WO2023105427A1

WO2023105427A1 - Simulation device

Info

Publication number: WO2023105427A1
Application number: PCT/IB2022/061865
Authority: WO
Inventors: Vladimiro VIDA; Francesco GALLIOTTO; Francesco BERTELLI; Claudia CATTAPAN; Alvise GUARIENTO
Original assignee: Azienda Ospedale Universita' Padova; Universita degli Studi di Padova
Current assignee: Azienda Ospedale Universita' Padova; Universita degli Studi di Padova
Priority date: 2021-12-10
Filing date: 2022-12-07
Publication date: 2023-06-15
Anticipated expiration: 2024-06-10
Also published as: IT202100031058A1

Abstract

A simulation device (100) for simulating a cardiac surgery operation preferably pediatric is described. The simulation device (100) includes a housing structure or housing body (10) defining an inner chamber (11) intended to house a model of artificial heart (101) and having a substantially box-like shape, having at least one top wall (12). The top wall (12) includes a primary hole (20) for accessing the inner chamber (11), and allowing a surgeon to simulate access to the model of artificial heart (11). The simulation device (10) includes at least one cover attachment (22) having a secondary through-hole (23) and apt to be removably associated, and at least partially overlapping, with said primary through-hole (20). A simulation method and kit including the device and an assortment of models of artificial heart is also described.

Description

SIMULATION DEVICE

DESCRIPTION

The present disclosure generally relates to a simulation device for a simulation of a cardiac surgery operation. In particular, preferably it is a simulation device for simulating a pediatric cardiac surgery operation.

Simulation devices having a housing structure which shape mimics the torso of a patient in a generally supine position during a cardiac surgery operation are known. The structure has a closed shape with a hole in the top area to access the inner zone where a model of artificial heart is placed. The model of artificial heart rests on a bottom plane under conditions that replicate real conditions as closely as possible. A surgeon can then access the model of artificial heart through the top hole and simulate an operation, i.e. under conditions similar to real ones.

The authors of the present disclosure started from the observation that the known housing structure is a rigid and static one that is poorly adapted to the variety of cardiac surgery pathologies, especially pediatric ones, and to the fact that the patient has to assume positions different than the properly supine one depending on the heart disease to be addressed. In other words, the surgery simulation devices currently in use are static, limited to a single surgery approach.

More specifically, underlying the present disclosure there is a recognition by the authors of the present disclosure that known rigid structures do not allow simulation of all possible heart disease to which patients, especially pediatric patients, may be exposed.

A technical problem underlying the present disclosure lies in providing a simulation device that allows to solve said drawback and/or to have additional advantages.

This problem is solved by a simulation device, a kit and a simulation method according to their respective independent claims.

Secondary features of the subject matter of this disclosure are defined in the respective dependent claims.

In particular, the simulation device for simulating cardiac surgery operation, preferably pediatric cardiac surgery operation, includes a housing body having a box structure defining an inner housing zone for housing a model of artificial heart. The housing body includes at least one top wall, wherein said top wall includes a primary hole for accessing an inner zone of said housing structure and allowing a surgeon to simulate access to the model of artificial heart. According to one aspect of the present disclosure, the simulation device includes at least one cover accessory having a secondary through-hole and apt to be removably associated with, and at least partially overlapping with, said primary through-hole. In practice, according to the present disclosure, a simulation device is provided wherein the top part is of the housing body is provided with an accessory or "cover." The latter is interchangeable with different cover accessories, that is, having a different secondary through-hole, so as to simulate a specific surgery access different from another. In this way, the simulation device can include, i.e., be provided with, an assortment of cover accessories which differ from each other on the base of the heart disease to be operated. This makes it possible to simulate the surgical correction of congenital heart disease by replicating different surgery accesses.

It is to be understood that the primary and secondary through-holes have dimensions such as to simulate a surgery access; therefore, they define a fixed opening, i.e., a well-defined passage or gap. Preferably, these are circular, elliptical or oval holes. In each case, the shape of the hole depends on the surgery access intended to be simulated.

In particular, according to a preferred aspect of the present disclosure, the secondary through-hole of a cover accessory of the assortment has a different shape with respect to the secondary through-hole of another cover accessory of the assortment. In other words, the cover accessories differ from each other at least in the shape or conformation of the respective secondary through-hole.

More specifically, the secondary through-hole of a cover accessory, or first cover accessory, differs from the secondary through-hole of a further additional cover accessory, or second cover accessory, in that the shape, or conformation of the secondary through-hole of the first cover accessory is related to a surgery access of a torso having a prone torso orientation while the shape, or conformation, of the secondary through-hole of the second, or further, cover accessory is related to a surgery access of a torso having a torso orientation arranged on a side, i.e., on the flank.

The cover accessories provided with the housing structure for simulating the various surgery approaches may preferably be 4 of which: 1) for left lateral thoracotomy, 2) for right lateral thoracotomy, 3) for mini-sternotomy. The simulator can also be used without a cover by simulating the classic sternotomy approach.

For example, the cover accessory is mounted on a free edge of the top wall defining said primary through-hole. Preferably, the cover accessory is made of soft material, e.g., elastic resin, to facilitate mounting.

Even more preferably, to reduce the bulkiness of the inner structure, the cover accessory includes a plate portion having said secondary through-hole and a perimeteral edge portion and surrounding said plate portion. The secondary through- hole is made in the plate portion. Preferably said edge portion is preferably made of a soft material, for example, rubber or as said elastic resin and suitable to be easily mounted by hand on the free edge of the top wall.

It follows that, as mentioned above, it can be provided a plurality of cover accessories each including a respective secondary through-hole, each hole is designed to simulate the shape and arrangement of a surgery access on the pediatric patient's body, and the perfectly prone, or arranged to one side, orientation of the torso depending on the heart disease to be operated.

For this purpose to allow for different accesses to be covered, the size of the primary through-hole is larger than the size of the secondary through-hole to allow for a different through-hole opening depending on the chosen cover accessory.

Preferably, the free edge of the primary through-hole and/or the edge portion of the cover accessory has slits which are radially distributed and intended to receive as many surgeon's thread needed during the operation. In other words, small incisions (preferably around the entire circumference or perimeter of the hole) may be provided on the cover accessory that serve as a support for the suture threads during simulation maneuvers, and in this way avoiding the addition of elements apt to support them. The same incisions or slits can be provided on the free edge of the primary through-hole if no cover accessory is used.

Even more preferably, especially if the edge of the cover accessory is soft and unsuitable for the formation of the incisions, the simulation device includes an additional ring-shaped accessory, shaped to be fitted on the edge portion of the cover accessory, said ring-shaped accessory having a plurality of radial slits.

In a preferred form, the housing structure has a bottom wall apt to be connected to the top wall to surround and/or define said inner chamber. This results in a boxshaped body that is extremely simple in construction and easy to assemble. For example, the housing structure has a substantially semi-tubular or semi-cylindrical shape with an end access to allow the placement of a model of artificial heart. Even more preferably, the housing structure comprises a base, which is slidably inserted, preferably in respective sliding guides formed on an inner side of the top wall, and intended to support the model of artificial heart. In other words, some models of artificial heart, or an assortment of models of artificial heart, i.e. for example 3D printed models of congenital heart disease made of suturable elastic resin, derived from the images of real patients, can be inserted within the housing structure by using a base or sliding plane. The model of artificial heart can be joined by means of magnets to the sliding base in order to facilitate its use.

A lightening device can be arranged within the housing structure to facilitate the view into the inner chamber. This allows for very important inner illumination in the case of minimally invasive procedures that result in difficulties with external illumination. The lightening device can be integrated within the housing structure and not require external power supply. This configuration allows producing a device which a user, such as a surgeon who needs to practice cardiac surgery operation techniques, can perform at any location. In fact, the user can assemble the housing structure, choose the necessary cover accessory corresponding to the surgery access he or she needs to simulate, insert the model of artificial heart, light up the inner working area, and simulate by means of surgeon threads the necessary operation.

Preferably, the simulation device includes a support frame for supporting the housing structure and provided with an articulation joint to allow for angular rotation of the housing structure, according to a predetermined orientation. In particular, a first position of the support frame corresponds to a simulation of a first torso orientation and a second position of the support frame corresponds to a simulation of a second torso orientation different from the first orientation. The first orientation of the torso may correspond to a prone orientation while the second orientation of the torso may correspond to an orientation arranged on a side.

In other words, the housing structure can be mounted on a simple support, such as a tripod with tilt angle for example up to 90°, simulating the real surgical position in the different approaches used (e.g., median sternotomy with supine patient, and thoracotomy with patient in lateral decubitus), or other surgery approaches.

Then it can be provided a kit including a simulation device, such as the one described so far, which in turn includes one or more cover accessories, and a model of artificial heart or an assortment of model of artificial heart. Preferably, each model of artificial heart in the assortment of models of artificial heart is shaped to replicate a corresponding heart disease. In other words, each model of artificial heart is shaped to replicate or form a copy of a corresponding heart disease.

According to a preferred aspect of the present disclosure, a first model of artificial heart of the assortment of models of artificial heart is associated with a corresponding first cover accessory of the assortment of cover accessories, and at least a second artificial heart of the assortment of models of artificial heart, different from the first model of artificial heart, is associated with a corresponding second cover accessory of the assortment of cover accessories.

Preferably, the entire kit can be easily made by 3D printing.

As anticipated above, in accordance with this disclosure, a method to simulate a cardiovascular surgery operation, preferably pediatric, using a simulation device such as the one mentioned above, is provided.

According to the simulation method, once a particular heart disease is identified the cover accessory and secondary through-hole apt to create an appropriate surgery access, are chosen and said operation can be simulated.

For example, the cover accessory is chosen to simulate a specific type of cardiac surgery operation, chosen from the group including left lateral thoracotomy, right lateral thoracotomy, mini-sternotomy and sternotomy.

Even more preferably, as mentioned the housing device can be specifically oriented according to the type of cardiac surgery operation to be performed.

It follows that a surgeon can practice consistently and with a very simple device that allows to address different types of access or surgery approaches.

The heart disease to be treated can be a natural or acquired heart disease.

Other advantages, features and ways of using the subject of this disclosure will be evident from the following detailed description of some of its preferred embodiments, provided for illustrative and non-limiting purposes. It is, however, evident how each embodiment can present one or more of the advantages listed above; in any case, it is not required that each embodiment present all the advantages listed simultaneously.

Reference will be made to the figures in the attached drawings, wherein:

Figure 1 shows a schematic view of a simulation device in the context of a pediatric cardiac surgery operation simulation;

Figure 2 shows an axonometric view of a simulation device according to a form of realization of the present disclosure;

Figure 3 shows a view of the Figure 2 simulation device with detached parts;

Figure 4 shows a side view of the Figure 2 simulation device without the cover accessory;

Figure 5 shows a top view of the Figure 2 simulation device without the cover accessory;

Figure 6 shows a cover accessory kit for a simulation device of the present disclosure;

Figures 7-10 show as many top views of top walls of simulation device of the present disclosure, wherein each top wall is provided with a cover accessory;

Figure 11 shows an axonometric view partially from above of the cover accessory coupled with an additional ferrule accessory;

Figure 12 shows a bottom view of the cover accessory coupled with the additional ring-shaped accessory;

Figure 13 shows an axonometric view partially from above of the additional ringshaped accessory;

Figure 14 shows a top view of the additional ring-shaped accessory.

With reference to the attached figures, a simulation device according to the present disclosure is indicated by reference number 100. It can be observed that the simulation device 100 is used to simulate a pediatric cardiac surgery operation, and is therefore arranged as if it were the torso of a pediatric patient in the operating room with the torso lying down and facing, essentially supine, or arranged on its side, toward a physician in the operating room, as schematically and by way of illustration shown in Figure 1.

It follows that the simulation device 100 in use has an arrangement substantially as the one illustrated in Figure 1. It follows that in the present disclosure any spatial reference, such as upon, side bottom, top, bottom, front or rear, or other spatial reference are to be understood in a non-limiting manner with reference to the operational arrangement of the simulation device illustrated in figure 1. The simulation device 100 includes a housing structure or housing body 10 defining an inner chamber 11 and having a substantially box-like shape, i.e., at least partially closed to allow the torso of a pediatric patient to be artificially replicated. Thus, the dimensions of the housing structure 10 and of the model of artificial heart 101 may be comparable to those of a pediatric patient, and a plurality of housing structures or models of artificial heart 101 dimensioned according to the patient’s age can be provided. A plurality of models of artificial heart each specifically shaped to replicate a specific heart disease may also be provided, as indicated below.

Lights or similar lightening devices, not shown in the drawings, can be arranged in the inner chamber 11 , preferably these are self-powered devices to best illuminate the cardiac surgeon's work zone.

In the example shown the housing structure 10 has a substantially semi-tubular or semi-cylindrical shape with an end access, e.g., front 13, and preferably also an access at the other end or rear 15 to allow the placement of a model of artificial heart 101.

More particularly, as for example visible in Figure 2, the housing structure 10 comprises at least a top wall 12 and a bottom wall 14 surrounding said inner chamber 11. More preferably, as illustrated in the drawings, the simulation device includes a base 17 which is slidably inserted into sliding guides 18 formed on an inner side of the top wall 12 and intended to support the model of artificial heart 101. It can be observed that bottom wall 14, base 17 and top wall 12 are parts that can be disassembled and easily assembled to make the housing structure 10.

The top wall 12 includes a primary hole 20 to access the inner chamber 11 , and allow a surgeon to simulate access to the pediatric patient's heart.

According to an aspect of the present disclosure, the simulation device 10 includes at least one cover accessory 22 having a secondary through-hole 23 and apt to be removably associated with said primary through-hole 20, preferably in stable association with the top wall 12, to simulate a given surgery approach.

In other words, the primary through-hole 20 defines a free edge 16 of substantially closed circular shape, for example, substantially round, in the top wall 12, and said cover accessory 22 is configured to be removably attached to the free edge 16. Once attached to the free edge 16, the cover accessory 22 defines a specific opening or passage space in the top wall 12. Preferably the cover accessory 22 includes a plate portion 25 having said secondary through-hole 23 and a perimetral edge portion 26 and surrounding said plate portion 25. Said edge portion 26 is preferably made of a soft material, e.g., rubber and apt to be easily mounted by hand by a surgeon on the free edge 16 of the top wall 12. Preferably the free book edge 16 of the top wall 12 of the housing structure 10 also has a conformation suitable for form-fitting coupling with the edge portion 26 of the cover accessory so as to allow a stable coupling of the cover accessory 22.

According to a preferred aspect of the present disclosure, a plurality of cover accessories 22 are provided, as illustrated in Figure 6, and denoted respectively by reference numbers 22a, 22b, 22c each including a respective secondary through-hole 23a, 23b, 23c. Each hole is designed to simulate the shape and arrangement of the surgery approach on the pediatric patient's body, and the orientation of the torso perfectly prone, or arranged on a side, depending on the heart disease to be operated.

It follows that by changing the cover accessory 22, the cardiac surgery operation to be simulated can be changed. In other words, in use, depending on the chosen cover accessory 22, it will be possible to simulate a different cardiac surgery operation.

In other words, the simulating device includes a plurality of cover accessories 22, 22a, 22b, 22c, different from each other, apt to be associated in a removable and interchangeable way, while on the respective top wall each cover accessory has a hole having an orientation and/or extension and different from the others which is chosen so as to simulate a specific type of cardiac surgery operation, such as for example 1) for left lateral thoracotomy, 2) for right lateral thoracotomy, 3) for ministernotomy. That is, the simulation device comprises an assortment of cover accessories 22, 22a, 22b, 22c, wherein each cover accessory 22, 22a, 22b, 22c of the assortment of cover accessories is different from another, or additional, cover accessory 22, 22a, 22b, 22c of the assortment of cover accessories. In particular, each cover accessory 22, 22a, 22b, 22c of the assortment of cover accessories is likely to simulate a surgery access different from a surgery access simulated by another cover accessory 22, 22a, 22b, 22c of the assortment of cover accessories.

It is to be understood that the simulation device 100 can also be used without cover accessory 22 simulating, for example, a classic sternotomy approach.

According to an embodiment, the secondary through-hole 23, 23a, 23b, 23c of a cover accessory 22, 22a, 22b, 22c of the assortment of cover accessories has a different shape with respect to the secondary through-hole 23, 23a, 23b, 23c of another cover accessory 22, 22a, 22b, 22c of the assortment of cover accessories 22, 22a, 22b, 22c. That is preferably each cover accessory 22, 22a, 22b, 22c of the assortment can have a secondary through-hole 23, 23a, 23b, 23c having a different conformation than the secondary through-hole 23, 23a, 23b, 23c of another cover accessory 22, 22a, 22b, 22c of the same assortment.

For example, the secondary through-hole 23, 23a, 23b, 23c of a cover accessory 22, 22a, 22b, 22c of the assortment of cover accessories may have different size and/or geometric shape than the secondary through-hole 23, 23a, 23b, 23c of another cover accessory 22, 22a, 22b, 22c of the same assortment.

As mentioned above, the secondary through-hole 23, 23a, 23b, 23c of a cover accessory 22, 22a, 22b, 22c of the assortment of cover accessories, i.e., of a first cover accessory, is preferably different from the secondary through-hole 23, 23a, 23b, 23c of a further cover accessory, i.e., of a second cover accessory 22, 22a, 22b, 22c of the assortment of cover accessories 22, 22a, 22b, 22c. More preferably, the shape of the secondary through-hole 23, 23a, 23b, 23c of the first cover accessory 22, 22a, 22b, 22c is related to a surgery access of a torso having a prone orientation, while the shape of the secondary through-hole 23, 23a, 23b, 23c of the second cover accessory 22, 22a, 22b, 22c is related to a surgery access of a torso having an orientation arranged on a side, i.e., on the flank.

Preferably, the free edge 16 of the primary through-hole 20 has slits 30 radially distributed and intended to receive as many surgeon threads as needed during the operation.

The cover accessory 22 can also have said slits on the edge portion 23. Alternatively, the simulation device 100 may include an additional ring-shaped accessory 40, i.e., having a substantially annular shape, and having a plurality of upwardly facing slits 42. The additional ring-shaped accessory 40 is shaped to be fitted, for example by slight screwing rotation, on the edge portion 23 of the cover accessory.

Preferably, the dimensions of the primary through-hole 20 are greater than the dimensions of the secondary through-hole 23 to allow obtaining a different through opening depending on the chosen cover accessory.

Preferably in an embodiment of the present disclosure such as that shown in Figure 1 , the dissimulation device 100 also includes a support frame 105 having support legs 106 and a support surface 107 where the housing body is stably mounted.

An articulation joint 108, for example a ball joint, can be provided between the support legs and the support surface 107 to allow angularly rotating the housing structure 10 according to a predetermined orientation. In particular, according to a preferred embodiment of the simulation device according to the present invention, a first position of the support frame 105 corresponds to a simulation of a first orientation of the torso, while a second position of the support frame corresponds to a simulation of a second orientation of the torso, different from the first orientation, for example to simulate a different cardiac approach.

Preferably, the first orientation of the torso is, i.e. corresponds to, the prone orientation and the second orientation of the torso is, i.e. corresponds to, the orientation arranged on a side.

This allows changing the orientation of the housing structure 10 and of the primary through-hole 20 and of the secondary through-hole 23 according to the type of surgery operation to be performed, and to the position of the pediatric patient's torso for said specific operation.

For example, by appropriately choosing the cover accessory 22 and its secondary through-hole 23, and the angle assumed by the housing structure by means of the support frame 105, a given position of the patient at the time of surgery operation, and the surgery approach required to perform the surgery operation, can be perfectly simulated.

In a preferred embodiment, each of the model of artificial heart 101 and/or the housing structure set 12 and/or each of the cover accessories 22, 22a, 22b, 22c can be made by 3d printing.

The present disclosure further relates to a kit comprising a simulation device 100 according to one or more of the described embodiments and one or more models of artificial heart 101. In other words, the kit includes in addition to the previously described simulation device 100 a model of artificial heart or a plurality or assortment of artificial hearts.

Preferably, the kit includes a plurality or assortment of models of artificial heart 101 , wherein each model of artificial heart in the assortment of models of artificial heart is shaped, that is, conformed, to replicate a corresponding heart disease. io According to an embodiment, a first model of artificial heart from the assortment of models of artificial heart is associated with a corresponding first cover accessory 22, 22a, 22b, 22c from the assortment of cover accessories, and at least a second model of artificial heart from the assortment of models of artificial heart, different from the first model of artificial heart, is associated with a corresponding second cover accessory 22, 22a, 22b, 22c from the assortment of cover accessories.

That is, it is possible to provide a kit comprising a plurality of cover accessories of the simulation device and a plurality of models of artificial heart, where each model of artificial heart is preferably shaped to simulate a different heart disease and corresponds to a corresponding cover accessory 22, 22a, 22b, 22c configured to simulate a corresponding cardiac surgery approach.

It can be understood that by means of the simulation device 100 it can be provided a method for the simulation of a cardiac surgery operation preferably pediatric, wherein with the same simulation device a wide range of heart diseases can be addressed. The method involves using a simulation device like the one defined above, and wherein to determine a given surgical position only the cover accessory 22 is changed to vary the shape and arrangement of the secondary through-hole 23. In other words, the cover accessory 22 and its secondary through-hole 23 suitable for the heart disease to be addressed are chosen. Then, an operation to operate that heart disease is simulated.

Preferably, the method involves choosing the cover accessory 22 to simulate a specific type of cardiac surgery operation, chosen from the group including left lateral thoracotomy, right lateral thoracotomy, mini-sternotomy and sternotomy.

Possibly, it is also possible to choose to change the orientation of the housing structure 10 acting on the articulation joint 108 of the support frame 105. In other words, the method can involve orienting the housing structure 10 specifically according to the type of cardiac surgery operation to be performed.

According to a preferred embodiment, according to the heart disease, the method can also involve choosing a model of artificial heart 101 from an assortment of models of artificial heart, wherein each model of artificial heart in the assortment is different from another model of artificial heart of the assortment, and wherein each model of artificial heart has a shape or conformation corresponding to a heart disease or is shaped to simulate a corresponding heart disease. Preferably, a specific artificial heart from the assortment of models of artificial heart is chosen in combination with a specific cover accessory 22, 22a, 22b, 22c from the assortment.

That is, an assortment of models of artificial heart 101 and a simulation device comprising an assortment of cover accessories 22, 22a, 22b, 22c can be provided, wherein each model of artificial heart of the assortment of models of artificial heart is shaped to simulate a specific heart disease and can be associated to, i.e. , can be used in combination with, a corresponding cover accessory from the assortment of cover accessories to simulate a corresponding cardiac surgery approach. In other words, it can be provided, for example, pairs consisting of a model of artificial heart, each shaped to simulate a different heart disease, and a corresponding cover accessory configured to enable a specific cardiac surgery approach.

The subject matter of the present disclosure has been described in so far with reference to its embodiments. It is to be understood that there may be other embodiments pertaining to the same inventive core, all of which fall within the scope of protection of the claims set forth below.

Claims

1. Simulation device (100) for simulating a cardiac surgery operation, preferably a pediatric cardiac surgery operation, wherein the simulating device (100) includes a housing structure or housing body (10) defining an inner chamber (11) intended to house an model of artificial heart (101) and having a substantially box-like shape, wherein the housing structure (10) has at least one top wall (12) and said top wall (12) includes a primary through-hole (20) for accessing the inner chamber (11), and allowing a surgeon to simulate a surgery approach to the model of artificial heart (11), and wherein the simulation device (10) includes at least one cover accessory (22) having a secondary through-hole (23) and apt to be removably associated, and at least partially overlapping, with said primary through-hole (20).

2. Simulation device (100) according to claim 1 , wherein the cover accessory (22) is mounted on a free edge (16) of the top wall (12) defining said primary through-hole (20).

3. Simulation device (100) according to claim 2, wherein the cover accessory (22) includes a plate portion (25) having said secondary through-hole (23) and a perimeteral edge portion (26) surrounding said plate portion (25).

4. Simulation device (100) according to the preceding claim, wherein said edge portion (26) is preferably made of a soft material, e.g., rubber, and apt to be easily mounting by hand on the free edge (16) of the top wall (12).

5. Simulation device (100) according to any one of the preceding claims, comprising an assortment of said cover accessories (22, 22a, 22b, 22c), said assortment of cover accessories comprising a plurality of cover accessories (22, 22a, 22b, 22c), wherein each cover accessory (22, 22a, 22b, 22c) of the assortment of cover accessories is different from another each cover accessory (22, 22a, 22b, 22c) of the assortment of cover accessories, wherein each cover accessory (22, 22a, 22b, 22c) of the assortment of cover accessories is apt to simulate a surgery access different from a surgery access simulated by another cover accessory (22, 22a, 22b, 22c) of the assortment of cover accessories.

6. Simulation device (100) according to the preceding claim, wherein the secondary through-hole (23, 23a, 23b, 23c) of a cover accessory (22, 22a, 22b, 22c) of the assortment of cover accessories has a different shape with respect to the secondary through-hole (23, 23a, 23b, 23c) of another cover accessory (22, 22a, 22b,

7. Simulation device (100) according to preceding claim, wherein the secondary through-hole (23, 23a, 23b, 23c) of a first cover accessory (22, 22a, 22b, 22c) of the assortment is different from the secondary through-hole (23, 23a, 23b, 23c) of a second cover accessory (22, 22a, 22b, 22c) of the assortment of said cover accessories (22, 22a, 22b, 22c), wherein the shape of the secondary through-hole (23, 23a, 23b, 23c) of the first cover accessory (22, 22a, 22b, 22c) is related to a surgery access of a torso having a prone torso orientation and the shape of the secondary through-hole (23, 23a, 23b, 23c) of the second cover accessory (22, 22a, 22b, 22c) is related to a surgery access of a torso having an orientation arranged on a side.

8. Simulation device (100) according to any one of the preceding claims, wherein the dimensions of the primary through-hole (20) are greater than the dimensions of the secondary through-hole (23) to allow for a different surgery approach opening depending on the cover accessory (22).

9. Simulation device (100) according to any one of the preceding claims in combination with claim 3, wherein the free edge (16) of the primary through-hole (20) and/or the edge portion (23) of the cover accessory (22) has slits radially distributed and intended to receive as many surgeon threads as needed during the surgery operation.

10. Simulation device (100) according to any one of the preceding claims in combination with claim 3, wherein the simulation device (100) includes an additional ring-shaped accessory (40), shaped to be fitted, on the edge portion (26) of the cover accessory (22), said ring-shaped accessory (40) having a plurality of radial slits (42).

11. Simulation device (100) according to any one of the preceding claims, wherein the housing structure (10) has a bottom wall (14) apt to be connected to the top wall (12) to surround and/or define said inner chamber (11).

12. Simulation device (100) according to any one of the preceding claims, wherein the housing structure (10) has a substantially semi-tubular or semi-cylindrical shape with an end access (13) to allow the placement of a model of artificial heart (101).

13. Simulation device (100) according to any one of the preceding claims, wherein the housing structure (10) comprises a base (17) which is slidably inserted into sliding guides (18) formed on an inner side of the top wall (12) and intended to support the model of artificial heart (101).

14. Simulation device (100) according to any one of the preceding claims, further including a support frame (105) for supporting the housing structure (10) and provided with an articulation joint (108), to allow angular rotation of the housing structure (10), according to a predetermined orientation, wherein a first position of the support frame (105) corresponds to a simulation of a first orientation of the torso and a second position of the support frame corresponds to a simulation of a second orientation of the torso different from the first orientation.

15. Simulation device (100) according to any of the preceding claims, in combination with claim 7, wherein the first orientation of the torso is said prone orientation and said second orientation of the torso is said orientation arranged on a side.

16. Kit including a simulation device (100) according to any of the previous claims, and a model of artificial heart or an assortment of models of artificial heart (101).

17. Kit according to claim 16, including an assortment of models of artificial heart (101), wherein each artificial heart in the assortment of model of artificial heart is shaped to replicate a corresponding heart disease.

18. Kit according to the preceding claim in combination with any one of claims 6 to 8, wherein a first model of artificial heart of the assortment of models of artificial heart is associated with a corresponding first cover accessory (22, 22a, 22b, 22c) of the assortment of cover accessories, and at least a second model of artificial heart of the assortment of models of artificial heart different from the first model of artificial heart is associated with a corresponding second cover accessory (22, 22a, 22b, 22c) of the assortment of cover accessories (22, 22a, 22b, 22c).

19. Method for simulating a cardiovascular surgery operation, preferably a pediatric cardiovascular surgery operation, by means of a simulation device (100) according to any of the preceding claims, wherein, once a particular heart disease is identified, the cover accessory (22) and its secondary through-hole (23) suitable for said heart disease are chosen and an operation to operate said heart disease is simulated.

20. Method according to the previous claim, in which the cover accessory (22) is chosen to simulate a specific type of cardiac surgery operation, chosen by the group including left lateral thoracotomy, right lateral thoracotomy, mini-sternotomy and sternotomy.

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21. Method according to claim 19 or 20, in which the housing structure (10) is specifically oriented according to the type of cardiac surgery operation to be performed.

22. Method according to any of the preceding claims 19 to 21, wherein according to the heart disease, a model of artificial heart (101) is chosen from an assortment of artificial hearts, wherein each model of artificial heart in the assortment is different from another artificial heart in the assortment, and wherein each model of artificial heart has a shape corresponding to a heart disease.

23. Method according to the preceding claim in combination with any of claims 6 to 8, wherein a specific model of artificial heart from the assortment of models of artificial heart is chosen in combination with a specific cover accessory (22 22a, 22b, 22c) from the assortment of cover accessories (22, 22a, 22b, 22c).

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