A fluorescent developer synthetic injection control system, injection pump and storage medium

Abstract

The present invention belongs to the technical field of medical devices, and specifically relates to a fluorescent contrast agent synthesis injection control system, an injection pump and a storage medium. The system of the present invention is used to assist in calculating the injection rate of the fluorescent contrast agent in near-infrared fluorescence navigation laparoscopic hepatectomy, and includes an input module and a calculation module; the input module is used to input the parameters required for the calculation; the first calculation module is configured to calculate the injection rate of the fluorescent contrast agent when the input is the liver texture condition; the second calculation module is configured to calculate the injection rate of the fluorescent contrast agent when the input is the test result of the 15-minute retention rate of indocyanine green. The present invention further provides an injection pump integrated with the above system. The present invention can effectively improve the effect of fluorescent imaging in near-infrared fluorescence navigation laparoscopic hepatectomy, ensure the accuracy and treatment effect of the operation, and has a good application prospect.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a fluorescent developer synthesis injection control system, an injection pump and a storage medium. Background Art

[0002] Near-infrared fluorescence navigation laparoscopic liver resection is a technique that uses near-infrared fluorescence (NIRF) imaging technology to assist liver surgery. It uses NIRF imaging technology for real-time intraoperative navigation and uses specific fluorescent contrast agents (such as indocyanine green) to mark specific parts of the liver to achieve liver segment positioning, thereby helping surgeons to more accurately identify and remove diseased tissues or tumors during surgery.

[0003] In near-infrared fluorescence navigation laparoscopic liver resection, NIRF imaging has the advantages of low cost, ease of use, no radioactivity, and high safety compared to traditional imaging techniques (such as CT or MRI). In addition, NIRF imaging can provide real-time navigation to help doctors detect primary or metastatic liver tumors, divide atrophic liver segments, and play a role in liver transplantation surgery.

[0004] In practical applications, improving the effect of fluorescence imaging is the key to ensuring high-quality completion of surgery. Based on this purpose, most research ideas in the prior art focus on improving the formula of fluorescent imaging agents. For example, the Chinese invention patent application "CN118718022A-A near-infrared fluorescent imaging agent for navigation of laparoscopic liver resection surgery and its preparation method and application" optimizes the formula of the fluorescent imaging agent, thereby improving the effect of fluorescence imaging.

[0005] In near-infrared fluorescence navigation laparoscopic liver resection, the doctor first blocks the blood supply to the liver to be removed by ligation, and then injects fluorescent contrast agent into the patient's peripheral vein, so that the liver that has not blocked the blood flow absorbs the fluorescent contrast agent and produces fluorescent imaging under the stimulation of near-infrared rays, thereby locating different liver segments. At present, the intravenous injection of fluorescent contrast agents during surgery mostly uses various commercial 1-5ml ordinary syringes for rapid one-time injection.

[0006] In practical applications, it is found that the intravenous injection rate of fluorescent contrast agents can also significantly affect the imaging effect. However, there is a lack of relevant research in the existing technology, and it is not clear how to control the intravenous injection rate of fluorescent contrast agents. In addition, the existing traditional injection method cannot be specially set for near-infrared fluorescence navigation laparoscopic liver resection, so as to effectively select the optimal injection rate suitable for the current surgical patient.

[0007] Therefore, it is crucial to study the relationship between the intravenous injection rate and the optimal fluorescent imaging effect and develop a system and injection pump that can calculate the optimal injection rate for specific patients, which can improve the accuracy of liver segment positioning during surgery, improve surgical precision, and obtain better surgical treatment effects. Summary of the invention

[0008] In view of the problems of the prior art, the present invention provides a fluorescent developer synthesis injection control system, an injection pump and a storage medium.

[0009] A fluorescent contrast agent synthetic injection control system, used for assisting calculation of the injection rate of the fluorescent contrast agent in near-infrared fluorescence navigation laparoscopic liver resection, comprises an input module and a calculation module, wherein the calculation module comprises one or a combination of a first calculation module and a second calculation module;

[0010] The input module is configured to input the test results of liver texture or 15-minute retention rate of indocyanine green, and the percentage of remaining liver parenchyma that requires fluorescent counterstaining for the proposed surgical method; the liver texture is the result of classifying the patient's liver into five types: normal, mild cirrhosis, moderate cirrhosis, severe cirrhosis, and cholestatic cirrhosis;

[0011] The first calculation module is configured to calculate the injection rate of the fluorescent contrast agent when the input is the liver texture condition, and the calculation formula is:

[0012] Injection rate = Auto × RLV

[0013] Among them, Auto represents the preset baseline value for different liver texture conditions, and RLV represents the percentage of the remaining liver parenchyma that needs fluorescent counterstaining for the proposed surgical approach;

[0014] The second calculation module is configured to calculate the injection rate of the fluorescent developer when the input is the test result of the 15-minute retention rate of indocyanine green, and the calculation formula is:

[0015] When ICG R15% ≤ 5%,

[0016] Injection rate = Manul × RLV

[0017] When ICG R15%>5%,

[0018] Injection rate = Manul × RLV × (1-ICG R15%) / k

[0019] Wherein, Manul represents the preset baseline value, ICG R15% represents the test result of the 15-minute retention rate of indocyanine green, k is a constant, and the value range of k is 0.95-1.00.

[0020] Preferably, the preset value of the parameter Auto is:

[0021] When the liver texture is normal, Auto=0.05-0.07 mg / min;

[0022] When the liver texture is mild cirrhosis, Auto=0.04-0.06 mg / min;

[0023] When the liver texture is moderate cirrhosis, Auto=0.03-0.05 mg / min;

[0024] When the liver texture condition is severe cirrhosis, Auto=0.02-0.04 mg / min;

[0025] When the liver texture is cholestatic cirrhosis, Auto=0.02-0.04mg / min;

[0026] And / or, the preset value of the parameter Manul is Manul=0.05-0.07 mg / min.

[0027] Preferably, the preset value of the parameter Auto is:

[0028] When the liver texture is normal, Auto=0.05 mg / min;

[0029] When the liver texture is mild cirrhosis, Auto=0.04mg / min;

[0030] When the liver texture condition is moderate cirrhosis, Auto=0.03 mg / min;

[0031] When the liver texture condition is severe cirrhosis, Auto=0.02mg / min;

[0032] When the liver texture is cholestatic cirrhosis, Auto=0.02 mg / min;

[0033] And / or, the preset value of the parameter Manul is Manul = 0.05 mg / min.

[0034] Preferably, in the fluorescent developer, the concentration of the fluorescent substance is 0.01-0.07 mg / ml;

[0035] The default value of the parameter Auto is:

[0036] When the liver texture is normal, Auto=1-2 ml / min;

[0037] When the liver texture is mild cirrhosis, Auto=0.8-1.6 ml / min;

[0038] When the liver texture is moderate cirrhosis, Auto=0.6-1.2 ml / min;

[0039] When the liver texture is severe cirrhosis, Auto=0.4-1 ml / min;

[0040] When the liver texture is cholestatic cirrhosis, Auto=0.4-2 ml / min;

[0041] And / or, the preset value of the parameter Manul is Manul = 1-2 ml / min.

[0042] Preferably, in the fluorescent developer, the concentration of the fluorescent substance is 0.01 mg / ml;

[0043] The default value of the parameter Auto is:

[0044] When the liver texture is normal, Auto=1 ml / min;

[0045] When the liver texture is mild cirrhosis, Auto=0.8 ml / min;

[0046] When the liver texture is moderate cirrhosis, Auto=0.6 ml / min;

[0047] When the liver texture condition is severe cirrhosis, Auto=0.4 ml / min;

[0048] When the liver texture is cholestatic cirrhosis, Auto=0.4 ml / min;

[0049] And / or, the preset value of the parameter Manul is Manul = 1 ml / min.

[0050] Preferably, the fluorescent developer is indocyanine green or a complex containing indocyanine green, and the complex containing indocyanine green is a complex formed by indocyanine green and human serum albumin at a molar mass ratio of 1:(3-10.5).

[0051] The present invention also provides a fluorescent developer synthesis injection pump, comprising:

[0052] A solution containing and delivering component, used for preparing and / or storing fluorescent developer, and delivering fluorescent developer;

[0053] A driving component, used for driving the fluorescent contrast agent into the patient's body;

[0054] A control system is integrated with the above-mentioned fluorescent contrast agent synthesis injection control system, and the firmware of the control system can control the movement of the driving component according to the calculation results of the fluorescent contrast agent synthesis injection control system, so that the fluorescent contrast agent is injected into the patient's body according to the calculated injection rate.

[0055] Preferably, it also includes:

[0056] The temperature control component is used to control the temperature of the fluorescent developer at 32-42°C.

[0057] Preferably, the temperature control component is used to control the temperature of the fluorescent developer at 37°C.

[0058] Preferably, the solution containing and delivering component is a disposable component or a replaceable component.

[0059] The present invention also provides a computer-readable storage medium on which a computer program is stored, and the computer program is used to implement the above-mentioned fluorescent developer synthesis injection control system.

[0060] definition:

[0061] In the present invention, "liver texture" refers to the classification judgment that doctors can make when observing liver texture during surgery. The judgment criteria are: satisfying the "morphological characteristics" and meeting at least one of the "objective indicators". The morphological characteristics and objective indicators are as follows:

[0062] Normal:

[0063] Morphological characteristics:

[0064]

[0065] Objective indicators: ICG R15% ≤ 10% or Child-Pugh score of liver function is A.

[0066] Mild cirrhosis:

[0067] Morphological characteristics:

[0068]

[0069] Objective indicators: 10%<ICG R15%≤20% or Child-Pugh score of liver function is A.

[0070] Moderate cirrhosis:

[0071] Morphological characteristics:

[0072]

[0073] Objective indicators: 20%<ICG R15%≤30% or Child-Pugh score of liver function is B.

[0074] Severe cirrhosis:

[0075] Morphological characteristics:

[0076]

[0077] Objective indicators: ICG R15%>30% or Child-Pugh score of liver function is C.

[0078] Cholestatic cirrhosis (CC):

[0079] Morphological characteristics:

[0080]

[0081] Objective indicators: liver function total bilirubin ≧100umol / L.

[0082] The classification and judgment criteria for liver texture are formulated with reference to the following literature:

[0083] 1. Makuuchi M, Thai BL, Takayama T, et al. Preoperative portal veinembolization to increase safety of major hepatectomy for hilar bileductcarcinoma: a preliminary report. Surgery . 1994;115(4):444-449. doi:10.1016 / 0039-6060(94)90196-1;

[0084] 2. Gotoh M, Miyata Y, Hashimoto S, et al. Indocyanine green clearance test for evaluating liver function. HepatologyResearch . 1995;2(2):123-135.doi:10.1016 / 1386-6346(95)00003-X;

[0085] 3、Kobayashi Y, Kishi Y, Tanaka H, et al. Evaluation of liver functionfor hepaticresection for hepatocellular carcinoma in Child-Pugh Bpatients. World Journal of Surgery . 2014;38(5):1122-1131. doi:10.1007 / s00268-013-2297-8;

[0086] 4、Takahashi Y, Hasegawa K, Aoki T, et al. Preoperative assessment ofliver function for surgical decision making in patients with hepatocellularcarcinoma. Annals of Surgery . 2018;267(6):991-998. doi:10.1097 / SLA.0000000000002609;

[0087] 5、Yokoyama Y, Ebata T, Igami T, et al. Risk assessment forpostoperative liver failure based on ICGclearance in liver surgery. Liver International . 2019;39(5):957-964. doi:10.1111 / liv.14062;

[0088] 6、Fukuda S, Imai K, Yamada M, et al. ICG-R15 as a predictor ofcomplications after hepatectomy for hepatocellular carcinoma in patients withcirrhosis. Journal of Hepatology . 2017;67(6):1151-1159. doi:10.1016 / j.jhep.2016.11.021;

[0089] 7. Watanabe Y, Sato S, Kubota K, et al. Correlation between ICG-R15 and liver fibrosis in patients with chronic liver disease. Hepatology . 2013;57(4):1393-1399. doi:10.1016 / j.hep.2013.04.021.

[0090] An existing test method is the "15-minute retention rate of indocyanine green" (ICG R15%), which is a test used to assess liver function. In this test, after intravenous injection, indocyanine green is selectively taken up by the liver and excreted through the bile. By measuring the percentage of ICG remaining in the blood after 15 minutes, the functional status of the liver can be assessed.

[0091] "The remaining liver parenchyma that requires fluorescent counterstaining for the proposed surgical procedure" refers to the normal liver parenchyma tissue that remains and needs to be protected after the liver tissue where the lesion is located is removed.

[0092] In the present invention, the unit of "molar mass ratio" is g / mol.

[0093] The present invention provides a system capable of calculating the optimal injection rate for near-infrared fluorescence navigation laparoscopic liver resection, and an injection pump integrated with the system that can automatically calculate and control the injection rate during surgery. The system and injection pump of the invention can provide the most suitable injection rate for a specific surgical patient, thereby achieving the best fluorescence imaging effect and realizing more accurate liver segment positioning, thereby improving the accuracy of the surgery and the treatment effect. Therefore, the system and injection pump of the present invention have a good application prospect.

[0094] Obviously, according to the above contents of the present invention, in accordance with common technical knowledge and customary means in the art, without departing from the above basic technical ideas of the present invention, other various forms of modification, replacement or change may be made.

[0095] The above contents of the present invention are further described in detail below through specific implementation methods in the form of embodiments. However, this should not be understood as the scope of the above subject matter of the present invention being limited to the following examples. All technologies realized based on the above contents of the present invention belong to the scope of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0096] Figure 1 The working principle and control panel design schematic diagram of the injection pump in Example 2, wherein (A) is a schematic diagram of the working principle of the injection pump; (B) is a schematic diagram of the control panel design.

[0097] Figure 2 The figures are the experimental results of Experimental Example 1, where (A) is an example of fluorescent development in mouse liver; (B) is an example of placing mice in an in vivo imager for near-infrared in vivo fluorescence imaging intensity analysis; (C) is a fluorescence imaging intensity experimental result diagram of different ICG@HSA solution concentrations; and (D) is a fluorescence imaging intensity experimental result diagram of different injection rates.

[0098] Figure 3 This is a graph showing the temperature optimization experimental results of Experimental Example 2. DETAILED DESCRIPTION

[0099] In the following examples and experimental examples, reagents and raw materials not specifically described are all commercially available. Algorithms for data collection, transmission, storage and processing steps not specifically described in the examples, as well as hardware structures, circuit connections, etc. not specifically described can all be implemented through the disclosed content of the prior art.

[0100] Example 1 Fluorescent developer synthesis injection control system

[0101] The system of this embodiment is used to assist in calculating the injection rate of the fluorescent contrast agent in near-infrared fluorescence navigation laparoscopic liver resection.

[0102] The system of this embodiment includes an input module and a calculation module, and the calculation module includes a first calculation module, a second calculation module, or a combination of the two.

[0103] The configuration of each module is as follows:

[0104] An input module is configured to input a liver texture condition or an indocyanine green 15-minute retention rate (ICG R15%) test result, and a percentage of the remaining liver parenchyma that needs fluorescent counterstaining for a proposed surgical approach;

[0105] The first calculation module is configured to calculate the injection rate of the fluorescent contrast agent when the input is the liver texture condition;

[0106] The second calculation module is configured to calculate the injection rate of the fluorescent developer when the input is the test result of the 15-minute retention rate of indocyanine green.

[0107] in,

[0108] In a specific operation, either the liver texture or the ICG R15% test result can be selected for input. For cases where the preoperative liver reserve function ICG R15% has been completed, the ICG R15% test result can be directly input, and the optimal injection rate can be calculated by the second calculation module. For cases where the preoperative liver reserve function ICGR15% has not been completed, the doctor observes the liver texture during the operation and inputs the observation results, and the optimal injection rate is calculated by the first calculation module.

[0109] The liver texture condition is the result of classifying the patient's liver into five types: normal, mild cirrhosis, moderate cirrhosis, severe cirrhosis and cholestatic cirrhosis. The judgment criteria are: meeting the "morphological characteristics" and at least one of the "objective indicators". The morphological characteristics and objective indicators are as follows:

[0110] Normal:

[0111] Morphological characteristics:

[0112]

[0113] Objective indicators: ICG R15% ≤ 10% or Child-Pugh score of liver function is A.

[0114] Mild cirrhosis:

[0115] Morphological characteristics:

[0116]

[0117] Objective indicators: 10%<ICG R15%≤20% or Child-Pugh score of liver function is A.

[0118] Moderate cirrhosis:

[0119] Morphological characteristics:

[0120]

[0121] Objective indicators: 20%<ICG R15%≤30% or Child-Pugh score of liver function is B.

[0122] Severe cirrhosis:

[0123] Morphological characteristics:

[0124]

[0125] Objective indicators: ICG R15%>30% or Child-Pugh score of liver function is C.

[0126] Cholestatic cirrhosis (CC):

[0127] Morphological characteristics:

[0128]

[0129] Objective indicators: liver function total bilirubin ≧100umol / L.

[0130] The injection rate calculation formula in the first calculation module is:

[0131] Injection rate = Auto × RLV

[0132] Among them, Auto represents the preset baseline value for different liver texture conditions, and RLV represents the percentage of the remaining liver parenchyma that requires fluorescent counterstaining for the proposed surgical approach.

[0133] The injection rate calculation formula in the second calculation module is:

[0134] When ICG R15% ≤ 5%,

[0135] Injection rate = Manul × RLV

[0136] When ICG R15%>5%,

[0137] Injection rate = Manul × RLV × (1-ICG R15%) / k

[0138] Wherein, Manul represents a preset baseline value, ICG R15% represents the test result of the 15-minute retention rate of indocyanine green, and the value range of the constant k is 0.95-1.00, and in this embodiment, it is set to 0.95.

[0139] In this embodiment, the injected fluorescent imaging agent is a solution of a complex formed by indocyanine green and human serum albumin at a molar mass ratio of 1:6 in physiological saline (ICG@HSA solution). The concentration of the complex in the ICG@HSA solution is 0.01 mg / ml.

[0140] The default value of the parameter Auto is:

[0141] When the liver texture is normal, Auto=0.05 mg / min (equivalent to 5 ml / min);

[0142] When the liver texture is mild cirrhosis, Auto=0.04 mg / min (equivalent to 4 ml / min);

[0143] When the liver texture is moderate cirrhosis, Auto=0.03 mg / min (equivalent to 3 ml / min);

[0144] When the liver texture condition is severe cirrhosis, Auto=0.02 mg / min (equivalent to 2 ml / min);

[0145] When the liver texture is cholestatic cirrhosis, Auto=0.02 mg / min (equivalent to 2 ml / min);

[0146] The default value of the parameter Manul is Manul = 0.05 mg / min (equivalent to 5 ml / min).

[0147] In this embodiment, the design principle of the calculation method of the calculation module is: for patients with ICG R15% test results, the second calculation module can be used to calculate the injection rate. The higher the ICG R15% test result value, the deeper the liver cirrhosis of the patient. At this time, the slower the injection rate, the better the effect of fluorescence imaging. On the other hand, the lower the RLV ratio, the slower the injection rate, the better the effect of fluorescence imaging. Parameters Manul and k are empirical parameters that can be fine-tuned according to the actual fluorescence imaging effect.

[0148] For hospitals that do not have the conditions to perform ICG R15% testing, the first calculation module can be used. The principle of the calculation formula is that the doctor confirms the patient's liver texture during surgery and assigns different values ​​to the parameter Auto in the formula according to the different liver textures. The different values ​​of the parameter Auto also reflect the characteristic that the deeper the patient's liver cirrhosis, the slower the injection rate needs to be.

[0149] In other embodiments, the fluorescent developer may also be free indocyanine green or other complexes containing indocyanine green. The parameters Auto and Manul may also be fine-tuned according to the concentration of the fluorescent developer and the actual development effect.

[0150] Example 2 Fluorescent contrast agent synthesis injection pump for near-infrared fluorescence navigation laparoscopic liver resection

[0151] The basic structure of the injection pump of this embodiment can be implemented with reference to the prior art, and the fluorescent developer synthesis injection control system described in Example 1 is integrated into the control system.

[0152] Specifically, the injection pump of this embodiment is as follows Figure 1 As shown in A, including:

[0153] A solution containing and delivering component, used for preparing and / or storing fluorescent developer, and delivering fluorescent developer;

[0154] A driving component, used for driving the fluorescent contrast agent into the patient's body;

[0155] A control system, integrated with the fluorescent contrast agent synthetic injection control system described in Example 1, wherein the firmware of the control system can control the movement of the driving component according to the calculation result of the fluorescent contrast agent synthetic injection control system, so that the fluorescent contrast agent is injected into the patient's body according to the calculated injection rate;

[0156] The temperature control component is used to control the temperature of the fluorescent developer at 37°C.

[0157] As a preferred method, in order to facilitate the input of necessary parameters, on the control panel of the injection pump (such as Figure 1 B), several selection buttons can be set, each button corresponds to a different injection rate calculation formula and a different baseline value. For example, set the "Manul" button, enter the manual mode after selection, and further use the numeric keys (or the gear selection keys divided by the threshold) to enter RLV and ICG R15%, and then get the calculation result; set the "Auto" button, enter the automatic mode after selection, and further use different buttons to select the classification result of liver texture, and then use the numeric keys (or the gear selection keys divided by the threshold) to enter RLV, and then get the calculation result.

[0158] By using the injection pump of this embodiment, the fluorescent contrast agent injection control system can be used during surgery to calculate the optimal injection rate for the surgical patient, control the driving speed of the driving component, and control the injection rate of the fluorescent contrast agent according to the calculated result.

[0159] The technical effects of the present invention are further described by experiments. It should be noted that a specific ratio and concentration of the complex of the fluorescent developer are defined in the following experimental examples. In actual research, the present invention also tests other ratios and concentration ranges, and the performance of the experimental results is the same as that of the embodiments provided below, that is, when the molar mass ratio of indocyanine green to human serum albumin is in the range of 1:(3-10.5) and the concentration is in the range of 0.01-0.07 mg / ml, the injection rate determined according to the method of the present invention can achieve enhanced fluorescence intensity.

[0160] Experimental Example 1 Optimization of Baseline Speed

[0161] 1. Experimental Methods

[0162] In vitro, indocyanine green (ICG, Redo, Dandong Yichuang Pharmaceutical Co., Ltd.) and human serum albumin (HSA, CSL Behring GmbH) were dissolved and combined in physiological saline at a molar mass ratio of 1:6 to form ICG@HSA inclusions to obtain ICG@HSA solution.

[0163] In the in vivo animal experiment, a fluorescent endoscope system was used to observe the fluorescence of the liver after different concentrations of ICG@HSA solution (molar mass ratio = 1:6; temperature = 37°C) were injected into the mouse tail via a micro-pump pulse (the left hepatic pedicle of the mouse was ligated and blocked). The injection was stopped when the mouse liver showed fluorescence. The mouse was placed in a living imager for near-infrared living fluorescence imaging intensity analysis. The detection time points were 1 hour, 2 hours, 3 hours, and 4 hours (such as Figure 2 B).

[0164] 2. Experimental Results

[0165] An example of fluorescence imaging is shown in the figure below. Figure 2 A. Comparison of ICG@HSA solutions with different concentrations showed that Figure 2 As shown in Figure C, under the condition of an injection speed of 0.01 mg / min, the ICG@HSA solution has a better fluorescence development effect when the complex concentration is above 0.01 mg / ml, especially when the complex concentration is 0.01 mg / ml, it has the best fluorescence development effect. Figure 2 As shown in D, when the concentration of the complex in the ICG@HSA solution is 0.01 mg / ml, the injection rate is above 0.03 mg / min and has a better fluorescence development effect, especially when the injection rate is 0.05 mg / min, it has the best fluorescence development effect.

[0166] In summary, the optimal injection method is 0.01 mg / ml ICG@HSA complex concentration and 0.05 mg / min injection speed in normal mice. The experimental results provide a reference standard for the concentration and speed of ICG@HSA in human body, which can be used as a reference value for determining the parameters in the injection rate calculation formula.

[0167] Experimental Example 2 Optimization of injection temperature

[0168] 1. Experimental Methods

[0169] Indocyanine green (ICG, Redo, Dandong Yichuang Pharmaceutical Co., Ltd.) and human serum albumin (HSA, CSL Behring GmbH) were dissolved and combined in physiological saline at a molar mass ratio of 1:6 to form ICG@HSA inclusions and obtain ICG@HSA solution. UV absorption spectra were tested at different temperatures for 0-48 h.

[0170] 2. Experimental Results

[0171] The results are as follows Figure 3 As shown in the figure, within the room temperature range, the stability of the complex is best at a solution temperature of 37°C. Therefore, 37°C is the optimal injection temperature.

[0172] Experimental Example 3 Effect of injection rate on fluorescence imaging effect

[0173] 1. Experimental Methods

[0174] The experimental group and the control group each included 31 patients who underwent near-infrared fluorescence navigation laparoscopic liver resection and their surgical videos were used to evaluate the fluorescence effect.

[0175] The experimental group used the system of Example 1 to calculate the injection rate and the injection pump of Example 2 for injection, so all the patients enrolled had normal liver or mild cirrhosis of the liver (classified according to the liver texture judgment standard of Example 1, and the injection rate was calculated by the first calculation module). Among them, there were 23 normal livers and 8 mild cirrhosis of the liver. The control group used the traditional injection speed (injection volume 1-2ml direct peripheral vein rapid injection, injection completed in about 5 seconds). The fluorescence effect scores during the two groups were compared.

[0176] 2. Experimental Results

[0177] The fluorescence effect score of the experimental group using the system of Example 1 to calculate the injection rate was 4.78 ± 0.92 (n=31), and the fluorescence effect score of the control group using the traditional injection rate was 3.99 ± 1.01 (n=31). P=0.002 between the two groups, which was significantly different.

[0178] It can be seen from the above experimental results that using the system of Example 1 to calculate the injection rate can effectively improve the fluorescence imaging effect in infrared fluorescence navigation laparoscopic hepatectomy.

[0179] In addition, for patients with ICG R15% test results (calculated using the second calculation module), patients with moderate cirrhosis (calculated using the first calculation module), patients with severe cirrhosis (calculated using the first calculation module) and patients with cholestatic cirrhosis (calculated using the first calculation module), clinical experimental results also show that the injection rate calculated by the system of Example 1 can improve the fluorescence imaging effect.

[0180] It can be seen from the above embodiments and experimental examples that the present invention provides a system capable of calculating the optimal injection rate in infrared fluorescence navigation laparoscopic liver resection and an injection pump integrated with the system, which can effectively improve the effect of fluorescence imaging, thereby ensuring the accuracy of the operation and the therapeutic effect, and has a good application prospect.

Claims

1. A fluorescent developer synthetic injection control system, characterized in that: Used to assist in calculating the injection rate of fluorescent contrast agent in near-infrared fluorescence navigation laparoscopic liver resection, comprising an input module and a calculation module, wherein the calculation module comprises one of a first calculation module and a second calculation module or a combination of the two; The input module is configured to input the test results of liver texture or 15-minute retention rate of indocyanine green, and the percentage of remaining liver parenchyma that requires fluorescent counterstaining for the proposed surgical method; the liver texture is the result of classifying the patient's liver into five types: normal, mild cirrhosis, moderate cirrhosis, severe cirrhosis, and cholestatic cirrhosis; The first calculation module is configured to calculate the injection rate of the fluorescent contrast agent when the input is the liver texture condition, and the calculation formula is: Injection rate = Auto × RLV Among them, Auto represents the preset baseline value for different liver texture conditions, and RLV represents the percentage of the remaining liver parenchyma that needs fluorescent counterstaining for the proposed surgical approach; The second calculation module is configured to calculate the injection rate of the fluorescent developer when the input is the test result of the 15-minute retention rate of indocyanine green, and the calculation formula is: When ICG R15% ≤ 5%, Injection rate = Manul × RLV When ICG R15%>5%, Injection rate = Manul × RLV × (1-ICG R15%) / k Wherein, Manul represents the preset baseline value, ICG R15% represents the test result of the 15-minute retention rate of indocyanine green, k is a constant, and the value range of k is 0.95-1.

00.

2. The fluorescent developer synthetic injection control system according to claim 1, characterized in that: The default value of the parameter Auto is: When the liver texture is normal, Auto=0.05-0.07 mg / min; When the liver texture is mild cirrhosis, Auto=0.04-0.06 mg / min; When the liver texture is moderate cirrhosis, Auto=0.03-0.05 mg / min; When the liver texture condition is severe cirrhosis, Auto=0.02-0.04 mg / min; When the liver texture is cholestatic cirrhosis, Auto=0.02-0.04mg / min; And / or, the preset value of the parameter Manul is Manul=0.05-0.07 mg / min.

3. The fluorescent developer synthetic injection control system according to claim 2, characterized in that: The default value of the parameter Auto is: When the liver texture is normal, Auto=0.05 mg / min; When the liver texture is mild cirrhosis, Auto=0.04mg / min; When the liver texture condition is moderate cirrhosis, Auto=0.03 mg / min; When the liver texture condition is severe cirrhosis, Auto=0.02mg / min; When the liver texture is cholestatic cirrhosis, Auto=0.02mg / min; And / or, the preset value of the parameter Manul is Manul = 0.05 mg / min.

4. The fluorescent developer synthetic injection control system according to claim 1, characterized in that: In the fluorescent developer, the concentration of the fluorescent substance is 0.01-0.07 mg / ml; The default value of the parameter Auto is: When the liver texture is normal, Auto=1-2 ml / min; When the liver texture is mild cirrhosis, Auto=0.8-1.6 ml / min; When the liver texture is moderate cirrhosis, Auto=0.6-1.2 ml / min; When the liver texture is severe cirrhosis, Auto=0.4-1 ml / min; When the liver texture is cholestatic cirrhosis, Auto=0.4-2 ml / min; And / or, the preset value of the parameter Manul is Manul = 1-2 ml / min.

5. The fluorescent developer synthetic injection control system according to claim 4, characterized in that: In the fluorescent developer, the concentration of the fluorescent substance is 0.01 mg / ml; The default value of the parameter Auto is: When the liver texture is normal, Auto=1 ml / min; When the liver texture is mild cirrhosis, Auto=0.8 ml / min; When the liver texture is moderate cirrhosis, Auto=0.6 ml / min; When the liver texture condition is severe cirrhosis, Auto=0.4 ml / min; When the liver texture is cholestatic cirrhosis, Auto=0.4 ml / min; And / or, the preset value of the parameter Manul is Manul = 1 ml / min.

6. The fluorescent developer synthetic injection control system according to any one of claims 1 to 5, characterized in that: The fluorescent developer is indocyanine green or a complex containing indocyanine green. The complex containing indocyanine green is a complex formed by indocyanine green and human serum albumin at a molar mass ratio of 1:(3-10.5).

7. A fluorescent developer synthesis injection pump, characterized in that: include: A solution containing and delivering component, used for preparing and / or storing fluorescent developer, and delivering fluorescent developer; A driving component, used for driving the fluorescent contrast agent into the patient's body; A control system, integrating the fluorescent contrast agent synthetic injection control system according to any one of claims 1 to 6, wherein the firmware of the control system can control the movement of the driving component according to the calculation result of the fluorescent contrast agent synthetic injection control system, so that the fluorescent contrast agent is injected into the patient's body at the calculated injection rate.

8. The fluorescent developer synthesis injection pump according to claim 7, characterized in that: Also includes: The temperature control component is used to control the temperature of the fluorescent developer at 32-42°C.

9. The fluorescent developer synthesis injection pump according to claim 7, characterized in that: The solution containing and delivering assembly may be a disposable component or a replaceable component.

10. A computer-readable storage medium, characterized in that: A computer program is stored thereon, and the computer program is used to implement the fluorescent contrast agent synthesis injection control system as described in any one of claims 1-6.

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