Tricuspid valve interventional valve outer stent and inner stent, and tricuspid valve interventional valve

Abstract

A tricuspid valve interventional valve outer stent and inner stent, and a tricuspid valve interventional valve. The tricuspid valve interventional valve outer stent (1) comprises an outer stent main body ring (11), a plurality of outer expansion stents (12), and a plurality of inner expansion stents (13). The plurality of outer expansion stents (12) are fixed on the outer stent main body ring (11) in the circumferential direction of the outer stent main body ring (11), and extend outwards in the radial direction of the outer stent main body ring (11). The plurality of inner expansion stents (13) are fixed on the outer stent main body ring (11) in the circumferential direction of the outer stent main body ring (11) and extend inwards in the radial direction of the outer stent main body ring (11). The tricuspid valve interventional valve outer stent (1) and the tricuspid valve interventional valve inner stent (2) cooperate with an anchoring key (22) by means of the inner expansion stents (13), such that the tricuspid valve interventional valve outer stent (1) and the tricuspid valve interventional valve inner stent (2) form a sandwich engagement structure, greatly enhancing the stability of valve anchoring, and greatly reducing valve avulsion and even cardiac rupture and hemorrhage caused by valve oscillation due to unstable valve anchoring after valve implantation.

Description

Tricuspid valve interventional valve external stent, internal stent and tricuspid valve interventional valve Technical Field

[0001] The present invention relates to the technical field related to medical devices, and in particular to a tricuspid valve interventional valve external stent, an internal stent and a tricuspid valve interventional valve. Background Art

[0002] Severe tricuspid regurgitation (TR), especially the long-term incidence of severe TR after left heart valve surgery, is high.

[0003] Surgical treatment is ineffective. Traditional mid-thoracotomy and subsequent extracorporeal circulation surgery is highly invasive, causes significant bleeding, and has a mortality rate as high as 10-25%. Interventional valves, with their minimal trauma and lack of extracorporeal circulation, offer a novel treatment option for critically ill patients and are widely used in patients with high-risk aortic valve disease.

[0004] However, existing interventional valves are not specifically designed for the tricuspid valve. Implantation with these valves is fragile, and post-implantation, due to a weak anchoring, can easily lead to valve avulsion or even cardiac rupture and bleeding during valve swing. During percutaneous tricuspid valve interventions, valve anchoring displacement or detachment, leading to conversion to open-chest surgery, is a common complication of interventional surgery. Summary of the Invention

[0005] Based on this, it is necessary to provide a tricuspid valve interventional valve external stent, internal stent and tricuspid valve interventional valve to address the technical problem of weak anchoring of the tricuspid valve interventional valve in the existing technology.

[0006] The present invention provides a tricuspid valve interventional valve external stent, comprising: an external stent main ring, multiple external expansion stents and multiple internal expansion stents, wherein the multiple external expansion stents are fixed on the external stent main ring along the circumferential direction of the external stent main ring and extend radially outward along the external stent main ring, and the multiple internal expansion stents are fixed on the external stent main ring along the circumferential direction of the external stent main ring and extend radially inward along the external stent main ring.

[0007] Furthermore, the outer support body ring is elliptical.

[0008] Furthermore, a line connecting ends of the plurality of inner expansion stents away from the outer stent main body ring is circular.

[0009] Furthermore, a plurality of rivets extending radially outward from the outer bracket body ring are fixed to the outer bracket body ring, and the length of the rivets is less than the distance from the end of the outer extension bracket away from the outer bracket body ring to the outer bracket body ring.

[0010] Furthermore, the outer expansion stent and the inner expansion stent are petal-shaped expansion stents.

[0011] The present invention provides a tricuspid valve interventional valve stent, comprising an inner stent body ring and a plurality of anchoring keys, wherein the plurality of anchoring keys are fixed on the inner stent body ring along the circumferential direction of the inner stent body ring and extend radially outward along the inner stent body ring.

[0012] Furthermore, the anchor key includes a connecting portion support and a limiting member, one end of the connecting portion support is connected to the inner bracket body ring, and the other end is connected to the limiting member.

[0013] The present invention provides a tricuspid valve interventional valve, comprising the tricuspid valve interventional valve external stent as described above and the tricuspid valve interventional valve internal stent as described above, the inner stent body ring of the tricuspid valve interventional valve internal stent is located within the outer stent body ring of the tricuspid valve interventional valve external stent, and the anchor key overlaps with the outer stent body ring, the inner expansion stent overlaps with the inner stent body ring, and the inner ring of the inner stent body ring is sewn with leaflets.

[0014] Furthermore, the line connecting the ends of the multiple inner expansion brackets away from the outer bracket main body ring is circular, the inner bracket main body ring is annular, the diameter of the inner bracket main body ring is larger than the diameter of the line connecting the ends of the multiple inner expansion brackets away from the outer bracket main body ring, the anchor key extends radially outward along the inner bracket main body ring and partially extends out of the outer bracket main body ring, and the anchor key is fixed with a limiting member at the end away from the inner bracket main body ring.

[0015] Furthermore, the diameter of the inner stent body ring is 2-3 mm larger than the diameter of the line connecting the ends of the plurality of inner expansion stents away from the outer stent body ring, and the length of the anchor key extending from the outer stent body ring is 1-2 mm.

[0016] The tricuspid valve interventional valve external stent and the tricuspid valve interventional valve internal stent of the present invention cooperate with the anchoring key through the internal expansion stent, so that the tricuspid valve interventional valve external stent and the tricuspid valve interventional valve internal stent form a sandwich structure, which greatly enhances the firmness of the valve anchoring and can greatly reduce the valve avulsion and even heart rupture and bleeding caused by the valve swinging due to loose valve anchoring after valve implantation. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] FIG1 is a schematic structural diagram of a tricuspid valve interventional external valve stent according to an embodiment of the present invention;

[0018] FIG2 is a schematic diagram showing the connection lines of the inner extension stent end portion of a tricuspid valve interventional external stent according to another embodiment of the present invention;

[0019] FIG3 is a schematic structural diagram of a tricuspid valve interventional intravalvular stent according to an embodiment of the present invention;

[0020] FIG4 is a schematic diagram of a tricuspid interventional valve according to an embodiment of the present invention.

[0021] Marking explanation 1-tricuspid valve intervention valve external stent; 11-external stent main ring; 12-external expansion stent; 13-inner expansion stent; 14-rivet; 15-circular; 2-tricuspid valve intervention valve internal stent; 21-inner stent main ring; 22-anchor key; 221-connecting part support; 222-limiting piece. DETAILED DESCRIPTION

[0022] The following further describes specific embodiments of the present invention with reference to the accompanying drawings. Like components are denoted by like reference numerals. It should be noted that the terms "front," "rear," "left," "right," "up," and "down" used in the following description refer to directions in the accompanying drawings, and the terms "inward" and "outward" refer to directions toward or away from the geometric center of a particular component, respectively.

[0023] As shown in Figure 1, this is a structural schematic diagram of a tricuspid valve interventional valve external stent 1 of the present invention, including: an external stent main ring 11, multiple external expansion stents 12 and multiple internal expansion stents 13. The multiple external expansion stents 12 are fixed on the external stent main ring 11 along the circumferential direction of the external stent main ring 11 and extend radially outward along the external stent main ring 11. The multiple internal expansion stents 13 are fixed on the external stent main ring 11 along the circumferential direction of the external stent main ring 11 and extend radially inward along the external stent main ring 11.

[0024] Specifically, the outer stent body ring 11 is fixedly connected with a plurality of outward-facing outer extension stents 12 and a plurality of inward-facing inner extension stents 13. Outward refers to the outer side of the outer stent body ring 11 in the radial direction, and inward refers to the inner side of the outer stent body ring 11 in the radial direction.

[0025] The external expansion stent 12 is extended into the right ventricle and fixed. Specifically, the external expansion stent 12 is supported below the valve ring of the implanted tricuspid valve.

[0026] The inner expansion stent 13 is used to cooperate with the tricuspid valve intervention valve inner stent, and the inner expansion stent 13 is connected to the tricuspid valve intervention valve inner stent, so that the tricuspid valve intervention valve outer stent and the tricuspid valve intervention valve inner stent form a sandwich structure.

[0027] The tricuspid valve interventional valve external stent and the tricuspid valve interventional valve internal stent of the present invention cooperate with the anchoring key through the internal expansion stent, so that the tricuspid valve interventional valve external stent and the tricuspid valve interventional valve internal stent form a sandwich structure, which greatly enhances the firmness of the valve anchoring and can greatly reduce the valve avulsion and even heart rupture and bleeding caused by the valve swinging due to loose valve anchoring after valve implantation.

[0028] In one embodiment, the outer support body ring 11 is elliptical.

[0029] Specifically, the outer stent main body ring 11 is an irregular ellipse to adapt to the shape of the tricuspid valve ring, while having a certain supporting effect on the right ventricle and not affecting the ventricular and valve morphology after valve implantation.

[0030] In one embodiment, a line connecting ends of the plurality of inner expansion stents 13 away from the outer stent main body ring 11 is a circle.

[0031] Specifically, the inner expansion stent 13 is connected to the tricuspid valve interventional valve stent, and the main body of the tricuspid valve interventional valve stent is circular. Therefore, as shown in Figure 2, the line connecting the end of the inner expansion stent 13 away from the outer stent main body ring 11 is a circle 15, thereby cooperating with the inner stent main body ring 21 of the tricuspid valve interventional valve stent 2.

[0032] Furthermore, since the inner expansion stents 3 are fixed to the outer stent main ring 11, which is elliptical in shape, some of the inner expansion stents 3 need to extend inward to form a circle 15 with the line connecting the ends of the other inner expansion stents 13. Furthermore, it is not necessary for all of the inner expansion stents 3 to have their ends on the circle 15; it is sufficient for most of the inner expansion stents 13 to be away from the line connecting the ends of the outer stent main ring 11 to form the circle 15.

[0033] In this embodiment, the line connecting the ends of the inner expansion stent away from the outer stent main ring is set to a circle to match the tricuspid valve interventional valve inner stent and ensure the stability of the tricuspid valve interventional valve outer stent and the tricuspid valve interventional valve inner stent.

[0034] In one embodiment, a plurality of rivets 14 extending radially outward along the outer support body ring 11 are fixed to the outer support body ring 11, and the length of the rivets 14 is less than the distance from the end of the outer extension support 12 away from the outer support body ring 11 to the outer support body ring 11.

[0035] Specifically, the length of the rivet 14 is less than the distance from the end of the outer expansion stent 12 distal from the outer stent main ring 11 to the outer stent main ring 11. The rivet 14 is a reverse short-stab rivet, and is used to be inserted into the implanted tricuspid valve annulus from the inside outward. Since blood flow is from the atrium to the ventricle, the rivet 14 is a reverse rivet, meaning it is inserted from the ventricle to the atrial surface, thereby conducting force in the opposite direction of the heartbeat, thereby more firmly securing the implanted tricuspid valve.

[0036] In this embodiment, rivets are inserted into the right ventricle to help fix the external expansion stent on the fragile valve ring of the tricuspid valve.

[0037] In one embodiment, the outer expansion stent 12 and the inner expansion stent 13 are petal-shaped expansion stents.

[0038] Specifically, a plurality of outward-facing petal-shaped outer expansion brackets 12 and a plurality of inward-facing petal-shaped inner expansion brackets 13 are fixedly connected to the outer bracket main body ring 11 .

[0039] This embodiment uses a petal-shaped expansion stent. The main function of the petal ring is to disperse the force. The heart tissue is relatively fragile. The petal ring disperses the force on the tricuspid valve ring to the surroundings, making it less likely for tissue tearing to occur.

[0040] As shown in Figure 3, a tricuspid valve interventional valve stent 2 according to an embodiment of the present invention includes an inner stent main ring 21 and a plurality of anchoring keys 22. The plurality of anchoring keys 22 are fixed on the inner stent main ring 21 along the circumferential direction of the inner stent main ring 21 and extend radially outward along the inner stent main ring 21.

[0041] Specifically, a plurality of outward-facing anchoring keys 22 are provided on the inner stent body ring 21 of the tricuspid valve interventional valve stent 2. The anchoring keys 22 are used to connect to the tricuspid valve interventional valve stent. By connecting the anchoring keys 22 to the tricuspid valve interventional valve stent, the tricuspid valve interventional valve stent and the tricuspid valve interventional valve stent form a sandwich structure.

[0042] The tricuspid valve interventional valve external stent and the tricuspid valve interventional valve internal stent of the present invention cooperate with the anchoring key through the internal expansion stent, so that the tricuspid valve interventional valve external stent and the tricuspid valve interventional valve internal stent form a sandwich structure, which greatly enhances the firmness of the valve anchoring and can greatly reduce the valve avulsion and even heart rupture and bleeding caused by the valve swinging due to loose valve anchoring after valve implantation.

[0043] In one embodiment, the anchor key 22 includes a connecting portion pillar 221 and a limiting member 222 . One end of the connecting portion pillar 221 is connected to the inner bracket body ring 21 , and the other end is connected to the limiting member 222 .

[0044] Specifically, the limiting member 222 is preferably a blunt-shaped oblate structure, slightly larger than the connecting portion support 221, so as to provide a stable structure and prevent it from slipping or shifting.

[0045] In this embodiment, a limiting member is fixed at the end of the anchor key. The tricuspid valve interventional valve stent serves as the valve stent body. The leaflets (not shown in the figure) are sewn on the inner ring of the tricuspid valve interventional valve stent and the tricuspid valve interventional valve stent together with the tricuspid valve interventional valve stent form an interventional valve (or artificial valve). After the anchor key is fixed to the tricuspid valve interventional valve stent, the tricuspid valve interventional valve stent clamps the tricuspid valve interventional valve stent to limit the force of the interventional valve toward the atrial surface. The anchor key is tightly fastened to the atrial surface of the stent to limit the force of the valve toward the ventricular surface. The clamping form in two directions is like a sandwich or a hairpin.

[0046] As shown in Figure 4, this is a schematic diagram of a tricuspid valve interventional valve according to an embodiment of the present invention, comprising the tricuspid valve interventional valve external stent 1 as described above and the tricuspid valve interventional valve internal stent 2 as described above, the inner stent body ring 21 of the tricuspid valve interventional valve internal stent 2 being located within the outer stent body ring 11 of the tricuspid valve interventional valve external stent 1, and the anchoring key 22 is overlapped with the outer stent body ring 11, the inner expansion stent 13 is overlapped with the inner stent body ring 21, and the inner circle of the inner stent body ring 21 is sewn with the leaflet.

[0047] Specifically, the leaflets are preferably made of bovine pericardium, and the leaflets are treated with the existing hydroxychromium anti-calcification treatment technology. The existing interventional valve suturing method is used to sew the leaflets to the inner ring of the inner stent body ring 21 of the tricuspid valve interventional valve stent 2, and form an interventional valve (or artificial valve) with the tricuspid valve interventional valve stent 1. The outer expansion stent 12 of the tricuspid valve interventional valve stent 1 is inserted into the right ventricle, and the rivet 14 penetrates the tissue. The outer expansion stent 12 is supported below the implanted tricuspid valve annulus and supports the annulus upward. After observing under fluoroscopy that the position is appropriate and stable and there is no displacement, the tricuspid valve interventional valve stent 2 is released, and the anchor key 22 of the tricuspid valve interventional valve stent 2 is pressed down above the tricuspid valve annulus to form a sandwich structure. The inner expansion stent 13 presses the inner stent body ring 21 of the tricuspid valve interventional valve stent 2, and also plays a certain supporting role on the tricuspid valve annulus.

[0048] The tricuspid valve interventional valve external stent and the tricuspid valve interventional valve internal stent of the present invention cooperate with the anchoring key through the internal expansion stent, so that the tricuspid valve interventional valve external stent and the tricuspid valve interventional valve internal stent form a sandwich structure, which greatly enhances the firmness of the valve anchoring and can greatly reduce the valve avulsion and even heart rupture and bleeding caused by the valve swinging due to loose valve anchoring after valve implantation.

[0049] In one embodiment, the line connecting the ends of the multiple inner expansion stents 13 away from the outer stent main body ring 11 is circular, the inner stent main body ring 21 is annular, the diameter of the inner stent main body ring 21 is larger than the diameter of the line connecting the ends of the multiple inner expansion stents 13 away from the outer stent main body ring 11, the anchor key 22 extends outward radially along the inner stent main body ring 21 and partially extends out of the outer stent main body ring 11, and the anchor key 22 is fixed to the end away from the inner stent main body ring 21 with a limiting member 222.

[0050] Specifically, the diameter of the inner stent body ring 21 is larger than the diameter of the line connecting the ends of the multiple inner expansion stents 13 away from the outer stent body ring 11, so that the inner expansion stents 13 and the inner stent body ring 21 can reliably clamp the human valve annulus tissue, providing good support and fixation for the implanted interventional valve. During installation, the anchor key 22 extends radially outward along the inner stent body ring 21 and partially extends out of the outer stent body ring 11, and the end of the anchor key 22 away from the inner stent body ring 21 is fixed with a limiter 222. Therefore, the limiter 222 extends out of the outer stent body ring 11, thereby limiting the movement of the inner stent body ring 21 in the radial direction of the inner stent body ring 21 through the limiter 222, thereby preventing the anchor key from falling off the tricuspid valve interventional valve outer stent, ensuring the stability of the tricuspid valve interventional valve outer stent and the tricuspid valve interventional valve inner stent.

[0051] This embodiment ensures the stability of the tricuspid valve interventional valve outer stent and the tricuspid valve interventional valve inner stent by setting the diameter of the inner stent main ring to be larger than the diameter of the line connecting the ends of the multiple inner expansion stents away from the outer stent main ring, and limiting the movement of the inner stent main ring in the radial direction of the inner stent main ring through a limiter.

[0052] In one embodiment, the diameter of the inner stent body ring 21 is 2-3 mm larger than the diameter of the line connecting the ends of the plurality of inner expansion stents 13 away from the outer stent body ring 11 , and the length of the anchor key 22 extending from the outer stent body ring 11 is 1-2 mm.

[0053] Specifically, the inner stent main ring 21 of the tricuspid valve interventional valve inner stent 2 is 2-3 mm larger in diameter than the annular diameter formed between the inner expansion stent 13 of the tricuspid valve interventional valve outer stent 1. The multiple anchoring keys 22 on the inner stent main ring 21 are slightly curved, and the length of the anchoring keys 22 is 1-2 mm longer than the inner expansion stent 13 of the tricuspid valve interventional valve outer stent 1.

[0054] The above-described embodiments merely illustrate several implementations of the present invention, and while their descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the present invention. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the present invention shall be determined by the appended claims.

Claims

1. A tricuspid valve interventional extravalvular stent (1), characterized in that: include: An outer support body ring (11), a plurality of outer expansion supports (12) and a plurality of inner expansion supports (13), wherein the plurality of outer expansion supports (12) are fixed on the outer support body ring (11) along the circumferential direction of the outer support body ring (11) and extend radially outward of the outer support body ring (11), and the plurality of inner expansion supports (13) are fixed on the outer support body ring (11) along the circumferential direction of the outer support body ring (11) and extend radially inward of the outer support body ring (11).

2. The tricuspid valve interventional extravalvular stent (1) according to claim 1, characterized in that: The outer support body ring (11) is elliptical.

3. The tricuspid valve interventional extravalvular stent (1) according to claim 1, characterized in that: The connecting line of the ends of the plurality of inner expansion stents (13) away from the outer stent main body ring (11) is circular.

4. The tricuspid valve interventional extravalvular stent (1) according to claim 1, characterized in that: A plurality of rivets (14) extending radially outward from the outer support body ring (11) are also fixed to the outer support body ring (11), and the length of the rivets (14) is less than the distance from the end of the outer extension bracket (12) away from the outer support body ring (11) to the outer support body ring (11).

5. The tricuspid valve interventional extravalvular stent (1) according to any one of claims 1 to 4, characterized in that: The outer expansion stent (12) and the inner expansion stent (13) are petal-shaped expansion stents.

6. A tricuspid valve interventional stent (2), characterized in that: The invention comprises an inner support body ring (21) and a plurality of anchor keys (22), wherein the plurality of anchor keys (22) are fixed on the inner support body ring (21) along the circumferential direction of the inner support body ring (21) and extend radially outwards of the inner support body ring (21).

7. The tricuspid valve interventional intravalvular stent (2) according to claim 6, characterized in that: The anchor key (22) comprises a connecting portion pillar (221) and a limiting member (222); one end of the connecting portion pillar (221) is connected to the inner support body ring (21), and the other end is connected to the limiting member (222).

8. A tricuspid valve interventional valve, characterized in that: It comprises a tricuspid valve interventional valve external stent (1) as described in any one of claims 1 to 5 and a tricuspid valve interventional valve internal stent (2) as described in any one of claims 6 to 7, wherein the inner stent body ring (21) of the tricuspid valve interventional valve internal stent (2) is located within the outer stent body ring (11) of the tricuspid valve interventional valve external stent (1), and the anchor key (22) overlaps the outer stent body ring (11), the inner expansion stent (13) overlaps the inner stent body ring (21), and the inner ring of the inner stent body ring (21) is sewn with leaflets.

9. The tricuspid valve interventional valve according to claim 8, characterized in that: The line connecting the ends of the plurality of inner expansion stents (13) away from the outer stent main body ring (11) is circular, the inner stent main body ring (21) is annular, the diameter of the inner stent main body ring (21) is larger than the diameter of the line connecting the ends of the plurality of inner expansion stents (13) away from the outer stent main body ring (11), the anchor key (22) extends radially outwardly along the inner stent main body ring (21) and partially extends out of the outer stent main body ring (11), and the anchor key (22) is fixed to the end away from the inner stent main body ring (21) with a limiting member (222).

10. The tricuspid interventional valve according to claim 9, characterized in that: The diameter of the inner stent main ring (21) is 2-3 mm larger than the diameter of the line connecting the ends of the plurality of inner expansion stents (13) away from the outer stent main ring (11), and the length of the anchor key (22) extending out of the outer stent main ring (11) is 1-2 mm.

Images