Device and assembly process for implanting heart valve prosthesis

Abstract

The invention relates to a device and an assembly process for implanting a heart valve prosthesis. Specifically, the invention relates to a device for implanting a heart prosthesis, comprising a central body (16) and a receiving portion (18) having one or more subassemblies (22); comprising a release device for the central body, the release device being insertable into the catheter; and means for assisting the operation of connection between the central body (16) and the sub-assemblies of the receiving portion (18), comprising a conduit assembly wherein each sub-assembly of the receiving portion has at least two conduits, which are connected to each other on a portion thereof and have at least one free end for each conduit.

Description

[0001] This application is a divisional application of Chinese Patent Application No. 202080039102.8 entitled “Device and assembly process for implanting a heart valve prosthesis”, filed on July 23, 2020. Technical Field

[0002] This invention relates to a device and assembly process for implanting a prosthetic heart valve.

[0003] Although not limiting, the present invention has been developed specifically for devices used in the implantation of cardiac prostheses for replacing the physiological function of dysfunctional heart valves, particularly cardiac prostheses for atrioventricular heart valves. Background Technology

[0004] Heart valves are complex and delicate organs that control the normal function of the human heart. Their main purpose is to allow blood to flow in one direction within the heart chambers, which is essential during both the filling phase (i.e., diastole) and the expulsion phase (i.e., systole).

[0005] To optimize the efficiency of blood pumping, the heart is structured into two distinct compartments: the right ventricle and the left ventricle. Each compartment is further divided into two chambers: the atrium and the ventricle. The right ventricle, consisting of the right atrium and right ventricle, returns blood from the peripheral circulation and directs it to the pulmonary circulation for oxygenation. The left ventricle, similarly divided into the left atrium and left ventricle, supplies blood to the peripheral vessels and pumps oxygenated blood from the pulmonary circulation into the systemic circulation.

[0006] To ensure unidirectional blood flow within the heart, valves are located at the outlet of each chamber. The valves at the outlet of the atria are atrioventricular valves because they connect the atrial chambers to the ventricular chambers on each side of the heart. On the right side of the heart, this valve is also called the tricuspid valve, and on the left side, it is usually called the mitral valve. Finally, the valve at the outlet of the right ventricle is called the pulmonary valve, and the valve at the outlet of the left ventricle is called the aortic valve.

[0007] Pathologies affecting heart valve function are among the most serious in the cardiovascular field. Mitral valve insufficiency, meaning the inability to completely close the valve, is a highly damaging valvular pathology because it reduces the pumping efficiency of the left side of the heart, which is responsible for systemic blood circulation.

[0008] In current technology, the standard treatment for severe valvular dysfunction is valve replacement with an implantable prosthesis. In other cases, primarily mitral valve dysfunction, repair is prescribed. In both cases, this is provided through an open-heart surgery procedure that directly accesses the dysfunctional valve. This procedure requires temporary cardiac arrest and the creation of extracorporeal circulation via a suitable pump and oxygen exchanger. Although techniques for managing cardiac arrest and improving extracorporeal circulation have improved, treatment under open-heart conditions carries risks due to its invasiveness and duration. In fact, implantable prostheses commonly used in traditional surgical approaches for repair and replacement often require lengthy surgeries to secure them in place using specific suturing techniques. In some cases, surgical intervention may not even be feasible due to the patient's general condition, such as advanced age or the presence of concomitant pathology.

[0009] To overcome these limitations, a procedure with a reduced invasiveness, known as transcatheter surgery, has recently been developed. This utilizes a radially collapsible prosthesis that can self-anchor at the implantation site. The prosthesis can be implanted via a catheter that is capable of navigating within the vascular system and reaching the implantation site via a remote pathway created in, for example, a peripheral vessel (such as the femoral vein or artery). Therefore, valvular dysfunction can be corrected in a beating heart with limited surgical intervention. Currently, transcatheter techniques are the standard of care for aortic valve treatment only.

[0010] The treatment of atrioventricular valve dysfunction, especially mitral valve insufficiency, presents a different challenge. The complex anatomy and pathological variability of the valves and surrounding structures vary greatly, directly or indirectly affecting the valves. Therefore, it is extremely difficult to meet the requirements for reliable and effective implantation into the mitral valve via a transcatheter approach.

[0011] Among the various individual designs developed, the primary technique for developing transcatheter prostheses for atrioventricular valves provides access to the apical region of the heart. This procedure requires a thoracic incision to expose the apex of the left ventricle. Subsequently, the apex is punctured to allow insertion of the apical port. Through the apical port, the catheters required to complete the procedure are continuously inserted.

[0012] One problem with this method is that it can damage the heart in rather vulnerable areas (such as the apex), leading to adverse consequences for the patient, such as bleeding, aneurysms, etc. Summary of the Invention

[0013] One object of the present invention is to address the problems of the prior art, and in particular to provide a method for implanting a cardiac prosthesis that is transcatheter and does not damage the apex of the heart. Another object is to provide a safer procedure for the patient. In particular, one object is to provide a reliable and safe guidewire guide device and an apparatus for implanting a cardiac prosthesis during use, allowing such a procedure to be performed. Another object is to provide a procedure for assembling a cardiac prosthesis using such an implantation device.

[0014] This invention relates to a guidewire guide device and a device for implanting a cardiac prosthesis, specifically developed to allow transcatheter implantation procedures with a transseptal access, as developed by the applicant. A transseptal access should be understood as a pathway to the mitral valve that begins in the peripheral femoral vein, navigates up the inferior vena cava to the right atrium, and finally reaches the left atrium through an opening formed in the septum between the two atria using an interventional method. The left atrium can then antegradely access the mitral valve to be treated. In this way, damage to the left ventricle, i.e., perforation, associated with transapical procedures, is prevented, which would provide a ventricular-side access to the mitral valve, i.e., retrograde access.

[0015] According to a first aspect, a guidewire guide device for positioning at least one guidewire around a heart valve is described. The device may be capable of deploying the guidewire via a transseptal pathway. The device may include a first catheter, which may be provided with at least one distal deflection system. The device may include a second catheter that can be inserted into the first catheter. The second catheter may include a lumen adapted to allow the guidewire to slide therein. The second catheter may be provided with a distal deflection system for deflecting its end, preferably at an angle greater than 90°, to allow optimal access to the region directly beneath the leaflet of the heart valve. The device may include a third catheter. The third catheter may be inserted into the first catheter. The third catheter may have means therein for capturing the guidewire. The third catheter may be provided with a distal deflection system. The deflection system of the second catheter may include a wire.

[0016] According to another aspect, a guidewire guide device for deploying at least two guidewires around a heart valve is described. The second catheter may include two lumens adapted to allow the guidewires to slide therein. The two lumens may terminate in substantially opposite directions.

[0017] According to an advantageous aspect, the guidewire guide device includes a second catheter. The guidewire guide device is provided with radiopaque and / or echo-proof elements. The radiopaque / echo-proof elements can be positioned on the distal tip of the second catheter, preferably embedded therein.

[0018] According to another option, the guidewire guide device may include a first catheter having a single lumen.

[0019] According to another aspect, a procedure for positioning at least one guidewire around a heart valve is described; the procedure may include providing access to a first catheter via a vein, preferably the femoral vein. The first catheter may be introduced into the right atrium via the inferior vena cava (IVC). To access the left atrium, a perforation may be created in the septum between the two atria. The procedure may include inserting a guidewire guiding device into the left ventricle, through the mitral valve, and deploying one or more guidewires around the valve.

[0020] According to a preferred aspect, a procedure for positioning at least one guidewire around a heart valve is described, the procedure comprising the following steps:

[0021] - Access to the first catheter is provided via a vein.

[0022] - The first catheter is inserted into the right atrium via the inferior vena cava, and then punctured through the septum between the two atria to enter the left atrium.

[0023] - Insert the guidewire guide device into the left ventricle, through the mitral valve, and position one or more guidewires around the autologous valve.

[0024] According to another aspect, a device for implanting a cardiac prosthesis is described. The cardiac prosthesis may include a central body and a receiving portion. The receiving portion may be subdivided into one or more sub-assemblies. The device for implanting the cardiac prosthesis may include a release device for the central body. The release device is insertable into a catheter. The device for implanting the cardiac prosthesis may include means for assisting connection operations between the sub-assemblies of the central body and the receiving portion. The means for assisting connection operations between the sub-assemblies of the central body and the receiving portion may include a catheter assembly. Each sub-assembly of the receiving portion may have at least two catheters. The catheters may be connected to each other through a portion thereof and may each have at least one free end. The catheters may be assembled together in the same sheath. The sheath may assemble the catheters together along a portion of the catheters. The sheath may leave at least one end free for each catheter. The sheath may also include an additional lumen for a guidewire, preferably a central lumen. Advantageously, the catheters constituting the catheter assembly can be stably connected to each other.

[0025] According to another aspect, the means for connecting the sub-assemblies of the auxiliary central body and the receiving portion may include a catheter assembly that is incompressible in the longitudinal direction. In this way, during use, they form an incompressible adjacent channel for the guidewire. Preferably, the catheters constituting the catheter assembly may be flexible.

[0026] According to another aspect, a process for assembling a cardiac prosthesis is described. The cardiac prosthesis may include a central body and a receiving portion. The receiving portion may be subdivided into one or more sub-assemblies. The described process may include the step of inserting a guidewire into each sub-assembly of the receiving portion. It may include the step of sliding the sub-assemblies in such a manner that both ends of the guidewire are outside the sub-assembly itself. The process may include the steps of inserting each end of the guidewire into a corresponding connecting element for connecting the central body and the receiving portion for each sub-assembly of the receiving portion. The process may include the step of inserting each end of the guidewire into a corresponding catheter of a catheter assembly. It may include the step of pulling out the end of each guidewire to connect the central body and the sub-assemblies of the receiving portion.

[0027] According to another aspect, a procedure for implanting a cardiac prosthesis is also described. The cardiac prosthesis may include a central body and a receiving portion, which is subdivided into one or more sub-components. The procedure may include providing access to a first catheter via a vein. Preferably, access may be provided in the femoral vein. The procedure may include inserting the first catheter through the inferior vena cava (IVC). The first catheter may be inserted into the right atrium. A puncture may be created in the septum between the two atria. Through this puncture, access to the left atrium can be made. The procedure may include providing one or more guidewires around an autologous valve; this operation may be performed using a guidewire guiding device. Sub-components of the receiving portion may be inserted. The procedure may include inserting a device for implanting the cardiac prosthesis. The central body may then be connected to sub-component 22 of the receiving portion 18. The central body can be released into place by pushing the central body out of the device for implantation.

[0028] According to another aspect, the procedure for implanting a cardiac prosthesis includes the step of inserting each sub-component into the heart by guiding each sub-component with at least one guidewire arranged around the autologous valve, preferably by sliding each sub-component over at least one guidewire (on the guidewire).

[0029] According to another aspect, the procedure for implanting a cardiac prosthesis may provide the use of a device for implanting the cardiac prosthesis, including means for assisting the operation of connecting a central body and a sub-assembly that may include a receiving portion of a catheter assembly; the procedure may include steps of inserting each end of a guidewire at its free end into a corresponding connecting element for connecting the central body and the receiving portion, and inserting each end of the guidewire into a corresponding catheter of the catheter assembly. The procedure may also include steps of acting on the ends of the guidewire to establish a connection between the central body and the sub-assembly of the receiving portion.

[0030] According to another aspect, a procedure for implanting a cardiac prosthesis is described, the procedure including a central body for prosthetic leaflets and a receiving portion subdivided into one or more sub-components, the procedure including the following steps:

[0031] - Access to the first catheter is provided via a vein.

[0032] - The first catheter is inserted into the right atrium via the inferior vena cava and then into the left atrium via diaphragmatic puncture.

[0033] - Provide one or more guidewires around the autologous valve.

[0034] - Insert a child component from the container section.

[0035] - Insert a device for implanting a heart prosthesis.

[0036] - Connect the central body to the sub-component of the receiving part.

[0037] - Push the central body until it is in place and released.

[0038] The procedure for implanting a cardiac prosthesis is further described, in which each sub-component is inserted by sliding it over one of the guidewires arranged around the autologous valve.

[0039] Advantageously, the procedure for implanting a cardiac prosthesis uses a device for implanting a cardiac prosthesis having all or some of the features described above; according to the procedure, after the insertion of the sub-components, for each sub-component housing the portion, the following steps are performed:

[0040] - Insert each end of the guidewire into the corresponding connecting element to connect the central body and the receiving part.

[0041] - Insert each end of the guidewire into the corresponding catheter in the catheter assembly at its free end.

[0042] - Tighten the end of the guidewire to create a connection between the central body and the sub-assembly of the receiving portion. Preferably, the access is achieved via the femoral vein. Attached Figure Description

[0043] The solutions according to one or more embodiments of the invention, as well as additional features and relative advantages, will be better understood with reference to the following detailed description, which is given only as a non-limiting example and is intended to be consistent with the appended... Figure 1 For the sake of simplicity, corresponding elements are indicated by the same or similar reference numerals, and their explanations are not repeated. It is clearly understood that the figures are not necessarily drawn to scale, some details may be exaggerated and / or simplified, and unless otherwise stated, they are only used to conceptually illustrate the described structures and processes.

[0044] Specifically:

[0045] Figure 1 This is a general schematic diagram of a cardiac prosthesis for treating heart valves according to an embodiment of the present invention.

[0046] Figure 2 Showing the disassembled state Figure 1 Heart prosthesis.

[0047] Figure 3 The steps of the procedure for implanting a cardiac prosthesis are shown, in which a pathway is provided through the interatrial septum.

[0048] Figure 4 Details of the second catheter of the guidewire guide device are shown.

[0049] Figure 5 Is with Figure 4 Different views of the same details.

[0050] Figure 5a A variant of the second catheter of the guidewire guide device is shown.

[0051] Figure 6 The procedure for implanting a cardiac prosthesis is shown, in which the second catheter of the guidewire guide device is advanced in the direction of the mitral valve.

[0052] Figure 7 The procedure for implanting a cardiac prosthesis is illustrated, in which the second catheter of the guidewire guide device enters the left ventricle through the mitral valve.

[0053] Figure 8 Shown in close-up view Figure 7 The steps.

[0054] Figure 9 The procedure for implanting a cardiac prosthesis is illustrated, in which a capture device for the guidewire is positioned.

[0055] Figure 10 The procedure for implanting a cardiac prosthesis is shown, in which the first guidewire is positioned.

[0056] Figure 11 The steps of the procedure for implanting a cardiac prosthesis are shown, including the positioning of the first guidewire.

[0057] Figure 12 The procedure for implanting a heart prosthesis is illustrated, in which a sub-component of the receiving portion of the heart prosthesis is inserted.

[0058] Figure 13 The procedure for implanting a heart prosthesis is illustrated, in which a device for implanting the heart prosthesis is inserted.

[0059] Figure 14 This is a view of a device used to facilitate the connection operation between the central body and the sub-components of the housing portion.

[0060] Figure 15 yes Figure 14 Cross-section of the device.

[0061] Figure 16 The procedure for implanting a cardiac prosthesis is shown, in which the central body is advanced.

[0062] Figure 17 The procedure for implanting a cardiac prosthesis is illustrated, in which a central body and a sub-component for receiving the prosthesis are connected.

[0063] Figure 18 The procedure for implanting a heart prosthesis is shown, during which auxiliary devices are removed.

[0064] Figure 19 The image shows a heart prosthesis in a configuration ready for in-situ release.

[0065] Figure 20 A heart prosthesis, ready for in-situ release, is shown in the heart.

[0066] Figure 21 This shows a heart prosthesis in the correct position.

[0067] Figure 22 It is a cross-section of the second and third catheter variants of the guidewire guide device.

[0068] Figures 23 to 26 Another variation of the second and third catheters of the guidewire guide device is shown. Detailed Implementation

[0069] Now referring to the attached diagram, in Figure 1 and Figure 2 The text describes an implantable cardiac prosthesis 10 for replacing the function of the atrioventricular valve.

[0070] The cardiac prosthesis 10 includes a prosthesis structure 12 for supporting and connecting to the autologous valve and via a set of flexible prosthesis leaflets 14 fixed therein. The prosthesis structure 12 particularly includes:

[0071] -Centrosome 16,

[0072] -Accommodation section 18,

[0073] - Connecting element 20 for connecting the central body 16 and the receiving part 18.

[0074] The prosthesis structure 12, in each of its components, is configured to be foldable without affecting the safety and functionality of the cardiac prosthesis. Therefore, the radial dimension of the prosthesis can be temporarily reduced to allow it to be introduced into the heart chamber through an access port with a reduced aperture and compatible with minimally invasive surgical techniques, particularly with the transcatheter positioning and cardiac prosthesis implantation techniques according to the invention. In other words, the cardiac prosthesis 10 can be inserted into a catheter with a small radial profile, which allows for delivery of the prosthesis into the heart chamber, near the implantation site, via a minimally invasive pathway, where it can be deployed and implanted, functionally replacing the autologous valve.

[0075] The different parts into which the prosthesis structure 12 is divided are described in detail below.

[0076] The central body 16 is part of the prosthetic structure 12, defining a channel for blood to pass through the device. A flexible prosthetic leaflet 14 is fixed within the central body 16, allowing unidirectional blood flow within the catheter, as known, for example, from Italian Patent No. 20140204 of the same applicant.

[0077] The central body 16 is a radially foldable elastic structure that, due to elastic recovery, also tends to expand to a diameter greater than the maximum diameter, which maintains the engagement, i.e., the contact between the free edges of the closed prosthetic leaflets 14.

[0078] The receiving portion 18 is part of the prosthesis structure that counteracts and restricts the free expansion of the central body 16, preventing it from exceeding the maximum diameter compatible with the engagement between the central body 16 and the prosthesis leaflet 14. The receiving portion 18 has a substantially annular geometry and is not longitudinally extensible, that is, it does not significantly change its peripheral extent even when the central body 16 expands internally while applying radial forces outward.

[0079] The receiving portion 18 is preferably subdivided into two separate, substantially arc-shaped sub-components 22; for simplicity, these two sub-components will be referred to below by the term "arc". Each arc 22 may optionally engage with the connecting element 20, in which it is stably engaged with the connecting element 20 in the final implantation configuration.

[0080] Each end 24 of each sub-assembly 22 is equipped with a engagement portion 26, preferably oriented outside the annular plane. In the depicted embodiment, the engagement portion 26 is oriented substantially perpendicular to the plane of the valve annulus. Furthermore, the connecting element 20 is equipped with a pin 28 adapted to be received in an axial hole 27 present in the engagement portion 26. A pair of pins 28 are present on each of the two connecting elements 20, arranged substantially at angular positions radially opposite to the central body 16. These pins 28, as well as the engagement portions 26 present at the ends of the arcuate 22 of the receiving portion 18, may be provided with barbs or lips or other surface discontinuities intended to create mechanical interference between these portions and / or to increase friction in the pin / hole connection, thereby improving the stability of the connection between the sub-assembly 22 of the receiving portion 18 and the connecting element 20. The orientation of the pins 28 relative to the engagement portions 26 present on the sub-assembly 22 of the receiving portion 18 is coherent, such that the pin / hole connection holds the receiving portion in a plane having a consistent geometry with the autologous valve annulus. In addition, pin 28 is axially punctured to allow the guidewire to pass through, as better described below.

[0081] It is evident that the pin / hole connection mechanism may alternatively include a pin at the end of the subassembly 22 and a cylindrical hole in the connecting element 20. More generally, the pin / hole connection is for purely exemplary purposes and is not intended to limit the generality of the solution.

[0082] Naturally, the prosthesis can also include a different number of sub-components 22. For example, it can include a single sub-component and thus be formed in an open-loop manner. However, the version described using two sub-components 22 is preferred because it allows the use of two guidewires, which, due to the guidewire guide device described below, is easier to position correctly than a single guidewire that might remain entangled in the chordae tendineae. However, a third sub-component does not simplify the positioning operation and is therefore substantially unnecessary but should not be excluded.

[0083] During use, the leaflet of the autologous valve remains trapped within the connector between the central body 16 and the receiving portion 18. Furthermore, the receiving portion 18 also functions to stabilize the autologous valve annulus, preventing radial forces exerted by the central body 16, while ensuring effective anchoring of the prosthesis to the surrounding anatomical morphology, which is typically influenced by degenerative and dilatational processes associated with pathologies leading to atrioventricular valve dysfunction.

[0084] For clarity, Figure 1 and Figure 2In the accompanying drawings, and in subsequent figures, the outer diameter of the central body 16 is illustrated as having a smaller dimension than the internal dimension of the receiving portion 18. In other words, these figures depict the two components of the prosthetic structure 12 that do not contact each other in a fully expanded configuration. In practice, the size of the central body 16 may be excessive relative to the size of the receiving portion 18. In this case, interference exists between the two portions of the prosthetic structure 12, and the central body 16 effectively applies radial pressure to the receiving portion 18 when the receiving portion 18 performs its constraint action with respect to expansion independently of the thickness of the tissue held between the two portions of the prosthetic structure 12. This radial pressure increases the stability of the anchorage of the autologous leaflet.

[0085] The preferred procedure for implanting the aforementioned cardiac prosthesis 10 will now be described.

[0086] Initially, access was provided via the femoral vein or iliac vein. Where possible, access via the femoral vein was preferred because it was significantly simpler and more direct. In particular, it did not require invasive surgery. The guide catheter could be used primarily for the purpose of protecting the femoral vein, which has a small diameter.

[0087] The guide catheter, when present, is positioned via the femoral vein to create access to a vessel with a larger diameter. A master cannula 32 is then inserted, which, when provided, slides within the guide catheter through the inferior vena cava (IVC) to the right atrium, as... Figure 3 As shown.

[0088] The main cannula 32 is equipped with a distal deflection system, allowing its end 34 to be bent by the operator in the direction of the left atrium. Puncture is then performed in the septum S between the two atria, allowing access to the left atrium. A guidewire guide device 36 is inserted into the main cannula 32.

[0089] As described above, providing a guide catheter is not mandatory; instead, the main catheter 32, which enters the right atrium via the inferior vena cava, can be used directly. Alternatively, the main catheter can be inserted into the left atrium. This allows the guidewire guide device 36 to be directly inserted into the left atrium.

[0090] The guidewire guide device 36 is a device that allows for the deployment of a guidewire around the leaflet of the autologous mitral valve V, which is necessary for the subsequent positioning of the cardiac prosthesis 10.

[0091] The guidewire guide device 36 includes a first catheter 40, a second catheter 44, and a third catheter 45 that slide within the first catheter 40. The first catheter 40 is a single-lumen catheter. It is equipped with a distal deflection system that allows its tip 42 to be oriented by the operator in the direction of the mitral valve V.

[0092] In detail Figure 4 and Figure 5The second conduit 44, which can be better seen in the image, includes two lumens 46 and 48 adapted to allow guidewires to slide within them. The two lumens are parallel to each other and arranged side-by-side over a larger portion of the second conduit 44. At the end 50 of the second conduit 44, the two lumens are bent at an angle of approximately 90° in substantially opposite directions. Therefore, the two lumens 46 and 48 do not terminate at the distal tip 51 of the conduit 44, but rather terminate on its sides, in diameter-opposite positions in corresponding orifices 41 and 43. In other words, two guidewires inserted into the lumens 46 and 48 exit from the second conduit 44, which is oriented in opposite diameter directions.

[0093] The second conduit 44 also includes a deflection system. The deflection system according to the depicted exemplary embodiment includes a wire 52. The wire 52 is secured to the end 50 of the conduit, passes a small portion through the outside of the conduit, and then extends inside the conduit. An operator can pull the wire 52 to create a curvature for the second conduit 44 that can be very pronounced, such as... Figure 4 As can be clearly seen, the curvature is greater than 90°. However, it is not impossible to use other deflection systems. For example, a section of shape memory material could be included within the second conduit, allowing it to be inserted into the first conduit 40 in a stretched state and to recover the correct curvature when it is ejected from the first conduit 40. Figure 5a An example of this configuration is shown, in which a wire 152 of a shape memory material, such as a titanium-nickel alloy (nickel-titanium alloy), is incorporated into a second conduit 144.

[0094] A segment 53 of non-transmissive or non-reflective material is provided at the distal tip 51. The segment 53 is embedded within the distal tip 51, which is preferably circular to prevent accidental damage.

[0095] As better described below, a third catheter 45 is also inserted into the first catheter 40 and receives therein a guidewire capturing device 47 (snaring device), as better described below. It can be noted that the depicted guidewire capturing device, comprising different collapsible loops or circuits combined together, is one of many possible capturing devices that have been found to be particularly effective for specific applications. However, different capturing devices are not excluded, for example, having a single circuit or a different number of circuits than one of the depicted devices.

[0096] Now proceeding to the implantation of the cardiac prosthesis, the guidewire guide device 36, already inserted inside the main cannula 32, is advanced into the left atrium. Figure 3 (), through diaphragm S. It can be noted that the end 34 of the main catheter 32 can be located in the right atrium, as shown, or in the left atrium. The end 42 of the first catheter 40 of the guidewire guide device 36 is bent so that it points towards valve V, and therefore towards Figure 6 The bottom of the middle.

[0097] The second conduit 44 of the guidewire guide device 36 slides within the first conduit 40 of the guidewire guide device 36. Figure 6 The end 50 exits and exhibits a pronounced curvature that points in the opposite direction to the curvature of the end 42 of the first catheter 40. The second catheter 44 is actually in... Figure 6 It curves upwards.

[0098] The guide wire guide device 36 is further advanced within the main guide tube 32. Figure 7 And the second catheter 44 is pushed into the left ventricle through valve V.

[0099] Once the second catheter 44 of the guidewire guide device 36 is in the left ventricle, it is slightly retracted so that its distal tip 51 is positioned behind the posterior leaflet of the autologous valve. Specifically, the distal tip 51 is preferably positioned behind the central segment (fan-shaped section) typically designated P2. For this purpose, the presence of a radiopaque segment 53 at the distal tip 51 is particularly advantageous. If there is any doubt regarding the accurate positioning or orientation of the catheter tip 50, it can actually be verified directly with an ultrasound probe or by fluorescence examination. The radiopaque segment 53 will be oriented in a direction tangential to the valve margin.

[0100] Figure 8 A detailed schematic diagram of the left ventricle is shown, in which the autologous mitral valve V is clearly visible, with two bundles of chordae tendineae T and the aortic valve A. The end 50 of the second catheter 44 of the guidewire guide device 36 is depicted in the correct positioning behind the posterior leaflet of the autologous valve V. Note that the catheter 44 does not pass through the chordae tendineae bundles.

[0101] Now for reference Figure 9 The third catheter 45, equipped with a guidewire capturing device 47, slides within the first catheter 40 until it is introduced into the left ventricle. The second catheter also has a deflection system 56 near its end 54. This deflection system can generally be the same as the wire 52 described above with reference to the second catheter 44. However, according to a preferred variation, for structural simplicity, it is made of a wire that slides within the catheter wall; a flexible metal structure with a rigid skeleton embedded in the catheter thickness produces a bending effect. However, other known mechanisms in the prior art should not be excluded. Furthermore, the guidewire capturing device 47 is inserted into a covering sheath 55.

[0102] The third catheter 45 is oriented such that its end 54 bends in the opposite direction to the bending direction of the end 50 of the second catheter, and thus in the direction of the aortic valve. The guidewire capture device 47 is advanced by pushing out the corresponding third catheter 45 and sheath 55 until it is positioned in the LVOT (left ventricular outflow tract), i.e., before the aortic valve.

[0103] By holding the guidewire capture device 47 in this position, the first guidewire 56 is inserted into the first lumen 46 of the second catheter of the guidewire guide device 36. The end 57 of the guidewire 56 is pushed in by the operator. Figure 10 (Ventricular) Due to the precise positioning of the distal tip 51 of the second catheter 44, the lateral position of the outlet 41 of the lumen 46, the cardiac structure, and the influence of blood flow naturally directed towards the aortic valve A during systole, the tip 57 of the guidewire 56 is driven around the valve and in the direction of the LVOT. Once it reaches the LVOT, it is captured by the pre-positioned guidewire capture device 47. Subsequently, the tip 57 of the guidewire 56 is retrieved by withdrawing the third catheter 45.

[0104] Alternatively, the guidewire capture device 47 can be positioned within the aorta, beyond the aortic valve A. The guidewire will be pushed into the aorta by the blood flow, thus enabling the capture operation.

[0105] Once the end 57 of guidewire 56 has been captured, guidewire 56 forms a half-circuit around valve V. Figure 11 ).

[0106] In a generally symmetrical manner, a second guidewire 58, inserted into the second lumen 48 of the second catheter 44, forms a similar semi-circuit around the valve V. In this way, the valve V is completely surrounded by two correctly positioned guidewires 56 and 58. For this purpose, the same guidewire capturing device 47 used to capture the first guidewire can be used, or preferably, another guidewire capturing device 47 is also received in the third catheter 45. In this case, the third catheter 45 preferably has a double lumen.

[0107] Naturally, a guidewire positioning device similar to the one described in detail above can also be used to position a single guidewire around the autologous valve to perform a complete circuit. However, in this case, the guidewire positioning process becomes more complex: while fewer steps are required (these steps do not need to be repeated for the second wire), positioning the guidewire around the entire valve in a sufficiently precise manner is not easy due to the risk of entanglement in the chordae tendineae. In practice, using two guidewires allows for leveraging the geometry of the heart and natural blood flow to facilitate the procedure and minimize the risk of errors that could have serious consequences for the patient if not identified and corrected immediately.

[0108] Now for reference Figure 12In this step, the first catheter 40 and the second catheter 44 are preferably left in place to facilitate the insertion of the two arcs 22 constituting the receiving portion 18 of the cardiac prosthesis 10 into the ventricle. The two arcs are inserted onto a guidewire, i.e., by sliding along the guidewire. In other words, a longitudinal channel extending through one of the two arcs is used to insert the end 57 of the newly repositioned guidewire 56; similarly, the end of the guidewire 58 is inserted into the longitudinal channel extending through the other arc. The two arcs 22 are then pushed until they exit the first catheter 40 and enter the heart. The arcs 22 are pushed until they contact the tip 51 of the second catheter 44. At this point, the first catheter 40 and the second catheter 44 can be removed.

[0109] Preferably, the main catheter 32 is left in place and subsequently used to introduce the device 60 for implanting the cardiac prosthesis, in which the central body 16 is inserted. Removal of the main catheter 32 or replacement with another catheter is not excluded in any case.

[0110] The device 60 for implanting a cardiac prosthesis, details of which can be found in Figure 13 , 14 As seen in Figures 15 and 16, the catheter 61, all other components, and the central body 16 of the prosthesis are inserted through the catheter.

[0111] The device for implanting a cardiac prosthesis also includes a release device 62 for a central body 16 of the prosthesis. The release device 62 is adapted to be inserted into a catheter to advance the central body 16 therein. The device 60 for implanting a cardiac prosthesis also includes a device 64 for assisting connection operations between the central body 16 and the sub-assemblies of the receiving portion 18. This assisting device 64 includes an assembly of catheters 66, wherein for each arc of the receiving portion there are at least two catheters, which are combined together in the same sheath 68, which partially covers the catheters and leaves at least one free end 70 for each catheter.

[0112] In the preferred embodiment depicted, the prosthesis comprises two arcs 22, and the auxiliary device 64 comprises four catheters 66. Naturally, if the prosthesis comprises a single sub-assembly housing portion 18, two catheters are sufficient. However, if the prosthesis comprises three or more sub-assemblies, six or more catheters will be provided.

[0113] The catheters 66 are incompressible and flexible in the longitudinal direction. Furthermore, they are secured within a sheath 68 so that they do not slide relative to each other. Preferably, the sheath 68 also includes a free longitudinal lumen 72 in which, if advantageous, the guidewire can slide.

[0114] Turning now to the implantation procedure of the cardiac prosthesis 10, for each arc 22 of the receiving portion 18, the ends of guidewires 56, 58 extending through them are inserted into the corresponding pins 28 of the two connecting elements 20, and then into the catheter 66 of the auxiliary device 64. For example, the guidewire 56 passes sequentially through the first catheter 66, the first pin 28 of the first connecting element 20, the arc 22, the first pin 28 of the other connecting element 20, and the second catheter 66, as shown in [reference needed]. Figure 13 visible.

[0115] Then the catheter 61 is forced to advance within the main canal 32 and through the mitral valve until its tip 63 is in the left ventricle. Although for clarity, Figures 16 to 19 Only the device is shown, but the operations depicted are typically performed inside a patient's heart.

[0116] The central body 16 is then pushed further within the conduit 61 until the connecting element 20 is released from the conduit. It can be noted that when the central body 16 is in its folded configuration, the connecting elements deform in order to slide within the conduit. However, they are made of shape memory material, so once they leave the conduit, they immediately assume the intended configuration.

[0117] To connect the central body 16 and the receiving portion 18, or in other words, to engage the arc 22 with the connecting element 20, it is now sufficient to pull the end of each guide wire. Figure 17 In this manner, the pin 28 of the connecting element 20 is inserted into the axial hole 27 of the engagement 26 located at the end of the arc 22. It can be noted that the presence of the auxiliary device 64 is crucial for tightening, especially the conduit 66. In fact, the incompressible conduit 66 allows the guide wire to be pulled without kinking against the edge of the conduit 61. In other words, the conduit allows traction that would otherwise be impossible to apply to the guide wire portion within each arc, which is sufficient to connect the arc 22 and the connecting element 20 to each other.

[0118] Once the components of the prosthesis are secured to each other, the guidewire and auxiliary device 64 can be retracted. Figure 18 ).

[0119] Therefore, the prosthesis is assembled and held in the correct position, the central body 16 remains within the catheter 61, and the two arcs 22 are correctly oriented relative to each other, thus forming the receiving portion 18 of the prosthesis. Figure 19 and 20 ).

[0120] By acting on the release device 62 and the catheter 61, the central body 16 of the prosthesis is forced to advance within the catheter 61, while the catheter 61 is retracted. The central body remains substantially in a stable position within the heart, such that the receiving portion 18 does not lose contact with the annulus of the autologous valve during the retraction of the catheter 61. When the central body 16 is released from the catheter 61, it expands within the autologous valve until it is restrained by the receiving portion 18. Figure 21 The leaflet of the autologous valve is thus held captive between the central body and receiving portion 18 of the cardiac prosthesis. This configuration provides stable and secure positioning of the prosthesis.

[0121] All that has been described above should be naturally understood as one possible implementation of the invention, and not the only one. Some variations of the above-described objects will now be described by way of example. However, it should be understood that this is not an exhaustive list of possible variations.

[0122] According to a variant of the invention, in Figure 22 The second conduit 244 and the third conduit 245, visible in cross-section, slide within the first conduit 40 of the guidewire guide device 36. The second conduit 244 provides two lumens 46 and 48 adapted to allow the guidewire to slide therein. Unlike the second conduit 44 described above, the conduit 244 has a D-shaped cross-section. Preferably, the second conduit 244 provides an additional lumen 250 for the passage of the wire 52 of the deflection system at the distal end of the conduit.

[0123] The third catheter 254 also has two lumens 45a and 45b, adapted to accommodate two guidewire capture devices 47. The third catheter 245 also has a D-shaped cross-section complementary to that of the second catheter 244. In this way, proper mutual orientation between catheters 244 and 245 is ensured, and therefore proper mutual orientation between the guidewires inserted into lumens 46 and 48 and the guidewire capture devices 47. This allows for easier positioning of the guidewire around the valve annulus.

[0124] In this respect, the D-shape is clearly intended to be understood as exemplary: the cross-sections of the two catheters 244 and 245 are sufficient to ensure proper mutual orientation. For example, the cross-sections of the two catheters 244 and 245 are complementary within the catheter 40 (in other words, the two side-by-side cross-sections correspond to the cross-section of the first catheter 40 of the guidewire guide device 36), and the two catheters 244 and 245 each include at least one planar abutment surface 270 and 272. It should be understood that the catheters 244 and 245 can slide independently within the first catheter 40. A single lumen 45a may also be provided.

[0125] The third catheter 245 also has an additional lumen 260 for the passage of the wire in the deflection system of the distal portion of the catheter.

[0126] Now for reference Figures 23 to 26 The second catheter 344 and the third catheter 345 may include mechanically bendable metal structures. These metal structures form lumens 346 and 348 of the second catheter 344 and lumens 345a and 345b of the third catheter 345. Each lumen 346 and 348 has a wire 352 that allows it to bend. Preferably, each lumen 346 and 348 may form two curves. The first curve is greater than 90°, preferably between 120° and 180°; the second curve is about 90°. Preferably, the two curves lie in two mutually perpendicular planes. These two curves are obtained by corresponding portions 354 and 356, which are appropriately perforated to create anisotropic portions that advantageously ensure the precise and well-defined orientation of the lumens. This variation also allows all lumens to be straightened before the second and third catheters are removed. In this way, friction associated with catheter 40, where catheters 344 and 345 slide, and associated with the guidewire sliding therein, is greatly reduced, making the second and third catheters easier and faster to withdraw. In addition, the metal lumen has a particularly small thickness.

[0127] Catheters 344 and 345 slide within catheter 40 with a straightening configuration. Figure 24 As they exit from conduit 40, deflection is then activated to bend portion 354 and create the first curve. Figure 25 Then activate the distal deflection of part 356 to produce the second curve (). Figure 26 In a largely similar manner, deflections on lumens 345a and 345b of the third catheter were also activated. At the end of the guidewire positioning procedure, all lumens were straightened. Figure 24 To remove it.

[0128] Naturally, the principles of the invention remain unchanged, but the form and construction details of the embodiments can be varied extensively with respect to those described and illustrated, without departing from the scope of the invention.

Claims

1. A device (64) for assisting in connection operation between a central body (16) and one or more sub-components (22) of a receiving portion (18) included in a cardiac prosthesis, the device comprising a catheter assembly (66) wherein the catheters constituting the catheter assembly are incompressible in the longitudinal direction, the catheters are connected to each other on a portion thereof and each catheter has at least one free end (70).

2. The device according to claim 1, wherein the catheter (66) constituting the catheter assembly is flexible.

3. The device according to any one of the preceding claims, wherein the catheters (66) constituting the catheter assembly are combined in the same sheath (68) that combines the catheters together along a portion thereof.

4. The device according to claim 3, wherein the sheath further comprises a longitudinal lumen (72).

5. The device according to any one of the preceding claims, wherein at least four catheters (66) of the catheter assembly are present.

6. The device according to any one of the preceding claims, wherein the catheter assembly comprises at least two catheters (66) for each sub-assembly (22) of the receiving portion (18).

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