Procedure simulator and simulation method

Abstract

The present invention pertains to a manipulation simulator (10) and a simulation method. The manipulation simulator (10) is provided with a blood vessel model (24). The blood vessel model (24) has an aorta model (38) that imitates a clinical case where an artificial blood vessel is substituted for a portion of a thoracic aorta of a human body. The aorta model (38) has an imitation blood vessel part (42) and an artificial blood vessel (48) that is a medical device connected to the imitation blood vessel part (42).

Description

[Technical Field]

[0001] The present invention relates to a procedure simulator and a simulation method. [Background technology]

[0002] For example, Japanese Patent Application Laid-Open Publication No. 2015-64487 discloses a procedure simulator for training the procedure of stent graft insertion surgery in which a stent graft is placed in a thoracic aorta model that imitates the thoracic aorta of a human body. Summary of the Invention

[0003] In the treatment of thoracic aortic aneurysms, even after surgery to replace part of the thoracic aorta with an artificial blood vessel, a recurrence of a thoracic aortic aneurysm may occur. In recent years, advances in treatment devices have made it possible to percutaneously place a stent graft in the affected area (aneurysm or dissection) of the thoracic aorta, even in retreatment cases. Furthermore, in cases of Stanford type B dissection, in which the wall of the descending aorta tears and divides into two lumens (true and false lumens), surgery to place a stent graft in the descending aorta using endovascular surgery may be performed early in the course of the dissection. While advances in treatment devices have made percutaneous treatment possible even in complex cases, physicians are also required to quickly master the operation of the latest treatment devices.

[0004] The procedure simulator in JP 2015-64487 A mentioned above is not designed for training in such complex cases, and does not reproduce the sensation of graft insertion that doctors experience in complex cases.Furthermore, it does not allow doctors to learn placement techniques while actually taking CT scans.

[0005] The present invention has been made in consideration of these problems, and aims to provide a procedure simulator and a simulation method that enable a simulated experience of stent graft insertion surgery for complex cases of the thoracic aorta and enable the efficient learning of the stent graft insertion surgery.

[0006] One aspect of the present invention is a procedure simulator equipped with a blood vessel model, the blood vessel model having an aortic model simulating a case in which a portion of the thoracic aorta of a human body has been replaced with an artificial blood vessel, the aortic model having a simulated blood vessel portion and an artificial blood vessel that is a medical device connected to the simulated blood vessel portion.

[0007] Another aspect of the present invention is a simulation method using the above-mentioned procedure simulator, including a water circulation step of circulating water within the vascular model, an introduction step of guiding a stent graft incorporated into the tip of the catheter into the aortic model by operating a catheter while the water is circulating within the vascular model, and a deployment step of deploying the stent graft after the introduction step.

[0008] According to the present invention, since the aortic model includes a simulated blood vessel section and an artificial blood vessel, it is possible to simulate the stent graft insertion procedure for a complicated case of the thoracic aorta, and therefore, the stent graft insertion procedure can be efficiently learned. [Brief explanation of the drawings]

[0009] [Figure 1] 1 is a front view of a procedure simulator according to an embodiment of the present invention. [Figure 2] FIG. 2 is a plan view of the simulator body of FIG. 1. [Figure 3] FIG. 3 is a longitudinal sectional view of the aortic model of FIG. 2, with a portion omitted. [Figure 4] FIG. 4 is an enlarged longitudinal sectional view of a portion of the aortic model of FIG. 3. [Figure 5] FIG. 4 is a cross-sectional view of the first connection portion (second connection portion) of FIG. 3. [Figure 6] 10 is a flowchart illustrating a simulation method using the procedure simulator of FIG. 1. [Figure 7] FIG. 1 is an explanatory diagram of a water circulation process and an introduction process. [Figure 8]FIG. [Figure 9] FIG. 2 is an explanatory diagram of a radiation image captured in the imaging process. [Figure 10] FIG. 1 is an explanatory diagram of a simulation method using a procedure simulator according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0010] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS A procedure simulator and a simulation method according to preferred embodiments of the present invention will be described below with reference to the accompanying drawings.

[0011] A procedure simulator 10 according to one embodiment of the present invention is used for training in endovascular stent graft insertion into the thoracic aorta.

[0012] As shown in Fig. 1, the procedure simulator 10 includes an operating table 12 placed on a floor surface 300, a simulator main body 14 provided on the operating table 12, and a radiological imaging device 16 also placed on the floor surface 300. The operating table 12 extends in one direction (the direction of the arrow X). The operating table 12 can be raised and lowered in the height direction (the direction of the arrow Z).

[0013] 1 and 2, the simulator body 14 includes a water tank 18, a pump 20, a connection circuit 22, and a blood vessel model 24. The water tank 18 is made of, for example, polyvinyl chloride (PVC). The water tank 18 is disposed at one end of the operating table 12 in the longitudinal direction (the end in the direction of arrow X1).

[0014] In Figure 2, water tank 18 is located approximately in the center of the short side direction (width direction, arrow Y direction) of operating table 12. Water tank 18 is formed in a box shape that is open at the top. Water tank 18 is made of transparent resin. Water tank 18 includes a rectangular bottom wall portion 26 (see Figure 2) and first to fourth side walls 28a to 28d that protrude in the height direction (arrow Z direction) from each side of bottom wall portion 26.

[0015] The first side wall 28a is located at the end of the bottom wall 26 in the direction of arrow Y1 (one side in the short direction of the operating table 12). The second side wall 28b is located at the end of the bottom wall 26 in the direction of arrow Y2 (the other side in the short direction of the operating table 12). The third side wall 28c is located at the end of the bottom wall 26 in the direction of arrow X1. The fourth side wall 28d is located at the end of the bottom wall 26 in the direction of arrow X2 (the opposite direction to the direction of arrow X1).

[0016] The fourth side wall portion 28d is provided with a first tube connector 30a, a second tube connector 30b, a third tube connector 30c, a fourth tube connector 30d, and a fifth tube connector 30e. The constituent material, shape, and size of the water tank 18 can be set as appropriate.

[0017] The pump 20 sucks water from the water tank 18 and supplies it to the blood vessel model 24. The pump 20 supplies water into the blood vessel model 24 so that a pressure equivalent to arterial pressure is applied. The pump 20 has an intake port 32 for sucking in water and an outlet port 34 for discharging water.

[0018] The connection circuit 22 is for circulating water in the water tank 18 through the blood vessel model 24. The connection circuit 22 has a first connection tube 36a, a second connection tube 36b, a third connection tube 36c, and a fourth connection tube 36d. The first connection tube 36a forms a flow path for guiding water in the water tank 18 to the pump 20. The first connection tube 36a connects the first tube connector 30a to the suction port 32 of the pump 20. The inner cavity of the first connection tube 36a communicates with the inside of the water tank 18 via the first tube connector 30a. The second connection tube 36b forms a flow path for guiding water discharged from the pump 20 into the blood vessel model 24. The second connection tube 36b connects the discharge port 34 of the pump 20 to the second tube connector 30b.

[0019] The third connecting tube 36c and the fourth connecting tube 36d each form a flow path for returning water that has flowed through the blood vessel model 24 into the water tank 18. The third connecting tube 36c connects the third tube connector 30c and the simulated femoral artery 90 to each other. The fourth connecting tube 36d connects the fourth tube connector 30d and the simulated femoral artery 90 to each other.

[0020] The blood vessel model 24 includes an aorta model 38 that is placed so as to be submerged in the water tank 18 , and a femoral artery model 40 that is placed outside the water tank 18 .

[0021] 2 and 3, the aorta model 38 simulates a case in which a portion of the thoracic aorta of a human body has been replaced with an artificial blood vessel. The aorta model 38 has a simulated blood vessel portion 42 and an artificial blood vessel 48, which is a medical device, connected to the simulated blood vessel portion 42. In this embodiment, the artificial blood vessel 48 is provided in a portion of the aorta model 38 that corresponds to the aortic arch of a human body.

[0022] 8, a first distance L1 between the aorta model 38 and the first side wall 28a is shorter than a second distance L2 between the aorta model 38 and the second side wall 28b. The second distance L2 is longer than a height H1 of the second side wall 28b (the length from the bottom wall 26 to the protruding end of the second side wall 28b). The aorta model 38 is disposed adjacent to the first side wall 28a. In other words, the aorta model 38 is located on the side where the first side wall 28a is located (in the direction of the arrow Y1) relative to the center of the water tank 18 in the direction of the arrow Y.

[0023] As shown in FIG. 3 , the simulated blood vessel 42 includes a tubular inner wall 50 and a tubular outer wall 52 provided on the outer surface of the inner wall 50. The inner wall 50 and the outer wall 52 are each made of silicone. The thickness of the inner wall 50 is thinner than the thickness of the outer wall 52. Specifically, the thickness of the inner wall 50 is preferably 0.2 mm to 0.7 mm, more preferably 0.3 mm to 0.6 mm, and even more preferably approximately 0.5 mm. The thickness of the outer wall 52 is preferably 1.3 mm to 2.5 mm, more preferably 1.5 mm to 2.2 mm, and even more preferably approximately 2.0 mm. However, the thicknesses of the inner wall 50 and the outer wall 52 can be set as appropriate.

[0024] The elongation of the inner wall portion 50 is greater than that of the outer wall portion 52. Specifically, the elongation of the inner wall portion 50 is preferably 500% or more and 700% or less, more preferably 550% or more and 650% or less, and even more preferably about 600%. The elongation of the outer wall portion 52 is preferably 200% or more and 400% or less, more preferably 250% or more and 350% or less, and even more preferably about 300%. However, the elongation of each of the inner wall portion 50 and the outer wall portion 52 can be set as appropriate.

[0025] The tear strength of the inner wall portion 50 is greater than the tear strength of the outer wall portion 52. Specifically, the tear strength of the inner wall portion 50 is preferably 30 kgf or more and 40 kgf or less, and more preferably about 36 kgf. The tear strength of the outer wall portion 52 is preferably 10 kgf or more and 20 kgf or less, and more preferably about 17 kgf.

[0026] A surfactant is applied to the inner surface of the inner wall portion 50. This prevents the stent graft 202 (see FIG. 7) in a folded state from getting stuck on the inner surface of the inner wall portion 50 when the stent graft 202 is inserted.

[0027] The simulated blood vessel section 42 includes a simulated aortic root 42a, a simulated ascending aorta 42b, a simulated coronary artery 42c, a simulated descending aorta 42d, and a simulated abdominal aorta 42e. The simulated aortic root 42a simulates the aortic root of a human body. The simulated ascending aorta 42b simulates the ascending aorta of a human body. The simulated ascending aorta 42b extends from the simulated aortic root 42a in the direction of arrow X1. The extending end of the simulated ascending aorta 42b (the end in the direction of arrow X1) is connected to an artificial blood vessel 48. The simulated abdominal aorta 42e simulates the abdominal aorta of a human body.

[0028] The simulated coronary artery 42c simulates a human coronary artery. The simulated coronary artery 42c extends from the simulated aortic root 42a in the direction of arrow X2. In FIG. 2, an introduction tube 54 is liquid-tightly connected to the extending end of the simulated coronary artery 42c. The introduction tube 54 is connected to a second tube connector 30b provided on the fourth side wall 28d of the water bath 18. In other words, the lumen of the introduction tube 54 communicates with the lumen of the second connection tube 36b via the second tube connector 30b.

[0029] 3, the simulated descending aorta 42d simulates the descending aorta from a part of the aortic arch of a human body. The simulated descending aorta 42d extends in the direction of arrow X. The end of the simulated descending aorta 42d in the direction of arrow X1 is connected to an artificial blood vessel 48.

[0030] 2, the simulated abdominal aorta 42e extends from the simulated descending aorta 42d in the direction of arrow X2. The extending end of the simulated abdominal aorta 42e is connected to a fifth tube connector 30e provided on the fourth side wall portion 28d of the water bath 18.

[0031] An aneurysm 56 and a dissection 58 are formed in the simulated blood vessel portion 42. The aneurysm 56 is provided at the end of the simulated descending aorta 42d in the direction of arrow X1. The dissection 58 is provided at a midpoint of the simulated descending aorta 42d. The dissection 58 simulates a so-called Stanford type B dissection. The dissection 58 includes a partition 62 that separates the lumen of the simulated descending aorta 42d into a true lumen 60a and a false lumen 60b. The partition 62 has a hole 64 formed therein that connects the true lumen 60a and the false lumen 60b to each other.

[0032] 3, the artificial blood vessel 48 is connected to the simulated blood vessel portion 42, forming a blood vessel model 24 corresponding to a so-called elephant trunk case. The artificial blood vessel 48 is made of, for example, polyethylene terephthalate (PET), polyurethane, polytetrafluoroethylene (PTFE), or the like. The artificial blood vessel 48 includes an artificial blood vessel main body 70 that connects the simulated ascending aorta 42b and the simulated descending aorta 42d to each other, and a first branch pipe portion 72a, a second branch pipe portion 72b, and a third branch pipe portion 72c that extend from the artificial blood vessel main body 70 in the direction of arrow X1.

[0033] 4 and 5, the first connecting portion 74a connecting the artificial blood vessel main body 70 and the simulated ascending aorta 42b includes a first annular connecting portion 76a, a first annular end portion 78a, a first nonwoven fabric 80a, a first suture 82a, and a first sealing member 84a. The first annular connecting portion 76a forms one end of the artificial blood vessel main body 70. The first annular end portion 78a forms the end of the simulated ascending aorta 42b in the direction of arrow X1. The outer peripheral surface of the first annular connecting portion 76a contacts the inner peripheral surface of the first annular end portion 78a (the inner peripheral surface of the inner wall portion 50).

[0034] The first nonwoven fabric 80a is an annular mesh member and is provided on the outer peripheral surface of the first annular end portion 78a (the outer peripheral surface of the outer wall portion 52). That is, in the first connecting portion 74a, the first annular connecting portion 76a, the first annular end portion 78a, and the first nonwoven fabric 80a are arranged so as to overlap one another in the radially outward direction. The first nonwoven fabric 80a extends in an annular shape so as to go around the outer peripheral surface of the first annular end portion 78a. The first nonwoven fabric 80a is made of a soft resin material. Examples of soft resin materials that make up the first nonwoven fabric 80a include fibers such as polyester, silicone, etc.

[0035] The first annular connecting portion 76a, the first annular end portion 78a, and the first nonwoven fabric 80a are sewn together with a first suture 82a while overlapping each other. The first suture 82a is located at the end of the first annular end portion 78a on the side where the first branch pipe portion 72a is located (see FIG. 4). The first sealing member 84a is made of a resin material such as silicone. The first sealing member 84a is provided so as to cover the entire first nonwoven fabric 80a. The first sealing member 84a is filled into the mesh of the first nonwoven fabric 80a. The first sealing member 84a covers the end face of the first annular end portion 78a (see FIG. 4). The first sealing member 84a does not directly cover the artificial blood vessel main body 70.

[0036] The second connecting portion 74b, which connects the artificial blood vessel main body 70 and the simulated descending aorta 42d, includes a second annular connecting portion 76b, a second annular end portion 78b, a second nonwoven fabric 80b, a second suture 82b, and a second sealing member 84b. The second annular connecting portion 76b forms an intermediate portion of the artificial blood vessel main body 70. The second annular end portion 78b forms the end portion of the simulated descending aorta 42d in the direction of arrow X1. The outer peripheral surface of the second annular connecting portion 76b contacts the inner peripheral surface of the second annular end portion 78b (the inner peripheral surface of the inner wall portion 50).

[0037] The second nonwoven fabric 80b is an annular mesh member and is provided on the outer peripheral surface of the second annular end portion 78b (the outer peripheral surface of the outer wall portion 52). That is, in the second connecting portion 74b, the second annular connecting portion 76b, the second annular end portion 78b, and the second nonwoven fabric 80b are arranged so as to overlap one another in the radially outward direction. The second nonwoven fabric 80b extends in an annular shape so as to go around the outer peripheral surface of the second annular end portion 78b. The second nonwoven fabric 80b is made of a soft resin material. Examples of soft resin materials that make up the second nonwoven fabric 80b include fibers such as polyester and silicone.

[0038] The second annular connecting portion 76b, the second annular end portion 78b, and the second nonwoven fabric 80b are sewn together with a second suture 82b while overlapping each other. The second suture 82b is located at the end of the second annular end portion 78b on the side where the third branch pipe portion 72c is located (see FIG. 4). The second sealing member 84b is made of a resin material such as silicone. The second sealing member 84b is provided so as to cover the entire second nonwoven fabric 80b. The second sealing member 84b is filled into the mesh of the second nonwoven fabric 80b. The second sealing member 84b covers the end face of the second annular end portion 78b (see FIG. 4).

[0039] As shown in Fig. 3, the other end of the artificial blood vessel main body 70 is inserted into the lumen of the simulated descending aorta 42d so as to cover the aneurysm 56 from the inside. In Fig. 2, a first tube 86a is liquid-tightly connected to the extending end of the first branch pipe portion 72a. The first tube 86a is provided with a first engaging member 88a that can be detached and attached to a desired position on the third side wall portion 28c of the water tank 18. The first engaging member 88a has a suction cup that can be attached to the inner surface of the third side wall portion 28c.

[0040] A second tube 86b is liquid-tightly connected to the extending end of the second branch pipe 72b. The second tube 86b is provided with a second locking member 88b that can be attached to a desired position on the third side wall 28c of the water tub 18. The second locking member 88b has a suction cup that can be attached to the inner surface of the third side wall 28c. The opening at the extending end of the third branch pipe 72c communicates with the inside of the water tub 18.

[0041] Such an aortic model 38 is manufactured as follows. First, 3D data (including thoracic aortic aneurysm and Stanford type B dissection) of the patient's thoracic aorta and abdominal aorta is created from clinical data (DICOM data, etc.). Then, a blood vessel mold is formed using a 3D printer based on the 3D data. After that, a first silicone for forming the inner wall portion 50 is applied to the blood vessel mold. Specifically, the blood vessel mold is immersed (dipped) in the first silicone. This forms the inner wall portion 50 of the simulated blood vessel portion 42.

[0042] Next, a second silicone is applied to the outer surface of the inner wall portion 50 to form the outer wall portion 52. Specifically, the blood vessel molding mold on which the inner wall portion 50 has been formed is immersed (dipped) in the second silicone. This forms the outer wall portion 52 of the simulated blood vessel portion 42. The blood vessel molding mold is then dissolved and removed from the inside of the inner wall portion 50. Of the simulated blood vessel portion thus formed, which simulates the patient's thoracic aorta and abdominal aorta, a portion corresponding to the aortic arch of a human body is replaced with an artificial blood vessel 48, which is a medical device. This allows for the production of an aortic model 38 having the simulated blood vessel portion 42 and the artificial blood vessel 48. In other words, the aortic model 38 is missing a portion of the shape of an actual blood vessel, and that portion has been replaced with the artificial blood vessel 48, which is a treatment device.

[0043] 1 and 2, the femoral artery model 40 is placed on the operating table 12 so as to be adjacent to the fourth side wall portion 28d of the water tank 18 in the direction of arrow X2. The femoral artery model 40 has a simulated femoral artery 90 and a block member 92 in which the simulated femoral artery 90 is embedded.

[0044] The simulated femoral artery 90 is a tubular member integrally molded from a resin material such as silicone. The simulated femoral artery 90 is transparent. The simulated femoral artery 90 includes a connecting tube 94, a simulated left femoral artery 96L, a simulated right femoral artery 96R, a left connecting passage 97L, and a right connecting passage 97R.

[0045] One end of the connecting tube 94 is exposed from the block member 92 and is connected to the fifth tube connector 30e. That is, the lumen of the connecting tube 94 communicates with the lumen of the simulated abdominal aorta 42e via the fifth tube connector 30e. The simulated left femoral artery 96L and the simulated right femoral artery 96R extend so as to branch off from the other end of the connecting tube 94. In other words, one end of the simulated left femoral artery 96L is connected to the other end of the connecting tube 94. One end of the simulated right femoral artery 96R is connected to the other end of the connecting tube 94. The other ends of the simulated left femoral artery 96L and the simulated right femoral artery 96R are exposed from the block member 92.

[0046] A check valve 98, through which a medical device 200 (see FIG. 7) can be inserted, is provided at the other end of the simulated left femoral artery 96L. The check valve 98 prevents water from leaking from the simulated left femoral artery 96L. The left connecting path 97L branches off from the simulated left femoral artery 96L on the connecting tube 94 side of the check valve 98 and connects to the third connecting tube 36c. The other end of the simulated right femoral artery 96R may be closed, or may be provided with a check valve similar to the simulated left femoral artery 96L. The right connecting path 97R branches off from the connecting tube 94 side of the simulated right femoral artery 96R and connects to the fourth connecting tube 36d.

[0047] The block member 92 is formed in a rectangular parallelepiped shape. The block member 92 is made of a hard resin material. That is, the block member 92 suppresses radially outward elastic deformation of the simulated femoral artery 90. This makes it difficult for pressure (arterial pressure) from the pump 20 to escape from the simulated femoral artery 90, allowing the aorta model 38 to pulsate like an aorta in an actual human body. Examples of hard resin materials that may be used for the block member 92 include silicone. The block member 92 is transparent. This allows the user to view the medical device 200 inserted into the lumen of the artery model body from the outside of the block member 92. Furthermore, by surrounding the simulated femoral artery 90 with the block member 92, the durability of the simulated femoral artery 90 can be improved.

[0048] 1, the radiographic image capturing device 16 includes an image capturing device main body 100 arranged in the direction of arrow X1 of the operating table 12, and a display unit 102 that displays an image captured by the image capturing device main body 100. The image capturing device main body 100 includes a base 104 installed on a floor surface 300, a C-shaped arm 106 rotatably provided with respect to the base 104, a radiation source 108 provided at one end of the arm 106, and a detection unit 110 provided at the other end of the arm 106.

[0049] The radiation source 108 irradiates the subject with radiation. The detection unit 110 detects the radiation that has passed through the subject. The imaging device main body 100 has a control unit (not shown) that creates a radiographic image based on the radiation detected by the detection unit 110 and displays the image on the display unit 102. The display unit 102 is a display made of liquid crystal, organic electroluminescence, or the like.

[0050] Next, a simulation method using the procedure simulator 10 according to this embodiment will be described. In this embodiment, training in a procedure for treating Stanford type B dissection that has developed in the descending aorta after at least a portion of the aortic arch has been replaced with an artificial blood vessel (elephant trunk) by endovascular stent grafting will be described. However, the procedure simulator 10 is not limited to training in such a procedure. It is sufficient to train again the descending aorta after at least a portion of the aortic arch has been replaced with an artificial blood vessel (elephant trunk).

[0051] As shown in FIG. 6, the simulation method according to this embodiment includes a preparation step, a setting step, a water flow step, an introduction step, a photographing step, a development step, and a removal step.

[0052] First, in a preparation step (step S1), the above-described blood vessel model 24 is prepared. Then, in a setting step (step S2), the user sets the blood vessel model 24 as shown in FIG. 2. Specifically, in the setting step, the user places the aorta model 38 so that it is submerged in the water tank 18. At this time, the user places the aorta model 38 in a position shifted in the direction of arrow Y1 from the center of the water tank 18 in the Y direction. The user also adjusts the locking positions of the first locking member 88a and the second locking member 88b with respect to the third side wall portion 28c of the water tank 18 to position and pose the aorta model 38 in a desired position.

[0053] Next, in the water circulation step (step S3), water is circulated through the blood vessel model 24. Specifically, in the water circulation step, the user drives the pump 20. Then, as shown in FIG. 7, the pump 20 sucks water stored in the water tank 18 through the first connection tube 36a and discharges it into the second connection tube 36b. The water discharged into the second connection tube 36b is guided to the artificial blood vessel main body 70 via the introduction tube 54, the simulated coronary artery 42c, the simulated aortic root 42a, and the simulated ascending aorta 42b. The water guided to the artificial blood vessel main body 70 is divided into the third branch pipe portion 72c and the simulated descending aorta 42d. The water flowing into the third branch pipe portion 72c is discharged into the water tank 18. The water that flows into the simulated descending aorta 42d flows through the simulated abdominal aorta 42e and the connecting tube 94, and then branches off into the simulated left femoral artery 96L and the simulated right femoral artery 96R. The water that flows into the simulated left femoral artery 96L is returned to the water bath 18 via the third connecting tube 36c. The water that flows into the simulated right femoral artery 96R is returned to the water bath 18 via the fourth connecting tube 36d.

[0054] Thereafter, in the introduction step (step S4 in FIG. 6 ), the user introduces the medical device 200 (a catheter 204 having a stent graft 202 incorporated in its distal end) into the diseased portion (dissection portion 58) of the simulated blood vessel portion 42. Specifically, the user inserts the medical device 200 from the check valve 98 into the simulated left femoral artery 96L. Then, the user operates the catheter 204 to advance the distal end (stent graft 202) of the catheter 204 from the simulated left femoral artery 96L through the simulated abdominal aorta 42e to the simulated descending aorta 42d. At this time, the user inserts the distal end of the catheter 204 into the lumen of the artificial blood vessel 48.

[0055] In the imaging step (step S5), the radiographic imaging device 16 is driven to image the medical device 200 in the aorta model 38. At this time, as shown in FIG. 8, the arm 106 is rotated (tilted) by a predetermined angle θ with respect to the base 104. Specifically, the imaging device main body 100 tilts the arm 106 so that the radiation source 108 is located on the second side wall 28b side and the detection unit 110 is located on the first side wall 28a side. In this case, the second side wall 28b is displayed in the radiographic image (see FIG. 9). However, because the aorta model 38 is spaced from the second side wall 28b by the second distance L2, the second side wall 28b is not displayed overlapping the medical device 200 in the radiographic image. Therefore, the medical device 200 can be clearly seen in the radiographic image.

[0056] Next, in the deployment step (step S6 in FIG. 6 ), with the distal end (stent graft 202) of the catheter 204 positioned at a position corresponding to the dissection portion 58 of the simulated descending aorta 42d, the user deploys the stent graft 202 by operating the catheter 204. This causes the stent graft 202 to expand in diameter, as shown in FIG. 10 . As a result, one end of the stent graft 202 is pressed against (comes into contact with) the inner surface of the other end of the artificial blood vessel 48. Furthermore, the middle portion and the other end of the stent graft 202 are pressed against the inner surface of the simulated blood vessel portion 42. In other words, the hole 64 in the bulkhead 62 of the dissection portion 58 is blocked by the stent graft 202.

[0057] Thereafter, in the removal step (step S7 in FIG. 6), the user removes the catheter 204 from the blood vessel model 24. Note that in this removal step, the placed stent graft 202 may be removed from the blood vessel model 24 together with the catheter 204. In this case, although the diameter of the stent graft 202 has expanded, the elongation of the inner wall portion 50 of the simulated blood vessel section 42 is greater than the elongation of the outer wall portion 52, so the stent graft 202 can be removed relatively smoothly. By performing the removal step, the simulation using the procedure simulator 10 is completed.

[0058] The procedure simulator 10 and simulation method according to this embodiment have the following advantages.

[0059] In the procedure simulator 10, the vascular model 24 has an aorta model 38 that simulates a case in which part of the thoracic aorta of a human body has been replaced with an artificial blood vessel, and the aorta model 38 has a simulated blood vessel section 42 and an artificial blood vessel 48, which is a medical device connected to the simulated blood vessel section 42.

[0060] With this configuration, the aorta model 38 has the simulated blood vessel portion 42 and the artificial blood vessel 48, so it is possible to simulate the stent graft insertion procedure for a case (complex case) in which part of the thoracic aorta is replaced with an artificial blood vessel, thereby enabling participants to efficiently learn the stent graft insertion procedure.

[0061] The artificial blood vessel 48 of the aorta model 38 is provided in a portion of the aorta model 38 that corresponds to at least a part of the aortic arch of a human body.

[0062] This configuration makes it possible to simulate the experience of endovascular stent grafting in a case where at least a portion of the aortic arch has been replaced with an artificial blood vessel. Furthermore, by not providing the aorta model 38 at least partially on the outside of the artificial blood vessel 48, the feeling of inserting the stent graft 202 into the artificial blood vessel 48 is not obstructed by the resin blood vessel wall, making it possible to simulate the experience of a sensation close to that of an actual thoracic aorta being stretched during endovascular stent grafting.

[0063] The first connecting portion 74a between the simulated blood vessel portion 42 and the artificial blood vessel 48 of the aorta model 38 includes a first annular end portion 78a that forms the simulated blood vessel portion 42 (simulated ascending aorta 42b) and a first annular connecting portion 76a that forms the artificial blood vessel 48 of the aorta model 38. The first annular connecting portion 76a is liquid-tightly connected to the first annular end portion 78a when inserted into the inner cavity of the first annular end portion 78a. The second connecting portion 74b between the simulated blood vessel portion 42 and the artificial blood vessel 48 of the aorta model 38 includes a second annular end portion 78b that forms the simulated blood vessel portion 42 (simulated descending aorta 42d) and a second annular connecting portion 76b that forms the artificial blood vessel 48 of the aorta model 38. The second annular connecting portion 76b is liquid-tightly connected to the second annular end portion 78b when inserted into the inner cavity of the second annular end portion 78b.

[0064] With this configuration, it is possible to prevent water from leaking from the aorta model 38 through the first connecting portion 74a and the second connecting portion 74b.

[0065] The first connecting portion 74a has a first nonwoven fabric 80a made of soft resin provided on the outer peripheral surface of the first annular end portion 78a. The first annular connecting portion 76a, the first annular end portion 78a, and the first nonwoven fabric 80a are sewn together with a first sewing thread 82a while overlapping each other. The second connecting portion 74b has a second nonwoven fabric 80b made of soft resin provided on the outer peripheral surface of the second annular end portion 78b. The second annular connecting portion 76b, the second annular end portion 78b, and the second nonwoven fabric 80b are sewn together with a second sewing thread 82b while overlapping each other.

[0066] With this configuration, the flexibility of each of the first connecting portion 74a and the second connecting portion 74b is made similar to that of the connecting portion between the actual thoracic aorta and the artificial blood vessel 48. Furthermore, the simulated blood vessel portion 42, which is made of resin and cannot normally be bonded, can be connected to the artificial blood vessel 48 while maintaining its strength. This effectively prevents the artificial blood vessel 48 from coming off the simulated blood vessel portion 42, even when arterial pressure is applied to the water in the aorta model 38. Furthermore, providing the first nonwoven fabric 80a at the first connecting portion 74a prevents the simulated blood vessel portion 42 (first annular end portion 78a) from tearing when suturing with the first suture 82a. Furthermore, providing the second nonwoven fabric 80b at the second connecting portion 74b prevents the simulated blood vessel portion 42 (second annular end portion 78b) from tearing when suturing with the second suture 82b.

[0067] The first connecting portion 74a includes a first sealing member 84a made of resin provided on the first nonwoven fabric 80a, and the second connecting portion 74b includes a second sealing member 84b made of resin provided on the second nonwoven fabric 80b.

[0068] With this configuration, it is possible to further prevent water from leaking from the aorta model 38 through the first connecting portion 74a and the second connecting portion 74b.

[0069] The blood vessel model 24 has a simulated femoral artery 90 that simulates a human femoral artery, and a block member 92 in which the simulated femoral artery 90 is embedded. The simulated blood vessel portion 42 and the simulated femoral artery 90 are each made of a soft resin material, and the block member 92 is made of a hard resin material.

[0070] With this configuration, when arterial pressure is applied to the water in the blood vessel model 24, the block member 92 can prevent the arterial pressure from escaping from the simulated femoral artery 90. This allows the simulated blood vessel portion 42 to pulsate in the same manner as the actual thoracic aorta. Furthermore, the durability of the simulated femoral artery 90 can be improved. In particular, when inserting the stent graft 202 into a simulated blood vessel manufactured using only a resin tube, the stent graft does not slide well and does not advance in the insertion direction, or the simulated blood vessel kinks. Embedding the simulated femoral artery 90 in hard resin allows the stent graft to be inserted smoothly into the simulated femoral artery 90.

[0071] The procedure simulator 10 includes a box-shaped water tank 18 for storing water and housing an aorta model 38 submerged in the water, a connection circuit 22 for circulating the water in the water tank 18 through a blood vessel model 24, and a pump 20 for applying arterial pressure to the water in the blood vessel model 24.

[0072] This configuration allows the simulated blood vessel section 42 to efficiently pulsate. Furthermore, even if water leaks from the connection (first connection section 74a or second connection section 74b) between the artificial blood vessel 48 and the simulated blood vessel section 42, it is possible to prevent devices (such as the operating table 12 and the radiographic imaging device 16) located outside the water tank 18 from getting wet.

[0073] The water tank 18 has a bottom wall 26 and a first side wall 28a and a second side wall 28b that protrude from the bottom wall 26 and face each other. A first distance L1 between the aorta model 38 and the first side wall 28a is shorter than a second distance L2 between the aorta model 38 and the second side wall 28b, and the second distance L2 is longer than a height H1 of the second side wall 28b.

[0074] With this configuration, when radiation is irradiated onto the aortic model 38 from diagonally above (above the second side wall portion 28b) during stent graft insertion surgery and a radiological image is taken, it is possible to prevent the second side wall portion 28b from overlapping with the aortic model 38 in the radiological image.

[0075] The simulated blood vessel portion 42 has a tubular inner wall portion 50 and a tubular outer wall portion 52 provided on the outer peripheral surface of the inner wall portion 50. The inner wall portion 50 and the outer wall portion 52 are each made of a soft resin material, and the elongation of the inner wall portion 50 is greater than the elongation of the outer wall portion 52.

[0076] According to this configuration, the inner wall portion 50, which comes into contact with the medical device 200 during stent graft insertion, stretches in the longitudinal direction (the insertion direction of the medical device 200), making it possible to prevent the stent graft 202 from getting stuck on the inner wall portion 50 when inserting the medical device 200 (and also when removing the stent graft 202, if necessary).In addition, when the diameter of the stent graft 202 is expanded, it is possible to prevent the simulated blood vessel portion 42 from spreading excessively outward in the radial direction.

[0077] The simulated blood vessel portion 42 has a partition 62 that separates the lumen of the simulated blood vessel portion 42 into a true lumen 60a and a false lumen 60b, and the partition 62 has a hole 64 formed therein that connects the true lumen 60a and the false lumen 60b to each other.

[0078] With this configuration, the dissection portion 58 can be reproduced in the simulated blood vessel portion 42.

[0079] The simulation method using the procedure simulator 10 includes a water circulation process in which water is circulated through the blood vessel model 24, an introduction process in which the stent graft 202 incorporated into the tip of the catheter 204 is guided into the aortic model 38 by operating the catheter 204 while water is circulating through the blood vessel model 24, and a deployment process in which the stent graft 202 is deployed after the introduction process.

[0080] According to this simulation method, the same effects as those of the procedure simulator 10 described above can be achieved.

[0081] The present invention is not limited to the above-described embodiment, and various modifications are possible without departing from the gist of the present invention.

[0082] The above embodiments can be summarized as follows.

[0083] The above embodiment discloses a procedure simulator (10) equipped with a blood vessel model (24), the blood vessel model having an aorta model (38) simulating a case in which a part of the thoracic aorta of a human body has been replaced with an artificial blood vessel, and the aorta model has a simulated blood vessel section (42) and an artificial blood vessel (48), which is a medical device, connected to the simulated blood vessel section.

[0084] In the above-described procedure simulator, the artificial blood vessel of the aortic model may be provided in a portion of the aortic model that corresponds to at least a part of the aortic arch of a human body.

[0085] In the above-mentioned procedure simulator, the connection portion (74a, 74b) between the simulated blood vessel portion and the artificial blood vessel of the aortic model includes annular end portions (78a, 78b) that form the simulated blood vessel portion and annular connecting portions (76a, 76b) that form the artificial blood vessel of the aortic model, and the annular connecting portions may be fluid-tightly connected to the annular end portions when inserted into the inner cavity of the annular end portions.

[0086] In the above-mentioned procedure simulator, the connection portion has a nonwoven fabric (80a, 80b) made of soft resin provided on the outer surface of the annular end portion, and the annular connection portion, the annular end portion and the nonwoven fabric may be sewn together with suture thread (82a, 82b) while overlapping each other.

[0087] In the above procedure simulator, the connection portion may include resin sealing members (84a, 84b) provided on the nonwoven fabric.

[0088] In the above-described procedure simulator, the blood vessel model includes a simulated femoral artery (90) that imitates the femoral artery of a human body, and a block member (92) in which the simulated femoral artery is embedded, and the simulated blood vessel portion and the simulated femoral artery may each be made of a soft resin material, and the block member may be made of a hard resin material.

[0089] The above-mentioned procedure simulator may also include a box-shaped water tank (18) for storing water and accommodating the aorta model submerged in the water, a connection circuit (22) for circulating the water in the water tank through the blood vessel model, and a pump (20) for applying arterial pressure to the water in the blood vessel model.

[0090] In the above-mentioned procedure simulator, the water tank has a bottom wall portion (26) and a first side wall portion (28a) and a second side wall portion (28b) protruding from the bottom wall portion so as to face each other, and a first distance (L1) between the aorta model and the first side wall portion is shorter than a second distance (L2) between the aorta model and the second side wall portion, and the second distance may be longer than a height (H1) of the second side wall portion.

[0091] In the above-mentioned procedure simulator, the simulated blood vessel portion has a tubular inner wall portion (50) and a tubular outer wall portion (52) provided on the outer peripheral surface of the inner wall portion, and each of the inner wall portion and the outer wall portion is made of a soft resin material, and the elongation of the inner wall portion may be greater than the elongation of the outer wall portion.

[0092] In the above-mentioned procedure simulator, the simulated blood vessel portion has a partition (62) that separates the inner cavity of the simulated blood vessel portion into a true lumen (60a) and a false lumen (60b), and the partition may have a hole (64) formed therein that connects the true lumen and the false lumen to each other.

[0093] This embodiment discloses a simulation method using the above-mentioned procedure simulator, which includes a water circulation step of circulating water within the vascular model, an introduction step of guiding a stent graft (202) incorporated into the tip of the catheter (204) into the aortic model by operating the catheter (204) while the water is circulating within the vascular model, and a deployment step of deploying the stent graft after the introduction step.

Claims

1. A procedure simulator equipped with a vascular model, The vascular model has an aortic model simulating a case in which a part of the thoracic aorta of a human body is replaced with an artificial blood vessel, the aorta model has a simulated blood vessel portion and an artificial blood vessel which is a medical device connected to the simulated blood vessel portion, The blood vessel model is a simulated femoral artery that mimics a human femoral artery; a block member in which the simulated femoral artery is embedded, the simulated blood vessel portion and the simulated femoral artery are each made of a soft resin material; The block member is made of a hard resin material.

2. 2. The procedure simulator according to claim 1, a procedure simulator, wherein the artificial blood vessel of the aortic model is provided in a portion of the aortic model that corresponds to at least a part of the aortic arch of a human body.

3. 3. The procedure simulator according to claim 1, The connection portion between the simulated blood vessel portion and the artificial blood vessel of the aorta model is a ring-shaped end portion forming the simulated blood vessel portion; and an annular connection portion forming the artificial blood vessel of the aorta model, The annular connecting portion is inserted into the inner cavity of the annular end portion and is connected to the annular end portion in a liquid-tight manner.

4. A procedure simulator equipped with a vascular model, the vascular model has an aortic model simulating a case in which a part of the thoracic aorta of a human body is replaced with an artificial blood vessel; the aorta model has a simulated blood vessel portion and an artificial blood vessel which is a medical device connected to the simulated blood vessel portion, The connection portion between the simulated blood vessel portion and the artificial blood vessel of the aorta model is a ring-shaped end portion forming the simulated blood vessel portion; and an annular connection portion forming the artificial blood vessel of the aorta model, the annular connecting portion is inserted into the inner cavity of the annular end portion and is fluid-tightly connected to the annular end portion, the connecting portion has a nonwoven fabric made of soft resin provided on an outer peripheral surface of the annular end portion, The annular connection portion, the annular end portion, and the nonwoven fabric are sewn together with a suture while overlapping each other.

5. 5. The procedure simulator according to claim 4, The connection portion includes a resin sealing member provided on the nonwoven fabric.

6. The procedure simulator according to any one of claims 1 to 5, a box-shaped water tank for storing water and accommodating the aorta model in a submerged state; a connection circuit for circulating the water in the water tank through the blood vessel model; a pump for applying arterial pressure to the water in the blood vessel model.

7. 7. The procedure simulator according to claim 6, The water tank is A bottom wall portion; a first side wall portion and a second side wall portion projecting from the bottom wall portion so as to face each other, a first distance between the aorta model and the first side wall portion is shorter than a second distance between the aorta model and the second side wall portion; The second distance is greater than the height of the second side wall portion.

8. The procedure simulator according to any one of claims 1 to 7, The simulated blood vessel portion is a tubular inner wall portion; a tubular outer wall portion provided on an outer peripheral surface of the inner wall portion, each of the inner wall portion and the outer wall portion is made of a soft resin material; The inner wall portion has a greater elongation than the outer wall portion.

9. The procedure simulator according to any one of claims 1 to 8, the simulated blood vessel portion has a partition wall that separates the lumen of the simulated blood vessel portion into a true lumen and a false lumen, A procedure simulator, wherein the partition has a hole formed therein that connects the true lumen and the false lumen to each other.

10. A simulation method using the procedure simulator according to any one of claims 1 to 9, a water circulating step of circulating water through the blood vessel model; an introduction step of guiding the stent graft incorporated into the distal end portion of the catheter into the aortic model by operating a catheter while the water is circulating through the blood vessel model; a deployment step of deploying the stent graft after the introduction step.

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