Organ model apparatus for evaluation, organ model system for evaluation, and method for controlling model system for evaluation

Abstract

To obtain information for evaluating the contact region between an organ model evaluation apparatus and an insertion portion of a medical device.SOLUTION: An organ model evaluation apparatus includes: an organ model main body having a shape that simulates at least a part of a biological organ, the organ model main body being configured such that an insertion portion of a medical device can be inserted into the inside of the organ model main body; and an evaluation temperature sensor unit disposed in the organ model main body to measure the temperature of the organ model main body. The organ model evaluation apparatus outputs evaluation temperature information for evaluating the contact region between the insertion portion of the medical device and the inner surface of the organ model main body, on the basis of the result of measurement by the evaluation temperature sensor unit.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present invention relates to an organ model device for evaluation, an organ model system for evaluation, and a method for controlling an organ model system for evaluation. [Background technology]

[0002] In recent years, medical technology has become more sophisticated and complex. Accordingly, the skills required of surgeons have also become more sophisticated and diverse. For this reason, surgical simulators are sometimes used. These simulators allow junior surgeons to train and also allow experienced surgeons to rehearse before surgery.

[0003] Among such medical technologies, for example, catheter ablation therapy is a treatment method in which a target site within the body is ablated using a catheter inserted into the body. For example, by destroying the target site through ablation, diseases such as arrhythmia caused by atrial fibrillation, endometriosis, and cancer are treated. A balloon catheter having a balloon at its distal end is known as a catheter used in catheter ablation therapy.

[0004] When the balloon catheter is inserted into the body, the balloon is deflated and stretched in the longitudinal direction of the balloon catheter. Once the balloon catheter is inserted into the body, a liquid is supplied to the balloon catheter. The balloon expands as the liquid is supplied. The surface temperature of the balloon is controlled by adjusting the temperature of the liquid inside the balloon. By bringing the balloon, which has been adjusted to a predetermined surface temperature, into contact with a circumferential target region, for example, a connection region of a vein to the atrium, the circumferential target region can be ablated all at once.

[0005] In ablation treatment using a balloon catheter, it is important to control the temperature of the target site, the surface temperature of the balloon, the contact of the balloon with the target site, the ablation time, and the like.

[0006] Here, as a conventional technology used for training or simulating a user's medical procedures as described above, for example, an organ model and a temperature indicator patch have been proposed that allow the user to grasp the temperature state of the actual model in a surgical simulator (see, for example, Patent Document 1). [Prior art documents] [Patent documents]

[0007] [Patent Document 1] Patent No. 6801878 Summary of the Invention [Problem to be solved by the invention]

[0008] In the above-mentioned prior art, in order for a user to grasp the temperature state of the actual model of the surgical simulator, an irreversible thermochromic pigment in a temperature indicator attached to the organ model changes color when it reaches the lower limit temperature of the saturation increase range.

[0009] Therefore, in the above-mentioned conventional technology, even if the insertion part of the medical device is inserted into and comes into contact with the organ model, the irreversible thermochromic pigment does not develop color unless it reaches the lower limit temperature of the saturation increase region. Furthermore, even if the insertion part of the medical device is separated from the organ model, the colored state is maintained due to the irreversible properties of the thermochromic pigment.

[0010] That is, the above-described conventional technology has a problem in that it is not possible to appropriately obtain information for evaluating the contact area between the organ model and the insertion portion of the medical device.

[0011] The present invention is based on this finding of the present inventors, and aims to obtain information for evaluating the contact area between the organ model device for evaluation and the insertion part of the medical device. [Means for solving the problem]

[0012] An evaluation organ model device according to an embodiment of one aspect of the present invention is an evaluation organ model device comprising an organ model body having a shape that mimics at least a part of an organ of a living organism, into which an insertion portion of a medical device can be inserted, and an evaluation temperature sensor unit that is disposed on the organ model body and measures the temperature of the organ model body, and outputs evaluation temperature information for evaluating the contact area where the insertion portion of the medical device comes into contact with the internal surface of the organ model body based on the measurement results of the evaluation temperature sensor unit.

[0013] In the above-mentioned organ model device for evaluation, the medical device may be a balloon catheter system applied to balloon catheter treatment, and the insertion portion of the medical device may include a balloon of a balloon catheter for ablation treatment.

[0014] In the organ model device for evaluation, the contact area may be an area where the inner surface of the inside of the organ model main body and the surface of the balloon come into contact.

[0015] In the evaluation organ model device, the evaluation temperature sensor unit may be configured to measure the change in temperature inside the organ model main body due to the heated or cooled balloon coming into contact with the inside of the organ model main body.

[0016] In the above-mentioned organ model device for evaluation, the evaluation temperature sensor section may include a plurality of sensor elements arranged in the organ model main body and capable of measuring the temperature inside the organ model main body.

[0017] In the evaluation organ model device, the sensor element may include a thermocouple that is arranged in the organ model main body and is capable of measuring the temperature of the position on the inner surface of the organ model main body where it is arranged.

[0018] In the above-mentioned evaluation organ model device, the area in the organ model main body in which the plurality of sensor elements are arranged may include at least the target area inside the organ model main body with which the insertion portion of the medical device should come into contact.

[0019] In the organ model device for evaluation, the temperature information for evaluation may include temperature information representing the temperatures measured by the plurality of sensor elements, respectively.

[0020] In the organ model device for evaluation, the temperature information for evaluation may include position information of positions on the inner surface of the organ model main body measured by each of the plurality of sensor elements.

[0021] In the organ model device for evaluation, the temperature sensor for evaluation may output the temperature information for evaluation for evaluating the contact area by wired communication or wireless communication.

[0022] In the evaluation organ model device, the organ model main body may have a shape that imitates the structure of the heart as an organ of a living body.

[0023] The organ model device for evaluation may be an apparatus used for training or simulation of a user's medical procedure.

[0024] In the evaluation organ model device, the inner surface of the organ model body may be set to a predetermined temperature range, and the balloon may be inserted into the organ model body, and the temperature of the balloon may be heated or cooled to a temperature different from that of the inner surface of the organ model body, so that the inner surface of the organ model body and the surface of the balloon come into contact with each other.

[0025] In the evaluation organ model device, the temperature range of the inner surface of the organ model main body may be set to the range of body temperature of the living body.

[0026] In the evaluation organ model device, based on the evaluation temperature information, a region of the inner surface of the organ model main body where the temperature measured by the temperature sensor unit differs from the temperature range may be evaluated as a contact region where the inner surface of the organ model main body comes into contact with the surface of the balloon.

[0027] An evaluation organ model system according to an embodiment of one aspect of the present invention is an evaluation organ model system comprising: an organ model main body having a shape that mimics at least a part of an organ of a living organism, wherein an insertion portion of a medical device can be inserted into the organ model main body; an evaluation organ model device comprising an evaluation temperature sensor unit disposed on the organ model main body and that measures the temperature of the organ model main body; and an analysis device that analyzes information output by the evaluation organ model device, wherein the evaluation organ model device outputs evaluation temperature information for evaluating a contact area where the insertion portion of the medical device comes into contact with the internal surface of the organ model main body based on the measurement results of the evaluation temperature sensor unit, and the analysis device outputs evaluation information regarding the contact area based on the evaluation temperature information.

[0028] In the above-mentioned organ model system for evaluation, the inner surface of the organ model body may be set to a predetermined temperature range, and the insertion portion 25 of the medical device may be inserted into the organ model body, and the inner surface of the organ model body may come into contact with the surface of the insertion portion while the temperature of the insertion portion is heated or cooled to a temperature different from that of the inner surface of the organ model body.

[0029] In the evaluation organ model device, the temperature range of the inner surface of the organ model main body may be set to the temperature range of the body temperature of the living body.

[0030] In the organ model device for evaluation, the analysis device may evaluate, based on the evaluation temperature information, a region of the inner surface of the organ model main body where the temperature measured by the temperature sensor unit differs from the temperature range as a contact region where the inner surface of the organ model main body comes into contact with the surface of the insertion part.

[0031] In the above-mentioned organ model system for evaluation, the analysis device may include an input unit to which evaluation temperature information acquired by the organ model device for evaluation is input, a processing unit that analyzes and evaluates the contact area where the inner surface of the organ model main body comes into contact with the insertion portion of the medical device based on the evaluation temperature information, and acquires evaluation information regarding the evaluated contact area, and an output unit that outputs the evaluation information acquired by the processing unit.

[0032] In the above-mentioned organ model system for evaluation, the evaluation information may include an image illustrating an area including the contact area on the organ model main body, and / or text information including information indicating the contact area on the organ model main body.

[0033] In the above-mentioned evaluation organ model system, the evaluation temperature sensor unit may output the evaluation temperature information to the analysis device by wired communication using wiring provided between the evaluation organ model device and the analysis device, or by wireless communication using communication units provided in the evaluation organ model device and the analysis device.

[0034] A control method for an evaluation organ model system according to an embodiment of one aspect of the present invention is a control method for an evaluation organ model system comprising: an organ model main body having a shape that mimics at least a part of an organ of a living organism, into which an insertion portion of a medical device can be inserted; an evaluation organ model device comprising: an evaluation temperature sensor unit disposed on the organ model main body and measuring the temperature of the organ model main body; and an analysis device that analyzes information output by the evaluation organ model device, wherein the evaluation organ model device outputs evaluation information regarding the contact area where the insertion portion of the medical device comes into contact with the internal surface of the organ model main body based on the measurement results of the evaluation temperature sensor unit. [Effects of the Invention]

[0035] According to the present invention, it is possible to obtain information for evaluating the contact area between the organ model device for evaluation and the insertion part of the medical device. [Brief explanation of the drawings]

[0036] [Figure 1] FIG. 1 is a diagram showing an example of a configuration including an organ model system for evaluation including an analysis device and an organ model device for evaluation according to an embodiment, and a balloon catheter system applied to balloon catheter treatment. [Figure 2] FIG. 2 is a diagram showing an example of the configuration of the organ model device for evaluation shown in FIG. 1 when a balloon is inserted. [Figure 3A] 3A is a diagram showing an example of a part of the external appearance of the configuration of the organ model main body of the organ model device for evaluation shown in FIG. 2. FIG. [Figure 3B] 3B is a diagram showing an example of a part of the external appearance of the configuration of the organ model main body of the organ model device for evaluation shown in FIG. 2, seen from a direction different from that of FIG. 3A. [Figure 3C] 3C is a diagram showing a part of the configuration of the organ model main body of the organ model device for evaluation shown in FIG. 2, seen from a direction different from that shown in FIGS. 3A and 3B. [Figure 4]FIG. 4 is a diagram illustrating an example of the configuration of the analysis device illustrated in FIG. [Figure 5] FIG. 5 is a diagram showing an example of the configuration of the balloon catheter system 10 shown in FIG. [Figure 6A] FIG. 6A is a diagram showing an example of the configuration of the vicinity of the balloon of the balloon catheter in an inflated state in region Z of FIG. [Figure 6B] FIG. 6B is a diagram showing an example of the configuration of the vicinity of the balloon of the balloon catheter in a deflated state in region Z of FIG. [Figure 7] FIG. 7 is a cross-sectional view taken along line IV-IV in FIG. 6A. [Figure 8] FIG. 8 is a diagram for explaining an example of a control method for the organ model system for evaluation shown in FIG. [Figure 9] FIG. 9 is a diagram showing an example of evaluation information output by the organ model system for evaluation when the output unit of the analysis device shown in FIG. 4 is a display device. [Figure 10] FIG. 10 is a diagram showing an example of evaluation information output by the organ model system for evaluation when the output unit of the analysis device shown in FIG. 4 is a display device. DETAILED DESCRIPTION OF THE INVENTION

[0037] An embodiment of the present disclosure will be described below with reference to the drawings. In the drawings accompanying this specification, the scale and aspect ratios have been appropriately changed and exaggerated from those of the actual objects for ease of understanding. Configurations shown in some drawings may be omitted in other drawings. The scale and aspect ratios may differ between the drawings.

[0038] In this specification, terms that specify shapes, geometric conditions, and their degrees, such as "parallel," "orthogonal," and "identical," as well as values ​​of lengths and angles, are not limited to their strict meanings, but are interpreted to include a range within which similar functions can be expected.

[0039] In the embodiment described below, an organ model system for evaluation 1000 that outputs evaluation information for use in training or simulation of a user's medical procedure will be described.

[0040] As an example of a medical device applicable to the organ model system for evaluation according to the present invention, a balloon catheter that is inserted into an organ of a living body (e.g., a human, an animal, etc.) and pressed against the inner surface of the organ will be described. In particular, as an example of this balloon catheter, a balloon catheter that is applied to balloon catheter treatment for arrhythmia such as atrial fibrillation will be described, but the system can also be applied to balloon catheters for other treatments such as endometriosis and cancer.

[0041] Furthermore, medical devices applicable to the present invention are not limited to balloon catheters, but may be other medical devices having similar functions. In particular, the medical devices in this embodiment are not limited to medical devices used in actual surgeries, but may be simulated medical devices for training or simulation.

[0042] Here, Fig. 1 is a diagram showing an example of a configuration including an organ model system for evaluation including an analysis device and an organ model device for evaluation according to an embodiment, and a balloon catheter system applied to balloon catheter treatment. Fig. 2 is a diagram showing an example of the configuration of the organ model device for evaluation shown in Fig. 1 when a balloon is inserted. Fig. 3A is a diagram showing an example of a portion of the external appearance of the configuration of the organ model main body of the organ model device for evaluation shown in Fig. 2. Fig. 3B is a diagram showing an example of a portion of the external appearance of the configuration of the organ model main body of the organ model device for evaluation shown in Fig. 2, viewed from a direction different from that of Fig. 3A. Fig. 3C is a diagram showing a portion of the configuration of the organ model main body of the organ model device for evaluation shown in Fig. 2, viewed from a direction different from that of Figs. 3A and 3B.

[0043] [Organ model system for evaluation] For example, as shown in FIG. 1, the organ model system for evaluation 1000 according to this embodiment is configured to output evaluation information for use in training or simulation of medical procedures of a user who uses the medical device 10.

[0044] As described above, in this embodiment, the medical device 10 will be described as an example of a balloon catheter system 10 applied to balloon catheter treatment.

[0045] This organ model system for evaluation 1000 includes, for example, an analysis device 100 and an organ model device for evaluation 200, as shown in FIG.

[0046] [Organ model device for evaluation] The organ model device for evaluation 200 according to this embodiment is a device that is actually used for training or simulation of a medical procedure using the medical device 10. This organ model device for evaluation 200 includes an organ model main body H and an evaluation temperature sensor unit S, as shown in Fig. 4, for example.

[0047] [Organ model body] The organ model main body H is an organ model having a shape that imitates at least a part of an organ of a living body (for example, a human or an animal). The insertion portion of the medical device 10 can be inserted into the interior R of this organ model main body H.

[0048] In this embodiment, the organ model main body H has a shape that imitates the structure of a human heart as an organ of a living organism, as shown in Figures 3A to 3C. Note that the organ model main body H may also include organs other than the heart, such as blood vessels, which are not shown in Figures 3A to 3C.

[0049] As described above, the insertion portion of the medical device 10, which is the balloon catheter system 10, includes the balloon 25 of the balloon catheter for ablation treatment.

[0050] Then, the insertion portion 25 of the medical device is inserted into the interior R of the organ model main body H, and the temperature of the insertion portion 25 is heated (heated to a temperature for ablation treatment) or cooled to a temperature different from the inner surface of the interior R of the organ model main body H, and the inner surface of the interior R of the organ model main body H and the surface of the insertion portion (balloon 25) come into contact.

[0051] [Temperature sensor for evaluation] Furthermore, the evaluation temperature sensor unit S is arranged in the organ model main body H and is configured to measure the temperature of the organ model main body H. In particular, this evaluation temperature sensor unit S is configured to measure the temperature of the inner surface of the interior R of the organ model main body H.

[0052] The evaluation temperature sensor unit S is configured to output evaluation temperature information for evaluating the contact area A based on the result of measuring the temperature of the inside R of the organ model main body H. In this embodiment, the contact area A is the area where the inner surface of the inside R of the organ model main body H and the surface of the balloon 25 come into contact.

[0053] The inner surface of the interior R of the organ model main body H is set, for example, to a predetermined temperature range. When the insertion section of the medical instrument 10 is inserted into the evaluation organ model device 200, the temperature range of the inner surface of the interior R of the organ model main body H is set, for example, to the range of body temperature of a living organism (for example, a human being) (for example, 35°C to 38°C). Therefore, as the evaluation temperature sensor section S, a temperature sensor is selected that can measure at least the range of the temperature of the inner surface of the interior R of the organ model main body H that changes when heated or cooled by the balloon 25.

[0054] Then, for example, by operation of the user, a balloon 25 is inserted into the interior R of the organ model main body H, and in a state where the temperature of the balloon 25 is heated (heated to a temperature for ablation treatment) or cooled to a temperature different from the inner surface of the interior R of the organ model main body H, the inner surface of the interior R of the organ model main body H comes into contact with the surface of the balloon 25. This causes the temperature of the region of the inner surface of the interior R of the organ model main body H to change partially.

[0055] This evaluation temperature sensor unit S includes a plurality of sensor elements Sa, for example, as shown in Fig. 2. These plurality of sensor elements Sa are arranged in the organ model main body H, for example, as shown in Figs. 3A to 3C, and the sensor elements Sa capable of measuring the temperature of the interior R of the organ model main body H include, for example, thermocouples arranged in the organ model main body H and capable of measuring the temperature at the respective positions on the inner surface of the interior R of the organ model main body H. For these thermocouples, the type of thermocouple to be applied, the metal to be used, etc. are selected so that the change in temperature of the organ model main body H can be measured, and the measurement range, measurement accuracy, etc. are set.

[0056] In the organ model main body H, the region where the plurality of sensor elements Sa are arranged includes at least a target region of the interior R of the organ model main body H where the insertion part (balloon 25) of the medical device 10 should come into contact. This enables the evaluation temperature sensor unit S to measure the temperature of the area where the area on the internal surface of the organ model main body H that is intended for treatment comes into contact with the surface of the insertion part (balloon 25) of the medical device 10.

[0057] The evaluation temperature sensor section S is configured to measure a change in temperature of the inside R of the organ model main body H caused by the heated or cooled balloon 25 coming into contact with the inside R of the organ model main body H.

[0058] The temperature information for evaluation includes temperature information that is each temperature measured by each of the plurality of sensor elements Sa. Furthermore, the temperature information for evaluation may include position information of the position of the inner surface of the interior R of the organ model main body H that is measured by each of the plurality of sensor elements Sa.

[0059] That is, the evaluation temperature information includes information that enables the temperature distribution of the region in the organ model body H where the plurality of sensor elements Sa are arranged to be acquired.

[0060] The evaluation temperature sensor unit S outputs evaluation temperature information for evaluating the contact area A by wired communication or wireless communication. Although Figures 3A to 3C do not show wiring for wired communication with the analysis device 100 or a communication unit for wireless communication, the organ model device for evaluation 200 may be provided with such wiring and communication unit as necessary.

[0061] That is, the evaluation temperature sensor unit S outputs evaluation temperature information to the analysis device 100 by wired communication using wiring (not shown) provided between the evaluation organ model device 200 and the analysis device 100, or by wireless communication using a communication unit (not shown) provided in the evaluation organ model device 200 and the analysis device 100.

[0062] [Analysis equipment] The analysis device 100 analyzes and evaluates the information output by the organ model device for evaluation 200, and outputs the obtained evaluation information.

[0063] For example, based on the evaluation temperature information output by the evaluation organ model device 200, this analysis device 100 evaluates the area of ​​the inner surface of the interior R of the organ model main body H where the temperature range differs from the temperature measured by the temperature sensor unit S as a contact area where the inner surface of the interior R of the organ model main body H comes into contact with the surface of the balloon 25.

[0064] In this manner, in this embodiment, analysis device 100 outputs evaluation information regarding contact area A based on the evaluation temperature information.

[0065] The evaluation information includes, for example, an image illustrating an area including the contact area A in the organ model body H, and / or text information including information indicating the contact area A in the organ model body H. Furthermore, the evaluation information is not limited to the image and text information, but may also include audio information or other information related to the contact area A.

[0066] Here, Fig. 4 is a diagram showing an example of the configuration of the analysis device shown in Fig. 1. This analysis device 100 includes, for example, an input unit IN, a processing unit Y, an output unit D, and a storage unit M, as shown in Fig. 4.

[0067] The input unit IN of the analysis device 100 is configured to receive the evaluation temperature information acquired by the evaluation organ model device 200 via wired or wireless communication. As described above, in the case of wired communication, this input unit IN is connected to the temperature sensor unit S of the evaluation organ model device 200 via wiring or the like. On the other hand, in the case of wireless communication, this input unit IN is connected to the evaluation temperature sensor unit S of the evaluation organ model device 200 via a communication unit or the like so as to be able to communicate with it.

[0068] In addition, the processing unit Y of the analysis device 100 analyzes and evaluates the contact area A where the inner surface of the interior R of the organ model main body H comes into contact with the insertion portion of the medical device 10 based on the evaluation temperature information, and obtains evaluation information regarding the evaluated contact area A.

[0069] Specifically, based on the evaluation temperature information, the processing unit Y of the analysis device 100 evaluates the area of ​​the inner surface of the interior R of the organ model main body H where the temperature measured by the evaluation temperature sensor unit S differs from the previously described predetermined temperature range as a contact area A where the inner surface of the interior R of the organ model main body H comes into contact with the surface of the balloon 25.

[0070] Furthermore, based on the evaluation temperature information, the processing unit Y of the analysis device 100 may evaluate, as the contact area, the area of ​​the inner surface of the interior R of the organ model main body H where the temperature measured by the evaluation temperature sensor unit S has changed from the previously described predetermined temperature range after the balloon 25 is inserted into the interior R of the organ model main body H.

[0071] For example, based on the evaluation temperature information, the processing unit Y of the analysis device 100 may evaluate, if the balloon 25 is heated after the balloon 25 is inserted into the interior R of the organ model main body H, the area of ​​the inner surface of the interior R of the organ model main body H where the measured temperature has increased as the contact area.

[0072] On the other hand, for example, the processing unit Y of the analysis device 100 may evaluate, based on the evaluation temperature information, the area of ​​the inner surface of the interior R of the organ model main body H where the measured temperature has dropped, if the balloon 25 has been cooled after the balloon 25 has been inserted into the interior R of the organ model main body H.

[0073] The processing unit Y is configured with hardware such as a CPU, for example. At least a part of the processing unit Y may be configured with software. In addition, some of the components of the processing unit Y may be able to cooperate with the above-mentioned control device 70 by communication via a network.

[0074] Furthermore, the output unit D outputs the evaluation information acquired by the processing unit Y. This output unit D is, for example, a display device that displays the evaluation information externally.

[0075] When the output unit D is a display device, the evaluation information is, for example, an image illustrating an area including the contact area A in the organ model body H, but instead of or together with the image, it may include text information including information indicating the contact area A in the organ model body. As mentioned above, the evaluation information is not limited to the image or text information, but may also include audio information or other information related to the contact area A.

[0076] The storage unit M stores evaluation temperature information, evaluation information, information for the processing unit Y to execute predetermined processing, etc. The storage unit M is, for example, a nonvolatile memory such as a NAND flash memory.

[0077] [Balloon catheter system] Here, a specific configuration of a balloon catheter system will be described as an example of the above-mentioned medical device.

[0078] Fig. 5 is a diagram showing an example of the configuration of the balloon catheter system 10 shown in Fig. 1. Fig. 6A is a diagram showing an example of the configuration of the vicinity of the balloon of the balloon catheter in an inflated state, in region Z of Fig. 5. Fig. 6B is a diagram showing an example of the configuration of the vicinity of the balloon of the balloon catheter in a deflated state, in region Z of Fig. 5. Fig. 7 is a cross-sectional view taken along line IV-IV of Fig. 6A.

[0079] 5, 6A, and 6B, a balloon catheter system 10 that is applied to balloon catheter treatment of a living body that is a subject will be described as an example of a medical device that is applied to an organ model system for evaluation.

[0080] 5, a balloon catheter system 10 includes a balloon catheter 15, a control device 70, and a stirring device 75 connected to the balloon catheter 15. The balloon catheter 15 also includes a catheter body 20 having a longitudinal direction LD, and a handle 50 connected to the proximal end of the catheter body 20.

[0081] 6A, the catheter main body 20 has a balloon 25, an outer cylindrical shaft 30 connected to the proximal end 25b of the balloon 25, an inner cylindrical shaft 35 connected to the distal end 25a of the balloon 25, and a heating member 40 disposed within the balloon 25. The inner cylindrical shaft 35 passes through the outer cylindrical shaft 30 and extends into the balloon 25. A liquid delivery path LP that communicates with the inside of the balloon 25 is formed between the outer cylindrical shaft 30 and the inner cylindrical shaft 35. The heating member 40 heats the liquid within the balloon 25.

[0082] The longitudinal direction LD of the catheter main body 20 is specified as the direction in which the central axes of the outer cylindrical shaft 30 and the inner cylindrical shaft 35 extending from the outer cylindrical shaft 30 extend. In this specification, the "distal" side used with respect to each component of the balloon catheter 15 and the catheter main body 20 means the side away from the operator (surgeon) of the handle 50 and the balloon catheter 15 along the longitudinal direction LD of the catheter main body 20, or in other words, the tip side. In addition, the "proximal" side used with respect to each component of the balloon catheter 15 and the catheter main body 20 means the side close to the operator (surgeon) of the handle 50 and the balloon catheter 15 along the longitudinal direction LD of the catheter main body 20, or in other words, the base end side.

[0083] The balloon catheter system 10 and the balloon catheter 15 will be described in further detail below. First, the catheter body 20 of the balloon catheter 15 will be described in detail. As described above, the catheter body 20 of the balloon catheter 15 includes the balloon 25, the outer cylindrical shaft 30, the inner cylindrical shaft 35, the heating element 40, and the temperature sensor 45.

[0084] Of these, the outer cylindrical shaft 30 and the inner cylindrical shaft 35 are both configured in a tubular, typically cylindrical, shape. Therefore, the outer cylindrical shaft 30 and the inner cylindrical shaft 35 each form a lumen as an internal space. For example, a guidewire (not shown) is inserted into the lumen formed by the inner cylindrical shaft 35. The inner cylindrical shaft 35 is inserted into the lumen formed by the outer cylindrical shaft 30. That is, the outer cylindrical shaft 30 and the inner cylindrical shaft 35 have a double-tube shaft configuration. The inner diameter of the outer cylindrical shaft 30 is larger than the outer diameter of the inner cylindrical shaft 35. Therefore, a lumen remains between the outer cylindrical shaft 30 and the inner cylindrical shaft 35. This lumen between the outer cylindrical shaft 30 and the inner cylindrical shaft 35 forms a liquid delivery path LP. As shown in FIG. 6A , the liquid delivery path LP is connected to the balloon 25. The liquid delivery path LP also extends into the handle 50.

[0085] A balloon 25 is connected to the outer cylindrical shaft 30 and the inner cylindrical shaft 35. The balloon 25 is formed so as to be expandable by filling it with a liquid and contractable by discharging the liquid. The balloon 25 preferably has a shape that can fit the target site (e.g., a blood vessel) to be treated. As an example, a spherical shape with a diameter of 15 mm to 40 mm can be adopted as the shape of the balloon 25 that fits the pulmonary vein junction of the left atrium. Here, the spherical shape includes a perfect sphere, an oblate spheroid, and an elongated spheroid, and also includes a nearly spherical shape.

[0086] 6A and 6B, in the illustrated catheter main body 20, the distal end (tip) 25a of the balloon 25 is fixed to the distal end (tip) 35a of the inner cylindrical shaft 35. The proximal end (base end) 25b of the balloon 25 is fixed to the distal end (tip) 30a of the outer cylindrical shaft 30. The balloon 25 can be connected to the outer cylindrical shaft 30 and the inner cylindrical shaft 35 by bonding or thermal welding.

[0087] Relative movement of the outer cylindrical shaft 30 and the inner cylindrical shaft 35 in the longitudinal direction LD deforms the balloon 25 connected to the outer cylindrical shaft 30 and the inner cylindrical shaft 35. In the illustrated example, the relative movement of the outer cylindrical shaft 30 and the inner cylindrical shaft 35 allows the size of the balloon 25 in the longitudinal direction LD to be adjusted. As shown in FIG. 6B, relative movement of the inner cylindrical shaft 35 toward the distal side in the longitudinal direction LD with respect to the outer cylindrical shaft 30 stretches the balloon 25 in the longitudinal direction LD and places it in a more tense state. In the illustrated example, the distal movement range of the inner cylindrical shaft 35 in the longitudinal direction LD with respect to the outer cylindrical shaft 30 is restricted by the balloon 25. Relative movement of the inner cylindrical shaft 35 from the state shown in FIG. 6B toward the proximal side in the longitudinal direction LD with respect to the outer cylindrical shaft 30 places the balloon 25 in a relaxed state. The relaxed balloon 25 can be inflated by introducing a liquid into the interior of the balloon 25, as shown in FIG. 6A. That is, the size of the balloon 25 in the longitudinal direction LD can be adjusted by moving the outer cylindrical shaft 30 and the inner cylindrical shaft 35 relative to each other.

[0088] Furthermore, the heating element 40 is disposed within the balloon 25. The heating element 40 is a member for heating the liquid filled within the balloon 25. As one example, a nichrome wire that generates heat through electrical resistance can be used as the heating element 40. As another example of the heating element 40, a coil electrode 41 can be used, as shown in FIGS. 6A and 6B. By applying high-frequency current to the heating element 40 serving as the coil electrode 41, a high-frequency current flows between the coil electrode 41 and an externally disposed counter electrode 77 (FIG. 5), and the liquid located between the coil electrode 41 and the counter electrode 77 generates Joule heat. The counter electrode 77 is disposed, for example, on the back of the patient.

[0089] 6A and 6B, the coil electrode 41 is provided on the inner cylindrical shaft 35 extending inside the balloon 25. The coil electrode 41 may be formed by a conductive wire wound around the inner cylindrical shaft 35. The coil electrode 41 is electrically connected to a wiring 42 for high-frequency current application. The wiring 42 extends to the handle 50 through the liquid transfer path LP, which serves as a lumen between the outer cylindrical shaft 30 and the inner cylindrical shaft 35.

[0090] The diameter of the coil electrode 41 and the wiring 42 may be 0.1 mm or more and 1 mm or less, or 0.1 mm or more and 0.4 mm or less. Examples of conductive materials that may be used to form the coil electrode 41 and the wiring 42 include copper, silver, gold, platinum, and alloys thereof. As shown in FIG. 7, the wiring 42 may include a conductive linear portion such as a metal wire and an insulating coating that covers the conductive linear portion. The insulating coating can prevent short circuits in the wiring 42. Examples of materials that may be used to form the insulating coating include fluoropolymers.

[0091] The temperature sensor 45 acquires information about the temperature of the liquid. The temperature sensor 45 has a heat-sensing part 46 disposed in the liquid transfer path LP located between the outer cylindrical shaft 30 and the inner cylindrical shaft 35.

[0092] For the purpose of determining the surface temperature of the balloon 25 with high accuracy, the preferred length along the longitudinal direction LD of the outer tubular shaft from the distal end 30a of the outer tubular shaft 30 to the heat-sensing portion 46 of the temperature sensor 45 strictly depends on the amount of liquid supplied and discharged by the stirring device 75 described below.

[0093] 6A and 6B, the temperature sensor 45 typically has a heat-sensing part 46 disposed in the liquid path LP and a lead wire 47 electrically connected to the heat-sensing part 46. In a temperature sensor 45 that is a thermocouple, the part where dissimilar metals are connected forms the heat-sensing part 46. In a temperature sensor 45 that is a thermistor, a ceramic element forms the heat-sensing part 46. The lead wire 47 extends to the handle 50 through the liquid transfer path LP, which is a lumen between the outer cylindrical shaft 30 and the inner cylindrical shaft 35.

[0094] In the illustrated example, the temperature sensor 45 is attached to the inner cylindrical shaft 35. As shown in Figures 6A and 6B, the lead wires 47 of the temperature sensor 45 are fixed, thereby attaching the temperature sensor 45 to the inner cylindrical shaft 35. The heat-sensing part 46 is spaced apart from both the outer cylindrical shaft 30 and the inner cylindrical shaft 35.

[0095] The handle 50 is a part that is held by the user (operator) while using the balloon catheter system 10, as shown in FIG.

[0096] The handle 50 shown in Fig. 5 has a first handle section 51 and a second handle section 52 that are slidable relative to each other. The first handle section (front handle section) 51 is connected to the outer cylindrical shaft 30 of the catheter main body 20. The second handle section (rear handle section) 52 is connected to the inner cylindrical shaft 35 of the catheter main body 20. By moving the second handle section 52 relative to the first handle section 51, the inner cylindrical shaft 35 can be moved relative to the outer cylindrical shaft 30.

[0097] As shown in FIG. 5, the handle 50 also serves as a site for connecting the balloon catheter 15 to other devices included in the balloon catheter system 10.

[0098] First, a connector 56 extends from the second handle portion 52. This connector 56 electrically connects the wiring 42 of the catheter main body 20 and the lead wire 47 of the temperature sensor 45 to the external control device 70. The connector 56 extends from one of multiple branch portions 52a provided on the second handle portion 52.

[0099] The second handle portion 52 has branches 52b and 52c in addition to the branch 52a to which the connector 56 is connected. These branches 52b and 52c function as portions for supplying liquid to the lumen, which is the internal space of the inner cylindrical shaft 35, and as portions from which a guidewire inserted into the lumen of the inner cylindrical shaft 35 extends. During cardiac ablation treatment, a small amount of saline solution, approximately 100 ml per hour, is typically discharged into the body through the lumen of the inner cylindrical shaft 35. Discharging the saline solution effectively prevents blood from flowing back into the lumen of the inner cylindrical shaft 35.

[0100] 5, an extension tube 57 extends from the first handle portion 51. This extension tube 57 connects the liquid feed path LP of the catheter main body 20 to an external supply device 74 or agitator 75. The extension tube 57 extends from a branch portion 51a provided in the first handle portion 51. The extension tube 57 is connected to the supply device 74 and the agitator 75 via a valve 58. In the illustrated example, by operating the valve 58, it is possible to select whether the liquid feed path LP is connected to either the supply device 74 or the agitator 75. A three-way stopcock can be used as the valve 58.

[0101] Next, the devices that constitute the balloon catheter system 10 together with the balloon catheter 15 described above, specifically the control device 70, the supply device 74, and the stirring device 75, will be described.

[0102] The illustrated control device 70 is electrically connected to the coil electrode 41 via wiring 42. The control device 70 has a high-frequency current control unit 70A that controls the application of high-frequency current to the coil electrode 41. In the illustrated example, the output from the heating member 40 is adjusted by controlling the application of high-frequency current to the coil electrode 41 with the high-frequency current control unit 70A. The high-frequency current control unit 70A can control the application of high-frequency current to the coil electrode 41 based on the surface temperature of the balloon 25 determined by a temperature calculation unit 70B (described later), or in accordance with preset processing, or in accordance with input from the user.

[0103] The control device 70 is also electrically connected to the lead wire 47 of the temperature sensor 45. The control device 70 has a temperature calculation unit 70B that calculates information related to the temperature acquired by the temperature sensor 45. The temperature calculation unit 70B calculates the liquid temperature in the liquid transfer path LP based on the information related to the temperature acquired by the temperature sensor 45, and further estimates the surface temperature of the balloon 25 based on the calculated liquid temperature. The temperature calculation unit 70B may display the identified surface temperature of the balloon 25 on the display unit 71.

[0104] Furthermore, the control device 70 has an agitator control section 70C that controls the agitator 75. The agitator control section 70C may be configured to display the control conditions of the agitator 75 on the display section 71.

[0105] The supply device 74 also supplies liquid into the liquid transfer path LP. By supplying liquid from the supply device 74 to the balloon 25 via the liquid transfer path LP, the balloon 25 can be inflated as shown in FIG. 6A. On the other hand, by discharging liquid from the balloon 25 via the liquid transfer path LP from the supply device 74, the balloon 25 can be deflated. The liquid supplied into the liquid transfer path LP can typically be physiological saline. As shown in the figure, a syringe can be used as the supply device 74. However, a pump or the like can also be used as the supply device 74.

[0106] The agitator 75 is provided to agitate the liquid in the balloon 25. By agitating the liquid in the balloon 25, the heat supplied to the inside of the balloon 25 can be dispersed or uniformized, thereby adjusting the surface temperature of the balloon 25. The agitator 75 repeatedly supplies liquid to the liquid feed path LP and discharges liquid from the liquid feed path LP.

[0107] Next, a control method for the organ model system for evaluation according to this embodiment having the above-described configuration and functions will be described.

[0108] FIG. 8 is a diagram for explaining an example of a control method for the organ model system for evaluation shown in FIG.

[0109] First, for example, the insertion portion (balloon 25) of the medical device (balloon catheter system) 10 is inserted into the interior R of the organ model main body H of the evaluation organ model device 200 by a user's operation (step S1 in FIG. 8).

[0110] Next, for example, by the user's operation, the temperature of the balloon 25 constituting the insertion part is heated to a temperature different from the temperature of the inner surface of the inner surface R of the organ model main body H (heated to a temperature for ablation treatment) or cooled, and the inner surface of the inner surface R of the organ model main body H is brought into contact with the surface of the balloon 25 (step S2 in FIG. 8). As a result, the temperature of the region of the inner surface of the inner surface R of the organ model main body H changes partially.

[0111] Then, the evaluation temperature sensor unit S of the evaluation organ model device 200 measures the surface temperature of the inside R of the organ model main body H (step S3 in FIG. 8). Based on the result of this measurement, the evaluation temperature sensor unit S of the evaluation organ model device 200 acquires evaluation temperature information for evaluating the contact area A. Then, the evaluation temperature sensor unit S of the evaluation organ model device 200 outputs the evaluation temperature information for evaluating the contact area A to the input unit IN of the analysis device 100 by wired communication or wireless communication (step S4 in FIG. 8).

[0112] In step S4 of FIG. 8, the input unit IN of the analysis device 100 receives the temperature information for evaluation acquired by the organ model device for evaluation 200 via wired or wireless communication.

[0113] Next, the processing unit Y of the analysis device 100 analyzes and evaluates the contact area A where the inner surface of the interior R of the organ model main body H comes into contact with the insertion portion of the medical device 10 based on the evaluation temperature information input to the input unit IN, and obtains evaluation information regarding the evaluated contact area A (step S5 in Figure 8).

[0114] Next, output unit D of analysis device 100 outputs the evaluation information acquired by processing unit Y of analysis device 100 (step S6 in FIG. 8).

[0115] Here, Fig. 9 is a diagram showing an example of evaluation information output by the organ model system for evaluation when the output unit of the analysis device shown in Fig. 4 is a display device. Also, Fig. 10 is a diagram showing an example of evaluation information output by the organ model system for evaluation when the output unit of the analysis device shown in Fig. 4 is a display device. Note that the direction in which the organ model body H is displayed in the images shown in Fig. 9 and Fig. 10 is the same as the direction in Fig. 3B described above, but the images may be displayed in a different direction.

[0116] Fig. 9 shows an example of an image of contact area A where balloon 25 constituting the insertion part of balloon catheter system 10, which is a medical device, is in contact with the front side of the inside of organ model main body H. Fig. 10 shows an example of an image of contact area A where balloon 25 constituting the insertion part of balloon catheter system 10, which is a medical device, is in contact with the back side of the inside of organ model main body H.

[0117] 9 and 10, the contact area A is displayed as being filled in with one color in the image of the organ model body H. In addition, in Figures 9 and 10, the area Q where the balloon 25 of the balloon catheter system 10, which is a medical device, does not contact the inner surface of the interior R of the organ model body H is displayed in the same manner as in the image of the organ model body H shown in Figure 3B.

[0118] For example, by referring to the evaluation information such as that shown in Figures 9 and 10 output from the evaluation organ model system 1000, the user can properly recognize the contact area A where the balloon 25 of the balloon catheter system 10, which is a medical device, is in contact with the inner surface of the interior R of the organ model body H.

[0119] As already mentioned, in the examples of Figures 9 and 10, the evaluation information is an image illustrating an area including contact area A in the organ model body H, but as already mentioned, instead of or together with the image, it may also include text information including information indicating contact area A in the organ model body.

[0120] As described above, the organ model system for evaluation 1000 according to this embodiment can obtain information for evaluating the contact area between the organ model device for evaluation 200 and the insertion part of the medical instrument.

[0121] This allows, for example, a doctor who is the user, to appropriately train or simulate a medical procedure by referring to the evaluation information that evaluates the contact area between the evaluation organ model device 200 and the insertion part of the medical instrument.

[0122] Although several embodiments of the present invention have been described, these embodiments are presented as examples and are not intended to limit the scope of the invention. These embodiments can be implemented in various other forms, and various omissions, substitutions, and modifications can be made without departing from the spirit of the invention. These embodiments and their modifications are included within the scope and spirit of the invention, as well as within the scope of the invention described in the claims and their equivalents. [Industrial Applicability]

[0123] This embodiment can be used in a balloon catheter system and a balloon catheter for treating arrhythmia such as atrial fibrillation, endometriosis, cancer, and the like. [Explanation of symbols]

[0124] 1000 Organ Model System for Evaluation 100 Analyzer 200 Organ model device for evaluation H Organ model body S Temperature sensor for evaluation

Claims

1. an organ model body having a shape that resembles at least a part of an organ of a living body and into which an insertion portion of a medical device can be inserted; an evaluation temperature sensor unit disposed on the organ model main body and measuring the temperature of the organ model main body; An evaluation organ model device that outputs evaluation temperature information for evaluating the contact area where the insertion portion of the medical device comes into contact with the internal surface of the organ model main body based on the measurement results of the evaluation temperature sensor unit.

2. 2. The organ model device for evaluation according to claim 1, wherein the medical device is a balloon catheter system applied to balloon catheter treatment, and the insertion portion of the medical device includes a balloon of a balloon catheter for ablation treatment.

3. 3. The organ model device for evaluation according to claim 2, wherein the contact area is an area where the inner surface of the organ model body contacts the surface of the balloon.

4. An evaluation organ model device as described in any one of claims 2 to 3, wherein the evaluation temperature sensor unit measures the change in temperature inside the organ model main body due to the heated or cooled balloon coming into contact with the inside of the organ model main body.

5. An evaluation organ model device according to any one of claims 1 to 4, wherein the area in which the evaluation temperature sensor unit is arranged includes a target area inside the organ model main body with which the insertion portion of the medical device is to come into contact.

6. An organ model device for evaluation according to any one of claims 1 to 5, wherein the evaluation temperature information includes position information of the position of the inner surface of the organ model main body measured by each of the evaluation temperature sensor units.

7. 7. The organ model device for evaluation according to claim 1, wherein the organ model main body has a shape that imitates the structure of a heart as an organ of a living body.

8. 8. The organ model device for evaluation according to claim 1, which is a device used for training or simulating a user's medical procedure.

9. the inner surface of the organ model body is set to a predetermined temperature range; 5. An organ model device for evaluation as described in claim 4, wherein the balloon is inserted into the organ model main body, and the inner surface of the organ model main body and the surface of the balloon come into contact with each other while the temperature of the balloon is heated or cooled to a temperature different from the inner surface of the organ model main body.

10. the temperature range of the inner surface of the organ model main body is set to the range of body temperature of the living body; The organ model device for evaluation according to claim 9.

11. An organ model device for evaluation according to any one of claims 9 to 10, wherein, based on the evaluation temperature information, a region of the inner surface of the organ model main body where the temperature measured by the evaluation temperature sensor unit differs from the temperature range is evaluated as a contact region where the inner surface of the organ model main body comes into contact with the surface of the balloon.

12. an organ model device for evaluation comprising an organ model main body having a shape that mimics at least a part of an organ of a living body and into which an insertion part of a medical device can be inserted, and an evaluation temperature sensor unit that is disposed on the organ model main body and measures the temperature of the organ model main body; an analysis device that analyzes the information output by the organ model device for evaluation, the organ model device for evaluation outputs evaluation temperature information for evaluating a contact area where the insertion part of the medical device comes into contact with the internal surface of the organ model main body, based on the measurement result of the evaluation temperature sensor unit; The analysis device outputs evaluation information regarding the contact area based on the temperature information for evaluation.

13. the inner surface of the organ model body is set to a predetermined temperature range; 13. An organ model system for evaluation as described in claim 12, wherein the insertion portion 25 of the medical device is inserted into the organ model main body, and the inner surface of the organ model main body and the surface of the insertion portion come into contact with each other while the temperature of the insertion portion is heated or cooled to a temperature different from the inner surface of the organ model main body.

14. 14. The organ model system for evaluation according to claim 13, wherein the temperature range of the inner surface of the organ model main body is set to the temperature range of the body temperature of the living organism.

15. The organ model system for evaluation according to any one of claims 13 to 14, wherein the analysis device evaluates, based on the evaluation temperature information, a region of the inner surface of the organ model main body where the temperature measured by the evaluation temperature sensor unit differs from the temperature range as a contact region where the inner surface of the organ model main body comes into contact with the surface of the insertion part.

16. The analysis device an input unit to which temperature information for evaluation acquired by the organ model device for evaluation is input; a processing unit that analyzes and evaluates a contact area between an inner surface of the organ model main body and an insertion part of the medical device based on the evaluation temperature information, and acquires evaluation information regarding the evaluated contact area; an output unit that outputs the evaluation information acquired by the processing unit; The organ model system for evaluation according to any one of claims 12 to 15, comprising:

17. An organ model system for evaluation according to any one of claims 12 to 16, wherein the evaluation information includes an image illustrating an area including the contact area in the organ model main body, and / or text information including information indicating the contact area in the organ model main body.

18. The organ model system for evaluation according to any one of claims 12 to 17, wherein the evaluation temperature sensor unit outputs the evaluation temperature information to the analysis device by wired communication using wiring provided between the organ model device for evaluation and the analysis device, or by wireless communication using a communication unit provided in the organ model device for evaluation and the analysis device.

19. A control method for an evaluation organ model system comprising: an evaluation organ model device comprising an organ model main body having a shape that mimics at least a part of an organ of a living body and into which an insertion part of a medical device can be inserted; an evaluation temperature sensor unit that is disposed on the organ model main body and measures the temperature of the organ model main body; and an analysis device that analyzes information output by the evaluation organ model device, outputting evaluation temperature information for evaluating a contact area where the insertion part of the medical device and the internal surface of the organ model main body come into contact based on the measurement result of the evaluation temperature sensor unit obtained from the evaluation organ model device; A control method for an organ model system for evaluation, which outputs evaluation information regarding the contact area based on the temperature information for evaluation obtained from the analysis device.

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