CN110811928A - Tricuspid valve forming ring - Google Patents

Abstract

The invention relates to a tricuspid valve annuloplasty ring, which comprises an open ring body, wherein the ring body continuously and sequentially consists of a front ring segment suitable for fixing a front valve leaflet and a nearby region thereof, a rear ring segment suitable for fixing a nearby region of a rear valve leaflet and a spacer ring segment suitable for fixing a nearby region of a spacer valve leaflet, wherein the one-third position of the front ring segment near the open end, the one-third position of the rear ring segment near the spacer ring segment and the spacer ring segment are rigid modeling regions which are difficult to deform; the position of one third of the front ring section near the rear ring section and the position of one third of the rear ring section near the front ring section are deformable plastic modeling areas. The invention has the advantages that the distance between the tricuspid valve anterior valve ring and the valve separating ring can be reduced, the specific setting can be realized for the conditions of significant right ventricle expansion, significant papillary muscle displacement and valve leaflet constraint, the coaptation area and the coaptation height of the valve leaflets can be effectively increased on the premise of ensuring enough opening area, and the effective and durable forming effect is provided.

Description

Tricuspid valve forming ring

Technical Field

The invention relates to the technology of medical instruments, in particular to a tricuspid valve annuloplasty ring.

Background

Normal human heart valves are located between the atria and ventricles and between the ventricles and the aorta, and 4 valves are the mitral, aortic, tricuspid and pulmonary valves, respectively, which function as one-way valves to assist one-way circulation of blood flow. For the tricuspid valve, non-oxygenated blood passes from the right atrium into the right ventricle through the open tricuspid orifice when the right ventricle is in a relaxed state, and the tricuspid valve closes to prevent backflow of blood into the right atrium when the right ventricle contracts.

Fig. 1 is a schematic diagram of a normal tricuspid valve closed state from the right atrial surface, wherein the leaflets comprise an anterior leaflet 101, a posterior leaflet 102, and a septal leaflet 103 having the largest area, and further comprise leaflet segments having three valve interfaces between adjacent leaflets, namely, an anterior septal interface 111, an anterior posterior interface 112, and a posterior septal interface 113. The tricuspid annulus is a heterogeneous virtual anatomic structure comprising, in order from the antero-septal junction, an aortic segment 121, an anterior segment 122 to which the anterior leaflet and the antero-posterior junction leaflet are attached, a posterior segment 123 to which the posterior leaflet and the postero-septal junction leaflet are attached, and a septal segment 124 to which the septal leaflet and the antero-septal junction leaflet are attached. Fig. 2 is a schematic view of the open state of the tricuspid valve showing the subvalvular suspension system consisting of chordae tendineae 130 and papillary muscles, generally grouped into three groups, the thickest, and the anterior papillary muscles 141 with chordae tendineae suspended from the anterior and posterior leaflets at the anterior-posterior junction; posterior papillary muscles 142 located at the posterior septal junction chordae tendineae suspended from the posterior and septal leaflets; and papillary muscles 143 located at the antero-septal junction, whose chordae tendineae are suspended from the septal and anterior leaflets. Overall, the tricuspid valve has thinner leaflets, thinner chordae, weaker annulus, less pronounced, and larger orifice closer to the oval shape than the mitral valve. Each leaflet is shown in fig. 3 divided equally into an anterior valve proximal region 101a, a posterior valve proximal region 102a, a septal valve proximal region 103a covering the tricuspid orifice, and an anterior valve coaptation region 101b, a posterior valve coaptation region 102b, and a septal valve coaptation region 103b coaptation with each other.

The tricuspid valve disease has not gained increasing attention until recently as opposed to left heart valve disease, and more commonly than valvular stenosis, the location of the tricuspid valve is a valvular insufficiency of various causes. Tricuspid regurgitation can be classified into functional and organic depending on whether there is an valvular organic lesion. Among these, functional tricuspid regurgitation is the most common clinical disorder of the tricuspid valve that occurs in a range of pathophysiological conditions that can lead to pulmonary hypertension, right ventricular insufficiency, and right ventricular volume overload, and is reversible when these factors return to normal. However, when the above factors and their resulting functional tricuspid regurgitation persist, as it can ensue with continued right ventricular enlargement and the process is accompanied by increasingly severe tricuspid annuloplasty and papillary muscle displacement, these three factors will further exacerbate functional tricuspid regurgitation, thereby creating a vicious cycle, which will later progress to irreversible tricuspid regurgitation and coalescence and further organic damage.

It should be noted that whatever pathological factor may cause damage to multiple components of the tricuspid valve at the same time. Among them, the annular dilation is the most common cause of tricuspid regurgitation, and generally, 20% increase in annular diameter causes poor coaptation of the leaflets and regurgitation. As shown in fig. 4, the expansion of the tricuspid annulus is unequal in the four segments, and the circumferential diameter of the annulus is used as a measure, and the three segments mainly expand along the posterior segment 123 and the posterior segment 122; the length of the posterior segment 123 can be increased by about 80% compared with its physiological value, the anterior segment 122 and the aortic segment 121 can be increased by about 40% compared with the valve ring of the functional tricuspid valve during regurgitation, the anterior-posterior junction 112 and the posterior junction 113 can be expanded by 30%, and the separation segment 124 is positioned between the left and right fibrous trigones and closely connected with the ventricular septum, so that the distensibility is limited, and the valve ring length is relatively fixed.

Tricuspid insufficiency can be classified into types I-III of Carpentier functional classification according to the state of motion of the leaflets. The most common cause of type I is annular dilatation, type II is mostly caused by elongation or rupture of chordae tendineae, type IIIb is marked by right ventricle dilatation, papillary muscles are displaced along the long axis of the right ventricle towards the distal apex, the chordae tendineae-papillary muscle complex is functionally shortened, and annular dilatation increases the stress on the leaflets per unit length of the annulus in the direction of annular dilatation by 3-4 times in physiological state. These factors all cause the tricuspid valve leaflets to be pulled and bound to the ventricular side, and the mobility is greatly reduced. In addition, since these patients with significant right ventricle dilation are bound to have different degrees of annular dilation, and often more severe, the tricuspid valve closure requires a larger area of leaflet non-coaptation to cover the orifice. Under the combined action of the above factors, each valve leaflet of the tricuspid valve in the contraction period is in a completely stretched state when the chordae tendineae are positioned at the movable highest position and still cannot be effectively involuted, so that IIIb regurgitation is generated. It is noted that once tricuspid regurgitation occurs, regardless of functional typing, further annular dilation, right ventricular dilation reconstruction and papillary muscle displacement ensue over time without treatment, which in turn further exacerbates tricuspid regurgitation to form a vicious circle. Therefore, regardless of the type of functionally-typed regurgitation at the beginning, particularly type I or IIIb regurgitation at the beginning, when the middle or late stage of the disease process occurs, patients with tricuspid regurgitation, particularly severe regurgitation, have marked enlargement of the right ventricle, marked displacement of papillary muscles toward the apical side of the right ventricular long axis, and annular dilatation, and consequently bind the leaflets to the right ventricle side, and the leaflets are less active and cannot be effectively coaptated.

It has now been found that without surgical intervention, tricuspid regurgitation progressively worsens and significantly worsens the patient's long term prognosis. It is a well-recognized fact that severe tricuspid regurgitation will reduce the patient's long-term survival by about 50% within 3 years, and even moderate tricuspid regurgitation can negatively impact patient survival. For functional tricuspid regurgitation which is combined during left heart valve operation, due to uncertainty of the function development of the tricuspid valve after mitral valve or aortic valve operation, such as continuous expansion of the tricuspid valve ring and aggravation of regurgitation, the view that the tricuspid regurgitation can be recovered after the correction of left heart valve lesion is abandoned at present, and on the contrary, the treatment is actively carried out as long as the tricuspid valve ring is expanded regardless of the regurgitation when the left heart valve is treated. And the isolated severe regurgitation of the tricuspid valve, such as patients with symptoms or combined symptoms of right heart failure and systemic circulation congestion, can also be treated by operation.

Surgical treatment of tricuspid regurgitation has primarily involved tricuspid valve replacement surgery and tricuspid valvuloplasty using biological or mechanical prosthetic valve prostheses. Because the valve replacement at the tricuspid valve position is carried out with great care, the forming operation is more beneficial to the molding of the diastole ventricle and protects the function of the right ventricle, and the incidence rate of the postoperative thromboembolism, endocarditis and the like is lower, so the method is a preferred treatment method better than the valve replacement when the conditions are allowed. The principle of tricuspid valvuloplasty is as follows: providing larger coaptation area of the valve leaflets, reshaping the valve ring and recovering the intact motion energy of the valve leaflets. Wherein, the key to obtain satisfactory near and far term effect after operation is to maintain enough involution area reserve. Techniques for shaping include Kay, De Vega and various modifications thereof directed to tricuspid valve annuloplasty, which are intended to over-constrict the orifice, but these techniques are not satisfactory for long term, the post-operative annular dilation process is not halted, and 30% of patients may have a long term recurrence of moderate to severe tricuspid regurgitation and annular dilation. It is well recognized that greater long-term remodeling of the annulus is achieved than with simple annular tightening, wherein the long-term remodeling is still less effective with a soft ring or soft molding band, and the reflux recurrence rate is high. And the long-term effect of the application of the hard ring is good.

However, as shown in fig. 5, the significant right ventricular dilation caused by tricuspid regurgitation and the papillary muscle to apex displacement accompanying the right ventricular dilation are the cardiac remodeling manifestations that most patients must present before surgery, with anterior papillary muscle to apex displacement being the most relevant to cause tricuspid regurgitation. In severe tricuspid regurgitation, right ventricular dilation and papillary muscle displacement to the apex are more pronounced, the leaflets are constrained by traction, and the distance of the plane of the annulus from the coaptation upper edges of the leaflets increases, resulting in a type IIIb or mixed lesion, as shown in fig. 6. Such severe cases of tricuspid regurgitation with significant dilation of the right ventricle tend to be very difficult to treat due to the simultaneous presence of annular dilation; for example, the existing oval artificial tricuspid valve is used for forming annular valve ring for remodeling according to the classical method for selecting the valve ring model, namely, the distance between two ends of the base part of the septal valve is measured, and the area of most of the front valve leaflets and part of the back valve leaflets attached to the front papillary muscle is selected to obtain the valve ring with the corresponding model, and the valve leaflets are seriously pulled and bound to the ventricular side, so that effective coaptation cannot be formed after remodeling, as shown in fig. 11. This is because the method only corrects the effect of the tricuspid regurgitation caused by the factor of annular dilation, but the right heart enlargement and the displacement of papillary muscle to the apex functionally act as chordae tendineae in the region where the free edge of the pulled and bound leaflet has a certain height, and the area of the coaptation area of the actual functional leaflet is greatly reduced and is not enough to form an effective coaptation plane and coaptation height. Research has confirmed that annulus enlargement consumes the most of the coaptation area of the anterior valve with the greatest mobility and leaflet area, while annulus enlargement with displacement of papillary muscles consumes the most of the coaptation area of the posterior valve located in the free wall of the ventricle. In conclusion, because it is difficult to obtain satisfactory shaping effect for severe regurgitation patients with severe right heart enlargement and papillary muscle displacement only by the existing tricuspid valve shaping ring, in order to avoid postoperative regurgitation, these severe cases can only adopt the palliative techniques of suturing the midpoint of the free edge of three leaflets by the edge-to-edge technique, i.e. tricuspid valve three-hole shaping method, and suturing the coaptation edge of anterior and posterior or posterior septal leaflets to bifolize the three leaflets. However, the tension of the valve leaflet corresponding to the valve annulus with unit length after the three-hole method is reported to be not reduced compared with the tension before the operation, which suggests that the method can not prevent the valve annulus from continuing to expand after the operation, and the long-term effect is worried, so that the patients still adopt more optimized valve annulus to perform remodeling under the ideal state.

It is expected that in the severe cases of tricuspid regurgitation with significant enlargement of the right ventricle, better proximal and distal reshaping effects, i.e. a sufficiently large valve apposition area and apposition height, can be obtained only by directly or indirectly correcting several other factors in addition to the annular dilation during the annular remodeling. In another case, for chordae elongation, the upper edge of the coaptation of the shaped posterior leaflet is above the annulus plane, and even if the effect is good immediately after shaping, the lasting effect of post-operative right ventricular remodeling recovery on the shaping effect should be considered. In the short post-operative period, the expanded right ventricle and papillary muscle displacement still exist, the tricuspid valve in the condition is closed well, the coaptation area and the height of the tricuspid valve are gradually reduced along with the gradual reduction of the right ventricle and the gradual reduction of the papillary muscle displacement along with the time lapse, the valve leaflet coaptation is gradually reduced to a higher plane, and even the regurgitation is not generated in the long term because of the insufficient coaptation height of the valve leaflet immediately after the operation.

In conclusion, obtaining sufficient leaflet coaptation area and height after the angioplasty is a key indicator of success of the angioplasty and obtaining a satisfactory long-term prognosis. For patients with severe tricuspid regurgitation, particularly patients with IIIb type and difficult to obtain good effects, wherein the right ventricle is severely dilated, papillary muscles are obviously displaced, and the constraint of valve leaflets on the activity is limited, an annuloplasty ring with new core characteristics is designed and developed so as to obtain a satisfactory annuloplasty effect on the premise of ensuring sufficient valve opening area, namely, effective leaflet coaptation is obtained, the height and area of the coaptation are increased as much as possible, so that the most important index for investigating the tricuspid valvoplasty effect has sufficient 'reserve' after surgery, and the guarantee of good long-term effect is an important problem to be clinically solved urgently.

Disclosure of Invention

The invention aims to overcome the defects of the prior art and solve the problems that the existing mainstream oval hard tricuspid valve forming ring can not realize effective leaflet coaptation and satisfactory tricuspid valve forming effect in the case of severe IIIb type tricuspid valve regurgitation due to long course of disease and remarkable right ventricle enlargement and papillary muscle displacement combined.

In order to achieve the above object, the present invention provides a tricuspid valve annuloplasty ring, comprising an open ring body, the ring body being continuously and sequentially composed of an anterior ring segment adapted to fix anterior valve leaflets and its vicinity, a posterior ring segment adapted to fix posterior valve leaflets and its vicinity, and a spacer ring segment adapted to fix spacer valve leaflets and its vicinity; the one-third position of the front ring section close to the opening end, the one-third position of the rear ring section close to the spacer ring section and the spacer ring section are rigid modeling areas which are difficult to deform; the position of one third of the front ring section near the rear ring section and the position of one third of the rear ring section near the front ring section are deformable plastic modeling areas.

The opening is located between the front ring section and the spacer ring section of the ring body, and the opening of the front ring section and the spacer ring section is an opening end.

The rigid modeling area is a ring body at the position, which has a hard structure and is difficult to deform under the action of external force, and generally, the material can be carbon fiber ring bodies, glass ring bodies and other materials which are considered to have a hard structure by common technicians in the field, or thicker titanium alloy rods, memory alloy braided rods with higher density and the like are adopted.

The plastic molding area referred to herein means that the ring structure at the area has a certain deformation capability, and the shape can be changed and maintained by the synergistic effect of a large external force or other environmental factors, and only elastic deformation occurs under a small force, and generally, materials known to have the above characteristics by those skilled in the art, such as coated and isolated Fe-Mn-Si shape memory alloy or NiAl shape memory alloy, even polymers with similar physicochemical properties, and the like, can be selected, or thin shape titanium alloy rods, memory alloy braided rods with low density, and the like are adopted.

Preferably, two thirds of the length of the front ring section close to the rear ring section and two thirds of the length area of the rear ring section close to the front ring section are recessed towards the center of the ring body.

The ring body can be shaped inwards under the action of external force to reduce the average distance between the front ring section and the rear ring section and the diaphragm section so as to form a smaller average distance between the front ring section and the rear ring section and the diaphragm section than that of the existing mainstream oval tricuspid valve annuloplasty ring.

The ring body segment in the specific area is sunken towards the center of the ring body, and the ring body segment is in a roughly saddle shape under the initial unstressed condition of the finished ring body; after being implanted into a body, the depression enables the posterior valve ring and the anterior valve ring with the most obvious expansion of the tricuspid valve ring to be close to the separating valve, so that compared with an egg forming ring with the same model, on the basis of the ring-contracting tricuspid valve forming ring, the distance between the three valve leaflets of the tricuspid valve is further reduced, and the valve leaflet fitting degree is increased.

Preferably, the middle third section of the front ring section and the middle third section of the rear ring section are rigid plastic transition areas, and the whole ring body is in smooth transition.

I.e., the change in curvature of the ring body is not angular.

The rigid-plastic transition region referred to herein means a region where the rigidity and plasticity are between the rigid modeling region and the plastic modeling region, and may be generally selected from a structure that is generally known to those skilled in the art to achieve rigid-plastic transition, such as gradually fitting or inserting the rigid modeling region and the plastic modeling into each other, or a variable cross-section titanium alloy rod, a variable density memory alloy braided rod, and the like, as described below.

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

The inner core mainly plays a role of a framework of the ring body, and can be isolated from outside contact through the outer layer coating, so that the substances of the inner core are prevented from being damaged or the substances of the inner core are prevented from being leaked.

Preferably, the cross section area of the metal inner core in the rigid modeling area is a, the cross section area of the metal inner core in the plastic modeling area is b, wherein a is more than b; the cross-sectional area of the metal inner core in the rigid plastic transition area is gradually reduced from a adjacent to one end of the rigid modeling area to b adjacent to one end of the plastic modeling area.

The larger the sectional area of the metal inner core is, the higher the rigidity of the metal inner core is, and the smaller the sectional area is, the more the metal inner core meets the requirement characteristic of a plastic molding area.

Preferably, the overall length-diameter ratio of the ring body is 4: (0.6-2.4).

The aspect ratio of the entire ring body referred to herein means a state in which the ring body is not subjected to a force after the in vitro molding.

Preferably, the central axis length ratio of the ring body of the front ring segment, the rear ring segment and the partition ring segment is (1-1.1): 1: (0.4-0.5).

Preferably, the ring body is wrapped with an elastic sleeve.

The elastic sleeve may be constructed of an inner core or surrounding molded silicone rubber or other similar material conventionally available in the art. The elastic sleeve provides an interface that allows sutures to pass through.

Preferably, the elastic sleeve is further coated with a biocompatible fabric.

The coated fabric may be any biocompatible and flexible material known in the art, and may be conventionally selected from polyethylene terephthalate.

Through improving on conventional hard ring body, set up rigid modeling district and plastic modeling district, provided the individualized adjustment function after leaving the factory that the hard ring does not possess, combine specific proportion size for the shaping ring can realize more effectively matching to the pathological change position.

The specific ring segment is selected for the recessed area because the anterior tricuspid leaflet 101 has the greatest mobility, while the posterior 123 and anterior 122 segments have the greatest expansion near the posterior leaflet 102, and the negative curvature of the ring is such that the major ring segment that causes the expansion of the annulus and the anterior leaflet that contributes most to leaflet coaptation are the most significantly reduced in average vertical distance to the annulus septal segment, which most effectively increases the leaflet coaptation area and height, and prevents the tricuspid annuloplasty annulus from continuing to expand, and since this range of the annulus is primarily located on the right ventricle free wall rather than the aortic segment 121 or septal segment 144, it is very safe to reposition the annulus. Meanwhile, the adoption of the concave design on the ring body can draw the most expanded valve ring part to the maximum extent, and compared with the prior oval forming ring with the same model, the concave ring provides an additional forming effect of increasing the coaptation area of the valve leaflets.

The arrangement of the rigid plastic transition region provides a foundation for the whole smooth transition of the ring body, and prevents the angulation on the ring body from stimulating the fragile organs in the body.

The inner core is a strip-shaped metal inner core, and a rigid modeling area and a plastic modeling area are conveniently arranged on the ring body while providing a framework for the ring body.

The adjustment of the rigidity and plasticity of the ring body in a specific area is realized through the size arrangement of the section of the metal inner core.

The length-diameter ratio of the whole ring body is 4: (0.6-2.4) so that the ring body is no longer of a conventional oval shape, but rather a relatively "prolate" morphology. Therefore, on the basis of reducing the valve ring, a closing force is further provided for the front valve ring, the rear valve ring and the isolating valve ring, the front valve leaf and the isolating valve leaf attached to the front valve ring are closer to each other, the involution area is increased, the involution is facilitated, and the regurgitation is further reduced or even eliminated on the basis of the reducing ring.

The length ratio of central axes of the ring bodies of the front ring segment, the rear ring segment and the partition ring segment is (1-1.1): 1: (0.4-0.5), the design guidance of the ring body is provided, so that the parts of the front ring section, the rear ring section and the spacing ring section, which correspond to the human body, cannot be changed after the ring body is implanted and deformed.

The wrapping elastic sleeve is used for isolating the inner core; the design of the covering fabric not only further isolates the inner core, but also facilitates drawing the front and rear sections of the ring body, the junction marking lines of the rear and partition sections and the sewing indicating lines on the surface of the covering fabric.

The invention has the advantages that the forming ring reduces the distance between the anterior valve ring, the posterior valve ring and the valve separating ring of the tricuspid valve, can be set pertinently under the conditions of significant expansion of the right ventricle, significant displacement of papillary muscles and constraint of valve leaflets, effectively increases the coaptation area and the apposition degree of the valve leaflets on the premise of ensuring enough opening area, and provides effective and lasting forming effect.

Drawings

FIG. 1 is a schematic representation of a closed state of the tricuspid valve with indicia as viewed from a typical orientation of the right atrial surface;

FIG. 2 is a schematic view of the tricuspid valve with markers as seen from the typical orientation of the right atrial surface;

fig. 3 is a schematic view of the deployment of the proximal region of each leaflet evenly covering the tricuspid orifice;

FIG. 4 is a schematic view of the tricuspid annulus dilation feature;

FIG. 5 is a general displacement of the three papillary muscles of the tricuspid valve in the direction of the annulus plane and the long axis of the ventricle when the right ventricle is expanded;

FIG. 6 is a graph of the effect of right ventricular dilation and papillary muscle displacement on the commissure of the tricuspid valve leaflets;

FIG. 7 is a schematic view of the overall structure of a tricuspid annuloplasty ring according to the present invention;

FIG. 8 is a schematic cross-sectional view of a tricuspid annuloplasty ring according to the present invention;

FIG. 9 is a schematic overall structure diagram of the first embodiment of the present invention;

FIG. 10 is a schematic view of the core construction of the first embodiment of the present invention;

FIG. 11 is a schematic representation of a prior art post-operative tricuspid annuloplasty ring;

FIG. 12 is a schematic view of a post-operative annuloplasty ring employing aspects of the present invention;

wherein:

101-anterior leaflet 102-posterior leaflet 103-septal leaflet

111-forward septal interface 112-forward posterior interface 113-rearward septal interface

121-aortic segment 122-anterior segment 123-posterior segment

124-septal segment 130-chordae tendineae 101 a-anterior valve proximal region

101 b-anterior valve coaptation zone 102 a-posterior valve proximal zone 102 b-posterior valve coaptation zone

103 a-septal valve proximal zone 103 b-septal valve coaptation zone 141-anterior papillary muscle

142-posterior papillary muscle 143-septal papillary muscle 1-ring body

11-front ring segment 12-rear ring segment 13-spacer ring segment

14-open end 21-rigid moulding zone 22-plastic moulding zone

23-rigid plastic transition zone 3-elastic sleeve 4-fabric

5-inner core 51-metal inner core

Detailed Description

The invention is further described below with reference to the following figures and specific examples.

The tricuspid annuloplasty ring shown in fig. 7 and 8 comprises an open ring body 1, wherein the ring body 1 is composed of an anterior ring segment 11 suitable for fixing the anterior leaflet and the vicinity thereof, a posterior ring segment 12 suitable for fixing the vicinity thereof, and a spacer ring segment 13 suitable for fixing the vicinity thereof, wherein the one-third position of the anterior ring segment 11 near the open end 14, the one-third position of the posterior ring segment 12 near the spacer ring segment 13, and the spacer ring segment 13 are rigid modeling regions 21 which are difficult to deform; the deformable plastic molding area 22 is arranged at one third position of the front ring segment 11 close to the rear ring segment 12 and one third position of the rear ring segment 12 close to the front ring segment 11. The ring body 1 is in smooth transition integrally, and the middle third position of the front ring section 11 and the middle third position of the rear ring section 12 are rigid plastic transition areas 23. The length-diameter ratio of the whole ring body 1 is 4: (0.6-2.4). The length ratio of the central axis of the ring body of the front ring segment 11, the rear ring segment 12 and the spacing ring segment 13 is (1-1.1): 1: (0.4-0.5). The framework of the ring body 1 is an inner core 5, and an elastic sleeve 3 is wrapped outside the inner core. The elastic sleeve 3 is also covered with a biocompatible fabric 4.

In the first embodiment shown in fig. 9, 10 and 12, the two thirds of the length of the front ring segment 11 near the rear ring segment 12 and the 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 tricuspid valve forming ring body 1 is a strip-shaped metal inner core 51; the cross section of the metal inner core 51 in the rigid modeling area 21 is a, the cross section of the metal inner core 51 in the plastic modeling area 22 is b, wherein a is larger than b; the cross-sectional area of the metal core 51 in the rigid plastic transition zone 23 gradually decreases from a adjacent one end of the rigid shaping zone 21 to b adjacent one end of the plastic shaping zone 22.

Similar to existing prosthetic valve rings, the ring may be similar to a conventional long diameter, i.e., ranging from 32-44mm for the outer diameter and 24-36mm for the inner diameter.

In a typical implementation, the elastic sleeve 3 is made of silicone rubber or other similar material molded around the inner core 5. The elastic sleeve 3 provides an interface allowing the passage of sutures. The elastic sleeve 3 has a thickness of about 0.4mm around the majority of the inner core 5, but is thicker by about 0.6mm at both open ends 14. The fabric 4 may in a typical implementation be any medical grade biocompatible material, such as polyethylene terephthalate with a thickness of about 0.3 mm. The surface of the fabric 4 can be used for drawing the indicating mark lines of the front and rear sections and the junction of the rear and partition sections of the ring body, and can also be used for drawing the sewing indicating lines.

While the preferred embodiments of the present invention have been described in detail, it will be understood by those skilled in the art that the invention is not limited to the embodiments disclosed, but is capable of numerous equivalents and substitutions, all of which are within the scope of the invention as defined by the appended claims.

Claims (9)

1. A tricuspid valve annuloplasty ring comprises an open ring body, and the ring body is continuously and sequentially composed of a front ring segment suitable for fixing an anterior valve leaflet and a nearby region thereof, a rear ring segment suitable for fixing a nearby region of a posterior valve leaflet and a spacer ring segment suitable for fixing a nearby region of a spacer valve leaflet, and is characterized in that the one-third position of the proximal opening end of the front ring segment, the one-third position of the proximal spacer ring segment of the rear ring segment and the spacer ring segment are rigid modeling regions which are difficult to deform; the position of one third of the front ring section near the rear ring section and the position of one third of the rear ring section near the front ring section are deformable plastic modeling areas.

2. The tricuspid annuloplasty ring according to claim 1, wherein the area of two thirds of the length of the anterior ring segment proximal to the posterior ring segment and two thirds of the length of the posterior ring segment proximal to the anterior ring segment is recessed toward the center of the ring.

3. The tricuspid annuloplasty ring according to claim 2, wherein the ring body is entirely rounded, and the middle third of the anterior ring segment and the middle third of the posterior ring segment are rigid plastic transition zones.

4. The tricuspid annuloplasty ring according to any one of claims 1 to 3, wherein the inner core of the ring body is a strip-shaped inner core of metal.

5. The tricuspid annuloplasty ring according to claim 4, wherein the cross-sectional area of the inner metal core in the rigid sculpted area is a, the cross-sectional area of the inner metal core in the plastic sculpted area is b, wherein a > b; the cross-sectional area of the metal inner core in the rigid plastic transition area is gradually reduced from a adjacent to one end of the rigid modeling area to b adjacent to one end of the plastic modeling area.

6. The tricuspid annuloplasty ring according to claim 1, wherein the overall aspect ratio of the ring body is 4: (0.6-2.4).

7. The tricuspid annuloplasty ring according to claim 1, wherein the anterior, posterior and septal ring segments have a ring body central axis length ratio of (1-1.1): 1: (0.4-0.5).

8. The tricuspid annuloplasty ring according to claim 1, wherein an elastic sleeve is further wrapped around the outside of the ring body.

9. The tricuspid annuloplasty ring according to claim 8, wherein the elastic sheath is further covered with a biocompatible fabric.

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