Aortic valved conduit with positioning function

Abstract

The application discloses an aortic valved conduit with positioning function, which comprises a valve prosthesis, an ascending aorta prosthesis comprising an ascending aorta stent, a connecting tendon unit arranged on the ascending aorta stent along the axial direction, the connecting tendon unit being used for restricting the ascending aorta stent to bend in only one direction, a positioning ring being a ring-shaped stent with multiple positioning ends and in a corrugated shape, the positioning ring being fitted on the valve stent at a position close to an inflow end, the connecting ends of the positioning ring being connected with the valve stent, and the position of one of the positioning ends corresponding to the bending direction of the ascending aorta stent restricted by the connecting tendon unit. The application can ensure the precision of the implanted position of the valved conduit, improve the efficiency of the implantation operation, make the implantation operation of the valved conduit simpler, and greatly reduce the requirement for the operation level of the operator.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to an aortic valve conduit with positioning function. Background Technology

[0002] For the treatment of ascending aortic aneurysm or dissection, combined with aortic regurgitation, the traditional surgical open-chest approach is used for vascular repair and valve replacement. This method is highly invasive, has a slow recovery, and requires a high level of experience and skill from the surgeon.

[0003] Endobentall surgery treats ascending aortic lesions and acute aortic dissection by implanting a stent with a valve, simplifying the surgical procedure and shortening postoperative recovery time. Endobentall devices generally consist of a large vessel replacing the ascending aorta and an aortic valve with leaflets. Some products or technologies also integrate artificial vessels or endovascular stents for left and right coronary artery bypass grafting. Previously, Endobentall devices were often implanted in stages: first, a endovascular stent to replace the ascending aorta was implanted via the apex or femoral artery; then, an artificial valve (mostly a bulbar valve) was implanted via the apex; finally, interventional coronary artery bypass grafting was performed. This approach was complex and had poor device compatibility. For aortic replacement in patients with pure aortic regurgitation, there were issues with insufficient device positioning accuracy and easy displacement during device deployment. Summary of the Invention

[0004] The purpose of this invention is to provide an aortic valve conduit with positioning function to solve the problems of complex implantation operation, difficulty in ensuring implantation position accuracy, and easy displacement of the product during the implantation process of existing products.

[0005] This invention is achieved through the following technical solution: Valved aortic conduits with positioning function include: Valve prostheses, including valve stents and valve leaflets; An ascending aortic prosthesis includes an ascending aortic stent, and an ascending aortic tunic covering the outside of the ascending aortic stent; a connecting rib unit is provided on the ascending aortic stent along its axial direction, and the connecting rib unit is used to constrain the ascending aortic stent to bend only in one direction. The positioning ring is a corrugated annular stent with multiple positioning ends. The positioning ring is fitted onto the valve stent near the inflow end and is connected to the valve stent at its connecting end. The position of one of the positioning ends corresponds to the bending direction of the connecting rib unit constraining the ascending aortic stent. During implantation, the circumferential position of the valve prosthesis is positioned by the cooperation between the positioning end and each native leaflet. At the corresponding position of the positioning end, each native leaflet can be clamped between the positioning ring and the valve stent, thus fixing the valve prosthesis at the implantation position.

[0006] In some embodiments, the positioning end is spaced apart from the valve stent inflow end and located above the valve stent inflow end.

[0007] In some embodiments, the connecting rib unit includes two connecting ribs symmetrically arranged on both sides of the ascending aortic stent, or includes multiple connecting ribs arranged on one side of the ascending aortic stent.

[0008] In some embodiments, the connecting ribs are pre-bent and shaped so that the ascending aortic stent can bend in the direction of the constraint bending of the connecting rib unit on the ascending aortic stent in a free state.

[0009] In some embodiments, the ascending aortic drape is a cylindrical structure with one end inclined, and the length of the ascending aortic drape on the larger diameter side of the bend is greater than its length on the smaller diameter side of the bend, so that during the deployment of the ascending aortic stent, the ascending aortic drape can constrain the ascending aortic stent to bend in the direction of the constraint bending of the ascending aortic stent by the connecting rib unit.

[0010] In some embodiments, the location of one positioning end of the positioning ring is aligned with the center of one or more of the two connecting ribs.

[0011] In some embodiments, the positioning ring is integrally formed by cutting or winding wire.

[0012] In some embodiments, the ascending aortic stent includes a plurality of coaxially spaced stent units in an annular corrugated shape, which are connected by connecting rib units.

[0013] In some embodiments, the support unit and the connecting rib unit are integrally formed.

[0014] In some embodiments, the ascending aortic stent and the valve stent are integrally formed.

[0015] In some embodiments, an annular occlusion portion is provided at one or both ends of the ascending aortic stent to form a seal between the ascending aortic prosthesis and the ascending aorta.

[0016] In some embodiments, the valve prosthesis has a window located at a position corresponding to the sinus coronary artery region for adapting to the secondary coronary treatment pathway.

[0017] Compared with the prior art, the present invention has the following advantages and beneficial effects: This invention employs an integrated structure consisting of an ascending aortic prosthesis and a valve prosthesis. A connecting rib unit is incorporated into the ascending aortic prosthesis to control its bending direction during implantation. A positioning ring is placed on the valve prosthesis. Through the interaction between the positioning ring and the native valve leaflet, the valve prosthesis is positioned and fixed circumferentially and axially. Furthermore, by designing the positions of the connecting rib unit and the positioning ring, the bending direction of the ascending aortic prosthesis during implantation constrains the circumferential position of the positioning ring. This achieves automatic adjustment and precise positioning of the aortic valved conduit implantation, avoiding repeated adjustments during the implantation process. While ensuring the accuracy of the valved conduit implantation position, this invention improves the efficiency of the implantation operation, simplifies the procedure, and significantly reduces the skill requirements of the surgeon.

[0018] This invention uses pre-bent connecting ribs or ascending aortic lining to constrain the bending direction of the ascending aortic prosthesis, enabling the ascending aortic prosthesis to actively adapt to the physiological curvature of the ascending aorta when unfolded, thereby better ensuring the coaxiality between the product and the ascending aorta after implantation.

[0019] By employing pre-bent and shaped connecting ribs and combining them with the connecting rib unit to control the bending direction, the pre-bent and shaped connecting ribs actively restrict the bending tendency, enabling the product to actively bend towards the smaller diameter side. When the product is implanted across the arch, it can better actively adapt to the bending shape of the arch between the ascending and descending aortas, achieving active rotational adjustment in the circumferential direction during the product's passage across the arch. This better ensures the precise positioning of the positioning ring at the original leaflet positioning position, thereby further improving the positioning accuracy of the product implantation. Attached Figure Description

[0020] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings in the embodiments will be briefly described below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0021] Figure 1 A schematic diagram of an ascending aortic aneurysm in the ascending aorta.

[0022] Figure 2 This is a schematic diagram of the aortic valve conduit implantation state in an embodiment of the present invention.

[0023] Figure 3 This is a schematic diagram of the aortic valve conduit structure according to an embodiment of the present invention.

[0024] Figure 4 This is a front view of the aortic valve conduit structure according to an embodiment of the present invention.

[0025] Figure 5 This is a schematic diagram of the positioning ring structure in the aortic valve conduit according to an embodiment of the present invention.

[0026] Figure 6 This is a schematic diagram of the aortic valve conduit skeleton structure according to an embodiment of the present invention.

[0027] Figure 7 This is a front view of the aortic valve conduit skeleton structure according to an embodiment of the present invention.

[0028] Figure 8 This is a side view of the aortic valve conduit skeleton structure according to an embodiment of the present invention.

[0029] Figure 9 This is a schematic diagram of the aortic valve conduit skeleton and positioning ring structure according to an embodiment of the present invention.

[0030] Figure 10 This is a schematic diagram of the delivery system for aortic valve conduit implantation according to an embodiment of the present invention.

[0031] Figure 11 This is a schematic diagram of the structure of the aortic valve conduit implanted with a self-positioning system in an embodiment of the present invention.

[0032] in: 100. Flange-shaped tube; 10. Ascending aortic prosthesis; 11. Ascending aortic stent; 111. Stent unit; 12. Ascending aortic endovascular graft; 13. Occlusion site; 14. Connecting rib. 20. Valve prosthesis; 21. Valve stent; 211. Stent connector; 212. Leaflet connector; 213. Annulus mating part; 22. Valve cover; 23. Valve leaflet; 24. Fenestration. 30. Positioning ring; 31. Positioning end; 32. Connecting end; 40. Conveying system; 41. Handle; 42. Wheel; 43. Inner sheath; 44. Instrument delivery tube; 45. Retraction device; 46. Tip. Detailed Implementation

[0033] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are some embodiments of the present invention, but not all embodiments.

[0034] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., used to indicate the orientation or positional relationship are based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship that the product of this invention is usually placed in during use. They are only for the convenience of describing this invention and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0035] Furthermore, the use of terms such as "horizontal" and "vertical" in the description of this invention does not imply that the components are required to be absolutely horizontal or suspended, but rather that they can be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal than "vertical," and does not mean that the structure must be completely horizontal, but can be slightly tilted. When the terms "distal" and "proximal" do not specify a reference point, the practitioner is usually used as the reference. That is, the end closer to the practitioner or farther from the patient can be considered the "proximal," while the end farther from the practitioner or closer to the patient can be considered the "distal."

[0036] In the description of this invention, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0037] The present invention is an instrument product suitable for implantation in Endobentall surgery, which can be well adapted to various valve annulus anatomical structures.

[0038] In particular, the embodiments of the present invention adopt a structural design of connecting rib units. By setting the connecting rib units, the bending direction of the valved conduit during the implantation process is constrained, so as to realize the automatic adjustment and positioning of the implantation angle of the instrument during the input process. It can accurately control the bending direction of the instrument during the delivery process in the body, facilitate the adjustment and control of the implantation angle of the instrument, achieve precise alignment with the original leaflet junction edge, and ensure the implantation position accuracy of the valved conduit.

[0039] Furthermore, in this embodiment of the invention, a positioning ring is used to locate the implantation position of the valved conduit. Through the cooperation between the positioning ring and the connecting rib unit in terms of their positional relationship, the rapid implantation and precise positioning of the valved conduit are achieved.

[0040] In some embodiments of the present invention, reference is made to Figure 1 and Figure 2 The Endobentall device shown in the figure is an interventional aortic valve conduit 100 used to treat ascending aortic aneurysms (aortic lesions located at a depth not lower than the junction of the sinus and the artery). It can be implanted through a blood vessel and can replace the aortic valve while treating the vascular lesion.

[0041] Reference Figure 3 , Figure 4 , Figure 5 , Figure 6 , Figure 7 , Figure 8 and Figure 9 Interventional aortic valve conduit 100, including: The valve prosthesis 20 includes a valve stent 21 and valve leaflets 23. The valve stent 21 includes a stent connecting portion 211, a leaflet connecting portion 212 and a valve annulus mating portion 213 arranged sequentially. A valve cover 22 is provided on the outside of the stent connecting portion 211 and the valve annulus mating portion 213, and the valve cover 22 provided on the valve annulus mating portion can adapt to the autologous valve annulus and form a sealing contact at the autologous valve annulus position. The ascending aortic prosthesis 10 includes an ascending aortic stent 11, and an ascending aortic lining 12 is provided over the ascending aortic stent 11. The ascending aortic lining 12 allows the ascending aortic prosthesis to fit the inner wall of the ascending aorta and form a sealed fit. A connecting rib unit is provided on the ascending aortic stent 11 along its axial direction. The connecting rib unit is used to constrain the ascending aortic stent to bend in only one direction. The positioning ring 30 is a corrugated annular stent with multiple positioning ends 31. The positioning ring 30 is fitted onto the valve stent 21 near the inflow end and is connected to the valve stent 21 at the connecting end. The position of one of the positioning ends corresponds to the constraint bending direction of the connecting rib unit on the ascending aortic stent. During implantation, the circumferential position of the valve prosthesis is positioned by the cooperation between the positioning end and each native leaflet. At the corresponding position of the positioning end, each native leaflet can be clamped between the positioning ring and the valve stent to fix the valve prosthesis at the implantation position.

[0042] like Figure 9As shown, the positioning ring 30 has a ring-shaped corrugated structure and is a self-expanding stent structure made of alloy. The positioning ring and the valve prosthesis can be connected by sutures. During the implantation procedure, the positioning ring's three positioning ends are positioned and engaged at the three original leaflet support positions to achieve precise positioning of the valved conduit within the body, ensuring alignment between the implanted instrument and the original leaflet junction.

[0043] The positioning ring 30 can be integrally formed by cutting or winding wire.

[0044] In some embodiments, such as Figure 5 As shown, the positioning end of the positioning ring is spaced apart from the valve stent inflow end and located above the valve stent inflow end; for example, the distance L between the positioning end and the valve stent inflow end can be set to 2-6mm. Through the positioning and cooperation between the positioning ring and the original valve leaflet, the implantation depth of the valve prosthesis is constrained. At the valve prosthesis inflow end, the valve prosthesis and the aorta can form a good fit, avoiding the occurrence of paravalvular leakage.

[0045] In some embodiments, refer to Figure 7 and Figure 8 The connecting rib unit adopts a structure consisting of two connecting ribs 14 symmetrically arranged on both sides of the ascending aortic stent, or a structure consisting of multiple connecting ribs 14 arranged on one side of the ascending aortic stent. Both of these structures can constrain the bending direction of the ascending aortic stent, restricting the ascending aortic stent to bend only in a single direction. Thus, during implantation, the valved conduit can be adaptively adjusted and controlled by the implantation angle when passing through the arch.

[0046] Multiple connecting ribs are arranged side by side with spacing between them. These connecting ribs can be connected at both ends to form an integral connecting rib unit. One end of the connecting rib unit is connected to the valve stent.

[0047] At this point, by coordinating the positions of the positioning ring and the connecting rib, each positioning end can be automatically aligned with the bottom of the three original leaflets during the implantation process. This avoids repeated adjustments to the valved conduit during implantation, improves and greatly simplifies the implantation operation, and ensures the accuracy of the valved conduit's implantation position.

[0048] Reference Figure 1 and Figure 2The ascending aortic prosthesis has a certain physiological curvature corresponding to the ascending aorta at the implantation site. In some embodiments, the connecting rib 14 is pre-bent and shaped so that the ascending aortic stent can bend in the direction of the connecting rib unit's constraint bending of the ascending aortic stent in its free state; or, the ascending aortic lining structure is designed so that during the deployment of the ascending aortic stent, the ascending aortic lining can constrain the ascending aortic stent to bend in the direction of the connecting rib unit's constraint bending of the ascending aortic stent.

[0049] The pre-bending and shaping of the connecting rib 14 can be achieved by heat shaping, for example, by using a mold to bend and constrain the connecting rib, and then heating it to a certain temperature under a certain vacuum to perform shaping.

[0050] The pre-bending direction of the connecting rib is the same as the bending direction of the connecting rib unit constraining the ascending aortic stent. Taking a connecting rib unit formed by multiple connecting ribs set on one side as an example, the connecting rib unit constrains the ascending aortic stent to bend only in the direction directly opposite the connecting rib unit. At this time, the pre-bending direction of multiple connecting ribs set side by side at intervals is set to be the same as the bending constraint direction of the ascending aorta, so that the pre-bending shape of the connecting rib and the constraint bending direction of the connecting rib unit form an effective match.

[0051] Reference Figure 2 Using the inner side of the curvature as the small diameter side and the outer side of the curvature as the large diameter side, it can be seen from the figure that when the product unfolds at the implantation position, it will adapt to the curvature of the ascending aorta. At this time, the height H1 of the ascending aortic prosthesis on the large diameter side is greater than its height H2 on the small diameter side.

[0052] When using an ascending aortic graft to actively adapt the ascending aortic prosthesis to the curvature of the ascending aorta, the ascending aortic graft 12 is designed as a cylindrical structure with one end tilted, and the length of the ascending aortic graft on the side of the greater curvature is greater than its length on the side of the lesser curvature. When this ascending aortic graft is sewn onto the ascending aortic stent, the tilted side is aligned with the end of the ascending aortic stent. When the ascending aortic stent deploys, the length difference between the two sides constrains the ascending aortic stent to actively bend towards the side of the lesser curvature.

[0053] Similarly, taking a connecting rib unit formed by multiple connecting ribs set on one side as an example, the side where the connecting rib unit is located is the side with the large diameter of the bend, and the side directly opposite the connecting rib unit is the side with the small diameter of the bend. When sewing the ascending aortic cover, the ascending aortic cover is adjusted to match the position of the connecting rib unit so that the constraints of both on the bending direction of the ascending aortic stent are in the same direction.

[0054] In some embodiments, one of the positioning ends of the positioning ring 30 is configured to be aligned with the location of the connecting rib unit. For example, when the connecting rib unit consists of two symmetrically arranged connecting ribs, one of the positioning ends is aligned axially with one of the connecting ribs, so that the position of the positioning end corresponds to the bending direction of the valved pipe; or when the connecting rib unit consists of two connecting ribs arranged on one side, one of the positioning ends is aligned with the middle position of the two connecting ribs, which usually achieves a correspondence between the positioning end and the bending direction of the valved pipe.

[0055] The ascending aortic stent 11 includes multiple stent units 111 with an annular corrugated structure spaced apart along the axial direction of the ascending aortic prosthesis. Each stent unit 111 is connected to the stent unit 111 by a connecting rib 14, thus connecting the stent units 111 into a whole. The stent unit 111 is also connected to the valve stent 21 by the connecting rib 14, thus connecting the valve stent 21 and the ascending aortic stent 11, which facilitates the integral molding of the valved conduit skeleton structure.

[0056] The ascending aortic stent is connected into a whole by connecting ribs, and the connection between the ascending aortic stent and the valve stent is realized. This allows the skeletal structure of the valved conduit to be formed as a single piece, which simplifies the design structure of the device and facilitates the implantation operation.

[0057] Of course, the stent unit 111, valve stent 21 and connecting rib 30 can also be formed separately, and then the ascending aortic stent and valve stent can be connected into an integrated structure by welding, riveting or sewing processes.

[0058] Ascending aortic stents, serving as the supporting structure or framework for ascending aortic prostheses, can be formed by laser cutting of nickel-titanium alloy, or by weaving of nickel-titanium alloy wire, or by other self-expanding stents.

[0059] In some embodiments, an annular occlusion portion 13 is provided at one or both ends of the ascending aortic stent. The occlusion portion 13 is provided to protrude radially from the surface of the ascending aortic cover 12 and is used to form a seal between the ascending aortic prosthesis and the ascending aorta.

[0060] The sealing part 13 is formed using foamed silicone or polyester cloth filler or other similar materials.

[0061] The structural strength of the ascending aortic stent at the occlusion site is greater than that at other sites, enabling the stent to withstand greater radial forces at the occlusion site and effectively support the occlusion site, thus achieving a better seal between the occlusion site and the autologous ascending aorta.

[0062] In some embodiments, the ascending aortic graft 12 and the valve annulus graft 22 are made of materials such as EPTFE thermal graft and PET film, and the grafts are connected to the ascending aortic stent and the valve stent respectively by suturing.

[0063] A film can be applied to the outside of the bracket connection.

[0064] In some embodiments, the valve prosthesis 20 has a window 24 located at a position corresponding to the sinus coronary artery region for adapting to the coronary secondary treatment pathway. The window design on the valve prosthesis within the coronary artery range ensures the coronary secondary treatment pathway.

[0065] The valved conduit in the above embodiments can be adopted Figure 10 and Figure 11 The delivery system shown is used for implantation.

[0066] Reference Figure 10 and Figure 11 The delivery system 40 includes a handle 41, a wheel 42, an inner pin 43, an instrument delivery tube 44, a retraction device 45, and a tip 46. The wheel is used to control the delivery of the delivery system components. The inner pin is designed to reduce the profile of the instrument. The instrument delivery tube can be made of reed tubing or hyaluronic acid tubing to adapt to any curvature of the implantation delivery, 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.

[0067] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Any simple modifications or equivalent changes made to the above embodiments based on the technical essence of the present invention shall fall within the protection scope of the present invention.

Claims

1. A valved aortic conduit with positioning function, characterized in that, include: Valve prostheses, including valve stents and valve leaflets; An ascending aortic prosthesis includes an ascending aortic stent, and an ascending aortic tunic covering the outside of the ascending aortic stent; a connecting rib unit is provided on the ascending aortic stent along its axial direction, and the connecting rib unit is used to constrain the ascending aortic stent to bend only in one direction. The positioning ring is a corrugated annular stent with multiple positioning ends. The positioning ring is fitted onto the valve stent near the inflow end and is connected to the valve stent at its connecting end. The position of one of the positioning ends corresponds to the bending direction of the connecting rib unit constraining the ascending aortic stent. During implantation, the circumferential position of the valve prosthesis is positioned by the cooperation between the positioning end and each native leaflet. At the corresponding position of the positioning end, each native leaflet can be clamped between the positioning ring and the valve stent, thus fixing the valve prosthesis at the implantation position.

2. The aortic valve conduit with positioning function according to claim 1, characterized in that, The positioning end is spaced apart from the valve stent inflow end and is located above the valve stent inflow end.

3. The aortic valve conduit with positioning function according to claim 1, characterized in that, The connecting rib unit includes two connecting ribs symmetrically arranged on both sides of the ascending aortic stent, or includes multiple connecting ribs arranged on one side of the ascending aortic stent.

4. The aortic valve conduit with positioning function according to claim 3, characterized in that, The connecting ribs are pre-bent and shaped so that the ascending aortic stent can bend in the direction of the constraint bending of the connecting rib unit on the ascending aortic stent in a free state.

5. The aortic valve conduit with positioning function according to any one of claims 1, 3, or 4, characterized in that, The ascending aortic drape is a cylindrical structure with one end inclined, and the length of the ascending aortic drape on the larger diameter side of the bend is greater than its length on the smaller diameter side of the bend, so that during the deployment of the ascending aortic stent, the ascending aortic drape can constrain the ascending aortic stent to bend in the direction of the constraint bending of the ascending aortic stent by the connecting rib unit.

6. The aortic valve conduit with positioning function according to claim 3, characterized in that, The position of one positioning end of the positioning ring is aligned with the center of one or more of the two connecting ribs.

7. The aortic valve conduit with positioning function according to claim 1, characterized in that, The positioning ring is integrally formed by cutting or winding wire.

8. The aortic valve conduit with positioning function according to claim 1, characterized in that, The ascending aortic stent comprises multiple coaxially spaced stent units in a ring-shaped corrugated configuration, which are connected by connecting rib units.

9. The aortic valve conduit with positioning function according to claim 1, characterized in that, A ring-shaped occlusion portion is provided at one or both ends of the ascending aortic stent to form a seal between the ascending aortic prosthesis and the ascending aorta.

10. The aortic valve conduit with positioning function according to claim 1, characterized in that, The valve prosthesis has a window located at a position corresponding to the sinus coronary artery region to accommodate the secondary coronary treatment pathway.

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