement injection system of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0028] The technical contents, features and effects of the present invention will be described below using specific embodiments as examples, and can be implemented using these examples. However, it should be noted that the scope of protection of the present invention is not limited thereto.

[0029] (Example 1: Pressure-guided bone cement injection device) The pressure-guided bone cement injection method of this embodiment requires the use of a pressure-guided bone cement injection device 10. The device includes a pressure pump as a pressure-inducing source, which is connected to a needle tube having an injection opening at its other end. Pressure is introduced into the target site through the needle tube. Meanwhile, the bone cement injection pump is provided with a regulator valve for controlling the positive pressure of the bone cement injection pump. The bone cement injection pump is also connected to a needle tube having an injection opening at its other end, allowing bone cement to be introduced into the target site under pressure provided by the bone cement injection pump.

[0030] Regarding the sensing unit 14, the pressure-guided bone cement injection device 10 is equipped with a pressure sensor for detecting the pressure value at the target site, which allows the resistance state at the target site to be evaluated and the pressure intensity or the injection rate of the bone cement to be adjusted.

[0031] Additionally, the control unit 13 of this embodiment includes an algorithm module 131 that can record and analyze pressure change signals from the target site and the bone cement injection device, integrates relevant data to evaluate bone cement injection patterns, adjust pressure intensity, and provide commands or prompts to stop bone cement injection based on the analyzed information.

[0032] Example 2: Method of Operating Pressure-Guided Bone Cement Injection Before starting the pressure-guided bone cement injection device 10 provided in embodiment 1, the operator can determine an initial output pressure value for the pressure unit 11. After determining the initial pressure output value, the control system 13 calculates that the bone cement is approaching its saturation range. The pressure pump in the pressure unit 11 starts operating, and a pressure sensor measures the pressure value, which is then fed back to an algorithm for calculating the pressure change rate. The calculated rate is compared with a pressure change threshold. If the detected pressure change exceeds the threshold, a control signal is sent to stop the cement injection. If the detected pressure change is below the threshold, the pressure output value is increased until it reaches the maximum pressure output value or approaches the saturation range of the bone cement. Then, a control signal is sent to stop the cement injection.

[0033] In this embodiment, the command to the pressure output device sets its initial pressure output value to 400 mmHg. If the pressure within the vertebral body at 400 mmHg is not enough to displace the bone cement, the intermediate pressure value is increased to 500 mmHg. This process continues with gradually increasing pressure output values ​​until the maximum output value is reached, which in this example is 680 mmHg. The algorithm then determines to stop the injection and issues a command to abort the bone cement injection.

[0034] In this embodiment, after a certain period of time, when an increase in pressure change within the target is detected, the rotation speed of the pressure motor gradually increases to increase the applied pressure. In this example, the maximum output value is set to 680 mmHg. Based on the above-mentioned principles, as shown in Figures 4 and 5, the pressure-guided bone cement injection method provided by the present invention accelerates the process of introducing bone cement into the affected area through pressure guidance. At the same time, the bone cement continues to flow without stagnation, reducing the possibility of solidification during the introduction process. By guiding the pressure, most of the bone cement is carried away from the vertebral body, leaving only a small amount on the inner wall of the vertebral body. This step allows the bone cement to slowly fill the vertebral body.

[0035] Example 3: Evaluation of bone cement injection efficiency in an algorithm-controlled pressure-guided bone cement injection system The evaluation criteria for the effectiveness of bone cement injection in spinal augmentation procedures or balloon kyphoplasty are shown in the X-ray images of Fig. 6, as shown in the figures of the present invention. Fig. 6 shows an X-ray image of the bone cement injection situation. When the distribution of bone cement is considered "good," a large amount of fluid bone cement is observed aspirated under pressure immediately after the start of cement injection, as shown in Fig. 6. Only a small amount of bone cement remains and solidifies on the inner wall of the vertebral body.

[0036] The above-described embodiments are merely exemplary embodiments of the present disclosure and are not intended to limit the scope of the present disclosure. All variations and modifications within the spirit and scope of the claims of this application, including changes in shape, structure, features, and spirit, are intended to be embraced within the scope of the claims of this application. [Explanation of symbols]

[0037] 10. Pressure-guided bone cement injection device 11 Pressure Unit 12 Propulsion Unit 13 Control Unit 14 Sensing Unit 101 Control Algorithm 131 Algorithm Module

Claims

1. a pressure unit for introducing pressure; a propulsion unit for propelling bone cement injection into the vertebral body; at least one sensing unit for detecting at least one environmental parameter and monitoring the monitored pressure value from said pressure unit; a control unit connecting the pressure unit, the propulsion unit, and the sensing unit, the control unit comprising an algorithm module; Including, The algorithm module: (a) setting an initial pressure output value; (b) receiving at least one of the environmental parameters sensed by the sensing unit and a monitored pressure value; (c) obtaining data through a calculation process based on at least one of said environmental parameters and the monitored pressure values; (d) continuing or stopping the injection of bone cement through a data comparison process and modifying the pressure output value of the pressure unit if the injection of bone cement is to continue; Including, The calculation process comprises: calculating a saturation level of the injected bone cement by dividing the monitored pressure value by the pressure output value; multiplying the pressure output value by a manually set parameter and subtracting the pressure output value from the result to determine a saturation range of the bone cement; and calculating the rate of change of pressure using differential or derivative methods; Including, The data comparison process is comparing the rate of change of pressure to a default pressure change threshold, and commanding the pressure unit to increase the pressure output value if the rate of change of pressure is less than the default pressure change threshold; comparing the monitored pressure value with a saturation range, and if the monitored pressure value is less than the saturation range, instructing the sensing unit to re-monitor the pressure value and repeating steps (a) to (d) until the pressure output value reaches a maximum pressure output value; and commanding the propulsion unit to stop injecting bone cement if the pressure value monitored during step (d) exceeds a saturation range; 1. A pressure-guided bone cement injection device comprising:

2. A pressure-guided bone cement injection device as described in claim 1, wherein the algorithm module determines that the pressure output value should not exceed a maximum pressure output value.

3. A pressure-guided bone cement injection device as described in claim 1, wherein the initial pressure output value is not allowed to be less than 0 mmHg.

4. (a) setting an initial pressure output value; (b) receiving at least one of the environmental parameters sensed by the sensing unit and the monitored pressure value; (c) obtaining data through a calculation process based on at least one of said environmental parameters and the monitored pressure values; (d) continuing or stopping the injection of bone cement through a data comparison process and modifying the pressure output value of the pressure unit if the injection of bone cement is to continue; Including, The calculation process comprises: calculating a saturation level of the injected bone cement by dividing the monitored pressure value by the pressure output value; multiplying the pressure output value by a manually set parameter and subtracting the pressure output value from the result to determine a saturation range of the bone cement; and calculating the rate of change of pressure using differential or derivative methods; Including, The data comparison process is comparing the rate of change of pressure to a default pressure change threshold, and commanding the pressure unit to increase the pressure output value if the rate of change of pressure is less than the default pressure change threshold; comparing the monitored pressure value with a saturation range, and if the monitored pressure value is less than the saturation range, instructing the sensing unit to re-monitor the pressure value and repeating steps (a) to (d) until the pressure output value reaches a maximum pressure output value; and commanding the propulsion unit to stop injecting bone cement if the pressure value monitored during step (d) exceeds a saturation range; 10. A method of operating a pressure-guided bone cement injection device according to claim 1, comprising:

5. A method of operating a pressure-guided bone cement injection device as described in claim 4, wherein the algorithm module determines that the pressure output value should not exceed a maximum pressure output value.

6. A method for operating a pressure-guided bone cement injection device as described in claim 4, wherein the initial pressure output value is not allowed to be less than 0 mmHg.

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