Blood vessel model and evaluation method for long medical object
The blood vessel model addresses the challenge of evaluating medical elongated objects in acute-angled branch vessels by simulating diverse branch angles and diameters, enhancing the evaluation of selectivity and navigability for procedures like prostate and liver arterial embolization.
Patent Information
- Application Number
- JP2022534071
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2020-07-01
- Filing Date
- 2021-06-30
- Publication Date
- 2025-11-21
- Estimated Expiration
- 2041-06-30
AI Technical Summary
Existing blood vessel models struggle to effectively evaluate the selectivity of medical elongated objects like microcatheters and guidewires in thin branch blood vessels that branch off at acute angles from main blood vessels, particularly in procedures such as prostate and liver arterial embolization, due to difficulties in navigating and maintaining contact within complex vascular structures.
A blood vessel model simulating a main passage with branch passages that branch off at acute angles, featuring varying branch angles and diameters, allowing evaluation of medical elongated objects' selectivity and navigability through multiple branches.
Enables accurate evaluation of medical elongated objects' selectivity and navigability in branch vessels, simulating various vascular configurations to assess performance in realistic scenarios, facilitating improved procedural success.
Smart Images

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Abstract
Description
[Technical Field]
[0001] The present invention relates to a blood vessel model that simulates a blood vessel and a method for evaluating a medical elongated object using the blood vessel model. [Background technology]
[0002] In recent years, interventions have been performed in which a medical elongated object such as a catheter or a guidewire is inserted through the skin into a blood vessel and reaches a target location through the blood vessel. Because interventions are performed through blood vessels that are complexly curved, the catheter is required to be able to reach the target location. For this reason, for example, Patent Document 1 describes a blood vessel model used to test the operability and other properties of a medical elongated object. [Prior art documents] [Patent documents]
[0003] [Patent Document 1] Japanese Patent Application Publication No. 2017-003637 Summary of the Invention [Problem to be solved by the invention]
[0004] In prostate arterial embolization as a treatment for benign prostatic hyperplasia and liver arterial embolization as a treatment for liver cancer, selection of a thin branch blood vessel that branches off at an acute angle from a thick main blood vessel using a microcatheter or guidewire can be difficult. In particular, when the main blood vessel is thick, the microcatheter is prone to bending, making it difficult to enter the branch blood vessel, or even if it does enter, the tip of the microcatheter may slip out. Furthermore, when the branch blood vessel forms an acute angle with the main blood vessel, the tip of the microcatheter is likely to slip out of the branch blood vessel, making selection even more difficult.
[0005] In arterial embolization of the prostate, the internal iliac artery, which is the main blood vessel, has an inner diameter of 2 to 8 mm, and the branch blood vessels have an inner diameter of approximately 1 mm. In arterial embolization of the liver, the main blood vessel has an inner diameter of 2 to 5 mm, and the branch blood vessels have an inner diameter of approximately 1 mm, and there may be further branches. When a branch blood vessel has further branches, it becomes even more difficult to select the branch blood vessel using a microcatheter or guidewire.
[0006] With the blood vessel model described in Patent Document 1, it is difficult to evaluate the selectivity of elongated medical objects such as microcatheters and guidewires in thin branch blood vessels that branch off at acute angles from the main blood vessel as described above.
[0007] The present invention has been made to solve the above-mentioned problems, and aims to provide a vascular model and an evaluation method for a medical elongated body that can evaluate the selectivity of a medical elongated body to a branch blood vessel that branches off at an acute angle from a main blood vessel in a turning-back manner. [Means for solving the problem]
[0008] The blood vessel model according to the present invention, which achieves the above object, simulates a main blood vessel. Extends linearly A blood vessel model having a main passage and a branch passage that is narrower than the main passage and that simulates a branch blood vessel branching from the main blood vessel, a plurality of branch passages arranged along the main passage and having different branch angles with respect to the main passage; and peripheral branch passages branching off from each of the branch passages at a peripheral side away from the main passage, The branch passage Each The branch angle with respect to the main passage is greater than 0 degrees and less than 90 degrees, where 0 degrees is defined as the angle when the branch passage turns back in the opposite direction to the main passage. Each of the peripheral branch passages provided at the periphery of each of the branch passages is another branch passage. It is characterized by the following.
[0009] The method for evaluating a medical elongated object according to the present invention, which achieves the above object, is a method for evaluating a medical elongated object using a blood vessel model, which simulates a main blood vessel. Extends linearly A main passage and a branch blood vessel branching from the main blood vessel are simulated, the branch blood vessel being thinner than the main passage. a plurality of nozzles arranged along the main passage and having different branch angles with respect to the main passage; A branching passage and a peripheral branch passage branching off from each of the branch passages at a peripheral side distant from the main passage; and the branch passage EachThe branch angle with respect to the main passage is greater than 0 degrees and less than 90 degrees, where 0 degrees is defined as the angle when the branch passage turns back in the opposite direction to the main passage. Each of the peripheral branch passages provided at the periphery of each of the branch passages is another branch passage. a step of preparing a blood vessel model, inserting the medical elongated object into the main passage, and extending the main passage to the branch passage; through the peripheral branch passage and attempting to reach said branch path. from the peripheral branch passage and determining whether or not the route reaches the destination. [Effects of the Invention]
[0010] The blood vessel model and the method for evaluating a medical elongated body configured as described above can evaluate the selectivity of a medical elongated body to a branch blood vessel that branches off at an acute angle so as to turn back from a main blood vessel.
[0011] The blood vessel model may have a plurality of branch passages with different branch angles relative to the main passage, thereby enabling evaluation of the selectivity of the medical elongated object in branch blood vessels with various branch angles using a single blood vessel model.
[0012] The blood vessel model may have a plurality of main passages with different inner diameters, and the branch passages may be provided branching from each of the main passages. This provides a plurality of combinations of main passages and branch passages, so that a single blood vessel model can be used to reproduce branch blood vessels that branch at acute angles so as to turn back from main blood vessels of various inner diameters, thereby enabling evaluation of the selectivity of the medical elongated object.
[0013] The inner diameters of the plurality of main passages having different inner diameters may decrease stepwise toward the periphery, thereby simulating the actual diameter of a blood vessel and making the blood vessel model compact.
[0014] The blood vessel model may have at least one peripheral branch passage that branches off from the main passage on the peripheral side of the branch passage, thereby enabling evaluation of the selectivity of the medical elongated object that passes through multiple branches in succession.
[0015] The blood vessel model may have a plurality of branch passages with different branch angles relative to the main passage, and at least one of the peripheral branch passages provided at the periphery of the branch passage may be another branch passage. This allows a peripheral branch passage provided at the periphery of one of the branch passages to be reproduced by another branch passage, thereby making it possible to realize a compact blood vessel model.
[0016] The main passage may be branched into a plurality of passages. This allows for efficient placement of the plurality of main passages, thereby enabling a compact vascular model having a plurality of main passages. Furthermore, it is possible to evaluate the selectivity of a medical elongated object that has passed through a plurality of branched main passages to a branched blood vessel.
[0017] A plurality of branch passage groups, each having a different branch angle relative to the main passage and arranged in the extension direction of the main passage, may be provided at different positions in the circumferential direction of the main passage. This makes it possible to evaluate the selectivity of the medical elongated body in various branch blood vessels using a single blood vessel model. [Brief explanation of the drawings]
[0018] [Figure 1] FIG. 2 is a plan view showing a blood vessel model according to the embodiment. [Figure 2] FIG. 2 is a side view showing a blood vessel model according to the embodiment. [Figure 3] FIG. 10 is a plan view showing a state in which a blood vessel model is used. [Figure 4] FIG. 10 is a plan view showing a state in which a blood vessel model is used. DETAILED DESCRIPTION OF THE INVENTION
[0019] Hereinafter, embodiments of the present invention will be described with reference to the drawings. Note that dimensions in the drawings may be exaggerated for convenience of explanation and may differ from actual dimensions. Furthermore, in this specification and drawings, components having substantially the same functions are designated by the same reference numerals, and redundant description will be omitted.
[0020] The blood vessel model 10 according to this embodiment is a model that simulates a blood vessel in order to evaluate the selectivity of branched blood vessels of a medical elongated object such as a microcatheter or a guidewire. Note that the use of the blood vessel model 10 is not limited to the evaluation of a medical elongated object, and it may also be used, for example, for training in procedures.
[0021] As shown in FIGS. 1 and 2 , the blood vessel model 10 includes two division simulation sections 11, two holding plates 12 sandwiching the division simulation sections 11, multiple connectors 13, and an insertion port 14. The two division simulation sections 11 are substantially rectangular flat plates with grooves simulating blood vessels formed on their opposing surfaces 15. The two division simulation sections 11 are formed with plane symmetry. Therefore, when the division simulation sections 11 overlap on the opposing surfaces 15, the grooves overlap, forming a blood vessel simulation section 20 simulating a blood vessel with a substantially circular cross section. The division simulation section 11 is preferably transparent or translucent to allow visual observation of the interior and is preferably made of a flexible material similar to that of actual biological tissue. The constituent material of the division simulation section 11 is not particularly limited, but examples include silicone resin and various elastomer resins such as SEBS, polyolefin elastomer, polyamide elastomer, acrylic elastomer, and fluorine-containing elastomer. In this embodiment, the constituent material of the division simulation section 11 is silicone resin. The division simulation portion 11 is preferably formed using a mold, but the method of formation is not particularly limited, and it may be formed, for example, by a 3D printer.
[0022] The holding plates 12 are members that sandwich the two flexible division simulation portions 11 to hold them in an overlapping state. Each holding plate 12 is a substantially rectangular flat plate that can cover the division simulation portion 11. The holding plates 12 are preferably transparent or translucent so that the interior can be visually observed, and are formed from a hard material that can hold the flexible division simulation portion 11. The constituent material of the holding plates 12 is not particularly limited, but examples include acrylic resin, ABS resin, acrylic resin, methacrylic resin, polycarbonate, melamine resin, styrene resin, hard vinyl chloride resin, fluororesin, glass, etc. In this embodiment, the constituent material of the holding plates 12 is acrylic resin.
[0023] The connector 13 is a member for holding the split simulation part 11 sandwiched between the holding plates 12. The connector 13 is made up of, for example, a bolt and nut that can pass through through holes formed in the split simulation part 11 and the holding plates 12 and hold the two holding plates 12 together. The configuration of the connector 13 is not particularly limited, and may be, for example, a clamp or the like.
[0024] The insertion port 14 is a site where the medical elongated body is inserted into the blood vessel model 10. The insertion port 14 is arranged on the side end surfaces of the two divided simulation sections 11, in communication with the grooves so as to be sandwiched between the opposing grooves. The insertion port 14 is configured, for example, with a hemostatic valve having a three-way stopcock or a Y-connector. The insertion port 14 is a site where the medical elongated body is inserted, and is connected to a communication passage 21 (described later) of the blood vessel simulation section 20. Note that the insertion port 14 equipped with a hemostatic valve or the like may also be arranged at an opening on the side end surfaces of the two divided simulation sections 11 other than the communication passage 21. This makes it easy to fill the inside of the blood vessel simulation section 20 with liquid and ensures that the state where it is filled with liquid can be maintained well.
[0025] The blood vessel model 10 is a model having a substantially planar structure. The thickness of the blood vessel model 10 having a substantially planar structure is 100 mm or less, preferably 50 mm or less, and more preferably 30 mm or less.
[0026] Next, the blood vessel simulation portion 20 formed in the divided simulation portion 11 will be described in detail. As shown in FIG. 1, the blood vessel simulation section 20 includes a communication passage 21 to which the insertion port 14 is connected, a plurality of main passages 30 that simulate main blood vessels, a plurality of branch passages 40 that simulate branch blood vessels that branch off from the main blood vessels, and an auxiliary passage 50 for venting air when the blood vessel simulation section 20 is filled with liquid.
[0027] The multiple main passages 30 include a base-end main passage 31 extending from the connecting passage 21, a first main passage 32 communicating with the base-end main passage 31, a second main passage 33 branching off from the base-end main passage 31, a third main passage 34 communicating with the second main passage 33, and a fourth main passage 35 communicating with the third main passage 34.
[0028] The proximal main passage 31 extends linearly from the communication passage 21. The inner diameter of the proximal main passage 31 is not particularly limited, but is, for example, 5 mm.
[0029] The first main passage 32 is located on the distal side of the proximal main passage 31 and extends linearly from the proximal main passage 31. The first main passage 32 and the proximal main passage 31 are aligned coaxially. The inner diameter of the first main passage 32 is larger than the inner diameter of the proximal main passage 31. The inner diameter of the first main passage 32 is not particularly limited, but is, for example, 8 mm. The distal side refers to the side of the passage that is farther from the insertion port 14 (the side in the direction of travel of the inserted elongated medical object). The proximal main passage 31 and the first main passage 32 are smoothly connected by the inner diameter tapering from the proximal main passage 31 to the first main passage 32.
[0030] The second main passage 33 is a passage that branches off from the proximal main passage 31 at a predetermined branching angle α. The second main passage 33 extends linearly from the proximal main passage 31. The inner diameter of the second main passage 33 is equal to the inner diameter of the proximal main passage 31. The inner diameter of the second main passage 33 is not particularly limited, but is, for example, 5 mm. The branching angle is defined as 0 degrees when one passage extending toward the distal side branches off from the other passage and the other passage turns back to the opposite distal side (the insertion opening 14 side) from the one passage, and as 180 degrees when the other passage extends in the same direction (the distal side) as the one passage.
[0031] The third main passage 34 is located distal to the second main passage 33 and extends linearly from the second main passage 33. The third main passage 34 and the second main passage 33 are aligned coaxially. The inner diameter of the third main passage 34 is smaller than the inner diameter of the second main passage 33. The inner diameter of the third main passage 34 is not particularly limited, but is, for example, 2 mm. The second main passage 33 and the third main passage 34 are smoothly connected by the inner diameter tapering from the second main passage 33 to the third main passage 34.
[0032] The fourth main passage 35 is located distal to the third main passage 34 and extends linearly from the third main passage 34. The fourth main passage 35 and the third main passage 34 are aligned coaxially. The inner diameter of the fourth main passage 35 is smaller than the inner diameter of the third main passage 34. The inner diameter of the fourth main passage 35 is not particularly limited, but is, for example, 1.2 mm.
[0033] A plurality of branch passages 40 are connected to the first main passage 32, the second main passage 33, the third main passage 34 and the fourth main passage 35 in the extension direction of the main passage 30, and branch off from the main passage 30 at different branch angles.
[0034] The multiple branch passages 40 include a first branch passage 41, a second branch passage 42, a third branch passage 43, and a fourth branch passage 44 that branch off from the second main passage 33. The first branch passage 41, the second branch passage 42, the third branch passage 43, and the fourth branch passage 44 are lined up toward the peripheral side along the extension direction of the second main passage 33, and branch off from the second main passage 33. The axes of the first branch passage 41, the second branch passage 42, the third branch passage 43, and the fourth branch passage 44 are arranged on the same plane.
[0035] The first branch passage 41 branches off from the second main passage 33 at a branch angle θ1.
[0036] The second branch passage 42 branches off from the second main passage 33 at a branch angle θ2 on the more peripheral side than the first branch passage 41. The branch angle θ2 is larger than the branch angle θ1.
[0037] The third branch passage 43 branches off from the second main passage 33 at a branch angle θ3 on the more peripheral side than the second branch passage 42. The branch angle θ3 is larger than the branch angle θ2.
[0038] The fourth branch passage 44 branches off from the second main passage 33 at a branch angle θ4 on the more peripheral side than the third branch passage 43. The branch angle θ4 is larger than the branch angle θ3.
[0039] The branch angles θ1 to θ4 are greater than 0 degrees and less than 90 degrees, and preferably greater than or equal to 30 degrees and less than or equal to 75 degrees. For example, the branch angle θ1 is 30 degrees, the branch angle θ2 is 45 degrees, the branch angle θ3 is 60 degrees, and the branch angle θ4 is 75 degrees.
[0040] The branch passage 40 has a peripheral branch passage 45 that branches off at a branch angle β from the second branch passage 42, the third branch passage 43, and the fourth branch passage 44. The branch angle β of the peripheral branch passage 45 is not particularly limited, but is greater than 0 degrees and less than 90 degrees, for example, 75 degrees.
[0041] A peripheral branch passage 45 branching from the second branch passage 42 is connected to communicate with the first branch passage 41. In other words, the first branch passage 41 is also a second peripheral branch passage that further branches at a branching angle γ from the peripheral branch passage 45 branching from the second branch passage 42.
[0042] A peripheral branch passage 45 branching from the third branch passage 43 is connected to communicate with the second branch passage 42. That is, the second branch passage 42 is also a second peripheral branch passage that further branches at a branching angle γ from the peripheral branch passage 45 branching from the third branch passage 43.
[0043] A peripheral branch passage 45 branching from the fourth branch passage 44 is connected to communicate with the third branch passage 43. That is, the third branch passage 43 is also a second peripheral branch passage that further branches at a branching angle γ from the peripheral branch passage 45 branching from the fourth branch passage 44.
[0044] The branching angle γ of the second peripheral branch passage is not particularly limited, but is greater than 0 degrees and equal to or less than 90 degrees, for example, 90 degrees.
[0045] The inner diameters of the first branch passage 41, the second branch passage 42, the third branch passage 43, the fourth branch passage 44 and the peripheral branch passage 45 are smaller than the inner diameter of the second main passage 33, which is the main passage 30 from which they branch, and are, for example, 1 mm.
[0046] Similar to the second main passage 33 described above, a first branch passage 41, a second branch passage 42, a third branch passage 43, a fourth branch passage 44, and a peripheral branch passage 45 branch off from the third main passage 34 and the fourth main passage 35. The branch angles θ1 to θ4 of the branch passage 40 relative to the third main passage 34 or the fourth main passage 35 preferably match the branch angles θ1 to θ4 of the branch passage 40 relative to the second main passage 33 described above, but they do not have to match. Furthermore, the branch angle β of the peripheral branch passage 45 branching off on the peripheral side of the third main passage 34 or the fourth main passage 35 and the branch angle γ of the second peripheral branch passage preferably match the branch angle β of the peripheral branch passage 45 branching off on the peripheral side of the second main passage 33 and the branch angle γ of the second peripheral branch passage, but they do not have to match.
[0047] Two branch passage groups 46 consisting of a second branch passage 42, a third branch passage 43, and a fourth branch passage 44 branch off from the first main passage 32. The two branch passage groups 46 are connected in opposite directions in the circumferential direction of the first main passage 32. Therefore, the first main passage 32 and the two branch passage groups 46 are arranged on the same plane.
[0048] Next, a method for evaluating a medical elongated object using the blood vessel model 10 according to this embodiment will be described.
[0049] First, the tester performing the evaluation test determines the main passage 30 and the branch passage 40 into which the microcatheter 100 is to be inserted. For example, the tester determines to insert the microcatheter 100 from the first main passage 32 into one of the third branch passages 43, as shown in FIG.
[0050] The tester injects water, saline, a surfactant-containing solution, or the like into the blood vessel model 10 through the insertion port 14. This causes the water, saline, a surfactant-containing solution, or the like to flow into the blood vessel simulation portion 20 of the blood vessel model 10. Air inside the blood vessel model 10 is discharged to the outside through openings formed on the side end surfaces of the blood vessel simulation portion 20, the auxiliary passage 50, or the like. This causes the inside of the blood vessel simulation portion 20 of the blood vessel model 10 to be filled with water, saline, a surfactant-containing solution, or the like. Alternatively, a surfactant or a lubricating polymer may be applied to the inner surface of the blood vessel simulation portion 20 in advance, or a hydrophilic lubricating polymer containing acrylamide or a hydrophobic lubricating polymer such as a fluororesin may be applied as the lubricating polymer.
[0051] Next, the tester inserts a guiding catheter (not shown) through the insertion port 14 communicating with the communication passage 21, reaches the proximal main passage 31, and inserts the microcatheter 100 into it, passing it from the communication passage 21 through the proximal main passage 31 to the first main passage 32. Next, the tester attempts to select the third branch passage 43 with the tip of the microcatheter 100 and push the microcatheter 100 into the third branch passage 43. This allows the tester to evaluate, using the blood vessel model 10, whether the microcatheter 100 was able to select the third branch passage 40 from the first main passage 32. Note that the inner diameter of the first main passage 32 is 8 mm, and the inner diameter of the third branch passage 43 is 1 mm, resulting in a large difference in inner diameter. Under these conditions, it is difficult to select the third branch passage 43, so it is effective to use a microcatheter 100 shaped with a curved tip. However, because the branching angle θ3 is an acute angle, even if the tip of the microcatheter 100 is inserted into the third branch passage 43, further pushing the microcatheter 100 may cause the microcatheter 100 to bend inside the first main passage 32 and prolapse toward the periphery, as shown by the dashed-dotted line in FIG. 3 , and possibly come out of the third branch passage 43. By using this vascular model 10, the tester can evaluate whether the microcatheter 100 has high supportability for feeding a guidewire passing through the microcatheter 100 into the third branch passage 43 without prolapsing. In addition, by using this vascular model 10, the tester can evaluate whether the microcatheter 100 has branch vessel selectivity for pushing the microcatheter 100 toward the periphery by making the microcatheter 100 follow the guidewire after inserting the guidewire into the microcatheter 100 into the third branch passage 43.
[0052] When the tester decides to insert the microcatheter 100 from the second main passage 33, for example, into the second branch passage 42, as shown in FIG. 4 , the tester inserts the microcatheter 100 from the insertion port 14 and passes through the connecting passage 21 and the proximal main passage 31 to the second main passage 33. Next, the tester selects the second branch passage 42 with the tip of the microcatheter 100 and attempts to push the microcatheter 100 into the second branch passage 42. This allows the tester to evaluate, using the blood vessel model 10, whether or not the microcatheter 100 can select the second branch passage 42 from the second main passage 33. Note that the inner diameter of the second main passage 33 is 5 mm, which is smaller than the inner diameter (8 mm) of the first main passage 32. Therefore, it is easier to select a branch passage 40 compared to the above-described case of selecting one of the branch passages 40 from the first main passage 32 with the microcatheter 100. Furthermore, a peripheral branch passage 45 and a second peripheral branch passage (first branch passage 41) are further branched on the peripheral side of the second branch passage 42 branching from the second main passage 33. Therefore, using this blood vessel model 10, the tester can evaluate whether the microcatheter 100 can reach the peripheral branch passage 45 and the second peripheral branch passage (first branch passage 41) by following the guidewire without prolapsing. Furthermore, the first main passage 32 branches off from the proximal main passage 31. Therefore, at the branch point between the proximal main passage 31 and the first main passage 32, the force pushing the microcatheter 100 along the guidewire is not dispersed, and it is possible to evaluate whether the microcatheter 100 can follow the guidewire without prolapsing. The difference in the performance of the microcatheter 100 in terms of followability to the guidewire is brought about by a combination of multiple factors, such as the flexibility of the section of the microcatheter 100 from the tip to the base end approximately 5 mm from the tip, the rigidity arrangement from that section to approximately 30 mm from the base end, the shaft rigidity further to the base end, the outer diameter of the tip, kink resistance, slipperiness, the chamfered shape of the tip, the rigidity and slipperiness of the guidewire, and the clearance between the microcatheter 100 and the guidewire, but it mainly depends on the flexibility, rigidity arrangement, and outer diameter of the tip section of the microcatheter 100. Therefore, when the difference in performance of the microcatheter 100 appears due to the multiple factors mentioned above, it is effective to evaluate the performance difference using this vascular model 10.
[0053] When the tester decides to insert the microcatheter 100 from the third main passage 34 into one of the branch passages 40, the tester can use this blood vessel model 10 to perform the same evaluation as when inserting the microcatheter 100 from the second main passage 33 into one of the branch passages 40 described above. The inner diameter of the third main passage 34 is 2 mm, which is smaller than the inner diameter of the second main passage 33, which is 5 mm. Therefore, the range in which the microcatheter 100 and the guidewire can bend is narrow (the range in which the pushing force escapes is small), and therefore differences in the performance of the microcatheter 100 in terms of followability to the guidewire are unlikely to occur. However, when there are relatively large differences in the flexibility, rigidity arrangement, outer diameter, etc. of the tip portion of the microcatheter 100, differences in the performance of the microcatheter 100 are likely to appear, and therefore evaluation of the performance differences using this blood vessel model 10 is effective.
[0054] When the tester decides to insert the microcatheter 100 from the fourth main passage 35 into one of the branch passages 40, the tester can use this blood vessel model 10 to perform the same evaluation as when inserting the microcatheter 100 from the second main passage 33 into one of the branch passages 40 described above. The inner diameter of the fourth main passage 35 is 1.2 mm, which is smaller than the inner diameter of the second main passage 33 (5 mm) and the inner diameter of the third main passage 34 (2 mm). Therefore, the range in which the microcatheter 100 and the guidewire can bend is even narrower (the range in which the pushing force escapes is smaller), so differences in the performance of the microcatheter 100 in terms of followability to the guidewire are unlikely to occur. However, when there are relatively large differences in the flexibility, rigidity arrangement, outer diameter, etc. of the tip portion of the microcatheter 100, differences in the performance of the microcatheter 100 are likely to appear, and therefore evaluation of the performance differences using this blood vessel model 10 is effective.
[0055] As described above, the vascular model 10 according to this embodiment has a main passage 30 that simulates a main blood vessel, and a branch passage 40 that is narrower than the main passage 30 and simulates a branch blood vessel that branches off from the main blood vessel. The branch angles θ1 to θ4 of the branch passage 40 relative to the main passage 30 are greater than 0 degrees and less than 90 degrees, with 0 degrees being defined as the angle when the branch passage 40 turns back in the opposite direction relative to the main passage 30.
[0056] The blood vessel model 10 configured as described above can be used to evaluate the selectivity of a medical elongated object to a branch blood vessel that branches off at an acute angle so as to turn back from a main blood vessel.
[0057] The blood vessel model 10 has a plurality of branch passages 40 with different branch angles θ1 to θ4 relative to the main passage 30. This makes it possible to use a single blood vessel model 10 to evaluate the selectivity of medical elongated objects in the branch passages 40 with various branch angles θ1 to θ4.
[0058] Furthermore, the blood vessel model 10 has a plurality of main passages 30 with different inner diameters, and is provided with branch passages 40 branching off from each of the main passages 30. As a result, multiple combinations of the main passages 30 and the branch passages 40 are provided, and therefore, with a single blood vessel model 10, it is possible to reproduce branch blood vessels that branch off at acute angles so as to turn back from main blood vessels of various inner diameters, and to evaluate the selectivity performance of the medical elongated body.
[0059] Alternatively, the blood vessel model 10 may have multiple main passages 30 with different inner diameters that gradually decrease in diameter toward the periphery, rather than branching off from the main passage 30 or the proximal main passage 31. In this embodiment, the inner diameter of the second main passage 33 is 5 mm, the inner diameter of the third main passage 34 is 2 mm, and the inner diameter of the fourth main passage 35 is 1.2 mm, which gradually decrease in diameter. This allows for simulation of actual blood vessel diameters, and allows multiple main passages with different inner diameters to be efficiently arranged without gaps, making the blood vessel model 10 compact.
[0060] The blood vessel model 10 also has at least one peripheral branch passage 45 that branches off from the branch passage 40 on the peripheral side away from the main passage 30. This makes it possible to evaluate the selectivity of a medical elongated object that passes through multiple branches in succession.
[0061] Furthermore, the blood vessel model 10 has a plurality of branch passages 40 with different branch angles relative to the main passage 30, and at least one of the peripheral branch passages 45 provided at the periphery of a branch passage 40 is another branch passage 40. This allows a second peripheral branch passage provided at the periphery of one of the branch passages 40 to be reproduced by another branch passage 40, thereby enabling the blood vessel model 10 to be realized in a compact form.
[0062] Furthermore, multiple branched main passages 30 are provided. This allows for efficient arrangement of multiple main passages 30, making it possible to compactly realize a blood vessel model 10 having multiple main passages 30. Furthermore, it is possible to evaluate the selectivity of a medical elongated object that has passed through multiple branched main passages 30 into a branch passage 40.
[0063] Furthermore, a plurality of branch passage groups 46, each having a plurality of branch passages 40 with different branch angles θ2 to θ4 relative to the main passage 30 lined up in the extension direction of the main passage 30, are provided at different positions in the circumferential direction of the main passage 30. This makes it possible to evaluate the selectivity of medical elongated bodies in various branch passages 40 using a single blood vessel model 10.
[0064] Furthermore, the method for evaluating a medical elongated body using the blood vessel model 10 according to this embodiment includes the steps of: preparing a blood vessel model 10 having a main passage 30 that simulates a main blood vessel; and a branch passage 40 that is narrower than the main passage 30 and simulates a branch blood vessel that branches off from the main blood vessel, wherein the branching angles θ1 to θ4 of the branch passage 40 relative to the main passage 30 are greater than 0 degrees and less than 90 degrees, where 0 degrees is defined as the angle when the branch passage 40 turns back in the opposite direction relative to the main passage 30; inserting the medical elongated body into the main passage 30 and attempting to reach the branch passage 40 from the main passage 30; and determining whether the branch passage 40 is reached.
[0065] The evaluation method configured as described above makes it possible to easily evaluate the selectivity of a medical elongated body to a branch blood vessel that branches off at an acute angle so as to turn back from a main blood vessel.
[0066] The present invention is not limited to the above-described embodiment, and various modifications can be made by those skilled in the art within the technical concept of the present invention.
[0067] For example, the blood vessel model 10 may be a jig. For example, the blood vessel model 10 may be connected to a sensor such as an autograph. This makes it possible to detect the force acting on the blood vessel model 10 when inserting a medical elongated object into the blood vessel model 10, the amount of movement of the blood vessel model 10, and the like. The blood vessels simulated by the blood vessel model 10 are not particularly limited, but may be the prostatic artery, uterine artery, or hepatic artery. Alternatively, to help beginners get used to the model, some branch passages may be provided at a branch angle of 90 degrees or more relative to the main passage.
[0068] This application is based on Japanese Patent Application No. 2020-114084 filed on July 1, 2020, the disclosures of which are incorporated herein by reference in their entirety. [Explanation of symbols]
[0069] 10 Blood vessel model 11 Split simulation part 12 Holding plate 13 Connectors 14 Insertion port 15 Opposite Surface 20 Blood vessel simulation section 21 Connecting passage 30 Main aisle 31 Proximal main passage 32 1st main passage 33 2nd main passage 34 Third main passage 35 4th main aisle 40 Branch Passage 41 First Branch Passage 42 Second Branch Passage 43 Third Branch Passage 44 4th Branch Passage 45 Peripheral Branching Passage 46 Branching Passages 50 Auxiliary passage 100 Microcatheter (medical long body)
Claims
1. A blood vessel model having a main passageway extending linearly to simulate a main blood vessel, and a branch passageway narrower than the main passageway to simulate a branch blood vessel branching from the main blood vessel, a plurality of branch passages arranged along the main passage and having different branch angles with respect to the main passage; a peripheral branch passage branching off from each of the branch passages at a peripheral side distant from the main passage, a branch angle of each of the branch passages with respect to the main passage is greater than 0 degrees and less than 90 degrees, where 0 degrees is defined as the angle when the branch passage turns back in the opposite direction to the main passage; A blood vessel model, characterized in that each of the peripheral branch passages provided at the periphery of each of the branch passages is another branch passage.
2. 2. The blood vessel model according to claim 1, wherein the blood vessel model has a plurality of main passages with different inner diameters, and the branch passages branch off from each of the main passages.
3. 3. The blood vessel model according to claim 1, wherein the inner diameters of the plurality of main passages having different inner diameters decrease stepwise toward the periphery.
4. 4. The blood vessel model according to claim 1, wherein the main passage is branched into a plurality of passages.
5. The blood vessel model according to any one of claims 1 to 4, characterized in that a group of branch passages, each of which has a different branch angle relative to the main passage and is arranged in the extension direction of the main passage, is provided at different positions circumferentially of the main passage.
6. A method for evaluating a medical elongated object using a blood vessel model, comprising: preparing a blood vessel model having a main passageway extending linearly to simulate a main blood vessel, a plurality of branch passageways which are narrower than the main passageway and which are arranged along the main passageway to simulate branch blood vessels branching from the main blood vessel, and which have different branching angles relative to the main passageway, and peripheral branch passageways which branch off from each of the branch passageways at a peripheral side away from the main passageway, wherein the branching angle of each of the branch passageways relative to the main passageway is greater than 0 degrees and less than 90 degrees, where 0 degrees is defined as the angle when the branch passageway turns back in the opposite direction relative to the main passageway, and each of the peripheral branch passageways provided at the peripheral of each of the branch passageways is another branch passageway; a step of inserting the medical elongate body into the main passage and attempting to reach the peripheral branch passage from the main passage via the branch passage; and determining whether or not the branch passage reaches the peripheral branch passage.
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