Device for implanting a prosthesis for a heart valve and assembly procedure

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

(19) State Intellectual Property Office (12) Invention Patent Application (10) Application Publication Number (43) Application Publication Date (21) Application Number 202511347033.8 (22) Application Date 2020.07.23 (30) Priority Data 102019000015653 2019.09.05 IT 16 / 522,164 2019.07.25 US (62) Divisional Application Data 202080039102.8 2020.07.23 (71) Applicant: Innovation Heart Co., Ltd. Address: Milan, Italy (72) Inventors: Giovanni Rigini, Cindy Trien, Dongke Andy Dennison, Kevin Maglini (74) Patent Agency: Beijing Kangxin Intellectual Property Agency Co., Ltd. 11240 Patent Attorney: Chen Zhiyu (51) Int.Cl. A61F 2 / 24 (2006.01) A61M 25 / 14 (2006.01) A61M 25 / 09 (2006.01) (54) Title of Invention: Apparatus and Assembly Process for Implanting a Heart Valve Prosthesis (57) Abstract: This invention relates to an apparatus and assembly process for implanting a heart valve prosthesis. Specifically, the invention relates to an apparatus for implanting a heart prosthesis comprising a central body (16) and a receiving portion (18) having one or more sub-assemblies (22); including a release device for the central body capable of being inserted into a catheter; and means for assisting connection operations between the sub-assemblies of the central body (16) and the receiving portion (18), including a catheter assembly, wherein each sub-assembly of the receiving portion has at least two catheters, the catheters being connected to each other on a portion thereof and having at least one free end for each catheter. Claims 1 page, Description 10 pages, Drawings 18 pages, CN 120938674 A 2025.11.14 CN 1 20 93 86 74 A 1. A device (64) for assisting a 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), the catheters constituting the catheter assembly being incompressible in the longitudinal direction, the catheters being connected to each other on a portion thereof and each catheter having at least one free end (70). 2. The device of claim 1, wherein the catheters (66) constituting the catheter assembly are flexible. 3. The device of any preceding claim, wherein the catheters (66) constituting the catheter assembly are assembled in the same sheath (68) that assembles the catheters together along a portion thereof. 4. The device of 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). Claims 1 / 1 page 2 CN 120938674 A Device and assembly process for implanting a heart valve prosthesis

[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] The present invention relates to a device and assembly process for implanting a heart valve prosthesis.

[0003] Although in a non-limiting manner, the present invention has been developed particularly toward a device used in the process of implanting a heart prosthesis for replacing the physiological function of a dysfunctional heart valve, particularly a heart prosthesis for an atrioventricular heart valve. Background Art

[0004] Heart valves are complex and delicate organs that control the normal function of the human heart. Their main purpose is to allow unidirectional flow of blood 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 constructed into two distinct compartments, the right and left compartments, each further subdivided into two chambers: the atrium and the ventricle. The right compartment, 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 compartment is similarly divided into the left atrium and left ventricle, supplying peripheral blood vessels, returning oxygenated blood from the pulmonary circulation and pumping it into the systemic circulation.

[0006] To allow unidirectional flow of blood within the heart, valves are located at the outlet of each chamber. The valves located at the atrial outlet are atrioventricular valves, as 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 located at the outlet of the right ventricle is called the pulmonary valve, and the valve located 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, i.e., the inability to close completely, 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 the current art, the standard treatment for severe valvular dysfunction is valve replacement with an implantable prosthesis. In other cases, primarily in the case of mitral valve dysfunction, repair is prescribed. In both cases, it is provided through an open-heart surgical procedure that allows direct access to the dysfunctional valve.This procedure requires temporary cardiac arrest and the creation of extracorporeal artificial blood circulation via a suitable pump and oxygen exchanger. While techniques for managing cardiac arrest and improving extracorporeal circulation have improved, treatment under open-heart conditions carries risks due to its invasiveness and duration. Indeed, implantable prostheses commonly used in conventional surgical procedures 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 accompanying pathology.

[0009] To overcome these limitations, procedures with reduced invasiveness, known as transcatheter procedures, have recently been developed. For this purpose, radially collapsible prostheses that can self-anchor at the implantation site are used. The prosthesis can be implanted via a catheter capable of navigating within the vascular system and reaching the implantation site via a remote pathway created, for example, in a peripheral vessel (e.g., the femoral vein or artery). Thus, valvular dysfunction can be corrected in a beating heart with limited surgical intervention. Currently, transcatheter techniques are the standard of care for treating aortic valve dysfunction only.

[0010] The situation is different for the treatment of atrioventricular valve dysfunction, particularly mitral valve insufficiency. The complex anatomy and pathological variability of the valves and surrounding structures vary greatly from one another, directly or indirectly affecting the valves, making reliable and effective implantation in the mitral valve via a transcatheter approach extremely difficult.

[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 approach is that it can damage the heart in a rather vulnerable area (e.g., the apex), leading to adverse consequences for the patient, such as bleeding, aneurysm, etc.

[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, which 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 a device for implanting a cardiac prosthesis during use to allow such a procedure to be performed. Another object is to provide a procedure for assembling a cardiac prosthesis using such an implantation device.

[0014] The present invention relates to a guidewire guide device and a device for implanting a cardiac prosthesis, which are specifically developed to allow a transcatheter implantation procedure with a transseptal access, as developed by the applicant. A transseptal access should be understood as such.The pathway to the mitral valve: This pathway 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 associated with transapical surgery, i.e., perforation, which provides access to the mitral valve from the ventricular side, i.e., retrograde, is prevented.

[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 able to deploy the guidewire via a transseptal pathway. The device may include a first catheter that 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 area directly below the leaflet of the valvular valve. The device may include a third catheter. The third catheter may be inserted into the first catheter. The third catheter may have a means for capturing a guidewire therein. 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 may be positioned on the distal tip of the second catheter, preferably embedded therein.

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

[0019] According to another aspect, a process for positioning at least one guidewire around a heart valve is described; the process may include the step of 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 can be created in the septum between the two atria. This specification, page 2 / 10, CN 120938674 A, describes a procedure that may include inserting a guidewire guide device into the left ventricle, passing it 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 steps of:

[0021] - providing access to a first catheter via a vein,

[0022] - inserting the first catheter into the right atrium via the inferior vena cava and puncturing into the left atrium through the septum between the two atria,

[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, an apparatus 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 apparatus for implanting the cardiac prosthesis may include a release device for the central body. The release device is capable of being inserted into a catheter. The apparatus 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 the guidewire, preferably a central lumen. Advantageously, the catheters constituting the catheter assembly may be stably connected to each other.

[0025] According to another aspect, the means for assisting the connection operation between the sub-assemblies of the 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 a guidewire. Preferably, the catheter 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 way that both ends of the guidewire are outside the sub-assembly itself. The process may include the step 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 the 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 process 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 achieved. The procedure may include providing one or more guidewires around the autologous valve.The procedure can be performed using a guidewire guide device. A sub-assembly of the receiving portion can be inserted. The procedure may include the step of inserting a device for implanting a cardiac prosthesis. The central body can then be connected to the sub-assembly 22 of the receiving portion 18. The placement release of the central body can be achieved by pushing the central body out of the device for implantation.

[0028] According to another aspect, the procedure for implanting a cardiac prosthesis provides the step of inserting each sub-assembly into the heart by guiding each sub-assembly with at least one guidewire arranged around an autologous valve, preferably sliding each sub-assembly over at least one guidewire (on the guidewire). Specification 3 / 10 pages 5 CN 120938674 A

[0029] According to another aspect, the procedure for implanting a cardiac prosthesis may provide the use of a device for implanting a cardiac prosthesis, including means for assisting the connection of the central body and the sub-assembly that may include a receiving portion of a catheter assembly; the procedure may include the 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 process may also include a step of acting on the end of a guidewire to establish a connection between the central body and the sub-assemblies of the receiving portion.

[0030] According to another aspect, a process for implanting a cardiac prosthesis is described, the process comprising a central body for a prosthetic valve leaflet and a receiving portion subdivided into one or more sub-assemblies, the process comprising the steps of:

[0031] - providing access to a first catheter via a vein,

[0032] - inserting the first catheter into the right atrium via the inferior vena cava and into the left atrium via septal puncture,

[0033] - providing one or more guidewires around the autologous valve,

[0034] - inserting the sub-assemblies of the receiving portion,

[0035] - inserting a device for implanting the cardiac prosthesis,

[0036] - connecting the central body to the sub-assemblies of the receiving portion,

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

[0038] A process for implanting a cardiac prosthesis is further described, wherein each sub-assembly is inserted by sliding on 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 part of the features described above; according to the procedure, after the insertion of a sub-assembly, for each sub-assembly of the receiving portion, the following steps are performed:

[0040] - Inserting each end of a guidewire into a corresponding connecting element for connecting the central body and the receiving portion,

[0041] - Inserting each end of the guidewire into a corresponding catheter of the catheter assembly at its free end,

[0042] - Tightening the end of the guidewire to create a connection between the central body and the sub-assemblies of the receiving portion. Preferably, the access is achieved via the femoral vein. Brief Description of the Drawings

[0043] The solution according to one or more embodiments of the invention will be better understood with reference to the following detailed description.In addition to additional features and relative advantages, this detailed description is given only as a non-limiting example and is intended to be read in conjunction with the accompanying drawings, wherein, for simplicity, corresponding elements are indicated by the same or similar reference numerals and their explanations are not repeated. In this regard, it is clearly understood that the drawings 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] In particular:

[0045] FIG1 is a general schematic diagram of a cardiac prosthesis for treating heart valves according to an embodiment of the invention.

[0046] FIG2 shows the cardiac prosthesis of FIG1 in a disassembled state.

[0047] FIG3 shows the steps of the procedure for implanting the cardiac prosthesis, wherein access is provided through the interatrial septum.

[0048] FIG4 shows details of the second catheter of the guidewire guide device.

[0049] FIG5 is a different view of the same details as FIG4.

[0050] FIG5a shows a variant of the second catheter of the guidewire guide device.

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

[0052] Figure 7 illustrates the steps of the procedure for implanting a cardiac prosthesis, wherein the second catheter of the guidewire guide device enters the left ventricle through the mitral valve.

[0053] Figure 8 shows the steps of Figure 7 in a close-up view.

[0054] Figure 9 illustrates the steps of the procedure for implanting a cardiac prosthesis, wherein a capture device for the guidewire is positioned.

[0055] Figure 10 illustrates the steps of the procedure for implanting a cardiac prosthesis, wherein the first guidewire is positioned.

[0056] Figure 11 illustrates the steps of the procedure for implanting a cardiac prosthesis, wherein the positioning of the first guidewire is completed.

[0057] Figure 12 illustrates the steps of the procedure for implanting a cardiac prosthesis, wherein a sub-assembly of the receiving portion of the cardiac prosthesis is inserted.

[0058] Figure 13 illustrates the steps of the procedure for implanting a cardiac prosthesis, wherein a device for implanting the cardiac prosthesis is inserted.

[0059] FIG. 14 is a view of an apparatus for assisting the connection operation between the central body and the receiving portion sub-assembly.

[0060] FIG. 15 is a cross-section of the apparatus of FIG. 14.

[0061] FIG. 16 illustrates a step in the process of implanting a cardiac prosthesis, wherein the central body is advanced.

[0062] FIG. 17 illustrates a step in the process of implanting a cardiac prosthesis, wherein the central body and the receiving portion sub-assembly are connected.

[0063] FIG. 18 illustrates a step in the process of implanting a cardiac prosthesis, wherein the assisting device is removed.

[0064] FIG. 19 shows a cardiac prosthesis in a configuration ready for in-situ release.

[0065] FIG. 20 shows a cardiac prosthesis ready for in-situ release, shown in the heart.

[0066] FIG. 21 shows a cardiac prosthesis in a correctly positioned state.

[0067] Figure 22 is a cross-section of a variant of the second and third catheters of the guidewire guide device.

[0068] Figures 23 to 26 show another variant of the second and third catheters of the guidewire guide device. Detailed Description

[0069] Referring now to the drawings, an implantable cardiac prosthesis 10 for replacing atrioventricular valve function is described in Figures 1 and 2.

[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 includes, in particular:

[0071] - a central body 16,

[0072] - a receiving portion 18,

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

[0074] The prosthesis structure 12, with respect to each of its elements, is configured to be foldable without affecting the safety and functionality of the cardiac prosthesis. Therefore, the radial dimensions 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 is capable of delivering the prosthesis into the heart chamber, near the implantation site, through a minimally invasive pathway, and therefor its deployment and implantation, 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 prosthesis structure 12, which defines a channel for blood to pass through the device. A flexible prosthesis leaflet 14 is fixed within the central body 16, which allows 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 its 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 prosthetic 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 prosthetic leaflets 14 as specified on page 5 / 10 of the specification (CN 120938674 A). The receiving portion 18 has a substantially annular geometry and is not longitudinally extensible, i.e., 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 substantially arcuate, separated sub-assemblies 22; for simplicity, the term "arc" will be used hereinafter to refer to these two sub-assemblies. Each arc 22 may selectively engage with the connecting element 20, which stably engages with the connecting element 20 in the final implant 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. Furthermore, pin 28 is axially pierced to allow the guidewire to pass through, as better described below.

[0081] It is obvious that the pin / hole connection mechanism may alternatively include a pin at the end of sub-assembly 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 may also include a different number of sub-assemblies 22. For example, it may include a single sub-assembly and thus be formed in an open-loop manner. However, the version described using two sub-assemblies 22 is preferred because it allows the use of two guidewires, which is easier to position correctly than a single guidewire that may remain entangled in the chordae tendineae, thanks to the guidewire guide device described below. However, a third sub-assembly does not simplify the positioning operation and is therefore substantially unnecessary but should not be excluded.

[0083] In use, the leaflet of the autologous valve remains truncated 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, which is typically affected by degenerative and dilatational processes associated with pathologies leading to atrioventricular valve dysfunction.

[0084] For clarity, in the figures of Figures 1 and 2, and in subsequent figures, the outer diameter of the central body 16 is illustrated as having a smaller size than the internal dimensions of the receiving portion 18. In other words, these figures depict the two components of the prosthesis structure 12 that do not contact each other in a fully dilated 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 prosthesis structure 12, and when the receiving portion 18 is independent of the retaining portion 18,When the thickness of the tissue captured between the two parts of the prosthesis structure 12 performs its constraint action with respect to expansion, the central body 16 effectively applies radial pressure to the receiving part 18. This radial pressure increases the stability of the anchoring of the autologous leaflet.

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

[0086] Initially, a pathway is provided through the femoral vein or iliac vein. Where possible, access via the femoral vein is preferred because it is significantly simpler and more direct. In particular, it does not require invasive surgery. The guide catheter can be used for the primary purpose of protecting the femoral vein, which has a small diameter. Specification 6 / 10 pages 8 CN 120938674 A

[0087] The guide catheter, when present, is positioned via the femoral vein to form a pathway to a vessel with a larger diameter. The master tube 32 is then inserted, which, when provided, slides within the guide catheter through the inferior vena cava IVC to the right atrium, as shown in Figure 3.

[0088] The main catheter 32 is provided 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 within the main catheter 32.

[0089] As described above, providing a guide catheter is not mandatory, but 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 a position within 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 functions to allow the deployment of a guidewire around the leaflet of the autologous mitral valve V, which is necessary for 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 provided with a distal deflection system, such that its end 42 can be oriented by the operator in the direction of the mitral valve V.

[0092] The second catheter 44, which can be better seen in detailed Figures 4 and 5, includes two lumens 46 and 48 adapted to allow guidewires to slide therein. The two lumens are parallel to each other and arranged side by side over a larger portion of the second catheter 44. In the end 50 of the second catheter 44, the two lumens are bent at an angle of approximately 90° in substantially opposite directions. Thus, the two lumens 46 and 48 do not terminate at the distal tip 51 of the catheter 44, but rather terminate on its sides, in diametrically opposed positions in corresponding orifices 41 and 43. In other words, two guidewires inserted in the lumens 46 and 48 are withdrawn from the second catheter 44 oriented in diametrically opposite directions.

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

[0094] A segment 53 of radiopaque or echo-proof 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 injury.

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

[0096] Turning now to the procedure of implanting the cardiac prosthesis, the guidewire guide device 36, already inserted inside the main cannula 32, is advanced into the left atrium (FIG. 3) through the diaphragm S. It can be noted that the end 34 of the main cannula 32 may 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 toward the valve V, and thus toward the bottom in FIG. 6.

[0097] The second catheter 44 of the guidewire guide device 36 is slid within the first catheter 40 of the guidewire guide device 36 (Figure 7 / 10, page 9, CN 120938674 A 6); the end 50 withdraws and exhibits a pronounced curvature pointing in the opposite direction to the curvature of the end 42 of the first catheter 40. The second catheter 44 is actually curved upward in Figure 6.

[0098] The guidewire guide device 36 is further advanced within the main catheter 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 such that its distal tip 51 is positioned behind the posterior leaflet of the autologous valve. In particular, the distal tip 51 is preferably positioned behind the central segment (fan-shaped) generally designated P2. For this purpose, it is particularly advantageous to have a segment 53 of radiopaque material at the distal tip 51. If there is any doubt about the accurate positioning or orientation of the catheter tip 50, it can actually be checked directly with an ultrasound probe or through fluorescence examination.Verification is performed. The segment 53 of the non-transparent material will be oriented in a direction tangential to the valve edge.

[0100] Figure 8 shows a detailed schematic diagram of the left ventricle, 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. It can be noted that the catheter 44 does not pass through the chordae tendineae bundles.

[0101] Referring now to Figure 9, a third catheter 45 with a guidewire capture 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 capture device 47 is inserted into the covering sheath 55.

[0102] The third catheter 45 is oriented such that its end 54 bends in the opposite direction to the bend of the end 50 of the second catheter, and thus in the direction of the aortic valve. The guidewire capture device 47 is pushed out of 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 into the ventricle (FIG. 10) by the operator. 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 the blood flow naturally directed toward the aortic valve A during systole, the end 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. The end 57 of the guidewire 56 is then retrieved by withdrawing the third catheter 45.

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

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

[0106] A similar half-loop is formed around the valve V using a second guidewire 58 inserted into the second lumen 48 of the second catheter 44 in a generally symmetrical manner. In this way, the valve V is completely surrounded by two correctly positioned guidewires 56 and 58. For this purpose, the same guidewire capture device 47 used for capturing the first wire can be used, or preferably, another guidewire capture device 47 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 complicated: although fewer steps are required (these steps do not need to be repeated for the second wire), it is not easy to position the guidewire around the entire valve guidewire in a sufficiently precise manner because of the risk of entanglement in the chordae tendineae. In fact, using two guidewires allows the use of the geometry of the heart and natural blood flow to facilitate the operation and minimize the risk of errors that could have serious consequences for the patient if not identified and corrected immediately. Specification 8 / 10 pages 10 CN 120938674 A

[0108] Referring now to FIG12, the first catheter 40 and the second catheter 44 are preferably left in place in this step 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 on the wire, i.e. by sliding on 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 restored 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 arc 22 is pushed until it contacts 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 tube 32 is left in place and subsequently used to introduce the device 60 for implanting a cardiac prosthesis, through which the central body 16 is inserted. Removal of the main tube 32 or replacement with another catheter is not excluded in any case.

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

[0111] The device for implanting a cardiac prosthesis also includes a release device 62 for the central body 16 of the prosthesis. Release device 62 is adapted to be inserted into a catheter to advance the central body 16 of the prosthesis therein. Device 60 for implanting the cardiac prosthesis also includes device 64 for assisting the connection operation 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 each arc of the receiving portion has at least two catheters, which are assembled 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, where the prosthesis comprises two arcs 22, the assisting device 64 comprises four catheters 66. Naturally, if the prosthesis comprises a single sub-assembly of the receiving 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 the guidewire can slide, if advantageous.

[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 catheters 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 can be seen with reference to Figure 13.

[0115] The catheter 61 is then forced to advance within the main tube 32 and through the mitral valve until its end 63 is in the left ventricle. Although Figures 16 to 19 only show the device for clarity, the operations shown therein are typically performed within the patient's heart.

[0116] The central body 16 is then pushed further into 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 a folded configuration, the connecting elements deform to allow sliding 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 guidewire (FIG. 17). In this way, the pin 28 of the connecting element 20 is inserted into the axial hole 27 of the engagement portion 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 guidewires to be pulled without kinking against the edge of the conduit 61. In other words, the conduit allows traction that would otherwise not be applied to the guidewire 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 (Fig. 18).

[0119] Thus, 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, thereby forming the receiving portion 18 of the prosthesis (Figs. 19 and 20). Specification 9 / 10 pages 11 CN 120938674 A

[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 withdrawn. The central body is essentially held in a stable position within the heart so that the receiving portion 18 does not lose contact with the annulus of the autologous valve when the catheter 61 is withdrawn. When the central body 16 is released from the catheter 61, it expands within the autologous valve, straightIt is constrained by the receiving portion 18 (Fig. 21). The leaflet of the autologous valve is thus held between the central body of the cardiac prosthesis and the receiving portion 18. This configuration provides stable and secure positioning of the prosthesis.

[0121] All that has been described above must be naturally understood as one possible implementation of the invention, not the only one. Some variations of the above-described object will now be described in an exemplary manner. However, it should be understood that this is not an exhaustive list of possible variations.

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

[0123] The third catheter 254 also has two lumens 45a, 45b adapted to receive two guidewire capture devices 47. The third catheter 245 also has a D-shaped cross-section complementary to the cross-section 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 guidewire inserted into lumens 46 and 48 and the guidewire capturing device 47 is ensured. This allows for easier positioning of the guidewire around the valve annulus.

[0124] In this respect, it is clear that the D-shape is 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 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 through which the wire of the deflection system for the distal portion of the catheter passes.

[0126] Referring now to 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 suitablyPerforation is used to create an anisotropic portion that advantageously ensures precise and well-defined orientation of the lumen. This variation also allows all lumens to be straightened before the removal of the second and third catheters. 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. Furthermore, the metal lumen has a particularly small thickness.

[0127] Catheters 344 and 345 slide within catheter 40 in a straightened configuration (Fig. 24). As they are externalized from catheter 40, deflection is then activated to bend portion 354 and create a first curve (Fig. 25). The distal deflection of portion 356 is then activated to create a second curve (Fig. 26). In a substantially similar manner, deflection on lumens 345a and 345b of the third catheter is also activated. At the end of the guidewire positioning operation, all lumens are straightened (Fig. 24) to remove them.

[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. Instruction Manual Page 10 / 10 12 CN 120938674 A Figure 1 Figure 2 Instruction Manual Appendix 1 / 18 Page 13 CN 120938674 A Figure 3 Figure 4 Instruction Manual Appendix 2 / 18 Page 14 CN 120938674 A Figure 5 Figure 5a Instruction Manual Appendix 3 / 18 Page 15 CN 120938674 A Figure 6 Instruction Manual Appendix 4 / 18 Page 16 CN 120938674 A Figure 7 Instruction Manual Appendix 5 / 18 Page 17 CN 120938674 A Figure 8 Instruction Manual Appendix 6 / 18 Page 18 CN 120938674 A Figure 9 Instruction Manual Appendix 7 / 18 Page 19 CN 120938674 A Figure 10 Instruction Manual Appendix 8 / 18 Page 20 CN 120938674 A Figure 11 Instruction Manual Appendix 9 / 18 Page 21 CN 120938674 Figure 12, Appendix to the Instruction Manual, Page 10 / 18, 22 CN 120938674 Figure 13, Figure 14, Appendix to the Instruction Manual, Page 11 / 18, 23 CN 120938674 Figure 15, Figure 16, Appendix to the Instruction Manual, Page 12 / 18, 24 CN 120938674 Figure 17, Figure 18, Appendix to the Instruction Manual, Page 13 / 18, 25 CN 120938674 Figure 19, Appendix to the Instruction Manual, Page 14 / 18, 26 CN 120938674 Figure 20, Appendix to the Instruction ManualPage 15 / 18, Figure 21 of CN 120938674 A, Description of the Drawings Page 16 / 18, Figure 24 of CN 120938674 A, Description of the Drawings Page 17 / 18, Figure 29 of CN 120938674 A, Description of the Drawings Page 18 / 18, Figure 30 of CN 120938674 A, Abstract The present invention relates to a device for implanting a prosthesis for a heart valve and assembly procedure. Specifically, the present invention relates to a device for implanting a heart prosthesis which comprises a central body (16) and a containment portion (18), having one or more sub-components (22), comprises a release device for the central body which is capable of being inserted into a catheter, and a device for assisting the connection operation between the central body (16) and the sub-components of the containment portion (18), comprising an assembly of catheters, of which there are at least two catheters for each sub-component of the containment portion, the catheters being joined to each other over a portion thereof and having at least one free end for each catheter.

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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