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CN-121987315-A - Intelligent bone cement injection system of bionic hollow screw and control method

CN121987315ACN 121987315 ACN121987315 ACN 121987315ACN-121987315-A

Abstract

The invention discloses an intelligent bone cement injection system of a bionic hollow screw and a control method. The intelligent bone cement injection system of the bionic hollow screw comprises an intelligent profiling interface, a multichannel independent injection and sensing module, a piezoelectric ceramic micropump, a central control module and a three-dimensional navigation verification module. And loading three-dimensional micropore topological data of the flow control device through scanning screws to construct a personalized perfusion model, and dynamically distributing multichannel flow based on the model. The intelligent bone cement injection system and the control method for the bionic hollow screw solve the problems that in the prior art, bone cement injection equipment is not matched with a novel 3D printing screw interface, the injection process is uncontrollable, an orientation strategy is lacked, and real-time feedback is lacked, accurate, uniform and safe filling of bone cement in a complex micropore network is realized, and stability, safety and predictability of an osteoporosis fracture internal fixation operation are remarkably improved.

Inventors

  • WANG PENGFEI
  • ZHANG KUN
  • XING JIAN
  • HAN SHUANG

Assignees

  • 西安市红会医院（西安市骨科研究所）

Dates

Publication Date
20260508
Application Date
20260318

Claims (10)

  1. 1. An intelligent bone cement injection system of a bionic cannulated screw, comprising: the intelligent profiling interface module is used for being detachably connected with the tail of the bionic hollow screw and forming fluid seal, and comprises a driving head (3) matched with a screw tail driving structure; A multi-channel independent injection and sensing module comprising a multi-channel flow divider (4) for dividing a flow of bone cement into a plurality of channels (41), each channel (41) corresponding to a pressure sensor for monitoring the injection pressure of the respective channel; The power module is used for providing injection power capable of being accurately controlled for the system; The central control and processing module is used for receiving and processing screw identification information and pressure sensor signals and generating control instructions for the power module and the multichannel independent injection and sensing module according to the screw identification information and the pressure sensor signals; and the three-dimensional navigation and verification module is used for receiving the medical image data in the operation, registering and fusing the medical image data with the digital model of the screw, and generating and displaying a three-dimensional visual image of the penetration condition of the bone cement in the micropore structure of the screw in real time.
  2. 2. The intelligent bone cement injection system of the bionic cannulated screw according to claim 1, wherein the driving head (3) is one of hexagonal and quincuncial, the dimensions of which match the central channel of the screw.
  3. 3. The intelligent bone cement injection system of a biomimetic cannulated screw according to claim 1, wherein the multi-channel independent injection and sensing module further comprises an independent flow control valve (411) provided on each channel (41), the flow control valve (411) being controlled by the central control and processing module.
  4. 4. The intelligent bone cement injection system of a biomimetic cannulated screw of claim 1, wherein the central control and processing module comprises: the identification code reading unit is used for acquiring the unique identification code of the screw; The data calling unit is used for calling the micropore topological parameter of the screw from a local or remote database according to the identification code; The control algorithm unit is used for running a pressure early warning algorithm and an adaptive flow control algorithm, wherein the pressure early warning algorithm is configured to diagnose the blockage risk according to the real-time pressure change rate and trigger a coping strategy, and the adaptive flow control algorithm is configured to dynamically adjust the injection speed of each channel (41) according to the screw topology parameter and the real-time pressure feedback.
  5. 5. The intelligent bone cement injection system of a biomimetic cannulated screw of claim 4, wherein the coping strategies include one or more of triggering a piezo ceramic micropump to generate a pulse flow of a specific frequency and amplitude, adjusting the injection reference flow rate, triggering a reverse pumping pulse, suspending the injection.
  6. 6. The intelligent bone cement injection system of a biomimetic cannulated screw of claim 1, wherein the three-dimensional navigation and verification module comprises: the image data interface is used for receiving DICOM format image data from O-arm, C-arm and CT; The image registration engine is used for spatially aligning the screw in the image data with the preloaded screw digital model; a visual rendering engine for calculating and rendering a cement-filled distribution thermodynamic diagram; the intelligent analysis unit is used for calculating the filling coverage rate in real time, identifying unfilled areas and leakage risk areas and providing decision prompts according to preset rules.
  7. 7. A control method suitable for use in the intelligent bone cement injection system of any one of claims 1-6, comprising the steps of: s1, loading screw micropore topological data, constructing a multichannel perfusion path model, and calculating a safety pressure threshold value for each path; S2, dynamically distributing initial injection flow according to the total flow cross section of the micropores at the downstream of each perfusion path; S3, starting injection, monitoring the pressure of each channel in real time, dynamically adjusting the injection speed of each channel according to pressure feedback and a preset aperture-speed mapping relation, and executing grading protection action when the pressure is abnormal; and S4, acquiring and fusing the intraoperative images in real time, generating a bone cement penetration three-dimensional thermodynamic diagram, and carrying out real-time visual monitoring and intelligent evaluation.
  8. 8. The control method according to claim 7, characterized in that in step S1, the safety pressure threshold p_max is calculated by the following formula: Pmax=k*(d_min) 2 /cos(θ_max) Where k is the viscosity coefficient of the selected bone cement, d_min is the smallest pore size of the micropores on the current perfusion path, and θ_max is the maximum inclination of the micropores on the path.
  9. 9. The method according to claim 7, wherein in the step S3, the pore size-speed mapping relationship is that the pore size of the micropores is divided into at least two sections, a lower injection speed level and a higher pressure protection threshold value are associated for a smaller pore size section, a higher injection speed level and a lower pressure protection threshold value are associated for a larger pore size section, and the step protection action includes triggering a pulse, reducing a flow rate, suspending injection, or back flushing.
  10. 10. The control method according to claim 7, wherein in step S4, the intelligent evaluation includes: Calculating the filling coverage rate of the whole and the regional bone cement; if the overall coverage rate is lower than a first preset threshold value, automatically analyzing the distribution of the unfilled region and planning a supplementary note suggestion; If the filling rate of the leakage risk area is higher than a second preset threshold value, an alarm is triggered and stopping the injection operation is suggested or automatically performed.

Description

Intelligent bone cement injection system of bionic hollow screw and control method Technical Field The invention relates to the technical field of medical instruments, in particular to an intelligent bone cement injection system of a bionic cannulated screw and a control method. Background With the increasing trend of global population aging, osteoporosis has become a major disease affecting bone health in the middle-aged and elderly people. Osteoporosis results in reduced bone density, degraded bone microstructure, and increased bone fragility, making patients very prone to fractures when they suffer from low energy wounds (e.g., falls), with pelvic fragility fractures being particularly common. The fracture has the characteristics of high morbidity, high disability rate and high mortality rate, seriously influences the life quality of patients and brings heavy medical burden to society and families. Currently, surgical treatment has become mainstream for unstable osteoporotic pelvic fractures. Minimally invasive percutaneous cannulated screw internal fixation is widely considered the preferred treatment for its advantages of small trauma, less bleeding, rapid recovery, etc. The technique realizes the stabilization of the pelvis ring by arranging the channel screw under the image guidance through the small incision on the body surface. However, the bone mass of patients with severe osteoporosis is remarkably lost, the strength of the bone-screw interface is seriously insufficient, so that the immediate holding force (initial stability) and the long-term holding force (cutting resistance and loosening resistance) of the traditional screw are not ideal, and the risk of failure of postoperative internal fixation (such as cutting, loosening and displacement of the screw) is remarkably increased. To increase the anchoring strength of screws in osteoporotic bone, various enhancement techniques have been developed in clinical practice. One common method is to inject bone cement (mainly polymethyl methacrylate, PMMA) into the bone through the central passage of a cannulated screw, with the use of a "cement-bone" composite formed after setting of the bone cement to enhance the holding force of the screw. Another method is to inject bone cement directly around the screw (in the bone canal) to form a reinforcing layer around the screw. Although the stability of the method is improved to a certain extent, the method still has the problems of uncontrollable bone cement distribution, high leakage risk, nonuniform strengthening effect and the like. In recent years, with the deep application of additive manufacturing (3D printing) technology in the field of medical instruments, novel cannulated screws with bionic micropore structures are emerging. Such screws are typically manufactured by precision 3D printing techniques using biocompatible materials such as titanium alloys. The core innovation of the novel screw is that a complex three-dimensional micropore network topological structure is designed inside the screw. The structure typically includes a central main channel, a plurality of channels axially distributed along the screw, and hundreds of micro-holes (typically in the range of 200-500 μm) radiating from the channels at a specific angle (e.g., 45 deg. + -5 deg.) to the surface of the screw. Bone cement is injected into the micropore network in the operation, the cement is penetrated into the bone trabecular gaps around the screw outwards through micropores, and a plurality of tiny anchor bolts and staggered root systems are formed after solidification, so that the screw and bone tissues are firmly locked together, and the anti-extraction force and the anti-rotation force are greatly improved. This "screw-cement-bone tissue" interlocking provides a revolutionary solution to internal fixation under osteoporotic conditions. However, the utility of such advanced screws is highly dependent on whether a proper viscosity, proper dosage of bone cement can be accurately, uniformly, and completely poured into its complex network of micropores. The existing bone cement injection equipment (mostly manual push rod type, gun type or simple electric propeller) used clinically exposes a series of technical bottlenecks to be solved when facing the novel personalized screw: 1. The mechanical interface is incompatible with the sealing problem that the 3D printing bionic hollow screw is driven and sealed, and the tail part of the 3D printing bionic hollow screw is usually designed with a special mechanical structure, such as a driving interface of a hexagon socket, a hexagram socket and the like, and a precise flaring sealing surface. The injection head (typically a flat head or a simple conical head) of a conventional bone cement injector cannot be made to effectively and quickly intraoperatively connect to these special structures. Forced connection is easy to cause misalignment and connection instability, and more importantly, re