A system for early or post-operative vascular evaluation of the subchondral bone of the femoral head

Abstract

The application discloses a femoral head subchondral bone early or postoperative blood vessel evaluation system and belongs to the field of ultrasonic medical devices. The technical problem to be solved is that the existing monitoring has a lag in monitoring the very early hemodynamic changes and the dynamic changes of microcirculation after treatment, and cannot perform dynamic, quantitative, bedside evaluation of the microcirculation function and structure. The technical scheme is as follows: ultramicro blood flow imaging records microvessel morphology and demarcates an ROI region; ultrasonic contrast and ultramicro blood flow imaging image space registration are performed to collect continuous dynamic images in real time, provide micro blood flow perfusion data, collect the peak time in the ultrasonic contrast time-intensity curve and the curve rising slope, construct early warning values based on the two, obtain femoral head necrosis early evaluation and hip preservation postoperative blood vessel regeneration effect evaluation based on the early warning values, and comprehensively guide the clinic by combining the microvessel morphology abnormality graph with the early warning values.

Description

Technical Field

[0001] This invention relates to the field of ultrasound medical devices, specifically to an early or postoperative vascular evaluation system for the subchondral bone of the femoral head. Background Technology

[0002] Osteonecrosis of the femoral head (ONFH) is a pathological process in which the blood supply to the femoral head is interrupted or damaged, leading to the death of bone cells and bone marrow components, which in turn causes structural changes and collapse of the femoral head. The disease often has an insidious onset in its early stages, and without effective intervention, most lesions will progressively worsen, eventually causing hip pain and dysfunction. This is particularly severe for young and middle-aged patients, often forcing them to undergo total hip arthroplasty (THA) at a younger age, thus facing long-term challenges such as prosthesis lifespan and the need for revision surgery. Therefore, identifying and effectively intervening in early ONFH is crucial for preserving hip joint function and avoiding or delaying joint replacement.

[0003] Microcirculatory disturbances in the subchondral bone region of the femoral head are a classic manifestation of early-stage osteophyte-induced hip necrosis (ONFH). This region, acting as a blood supply hub for the femoral head, contains numerous arteries, veins, and sinusoidal canals that traverse the vascular channels of the cortical endplate, forming a core microcirculatory network connecting the medullary cavity and cartilage. Therefore, in the early stages of ONFH, dynamic monitoring of the vascular microcirculation within the femoral head, especially in the subchondral bone region, plays a crucial role in assessing disease progression, prognosis, and vascular regeneration and repair after hip-preserving treatment.

[0004] Relevant patent documents retrieved: This patent, published in China (CN119344773B) on March 21, 2025, discloses a method and system for musculoskeletal ultrasound-based microvascular flow grading based on optical flow analysis. The method includes: acquiring a sequence of original microvascular flow images of the object to be tested; preprocessing the original microvascular flow image sequence; extracting a region of interest (ROI) from the preprocessed microvascular flow image sequence; extracting microvascular morphology within the ROI; performing dynamic analysis on the microvascular flow within the ROI, including: calculating microvascular flow, estimating the motion optical flow field, and fusing microvascular morphological features; generating two indices—motion density of microvascular flow and elastic density of microvascular vessels—based on the dynamic analysis results; and grading the blood flow signal of the ROI based on the motion density and elastic density. This invention improves the accuracy of musculoskeletal ultrasound-based microvascular flow grading.

[0005] This Chinese patent, CN118121232A, published on June 4, 2024, discloses a method for monitoring ovarian microcirculation hemodynamics. The method includes: real-time acquisition of CEUS (contrast-enhanced ultrasound) dynamic images of the ovary at different reproductive states of the subject, and classifying and storing the acquired ultrasound images; based on the obtained ultrasound images, selecting three regions of ovarian parenchyma perpendicular to the sound beam (upper, middle, and lower segments of the largest cross-section at the center of the ovary) as regions of interest, and obtaining TIC (transient infusion curve) curves for blood flow perfusion at different ovarian sites; and analyzing the ovarian hemodynamic characteristics of the subject at different reproductive states based on the TIC curves. This method can quantitatively monitor the blood flow characteristics of the rat ovary during juvenile and gestational stages, thereby indirectly reflecting the ovarian functional status at different reproductive states, providing a theoretical basis and experimental evidence for non-invasive CEUS monitoring of ovarian functional diseases.

[0006] Relevant non-patent literature retrieved: The journal title is "Tumor Prevention and Treatment," and the article title is "Comparative Study of Ultrasound Flow Imaging and Contrast-Enhanced Ultrasound in Differential Diagnosis of Early Cervical Cancer and Precancerous Lesions," Volume 37, Publication Date: September 26, 2024. This article discloses a comparative study of the value of ultrasound flow imaging (SMI) and contrast-enhanced ultrasound (CEUS) in differentiating early cervical cancer and high-grade intraepithelial lesions. It found that SMI showed comparable efficacy to CEUS in differentiating early cervical cancer and precancerous lesions.

[0007] The existing technologies represented by the aforementioned literature suffer from at least the following unresolved technical problems or defects, which severely restrict detection efficiency and reliability, mainly reflected in: 1. CN119344773B improves the accuracy of ultra-micro blood flow grading to some extent, but it still has problems such as dynamic monitoring lag, low spatial resolution, inconvenient equipment operation, and long examination time. 2. CN118121232A has been improved to address the shortcomings of low spatial resolution, inconvenient equipment operation, and long inspection time, but it still has the defect of qualitative monitoring of blood flow characteristics. 3. "Comparative Study on Differential Diagnosis of Early Cervical Cancer and Precancerous Lesions by Ultrasound Blood Flow Imaging and Contrast-Enhanced Ultrasound" improves upon the shortcomings of qualitative blood flow characteristic measurement, but it cannot guarantee the effectiveness of equipment operation.

[0008] In summary, existing detection technologies have a clear technological gap in achieving dynamic, quantitative, and bedside assessment of the microcirculatory function and structure within the femoral head of patients in the early stages or postoperatively. Therefore, the industry urgently needs a precise imaging assessment solution that can focus on the microcirculatory pathological changes in the subchondral bone of the femoral head in patients with early stages or postoperatively. Summary of the Invention

[0009] The purpose of this invention is to provide: A system for evaluating the vascularity of the subchondral bone of the femoral head in the early or postoperative period, to address technical issues such as the lack of dynamic, quantitative, and bedside assessment of the microcirculation and structure within the femoral head in early or postoperative ONFH patients, or a combination thereof.

[0010] Terminology Explanation: Unless otherwise defined, all technical terms used herein have the same meanings as commonly understood by one of ordinary skill in the art to which this subject matter pertains. Unless otherwise stated, all patents, patent inventions, and disclosures cited throughout this document are incorporated herein by reference in their entirety. Where multiple definitions exist for terms herein, the definitions provided in this chapter shall prevail.

[0011] It should be understood that the above brief description and the following detailed description are exemplary and for illustrative purposes only, and do not limit the subject matter of the invention in any way. In this invention, the singular is used in conjunction with the plural unless otherwise specifically stated. It should also be noted that, unless otherwise stated, the use of “or” or “or” means “and / or”. Furthermore, the use of the term “comprising” and other forms such as “including,” “containing,” and “contains” are not limiting.

[0012] The definition of the standard term can be found in the reference "Ultrasound Contrast Diagnosis", People's Medical Publishing House, edited by Dong Baowei and Liang Ping.

[0013] Unless otherwise stated, conventional methods within the scope of the art, such as region of interest selection, shall be used.

[0014] Unless specifically defined herein, the use of all commercially available products herein employs standard techniques. For example, it may be carried out using the manufacturer's instructions for use with the kit, or in accordance with methods known in the art or the description of this invention. The techniques and methods described herein can generally be implemented according to conventional methods well known in the art, based on the descriptions in the various summary and more specific documents cited and discussed in this specification.

[0015] The terms “optional / arbitrary” or “optionally / arbitrarily” mean that the event or situation described below may or may not occur, including both the occurrence and non-occurrence of the event or situation.

[0016] The term "SMI" used in this article refers to ultramicrovascular imaging, which reflects the morphology, distribution, and orientation of newly formed microvessels.

[0017] The term "CEUS" used in this article refers to contrast-enhanced ultrasound, which reflects the hemodynamic parameters of blood vessels.

[0018] The term "ROI" used in this article refers to the Region of Interest, a specific area for focused observation and analysis, which can narrow down the scope of observation.

[0019] The term "TIC" used in this article refers to the time-intensity curve, which reflects the change in concentration over time.

[0020] The term “TTP” used in this article refers to Time to Peak Flow, measured in seconds (s), which reflects the rate of blood perfusion.

[0021] The term "AS" used in this article refers to the slope of the curve, which reflects the speed at which the contrast agent enters the target area. The larger the slope, the faster the contrast agent enters and the smoother the arterial perfusion.

[0022] The term "ARCO" used in this article refers to the ARCO staging system developed by the International Society for Bone Circulation. The ARCO staging system is used to stage the disease, assess the severity, select treatment options, and predict the prognosis of avascular necrosis of the femoral head.

[0023] This invention provides an early or postoperative vascular evaluation system for the subchondral bone of the femoral head, comprising: The microvascular morphology acquisition module is used to record the morphological characteristics of newly formed subchondral microvessels in the early stage of femoral head necrosis or after surgery, and to obtain microvascular morphology images. The targeted region selection module is used to determine the ROI region based on the microvascular morphology map, so as to narrow the observation range and perform dynamic image acquisition for the region. The hemodynamic data acquisition module is used to acquire hemodynamic data of blood vessels within the ROI region, obtain CEUS images, and acquire time-intensity curves in the CEUS images. Based on the time-intensity curves, core parameters are obtained, including peak time and curve rise slope. The vascular perfusion evaluation module is used to construct early warning values ​​based on the core parameters, obtain early evaluation of femoral head necrosis and evaluation of vascular regeneration effect after hip preservation surgery based on the early warning values, and combine microvascular morphological abnormalities with the early warning values ​​to provide comprehensive clinical guidance.

[0024] The term "ultra-micro blood flow imaging" is selected from: ultrasound blood flow imaging / Doppler ultrasound blood flow imaging.

[0025] The term "ultra-micro blood flow imaging" is preferably: high-definition micro blood flow imaging, micro blood flow vascular imaging, ultra-high resolution microvascular imaging, and low-velocity blood flow sensitive imaging.

[0026] The term "ultra-micro blood flow imaging" is further preferably: SMI.

[0027] The term "dynamic image acquisition" is selected from: real-time image acquisition.

[0028] The preferred terms for "dynamic image acquisition" are: ultrasound dynamic image acquisition, blood perfusion dynamic image acquisition, and CEUS dynamic image acquisition.

[0029] The term "dynamic image acquisition" is further preferred to be: CEUS dynamic image acquisition.

[0030] Based on further solutions to the technical problems of the present invention, or simultaneous solutions to multiple technical problems, the preferred solutions provided by the present invention include: First preferred option: The microvascular morphology acquisition module uses ultra-micro blood flow imaging to record the morphological characteristics of newly formed subchondral microvessels in the early stage of femoral head necrosis, with a frequency range of 6MHz-9MHz.

[0031] This technical solution not only solves the technical problem of "dynamic monitoring lag", but also addresses the technical problems of "limitations of microcirculation imaging, imaging risks, and contraindications for special populations in traditional ultrasound".

[0032] Second preferred option: The hemodynamic data acquisition module uses CEUS technology to acquire hemodynamic data of blood vessels, with a frequency range of 1MHz-5MHz. After intravenous injection of microbubble contrast agent, dynamic images are continuously acquired for more than 120 seconds, completely covering the ROI area.

[0033] This technical solution not only addresses the technical problem of "lagging dynamic monitoring," but also further solves the technical problems of "inconvenient equipment operation and waste of resources."

[0034] Third preferred option: The hemodynamic data acquisition module accurately spatially registers the ROI region with the CEUS image. Registration is based on the selection of key vascular landmarks, so that the microvascular morphology map and the CEUS image are in the same anatomical coordinate system. Key vascular landmarks include vascular branches and vascular intersections.

[0035] This technical solution not only addresses the technical problem of "insufficient objectivity in analysis results," but also further solves the technical problem of "lack of a single modal evaluation dimension."

[0036] Fourth preferred option: The formula for calculating the warning value is:

[0037] in This is a warning value. The slope of the curve is the upward slope. To reach peak time.

[0038] This technical solution not only addresses the technical problem of "insufficient objectivity in analysis results," but also further solves the technical problem of "inability to objectively assess the quantification of microvascular perfusion and vascular regeneration status in the femoral head."

[0039] Fifth preferred option: When evaluating the early stage of femoral head necrosis, the threshold for the warning value is set at 0.050-0.070. If the value is higher than the threshold range, it is judged as early congestive necrosis and dynamic mismatch.

[0040] This technical solution not only addresses the technical problem of "insufficient objectivity in analysis results," but also further solves the technical problem of "the inability of a single parameter to objectively determine the condition of femoral head necrosis."

[0041] Sixth preferred option: When assessing the effect of vascular regeneration after hip preservation surgery, the threshold for the warning value is set at 0.050-0.060. If the value is below the threshold range, it is determined to be ischemic necrosis or failure of vascular regeneration. If the value is within the threshold range, it indicates normal blood perfusion, i.e., normal regeneration.

[0042] This technical solution not only addresses the technical problem of "insufficient objectivity in analysis results," but also further solves the technical problem of "the inability of a single parameter to objectively determine the condition of femoral head necrosis."

[0043] Seventh preferred option: The microvascular morphological abnormalities include disordered vascular morphology, vascular dilation, vascular occlusion, and irregular distribution.

[0044] This technical solution not only addresses the technical problem of "insufficient objectivity in analysis results," but also further resolves the technical issues of "dual authentication for determining the condition of avascular necrosis of the femoral head."

[0045] In addition, the present invention also provides a method for evaluating early-stage subchondral bone angiogenesis in the femoral head, comprising: S1. Using the microvascular morphology acquisition module, the morphological characteristics of newly formed subchondral microvessels in the early stage of femoral head necrosis or after surgery are recorded to obtain microvascular morphology maps. S2. The targeted region selection module is used to determine the ROI region based on the microvascular morphology map, so as to narrow the observation range and perform dynamic image acquisition for the region. S3. Hemodynamic data acquisition module, used to acquire hemodynamic data of blood vessels in the ROI area, obtain CEUS images, and acquire time-intensity curves in the CEUS images. Based on the time-intensity curves, core parameters are obtained, including peak time and curve rise slope. S4. Used to construct early warning values ​​based on the core parameters, obtain early evaluation of femoral head necrosis and evaluation of postoperative vascular regeneration effect based on the early warning values, and combine microvascular morphological abnormality map with the early warning values ​​to provide comprehensive clinical guidance.

[0046] The present invention has at least the following beneficial effects: 1. Compared with the prior art, the present invention provides a technical solution with a different technical concept, and its technical effect is equivalent to or slightly improved with the prior art. The difference between the technical concept of the present invention and the prior art includes, but is not limited to, single-modal evaluation.

[0047] 2. Compared with the prior art, the present invention has better technical effects in terms of cost saving.

[0048] According to experimental tests, this invention optimizes the detection process by first using the SMI function of an ultrasound diagnostic instrument to perform a full-scale scan of the detection area. Leveraging the advantages of SMI function—no contrast agent and high sensitivity—it quickly identifies and accurately selects ROI areas with obvious microvascular features that require focused analysis. Then, it performs CEUS dynamic image acquisition on these ROI areas, effectively narrowing the CEUS acquisition range and avoiding problems such as contrast agent waste and excessive examination time caused by full-range CEUS acquisition. This achieves cost savings in terms of consumables, equipment, and manpower, while also ensuring both detection accuracy and efficiency.

[0049] 3. Compared with the prior art, the present invention has better technical effects in terms of accuracy and repeatability of microvascular assessment.

[0050] According to experimental tests, this invention accurately integrates microvascular morphology maps and CEUS blood flow perfusion maps through spatial registration, enabling simultaneous analysis and interpretation of morphological and functional data in the same anatomical coordinate system. This solves the problem of data disconnect and large evaluation deviation in traditional technologies, thereby significantly improving the accuracy and repeatability of the evaluation.

[0051] 4. Compared with the prior art, the present invention has better technical effects in quantitative analysis of angiogenesis and grading.

[0052] Based on experimental testing, this invention establishes a quantitative analysis standard for early warning values ​​using time-intensity curves in CEUS images. This standard, combined with microvascular morphology mapping, enables early evaluation of femoral head necrosis and assessment of postoperative vascular regeneration after hip preservation surgery. Postoperative evaluation criteria are categorized into good regeneration and limited regeneration based on the early warning value. This set of quantitative parameters and corresponding grading methods effectively addresses the technical pain points of subjective analysis and significant result bias in traditional vascular regeneration grading, significantly improving the objectivity and stability of early femoral head necrosis and postoperative vascular regeneration assessment results.

[0053] 5. Compared with the prior art, the present invention has better technical effect in terms of prognostic judgment.

[0054] According to experimental tests, the present invention combines the evaluation results of the combined early warning value with the microvascular morphological abnormality map to provide clinical guidance, offering patients personalized postoperative rehabilitation guidance and treatment decisions, such as adjusting weight-bearing, drug intervention, and physical therapy, thereby achieving closed-loop management from "diagnosis" to "treatment" and providing reliable support for early clinical grading diagnosis and prognosis of femoral head necrosis. Attached Figure Description

[0055] Figure 1 This is a system framework diagram of the present invention; Figure 2 For early-stage patients, the ROI area is [not specified]. Figure 3 TIC plot for early-stage patients; Figure 4 This refers to the ROI area of ​​the postoperative patient. Figure 5 This is a TIC image of a patient after surgery. Detailed Implementation

[0056] The following non-limiting embodiments are intended to enable those skilled in the art to gain a more comprehensive understanding of the present invention, but do not limit the invention in any way. The following content is merely an exemplary description of the scope of protection claimed by the present invention, and those skilled in the art can make various changes and modifications to the present invention based on the disclosed content, and such changes should also fall within the scope of protection claimed by the present invention.

[0057] The present invention will be further described below by way of specific embodiments. Unless otherwise specified, all instruments, devices, equipment, reagents, products, etc., used in the embodiments of the present invention are obtained through conventional commercial means.

[0058] Example 1 This embodiment provides an early or postoperative vascular evaluation system for the subchondral bone of the femoral head, such as... Figure 1 As shown, it includes: The microvascular morphology acquisition module is used to record the morphological characteristics of newly formed subchondral microvessels in the early stage of femoral head necrosis or after surgery, and to obtain microvascular morphology images. The targeted region selection module is used to determine the ROI region based on the microvascular morphology map, so as to narrow the observation range and perform dynamic image acquisition for the region. The hemodynamic data acquisition module is used to acquire hemodynamic data of blood vessels within the ROI region, obtain CEUS images, and acquire time-intensity curves in the CEUS images. Based on the time-intensity curves, core parameters are obtained, including peak time and curve rise slope. The vascular perfusion evaluation module is used to construct early warning values ​​based on the core parameters, obtain early evaluation of femoral head necrosis and evaluation of vascular regeneration effect after hip preservation surgery based on the early warning values, and combine microvascular morphological abnormalities with the early warning values ​​to provide comprehensive clinical guidance.

[0059] Precise spatial registration of the ROI region with the CEUS image is achieved by selecting key vascular landmarks, so that the microvascular morphology map and the CEUS image are in the same anatomical coordinate system. Key vascular landmarks include vascular branches and vascular intersections, enabling an integrated assessment of the "morphology and function" of microvessels in the subchondral bone region of the femoral head.

[0060] During CEUS image acquisition, microbubble contrast agent is injected intravenously, followed by continuous acquisition of dynamic images for more than 120 seconds to fully cover the ROI area.

[0061] The sulfur hexafluoride microbubble contrast agent can be SonoVue, Definity, etc., and in this example it is SonoVue, manufactured by Bracco, an Italian company.

[0062] The contrast agent injection volume is usually 1.5-2.0 mL, depending on the patient's weight and condition, and rapid injection should be ensured to enhance the perfusion signal.

[0063] Quantitative parameters collected from TIC (Time to Peak) are used to evaluate the early stage of femoral head necrosis and the effectiveness of angiogenesis after hip preservation surgery. The quantitative parameters are time to peak and curve slope. An early warning value is derived based on these parameters, and the formula for calculating the early warning value is as follows:

[0064] in The warning value represents the rate of change of the slope per second. The slope of the curve is the upward slope. To reach peak time.

[0065] The early warning threshold for femoral head necrosis is set at 0.050-0.070. When the warning value exceeds the upper limit of the threshold, it is determined to be early congestion-type necrosis and dynamic mismatch; When the warning value is within the threshold range, it indicates a critical abnormality or a highly suspicious condition, assisting doctors in conducting early and close follow-up.

[0066] The warning threshold for evaluating the effect of angiogenesis after hip preservation surgery is set at 0.050-0.060; When the warning value is lower than the lower limit of the threshold, it is determined to be ischemic necrosis or failure of angiogenesis; A warning value within the threshold range indicates normal blood perfusion, i.e., normal regeneration.

[0067] When an abnormality is detected by the early or postoperative vascular evaluation system based on the femoral head subchondral bone through warning values ​​(such as early critical abnormality or high suspicion of femoral head necrosis, postoperative ischemic necrosis or failure of angiogenesis), the system will export the corresponding microvascular morphology map, and the microvascular morphology will be manually verified to see if it is abnormal. Abnormalities include: disordered vascular morphology, vascular dilation, vascular occlusion and irregular distribution.

[0068] The combined early warning value evaluation results and microvascular morphological abnormalities provide comprehensive clinical guidance, offering patients personalized postoperative rehabilitation guidance and treatment decisions. These treatment decisions include one or more of the following: adjusting weight-bearing, drug intervention, and physical therapy, enabling closed-loop management from "diagnosis" to "treatment".

[0069] Example 2 This embodiment provides the following specific steps for evaluating patients with early-stage osteonecrosis of the femoral head (ONFH): Application scenario: Screening for hemodynamic characteristics in areas suspected of early-stage femoral head necrosis.

[0070] S1. Patient preparation and positioning The target patient is Patient A, who is clinically suspected of having early-stage avascular necrosis of the femoral head (ARCO stage 1-2).

[0071] Patients in the early stages of femoral head injury should lie flat with the affected thigh naturally externally rotated so that the ultrasound probe can easily scan the anterior region of the femoral head.

[0072] S2. Preparation of Ultrasonic Equipment The testing instrument was a Mindray Resona8 color Doppler ultrasound diagnostic instrument, which has SMI and CEUS functions and can simultaneously assess microvascular morphology and perfusion function.

[0073] S3. Detailed Operating Procedures S31. Microvascular morphological assessment under SMI mode Initial scanning was performed using an SMI probe with a high-frequency linear array of 6-9 MHz to perform superficial scanning of the femoral head region, particularly the subchondral bone plate region.

[0074] Preliminary screening is conducted to examine the morphology, branching pattern, and vascular density of new blood vessels, and to observe for signs of irregular vessels, vascular occlusion, or vascular dilation.

[0075] Record the morphology of blood vessels: such as linear, dendritic, or disordered punctate.

[0076] S32. ROI Selection and Calibration Based on the vascular morphology data displayed by SMI, areas with dense neovascularization or abnormal morphology were selected as ROI regions, such as... Figure 2 As shown, further observation of the functional recovery of blood perfusion was conducted.

[0077] S33. Hemodynamic data acquisition in CEUS mode Select SonoVue contrast agent, inject 5.0 mL of 0.9% sterile saline into the vial, gently shake to mix evenly, inject 2.4 mL of contrast agent through the antecubital vein, and then immediately flush the vial with 5.0 mL of saline.

[0078] Using a low-frequency convex array probe with a frequency of 1-5MHz, dynamic image acquisition was performed on the ROI region calibrated by SMI for 120 seconds, the TIC curve of blood flow was recorded, and quantitative parameters TTP and AS were acquired.

[0079] S34.TIC Data Analysis like Figure 3 As shown, the horizontal axis represents time in seconds, and the vertical axis represents the relative change in echo intensity in dB. The slope of the curve for obtaining TIC is 2.00, and the time to peak is 20.83 seconds.

[0080] The system automatically calculates the warning value: .

[0081] System output result: Because the index (0.096) The value is significantly higher than the preset upper limit of the baseline threshold (0.070). The system issued a "mismatch of abnormally high dynamic injection" alert.

[0082] Blood flow status indicates that the local microcirculation is currently in a state of abnormal congestion and dynamic mismatch. The microvascular network shows extremely rapid inflow and abnormal flow, which is consistent with the hemodynamic characteristics of the early necrosis and inflammation stage and abnormal shunt.

[0083] S4. Clinical Guidance The diagnostic approach in this embodiment is not intended to replace MRI as the gold standard for anatomical diagnosis, but rather to provide a clinical guidance tool for "early functional warning" and "dynamic microcirculation monitoring." Its specific clinical guidance significance is as follows: This invention achieves a complementary advantage between "anatomical morphology" and "blood flow function": MRI excels at reflecting existing structural damage to the femoral head (such as bone marrow edema and necrotic zones), representing a "delayed" morphological diagnosis. In contrast, this invention (contrast-enhanced ultrasound combined with SMI) can directly and in real-time display abnormalities in microcirculatory blood perfusion. Before irreversible structural collapse occurs on MRI, this method captures ischemic signals in advance, prompting clinicians to intervene as early as possible.

[0084] Provides continuous, radiation-free treatment follow-up guidance: For patients with abnormal blood perfusion (similar to elevated "fever" warning indicators) in clinical practice, doctors cannot frequently use MRI for intensive follow-up. The solution of this invention has the advantages of high portability, no radiation, and low cost. It can be used as a routine dynamic monitoring method during clinical treatment (such as vasodilator therapy and physical therapy), guiding doctors to assess the effect of "blood flow restoration" at any time, thereby adjusting the treatment plan.

[0085] Combining microvascular morphology diagrams: Example 3 The specific steps for evaluating the vascular regeneration effect after hip preservation surgery provided in this embodiment are as follows: Application scenario: To quantitatively assess the microvascular reconstruction status 6-12 months after hip-preserving surgery (such as core decompression and bone grafting).

[0086] S1. Patient preparation and positioning The target patient is Patient B, who will have an outpatient follow-up 6 months after hip-preserving surgery.

[0087] After femoral head surgery, patients should lie flat with the affected thigh naturally externally rotated so that the ultrasound probe can easily scan the anterior region of the femoral head.

[0088] S2. Preparation of Ultrasonic Equipment The testing instrument was a Mindray Resona8 color Doppler ultrasound diagnostic instrument, which has SMI and CEUS functions and can simultaneously assess microvascular morphology and perfusion function.

[0089] S3. Detailed Operating Procedures S31. Microvascular morphological assessment under SMI mode Initial scanning was performed using an SMI probe with a high-frequency linear array of 6-9 MHz to perform superficial scanning of the femoral head region, particularly the subchondral bone plate region.

[0090] Preliminary screening is conducted to examine the morphology, branching pattern, and vascular density of new blood vessels, and to observe for signs of irregular vessels, vascular occlusion, or vascular dilation.

[0091] Record the morphology of blood vessels: such as linear, dendritic, or disordered punctate.

[0092] S32. ROI Selection and Calibration Based on the vascular morphology data displayed by SMI, areas with dense neovascularization or abnormal morphology were selected as ROI regions, such as... Figure 4 As shown, further observation of the functional recovery of blood perfusion was conducted.

[0093] S33. Hemodynamic data acquisition in CEUS mode Select SonoVue contrast agent, inject 5.0 mL of 0.9% sterile saline into the vial, gently shake to mix evenly, inject 2.4 mL of contrast agent through the antecubital vein, and then immediately flush the vial with 5.0 mL of saline.

[0094] Using a low-frequency convex array probe with a frequency of 1-5MHz, dynamic image acquisition was performed on the ROI region calibrated by SMI for 120 seconds, the TIC curve of blood flow was recorded, and quantitative parameters TTP and AS were acquired.

[0095] S34.TIC Data Analysis like Figure 5 As shown, the horizontal axis represents time in seconds, and the vertical axis represents the relative change in echo intensity in dB. The slope of the curve for obtaining TIC is 0.52, and the time to peak is 20.49 seconds.

[0096] The system automatically calculates the warning value: .

[0097] System output result: Because the index (0.025) The value is significantly lower than the preset lower limit of the benchmark threshold (0.050). The system will issue a "low infusion efficiency / limited regeneration" warning.

[0098] Blood flow status indicates that the microcirculation in the detection area is currently in a state of slow perfusion and low dynamics, with slow blood flow and high flow resistance, suggesting that the local microvascular network has failed to achieve effective functional remodeling, and blood flow cannot effectively perfuse to the deep part of the bed.

[0099] S4. Clinical Guidance If the system assessment indicates "normal regeneration," combined with the microvascular morphology map, clinicians can conclude that the risk of structural collapse in this area is reduced, and may consider guiding the patient to perform rehabilitation exercises to gradually restore joint mobility.

[0100] If the system assessment indicates "poor perfusion efficiency / limited regeneration," combined with microvascular morphology mapping, clinicians can conclude that the repair process is in a "stalemate phase," with weak mechanical support. At this point, caution should be exercised regarding premature weight-bearing leading to bone fragmentation. Maintaining a strict non-weight-bearing state is recommended, along with consideration of strengthening interventions with blood-activating and stasis-removing drugs to improve microcirculatory mismatch.

[0101] The above specific embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit it. Although the present invention has been described in detail with reference to examples, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the scope of the technical solutions of the present invention, and all such modifications or substitutions should be covered within the scope of the claims of the present invention.

Claims

1. A system for evaluating the early or postoperative vascularity of the subchondral bone of the femoral head, characterized in that, include: The microvascular morphology acquisition module is used to record the morphological characteristics of newly formed subchondral microvessels in the early stage of femoral head necrosis or after surgery, and to obtain microvascular morphology images. The targeted region selection module is used to determine the ROI region based on the microvascular morphology map, so as to narrow the observation range and perform dynamic image acquisition for the region. The hemodynamic data acquisition module is used to acquire hemodynamic data of blood vessels within the ROI region, obtain CEUS images, and acquire time-intensity curves in the CEUS images. Based on the time-intensity curves, core parameters are obtained, including peak time and curve rise slope. The vascular perfusion evaluation module is used to construct early warning values ​​based on the core parameters, obtain early evaluation of femoral head necrosis and evaluation of vascular regeneration effect after hip preservation surgery based on the early warning values, and combine the abnormalities of microvascular morphology map with the early warning values ​​to provide comprehensive clinical guidance.

2. The femoral head subchondral bone early or postoperative vascular evaluation system according to claim 1, characterized in that, The microvascular morphology acquisition module uses ultra-micro blood flow imaging to record the morphological characteristics of newly formed subchondral microvessels in the early stage of femoral head necrosis, with a frequency range of 6MHz-9MHz.

3. The femoral head subchondral bone early or postoperative vascular evaluation system according to claim 1, characterized in that, The hemodynamic data acquisition module uses CEUS technology to acquire hemodynamic data of blood vessels, with a frequency range of 1MHz-5MHz. After intravenous injection of microbubble contrast agent, dynamic images are continuously acquired for more than 120 seconds, completely covering the ROI area.

4. The femoral head subchondral bone early or postoperative vascular evaluation system according to claim 1, characterized in that, The hemodynamic data acquisition module accurately spatially registers the ROI region with the CEUS image. Registration is based on the selection of key vascular landmarks, so that the microvascular morphology map and the CEUS image are in the same anatomical coordinate system. Key vascular landmarks include vascular branches and vascular intersections.

5. The femoral head subchondral bone early or postoperative vascular evaluation system according to claim 1, characterized in that, The formula for calculating the warning value is: in This is a warning value. The slope of the curve is the upward slope. To reach peak time.

6. The femoral head subchondral bone early or postoperative vascular evaluation system according to claim 1, characterized in that, When evaluating the early stage of femoral head necrosis, the threshold for the warning value is set at 0.050-0.

070. When the warning value is higher than the upper limit of the threshold, it is determined to be early congestive necrosis and dynamic mismatch.

7. The femoral head subchondral bone early or postoperative vascular evaluation system according to claim 1, characterized in that, When assessing the effect of vascular regeneration after hip preservation surgery, the threshold for the warning value is set at 0.050-0.

060. When the warning value is lower than the lower limit of the threshold, it is determined to be ischemic necrosis or restricted vascular regeneration. Within the threshold range, it indicates normal blood perfusion, i.e., normal regeneration.

8. The femoral head subchondral bone early or postoperative vascular evaluation system according to claim 1, characterized in that, The microvascular morphological abnormalities include disordered vascular morphology, vascular dilation, vascular occlusion, and irregular distribution.

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