Coronary artery motion simulator and vascular model

Abstract

The present invention is a coronary artery motion simulator that simulates the movement of a coronary artery that occurs in tandem with the heartbeat, and comprises: a simulated blood vessel unit 11 including a blood vessel model 14 that simulates a predetermined part of a coronary artery; and a model support unit 12 that supports the simulated blood vessel unit 11. The model support unit 12 is configured to hold the blood vessel model 14 which is disposed so as to be inclined relative to an installation surface B of the model support unit, in a manner allowing the blood vessel model 14 to rotate along a predetermined surface, and is configured such that the repetition of said rotary motion in the forward and reverse directions allows simulation of the way the blood vessel model 14 is displaced in tandem with the heartbeat. The model support unit 12 is provided with: an inclined base 17 installed on the installation surface B; and a movable device 18 having a mechanism for carrying out a rotary motion while the blood vessel model 14 is held. The inclined base 17 has an inclined surface portion 21 disposed at a predetermined angle relative to the installation surface B, and the movable device 18 is disposed so as to be inclined along the inclined surface portion 21.

Description

Technical Field

[0001] The present invention relates to a coronary artery motion simulator that simulates the operation of the coronary artery accompanying the heartbeat of the heart and a blood vessel model used therefor.

Background Art

[0002] The coronary artery is a blood vessel that sends blood to the surface of the heart to move the myocardium, and consists of the left coronary artery and the right coronary artery that are branched into two from the base of the aorta to the left and right. Here, the left coronary artery is a very important blood vessel that supplies blood containing oxygen and nutrients to move the left ventricular myocardium that plays a role in sending blood to the whole body. This left coronary artery branches into the left anterior descending coronary artery (LAD) and the left circumflex coronary artery (LCx) midway from the main trunk (LMT: Left main truck) connected to the aorta. The left anterior descending coronary artery (LAD) is mainly responsible for supplying blood to the anterior wall and the interventricular septum of the left ventricle, and the left circumflex coronary artery (LCx) is responsible for supplying blood from the lateral wall to the posterior wall of the left ventricle.

[0003] As treatment methods for ischemic heart disease in which sufficient blood does not circulate in the heart due to stenosis or occlusion of the coronary artery, drug treatment, coronary artery bypass surgery in which a bypass blood vessel is provided before and after stenosis, and percutaneous coronary angioplasty using a catheter are mainly known. As one of the percutaneous coronary angioplasties, there is coronary artery intervention treatment using a stent. In this treatment, a metal mesh-like stent crimped on a balloon made of a polymer thin film is inserted from the blood vessel at the root of the thigh or the blood vessel of the wrist using a catheter, the stent is carried to the stenotic blood vessel site in the blood vessel, and the balloon is expanded so that the stenotic lesion is expanded by the stent and crimped in the blood vessel, and blood flow is ensured.

[0004] Among ischemic heart diseases, left main coronary artery bifurcation lesions are conditions in which stenosis or occlusion occurs in the blood vessels at the base of the anterior descending artery (LAD) and circumflex artery (LCx) that branch off from the main coronary artery (LMT), and can be directly life-threatening. Stent treatment for left main coronary artery bifurcation lesions has long-term outcomes that are a challenge compared to coronary artery bypass surgery, and many clinical technique improvements are being considered to improve treatment outcomes. Recently, advances in drug-eluting stents have improved treatment outcomes, and coronary intervention is now acceptable for relatively simple left main coronary artery bifurcation lesions that can be treated with a single stent. On the other hand, for complex left main coronary artery bifurcation lesions, the 2-stent method using two stents is necessary, but due to the high frequency of thrombosis and restenosis, coronary artery bypass surgery is recommended.

[0005] In clinical practice, treatment of the left main coronary artery bifurcation is performed while the heart is beating, making it difficult to identify the structure of the stent within the coronary artery on the fluoroscopic X-ray image. Furthermore, in clinical treatment, the limited mobility of the X-ray angiography equipment used in conjunction with the procedure can cause the anterior descending artery (LAD) and circumflex artery (LCx) to appear overlapping. Additionally, because it is a fluoroscopic image, treatment is performed while observing with a surrogate viewpoint that shortens the length of the vessel. Therefore, in order to verify and evaluate what techniques can appropriately expand the lesion with two stents and suppress stent protrusion into the vascular lumen, which can cause thrombosis, an experimental system that is relevant to real-world clinical practice is necessary.

[0006] The inventors have previously conducted research and development on stent treatment methods and stent selection using an elastic vascular model that mimics the diameter and angle of the left main coronary artery bifurcation vessel, while the model is in a stationary state (see Non-Patent Literature 1). [Prior art documents] [Non-patent literature]

[0007] [Non-Patent Document 1] Yutaka Hikichi, Kiyotaka Iwasaki et al., Reduction in incomplete stent apposition area caused by jailed struts after single stenting at left main bifurcation lesions: micro-CT analysis using a three-dimensional elastic bifurcated coronary artery model, Cardiovasc Interv and Ther, 2017 January, 32, P.12-17 [Overview of the Initiative] [Problems that the invention aims to solve]

[0008] However, the aforementioned prior research by the inventors involved testing and evaluation using a static vascular model, and did not simulate the movement of the vascular model accompanying the contraction and expansion of a patient's heart. To date, no testing system has existed that takes into account the movement of the vascular model accompanied by the beating of the heart. Furthermore, through further research by the inventors, it was possible to identify the displacement state (amount of displacement, angle) of the left main coronary artery bifurcation between the diastole and systole of the heart, and to quantitatively understand the movement state of the left main coronary artery bifurcation accompanying the beating of the heart.

[0009] The present invention was devised based on the above-mentioned problems and the inventors' knowledge, and its purpose is to provide a coronary artery motion simulator and vascular model that can simulate the movement of coronary arteries in conjunction with the beating of the heart, and that can be used to test and evaluate medical devices such as stents and treatment methods. [Means for solving the problem]

[0010] To achieve the above objective, the present invention provides a coronary artery motion simulator that primarily simulates the movement of coronary arteries associated with the beating of the heart, comprising a vascular model that simulates a predetermined part of the coronary artery and a model support unit that supports the vascular model, wherein the model support unit holds the vascular model, which is inclined with respect to its installation surface, so as to be able to rotate along the predetermined surface, and is configured to simulate the displacement of the vascular model associated with the beating by repeatedly performing this rotation in forward and reverse directions. [Effects of the Invention]

[0011] According to the present invention, the movement of coronary arteries accompanying the contraction and expansion of a patient's heart can be simulated using a simple mechanism and a simple drive system, making it possible to evaluate the effectiveness and safety of coronary artery treatment in an environment that is closer to actual clinical practice than before. [Brief explanation of the drawing]

[0012] [Figure 1] This is a conceptual diagram of a side view of the coronary artery motion simulator according to this embodiment. [Figure 2] This is a schematic front view of the simulated blood vessel unit. [Figure 3] This is a schematic side view of a simulated blood vessel unit. [Figure 4] This is a schematic plan view of the movable device. [Figure 5] This is a schematic perspective view of the support structure. [Figure 6] This is a schematic perspective view of the fixing part as seen from the top. [Figure 7] This is a schematic front view of the fixed part. [Figure 8] This is a schematic perspective view of the operating part as seen from the back. [Figure 9] This is a schematic front view of the operating section. [Figure 10] This is a schematic plan view of the movable device to explain the state in which the operating part rotates from the state shown in Figure 4. [Modes for carrying out the invention]

[0013] Hereinafter, embodiments of the present invention will be described with reference to the drawings.

[0014] FIG. 1 shows a conceptual diagram in a side view of a coronary artery motion simulator according to this embodiment. In this figure, the coronary artery motion simulator 10 includes a simulated blood vessel unit 11 including a portion simulating the left main coronary artery bifurcation, which is a predetermined site of the coronary artery, and a model support unit 12 that supports the simulated blood vessel unit 11 and is configured to simulate the operation of the left main coronary artery bifurcation accompanying the heartbeat of the heart.

[0015] As shown in FIGS. 2 and 3, the simulated blood vessel unit 11 includes a planar Y-shaped blood vessel model 14 simulating blood vessels near the left main coronary artery bifurcation and a block-shaped base 15 to which the blood vessel model 14 is integrally fixed.

[0016] The blood vessel model 14 is formed in an elastic tube shape from a material such as silicone, and a cross-section (inner lumen cross-section) orthogonal to the extending direction of the blood vessel in the inner lumen, which is the inner space thereof, is elliptical. This blood vessel model 14 includes a main portion 14A corresponding to the main trunk (LMT) of the left coronary artery, and branch portions 14B and 14C that branch from the main portion 14A so as to correspond to the left anterior descending branch (LAD) and the circumflex branch (LCx) of the left coronary artery, respectively. The intersection of the blood vessel axes of the main portion 14A and the branch portions 14B and 14C is referred to as a branch center 14D.

[0017] The branch portions 14B and 14C branch into two branches from the main portion 14A in the plan view of FIG. 2, and are arranged to bend from the branch center 14D with respect to the main portion 14A in the side view of FIG. 3. Therefore, the blood vessel model 14 has a three-dimensional shape in which the blood vessel portion extends. Although not shown, during a test using the coronary artery motion simulator 10, the ends of the main portion 14A and the branch portions 14B and 14C are connected to another tube and arranged as part of a test circuit filled with a liquid or the like.

[0018] The base 15 has a bent shape corresponding to the bent state of the blood vessel model 14, and a part of the surface of the blood vessel model 14 is embedded therein. Among them, the part where the main part 14A is embedded becomes an attachment part 15A attached to the model support unit 12.

[0019] The model support unit 12 employs a structure capable of simulating the displacement and rotation conditions of the coronary artery accompanying the heartbeat of the heart. As shown in FIG. 1, this model support unit 12 includes an inclined table 17 installed on a predetermined installation surface B, and a movable device 18 that is placed on the upper surface of the inclined table 17 and is inclined, and has a mechanism for performing a rotational operation while holding the simulated blood vessel unit 11.

[0020] The inclined table 17 includes an installation part 20 installed on the installation surface B assuming the surface of the operating table, a flat inclined surface part 21 that is inclined upward in the figure toward the right side in the figure at a predetermined inclination angle (for example, 35 degrees) from the tip side on the left side in FIG. 1 of the installation part 20, and a side part 22 that stands up from near the right end in the figure of the installation part 20 and supports the inclined surface part 21 from below.

[0021] The movable device 18 is configured to be able to simulate the displacement of the blood vessel model 14 accompanying the heartbeat of the heart by rotating the simulated blood vessel unit 11 while being fixed to the inclined surface part 21 of the inclined table 17.

[0022] As shown in FIGS. 1 and 4, this movable device 18 includes a support 24 configured to enable a predetermined rotational operation while supporting the simulated blood vessel unit 11, and a drive device 25 that operates the support 24.

[0023] As shown in FIG. 5, the support 24 includes a fixing part 27 located on the lower side in the figure and fixed to the inclined table 17 (see FIG. 1), and an operating part 28 connected to the fixing part 27 so as to be relatively rotatable along the surface (predetermined surface) of the fixing part 27.

[0024] <000|0113>As shown in Figures 6 and 7, the fixing portion 27 comprises a roughly rectangular plate-shaped main body 30 whose back surface is fixed to the inclined surface portion 21 (see Figure 1) with screws (not shown), and a rail 31 that protrudes from near the center of the upper surface of the main body 30 on the opposite side of the inclined surface portion 21 and extends in an arc shape.

[0025] As shown in Figures 5, 8, and 9, the operating unit 28 comprises a base 33 that is roughly rectangular in shape, a pair of model holding parts 34 that are positioned upright on the upper surface of the base 33 and hold the simulated blood vessel unit 11 (see Figure 1, etc.), a guide 35 that protrudes from the lower surface of the base 33, and a connecting part 36 that rises from the outer edge of one corner on the upper surface of the base 33 and to which the drive device 25 (see Figure 1, etc.) is connected.

[0026] The model holding parts 34 are identical in shape, forming a trapezoidal shape in side view, and are arranged parallel to each other in the same orientation. The mounting surface 34A on the top of each model holding part 34 is positioned so as to be inclined vertically at a predetermined angle relative to the top surface of the base 33. The base 15 (see Figure 1, etc.) of the simulated blood vessel unit 11 is detachably attached to this mounting surface 34A by screws or the like (not shown). In this mounting state, as shown in Figures 1 and 4, the blood vessel model 14 is positioned facing the base 33. Also, as shown in Figure 5, the model holding part 34 is fixed to the base 33 at an angle such that its short side, the back surface 34B, faces the direction of the connection part 36. At this time, in the initial state shown in Figure 4 before operation, the arrangement angle in plan view between the axis of the main part 14A of the mounted blood vessel model 14 and the reference edge 33A (reference line) of the base 33 is set to a predetermined value (for example, 33 degrees). In this initial state, the base 33 is positioned such that its reference edge 33A aligns with the inclination direction of the inclined surface portion 21 (see Figure 1).

[0027] As shown in Figure 8, the guide 35 consists of two arc-shaped members of different sizes, spaced apart from each other at different diameters from the same center. The rail 31 (see Figure 6) of the fixing part 27 is fitted into the space S between these arc-shaped members. The guide 35 is also slidable along the rail 31, and this sliding allows the operating part 28 to rotate along the surface of the main body 30 of the fixing part 27, as shown in Figure 10, with the center of the guide 35 as the center of rotation. As a result, the model holding part 34 and the simulated blood vessel unit 11 rotate together with the base 33 relative to the fixing part 27. Here, the shape and position of the rail 31 and the guide 35 are set to enable rotational oscillation that causes the branching center 14D of the blood vessel model 14 to be attached to the model holding part 34 to reciprocate within a predetermined range of angle and movement. In this embodiment, although not particularly limited, the blood vessel model 14 is set to rotate and oscillate along the surface of the fixed part 27 within a range of a predetermined rotation angle (e.g., 7.4 degrees) and a predetermined amount of movement (e.g., 3.7 mm) from the initial position.

[0028] As shown in Figure 1, the drive unit 25 includes an actuator 38 that applies an external force to the support 24 and a control unit 39 consisting of a computer that controls the operation of the actuator 38.

[0029] The actuator 38 is a linear actuator that uses a motor to enable linear reciprocating motion. As shown in Figures 1 and 4, the reciprocating part is connected via a universal joint 40 to a connection part 36 located near the end of the operating part 28, away from the center of rotation. Therefore, when the actuator 38 is driven, an external force is applied to the base 33 of the operating part 28 by repeatedly pushing and pulling, causing the operating part 28 to move relative to the fixed part 27, accompanied by bending of the universal joint 40. In other words, the reciprocating motion of the actuator 38 in one direction causes the operating part 28 to rotate in forward and reverse directions along the surface of the main body 30 of the fixed part 27, as shown in Figures 4 and 10, causing the simulated blood vessel unit 11 to oscillate within a predetermined range.

[0030] The control unit 39 drives the actuator 38 in the forward direction and repeatedly drives it in the reverse direction in a cycle that includes a drive time equivalent to the time from diastole to systole of the heart and a predetermined stop time, based on conditions specified by the user, so that the vascular model 14 is displaced in accordance with the heartbeat state. Here, the drive time is set to correspond to the assumed heart rate.

[0031] In the model support unit 12 described above, the inclination angle of the inclined table 17, the inclination angle of the mounting surface 34A of the model holding part 34, and the position angle of the model holding part 34 relative to the reference edge 33A on the base 33 are set to angles that match the position of the left main coronary artery bifurcation of the patient during actual surgery. In other words, the displacement of the left main coronary artery bifurcation accompanying pulsation is simulated by this position setting and the rotational displacement of the vascular model 14 in the planar direction of the operating part 28, that is, the movement vector in the direction of displacement, the amount of displacement, the amount of rotation, and the position at the initial position at a reference point (during dilation or systole) in a predetermined reference coordinate system.

[0032] Therefore, according to this embodiment, without using devices such as a simulated heart that reproduce the six-axis movement of the heart which requires complex mechanisms and drive systems, the displacement of the left main coronary artery bifurcation associated with the heartbeat can be simulated by the simple rotational oscillation of the vascular model 14 driven by a drive device 25 that performs reciprocating motion in only one direction. Accordingly, the coronary artery motion simulator 10 of this embodiment makes it possible to evaluate the effectiveness and safety of treatment of the left main coronary artery bifurcation in an environment that closely resembles actual clinical practice.

[0033] In the above embodiment, the displacement of the left main coronary artery bifurcation was simulated. However, by using a vascular model that simulates other coronary artery locations and appropriately adjusting the design values ​​of each part of the model support unit 12, evaluation of other locations is also possible.

[0034] Furthermore, the model support unit 12 in the present invention can employ various structures, depending on the location of the target coronary artery, as long as it can simulate various movements of the coronary artery associated with the heartbeat, namely displacement movements that mimic the movement vector and displacement amount of the coronary artery, and / or rotational movements that mimic the amount and range of rotation of the coronary artery.

[0035] Furthermore, the configuration of each part of the apparatus in this invention is not limited to the illustrated configuration example, and various modifications are possible as long as they perform substantially the same function. [Explanation of Symbols]

[0036] 10 Coronary Artery Movement Simulator 11. Simulated blood vessel unit 12 Model Support Units 14. Vascular Models 17 Slope 18 Movable device 21 Slope section 24 Support 25 Drive unit 27 Fixed part 28 Operating section 33 Pedestal 34 Model holding section 38 Actuators 39 Control Unit 40 Universal Joint

Claims

1. A coronary artery motion simulator that simulates the movement of the coronary arteries in conjunction with the beating of the heart, The system comprises a vascular model that simulates a predetermined portion of the coronary artery, and a model support unit that supports the vascular model. The coronary artery motion simulator is characterized in that the model support unit holds the blood vessel model, which is positioned at an angle with respect to its installation surface, so that it can rotate along a predetermined plane, and by repeatedly performing this rotation in forward and reverse directions, it is possible to simulate the displacement of the blood vessel model associated with the pulsation.

2. The model support unit comprises an inclined platform installed on the mounting surface and a movable device having a mechanism for performing the rotational movement while holding the blood vessel model. The inclined base has an inclined surface portion that is positioned at a predetermined inclination angle with respect to the installation surface, The coronary artery motion simulator according to claim 1, characterized in that the movable device is arranged at an inclination along the inclined surface.

3. The movable device comprises a support configured to enable the rotational movement and a drive device for operating the support. The coronary artery motion simulator according to claim 2, characterized in that the drive device includes an actuator that applies an external force to the support, and by applying the external force, it simulates the displacement of the blood vessel model associated with the pulsation.

4. The support comprises a fixing part fixed to the inclined surface and an operating part connected to the fixing part so as to be rotatable relative to the surface of the fixing part. The coronary artery motion simulator according to claim 3, characterized in that the operating unit comprises a base having a structure that can rotate along the surface of the fixed unit by the drive of the drive device, and a model holding unit that is positioned upright on the base and can detachably hold the blood vessel model.

5. The model holding portion is positioned to hold the blood vessel model at a predetermined angle of inclination relative to a reference line within the base that is aligned with the inclination direction of the inclined surface portion, in a plan view. The coronary artery motion simulator according to claim 4, characterized in that the operating part has a structure that rotates relative to the fixed part within a predetermined range of rotation angle and displacement.

6. The actuator applies an external force to the base while repeatedly performing a linear reciprocating motion in one direction. The coronary artery motion simulator according to claim 4, characterized in that the operating unit is configured to rotate in forward and reverse directions within a predetermined range of rotation angle and displacement relative to the fixed unit by the linear reciprocating motion of the actuator, thereby causing the blood vessel model to oscillate relative to the fixed unit.

7. The aforementioned vascular model has a three-dimensional shape that simulates the bifurcation of the left main coronary artery. The model holding portion is provided so as to be able to hold the blood vessel model at a predetermined inclination angle that is inclined vertically with respect to the base, The coronary artery motion simulator according to claim 5, characterized in that the respective inclination angles of the inclined table and the model holder, and the positioning angle of the model holder with respect to the reference line on the base, are set to angles that match the condition of the left main coronary artery bifurcation of a patient during actual surgery.

8. The drive device further comprises a control unit for controlling the drive of the actuator, The control unit drives the actuator in the forward direction for a period of time that is the sum of a drive time corresponding to the time from the diastole to the systole of the heart and a predetermined stop time, and repeatedly drives the actuator in a cycle that also includes driving in the reverse direction, as described in claim 6.

9. The coronary artery motion simulator according to claim 6, characterized in that the operating part of the actuator is connected via a universal joint to an end of the operating part that is far from the center of rotation of the operating part.

10. A vascular model used in the coronary artery motion simulator described in claim 1, which simulates the bifurcation of the left main coronary artery, A vascular model characterized by comprising a main section corresponding to the main trunk of the left coronary artery and branch sections corresponding to the anterior descending branch and circumflex branch of the left coronary artery, wherein the branch sections are formed in a three-dimensional shape so as to branch into two relative to the main section in a plan view and bend at a predetermined angle relative to the main section in a side view.

11. The blood vessel model according to claim 10, characterized in that the luminal cross-section is formed in an elliptical shape.

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