JP2011027794A - Biological model for training - Google Patents

Abstract

A training living body capable of training a training living body model by approximating physical properties of an actual lesion when performing training for improving an operator's technique using the living body model for training. Providing a model.
A living body model for training 1 includes a tubular body having a lumen portion 43, and is arranged in a pseudo-tubular tissue 10 imitating a tubular tissue and a lumen portion 43 of the pseudo-tubular tissue 10, and the lumen portion. 43 has a shape that narrows or closes 43, and includes a pseudo-lesion member 21 simulating a lesion portion generated in a tubular tissue. Each of the pseudo-tubular tissue 10 and the pseudo-lesioned member 21 is made of a plastically deformable material, and when the extension training is performed on the pseudo-lesioned member 21 in order to secure a flow path in the pseudo-tubular tissue 10, the expansion is performed. Thus, the plastic deformation is performed so as not to return to the shape before expansion.
[Selection] Figure 5

Description

  The present invention relates to a biological model for training.

  As one of the percutaneous coronary angioplasty, for example, PTCA (Percutaneous Transluminal Coronary Angioplasty) is known.

  In this PTCA technique, when the transfemoral artery method is applied, the blood flow in the blood vessel is recovered through the following procedure. That is, I.I. First, insert a sheath catheter into the femoral artery, then insert a guide catheter guide wire into the femoral artery, and advance the guide catheter along the guide catheter guide wire with its tip advanced to the vicinity of the coronary artery entrance. The tip is located at the coronary ostium. II. Next, the guide wire for the guide catheter is removed, the guide wire for the balloon catheter is inserted into the guide catheter, the guide wire for the balloon catheter is projected from the distal end of the guide catheter, and a stenotic site (lesion) occurring in the coronary artery Advance to a position beyond (part). III. Next, the balloon catheter is advanced to the stenosis site via the balloon catheter guide wire, and after the balloon portion is positioned at the stenosis site, the balloon is inflated to widen the stenosis site, that is, the blood vessel wall and re-open the blood passage. Form and restore blood flow.

  As described above, in order to position the balloon catheter at the stenosis site, there are complicated steps, and the operator is required to have a very advanced technique.

  Therefore, in recent years, in addition to surgery for patients, development of a biological model used for training for improving an operator's technique is required.

  As such a living body model, for example, Patent Document 1 proposes a method of manufacturing a tube model using a tube such as a blood vessel or a lymph vessel.

  That is, in Patent Document 1, first, a cavity region of the subject is extracted based on the tomographic image data of the subject obtained by an image diagnostic apparatus such as a CT scanner or an MRI scanner, and corresponds to the cavity region. Laminate the lumen model. Next, the three-dimensional model molding material is cured in a state where the periphery of the lumen model is surrounded by the three-dimensional model molding material, and then the lumen model is removed to form a tube model (three-dimensional model).

  In the three-dimensional model having such a configuration, silicone rubber, polyurethane elastomer, or the like is used as the three-dimensional model molding material, and the tube model is formed by approximating the physical properties of blood vessels and lymph vessels. Since this three-dimensional model is formed so as to surround the lumen model, a stenosis site, which is a lesion site, is also formed integrally with the tube and exhibits the same physical properties as the tube. However, for example, a stenosis site formed in a blood vessel is mainly composed of plaques (deposits) on which cholesterol is deposited, so that its physical properties are significantly different from those of blood vessels.

  Therefore, in the three-dimensional model described in Patent Document 1, it is not possible to carry out training corresponding to the physical properties of the actual plaque generated in the stenosis site, and the state of the plaque after the balloon is inflated at the stenosis site cannot be confirmed. There is a problem that it is impossible to know how the blood flow path is reconstructed.

Japanese Patent No. 361568

  An object of the present invention is to train a biological model for training by approximating physical properties of an actual lesion when performing training for improving the skill of an operator using the biological model for training. It is to provide a biological model for training.

Such an object is achieved by the present inventions (1) to (18) below.
(1) a pseudo-tubular tissue that is composed of a tubular body having a lumen and imitates a tubular tissue;
A pseudo lesion member that is disposed in the lumen portion of the pseudo-tubular tissue, has a shape that narrows or closes the lumen portion, and imitates a lesion portion that has occurred in the tubular tissue;
Each of the pseudo-tubular tissue and the pseudo-lesioned member is made of a plastically deformable material, and when the extension training is performed on the pseudo-lesioned member in order to secure a flow path in the pseudo-tubular tissue, the expansion is performed. Therefore, the biological model for training is characterized in that it is plastically deformed to such an extent that it does not return to the shape before expansion.

  (2) The biological model for training according to (1), wherein the pseudo-lesioned member is more easily deformed than the pseudo-tubular tissue.

  (3) The training biological model according to (1) or (2), wherein the pseudo-lesioned member is less likely to return to a shape before expansion than the pseudo-tubular tissue.

  (4) The biological model for training according to any one of (1) to (3), wherein the pseudo tubular tissue is made of a thermoplastic resin.

(5) The pseudo-tubular tissue is obtained by pulling a strip of the tubular body, which becomes the pseudo-tubular tissue, at a normal temperature and extending in the circumferential direction of the tubular body so that the elongation becomes 100% in 1 minute. the initial tensile stress and _{f 0,} the tensile stress after 5 minutes by holding the elongation of the 100% and _{f t} as the stress relaxation rate _{((f 0 -f t) /} f 0) when a × 100 The biological model for training according to any one of (1) to (4), which is made of a material having a stress relaxation rate of 20 to 60%.

  (6) The training biological model according to any one of (1) to (5), wherein a tensile elastic modulus of the pseudo-tubular tissue is equal to or greater than a compression elastic modulus of the pseudo-lesioned member.

  (7) The biological model for training according to any one of (1) to (6), wherein the tensile elastic modulus of the pseudo-tubular tissue is 0.5 to 50 MPa.

(8) The above (1) to (1), wherein the pseudo-tubular tissue satisfies the relationship that d ₂ / d ₁ is 1.01 to ₂ when the inner diameter is φd ₁ and the outer diameter is φd _2. 7) The biological model for training according to any one of 7).

(9) The living body model for training according to (8), wherein the inner diameter φd1 is 0.5 to ₁₀ mm.

  (10) The training biological model according to any one of (1) to (9), wherein the pseudo-tubular tissue has a branched portion that is branched in the middle.

  (11) The biological model for training according to (10), wherein the pseudo-lesioned member is arranged at the branch portion.

(12) The pseudo lesion member has a through-hole penetrating in a longitudinal direction of the pseudo tubular tissue,
The living body model for training according to any one of (1) to (11), wherein inner surfaces of the through holes are in contact with each other or separated from each other.

  (13) The training hole according to (12), wherein the through-hole is formed with a tapered portion in which the diameter of the through-hole gradually increases from the inner side toward the end side at one or both ends thereof. Living body model.

  (14) The training biological model according to any one of (1) to (13), wherein the pseudo-lesioned member is inserted in a compressed state in the lumen.

  (15) The simulated lesion member according to any one of (1) to (14), wherein the pseudo lesion member is made of a material containing at least one of silicone clay, rubber clay, resin clay, and oil clay. Living body model.

  (16) The biological model for training according to any one of (1) to (15) above, wherein the pseudo-lesion member has a compression elastic modulus of 0.001 to 0.5 MPa.

  (17) The above (1) to (1), which are used for training for expanding one or more types of medical instruments after passing through the pseudo-tubular tissue and reaching the pseudo-lesioned member. The biological model for training according to any one of 16).

  (18) The living body model for training according to (17), wherein the medical device is a balloon catheter and / or a stent used for percutaneous coronary angioplasty.

  According to the present invention, a pseudo-lesioned member that approximates a physical property to a lesioned part that occurs in a tubular tissue can be arranged in an arbitrary shape at an arbitrary position of the pseudo-tubular tissue. Therefore, since the training corresponding to various patient pathologies can be performed using the biological model for training provided with the pseudo-lesioned member, the surgeon learns a higher level technique in a place other than the operation performed on the patient. be able to.

It is a schematic diagram which shows the artery (a heart is included) in a human body whole body. It is a whole photograph of what applied the artery shown in Drawing 1 to a solid model. It is a schematic diagram which shows 1st Embodiment by which the biological model for training of this invention was arrange | positioned in the right coronary artery. It is a figure which shows the procedure of performing the training of PTCA operation with respect to the biological model for training arrange | positioned in the right coronary artery. It is a figure (left figure is a longitudinal cross-sectional view, the right figure is an AA line sectional view of the left figure) which shows various composition of a living body model for training of a stenosis type. It is a figure (left figure is a longitudinal cross-sectional view, the right figure is an AA line sectional view of the left figure) which shows various composition of a living body model for training of a stenosis type. It is a figure (left figure is a longitudinal cross-sectional view, the right figure is an AA line sectional view of the left figure) which shows various composition of an obstruction type living body model for training. It is a figure (left figure is a longitudinal cross-sectional view, the right figure is an AA line sectional view of the left figure) which shows various composition of an obstruction type living body model for training. It is a longitudinal cross-sectional view which shows the state of the biological model for training after training. It is a figure for demonstrating the method to manufacture the biological model for training of this invention. It is a figure for demonstrating the other manufacturing method which manufactures the biological model for training of this invention. It is a figure which shows the other structure of the pusher used when manufacturing the biological model for training of this invention. It is a figure (a figure (a) is a perspective view and a figure (b) is a longitudinal section) for explaining the composition of a connecting tool. It is a figure (a figure (a) is a perspective view and a figure (b) is a longitudinal section) for explaining the composition of a connection mechanism. It is a schematic diagram which shows 2nd Embodiment by which the biological model for training of this invention was arrange | positioned in the left coronary artery. It is a longitudinal cross-sectional view which shows the various structures of the pseudo-lesioned member arrange | positioned at a branch part. It is a figure for showing the frequent occurrence site of a lesion where the living body model for training of the present invention is arranged. It is a figure which shows the test method which tests the material characteristic of a pseudo-tubular member. It is a graph which shows the material characteristic (change with time of stress) of the pseudo tubular member tested by the test method shown in FIG.

  Hereinafter, a living body model for training of the present invention is explained in detail based on a suitable embodiment shown in an accompanying drawing.

  FIG. 1 is a schematic diagram showing arteries (including the heart) in the whole human body, FIG. 2 is an overall photograph of the arteries shown in FIG. 1 applied to a three-dimensional model, and FIG. FIG. 4 is a schematic diagram showing the first embodiment arranged in the coronary artery, FIG. 4 is a diagram showing a procedure for performing PTCA training on a living body model for training arranged in the right coronary artery, and FIG. 5 is a stenosis type training. FIG. 6 is a diagram showing various configurations of a biological model for a living body (the left diagram is a longitudinal sectional view, the right diagram is a sectional view taken along the line AA in the left diagram), and FIG. The figure is a longitudinal sectional view, the right figure is a sectional view taken along the line AA in the left figure, and FIG. 7 is a diagram showing various configurations of the obstructive living body model for training (the left figure is the longitudinal sectional view, the right figure is the left figure) FIG. 8 is a diagram showing various configurations of the obstructive training biological model (the left diagram is a longitudinal sectional view, the right diagram is the AA line of the left diagram). FIG. 9 is a longitudinal sectional view showing the state of the training biological model after training, FIG. 10 is a diagram for explaining the method of manufacturing the training biological model of the present invention, and FIG. The figure for demonstrating the other manufacturing method which manufactures the biological model for training of invention, FIG. 12 is a figure which shows the other structure of the pusher used when manufacturing the biological model for training of this invention, FIG. FIG. 14 is a diagram for explaining the configuration of the connector (FIG. (A) is a perspective view, FIG. (B) is a longitudinal sectional view), and FIG. 14 is a diagram for explaining the configuration of the connection mechanism (FIG. (A)). Is a perspective view, FIG. 15B is a longitudinal sectional view), FIG. 15 is a schematic view showing a second embodiment in which the living body model for training of the present invention is arranged in the left coronary artery, and FIG. FIG. 17 is a longitudinal sectional view showing various configurations of the pseudo-lesioned member, and FIG. 17 is a lesion-prone portion where the living body model for training of the present invention is arranged FIG. 18 is a diagram showing a test method for testing the material characteristics of the pseudo-tubular member. FIG. 19 is a diagram showing material characteristics (stress over time) of the pseudo-tubular member tested by the test method shown in FIG. It is a graph showing (change). In the following description, the upper side in FIGS. 3 to 17 is referred to as “upper” and the lower side is referred to as “lower”. 3, 15, and 17 also illustrate the shape of the heart so that the shape and position of the coronary artery can be easily understood.

  The three-dimensional model shown in FIG. 2 is artificially manufactured by reproducing the various tubular tissues of a human living body including tubular tissues such as blood vessels (arteries, veins), lymphatic vessels, bile ducts, ureters, and oviducts. It is a thing. Using this three-dimensional model, a medical device such as a balloon catheter is made to reach the pseudo-lesioned member, and then the pseudo-lesioned member is expanded to secure a flow path or to place the stent on the expanded pseudo-lesioned member Training is conducted. Below, the case where the pseudo-lesioned member imitating the lesion part which arose in the said artery is arrange | positioned as an example to the pseudo-tubular tissue (simulating a tubular tissue) formed corresponding to the shape of the artery will be described.

  Arteries (including the heart) in the whole human body have a shape as shown in the schematic diagram of FIG. A three-dimensional model corresponding to the shape of the artery is manufactured as follows based on, for example, the description of Japanese Patent No. 3613568.

  First, tomographic image data of a cavity (blood flow path) provided in an artery is obtained using an image diagnostic apparatus such as a CT scanner or an MRI scanner, and then based on the tomographic image data corresponding to the lumen of the artery. Then, a lumen model that forms the shape of the lumen of the artery is layered.

  Next, after hardening the three-dimensional model molding material in a state in which the periphery of the lumen model is surrounded by the three-dimensional model molding material, the lumen model is removed, and the shape of the artery as shown in the whole photograph of FIG. An arterial model (three-dimensional model) corresponding to is formed.

  By placing a pseudo-lesioned member at an arbitrary position such as a coronary artery, a cerebral artery, a carotid artery, a renal artery, a brachial artery, etc. After the medical instrument is positioned on the pseudo-lesioned member (stenosis model), it is possible to perform training to secure the flow path by expanding the pseudo-lesioned member. In the present embodiment, the training biological model 1 is configured such that a pseudo-lesion member (lesion model) 21 is disposed in a coronary artery (pseudo-tubular tissue) 10 included in the arterial model.

  The coronary artery 10 includes a left coronary artery 3 and a right coronary artery 4 that branch left and right in the Valsalva sinus of the aorta 5.

  The right coronary artery 4 exits from the upper part of the right coronary sinus, one of the Valsalva caves, and is covered by the right atrial appendage and travels between the right atrium and the pulmonary artery, and sharp edges along the right interventricular groove A blood vessel that feeds the posterior wall of the left ventricle and the lower side of the septum is derived from the posterior interventricular groove through the part 41 and toward the posterior descending branch 42.

  In the right coronary artery 4, the upper half of the right coronary artery 4 from the entrance to the sharp edge 41 is called Segment1 (# 1: Proxy), and the lower half is called Segment2 (# 2: Middle). The process from the sharp edge 41 to the branch at the descending descending branch 42 is called Segment 3 (# 3: distal). Further, the branch and subsequent branches of the rear descending branch 42 are referred to as Segment 4, and this Segment 4 is divided into three parts, # 4AV, # 4PD, and # 4PL.

  The left coronary artery 3 branches leftward from the upper part of the left coronary sinus, which is one of the Valsalva sinus, and branches into a left anterior descending branch 31 and a left convoluted branch 32 that enter the anterior chamber groove.

  A portion from the aorta 5 to the branch to the left anterior descending branch 31 and the left rotating branch 32 is referred to as a left main trunk 33 (Segment 5). The left front descending branch 31 is subdivided into Segments 6 to 10, and the main trunk of the left front descending branch 31 is Segment 6 (# 6: Proximal), Segment 7 (# 7: Middle), Segment 8 (# 8: (segment 9), segment 9 (# 9: first diagonal branch) branches from between segment 6 and segment 7, and segment 10 (# 10: second diagonal branch) from between segment 7 and segment 8. Branched. Further, the left circumflex branch 32 is subdivided into Segments 11 to 15, and the main trunk of the left convolution branch 32 is classified into two segments, Segment 11 (# 11: Proximal) and Segment 13 (# 13: distal). Segment 12 (# 12: obtuse marginal branch: OM) branches off from the connection part of Segment 11 and Segment 13.

<< First Embodiment >>
The training biological model 1 of the first embodiment includes a right coronary artery 4 (Segment 2) of the coronary artery 10, a pseudo-lesion member 21 disposed in the right coronary artery 4, and connections provided at both ends of the right coronary artery 4. Part 11. In the right coronary artery 4, the end portion of the Segment 2 is connected to the Segment 1 and the Segment 3 via the respective connection portions 11. In this case, each connection part 11 is preferably configured to be detachable from Segment 1 and Segment 3.

  Further, PTCA surgery training is performed on the pseudo-lesioned member 21 disposed at such a position, and such training is performed in the following procedure.

  [1] First, a sheath catheter (not shown) is inserted into the femoral artery, then a guide catheter guide wire (not shown) is inserted into the femoral artery, and the distal end is advanced to the vicinity of the entrance of the right coronary artery 4 Then, the guide catheter 61 is advanced along the guide wire for the guide catheter, and the distal end thereof is positioned at the entrance of the right coronary artery 4 (see FIG. 4A).

  [2] Next, the guide catheter guide wire 62 is removed, the balloon catheter guide wire 62 is inserted into the guide catheter 61, the balloon catheter guide wire 62 projects from the distal end of the guide catheter 61, and the right coronary artery 4. The guide wire 62 for the balloon catheter is advanced to a position beyond the pseudo-lesioned member 21 arranged in (see FIG. 4B).

  [3] Next, the distal end portion of the balloon catheter 63 inserted from the proximal end (femoral artery) side of the balloon catheter guide wire 62 is projected from the distal end of the guide catheter 61, and further along the balloon catheter guide wire 62. After the balloon 64 of the balloon catheter 63 is positioned on the pseudo-lesioned member 21, the balloon 64 is inflated by injecting a balloon inflation fluid into the balloon 64 from the proximal end side of the balloon catheter 63 (see FIG. 4 (c).) As a result, the pseudo-lesioned member 21 is expanded.

  [4] Next, the balloon inflation fluid is discharged from the proximal end side of the balloon catheter 63, and the balloon 64 is deflated as shown in FIG. Thereafter, the balloon catheter guide wire 62, balloon catheter 63, guide catheter 61 and sheath catheter are removed from the femoral artery side. Thereby, a blood flow path is formed in the pseudo-lesioned member 21.

First, the right coronary artery 4 serving as the Segment 2 will be described.
As shown in FIG. 5 (the same applies to FIGS. 6 to 9), the right coronary artery 4 is composed of a tubular body 40 having a lumen 43. In the right coronary artery 4, the inner diameter φd ₁ and the outer diameter φd ₂ are constant along the longitudinal direction.

  The right coronary artery 4 is made of a plastically deformable material, and the material is not particularly limited, and polyethylene, polypropylene, ethylene / vinyl acetate copolymer, nylon elastomer, soft polyvinyl chloride, ethylene / propylene copolymer. Examples thereof include thermoplastic resins such as polymers, and one or more of these can be used in combination. Of these thermoplastic resins, it is particularly preferable to use polyethylene. In this case, a resin in which different densities, that is, crystallinity, such as low density polyethylene and high density polyethylene are mixed can also be used. Further, the hardness of the right coronary artery 4 made of polyethylene is preferably 20 to 80 in Shore A (as defined in JIS K6253), and more preferably 25 to 35. The breaking strength is preferably 5 to 30 MPa, and more preferably 8 to 12 MPa. The elongation at break is preferably about 100 to 600%, more preferably about 100 to 200%.

  By using such polyethylene, the right coronary artery 4 can be reliably plastically deformed. As a result, the right coronary artery 4 and the pseudo-lesioned member 21 are collectively deformed when the expansion training is performed in combination with the pseudo-lesioned member 21 described later, and the deformed state (expanded state) is reliably maintained (FIG. 9). reference). Moreover, when manufacturing the right coronary artery 4, the tubular body (tube) 40 used as the base material of the right coronary artery 4 can be shape | molded by extrusion molding. And after shaping | molding a tubular body, the right coronary artery 4 of a desired magnitude | size can be manufactured by processing (for example, heating, compression, etc.) to the said tubular body (refer FIG. 3).

  In addition, the plastically deformable material constituting the right coronary artery 4, that is, the thermoplastic resin has a material characteristic that the stress relaxation rate is preferably 20 to 60%, more preferably 20 to 30%.

  Here, the “stress relaxation rate” is obtained (defined) for the tubular body 40 at room temperature by the test method shown in FIG.

  First, as shown in FIG. 18A, the tubular body 40 is made into a strip 400, and one end (left side in the figure) of the strip 400 is fixed to become a fixed end 401, and the other end (right side in the figure) is It is a free end 402. Further, the strip 400 at this time has an overall length L.

Next, from the state shown in FIG. 18A, the free end 402 of the strip 400 is pulled to the right side (longitudinal direction) in the figure at a predetermined speed (tensile speed) (see FIG. 18B). The conditions at this time are pulled so that the total length becomes 2 L in one minute. The initial tensile stress when the total length becomes 2 L is defined as f ₀ (see FIG. 19).

Next, the speed (tensile speed) is set to zero from the state shown in FIG. 18B, and the total length 2L is maintained (see FIG. 18C). Then, the tensile stress after 5 minutes from the speed set to zero and f _t (see FIG. 19).

Therefore, it is assumed that can represent a "stress relaxation ratio" in _{((f 0 -f t) /} f 0) × 100.

  When the stress relaxation rate is within such a numerical range, the right coronary artery 4 is more reliably deformed during expansion training, and thus approximates an actual human artery. Thereby, when extended training is performed, the same feeling as if the training is performing an actual procedure (PTCA technique) is obtained. The magnitude of the stress relaxation rate can be adjusted, for example, by appropriately selecting constituent materials.

  Further, the tensile elastic modulus in the circumferential direction of the right coronary artery 4 is preferably the same as or larger than the compressive elastic modulus of the pseudo-lesioned member 21. Specifically, when the compressive elastic modulus of the pseudo-lesioned member 21 is 0.001 to 0.5 MPa, the tensile elastic modulus in the circumferential direction of the right coronary artery 4 is preferably 0.5 to 50 MPa, 0.5 More preferably, it is ˜5 MPa.

The right coronary artery 4 is preferably one that satisfies the relationship of the ratio _d 2 / _{d 1} is 1.01 to 2, the ratio _d 2 / _{d 1} is more is achieved, thereby satisfying the 1.01 to 1.2 the relationship preferable. The inner diameter φd ₁ of the right coronary artery 4 (Segment 2) is preferably set to about 2 to 5 mm.

  Under such various conditions (numerical range), the right coronary artery 4 can be surely deformed by being pressed through the pseudo-lesioned member 21 when performing dilation training (see FIGS. 4 and 9). In addition, training corresponding to an actual human coronary artery can be performed with certainty, and the skill of the operator can be improved accurately.

Next, the pseudo lesion member 21 arranged in the lumen 43 of the right coronary artery 4 will be described.
The shape of the pseudo-lesioned member 21 is classified into a stenosis type or an occlusion type according to the degree of stenosis with respect to the lumen portion 43.

<Stenosis type>
Of the stenotic pseudo-lesion member 21, the pseudo-lesion member 21 having the first configuration shown in FIG. 5A has a through-hole 23 penetrating in the axial direction (longitudinal direction) substantially at the center thereof. The inner surfaces 231 are separated from each other, that is, a cylindrical body having an overall cylindrical shape.

  In the pseudo lesion member 21 having such a configuration, when the pseudo lesion member 21 is disposed in the lumen portion 43 of the right coronary artery 4, the lumen portion 43 is narrowed.

  In the pseudo lesion member 21 having the first configuration, in the step [3], the balloon catheter 63 is advanced along the balloon catheter guide wire 62 in the right coronary artery 4, and the balloon 64 is simulated to constrict the right coronary artery 4. It is suitable for training to expand the pseudo lesion member 21 (through hole 23) by reaching the lesion member 21, that is, the through hole 23 and then inflating the balloon 64.

  The length of the pseudo lesion member 21 is not particularly limited, but is preferably about 1 to 100 mm, and more preferably about 5 to 50 mm. By setting the length of the pseudo-lesioned member 21 within such a range, it is possible to perform training more suitable for the size of the actual lesion site (stenosis site).

In addition, the outer diameter φd ₄ of the pseudo-lesioned member 21 is appropriately set according to the size of the inner diameter φd ₁ of the right coronary artery 4 to be arranged, and is not particularly limited. In the natural state where no external force is applied, the right coronary artery 4 is preferably set to be larger than the inner diameter φd _{1 of} 4. As a result, the pseudo-lesioned member 21 is inserted into the right coronary artery (lumen) 4 in a compressed state, and as a result, the pseudo-lesioned member 21 is securely fixed in the right coronary artery 4. At this time, it is possible to reliably prevent the pseudo-lesioned member 21 from being unintentionally displaced due to contact with the balloon catheter guide wire 62 or the balloon catheter 63.

The inner diameter φd ₃ of the through-hole 23 of the pseudo-lesioned member 21 is not particularly limited, but it is preferable to set φd ₃ so that (φd ₁ −φd ₃ ) / φd ₁ is 50 to 100%. By setting within the above range the inside diameter .phi.d ₃ of the through hole 23 can be reliably drills suitable for actual stenosis of the stenosis, the surgeon improved technique is achieved in precisely.

Specifically, if φd ₁ is set to ₂ to 5 mm, φd ₃ is 0 to 2.5 mm, and the thickness of the pseudo-lesioned member 21 is about 0.5 to 2.5 mm. It should be noted that, if φd ₃ is 0mm, the total occlusion.

  Next, similarly to the pseudo lesion member 21 of the first configuration, the pseudo lesion member 21 of the second configuration shown in FIG. 5B has a through hole 23 penetrating in the axial direction at the center thereof. Although the entire shape is substantially cylindrical, the pseudo-lesioned member 21 is provided with tapered portions where the diameter (outer diameter) of the through-hole 23 gradually increases from the inner side toward the outer side at both ends thereof. The widths at both ends are substantially “0”.

  In other words, the through-hole 23 has a funnel shape at both ends thereof, and the inclined surfaces 22 in which the inner peripheral surfaces of both ends of the pseudo lesion member 21 are inclined from the inside of the pseudo lesion member 21 toward both end portions. Respectively.

  In the pseudo lesion member 21 having the second configuration, when the balloon 64 is caused to reach the through hole 23 in the step [3], the balloon catheter 63 is placed along the inclined surface 22 of the pseudo lesion member 21, It is suitable for training for expanding the pseudo-lesioned member 21 (through hole 23) by causing the balloon 64 to reach the inside of the through hole 23 and then inflating the balloon 64.

  The inclined surface 22 is not particularly limited, but is preferably inclined at an angle of approximately 15 ° to 65 ° with respect to the central axis of the through hole 23, and is inclined at an angle of approximately 22 ° to 55 °. More preferably. Thereby, the training more suitable for the shape of the actual stenosis part can be implemented reliably.

  Furthermore, in this embodiment, although the taper part is provided in the both ends of the pseudo-lesioned member 21, it is not limited to such a case, The taper part should just be provided in either one of two ends.

  Further, in the pseudo lesion member 21 of the first configuration and the second configuration, the case where the through hole 23 penetrates substantially perpendicularly in the axial direction (longitudinal direction) at the substantially central portion thereof has been described. Without limitation, the through hole 23 may be formed in any position and in any shape. For example, the through hole 23 may be unevenly distributed on the edge side (outer peripheral side) (FIG. 6A). It may be partly open at the edge (outer periphery) (FIG. 6 (b)), meandering (curved) (FIG. 6 (c)), or in the middle The diameter may be increased or decreased (FIG. 6 (d)).

<Occlusion type>
Among the closed pseudo lesion member 21, the pseudo lesion member 21 having the third configuration shown in FIG. 7A has a hole (through hole) 23 ′ continuous in the axial direction (longitudinal direction) at the center thereof. The pseudo-lesioned member 21 having the first configuration described above, except that when the pseudo-lesioned member 21 is placed in the right coronary artery 4, the inner surfaces 231 of the holes 23 ′ are in close contact with each other. It is the thing of the structure similar to.

  In the pseudo lesion member 21 having the third configuration, as described above, the inner surfaces 231 of the holes 23 ′ are in close contact with each other, so that the lumen portion of the right coronary artery 4 is located at the position where the pseudo lesion member 21 is disposed. 43 is blocked.

  In the pseudo-lesioned member 21 having the third configuration, when the balloon catheter 63 is advanced along the balloon catheter guide wire 62 in the right coronary artery 4 in the step [3], the balloon 64 is expanded while expanding the hole 23 '. This is suitable for training to expand the pseudo-lesioned member 21 (hole 23 ') by causing the balloon 64 to inflate and then inflate the balloon 64.

  Next, the pseudo-lesioned member 21 having the fourth configuration shown in FIG. 7B has through-holes 25 continuing from the hole 23 ′ at both ends of the hole 23 ′, and the diameter of the through-hole 25 is the inside thereof. Except for gradually increasing from the side toward the end side, the configuration is the same as the pseudo lesion member 21 having the third configuration described above.

  In other words, the pseudo lesion member 21 having the fourth configuration is a combination of the pseudo lesion member 21 having the second configuration and the pseudo lesion member 21 having the third configuration, and the inner surfaces 231 of the holes 23 ′ are formed with each other. The both end portions are formed of tapered portions having inclined surfaces 22.

  In the pseudo lesion member 21 of the fourth configuration, in the step [3], when the balloon 64 reaches the hole 23 ′, the balloon catheter 63 is placed along the inclined surface 22 of the pseudo lesion member 21, After introducing the tip to the entrance of the hole 23 ′, the balloon 64 is made to reach the hole 23 ′ while expanding the hole 23 ′, and then the pseudo-lesion member 21 (through hole 23) is expanded by inflating the balloon 64. It is suitable for performing training.

  In the pseudo-lesioned member 21 of the third configuration and the fourth configuration, the case has been described in which the hole 23 ′ is continuously formed substantially in the axial direction (longitudinal direction) substantially at the center thereof. However, it is not limited to such a configuration. Specifically, instead of the axially continuous hole 23 ′, an axially continuous cut 23 ″ may be provided. The cut 23 ″ may be formed at any position and in any shape. For example, the cut line 23 ″ may have a single character shape (FIG. 8 (a)) or a cross character shape (FIG. 8 (b)), or a U shape and unevenly distributed on the edge side (FIG. 8). (C)) may be formed, or one end of the cut 23 ″ may be opened at a part of the outer periphery (FIG. 8D).

  In the present invention, the pseudo lesion member 21 having each configuration having the above-described shape is made of a plastically deformable material, and the material is preferably different from the material of the right coronary artery 4. Specific examples include silicone clay, rubber clay, resin clay, and oil clay, and one or more of these can be used in combination.

  Among the above, for example, as silicone clay, as silicone rubber, polyorganosiloxane having a viscosity of about 5000 to 200,000 cSt (25 ° C.) and polyorganosiloxane having a viscosity of 1 million cSt (25 ° C.) or more are weighted. 100 parts by weight mixed at a ratio of 80:20 to 40:60, 20 combined with one or more of quartz powder, diatomaceous earth, magnesium silicate, calcium carbonate, talc, mica powder, etc. as inorganic filler 20 ˜100 parts by weight, and others containing 10 parts by weight as liquid paraffin if necessary. In addition, the silicone clay having such a structure is prepared with the above-mentioned silicone rubber, inorganic filler, and liquid paraffin as required, and these are kneaders used for ordinary rubber kneading such as rolls and kneaders. It can be obtained by using and kneading uniformly.

  In addition, although the average particle diameter of an inorganic filler is not specifically limited, It is preferable that it is about 0.1-50 micrometers, and it is more preferable that it is about 0.5-30 micrometers. If the average particle size is less than 0.1 μm, the silicone clay may be too hard or the viscosity may be poor depending on the type of the inorganic filler. On the other hand, if the average particle size exceeds 50 μm, depending on the type of the inorganic filler, it may be difficult to obtain stretched physical properties. When the blending amount of the inorganic filler is too small, it is difficult to obtain a preferable clay-like material, and when it is too large, there is a possibility that it becomes too hard.

  Further, liquid paraffin has a function of improving the viscosity, but if this content is too large, it may bleed and adhere to the hand.

  Examples of the rubber clay include those containing natural rubber or butyl rubber instead of the silicone rubber.

  In general, the resin clay includes clay composed mainly of starch and / or flour and a vinyl acetate emulsion adhesive. Examples of starch and cereal flour include corn starch, potato starch, wheat starch, rice starch, tapioca starch and sweet potato starch, and wheat flour, corn flour, rice flour and buckwheat flour, respectively. Examples of the vinyl acetate emulsion adhesive include a vinyl acetate resin emulsion, an ethylene-vinyl acetate copolymer emulsion, and an acrylic-vinyl acetate copolymer emulsion.

  In addition, it is preferable that these compounding quantities are about 100-150 weight part of vinyl acetate emulsion adhesives with respect to 100 weight part of starch and flour. In addition to these materials, the resin clay may contain inorganic powder, wax, soap and the like. Examples of the inorganic powder include quartz, kaolin, zeolite, diatomaceous earth, talc, bentonite, borax, and rock powder, and one or more of these can be used in combination. Examples of the wax include beeswax. Examples of the soap include fatty acid salt soap. However, as for these, it is preferable that the compounding quantity is all less than 10 weight part.

  As the oil clay, a mixture of an inorganic filler such as clay, calcium carbonate, sericite clay, soap and an oil component is usually used. More specifically, liquid paraffin and / or microcrystalline wax is contained as an oil component in an amount of about 15 to 45 parts by weight with respect to 100 parts by weight of the inorganic filler, and the soap includes alkali metal soap, alkaline earth metal soap, aluminum soap. Of these, those containing about 0.2 to 15 parts by weight of one or a combination of two or more of them, and further containing about 0.2 to 10 parts by weight of glycerin are preferably used.

  In addition, as a specific example of the above-mentioned silicone clay, transparent clay (manufactured by Nisshin Associates) is mentioned, and as a specific example of resin clay, excellent (manufactured by Nisshin Associates) is mentioned.

  By configuring the pseudo-lesioned member 21 with such a material, the pseudo-lesioned member 21 is more easily deformed than the right coronary artery 4. As a result, when the expansion training is performed, the pseudo-lesioned member 21 is deformed with priority over the expansion of the right coronary artery 4. This is almost the same phenomenon as when a stenosis is preferentially deformed over the right coronary artery when PTCA is performed on a stenosis that actually occurs in the human right coronary artery. Therefore, the trainer can perform training close to the actual procedure. Note that the compression modulus of the pseudo-lesioned member 21 is preferably about 0.001 to 0.5 MPa, and more preferably about 0.01 to 0.3 MPa. By setting the physical property value of the pseudo-lesioned member 21 within the above range, the physical properties of the pseudo-lesioned member 21 are plastically deformed in a state closer to the actual lesion site, and higher quality training is performed. Can be implemented.

  The right coronary artery 4 and the pseudo-lesioned member 21 are each deformed by dilatation training. However, the pseudo-lesioned member 21 is less likely to return than the right coronary artery 4 after the deformation. That is, the degree of plastic deformation of the right coronary artery 4 is smaller than that of the pseudo-lesioned member 21.

  The constituent material of the pseudo-lesion member 21 can cause the pseudo-lesion member 21 to exhibit the physical properties as described above, and maintains the plasticity for a long time. Therefore, the pseudo-lesioned member 21 is plastically deformed in a state closer to the actual lesion site, and thus the trainer can perform higher quality training.

  The state of the training biological model 1 when the PTCA surgery training is performed using the training biological model 1 (stereoscopic model) will be described in detail.

  In PTCA surgery, when the pseudo-lesion member 21 is expanded with the balloon 64, the moving portion 211 is generated by the end of the pseudo-lesion member 21 moving outward (plaque shift, see FIG. 9A). Securing the flow path in the right coronary artery 4 (recovering blood flow) without causing the generation of the dissociation part 212 (see FIG. 9B) due to the partial rupture of the pseudo-lesioned member 21 Is technically required.

  Therefore, if the biological training model 1 is used for training in PTCA surgery, training that does not cause the generation of the moving part 211 or the generation of the dissociating part 212 can be performed.

  When PTCA training is performed using the training biological model 1, the pseudo-lesion member 21 is pressed outward by the inflated balloon 64 in the step [3] shown in FIG. Further, the right coronary artery 4 is also pressed outward through the pseudo lesion member 21. Thereby, the pseudo-lesioned member 21 and the right coronary artery 4 are collectively expanded and deformed.

  Then, after the balloon catheter guide wire 62 and the balloon catheter 63 are removed from the pseudo-lesioned member 21 in the step [4] shown in FIG. 4D, the pseudo-lesioned member 21 and the right coronary artery 4 are respectively described above. As described above, since the plastic deformation occurs, the expanded and deformed state, that is, the shape expanded by the balloon 64 is maintained without returning to the shape before expansion. This is almost the same phenomenon as when the right coronary artery and stenosis are expanded when PTCA is performed on a stenosis that actually occurs in the human right coronary artery.

  Thus, by using the biological training model 1, the training biological model 1 approximates the physical properties of the actual lesion when performing training aimed at improving the skill of the surgeon. Therefore, it is possible to reliably perform training in accordance with the actual technique.

  Moreover, since it is possible to more reliably evaluate whether or not the moving part 211, the dissociation part 212, and the like have occurred in the pseudo-lesioned member 21 after the PTCA operation training, higher-quality training can be performed. .

  Further, training can be performed while observing the expansion of the balloon 64 in the step [3] visually or with an X-ray contrast image, the degree of expansion of the pseudo-lesioned member 21 and the right coronary artery 4, the moving unit 211 and the dissociating unit 212. Therefore, it is possible to carry out higher quality training from such a viewpoint.

  As shown in FIG. 9C, the stent 81 is applied to the pseudo-lesioned member 21 after the blood flow is restored by the step [4], that is, the pseudo-lesioned member 21 after the PTCA operation is performed. By indwelling, restenosis of the pseudo-lesioned member 21 and dissociation of the dissociation part 212 can be suppressed. The training biological model 1 can also be used for training of treatment in which such a stent 81 is placed, and if the training biological model 1 is used for such training, restenosis and dissociation of the dissociation part 212 are suitably suppressed. It is possible to carry out the evaluation of whether or not there is more reliably.

  The training biological model 1 having the above configuration can be manufactured by inserting the pseudo-lesioned member 21 into the Segment 2 of the right coronary artery 4 as follows, for example.

  [I] First, an outer cylinder (sheath) 71, a pusher 72 slidable in the outer cylinder 71 and provided with a through hole 73 in the axial direction, and a wire 74 inserted into the through hole 73. As shown in FIG. 10A, the wire 74 is inserted into the through hole 73 and the outer cylinder 71 with the pusher 72 inserted into the outer cylinder 71.

  [II] Next, a plastically deformable material (the clay) which is a constituent material of the pseudo-lesioned member 21 is molded by filling the outer cylinder 71 in a state where the wire 74 and the pusher 72 are inserted, The pseudo lesion member 21 is obtained in the outer cylinder 71 (see FIG. 10B).

  Here, in this embodiment, since the pusher 72 has a flat surface as shown in FIG. 10, the pseudo lesion member 21 is manufactured in the first configuration.

  Further, when molding a plastically deformable material, the through hole 23 can be meandered by meandering the wire 74 in the outer cylinder 71, and the wire 74 having a diameter that is enlarged or reduced can be used. Thus, the diameter of the through hole 23 can be increased or decreased.

  [III] Next, the Segment 2 of the right coronary artery 4 is removed at the connecting portion 11, and the outer cylinder 71 is inserted into the removed Segment 2 (see FIG. 10C).

  [IV] Next, the wire 74 is extracted from the outer cylinder 71 and the through hole 73, and then the pusher 72 is pressed and slid in the distal direction within the outer cylinder 71. Thereby, the pseudo-lesioned member 21 is pushed out from the inside of the outer cylinder 71, and is arrange | positioned in Segment2 (refer FIG.10 (d)).

  The inner surface of the outer cylinder 71 is preferably preliminarily coated with a release agent. Thereby, the pseudo lesion member 21 can be easily pushed out from the outer cylinder 71 by the pressing operation of the pusher 72 without causing deformation or the like in the pseudo lesion member 21. Moreover, it does not specifically limit as a peeling agent, For example, silicone oil etc. can be used.

  Through the above-described steps, the manufactured pseudo-lesioned member 21 is placed in the Segment 2 of the right coronary artery 4, that is, in the lumen of the tube.

  When the pseudo lesion member 21 having the second configuration is manufactured, as shown in FIG. 11A, two pushers 72 whose outer diameter is reduced toward the distal end are prepared. And the pseudo lesion member 21 of the 2nd structure can be manufactured by changing the said process [II] into the following processes [II '].

  [II ′] A plastically deformable material that is a constituent material of the pseudo-lesioned member 21 is filled in the outer cylinder 71 in a state where the pusher 72 whose diameter decreases toward the distal end and the wire 74 are inserted. Thereafter, another pusher 72 is inserted from the side opposite to the pusher 72 previously inserted. Thereafter, by molding the plastically deformable material in this state, the pseudo lesion member 21 having the second configuration can be obtained in the outer cylinder 71 (see FIG. 11B).

  Furthermore, when manufacturing the pseudo lesion member 21 having the second configuration in which the through hole 23 is unevenly distributed on the edge side, the through hole 73 is also unevenly distributed on the edge side in the pusher 72 as shown in FIG. If this is used, the pseudo-lesioned member 21 having such a configuration can be easily manufactured.

  In the manufacturing method of the training biological model 1, a thin plate having a relatively thin thickness may be used instead of the wire 74.

  Moreover, each connection part 11 is provided in the said both ends, respectively, in order to make the right coronary artery 4 which is Segment2 detachable in the both ends (refer FIG. 3). That is, Segment 2 is configured such that one end is connected to Segment 1 and the other end is connected to Segment 3 by connection 11, thereby being detachable from right coronary artery 4.

  Such a connection part 11 may be of any structure as long as it is detachable at the segment 2 part and can connect each end part to be connected liquid-tightly. By using the connection tool 12 or the connection mechanism 16 as shown in FIG. Since each connection part 11 is the same structure as each other, only one (Segment 1 side) connection part 11 will be described below.

<Connector>
As shown in FIG. 13, the connector 12 has a through-hole 14 penetrating in the axial direction (longitudinal direction) in the center thereof, and a main body 13 whose overall shape is substantially cylindrical, and the longitudinal direction of the main body 13 And a flange 15 provided at substantially the center.

  The main body 13 has a reduced diameter portion whose outer diameter is reduced at both ends, and the outer diameter of the reduced diameter portion is set to be smaller than the inner diameter of the right coronary artery 4 and is closer to the flange 15 than the reduced diameter portion. In (inner side), the outer diameter is set larger than the inner diameter of the right coronary artery 4.

  When the right coronary artery 4 is inserted from the distal end (cut surface) of the right coronary artery 4 toward the flange 15 with respect to the connector 12 having such a configuration, the inner diameter of the right coronary artery 4 is increased. Thereby, since the outer peripheral surface of the main body 13 and the inner peripheral surface of the right coronary artery 4 are in close contact with each other, the ends of the right coronary artery 4 are fluid-tightly connected by the connector 12.

  Although it does not specifically limit as a constituent material of the connection tool 12, Various resin materials are used suitably, Specifically, polyethylene, a polypropylene, an ethylene-propylene copolymer, ethylene-vinyl acetate copolymer (EVA), etc. Polyolefin, polyvinyl chloride, polyvinylidene chloride, polystyrene, polyamide, polyimide, polyamideimide, polycarbonate, poly- (4-methylpentene-1), ionomer, acrylic resin, polymethyl methacrylate, acrylonitrile-butadiene-styrene copolymer Polymer (ABS resin), acrylonitrile-styrene copolymer (AS resin), butadiene-styrene copolymer, polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polycyclohexane terephthalate (PCT) Polyester, polyether, polyetherketone (PEK), polyetheretherketone (PEEK), polyetherimide, polyacetal (POM), polyphenylene oxide, modified polyphenylene oxide, polysulfone, polyethersulfone, polyphenylene sulfide, polyarylate And various resin materials such as aromatic polyester (liquid crystal polymer), polytetrafluoroethylene, and polyvinylidene fluoride, and one or more of them can be used in combination.

<Connection mechanism>
As shown in FIG. 14, the connection mechanism 16 includes a flange 17 provided at each distal end (cut surface) of the cut right coronary artery 4 and a ring-shaped member (first member) rotatably supported by one right coronary artery 4. 1 ring-shaped member) 18 and a ring-shaped member (second ring-shaped member) 19 fixed to the other right coronary artery 4 so as to contact the flange 17.

  The ring-shaped member 18 has an open portion that opens to the flange 17 side, and a female screw 181 is formed on the inner surface of the open portion.

  In addition, the ring-shaped member 19 has a male screw 191 formed on the outer peripheral surface thereof, and the ring-shaped member 19 is set to a size that can be inserted into an opening formed in the ring-shaped member 18. The ring-shaped member 19 can be inserted (screwed) into the open portion of the ring-shaped member 18.

  In the connection mechanism 16 having such a configuration, with the end faces of the two flanges 17 in contact with each other, the female screw 181 and the male screw 191 respectively formed on the ring-shaped members 18 and 19 are screwed together to Since the end surfaces of the flange 17 are in close contact with each other, the end portions of the right coronary artery 4 are fluid-tightly connected by the connection mechanism 16.

  As the constituent material of the various constituent members of the connection mechanism 16, the same constituent materials as those of the connection tool 12 described above are preferably used.

  In addition, although it does not specifically limit as a constituent material of the part except Segment2 of the right coronary artery 4 of the coronary artery 10, For example, the material similar to Segment2 can be used. In addition, for example, silicone elastomer, silicone rubber such as silicone gel, polyurethane elastomer, silicone resin, epoxy resin, thermosetting resin such as phenol resin, polymethyl methacrylate, polyvinyl chloride, polyethylene, etc. A thermoplastic resin etc. are mentioned, Among these, it can use combining 1 type (s) or 2 or more types. Among these, it is particularly preferable to use silicone rubber.

  Specifically, the breaking strength of the coronary artery 10 made of silicone rubber is preferably about 0.5 to 3.0 MPa, and more preferably about 1.0 to 2.0 MPa.

  The breaking elongation of the coronary artery 10 is preferably about 50 to 300%, more preferably about 100 to 200%.

  Furthermore, the Shore A hardness (specified in JIS K6253) of the coronary artery 10 is preferably about 10 to 40, and more preferably about 25 to 35.

  Furthermore, the tensile elastic modulus of the coronary artery 10 is preferably about 0.01 to 5.0 MPa, and more preferably about 0.1 to 3.0 MPa.

  The inner diameter of the coronary artery 10 is not particularly limited, but is preferably set to about 0.5 to 10 mm, and more preferably set to about 1.0 to 5.0 mm.

<< Second Embodiment >>
In the first embodiment, the training biological model 1 is applied to the right coronary artery 4 side. However, in the second embodiment, the training biological model 1 is applied to the left coronary artery 3 side. . Hereinafter, the second embodiment will be described with a focus on differences from the first embodiment, and description of similar matters will be omitted.

  That is, in this embodiment (second embodiment), as shown in FIG. 15, the pseudo lesion member 21 is disposed at a bifurcation 34 where the segment 6 of the left coronary artery 3 branches into a segment 7 and a segment 9. The configuration is the same as that of the first embodiment except that the connection portion 11 is provided in the middle of the Segment 6, the Segment 7 and the Segment 9 via the pseudo lesion member 21.

  The pseudo lesion member 21 arranged in such a branching portion 34 has, for example, a fifth configuration as shown in FIG. 16 (a) or a sixth configuration as shown in FIG. 16 (b). Is mentioned.

  The pseudo lesion member 21 of the fifth configuration is a cylindrical body that increases in diameter from one end to the other end, and the second hole described above except that the diameter of the through hole 23 formed in the inside is also increased. It is the thing of the structure similar to the pseudo-lesioned member 21 of the structure. The pseudo lesion member 21 of the fifth configuration having such a configuration is arranged such that the tip of the branching portion 34 is inserted into the other end side whose diameter is increased.

  Further, the pseudo lesion member 21 of the sixth configuration is branched in a Y shape on the other end side where the diameter of the pseudo lesion member 21 is increased, and the through hole 23 formed therein is also branched in a Y shape. Except for the configuration, the configuration is the same as the pseudo lesion member 21 of the fifth configuration described above. The pseudo lesion member 21 of the sixth configuration having such a configuration is arranged so that the branch portion 34 of the left coronary artery 3 and the Y-shaped branch portion of the pseudo lesion member 21 are in contact with each other.

  In the pseudo-lesioned member 21 having the fifth and sixth configurations, usually, first, the balloon catheter guide wire 62 is inserted from the Segment 6 to the Segment 7 side, and the balloon catheter 63 is advanced along the balloon catheter guide wire 62. Thus, the balloon 64 is made to reach the position of the pseudo-lesioned member 21, and the balloon 64 is further inflated at this position to expand the segment 7 side of the pseudo-lesioned member 21. Next, the balloon catheter guide wire 62 is inserted from the Segment 6 to the Segment 9 side, and the balloon 64 is made to reach the position of the pseudo lesion member 21 in the same manner as described above, and then inflated to expand the Segment 9 side of the pseudo lesion member 21. Thus, training for securing the flow path is performed.

  In such training, when the segment 7 side of the pseudo-lesion member 21 is expanded, the balloon 64 also crushes the segment 9 side of the pseudo-lesion member 21, and as a result, the end of the pseudo-lesion member 21 on the segment 9 side is Advanced techniques are required to avoid movement (plaque shift) and eventually blockage of Segment 9. When the training biological model 1 is applied to such training, the pseudo lesion member 21 and the left coronary artery 3 are plastically deformed to the extent that they do not return to the shape before expansion due to expansion. It is possible to more reliably evaluate whether or not the segment 9 is blocked when the is expanded. Therefore, if the living body model 1 for training is applied to such training, higher quality training can be surely performed.

  In the present embodiment, as described above, the connection portion 11 is provided in the middle of the Segment 6, Segment 7 and Segment 9 so that the pseudo lesion member 21 can be disposed in the branch portion 34. A part of Segment 6, Segment 7 and Segment 9 including the branching portion 34 is configured to be detachable from the left coronary artery 3 (see FIG. 15).

  Further, the pseudo lesion member 21 having the fifth configuration and the sixth configuration described in the present embodiment can be manufactured in the same manner as the pseudo lesion member 21 described in the first embodiment. For example, prepare an outer cylinder that expands in a tapered shape, a pusher that has an outer diameter that matches the tapered inner diameter of the outer cylinder, and whose tip is reduced in diameter, and a wire that is inserted into the through hole. It can be formed by filling the outer cylinder with a plastically deformable material that is a constituent material of the member 21. Moreover, the pseudo lesion member 213 installed in the branch part 34 of FIG. 16B can be formed by separately covering the branch part 34 with a plastically deformable material.

  In the first embodiment, the case where the pseudo-lesioned member 21 is arranged in the Segment 2 (# 2: Middle) of the right coronary artery 4 will be described. In the second embodiment, the pseudo-lesioned member 21 is located in the left coronary artery 3. Segment 6 (# 6) has been described in the case where the segment 6 (# 6) is disposed at the branching portion 34 that branches into Segment 7 (# 7) and Segment 9 (# 9). However, the position at which the pseudo lesion member 21 is disposed is limited to such a position. First, the pseudo-lesioned member 21 may be arranged at a frequently occurring site where coronary artery stenosis or occlusion occurs with a high probability, and training corresponding to the frequently occurring site may be performed. In addition, as a frequent occurrence site | part in which such a pseudo lesion member 21 is arrange | positioned, the position of-mark shown in FIG. 17 is mentioned, for example.

  As described above, in the living body model 1 for training, the pseudo-lesioned member 21 that approximates the physical properties of the lesion site can be arranged in any shape at any position in the right coronary artery 4 or the left coronary artery 3. Since the training biomodel 1 can be used to perform training corresponding to various patient pathologies, the surgeon can learn more advanced techniques in a place other than the surgery performed on the patient.

  As mentioned above, although the biological model for training of this invention was demonstrated about embodiment of illustration, this invention is not limited to this, Each part which comprises the biological model for training is arbitrary which can exhibit the same function. It can be replaced with the configuration of Moreover, arbitrary components may be added.

  Moreover, the biological model for training of the present invention may be a combination of any two or more configurations (features) of the above embodiments.

  In addition, the pseudo-tubular tissue has been described as a typical example of a coronary artery (blood vessel), but is not limited thereto. For example, the esophagus, large intestine, small intestine, pancreatic duct, bile duct, ureter, oviduct, trachea, It may mimic the bronchi.

  Further, the pseudo-tubular tissue is not limited to a single-layer structure, and may be a structure in which a plurality of layers are stacked (laminated body).

  Moreover, the shape of the pseudo-tubular tissue may be linear, or a part or the whole may be curved.

1 Biological model for training 10 Coronary artery (pseudo tubular tissue)
DESCRIPTION OF SYMBOLS 11 Connection part 12 Connection tool 13 Main body 14 Through-hole 15 Flange 16 Connection mechanism 17 Flange 18, 19 Ring-shaped member 181 Female screw 191 Male screw 21 Pseudo lesion member (lesion model)
211 moving part 212 dissociating part 213 pseudo-lesioned member 22 inclined surface 23 through hole 23 'hole (through hole)
23 ”cut 231 inner surface 25 through-hole 3 left coronary artery 31 left anterior descending branch 32 left circumflex branch 33 left trunk 34 bifurcation
4 Right coronary artery 40 Tubular body (tube)
400 Strip 401 Fixed end 402 Free end 41 Sharp edge 42 Rear descending branch 43 Lumen 5 Aorta 61 Guide catheter 62 Balloon catheter guide wire 63 Balloon catheter 64 Balloon 71 Outer tube 72 Pusher 73 Through hole 74 Wire 81 Stent f ₀ initial tensile stress f _t after 5 minutes the tensile stress φd _1, φd ₃ inner diameter φd _2, φd ₄ outer diameter L, 2L total length

Claims (18)

A pseudo-tubular tissue that is configured by a tubular body having a lumen and imitates a tubular tissue;
A pseudo lesion member that is disposed in the lumen portion of the pseudo-tubular tissue, has a shape that narrows or closes the lumen portion, and imitates a lesion portion that has occurred in the tubular tissue;
Each of the pseudo-tubular tissue and the pseudo-lesioned member is made of a plastically deformable material, and when the extension training is performed on the pseudo-lesioned member in order to secure a flow path in the pseudo-tubular tissue, the expansion is performed. Therefore, the biological model for training is characterized in that it is plastically deformed to such an extent that it does not return to the shape before expansion.   The training biological model according to claim 1, wherein the pseudo lesion member is more easily deformed than the pseudo tubular tissue.   The training biological model according to claim 1 or 2, wherein the pseudo-lesioned member has a shape after expansion that is less likely to return to the shape before expansion than the pseudo-tubular tissue.   The biological model for training according to claim 1, wherein the pseudo-tubular tissue is made of a thermoplastic resin. The pseudo-tubular tissue is an initial tensile stress when a strip of the tubular body that becomes the pseudo-tubular tissue is pulled in the circumferential direction of the tubular body so that the elongation becomes 100% at 1 minute at room temperature. was a _{f 0,} as the tensile stress at 5 min after holding the elongation of the 100% _{f t,} when the stress relaxation rate and _{((f 0 -f t) /} f 0) × 100, the stress The training biological model according to any one of claims 1 to 4, wherein the training biological model is made of a material having a relaxation rate of 20 to 60%.   The training biological model according to claim 1, wherein a tensile elastic modulus of the pseudo-tubular tissue is equal to or greater than a compressive elastic modulus of the pseudo-lesioned member.   The training biological model according to any one of claims 1 to 6, wherein the pseudo-tubular tissue has a tensile elastic modulus of 0.5 to 50 MPa. The pseudo pseudo-tissue satisfies the relationship that d ₂ / d ₁ is 1.01 to ₂ when the inner diameter is φd ₁ and the outer diameter is φd _2. The described biological model for training. The biological model for training according to claim 8, wherein the inner diameter φd ₁ is 0.5 to ₁₀ mm.   The biological model for training according to any one of claims 1 to 9, wherein the pseudo-tubular tissue has a branched portion that is branched in the middle thereof.   The biological model for training according to claim 10, wherein the pseudo-lesioned member is arranged at the branch portion. The pseudo lesion member has a through-hole penetrating in a longitudinal direction of the pseudo tubular tissue,
The living body model for training according to any one of claims 1 to 11, wherein inner surfaces of the through holes are in contact with each other or apart from each other.   The living body model for training according to claim 12, wherein the through-hole is formed with a tapered portion at one end portion or both end portions thereof so that the diameter of the through-hole gradually increases from the inner side toward the end portion side.   The biological model for training according to claim 1, wherein the pseudo-lesioned member is inserted in a compressed state in the lumen portion.   The biological model for training according to any one of claims 1 to 14, wherein the pseudo lesion member is made of a material including at least one of silicone clay, rubber clay, resin clay, and oil clay.   The biological model for training according to claim 1, wherein the pseudo-lesion member has a compression elastic modulus of 0.001 to 0.5 MPa.   The medical device according to any one of claims 1 to 16, wherein one or more medical devices are used for training for extending the pseudo-lesioned member after passing through the pseudo-tubular tissue and reaching the pseudo-lesioned member. The described biological model for training.   The biological model for training according to claim 17, wherein the medical device is a balloon catheter and / or a stent used for percutaneous coronary angioplasty.

Images