JP2022071701A - Simulated organ model - Google Patents

Abstract

To provide a simulated organ model that a user can use more easily than an existing simulator or an existing organ model.SOLUTION: The simulated organ model includes: a simulated organ model body 1; an eccentric rotation body 2 in the simulated organ model body; and a driving unit 3 for driving the eccentric rotation body, the eccentric rotation body being relatively driven to the simulated organ model body and the surface of the eccentric rotation body and the simulated organ model body being directly slid so that periodic repetitive actions of the simulated organ model body in association with the slide can be reproduced.SELECTED DRAWING: Figure 1

Description

The present invention relates mainly to a simulated organ model used for training of surgical techniques.

(Surgery training using simulated organs)
Conventionally, surgical technique training using a simulated organ model has been performed mainly to compensate for the lack of surgical experience of young doctors.

As described below, such surgical technique training uses animal organs such as pigs called wet labs, artificial simulated organs such as simulators called dry labs, and organ models. In addition, although the number is small, training using live animals such as pigs, which is called Animal Lab, is also conducted.

(Off-JT)
Here, these wet laboratories, dry laboratories, etc. are collectively referred to as Off-the-job training (Off-JT) because they are performed in a time and environment different from clinical work for actual patients.

Off-JT is rapidly becoming widespread as a means for educating and training surgeons in surgical skills in situations where patients are not at risk. In Japan, the Cardiovascular Surgeon Certification Organization requires 30 hours of Off-JT experience to acquire a cardiologist.

(Dry lab)
As a means of Off-JT, the spread of dry laboratories is accelerating, but there is a problem in the reproducibility of the properties and anatomy of living tissues. Therefore, it is common practice to perform advanced training in a wet lab environment that is closer to clinical practice after repetitive basic training in a dry lab.

(Wet lab)
Wild animals are unsuitable for wet lab animal organs from the viewpoint of hygiene and safety, and livestock organs for meat use are suitable, and livestock organs for meat such as pigs are mainly used. Especially in cardiovascular surgery, the porcine heart is used for training because of its similar weight and dimensions. In gastrointestinal surgery, the pig stomach and large intestine are used, and in respiratory surgery, pig cardiopulmonary is used.

(Animal Lab)
Animal labs, on the other hand, are the most high-end training method using live animals.

At Animal Labs, pigs are mainly used. The use of a living body has merits such as blood circulation, bleeding, respiration, biological reaction to a drug, and anatomical reproducibility. In particular, biological heartbeat, respiration, gastrointestinal tract movement, and behavior are important factors in practicing surgical techniques.

However, Animal Labs are extremely limited in terms of ethics, safety, and cost, and are not suitable for daily training.

Therefore, conventionally, wet labs have been devised to impart movements and behaviors peculiar to living organisms to the organs to be trained.

(Prior technique of the type that pressurizes and drives the lumen of the simulated heart)
First, as a type of conventional technique for pressurizing and driving the lumen of a simulated heart, the techniques disclosed in JP-A-2006-276258, JP-A-6629002, JP-A-2012-203016, and Patent No. 581250. There is. The techniques disclosed in these documents reproduce the beating behavior of the heart by pressurizing and depressurizing the working fluid in the heart model and the porcine heart cavity.

Further, Japanese Patent Application Laid-Open No. 2020-091306 discloses a technique of filling the lumen of a target organ with a working fluid to reproduce hemodynamics and diffusion of a contrast medium, but this technique imparts exercise to the target organ. Not intended.

(Conventional technique of the type that drives the entire simulated heart)
Further, as a conventional technique of a type that drives the entire simulated heart, there is a technique disclosed in Japanese Patent Application Laid-Open No. 2005-2020267. This technique uses an external drive device that combines a rotation drive means and a swing means to apply motion to the entire target simulated organ.

(Conventional technique of the type that drives a part of the entire simulated heart)
Further, as a conventional technique of a type that drives a part of a simulated heart, there is one disclosed in Japanese Patent Application Laid-Open No. 2014-142535. This technique reproduces the movement of the stomach inside the stomach by connecting the rotating body and the rotating body and bringing the rotating body into contact with the stomach model.

In this way, in order to drive the target organ, a method of filling the inside with a working fluid and pressurizing / depressurizing, a method of applying motion to the entire simulated organ by an external driving means, and a method of applying motion to the entire simulated organ by an external driving means are used inside the simulated organ. Prior art is a method of imparting the desired movement.

Among surgical operations, cardiac surgery, laparoscopic surgery, thoracoscopic surgery, and among clinical examinations, gastrointestinal endoscopy, etc., have a large effect on the pulsation and movement of specific organs. Therefore, the training simulator for the procedure is required to reproduce the behavior.

Surgical training needs to be done easily with a small number of people due to the spread of new corona infections. When preparing and using the simulator, it is not possible to use a large amount of manpower, and there is a demand for a simulated organ model that has a simple and concise structure and has necessary and sufficient functions.

All of the above-mentioned organ driving methods according to the prior art have a complicated structure and require careful handling. For example, in driving the target organ by pressurizing or depressurizing the working fluid, ensuring confidentiality is a major issue, it is difficult to reliably prevent the leakage of the working fluid, and it is necessary for the maintenance staff to always manage the simulator. Also, driving an organ model by an external driving means has a mechanically complicated configuration and cannot be said to be simple.

For example, in cardiac surgery, it is required to beat the heart of an animal such as a pig in order to train coronary artery bypass grafting under heartbeat. There is a driving method such as internal pressurization and depressurization of a pig heart according to the above-mentioned conventional technique, but there is a problem that the device is large and complicated and cannot be used by a doctor who is a user alone. Even in Korona-ka, there is a need for surgical training such as the surgical technique examination committee led by a specialized society, and it is required to realize a wet lab that reproduces pulsation and behavior with a simple and simple structure. There is.

The present invention has been made in view of such circumstances, and an object of the present invention is to provide a simulated organ model that can be easily and easily used by an operator as compared with a conventional simulator or an organ model. Is.

The inventor made trial and error in order to improve the reproducibility of the behavior of human organs such as the heart and digestive tract in the surgical technique training, and found the knowledge about the means for imparting highly reproducible behavior to animal organs such as pigs and simulated organs. As a result of actually creating a prototype and developing it diligently, the present invention was completed.

That is, according to the main viewpoint of the present invention, the following configurations are provided.

(1) The simulated organ model body and
The eccentric rotating body placed inside this simulated organ model body,
Have,
By driving the eccentric rotating body to rotate relative to the simulated organ model body and directly sliding the surface of the eccentric rotating body and one surface of the simulated organ model body, the simulated organ related to this sliding is performed. A simulated organ model characterized by reproducing the periodic repetitive motion of a part of the model body.

(2) In the simulated organ model for surgical technique training described in (1) above,
A simulated organ model characterized in that the number of rotations of the eccentric rotating body coincides with the number of beats simulated by the simulated organ model.

(3) In the simulated organ model described in (2) above,
A simulated organ model characterized in that the rotation speed is 15 rpm to 60 rpm.

(4) In the simulated organ model described in (1) above,
Furthermore, a simulated organ model characterized by having a driving unit for driving the eccentric rotating body.

(5) In the simulated organ model described in (4) above,
The simulated organ model is characterized in that the driving body is arranged inside the simulated organ model body.

(6) In the simulated organ model described in (4) above,
A simulated organ model characterized by having a fixing means for fixing the driving body to the simulated organ model main body.

(7) In the simulated organ model described in (4) above,
The driving body is arranged outside the simulated organ model body.
A simulated organ model characterized in that the driving body and the eccentric rotating body are connected by a flexible shaft.

(8) In the simulated organ model described in (4) above,
The driving body is a simulated organ model characterized by being an electric motor having a rated voltage of 12 V or less.

(9) In the simulated organ model described in (1) above,
A simulated organ model characterized in that the shape of the outer surface of the eccentric rotating body sliding with the simulated organ model has a shape in which the tangent does not intersect with other positions on the outer surface.

(10) In the simulated organ model described in (1) above,
A simulated organ model characterized in that the ratio of the major axis length to the minor axis length in the direction orthogonal to the rotation axis of the eccentric rotating body is ½ or more.

(11) In the simulated organ model described in (1) above,
A simulated organ model characterized in that the eccentricity of the eccentric rotating body is ½ or more.

(12) In the simulated organ model described in (1) above,
The simulated organ model itself is a simulated organ model characterized by being an animal organ derived from livestock for meat.

(13) In the simulated organ model described in (12) above,
A simulated organ model characterized in that the animal organs derived from livestock for meat are pigs and sheep.

(14) In the simulated organ model described in (1) above,
The simulated organ model body is a simulated organ model characterized by having the heart, lungs, esophagus, stomach, small intestine, large intestine, and blood vessels.

(15) In the simulated organ model in (1) above,
The simulated organ model body is a simulated organ model characterized by being an artificial simulated organ model formed of an elastic material.

(16) In the simulated organ model in (1) above,
A simulated organ model characterized in that behaviors having different phases are reproduced by using one or two or more of the rotary drivers at the same time.

The features of the present invention other than the above are disclosed in the sections and drawings of the embodiments of the present invention below.

FIG. 1 is a schematic configuration diagram showing a simulated organ model according to an embodiment of the present invention.

FIG. 2 is also an explanatory diagram showing the embedding of the simulated organ model drive unit.

FIG. 3 is also a schematic configuration diagram showing a simulated organ model drive unit.

FIG. 4 is also a schematic view showing the shape of the eccentric rotating body.

FIG. 5 is also an explanatory diagram showing an embedding process of a simulated organ model drive unit.

FIG. 6 is also an explanatory diagram showing an embedding process of a simulated organ model drive unit.

FIG. 7 is also a schematic configuration diagram showing a modified example of the simulated organ model drive unit.

FIG. 8 is also a schematic configuration diagram showing a modified example of the simulated organ model.

FIG. 9 is also a schematic configuration diagram showing a second embodiment of the simulated organ model.

FIG. 10 is also a schematic configuration diagram showing a modified example of the simulated organ model drive unit.

Hereinafter, an embodiment of the present invention will be described with reference to the accompanying drawings.

(First Embodiment)
First, as a first embodiment, an example in which the present invention is applied to a simulated organ model for training a coronary artery bypass grafting technique in cardiovascular surgery will be described.

Coronary artery bypass surgery is a procedure for suturing a coronary artery of about 2 mm, and a procedure performed under heartbeat without using an artificial heart-lung machine is called off-pump coronary artery bypass surgery. This embodiment is a simulated organ model for training off-pump coronary artery bypass surgery, especially in coronary artery bypass surgery.

Hereinafter, it will be described in detail.

(Simulated organ model body)
In FIG. 1, reference numeral 1 is a simulated organ model body to be trained in a surgical technique. An organ drive unit 4 including an eccentric rotating body 2 for displacementing the simulated organ model main body 1 and a driving unit 3 for rotationally driving the eccentric rotating body inside the simulated organ model main body 1. Is embedded.

The simulated organ model body 1 is part of the pig heart in this first embodiment.

As shown in FIG. 2, the apex of the simulated organ model main body 1 (pig heart) is incised as shown by reference numeral A in the figure, and a part of the new inner wall is excised to obtain the eccentric rotating body and the driving part. A space 14 for embedding is formed, and the organ driving unit 4 is inserted into the space 14 as shown by an arrow in the figure.

(Eccentric rotating body)
FIG. 3 is a schematic configuration diagram showing an organ drive unit 4.

First, in the first embodiment, the eccentric rotating body 2 has a substantially semicircular spherical (mushroom umbrella-shaped) rotating body main body 5 and an eccentric shaft at a position deviated from the central axis B of the main body 5 by a predetermined dimension. It has an eccentric rotation center axis 6 attached to C.

The rotating body body 5 has one surface 5a on the side from which the rotation center axis 6 is derived, and a spherical outer surface 5b in contact with the lumen surface of the simulated organ model body 1. The outer surface 5b needs to be in direct contact with the simulated organ model main body 1 and to continue to rotate by sliding with the lumen surface of the space 14 when rotationally driven. Therefore, the outer surface 5b of the eccentric rotating body 2 is formed as a smooth surface without any protrusion or catching.

The shape of the eccentric rotating body 2 will be described below using the shape of the present embodiment (FIG. 4A).

(1) The tangent T does not interfere with other positions on the outer surface 5b. (2) A part of the outer surface 5b may have a concave portion, but it is not preferable that the convex portion is provided. (3) Rotating shaft The ratio of the major axis length to the minor axis length in the direction perpendicular to is 1/2 or more (the example in Fig. 4 (a) is a perfect circle, so the minor axis = the major axis, so the ratio is 1).
(4) The eccentricity ratio (S / L) is 1/2 or more. Further, it is preferable that the dimensions of the eccentric rotating body 2 are designed to match the dimensions of the simulated organ model main body 1. In the case of this example (pig heart), the outer diameter in the direction perpendicular to the central axis B is a perfect circle of 40 mm, and the thickness in the direction along the central axis B is 20 mm. The eccentric rotation central axis 6 is attached along the eccentric axis C at a position eccentric to the outside by 10 mm from the original central axis B.

The dimensions of the eccentric rotating body 2 and the shape of the outer surface 5b can be appropriately designed according to the dimensions of the simulated organ model main body 1, the organ type, and the shape and position of the portion to be displaced, as long as the above conditions are satisfied. Further, the position where the eccentric central axis is attached, that is, the attachment position where the eccentric behavior of the eccentric rotating body is determined can be appropriately determined in the same manner.

For example, as shown in FIG. 4B, the eccentric rotating body 2 may have an elliptical cross section. In this case, the eccentric rotation central axis 6 may be arranged along the central axis of the eccentric rotating body 2.

Further, an appropriate manufacturing method and material can be adopted for the eccentric rotating body 2, but in this example, the eccentric rotating body 2 is manufactured by using an FDM three-dimensional printer and is manufactured by using an ABS filament. There is.

(Drive)
Next, the drive unit 3 in this embodiment is a small DC reduction geared motor, which is directly connected to the eccentric rotation center shaft 6 as shown in FIG. 3 (b).

Specifically, in the drive unit 3, a reduction gear head 9 having a reduction ratio of 1:75 is attached to a DC 12V DC motor 8, and the eccentric rotation center shaft 6 is derived from the reduction gear head 9 as an output shaft. There is.

As a result, for example, the rotation speed of the eccentric rotating body 2 can be set to the same value as the general heart rate. In this example, the deceleration rotation speed from the reduction gear head 9 is set to 60 rotations per minute (60 rpm) according to the heartbeat number.

Further, the drive unit 3 is housed in, for example, an ABS resin exterior / housing 10, and is protected from blood and tissue fluid. Further, it is more preferable to protect the entire unit 4 including the eccentric rotating body 2 by covering the driving unit 3 and the eccentric rotating body 2 with a film made of polyethylene or polyvinyl chloride.

(Fixing the drive body)
Further, in order to prevent the drive unit 3 itself from rotating when the eccentric rotating body 2 is driven by the drive unit 3, the drive unit 3 may be fixed in the simulated organ model main body 1. is important.

In this embodiment, the drive unit 4 (drive unit 3 and eccentric rotating body 2) is installed in the space 14 inside the insertion port (FIG. 2) provided in the simulated organ model main body 1 (FIG. 5), and after installation. , The incised insertion slot is closed with a suture, a stapler, or the like as shown in FIG. As a result, the driving unit 3 can be fixed in the simulated organ model main body 1 by the external force from the myocardial tissue accompanying the closure.

When an animal organ is used as the simulated organ model body 1, there are individual differences in size and tissue properties. For example, when the drive unit 4 is installed in a relatively large animal heart, the drive unit 3 itself may rotate, and the sliding between the eccentric rotating body 2 and the simulated organ model body 1 may not function normally. Conceivable. In this case, the drive unit 3 is provided with a protrusion to be hooked on the housing 10 of the drive unit 3 so that the drive unit 3 can be easily fixed in the simulated organ model 1, or a stay 15 for fixing or the like is provided as shown in FIG. It is preferable to add the structure of the above and fix it to the simulated organ model main body 1 using this stay 15. The stay 15 may be fixed with a suture or a stapler.

(Power supply and operation specifications)
It is important that off-JT surgical technique training can be performed easily and with a minimum configuration. Typically, it is preferable to have a configuration that can be performed even on an office desktop, for example.

Therefore, in this embodiment, the USB connector 17 is adopted by interposing a booster circuit 16 as shown in FIG. 3B instead of a general AC-DC conversion power supply to operate the DC motor 8. are doing.

In this example, power is supplied to the drive unit 3 by connecting the USB connector to a USB power source having an electric capacity of 5V / 12W. USB power supplies are available anywhere in the world, including mobile batteries, and are small. However, since the output voltage is 5V, in this example, the booster circuit 16 is configured to boost the voltage to 12V.

(Operation example)
When the simulated organ model 1 having the above configuration is connected to the power supply using the USB connector 17. The eccentric rotating body 2 rotates at 60 times / minute via the eccentric rotation central axis 6. As a result, the outer surface 5b of the eccentric rotating body 2 slides while maintaining a state of being in close contact with the inner surface of the space 14 of the heart lumen, so that the myocardial portion follows the shape of the outer surface 5b of the eccentric rotating body 2. Then, the displacement is periodically repeated according to the eccentricity ratio / eccentricity amount of the eccentric axis.

In this embodiment, when a comparison was made between 180 degrees and 0 degrees in one rotation of the motor at 360 degrees, the variation in the normal direction on the myocardial surface was about 3 mm.

In this embodiment, the position and posture of the drive unit 3 and the eccentric rotating body 2 are arranged so that the eccentric rotating body is arranged directly under the left anterior descending coronary artery, which is the most frequent training point in coronary artery bypass surgery training. Has been adjusted. This makes it possible to obtain a periodic repetitive motion of about 3 mm specifically and locally in the anterior descending branch of the coronary artery.

Further, in this embodiment, the entire drive unit 4 is completely embedded in the simulated organ model main body 1, and the existence of the device itself cannot be recognized at first glance, so that it is visually natural and very realistic. A high pulsatile heart model can be obtained.

(Modification example)
In the above example, the simulated organ model body is a pig heart (320 g), but when a sheep heart or the like is used, the simulated organ model body is relatively small (120 g), and in this case, the driving body body is embedded. Creating spaces is difficult.

In this embodiment, the heart of the sheep is used as the simulated organ model main body 1, and as shown in FIG. 8, only the eccentric rotating body 2 is embedded in the simulated organ model main body 1 and attached to the eccentric rotating body 2. The eccentric rotation center axis 6 is extended by using a flexible shaft 18 with a resin protective film having a diameter of 6 mm and is led out to the outside of the simulated organ model main body 1 and connected to the drive unit 3. ..

When the drive unit 3 is operated in this state, the eccentric rotating body 2 can be eccentrically rotated in the heart lumen via the flexible shaft 18. As a result, since the outer surface 5b of the eccentric rotating body 2 slides in the heart lumen, it is possible to obtain a periodic repetitive motion on the outer surface of the myocardium.

When reproducing such respiratory behavior, the drive rotation speed of the drive body is preferably 10 to 30 rpm, preferably 15 rpm.

When reproducing a normal heartbeat, it is preferably 60 rpm to 120 rpm and tachycardia / arrhythmia 200 to 300 rpm.

(Second embodiment)
This second embodiment provides a simulated organ model that simulates a surgical procedure for hilar blood vessels under thoracoscopic surgery.

In recent years, the development of endoscopic surgery has been remarkable, and endoscopic surgery has been applied not only to gastrointestinal surgery but also to thoracic surgery and neurosurgery. Endoscopic surgery is difficult because it imparts respiratory behavior and pulse-derived behavior to the target organ. Therefore, for effective surgical training, simulated organ models are required to reproduce their behavior.

As shown in FIG. 19, in this embodiment, the simulated organ model body 1'is a part of the pig cardiopulmonary including the hilar blood vessel 19. In this example, a space corresponding to the back side of the hilar blood vessel 19 of the simulated organ model main body 1'is incised to form a space for embedding the drive unit 4'.

In this embodiment, the eccentric rotating body 2'has a cylindrical shape having a size of 15 mm along the axial direction and a diameter of 10 mm in the direction perpendicular to the shaft. Then, the rotation center axis 6 is derived from the eccentric position of the cylindrical eccentric rotating body 2'and connected to the drive unit 3. The drive unit 4'consisted in this way is embedded in the space of the simulated organ model main body 1', and the drive unit 3 is fixed by closing the incision position provided with the space.

According to such a configuration, the eccentric rotating body 2 can be driven by driving the driving unit 3 at 60 rotations per minute, and the surface of the eccentric rotating body 2 and the hilar blood vessel can be driven. The back surface of the can be slid. This makes it possible to periodically repetitively move the inner wall of the hilar blood vessel 60 times per minute with an amplitude of about 4 mm up and down.

Although one embodiment of the present invention has been described above, the present invention is not limited to the above-mentioned one embodiment, and various modifications can be made without changing the gist of the present invention.

For example, although the simulated organ model bodies 1, 1'are derived from animals, they may be formed of an artificial material such as silicon or gel.

Further, in the above embodiment, only a single driving body unit 4, 4'is embedded in the simulated organ model main body 1, 1', but two or more units 4, 4'are embedded to perform a complex operation. It may be given.

Further, it has already been described that the shape of the outer surface of the rotating body 2 needs to be a smooth shape that does not get caught on the inner surface of the simulated organ model main body 1, 1', and it is not preferable that the unevenness is formed. However, as shown in FIG. 10, there is no problem that the unevenness 21 is formed in the direction along the axial direction, not in the circumferential direction.

Further, in the above embodiment, the drive unit 4 is in direct contact with the inner surface of the simulated organ model main body 1, but for example, a lubricant or a lubricating member may be interposed. As the lubricating member, for example, a bag made of a flexible material may be inserted in close contact with the inner surface of the simulated organ model, and the drive unit 4 may be arranged in the bag. At this time, a lubricant may be applied to the inner surface of the bag.

1 ... Simulated organ model body 2 ... Eccentric rotating body 3 ... Drive unit 4 ... Organ drive unit 5 ... Rotating body body 5a ... One side 5b ... Outer surface 6 ... Eccentric rotation center axis 8 ... DC motor 9 ... Reduction gear head 10 ... Housing 14 … Space 15… Stay 16… Boost circuit 17… Connector 18… Flexible shaft 19… Hilar blood vessel 21… Concavo-convex

Claims (16)

The body of the simulated organ model and
The eccentric rotating body placed inside this simulated organ model body,
Have,
By driving the eccentric rotating body to rotate relative to the simulated organ model body and directly sliding the surface of the eccentric rotating body and one surface of the simulated organ model body, the simulated organ related to this sliding is performed. A simulated organ model characterized by reproducing the periodic repetitive motion of a part of the model body. In the simulated organ model for surgical technique training according to claim 1,
A simulated organ model characterized in that the number of rotations of the eccentric rotating body coincides with the number of beats simulated by the simulated organ model. In the simulated organ model according to claim 2,
A simulated organ model characterized in that the rotation speed is 15 rpm to 60 rpm. In the simulated organ model according to claim 1,
Furthermore, a simulated organ model characterized by having a driving unit for driving the eccentric rotating body. In the simulated organ model according to claim 4,
The simulated organ model is characterized in that the driving body is arranged inside the simulated organ model body. In the simulated organ model according to claim 4,
A simulated organ model characterized by having a fixing means for fixing the driving body to the simulated organ model main body. In the simulated organ model according to claim 4,
The driving body is arranged outside the simulated organ model body.
A simulated organ model characterized in that the driving body and the eccentric rotating body are connected by a flexible shaft. In the simulated organ model according to claim 4,
The driving body is a simulated organ model characterized by being an electric motor having a rated voltage of 12 V or less. In the simulated organ model according to claim 1,
A simulated organ model characterized in that the shape of the outer surface of the eccentric rotating body sliding with the simulated organ model has a shape in which the tangent does not intersect with other positions on the outer surface. In the simulated organ model according to claim 1,
A simulated organ model characterized in that the ratio of the major axis length to the minor axis length in the direction orthogonal to the rotation axis of the eccentric rotating body is ½ or more. In the simulated organ model according to claim 1,
A simulated organ model characterized in that the eccentricity of the eccentric rotating body is ½ or more. In the simulated organ model according to claim 1,
The simulated organ model itself is a simulated organ model characterized by being an animal organ derived from livestock for meat. In the simulated organ model according to claim 12,
A simulated organ model characterized in that the animal organs derived from livestock for meat are pigs and sheep. In the simulated organ model according to claim 1,
The simulated organ model body is a simulated organ model characterized by having the heart, lungs, esophagus, stomach, small intestine, large intestine, and blood vessels. In the simulated organ model according to claim 1,
The simulated organ model body is a simulated organ model characterized by being an artificial simulated organ model formed of an elastic material. In the simulated organ model according to claim 1,
A simulated organ model characterized in that behaviors having different phases are reproduced by using one or two or more of the rotary drivers at the same time.

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