Catheter insertion difficulty determination device, blood vessel model producing device, blood vessel model, catheter insertion difficulty determination method, program for determining difficulty of catheter insertion, and recording medium

Abstract

To provide a catheter insertion difficulty determination device and the like capable of objectively determining insertion difficulty of a catheter into a blood vessel without referring to a lot of pieces of case information.SOLUTION: A catheter insertion difficulty determination device comprises: an image data input part 3 which acquires image information equivalent to a photographed image of a human blood vessel; an image analysis part 4 which detects a traveling mode of the blood vessel based on the acquired image information; and a scoring part 1A and a determination part 1B which determine the insertion difficulty of the catheter based on a predetermined scoring table T indicating the insertion difficulty of the catheter with respect to the blood vessel for each of a plurality of difficulty evaluation items corresponding to the traveling mode of the blood vessel and the detected traveling mode.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention belongs to the technical field of a catheter insertion difficulty determination device, a blood vessel model manufacturing device, a blood vessel model, a catheter insertion difficulty determination method, a program for the catheter insertion difficulty determination device, and a recording medium for recording the program. More specifically, it belongs to the technical field of a catheter insertion difficulty determination device and a catheter insertion difficulty determination method for determining the difficulty when inserting a catheter into a human blood vessel, a program for the catheter insertion difficulty determination device, a recording medium for recording the program, a blood vessel model manufacturing device using difficulty information indicating the difficulty, and a blood vessel model manufactured by the blood vessel model manufacturing device.

Background Art

[0002] In recent years, various types of catheters have been developed and actually used for catheters passed through human blood vessels for treatment. At this time, as the number of types of catheters increases, the need to appropriately select the actually used catheter is increasing. As a document disclosing the prior art regarding such a catheter selection method, for example, Patent Document 1 below can be cited.

[0003] The prior art disclosed by this Patent Document 1 aims to "be able to propose a catheter suitable for surgery before surgery." In the prior art, "disease information of the surgery and blood vessel information regarding the shape of a part of the patient's blood vessels that can come into contact with the catheter and apply a backup force to the catheter are acquired, and the shape of the catheter used in a past similar surgery where the surgery and the disease information match and the surgery and the blood vessel information are similar is acquired. Based on the comparison result of comparing the blood vessel information of the surgery and the blood vessel information of the past similar surgery, the shape of the catheter used in the past similar surgery is modified, and the catheter with the modified shape is proposed as the catheter to be actually used."

Prior Art Documents

Patent Documents

[0004] Patent Document 1 Japanese Patent No. 6979470 Summary of the Invention Problems to be Solved by the Invention

[0005] However, in the prior art disclosed in the above Patent Document 1, it is necessary to derive a coincidence rate from the comparison between the blood vessel information of the target patient and the blood vessel information of past similar surgeries, and there is a problem that a large amount of past blood vessel data is required to improve the accuracy of catheter selection. In addition, since the main target of the prior art disclosed in the above Patent Document 1 is a catheter passed through the coronary artery of the heart (the coronary artery has few arterial variations and only the right coronary artery and the left coronary artery), the types of catheters for this purpose are few, and since it is easy to select the optimal catheter if the arterial shape of the patient is known, it cannot be applied to general arteries (blood vessels) other than the above coronary artery, and as a result, there is also a problem of poor versatility.

[0006] Therefore, the present invention has been made in view of the above problems, and an example of the problem is a catheter insertion difficulty determination device and a catheter insertion difficulty determination method capable of objectively determining the difficulty of inserting a catheter into a blood vessel without referring to a large amount of case information, a program for the catheter insertion difficulty determination device, a recording medium recording the program, and a blood vessel model production device using difficulty information indicating the difficulty and a blood vessel model produced by the blood vessel model production device. Means for Solving the Problems

[0007] In order to solve the above problems, the invention according to claim 1 includes: an image information acquisition means for acquiring image information corresponding to an image showing a human blood vessel; a detection means for detecting a running pattern of the blood vessel based on the acquired image information; a preset difficulty index indicating the difficulty of inserting a catheter into the blood vessel for each of a plurality of difficulty evaluation items corresponding to the running pattern; and a determination means for determining the difficulty based on the detected running pattern.

[0008] In order to solve the above problems, the invention according to claim 10 is a method for determining the difficulty of inserting a catheter, which is executed in a catheter insertion difficulty determination device including an image information acquisition means, a detection means, and a determination means. The method includes: an image information acquisition step of acquiring, by the image information acquisition means, image information corresponding to an image showing a human blood vessel; a detection step of detecting, by the detection means, a running pattern of the blood vessel based on the acquired image information; and a determination step of determining, by the determination means, the difficulty based on a preset difficulty index indicating the difficulty of inserting the catheter into the blood vessel for each of a plurality of difficulty evaluation items corresponding to the running pattern and the detected running pattern.

[0009] In order to solve the above problems, the invention according to claim 11 causes a computer included in a catheter insertion difficulty determination device to function as an image information acquisition means for acquiring image information corresponding to an image showing a human blood vessel, a detection means for detecting a running pattern of the blood vessel based on the acquired image information, and a determination means for determining the difficulty based on a preset difficulty index indicating the difficulty of inserting the catheter into the blood vessel for each of a plurality of difficulty evaluation items corresponding to the running pattern and the detected running pattern.

[0010] In order to solve the above problems, the invention according to claim 12 is such that the program for determining the difficulty of inserting a catheter according to claim 11 is recordable in a readable manner by the computer.

[0011] According to the invention described in any one of claim 1 or claims 10 to 12, the difficulty level is determined based on a difficulty index indicating the difficulty of catheter insertion for each of a plurality of items corresponding to the running pattern of blood vessels, and the running pattern of the blood vessels detected based on an image showing the blood vessels. Therefore, without referring to a large amount of case information, the difficulty of catheter insertion can be objectively determined. Also, by using the objectively determined difficulty of insertion, the versatility of catheter selection can be enhanced.

[0012] In order to solve the above problems, the invention described in claim 2 is the catheter insertion difficulty determination device described in claim 1, wherein the plurality of difficulty evaluation items are: (i) the angle formed by the direction of the aorta through which the catheter is to be passed and the direction of the first branch artery that branches from the aorta and through which the catheter is to be passed; (ii) the angles formed by the directions of each of the consecutive first branch arteries; (iii) the ratio of the width of the dilated portion of the first branch artery to the width of the constricted portion of the first branch artery; (iv) the ratio of the width of the first branch artery to the width of the second branch artery that further branches from the first branch artery and through which the catheter is to be passed; and (v) the number of meanders in the first branch artery.

[0013] According to the invention described in claim 2, in addition to the effects of the invention described in claim 1, the plurality of difficulty evaluation items are the angle formed by the direction of the aorta and the direction of the first branch artery, the angles formed by the directions of each of the consecutive first branch arteries, the ratio of the width of the dilated portion of the first branch artery to the width of the constricted portion of the first branch artery, the ratio of the width of the first branch artery to the width of the second branch artery, and the number of meanders in the first branch artery. Therefore, by using difficulty evaluation items along the actual running pattern of the blood vessels through which the catheter is to be passed, the difficulty of catheter insertion can be determined more objectively.

[0014] In order to solve the above problems, the invention described in claim 3 is the catheter insertion difficulty determination device described in claim 2, wherein the aorta is the abdominal aorta, the first branch artery is the celiac artery, and the second branch artery is the common hepatic artery.

[0015] According to the invention described in claim 3, in addition to the effect of the invention described in claim 2, since the aorta is the abdominal aorta, the first branch artery is the celiac artery, and the second branch artery is the common hepatic artery, by using the difficulty evaluation items along the running pattern of the abdominal aorta or the like through which the catheter is passed, the difficulty of inserting the catheter can be determined more objectively.

[0016] In order to solve the above problems, the invention described in claim 4 is configured such that, in the catheter insertion difficulty determination device described in any one of claims 1 to 3, the difficulty index is preset numerical data indicating the difficulty for each of the plurality of difficulty evaluation items.

[0017] According to the invention described in claim 4, in addition to the effect of the invention described in any one of claims 1 to 3, since the difficulty index is preset numerical data indicating the difficulty of catheter insertion for each of the plurality of difficulty evaluation items, the difficulty of catheter insertion can be determined more objectively.

[0018] In order to solve the above problems, the invention described in claim 5 further includes a recording means for pre-recording the difficulty index for each of the difficulty evaluation items in the catheter insertion difficulty determination device described in any one of claims 1 to 3, and the determination means is configured to read the recorded difficulty index from the recording means and use it for determining the difficulty.

[0019] According to the invention described in claim 5, in addition to the effect of the invention described in any one of claims 1 to 3, the difficulty index for each of the difficulty evaluation items is pre-recorded, and the recorded difficulty index is read out to determine the difficulty, so that the difficulty of catheter insertion can be determined objectively and uniformly while eliminating human factors.

[0020] In order to solve the above problems, the invention according to claim 6 is configured to use difficulty information indicating the difficulty level determined by the determination means when selecting and determining the catheter to be actually inserted into the person in the catheter insertion difficulty determination device according to any one of claims 1 to 3.

[0021] According to the invention described in claim 6, in addition to the operation of the invention described in any one of claims 1 to 3, since difficulty information is used when selecting and determining the catheter to be actually inserted, the selection and determination can be objectively performed.

[0022] In order to solve the above problems, the invention according to claim 7 further includes output means for outputting difficulty information indicating the difficulty level determined by the determination means to a blood vessel model manufacturing device for manufacturing a blood vessel model used for preoperative examination of the catheter insertion mode in the catheter insertion difficulty determination device according to any one of claims 1 to 3.

[0023] According to the invention described in claim 7, in addition to the operation of the invention described in any one of claims 1 to 3, since difficulty information is output to the blood vessel model manufacturing device for manufacturing a blood vessel model, a blood vessel model can be manufactured according to the difficulty level of catheter insertion.

[0024] In order to solve the above problems, the invention according to claim 8 includes manufacturing means for manufacturing the blood vessel model three-dimensionally according to the difficulty level based on the difficulty information output from the catheter insertion difficulty determination device according to claim 7.

[0025] According to the invention described in claim 8, since a three-dimensional blood vessel model is manufactured based on the difficulty information, a blood vessel model that can be effectively used for catheter insertion training can be manufactured.

[0026] In order to solve the above problems, the blood vessel model of the invention according to claim 9 is produced by the blood vessel model production device according to claim 8 in accordance with the difficulty level and three-dimensionally.

[0027] According to the invention described in claim 9, since it is produced three-dimensionally according to the difficulty level by the model determination device described in claim 8, catheter insertion training can be effectively performed.

Advantages of the Invention

[0028] According to the present invention, the difficulty level is determined based on a difficulty level index indicating the difficulty level of catheter insertion for each of a plurality of items corresponding to the running mode of the blood vessel and the running mode of the blood vessel detected based on an image showing the blood vessel.

[0029] Therefore, it is possible to objectively determine the difficulty level of catheter insertion without referring to a large amount of case information. In addition, by using the objectively determined insertion difficulty level, the versatility of catheter selection can also be enhanced.

Brief Description of the Drawings

[0030]

Figure 1

Figure 2

Figure 3

Modes for Carrying Out the Invention

[0031] Next, embodiments of the present invention will be specifically described with reference to FIGS. 1 to 3. The embodiments described below are embodiments when the present invention is applied to a catheter management system that performs management processing of the catheter including selection of a catheter used for a surgery related to blood vessels. FIG. 1 is a block diagram showing an outline configuration of the catheter management system of the embodiment, FIG. 2 is a diagram for explaining the contents of the scoring table of the embodiment, and FIG. 3 is a flowchart showing the catheter management processing of the embodiment.

[0032] As shown in FIG. 1, the catheter management system SS of the embodiment is composed of an image inspection device C that takes a CT (Computed Tomography) image or an MRI (Magnetic Resonance Imaging) image for diagnosis, a catheter insertion difficulty determination device S of the embodiment, and a blood vessel model production device B that produces a blood vessel model used for training for catheter insertion. On the other hand, the above-mentioned catheter insertion difficulty determination device (hereinafter simply referred to as the "insertion difficulty determination device") S is composed of a processing unit 1 including a CPU (Central Processing Unit), a ROM (Read Only Memory), a RAM (Random Access Memory), etc., a recording unit 2 composed of an HDD (Hard Disc Drive) or an SSD (Solid State Drive), etc., and the scoring table T of the embodiment is recorded non-volatily, an image data input unit 3, an image analysis unit 4, a display 5 composed of a liquid crystal display, etc., and an operation unit 6 composed of a keyboard and a mouse, etc. Further, the blood vessel model production device B of the embodiment includes a production unit 10. In the above configuration, the image data input unit 3 corresponds to an example of the "image information acquisition means" of the present invention, the image analysis unit 4 corresponds to an example of the "detection means" of the present invention, the processing unit 1 corresponds to an example of the "output means" of the present invention, and the recording unit 2 corresponds to an example of the "recording means" of the present invention. Also, the production unit 10 corresponds to an example of the "production means" of the present invention.

[0033] Furthermore, the processing unit 1 is composed of a scoring unit 1A and a determination unit 1B. At this time, the scoring unit 1A and the determination unit 1B may be realized by a hardware logic circuit that constitutes the processing unit 1, or may be realized software-wise by the processing unit 1 reading out and executing a program that corresponds to the insertion difficulty determination process of the embodiment included in the catheter management process of the embodiment described later and is recorded in advance in, for example, the recording unit 2. And the scoring unit 1A and the determination unit 1B correspond to an example of the "determination means" of the present invention.

[0034] In the catheter management system SS having the above configuration, the imaging inspection device C takes a diagnostic CT image, MRI image, etc. including an image of the blood vessel of the person (patient or person undergoing the examination) into whom the catheter of the embodiment is to be inserted using the same method as in the prior art, generates image data corresponding to the image, and outputs it to the insertion difficulty determination device S. As a result, the insertion difficulty determination device S determines the difficulty of inserting the catheter corresponding to the running mode of the blood vessel that is the insertion target of the catheter based on the image data, presents the determination result to the doctor who inserts the catheter using, for example, the display 5, and generates difficulty data indicating the difficulty and outputs it to the blood vessel model production device B. Then, the production unit 10 of the blood vessel model production device B produces a three-dimensional (stereoscopic) blood vessel model, for example, according to the difficulty of inserting the catheter based on the difficulty data. The production of this blood vessel model is preferably performed by, for example, a method developed by the inventors of the present invention (specifically, refer to the paper "Morita R, Nonoyama T, et al. Mechanical Properties of 3D-Printed Transparent Flexible Resin Used for Vascular Model Simulation Compared with Porcine Arteries. JVasc Interv Radiol 2023. DOI: 10.1016 / j.jvir.2023.01.008" by the inventors). The stereoscopic blood vessel model according to the difficulty level thus produced is utilized, for example, in the subsequent catheter management listed below. (I) Sale of the vascular model marked with the difficulty level (II) Development of a design method for a catheter insertable into various blood vessels using the vascular model according to the difficulty level and production of the insertable catheter (III) Examination of a training method for catheter insertion techniques using the vascular model according to the difficulty level (IV) Simulated generation of the running patterns of blood vessels according to the difficulty level by machine learning or deep learning (deep learning) using the vascular model according to the difficulty level as teacher data and production of a new vascular model corresponding to the running patterns

[0035] On the other hand, the image data input unit 3 of the difficulty determination device S that determines the difficulty level of the insertion based on the above image data from the imaging device C acquires the image data and outputs it to the image analysis unit 4 of the difficulty determination device S. Thereby, the image analysis unit 4 analyzes / detects the running pattern of the blood vessel (that is, the blood vessel into which the catheter is inserted) shown in the image corresponding to the image data using, for example, the same automatic or manual analysis method as in the prior art, generates running pattern data indicating the detected running pattern, and outputs it to the scoring unit 1A of the processing unit 1.

[0036] Here, the running pattern in the embodiment generally refers to, for example, the thickness of the blood vessel, the direction of the blood vessel (running (advancing) direction), the intersection angle of the portions where a plurality of the blood vessels intersect, or the number of meandering portions in the blood vessel. And the image analysis unit 4 in the embodiment extracts the values of five indicators (first indicator to fifth indicator) indicating the running pattern from the image corresponding to the image data as the values of the indicators used for determining the insertion difficulty level in the embodiment, and outputs them to the scoring unit 1A as the running pattern data.

[0037] At this time, as illustrated by the CT image thereof in Fig. 2(a), the first index is the angle α formed by the direction of the abdominal aorta AO through which the catheter should be passed and the direction of the celiac artery CE. Next, as illustrated by the CT image thereof in Fig. 2(b), the second index is the angle β formed by the directions of the respective continuous celiac arteries CE through which the catheter should be passed. Further, as illustrated by the CT image thereof in Fig. 2(c), the third index is the ratio (La / Lb) of the thickness (diameter; hereinafter the same) Lb of the dilated portion of the celiac artery CE through which the catheter should be passed to the thickness La of the stenotic portion. Furthermore, as illustrated by the CT image thereof in Fig. 2(d), the fourth index is the ratio (Ld / Lc) of the thickness Ld of the celiac artery CE through which the catheter should be passed to the thickness Lc of the common hepatic artery CH. Finally, as illustrated by the CT image thereof in Fig. 2(e), the fifth index is the number of meanders (see the white arrow in Fig. 2(e)) in the celiac artery CE through which the catheter should be passed.

[0038] And the scoring unit 1A that has acquired the running mode data for each index compares the running mode data with the threshold value (threshold value of the difficulty of catheter insertion) recorded in the scoring table T, and scores the running mode data.

[0039] Here, the threshold value recorded in the scoring table T will be described with reference to Fig. 1(b). As illustrated in Fig. 1(b), in the scoring table T, scores as threshold values for quantifying the running mode data extracted from the image corresponding to the image data are described for each of the above indices. At this time, the higher the score as the threshold value, the higher (more difficult) the difficulty of catheter insertion.

[0040] More specifically, for example, as shown in Fig. 1(b), when the angle α included in the driving mode data corresponding to the first index is 45 degrees or more, the insertion difficulty is set to "1 point"; when the angle α is 30 degrees or more and less than 45 degrees, the insertion difficulty is set to "2 points"; when the angle α is less than 30 degrees, the insertion difficulty is set to "3 points". Also, when the angle β included in the driving mode data corresponding to the second index is 150 degrees or more, the insertion difficulty is set to "1 point"; when the angle β is 100 degrees or more and less than 150 degrees, the insertion difficulty is set to "2 points"; when the angle β is less than 150 degrees, the insertion difficulty is set to "3 points". Further, when the ratio (La / Lb) included in the driving mode data corresponding to the third index is less than 2, the insertion difficulty is set to "1 point"; when the ratio (La / Lb) is 2 or more and less than 3, the insertion difficulty is set to "2 points"; when the ratio (La / Lb) is 3 or more, the insertion difficulty is set to "3 points". Furthermore, when the ratio (Ld / Lc) included in the driving mode data corresponding to the fourth index is less than 2.5, the insertion difficulty is set to "1 point"; when the ratio (Ld / Lc) is 2.5 or more, the insertion difficulty is set to "2 points". Finally, when the number of the meanders included in the driving mode data corresponding to the fifth index is 0 (no meander in the celiac artery CE), the insertion difficulty is set to "1 point"; when the number of the meanders is 1, the insertion difficulty is set to "2 points"; when the number of the meanders is 2 or more, the insertion difficulty is set to "3 points". Note that the content (specific scores) of the scoring table T itself may be changed according to the accumulation of future cases and the progress of research based on such accumulation.

[0041] Then, the scoring unit 1A compares the threshold value for each of the above-described indicators described in the scoring table T with the above-described driving mode data for each indicator, and uses the addition result of the values for each threshold value to determine the difficulty level of inserting the catheter into the blood vessel shown in the above image in three levels (difficulty level "high", difficulty level "medium", and difficulty level "low"), generates difficulty level data indicating the determination result, and outputs the data to the display 5 and the production unit 10 of the blood vessel model production device B. In addition, in the determination of the insertion difficulty level of the embodiment based on the content of the scoring table T, in addition to the case of using the above addition result, for example, the insertion difficulty level may be determined using the integration result of the values for each threshold value.

[0042] At this time, for example, when the above addition result for each threshold value is 5 points, the determination unit 1B determines that the difficulty level is "low"; when the addition result is 6 points, the determination unit 1B determines that the difficulty level is "medium"; and when the addition result is 7 points or more, the determination unit 1B determines that the difficulty level is "high". For example, for an image showing a person's blood vessel, if the above angle α is 59 degrees (which is "1 point" when compared with the threshold value of the first index of the scoring table T), the above angle β is 187 degrees (which is "1 point" when compared with the threshold value of the second index of the scoring table T), the above ratio (La / Lb) is 1.15 (which is "1 point" when compared with the threshold value of the third index of the scoring table T), the above ratio (Ld / Lc) is 1.41 (which is "1 point" when compared with the threshold value of the fourth index of the scoring table T), and the number of meandering lines is 0 (which is "1 point" when compared with the threshold value of the fifth index of the scoring table T), then their addition result is "5 points". Therefore, the determination unit 1B determines that the catheter insertion difficulty level for the blood vessel of the certain person is "low", generates difficulty level data indicating the determination result, and outputs it to the display 5 and the above preparation unit 10. Also, for an image showing another blood vessel, if the above angle α is 26 degrees (which is "3 points" when compared with the threshold value of the first index of the scoring table T), the above angle β is 221 degrees (which is "1 point" when compared with the threshold value of the second index of the scoring table T), the above ratio (La / Lb) is 2.49 (which is "2 points" when compared with the threshold value of the third index of the scoring table T), the above ratio (Ld / Lc) is 1.98 (which is "1 point" when compared with the threshold value of the fourth index of the scoring table T), and the number of meandering lines is 1 (which is "2 points" when compared with the threshold value of the fifth index of the scoring table T), then their addition result is "9 points". Therefore, the determination unit 1B determines that the catheter insertion difficulty level for the blood vessel of the other person is "high", generates difficulty level data indicating the determination result, and outputs it to the display 5 and the above preparation unit 10. Incidentally, when an operation or the like for designating the operation as the above insertion difficulty determination device S is performed by, for example, a doctor or the like at the operation unit 6, the operation unit 6 generates an operation signal corresponding to the operation or the like and outputs it to the processing unit 1. Thereby, the processing unit 1 performs overall control of the operation as the above insertion difficulty determination device S based on the operation signal. In addition to this, the processing unit 1 executes, as necessary, three-dimensional imaging of the blood vessel described later based on the image data from the image inspection device C.

[0043] After that, the display 5 that has acquired the difficulty data displays the difficulty corresponding to the difficulty data and presents it to a doctor or the like. Further, the production unit 10 produces, for example, a three-dimensional blood vessel model according to the difficulty of inserting the catheter based on the difficulty data.

[0044] Next, the catheter management process of the embodiment executed in the catheter management system SS described above will be collectively described with reference to FIG. 3. As shown in the corresponding flowchart in FIG. 3, when the catheter management process of the embodiment is disclosed by a predetermined operation or the like by a doctor or the like, first, the image data input unit 3 of the insertion difficulty determination device S acquires the image data from the image inspection device C (step S1), and then, the above-described difficulty is scored by the image analysis unit 4 and the scoring unit 1A of the processing unit 1 (step S2).

[0045] Next, the processing unit 1 uses the result of the scoring in step S2 to estimate a catheter considered appropriate for insertion into the blood vessel shown in the image data and a guiding sheath used together with the catheter (step S3). More specifically, when a catheter whose insertion difficulty has been determined in the past in the insertion difficulty determination device S of the embodiment is inserted into a blood vessel (including the case where a guiding sheath corresponding to the catheter is used), the combination data (not shown) in which the combination of the actual difficulty and the difficulty as the determination result is stored in a database, for example, in the recording unit 2, and using this, the catheter (and the combination with the corresponding guiding sheath) considered appropriate corresponding to the difficulty scored in step S2 is estimated by the processing unit 1. This estimation result is primarily recorded in, for example, the recording unit 2 and is used in step S7 or step S12 described later.

[0046] On the other hand, in parallel with the above step S3, based on the addition result of the scoring in the above step S2, the determination unit 1B determines the difficulty level (step S4). If the difficulty level is "low" in the determination of step S4 (step S4: low), preoperative training for inserting a catheter into the blood vessels shown in the upper image data is not required, and step S9 described later is executed.

[0047] On the other hand, if the difficulty level is "high" in the determination of step S4 (step S4: high), preoperative training for inserting a catheter into the blood vessels shown in the above image data is considered essential. Therefore, for example, the processing unit 1 performs three-dimensional imaging of the blood vessels based on the above image data from the imaging inspection device C (step S5), and based on the three-dimensional image and the above difficulty level data, the production unit 10 of the blood vessel model production device B produces a three-dimensional blood vessel model according to the difficulty level (step S6). Then, based on the estimation result of the above step S3 and the blood vessel model produced in step S6, an appropriate catheter (and a combination with a guiding sheath corresponding to the catheter) for insertion into the blood vessels shown in the upper image data is determined automatically based on, for example, the above combination data or, for example, as a result of deliberation by a plurality of doctors (step S7). Then, preoperative training for insertion into the blood vessels using the determined appropriate catheter is essential and is carried out (step S8) in preparation for the actual catheter insertion. Then, the processing unit 1 determines, for example, whether an operation to end the catheter management process of the embodiment has been performed on the operation unit 6 (step S9). If the operation to end has been performed in the determination of step S9 (step S9: YES), the processing unit 1 ends the catheter management process of the embodiment. On the contrary, if the operation to end has not been performed in the determination of step S9 (step S9: NO), the processing unit 1 returns to the above step S1 and repeats the above series of processes.

[0048] On the other hand, when the difficulty level is "medium" in the determination of step S4 (step S4: medium), preoperative training for inserting the catheter into the blood vessels shown in the upper image data is optional. Therefore, although three-dimensional imaging of the blood vessels based on the above image data is performed by the processing unit 1 (step S10), creation of a three-dimensional blood vessel model according to the difficulty level and similar to step S6 above (step S11), determination of an appropriate catheter similar to step S7 above (step S12), and preoperative training similar to step S8 above (step S13) are each executed optionally. When steps S11 to S13 are each executed optionally, the processing unit 1 then executes step S9 above.

[0049] Next, the effects of the catheter management process of the above-described embodiment will be described using Table 1 below. Table 1 is a table showing the effects, and for eleven cases (that is, cases in which image data was obtained by the imaging device C for eleven people (patients or those undergoing an examination)) respectively identified by case numbers 1 to 11, the determination results of the difficulty level of catheter insertion (the determination results shown as "visual difficulty level" in Table 1) made by a plurality of doctors visually observing the image data, and the actual insertion difficulty level (the insertion difficulty level shown as "blood vessel model difficulty level" in Table 1) found in the catheter insertion training using the blood vessel model created based on the score of the insertion difficulty level by the insertion difficulty level determination device S of the embodiment are listed.

Table 1

[0050] As described above respectively, according to the configuration and operation of the catheter management system SS of the embodiment, an index indicating the insertion difficulty level of the catheter for each of a plurality of items corresponding to the running pattern of a human blood vessel, and the running pattern of the blood vessel detected based on the image showing the blood vessel, the difficulty level is determined based on these, so that the insertion difficulty level of the catheter can be objectively determined without referring to a large amount of case information. Also, by using the objectively determined insertion difficulty level, the versatility of catheter selection can be enhanced.

[0051] In addition, since the plurality of the above-mentioned indexes are the first index to the fifth index, by being an index along the running pattern of the actual blood vessel through which the catheter passes, the insertion difficulty level of the catheter can be determined more objectively.

[0052] In the above-described embodiment, the abdominal aorta AO is used as an example of the "aorta" of the present invention, the celiac artery CE branched from the abdominal aorta AO is used as an example of the "first branched artery" of the present invention, and the common hepatic artery CH branched from the celiac artery CE is used as an example of the "second branched artery" of the present invention, and the case where the first index to the fifth index are examined has been described. However, in addition to the abdominal aorta AO, other examples of the "aorta" of the present invention can include, for example, the thoracic aorta, the aortic arch, or the aorta in the pelvis.

[0053] In addition to the celiac artery CE described above, other examples of the "first branch artery" of the present invention include: (i) the superior mesenteric artery, inferior mesenteric artery, bilateral renal arteries, or lumbar arteries as other branch arteries from the abdominal aorta AO; (ii) the intercostal artery, bronchial artery, intercostobronchial trunk, or left and right coronary arteries as branch arteries from the thoracic aorta; (iii) the brachiocephalic artery, left common carotid artery, left subclavian artery, or (iv) the bilateral common iliac arteries as branch arteries from the large arteries within the pelvis, as branch arteries from the aortic arch of the head.

[0054] Furthermore, in addition to the common hepatic artery CH described above, other examples of the "second branch artery" of the present invention include: (v) the left gastric artery or splenic artery as other branch arteries from the celiac artery CE; (vi) the bronchial artery as a branch artery from the intercostobronchial trunk; (vii) the right common carotid artery or right subclavian artery as a branch artery from the brachiocephalic artery; (viii) the left internal carotid artery or left external carotid artery as a branch artery from the left common carotid artery; (ix) the left vertebral artery as a branch artery from the left subclavian artery; or (x) the bilateral internal iliac arteries or bilateral external iliac arteries as branch arteries from each of the bilateral common iliac arteries.

[0055] Moreover, since each threshold index recorded in the scoring table T is predetermined numerical data indicating the difficulty level of catheter insertion for each of a plurality of indices (the above first index to the above fifth index), the difficulty level of catheter insertion can be determined more objectively.

[0056] In addition, the scoring table T including each threshold value is pre-recorded in the recording unit 2, and the recorded threshold value is read out to determine the difficulty level. Therefore, the difficulty level of catheter insertion can be determined objectively and uniformly while eliminating human factors.

[0057] Furthermore, since the difficulty level data is output to the blood vessel model manufacturing apparatus B for manufacturing the blood vessel model, a blood vessel model can be manufactured according to the difficulty level of catheter insertion.

[0058] Furthermore, when selecting and determining the catheter to be actually inserted (see steps S3, S7, and S12 in FIG. 3), the selection and determination can be objectively made.

[0059] In addition, when a three-dimensional vascular model based on difficulty data is created (see step S6 or S11 in FIG. 3), a vascular model that can be effectively utilized for catheter insertion training (see step S8 or S13 in FIG. 3) can be created. Also, by using the vascular model, catheter insertion training can be effectively performed.

Industrial Applicability

[0060] As described above, the present invention can be used in the field of a device for determining the difficulty of inserting a medical catheter, and particularly, when applied to a device for determining the insertion difficulty used for selecting an actually used catheter, etc., a particularly remarkable effect can be obtained.

Explanation of Signs

[0061] 1 Processing unit 1A Scoring unit 1B Determination unit 2 Recording unit 3 Image data input unit 4 Image analysis unit 5 Display 6 Operation unit 10 Creation unit C Imaging device S Catheter insertion difficulty determination device B Vascular model creation device T Scoring table SS Catheter management system AO Abdominal aorta CE Celiac artery α, β Angles CH Coronary artery La, Lb, Lc, Ld Thickness

Claims

1. Image information acquisition means for acquiring image information corresponding to an image of a human blood vessel, Detection means for detecting the running pattern of the blood vessel based on the acquired image information, Determination means for determining the difficulty level based on a preset difficulty level index indicating the difficulty level of inserting a catheter into the blood vessel for each of a plurality of difficulty level evaluation items corresponding to the running pattern, and the detected running pattern, A catheter insertion difficulty determination device comprising the above.

2. In the catheter insertion difficulty determination device according to Claim 1, The plurality of difficulty level evaluation items are, (i) The angle formed between the direction of the aorta through which the catheter is to be passed and the direction of the first branch artery branching from the aorta through which the catheter is to be passed, (ii) The angles formed between the directions of the successive first branch arteries, (iii) The ratio of the width of the dilation part of the first branch artery to the width of the stenosis part of the first branch artery, (iv) The ratio of the width of the first branch artery to the width of the second branch artery that further branches from the first branch artery and through which the catheter is to be passed, and, (v) The number of meanders in the first branch artery, A catheter insertion difficulty determination device characterized by the above.

3. In the catheter insertion difficulty determination device according to Claim 2, The aorta is the abdominal aorta, the first branch artery is the celiac artery, and the second branch artery is the common hepatic artery. A catheter insertion difficulty determination device characterized by the above.

4. In the catheter insertion difficulty determination device according to any one of Claims 1 to 3, The difficulty level index is preset numerical data indicating the difficulty level for each of the plurality of difficulty level evaluation items. A catheter insertion difficulty determination device characterized by the above.

5. In the catheter insertion difficulty determination device according to any one of Claims 1 to 3, The catheter insertion difficulty determination device further comprises a recording means for pre-recording the difficulty level index for each of the difficulty level evaluation items, The determination means reads the recorded difficulty level index from the recording means and uses it for determining the difficulty level. A catheter insertion difficulty determination device characterized by the above.

6. In the catheter insertion difficulty determination device according to any one of Claims 1 to 3, A catheter insertion difficulty determination device characterized by using difficulty information indicating the difficulty level determined by the determination means when selecting and determining the catheter to be actually inserted into the person.

7. In the catheter insertion difficulty determination device according to any one of Claims 1 to 3, An output means for outputting difficulty information indicating the difficulty level determined by the determination means to a blood vessel model production device for producing a blood vessel model used for preoperative consideration of the insertion mode of the catheter. A catheter insertion difficulty determination device characterized by further comprising:

8. A blood vessel model production device comprising production means for producing the blood vessel model three-dimensionally according to the difficulty level based on the difficulty information output from the catheter insertion difficulty determination device according to Claim 7.

9. A blood vessel model characterized by being produced three-dimensionally according to the difficulty level by the blood vessel model production device according to Claim 8.

10. A catheter insertion difficulty determination method executed in a catheter insertion difficulty determination device including an image information acquisition means, a detection means, and a determination means, An image information acquisition step of acquiring, by the image information acquisition means, image information corresponding to an image showing a person's blood vessel; A detection step of detecting, by the detection means, a running mode of the blood vessel based on the acquired image information; A determination step of determining the difficulty level by the determination means based on a preset difficulty index showing the difficulty level of inserting the catheter into the blood vessel for each of a plurality of difficulty evaluation items corresponding to the running mode and the detected running mode. A catheter insertion difficulty determination method characterized by including:

11. A computer included in a catheter insertion difficulty determination device, An image information acquisition means for acquiring image information corresponding to an image showing a person's blood vessel, A detection means for detecting a running mode of the blood vessel based on the acquired image information, and A determination means for determining the difficulty level based on a preset difficulty index showing the difficulty level of inserting the catheter into the blood vessel for each of a plurality of difficulty evaluation items corresponding to the running mode and the detected running mode. A program for determining the insertion difficulty of a catheter, characterized by causing the program to function as:

12. A recording medium, characterized in that the program for determining the ease of insertion of the catheter according to claim 11 is recorded so as to be readable by the computer.

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