Organ model for catheter simulator
11195436 · 2021-12-07
Assignee
Inventors
- Keita Okayama (Suita, JP)
- Yasushi Sakata (Suita, JP)
- Daichi Watanabe (Yokohama, JP)
- Makoto Inada (Yokohama, JP)
- Munekuni Sato (Nishitokyo, JP)
Cpc classification
G09B23/303
PHYSICS
G09B23/286
PHYSICS
G09B23/285
PHYSICS
International classification
Abstract
An organ model for a catheter simulator is formed from elastic materials, and a heart model for a catheter simulator includes a main body of heart and coronary arteries laid along the surface of the main body of heart, in which a portion of the coronary arteries is attachable and detachable.
Claims
1. An organ model for a catheter simulator, the organ model comprising: a simulated organ having a simulated blood vessel, which is formed from an elastic material, wherein the simulated blood vessel includes a mounting portion, and a vascular part, the vascular part is attached to and detached from the simulated blood vessel, the vascular part has two ends with openings, the two ends of the vascular part are connected to the mounting portion of the simulated blood vessel, the mounting portion of the simulated blood vessel includes ends which become connecting portions relative to the vascular part such that the simulated blood vessel is partly connected between the ends of the mounting portion when the vascular part is removed from the simulated blood vessel, and a distance between the ends of the mounting portion is shorter than a distance of the vascular part.
2. The organ model for a catheter simulator according to claim 1, wherein the elastic material has X-ray transmissibility, and the simulated blood vessel includes an X-ray opaque portion.
3. The organ model for a catheter simulator according to claim 1, wherein when the two ends of the vascular part are connected to the mounting portion of the simulated blood vessel, an inner diameter of portions other than the vascular part in the simulated blood vessel approximately coincides with an inner diameter of the vascular part.
4. The organ model for a catheter simulator according to claim 1, wherein the mounting portion of the simulated blood vessel has, at the two ends, an edge serving as a connection unit to the vascular part, and an inner surface of the edge is elastically adhered closely to an outer surface of the edge of the vascular part.
5. The organ model for a catheter simulator according to claim 1, wherein a thickness of a side wall of the vascular part is thinner than a thickness of a side wall of a portion other than the vascular part in the simulated blood vessel.
6. The organ model for a catheter simulator according to claim 1, wherein the simulated organ is a heart model, the heart model has a main body of heart and coronary arteries laid along a surface of the main body of heart, and the vascular part is a coronary artery part.
7. The organ model for a catheter simulator according to claim 6, wherein the heart model has an aorta protruding toward an interior of the main body of heart; and an aortic valve positioned at a tip of the aorta.
8. The organ model for a catheter simulator according to claim 1, wherein a portion corresponding to a vascular wall of the vascular part has a multiple structure with a double or higher structure.
9. The organ model for a catheter simulator according to claim 1, further comprising an auxiliary part, the auxiliary part being a tubular body to be inserted inside the vascular part.
10. The organ model for a catheter simulator according to claim 9, wherein the auxiliary part has a diseased portion formed therein, the diseased portion having a smaller diameter than other regions, and in a state of having the auxiliary part inserted inside the vascular part, a gap is formed between an outer surface of the diseased portion and an inner surface of the vascular part.
11. The organ model for a catheter simulator according to claim 10, wherein at least one of the auxiliary part or the vascular part includes a hole or a slit continuing from a gap formed between the outer surface of the diseased portion and the inner surface of the vascular part, or the small hole and the slit.
12. The organ model for a catheter simulator according to claim 9, wherein a flange protruding in a diameter direction along a circumferential direction is formed in any one of edges of the auxiliary part.
13. The organ model for a catheter simulator according to claim 1, wherein the vascular part includes convexities simulating thrombi in a portion of the inner surface of the vascular part.
14. The organ model for a catheter simulator according to claim 1, wherein an inner diameter of the inner surface of the vascular part is partially enlarged.
15. The organ model for a catheter simulator according to claim 1, wherein an inner diameter of the vascular part is partially made small.
16. An organ model for a catheter simulator, the organ model comprising: a simulated organ having a simulated blood vessel, which is formed from an elastic material, wherein the simulated blood vessel includes a mounting portion, and a vascular part, the vascular part is attachable to and detachable from the simulated blood vessel, the vascular part has two ends with openings, the two ends of the vascular part are connected to the mounting portion of the simulated blood vessel, the simulated blood vessel further includes an auxiliary part having a tubular shape and inserted into the vascular part, the auxiliary part includes a diseased portion having a diameter smaller than a diameter of other portions, and a gap is formed between an outer portion of the diseased portion and an inner portion of the vascular part in a condition where the auxiliary part is disposed inside the vascular part, the gap being configured to be filled with a liquid in the simulated blood vessel.
17. The organ model for a catheter simulator according to claim 16, wherein the elastic material has X-ray transmissibility, and the simulated blood vessel includes an X-ray opaque portion.
18. The organ model for a catheter simulator according to claim 16, wherein when the two ends of the vascular part are connected to the mounting portion of the simulated blood vessel, an inner diameter of portions other than the vascular part in the simulated blood vessel approximately coincides with an inner diameter of the vascular part.
19. The organ model for a catheter simulator according to claim 16, wherein the mounting portion of the simulated blood vessel has, at the two ends, an edge serving as a connection unit to the vascular part, and an inner surface of the edge is elastically adhered closely to an outer surface of the edge of the vascular part.
20. The organ model for a catheter simulator according to claim 16, wherein a thickness of a side wall of the vascular part is thinner than a thickness of a side wall of a portion other than the vascular part in the simulated blood vessel.
21. The organ model for a catheter simulator according to claim 16, wherein the simulated organ is a heart model, the heart model has a main body of heart and coronary arteries laid along a surface of the main body of heart, and the vascular part is a coronary artery part.
22. The organ model for a catheter simulator according to claim 21, wherein the heart model has an aorta protruding toward an interior of the main body of heart; and an aortic valve positioned at a tip of the aorta.
23. The organ model for a catheter simulator according to claim 16, wherein at least one of the auxiliary part or the vascular part includes a small hole or a slit continuing from a gap between an outer surface of a diseased portion and the inner surface of the vascular part, or the small hole and the slit.
24. The organ model for a catheter simulator according to claim 16, wherein a flange protruding in a diameter direction along a circumferential direction is formed in any one of edges of the auxiliary part.
Description
BRIEF DESCRIPTION OF DRAWINGS
(1)
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MODE(S) FOR CARRYING OUT THE INVENTION
(6) In the following description, an embodiment of the organ model according to the invention will be explained by taking a heart model as an example, with reference to the drawings.
(7)
(8) The catheter simulator 100 illustrated in
(9) The pump 60 is connected to the container 10 through a suction tube 61 and an extrusion tube 63. As shown in the diagram, the container 10 is formed into a rectangular parallelepiped shape (capacity is about 6 L) with the upper side being opened, and on one of the side walls, a discharge port 11b and an inlet port 11a are formed. At the discharge port 11b, a communicating hole is formed so that a liquid can pass therethrough, and the discharge port 11b is connected to the suction tube 61 of the pump 60. When the pump 60 is operated, the liquid inside the container 10 is drawn from the discharge port 11b into the pump 60 through the suction tube 61.
(10) In
(11) The one end 78 of the two-way cock 70 can be used as a catheter inlet tube that will be described below. As the two-way cock 70 is connected to the inlet port 11a, inflow of a pulsatile flow and introduction of a catheter can both be realized through one opening (inlet port 11a) as such. Meanwhile, the two-way cock 70 is not necessarily needed, and the inlet port 11a may be configured to be proximately separated into two sites, with one of the sites being used for the connection of the extrusion tube 63 (inflow of pulsatile flow), and the other site being used for the introduction of a catheter. Furthermore, in a case in which catheter introduction through the inlet port 11a is unnecessary, or the like, the two-way cock 70 may be omitted, and the inlet port 11a and the extrusion tube 63 may be directly connected, similarly to the connection of the discharge port 11b and the suction tube 61 as described above. In
(12) On the side walls of the container 10, connection units 11g and 11e for connecting the inlet tubes 50 and 52, through which a catheter operated by a trainee is introduced from the outside of the container 10, are formed. At the connection units 11g and 11e, communicating holes for inserting a catheter are formed. The positions of the connection units 11g and 11e can be changed according to the simulation or the heart model, and also, the number of the connection units is not limited to two.
(13) Inside the container 10, a heart model 30 that serves as an object of simulation is installed in a state of being filled with a liquid. It is desirable that the liquid is easily handleable and has visible transmissibility and X-ray transmissibility; however, there are no particular limitations. It is general to use water, or water mixed with a solvent.
(14) The heart model 30 is installed inside the container 10 by being inserted into holding protrusions provided at the inlet port 11a and the connection unit 11g. The holding protrusions are such that the tips are formed in a tapered form (not illustrated in the diagram) so as to protrude toward the inner surface of the container 10, and by plugging in the edges of the heart model 30 into the holding protrusions, the heart model 30 can be connected easily to the container 10, while the heart model 30 can be retained in a state of floating in the liquid. As the heart model 30 is in a floating state, the trainee may obtain a feeling that more closely resembles an actual clinical condition at the time of catheter operation.
(15) Meanwhile, the method for installing the heart model 30 is not limited to a method of plugging in the heart model 30 into the holding protrusions provided at the inlet port 11a and the connection unit 11g, and any configuration in which the heart model 30 can be installed so as to be in a state of floating in the liquid charged into the container 10, may be employed. For example, a configuration in which the heart model 30 is installed by means of the holding protrusion of the connection unit 11e described above, or a holder for exclusive use is provided inside the container 10, and the heart model 30 is installed using the holder, may also be employed.
(16) As described above, when the container 10 filled with a liquid, the heart model 30, the pump 60, the suction tube 61, and the extrusion tube 63 are connected, and the pump 60 is operated, a pulsatile flow produced in the pump 60 passes through the extrusion tube 63 and the inlet port 11a, flows into the heart model 30, passes through the heart model 30, subsequently flows out through the opening of the heart model 30 into the container 10, and returns to the pump 60 through the discharge port 11b and the suction tube 61. The trainee introduces a catheter through the connection units 11g and 11e or through the one end 78 of the two-way cock 70, in a state in which a liquid (pulsatile flow) circulates in the catheter simulator 100 as such, and performs a simulation.
(17) Next, using
(18) The organ model according to the invention has at least a simulated organ or simulated blood vessels. The heart model 30 of the present embodiment has, as illustrated in
(19) The human heart includes right atrium, right ventricle, left atrium, and left ventricle; however, the main body 30A does not include such an internal structure, and the interior forms a cavity. The main body 30A may include the entirety or a portion of the internal structure of the human heart, depending on the type, purpose, and the like of simulation. For example, when a structure including an aorta and an aortic valve in the interior is adopted, a catheter simulation such as transcatheter aortic valve implantation (TAVI) can be carried out.
(20) On the head side of the main body 30A, an aorta 32 is installed, as in the case of the human heart. Furthermore, at the apex section formed on the tail side of the main body 30A, an inflow tube (edge) 31 is provided. The inflow tube 31 does not exist in the human body; however, in the present embodiment, the inflow tube 31 serves as a path for causing a liquid sent from the pump 60 (pulsatile flow) to flow into the main body 30A. The liquid that has flowed into the main body 30A through the inflow tube 31, passes through the interior of the cavity with certain directionality and arrives at the aorta 32 by an intact flow.
(21) On the surface of the main body 30A, a large number of coronary arteries 33 having a fine and complicated shape are formed, as in the case of human heart. The coronary arteries 33 are branched from the root of the aorta 32 and are installed so as to be laid along the surface of the main body 30A. In the present embodiment, the discharge port 33a is formed at the proximal region of the coronary arteries 33, and the liquid that has flowed into the coronary arteries 33 is discharged out of the heart model 30 through the discharge port 33a.
(22) It is preferable that a simulated body of a blood vessel that is connected to the aorta in the human body is installed on the path to the aorta 32. Thereby, the trainee can perform a simulation in a condition that more closely resembles an actual clinical condition. In the present embodiment, the simulated blood vessels illustrated in
(23) When the heart model 30 having the above-described configuration is installed as shown in
(24) The liquid that has flowed into the coronary arteries 33 is discharged out of the heart model 30 through the discharge port 33a provided at the tip of the coronary arteries 33, and joins with the liquid filling the container 10. Meanwhile, the liquid that flows along the aorta 32 is discharged into the container 10 through the common carotid arteries 35 and 36 and the left subclavian artery 37, which are blood vessels provided on the path of the aorta 32, and joins with the liquid filling the container 10. The liquid discharged into the container 10 through the respective tip openings of the coronary arteries 33, common carotid arteries 35 and 36, and left subclavian artery 37 flows out through the discharge port 11b and circulates to the pump 60.
(25) Next, the invention will be explained using the heart model 30, which is an example of the invention, and a coronary artery part 40, with reference to
(26) As shown in
(27) As shown in
(28)
(29) As shown in
(30) As illustrated in
(31) In a case in which the length L40 of the coronary artery part 40 is smaller than the length of the opening 33c (distance between the edges 33b) L33c, a gap is produced between the two ends of the coronary artery part 40 and the mounting unit 33e, and the liquid is leaked. Furthermore, in a case in which the length L40 is larger than the length L33e of the mounting unit 33e, the coronary artery part 40 reaches to the outer side of the edges 33b that serve as connection units. Therefore, there occurs a problem that the coronary artery part 40 cannot be smoothly mounted. Therefore, it is preferable that the length L40 is formed to be shorter than or equal to the length L33e, and longer than or equal to the length of opening 33c, the length L33C.
(32) Furthermore, the outer diameter of the coronary artery part 40 is formed to be equal to or slightly larger than the inner diameter R33b of the edges of the mounting unit 33e, in a state in which the coronary artery part 40 has been removed as shown in
(33) By employing such a configuration, the coronary artery part 40 can be mounted such that the coronary artery part 40 and the mounting unit 33e elastically adhere closely to each other, and in a case in which a liquid passes through the interior of the coronary artery part 40 and the mounting unit 33e that are in communication, the occurrence of an unnatural flow of the passing liquid and a defective flow of the liquid in the vicinity of the opening 40a of the coronary artery part 40 can be prevented without having any leaking of the liquid. That is, the coronary artery part can be made attachable and detachable, while the flow of the liquid (blood flow) is maintained in a state closely resembling an actual clinical condition.
(34) On the other hand, when a case in which a coronary artery 33 has stenosis, occlusion or the like is reproduced, the inner diameter R40 of the coronary artery part 40 is partially made smaller (reproducing stenosis) or made larger (reproducing swelling), or a gradient is applied to the inner surface, or convexities simulating thrombi are formed in a portion of the inner surface. Furthermore, when the side wall (portion corresponding to the vascular wall) of the coronary artery part 40 is made into a multiple structure with a double or higher structure, and a gap is purposely provided in the vascular wall, dissociation of the coronary artery can be reproduced. Thereby, a flow different from the normal state can be produced in the liquid that passes therethrough, and thus, the coronary artery part can be made attachable and detachable while the liquid flow (blood flow) is reproduced into a state closely resembling that of a patient in an actual clinical condition (such a coronary artery part 40 that realizes a blood flow different from the normal state will be hereinafter referred to as “lesion model part”).
(35) Furthermore, in a case in which the heart model 30 and the coronary artery part 40 are formed from a material having X-ray transmissibility, a simulation can be carried out even under X-ray illumination; however, in this case, for example, when an X-ray opaque material is applied and laminated on the inner surface of the coronary artery part 40, a shadow is produced at the portion of application and lamination under X-ray illumination, and a condition in which a portion of the coronary artery has been calcified can be reproduced (such a coronary artery part 40 that reproduces calcification will be hereinafter referred to as “calcification model part”).
(36) Furthermore, in a case in which a simulation of placing a stent inside a coronary artery part 40 is carried out, the thickness D40 of the side wall of the coronary artery part 40 may be made thinner than the thickness D33 of the side wall of the coronary artery 33, according to the type, material, and the like of the stent. Regarding the stent, there are available a stent employing a system that is formed from a shape memory alloy, expands at a temperature close to the body temperature (30° C. to near 40° C.), and is placed so as to extend the inner diameter of the coronary artery, and the like. However, there are occasions in which, because the hardness of the coronary artery 33 is too high, the stent cannot expand smoothly, or the shape of the stent becomes curved and distorted. In order to solve this, when the hardness is decreased by reducing the thickness D33 of the side wall of the coronary artery 33, there occurs a problem that the shape of the coronary artery 33 itself may not be maintained. In order to solve such a problem, when only the thickness D40 of the coronary artery part 40 is reduced, the stent can be expanded without difficulties inside the coronary artery part 40, while the shape of the coronary artery 33 is maintained.
(37) In the coronary artery part 40, a diseased portion such as a stenosed state may be formed singly as described above; however, diseased portions can also be formed easily as follows by combining a plurality of members. An embodiment of this combination of a plurality of members will be explained by taking an example of an auxiliary part 44 that is used as inserted in the coronary artery part 40, with reference to
(38)
(39) As shown in the diagram, the auxiliary part 44 is a tubular body having an opening 44a at both ends, and in the longitudinally central region of the tubular body, a diseased portion 44b that has been narrowed by making the diameter smaller than the diameters of other regions is formed. Furthermore, the auxiliary part 44 is formed from an elastic material such that the largest outer diameter is approximately equal to or slightly larger than the inner diameter of the coronary artery part 40. When such an auxiliary part 44 is inserted through the opening 40a of the coronary artery part 40 as shown in
(40) When the auxiliary part 44 is inserted into a coronary artery part 40, the coronary artery part 40 is mounted in a heart model 30, and a liquid that serves as a simulated blood is caused to flow into the heart model 30, the liquid that passes through the coronary artery part 40 passes through the auxiliary part 44 placed therein. That is, by combining a coronary artery part 40 (normal model part) with a diseased portion 44b of an auxiliary part 44 and producing a multiple structure, a condition different from the normal condition can be produced, similarly to the diseased model part in which the coronary artery part 40 itself has a diseased portion. In the present example, a double structure obtained by combining parts has been mentioned; however, for example, these may be integrally formed, or a multiple structure with a triple or higher structure may also be used.
(41) As described above, when a diseased portion 44b is reproduced by inserting an auxiliary part 44 into a normal model part, for example, in the case of performing a simulation of placing a stent, there is an advantage that expansion of the stent is achieved more easily. As shown in
(42) Furthermore, when a device such as a stent or a balloon catheter is passed, a portion or the entirety of the coronary artery part 40 and the auxiliary part 44 may be adhered together so that these parts do not slip off from each other. At this time, since it becomes difficult for the liquid of the gap G to escape, a small hole or a slit may be provided at the coronary artery part 40 or the auxiliary part 44 (not illustrated in the diagram). Meanwhile, the provision of a small hole or a slit does not depend on the presence or absence of adhesion between the coronary artery part 40 and the auxiliary part.
(43) In the embodiment described above, the diseased portion 44b of the auxiliary part 44 is formed in the longitudinally central region of the tubular body; however, the place of formation is not limited to the central region. Furthermore, the diseased portion 44b of the auxiliary part 44 is not limited to stenosis where the diameter has been narrowed to be small, and the diseased portion 44b may be a reproduction of a symptom other than stenosis. For example, dissection of a coronary artery can be reproduced by providing a gap between the coronary artery part 40 and an auxiliary part.
(44) Furthermore, the coronary artery part 40 into which an auxiliary part 44 is inserted is not limited to the normal model part described above. For example, when an auxiliary part 44 reproducing stenosis is inserted into the calcification model part described above, a symptom in which both calcification and stenosis have occurred can be easily reproduced.
(45) In the auxiliary part 44 according to the present embodiment, as illustrated in
(46) It is not necessarily needed to coincide the longitudinal length of the auxiliary part 44 according to the present embodiment with the longitudinal length of the coronary artery part 40. For example, by making one end or both ends of the auxiliary part 44 longer than the coronary artery part 40, the gap between the coronary artery part 40 and the coronary artery 33 is made smaller, and leaking of a liquid can be prevented. In addition, stability at the time of mounting of the coronary artery part 40 can be enhanced.
(47) For the purpose of position adjustment in the circumferential direction of the auxiliary part 44 to the coronary artery part 40, a cutout portion (not illustrated in the diagram) may be formed in a portion of an edge of the coronary artery part 40, and a protrusion (not illustrated in the diagram) that is engaged with the cutout portion may be formed in a portion on the outer surface of the auxiliary part 44, or combined shapes may be integrally formed from the beginning.
(48) By having a variety of coronary artery parts 40 formed and prepared as such, various simulations can be carried out by using one heart model 30. For example, in
(49) Next, the flow of a catheter simulation performed using a heart model 30 having the above-described coronary artery part 40 will be explained. As explained for
(50) In the present embodiment, two kinds of simulations can be carried out, namely, the case of inserting a catheter through an artery of an arm and the case of inserting a catheter through an artery of the groin region. In a case in which the trainee simulates catheter insertion through an artery of an arm, the catheter passes by way of right subclavian artery 34 by means of an inlet tube 52 and reaches the aorta 32. Subsequently, when the catheter is further inserted, the catheter passes through the inside of the aorta 32 and is positioned at the inlet port of the coronary artery 33 (corresponding to the coronary ostium), which is branched near the connection unit to the main body 30A. At this time, the trainee identifies the ostium while observing the coronary artery 33 that becomes the object of insertion (object of treatment) between the left and right coronary arteries, and performs an operation so that the catheter is engaged with the target coronary ostium. Under X-ray illumination, the trainee engages a catheter while looking for the coronary ostium, by making use of an imaging agent or the like according to an actual clinical procedure. Subsequently, a guide wire that is needed for treatment is moved forward to the distal portion of a target site, that is, a site in need of treatment (coronary artery part 40), and a training according to actual catheter examination and surgical operation (coronary angiography and coronary angioplasty), such as vasodilation by means of a balloon catheter or stent placement, is carried out along the guide wire.
(51) On the other hand, in a case in which the trainee simulates catheter insertion through an artery of the groin region, a catheter is introduced through the caudal tip (portion corresponding to the groin region) of the aorta 32 by means of an inlet tube 50. The catheter passes through the inside of the aorta 32 and arrives at the inlet port of a coronary artery 33 installed near the connection unit between the aorta 32 and the main body 30A. In this case, the introduction path of the catheter is only the route through the aorta 32; however, since a bifurcation point between the common carotid arteries 35 and 36 and the left subclavian artery 37 exists on the route, on the occasion of operating the catheter, a training of reaching the catheter to the inlet port corresponding to the coronary ostium while checking the positional relation with various simulated blood vessels and the like, can be carried out. The trainee can carry out a training of catheter examination and surgical operation by moving the catheter forward to the coronary artery part 40 that is in need of treatment, similarly to the case of performing through a blood vessel of an arm as described above.
(52) After completion of the simulation, the coronary artery part 40 is removed from the mounting unit 33e of the heart model 30, and in a case in which a stent has been placed, the stent can be manually removed from the coronary artery part 40. Subsequently, when a coronary artery part 40 is attached to the mounting unit 33e, the next simulation can be carried out immediately.
(53) As described above, when the coronary artery part 40 described above is used, a plurality of patterns of cardiac catheter skills can be trained more conveniently and continuously. Furthermore, since the heart model 30 and the coronary artery part 40 described above can be produced on the basis of CT images of actual patients, or on the basis of individual cases, pre-operative simulation can be carried out for each and every case.
(54) Thus, with regard to embodiments of an organ model for a catheter simulator according to the invention, examples of the case of a heart model have been disclosed. However, the invention is not intended to be limited to the embodiments described above, and various modifications can be added to the extent that maintains the gist of the invention. For example, the pump 60 is not necessarily needed upon the use of the invention, and a more convenient simulation may be carried out by blocking the communicating hole for a liquid formed on a side wall of the container 10, and introducing a catheter simply in a state in which the heart model 30 is installed in the container 10 filled with a liquid. Furthermore, it is possible to apply the organ model to a cerebral blood vessel, a thoracoabdominal blood vessel, blood vessels of the limbs, and the like.
EXPLANATIONS OF LETTERS OR NUMERALS
(55) 10 CONTAINER FOR CATHETER SIMULATOR 11a INLET PORT 11b DISCHARGE PORT 11e, 11g CONNECTION UNIT 30 HEART MODEL (ORGAN MODEL) 30A MAIN BODY OF HEART (SIMULATED ORGAN) 31 INFLOW TUBE 33 CORONARY ARTERY (SIMULATED BLOOD VESSEL) 40 CORONARY ARTERY PART (VASCULAR PART) 40a OPENING OF CORONARY ARTERY PART 44 AUXILIARY PART 44b DISEASED PORTION 44c FLANGE 60 PULSATILE FLOW-PRODUCING PUMP 100 CATHETER SIMULATOR