JP5289997B2 - 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 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.

  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 ( 9 ) below.
(1) A lesion model that is disposed in the lumen portion of a tube having a lumen portion, and has a shape that narrows or closes the lumen portion when disposed in the lumen portion,
The lesion model is composed of a plastically deformable material mainly composed of at least one of silicone clay, resin clay and oil clay .
When the lesion model is placed in the lumen part and subjected to training for expansion to ensure a flow path, it is plastically deformed to the extent that it does not return to the shape before expansion due to the expansion. Lesion model.

(2) The lesion model according to (1), which has a smaller elastic modulus than the tube .

( 3 ) The lesion according to the above (1) or (2) , which has a through-hole penetrating in the axial direction and narrows the lumen by the outer peripheral portion of the through-hole when arranged in the lumen. model.

( 4 ) The lesion model according to ( 3 ), wherein the through hole includes a tapered portion in which the diameter of the through hole gradually increases from the inner side toward the end side at one end portion or both end portions thereof.

( 5 ) The above or (2 ) which has an axially continuous cut or hole and closes the lumen when the inner surfaces of the cut or the hole are in close contact with each other when arranged in the lumen. ) Lesion model described in.

( 6 ) One end or both ends of the cut or hole have a through hole continuous from the cut or hole, and the through hole has a tapered portion whose diameter gradually increases from the inner side toward the end side. The lesion model according to ( 5 ) above.

( 7 ) The lesion model according to any one of (1) to ( 6 ), wherein the lesion model is inserted into the lumen in a compressed state.

( 8 ) The lesion model according to any one of (1) to ( 7 ), wherein a plastically deformable material is filled in an outer cylinder into which a wire and a pusher are inserted.

( 9 ) Any one of the above (1) to ( 8 ) used for training for extending the lesion model after one or more medical devices are inserted through the tube to reach the lesion model The lesion model described in 1.

  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 mimetic diagram showing a 1st embodiment where a lesion model of the present invention is arranged in a 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 longitudinal cross-sectional view which shows the state of the lesion model after training. 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 schematic diagram which shows 2nd Embodiment by which the lesion model of this invention was arrange | positioned at the bifurcation part of the left coronary artery. It is a longitudinal cross-sectional view which shows the various structures of the lesion model arrange | positioned at a branch part. 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 that is disposed in the lumen portion of a tube having a lumen portion, and has a shape that narrows or closes the lumen portion when disposed in the lumen portion. The model is made of a plastically deformable material, and when the lesion model is placed in the lumen and is trained to expand to secure a flow path, the expansion returns to the shape before expansion. It will be plastically deformed to a certain extent.

  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.) Using this three-dimensional model, a medical device such as a balloon catheter is made to reach the lesion model, and then the lesion model is expanded to secure a flow path, or a stent is attached to the expanded lesion model. Training for detention is conducted. 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 placing the lesion model of the present invention in any position such as coronary artery, cerebral artery, carotid artery, renal artery, brachial artery, etc., in each part of the arterial model as described above (balloon catheter) After positioning a medical instrument such as a lesion model (stenosis model) and then expanding the lesion model, training can be performed to secure a flow path. The case where the lesion model of the invention is arranged will be described as a representative.

  FIG. 3 is a schematic diagram showing a first embodiment in which the lesion model of the present invention is placed in the right coronary artery, and FIG. 4 is a diagram showing a procedure for performing PTCA training on the lesion model placed in the right coronary artery. 5 and 6 are diagrams showing various configurations of a stenosis type lesion model (the left figure is a longitudinal sectional view, the right figure is a sectional view taken along the line AA of the left figure), and FIGS. 7 and 8 are occlusion types. (Left figure is a longitudinal sectional view, Right figure is a sectional view taken along line AA in the left figure), FIG. 9 is a longitudinal sectional view showing the state of a lesion model after training, FIG. FIG. 11 is a diagram for explaining a method of manufacturing the lesion model of the present invention and arranging the manufactured lesion model in the lumen of the tube, and FIG. 11 shows another manufacturing method of manufacturing the lesion model of the present invention. FIG. 12 for explanation, FIG. 12 is a diagram showing another configuration of the pusher used in manufacturing the lesion model of the present invention, FIG. The figure for demonstrating the structure of a connector (a figure (a) is a perspective view, the figure (B) is a longitudinal cross-sectional view), FIG. 14 is the figure (a figure (a) is a figure for demonstrating the structure of a connection mechanism. FIG. 15 is a schematic view showing a second embodiment in which the lesion model of the present invention is arranged at the bifurcation of the left coronary artery, and FIG. 16 is arranged at the bifurcation. FIG. 17 is a view for showing a site where a lesion is frequently generated, in which the lesion model of the present invention is arranged. 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 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.

  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 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 right coronary artery 4 exits from the upper part of the right coronary sinus, one of the Valsalva caves, and is covered with the right atrial appendage and travels between the right atrium and the pulmonary artery, and sharp edges along the interatrial 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 interventricular groove through the part 41 and toward the descending 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.

  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 >>
First, in the present embodiment (the first embodiment), in the coronary artery 10 having such a configuration, the lesion model 21 of the present invention is arranged in the Segment 2 (# 2: Middle) of the right coronary artery 4, and at both ends of the Segment 2 A connection part 11 is provided via a lesion model 21.

  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, 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 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 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 lesion model 21.

  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, in the step [3], the balloon catheter 63 is advanced in the right coronary artery 4 along the balloon catheter guide wire 62 and the balloon 64 is narrowed in the right coronary artery 4. 21, which is suitable for training to expand the lesion model 21 (through hole 23) by reaching the inside of the through hole 23 and then inflating the balloon 64.

  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.

  Furthermore, 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.

  Next, similarly 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 penetrating in the axial direction at the center thereof, and the whole Although the shape is substantially cylindrical, 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 at both ends thereof is provided at both ends of the lesion model 21. The width 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 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 lesion model 21, and the balloon 64 is moved. It is suitable for training to expand the lesion model 21 (through hole 23) by allowing the 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 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 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 the hole 23 'is expanded. It is suitable for training to expand the lesion model 21 (hole 23 ') by reaching the hole 23' and then inflating the balloon 64.

  Next, the lesion model 21 of 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 inner side thereof. Except for gradually increasing from the end toward the end side, it has the same configuration as the lesion model 21 of the third configuration described above.

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

  In the lesion model 21 having the fourth configuration, when the balloon 64 is made to reach the hole 23 ′ in the step [3], the balloon catheter 63 is placed along the inclined surface 22 of the lesion model 21, and the distal end thereof is moved. Is introduced 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 balloon 64 is inflated to expand the lesion model 21 (through hole 23). Suitable for doing.

  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).

  In the present invention, the lesion model 21 of each configuration having the above-described shape is made of a plastically deformable material, and is placed in the right coronary artery 4 and trained to expand to secure a flow path. Sometimes, the expansion causes plastic deformation to such an extent that it does not return to the shape before expansion.

  Here, in the PTCA technique, when the lesion model 21 is expanded with the balloon 64, the movement part 211 is generated by the end of the lesion model 21 moving outward (plaque shift, see FIG. 9A). It is technically necessary to secure the flow path (recover blood flow) without causing the generation of the dissociation part 212 (see FIG. 9B) due to the part of the lesion model 21 being torn. Desired.

  Therefore, if the lesion model 21 is used for training of PTCA surgery, the lesion model 21 is plastically deformed. Therefore, even after the balloon catheter guide wire 62 and the balloon catheter 63 are removed from the lesion model 21 in the step [4], The lesion model 21 maintains the shape expanded by the balloon 64. For this reason, it is possible to more reliably evaluate whether or not the moving part 211, the dissociating part 212, and the like have occurred in the lesion model 21 after the PTCA operation training, so that higher quality training can be performed.

  In addition, training can be performed while observing the expansion of the balloon 64 in the step [3] visually or with an X-ray contrast image, and whether the degree of expansion of the lesion model 21, the moving part 211, the dissociating part 212, etc. has occurred Since it can be judged on the spot, higher quality training can be implemented from this point of view.

  In addition, as shown in FIG. 9C, the stent 81 is placed in the lesion model 21 after the blood flow is restored by the step [4], that is, the lesion model 21 after the PTCA operation. By doing so, restenosis of the lesion model 21 and dissociation of the dissociation part 212 can be prevented. It is possible to use the lesion model 21 for training of treatment for placing the stent 81. Whether the lesion model 21 is used for such training, whether restenosis or dissociation of the dissociation part 212 is suitably prevented is determined. Evaluation can be carried out more reliably.

  Further, it is preferable that the lesion model 21 that undergoes plastic deformation has a smaller elastic modulus than the right coronary artery 4 in which the lesion model 21 is disposed. 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 its elastic modulus is smaller than that of blood vessels. Therefore, by making the elastic modulus of the lesion model 21 smaller than the elastic modulus of the right coronary artery 4, it is possible to reliably perform training that approximates the physical properties of the actual lesion site.

  Therefore, the compression elastic modulus of the lesion model 21 is preferably about 0.001 to 0.5 MPa, and more preferably about 0.01 to 0.3 MPa.

  By making the physical property value of the lesion model 21 within such a range, the physical properties of the lesion model 21 are plastically deformed in a state closer to the actual lesion site, and higher quality training is performed. be able to.

  The constituent material of the lesion model 21 can cause the lesion model 21 to exhibit the physical properties as described above, and the plastic properties are maintained for a long time, and the physical properties of the lesion model 21 are difficult to change even after the lesion model 21 is molded. Those are preferred.

  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 the 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 viscosity, transparent clay (manufactured by Nisshin Associates) is mentioned, and as a specific example of resin clay, excellent (manufactured by Nisshin Associates) is mentioned.

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, a plastically deformable material that is a constituent material of the lesion model 21 is filled into the outer cylinder 71 in a state where the wire 74 and the pusher 72 are inserted, and is molded into the outer cylinder 71. A lesion model 21 is obtained (see FIG. 10B).

  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 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. 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 and the wire 74 whose diameter is reduced toward the distal end are inserted, a plastically deformable material which is a constituent material of the lesion model 21 In addition, another pusher 72 is inserted from the side opposite 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 molding the fluid 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 is what 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.

<< Second Embodiment >>
Next, unlike the Segment 2 (# 2: Middle) of the right coronary artery 4, a second embodiment in which a lesion model 21 is arranged in the left coronary artery 3 will be described.

  Hereinafter, the second embodiment in which the lesion model 21 is disposed in the left coronary artery 3 will be described focusing on the differences from the first embodiment, and description of similar matters will be omitted.

  That is, in the present embodiment (second embodiment), as shown in FIG. 15, the lesion model 21 is arranged 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 model 21.

  For example, the lesion model 21 arranged in the branching section 34 has a fifth configuration as shown in FIG. 16A or a sixth configuration as shown in FIG. Can be mentioned.

  The lesion model 21 of the fifth configuration has 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 therein is also increased. It is the thing of the structure similar to the lesion model 21 of a structure. The lesion model 21 of the fifth configuration having such a configuration is arranged so that the tip of the branching portion 34 is inserted into the other end side whose diameter is increased.

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

  In the lesion models 21 of 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. The balloon 64 is made to reach the position of the lesion model 21, and the balloon 64 is further inflated at this position to expand the segment 7 side of the lesion model 21. Next, the balloon catheter guide wire 62 is inserted from the Segment 6 to the Segment 9 side, and after the balloon 64 reaches the position of the lesion model 21 in the same manner as described above, the balloon 64 is inflated, and the Segment 9 side of the lesion model 21 is expanded. A training to secure the flow path is carried out.

  In such training, when the segment 7 side of the lesion model 21 is expanded, the balloon 64 also crushes the segment 9 side of the lesion model 21, and the segment 9 side end of the lesion model 21 moves (plaque) Advanced technology is required to avoid the segment 9 from being blocked. When the lesion model 21 of the present invention is applied to such training, the lesion model 21 is plastically deformed to the extent that it does not return to the shape before expansion due to expansion, so when the Segment 7 side of the lesion model 21 is expanded. In addition, it is possible to more reliably evaluate whether or not the segment 9 is blocked. Therefore, if the lesion model of the present invention is applied to such training, higher quality training can be reliably performed.

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

  The lesion model 21 having the fifth configuration and the sixth configuration described in the present embodiment can also be manufactured in the same manner as the lesion model 21 described in the first embodiment. For example, a lesion model is prepared by preparing an outer cylinder that expands in a taper shape, an outer diameter that matches the tapered inner diameter of the outer cylinder, and a wire that is inserted through the through hole. It can be formed by filling the outer cylinder with a plastically deformable material, which is a constituent material of No. 21. Moreover, the lesion model 213 installed in the branch part 34 of FIG.16 (b) can be separately formed by covering the branch part 34 with a plastically deformable material.

  In the first embodiment, the case where the lesion model 21 is arranged in Segment 2 (# 2: Middle) of the right coronary artery 4 will be described. In the second embodiment, the lesion model 21 is segment 6 of the left coronary artery 3. Although the case where (# 6) is arranged at the branching portion 34 that branches into Segment 7 (# 7) and Segment 9 (# 9) has been described, 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 at 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. 17 is mentioned, for example.

  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.

  Note that, as described in the above embodiment, the lesion model of the present invention does not return to the shape before expansion due to the expansion so that the lesion model can be suitably used for training to expand to secure a flow path in the lesion model. The lesion model of the present invention is naturally applied to training or the like in which the lesion model is passed through the guide wire without expansion of the lesion model.

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 211 Moving part 212 Dissociation part 213 Lesion model 22 Inclined surface 23 Through-hole 23 'hole 23 "cut 24 side face 25 through hole 3 left coronary artery 31 left anterior descending branch 32 left circumflex branch 33 left main trunk 34 bifurcation 4 right coronary artery 41 sharp edge 42 posterior descending branch 5 aorta 61 guide catheter 62 guide for balloon catheter Wire 63 Balloon catheter 64 Balloon 71 Outer cylinder 72 Pusher 73 Through hole 74 Wire 81 Stent

Claims (9)

A lesion model that is disposed in the lumen portion of a tube having a lumen portion and has a shape that narrows or occludes the lumen portion when disposed in the lumen portion;
The lesion model is composed of a plastically deformable material mainly composed of at least one of silicone clay, resin clay and oil clay .
When the lesion model is placed in the lumen part and subjected to training for expansion to ensure a flow path, it is plastically deformed to the extent that it does not return to the shape before expansion due to the expansion. Lesion model.   The lesion model according to claim 1, wherein the elastic modulus is smaller than that of the tube. Has a through hole penetrating in the axial direction, when disposed in said lumen, lesion model according to claim 1 or 2, narrowing the lumen by the outer peripheral portion of the through hole. The lesion model according to claim 3 , wherein the through-hole includes a tapered portion at one end portion or both end portions where the diameter of the through-hole gradually increases from the inner side toward the end side. 3. The device according to claim 1, wherein when having an incision or a hole continuous in the axial direction and being disposed in the lumen, the inner surface of the incision or the hole is in close contact with each other to close the lumen. Lesion model. At one or both ends of the cuts or holes, it has a through hole continuous from the cut or hole, the through hole, according to claim 5 comprising a tapered portion whose pore size gradually increases toward the end portion side from the inner side The lesion model described in 1. The lesion model according to any one of claims 1 to 6 , wherein the lesion model is inserted into the lumen in a compressed state. The lesion model according to any one of claims 1 to 7 , which is formed by filling a plastically deformable material into an outer cylinder into which a wire and a pusher are inserted. The lesion model according to any one of claims 1 to 8 , which is used for training to expand the lesion model after one or more medical devices are inserted through the tube to reach the lesion model.

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