A tricuspid annuloplasty ring

Abstract

The present invention relates to a tricuspid annulus shaping ring, comprising an open ring body, wherein the ring body is continuously and sequentially composed of a front ring segment suitable for fixing anterior valve leaflet and its vicinity, a rear ring segment suitable for fixing posterior valve leaflet and its vicinity, and a septal ring segment suitable for fixing septal valve leaflet and its vicinity, wherein one-third of the front ring segment near the opening end, one-third of the rear ring segment near the septal ring segment, and the septal ring segment are rigid shaping areas that are difficult to deform; one-third of the front ring segment near the posterior ring segment and one-third of the rear ring segment near the anterior ring segment are deformable plastic shaping areas. The beneficial effect of the present invention is that it can reduce the distance between the anterior valve ring and the septal valve ring of the tricuspid valve, and can be specifically set for situations where there is significant dilation of the right ventricle, significant displacement of the papillary muscle, and valve leaflet binding, effectively increasing the valve leaflet coaptation area and coaptation height under the premise of ensuring sufficient opening area, and providing an effective and lasting shaping effect.

Description

Technical Field

[0001] The invention relates to medical device technology, and in particular to a tricuspid annuloplasty ring. Background Art

[0002] Normal human heart valves are located between the atria and ventricles and between the ventricles and aortas. The four valves are the mitral valve, aortic valve, tricuspid valve and pulmonary valve, which act as one-way valves to help blood circulate in one direction. For the tricuspid valve, when the right ventricle is in diastole, non-oxygenated blood enters the right ventricle from the right atrium through the open tricuspid valve orifice. When the right ventricle contracts, the tricuspid valve closes to prevent blood from flowing back to the right atrium.

[0003] Figure 1 It is a schematic diagram of the normal tricuspid valve closed state viewed from the right atrium, wherein the leaflets include the largest anterior leaflet 101, posterior leaflet 102 and septal leaflet 103, and also include the leaflet parts of three valve junctions between adjacent leaflets, namely the anterior septal junction 111, the anterior-posterior junction 112 and the posterior-septal junction 113. The tricuspid valve ring is a heterogeneous virtual anatomical structure, and the valve ring is composed of the aortic segment 121, the anterior segment 122 to which the anterior leaflet and the anterior-posterior junction leaflets are attached, the posterior segment 123 to which the posterior leaflet and the posterior-septal junction leaflets are attached, and the septal segment 124 to which the septal leaflet and the anterior-septal junction leaflets are attached, in a clockwise direction. Figure 2 It is a schematic diagram of the tricuspid valve in the open state, showing that the subvalvular suspension system is composed of chordae 130 and papillary muscles. The papillary muscles are generally divided into three groups, namely, the thickest, located at the anterior and posterior junction, with chordae suspending the anterior and posterior leaflets of the anterior papillary muscle 141; located at the posterior septum junction, with chordae suspending the posterior and septal leaflets of the posterior papillary muscle 142; and located at the anterior septum junction, with chordae suspending the septal and anterior leaflets of the septal papillary muscle 143. In general, compared with the mitral valve, the tricuspid valve leaflets are thinner, the chordae are thinner, the valve ring is weaker and less obvious, and the valve opening is larger and closer to an oval shape. Figure 3 It is shown that each leaflet is divided into anterior leaflet proximal region 101a, posterior leaflet proximal region 102a, septal leaflet proximal region 103a covering the tricuspid valve orifice and anterior leaflet coaptation region 101b, posterior leaflet coaptation region 102b and septal leaflet coaptation region 103b that are in apposition with each other.

[0004] Compared with left heart valve disease, tricuspid valve disease has only received increasing attention in recent years. Compared with valvular stenosis, tricuspid valve position is more commonly caused by valvular insufficiency due to various reasons. According to the presence or absence of organic valvular lesions, tricuspid regurgitation can be divided into functional and organic. Among them, functional tricuspid regurgitation is the most common tricuspid valve dysfunction in clinical practice. It can occur in a series of pathological and physiological conditions that can lead to pulmonary hypertension, right ventricular dysfunction, and right ventricular volume overload. When these factors return to normal, regurgitation is also reversible. However, when the above factors and the functional tricuspid regurgitation caused by them persist, because they can cause continuous right ventricular enlargement, and this process is accompanied by increasing tricuspid valve ring enlargement and papillary muscle displacement, these three factors will further aggravate functional tricuspid regurgitation, thus forming a vicious circle, which will later evolve into irreversible tricuspid regurgitation and combined with further organic damage.

[0005] It should be pointed out that no matter what the pathological factors are, they can cause damage to multiple components of the tricuspid valve at the same time. Among them, annular dilatation is the most common cause of tricuspid regurgitation. Generally, a 20% increase in the diameter of the annular valve can cause malalignment of the valve leaflets and thus regurgitation. Figure 4 As shown, when the tricuspid valve ring expands, the expansion degree of its four segments is uneven. Taking the ring circumference as the measurement standard, it mainly expands along the posterior segment 123 and the posterior half of the anterior segment 122; during functional tricuspid valve regurgitation, the ring length of the posterior segment 123 can increase by about 80% compared with its physiological value, followed by the anterior segment 122 and the aortic segment 121, which can increase by about 40%, the anterior-posterior junction 112 and the posterior septum junction 113 can expand by 30%, and the septum segment 124 is located between the left and right fibrous triangles and is closely connected to the ventricular septum, which limits its expansibility and the ring length is relatively fixed.

[0006] Tricuspid regurgitation can be divided into Carpentier functional classification types I-III according to the movement of the valve leaflets. The most common cause of type I is annular dilatation, type II is mostly caused by elongation or rupture of chordae tendineae, and type IIIb is caused by significant dilatation of the right ventricle, displacement of the papillary muscles along the long axis of the right ventricle toward the distal apex, and functional shortening of the chordae-papillary muscle complex. In addition, the annular dilatation increases the stress on the valve leaflets per unit length of the annular ring in the direction of annular dilatation by 3-4 times that in the physiological state. These factors all cause the tricuspid valve leaflets to be pulled and restrained toward the ventricular side, greatly reducing their mobility. In addition, since these patients with significant right ventricular dilatation must be accompanied by varying degrees of annular dilatation, and the degree of dilatation is often more severe, a larger area of ​​non-coaptation area of ​​the valve leaflets is required to cover the valve orifice when the tricuspid valve is closed. Under the combined effect of the above factors, the tricuspid valve leaflets cannot effectively coapt when the chordae tendineae are in a fully stretched state and the leaflets are in the highest movable position during systole, resulting in IIIb regurgitation. It should be pointed out that once tricuspid regurgitation occurs, regardless of the functional classification, if it is not treated, it will progress over time and will lead to further annular dilatation, right ventricular enlargement and reconstruction, and papillary muscle displacement. These factors in turn further aggravate tricuspid regurgitation, thus forming a vicious circle. Therefore, regardless of the initial functional classification of regurgitation, especially type I or type IIIb regurgitation, once in the middle and late stages of the disease, patients with tricuspid regurgitation, especially severe regurgitation, will have significant enlargement of the right ventricle, obvious displacement of the papillary muscles toward the apical side of the long axis of the right ventricle, and annular dilatation, thereby binding the valve leaflets to one side of the right ventricle, reducing the mobility of the valve leaflets, and failing to effectively appose.

[0007] It has been found that without surgical intervention, tricuspid regurgitation will progressively worsen and significantly worsen the patient's long-term prognosis. It is a recognized fact that severe tricuspid regurgitation will reduce the patient's long-term survival rate, which will be reduced by about 50% within 3 years. Even moderate tricuspid regurgitation will have a negative impact on the patient's survival rate. For functional tricuspid regurgitation present during left heart valve surgery, due to the uncertainty of tricuspid valve function progression after mitral or aortic valve surgery, such as continued dilation of the tricuspid valve ring and worsening regurgitation, the previous view that tricuspid regurgitation will recover on its own after correction of left heart valve disease has been abandoned. On the contrary, it is believed that when dealing with left heart valves, as long as the tricuspid valve ring is dilated, it should be actively treated regardless of whether there is regurgitation. For isolated severe tricuspid regurgitation, if the patient has symptoms or is combined with right heart failure and systemic congestion symptoms, surgical treatment should also be given.

[0008] The surgical treatment of tricuspid regurgitation mainly includes tricuspid valve replacement surgery and tricuspid valvuloplasty using biological or mechanical artificial valve prostheses. Since tricuspid valve position replacement should be very cautious, valvuloplasty is more conducive to diastolic ventricular shaping and protection of right ventricular function, and the incidence of postoperative thromboembolism and endocarditis is low, so it is the preferred treatment method that is superior to valve replacement when conditions permit. The principle of tricuspid valvuloplasty is to provide a larger leaflet coaptation area, reshape the valve ring, and restore the kinetic energy of intact leaflet movement. Among them, maintaining sufficient coaptation area reserve is the key to obtaining satisfactory short-term and long-term effects after surgery. The shaping techniques include the Kay method, De Vega method and various modified techniques for tricuspid valve ring expansion, which are intended to over-tighten the valve orifice, but the long-term effects of these techniques are not satisfactory. The process of valve ring expansion has not stopped after surgery, and 30% of patients may relapse with moderate to severe tricuspid valve regurgitation and valve ring expansion in the long term. It is a consensus that annular remodeling can achieve better long-term results than simple annular tightening. Among them, the long-term effect of remodeling using soft rings or soft shaping bands is still poor, and the recurrence rate of reflux is high. However, the long-term effect of using hard rings is good.

[0009] However, if Figure 5 As shown in the figure, the obvious right ventricular enlargement caused by tricuspid regurgitation and the displacement of the papillary muscles toward the apex that accompanies the right ventricular enlargement are the inevitable cardiac remodeling manifestations in most patients before surgery. Among them, the displacement of the anterior papillary muscle toward the apex is the most correlated with tricuspid regurgitation. In severe tricuspid regurgitation, the right ventricular dilation and the displacement of the papillary muscles toward the apex are more obvious, the leaflets are pulled and restrained, and the distance between the annular plane and the upper edge of the leaflet apex increases, thus forming a Class IIIb or mixed lesion, such as Figure 6 As shown in the figure. Since there is also annular dilatation, such cases of severe tricuspid regurgitation with significant right ventricular dilatation are often difficult to treat by plastic surgery. If the classic method of selecting the valve ring model is used to reshape the valve ring with the existing oval artificial tricuspid valve plastic ring, that is, the distance between the two ends of the base of the septal valve is measured, as well as the area of ​​most of the anterior leaflet and part of the posterior leaflet attached to the anterior papillary muscle to select the corresponding valve ring model, the leaflet is severely pulled toward the ventricle, and effective apposition is often not formed after remodeling. Fig.11As shown in the figure. This is because this method only corrects the effect of the valve ring expansion on tricuspid regurgitation, but the right heart enlargement and the displacement of the papillary muscle toward the apex make the area near the free edge of the stretched and bound valve leaflet have a considerable height function as the chordae tendineae, and the area of ​​the truly functional valve leaflet coaptation area is greatly reduced, which is not enough to form an effective coaptation surface and coaptation height. Studies have confirmed that the valve ring expansion consumes the largest coaptation area of ​​the anterior leaflet with the largest mobility and the largest valve leaflet area, while the valve ring expansion with papillary muscle displacement consumes the largest coaptation area of ​​the posterior leaflet located on the ventricular free wall. In short, it is often difficult to obtain satisfactory shaping effects for patients with severe regurgitation with severe right heart enlargement and papillary muscle displacement only with the existing tricuspid annuloplasty ring. In order to avoid regurgitation after surgery, these severe cases can only use the edge-to-edge technique to sew the midpoints of the free edges of the three valve leaflets, that is, the tricuspid three-hole annuloplasty method, and sew the coaptation edges of the anterior and posterior or posterior septal leaflets to make them bicuspid. However, there are reports that the tension on the leaflets per unit length of the valve ring after three-hole reshaping did not decrease compared with before the operation, suggesting that this method cannot prevent the continued expansion of the valve ring after surgery and the long-term effect is worrying. Therefore, under ideal conditions, such patients should still use a more optimized valve ring remodeling.

[0010] It can be predicted that for the above-mentioned cases of severe tricuspid regurgitation with significant right ventricular enlargement, only by directly or indirectly correcting several other factors besides annular dilation during annular remodeling can better short-term and long-term remodeling effects be achieved, that is, a sufficiently large valve coaptation area and coaptation height can be obtained. In another case, for patients with elongated chordae tendineae and the upper edge of the coaptation surface of the valve leaflets above the annular plane after remodeling, even if the immediate effect after remodeling is good, the continued impact of postoperative right ventricular remodeling recovery on the remodeling effect should still be considered. In the short term after surgery, the enlarged right ventricle and papillary muscle displacement still exist. Under this condition, the tricuspid valve closes well, and its coaptation area and height will gradually decrease over time as the right ventricle gradually shrinks, the papillary muscle displacement gradually alleviates, and the valve leaflets coapt to a higher plane. Regurgitation may even occur again in the long term due to insufficient valve leaflet coaptation height immediately after surgery.

[0011] In summary, obtaining sufficient leaflet coaptation area and height after the annuloplasty is a key indicator for the success of the annuloplasty and a satisfactory long-term prognosis. For patients with severe tricuspid regurgitation with severe right ventricular dilatation and significant papillary muscle displacement, and limited leaflet binding activity, especially those with Class IIIb, for whom existing annular remodeling is difficult to achieve good results, it is important to design and develop an annuloplasty ring with new core features to obtain a satisfactory annular remodeling effect while ensuring sufficient valve opening area, that is, to obtain an effective leaflet coaptation surface and increase the coaptation surface height and area as much as possible, so that this most important indicator for evaluating the effect of tricuspid annuloplasty has sufficient "reserve" after surgery, and to ensure good long-term results is an important issue that needs to be solved clinically. Summary of the invention

[0012] The purpose of the present invention is to overcome the shortcomings of the prior art and solve the problem that the existing mainstream oval rigid tricuspid annuloplasty ring cannot achieve effective leaflet apposition and satisfactory tricuspid annuloplasty effect in cases with a long course of disease, significant right ventricular enlargement and papillary muscle displacement, and severe type IIIb tricuspid regurgitation.

[0013] In order to achieve the above-mentioned purpose of the invention, a tricuspid valve shaping ring is provided, including an open ring body, wherein the ring body is continuously and sequentially composed of a front ring segment suitable for fixing the front valve leaflet and the vicinity thereof, a rear ring segment suitable for fixing the rear valve leaflet and the vicinity thereof, and a septal ring segment suitable for fixing the septal valve leaflet and the vicinity thereof; one-third of the front ring segment near the opening end, one-third of the rear ring segment near the septal ring segment, and the septal ring segment are rigid molding areas that are difficult to deform; one-third of the front ring segment near the rear ring segment and one-third of the rear ring segment near the front ring segment are deformable plastic molding areas.

[0014] The opening referred to here is located between the front ring section and the partition ring section of the ring body, and the front ring section and the partition ring section are open ends at the opening.

[0015] The rigid modeling area referred to here means that the ring structure at this location is hard and difficult to deform under the action of external force. Generally, the optional materials are carbon fiber ring body, glass ring body and other conventional materials that are known to those skilled in the art to have a hard structure, or thicker titanium alloy rods as described below, higher density memory alloy braided rods, etc.

[0016] The plastic shaping zone referred to herein means that the ring structure at this location has a certain deformation ability, and its shape can be changed and maintained through the synergistic effect of larger external forces or other environmental factors, and only elastic deformation occurs under smaller forces. Generally, optional materials include coated and isolated Fe-Mn-Si shape memory alloys or NiAl shape memory alloys, or even polymers with similar physical and chemical properties, and other materials that are conventionally known to those skilled in the art to have the above characteristics, or thinner shaped titanium alloy rods, lower density shape memory alloy braided rods, etc. as described below.

[0017] Preferably, two-thirds of the length of the front ring segment near the rear ring segment and two-thirds of the length of the rear ring segment near the front ring segment are recessed toward the center of the ring body.

[0018] Under the action of external force, the ring body can be shaped inward to reduce the average distance between the anterior and posterior ring segments and the diaphragmatic segment, so as to form an average distance from the anterior and posterior ring segments to the diaphragmatic ring segment that is smaller than that of the existing mainstream oval tricuspid annuloplasty ring.

[0019] The specific area of ​​the ring body segment referred to here is concave towards the center of the ring body, which refers to the state of the finished ring body when it is initially not under force, and is roughly "saddle" shaped; after implantation in the body, the concave will cause the posterior valve ring and the posterior segment of the anterior valve ring, where the expansion of the tricuspid valve ring is most obvious, to move closer to the septal valve, thereby further reducing the distance between the three leaflets of the tricuspid valve and increasing the degree of leaflet coaptation compared to an oval forming ring of the same model, based on the contraction of the tricuspid valve forming ring.

[0020] Preferably, the middle third of the front ring segment and the middle third of the rear ring segment are rigid plastic transition zones, and the ring body has an overall smooth transition.

[0021] That is, there is no angle in the change of the ring body curvature.

[0022] The rigid-plastic transition zone referred to herein means that the rigidity and plasticity of this area are between the rigid modeling zone and the plastic modeling zone. Generally, the optional structure is to gradually embed or insert the rigid modeling zone and the plastic modeling into each other, etc., which is conventionally known to those skilled in the art to achieve the rigid-plastic transition, or to use the variable-section titanium alloy rod, variable-density memory alloy braided rod, etc. as described below.

[0023] Preferably, the inner core of the ring body is a strip-shaped metal inner core.

[0024] The inner core referred to here mainly serves as the skeleton of the ring body, and can be isolated from external contact by the outer layer to prevent the inner core material from being damaged or leaking.

[0025] Preferably, the cross-sectional area of ​​the metal inner core in the rigid molding zone is a, and the cross-sectional area of ​​the metal inner core in the plastic molding zone is b, wherein a>b; the cross-sectional area of ​​the metal inner core in the rigid-plastic transition zone gradually decreases from a adjacent to one end of the rigid molding zone to b adjacent to one end of the plastic molding zone.

[0026] The larger the cross-sectional area of ​​the metal core, the stronger its rigidity is, and the smaller the cross-sectional area is, the more it meets the requirements of the plastic molding zone.

[0027] Preferably, the overall aspect ratio of the ring body is 4:(0.6-2.4).

[0028] The aspect ratio of the entire ring body referred to herein refers to the state without stress after in vitro molding.

[0029] Preferably, the ratio of the lengths of the central axis of the ring bodies of the front ring segment, the rear ring segment and the spacer ring segment is (1-1.1):1:(0.4-0.5).

[0030] Preferably, the outer ring body is further wrapped with an elastic sleeve.

[0031] The elastic sleeve can be made of silicone rubber or other similar materials conventionally available in the art molded around the inner core. The elastic sleeve provides an interface that allows sutures to pass through.

[0032] Preferably, the elastic sleeve is also covered with a biocompatible fabric.

[0033] The coated fabric can be any biocompatible and tough material known in the art, and polyethylene terephthalate can be conventionally selected.

[0034] By improving the conventional hard ring body and setting up a rigid molding area and a plastic molding area, a personalized adjustment function after leaving the factory that the hard ring does not have is provided. Combined with the specific proportional dimensions, the molding ring can more effectively match the lesion site.

[0035] The concave area selects a specific ring segment because the anterior leaflet 101 of the tricuspid valve has the greatest mobility, while the posterior segment 123 and the anterior segment 122 of the valve ring near the posterior leaflet 102 have the greatest expansion. The negative curvature of the ring body makes the average vertical distance from the main ring segment that causes the valve ring expansion and the anterior leaflet that plays the most important role in the valve leaflet coaptation to the valve ring septum segment most significantly reduced, which can most effectively increase the valve leaflet coaptation area and height, and prevent the valve ring from continuing to expand after tricuspid valvuloplasty to the greatest extent. Moreover, since the valve ring in this range is mainly located on the free wall of the right ventricle rather than the aortic segment 121 or the septum segment 144 of the valve ring, it is very safe to change the position of this segment of the valve ring. At the same time, the use of this concave design on the ring body can maximize the closeness of the most expanded valve ring part, providing an additional shaping effect of increasing the valve leaflet coaptation area compared to the current oval shaping ring of the same model.

[0036] The setting of the rigid plastic transition zone provides a basis for the overall smooth transition of the ring body, avoiding the angulation of the ring body that may stimulate fragile organs in the body.

[0037] The inner core is a strip-shaped metal inner core, which provides a skeleton for the ring body and facilitates setting a rigid shaping area and a plastic shaping area on the ring body.

[0038] By setting the size of the cross section of the metal inner core, the rigidity and plasticity of the ring body in a specific area can be adjusted.

[0039] The overall length-to-diameter ratio of the ring body is 4:(0.6-2.4), which makes the ring body no longer a conventional oval shape, but a relatively "flat and long" shape. Thus, on the basis of reducing the valve ring, further provide a force for the anterior and posterior valve rings and the septal valve ring to come closer, and bring the anterior valve leaflet and the septal valve leaflet attached to the anterior valve ring closer, increase the coaptation area, facilitate coaptation, and further reduce or even eliminate regurgitation on the basis of ring shrinkage.

[0040] The ratio of the center axis lengths of the front ring segment, the rear ring segment, and the septum ring segment is (1-1.1):1:(0.4-0.5), which provides a design guide for the ring body so that the ring body will not change the position of the front ring segment, the rear ring segment, and the septum ring segment corresponding to the human body after deformation during implantation.

[0041] The wrapping elastic sleeve is used to isolate the inner core; the design of the covering fabric not only further isolates the inner core, but also facilitates drawing marking lines of the front and rear segments of the ring body and the junction of the rear and septal segments and suture indicator lines on its surface.

[0042] The beneficial effect of the present invention is that the shaping ring reduces the distance between the anterior and posterior tricuspid valve rings and the septal valve ring, and can be specifically set for situations where there is significant right ventricular dilation, obvious papillary muscle displacement, and leaflet binding. It can effectively increase the leaflet coaptation area and degree of coaptation while ensuring sufficient opening area, providing an effective and lasting shaping effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Figure 1 This is a schematic diagram of the closed state of the tricuspid valve with markings as viewed from the typical orientation direction of the right atrium;

[0044] Figure 2 This is a schematic diagram of the tricuspid valve opening state with markings as viewed from the typical orientation direction of the right atrium;

[0045] Figure 3 A schematic diagram of the proximal area covering the tricuspid orifice is developed for each leaflet;

[0046] Figure 4 This is a schematic diagram of the dilation characteristics of the tricuspid valve ring;

[0047] Figure 5 It is the general displacement of the three groups of papillary muscles of the tricuspid valve in the plane of the valve ring and the long axis of the ventricle when the right ventricle expands;

[0048] Figure 6 The effect of right ventricular expansion and papillary muscle displacement on the coaptation surface of tricuspid valve leaflets;

[0049] Figure 7 A schematic diagram of the overall structure of the tricuspid annuloplasty ring provided by the present invention;

[0050] Figure 8 A schematic cross-sectional view of a tricuspid annuloplasty ring provided by the present invention;

[0051] Fig. 9 It is a schematic diagram of the overall structure of the first embodiment of the present invention;

[0052] Fig.10 This is a schematic diagram of the inner core structure of the first embodiment of the present invention;

[0053] Fig.11This is a schematic diagram after a tricuspid annuloplasty ring operation using the prior art;

[0054] Fig.12 This is a schematic diagram of the post-operative shaping ring using the solution of the present invention;

[0055] in:

[0056] 101- anterior leaflet 102- posterior leaflet 103- septal leaflet

[0057] 111- anterior septum junction 112- anterior septum junction 113- posterior septum junction

[0058] 121- aortic segment 122- anterior segment 123- posterior segment

[0059] 124-septum 130-chord 101a-proximal area of ​​the anterior valve

[0060] 101b-front lobe coaptation area 102a-posterior lobe proximal area 102b-posterior lobe coaptation area

[0061] 103a- proximal area of ​​septal flap 103b- apposition area of ​​septal flap 141- anterior papillary muscle

[0062] 142-posterior papillary muscle 143-septal papillary muscle 1-annular body

[0063] 11-front ring segment 12-back ring segment 13-spacer ring segment

[0064] 14-open end 21-rigid shaping area 22-plastic shaping area

[0065] 23-rigid plastic transition zone 3-elastic sleeve 4-fabric

[0066] 5-Inner core 51-Metal inner core DETAILED DESCRIPTION

[0067] The present invention is further described below in conjunction with the accompanying drawings and specific embodiments.

[0068] according to Figure 7 , Figure 8A tricuspid annuloplasty ring is shown, comprising an open ring body 1, wherein the ring body 1 is continuously and sequentially composed of a front ring segment 11 suitable for fixing the front leaflet and its vicinity, a rear ring segment 12 suitable for fixing the rear leaflet and its vicinity, and a septal ring segment 13 suitable for fixing the septal leaflet and its vicinity, wherein one-third of the front ring segment 11 near the opening end 14, one-third of the rear ring segment 12 near the septal ring segment 13, and the septal ring segment 13 are rigid molding areas 21 that are difficult to deform; one-third of the front ring segment 11 near the rear ring segment 12 and one-third of the rear ring segment 12 near the front ring segment 11 are deformable plastic molding areas 22. The ring body 1 has a smooth transition as a whole, and the middle one-third of the front ring segment 11 and the middle one-third of the rear ring segment 12 are rigid plastic transition areas 23. The overall length-to-short diameter ratio of the ring body 1 is 4:(0.6-2.4). The ratio of the length of the central axis of the front ring segment 11, the rear ring segment 12 and the spacer ring segment 13 is (1-1.1):1:(0.4-0.5). The skeleton of the ring body 1 is an inner core 5, which is also wrapped with an elastic sleeve 3. The elastic sleeve 3 is also covered with a biocompatible fabric 4.

[0069] according to Fig. 9 , Fig.10 and Fig.12 In the first embodiment shown, two-thirds of the length of the front ring segment 11 near the rear ring segment 12 and two-thirds of the length of the rear ring segment 12 near the front ring segment 11 are recessed toward the center of the ring body 1. The inner core 5 of the ring body 1 of the tricuspid annuloplasty ring is a strip-shaped metal inner core 51; the cross-sectional area of ​​the metal inner core 51 in the rigid shaping area 21 is a, and the cross-sectional area of ​​the metal inner core 51 in the plastic shaping area 22 is b, wherein a>b; the cross-sectional area of ​​the metal inner core 51 in the rigid-plastic transition area 23 gradually decreases from a at one end adjacent to the rigid shaping area 21 to b at one end adjacent to the plastic shaping area 22.

[0070] Similar to existing artificial valve rings, the shaping ring can be similar to the conventional long diameter, that is, the outer diameter selection range is 32-44mm, and the inner diameter selection range is 24-36mm.

[0071] In general implementation, the elastic sleeve 3 is made of silicone rubber or other similar materials molded around the inner core 5. The elastic sleeve 3 provides an interface that allows sutures to pass through. The elastic sleeve 3 has a thickness of about 0.4mm around most of the inner core 5, but is thicker at the two open ends 14, which is about 0.6mm. The fabric 4 can be any medical biocompatible material in general implementation, such as polyethylene terephthalate with a thickness of about 0.3mm. The surface of the fabric 4 can be used to draw indicative marking lines of the anterior and posterior segments of the ring body and the junction of the posterior and septal segments, and can also be used to draw suture indicator lines.

[0072] The preferred embodiments of the present invention have been specifically described above, but the present invention is not limited to the described embodiments. Those skilled in the art may make various equivalent modifications or substitutions without violating the spirit of the present invention. These equivalent modifications or substitutions are all included in the scope defined by the claims of this application.

Claims

1. A tricuspid annuloplasty ring, comprising an open ring body, wherein the ring body is sequentially composed of an anterior ring segment suitable for fixing an anterior valve leaflet and its vicinity, a posterior ring segment suitable for fixing a posterior valve leaflet and its vicinity, and a septal ring segment suitable for fixing a septal valve leaflet and its vicinity, characterized in that: The one-third position of the front ring segment near the opening end, the one-third position of the rear ring segment near the septal ring segment and the septal ring segment are rigid molding areas that are difficult to deform; the one-third position of the front ring segment near the rear ring segment and the one-third position of the rear ring segment near the front ring segment are deformable plastic molding areas; The area of ​​the front ring segment close to two-thirds of the length of the rear ring segment and the area of ​​the rear ring segment close to two-thirds of the length of the front ring segment are concave toward the center of the ring body; The outer ring body is further wrapped with an elastic sleeve.

2. The tricuspid annuloplasty ring according to claim 1, characterized in that: The ring body has a smooth transition as a whole, and the middle third of the front ring segment and the middle third of the rear ring segment are rigid plastic transition zones.

3. The tricuspid annuloplasty ring according to claim 2, characterized in that: The inner core of the ring body is a strip-shaped metal inner core.

4. The tricuspid annuloplasty ring according to claim 3, characterized in that: The cross-sectional area of ​​the metal core in the rigid molding zone is a, and the cross-sectional area of ​​the metal core in the plastic molding zone is b, wherein a>b; the cross-sectional area of ​​the metal core in the rigid-plastic transition zone gradually decreases from a adjacent to one end of the rigid molding zone to b adjacent to one end of the plastic molding zone.

5. The tricuspid annuloplasty ring according to claim 1, characterized in that: The overall length-to-short diameter ratio of the ring body is 4:(0.6-2.4).

6. The tricuspid annuloplasty ring according to claim 1, characterized in that: The ratio of the lengths of the central axes of the ring bodies of the front ring segment, the rear ring segment and the spacer ring segment is (1-1.1):1:(0.4-0.5).

7. The tricuspid annuloplasty ring according to claim 1, characterized in that: The elastic sleeve is also coated with biocompatible fabric.

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