Tricuspid valve implanting device with open-loop structure

Abstract

The utility model discloses a tricuspid valve implanting device of an open-loop structure. The tricuspid valve implanting device comprises a valve supporting ring and a flexible valve leaflet. The valve supporting ring is of an open ring structure and is provided with a head end and a tail end, and the tail end and the head end are connected to form a ring shape. One end of each flexible valve leaflet is connected with the valve supporting ring, the other end of each flexible valve leaflet is a free edge, a gap is formed between the free edges of the adjacent flexible valve leaflets, and the free edges and the fixed edges of the flexible valve leaflets are concave; the open-loop structure of the valve supporting ring is located between a set of adjacent flexible valve leaflets, and semi-annular avoiding openings are formed in the sides, close to the open-loop structure, of the free edges of the flexible valve leaflets on the two sides of the open-loop structure. The valve supporting ring is of the open-loop structure, the receding opening is formed in the portion, on the open-loop structure side, of the flexible valve leaflet, and the pace-making wire can be led in and fixed to the receding opening of the flexible valve leaflet through the open-loop structure, so that friction between the pace-making wire and the flexible valve leaflet is avoided, damage to the flexible valve leaflet is greatly reduced, and the service life of the flexible valve leaflet is prolonged. Therefore, tricuspid valve regurgitation is reduced.

Description

TECHNICAL FIELD

[0001] The utility model relates to medical equipment technical field, concretely relates to a three cuspid valve implantation device of open loop structure. BACKGROUND

[0002] In recent years, with the increasing number of cardiac pacemaker implantation, lead-related complications also increase year by year. Lead-related tricuspid regurgitation (LRTR) is one of the most common clinical complications in cardiac pacing therapy. Most cardiac implantable electronic devices (CIED) need to cross the tricuspid valve to implant the right ventricular electrode lead, and lead-related tricuspid regurgitation refers to the newly discovered or progressive aggravation of tricuspid regurgitation caused by right ventricular lead implantation. The main mechanisms of its formation are the damage of electrode lead implantation to tricuspid valve or subvalvular structure, mainly including: (1) the lead is located between the leaflets, interfering with the closure of the leaflets; (2) the lead hits the leaflet, causing fibrosis, scarring of the leaflet, and adhesion of the lead to the leaflet; (3) the lead is wrapped by the leaflet and extravalvular structure; (4) the leaflet is perforated, damaged or the annulus is dilated; (5) the subvalvular structure is damaged, such as the lead is entangled with the chordae tendineae and the papillary muscle is perforated.

[0003] At present, the treatment of severe cardiac function decline caused by LRTR is mainly through surgical or interventional tricuspid valve repair or replacement. However, there are still many problems at present:

[0004] 1) When performing surgical and transcatheter tricuspid valve replacement, the usual practice is to press the pacing lead to the edge of the implanted valve. However, in clinical practice, when patients receiving cardiac implantable device therapy have pacing or defibrillation lead damage or related infection, the pacing or defibrillation lead needs to be completely removed according to industry guidelines to improve the patient's condition. The above-mentioned tricuspid valve implantation method greatly limits the possibility of future pacing or defibrillation lead removal for patients.

[0005] 2) Another surgical operation is to remove the pacing or defibrillation lead during the surgical procedure, and then perform valve replacement surgery. After valve surgery, new pacing or defibrillation leads are considered for reimplantation according to the patient's condition. This type of operation increases the treatment cost for patients, and the newly implanted pacing or defibrillation lead may still cause tricuspid regurgitation to occur or worsen.

[0006] Therefore, there is currently no mature solution for LRTR. CONTENT OF THE UTILITY MODEL

[0007] To solve the above problems in the prior art, the utility model provides a three cuspid valve implantation device of open loop structure, which is suitable for tricuspid valve replacement in patients with existing pacing leads, and can reduce leaflet damage and the occurrence of tricuspid regurgitation.

[0008] To achieve the above technical purpose, the utility model adopts the technical scheme of:

[0009] A kind of open loop structure tricuspid valve implant device, including valve support ring and flexible leaflet;The valve support ring is open loop structure, is equipped with head end and tail end, tail end is connected with head end to form annular;Flexible leaflet one end is connected with valve support ring, other end is free edge, there is gap between the free edge of adjacent flexible leaflet, the free edge of flexible leaflet and fixed edge is concave;The open loop structure of valve support ring is located between a group of adjacent flexible leaflets, and the free edge of flexible leaflet on the both sides of open loop structure is equipped with half-ring-shaped avoiding port close to open loop structure side.

[0010] Further, the head end and the tail end of the valve support ring are connected by a buckle structure.

[0011] Preferably, the buckle structure includes a catch provided on the end face of the head end and a card hole provided on the end face of the tail end, and the catch of the head end is engaged in the card hole of the tail end.

[0012] Another preferred, the buckle structure includes a strip-shaped catch provided on the end face of the head end and a card slot provided in the end face of the tail end, a plurality of reverse teeth are provided on the strip-shaped catch, and a plurality of card holes are provided in the card slot, and the reverse teeth are matched with the card holes.

[0013] Further, a limiting sealing structure is provided on the end face of the head end and the tail end of the valve support ring.

[0014] Preferably, the limiting sealing structure includes a positioning boss provided on the end face of the head end and a positioning groove provided on the end face of the tail end, and the buckle structure is provided on the positioning boss and the positioning groove, and the positioning boss is matched with the positioning groove.

[0015] Further, the diameter of the half-ring-shaped avoiding port is 2-8mm.

[0016] Preferably, the diameter of the half-ring-shaped avoiding port is 2mm, 3mm, 5mm, 7mm or 8mm.

[0017] Further, an anti-endothelialization and anti-thrombosis coating is provided on the outer periphery of the half-ring-shaped avoiding port.

[0018] Preferably, the anti-endothelialization and anti-thrombosis coating is a rapamycin coating or a heparin coating.

[0019] The utility model has the following beneficial effects:

[0020] The open loop structure tricuspid valve implant device, the valve support ring is in an open loop structure, and an avoiding opening is arranged on the flexible valve leaflet at the side of the open loop structure, in the surgical implantation process, the pacing lead can be introduced through the open loop structure part and fixed at the avoiding opening of the flexible valve leaflet, the friction between the pacing lead and the flexible valve leaflet is avoided, the damage of the flexible valve leaflet is greatly reduced, and the occurrence of tricuspid regurgitation is reduced.

[0021] The open loop structure tricuspid valve implant device, the avoiding opening of the flexible valve leaflet has an endothelialization-resistant and thrombosis-resistant coating layer on the surrounding surface, endothelial cell migration and endothelialization at the position can be obviously reduced, and the feasibility and operability of future pacing lead removal of the patient are greatly ensured. BRIEF DESCRIPTION OF DRAWINGS

[0022] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings needed to be used in the embodiments will be briefly introduced below, and it should be understood that the following drawings only show some embodiments of the present application, and therefore should not be regarded as a limitation on the scope, and for ordinary skilled in the art, other related drawings can also be obtained without creative labor on the basis of these drawings.

[0023] Figure 1 is a whole structure schematic view of the embodiment of the present application;

[0024] Figure 2 is a cross-sectional structure schematic view of one embodiment of the present application;

[0025] Figure 3 is Figure 2 schematic view of the expanded state;

[0026] Figure 4 is a cross-sectional structure schematic view of another embodiment of the present application;

[0027] Reference signs: 1-valve support ring, 2-flexible valve leaflet, 3-semi-ring avoiding opening, 11-head end, 12-tail end, 13-catch, 14-card hole, 15-bar-shaped clamping tooth, 16-card slot, 17-positioning boss, 18-positioning groove. DETAILED DESCRIPTION

[0028] To make the purposes, technical solutions, and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only some but not all of the embodiments of the present application. The components of the embodiments of the present application described and shown in the drawings herein can be arranged and designed in various different configurations. Therefore, the following detailed description of the embodiments of the present application provided in the drawings is not intended to limit the scope of the claimed present application, but merely represents selected embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by a person of ordinary skill in the art without creative work fall within the scope of protection of the present application.

[0029] A three-cusp valve implant device with an open ring structure, as shown in Figures 1-4 includes a valve support ring 1 and flexible leaflets 2; the valve support ring 1 is an open ring structure, provided with a head end 11 and a tail end 12, and the tail end 12 is connected to the head end 11 to form a ring shape; one end of the flexible leaflet 2 is connected to the valve support ring 1, and the other end is a free edge, and there is a gap between the free edges of adjacent flexible leaflets 2, and the free edge of the flexible leaflet 2 is concave between the fixed edge; the open ring structure of the valve support ring 1 is located between a group of adjacent flexible leaflets, and the free edge of the flexible leaflet 2 on both sides of the open ring structure is provided with a semi-ring avoiding port 3 close to the side of the open ring structure.

[0030] Preferably, the head end 11 and the tail end 12 of the valve support ring 1 are connected by a buckle structure. In a specific embodiment, the buckle structure includes a clamping hook 13 provided on the end face of the head end 11 and a clamping hole 14 provided on the end face of the tail end 12, and the clamping hook 13 of the head end 11 is clamped in the clamping hole 14 of the tail end 12 to realize the connection of the head end and the tail end. In another preferred embodiment, the buckle structure includes a strip-shaped clamping tooth 15 extending on the end face of the head end 11 and a clamping groove 16 extending in the end face of the tail end, a plurality of reverse teeth are arranged on the strip-shaped clamping tooth 15, a plurality of clamping holes are arranged in the clamping groove 16, the reverse teeth are matched with the clamping holes, and the connection stability of the head end 11 and the tail end 12 of the valve support ring 1 is improved by matching the plurality of reverse teeth on the strip-shaped clamping tooth 15 with the clamping holes in the clamping groove 16. The strip-shaped clamping tooth 15 can be linear or arc-shaped, and when the strip-shaped clamping tooth 15 is arc-shaped, it is matched with the curvature of the valve support ring 11.

[0031] Further, the head end 11 and the tail end 12 of the valve support ring 1 are provided with a limiting sealing structure; the limiting sealing structure comprises a positioning boss 17 arranged on the end face of the head end 11, and a positioning groove 18 arranged on the end face of the tail end 12, a clamping hook 13 or a strip-shaped clamping tooth 15 is arranged on the positioning boss 17, and a clamping hole 14 or a clamping groove 16 is arranged on the side of the positioning groove 18 away from the end face of the tail end, the positioning boss 17 is matched with the positioning groove 18, and the tail end and the head end are positioned, and the sealing connection of the tail end and the head end is realized.

[0032] Further, the diameter of the semi-annular avoiding opening 3 is 2-8 mm, preferably, the diameter of the semi-annular avoiding opening 3 is 2 mm, 3 mm, 5 mm, 7 mm or 8 mm, different specifications are arranged to meet the placement requirements of different specifications of lead wires.

[0033] Further, the semi-annular avoiding opening 3 is provided with an anti-endothelialization and anti-thrombosis coating on the outer periphery. The anti-endothelialization and anti-thrombosis coating is a rapamycin coating or a heparin coating. Rapamycin is an effective and specific mammalian target of rapamycin (mTOR) inhibitor, which can inhibit the proliferation and migration of endothelial cells, promote the apoptosis and autophagy of endothelial cells, and can be used for anti-endothelialization and anti-thrombosis. Heparin has the functions of anti-coagulation, anti-thrombosis, anti-smooth muscle cell proliferation, anti-inflammation and regulation of various growth factors. The anti-endothelialization and anti-thrombosis coating provided on the outer periphery of the semi-annular avoiding opening 3 can significantly reduce the migration and endothelialization of endothelial cells at this position, greatly ensuring the feasibility and operability of the future removal of the pacing lead of the patient.

[0034] The open-loop structure tricuspid valve implantation device of the utility model, the valve support ring is of open-loop structure, and the avoiding opening is arranged on the flexible valve leaflet at the side of the open-loop structure. In the surgical implantation process, the pacing lead can be introduced to the appropriate position through the open-loop structure part, and the pacing lead is fixed at the avoiding opening of the flexible valve leaflet, so as to avoid the friction between the pacing lead and the flexible valve leaflet, greatly reduce the damage of the flexible valve leaflet, and reduce the occurrence of tricuspid regurgitation. The surface around the avoiding opening of the flexible valve leaflet is provided with an anti-endothelialization and anti-thrombosis coating, which can significantly reduce the migration and endothelialization of endothelial cells at this position, greatly ensuring the feasibility and operability of the future removal of the pacing lead of the patient.

[0035] Of course, the utility model can also have other various embodiments, and those skilled in the art can make various corresponding changes and modifications according to the utility model without departing from the spirit and essence of the utility model, but these corresponding changes and modifications should all belong to the protection scope of the claims attached to the utility model.

Claims

1. An open-loop structured tricuspid valve implant device, characterized by: The valve support ring (1) is an open loop structure, provided with a head end (11) and a tail end (12), and the tail end (12) is connected with the head end (11) to form a ring shape; one end of the flexible leaflet (2) is connected with the valve support ring (1), and the other end is a free edge, there is a gap between the free edges of adjacent flexible leaflets (2), and the free edge of the flexible leaflet (2) is concave between the fixed edge; the open loop structure of the valve support ring (1) is located between a group of adjacent flexible leaflets (2), and the free edge of the flexible leaflet (2) on both sides of the open loop structure is provided with a semi-ring avoiding port (3) close to the side of the open loop structure.

2. The open-loop structured tricuspid valve implant device of claim 1, wherein: The head end (11) and the tail end (12) of the valve support ring (1) are connected through a buckle structure.

3. The open-loop structured tricuspid valve implant device of claim 2, wherein: The buckle structure includes a clamping hook (13) provided on the end face of the head end (11) and a clamping hole (14) provided on the end face of the tail end (12), and the clamping hook (13) of the head end (11) is clamped in the clamping hole (14) of the tail end (12).

4. The open-loop structured tricuspid valve implant device of claim 2, wherein: The buckle structure includes a strip-shaped clamping tooth (15) extending on the end face of the head end (11) and a clamping groove (16) extending on the end face of the tail end, a plurality of reverse teeth are arranged on the strip-shaped clamping tooth (15) at intervals, and a plurality of clamping holes are arranged in the clamping groove (16) at intervals, and the reverse tooth is matched with the clamping hole.

5. The open-loop structured tricuspid valve implant device of claim 2, wherein: The head end (11) and the tail end (12) of the valve support ring (1) are provided with a limiting sealing structure on the end face.

6. The open-loop structured tricuspid valve implant device of claim 5, wherein: The limiting sealing structure includes a positioning boss (17) provided on the end face of the head end (11) and a positioning groove (18) provided on the end face of the tail end (12), and the buckle structure is arranged on the positioning boss (17) and the positioning groove (18), and the positioning boss (17) is matched with the positioning groove (18).

7. The open-loop structured tricuspid valve implant device according to claim 1, characterized in that: The diameter of the semi-ring avoiding port (3) is 2-8mm.

8. The open-loop structured tricuspid valve implant device of claim 7, wherein: The diameter of the semi-ring avoiding port (3) is 2mm, 3mm, 5mm, 7mm or 8mm.

9. The open-loop structured tricuspid valve implant device according to claim 1, characterized in that: The semi-ring avoiding port (3) is provided with an anti-endothelialization and anti-thrombosis coating on the outer periphery.

10. The open-loop structured tricuspid valve implant device of claim 9, wherein: The anti-endothelialization and anti-thrombosis coating is a rapamycin coating or a heparin coating.

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