Patent Description:
Medical devices such as a catheter are used for minimally invasive treatment or inspection for a living body lumen such as a circulatory system and a digestive system. In addition, there are known devices and systems that allow operators such as surgeons to simulate a procedure using these medical devices. For example, Patent Literature <NUM> discloses a simulation system including an aorta model that simulates a patient's aorta having aortic aneurysm or aortic dissection and capable of simulating a stent graft insertion procedure using a catheter. On the other hand, for example, Patent Literature <NUM> discloses a cardiac simulation device including an expandable and contractable heart for training and capable of simulating coronary artery bypass graft (CABG) procedure that is an ordinary open-heart surgery.

<CIT> discloses a training apparatus comprising a simulated body including a guide tubing for delivering a catheter and a treating part to be treated by said catheter.

<CIT> shows a liquid circulator for a blood vessel model having a closed system for circulating a liquid and being capable of forming a pulsatile flow.

From <CIT>, a heart simulation device is known which comprises a deformation part formed on a training heart and a training blood vessel part. When the deformation part is expanded and shrunk, a beating operation of the training heart can be simulated. Said beating operation is supposed to feed a working fluid to the training blood vessel part.

<CIT> describes a thoracic cavity simulator providing a surgical environment for training purposes.

<CIT> discloses a simulator system for teaching patient care to a user, the system comprising a model with first and second lungs and a fluid passage being in fluid communication with the lungs. Pressurized fluid can be provided through the fluid passage to the lungs based on the regulation of a breathing valve.

However, since the simulation system described in Patent Literature <NUM> does not have a biological model other than the aorta model, the system has had a problem that e.g. the system cannot simulate a treatment or inspection procedure for heart, such as percutaneous coronary intervention (PCI) for coronary ischemic heart disease. In addition, for the cardiac simulation device described in Patent Literature <NUM>, simulation of a procedure using a medical device for minimally invasive treatment or inspection, such as a catheter is not taken into consideration.

The present invention has been made to solve the above problems, and an object of the present invention is to provide a human body simulation device capable of simulating treatment or inspection using a medical device for minimally invasive treatment or inspection of heart.

The object of the present invention is solved by a human body simulation device according to claim <NUM>, a method for controlling a human body simulation device according to claim <NUM> and a computer program according to claim <NUM>.

The present invention been made to solve at least a part of the aforementioned problems, and can be achieved as the following aspects.

According to this configuration, the human body simulation device includes the heart model simulating a heart and the blood vessel model simulating a blood vessel, it is possible to simulate e.g. a treatment or inspection procedure using a medical device for minimally invasive treatment or inspection for heart, such as percutaneous coronary intervention (PCI) for ischemic heart disease. In addition, since the control portion of the human body simulation device can change the beat rate in causing the heart model to beat and a pulsation rate in sending the fluid into the blood vessel model depending on the prescribed heart rate, it is possible to simulate a treatment or inspection procedure under various beat rate and pulsation rate conditions.

Incidentally, the present invention can be achieved in various manners, and can be achieved in aspects of e.g. a human body simulation device, a biological model such as a blood vessel model and an organ model, a method for controlling the human body simulation device, and the like.

<FIG> and <FIG> are diagrams illustrating a schematic configuration of a human body simulation device <NUM> according to the first embodiment. The human body simulation device <NUM> according to the first embodiment is used to simulate a treatment or inspection procedure using a medical device for minimally invasive treatment or inspection, such as a catheter and a guide wire in a living body lumen such as a circulatory system, a digestive system and a respiratory system of a human body. The human body simulation device <NUM> includes a model <NUM>, an accommodation portion <NUM>, a control portion <NUM>, an input portion <NUM>, a pulsation portion <NUM>, a beat portion <NUM>, and a breathing portion <NUM>.

As illustrated in <FIG>, the model <NUM> includes a heart model <NUM> simulating a human heart, a lung model <NUM> simulating a lung, a diaphragm model <NUM> simulating a diaphragm, a brain model <NUM> simulating a brain, a liver model <NUM> simulating a liver, a lower limb model <NUM> simulating a lower limb, and an aorta model <NUM> simulating an aorta. Hereinafter, the heart model <NUM>, the lung model <NUM>, the diaphragm model <NUM>, the brain model <NUM>, the liver model <NUM>, and the lower limb model <NUM> are also collectively referred to as a "biological model". The lung model <NUM> and the diaphragm model <NUM> are also collectively referred to as a "respiratory organ model". Each biological model excluding the lung model <NUM> and the diaphragm model <NUM> is connected to the aorta model <NUM>. The model <NUM> will be described in detail later.

The accommodation portion <NUM> includes a water bath <NUM> and a covering portion <NUM>. The water bath <NUM> is a substantially rectangular parallelepiped water bath with an opening top. As illustrated in <FIG>, when the model <NUM> is located on a bottom face of the water bath <NUM> while an inside of the water bath <NUM> is filled with a fluid, the model <NUM> is submerged in the fluid. Since water (liquid) is used as the fluid in the first embodiment, the model <NUM> can be maintained in a moist state like an actual human body. Incidentally, another liquid (e.g. physiological saline, an aqueous solution of an arbitrary compound, or the like) may be adopted as the fluid. The fluid charged in the water bath <NUM> is taken into the aorta model <NUM> and the like of the model <NUM> and functionally serves as a "simulation blood" that simulates blood.

The covering portion <NUM> is a plate-like member that covers the opening of the water bath <NUM>. In a state that one side face of the covering portion <NUM> is brought into contact with the fluid and the other side face is brought into contact with outside air, the covering portion <NUM> is located on the water bath <NUM>, and therefore the covering portion <NUM> functionally serves as a wave-dissipating plate. Thereby, it is possible to suppress decrease in visual recognizability due to waving of the fluid inside the water bath <NUM>. Since the water bath <NUM> and the covering portion <NUM> according to the first embodiment are made of a synthetic resin having X-ray transparency and high transparency (e.g. acrylic resin), visual recognizability for the model <NUM> from the outside can be improved. Incidentally, the water bath <NUM> and the covering portion <NUM> may be made of another synthetic resin, and the water bath <NUM> and the covering portion <NUM> may be made of different materials.

The control portion <NUM> includes a CPU, a ROM, a RAM, and a storage portion that are not illustrated. A computer program stored in the ROM is developed to the RAM and executed, so that operations of the pulsation portion <NUM>, the beat portion <NUM>, and the breathing portion <NUM> are controlled (described in detail later). The input portion <NUM> refers to various interfaces used for the user to input information to the human body simulation device <NUM>. As the input portion <NUM>, for example, a touch panel, a keyboard, a manipulation button, a manipulation dial, a microphone, or the like can be adopted. Hereinafter, the touch panel will be illustrated as the input portion <NUM>.

The pulsation portion <NUM> is a "fluid feeding portion" that sends the pulsated fluid into the aorta model <NUM>. Specifically, as indicated by a white arrow in <FIG>, the pulsation portion <NUM> circulates the fluid in the water bath <NUM> to feed the fluid to the aorta model <NUM> of the model <NUM>. The pulsation portion <NUM> according to the first embodiment includes a filter <NUM>, a circulation pump <NUM>, and a pulsation pump <NUM>. The filter <NUM> is connected to an opening <NUM> of the water bath <NUM> through a tubular body <NUM>. The filter <NUM> filters the fluid passing through the filter <NUM> to remove impurities (e.g. contrast medium used in the procedure) in the fluid. The circulation pump <NUM> is e.g. a non-positive displacement type centrifugal pump, which circulates the fluid fed from the water bath <NUM> through the tubular body <NUM> at a constant flow rate.

The pulsation pump <NUM> is e.g. a positive displacement type reciprocating pump, which pulsates the fluid sent out from the circulation pump <NUM>. The pulsation pump <NUM> is connected to the aorta model <NUM> of the model <NUM> through a tubular body <NUM> (<FIG>). Thus, the fluid sent out from the pulsation pump <NUM> is fed to an inner cavity of the aorta model <NUM>. Incidentally, as the pulsation pump <NUM>, a rotary pump that is operated at a low speed may be used instead of the reciprocating pump. In addition, the filter <NUM> and the circulation pump <NUM> may be omitted. The tubular body <NUM> and the tubular body <NUM> are flexible tubes made of a synthetic resin (e.g. silicone or the like) that is an X-ray-transparent soft material.

The beat portion <NUM> causes the heart model <NUM> to beat. Specifically, as indicated by an arrow hatched by oblique lines in <FIG>, the beat portion <NUM> expands the heart model <NUM> by sending the fluid into an inner cavity of the heart model <NUM>, and contracts the heart model <NUM> by sucking out the fluid in the inner cavity of the heart model <NUM>. The beat portion <NUM> repeats the sending and suck to achieve beating (expansion and contraction) of the heart model <NUM>. As the fluid used in the beat portion <NUM> (hereinafter, also referred to as "expansion medium"), a liquid may be used similarly to the simulation blood, or e.g. a gas such as air may be used. The expansion medium is preferably an organic solvent such as benzene and ethanol, or a radiolucent liquid such as water. The beat portion <NUM> can be achieved by using e.g. a positive displacement type reciprocating pump. The beat portion <NUM> is connected to the heart model <NUM> of the model <NUM> through a tubular body <NUM> (<FIG>). The tubular body <NUM> is a flexible tube made of a synthetic resin (e.g. silicone or the like) that is an X-ray-transparent soft material.

The breathing portion <NUM> causes the lung model <NUM> and the diaphragm model <NUM> to simulate breathing. Specifically, as indicated by an arrow hatched by dots in <FIG>, the breathing portion <NUM> expands the lung model <NUM> and contracts the diaphragm model <NUM> by sending the fluid into an inner cavity of the lung model <NUM> and the diaphragm model <NUM>. In addition, the breathing portion <NUM> contracts the lung model <NUM> and relaxes the diaphragm model <NUM> by sucking the fluid from the inner cavity of the lung model <NUM> and the diaphragm model <NUM>. The breathing portion <NUM> repeats the sending and suck to achieve beating of the lung model <NUM> and the diaphragm model <NUM>. As the fluid used in the breathing portion <NUM>, a liquid may be used similarly to the simulation blood, or e.g. a gas such as air may be used. The breathing portion <NUM> can be achieved by using e.g. a positive displacement type reciprocating pump. The breathing portion <NUM> is connected to the lung model <NUM> of the model <NUM> through a tubular body <NUM>, and connected to the diaphragm model <NUM> through a tubular body <NUM> (<FIG>). The tubular bodies <NUM> and <NUM> are flexible tubes made of a synthetic resin (e.g. silicone or the like) that is an X-ray-transparent soft material.

<FIG> is a diagram illustrating an example of a configuration of the aorta model <NUM>. The aorta model <NUM> is composed of each portion simulating a human aorta, i.e. an ascending aorta portion <NUM> simulating an ascending aorta, an aortic arch portion <NUM> simulating an aortic arch, an abdominal aorta portion <NUM> simulating an abdominal aorta, and a common iliac aorta portion 164R, <NUM> simulating a common iliac aorta.

The aorta model <NUM> includes a second connection portion 161J for connecting the heart model <NUM> on an end portion of the ascending aorta portion <NUM>. Similarly, the aorta model <NUM> includes a first connection portion 162J for connecting the brain model <NUM> in the vicinity of the aortic arch portion <NUM>, a third connection portion 163Ja for connecting the liver model <NUM> in the vicinity of the abdominal aorta portion <NUM>, and two fourth connection portions 164J for connecting the right and left lower limb models <NUM> on an end portion of the common iliac aorta portion 164R, <NUM>. Incidentally, the second connection portion 161J only needs to be disposed on or near the ascending aorta portion <NUM>, and the fourth connection portion 164J only needs to be disposed on or near the common iliac aorta portion 164R, <NUM>. Hereinafter, these first to fourth connection portions 161J to 164J are also collectively referred to as a "biological model connecting portion". In addition, the aorta model <NUM> includes a fluid feeding portion connecting portion 163Jb for connecting the pulsation portion <NUM> in the vicinity of the abdominal aorta portion <NUM>. Incidentally, the fluid feeding portion connecting portion 163Jb may be disposed not only in the vicinity of the abdominal aorta portion <NUM> but also at any position such as the vicinity of the ascending aorta portion <NUM> and a vicinity of a cerebral vessel model <NUM> (e.g. common carotid artery). In addition, the aorta model <NUM> may include a plurality of the fluid feeding portion connecting portions 163Jb disposed at different positions.

In addition, in the aorta model <NUM>, opening inner cavities <NUM> are formed on each of the aforementioned biological model connecting portions and fluid feeding portion connecting portions (first connection portion 162J, second connection portion 161J, third connection portion 163Ja, two fourth connection portions 164J, and fluid feeding portion connecting portion 163Jb). The inner cavity <NUM> functionally serves as a flow passage for transporting the simulation blood (fluid) fed from the pulsation portion <NUM> to the heart model <NUM>, the brain model <NUM>, the liver model <NUM>, and the lower limb model <NUM>.

The aorta model <NUM> according to the first embodiment is made of a synthetic resin (e.g. polyvinyl alcohol (PVA), silicone, or the like) that is an X-ray-transparent soft material. In particular, it is preferable to use a PVA in that a tactile sensation of the aorta model <NUM> submerged in the liquid can resemble a tactile sensation of an actual human aorta by hydrophilicity of the PVA.

The aorta model <NUM> can be produced e.g. in the following manner. First, a mold that simulates a shape of the human aorta is prepared. Among human body model data generated by analyzing a computed tomography (CT) image, a magnetic resonance imaging (MRI) image, or the like of an actual human body, data of a part corresponding to an aorta is input into e.g. a 3D printer and printed out, to produce the mold. The mold may be made of a plaster, a metal, or a resin. Subsequently, a liquefied synthetic resin material is applied inside the prepared mold, and after the synthetic resin material is cooled and solidified, the resin is released from the mold. In this way, the aorta model <NUM> having the inner cavity <NUM> can be easily produced.

<FIG> and <FIG> are diagrams illustrating an example of a configuration of the model <NUM>. <FIG> is a diagram illustrating an example of the heart model <NUM>. As illustrated in <FIG>, the heart model <NUM> has a shape simulating a heart, and includes an inner cavity <NUM> thereinside. The heart model <NUM> according to the first embodiment is made of a synthetic resin (e.g. silicone or the like) that is a X-ray-transparent soft material, and can be formed by applying the synthetic resin material inside the mold produced from the human body model data and releasing the resin from the mold, similarly to the aorta model <NUM>. In addition, the heart model <NUM> includes a cardiac vessel model <NUM> and a tubular body <NUM>. Incidentally, in <FIG>, illustration of the inner cavity <NUM> and the tubular body <NUM> of the heart model <NUM> is omitted.

The cardiac vessel model <NUM> is a tubular blood vessel model simulating a part of an ascending aorta and a coronary artery, and is made of a synthetic resin (e.g. PVA, silicone, or the like) that is an X-ray-transparent soft material. As illustrated in <FIG>, a proximal end 111P of the cardiac vessel model <NUM> is connected to the second connection portion 161J of the aorta model <NUM>. Herein, the proximal end 111P of the cardiac vessel model <NUM> is connected to the second connection portion 161J such that an inner cavity <NUM> of the cardiac vessel model <NUM> and the inner cavity <NUM> of the aorta model <NUM> communicate with each other. In addition, as illustrated in <FIG>, a distal end 111D of the cardiac vessel model <NUM> is branched into a tubular right coronary artery model 112R simulating a right coronary artery and a tubular left coronary artery model <NUM> simulating a left coronary artery, and each of the branches is arranged on a surface <NUM> of the heart model <NUM>.

A distal end portion of each branch of the left and right coronary artery models <NUM> and 112R has an opening <NUM> through which the fluid fed from the aorta model <NUM> (inner cavity <NUM>) through the cardiac vessel model <NUM> (inner cavity <NUM>) is discharged to the outside (inside the water bath <NUM>). Incidentally, the right and left coronary artery models <NUM> may or may not include an opening <NUM>. The tubular body <NUM> is a flexible tube made of a synthetic resin (e.g. silicone or the like) that is an X-ray-transparent soft material. The tubular body <NUM> has a distal end 115D communicatively connected to the inner cavity <NUM> of the heart model <NUM>, and a proximal end 115P communicatively connected to the tubular body <NUM> leading to the beat portion <NUM>.

The lung model <NUM> (<FIG>) has a shape simulating a right lung and a left lung. Inside the lung model <NUM>, one inner cavity <NUM> in which the right lung and the left lung communicate with each other is formed. The lung model <NUM> is disposed so as to cover the right and left sides of the heart model <NUM>. A material and a production method that can be adopted to produce the lung model <NUM> are the same as those for the heart model <NUM>. The material of the lung model <NUM> and the material of the heart model <NUM> may be the same or different. In addition, the lung model <NUM> includes a trachea model <NUM> that is a tubular model simulating a part of a trachea. The trachea model <NUM> can be made of the same material as of the tubular body <NUM> of the heart model <NUM>. The material of the trachea model <NUM> and the material of the tubular body <NUM> may be the same or different. The trachea model <NUM> has a distal end 121D communicatively connected to the inner cavity <NUM> of the lung model <NUM>, and a proximal end 121P communicatively connected to the tubular body <NUM> leading to the breathing portion <NUM>.

The diaphragm model <NUM> (<FIG>) has a shape simulating a diaphragm, and includes an inner cavity <NUM> thereinside. The diaphragm model <NUM> is disposed under the heart model <NUM> (in other words, opposite to the brain model <NUM> with the heart model <NUM> therebetween). A material and a production method that can be adopted to produce the diaphragm model <NUM> are the same as those for the heart model <NUM>. The material of the diaphragm model <NUM> and the material of the heart model <NUM> may be the same or different. In addition, the diaphragm model <NUM> is connected with the tubular body <NUM> leading to the breathing portion <NUM> such that the inner cavity <NUM> of the diaphragm model <NUM> and the inner cavity of the tubular body <NUM> communicate with each other.

The brain model <NUM> (<FIG>) has a shape simulating a brain and is solid with no inner cavity. The brain model <NUM> is disposed above the heart model <NUM> (in other words, opposite to the diaphragm model <NUM> with the heart model <NUM> therebetween). A material and a production method that can be adopted to produce the brain model <NUM> are the same as those for the heart model <NUM>. The material of the brain model <NUM> and the material of the heart model <NUM> may be the same or different. In addition, the brain model <NUM> includes the cerebral vessel model <NUM> that is a tubular blood vessel model simulating at least a part of major vessels including from right and left common carotid arteries to right and left vertebral arteries. The cerebral vessel model <NUM> can be made of the same material as of the cardiac vessel model <NUM> of the heart model <NUM>. The material of the cerebral vessel model <NUM> and the material of the cardiac vessel model <NUM> may be the same or different. In addition, although not illustrated, the cerebral vessel model <NUM> may simulate not only arteries but also major veins including a superior cerebral vein and a straight sinus.

Incidentally, the brain model <NUM> may be a complex additionally including a bone model simulating a human cranium and cervical spine. For example, the cranium has a hard resin case simulating a parietal bone, a temporal bone, an occipital bone, and a sphenoid bone, and a lid simulating a frontal bone. The cervical spine may have a plurality of rectangular resin bodies having a through hole through which the blood vessel model can pass. When including a bone model, the bone model is made of a resin having a hardness different from that of an organ model such as a blood vessel model and a brain model, and for example, the cranium can be made of an acrylic resin and the vertebra can be made of a PVA.

The cerebral vessel model <NUM> has a distal end 131D connected to the brain model <NUM> and a proximal end 131P connected to the first connection portion 162J of the aorta model <NUM> (e.g. connected to a human brachiocephalic artery, subclavian artery, or the vicinity thereof). Herein, similarly to the cardiac vessel model <NUM>, the distal end 131D of the cerebral vessel model <NUM> may simulate a vertebral artery passing through a vertebra and other vessels arranged on a surface and/or inside of the brain model <NUM> (e.g. posterior cerebral artery, middle cerebral artery), and further may simulate a posterior communicating artery so as to be connected with a common carotid artery peripheral part. In addition, the proximal end 131P of the cerebral vessel model <NUM> is connected to the first connection portion 162J such that the inner cavity of the cerebral vessel model <NUM> and the inner cavity <NUM> of the aorta model <NUM> communicate with each other.

The liver model <NUM> (<FIG>) has a shape simulating a liver and is solid with no inner cavity. The liver model <NUM> is disposed under the diaphragm model <NUM>. A material and a production method that can be adopted to produce the liver model <NUM> are the same as those for the heart model <NUM>. The material of the liver model <NUM> and the material of the heart model <NUM> may be the same or different. In addition, the liver model <NUM> includes a hepatic vessel model <NUM> that is a tubular blood vessel model simulating a part of a hepatic artery. The hepatic vessel model <NUM> can be made of the same material as of the cardiac vessel model <NUM> of the heart model <NUM>. The material of the hepatic vessel model <NUM> and the material of the cardiac vessel model <NUM> may be the same or different.

The hepatic vessel model <NUM> has a distal end 141D connected to the liver model <NUM> and a proximal end 141P connected to the third connection portion 163Ja of the aorta model <NUM>. Herein, similarly to the cardiac vessel model <NUM>, the distal end 141D of the hepatic vessel model <NUM> may simulate other blood vessels (e.g. hepatic artery) arranged on the surface and/or inside of the liver model <NUM>. In addition, the proximal end 141P of the hepatic vessel model <NUM> is connected to the third connection portion 163Ja such that the inner cavity of the hepatic vessel model <NUM> and the inner cavity <NUM> of the aorta model <NUM> communicate with each other.

The lower limb model <NUM> (<FIG>) includes a lower limb model 150R corresponding to a right leg and a lower limb model <NUM> corresponding to a left leg. Since the lower limb models 150R and <NUM> have the same configuration except that they are symmetrical, hereinafter they will be explained as the "lower limb model <NUM>" without distinction. The lower limb model <NUM> has a shape simulating at least a part of major tissues such as a quadriceps muscle of a femur, and a tibialis anterior muscle, a peroneus longus muscle and an extensor digitorum longus muscle of a crus, and is solid with no inner cavity. A material and a production method that can be adopted to produce the lower limb model <NUM> are the same as those for the heart model <NUM>. The material of the lower limb model <NUM> and the material of the heart model <NUM> may be the same or different. In addition, the lower limb model <NUM> includes a lower limb vessel model <NUM> (lower limb vessel models 151R and <NUM>) that is a tubular blood vessel model simulating at least a part of major blood vessels including from a femoral artery to a dorsalis pedis artery. The lower limb vessel model <NUM> can be made of the same material as of the cardiac vessel model <NUM> of the heart model <NUM>. The material of the lower limb vessel model <NUM> and the material of the cardiac vessel model <NUM> may be the same or different. In addition, although not illustrated, the lower limb vessel model <NUM> may simulate not only arteries but also major veins including from a common iliac vein to a greater saphenous vein.

The lower limb vessel model <NUM> is disposed so as to extend along an extension direction from the femur to the crus side in the lower limb model <NUM>. The lower limb vessel model <NUM> has a distal end 151D exposed from the lower end of the lower limb model <NUM> (position corresponding to a part from a tarsus portion to a dorsum pedis portion), and a proximal end 151P connected to the fourth connection portion 164J of the aorta model <NUM>. Herein, the proximal end 151P is connected to the fourth connection portion 164J such that an inner cavity of the lower limb vessel model <NUM> and the inner cavity <NUM> of the aorta model <NUM> communicate with each other.

Incidentally, the aforementioned cardiac vessel model <NUM>, cerebral vessel model <NUM>, hepatic vessel model <NUM>, and lower limb vessel model <NUM> are also collectively referred to as a "partial blood vessel model". In addition, the partial blood vessel model and the aorta model <NUM> are also collectively referred to as a "blood vessel model". Such a configuration allows the partial blood vessel model arranged on the surface of each biological model to simulate e.g. a posterior cerebral artery of a brain, a left coronary artery and a right coronary artery of a heart, and the like. In addition, the partial blood vessel model arranged inside each biological model can simulate e.g. a middle cerebral artery of a brain, a hepatic artery of a liver, a femoral artery of a lower limb, and the like.

<FIG> is an explanatory diagram illustrating an example of a configuration of the model <NUM>. In the human body simulation device <NUM> according to the first embodiment, at least one or more biological models (heart model <NUM>, lung model <NUM>, diaphragm model <NUM>, brain model <NUM>, liver model <NUM>, lower limb model <NUM>) are attached to or detached from the aorta model <NUM>, so that the models <NUM> in various manners can be configured. In the example of <FIG>, the model <NUM> is configured such that only the heart model <NUM> is attached to the aorta model <NUM>, and the other biological models (lung model <NUM>, diaphragm model <NUM>, brain model <NUM>, liver model <NUM>, lower limb model <NUM>) are detached. In addition, the model <NUM> is connected with a pulsation portion <NUM> for sending the simulation blood into the aorta model <NUM>, and a beat portion <NUM> for causing the heart model <NUM> to beat. For example, when using the human body simulation device <NUM> to simulate a cardiac catheter treatment or inspection procedure such as Percutaneous Coronary Intervention (PCI) for ischemic heart disease, the model <NUM> in the manner illustrated in <FIG> may be used.

<FIG> is an explanatory diagram illustrating another example of a configuration of the model <NUM>. In the example of <FIG>, the model <NUM> is configured such that only the brain model <NUM> is attached to the aorta model <NUM>, and the other biological models (heart model <NUM>, lung model <NUM>, diaphragm model <NUM>, liver model <NUM>, lower limb model <NUM>) are detached. In addition, the model <NUM> is connected with the pulsation portion <NUM> for sending the simulation blood into the aorta model <NUM>. For example, when using the human body simulation device <NUM> to simulate a cerebrovascular catheter treatment or inspection procedure such as coil embolization for a cerebral aneurysm, the model <NUM> in the manner illustrated in <FIG> may be used.

Note that the models illustrated in <FIG> and <FIG> are merely examples of the model <NUM>. The combination of the biological models (heart model <NUM>, lung model <NUM>, diaphragm model <NUM>, brain model <NUM>, liver model <NUM>, lower limb model <NUM>) to be attached to the aorta model <NUM> can be freely changed depending on an organ required for a procedure. For example, when configuring the model <NUM> to which the heart model <NUM> and the lower limb model <NUM> are attached, a Trans-Femoral Intervention (TFI) procedure of PCI can be simulated using the human body simulation device <NUM>. Additionally, for example, all biological models excluding the lower limb model <NUM> may be attached to the model <NUM>, the heart model <NUM> and the lung model <NUM> may be attached to the model <NUM>, the lung model <NUM> and the diaphragm model <NUM> may be attached to the model <NUM>, only the liver model <NUM> may be attached to the model <NUM>, or only the lower limb model <NUM> may be attached to the model <NUM>.

As described above, in the human body simulation device <NUM> according to the first embodiment, the biological model connecting portion (first connection portion 162J, second connection portion 161J, third connection portion 163Ja, fourth connection portion 164J) is connected with the biological model simulating a part of a human body (heart model <NUM>, brain model <NUM>, liver model <NUM>, lower limb model <NUM>), so that it is possible to simulate various procedures using a medical device such as a catheter and a guide wire for a living body lumen of each organ according to the connected biological model, such as a circulatory system and a digestive system. In addition, since the biological model connecting portions 161J to 164J can connect with the biological models in an attachable/detachable manner, a biological model unnecessary for the procedure can be detached and separately stored, so that convenience can be improved.

In addition, when the human body simulation device <NUM> according to the first embodiment is connected with a biological model related to a respiratory system (lung model <NUM>, diaphragm model <NUM>), an operation of the respiratory system can affect other biological models (heart model <NUM>, brain model <NUM>, Liver model <NUM>, lower limb model <NUM>), and therefore it is possible to simulate the procedure under a more practical environment.

Furthermore, in the human body simulation device <NUM> according to the first embodiment, since the biological model connecting portion includes four types of connection portions (first connection portion 162J, second connection portion 161J, third connection portion 163Ja, fourth connection portion 164J), two or more of the heart model <NUM>, the brain model <NUM>, the liver model <NUM>, and the lower limb model <NUM> can be simultaneously connected to the aorta model <NUM>. As a result, for example, treatment or inspection for the plurality of blood vessels can be simulated in one human body simulation device <NUM>.

Furthermore, as for the human body simulation device <NUM> according to the first embodiment, in the aorta model <NUM>, the first connection portion 162J is disposed on or near an aortic arch (aortic arch portion <NUM>), the second connection portion 161J is disposed on or near an ascending aorta (ascending aorta portion <NUM>), the third connection portion 163Ja is disposed on or near an abdominal aorta (abdominal aorta portion <NUM>), the fourth connection portion 164J is disposed on or near a common iliac aorta (common iliac aorta portion 164R, <NUM>), and therefore the brain model <NUM>, heart model <NUM>, liver model <NUM>, and lower limb model <NUM> that are connected to the aorta model <NUM> can be facilely disposed at positions of the brain, heart, liver, and lower limbs in an actual human body.

Furthermore, in the human body simulation device <NUM> according to the first embodiment, the heart model <NUM> can be caused to beat in the same manner as an actual heart by the beat portion <NUM> that sends and sucks the expansion medium into/from the inner cavity of the heart model <NUM>. In addition, when a radiolucent liquid is used as the expansion medium in the beat portion <NUM>, the expansion medium can be prevented from entering an angiographic image, so that an immersive feeling of the user can be improved.

<FIG> is a diagram for explaining an example of a biological model connecting portion. In <FIG>, XYZ axes that are orthogonal to each other are illustrated. The second connection portion 161J as the biological model connecting portion is disposed on the end portion of the ascending aorta portion <NUM> and includes an opening <NUM> leading to an inner cavity <NUM> of the ascending aorta portion <NUM>. Similarly, the cardiac vessel model <NUM> as the partial blood vessel model is disposed on the end portion (proximal end 111P) of the cardiac vessel model <NUM> and includes an opening 111O leading to the inner cavity <NUM> of the cardiac vessel model <NUM>. In this case, when connecting the heart model <NUM> to the aorta model <NUM>, the second connection portion 161J and the cardiac vessel model <NUM> are fixed to each other using a fixture (not illustrated) such as a clip, in a state that an end face of the second connection portion 161J and an end face of the cardiac vessel model <NUM> are abutted against each other and the inner cavity <NUM> and the inner cavity <NUM> communicate with each other. Thereby, the heart model <NUM> can be connected to the aorta model <NUM>, so that the fluid flowing through the inner cavity <NUM> of the aorta model <NUM> can be fed to the inner cavity <NUM> of the cardiac vessel model <NUM>.

Incidentally, in <FIG>, the second connection portion 161J is illustrated as an example of the biological model connecting portion, and the cardiac vessel model <NUM> is illustrated as an example of the partial blood vessel model. However, the same configuration can be adopted for the other biological model connecting portions (first connection portion 162J, third connection portion 163Ja, fourth connection portion 164J), the fluid feeding portion connecting portion 163Jb, the other partial blood vessel models (cerebral vessel model <NUM>, hepatic vessel model <NUM>, lower limb vessel model <NUM>), and the trachea model <NUM>.

<FIG> and <FIG> are diagrams for explaining another example of the biological model connecting portion. XYZ axes in <FIG> and <FIG> correspond to the XYZ axes respectively in <FIG>. The second connection portion 161J as the biological model connecting portion additionally includes a first flange portion <NUM> formed on an outer periphery of the opening <NUM> leading to the inner cavity <NUM> of the ascending aorta portion <NUM> (aorta model <NUM>). The first flange portion <NUM> has a cylindrical body <NUM> that covers a surface of the ascending aorta portion <NUM> along an extension direction (X-axis direction) of the ascending aorta portion <NUM>, and a disk member <NUM> disposed on an opening 161O-side end portion of the cylindrical body <NUM> and extending in the YZ directions. An opening (through hole) <NUM> communicating with the inner cavity <NUM> is formed substantially in the center of the disk member <NUM>.

Similarly, the cardiac vessel model <NUM> as the partial blood vessel model further includes a second flange portion <NUM> formed on an outer periphery of the opening 111O leading to the inner cavity <NUM> of the cardiac vessel model <NUM>. The second flange portion <NUM> has a cylindrical body <NUM> that covers a surface of the cardiac vessel model <NUM> along an extension direction (X-axis direction) of the cardiac vessel model <NUM>, and a disk member <NUM> disposed on an opening 111O-side end portion of the cylindrical body <NUM> and extending in the YZ directions. An opening (through hole) communicating with the opening 111O is formed substantially in the center of the disk member <NUM>.

<FIG> and <FIG> are diagrams for explaining an example of a fixation member. XYZ axes in <FIG> and <FIG> correspond to the XYZ axes respectively in <FIG>. A fixation member <NUM> is a semicircular member having a cut-out part 95N as illustrated in <FIG>, and has an engagement portion <NUM> therein, which engages with the first and second flange portions <NUM> and <NUM>, as illustrated in <FIG>. The first flange portion <NUM>, the second flange portion <NUM>, and the fixation member <NUM> can be made of a synthetic resin such as a polyethylene, a polypropylene, and an acrylic resin.

In this case, when connecting the heart model <NUM> to the aorta model <NUM>, the first and second flange portions <NUM> and <NUM> are fixed to each other using the fixation member <NUM> such that a -X axis-direction face of the disk member <NUM> of the first flange portion <NUM> and a +X axis-direction face of the disk member <NUM> of the second flange portion <NUM> are abutted against each other, as illustrated in <FIG>. The cut-out part 95N is fitted into the cylindrical bodies <NUM> and <NUM>, and the engagement portion <NUM> engages with outer edges of the disk members <NUM> and <NUM>, so that the fixation member <NUM> fixes the first and second flange portions <NUM> and <NUM> to each other. Thereby, the heart model <NUM> can be connected to the aorta model <NUM> in the same manner as in <FIG>, so that the fluid flowing through the inner cavity <NUM> of the aorta model <NUM> can be fed to the inner cavity <NUM> of the cardiac vessel model <NUM>. Incidentally, the configurations in <FIG> may be adopted for the other biological model connecting portions, the fluid feeding portion connecting portion 163Jb, the other partial blood vessel models, and the trachea model <NUM>.

As described above, in this case, the first flange portion <NUM> on the ascending aorta portion <NUM> (aorta model <NUM>) side and the second flange portion <NUM> on the cardiac vessel model <NUM> (partial blood vessel model) side are fixed to each other so as to be abutted against each other, so that the biological model can be easily connected to the aorta model <NUM>. Additionally, in this case, the first flange portion <NUM> and the second flange portion <NUM> can be easily fixed to each other using the fixation member <NUM>. Incidentally, when fixing the first and second flange portions <NUM> and <NUM> to each other without using the fixation member <NUM>, the disk members <NUM> and <NUM> may be fixed to each other using a fixture such as a clip.

Incidentally, in the cases of <FIG> and <FIG>, elastic body layers <NUM> and <NUM> made of an elastic body are disposed on an abutting face between the first flange portion <NUM> and the second flange portion <NUM> (specifically, the -X axis-direction face of the disk member <NUM> and the +X axis-direction face of the disk member <NUM>) respectively. Similarly to the disk members <NUM> and <NUM>, the elastic body layers <NUM> and <NUM> have openings (through holes) communicating with the openings <NUM> and 111O. Such a configuration having the elastic body layers <NUM> and <NUM> makes it possible to improve airtightness of the connection portion between the first flange portion <NUM> and the second flange portion <NUM>, in other words, the connection portion between the ascending aorta portion <NUM> (aorta model <NUM>) and the cardiac vessel model <NUM> (partial blood vessel model) to prevent the fluid from leaking on the connection portion.

Incidentally, the aforementioned first flange portion <NUM> and second flange portion <NUM> may be provided with different shapes, different colors, and different marks for each combination of the biological model connecting portion and the corresponding partial blood vessel model. For example, the first flange portion <NUM> of the first connection portion 162J and the second flange portion <NUM> of the cerebral vessel model <NUM> may be colored yellow, and the first flange portion <NUM> of the first connection portion 162J and the second flange portion <NUM> of the cardiac vessel model <NUM> may be colored red. In this way, it is possible to grasp at a glance what biological model (specifically, the partial blood vessel model leading to the biological model) is preferably connected to what biological model connecting portion, and therefore the usability can be improved. In addition, the disk member <NUM> of the first flange portion <NUM> of the first connection portion 162J and the disk member <NUM> of the second flange portion <NUM> of the cerebral vessel model <NUM> may be formed in a rectangular shape, and the disk member <NUM> of the first flange portion <NUM> of the first connection portion 162J and the disk member <NUM> of the second flange portion <NUM> of the cardiac vessel model <NUM> may be formed in a semicircular shape. The same effect can also be obtained in this way.

<FIG> is a diagram for explaining an example of the biological model connecting portion during nonuse. XYZ axes in <FIG> correspond to the XYZ axes respectively in <FIG>. When the biological model (heart model <NUM>) is not connected to the ascending aorta portion <NUM> (aorta model <NUM>), an occlusion member <NUM> illustrated in <FIG>, instead of the first flange portion <NUM> explained in <FIG> and <FIG>, may be attached to the ascending aorta portion <NUM>. The occlusion member <NUM> includes a disk member <NUM> having no opening, instead of the disk member <NUM>. When the occlusion member <NUM> is attached to the ascending aorta portion <NUM>, the opening <NUM> formed on the ascending aorta portion <NUM> of the ascending aorta portion <NUM> is closed, so that the fluid passing through the inner cavity <NUM> can be prevented from leaking from the opening <NUM>. Incidentally, during nonuse, the occlusion member <NUM> illustrated in <FIG> may be attached to the other biological model connecting portions, the fluid feeding portion connecting portion 163Jb, the other partial blood vessel models, and the trachea model <NUM>.

<FIG> is a flowchart illustrating an example of a processing procedure in the control portion. The control portion <NUM> controls operations of the pulsation portion <NUM>, the beat portion <NUM>, and the breathing portion <NUM> by the processing illustrated in <FIG>. The control portion <NUM> starts the processing in <FIG> at any timing (e.g. a timing when the human body simulation device <NUM> is powered on, a timing when the processing start instruction is acquired from the input portion <NUM>, or the like).

In step S12, the control portion <NUM> acquires a heart rate i. Specifically, the control portion <NUM> causes the input portion <NUM> (touch panel) to display a screen for designating a heart rate, and acquires a value input by the user. The value is defined as the heart rate i. If the user does not designate the heart rate, the control portion <NUM> may designate the heart rate i as a prescribed default value. In step S14, the control portion <NUM> acquires a respiratory rate j. Specifically, the control portion <NUM> causes the input portion <NUM> to display a screen for designating a respiratory rate, and acquires a value input by the user. The value is defined as the respiratory rate j. If the user does not designate the respiratory rate, the control portion <NUM> may designate the respiratory rate j as a prescribed default value. Incidentally, steps S12 and S14 may be performed at the same time.

In step S16, the control portion <NUM> acquires an operation target. Specifically, the control portion <NUM> causes the input portion <NUM> to display a screen for designating what operation portion is operated among the pulsation portion <NUM>, the beat portion <NUM>, and the breathing portion <NUM>, and acquires an operation target designated by the user. Incidentally, the user can designate one or more (a plurality) of the pulsation portion <NUM>, the beat portion <NUM>, and the breathing portion <NUM> as the operation targets. In step S18, the control portion <NUM> determines whether the operation target designated in step S16 is a part or the whole of the pulsation portion <NUM>, the beat portion <NUM>, and the breathing portion <NUM>. When the designated operation target is a part (step S18: part), the control portion <NUM> shifts the processing to step S20. On the other hand, when the designated operation target is the whole (step S18: whole), the control portion <NUM> shifts the processing to step S30.

In step S20, the control portion <NUM> operates an operation portion designated by the user in step S16. When operation of the pulsation portion <NUM> is designated, the control portion <NUM> operates the pulsation portion <NUM> such that a pulsation rate of the pulsation portion <NUM> coincides with the heart rate i acquired in step S12. When operation of the beat portion <NUM> is designated, the control portion <NUM> operates the beat portion <NUM> such that a beat rate of the beat portion <NUM> coincides with the heart rate i acquired in step S12. Incidentally, when both the pulsation portion <NUM> and the beat portion <NUM> are operated, the control portion <NUM> may shift a phase of the pulsation portion <NUM> and a phase of the beat portion <NUM>. When operation of the breathing portion <NUM> is designated, the control portion <NUM> operates the breathing portion <NUM> such that a respiratory rate of the breathing portion <NUM> coincides with the respiratory rate j acquired in step S14.

In step S22, the control portion <NUM> determines whether or not a termination condition of the processing has been satisfied. Various arbitrary conditions can be adopted as the termination condition. For example, when the human body simulation device <NUM> is powered off, or when a termination instruction of the processing is acquired from the input portion <NUM>, or the like, the control portion <NUM> can determine that the termination condition has been satisfied. When the termination condition has been satisfied (step S22: YES), the control portion <NUM> terminates the processing. If the termination condition has not been satisfied (step S22: NO), the control portion <NUM> shifts the processing to step S20 and continues the designated operation of the operation portion using the designated heart rate i and respiratory rate j.

On the other hand, in step S30, the control portion <NUM> acquires an operation mode. Specifically, the control portion <NUM> causes the input portion <NUM> to display a screen for designating which operation mode is selected between "first mode" and "second mode", and acquires an operation mode designated by the user. In the first embodiment, the first mode means an operation mode for regularly keeping the beat rate of the beat portion <NUM>, the pulsation rate of the pulsation portion <NUM>, the respiratory rate of the breathing portion <NUM> by constantly keeping the heart rate i and the respiratory rate j. On the other hand, the second mode means an operation mode for irregularly changing the beat rate of the beat portion <NUM>, the pulsation rate of the pulsation portion <NUM>, the respiratory rate of the breathing portion <NUM> by irregularly changing the heart rate i and the respiratory rate j.

In step S32, the control portion <NUM> shifts the processing depending on the operation mode acquired in step S30. When the operation mode acquired in step S30 is the first mode (step S32: first mode), the control portion <NUM> shifts the processing to step S40. When the operation mode acquired in step S30 is the second mode (step S32: second mode), the control portion <NUM> shifts the processing to step S50. The second mode processing in step S50 will be explained in <FIG>.

In step S40, the control portion <NUM> executes the first mode processing in steps S40 to S46. Specifically, in step S40, the control portion <NUM> operates the pulsation portion <NUM> such that the pulsation rate of the pulsation portion <NUM> is a pulsation rate (i, cos) of which a phase is shifted by <NUM> degrees from the heart rate i acquired in step S12. In step S42, the control portion <NUM> operates the beat portion <NUM> such that the beat rate of the beat portion <NUM> coincides with the heart rate i acquired in step S12. In step S44, the control portion <NUM> operates the breathing portion <NUM> such that the respiratory rate of the breathing portion <NUM> coincides with the respiratory rate j acquired in step S14.

Then, in step S46, the control portion <NUM> determines whether or not a termination condition of the processing has been satisfied. Similarly to step S22, various arbitrary conditions can be adopted as the termination condition. The termination condition of step S46 and the termination condition of step S22 may be the same or different. When the termination condition has been satisfied (step S46: YES), the control portion <NUM> terminates the processing. If the termination condition has not been satisfied (step S46: NO), the control portion <NUM> shifts the processing to step S40 and continues the first mode processing.

<FIG> is a flowchart illustrating an example of a procedure of a second mode processing. In step S52, the control portion <NUM> acquires a current time, and the current time is defined as a start time t0. In step S54, the control portion <NUM> initializes a variable for use in the second mode processing. Specifically, in the control portion <NUM>, the heart rate i acquired in step S12 (<FIG>) is assigned to a variable n and a variable o, and the respiratory rate j acquired in step S14 (<FIG>) is assigned to a variable p.

In steps S60 to S64, the control portion <NUM> operates the pulsation portion <NUM>, the beat portion <NUM>, and the breathing portion <NUM> by using the variables n, o, and p. Specifically, in step S60, the control portion <NUM> operates the pulsation portion <NUM> such that the pulsation rate of the pulsation portion <NUM> is a pulsation rate (n, cos) of which a phase is shifted by <NUM> degrees from the variable n. In step S62, the control portion <NUM> operates the beat portion <NUM> such that the beat rate of the beat portion <NUM> coincides with the variable o. In step S64, the control portion <NUM> operates the breathing portion <NUM> such that the respiratory rate of the breathing portion <NUM> coincides with the variable p. In steps S60 to S64 after initialization of the variables n, o, and p (step S54), the variables n and o are equal to the heart rate i input by the user, and the variable p is equal to the respiratory rate j input by the user. Thus, in steps S60 to S64 after initialization of the variables n, o, and p (step S54), the pulsation portion <NUM>, the beat portion <NUM>, and the breathing portion <NUM> are operated using a constantly-kept heart rate i (variable n, o) and a constantly-kept respiratory rate j (variable p).

In step S70, the control portion <NUM> generates a random number, and this random number is defined as a time coefficient x. In step S72, the control portion <NUM> generates a random number, and this random number is defined as a beat coefficient k.

In step S74, the control portion <NUM> determines an abnormal heartbeat occurrence time m1 and an abnormal heartbeat duration time m2 from the time coefficient x. Herein, the abnormal heartbeat occurrence time m1 means a time to start the change (from the constant mode to the irregular mode) in the beat rate of the beat portion <NUM>, the pulsation rate of the pulsation portion <NUM>, and the respiratory rate of the breathing portion <NUM>. In addition, the abnormal heartbeat duration time m2 means a duration time for irregularly keeping the beat rate of the beat portion <NUM>, the pulsation rate of the pulsation portion <NUM>, and the respiratory rate of the breathing portion <NUM>. The control portion <NUM> can determine the abnormal heartbeat occurrence time m1 and the abnormal heartbeat duration time m2 using the time coefficient x in any method. For example, in the control portion <NUM>, the abnormal heartbeat occurrence time m1 may be represented by t0+x (min), and the abnormal heartbeat duration time m2 may be represented by x (min). In this case, when the time coefficient x being <NUM> is taken as an example, the abnormal heartbeat occurrence time m1 is <NUM> minutes after the start time t0 of step S52, and the abnormal heartbeat duration time m2 is <NUM> minutes.

<FIG> is a diagram for explaining step S76 in the second mode processing. In step S76 in the second mode processing (<FIG>), the control portion <NUM> determines whether or not a sum (i.e. current time) of the start time t0 acquired in step S52 and an elapsed time Δt from the start time t0 is smaller than the abnormal heartbeat occurrence time m1 determined in step S74. If the current time is smaller than the abnormal heartbeat occurrence time m1 (step S76: YES, <FIG>: region A1), the control portion <NUM> shifts the processing to step S78. In step S78, the control portion <NUM> determines whether or not a termination condition of the processing has been satisfied. Similarly to step S22 in <FIG>, various arbitrary conditions can be adopted as the termination condition. The termination condition of step S78 and the termination condition of step S22 may be the same or different.

If the current time is larger than or equal to the abnormal heartbeat occurrence time m1 (step S76: NO, <FIG>: region A2 or region A3), the control portion <NUM> shifts the processing to step S80. In step S80, the control portion <NUM> determines whether or not the sum (i.e. current time) of the start time t0 acquired in step S52 and the elapsed time Δt from the start time t0 is smaller than a sum of the abnormal heartbeat occurrence time m1 and the abnormal heartbeat duration time m2 determined in step S74. If the current time is larger than or equal to the sum of the times m1 and m2 (step S80: NO, <FIG>: region A3), the control portion <NUM> shifts the processing to step S52 (acquisition of the start time t0) and repeats the processing.

If the current time is smaller than the sum of the times m1 and m2 (step S80: YES, <FIG>: region A2), the control portion <NUM> shifts the processing to step S82. In step S82, the control portion <NUM> allocates the processing to the following first to third patterns depending on a value obtained by multiplying the heart rate i acquired in step S12 (<FIG>) by the beat coefficient k generated in step S72. The following first to third patterns correspond to a plurality of patterns that simulate severities of a patient. In the case of <FIG>, it is assumed that the third pattern is the most serious and the first pattern is the mildest.

When the value obtained by multiplying the heart rate i by the beat coefficient k is smaller than or equal to <NUM> (step S82: i*k≤<NUM>), the control portion <NUM> adds a correction value in the first pattern in step S84. Specifically, in the control portion <NUM>, the product obtained by multiplying the heart rate i by the beat coefficient k is assigned to the variable n, the product obtained by multiplying the heart rate i by the beat coefficient k is assigned to the variable o, and the product obtained by multiplying the respiratory rate j by (respiratory rate j × beat coefficient k / variable o) is assigned to the variable p.

When the value obtained by multiplying the heart rate i by the beat coefficient k is larger than <NUM> and smaller than or equal to <NUM> (step S82: <NUM><i*k≤<NUM>), the control portion <NUM> adds a correction value in the second pattern in step S86. Specifically, in the control portion <NUM>, the product obtained by multiplying the heart rate i by the beat coefficient k is assigned to the variable n, <NUM> is assigned to the variable o, and the product obtained by multiplying the respiratory rate j by (respiratory rate j × beat coefficient k / variable o) is assigned to the variable p.

When the value obtained by multiplying the heart rate i by the beat coefficient k is larger than <NUM> (step S82: <NUM><i*k), the control portion <NUM> adds a correction value in the third pattern in step S88. Specifically, in the control portion <NUM>, the product obtained by multiplying the heart rate i by the beat coefficient k is assigned to the variable n, <NUM> is assigned to the variable o, and <NUM> is assigned to the variable p.

After steps S84, S86, and S88 are completed, the control portion <NUM> shifts the processing to step S60 and repeats the aforementioned processing. Thereby, in steps S60, S62, and S64, the pulsation portion <NUM>, the beat portion <NUM>, and the breathing portion <NUM> are operated, using the variables n, o, and p to which correction values have been added in any of the first to third patterns, in other words, using the variables n, o, and p that have been irregularly changed by the first to third patterns and the randomly-generated beat coefficient k.

As described above, since the human body simulation device <NUM> according to the first embodiment includes the heart model <NUM> simulating a heart and the blood vessel models simulating blood vessels (aorta model <NUM>, cardiac vessel model <NUM>, cerebral vessel model <NUM>, hepatic vessel model <NUM>, lower limb vessel model <NUM>), it is possible to simulate e.g. a treatment or inspection procedure using a medical device for minimally invasive treatment or inspection for heart, such as Percutaneous Coronary Intervention (PCI) for ischemic heart disease. In addition, the control portion <NUM> of the human body simulation device <NUM> can change the beat rate of the beat portion <NUM> for causing the heart model <NUM> to beat, and a pulsation rate of the pulsation portion <NUM> for sending the fluid into each blood vessel model such as the aorta model <NUM>, depending on the prescribed heart rate i (<FIG>: steps S12, S20, S40, S42). Thus, it is possible to simulate a treatment or inspection procedure under various conditions of the beat rate and pulsation rate.

In addition, in the human body simulation device <NUM> according to the first embodiment, the control portion <NUM> can change the respiratory rate of the breathing portion <NUM> depending on the prescribed respiratory rate j (<FIG>: steps S14, S20, S44). Thereby, it is possible to simulate the treatment or inspection procedure in a more practical manner. Furthermore, since the human body simulation device <NUM> according to the first embodiment includes the input portion <NUM> for inputting the heart rate i and the respiratory rate j, the user of the human body simulation device <NUM> can freely set the beat rate of the beat portion <NUM>, the pulsation rate of the pulsation portion <NUM>, and the respiratory rate of the breathing portion <NUM>.

Furthermore, in the human body simulation device <NUM> according to the first embodiment, the control portion <NUM> can switch and execute the first mode simulating a patient in a normal state by regularly keeping the beat rate, the pulsation rate, and the respiratory rate (<FIG>: steps S40 to S46), and the second mode simulating a patient in an arrhythmic state by irregularly changing the beat rate, the pulsation rate, and the respiratory rate (<FIG>: step S50, <FIG>). Thus, the human body simulation device <NUM> makes it possible to simulate a treatment or inspection procedure under both the normal state and the arrhythmic state.

Furthermore, in the human body simulation device <NUM> according to the first embodiment, the control portion <NUM> determines the heart rate i and the respiratory rate j (i.e. variables n, o, p) in the second mode (<FIG>) in accordance with one pattern randomly selected from the first to third patterns simulating the severities of the patient using the randomly determined beat coefficient k (step S82). Thus, to simulate a sudden change of an actual patient's condition, the beat rate of the beat portion <NUM>, the pulsation rate of the pulsation portion <NUM>, and the respiratory rate of the breathing portion <NUM> can be changed in a manner unpredictable by the user of the human body simulation device <NUM>. Thus, the human body simulation device <NUM> make it possible to simulate a treatment or inspection procedure in a more practical manner.

Furthermore, in the human body simulation device <NUM> according to the first embodiment, since the control portion <NUM> repeatedly executes the first cycle (<FIG>: regions A1, A3) in which the beat rate, the pulsation rate, and the respiratory rate are kept constant and the second cycle (<FIG>: region A2) in which the beat rate, the pulsation rate, and the respiratory rate are changed in the second mode (<FIG>), a patient's condition repeating arrhythmia and lull can be reproduced. Additionally, in the control portion <NUM>, an abnormal heartbeat occurrence time m1 at which the second cycle starts for changing the beat rate, the pulsation rate, and the respiratory rate, and the abnormal heartbeat duration time m2 during which the second cycle continues are randomly determined using the randomly-determined time coefficient x, in the second mode (<FIG>: step S74). Thus, the beat rate, the pulsation rate, and the respiratory rate can be changed in a manner unpredictable by the user of the human body simulation device <NUM>. As a result, the human body simulation device <NUM> makes it possible to simulate a treatment or inspection procedure in a more practical manner.

Furthermore, the control portion <NUM> can switch and execute a partial operation for operating at least any one of the pulsation portion <NUM>, the beat portion <NUM>, and the breathing portion <NUM> (<FIG>: step S20) and the whole operation for operating the all portions (<FIG>: steps S40 to S44) (<FIG>: step S18). Thus, convenience for the user of the human body simulation device <NUM> can be improved.

<FIG> is an explanatory diagram illustrating an example of a configuration of a model 10a according to the second embodiment. The first embodiment (<FIG>) describes, as an example, a case that, among the biological model connecting portions included in the aorta model <NUM>, the second connection portion 161J is connected with the heart model <NUM>, the first connection portion 162J is connected with the brain model <NUM>, and the third connection portion 163Ja is connected with the liver model <NUM>, and the fourth connection portion 164J is connected with the lower limb model <NUM>. However, the biological model connecting portions and the biological models connected to the biological model connecting portions are not necessarily combined in the aforementioned combinations. For example, as illustrated in <FIG>, the liver model <NUM> may be connected to the second connection portion 161J. Additionally, in the second embodiment, instead of the aorta model <NUM> having the plurality of biological model connecting portions, an aorta model 160a having one biological model connecting portion (the second connection portion 161J in the illustrated case). Also in such a way, the same effect as in the aforementioned first embodiment can be exhibited.

<FIG> is a diagram illustrating an example of a heart model 110b according to the third embodiment. In the first embodiment (<FIG>), the distal end 111D of the cardiac vessel model <NUM> was supposed to branch into the integrally-formed left and right coronary artery models <NUM> and 112R. However, the left and right coronary artery models <NUM> and 112R may include a plurality of blood vessel constituting portions <NUM>, <NUM>, <NUM>, <NUM>, and <NUM> that constitute each portion of the blood vessel. In addition, lesion portions simulating lesions inside and outside the blood vessel may be formed on at least a part of each blood vessel constituting portion <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>. In the case of <FIG>, a bump-like lesion portion LP is formed outside the blood vessel of the blood vessel constituting portion <NUM> in the left coronary artery model <NUM>. In addition, a stenosed lesion portion LP is formed inside the blood vessel of the blood vessel constituting portion <NUM> in the right coronary artery model 112R. In such a heart model 110b according to the third embodiment, for the same vascular constituting portion, both a blood vessel constituting portion having no lesion portion LP and a blood vessel constituting portion having the lesion portion LP are further prepared, and may be configured so as to be replaceable with each other.

Incidentally, in <FIG>, the heart model 110b is illustrated. However, the same configuration as in the third embodiment can be adopted also for other biological models having a partial blood vessel model (<FIG>: brain model <NUM>, liver model <NUM>, lower limb model <NUM>). Also, the same configuration as in the third embodiment may be adopted for the aorta model <NUM> (<FIG>).

Also in such a way, the same effect as in the first embodiment can be exhibited. In addition, in a model 10b according to the third embodiment, the partial blood vessel model (cardiac vessel model <NUM>) includes the plurality of blood vessel constituting portions <NUM>, <NUM>, <NUM>, <NUM>, and <NUM>, and the lesion portions LP simulating lesions are formed on at least a part of the plurality of blood vessel constituting portions <NUM>, <NUM>, <NUM>, <NUM>, and <NUM>. Thus, an operator can simulate a procedure (e.g. a procedure such as PCI) using a medical device such as a guide wire and a catheter for the lesion portion LP formed on the partial blood vessel model.

<FIG> is a diagram for explaining a biological model connecting portion according to the fourth embodiment. In the first embodiment (<FIG>), the first flange portion <NUM> and the second flange portion <NUM> were fixed to each other by using the fixation member <NUM> having the configuration illustrated in <FIG> and <FIG>. However, the first flange portion <NUM> and the second flange portion <NUM> may be fixed to each other by using a fixation member having a configuration different from that of the fixation member <NUM>. For example, as illustrated in <FIG>, the first flange portion <NUM> and the second flange portion <NUM> may be fixed to each other by using the screw <NUM>. Also in such a way, the same effect as in the aforementioned first embodiment can be exhibited.

<FIG> is a diagram for explaining a biological model connecting portion according to the fifth embodiment. In the first embodiment (<FIG>), the elastic body layers <NUM> and <NUM> made of the elastic body were disposed on the abutting faces of the first flange portion <NUM> and the second flange portion <NUM> respectively. However, at least one of the elastic body layers <NUM> and <NUM> may be omitted. For example, as illustrated in <FIG>, it is allowed to adopt a configuration in which a first flange portion 91d does not include the elastic body layer and the second flange portion 92d does not include the elastic body layer. Also in such a way, the same effect as in the aforementioned first embodiment can be exhibited.

<FIG> is a diagram illustrating a schematic configuration of a human body simulation device 1e according to the sixth embodiment. <FIG> is a flowchart illustrating an example of a procedure of a second mode processing according to the sixth embodiment. In the first embodiment (<FIG> and <FIG>), the control portion <NUM> randomly determined the time coefficient x and the beat coefficient k to be used in the second mode processing, by using the random number. However, the time coefficient x and the beat coefficient k to be used in the second mode processing may be determined depending on a state of a biological model.

For example, as illustrated in <FIG>, in the human body simulation device 1e according to the sixth embodiment, a model 10e includes a sensor <NUM> disposed on the distal end 111D of the cardiac blood vessel model <NUM>, specifically the distal ends of the left and right coronary artery models <NUM> and 112R (<FIG>, apex-side end portions of the left and right coronary artery models <NUM> and 112R). The sensor <NUM> detects a fluid pressure (blood pressure of the simulation blood) in a peripheral blood vessel. Similarly, the model 10e includes a sensor <NUM> disposed on the distal end 131D of the cerebral vessel model <NUM>, a sensor <NUM> disposed on the distal end 141D of the hepatic vessel model <NUM>, and a sensor <NUM> disposed on the distal end 151D of the lower limb vessel model <NUM>. Each of the sensors <NUM>, <NUM>, <NUM>, and <NUM> functionally serves as a "pressure measuring portion" for measuring the fluid pressure in the peripheral part of the partial blood vessel model.

As illustrated in <FIG>, in the second mode processing according to the sixth embodiment, a control portion 40e determines the time coefficient x and the beat coefficient k depending on the pressure measured by the sensors <NUM>, <NUM>, <NUM>, and <NUM>. Specifically, in the second mode processing in <FIG>, steps S90, S92, and S94 are executed instead of steps S70 and S72 in <FIG> (first embodiment). In step S90, the control portion 40e acquires the values measured by the sensors <NUM>, <NUM>, <NUM>, and <NUM>.

In step S92, the control portion 40e determines the time coefficient x from each sensor measurement value acquired in step S90. Specifically, the control portion 40e can determine the time coefficient x by means such as calculation (e.g. multiplication/division by a prescribed coefficient) using the sensor measurement value, and search (e.g. search for correspondence between a predetermined threshold value of the sensor measurement value and the time coefficient) using the sensor measurement value. At this time, the control portion 40e may determine the time coefficient x using only the measurement value of one sensor, or may determine the time coefficient x using the measurement values of a plurality of sensors. In step S94, the control portion 40e determines the beat coefficient k from each sensor measurement value acquired in step S90. Similarly to step S92, the control portion 40e can determine the beat coefficient k by means such as calculation using one or a plurality of sensor measurement values, and search using one or a plurality of sensor measurement values.

Also in such a way, the same effect as in the aforementioned first embodiment can be exhibited. In addition, in the human body simulation device 1e according to the sixth embodiment, the control portion 40e determines the heart rate i and the respiratory rate j (i.e. variables n, o, p) in the second mode (<FIG>) in accordance with one pattern selected from the first to third patterns simulating the severities of the patient depending on the fluid pressure (i.e. value measured by the sensor <NUM>, <NUM>, <NUM>, <NUM>) in the peripheral part of the blood vessel model (cardiac vessel model <NUM>, cerebral vessel model <NUM>, hepatic vessel model <NUM>, lower limb vessel model <NUM>) (step S82). That means, the control portion 40e can change the beat rate of the beat portion <NUM>, the pulsation rate of the pulsation portion <NUM>, and the respiratory rate of the breathing portion <NUM> correspondingly to change in the blood pressure in the peripheral blood vessel. Thus, the human body simulation device 1e according to the sixth embodiment makes it possible to simulate a treatment or inspection procedure in a more practical manner.

<FIG> is a diagram illustrating a schematic configuration of a human body simulation device 1f according to the seventh embodiment. In the first embodiment (<FIG>), an example of the device configuration of the human body simulation device <NUM> has been explained. However, the human body simulation device <NUM> may include various units used in actual treatment or inspection. For example, as illustrated in <FIG>, the human body simulation device 1f according to the seventh embodiment includes a monitor (display portion) <NUM> connected to a control portion 40f. During execution of the processing explained in <FIG> and <FIG>, the control portion 40f causes the monitor <NUM> to display a graph presenting the prescribed heart rate i and respiratory rate j, and the heart rate i and respiratory rate j changed in the second mode processing (i.e. variables n, o, p).

Also in such a way, the same effect as in the aforementioned first embodiment can be exhibited. In addition, in the human body simulation device 1f according to the seventh embodiment, since the control portion 40f causes the display portion <NUM> to display the graph presenting changes in the heart rate i and the respiratory rate j, a scene of the treatment or inspection can be reproduced in a more practical manner, and convenience for the user can be improved.

The present inventionis not limited to the above embodiments, and can be implemented in various aspects without departing from the gist of the disclosed embodiments. For example, the following modifications are also possible.

In the above first to seventh embodiments, some examples of the configurations of the human body simulation devices <NUM>, 1e and 1f have been described. However, the configuration of the human body simulation device can be variously changed. For example, the human body simulation device need not include at least one of the water bath and the covering portion that covers the water bath. For example, the human body simulation device may include an input portion using a means other than the touch panel (e.g. sound, manipulation dial, button, or the like).

In the above first to seventh embodiments, some examples of the configurations of the models <NUM>, 10a, 10b, 10e, and 10f have been described. However, the configuration of the model can be variously modified. For example, the aorta model need not include at least a part of the aforementioned first to fourth connection portions. For example, the arrangement of the aforementioned first to fourth connection portions in the aorta model may be optionally changed, and the first connection portion need not be disposed on or near the aortic arch. Similarly, the second connection portion need not be disposed on or near the ascending aorta, the third connection portion need not be disposed on or near the abdominal aorta, and the fourth connection portion need not be disposed on or near the common iliac aorta. For example, the number of the biological model connecting portions in the aorta model can be optionally changed, and a new biological model connecting portion for connecting biological models (e.g. stomach model, pancreas model, kidney model, or the like) not described above may be provided.

For example, the model need not include at least a part of the heart model, the lung model, the brain model, the liver model, the lower limb model, and the diaphragm mode. When omitting the heart model, the beat portion can be concurrently omitted. When omitting the lung model and the diaphragm model, the breathing portion can be concurrently omitted. For example, the model may be configured as a complex additionally including bone models simulating at least a part of human skeletons such as rib, sternum, thoracic spine, lumbar spine, femur, and tibia.

For example, the configurations of the aforementioned heart model, lung model, brain model, liver model, lower limb model, and diaphragm model may be optionally changed. For example, the inner cavity of the heart model and the beat portion that sends the fluid into the inner cavity of the heart model may be omitted (<FIG>). For example, the cardiac vessel model of the heart model need not include the right and left coronary artery models, and each of the right and left coronary artery models may be configured in an attachable/detachable manner (<FIG>). For example, in the lung model, an individual inner cavity may be placed on each of the right and left lungs (<FIG>). For example, the lower limb model may additionally include a skin model that covers a femoral muscle (<FIG>).

In the above first to seventh embodiments, some examples of the processing procedures in the control portions <NUM>, 40e, and 40f have been described. However, the processing in the control portion can be variously modified. For example, at least either one of the partial operation of the pulsation portion, the beat portion, and the breathing portion (<FIG>: steps S20, S22) or the whole operation (<FIG>: steps S30 to S50) may be omitted. For example, at least either one of the first operation mode processing (<FIG>: steps S40 to S46) or the second operation mode processing (<FIG>: steps S50, <FIG>, <FIG>) may be omitted. For example, the control portion may execute the second mode processing using one variable that unifies the time coefficient x and a time coefficient y.

For example, the control portion need not perform the breathing portion control based on the respiratory rate j and the respiratory rate j (or variable p) (<FIG>: steps S20, S44, <FIG>: step S64). For example, the control portion need not perform the pulsation portion control based on the heart rate i and the heart rate i (or variable n) (<FIG>: steps S20, S40, <FIG>: step S60). For example, the control portion need not perform the beat portion control based on the heart rate i and the heart rate i (or variable o) (<FIG>: steps S20, S42, <FIG>: step S62).

The configurations of the human body simulation devices according to the first to seventh embodiments, and the configurations of the human body simulation devices according to the modification examples <NUM> to <NUM> may be appropriately combined.

Claim 1:
A human body simulation device (<NUM>,1e,1f) for simulating a procedure of percutaneous coronary intervention comprising:
a heart model (<NUM>,110b) simulating a heart;
a beat portion (<NUM>) for causing the heart model (<NUM>,110b) to beat;
a blood vessel model (<NUM>,160a,<NUM>,<NUM>,<NUM>,<NUM>) simulating a blood vessel;
a pulsation portion (<NUM>) for sending a pulsated fluid into the blood vessel model (<NUM>,160a,<NUM>,<NUM>,<NUM>,<NUM>);
a control portion (<NUM>,40e,40f) for changing a beat rate of the beat portion (<NUM>) and a pulsation rate of the pulsation portion (<NUM>) depending on a prescribed heart rate, and
characterized in that the human body simulation device further comprises:
a diaphragm model (<NUM>) simulating a diaphragm; and
a breathing portion (<NUM>) causing the diaphragm model (<NUM>) to simulate breathing.