JP5136993B2 - Simulated stenotic blood vessel and method for producing the same - Google Patents

Description

  The present invention relates to a simulated stenotic blood vessel used for stent performance testing, cardiac surgery training such as coronary artery bypass surgery, and technique evaluation, and a method for manufacturing the same.

  When blood vessels are narrowed due to plaque formation, fat deposition, calcification, or fibrosis, the blood vessel lumen is expanded with a medical device called a stent to ensure blood flow. As with other medical devices, it is extremely important to evaluate the effectiveness and safety of this stent using an extracorporeal device that simulates animal experiments and patient lesions before use on a patient. However, there is no technique for creating a diseased animal with stenotic blood vessels, and even if it exists, it is considered extremely difficult to produce an animal having such a diseased blood vessel with good reproducibility. In addition, doctors who perform cardiac surgery such as coronary artery bypass surgery require advanced techniques for the surgery, and therefore artificial simulated stenotic blood vessels are required for routine procedure training. . By the way, an artificial simulated stenosis blood vessel in which a stenosis state due to plaque formation is simulated is known (see Patent Document 1). In this simulated stenotic blood vessel, a plaque-like stenotic lesion site is simulated by using polyvinyl alcohol hydrogel.

JP 2004-275682 A

  However, the simulated stenotic blood vessel of Patent Document 1 does not simulate a lesion portion including at least a part of hard calcification, but simulates a soft simple plaque. Therefore, the method disclosed in this document cannot simulate a lesion state caused by simple calcification or a complex lesion state including calcification, and simulates a state close to an actual stenotic lesion blood vessel caused by these lesions. A stenotic blood vessel cannot be manufactured.

  The present invention has been devised by paying attention to such problems, and its purpose is to simulate a lesion close to an actual stenosis due to a lesion caused by simple calcification or a complex lesion including calcification. The object is to provide a stenotic blood vessel and a method for producing the same.

In order to achieve the above object, the present invention provides a simulated blood vessel wall that simulates a blood vessel wall including a stenotic lesion site due to at least partial calcification, and a simulated lumen that simulates a lumen portion of a blood vessel. In stenotic blood vessels,
The simulated blood vessel wall includes a stenosis lesion area corresponding to the stenosis lesion site, a non-lesion area corresponding to the non-lesion site adjacent to the stenosis lesion area,
The stenotic lesion area is embedded in the inner part located on the simulated lumen side, the outer part located outside the inner part and continuous with the same material as the non-lesion area, and the outer part, Including an intermediate part that is harder than the inner part,
The inner portion is formed of any inorganic material of calcium, magnesium, sodium or a polymer material of silicone, latex, polyurethane, or a mixed material of the inorganic material and the polymer material,
The outer portion is formed of a polymer material such as silicone, latex, or polyurethane,
The intermediate part is configured to be formed of a resin material or a metal material different from the inner part.

  Here, the intermediate portion may be configured by a tube that is open at both ends in the extending direction, and arranged around the simulated lumen so that the inner portion is accommodated inside the tube. preferable.

In addition, the present invention provides a plurality of materials attached to the surface of a round bar-shaped mold partially formed with a dent, solidifies each material, and then removes the mold from the material, so that at least A method for producing a simulated stenotic blood vessel in which a stenotic lesion state due to partial calcification is simulated,
Solidifying by adhering an inorganic material of any one of calcium, magnesium and sodium or a polymer material of any of silicone, latex and polyurethane, or a mixed material of the inorganic material and the polymer material to the recess. After the inner portion is formed, the mold is inserted inside a tube having an inner diameter larger than the outer diameter of the mold, and the tube is disposed around the recessed portion, and then the entire outer peripheral surface of the mold is formed. After attaching and solidifying any polymeric material of silicone, latex, or polyurethane, when obtaining the simulated stenotic blood vessel by removing the mold,
As the tube, a technique is adopted in which a tube that is harder than the inner portion and has the same or shorter length than the length of the recessed portion is used.

  According to the present invention, it is possible to obtain a stenotic lesion site having mechanical properties close to an actual stenotic lesion state due to calcification at least partially using an artificial material.

1 is a schematic cross-sectional view of a simulated stenotic blood vessel according to the present embodiment. The schematic front view of the mold at the time of manufacturing the said simulated stenosis blood vessel. FIG. 3 is a schematic exploded cross-sectional view of a first formed body constituting the mold. (A)-(D) are the schematic diagrams for demonstrating the manufacture procedure of the simulated stenosis blood vessel.

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

  FIG. 1 shows a schematic cross-sectional view of a simulated stenotic blood vessel according to the present embodiment. In this figure, the simulated stenotic blood vessel 1 includes a simulated blood vessel wall 2 that simulates a blood vessel wall including a stenotic lesion site due to at least a portion of calcification, and a simulated lumen 3 that simulates a lumen portion of the blood vessel. Configured. Note that the stenotic lesion site in the present invention is assumed to be either a simple calcification lesion or a complex lesion in which at least one of plaque formation and fibrosis is combined with calcification.

  The simulated blood vessel wall 2 includes a stenosis lesion region 4 corresponding to the stenosis lesion site, and a non-lesion region 5 adjacent to the stenosis lesion region 4 and corresponding to a non-lesion site.

  The stenotic lesion region 4 is embedded in the inner portion 6 located on the simulated lumen 3 side, the outer portion 7 located outside the inner portion 6 and connected with the same material as the non-lesioned region 5, and the outer portion 7. And an intermediate portion 8 which is harder than the inner portion 6.

  The inner portion 6 includes a main layer 6A made of clay-like silicone admixture (product name “transparent clay”, distributor “Nisshin Associates, Inc.”), and on the simulated lumen 3 side with respect to the main layer 6A. The reinforcing layer 6B is laminated and prevents the main layer 6A from collapsing into the blood vessel lumen 3. The reinforcing layer 6B is made of silicone mixed with silicone oil.

  The material forming the inner portion 6 is not limited to the above, and any inorganic material such as calcium, magnesium, or sodium, or any polymeric material such as silicone, latex, or polyurethane, or the inorganic Any material and a mixed material of the polymer material may be used.

  Further, the reinforcing layer 6B of the inner portion 6 can be omitted depending on the material of the main layer 6A. That is, in the present embodiment, the silicone mixture is held in the simulated blood vessel wall 2 by surrounding the silicone mixture, which is a solid material, with the reinforcing layer 6B and the outer portion 7 during the manufacturing process described later. However, the inner part 6 can also be produced by using the fluid of the material described above as the material of the main layer 6A and heating and solidifying the fluid. In this case, the main layer 6A and the outer part 7 can be produced. Therefore, the reinforcing layer 6B is unnecessary.

  The outer portion 7 is formed of silicone mixed with silicone oil. However, the present invention is not limited to this, and any outer polymeric material such as silicone, latex, or polyurethane may be used. good.

  The intermediate portion 8 is made of a polyethylene tube that is open at both ends in the extending direction and is harder than the inner portion 6. The intermediate portion 8 is disposed around the simulated lumen 3, and the inner portion 6 is accommodated in the tube. Further, the length of the intermediate portion 8 in the axial direction is the same as or shorter than the length of the stenosis lesion region 4 in the blood vessel axial direction.

  The intermediate portion 8 may be made of a resin material or a metal material that is harder than the inner portion 6 and different from the inner portion 6. Specific examples include resin materials such as polyvinyl chloride, phenol resin, epoxy resin, polypropylene, polystyrene, polyvinyl acetate, ABS resin, acrylic resin, and polycarbonate.

  Further, as the intermediate portion 8, a tube having a hole or a slit formed on the wall surface, or a piece-like or block-like member can be adopted. It may be arranged in a scattered manner.

  Next, a method for manufacturing the simulated stenotic blood vessel 1 according to this embodiment will be described below.

  The simulated stenotic blood vessel 1 is produced using a mold 10 shown in FIGS. First, the mold 10 will be described.

  The mold 10 has a round rod shape made of stainless steel with a recess 12 formed in the center in the left-right direction, and can be divided in the axial direction at a center portion 14 in the center in the left-right direction in the recess 12. The mold 10 includes a first formed body 16 located on the left side in FIG. 2 with respect to the central portion 14, a second formed body 17 located on the right side in the drawing from the central portion 14, and the first and second portions. And a round bar-shaped shaft member 18 penetrating the inside of the formed bodies 16 and 17.

  The first and second formed bodies 16 and 17 have substantially the same shape, are arranged symmetrically in the use state of FIG. 2, and the tips 20 with the smallest outer diameters are butted against each other. It becomes a state. Hereinafter, the configuration and structure of the first forming body 16 will be described in detail, and the constituent parts of the second forming body 17 that are the same as or equivalent to the constituent parts of the first forming body 16 will be described using the same reference numerals. Is omitted.

  The first formed body 17 can be divided into three in the axial direction, and includes a tip member 22 including the tip 20 and an intermediate member 23 detachably connected to the left end side of the tip member 22 in FIG. The rear end member 24 is detachably connected to the left end side of the intermediate member 23 in the figure.

  As shown in FIG. 3, the tip member 22 includes a linear portion 26 having an outer diameter that is substantially constant, and a tapered portion 27 that continues to the linear portion 26 and gradually decreases toward the tip 20. 3 and an internal space 29 extending in the axial direction which is the left-right direction in FIG.

  The inner space 29 is open at both left and right ends in FIG. 3, and is formed so that the inner diameter gradually decreases from the left side in FIG. That is, the internal space 29 is open to the left end side in the figure and has a first space region 31 that is set to have the largest inner diameter, and the inner space 29 has a larger inner diameter than the first space region 31 through the first space region 31. Is set to be smaller, the third space region 33 is set to have a smaller inner diameter than the second space region 32 through the second space region 32, and the third space region. An inner diameter is set smaller than that of the third space region 33 through the third space region 33, and a fourth space region 34 is opened to the distal end 20 side. Here, a thread groove 36 is formed on the inner peripheral surface of the second space region 32, and the inner diameter of the fourth space region 34 is substantially the same as the outer diameter of the shaft member 18.

  The intermediate member 23 is provided on the same outer diameter as the linear portion 26 of the distal end member 22 and extends linearly, and is connected to the right side of the linear portion 38 in FIG. The connection part 39 inserted in the internal space 29 from the rear-end side used as the left end side in this figure, and the internal space 40 extended in an axial direction inside each of the linear part 38 and the connection part 39 are provided.

  The connecting portion 39 is fitted into the first and second space regions 31, 32 of the tip member 22 and is formed in a stepped bar shape having a size that can be accommodated in the space regions 31, 32. Yes. The connecting portion 39 includes a first projecting region 41 that is continuous with the linear portion 38, a second projecting region 42 that is continuous with the first projecting region 41, and has an outer diameter smaller than that of the first projecting region 41. Consists of. A thread groove 44 that engages with the thread groove 36 of the second space area 32 of the tip member 22 is formed on the outer peripheral surface of the second protrusion area 42, and the second protrusion area 42 is formed in the second space. By screwing into the region 32, the tip member 22 and the intermediate member 23 are connected to each other so as not to drop off.

  The inner space 40 is open at both left and right ends in FIG. 3, and is formed so that the inner diameter gradually decreases from the left side in FIG. The internal space 40 opens to the left end side in the figure and has a first space region 51 that is set to have the largest inner diameter. The inner space 40 communicates with the first space region 51 and has a smaller inner diameter than the first space region 51. A second space region 52 that is set, and a third space region 53 that communicates with the second space region 52 and has an inner diameter smaller than that of the second space region 52 and opens to the right end side in FIG. It is comprised by. Here, the first and second space regions 51 and 52 have substantially the same configuration, shape, and size as the first and second space regions 31 and 32 of the tip member 22, and the second here Similarly to the second space region 32 of the tip member 22, the space region 52 has a thread groove 36 formed on the inner peripheral surface. Although not particularly limited, the inner diameter of the third space region 53 is substantially the same as the third space region 33 of the tip member 22.

  The rear end member 24 is provided with the same outer diameter as each of the linear portions 26 and 38 and extends linearly, and is connected to the right side of the linear portion 55 in FIG. 23 is provided with a connecting portion 56 that is inserted into the internal space 40 from the left end side in the figure, and a linear portion 55 and an internal space 57 that extends in the axial direction inside each of the connecting portions 56.

  A screw hole 59 that opens to the outer peripheral surface and penetrates toward the internal space 57 is formed in the linear portion 55 on the rear end side that is the left end side in FIG.

  The connecting portion 56 is formed in a stepped rod shape that is fitted in the first and second space regions 51 and 52 of the intermediate member 23 so that almost the entire region can be accommodated in the space regions 51 and 52. Yes. The connecting portion 56 has substantially the same configuration, shape, and size as the connecting portion 39 of the intermediate member 23, and is connected to the first protruding region 61 connected to the linear portion 55 and the first protruding region 61. An outer diameter is set smaller than that of the first projecting region 61, and a second projecting region 62 having a thread groove 44 formed on the outer peripheral surface is formed. Therefore, by screwing the second protrusion region 62 into the second space region 52 of the intermediate member 23, the intermediate member 23 and the rear end member 24 are connected to each other so as not to drop off.

  The internal space 57 is open to the left and right ends in FIG. 3, and is formed in a stepped hole shape with partially different inner diameters. The internal space 57 communicates with the first space region 71 that opens to the left end side in FIG. 3 and the first space region 71 and has a second inner diameter that is set larger than that of the first space region 71. And a space area 72. The first space region 71 has an inner diameter that is substantially the same as the outer diameter of the shaft member 18, and the screw hole 59 is communicated therewith. The second space region 72 is not particularly limited, but is provided with substantially the same inner diameter as the third space regions 33 and 53 of the tip member 22 and the intermediate member 23.

  The shaft member 18 is longer than the combined length of the first and second forming bodies 16 and 17.

  The mold 10 configured as described above is integrated by the following procedure.

  First, the connecting members 39 and 56 of the intermediate member 23 and the rear end member 24 are screwed into the inner spaces 29 and 40 of the front end member 22 and the intermediate member 23, whereby the front end member 22, the intermediate member 23, and the rear end member 24 are moved. By connecting, the first and second formed bodies 16 and 17 in which these members 22 to 24 are integrated are obtained. The shaft members 18 are inserted into the internal spaces 29, 40, 57 of the respective forming bodies 16, 17 in a state in which the respective tips 20, 20 of the respective forming bodies 16, 17 are made to face each other and are almost exactly butted. Further, the screw S is inserted into the screw holes 59 and 59 provided in the rear end members 24 and 24 of the first and second formed bodies 16 and 17, and the shaft member 18 is pressed by the tip of the screw S. At this time, since the first space region 71 leading to the screw hole 59 has an inner diameter that is substantially the same as the outer diameter of the shaft member 18, the shaft member 18 is inserted almost exactly without a gap. The shaft member 18 is strongly pressed at the tip of the screw S. That is, in such an attached state, the movement and rotation of the first and second formed bodies 16 and 17 with respect to the shaft member 18 are prevented, and the separation and approach of the formed bodies 16 and 17 are restricted. As a result, the above-described butted state is maintained, and the relative rotation of the forming bodies 16 and 17 is restricted, and the twist of the mold 10 during the production of the simulated blood vessel is restricted.

  The mold 10 set as described above is gradually reduced in diameter toward the central portion 14 by the tips 20 and 20 of the tapered portions 27 and 27 of the first and second formed bodies 16 and 17 being abutted with each other. A concave portion 12 is formed so as to be curved, and left and right side portions of the concave portion 12 become straight portions 13 having an outer diameter substantially constant.

  Next, a procedure for producing the simulated stenotic blood vessel 1 using the mold 10 will be described with reference to FIG.

  First, as shown in FIG. 4A, after applying silicone 80 mixed with silicone oil to the surface of the recess 12, the mold 10 is placed in an oven at about 100 ° C. The silicone 80 is solidified while rotating in the circumferential direction for about 5 minutes, and the reinforcing layer 6B is formed.

  Next, the silicone admixture 82 is disposed on the outer portion of the reinforcing layer 6B formed on the surface side of the recess 12. Then, as shown in FIG. 4B, a polyethylene tube 83 is inserted from either one of the left and right ends of the mold 10, and the tube 83 is fixed so as to be positioned around the recessed portion 12. At this time, the reinforcing layer 6 </ b> B and the silicone blend 82 are disposed in the internal space of the tube 83, but the reinforcing layer is so arranged that air (bubbles) is not mixed between the silicone blend 82 and the tube 83. The same material as 6B, that is, silicone 85 mixed with silicone oil is filled.

  Thereafter, the mold 10 in which the tube 83 is fitted is placed in an oven at about 100 ° C., the movement of the tube 83 is restricted, and the mold 10 is allowed to stand while rotating in the circumferential direction for about 10 minutes. The silicone 85 filled in is solidified and the tube 83 is fixed, and an inner portion 6 formed inside the tube 83 and an intermediate portion 8 made of the tube are formed.

  Finally, as shown in FIG. 4C, a silicone 86 mixed with the same material as the material of the reinforcing layer 6B, that is, silicone oil, is formed on the entire outer peripheral surface of the mold 10 according to the desired blood vessel characteristics. Apply with. In other words, here, the silicone 86 is formed of the tube 83 already formed on the outer peripheral surface of the straight portion 13 and on the outer peripheral side of the recessed portion 12 on the tip side of the portion where the screw S (see FIG. 3) is attached. It is uniformly attached on the outer surface. Then, the mold 10 is placed in an oven at about 100 ° C. and left for about 20 minutes while rotating the mold 10, thereby solidifying the silicone 86 and forming the simulated stenotic blood vessel 1 on the outer peripheral surface of the mold 10. It will be. Thereafter, the screw S is removed from the mold 10 and the shaft member 18 is extracted from the rear end side of one of the first and second formed bodies 16 and 17. At this time, the first and second formed bodies 16 and 17 are in a state in which the respective details 27 and 27 are abutted with each other. However, since these details 27 and 27 are not directly connected, the shaft member 18 is not connected. As shown in FIG. 4 (D), the first and second details 27, 27 can be separated from each other by pulling the rear end side in the axial direction. 2 formed bodies 16 and 17 are pulled out. Here, since the mold 10 is formed of stainless steel, the first and second formed bodies 16 and 17 can be easily pulled out from the simulated stenotic blood vessel 1 without the silicones 80 and 86 being fixed to the mold 10. . The simulated stenotic blood vessel 1 obtained in this way simulates a stenotic lesion site of a blood vessel due to calcification.

  Next, a test for demonstrating that the simulated stenotic blood vessel 1 obtained as described above is in an elastic state close to an actual stenotic lesion coronary artery due to calcification was performed.

  Here, a balloon catheter on which a coronary artery stent (not shown) is mounted is inserted into the simulated lumen 3 of the simulated stenotic blood vessel 1 to increase the internal pressure of the balloon to expand the coronary stent, and then the balloon catheter. Was extracted from the simulated stenotic blood vessel 1 and tested for the state when a coronary stent was placed in the simulated lumen 3. That is, here, the measurement test of the recoil rate and the measurement test of the stent delivery ballon expansion (hereinafter referred to as “SU rate”) were performed.

The recoil rate is an index representing the change in the outer diameter of the coronary stent immediately after balloon expansion and after balloon contraction, and is defined as the outer diameter D ₀ of the coronary stent immediately after balloon expansion. When the outer diameter _DT of the subsequent coronary stent is used, the recoil rate is obtained by the following equation (1).
Recoil rate = (1− (D _T / D ₀ ) × 100 (1)

The SU ratio is an index that represents a change in the outer diameter of the balloon immediately after balloon expansion in actual use with respect to the balloon expansion diameter presented by the stent manufacturer. The balloon expansion diameter D _M presented by the stent manufacturer. and (index value), when the actual immediately after balloon dilatation in use outer balloon diameter D _J, SU rate is calculated by the following equation (2).
SU rate = (1− (D _J / D _M ) × 100 (2)

  The coronary stent used in this study is “Driver stent” (stent size: φ3.0 × 18, material: cobalt chrome) manufactured by Medtronic.

  The simulated stenotic blood vessel 1 as the object of this test was a non-lesional region 5, the reinforcing layer 6B of the inner portion 6, and the material of the outer portion 7 in which 60% by weight of silicone oil was blended with silicone. Further, as the mold 10, a mold having a size capable of having a blood vessel outer diameter and an inner diameter corresponding to the coronary artery of the human body is used. As the shape of the recess 12 of the mold 10, a stenosis lesion area is a stenosis significant lesion. The one capable of simulating 75% stenosis was used. The simulated stenotic blood vessel 1 obtained by the mold 10, that is, the simulated stenotic blood vessel 1 simulating the lesion state of the coronary artery that became 75% stenotic due to calcification, was tested as follows. The simulated blood vessel wall of the simulated stenotic blood vessel 1 is colorless and transparent. When the coronary stent is inserted into the simulated lumen 3 of the simulated stenotic blood vessel 1, the coronary artery stent becomes visible from the outside of the simulated stenotic blood vessel 1.

  In each measurement test of recoil rate and SU rate, the coronary artery stent inserted into the simulated lumen 3 is imaged from the outside of the simulated stenotic blood vessel 1 by a digital microscope (not shown), so that the stent outer diameter and balloon The diameter was measured and the recoil rate and the SU rate related to the coronary stent inserted into the simulated stenotic blood vessel 1 were obtained.

The recoil rate in the simulated stenotic blood vessel 1 was determined by the following procedure. First, a balloon catheter on which the coronary stent is mounted is inserted into the simulated stenotic blood vessel 1 and a balloon dilator is used to increase the balloon internal pressure at a rate of 1 atm / 5 sec. The balloon internal pressure was increased until the coronary stent was expanded. Then, to get an image of the coronary stent immediately after held in that state for 30 seconds the digital microscope, and the stent outer diameter measured at this time the outer diameter D ₀ of the coronary stent immediately after balloon dilatation. Thereafter, after the balloon is deflated, the balloon catheter is extracted from the simulated stenotic blood vessel 1 and an image of the coronary stent 180 seconds after the balloon deflation is acquired with a digital microscope. The outer diameter _DT of the coronary stent after a lapse of a certain time was determined. From Kakusoto径D ₀ and D _T obtained by the above was determined recoil ratio by the above formula (1). When the recoil rate was similarly obtained for a plurality of simulated stenotic blood vessels 1 having the same configuration, the simulated blood vessel according to the present embodiment belonged to a range in which the recoil rate was 8% to 10%.

Further, the SU rate in the simulated stenotic blood vessel 1 was obtained by the following procedure. That is, the coronary stent was expanded by raising the balloon internal pressure to 14.6 atm in the same manner as when the recoil rate was obtained. Then, to get the balloon image immediately after held in that state for 30 seconds digital microscope was a balloon outer diameter measured at this point and the actual immediately after balloon dilatation in use outer balloon diameter D _J. Further, in the coronary stent used, the balloon expansion diameter D _M (index value) presented by the stent manufacturer is about 3.1 mm at 14.6 atm, and the SD ratio is obtained by the above equation (2). It was. As a result, the SD rate was within the range of 16% to 17%.

  The clinical values when the Driver stent was inserted as a coronary stent into a coronary artery of a patient with significant lesions due to calcification were found to have a recoil rate of 9.02% and an SD rate of 17 when the balloon expansion pressure averaged 14.6 atm. Reported at 12%. In addition, the recoil rate in an actual stenotic lesion blood vessel due to calcification belongs to a range of about 8% to about 10%, and the SD rate in the same patient belongs to a range of about 16% to 18%. There is a report.

  Therefore, as a result of the above-described test, the simulated stenotic blood vessel 1 according to the present invention has the recoil rate and SU rate within the range of the recoil rate and SU rate of the blood vessel in the actual stenotic lesion blood vessel. It became very close to the clinical value. For this reason, the simulated stenotic blood vessel 1 according to the present invention has a mechanical property that approximates a coronary artery in which a stenosis lesion due to calcification has occurred, and a stenosis state close to an actual stenosis lesion blood vessel due to calcification is made of an artificial material. It was proved that it could be simulated.

  In addition, when the same test as described above was performed on the simulated stenotic blood vessel prepared without providing the intermediate portion 8 with respect to the above-described embodiment, both the recoil rate and the SD rate are within the above-described range in the actual stenotic diseased blood vessel. Nothing belonging to the inside was obtained.

  Further, by changing the compounding ratio of silicone oil to silicone, a stenotic lesion region 4 due to simple calcification lesions or a stenosis lesion region due to complex lesions in which at least one of plaque formation and fibrosis is combined with calcification is combined. Various stenotic lesion areas 4 that are at least partially calcified, such as 4, can be produced in a state close to reality.

  In addition, the structure in this invention is not limited to the example of illustration, A various change is possible as long as there exists a substantially similar effect | action.

  The present invention can be used as an artificial blood vessel for evaluation of a medical device such as a stent or for surgical training of a surgeon.

DESCRIPTION OF SYMBOLS 1 Simulated stenosis blood vessel 2 Simulated blood vessel wall 3 Simulated lumen 4 Stenosis lesion area 5 Non-lesion area 6 Inner part 7 Outer part 8 Middle part 10 Mold 12 Recessed part

Claims (3)

In a simulated stenotic blood vessel having a simulated blood vessel wall that simulates a blood vessel wall including a stenotic lesion site due to at least a portion of calcification, and a simulated lumen that simulates a lumen portion of the blood vessel,
The simulated blood vessel wall includes a stenosis lesion area corresponding to the stenosis lesion site, a non-lesion area corresponding to the non-lesion site adjacent to the stenosis lesion area,
The stenotic lesion area is embedded in the inner part located on the simulated lumen side, the outer part located outside the inner part and continuous with the same material as the non-lesion area, and the outer part, Including an intermediate part that is harder than the inner part,
The inner portion is formed of any inorganic material of calcium, magnesium, sodium or a polymer material of silicone, latex, polyurethane, or a mixed material of the inorganic material and the polymer material,
The outer portion is formed of a polymer material such as silicone, latex, or polyurethane,
The simulated stenotic blood vessel, wherein the intermediate portion is formed of a resin material or a metal material different from that of the inner portion.   The said intermediate part consists of a tube which the both ends of the extension direction open | releases, It arrange | positions around the said simulation lumen | bore so that the said inner part may be accommodated inside the said tube. Simulated stenotic blood vessel. A plurality of materials are attached to the surface of a round bar-shaped mold in which the dents are partially formed, and after each material is solidified, at least a part thereof is calcified by removing the mold from the material. A method for producing a simulated stenotic blood vessel in which a stenotic lesion state is simulated,
Solidifying by adhering an inorganic material of any one of calcium, magnesium and sodium or a polymer material of any of silicone, latex and polyurethane, or a mixed material of the inorganic material and the polymer material to the recess. After forming the reinforcing layer , the main layer made of the inorganic material, the polymer material, or the mixed material is disposed outside the reinforcing layer, and the inside of the tube having an inner diameter larger than the outer diameter of the mold The mold is inserted into the tube, the tube is arranged around the recess, and a polymer of silicone, latex, or polyurethane is used so that air does not enter between the main layer and the tube. the material filling the tube is fixed by solidifying, to the entire outer peripheral surface of the mold, filling the between said main layer tube Wherein after forming the simulated constriction vessel on the outer peripheral surface of the mold by solidifying by attaching the same material as the polymeric material, it is withdrawn axially by dividing the mold at the center of the recessed portion was In obtaining the simulated stenotic blood vessel,
Production of a simulated stenotic blood vessel, wherein the tube is harder than the main layer and the reinforcing layer and has the same or shorter length than the length of the recess. Method.

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