JP5452029B2 - A lesion model placed in the lumen of the duct - Google Patents

Description

  The present invention relates to a lesion model placed in the lumen of a tube.

  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 a deposit in which cholesterol is deposited, and thus its physical properties are greatly different from those of a blood vessel.

  Therefore, the three-dimensional model described in Patent Document 1 has a problem that training corresponding to the physical properties of the actual stenosis site cannot be performed.

  Furthermore, since the three-dimensional model is manufactured based on the tomographic image data of one subject, if this subject is a healthy person, training for the patient, that is, for the stenosis site, Training to inflate the balloon is not possible. Moreover, even if the subject is a patient, only the training for the position or shape of the stenosis site that the patient has can be performed, and training corresponding to the stenosis site that occurs in various positions and shapes cannot be performed. .

Japanese Patent No. 361568

  The object of the present invention is to use a lesion model in a tube having a lumen such as a blood vessel, and when performing training for improving the skill of the operator using this lesion model, An object of the present invention is to provide a lesion model that can be trained to approximate the physical properties of a lesion site and can be arranged in any shape at any position in the lumen.

Such an object is achieved by the present inventions (1) to ( 6 ) below.
(1) A lesion model arranged in the lumen of a tube having a lumen,
Having a through-hole penetrating in the axial direction,
The through-hole has 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,
A lesion model characterized in that, when placed in the lumen portion, the lumen portion is narrowed by an outer peripheral portion of the through hole .

(2) the pathology model, lesion model according to the above (1) to be inserted in a compressed state within said cavity.

( 3 ) The lesion model according to (1) or (2) , wherein the lesion model is elastically deformed.

( 4 ) Polystyrene-poly (ethylene / propylene) block copolymer, polystyrene-poly (ethylene / propylene) block-polystyrene copolymer, polystyrene-poly (ethylene / butylene) block-polystyrene copolymer, polystyrene -A polymer comprising a mixture of one or more copolymers selected from the group consisting of poly (ethylene-ethylene / propylene) block-polystyrene copolymers, and a softening agent for softening the polymer. The lesion model according to any one of (1) to ( 3 ) above.

( 5 ) Said ( 1 ) thru | or ( 4 ) which manufactured by filling the liquid material which melt | dissolved the constituent material of the said lesion model with the heat melting or the solvent in the outer cylinder in which the pusher was inserted, and then solidifying. ) A lesion model according to any one of

( 6 ) The lesion model according to any one of the above (1) to ( 5 ), which is used for training in which one or more medical devices are inserted into the tube to reach the lesion model for treatment.

  According to the present invention, in a three-dimensional model using a tube having a lumen such as a blood vessel, a lesion model that approximates the physical properties of a lesion site can be arranged in an arbitrary shape at an arbitrary position. For this reason, since a three-dimensional model including this lesion model can be used to perform training corresponding to various patient pathologies, the surgeon can acquire more advanced techniques in a place other than the surgery performed on the patient. .

FIG. 1 is a schematic diagram showing an artery (including a heart) in the whole human 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 an example which has arrange | positioned the lesion model of this invention in the right coronary artery. It is a figure which shows the procedure which performs the training of PTCA operation with respect to the lesion model 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 stenosis type lesion model. 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 stenosis type lesion model. 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 lesion model. 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 lesion model. 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 lesion model. It is a figure for demonstrating the method to manufacture the lesion model of this invention, and to arrange the manufactured lesion model in the lumen | bore part of a pipe | tube. It is a figure for demonstrating the other manufacturing method which manufactures the lesion model of this invention. It is a figure which shows the other structure of the pusher used when manufacturing the lesion model 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 figure for showing the frequent occurrence site of a lesion where the lesion model of the present invention is arranged.

Hereinafter, the lesion model of the present invention will be described in detail based on a preferred embodiment shown in the accompanying drawings.
The lesion model of the present invention is a lesion model arranged in the lumen portion of a tube having a lumen portion, and has a shape that narrows or closes the lumen portion when arranged in the lumen portion. It is what.

  This lesion model is, for example, a three-dimensional model (manufactured artificially by reproducing various pipes of a human body having lumens such as blood vessels (arteries, veins), lymphatic vessels, bile ducts, ureters, oviducts, etc.) A training for performing treatment by causing a medical instrument such as a guide wire or a balloon catheter to reach the lesion model is performed using the three-dimensional model. Below, the case where the lesion model of this invention is arrange | positioned to the solid model formed corresponding to the shape of the artery is demonstrated to an example.

  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 arranging the lesion model of the present invention in any position of the arteries of the arterial model as described above, for example, coronary artery, cerebral artery, carotid artery, renal artery, brachial artery, etc., a guide wire or a balloon catheter However, in this embodiment, the case where the lesion model of the present invention is arranged in the coronary artery included in the artery model will be described as a representative.

  FIG. 3 is a schematic diagram showing an example in which the lesion model of the present invention is placed in the coronary artery, FIG. 4 is a diagram showing a procedure for performing PTCA surgery on the lesion model placed in the right coronary artery, FIG. 5 and FIG. 6 is a diagram showing various configurations of a stenotic lesion model (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 FIGS. 7 to 9 are various diagrams of the obstructive lesion model. The figure which shows a structure (the left figure is a longitudinal cross-sectional view, the right figure is the AA sectional view taken on the left figure), FIG. 10 manufactures the lesion model of this invention, and the manufactured lesion model is the lumen | bore part of a pipe | tube. FIG. 11 is a diagram for explaining another manufacturing method for manufacturing the lesion model of the present invention, and FIG. 12 is used for manufacturing the lesion model of the present invention. The figure which shows the other structure of a pusher, FIG. 13 is the figure for demonstrating the structure of a connector (a figure (a) is a perspective view, a figure (b) is FIG. 14 is a diagram for explaining the configuration of the connection mechanism (FIG. (A) is a perspective view, FIG. (B) is a longitudinal sectional view), and FIG. 15 is a lesion model of the present invention. It is a figure for showing the site where lesions are common. In the following description, the upper side in FIGS. 3 to 15 is referred to as “upper” and the lower side is referred to as “lower”. 3 and 15 also illustrate the shape of the heart so that the shape and position of the coronary artery can be easily understood.

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 coronary artery 10 is composed of a cured product of the above-described three-dimensional model molding material.

  The three-dimensional model molding material is not particularly limited. For example, silicone elastomer, silicone rubber such as silicone gel, polyurethane elastomer, silicone resin, epoxy resin, thermosetting resin such as phenol resin, polymethyl methacrylate, etc. And thermoplastic resins such as polyvinyl chloride and polyethylene, and one or more of these can be used in combination. Among these, it is particularly preferable to use silicone rubber. By configuring the coronary artery 10 with a cured product of this material, the coronary artery 10 is excellent in transparency and exhibits elasticity and flexibility approximating that of the actual coronary artery.

  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%.

  Further, the Shore A hardness (specified in ASTM D2240) of the coronary artery 10 is preferably about 10 to 40, and more preferably about 25 to 35.

  The inner diameter φ of the coronary artery 10 is not particularly limited, but is preferably set to about 0.5 to 4.0 mm, and more preferably set to about 1.0 to 3.0 mm. By setting the inner diameter φ of the coronary artery 10 within such a range, training corresponding to an actual human coronary artery can be reliably performed, and the skill of the operator can be improved accurately.

  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 that enters the anterior chamber groove and a left circumflex branch 32. A portion from the aorta 5 until it branches into the left anterior descending branch 31 and the left rotating branch 32 is referred to as a left main trunk 33.

  Further, the right coronary artery 4 exits from the upper part of the right coronary sinus, which is one of the Valsalva caves, and is covered with the right atrial appendage and travels between the right atrium and the pulmonary artery, along the interatrial chamber groove A blood vessel that feeds the rear wall of the left ventricle and the lower side of the septum is derived from the posterior ventricular groove through the sharp edge 41 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 referred to as 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.

  In the coronary artery 10 having such a configuration, in the present embodiment, the lesion model 21 of the present invention is disposed in the Segment 2 (# 2: Middle) of the right coronary artery 4, and the connecting portion is connected to both ends of the Segment 2 via the lesion model 21. 11 is provided.

  PTCA surgery training is performed on the lesion model 21 arranged 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, a guide catheter guide wire (not shown) is then inserted into the femoral artery, and the tip is advanced to the vicinity of the right coronary artery 4 entrance. 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 lesion model 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 lesion model 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 (FIG. 4). (See (c).) Thereby, the lesion model 21 is expanded.

  [4] Next, the balloon expansion 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 lesion model 21.

  When an elastically deformable model as described later is used as the lesion model 21, the blood flow path formed in the lesion model 21 is closed again after the balloon 64 is deflated in this step [4]. The lesion model 21 will eventually recover almost the shape before training.

  The shape of the lesion model 21 used for the training as described above is classified into a stenosis type or an occlusion type depending on the degree of stenosis.

Hereinafter, the shape of the lesion model 21 will be described in order by classifying these types.
<Stenosis type>
Of the stenosis-type lesion model 21, the lesion model 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, and has an overall shape. Is a cylindrical body having a substantially cylindrical shape.

  In the lesion model 21 having such a configuration, when the lesion model 21 is placed in the right coronary artery (lumen portion) 4, the right coronary artery 4 is narrowed by the cylindrical body that forms the outer peripheral portion of the through hole 23.

  In the lesion model 21 having the first configuration, when the balloon catheter guide wire 62 is advanced to a position beyond the lesion model 21 in the step [2], the balloon catheter guide wire is placed on the side surface 24 of the lesion model 21. This is suitable for training for inserting the balloon catheter guide wire 62 into the through hole 23 while avoiding the hook 62 from being caught.

  In the step [3], the balloon catheter 63 is advanced along the balloon catheter guide wire 62 in the right coronary artery 4 to train the balloon 64 to reach the lesion model 21 that narrows the right coronary artery 4, that is, the through hole 23. It is suitable for performing.

  The length of the lesion model 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 lesion model 21 within such a range, it is possible to perform training more suitable for the size of the actual lesion site (stenosis site).

  Further, the outer diameter φ of the lesion model 21 is appropriately set according to the size of the inner diameter φ of the right coronary artery 4 to be arranged, and is not particularly limited, but is about 0.5 to 5.0 mm. Preferably, it is about 1.0-3.0 mm.

  The outer diameter φ of the lesion model 21 set within such a range is preferably set larger than the inner diameter φ of the right coronary artery 4. As a result, the lesion model 21 is inserted into the right coronary artery (lumen) 4 in a compressed state, and as a result, the lesion model 21 is securely fixed in the right coronary artery 4. In addition, it is possible to reliably prevent the lesion model 21 from being unintentionally displaced due to contact with the balloon catheter guide wire 62 or the balloon catheter 63.

  Further, the inner diameter φ of the through hole 23 of the lesion model 21 is not particularly limited, but is preferably about 0.1 to 2.0 mm, and more preferably about 0.3 to 1.0 mm. By setting the inner diameter φ of the through hole 23 within such a range, training suitable for the stenosis degree of the actual stenosis site can be surely performed, and the skill improvement of the operator can be achieved accurately.

  Similar to the lesion model 21 of the first configuration, the lesion model 21 of the second configuration shown in FIG. 5B has a through-hole 23 that penetrates in the axial direction at the center, and the overall shape is almost the same. Although it has a cylindrical shape, a taper portion in which the hole diameter (outer diameter) of the through-hole 23 gradually increases from the inner side toward the outer side is provided at both ends thereof, and the width at both ends of the lesion model 21 is increased. It is substantially “0”.

  In other words, the through-hole 23 has a funnel shape at both ends thereof, and the inner peripheral surfaces of both ends of the lesion model 21 are inclined surfaces 22 that are inclined from the inside of the lesion model 21 toward both ends. Have.

  In the lesion model 21 of the second configuration, when the balloon catheter guide wire 62 is advanced to a position beyond the lesion model 21 in the step [2], the balloon catheter guide is placed on the inclined surface 22 of the lesion model 21. This is suitable for training to insert the balloon catheter guide wire 62 into the through hole 23 while keeping the wire 62 along.

  In the step [3], when the balloon 64 reaches the through-hole 23, the balloon 64 reaches the through-hole 23 while keeping the balloon catheter 63 along the inclined surface 22 of the lesion model 21. Suitable for doing.

  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 lesion model 21, it is not limited to this case, The taper part should just be provided in either one of two ends.

  Moreover, in the lesion model 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, but the present invention is limited to this configuration. However, the through hole 23 may be formed at any position and in any shape. For example, the through hole 23 may be unevenly distributed on the edge side (FIG. 6A) or at the edge. A part thereof may be open (FIG. 6 (b)), meandering (curved) (FIG. 6 (c)), or enlarged and reduced (FIG. 6 (d) )) You may have.

<Occlusion type>
Among the occlusion type lesion models 21, the lesion model 21 having the third configuration shown in FIG. 7A has a hole 23 ′ continuous in the axial direction (longitudinal direction) at the center thereof. Is disposed in the right coronary artery 4, except that the inner surfaces of the hole 23 'are in close contact with each other, and has the same configuration as the lesion model 21 of the first configuration described above.

  In the lesion model 21 having the third configuration, as described above, the inner surfaces of the holes 23 ′ are in close contact with each other, whereby the right coronary artery 4 is occluded at the position where the lesion model 21 is disposed.

  In the lesion model 21 of the third configuration, when the balloon catheter guide wire 62 is advanced to a position beyond the lesion model 21 in the step [2], the balloon catheter guide wire is placed on the side surface 24 of the lesion model 21. It is suitable for training to insert the balloon catheter guide wire 62 while pushing and expanding the inside of the hole 23 ′ while preventing the 62 from being caught.

  Further, in the step [3], when the balloon catheter 63 is advanced along the balloon catheter guide wire 62 in the right coronary artery 4, training is performed for the balloon 64 to reach the hole 23 ′ while expanding the hole 23 ′. It is suitable for performing.

  The lesion model 21 having the fourth configuration shown in FIG. 7 (b) has through holes 25 continuous from the hole 23 'at both ends of the hole 23', and the diameter of the through hole 25 is the end from the inner side. Except for gradually increasing toward the side, it has the same configuration as the lesion model 21 of the third configuration described above.

  That is, the lesion model 21 of the fourth configuration is a combination of the lesion model 21 of the second configuration and the lesion model 21 of the third configuration, the inner surfaces of the holes 23 are in close contact with each other, and Both end portions are constituted by tapered portions having inclined surfaces 22.

  In the lesion model 21 of the fourth configuration, when the balloon catheter guide wire 62 is advanced to a position beyond the lesion model 21 in the step [2], the balloon catheter guide is placed on the inclined surface 22 of the lesion model 21. It is suitable for training to insert the balloon catheter guide wire 62 while expanding the inside of the hole 23 ′ after introducing the tip of the wire 62 to the entrance of the hole 23 ′ along the wire 62.

  In the step [3], when the balloon 64 reaches the hole 23 ', the tip of the balloon catheter 63 is introduced to the entrance of the hole 23' while keeping the balloon catheter 63 along the inclined surface 22 of the lesion model 21. After that, it is suitable for training to make the balloon 64 reach the hole 23 ′ while expanding the hole 23 ′.

  In the lesion model 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 may be open at a part of the outer periphery (FIG. 8D).

  The lesion model 21 of the fifth configuration shown in FIG. 9 (a) does not have the through-hole 23 and is configured by a plug-like solid body having a substantially cylindrical shape. The configuration is the same as that of the lesion model 21.

  Further, in the lesion model 21 of the sixth configuration shown in FIG. 9B, both ends of the plug-shaped solid body have through holes 25, and the diameter of the through hole 25 is from the inner side to the end side. Except for being configured with a taper portion that gradually increases toward, the same configuration as the lesion model 21 of the fifth configuration described above.

  That is, the lesion model 21 with the sixth configuration is a combination of the lesion model 21 with the second configuration and the lesion model 21 with the fifth configuration, and the main body portion is configured with a plug-like solid body. And the both ends are comprised by the taper part provided with the inclined surface 22. As shown in FIG.

  In the lesion models 21 having the fifth and sixth configurations, as described above, the right coronary artery 4 is occluded at the position where the lesion model 21 is disposed because the main body portion has a plug shape.

  In the lesion models 21 having the fifth and sixth configurations, the balloon catheter guide wire 62 is inserted into the lesion model 21 and the balloon 64 cannot be reached. Training in other percutaneous coronary angioplasty such as atherectomy such as coronary atherectomy (DCA) and percutaneous high-speed rotational coronary atherectomy (PTCRA) Is preferably used.

  As the lesion model 21 of each configuration having the above-described shape, one that is elastically deformed is normally used in PTCA training.

  If an elastically deformable lesion model 21 is used, after removing the balloon catheter guide wire 62 and the balloon catheter 63 from the lesion model 21 in the step [4], the shape before the training is almost recovered. The lesion model 21 can be used for repeated training without replacement.

  The lesion model 21 is not limited to elastic deformation but may be plastic deformation. If the lesion model 21 is to be plastically deformed, the shape expanded by the balloon 64 is maintained even after the balloon catheter guide wire 62 and the balloon catheter 63 are removed from the lesion model 21 in the step [4]. As a result, training can be evaluated more reliably, so that higher quality training can be implemented.

  Examples of the constituent material of the lesion model 21 that is elastically deformed include, for example, a polystyrene-poly (ethylene / propylene) block copolymer, a polystyrene-poly (ethylene / propylene) block-polystyrene copolymer, and a polystyrene-poly (ethylene / ethylene / ethylene / propylene) block. A polymer comprising one or a mixture of two or more copolymers selected from the group consisting of a copolymer of butylene) block-polystyrene and a copolymer of polystyrene-poly (ethylene-ethylene / propylene) block-polystyrene. And those containing a softening agent for softening the polymer.

  Specific examples of the copolymer include, for example, the Septon series (manufactured by Kuraray Plastics, thermoplastic elastomer), Espolex SB series (manufactured by Sumitomo Chemical Co., Ltd.), and the like.

  As the softener, process oil is particularly preferably used, and the process oil is not particularly limited, and any of paraffinic, naphthenic and aromatic types may be used, and one of these may be used. Alternatively, two or more kinds can be used in combination. Moreover, as a specific example of process oil, Diana process oil series (made by Idemitsu Kosan), JOMO process P (made by Japan Energy) etc. are mentioned, for example.

  The weight ratio of the copolymer to the softening agent is preferably about 1: 3 to 1:10, and more preferably about 1: 5 to 1: 7.

  Furthermore, in addition to the above-described constituent materials, other additives may be added to the elastically deformed lesion model 21 as necessary. Examples of such additives include preventing the aging of the lesion model 21. Anti-aging agents (antioxidants) and the like.

  The anti-aging agent is not particularly limited, and examples thereof include amine-based or phenol-based anti-aging agents. Examples of the amine-based anti-aging agent include N-isopropyl-N′-phenyl-p-phenylenediamine, N- ( 1,3-dimethylbutyl) -N′-phenyl-p-phenylenediamine, amine derivatives such as 6-ethoxy-2,2,4-trimethyl-1,2-dihydroquinoline, and phenolic aging The inhibitors include 2,6-di-tert-butyl-p-cresol, 2,5-di-tert-amylhydroquinone, 2,5-di-tert-butyl-hydroquinone, 4,4'-butylidene-bis (3-methyl-6-tert-butylphenol), 2,2′-methylene-bis (4-methyl-6-tert-butylphenol) and the like.

  This elastically deforming lesion model 21 preferably has a lower breaking strength than the right coronary artery 4 in which it is placed. An actual lesion site (stenosis site) formed in the human body is mainly composed of deposits in which cholesterol is deposited in blood vessels, and generally, the breaking strength thereof is lower than the breaking strength of blood vessels. Therefore, by making the breaking strength of the lesion model 21 lower than the breaking strength of the right coronary artery 4, it is possible to reliably perform training that approximates the physical properties of the actual lesion site.

  Specifically, the breaking strength of the lesion model 21 that is elastically deformed is preferably about 0.3 to 1.0 MPa, and more preferably about 0.5 to 0.8 MPa.

  Further, the elongation at break of the lesion model 21 is preferably about 2000 to 5000%, and more preferably about 3000 to 4000%.

  Furthermore, the 100% modulus of the lesion model 21 is preferably about 5 to 50 kPa, and more preferably about 10 to 30 kPa.

By making the physical property value of the lesion model 21 within such a range, the physical properties of the lesion model 21 are approximated to the actual lesion site, and higher quality training can be performed.
The lesion model 21 as described above can be manufactured, for example, as follows.

  [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, the liquid material containing the constituent material of the lesion model 21 is filled in the outer cylinder 71 in a state where the wire 74 and the pusher 72 are inserted, and then solidified, whereby the outer cylinder 71 is solidified. A lesion model 21 is obtained (see FIG. 10B).

  As the liquid material, a material obtained by heating and melting the constituent material of the lesion model 21 or a material dissolved in a solvent can be used. When such a constituent material is heated and melted, the liquid material is solidified by cooling the liquid material, and when the constituent material is dissolved in a solvent, the liquid material is solidified by desolvation from the liquid material.

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

  Further, when solidifying the liquid material, the through hole 23 can be meandered by meandering the wire 74 in the outer cylinder 71, and the wire 74 can be penetrated by expanding or reducing the diameter. The hole 23 can be expanded or contracted. Furthermore, when the insertion of the wire 74 is omitted, the lesion model 21 having the fifth configuration can be manufactured.

  [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. As a result, the lesion model 21 is pushed out from the outer cylinder 71 and placed in the Segment 2 (see FIG. 10D).

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

  The manufactured lesion model 21 is placed in the Segment 2 of the right coronary artery 4, that is, in the lumen of the tube through the above-described steps.

  When the lesion model 21 having the second configuration is manufactured, as shown in FIG. 11 (a), two pushers 72 whose tip portions are reduced in diameter toward the tip side are prepared, By changing [II] to the following process [II ′], the lesion model 21 having the second configuration can be manufactured.

  [II ′] After filling the outer cylinder 71 in a state where the pusher 72 whose diameter is reduced toward the distal end and the wire 74 are inserted, a liquid material containing the constituent material of the lesion model 21 is further filled. The other pusher 72 is inserted from the opposite side to the previously inserted pusher 72. Thereafter, in this state, the lesion material 21 having the second configuration can be obtained in the outer cylinder 71 by solidifying the liquid material (see FIG. 11B).

  Furthermore, when manufacturing the lesion model 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 used, the lesion model 21 having such a configuration can be easily manufactured.

  Further, as described in the manufacturing method of the lesion model 21 described above, the connection unit 11 is attached / detached at the segment 2 portion so that the lesion model 21 can be placed at the segment 2 (# 2: middle) position of the right coronary artery 4. In order to make it possible, they are provided at both ends of the Segment 2 (see 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 or the connection mechanism as shown in FIG.

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

  The main body 13 has a diameter-reduced portion that is reduced in diameter 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 the flange 15 side (inner side) from the reduced diameter portion Then, 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, polyphenylenesulfide, 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>
The connection mechanism 16 includes a flange 17 provided at each distal end (cut plane) of the cut right coronary artery 4 and a ring-shaped member (first ring-shaped member) 18 rotatably supported by one right coronary artery 4. And a ring-shaped member (second ring-shaped member) 19 fixed to the other right coronary artery 4 so as to be in contact with 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 surfaces 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 the present embodiment, the case where the lesion model 21 is arranged in the Segment 2 (# 2: Middle) of the right coronary artery 4 has been described. However, the position where the lesion model 21 is arranged is not limited to this position, and the coronary artery The lesion model 21 may be placed at a frequently occurring site where 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 where such a lesion model 21 is arrange | positioned, the position of-mark shown in FIG. 15 is mentioned, for example. In addition, at least two connecting portions 11 provided for arranging the lesion model 21 may be provided in the coronary artery 10 so as to pass through the lesion model 21.

  As described above, by using the lesion model of the present invention, in a three-dimensional model using a tube having a lumen such as a coronary artery (blood vessel), a lesion model that approximates the physical properties of a lesion site can be obtained at an arbitrary position. Can be arranged in any shape. For this reason, since a three-dimensional model including this lesion model can be used to perform training corresponding to various patient pathologies, the surgeon can acquire more advanced techniques in a place other than the surgery performed on the patient. .

  As mentioned above, although the lesion model of this invention was demonstrated about embodiment of illustration, this invention is not limited to this, Each part which comprises a lesion model is the thing of arbitrary structures which can exhibit the same function Can be substituted. Moreover, arbitrary components may be added.

  Further, in the embodiment, the case where the training is performed by arranging the lesion model of the present invention on a tube artificially manufactured by reproducing a blood vessel (coronary artery) is not limited to such a case, Training may be carried out by placing the lesion model of the present invention in a tube of an animal body other than a human body or a tube of a human cadaver, that is, a tube other than a tube of a human body.

DESCRIPTION OF SYMBOLS 10 Coronary artery 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 Lesion model 22 Inclined surface 23 Through-hole 23 'Hole 23 "Cut 24 Side 25 Through-hole 3 Left coronary artery 31 Left anterior descending branch 32 Left convolutional branch 33 Left main trunk 4 Right coronary artery 41 Sharp edge 42 Rear descending branch 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

Claims (6)

A lesion model placed in the lumen of a tube having a lumen,
Having a through-hole penetrating in the axial direction,
The through-hole has 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,
A lesion model characterized in that, when placed in the lumen portion, the lumen portion is narrowed by an outer peripheral portion of the through hole . Lesion model of claim 1 the lesion model is to be inserted in a compressed state within said cavity. The lesion model according to claim 1 or 2 , wherein the lesion model is elastically deformed. Polystyrene-poly (ethylene / propylene) block copolymer, polystyrene-poly (ethylene / propylene) block-polystyrene copolymer, polystyrene-poly (ethylene / butylene) block-polystyrene copolymer, polystyrene-poly ( 2. A polymer comprising a mixture of one or more copolymers selected from the group consisting of ethylene-ethylene / propylene) block-polystyrene copolymers, and a softening agent for softening the polymers. 4. The lesion model according to any one of 3 to 3 . The liquid material obtained by dissolving the constituent materials of the lesion model in heating and melting or solvent, was filled into the outer cylinder pusher is inserted, according to any one of claims 1 those prepared by solidifying 4 Lesion model. The lesion model according to any one of claims 1 to 5 , wherein the lesion model is used for training in which one or more medical instruments are inserted into the tube to reach the lesion model for treatment.

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