Surgical training device

Abstract

The present invention relates to a training device (50, 100, 200, 300) for a surgical procedure for endovascular treatment of an aneurysm, comprising a container (52) having a wall (54) defining a bounded chamber (56) and a first access opening (58) provided in the wall (54), the first access opening (58) being configured to allow insertion of a guide wire (17) and / or a guide catheter (26) for endovascular surgery into the container (52), a first tube (62) connected to the container (52) at the first access opening (58), a target (72, 172), and a movable element (70) comprising a control member (74) connected to the target (72, 172). The target (72, 172) is disposed within the container (52) and comprises a cannulation seat (84, 184) configured to receive the guide wire (17) and / or the guide catheter (26) for endovascular surgery, and the control member (74) at least partially protrudes from the container (52) through control openings (76, 82, 83) in the wall (54) of the container (52). The movable element (70) is movably constrained to the wall (54) of the container (52) at the control openings (76, 82, 83) such that the target (72, 172) can assume a plurality of different positions and / or orientations within the container (52). The present invention further relates to a training method for a surgical procedure for endovascular treatment of an aneurysm in which such a training device (50, 100, 200, 300) is used, and to the use of the device (50, 100, 200, 300) in such a training method.

Description

Technical Field

[0001] The present invention relates to a surgical training device, and more particularly to a training device for surgical procedures for endovascular treatment of aneurysms.

[0002] The present invention also relates to a training method for the above-described surgical procedures for endovascular treatment of aneurysms in which the above device is used, and to the use of the device in the above training method.

Background Art

[0003] An aneurysm is a permanent pathological dilation that affects the walls of blood vessels, usually arterial vessels. The occurrence of aneurysms is often associated with hypertension, dyslipidemia, age, smoking, or genetic factors.

[0004] The dilated portion of the wall becomes weak and continues to expand over time under the influence of blood pressure until it ruptures, often leading to fatal bleeding for the patient. Even if it does not rupture, large aneurysms can interfere with proper blood circulation, promote the formation of thrombi that can embolize, and cause ischemia of downstream tissues.

[0005] Aneurysms most frequently affect the aorta, the largest blood vessel in the cardiovascular system. In most cases, aneurysms are located in the infrarenal abdominal aortic region upstream of the iliac bifurcation.

[0006] Aneurysms can be treated by either conventional open surgery or endovascular procedures, and are currently considered the treatment of choice in most cases because they are very minimally invasive to the patient and have a high reproducibility of surgical techniques.

[0007] Endovascular treatment of aneurysms involves implanting a tubular internal prosthesis having a length and shape that excludes the dilated vascular region from the circulation into the aneurysmal portion of the blood vessel. The internal prosthesis is introduced into the circulatory system through a very small percutaneous access made in a peripheral body region (e.g., the groin area) and is carried to the aneurysm blood vessel by a guide and catheter as described in detail below.

[0008] Figures 1, 2 and 3 schematically illustrate some of the types of tubular endoprostheses commonly used in endovascular procedures, indicated by 1, 2 and 3.

[0009] The endoprostheses 1, 2 and 3 generally consist of a metal stent 4 made of steel or shape memory alloy, optionally coated with an impermeable material 5 such as woven form (Dacron), Gore-Tex® or polyethylene terephthalate (PTFE).

[0010] The endoprosthesis 1 is a branched multi-module type suitable for placement in a juxtarenal abdominal aortic aneurysm upstream of the iliac bifurcation.

[0011] The endoprosthesis 1 comprises a main module 6 including a central body 7 configured to be placed in the infrarenal aortic segment, an outer leg 8 configured to be placed in the external iliac artery, and a contralateral portion 9 that is shorter than the outer leg 8 and is configured to float within the aneurysm without contacting the wall of the contralateral iliac artery (see below until its subsequent connection to the contralateral module 10).

[0012] The endoprosthesis 1 also comprises a contralateral module 10 different from the main module 6. The contralateral module 10 is attached to the contralateral portion 9 at its end opening 11, also called the gate 11, to form a contralateral leg 12 configured to be placed in the contralateral iliac artery, thereby completely excluding the aneurysm from the circulation.

[0013] A free stent 13 is provided at the proximal end 14 of the main module 6 of the endoprosthesis 1, and its function is to improve the fixation of the endoprosthesis 1 to the aortic wall without occluding the origin of the aortic branches.

[0014] The internal artificial organ 2 is of a branched monomodular type and includes a single main module 6 having a central body 7 configured to be inserted into the aorta, and is provided with branch portions 15 (two as shown in FIG. 2) configured to facilitate the introduction of a covered stent into a blood vessel derived from an aneurysm sac.

[0015] The internal artificial organ 3 is of an fenestrated monomodular type. The internal artificial organ consists of a single main module 6 in which fenestrations 16 (two as shown in FIG. 3) are made to enable perfusion of collateral blood vessels. According to specific requirements, in most cases, additional modules are provided in the form of outer legs (not shown in this specification) implanted into collateral blood vessels starting from the fenestrations 16.

[0016] As described above, the internal artificial organ 1 is suitable for the treatment of abdominal aortic aneurysms and is generally made in standard sizes.

[0017] The internal artificial organ 2 is particularly suitable for the treatment of aneurysms located in the thoracoabdominal region of the aorta, for example, and is usually custom-designed according to the needs of the patient.

[0018] The internal artificial organ 3 is generally used in the treatment of aneurysms with special problems, such as aneurysms with an insufficient infrarenal aortic collar, and certain types of thoracoabdominal aortic aneurysms. The internal artificial organ 3 can be manufactured in standard sizes or custom designs.

[0019] To better understand how the endovascular artificial organ is inserted, FIG. 4 schematically illustrates in full some of the basic steps of an endovascular aneurysm repair (EVAR) surgical procedure.

[0020] The EVAR procedure illustratively exemplified in this specification is intended to implant the branched internal artificial organ 1 (FIG. 1) into the external iliac artery 18 and the contralateral iliac artery 20 in a juxtarenal abdominal aortic aneurysm located in the aortic region between the renal artery 16 and the bifurcation of the aorta, indicated by reference numeral A in FIG. 4.

[0021] The EVAR procedure conventionally starts with the creation of a first peripheral arterial access site in the common femoral artery (not visible here), formerly known as the external common femoral artery. A first guidewire 17 is introduced into this first access site and advanced through the external common femoral artery, the external iliac artery 18, and the aneurysm A to the suprarenal aorta region 22 (step (a) in FIG. 4).

[0022] The first guidewire 17 used is best illustrated in FIG. 5 and is thin, flexible, hydrophilic, and has a curved end 24 that facilitates proper routing during insertion.

[0023] Guidewires with different thicknesses and rigidities are commercially available and are selected ad hoc according to the requirements of a particular procedure.

[0024] Since the introduction path from the peripheral access site to the aneurysm A can also become quite complex, the first guidewire 17 is advanced with the aid of one or more guide catheters of different shapes.

[0025] FIG. 6 illustrates, by way of example, several guide catheters 26a, 26b, 26c, 26d, and 26e that can be used for this purpose. The guide catheters illustrated herein have respective terminal ends 28a, 28b, 28c, 28d, and 28e of various shapes and, by cooperating with the first guidewire 17 extending through their lumens, direct its end 24 in a particular direction. During the insertion procedure, depending on the anatomical configuration and where the first guidewire 17 is located in its advancement, the guide catheter with the most suitable terminal end for directing the guidewire in the desired direction is selected from time to time. For example, a guidewire having a diameter of approximately 1 mm can be used in cooperation with a catheter having a diameter of 3 - 4 mm.

[0026] The procedure involves sequentially using one or more intermediate low - stiffness first guidewires, which are ultimately replaced by a stiffer first final guidewire that then serves as a sliding track for the components that must reach the aneurysm A. For convenience, the same expression "first guidewire 17" is used to denote both the first intermediate guidewire and the first final guidewire.

[0027] In the next step (b) of the procedure, schematized in FIG. 4, the main module 6 (FIG. 1) of the endograft 1, which is attached to the first release catheter 30 and held in a compressed form by the first sheath 32, is advanced along the first guidewire 17 until the proximal end 14 of the main module 6 is below the renal artery 16.

[0028] Then, the first sheath 32 is withdrawn, and the central body 7, outer legs 8, and opposite portion 9 of the main module 6 of the endograft 1 automatically expand under the radial force of the stent 4 (FIG. 1) that forms the endograft 1 and adheres to the vessel wall. To improve adhesion and sealing, the expansion is generally facilitated by inflating a balloon advanced to the endograft 1 on the first guidewire 17 (step (c) of FIG. 4).

[0029] Next, a second peripheral arterial access is created in the contralateral common femoral artery (not visible) to complete the assembly of the endograft 1. Through the second peripheral arterial access, a second guidewire 34 similar to the first guidewire 17 is introduced.

[0030] In step (d) of the EVAR procedure, the second guidewire 34 is advanced, with the aid of one or more guide catheters as illustrated, for example, in FIG. 6, in a manner identical to that described above with reference to the first guidewire, through the contralateral common femoral artery, the contralateral iliac artery 20, and the aneurysm A to the suprarenal aorta region 22. The free stent 13 of the main module 6 spreads under the radial force and adheres to the suprarenal aorta region 22.

[0031] Also in this case, one or more intermediate low-rigidity second guidewires are sequentially used and are replaced by a final stiffer second final guidewire, all equally denoted by the expression "second guidewire 34" for convenience.

[0032] At this stage, the second guidewire 34 must be correctly routed to the end opening of the opposite part 9 of the main module 6 or to the gate 11 by performing the so-called cannulation operation of the gate 11.

[0033] In the next step (e) of the procedure, the opposite module 10 of the internal prosthesis 1 (FIG. 1), which is attached to a second release catheter (not shown) and held in a compressed form by a second sheath (not shown), is advanced along the second guidewire 34 until the proximal end of the opposite module 10 enters the end opening 11 of the opposite part 9 of the main module 6, defining an overlapping region 36 between the opposite part 9 of the main module 6 and the opposite module 10 of the internal prosthesis 1.

[0034] Then, the second sheath is withdrawn, pulled out from the second peripheral access part, and the opposite module 9 automatically expands under the radial force of the stent 4 (FIG. 1), attaching the distal end of the opposite module 10 to the blood vessel wall and causing adhesion between the opposite part 9 and the opposite module 10 in the overlapping region 36. The expansion and sealing are further assisted by the operation of an additional advanced balloon on the second guidewire 34 (step (f) in FIG. 4). The expansion of the outer leg 8 can be completed at this stage, for example, by reinterposing a balloon associated with the first guidewire 17.

[0035] Finally, in step (g), when the expansion in all sections of the endograft 1 is complete, the first guidewire 17 and the second guidewire 34 are removed by pulling them from their respective peripheral arterial access sites. Once fully assembled and expanded to adhere firmly to the vessel wall, the endograft 1 excludes the aneurysm A from the circulation.

[0036] The EVAR procedure is performed under fluoroscopic control to visualize in real time the morphology of the vessels marked with the appropriate contrast agent, as well as the position of the guidewire, guide catheter, and endograft 1 modules during introduction and advancement.

[0037] The implantation of the endografts 2 and 3 shown in FIGS. 2 and 3 is performed by endovascular procedures generally referred to as branched EVAR (B-EVAR) and fenestrated EVAR (F-EVAR), with the necessary modifications, similar to the EVAR procedure described above.

[0038] Such procedures involve the introduction of the main module 6 on a guidewire through the initial peripheral arterial access site, expansion after reaching the implant site, and the insertion of additional endograft modules (e.g., additional branches inserted into the fenestration 16 of the endograft 3) through additional guidewires inserted from the same peripheral access site or a further access site. In this type of procedure, it is common to provide the peripheral access site from above, in the axilla, instead of or in addition to the femoral access site from below.

[0039] Performing endovascular surgical procedures requires a high level of manual dexterity on the part of the surgeon.

[0040] The most delicate operation is the insertion of the guidewire and guide catheter. The vascular network to be traversed starts from the peripheral percutaneous access site to the aneurysm site and is actually very long and intricate, and may exhibit significant anatomical differences from patient to patient.

[0041] Furthermore, the guide wire and guide catheter are manipulated from outside the percutaneous access site and must be oriented in three-dimensional space based only on what the surgeon can infer from the two-dimensional images provided by the fluoroscopy device. Thus, the correct orientation of the guide wire and guide catheter is entirely entrusted to the surgeon's hand sensitivity and the surgeon's ability to interpret the radiographic images in real time.

[0042] Conventionally, most of the training for this type of procedure is done by trial and error in the field. During actual surgery, the most complex situations are often in the domain of the most experienced surgeons, so this training mode severely limits the practical possibility for young surgeons to improve their manual skills.

[0043] Artificial models of blood vessels are known in the industry and are used for research or surgical training purposes.

[0044] For example, there is a three-dimensional model of an aneurysm section of the abdominal aorta connected to two iliac arteries and other blood vessels. Such models are used in simulations of endovascular surgery where conditions as close as possible to those of an actual operation, including visualization by a fluoroscopic guide, are reproduced.

[0045] The applicant has noted that these models are usually custom-made and thus manufacturing is quite complex and expensive. Such models are also not very versatile for training purposes as they only allow practicing on specific anatomical forms.

[0046] The applicant has also realized that in addition to reproducing the entire procedure, it is advantageous for the surgeon to be able to test more skill-demanding technical maneuvers separately without the need to set up an overall surgical simulation.

[0047] The applicant has noted in particular that the most complex technical gestures, which require more practice, are in some cases guidewires that cooperate with a guiding catheter, and are intended to target and center on small openings, particularly those placed within a larger space, in a so-called cannulation operation.

[0048] For example, in the above-described EVAR procedure, it is not easy to introduce the end of the second guidewire 34 into the terminal opening 11 of the opposite portion 9 of the main module 6 of the endovascular prosthesis 1 (step (d)). Similarly, in the B-EVAR or F-EVAR procedures, it is particularly complex to correctly orient the guidewire so as to introduce it into the branch portion 15 of the endovascular prosthesis 2 or the fenestration 16 of the endovascular prosthesis 3 in FIG. 1. SUMMARY OF THE INVENTION PROBLEMS TO BE SOLVED BY THE INVENTION

[0049] Therefore, the applicant has set itself the goal of providing a surgical training device having a simple and inexpensive configuration that enables simulating a plurality of operating modes and / or anatomical forms of endovascular components in endovascular treatment procedures, for example in procedures similar to EVAR, B-EVAR or F-EVAR.

[0050] The applicant has also recognized that it is advantageous for it to be possible to smoothly and rapidly switch from one "simulated" operating mode of a component to another, or from one "simulated" anatomical form to another, so that many different surgical operations can be tested on a single device, and to be proficient in a relatively short time in the more complex technical gestures of typical endovascular procedures.

[0051] The applicant has further set itself the goal of providing a method of surgical training in which such a device is used. MEANS FOR SOLVING THE PROBLEMS

[0052] Accordingly, in its first aspect, the present invention relates to a training device for the surgical procedure of endovascular treatment of an aneurysm.

[0053] The device comprises a wall defining a bounded chamber and a container having a first access opening provided in the wall.

[0054] The first access opening is configured to allow insertion of a guide wire and / or a guide catheter for endovascular surgery into the container.

[0055] The device comprises a first tube connected to the container at the first access opening.

[0056] Advantageously, the device also comprises a movable element comprising a target and a control member connected to the target.

[0057] The target of the movable element is disposed within the container and comprises at least one cannulation site configured to receive the guide wire and / or the guide catheter for endovascular surgery.

[0058] The control member of the movable element at least partially protrudes from the container through a control opening in the wall of the container.

[0059] The movable element is movably constrained to the wall of the container at the control opening so that the target can take a plurality of different positions and / or orientations within the container.

[0060] As used herein and in the appended claims, "bounded chamber" refers to the space within the container that is surrounded on all sides by the walls of the container and is substantially enclosed apart from an opening made in a delimited area of the wall.

[0061] As used herein and in the appended claims, the terms "proximal", "distal", "lateral" and "contralateral" are used according to their ordinary meaning in the medical field.

[0062] In particular, when the terms "proximal" and "distal" are used with reference to anatomical parts of the cardiovascular system, they indicate regions closer to or farther from the heart, respectively. These terms also have a similar meaning when used with reference to artificial components that simulate or are implanted in anatomical parts of the cardiovascular system.

[0063] The terms "lateral" and "opposite" are understood in their ordinary meaning in the medical field. In particular, when used in relation to an anatomical structure or an artificial device that simulates an anatomical structure, the term "lateral" indicates a structure located in one half of the actual or virtual reference body, and the term "opposite" indicates a structure located in the opposite half of the reference body.

[0064] As used herein and in the appended claims, the "midplane of the container" refers to a plane that substantially bisects the container. When the container has an oval shape, the plane is orthogonal to the longitudinal direction of the container.

[0065] As used herein and in the appended claims, the "longitudinal direction" of a given element refers to its maximum deployment direction.

[0066] As used herein and in the appended claims, the terms "cannulation", "cannulation procedure" and similar expressions refer to any intravascular procedure aimed at inserting a guide wire or guide catheter for intravascular surgery into an opening of a particularly small size compared to the surrounding space in which the guide wire or catheter can be moved.

[0067] The applicant has verified that it is possible to effectively simulate situations where it is necessary to aim and center a small opening of an internal organ, such as the gate 11 of the internal organ 1 in FIG. 1 or the fenestration 16 of the internal organ 3, with a surgical guide wire or guide catheter, without constructing a complete model of the surgical situation, by placing a bounded container having a target with at least one cannulation site therein.

[0068] Furthermore, the applicant has found that since such a target is supported on a movable element that is movably constrained to the wall of the container, it is possible to change the position and / or orientation of the target within the container, and as a result, a plurality of simulated surgical situations are available for the surgeon to test their dexterity skills.

[0069] The applicant has also verified that by providing the movable element with a control member that at least partially protrudes from the container, it is possible to quickly and easily change the position and orientation of the target by acting from outside the container, even during the same surgical training session in some cases.

[0070] Thanks to the device provided by the applicant, trained surgeons are exposed to a number of complex surgical situations and have the opportunity to test a number of endovascular procedures using the same device, which is also very inexpensive by simply manually changing the target configuration.

[0071] In a second aspect, the invention also relates to a training method for endovascular surgical procedures for the treatment of aneurysms.

[0072] It is envisaged to prepare a training device according to the first aspect of the invention.

[0073] It is envisaged to prepare a guide wire for endovascular surgery and / or a guide catheter for endovascular surgery.

[0074] It is further contemplated that the guide wire, or the guide catheter, or the guide wire introduced into the guide catheter, is introduced into the container of the device through the first tube and the first access opening.

[0075] The distal end of the guide wire and / or the distal end of the guide catheter are oriented towards at least one cannulation site of the target of the movable element, and in some cases, an attempt is further made to introduce the distal end of the guide wire end and / or the distal end of the guide catheter into the at least one cannulation site of the target.

[0076] The applicant has found that the training method according to the present invention can be carried out quickly and easily, enables effective practice of operating conditions similar to the real world, and presents essentially no risk to the operator or other persons.

[0077] The device according to the present invention can include one or more of the following preferred features considered individually or in combination.

[0078] Preferably, the container has a spherical or oval shape.

[0079] Preferably, the wall of the container is made of a flexible or soft material.

[0080] In this way, the container can effectively simulate the structural characteristics of an actual aneurysm, and its wall bends when it comes into contact with the guide wire and / or the guide catheter during insertion.

[0081] Preferably, the wall of the container is made of a translucent or transparent material.

[0082] The transparency of the container allows the operator performing the training session to directly view on the device the progress of the guide wire / guide catheter and the position of the target within the container when the operator cannot accurately interpret the spatial configuration of the system from the fluoroscopic image alone. This enables the operator to obtain direct visual feedback and quickly make the necessary corrections in case of errors or very difficult operations.

[0083] For example, the wall of the container is made of a silicone material.

[0084] Preferably, at least one cannulation site of the target is made of a radiopaque material.

[0085] More preferably, the target is made of a radiopaque material.

[0086] Even more preferably, the movable element is made of a radiopaque material.

[0087] By making at least one cannulation site of a radiopaque material, it is possible to monitor its position under fluoroscopic control and thus conduct the training session under visual conditions similar to those of an actual operation.

[0088] Preferably, the movable element is made of a metallic material.

[0089] Preferably, the at least one cannulation site is selected from one or more cavities, one or more concave regions, one or more recesses, or one or more through-holes of the target.

[0090] Preferably, the target is a ring and the at least one cannulation site is a through-hole of the ring.

[0091] This embodiment can simulate any cannulation operation in a simple manner. This is particularly suitable for simulating, for example, the cannulation of the endoprosthesis 3 (FIG. 3) at its fenestration 16 in an F-EVAR procedure.

[0092] Alternatively, the target is a segment of an endovascular prosthesis, and the at least one cannulation site includes a through-hole in the segment of the endovascular prosthesis.

[0093] Preferably, the target is selected from a branched endoprosthesis segment, a bifurcated endoprosthesis segment, a fenestrated endoprosthesis segment, or a combination thereof.

[0094] Preferably, the at least one cannulation site is selected from the passage lumen of a tubular endoprosthesis segment, the passage lumen of a tubular endoprosthesis branch, and a fenestration made in the endoprosthesis wall.

[0095] In an embodiment, the target includes a plurality of cannulation sites.

[0096] Preferably, the target segment of the endovascular tubular prosthesis is at least partially transparent.

[0097] The transparency of the endoprosthesis segment advantageously enables visually tracking the position of the guide wire and / or guide catheter while routing towards the target and inserting into one or more cannulation sites embodied by the passage lumen of the tubular portion of any branch and / or any fenestration.

[0098] Preferably, the control aperture is an elongated cut or slit provided in the wall.

[0099] Preferably, the cut or slit includes a flexible edge flap.

[0100] This feature enables the movable element to be easily inserted into or removed from the container. For example, when the target is of a size that cannot be ignored (e.g., when the target is a tubular internal organ segment), the movable element can be exchanged with another movable element that supports a different target.

[0101] Preferably, the control member of the movable element comprises an outer portion that protrudes from the container through the control opening.

[0102] This outer portion of the control member can be gripped by the operator from outside the container, enabling the position and / or direction of the movable element to be manipulated.

[0103] Preferably, the control member comprises an inner portion disposed within the container.

[0104] Preferably, the movable element is movably constrained to the wall of the container at this control opening.

[0105] Preferably, the movable element remains reversibly constrained to the wall of the container by the friction of the flexible edge flap of the cut or slit with respect to the control member.

[0106] Preferably, the position of the movable element with respect to the container can be changed by applying a force to the control member that is greater than the frictional force between the edge flap of the cut or slit and the control member.

[0107] Preferably, the control member is firmly fixed to the target or is made integral with the target.

[0108] In this way, any movement imparted to the control member is firmly transmitted to the target, enabling the position and direction of the target within the container to be accurately controlled.

[0109] Preferably, the control member is an elongated arm.

[0110] Preferably, the device comprises a second access opening in the wall.

[0111] In such a case, the device preferably comprises a second tube connected to the container at the second access opening.

[0112] Preferably, the first and second access openings are arranged on the same side of the device with respect to the median plane of the device.

[0113] Preferably, the device comprises a third access opening in the wall.

[0114] In such a case, the device preferably comprises a second tube connected to the container at the second access opening.

[0115] Preferably, the third access opening and the first or second access opening are arranged on opposite sides of the device with respect to the median plane of the device.

[0116] In a particularly preferred embodiment, the container further comprises a plurality of additional openings distributed along the wall configured to allow passage of the guide wire and / or guide catheter for endovascular surgery.

[0117] The additional apertures serve as additional cannulation sites for testing the routing of the guide wire and / or guide catheter, so the presence of the additional apertures further enriches the various simulated configurations available to the operator during training.

[0118] Preferably, the container has a length of about 5 cm to about 20 cm, preferably about 7 cm to about 15 cm, parallel to the longitudinal direction of the device.

[0119] Preferably, the container has a width of about 3 cm to about 18 cm, preferably approximately 5 cm to approximately 13 cm, perpendicular to the longitudinal direction of the device.

[0120] Preferably, the first access opening and / or the second access opening is circular.

[0121] Preferably, one or more of the first access opening, the second access opening, and the third access opening have a passage diameter between about 4 mm and about 2 cm, preferably between about 6 mm and about 1.5 cm.

[0122] Preferably, the at least one cannulation site includes a circular through-hole having a diameter of about 2 mm to about 2 cm, preferably about 4 mm to about 1.5 cm, and even more preferably about 3 mm to about 8 mm.

[0123] Preferably, the additional openings in the container wall are circular, each having a diameter of about 2 mm to about 2 cm, preferably about 4 mm to about 1.5 cm, and even more preferably approximately 3 mm to approximately 8 mm.

[0124] In a particularly preferred embodiment, the device further includes a tank.

[0125] The tank preferably has a peripheral wall of such a height as to accommodate a fluid column capable of completely covering the container of the device when immersed in the tank.

[0126] Preferably, the tank has one or more holes in the peripheral wall, if provided, for passing the first tube, preferably the second tube and / or the third tube of the device.

[0127] By providing such a tank, it becomes possible to introduce fluid into the container, and thus more precisely simulate the operating conditions of intravascular procedures. By keeping the container submerged in the tank, the container remains filled with fluid even if some of such fluid exits the inner chamber through the control opening or, if present, through the additional openings in the wall.

[0128] Preferably, the recirculation tube connected to the first tube and / or the second tube and the third tube is provided to enable continuous circulation of the fluid in the container so as to simulate dynamic conditions comparable to blood circulation during in vivo treatment.

[0129] Preferably, in the training method according to the present invention, an attempt to route the distal end of the guide wire and / or the distal end of the guide catheter is made by sliding the guide wire and / or the guide catheter through the first access opening, or by moving the guide wire and / or the guide catheter forward or backward relative to the container.

[0130] Alternatively or additionally, an attempt to route the distal end of the guide wire and / or the distal end of the guide catheter is made by rotating the guide wire and / or the catheter about their respective longitudinal axes.

[0131] Alternatively or additionally, an attempt to route the distal end of the guide wire and / or the distal end of the guide catheter is made by sliding the guide wire and / or the guide catheter longitudinally relative to each other.

[0132] Preferably, according to the training method of the present invention, it is envisaged to change the position and / or orientation of the target relative to the container by manually acting on the control member.

[0133] Further features and advantages of the present invention will be best obtained from the following detailed description of some preferred embodiments thereof with reference to the accompanying drawings. Different features in the individual embodiments can be freely combined.

Brief Description of the Drawings

[0134]

Figure 1

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DETAILED DESCRIPTION OF THE INVENTION

[0135] The representations in the accompanying drawings are not necessarily to scale and do not necessarily take into account the ratios of the various parts.

[0136] With reference to FIGS. 7-8, a first preferred embodiment of a surgical training device according to the present invention, indicated by reference numeral 50, will now be described.

[0137] The device 50 comprises a rounded, for example oval, container 52 as illustrated.

[0138] The container 52 is formed by a substantially closed wall 54, except for an opening to be described below, and defines a chamber 56 within which a boundary is defined.

[0139] In FIG. 7, the longitudinal direction in which the length of the container 52 is defined and the median plane M (schematically shown in FIG. 7) perpendicular to the longitudinal direction L are specified.

[0140] The wall 54 of the container 52 is made of a soft, translucent or transparent material such as, for example, a silicone material, and enables components disposed within the chamber 56 to be seen or at least identified.

[0141] The container 52 is geometrically and structurally adapted to simulate an aneurysm in the arterial region of a blood vessel, for example an A aneurysm (FIG. 4) located in the infrarenal region of the abdominal aorta.

[0142] The container 52 comprises a first access opening 58 and a second circular access opening 60 disposed on a first side L1 of the device 50 with respect to the median plane M.

[0143] A first tube 62 and a second tube 64 are fluidly connected to and respectively connected to the container 52 at the first access opening 58 and the second access opening 60.

[0144] The first and second tubes 62, 64 are configured to simulate, for example, the lateral and contralateral iliac arteries 18, 20 connected to the aneurysm A (FIG. 4).

[0145] The container 52 preferably comprises a third access opening 66 disposed on a second side L2 of the device 50 opposite the first side L1 with respect to the median plane M, and a third tube 68 fluidly connected to and connected to the container 52 at the third access opening 66.

[0146] The third tube 68 simulates, for example, the portion of the abdominal aorta upstream of the aneurysm A (Figure 4).

[0147] The device 50 preferably comprises a movable element 70.

[0148] The movable element 70 comprises a target 72 and a control member 74 in the form of, for example, an elongated substantially straight arm.

[0149] The control member 74 is firmly fixed to the target 72. Thus, any movement manually applied to the control member 74 is firmly transmitted to the target 72.

[0150] The target 72 is completely positioned within a defined chamber 56 within the container 52.

[0151] The control member 74 projects at least partially out of the container 52 through a first control opening 76, such that there is an outer portion 78 of the control member 74 that is grippable from outside the container 52 and an inner portion 77 of the control member 74 attached to the target 72.

[0152] The first control opening 76 is in the form of an elongated slit having a flexible edge flap (not shown), which keeps the movable element 70 constrained against the wall 54 of the container 52 by creating friction on the portion 80 of the control member 74 that contacts the flexible edge flap.

[0153] In this way, the movable element 70 rotates substantially between the edge flaps of the first control opening 76. By operating the outer portion 78 of the control member 74, it is possible to change the position of the inner portion 77 of the control member 74, and as a result, it is possible to move and orient the target 72 variously within the inner chamber 56 of the container 52.

[0154] By pulling or pushing the control member 74 along it, for example, it is possible to insert the control member deeper into the container 52 or pull it out further from the container 52, bringing the target 72 closer to or farther from the first control opening 76. By tilting the control member 74, it is possible to impose a corresponding tilt on the target 72. By rotating the control member 74 about its axis, it is possible to change the direction of the target 72.

[0155] FIG. 8 shows an apparatus 50 having a movable element 70 whose position and orientation relative to the container 52 are changed relative to the case shown in FIG. 7, for example, by manually acting on the outer portion 78 of the control member 74.

[0156] Returning to FIG. 7, the first control opening 76 is arranged, for example, parallel to the median plane M of the apparatus 50, but can be positioned and oriented differently on the container 52. As in the illustrated case, additional control openings 82, 83 arranged parallel to the first control opening 76 can be provided, for example, for use when it is preferred or necessary to rotate the movable element 70 at different positions on the container 52.

[0157] The target 72 of the apparatus 50 is in the form of a ring firmly constrained to the inner portion 77 of the control member 74 and includes a cannulation seat 84 represented by its central circular hole.

[0158] The cannulation site 84 is sized to receive a guide wire and / or guide catheter of the type commonly used in endovascular surgical procedures, as illustratively exemplified in FIGS. 5 - 6.

[0159] FIG. 9 illustrates an apparatus 100 according to a different embodiment of the present invention.

[0160] The device 100 differs from the device 50 of FIGS. 7-8 only in that the target 172 is made from a tubular internal organ segment that is structurally similar to the internal organs 1-3 illustrated in FIGS. 1-3. The cannulation site 184 is, in this case, represented by the passage lumen of the target 172.

[0161] In this case, the control member 74 is preferably firmly fixed to the tubular wall 86 of the target 172.

[0162] The target 172 illustrated here is a "simple" tubular internal organ segment.

[0163] In other embodiments not illustrated herein, the target 172 may include internal organ segments of any type and of an articulated configuration. For example, the target 172 may include internal organ segments of a bifurcated type (similar to the internal organ 1 of FIG. 1), a branched type (similar to the internal organ 2 of FIG. 1) or a fenestrated type (similar to the internal organ 3 of FIG. 1).

[0164] Preferably, the internal organ segment forming the target 172 is transparent so that the position of a guide wire or guide catheter can be visually tracked during insertion into the target 172.

[0165] FIG. 10 illustrates a device 200 according to a further embodiment of the invention. The device 200 differs from the device 50 of FIGS. 7-8 only in that it comprises a plurality of additional apertures 88 positioned variously on the wall 54 of the container 52.

[0166] Such additional openings 88 are circular and are sized to allow the passage of a guide wire or guide catheter for endovascular surgery, for example, similar to those illustrated in FIGS. 5-6.

[0167] In other non-illustrated embodiments, a tubular branch extending from the additional opening 88, such as a tubular endograft segment or a stent segment, can be provided to increase the complexity and number of sites where a guidewire or guide catheter can be directed during training.

[0168] Referring to FIG. 11, a training method for a surgical procedure for endovascular treatment of an aneurysm according to the present invention will now be briefly illustrated.

[0169] In a training device according to one of the described embodiments, such as the training device 50 illustrated again here, the movable element 70 is initially operated by manually acting on the control member 74 such that the target 72 assumes a desired position and orientation within the defined chamber 56.

[0170] Then, when the guide catheter 26 is shown operably associated, the guidewire 17 is inserted through the first tube 62 and the first opening 58 until access to the inner chamber 56 of the container 52 is obtained. In this way, in an EVAR procedure, the introduction of the guidewire 17 and the guide catheter 26 into the iliac artery is simulated until the aneurysm region is reached.

[0171] By manipulating the guidewire 17 and the guide catheter 26 relative to each other and peripherally with respect to the container 52, the operator can practice directing the distal end 24 of the guidewire 17 and / or the distal end of the guide catheter 26 toward and into the cannulation site 84 of the target 72, simulating the cannulation procedure of an EVAR or B-EVAR / F-EVAR type endovascular procedure.

[0172] Between trials, the operator has the option to change the position and orientation of the target 72 within the defined chamber 56 to their preference to simulate different modes of operation.

[0173] If device 200 of FIG. 10 is used instead of device 50 illustrated in this specification, in addition to attempting to place at the center of target 72, the operator has the option of practicing routing the distal end 24 of guide wire 17 and / or the distal end of guide catheter 26 outside of container 52 through one or more of additional apertures 88 from within bounded chamber 56, thereby expanding the operator's training options.

[0174] FIG. 12 illustrates a device 300 according to a further embodiment of the present invention.

[0175] Device 300 differs from device 200 illustrated in FIG. 10 in that it further includes a tank 90 illustrated herein in a rectangular shape.

[0176] Tank 90 includes a peripheral wall 92 with only two sides 93, 94 illustrated for clarity so that components disposed within tank 90 can be seen.

[0177] Container 52 is on the bottom 91 of tank 90. The peripheral wall of the tank 92 includes holes 96 in its sides 93, 94, which allow passage of the first and second tubes 62, 64 and the third tube 68 of device 200. The holes 96 are hermetically sealed around the first tube 62, the second tube 64, and the third tube 68 by suitable gaskets.

[0178] By providing tank 90, it becomes possible to operate the device in the above-described manner and test the cannulation operation even in the presence of a fluid, such as water or another more dense fluid, in order to better simulate actual operating conditions.

[0179] In use, device 200 is actually completely submerged and filled with the fluid. The free surface 98 of the fluid is above the first and second tubes 62, 64 and the third tube 68 of device 200.

[0180] In this embodiment, it is possible to envision a recirculation system that enables a fluid to continuously circulate, for example, through the third pipe 68 at the inlet to the container 52 and out of the container 52, for example, through the first and second pipes 62, 64, so as to simulate a dynamic fluid situation.

[0181] To meet specific requirements, those skilled in the art can make many changes and modifications to the illustrated and described apparatuses 50, 100, 200, and 300 and related training methods, all of which are included within the scope of protection of the present invention as defined by the appended claims.

Claims

1. A training device for surgical procedures involving endovascular treatment of aneurysms, A container having a wall defining a bounded chamber, and a first access opening provided in the wall, wherein the first access opening is configured to allow insertion of a guidewire and / or guide catheter for endovascular surgery into the container, A first pipe connected to the container at the first access opening, A movable element comprising a target and a control member connected to the target, Equipped with, The target is located within the container and comprises at least one cannulation site configured to receive the guidewire and / or guide catheter for endovascular surgery, and the control member protrudes at least partially from the container through a control opening in the wall of the container. A training device in which the movable element is movably constrained to the wall of the container at the control opening, so as to allow the target to take on a plurality of different positions and / or orientations within the container.

2. The training apparatus according to claim 1, wherein the container has a spherical or egg-shaped form.

3. The training apparatus according to claim 1, wherein the walls of the container are made of a translucent or transparent material.

4. The training apparatus according to claim 1, wherein one or more of the at least one cannulation site, the target, and the movable elements are made of a radiopaque material.

5. The training apparatus according to claim 1, wherein the at least one cannulation area is divided between one or more cavities, one or more concave regions, one or more recesses, or one or more through holes in the target.

6. The training apparatus according to claim 1, wherein the control opening is an elongated cut or slit provided in the wall of the container, the cut or slit includes a flexible edge flap, and the movable element remains reversibly restrained to the wall of the container by friction of the flexible edge flap of the cut or slit with respect to the control member.

7. The training apparatus according to claim 1, wherein the control member of the movable element is firmly fixed to the target or is made integrally with the target.

8. The training apparatus according to claim 1, wherein the container comprises a plurality of additional openings distributed in the wall, configured to allow the passage of the guidewire and / or the guide catheter for endovascular surgery.

9. The training apparatus according to claim 1, further comprising a tank having a peripheral wall, wherein the peripheral wall has a height such that it can accommodate a fluid column capable of completely covering the container of the apparatus, which is arranged to be immersed in the tank.

10. The training apparatus according to claim 1, wherein one or more of the at least one cannulation site, the target, and the movable elements are made of a metallic radiopaque material.

11. A training method for surgical procedures involving endovascular treatment of aneurysms, Prepare the training device described in any one of claims 1 to 10, To prepare guidewires and / or guide catheters for endovascular surgery, The guide wire, or the guide catheter, or the guide wire introduced into the guide catheter, is introduced into the container of the device through the first tube and the access opening. Attempting to orient the end of the guide wire and / or the end of the guide catheter toward the cannulation portion of the target of the movable element, Training methods, including those mentioned above.

12. A training method for surgical procedures for endovascular treatment of aneurysms, Prepare the training device described in any one of claims 1 to 10, To prepare guidewires and / or guide catheters for endovascular surgery, The guide wire, or the guide catheter, or the guide wire introduced into the guide catheter, is introduced into the container of the device through the first tube and the access opening. Attempting to orient the end of the guide wire and / or the end of the guide catheter toward the cannulation portion of the target of the movable element, Introducing the terminal end of the guidewire and / or the terminal end of the guide catheter into the cannulation site of the target, Training methods, including those mentioned above.

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