Aortic valved conduit with coronary bridging vessel

Abstract

The invention discloses an aorta valved conduit with a coronary artery bridging vessel, comprising: an ascending aorta prosthesis comprising an ascending aorta stent; the valve prosthesis comprises a valve support and a valve blade, the valve support is coated with a valve covering film, and a bridging port used for bridging the coronary artery bridging blood vessel prosthesis or the coronary artery bridging blood vessel prosthesis communicated with the interior of the valve prosthesis is arranged on the valve covering film; the guide stent comprises at least one group of connecting rib units, the connecting rib units are connected with the ascending aorta stent and are arranged along the longitudinal direction of the ascending aorta stent, and one end of each connecting rib unit is connected with the valve stent so as to restrain the bending direction of the ascending aorta stent; the ascending aorta stent can only be bent along the plane where the connecting rib units and the central axis of the ascending aorta stent are located. The covering film is arranged outside the valve prosthesis in a covering mode, it is guaranteed that blood in the valve prosthesis cannot leak, and the coronary artery bridging blood vessel prosthesis is connected to the valve prosthesis so that the interior of the valve pipeline can be communicated with coronary artery blood flow.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to an aortic valved conduit with coronary artery bridging vessels. Background Art

[0002] For the treatment of ascending aortic aneurysm or dissection and combined aortic valve regurgitation, the traditional open-chest surgery for vascular repair and valve replacement has large surgical trauma, slow recovery, and high requirements for the experience and skills of surgeons.

[0003] The Endobentall operation aims to solve the treatment of ascending aortic lesions and acute aortic dissection by implanting a stent with a valve, which can simplify the surgical process and shorten the postoperative recovery time. The Bentall device generally consists of a large blood vessel replacing the ascending aorta and an aortic valve with valve leaflets. At the same time, some products or technologies also integrate artificial blood vessels or covered stents for coronary artery bypass grafting. In the past, most Endobentall surgical instruments were implanted step by step. First, a covered stent replacing the ascending aorta was implanted through the apex of the heart or the femoral artery, then an artificial valve (mostly balloon-expandable valves) was implanted through the apex of the heart, and finally, interventional coronary artery bypass grafting was performed. There are problems of complex implantation operations and poor compatibility of the instruments. For aortic replacement in patients with pure aortic regurgitation, there is currently no stent product that is completely suitable for all annulus anatomical structures, especially for patients with a bicuspid aortic valve annulus. It is difficult to effectively control the stent implantation position during the stent implantation operation, and the implantation accuracy is not high. Summary of the Invention

[0004] The purpose of the present invention is to provide an aortic valved conduit with coronary artery bridging vessels to solve the problems of complex stent implantation operations, difficulty in ensuring the accuracy of the stent implantation position, and synchronous treatment of coronary artery lesions.

[0005] The present invention is achieved by the following technical solutions: An aortic valved conduit with coronary artery bridging vessels, comprising: An ascending aorta prosthesis, including an ascending aorta stent, and an ascending aorta covering film is disposed outside the ascending aorta stent, so that the ascending aorta prosthesis can be adapted to the inner wall of the ascending aorta and form a sealed fit; A valve prosthesis, including a valve stent and valve leaflets, a valve covering film is disposed outside the valve stent, and a bridge interface for bridging a coronary artery bridging vessel prosthesis or a coronary artery bridging vessel prosthesis communicating with the inside of the valve prosthesis is disposed on the valve covering film; The guiding stent includes at least one set of connecting rib units, which are connected to the ascending aortic stent and arranged along the longitudinal direction of the ascending aortic stent, and one end of the connecting rib unit is connected to the valve stent to restrict the bending direction of the ascending aortic stent, so that the ascending aortic stent can only bend along the plane where the central axis of the connecting rib unit and the ascending aortic stent is located.

[0006] In some embodiments, the valve stent includes a stent connecting part, a leaflet connecting part, and an annulus mating part arranged in sequence, and the valve membrane arranged at the annulus mating part can be adapted to the autologous annulus and form a sealed contact at the position of the autologous annulus, and the connecting rib unit is connected to the stent connecting part.

[0007] In some embodiments, the ascending aortic membrane and the valve membrane are made of polymer or biological membrane materials.

[0008] In some embodiments, the guiding stent includes one set of connecting rib units; or the guiding stent includes two sets of connecting rib units, and the two sets of connecting rib units are symmetrically arranged relative to each other on both sides of the ascending aortic stent; or the guiding stent part includes at least two sets of connecting rib units, and the connecting rib units are all arranged on one side of the aortic stent; The connecting rib unit includes one connecting rib or multiple connecting ribs arranged side by side at equal intervals.

[0009] In some embodiments, an annular blocking part is arranged at one end or both ends of the ascending aortic stent, and the blocking part protrudes from the surface where the ascending aortic membrane is located in the radial direction.

[0010] In some embodiments, the blocking part is formed by using a foaming material or a fabric filler.

[0011] In some embodiments, the structural strength of the ascending aortic stent at the position corresponding to the blocking part is greater than that at other positions, so that the ascending aortic stent can withstand a greater radial force at the position corresponding to the blocking part than at other positions.

[0012] In some embodiments, the ascending aortic stent includes a plurality of annular corrugated stent units arranged at intervals along the axial direction of the ascending aortic prosthesis, and the connecting rib units are respectively connected to each stent unit.

[0013] In some embodiments, the ascending aortic stent, the valve stent and the connecting rib unit are integrally formed.

[0014] In some embodiments, the ascending aortic stent, the valve stent and the connecting rib unit are connected and formed by welding, riveting or sewing.

[0015] Compared with the prior art, the present invention has the following advantages and beneficial effects: The present invention adopts the structural design of connecting ribs. Through the arrangement of the connecting ribs, it is convenient to position the angle of the valved conduit during the input process, accurately control the bending direction of the valved conduit during the in-vivo transportation process, facilitate the adjustment and control of the implantation angle of the instrument, and thus can achieve precise alignment with the native valve leaflet junction edge, ensuring the implantation accuracy of the valved conduit.

[0016] A film is coated outside the valve prosthesis to ensure that the blood in the valve prosthesis does not leak, and a coronary artery bridging vascular prosthesis is connected to the valve prosthesis to realize the connection between the inside of the valved conduit and the coronary artery blood flow.

[0017] Based on the structure of the connecting ribs, the present invention connects the ascending aorta stent into a whole and realizes the connection between the ascending aorta stent and the valve stent, enabling the skeleton structure of the valved conduit to be integrally formed, simplifying the design structure of the instrument, and facilitating the implantation operation of the instrument. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as limiting the scope. For those of ordinary skill in the art, other related drawings can be obtained based on these drawings without creative efforts.

[0019] Figure 1 Schematic diagram of an ascending aortic aneurysm of the ascending aorta.

[0020] Figure 2 Schematic diagram of the implanted state structure of an aortic valved conduit with a coronary artery bridging vessel according to an embodiment of the present invention.

[0021] Figure 3 Front view of the structure of an aortic valved conduit with a coronary artery bridging vessel according to an embodiment of the present invention.

[0022] Figure 4 Front view of the structure of another aortic valved conduit with a separately arranged coronary artery bridging vessel according to the present invention.

[0023] Figure 5 Schematic diagram of the skeleton structure of an aortic valved conduit with a coronary artery bridging vessel according to an embodiment of the present invention.

[0024] Figure 6 Front view of the skeleton structure of an aortic valved conduit with a coronary artery bridging vessel according to an embodiment of the present invention.

[0025] Figure 7 Side view of the skeleton structure of an aortic valved conduit with a coronary artery bridging vessel according to an embodiment of the present invention.

[0026] Figure 8 This is a schematic structural diagram of another embodiment of the aortic valved conduit framework with coronary artery bridging vessels in the embodiments of the present invention.

[0027] Wherein: 100, valved conduit; 10, ascending aorta prosthesis, 11, ascending aorta stent, 111, stent unit, 12, ascending aorta membrane, 13, occlusion part; 20, valve prosthesis, 21, valve stent, 211, stent connection part, 212, leaflet connection part, 213, annulus fitting part, 22, valve membrane, 23, valve leaflet; 30, connecting tendon; 40, coronary artery bridging vessel prosthesis, 41, bridge interface. Specific embodiments

[0028] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are some, but not all, of the embodiments of the present invention.

[0029] The present invention is a device product applicable to Endobentall surgery implantation, which can well adapt to various annulus anatomical structures. It can not only be used for traditional patients with ascending aortic aneurysm combined with tricuspid aortic valve regurgitation, but also has good therapeutic effects on patients with pure aortic valve regurgitation of bicuspid or other leaflet structures, greatly expanding the applicable range of patients.

[0030] In particular, the present invention adopts the structural design of a connecting tendon. Through the position of the connecting tendon, it is convenient to position the angle of the device during the input process, accurately control the bending direction of the device during the in-vivo delivery process, facilitate the adjustment and control of the implantation angle of the device, achieve precise alignment with the native leaflet commissure edge, and ensure the implantation accuracy of the device.

[0031] Moreover, based on the structure of the connecting tendon, the ascending aorta stents are connected into a whole, and the connection between the ascending aorta stent and the valve stent is realized, enabling the framework structure of the valved conduit to be integrally formed, simplifying the design structure of the device, and facilitating the implantation operation of the device.

[0032] In some embodiments of the present invention, refer to Figure 1 and Figure 2, the aortic valved conduit 100 with coronary bridging vessels shown in the figure is a transvascular implantable Endobentall device for treating ascending aortic aneurysms (the depth of the aortic lesion location is not lower than the junction of the sinus and the arterial blood vessel), and can replace the aortic valve while treating vascular lesions.

[0033] Referring to Figure 3 , Figure 4 , Figure 5 , Figure 6 and Figure 7 , the aortic valved conduit with coronary bridging vessels includes: An ascending aortic prosthesis 10, including an ascending aortic stent 11, and an ascending aortic membrane 12 is disposed outside the ascending aortic stent 11, so that the ascending aortic prosthesis can be adapted to the inner wall of the ascending aorta and form a sealed fit; A valve prosthesis 20, including a valve stent 21 and valve leaflets 23, and a valve membrane 22 is disposed outside the valve stent 21, and the valve stent is completely covered by the valve membrane 22 to form a closed structure inside the valve prosthesis, ensuring that the internal blood flow will not leak.

[0034] The valve leaflets 23 are connected by sutures to the leaflet connection part 211 to form a valve prosthesis. The valve leaflets 23 can be made of natural biological materials, bio-modified materials or non-biological materials.

[0035] One or two bridge interfaces 41 for bridging the coronary bridging vessel prosthesis are provided on the valve membrane; Or one or two coronary bridging vessel prostheses 40 are provided on the valve membrane, and the coronary bridging vessel prostheses 40 are communicated with the inside of the valve prosthesis to realize the connection between the inside of the valved conduit and the coronary artery blood flow.

[0036] The coronary bridging vessel has obvious radiopaque imaging markers. When the coronary bridging vessel prosthesis 40 is implanted, it is respectively connected to the bridge interface and communicated with the inside of the valve prosthesis to realize the connection between the inside of the valved conduit and the coronary artery blood flow.

[0037] The coronary bridging vessel prosthesis adopts the traditional covered stent configuration process. After the valved conduit is implanted in place, interventional coronary artery bypass can be performed through the bridge interface, or the coronary bridging vessel can be directly sutured to the valved conduit and then implanted step by step.

[0038] Referring to Figure 2 As shown, after the aortic valved conduit is implanted, the coronary bridging vessel prostheses are respectively arranged in the branch vessels of the coronary artery to realize the normal blood flow after the aortic valved conduit is implanted.

[0039] In some embodiments, the valve stent 21 includes a stent connection part 211, a leaflet connection part 212, and an annulus fitting part 213 arranged in sequence. A valve membrane 22 is arranged outside and covering the annulus fitting part 213, enabling the annulus fitting part to adapt to the autologous annulus and form a sealed contact with the autologous annulus.

[0040] The ascending aorta membrane 12 and the valve membrane 22 are made of film materials such as polymers or biological materials. For example, the polymer film material can be ePTFE, PET film, etc. The films are respectively connected to the ascending aorta stent and the valve stent by suture.

[0041] A guiding stent is provided on the valved conduit according to an embodiment of the present invention. The guiding stent includes at least one set of connecting rib units. The connecting rib units are connected to the ascending aorta stent 11 and arranged along the longitudinal direction of the ascending aorta stent 11. One end of the connecting rib units is connected to the stent connection part 211 of the valve stent, so that the guiding stent can restrict the bending direction of the ascending aorta stent, and the ascending aorta stent can only bend along the plane where the connecting rib and the central axis of the ascending aorta stent are located.

[0042] In some embodiments, the guiding stent includes one set of connecting rib units; the connecting rib units include one connecting rib 30 or multiple connecting ribs 30 arranged side by side at equal intervals. Taking the connecting rib unit with one connecting rib as an example, the connecting rib provides a certain restriction on the bending direction of the ascending aorta stent, so that the ascending aorta stent can only bend along the plane where the connecting rib and the central axis of the ascending aorta stent are located, facilitating the control of the bending direction of the ascending aorta stent.

[0043] When the connecting rib units are composed of two or more connecting ribs, the connecting ribs can be connected at both ends to form an integral structure.

[0044] In some embodiments, the guiding stent includes two sets of connecting rib units, and the two sets of connecting rib units are symmetrically arranged on both sides of the ascending aorta stent. At this time, the two sets of connecting rib units provide restrictions on the bending direction of the ascending aorta stent. Referring to Figure 4 , taking the connecting rib unit with one connecting rib as an example, the two connecting ribs symmetrically arranged on both sides of the ascending aorta stent restrict the bending direction of the ascending aorta stent, so that the ascending aorta stent can only bend along the plane where the two connecting ribs and the central axis of the ascending aorta stent are located, realizing the control of the bending direction of the ascending aorta stent.

[0045] The design of using symmetrically arranged connecting ribs can accurately control the bending direction of the device during the implantation and delivery process in the body, and further accurately control the alignment of the implanted device with the junction edge of the native leaflets.

[0046] Referring to Figure 8, which is a connecting rib unit composed of two connecting ribs. The two connecting ribs in the connecting rib unit are arranged side by side at intervals and are connected at both ends. Two groups of connecting rib units are symmetrically arranged relative to each other on both sides of the ascending aortic stent. The connecting rib unit with this structure can provide more stable constraints for the bending direction of the ascending aortic stent.

[0047] In some embodiments, the guiding stent can adopt two groups, three groups or more groups of connecting rib units, and multiple groups of connecting rib units are all arranged on one side of the ascending aortic stent 11. At this time, the connecting ribs arranged on one side provide constraints for the ascending aortic stent, enabling it to bend only in the direction opposite to the side where the connecting ribs are arranged, so as to control the bending direction of the ascending aortic stent.

[0048] In some embodiments, an annular sealing part 13 is arranged at one end or both ends of the ascending aortic stent. The sealing part 13 protrudes from the surface where the ascending aortic membrane 12 is located in the radial direction.

[0049] Refer to Figure 3 、 Figure 4 and Figure 5 , sealing parts 13 are arranged at both ends of the ascending aortic stent. Through the sealing contact and cooperation between the sealing parts and the inner wall of the autologous aortic blood vessel, the sealing cooperation performance of the ascending aortic prosthesis is ensured. At the same time, through the interference fit formed between the sealing parts and the autologous aortic blood vessel, better anchoring force can be provided between the ascending aortic prosthesis and the autologous aortic blood vessel.

[0050] The design of the above structure is not limited by the valve leaf structure (monoleaflet valve, bicuspid valve, tricuspid valve, quadricuspid valve, etc.) during aortic valve replacement for pure aortic valve regurgitation patients, making it have good pathological compatibility.

[0051] The sealing part 13 is formed by using foaming materials or other similar materials such as fabric fillers. The fabric filler can adopt polyester cloth, etc.

[0052] The structural strength of the ascending aortic stent at the position corresponding to the sealing part is greater than that at other positions, enabling the ascending aortic stent to withstand greater radial force at the position corresponding to the sealing part, effectively supporting the sealing part at the sealing part position, and enabling the sealing part to form better sealing cooperation with the autologous ascending aortic blood vessel.

[0053] Refer to Figure 5 、 Figure 6 and Figure 7, the diameter of the stent connecting portion 211 should be smaller than the diameter of the ascending aortic stent 11. From the stent connecting portion 211 to the leaflet connecting portion 212, it is a gradually decreasing diameter tapered structure, and from the leaflet connecting portion 212 to the annulus mating portion 213, it is a gradually increasing diameter tapered structure, making the valve stent in a hourglass shape with larger diameters at both ends and a smaller diameter in the middle.

[0054] In some embodiments, the ascending aortic stent 11 includes a plurality of stent units 111 arranged at intervals along the axis of the ascending aortic prosthesis and having an annular corrugated structure. The stent units 111 are connected into a whole through connecting rib units respectively, and the valve stent 21 and the ascending aortic stent 11 are connected through the connection of the connecting rib 30, facilitating the integral molding of the overall skeleton structure of the valved conduit.

[0055] The number of stent units can be 6, 7 or more, and generally can be set to 6.

[0056] Of course, the stent units 111, the valve stent 21 and the connecting rib units can also be formed separately, and then the ascending aortic stent and the valve stent are connected and formed into an integral structure by processes such as welding, riveting or sewing.

[0057] The ascending aortic stent, as the support structure or skeleton of the ascending aortic prosthesis, can be formed by laser cutting of nitinol alloy, or formed by braiding nitinol alloy wires, or be a self-expanding stent in other ways.

[0058] In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the product of the present invention is usually placed when in use. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be construed as a limitation of the present invention.

[0059] In addition, when terms such as "horizontal" and "vertical" appear in the description of the present invention, it does not mean that the components are required to be absolutely horizontal or hanging vertically, but can be slightly inclined. For example, "horizontal" only means that its direction is more horizontal relative to "vertical", and does not mean that the structure must be completely horizontal, but can be slightly inclined.

[0060] In the description of the present invention, it should also be noted that unless otherwise clearly specified and defined, if the terms "arranged", "installed", "connected", and "coupled" are used, they should be understood in a broad sense. For example, it may be a fixed connection, a detachable connection, or an integral connection; it may be a mechanical connection or an electrical connection; it may be directly connected or indirectly connected through an intermediate medium, and it may be the communication inside two components. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific situations.

[0061] The above are only the preferred embodiments of the present invention, and do not impose any form of limitation on the present invention. Any simple modification or equivalent change made to the above embodiments based on the technical essence of the present invention falls within the protection scope of the present invention.

Claims

1. An aortic valved conduit with a coronary bridging vessel, characterized in that: include: The ascending aorta prosthesis comprises an ascending aorta stent, and an ascending aorta covering is provided outside the ascending aorta stent, so that the ascending aorta prosthesis can be adapted to the inner wall of the ascending aorta and form a sealing fit; A valve prosthesis, comprising a valve stent and valve leaflets, wherein the valve stent is covered with a valve covering, and a bridge interface for bridging a coronary bridging vascular prosthesis or a coronary bridging vascular prosthesis communicating with the interior of the valve prosthesis is provided on the valve covering; The guide stent includes at least one group of connecting rib units, which are connected to the ascending aorta stent and arranged along the longitudinal direction of the ascending aorta stent, and the connecting rib units are connected to the valve stent at one end to constrain the bending direction of the ascending aorta stent, so that the ascending aorta stent can only bend along the plane where the connecting rib units and the central axis of the ascending aorta stent are located.

2. The aortic valved conduit with a coronary bridging vessel according to claim 1, characterized in that: The valve stent includes a stent connection portion, a leaflet connection portion and a valve ring matching portion which are arranged in sequence, and the valve covering arranged at the valve ring matching portion can adapt to the native valve ring and form a sealing contact at the position of the native valve ring, and the connecting rib unit is connected to the stent connection portion.

3. The aortic valved conduit with a coronary bridging vessel according to claim 1, characterized in that: The ascending aorta coating and valve coating are made of polymer or biological coating materials.

4. The aortic valved conduit with a coronary bridging vessel according to claim 1, characterized in that: The guide bracket includes a group of connecting rib units; Or the guide stent includes two groups of connecting rib units, and the two groups of connecting rib units are relatively symmetrically arranged on both sides of the ascending aorta stent; Or the guide stent includes at least two groups of connecting rib units, and the connecting rib units are both arranged on one side of the aortic stent; The connecting rib unit includes one connecting rib or a plurality of connecting ribs arranged side by side at equal intervals.

5. The aortic valved conduit with a coronary bridging vessel according to any one of claims 1, 2 or 4, characterized in that: An annular blocking portion is arranged at one end or both ends of the ascending aorta stent, and the blocking portion protrudes from the surface of the ascending aorta covering in the radial direction.

6. The aortic valved conduit with a coronary bridging vessel according to claim 5, characterized in that: The blocking portion is formed by using foaming material or fabric filler.

7. The aortic valved conduit with a coronary bridging vessel according to claim 5, characterized in that: The structural strength of the ascending aorta stent at the position corresponding to the occluding part is greater than the structural strength at other positions, so that the ascending aorta stent at the position corresponding to the occluding part can withstand a greater radial force than other positions.

8. The aortic valved conduit with a coronary bridging vessel according to claim 1, characterized in that: The ascending aorta stent comprises a plurality of annular corrugated stent units which are spaced apart along the axial direction of the ascending aorta prosthesis, and the connecting rib units are respectively connected to the stent units.

9. The aortic valved conduit with a coronary bridging vessel according to claim 1 or 8, characterized in that: The ascending aorta stent, valve stent and connecting rib unit are integrally formed.

10. The aortic valved conduit with a coronary bridging vessel according to claim 1 or 8, characterized in that: The ascending aorta stent, the valve stent and the connecting rib unit are connected and formed by welding, riveting or sewing.

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