Operation training device
By designing a surgical training device containing a restricted chamber and movable elements, the problem of lack of effective training tools in the prior art is solved, and efficient simulation and skill improvement of endovascular surgical operations are achieved.
Patent Information
- Application Number
- CN202380055208.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2022-06-22
- Filing Date
- 2023-06-21
- Publication Date
- 2025-03-07
AI Technical Summary
The prior art is difficult to provide a simple and inexpensive surgical training device for simulating surgical operations for endovascular treatment of aneurysms, especially in the case of intubation operations, where surgeons lack effective training tools.
A training device containing a restricted chamber is designed with built-in movable elements and targets that allow the simulation of guidewire and guide catheter insertion process in endovascular surgical operations, through which the surgeon can practice manual control techniques in multiple operating configurations.
The device enables intern surgeons to perform numerous complex surgical simulations in a safe, low-cost environment, improving their manual skills in endovascular treatment, especially in intubation operations.
Smart Images
Figure CN119585784A_ABST
Abstract
Description
[0001] The present invention relates to a surgical training device, and more particularly to a surgical training device for intravascular treatment of aneurysms.
[0002] The invention also relates to a method for training the above-mentioned surgical procedure in the endovascular treatment of aneurysms using the device, and the use of the device in the training method.
[0003] An aneurysm is a permanent pathological dilation affecting the wall of a blood vessel, usually an artery. The occurrence of an aneurysm is often associated with high blood pressure, dyslipidemia, age, smoking or genetic predisposition.
[0004] The dilated portion of the wall becomes fragile and may continue to dilate over time under the influence of blood pressure until it ruptures, causing hemorrhage that is often fatal to the patient. Even without rupture, large aneurysms can impede normal blood circulation and promote the formation of blood clots, which can embolize and cause ischemia in downstream tissues.
[0005] Aneurysms most commonly affect the aorta, the largest blood vessel in the cardiovascular system. In most cases, the aneurysm is located in the infrarenal abdominal aorta region upstream of the iliac bifurcation.
[0006] Aneurysms can be treated by conventional open surgery or endovascular surgery, with endovascular surgery now considered the treatment of choice in most cases due to its very low invasiveness to the patient and the high reproducibility of the surgical technique.
[0007] Endovascular treatment of aneurysms involves implanting a tubular endoprosthesis in the aneurysmal portion of a vessel, the length and shape of which excludes the dilated vessel area from circulation. The endoprosthesis is introduced into the circulation through a very small percutaneous puncture made in a peripheral body area, such as in the groin area, and reaches the aneurysmal vessel via a guide and catheter, as described below.
[0008] Figure 1 , 2 and 3 schematically show some types of tubular endoprostheses commonly used in intravascular procedures, denoted by 1, 2, and 3.
[0009] The endoprostheses 1 , 2 and 3 consist of a metal stent 4 , usually made of steel or a shape memory alloy, coated with an impermeable material 5 , such as GoreTex or polyethylene terephthalate (PTFE), possibly in braided form (Dacron).
[0010] Endoprosthesis 1 is of bifurcated multi-module type and is suitable for placement in the infrarenal aortic aneurysm upstream of the iliac bifurcation.
[0011] The endoprosthesis 1 includes a main module 6, which includes a central body 7 configured to be placed in the infrarenal aorta segment, a side limb 8 configured to be placed in the lateral iliac artery, and a contralateral portion 9 that is shorter than the side limb 8 and is configured to remain floating within the aneurysm (until it is subsequently combined with a contralateral module 10, see below) without contacting the wall of the contralateral iliac artery.
[0012] The endoprosthesis 1 further comprises a contralateral module 10 distinct from the main module 6. The contralateral module 10 is attached to the contralateral portion 9 at its terminal opening 11 (also referred to as the door 11) to form a contralateral limb 12 configured to be placed in the contralateral iliac artery, thereby resulting in complete exclusion of the aneurysm from the circulation.
[0013] At the proximal end 14 of the main module 6 of the endoprosthesis 1 a free stent 13 is provided, the function of which is to improve the anchoring of the endoprosthesis 1 to the aortic wall without blocking the start of the aortic branch.
[0014] The endoprosthesis 2 is of a branched single-module type, comprising a single main module 6, the main module 6 comprising a central body 7, the central body 7 being configured for insertion into the aorta, the central body 7 being provided with branches 15 ( Figure 2 ) branches 15 are configured to facilitate introduction of the covered stent into a vessel originating from the aneurysm sac.
[0015] The internal prosthesis 3 is a single-module fenestrated type. It consists of a single main module 6, in which a window hole 16 ( Figure 3 Two are shown in the figure) to allow the perfusion of the collateral vessels. Depending on the specific requirements, in almost all cases, additional modules are provided in the form of side limbs (not shown here) to be implanted in the collateral vessels originating from the fenestration 16.
[0016] As mentioned above, the endoprosthesis 1 is suitable for treating abdominal aneurysms and it is usually manufactured in standard sizes.
[0017] For example, the endoprosthesis 2 is particularly suitable for treating aneurysms located in the thoracic and abdominal region of the aorta, and is generally custom designed according to the needs of the patient.
[0018] Endoprosthesis 3 is typically used to treat aneurysms with special problems, such as aneurysms with an inadequate infrarenal aortic annulus, and certain types of thoracoabdominal aneurysms. Endoprosthesis 3 can be manufactured in standard sizes or custom designs.
[0019] To better understand how vascular endoprostheses are inserted, Figure 4 Some basic steps of endovascular aneurysm repair (EVAR) surgical procedure are described in a completely schematic manner.
[0020] The EVAR procedure described herein is intended to implant a bifurcated endoprosthesis 1 ( Figure 1 ) to the infrarenal abdominal artery aneurysm (at Figure 4 The abdominal aneurysm is located in the aorta region between the renal arteries 16 and the aorta bifurcating into the lateral iliac artery 18 and the contralateral iliac artery 20 .
[0021] The EVAR procedure begins with the creation of a first peripheral arterial access at the common femoral artery (not shown), which is often referred to as the lateral common femoral artery, and the introduction of a first guidewire 17 into the first access, which is advanced through the lateral common femoral artery, the lateral iliac artery 18 and the aneurysm A to the suprarenal aorta region 22 ( Figure 4 step (a) in the above example.
[0022] The first guide wire 17 used (in Figure 5 The insert (best shown in FIG. 2 ) is thin, flexible and hydrophilic, having a curved end 24 that aids in proper guidance during insertion.
[0023] Guidewires with varying thicknesses and stiffness are available in the market and are selected on a case-by-case basis depending on the requirements of the specific procedure.
[0024] Since the introduction route from the peripheral puncture to the aneurysm A may also be quite complicated, the first guidewire 17 is advanced with the aid of one or more guide catheters of different shapes.
[0025] Figure 6 Some guide catheters 26a, 26b, 26c, 26d and 26e that can be used for this purpose are shown by way of example. The guide catheters shown herein have corresponding ends 28a, 28b, 28c, 28d and 28e of different shapes, which guide and direct their ends 24 in a specific direction by cooperating with the first guide wire 17 extending in its lumen. During the insertion operation, depending on the anatomical structure and the position of the first guide wire 17 in its advancement, the guide catheter with the most suitable end is selected from time to time to guide the guide wire in the desired direction. For example, a guide wire with a diameter of about 1 mm can be used in conjunction with a catheter with a diameter of 3-4 mm.
[0026] This operation involves the sequential use of one or more intermediate, low-stiffness first guidewires, which are eventually replaced by a stiffer first determining guidewire, which serves as a sliding track for the components that must subsequently reach the aneurysm A. For convenience, the same expression "first guidewire 17" will be used to refer to the first intermediate guidewire and the first determining guidewire.
[0027] exist Figure 4 In step (b) of the operation shown in FIG. 1 , the main module 6 ( Figure 1) is attached to the first delivery catheter 30 and is maintained in a compressed state by the first sheath 32 and 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, the side limbs 8 and the contralateral part 9 of the main module 6 of the endoprosthesis 1 are formed in the stent 4 ( Figure 1 ) under the radial force of the internal prosthesis 1, and adhere to the vessel wall. In order to improve the adhesion and sealing, the expansion object is usually expanded to the internal prosthesis 1 on the first guide wire 17 to promote the expansion (see Figure 4 step (c) in the above procedure.
[0029] To complete the assembly of the endoprosthesis 1, a second peripheral arterial puncture is then performed at the contralateral common femoral artery (not shown). Through the second peripheral arterial puncture, 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 positioned in a manner substantially similar to that described above with reference to the first guidewire (e.g., by means of one or more guidewires such as Figure 6 The guide catheter shown in FIG. 2 is advanced to the suprarenal aorta region 22 through the contralateral common femoral artery, the contralateral iliac artery 20 and the aneurysm A. The free stent 13 of the main module 6 is extended by radial force and attached to the suprarenal aorta region 22.
[0031] Also in this case, one or more intermediate, low-hardness second guidewires are used in sequence, eventually replaced by a final, harder second guidewire, all of which are identically denoted as "second guidewire 34" for convenience.
[0032] At this stage, the second guide wire 34 must be correctly introduced into the terminal opening or door 11 of the contralateral part 9 of the main module 6 by performing a so-called cannulation operation of the door 11 .
[0033] In the next step (e) of the operation, the contralateral module 10 ( Figure 1 ) is attached to a second release catheter (not shown) and is maintained in a compressed state by a second sheath (not shown in the figure), and is advanced along the second guide wire 34 until the proximal end of the contralateral module 10 enters the terminal opening 11 of the contralateral part 9 of the main module 6, thereby defining an overlapping area 36 between the contralateral part 9 of the main module 6 and the contralateral module 10 of the endoprosthesis 1.
[0034] Then the second sheath is pulled out and dragged out of the second peripheral passage, and the contralateral module 9 is automatically deployed under the radial force of the stent 4 ( Figure 1), resulting in the distal end of the contralateral module 10 being attached to the vessel wall, and the attachment between the contralateral portion 9 and the contralateral module 10 at the overlap region 36. Expansion and sealing are further facilitated by operating an additional push inflation over the second guide wire 34 ( Figure 4 Extension of the lateral limb 8 can be completed at this stage, for example by reinserting the expansion device associated with the first guide wire 17.
[0035] Finally, in step (g), once expansion of the endoprosthesis 1 in all its parts is complete, the first guidewire 17 and the second guidewire 34 are removed by pulling them out of their respective peripheral arterial passages. Once the endoprosthesis 1 is fully assembled and deployed so that it is firmly attached to the vessel wall, it excludes the aneurysm A from the circulation.
[0036] The EVAR procedure is performed under fluoroscopic control to allow real-time visualization of the vascular architecture (marked with appropriate contrast agents) and the position of the guidewire, guiding catheter, and endoprosthesis 1 module during introduction and advancement.
[0037] Figure 2 and Figure 3 Implantation of the illustrated endoprostheses 2 and 3 is performed by an endovascular procedure generally referred to as branched-EVAR (B-EVAR) and fenestrated-EVAR (F-EVAR), similar to the EVAR procedure described above, mutatis mutandis.
[0038] Such procedures include the introduction of the main module 6 over a guidewire through an initial peripheral arterial access and expansion after reaching the implantation site, and the insertion of further prosthetic modules (e.g., additional branches inserted into the fenestrations 16 of the endoprosthesis 3) through additional guidewires inserted from the same peripheral access or from another access. In this type of procedure, peripheral access is usually provided from above, in the axilla, as an alternative or in addition to femoral access from below.
[0039] Performing endovascular surgical procedures requires a high degree of manual dexterity on the part of the surgeon.
[0040] The most delicate operation is the insertion of the guidewire and guiding catheter. Starting from the peripheral percutaneous puncture to the aneurysm site, the vascular network to be traversed can actually be very long and complex, with considerable anatomical variation between individual patients.
[0041] Furthermore, guidewires and guide catheters must be manipulated from outside the percutaneous puncture and oriented in three dimensions based only on what the surgeon can infer from the two-dimensional images provided by fluoroscopy. Therefore, the correct orientation of the guidewire and guide catheter is entirely dependent on the surgeon's manual dexterity and his or her ability to interpret radiographic images in real time.
[0042] Traditionally, most training for these procedures has taken place in field trials, which severely limits the practical possibilities for young surgeons to improve their manual skills, since in real surgery the most complex cases are usually reserved for the most experienced surgeons.
[0043] Artificial models of vascular channels are known in the industry and are used for research or surgical training purposes.
[0044] For example, there are 3D models of an aneurysmal section of the abdominal aorta connected to two iliac arteries and other vessels. These models are used for simulations of endovascular surgery, where conditions replicate the actual surgery as closely as possible, including guided viewing via fluoroscopy.
[0045] The applicant notes that these models are usually custom made and therefore rather complex and expensive to produce. These models are also not very versatile for training purposes, as they only allow practicing specific anatomical structures.
[0046] Applicants have also recognized that, in addition to replicating an entire operation, it would be advantageous for the surgeon to be able to individually test technical gestures that require more dexterity without having to set up a simulation of the entire surgery.
[0047] The Applicant has particularly noted that the most complex technical gesture, requiring more practice, is the so-called cannulation maneuver, which aims to arrange a particularly small opening in a larger space, aligned with and centered on a guidewire (possibly in cooperation with a guide catheter).
[0048] For example, in the EVAR procedure described above, it is not easy to introduce the end of the second guide wire 34 into the terminal opening 11 of the contralateral portion 9 of the main module 6 of the endoprosthesis 1 (step (d)). Similarly, in the B-EVAR or F-EVAR procedure, it is not easy to properly guide the guide wire to introduce it into the branch 15 or Figure 1 The fenestration 16 of the endoprosthesis 3 is particularly complex.
[0049] The Applicant has therefore set itself the goal of providing a surgical training device of simple and inexpensive construction that allows simulating multiple operational configurations of intravascular components and / or anatomical structures during intravascular treatment procedures (e.g., in procedures similar to EVAR, B-EVAR or F-EVAR).
[0050] Applicants have also recognized that it would be advantageous to be able to switch smoothly and quickly from one "simulated" component operating configuration to another, or from one "simulated" anatomical configuration to another, so that many different surgical procedures can be tested with a single device and more complex technical gestures of typical intravascular procedures can be familiarized in a short period of time.
[0051] The Applicant has also set itself the object of providing a method for surgical training using such a device.
[0052] Thus, the present invention in its first aspect relates to a device for training surgical procedures for the endovascular treatment of aneurysms.
[0053] The device includes a container having a wall defining a confined chamber and a first access opening in the wall.
[0054] The first access opening is configured to allow a guidewire and / or a guide catheter for an endovascular procedure to be inserted into the container.
[0055] The device comprises a first tube connected to the container at a first access opening.
[0056] Advantageously, the device further comprises a movable element comprising a target and a control member connected to said target.
[0057] The target of the movable element is arranged in the container and comprises at least one tube rack configured to receive the guide wire and / or the guide catheter for intravascular surgery.
[0058] The control member of the movable element at least partially protrudes out of the container through a control opening in the container wall.
[0059] The movable element is movably constrained to the wall of the container at the control opening so as to enable the target to adopt a plurality of different positions and / or orientations within the container.
[0060] As used in this specification and the appended claims, "confined chamber" means a space within a container that is surrounded on all sides by walls of the container and is substantially closed except for openings formed in defined areas of the walls.
[0061] In this specification and the appended claims, the terms "proximal," "distal," "lateral," and "contralateral" are used according to their ordinary meaning in the medical art.
[0062] In particular, when used with reference to an anatomical portion of the cardiovascular system, the terms "proximal" and "distal" are meant to indicate areas closer to or farther from the heart. These terms also have similar meanings when used in relation to artificial components that simulate or are implanted in an anatomical portion of the cardiovascular system.
[0063] The terms "lateral" and "contralateral" are understood according to their usual meaning in the medical field. In particular, when used in conjunction with anatomical structures or artificial devices that simulate anatomical structures, the term "lateral" refers to structures located in a (real or hypothetical) half of the reference body, and the term "contralateral" refers to structures located in the other half opposite to the half of the reference body.
[0064] In the present specification and the appended claims, "median plane of the container" means a plane that substantially cuts the container in half. When the container is oval, the plane is orthogonal to the longitudinal direction of the container.
[0065] In this specification and the appended claims, the "longitudinal direction" of a given element refers to the direction of its greatest extension.
[0066] As used in this specification and the appended claims, "cannulation," "cannulate," and similar expressions refer to any procedure intended to insert a guidewire or guide catheter for intravascular surgery into a blood vessel through an opening of particularly small size compared to the surrounding space in which the guidewire or catheter can move.
[0067] Applicants have demonstrated that by arranging a constrained container with a target having at least one tube holder therein, it is possible to effectively simulate situations where a small opening of an endoprosthesis (e.g., Figure 1 The door 11 of the endoprosthesis 1 or the window 16 of the endoprosthesis 3 can be seen in the figure without having to build a complete model of the surgical situation.
[0068] Furthermore, the applicant has discovered that, since such a target is supported on a movable element which is movably constrained to the wall of the container, the position and / or orientation of the target within the container can be varied, thereby enabling a number of simulated surgical situations to be obtained in which the surgeon can test his manual control skills.
[0069] The Applicant has also demonstrated that by equipping the movable element with control members at least partially protruding from the container, the position and orientation of the target can be changed quickly and easily by actions from outside the container, possibly even during the same surgical training.
[0070] Thanks to the device provided by the applicant, trainee surgeons have the opportunity to be exposed to a large number of complex surgical situations and to test a large number of endovascular procedures using the same device, which is also very inexpensive and allows simple manual changes in target configuration.
[0071] In a second aspect, the present invention also relates to a method for training an endovascular surgical procedure for treating an aneurysm.
[0072] It is envisaged to provide a training device according to the first aspect of the present invention.
[0073] It is contemplated to provide a guidewire for an endovascular procedure and / or to provide a guide catheter for an endovascular procedure.
[0074] It is also envisaged that the guidewire, the guide catheter or the guidewire introduced into the guide catheter is introduced into a container of the device through the first tube and the first access opening.
[0075] It is also envisaged to attempt to direct the tip of the guidewire and / or the tip of the guide catheter to at least one scaffold of the target of the movable element and possibly to introduce said tip of the guidewire end and / or said tip of the guide catheter into said at least one scaffold of the target.
[0076] The Applicant has found that the training method according to the invention is quick and easy to perform and allows effective practice of real-life operating situations and poses substantially no risk to the operator or other persons.
[0077] The device according to the invention may comprise one or more of the following preferred features, considered alone or in combination.
[0078] Preferably, the container is spherical or ellipsoidal in shape.
[0079] Preferably, the walls of the container are made of a flexible or soft material.
[0080] In this way, the container can effectively simulate the structural properties of an actual aneurysm and its walls flex when contacted by the guidewire and / or guiding catheter during insertion.
[0081] Preferably, the wall of the container is made of a translucent or transparent material.
[0082] The transparency of the vessel allows the operator in training to observe the advancement of the guidewire / guide catheter and the position of the target within the vessel directly on the device in case the operator is unable to correctly interpret the spatial configuration of the system from the fluoroscopic image alone. This allows the operator to obtain direct visual feedback and quickly implement necessary corrections in the event of errors or difficult maneuvers.
[0083] For example, the walls of the container are made of silicone material.
[0084] Preferably, at least one tube support 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 manufacturing at least one of the tube holders from a radiopaque material, its position can be monitored under fluoroscopic control, allowing training to be performed under viewing conditions similar to actual surgery.
[0088] Preferably, the movable element is made of a metallic material.
[0089] Preferably, the at least one tube support is selected from one or more cavities, one or more recessed areas, one or more grooves or one or more through holes in the target.
[0090] Preferably, the target is a ring and the at least one tube support is a through hole of the ring.
[0091] This embodiment can simulate any intubation operation in a simple manner. For example, it is particularly suitable for simulating the insertion of an internal prosthesis 3 ( Figure 3 ) through a cannula at its window hole 16.
[0092] Alternatively, the target is a segment of a tubular endovascular prosthesis and the at least one scaffold comprises a through hole of the segment of the tubular endovascular prosthesis.
[0093] Preferably, the target is selected from a bifurcated endoprosthesis segment, a branched endoprosthesis segment, a fenestrated endoprosthesis segment, or a combination thereof.
[0094] Preferably, the at least one tubular support is selected from the group consisting of a channel lumen of a tubular endoprosthesis segment, a channel lumen of a tubular endoprosthesis branch and a fenestration made in an endoprosthesis wall.
[0095] In an embodiment, the target comprises a plurality of racks.
[0096] Preferably, said target section of the intravascular tubular prosthesis is at least partially transparent.
[0097] The transparency of the endoprosthesis segment advantageously allows visual tracking of the position of the guidewire and / or guide catheter during advancement toward the target and insertion into one or more scaffolds embodied by the tubular portion, any branches, and / or any perforated channel lumens.
[0098] Preferably, the control opening is an elongate cutout or slit in the wall.
[0099] Preferably, said cutout or said slit comprises a flexible edge flap.
[0100] This feature allows easy insertion / removal of the movable element into / from the container, for example replacing it with another movable element supporting a different target, in particular when the target has non-negligible dimensions (for example when the target is a tubular endoprosthesis segment).
[0101] Preferably, the control member of the movable element comprises an outer portion which projects out of the container through the control opening.
[0102] This outer part of the control member can be grasped by an operator from outside the container and allows the position and / or orientation of the movable element to be manipulated.
[0103] Preferably, the control member comprises an inner portion arranged within the container.
[0104] Preferably, the movable element is movably constrained to the wall of the container at the control opening.
[0105] Preferably, the movable element is held reversibly constrained to the container wall by friction of said flexible edge flaps of the cut-outs or slits in the control member.
[0106] Preferably, the position of the movable element relative to the container can be changed by applying a force to the control member which is greater than the friction between the edge flaps of the cutout or slit and the control member.
[0107] Preferably, the control member is rigidly fixed to the target or is made integrally with the target.
[0108] In this way, any movement imposed on the control member is rigidly transmitted to the target and the position and orientation of the target within the container can be precisely controlled.
[0109] Preferably, the control member is an elongate arm.
[0110] Preferably, the device comprises a second access opening in the wall.
[0111] In this case, the device preferably comprises a second tube connected to the container at the second passage opening.
[0112] Preferably, the first and second passage openings are arranged on the same side of the device relative to its mid-plane.
[0113] Preferably, the device comprises a third access opening in the wall.
[0114] In this case, the device preferably comprises a second tube connected to the container at the second passage opening.
[0115] Preferably, the third passage opening and the first or second passage opening are arranged on opposite sides of the device with respect to a median plane thereof.
[0116] In a particularly preferred embodiment, the container further comprises a plurality of additional openings distributed along said wall, said openings being configured to allow passage of said guide wire and / or guide catheter for intravascular surgery.
[0117] The presence of the additional holes further enriches the variety of simulation configurations available to the operator during training, as the additional holes serve as additional holders for testing the paths of guidewires and / or guide catheters.
[0118] Preferably, the length of the container is parallel to the longitudinal direction of the device, said length being comprised between about 5 cm and about 20 cm, preferably between about 7 cm and about 15 cm.
[0119] Preferably, the container has a width perpendicular to the longitudinal direction of the device, said width being comprised between about 3 cm and about 18 cm, preferably between about 5 cm and about 13 cm.
[0120] Preferably, the first passage opening and / or the second passage opening are circular.
[0121] Preferably, one or more of the first, second and third passage openings has a passage diameter comprised between about 4 mm and about 2 cm, preferably between about 6 mm and about 1.5 cm.
[0122] Preferably, said at least one tube support comprises a circular through hole, the diameter of which is comprised between about 2 mm and about 2 cm, preferably between about 4 mm and about 1.5 cm, even more preferably between about 3 mm and about 8 mm.
[0123] Preferably, said additional openings in the container wall are circular, each opening having a diameter comprised between about 2 mm and about 2 cm, preferably between about 4 mm and about 1.5 cm, even more preferably between about 3 mm and about 8 mm.
[0124] In particularly preferred embodiments, the device further comprises a fluid reservoir.
[0125] The reservoir preferably includes a peripheral wall of sufficient height to contain a column of liquid capable of completely covering the container of the device when submerged in the reservoir.
[0126] Preferably, the reservoir comprises one or more holes at the peripheral wall for the passage of the first tube and preferably the second tube and / or the third tube (if provided) of the device.
[0127] Providing such a reservoir allows liquid to be introduced into the container, thereby more closely simulating the operating conditions of endovascular surgery. By keeping the container immersed in the reservoir, the container remains full of liquid even if some of such liquid flows out of the inner chamber through the control opening or through additional openings in the wall (if present).
[0128] Preferably, a recirculation tube connected to the first tube and / or the second tube and the third tube is provided to allow continuous circulation of the liquid within the container, thereby simulating dynamic conditions comparable to blood circulation during in vivo processes.
[0129] Preferably, in the training method according to the invention, an attempt is made to guide the tip of the guide wire and / or the guide catheter by moving the guide wire and / or the guide catheter forwards or backwards relative to the container so that it slides through the first access opening.
[0130] Alternatively or additionally, an attempt is made to guide the tip of the guidewire and / or the tip of the guide catheter by rotating the guidewire and / or the catheter about the respective longitudinal axes.
[0131] Alternatively or additionally, an attempt is made to guide the tip of the guidewire and / or the tip of the guide catheter by sliding the guidewire and / or the guide catheter longitudinally relative to each other.
[0132] Preferably, the training method according to the invention envisages acting on the control member by manual action in order to change the position and / or orientation of the target relative to the container.
[0133] With reference to the accompanying drawings, further features and advantages of the present invention will be best reflected by the following detailed description of some preferred embodiments, and different features in various configurations can be combined at will. In these drawings,
[0134] Figure 1-3 is a schematic perspective view of an intravascular prosthesis according to the prior art and which has been described in detail above;
[0135] Figure 4 is a schematic diagram of the main steps of the known surgical procedure which have been described in detail above;
[0136] Figure 5 A guide wire has been described in detail and can be used Figure 4 In surgical procedures and in the training method according to the present invention;
[0137] Figure 6 Some guide catheters that have been described in detail are shown and can be used Figure 4 In surgical procedures and in the training method according to the present invention;
[0138] Figure 7-8 shows an apparatus in different operating configurations according to a first embodiment of the invention;
[0139] Fig. 9 shows an apparatus according to a second embodiment of the present invention;
[0140] Fig.10 shows an apparatus according to a third embodiment of the present invention;
[0141] Fig.11 The operation steps of the surgical training method according to the present invention are shown. Figure 7-8 devices; and
[0142] Fig.12 shows an apparatus according to a fourth embodiment of the present invention;
[0143] The representations in the drawings are not necessarily drawn to scale, nor are the individual parts necessarily to scale.
[0144] refer to Figure 7-8 , a first preferred embodiment of a surgical training device according to the present invention will now be described, indicated by reference numeral 50 .
[0145] The device 50 is a rounded, for example oval, container 52, as in the case shown.
[0146] The container 52 is formed by a substantially closed wall 54, except for an opening to be described below, defining a confined chamber 56 therein.
[0147] exist Figure 7 In FIG. 5 , a longitudinal direction defined along the length of the container 52 and a mid-plane M perpendicular to the longitudinal direction L are identified. Figure 7 Schematically shown in ).
[0148] The wall 54 of the container 52 is made of a soft, translucent or transparent material (eg, a silicone material) and allows components that may be disposed in the chamber 56 to be seen or at least discernible.
[0149] The container 52 is geometrically and structurally adapted to simulate an aneurysmal region of a blood vessel, such as an A-artery aneurysm located in the infrarenal region of the abdominal aorta ( Figure 4 )
[0150] The container 52 comprises a first passage opening 58 and a second circular passage opening 60 which are arranged on a first side L1 of the device 50 relative to the middle plane M.
[0151] A first tube 62 and a second tube 64 are connected to the container 52 in a fluid communication manner at the first passage opening 58 and the second passage opening 60, respectively.
[0152] The first and second tubes 62, 64 are configured to simulate, for example, the lateral and contralateral iliac arteries 18, 20 ( Figure 4 ).
[0153] The container 52 preferably comprises a third passage opening 66 arranged on a second side L2 opposite to the first side L1 of the device 50 relative to the midplane M and a third tube 68 connected in fluid communication to the container 52 at said third passage opening 66 .
[0154] The third tube 68 simulates, for example, a portion of the abdominal aorta upstream of aneurysm A ( Figure 4 ).
[0155] The device 50 advantageously comprises a movable element 70 .
[0156] The movable element 70 comprises a target 72 and a control member 74 , for example in the form of an elongated and substantially straight arm.
[0157] The control member 74 is rigidly fixed to the target 72. Therefore, any movement manually applied to the control member 74 is rigidly transmitted to the target 72.
[0158] The target 72 is located entirely within the confined chamber 56 within the container 52 .
[0159] The control member 74 at least partially protrudes from the container 52 through the first control opening 76 , resulting in an outer portion 78 of the control member 74 that can be grasped from outside the container 52 , and an inner portion 77 of the control member 74 that is attached to the target 72 .
[0160] The first control opening 76 is in the form of an elongated cutout with flexible edge flaps (not shown) which keep the movable element 70 constrained to the wall 54 of the container 52 by creating friction on the portion 80 of the control member 74 in contact therewith.
[0161] In this manner, movable element 70 pivots substantially between edge flaps of first control opening 76. By operating outer portion 78 of control member 74, the position of inner portion 77 of control member 74 can be changed, thereby moving and orienting target 72 within interior chamber 56 of container 52 in various ways.
[0162] By pulling or pushing the control member 74 in the way it can, for example, be inserted deeper into the container 52 or pulled further out of the container 52, bringing the target 72 closer to or further away from the first control opening 76. By tilting the control member 74, a corresponding tilt can be imposed on the target 72. By rotating the control member 74 about its axis, the direction of the target 72 can be changed.
[0163] For example, Figure 8The device 50 is shown with a movable element 70, the position and orientation of which relative to the container 52 can be adjusted by manually acting on the outer portion 78 of the control member 74. Figure 7 The situation shown has been changed.
[0164] Back to Figure 7 Although the first control opening 76 is arranged, for example, parallel to the middle plane M of the device 50, it can be positioned and oriented in a different manner on the container 52. Further control openings 82, 83 (arranged, for example, parallel to the first control opening 76) can be provided (as in the illustrated case) for pivoting the movable element 70 in different positions on the container 52, if preferred or necessary.
[0165] The target 72 of the device 50 is in the form of a ring, rigidly constrained to the inner portion 77 of the control member 74, and comprises a tubular support 84 represented by a circular hole in its center.
[0166] The tube holder 84 is sized to receive a guidewire and / or guide catheter of a type commonly used in endovascular surgical procedures, such as Figure 5-6 Those exemplarily shown in .
[0167] Fig. 9 An apparatus 100 according to different embodiments of the invention is shown.
[0168] Device 100 and Figure 7-8 The device 50 differs only in that the target 172 is made of a tubular endoprosthesis segment, which is similar in structure to Figure 1-3 The endoprosthesis 1 - 3 shown is similar. In this case, the tube frame 184 is represented by the channel cavity of the target 172.
[0169] In this case, the control member 74 is preferably rigidly fixed to the tubular wall of the target 172.
[0170] The target 172 shown here is a "simple" tubular endoprosthesis segment.
[0171] In other embodiments not shown herein, the target 172 may include any type of endoprosthesis segment, and may also include an articulated endoprosthesis segment. For example, the target 172 may include a bifurcated (similar to Figure 1 endoprosthesis 1), branched (similar to Figure 1 endoprosthesis2) or fenestrated (similar to Figure 1 Endoprosthesis 3) Endoprosthesis segment.
[0172] Preferably, the endoprosthesis segment forming the target 172 is transparent so that the position of the guidewire or guide catheter can be visually tracked during insertion of the target 172.
[0173] Fig.10 FIG. 2 shows an apparatus 200 according to another embodiment of the present invention. Figure 7-8 The device 50 of FIG. 5 only differs in that it comprises a plurality of additional holes 88 which are distributed in various ways on the wall 54 of the container 52 .
[0174] Such additional opening 88 is circular and sized to allow passage of a guide wire or guide catheter for intravascular surgery, similar to, for example, Figure 5-6 Those shown in .
[0175] In other non-illustrated embodiments, tubular branches, such as tubular endoprosthesis segments or stent segments, may be provided that exit from additional openings 88, thereby increasing the complexity and number of locations to which a guidewire or guide catheter may be directed during training.
[0176] Reference Fig.11 , a training method for surgical procedures for endovascular treatment of aneurysms according to the present invention will now be briefly described.
[0177] In a training device according to one of the embodiments, such as the training device 50 shown here again, the movable element 70 is initially operated by manually acting on the control member 74 so that the target 72 assumes a desired position and orientation within the confined chamber 56 .
[0178] Then, with the guidewire 17 operatively associated with the guide catheter 26, the guidewire 17 is inserted through the first tube 62 and the first opening 58 until entering the lumen 56 of the vessel 52. In this manner, the introduction of the guidewire 17 and the guide catheter 26 into the iliac artery until the aneurysm region is reached in an EVAR procedure is simulated.
[0179] By manipulating the guidewire 17 and guide catheter 26 peripherally relative to each other and relative to the vessel 52, the operator can practice directing the tip 24 of the guidewire 17 and / or the tip of the guide catheter 26 toward and into the tube holder 84 of the target 72, simulating the cannulation operation of an EVAR or B-EVAR / F-EVAR type intravascular operation.
[0180] Between trials, the operator may choose to change the position and orientation of the target 72 within the confined chamber 56 to his or her liking to simulate different operating configurations.
[0181] If instead of the device 50 shown here, Fig.10 With the illustrated apparatus 200 , in addition to attempting to center the target 72 , the operator may also elect to direct the terminal end 24 of the guidewire 17 and / or the end of the guide catheter 26 from within the restricted lumen 56 through one or more additional holes 88 to the exterior of the container 52 , thereby expanding his or her training options.
[0182] Fig.12 An apparatus 300 according to another embodiment of the present invention is shown.
[0183] Device 300 and Fig.10 The device 200 shown in FIG. 1 differs in that it also includes a reservoir 90 , shown here as a rectangle.
[0184] The reservoir 90 includes a peripheral wall 92 , of which only two sides 93 , 94 are shown for clarity to allow viewing of components disposed within the reservoir 90 .
[0185] The container 52 is located on the bottom 91 of the reservoir 90. The peripheral wall 92 of the reservoir comprises holes 96 at its sides 93, 94, which allow the passage of the first and second tubes 62, 64 and the third tube 68 of the device 200. The holes 96 are sealed around the first tube 62, the second tube 64 and the third tube 68 by suitable gaskets.
[0186] To better simulate actual operating conditions, the provision of reservoir 90 allows the device to be operated and cannula operation to be tested in the manner described above, even in the presence of liquid (eg, water or other denser liquids).
[0187] In use, the device 200 is substantially completely submerged and filled with liquid. The free surface 98 of the liquid is located above the first and second tubes 62, 64 and the third tube 68 of the device 200.
[0188] In this embodiment, a recirculation system can be envisioned that allows liquid to circulate continuously in the inlet of container 52 (e.g., through third tube 68) and the outlet of container 52 (e.g., through first tube 62 and second tube 64) to simulate dynamic fluid conditions.
[0189] In order to meet specific requirements, a person skilled in the art may make numerous changes and modifications to the devices 50, 100, 200 and 300 shown and described and to the related training method, 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 (50, 100, 200, 300) for performing an endovascular treatment of an aneurysm, comprising: A container (52) having a wall (54) defining a restricted chamber (56) and a first access opening (58) in the wall (54), the first access opening (58) being configured to allow a guidewire (17) and / or a guide catheter (26) for an intravascular procedure to be inserted into the container (52); a first tube (62) connected to the container (52) at the first passage opening (58); as well as A movable element (70) comprising a target (72, 172) and a control member (74) connected to the target (72, 172); wherein the target (72, 172) is arranged in the container (52) and includes at least one tube rack (84, 184), the at least one tube rack (84, 184) being configured to receive the guide wire (17) and / or the guide catheter (26) for intravascular surgery, and the control member (74) at least partially protrudes from the container (52) through a control opening (76, 82, 83) of a wall (54) of the container (52); and wherein the movable element (70) is movably constrained to the wall (54) of the container (52) at the control opening (76, 82, 83) to enable the target (72, 172) to adopt a plurality of different positions and / or orientations within the container (52).
2. The training device (50, 100, 200, 300) according to claim 1, wherein: The container (52) is spherical or ellipsoidal in shape.
3. The training device (50, 100, 200, 300) according to claim 1 or 2, wherein: The wall (54) of the container (52) is made of a translucent or transparent material.
4. The training device (50, 100, 200, 300) according to any one of the preceding claims, wherein: One or more of the at least one tube holder (84, 184), the target (72, 172) and the movable element (70) are made of a radiopaque material, preferably a metal.
5. The training device (50, 100, 200, 300) according to any one of the preceding claims, wherein: The at least one tube support (84, 184) is selected from one or more cavities, one or more recessed areas, one or more grooves, or one or more through holes in the target (72, 172).
6. The training device (50, 100, 200, 300) according to any one of the preceding claims, wherein: The control opening (76, 82, 83) is an elongated cut or slit in the wall (54) of the container (52), the cut or the slit comprising a flexible edge flap, and wherein the movable element (70) is held reversibly constrained on the wall (54) of the container (52) by the friction of the flexible edge flap of the cut or the slit on the control member (74).
7. The training device (50, 100, 200, 300) according to any one of the preceding claims, wherein: The control member (74) of the movable element (70) is rigidly fixed to the target (72, 172) or is made integrally with the target (72, 172).
8. The training device (50, 100, 200, 300) according to any one of the preceding claims, wherein: The container (52) comprises a plurality of additional openings (88) distributed on the wall (54), and the additional openings (88) are configured to allow the guide wire (17) and / or the guide catheter (26) used in intravascular surgery to pass through.
9. The training device (50, 100, 200, 300) according to any of the preceding claims, further comprising a fluid reservoir (90) having a peripheral wall (92), the peripheral wall (92) having a height capable of accommodating a liquid column capable of completely covering the container (52) of the device (50, 100, 200, 300) immersed in the fluid reservoir (90).
10. Training methods for endovascular treatment of aneurysms, including: Providing a training device (50, 100, 200, 300) according to any one of the preceding claims; Providing a guide wire (17) for endovascular surgery and / or a guide catheter (26) for endovascular surgery; introducing the guide wire (17), the guide catheter (26) or the guide wire (17) introduced in the guide catheter (26) into the container (52) of the device (50, 100, 200, 300) through the first tube (62) and the passage opening (58); attempting to guide the distal end of the guide wire (17) and / or the distal end of the guide catheter (26) toward a tube support (84, 184) of a target (72, 172) of the movable element (70); as well as Optionally, the distal end of the guide wire (17) and / or the distal end of the guide catheter is introduced into a tube holder (84, 184) of the target (72, 172).
11. Use of a training device (50, 100, 200, 300) according to any one of claims 1 to 9 in a training method according to claim 10.