Interventional aorta valved conduit

Abstract

The invention discloses an intrusive aorta valved conduit, comprising: an ascending aorta prosthesis comprising an ascending aorta stent, and an ascending aorta covering film covering 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 with the inner wall of the ascending aorta; the valve prosthesis comprises a valve support and a valve blade. Comprising at least one group of connecting rib units, the connecting rib units are connected with the ascending aorta stent and arranged in the longitudinal direction of the ascending aorta stent, and one ends of the connecting rib units are connected with the valve stent 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. Through the arrangement of the connecting ribs, the angle of the valved pipeline in the input process can be controlled, so that the bending direction of the valved pipeline in the in-vivo conveying process is accurately controlled, the implantation angle of the instrument is convenient to adjust and control, the instrument can be accurately aligned with the boundary edge of a native valve leaflet, and the implantation precision of the valved pipeline is guaranteed.

Description

Technical Field

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

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

[0003] The Endobentall operation aims to solve the treatment of ascending aortic lesions, acute aortic dissection and combined aortic valve lesions 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 will also integrate artificial blood vessels or covered stents for coronary artery bypass grafting on the left and right. 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 or femoral artery, then an artificial valve (mostly balloon-expandable valve) was implanted through the apex, 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 applicable to all annulus anatomical structures, especially 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 interventional aortic valved conduit to solve the problems of complex stent implantation operations and difficulty in ensuring the accuracy of the stent implantation position.

[0005] The present invention is achieved by the following technical solutions: The interventional aortic valved conduit includes: An ascending aorta prosthesis, including an ascending aorta stent, and an ascending aorta membrane 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 guiding stent, including at least one set of connecting rib units, the connecting rib units are connected to the ascending aorta stent and arranged along the longitudinal direction of the ascending aorta stent, and one end of the connecting rib units is connected to the valve stent to restrict the bending direction of the ascending aorta stent, so that the ascending aorta stent can only bend along the plane where the central axis of the connecting rib units and the ascending aorta stent is located.

[0006] In some embodiments of the present invention, 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 on both sides of the ascending aortic stent; Or the guiding stent 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.

[0007] In some embodiments of the present invention, an annular blocking portion is provided at one end or both ends of the ascending aortic stent, and the blocking portion protrudes from the surface where the ascending aortic membrane is located in the radial direction.

[0008] In some embodiments of the present invention, the blocking portion is formed by using a foaming material or a fabric filler.

[0009] In some embodiments of the present invention, the structural strength of the ascending aortic stent at the position corresponding to the blocking portion 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 portion than at other positions.

[0010] In some embodiments of the present invention, 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.

[0011] In some embodiments of the present invention, the number of the stent units is at least 6.

[0012] In some embodiments of the present invention, the ascending aortic stent, the valve stent and the connecting rib unit are integrally formed.

[0013] In some embodiments of the present invention, the ascending aortic stent, the valve stent and the connecting rib unit are formed by connecting through welding, riveting or suturing.

[0014] In some embodiments of the present invention, the valve stent includes a stent connecting portion, a leaflet connecting portion and an annulus mating portion arranged in sequence. A valve membrane is coated outside the stent connecting portion and the annulus mating portion, and the valve membrane arranged at the annulus mating portion can be adapted to the autologous annulus and form a sealing contact at the position of the autologous annulus. The connecting rib unit is connected to the stent connecting portion.

[0015] In some embodiments of the present invention, the valve leaflets are made of natural biological materials, bio-modified materials or non-biological materials.

[0016] In some embodiments of the present invention, the ascending aortic membrane and the valve membrane are made of polymer or biological membrane materials.

[0017] In some embodiments of the present invention, a hollowed-out area capable of being used for coronary blood perfusion is provided at a position on the valve prosthesis corresponding to the sinus coronary artery region.

[0018] Compared with the prior art, the present invention has the following advantages and beneficial effects: By providing the connecting rib unit, the present invention can control the angle of the valved conduit during the input process, accurately control the bending direction of the valved conduit during the in-vivo delivery process, facilitate the adjustment and control of the implantation angle of the instrument, and thus can accurately align with the native leaflet commissure edge, ensuring the implantation accuracy of the valved conduit.

[0019] Based on the structure of the connecting rib, the ascending aortic stent of the present invention is connected into a whole, and the connection between the ascending aortic 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 instrument, facilitating the implantation operation of the instrument, and simplifying the surgical operation process. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying 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.

[0021] Figure 1 Schematic diagram of an ascending aortic aneurysm of the ascending aorta.

[0022] Figure 2 Schematic diagram of the implanted state structure of the interventional aortic valved conduit according to the embodiment of the present invention.

[0023] Figure 3 Schematic diagram of the interventional aortic valved conduit according to the embodiment of the present invention.

[0024] Figure 4 Front view of the interventional aortic valved conduit according to the embodiment of the present invention.

[0025] Figure 5 Schematic diagram of the framework structure of the interventional aortic valved conduit according to the embodiment of the present invention.

[0026] Figure 6 Front view of the framework structure of the interventional aortic valved conduit according to the embodiment of the present invention.

[0027] Figure 7 Side view of the framework structure of the interventional aortic valved conduit according to the embodiment of the present invention.

[0028] Figure 8Schematic structural diagram of another embodiment of the stent of the transcatheter aortic valved conduit according to the embodiment of the present invention.

[0029] Figure 9 Schematic structural diagram of the delivery system for implanting the transcatheter aortic valved conduit according to the embodiment of the present invention.

[0030] Figure 10 Schematic structural diagram of implanting the transcatheter aortic valved conduit by using the delivery system according to the embodiment of the present invention.

[0031] 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 matching part, 22, valve membrane, 23, valve leaflet, 24, hollow area; 30, connecting rib; 40, delivery system, 41, handle, 42, runner, 43, inner connecting sheath, 44, instrument retracting and releasing tube, 45, retracting device, 46, tip. Detailed implementation manners

[0032] 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. Apparently, the described embodiments are some but not all of the embodiments of the present invention.

[0033] The present invention is an instrument 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 complicated 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.

[0034] Particularly, the present invention adopts the structural design of the connecting rib. By setting the connecting rib, it is convenient to position the angle of the instrument during the input process, can accurately control the bending direction of the instrument during the in-vivo delivery process, is convenient for adjusting and controlling the implantation angle of the instrument, realizes accurate alignment with the native leaflet commissure edge, and ensures the implantation accuracy of the instrument.

[0035] Based on the connecting rib, the ascending aorta stent is connected into a whole, and the connection between the ascending aorta stent and the valve stent is realized, so that the stent structure of the valved conduit can be integrally formed, simplifying the design structure of the instrument and facilitating the implantation operation of the instrument.

[0036] In some embodiments of the present invention, with reference to Figure 1 and Figure 2 , the interventional aortic valved conduit 100 shown in the figure is a transvascular implantable Endobentall device for treating ascending aortic aneurysms (the depth of the aortic lesion is not lower than the junction of the sinus and the arterial blood vessel), and can replace the aortic valve while treating the vascular lesion.

[0037] With reference to Figure 3 , Figure 4 , Figure 5 , Figure 6 and Figure 7 , the interventional aortic valved conduit 100 includes: An ascending aortic prosthesis 10, including an ascending aortic stent 11, with an ascending aortic membrane 12 disposed outside and covering the ascending aortic stent 11. By covering the ascending aortic membrane, 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. The valve stent 21 includes a stent connection portion 211, a leaflet connection portion 212, and an annulus mating portion 213 arranged in sequence. A valve membrane 22 is disposed outside and covering the stent connection portion 211 and the annulus mating portion 213, and the valve membrane disposed at the annulus mating portion can be adapted to the autologous annulus and form a sealed contact at the autologous annulus position.

[0038] The valve leaflets 23 are sutured and connected to the leaflet connection portion 211 to form the valve prosthesis. The valve leaflets 23 can be made of natural biological materials, bio-modified materials, or non-biological materials.

[0039] A guiding stent is provided on the interventional aortic valved conduit according to the 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 aortic stent 11 and arranged along the longitudinal direction of the ascending aortic stent 11, and one end of the connecting rib units is connected to the stent connection portion 211 of the valve stent, so that the guiding stent can restrict the bending direction of the ascending aortic stent, and the ascending aortic stent can only bend along the plane where the connecting rib and the central axis of the ascending aortic stent are located.

[0040] In some embodiments, the guiding stent includes one set of connecting rib units; the connecting rib units include a connecting rib 30 or multiple connecting ribs 30 arranged at equal intervals side by side. 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 aortic stent, so that the ascending aortic stent can only bend along the plane where the connecting rib and the central axis of the ascending aortic stent are located, so as to realize the control of the bending direction of the ascending aortic stent.

[0041] When the connecting rib unit is composed of two or more connecting ribs, the connecting ribs can be connected at both ends to form an integral structure.

[0042] In some embodiments, the guiding bracket includes two sets of connecting rib units, and the two sets of connecting rib units are symmetrically arranged on both sides of the ascending aortic stent. At this time, the two sets of connecting rib units provide constraints for the bending direction of the ascending aortic stent. Refer to Figure 5 , taking the connecting rib unit with one connecting rib as an example, the two sets of connecting rib units symmetrically arranged on both sides of the ascending aortic stent constrain the bending direction of the ascending aortic stent, so that the ascending aortic stent can only bend along the plane where the two connecting ribs and the central axis of the ascending aortic stent are located, realizing the control of the bending direction of the ascending aortic stent.

[0043] The design of using symmetrically arranged connecting rib units can accurately control the bending direction of the device during the implantation and delivery process in the body, and thus can accurately control the alignment of the implanted device with the junction edge of the native valve leaf.

[0044] Refer to Figure 8 , which is a schematic structural diagram of the arrangement of the connecting rib unit composed of two connecting ribs on the aortic valved conduit. The two connecting ribs in the connecting rib unit are arranged side by side at intervals and are connected at both ends. The two sets of connecting rib units are symmetrically arranged on both sides of the ascending aortic stent. This structure of the connecting rib unit can provide a more stable constraint for the bending direction of the ascending aortic stent.

[0045] In some embodiments, the guiding bracket can adopt two sets, three sets or more sets of connecting rib units, and multiple sets 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, so that it can only bend in the direction opposite to the side where the connecting ribs are arranged to control the bending direction of the ascending aortic stent.

[0046] In some embodiments, the ascending aortic stent 11 includes a plurality of stent units 111 arranged at intervals along the axial direction of the ascending aortic prosthesis and having an annular corrugated structure. The connecting rib units are respectively connected to each stent unit 111 to connect the stent units 111 into an integral body, and through the connection of the connecting rib 30 with the valve stent 21, the valve stent 21 is connected to the ascending aortic stent 11, and the integral forming of the overall skeleton structure of the valved conduit can be realized.

[0047] The number of the stent units can be 6, 7 or more, and generally can be set to 6.

[0048] Of course, the stent unit 111, the valve stent 21 and the connecting rib unit can also be formed separately, and then the ascending aortic stent and the valve stent are connected and formed into an integral structure by using processes such as welding, riveting or sewing.

[0049] The ascending aortic stent, as the supporting structure or framework of the ascending aortic prosthesis, can be formed by laser cutting of nitinol alloy, or woven from nitinol alloy wires, or be a self-expanding stent formed by other means.

[0050] In some embodiments, an annular blocking portion 13 is provided at one or both ends of the ascending aortic stent. The blocking portion 13 protrudes from the surface where the ascending aortic membrane 12 is located in the radial direction.

[0051] Refer to Figure 3 and Figure 4 , blocking portions 13 are provided at both ends of the ascending aortic stent. Through the sealing contact and cooperation formed by the blocking portions with 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 blocking portions and the autologous aortic blood vessel, a better anchoring force can be provided between the ascending aortic prosthesis and the autologous aortic blood vessel.

[0052] With the design of the above structure, when performing aortic valve replacement on patients with pure aortic valve regurgitation, it is no longer limited by the leaflet structure (monoleaflet valve, bicuspid valve, tricuspid valve, quadricuspid valve, etc.), making it have good pathological compatibility.

[0053] The blocking portion 13 is formed by using foaming materials or other similar materials such as fabric fillers. The fabric filler can be, for example, polyester cloth, etc.

[0054] The structural strength at the position corresponding to the blocking portion on the ascending aortic stent 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 portion, enabling effective support for the blocking portion at the blocking portion position, and enabling a better sealing fit to be formed between the blocking portion and the autologous ascending aortic blood vessel.

[0055] Refer to Figure 5 , Figure 6 and Figure 7 , the diameter of the stent connecting portion 211 is 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 changing structure with a gradually decreasing diameter, and from the leaflet connecting portion 212 to the annulus fitting portion 213, it is a gradually changing structure with a gradually increasing diameter, making the valve stent have a hourglass-shaped structure with large diameters at both ends and a small diameter in the middle.

[0056] In some embodiments, the ascending aortic membrane 12 and the valve membrane 22 are made of film materials such as high polymers or biological materials. The high polymer film material can be, for example, ePTFE, PET film, etc. The films are respectively connected to the ascending aortic stent and the valve stent by stitching.

[0057] In some embodiments, a hollowed-out area 24 is provided at a position corresponding to the sinus coronary region on the valve prosthesis 20, enabling the interior of the implantable valved conduit to communicate with the coronary blood flow.

[0058] The valved conduit in the above embodiments can be Figure 9 and Figure 10 implanted using the delivery system shown in. Refer to Figure 9 and Figure 10 , the delivery system 40 includes a handle 41, a rotating wheel 42, an inline sheath 43, an instrument retraction tube 44, a retraction device 45, and a tip 46. The rotating wheel is used to control the retraction and deployment of the components of the delivery system. The inline sheath is configured to reduce the profile of the instrument. The instrument retraction tube can be a coiled tube or a Hypotube to adapt to the curvature of the implant delivery arbitrarily, taking into account both strength and flexibility. The retraction device is used to connect the instrument to be implanted, and the tip is used to guide the implantation of the instrument.

[0059] 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 during 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. Therefore, it should not be construed as a limitation to the present invention.

[0060] In addition, in the description of the present invention, if terms such as "horizontal" and "vertical" appear, 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.

[0061] In the description of the present invention, it should also be noted that unless otherwise clearly specified and limited, if the terms "set", "installed", "connected", "connected" are used, they should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection, an electrical connection; it can be directly connected, or indirectly connected through an intermediate medium, and it can be the communication inside two elements. 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.

[0062] The above are only the preferred embodiments of the present invention, and do not impose any formal limitations on the present invention. Any simple modifications and equivalent changes made to the above embodiments based on the technical essence of the present invention all fall within the protection scope of the present invention.

Claims

1. An interventional aortic valved conduit, 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; Valve prostheses, including valve stents and valve leaflets; 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 central axis of the connecting rib units and the ascending aorta stent is located.

2. The invasive aortic valved conduit 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.

3. The invasive aortic valved conduit according to claim 1 or 2, 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.

4. The invasive aortic valved conduit according to claim 3, characterized in that: The blocking portion is formed by using foaming material or fabric filler.

5. The invasive aortic valved conduit according to claim 3, 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.

6. The invasive aortic valved conduit 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.

7. The invasive aortic valved conduit according to claim 6, characterized in that: The number of the bracket units is at least 6.

8. The invasive aortic valved conduit according to claim 1 or 6, characterized in that: The ascending aorta stent, valve stent and connecting rib unit are integrally formed.

9. The invasive aortic valved conduit according to claim 1 or 6, characterized in that: The ascending aorta stent, the valve stent and the connecting rib unit are connected and formed by welding, riveting or suturing.

10. The invasive aortic valved conduit according to claim 1, characterized in that: The valve stent includes a stent connecting portion, a leaflet connecting portion and a valve ring matching portion which are arranged in sequence. A valve covering is arranged on the outer sides of the stent connecting portion and the valve ring matching portion, and the valve covering arranged on 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. The connecting rib unit is connected to the stent connecting portion.

11. The invasive aortic valved conduit according to claim 1 or 10, characterized in that: The valve leaflets are made of natural biological materials, biologically modified materials or non-biological materials.

12. The invasive aortic valved conduit according to claim 10, characterized in that: The ascending aorta coating and valve coating are made of polymer or biological coating materials.

13. The invasive aortic valved conduit according to claim 1 or 10, characterized in that: The position on the valve prosthesis corresponding to the sinus coronary region is arranged as a hollow region that can be used for coronary blood perfusion.

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