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

Abstract

The present invention discloses a tricuspid valve intervention valve external stent, an internal stent and a tricuspid valve intervention valve. The tricuspid valve intervention valve external stent comprises: an external stent main body ring, a plurality of external expansion stents and a plurality of internal expansion stents, wherein the plurality of external expansion stents are fixed on the external stent main body ring along the circumferential direction of the external stent main body ring and extend radially outwardly along the external stent main body ring, and the plurality of internal expansion stents are fixed on the external stent main body ring along the circumferential direction of the external stent main body ring and extend radially inwardly along the external stent main body ring. The tricuspid valve intervention valve external stent and the tricuspid valve intervention valve internal stent of the present invention cooperate with the internal expansion stent and the anchoring key, so that the tricuspid valve intervention valve external stent and the tricuspid valve intervention valve internal stent form a sandwich interlocking structure, which greatly enhances the firmness of the valve anchoring, and can greatly reduce the valve tearing and even heart rupture and bleeding caused by the valve swinging due to the loose valve anchoring after the valve implantation.

Description

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 in the long term after left heart valve surgery, has a high incidence of severe TR.

[0003] The surgical treatment is ineffective. Traditional midline thoracotomy and extracorporeal circulation surgery cause great damage, heavy bleeding, and a high mortality rate of 10-25%. Interventional valves provide a new treatment method for critically ill patients because of their low trauma and the absence of extracorporeal circulation. They have been widely used in patients with high-risk aortic valve disease.

[0004] However, the existing interventional valves are not designed for the tricuspid valve. The existing interventional valves are not firmly implanted in the tricuspid valve. After the valve is implanted, the valve is not firmly anchored, which can easily cause valve tearing or even heart rupture and bleeding when the valve swings. During percutaneous interventional surgery of the tricuspid valve, the displacement of the valve anchor or the valve falling off, leading to the conversion of the surgery to open chest surgery, is one of the more common complications 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 prior art.

[0006] The present invention provides a tricuspid valve interventional valve external stent, comprising: an external stent main ring, a plurality of external expansion stents and a plurality of internal expansion stents, wherein the plurality of external expansion stents are fixed on the external stent main ring along the circumferential direction of the external stent main ring and extend radially outwardly along the external stent main ring, and the plurality of internal expansion stents are fixed on the external stent main ring along the circumferential direction of the external stent main ring and extend radially inwardly 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 outwardly along the outer support body ring are fixed to the outer support body ring, and the length of the rivets is less than the distance from the end of the outer extension support away from the outer support body ring to the outer support 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 outwardly along the inner stent body ring.

[0012] Furthermore, the anchor key includes a connection part pillar and a limiter, one end of the connection part pillar is connected to the inner bracket body ring, and the other end is connected to the limiter.

[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 main ring of the tricuspid valve interventional valve internal stent is located within the outer stent main ring of the tricuspid valve interventional valve external stent, and the anchor key overlaps with the outer stent main ring, the inner expansion stent overlaps with the inner stent main ring, and the inner circle of the inner stent main ring is sewn with valve leaflets.

[0014] Furthermore, a line connecting the ends of the plurality of inner extension stents away from the outer stent main body ring is circular, the inner stent main body ring is in the shape of a circular ring, a diameter of the inner stent main body ring is larger than a diameter of a line connecting the ends of the plurality of inner extension stents away from the outer stent main body ring, the anchor key extends radially outwardly along the inner stent main body ring and partially extends out of the outer stent main body ring, and a limiting member is fixed at the end of the anchor key away from the inner stent 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 out of 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 inner 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 possibility of valve avulsion or even heart rupture and bleeding caused by valve swinging due to loose valve anchoring after valve implantation. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 This is a schematic structural diagram of a tricuspid valve interventional external stent according to an embodiment of the present invention;

[0018] Figure 2 This is a schematic diagram of the connection lines of the inner extension stent end of a tricuspid valve interventional valve external stent according to another embodiment of the present invention;

[0019] Figure 3This is a schematic structural diagram of a tricuspid interventional valve stent according to an embodiment of the present invention;

[0020] Figure 4 This is a schematic diagram of a tricuspid interventional valve according to an embodiment of the present invention.

[0021] Marking Description

[0022] 1-tricuspid interventional valve external stent; 11-external stent main ring; 12-external expansion stent; 13-internal expansion stent; 14-rivet; 15-circular; 2-tricuspid interventional valve internal stent; 21-internal stent main ring; 22-anchor key; 221-connecting part support; 222-limiting piece. DETAILED DESCRIPTION

[0023] The specific embodiments of the present invention are further described below in conjunction with the accompanying drawings. The same components are represented by the same reference numerals. It should be noted that the words "front", "rear", "left", "right", "upper" and "lower" used in the following description refer to directions in the accompanying drawings, and the words "inner" and "outer" refer to directions toward or away from the geometric center of a specific component, respectively.

[0024] like Figure 1 Shown is a schematic structural diagram of a tricuspid interventional valve external stent 1 of the present invention, comprising: an external stent main body ring 11, a plurality of external expansion stents 12 and a plurality of internal expansion stents 13, wherein the plurality of external expansion stents 12 are fixed on the external stent main body ring 11 along the circumferential direction of the external stent main body ring 11 and extend radially outwardly along the external stent main body ring 11, and the plurality of internal expansion stents 13 are fixed on the external stent main body ring 11 along the circumferential direction of the external stent main body ring 11 and extend radially inwardly along the external stent main body ring 11.

[0025] Specifically, the outer support body ring 11 is fixedly connected with a plurality of outwardly extending outer supports 12 and a plurality of inwardly extending inner supports 13. Outwardly refers to the outer side of the outer support body ring 11 in the radial direction, and inwardly refers to the inner side of the outer support body ring 11 in the radial direction.

[0026] 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.

[0027] 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 with 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.

[0028] 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 inner 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 possibility of valve avulsion or even heart rupture and bleeding caused by valve swinging due to loose valve anchoring after valve implantation.

[0029] In one embodiment, the outer support body ring 11 is elliptical.

[0030] Specifically, the outer stent 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 morphology of the ventricle and valve after the valve is implanted.

[0031] In one embodiment, a line connecting ends of the plurality of inner expansion stents 13 away from the outer stent body ring 11 is circular.

[0032] Specifically, the inner expansion stent 13 is connected to the tricuspid valve interventional valve inner stent, and the main body of the tricuspid valve interventional valve inner stent is circular. Figure 2 As shown, the line connecting the end of the inner expansion stent 13 away from the outer stent body ring 11 is a circle 15, so as to cooperate with the inner stent body ring 21 of the tricuspid valve interventional valve inner stent 2.

[0033] In addition, since the inner expansion bracket 3 is fixed on the outer bracket main body ring 11, and the outer bracket main body ring 11 is elliptical, part of the inner expansion bracket 3 needs to be extended inward to form a circle 15 with the line connecting the ends of other inner expansion brackets 13. At the same time, it is not necessary for all the ends of the inner expansion bracket 3 to be on the circle 15, and it is only necessary for most of the inner expansion brackets 13 to form a circle 15 with the line connecting the ends away from the outer bracket main body ring 11.

[0034] In this embodiment, the line connecting the ends of the inner expansion stent away from the outer stent main ring is set to be circular 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.

[0035] 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.

[0036] Specifically, the length of the rivet 14 is less than the distance from the end of the outer extension stent 12 away from the outer stent main body ring 11 to the outer stent main body ring 11. The rivet 14 is a reverse short stab rivet. The rivet 14 is used to insert into the implanted tricuspid valve ring, and pierce from the inside of the tricuspid valve to the outside. Among them, the positive direction of blood flow is from the atrium to the ventricle. The rivet 14 is a reverse rivet, that is, the rivet 14 is inserted from the ventricle to the atrium, which is opposite to the direction of force transmission of the heartbeat, and can more firmly fix the implanted tricuspid valve.

[0037] 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.

[0038] In one embodiment, the outer expansion stent 12 and the inner expansion stent 13 are petal-shaped expansion stents.

[0039] Specifically, a plurality of petal-shaped outer expansion brackets 12 facing outward and a plurality of petal-shaped inner expansion brackets 13 facing inward are fixedly connected to the outer bracket main body ring 11 .

[0040] 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, and the petal ring disperses the force on the tricuspid valve ring to the surroundings, making it less likely for tissue tearing to occur.

[0041] like Figure 3 Shown is a tricuspid interventional valve stent 2 according to an embodiment of the present invention, comprising an inner stent body ring 21 and a plurality of anchoring keys 22, wherein the plurality of anchoring keys 22 are fixed on the inner stent body ring 21 along the circumferential direction of the inner stent body ring 21 and extend radially outward along the inner stent body ring 21.

[0042] Specifically, a plurality of outwardly facing anchoring keys 22 are arranged on the inner stent body ring 21 of the tricuspid valve interventional valve inner stent 2. The anchoring keys 22 are used to connect with the tricuspid valve interventional valve outer stent, and the anchoring keys 22 are connected with the tricuspid valve interventional valve outer stent, so that the tricuspid valve interventional valve outer stent and the tricuspid valve interventional valve inner stent form a sandwich mosaic structure.

[0043] 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 inner 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 possibility of valve avulsion or even heart rupture and bleeding caused by valve swinging due to loose valve anchoring after valve implantation.

[0044] In one embodiment, the anchor key 22 includes a connection pillar 221 and a stopper 222 . One end of the connection pillar 221 is connected to the inner support body ring 21 , and the other end is connected to the stopper 222 .

[0045] Specifically, the limiting member 222 is preferably a blunt-shaped oblate structure, slightly larger than the connecting portion support 221, so as to stabilize the position and prevent it from slipping or shifting.

[0046] In this embodiment, a limiting piece is fixed at the end of the anchor key, and the tricuspid valve intervention valve inner stent is used as the valve stent body. The valve leaflets (not shown in the figure) are sewn on the inner ring of the tricuspid valve intervention valve inner stent and the tricuspid valve intervention valve outer stent form an intervention valve (or artificial valve). After the anchor key is fixed on the tricuspid valve intervention valve outer stent, the force of the intervention valve toward the atrial surface is limited by clamping the tricuspid valve intervention valve inner stent by the tricuspid valve intervention valve outer stent, and the anchor key is tightly buckled on the atrial surface of the outer 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.

[0047] like Figure 4 Shown is a schematic diagram of a tricuspid interventional valve according to an embodiment of the present invention, comprising the tricuspid interventional valve external stent 1 as described above and the tricuspid interventional valve internal stent 2 as described above, the inner stent body ring 21 of the tricuspid interventional valve internal stent 2 being located within the outer stent body ring 11 of the tricuspid interventional valve external stent 1, and the anchor 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 valve leaflets.

[0048] Specifically, the leaflets are preferably made of bovine pericardium, and the leaflets are treated with the existing hydroxychromium anti-calcification treatment technology. The leaflets are sewn to the inner ring of the inner stent body ring 21 of the tricuspid valve intervention valve inner stent 2 using the existing intervention valve suturing method, and the leaflets are formed into an intervention valve (or artificial valve) with the tricuspid valve intervention valve outer stent 1. The outer expansion stent 12 of the tricuspid valve intervention valve outer 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 ring and supports the ring upward. After observing the position under perspective and finding that it is suitable and stable and there is no displacement, the tricuspid valve intervention valve inner stent 2 is released, and the anchor key 22 of the tricuspid valve intervention valve inner stent 2 is pressed down above the tricuspid valve ring to form a sandwich structure. The inner expansion stent 13 presses the inner stent body ring 21 of the tricuspid valve intervention valve inner stent 2, and also plays a certain supporting role on the tricuspid valve ring.

[0049] 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 inner 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 possibility of valve avulsion or even heart rupture and bleeding caused by valve swinging due to loose valve anchoring after valve implantation.

[0050] In one embodiment, the line connecting the ends of the multiple inner expansion stents 13 away from the outer stent body ring 11 is circular, the inner stent body ring 21 is annular, 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, 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 anchor key 22 is fixed to the end away from the inner stent body ring 21 with a limiting member 222.

[0051] Specifically, the diameter of the inner stent body ring 21 is larger than the diameter of the line connecting the ends of the plurality of inner extension stents 13 away from the outer stent body ring 11, so that the inner extension stents 13 and the inner stent body ring 21 can reliably clamp the human valve ring tissue, and provide a 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 limiting member 222, so that the limiting member 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 limiting member 222, thereby preventing the anchor key from falling off the tricuspid valve interventional valve outer stent, and ensuring the stability of the tricuspid valve interventional valve outer stent and the tricuspid valve interventional valve inner stent.

[0052] In this embodiment, the diameter of the inner stent body ring is set to be 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 movement of the inner stent body ring is limited in the radial direction of the inner stent body ring by a limiter, so as to ensure the stability of the tricuspid valve interventional valve outer stent and the tricuspid valve interventional valve inner stent.

[0053] 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 out of the outer stent body ring 11 is 1-2 mm.

[0054] Specifically, the inner stent main ring 21 of the tricuspid interventional valve inner stent 2 is 2-3mm larger in diameter than the annular diameter formed between the inner extended stent 13 of the tricuspid interventional valve outer stent 1, and the multiple anchoring keys 22 on the inner stent main ring 21 are slightly curved, and the length of the anchoring keys 22 is 1-2mm longer than the inner extended stent 13 of the tricuspid interventional valve outer stent 1.

[0055] The above-mentioned embodiments only express several implementation methods of the present invention, and the description thereof is relatively specific and detailed, but it cannot be understood as limiting the scope of the patent of the present invention. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, which all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. A tricuspid valve interventional valve, characterized in that: The invention comprises a tricuspid valve intervention valve external stent (1) and a tricuspid valve intervention valve internal stent (2), wherein the tricuspid valve intervention valve external stent (1) comprises: an external stent main body ring (11), a plurality of external expansion stents (12) and a plurality of internal expansion stents (13), wherein the plurality of external expansion stents (12) are fixed on the external stent main body ring (11) along the circumferential direction of the external stent main body ring (11) and extend radially outwardly of the external stent main body ring (11), and the plurality of internal expansion stents (13) are fixed on the external stent main body ring (11) along the circumferential direction of the external stent main body ring (11) and extend radially inwardly of the external stent main body ring (11); The tricuspid valve interventional valve stent (2) comprises an inner stent main body ring (21) and a plurality of anchoring keys (22), wherein the plurality of anchoring keys (22) are fixed to the inner stent main body ring (21) along the circumferential direction of the inner stent main body ring (21) and extend radially outwardly along the inner stent main body ring (21); The inner stent body ring (21) of the tricuspid valve interventional valve inner stent (2) is located inside the outer stent body ring (11) of the tricuspid valve interventional valve outer stent (1), and the anchor key (22) overlaps with the outer stent body ring (11), the inner expansion stent (13) overlaps with the inner stent body ring (21), and the inner ring of the inner stent body ring (21) is sewn with valve leaflets; The external expansion stent (12) is used to be inserted into the right ventricle, supported below the implanted tricuspid valve ring, and upwardly presses the tricuspid valve ring. The anchor key (22) is used to press downward above the tricuspid valve ring to form a sandwich structure, which is tightly fastened to the atrial surface through the anchor key (22).

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

3. The tricuspid interventional valve 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 interventional valve according to claim 1, characterized in that: A plurality of rivets (14) extending radially outwardly along 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 support (12) away from the outer support body ring (11) to the outer support body ring (11).

5. The tricuspid interventional valve 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. The tricuspid interventional valve according to claim 1, characterized in that: The anchor key (22) comprises a connection part pillar (221) and a stopper (222); one end of the connection part pillar (221) is connected to the inner support body ring (21), and the other end is connected to the stopper (222).

7. The tricuspid interventional valve according to claim 1, characterized in that: The connecting line of the ends of the plurality of inner extension 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 connecting line of the ends of the plurality of inner extension 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 piece (222).

8. The tricuspid interventional valve according to claim 7, characterized in that: 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 out of the outer stent body ring (11) is 1-2 mm.

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