CN106264793B - Self-adaptive heart valve prosthesis - Google Patents

Abstract

The invention relates to a self-adaptive heart valve prosthesis, which comprises a support and a prosthetic valve, wherein the support comprises a leakage-proof ring and a valve sewing section, the leakage-proof ring is connected with the valve sewing section, the prosthetic valve is fixedly connected on the valve sewing section, the valve sewing section is at least partially positioned between autologous valve leaflets of a patient, the cross section of the valve sewing section is smaller than that of the autologous valve annulus of the patient on the cross section perpendicular to the central axis of the prosthetic valve, so that the valve sewing section cannot directly and radially expand the autologous valve annulus of the patient, the cross section of the leakage-proof ring is larger than that of the autologous valve annulus of the patient in a free state, and the leakage-proof ring can conform to the uneven contour of the atrial chamber wall or the autologous valve annulus of the patient.

Description

Self-adaptive heart valve prosthesis

The technical field is as follows:

the invention belongs to the field of medical appliances, and particularly relates to a self-adaptive heart valve prosthesis.

Background art:

the mitral valve is located at the left atrioventricular orifice and is composed of five parts, an annulus, leaflets, chordae tendineae, papillary muscles, and an interfacing junction, which are anatomically known by the exact name mitral valve device (mitral apex) or mitral valve complex (mitral complex). The mitral annulus is a fibrous tissue band attached to the edge of the left atrioventricular orifice, and has an irregular "D" shape, the first third of the mitral annulus is a continuous part of the anterior valve and the aorta, the atria corresponding to the anterior valve and the posterior valve form different angles with the mitral annulus, and the left atrial appendage is also attached to the atria. Mitral insufficiency is one of the most common heart diseases, such as mitral insufficiency caused by conditions of mitral valve prolapse, mitral stenosis caused by valve damage due to rheumatic inflammation, and the like.

Mitral insufficiency can be classified into functional, degenerative, or mixed. Most common are degenerative and functional mitral insufficiency. Functionality is typically secondary to impaired left ventricular wall motor function, left ventricular dilatation, papillary muscle dysfunction, commonly found in heart failure patients. This fraction also includes ischemic mitral insufficiency secondary to coronary heart disease and mitral insufficiency associated with non-ischemic cardiomyopathy. Degenerative mitral regurgitation disease is generally considered to be a pathological change in the structure of the valve, or a pathological change in the structure under the valve, including abnormal extension or rupture of the chordae tendineae.

Mitral stenosis is the most common type of rheumatic heart valve disease, of which 40% of patients are simple mitral stenosis. Due to repeated rheumatic fever, early mitral valve is mainly formed by edema, inflammation and neoplasm (exudates) at the valve junction and the base part thereof, and adhesion and fusion are gradually formed at the front and back valve leaflet junctions, valve thickening, roughness, hardening and calcification, and chordae tendineae shortening and mutual adhesion are gradually formed in the healing process due to fibrin deposition and fibrosis, so that the valve mobility and opening are limited, and the valve orifice is narrowed. Other rare causes include senile annular or subcyclic calcification, congenital stenosis, and connective tissue disease.

The tricuspid valve is located at the orifice of the right atrioventricular, and the common onset is tricuspid valve insufficiency, namely, systolic blood flow flows back from the right ventricle to the right atrium, which causes the height of the right atrium to be enlarged, the pressure to be increased and venous blood backflow disorder. Right heart failure is likely to occur due to the compensatory hypertrophy of the load in the right ventricle.

Tricuspid valve regurgitation is generally caused by pulmonary hypertension, right ventricular enlargement and tricuspid valve annular dilation, and is clinically commonly represented by the causes of the tricuspid valve regurgitation (left heart failure, pulmonary hypertension and the like), and the symptoms of right heart failure such as tricuspid valve regurgitation, hypodynamia, ascites, edema, liver pain, dyspepsia, anorexia and the like are aggravated. Mild regurgitation of the tricuspid valve has no obvious clinical symptoms, but surgical treatment is required when there is severe regurgitation.

Traditional treatment approaches for mitral and tricuspid valve disease include medications for mild to severe regurgitation, and surgical procedures with corresponding surgical indications. Wherein the surgical method further comprises a valve replacement procedure and a valve repair procedure. In surgical procedures, typical open chest, open heart surgery is too invasive, requiring extracorporeal circulation to be established, with a high incidence of complications and risk of infection. Many patients do not tolerate the enormous surgical risk and can only remain indefinitely at risk for death.

With the first report of aortic valve intervention replacement, many companies have done a lot of work on interventional aortic valve technology, and the technology is mature. However, there remains a significant gap in the industry in the interventional treatment of atrioventricular valves. Although a few products currently exist for the interventional treatment of atrioventricular valves for transcatheter valvuloplasty and repair, no mature product is yet internationally available for transcatheter valve replacement. We will list several percutaneous interventional valve replacement techniques for mitral valves, most of which are in animal trials or clinical trials, each with limitations.

Patent CN102639179B and patent US8449599 describe a prosthetic device for mitral valve replacement by Edwards Lifesciences for implantation in the area of the native mitral valve of the heart, the native mitral valve having a native annulus and native valve leaflets, the prosthetic device comprising: a tubular body comprising a lumen for blood flow therethrough, an atrial end and a ventricular end, and configured for placement within the native annulus, the body being radially compressible to a radially compressed state for delivery into the heart, and self-expandable from the compressed state to a radially expanded state; at least one fixation device coupled to and external to the main body, the fixation device coupled to the main body such that when the main body is in the expanded state, the at least one fixation device is configured to hook around a native leaflet, defining a leaflet-receiving space between the at least one fixation device and the main body; and an annular flange portion extending radially outward from the atrial end of the main body, the annular flange portion including an atrial seal that prevents blood flow beyond the atrial end of the main body on an exterior of the main body when the prosthetic device is implanted. The fixing mode adopted by the technology is that the fixing device defined in the main right description is positioned outside the main body, the natural leaflets are flatly placed between the outer side surface of the blood channel of the stent main body and the inner side surface of the anchoring device, the fixing firmness is completely dependent on the friction force between the fixing device and the main body, and after being clamped, the native valve is always in the leaflet opening position and the leaflet unfolding state in the diastole period, the large-area annular block the blood flow of the left ventricle outflow channel, so that the blood flow flowing into the aorta from the left ventricle in the period is partially blocked and flows back to the left ventricle, and after long-term implantation, the heart failure and other diseases can occur. The difficulty of the operation is increased by the clamping mechanism of the autologous valve leaflet of the patient, especially when the autologous valve leaflet of the patient has heavy calcification, and in the clinical application of the product of Edwards, there are many cases that the operation fails because the autologous valve leaflet of the patient cannot be correctly grasped, the instrument is displaced and the patient finally dies or faces the death risk after the emergency open-chest surgery operation. Finally, the technique of clamping the native leaflets tends to compromise the re-sheathing function of the stent, and once released, it is irrevocable, presenting a significant surgical risk.

Patent CN201180020556 describes a mitral valve prosthesis from Medtronic, which comprises an inner support structure having a downstream portion and an upstream portion, wherein the upstream portion has a larger cross-sectional area than the downstream portion, the inner support structure being configured to be positioned at least partially on the atrial side of the native valve complex and to exert an axial force towards the left ventricle; and an outer support structure having two or more engagement arms, wherein the engagement arms are coupled to the inner support structure, wherein the prosthesis is configured to clamp a portion of a leaflet of a native valve between the inner support structure and the engagement arms upon implantation thereof. Similar to the Edwards design, the patient's native mitral valve is grasped by the upstream portion having the larger cross-sectional area against the mitral valve annulus, and by the engagement arms of the outer support structure. The whole body of the bracket still adopts a cylindrical symmetrical structure, so that a doctor still needs to select a large-sized valve to provide enough supporting force during operation, the blood supply of a left ventricular outflow tract is greatly blocked by the huge diameter of the valve, the flow rate of an aortic valve orifice is increased, the pressure is increased, and the heart failure condition is easy to occur for a long time. At the same time, the larger valve diameter fits directly across the annulus, compressing nearby tissue, including the aortic annulus.

Patent CN201610074782 provides a D-shaped intervention type artificial heart valve, which comprises a stent, valve leaflets arranged on the inner side of the stent, and a covering film arranged on the wall of the stent, wherein the stent comprises a first sub-stent, a second sub-stent and a third sub-stent which are sequentially connected, the first sub-stent is a mesh tube, the second sub-stent is a mesh tube with a D-shaped cross section, and the third sub-stent is a horn-shaped mesh tube. The maximum pipe diameter of the first sub-support is the same as that of the second sub-support, and the minimum pipe diameter of the third sub-support is the same as that of the second sub-support. Although it is claimed that the shape of the accommodation space enclosed by the wall of the native body of the in-situ mitral valve can be matched by the so-called D-shaped mesh tube, compared with the support with a circular section, the excessive compression of the support on the outline of the non-circular mitral valve, which causes the outflow tract of the heart to become narrow, can be avoided. The problem with this technique is that even if the stent cross-section is changed to D-shape, direct use of the full mesh structure to contact the mitral valve annulus can still cause compression on the surrounding tissue; meanwhile, the maximum pipe diameter of the first sub-stent is the same as that of the second sub-stent in the technology, which means that the cross section of the stent still is at least equal to the diameter of the mitral valve annulus, and the influence of the huge stent on outflow channels still exists; finally, in this technique, the second sub-stent is arranged in a D-shape, and the leaflets are sutured on the stent, the non-circular area necessarily affects the fit state of the sutured leaflets. Although this technique does not specifically disclose the way of the lobes, we can still see from their mating that their lobes are tri-lobed. Thus, non-circular sutures would be detrimental to leaflet closure performance and long-term leaflet fatigue.

Patent US20160074160 discloses a valve stent structure comprising an expanded outer stent made of a shape memory alloy, and an inner stent made of a shape memory alloy; the inner stent is composed of two parts, wherein in an initial state, the first part is in an expanded structure, the second part is in a compressed structure, the artificial valve is arranged on the first part of the inner stent, and the second part is also provided with a tether; the inner bracket is fixedly connected with the outer bracket. The problem with this solution is that the expanded outer stent remains supported on and radially expands the native annulus, while the larger cross-sectional area of the stent necessarily affects the outflow tract. In addition, the portion of the outer stent that is positioned over the mitral valve annulus does not conform to the uneven contours of the atrial chamber wall or the patient's own valve annulus, compresses the aorta or other heart tissue, and is not leak-proof.

Current clinical results indicate that there is no ideal product for interventional atrioventricular valve replacement. The main reason is that the mitral valve and the tricuspid valve have special physiological structures and complex physiological environments under the valve annulus, so that the accurate positioning and fixing of the product are very difficult. The problems of the prior art are summarized as follows: (1) at present, the anchoring technology mostly depends on the supporting force of a bracket on an atrioventricular valve ring, doctors often adopt a valve specification larger than the atrioventricular valve ring of a patient to cater to the contour of a mitral valve tissue, so that the huge bracket can influence an outflow channel, and easily press surrounding tissues, thereby further blocking the blood flow of a left ventricular outflow channel; (2) in the prior art, the support part positioned in the atrium is mostly in a grid form, the huge supporting force of the support part easily presses heart tissues, and the support part cannot completely conform to the uneven contour of the atrium wall or the valve annulus of a patient, so the leakage-proof effect is strong and not satisfactory; (3) for mitral valve replacement, the stent specification is too large, the anterior mitral valve is easily pushed to the left ventricular outflow tract, and the design of the clamping valve leaflets introduced for fixing the anterior mitral valve makes the release step very complicated, and is influenced by the calcification degree of the valve leaflets, thus influencing the success rate of the operation.

In summary, although the above-described techniques have certain effects on atrioventricular valve replacement, respectively, they still have disadvantages, and a new heart valve prosthesis is needed to solve the above problems in the field of surgery for treating valvular lesions.

The invention content is as follows:

the invention aims to overcome the limitations of the prior art and provides an adaptive heart valve prosthesis aiming at a patient needing to insert a valve replacement caused by mitral valve or tricuspid valve insufficiency or stenosis. The invention solves the problem caused by the radial expansion of the autologous valve annulus of the patient in the prior anchoring technology, can reduce the influence on the outflow channel after the release of the stent and avoid the traction on the autologous valve annulus on the basis of ensuring the anchoring effect of the implanted valve, can ensure that the opening area of the valve does not change too much due to the great difference between the patient valve annuluses, optimizes the valve performance and lightens the stock pressure of the product specification of manufacturers. Meanwhile, the leakage-proof ring can conform to the uneven contour of the atrial wall or the valve ring of the patient, so that the compression on the cardiac tissue can be reduced, and the leakage-proof effect can be improved.

The purpose of the invention is realized by the following technical scheme:

an adaptive heart valve prosthesis comprises a support and a prosthetic valve, and is characterized in that the support comprises a leakage-proof ring and a valve sewing section, the leakage-proof ring is connected with the valve sewing section, the prosthetic valve is fixedly connected to the valve sewing section, the valve sewing section is at least partially positioned between autologous valve leaflets of a patient, the cross section of the valve sewing section is smaller than that of the autologous valve annulus of the patient on the cross section perpendicular to the central axis of the prosthetic valve, so that the valve sewing section cannot directly and radially expand the autologous valve annulus of the patient, the cross section of the leakage-proof ring is larger than that of the autologous valve annulus of the patient in a free state, and the leakage-proof ring can conform to the uneven contour of the atrial chamber wall or the autologous valve annulus of the patient.

The purpose of the invention can be further realized by the following technical scheme:

preferably, on a cross section perpendicular to the central axis of the artificial valve, the center of the leakage-proof ring is not coincident with the center of the valve sewing section.

Preferably, the leakage prevention ring comprises a native annulus accommodating section and an atrial tissue accommodating section, which are respectively connected with the distal end portions of the valve sewing sections.

Preferably, the leakage prevention ring comprises a native annulus adaptation section and an atrial tissue adaptation section, the atrial tissue adaptation section is connected with the native annulus adaptation section, and the native annulus adaptation section is connected with the distal end part of the valve sewing section.

More preferably, the native annulus accommodating segment and the atrial tissue accommodating segment are of a unitary structure.

More preferably, the cross section of the self-body valve ring adapting section is of a D-shaped structure.

More preferably, the autologous annulus adapting section is provided with a connecting section, the cross section of the autologous annulus adapting section is of a D-shaped structure, the cross section of the connecting section is of a circular structure, and the autologous annulus adapting section is connected with the valve sewing section through the connecting section.

More preferably, the atrial tissue accommodating section has an elliptical or circular configuration or a D-shaped configuration in cross-section.

More preferably, the projection of the atrial tissue accommodating section is a disk-like structure or a bowl-like structure on a longitudinal section parallel to the central axis of the prosthetic valve.

Preferably, the valve sewing section is of a cylindrical grid structure, or the valve sewing section is of a cylindrical wavy structure.

Preferably, one end of the valve sewing section is provided with an extension section. The design enables the controllable release of the stent. More preferably, the extension section is detachably connected with the valve sewing section. By adopting the design, the extension section can be withdrawn from the body on the premise of ensuring the controllable release of the stent, so that the implants are greatly reduced, the contact and stimulation to the atrium are reduced, and the implantation limitation to the valve in the posterior valve is eliminated.

Preferably, the proximal skeleton portion of the valve sewing section is elongated. The design makes the proximal end of the stent maintain the compressed state, the leakage-proof ring can expand first, the position of the stent is adjusted, and the vessel wall is prevented from being punctured due to the expansion of the proximal end of the stent in the adjustment process.

Preferably, the leakage-proof ring is provided with a framework made of shape memory alloy, the framework is partially or completely coated with a film, and the film material comprises a metal material, polytetrafluoroethylene, polyethylene, polypropylene, terylene or an animal-derived material.

More preferably, the framework is composed of a plurality of support rods, or the framework is a wave-shaped structure, a zigzag structure or a grid structure formed by winding metal memory material wires. The width of the support rods or the diameter of the metallic memory material wire (e.g., nitinol wire) is in the range of 0.1-0.6 mm.

Preferably, the leakage-proof ring is provided with barbs which penetrate into autologous tissues of the patient in a free state.

Preferably, the leakage-proof ring and the valve sewing section are separately and independently manufactured and then connected into an integral structure.

Preferably, the leakage-proof ring and the valve sewing section are of an integral structure.

Preferably, the heart valve prosthesis further comprises a fixing device, one end of the fixing device is fixedly connected to the valve sewing section, and the other end of the fixing device is fixed to atrial tissue of the patient, or the other end of the fixing device is fixed to a blood vessel of the patient, or the other end of the fixing device is fixed to ventricular septum of the patient, or the other end of the fixing device is fixed to apical tissue of the patient.

Preferably, the fixing means is a wire or rod.

Preferably, the fixing device and the valve sewing section are of an integral structure.

More preferably, the fixing device is rigid, and the fixing device is formed by extending a skeleton at the proximal end of the valve sewing section, or the fixing device is formed by shaping a part of rod pieces in the proximal skeleton of the valve sewing section. More preferably, a reinforcing wave is arranged between the adjacent rod pieces to reinforce the transverse supporting force between the rod pieces. More preferably, the bars are located between adjacent waves in the lattice structure of the valve sewing section, or the bars are extensions of wave crests in the lattice structure of the valve sewing section.

Preferably, the fixation device is provided with a curved section so that the proximal portion of the fixation device can conform to the patient compartment space.

Preferably, the fixing device is a triangular structure, or the fixing device is an arc-shaped structure, or the fixing device is a grid-shaped structure. More preferably, a reinforcing rod is arranged in the fixing device.

Preferably, the fixing device is further provided with a fixing piece.

Preferably, the fixing piece and the fixing device are of an integrated structure, the fixing piece is a barb, or the fixing piece is of a sharp-pointed structure.

Preferably, the fixing member is an anchoring needle, and a limiting member is arranged at the tail of the anchoring needle.

More preferably, the fixing device is provided with a guide rail, the end of the guide rail is constricted, the anchoring needle is arranged in the guide rail, the needle tip part of the anchoring needle penetrates through the guide rail and is inserted into the heart tissue of the patient, and the diameter of the limiting part is larger than the caliber of the constriction.

More preferably, a connecting member is disposed on the limiting member, the connecting member is a linear member, one end of the connecting member is connected to the fixing device, and the other end of the connecting member is connected to the limiting member. The design is mainly to ensure that the implantation instrument is detachably connected with the pushing system, improve the accuracy of the needle insertion and prevent the anchoring needle from deviating from a preset needle insertion point.

Preferably, the fixing device is of an inverted cone structure, one end of the fixing device with the large diameter is connected with the near end of the valve sewing section, one end of the fixing device with the small diameter is connected with the connecting rod, the connecting rod is rigid, the near end part of the connecting rod is provided with a fixing piece, and the fixing device is fixed on the heart tissue through the fixing piece in a free state.

More preferably, the proximal end of the connecting rod is a hollow tube, a hole is arranged on the tube wall, and the most distal end of the fixing piece penetrates out of the hole on the hollow tube and penetrates into the heart tissue in the free state. The distal-most end of the anchor is pointed, the distal portion of the anchor is pre-shaped to one or a combination of the following shapes: a spiral, a circle, an arc, a combination of arc and straight, a bifurcated double hook, a 3D curve, a multi-segment curve, the distal end of the anchor being unbarbed or having one or more barbs.

More preferably, the fixing member is a suction cup-shaped member adapted to the contour of the apex of the heart, the surface of the proximal end portion of the connecting rod is provided with a thread, the fixing member is provided with a threaded hole, and the proximal end portion of the connecting rod is in threaded fit with the fixing member.

More preferably, the mounting is the sucking disc form component of adaptation apex of heart profile, be provided with projection, fastener and nut on the mounting, the projection cavity, the fastener is located in the projection, the projection surface is provided with the screw thread, the fastener cavity, the external diameter of fastener with the internal diameter of projection is equivalent, the internal diameter of fastener with the proximal part of connecting rod is equivalent, the connecting rod is located in the fastener, the fastener top is provided with the inclined plane, the fastener is provided with parallel cutting seam along the axis direction, be provided with in the nut and be greater than the inclined plane of fastener top inclined plane angle, work as when the nut with projection screw-thread fit, the clearance of cutting seam on the fastener diminishes, makes the connecting rod fix between the fastener.

More preferably, the fixing piece is a bracket with two large ends and a small middle, and is formed by shaping shape memory alloy.

More preferably, the fixing member is a cylindrical bracket.

Preferably, the outer surface of the valve sewing section is also provided with a filling device.

Preferably, the filling device is provided with a framework made of shape memory alloy, the framework is partially or completely coated with a film, and the film material comprises a metal material, polytetrafluoroethylene, polyethylene, polypropylene, terylene or an animal-derived material.

Preferably, on a cross section perpendicular to a central axis of the prosthetic valve, a projection of the filling device is an annular structure, and the annular structure comprises a circular ring structure or a D-shaped ring structure.

Preferably, the filling device and the leakage-proof ring are of an integral structure.

Preferably, a clamp is provided on a proximal end portion of the sewn valve section.

Compared with the prior art, the invention has the advantages that:

1. unlike the designs of most prior art products that utilize a stent to support the annulus, especially when the heart valve prosthesis is used for interventional replacement of the tricuspid valve, because the size of the patient's tricuspid valve annulus is very large, if it is supported within the patient's tricuspid valve annulus solely by a sewn segment of the valve, it is almost impossible from an engineering standpoint to achieve, if at all, a significant reduction in the valve life. In the invention, on the cross section vertical to the central axis of the artificial valve, the cross section area of the valve sewing section is smaller than that of the native valve annulus of the patient, so that the valve sewing section can not directly and radially expand the native valve annulus of the patient, thereby not only reducing the influence on the outflow channel after the release of the stent and avoiding the traction on the native valve annulus, but also ensuring that the opening area of the valve can not be changed too much due to the huge difference between the native valve annuluses of the patient, optimizing the valve performance, reducing the product specification of manufacturers and reducing the stock pressure of manufacturers.

2. Different from the prior art that most of the supports positioned in the atria adopt a grid form, the huge supporting force of the supports easily causes pressure on heart tissues (the heart tissues are prevented from contracting to influence blood supply when the heart tissues are more serious) and the leakage-proof effect is strong and not satisfactory.

3. Different from the concentric structure of most of the prior products, the center of the valve sewing section is not coincident with the center of the leakage-proof ring on the cross section vertical to the central axis of the artificial valve. When the heart valve prosthesis is used for intervention and replacement of a mitral valve, the central axis of the valve sewing section is deviated to the posterior valve area of the mitral valve of a patient, so that the obstruction to the left ventricular outflow tract can be further reduced; when the heart valve prosthesis is used for intervention replacement of the tricuspid valve, the central axis of the valve sewing section deviates to the valve separation area of the tricuspid valve of a patient, so that the fixing device can be favorably attached to a target anchoring area, the anchoring effect is more ideal, and the valve movement is more stable.

4. In the invention, the far-end framework of the valve sewing section is provided with an extension section, and the extension section is detachably connected with the valve sewing section. By the design, on the premise of ensuring controllable release of the support, the extension section can be withdrawn from the body, so that the number of implants is greatly reduced, the contact and stimulation to atria are reduced, a conveying system is convenient to withdraw from the body, and implantation limitation to the valve in the posterior is eliminated.

5. In the invention, the autologous valve ring adapting section is provided with the connecting section, the cross section of the autologous valve ring adapting section is of a D-shaped structure, the cross section of the connecting section is of a circular structure, and the leakage-proof ring is connected with the valve sewing section through the connecting section, so that the design has the advantages that on one hand, the connecting strength of the autologous valve ring adapting section and the valve sewing section is improved, on the other hand, the autologous valve ring adapting section can be designed to be more tightly attached to the valve ring of a patient, and meanwhile, the opening area of the valve can not be changed too much due to the huge difference between the valve rings of the patient.

Drawings

Fig. 1a-1c show schematic views of an embodiment of the invention.

Fig. 2a-2g show schematic diagrams of various embodiments of the present invention.

Figures 3a-3d show schematic views of various embodiments of the containment ring of the present invention.

Fig. 4a-4f show schematic diagrams of various embodiments of the present invention.

Fig. 5a-5g show schematic diagrams of various embodiments of the present invention.

Fig. 6a-6e show schematic diagrams of various embodiments of the present invention.

Fig. 7a-7e show schematic diagrams of various embodiments of the present invention.

Fig. 8a-8c show schematic diagrams of various embodiments of the present invention. Wherein figure 8b is a cross-sectional view of figure 8 a.

Fig. 9a-9d show schematic views of one delivery embodiment of the present invention.

Fig. 10a-10d show schematic views of another delivery embodiment of the present invention.

Fig. 11a-11d show schematic views of another embodiment of the present invention, wherein fig. 11c and 11d are cross-sectional views of fig. 11 a.

The specific implementation mode is as follows:

in order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail below with reference to the accompanying drawings and examples.

The distal end of the present invention refers to the end away from the apex of the heart, and the proximal end refers to the end near the apex of the heart.

The first embodiment is as follows:

for a long time, both Edwards and Medtronic, manufacturers of large valves have employed an enlarged stent-to-annulus radial expansion ratio to achieve adequate stent anchoring force, which has been well established and is well established in the field of aortic and pulmonary valve intervention replacements (typically 10% -15% for ideal circumferential expansion ratio). As for Jenavalve and Symetic, the leaflet clamping mechanism is applied to products, and still has a certain expansion ratio to the valve of a patient. However, the atrioventricular valves (including the mitral valve and the tricuspid valve) often make accurate positioning and fixation of the product very difficult due to their complex physiological structures and diseased mechanisms. Current techniques for atrioventricular valve intervention replacement, such as Edwards, Medtronic, and Tiara, all need to provide a certain radial expansion ratio to meet anchoring requirements without exception, and although they use a leaflet grip design to improve anchoring, they only slightly reduce the radial expansion ratio. Generally speaking, the existing anchoring technology mostly depends on the supporting force of a support on an atrioventricular valve ring, doctors often adopt a valve specification larger than the atrioventricular valve ring of a patient to cater to the tissue outline of the mitral valve, so that the huge support can influence an outflow channel, surrounding tissues are easily pressed, and the blood flow of a left ventricular outflow channel is further blocked; for mitral valve replacement, the stent specification is too large, the anterior mitral valve is easy to push to the left ventricular outflow tract, and the design of clamping valve leaflets introduced for fixing the anterior mitral valve makes the release step very complicated and is influenced by the calcification degree of the valve leaflets, thus influencing the success rate of the operation; for interventional replacement of the tricuspid valve, because the size of the patient's tricuspid valve annulus is very large, if supported within the patient's tricuspid valve annulus solely by the sewn segment of the valve, this is almost impossible from an engineering standpoint, and if not impossible, greatly reduces the valve life. In addition, the grid form is adopted in the support part positioned in the atrium in the prior art, the great supporting force of the support part easily causes the compression of heart tissues, the uneven contour of the atrium wall or the valve annulus of the patient is not completely conformed, the leakage prevention effect is strong and unsatisfactory, and the defects are frequently reported in the clinical report of the prior art.

Therefore, we propose a new heart valve prosthesis that can solve the above problems. In one embodiment, as shown in fig. 1a-1c, an adaptive heart valve prosthesis 100 for tricuspid valve intervention replacement therapy comprises a stent 110 and a prosthetic valve 120, wherein the stent 110 comprises a leakage-proof ring 111 and a valve sewing segment 112, the prosthetic valve 120 is fixedly connected to the valve sewing segment 112, and the valve sewing segment 112 is at least partially located between native valve leaflets of a patient. On the cross section perpendicular to the central axis of the artificial valve 120, the cross sectional area of the valve sewing section 112 is smaller than the cross sectional area of the patient native valve annulus 180, so that the valve sewing section 112 cannot radially expand the patient native valve annulus 180, the design not only can reduce the influence on the outflow channel after the release of the stent and avoid the traction on the native valve annulus, but also can ensure that the opening area of the valve does not change too much due to the huge difference between the patient annuluses, thereby optimizing the valve performance, reducing the product specification and relieving the stock pressure of manufacturers. The valve sewing section 112 is a cylindrical grid structure, the projection of the leakage-proof ring 111 is a circular ring structure, the valve sewing section 112 is located in the leakage-proof ring 111, the leakage-proof ring 111 is located in an atrium of a patient and is attached to an autologous valve ring 180 of the patient in a free state, the leakage-proof ring 111 can conform to the uneven contour of the atrium wall or the autologous valve ring of the patient and does not limit the contraction function of the atrium, on one hand, the leakage-proof effect is improved, and on the other hand, the heart tissue is prevented from being pressed. The heart valve prosthesis 100 further comprises a fixing device 113, one end of the fixing device 113 is connected to the valve sewing section 112, and the other end of the fixing device 113 is fixedly connected to the patient compartment 183. The distal framework of the valve sewing section 112 is provided with an extension section 1121, so that the stent can be controllably released, and the positioning precision is improved.

The fixing device 113 is an integral structure with the valve sewing section 112, in one embodiment, the fixing device 113 is an extension of the proximal skeleton of the valve sewing section 112, and the fixing device 113 is rigid. Such a design is mainly based on the consideration that the entire instrument is supported in the target position by means of the fixation means, the rigid design ensuring the anchoring function.

In one embodiment, as shown in fig. 2a and 2b, the fixation device 113 has a triangular structure, and a curved portion 1130 is provided on the fixation device 113 to allow a proximal portion of the fixation device 113 to conform to the patient compartment. The fixing device 113 is further provided with a fixing member 114, the fixing member 114 is an anchoring needle, a distal end portion of the anchoring needle 114 is pre-shaped, a tip portion of the anchoring needle 114 is pre-shaped in a spiral shape, a circumferential shape or an arc shape, and the tip portion of the anchoring needle 114 is provided with a plurality of barbs. A stopper 1140 is disposed at the tail of the anchoring needle 114, and the diameter of the stopper 1140 is greater than the needle diameter of the anchoring needle 114. The fixing device 113 is covered with a membrane 1131, the material of the membrane 1131 includes a metal material, polytetrafluoroethylene, polyethylene, polypropylene, dacron or an animal-derived material, and the needle tip portion of the anchoring needle 114 penetrates through the membrane 1131 and is inserted into the heart tissue of the patient.

In another embodiment, as shown in fig. 2c and 2d, the fixing device 113 has an arc-shaped structure, and the reinforcing rod 1132 is disposed inside the fixing device 113, so that the fixing device has the advantage of improving the rigidity of the fixing device and ensuring the anchoring function. The fixing member 114 is an anchor needle, a distal end portion of the anchor needle 114 is pre-shaped, a tip portion of the anchor needle 114 is pre-shaped in a combination of an arc and a straight line or a bifurcated double hook shape, and the tip portion of the anchor needle 114 is provided with a barb. The anchoring needle 114 is provided with a stopper 1140 at the tail. The fixing device 113 is provided with a hole 1133, the needle tip portion of the anchoring needle 114 penetrates through the hole 1133 and penetrates into the cardiac tissue of the patient, and the diameter of the retainer 1140 is larger than the aperture of the hole 1133.

In another embodiment, as shown in fig. 2e and 2f, the fixture 113 is a grid-like structure. The fixture 114 is an anchoring needle, a distal end portion of the anchoring needle 114 is pre-shaped, a needle tip portion of the anchoring needle 114 is pre-shaped in a 3D curved shape or a multi-segment curved shape, the needle tip portion of the anchoring needle 114 is unbarbed, and a stopper 1140 is provided at a tail portion of the anchoring needle 114. The fixing device 113 is provided with a guide rail 1134, an end portion 1135 of the guide rail 1134 is constricted, the anchoring needle 114 is disposed in the guide rail 1134, a needle tip portion of the anchoring needle 114 is inserted into the heart tissue of the patient through the guide rail 1134 by a pushing device (not shown), and the diameter of the position-limiting member 1140 is larger than the caliber of the constricted opening.

In another embodiment, as shown in fig. 2g, a connecting member 1141 is disposed on the position-limiting member 1140, and the connecting member 1141 is a linear member. One end of the connecting member 1141 is connected to the fixing device 113, and the other end of the connecting member 1141 is connected to the position-limiting member 1140. The design is mainly to ensure that the implantation instrument is detachably connected with the pushing system, improve the accuracy of the needle insertion and prevent the anchoring needle from deviating from a preset needle insertion point.

The leak-proof ring is positioned in the atrium of the patient and is attached to the valve ring of the autologous valve of the patient, the leak-proof ring can conform to the uneven contour of the wall of the atrium cavity or the valve ring of the autologous valve of the patient without limiting the contraction function of the atrium, and the leak-proof effect is improved. In one embodiment, as shown in fig. 3a, the leakage prevention ring 111 comprises a native annulus accommodating section 1115 and an atrial tissue accommodating section 1116, the native annulus accommodating section 1115 being smaller in diameter than the atrial tissue accommodating section 1116, and the native annulus accommodating section 1115 and the atrial tissue accommodating section 1116 are respectively connected to the distal end portion of the valve sewing section 112. The projection of the atrial tissue accommodating section 1116 is a disk-like structure in a longitudinal section parallel to the central axis of the prosthetic valve. As shown in fig. 3b-d, the leakage preventing ring 111 has a skeleton 1111 made of shape memory alloy, the skeleton 1111 is entirely covered with a film 1112, and the material of the film 1112 includes a metal material, teflon, polyethylene, polypropylene, dacron or an animal-derived material. The framework 1111 is a wavy structure, a zigzag structure or a grid structure formed by winding metal memory material wires, and the diameter of the metal memory material wires (such as nickel-titanium alloy wires) is 0.3 mm. The leakage-proof ring 111 and the valve sewing section 112 are separately manufactured and then sewn together by a sewing thread to form an integral structure.

The second embodiment is as follows:

in one embodiment, as shown in fig. 4a and 4b, an adaptive heart valve prosthesis 200 for mitral valve interventional replacement therapy includes a stent 210 and a prosthetic valve (not shown), the stent 210 includes a leakage prevention ring 211 and a valve sewing section 212, the prosthetic valve is fixedly connected to the valve sewing section 212, the leakage prevention ring 211 is located in an atrium of a patient and is seated on a native valve annulus 280 of the patient in a free state, the leakage prevention ring 211 can conform to uneven contours of an atrial wall or the native valve annulus of the patient without limiting contraction function of the atrium, the valve sewing section 212 is located at least partially between the native valve leaflets of the patient, and a cross-sectional area of the valve sewing section 212 is smaller than a cross-sectional area of the native valve annulus 280 of the patient in a cross-sectional area perpendicular to a central axis of the prosthetic valve, such that the valve sewing section 212 does not radially expand the native valve annulus 280 of the patient. The heart valve prosthesis 200 further comprises a fixing device 213, one end of the fixing device 213 is connected to the proximal end portion of the valve sewing section 212, and the other end of the fixing device 213 is provided with a fixing member 214 and is connected with the myocardial muscle of the patient through the fixing member 214.

In one embodiment, as shown in fig. 4c, the fixing device 213 is formed by shaping a part of the rod 2123 in the proximal frame of the sewing segment 212. For example, the rods 2123 are extensions of the peaks of the saw-wave in the lattice structure of the valve sewing segment 213. The fixing member 214 and the fixing device 213 are an integral structure, and the fixing member 214 is a sharp-shaped structure at the end of the rod 2123. The stem 2123 is provided with a curved section 2130 to allow the pointed structure of the stem 2123 to penetrate the patient's annulus tissue.

In another embodiment, as shown in fig. 4d, the fixing device 213 is formed by shaping a part of the rods 2123 in the proximal frame of the valve sewing segment 212, the rods 2123 are located between adjacent saw-shaped waves or adjacent wavy structures in the lattice structure of the valve sewing segment 213, and reinforcing waves 2124 are disposed between the rods 2123 for reinforcing the lateral supporting force between the rods 2123. The fixing member 214 and the fixing device 213 are of an integral structure, and the fixing member 214 is one or more barbs. The stem 2123 is provided with a curved section 2130 so that the proximal portion of the fixation device 213 can conform to the heart tissue of the patient, such as the valve annulus tissue, the valve, or the chordae tendineae, into which the barbs hook for secure fixation.

In one embodiment, as shown in fig. 4e and 4f, the anti-leakage ring 211 and the valve sewing section 212 are of an integral structure, the anti-leakage ring 211 has a skeleton 2111 made of shape memory alloy, the skeleton 2111 is completely covered with a film 2112, the skeleton 2111 is composed of a plurality of support bars, the support bars are formed by shaping part of the bars in the valve sewing section 212, and the width of the support bars is 0.4 mm. More preferably, the struts 2111 are wave-shaped, which advantageously increases the flexibility of the frame 2111, allowing the leakage prevention ring 211 to conform to the uneven contours of the atrial chamber wall or the native valve annulus of the patient, resulting in improved leakage prevention. The leakage-proof ring 211 comprises a native valve ring adapting section 2115 and an atrial tissue adapting section 2116, the atrial tissue adapting section 2116 is connected with the native valve ring adapting section 2115, the native valve ring adapting section 2115 is connected with the distal end part of the valve sewing section 212, the cross section of the native valve ring adapting section 2115 is in a D-shaped structure on the cross section perpendicular to the central axis of the artificial valve, and the center of the leakage-proof ring 211 (the intersection point of two dotted lines in figure 4 f) is not coincident with the center 2120 of the valve sewing section 212. In a preferred embodiment, the native annulus accommodating segment and the atrial tissue accommodating segment are of unitary construction. When the heart valve prosthesis of the present invention is used in the tricuspid valve field, the center 2120 of the sewing segment 212 is disposed between the center of the conforming segment 2115 and the straight segment of the "D" shape of the conforming segment 2115. When the heart valve prosthesis of the invention is used in the field of mitral valve, the center of the valve sewing segment is arranged between the center of the native valve annulus adapting segment and the arc line segment of the "D" shape of the native valve annulus adapting segment on the cross section perpendicular to the central axis of the artificial valve. The advantage of this design is that when the prosthesis is used in a tricuspid valve replacement, the fixation device can be advantageously positioned against the targeted anchoring area, with more optimal anchoring and more stable valve motion.

The third concrete embodiment:

in one embodiment, as shown in fig. 5a, an adaptive heart valve prosthesis 300, is used for tricuspid valve interventional replacement treatment and comprises a bracket 310 and a prosthetic valve (not shown), wherein the bracket 310 comprises a leakage-proof ring 311 and a valve sewing segment 312, the artificial valve is fixedly connected to the valve sewing section 312, the valve sewing section 312 is a cylindrical wave-shaped structure, the fixing device 313 is of an inverted cone-shaped structure, one end with a large diameter of the fixing device 313 is connected with the proximal end of the valve sewing section 312 by well-known technologies such as sewing, buckling or welding, the small diameter end of the fixing device 313 is provided with a connecting rod 315, the connecting rod 315 is rigid, one end of the connecting rod 315 is connected with the end of the fixing device 313, the proximal end portion of the connecting rod 315 is provided with a fixing member 314, in the free state, the fastening device 313 is fastened to the apical tissue 384 by the fastening element 314. The leakage-proof ring 311 is connected with the valve sewing section 312, in a free state, the leakage-proof ring 311 is positioned in an atrium of a patient and attached to a valve ring of the autologous valve of the patient, the leakage-proof ring 311 can conform to the uneven contour of the wall of the atrium cavity or the valve ring of the autologous valve of the patient without limiting the contraction function of the atrium, the valve sewing section 312 is at least partially positioned between the valve leaves of the autologous valve of the patient, and the cross section of the valve sewing section 312 is smaller than that of the valve ring of the autologous valve of the patient on the cross section perpendicular to the central axis of the artificial valve, so that the valve sewing section 312 cannot radially expand the valve ring of the.

The proximal end of the connecting rod 315 is a hollow tube, and a hole 3150 is formed in the wall of the hollow tube. The distal-most end of the anchor 314 is pointed, the distal portion of the anchor 314 is pre-shaped, and the distal portion of the anchor 314 is pre-shaped to one or a combination of the following shapes: spiral, circumferential, arc, combination of arc and straight, bifurcated double hook, 3D curved, multi-segmented curved, with the distal end of the anchor 314 being unbarbed or having one or more barbs. In the free state, the distal-most end of the anchor 314 extends out of the hole 3150 in the hollow tube 315 to penetrate apical tissue 384.

In another embodiment, as shown in fig. 5b, the fixing member 314 is a suction cup-shaped member adapted to the contour of the apex of the heart, the outer surface of the proximal portion of the connecting rod 315 is provided with threads, the fixing member 314 is provided with a threaded hole, and the proximal portion of the connecting rod 315 is threadedly engaged with the fixing member 314.

In another embodiment, as shown in fig. 5c-e, the fixing member 314 is a suction cup-shaped member adapted to the contour of the apex of the heart, and the fixing member 314 is provided with a boss 3141, a fastener 3142 and a nut 3143. The convex column 3141 is hollow, the fastening member 3142 is positioned in the convex column 3141, and the inner surface of the convex column 3141 is provided with threads. The fastening member 3142 is hollow, the outer diameter of the fastening member 3142 is equivalent to the inner diameter of the convex column 3141, the inner diameter of the fastening member 3142 is equivalent to the diameter of the proximal end part of the connecting rod 315, the connecting rod 315 is positioned in the fastening member 3142, the top end of the fastening member 3142 is provided with an inclined surface, and the fastening member 3142 is provided with parallel cutting seams 3144 along the axial direction. The nut 3143 is provided with an inclined surface with an angle larger than that of the top end of the fastening member 3142, and when the nut 3143 is in threaded fit with the boss 3141, the clearance of the cutting seam 3144 on the fastening member 3142 is reduced, so that the connecting rod 315 is fixed between the fastening members 3142.

In one embodiment, as shown in fig. 5f and 5g, the leakage prevention ring 311 includes a native valve annulus accommodating section 3115 and an atrial tissue accommodating section 3116, and the atrial tissue accommodating section 3116 has a projection in an elliptical or circular configuration or a D-shaped configuration in a cross-section perpendicular to a central axis of the prosthetic valve. In a longitudinal section parallel to the central axis of the prosthetic valve, the atrial tissue accommodating segment 3116 is projected as a bowl-shaped structure, which is supported within the atrium 381 of the patient. The leak-proof ring 311 has a skeleton 3111 made of a shape memory alloy, and the skeleton 3111 is partially covered with a film 3112 in order to prevent the leak-proof ring 311 supported in the atrial wall from obstructing the coronary sinus, the superior vena cava, and the inferior vena cava. The film 3112 material includes a metal material, polytetrafluoroethylene, polyethylene, polypropylene, polyester, or an animal-derived material. In another embodiment, as shown in fig. 5g, a gripping member 370 is provided on a proximal portion of the valve sewing section 312 for gripping native leaflets 389 to enhance anchoring effect.

The fourth concrete embodiment:

in one embodiment, as shown in fig. 6a, an adaptive heart valve prosthesis 400 is used for tricuspid valve interventional replacement therapy. The difference from the third embodiment is that the fixing member 414 is a bracket with two large ends and a small middle, and is formed by shaping a shape memory alloy, and the fixing member 414 is fixed on the room partition 483 in a free state.

In one embodiment, unlike the concentric structure of most existing products, in the present invention, the center of the valve sewing section 412 is not coincident with the center of the leakage preventing ring 411 in the cross section perpendicular to the central axis of the prosthetic valve, and the leakage preventing ring 411 is eccentrically disposed with respect to the valve sewing section 412. When the heart valve prosthesis is used for interventional replacement of a mitral valve, as shown in fig. 6b, the central axis of the sewing segment 412 is biased toward the posterior valve region 485 of the patient's mitral valve (in a dotted line), which can further reduce obstruction of the left ventricular outflow tract; as shown in fig. 6c, when the heart valve prosthesis is used for interventional replacement of a tricuspid valve, the central axis of the valve sewing section 412 is biased toward the valve separating region 486 of the tricuspid valve (dotted line portion) of a patient, which is beneficial for the fixing device to be able to cling to a target anchoring region, so that the anchoring effect is more desirable and the valve movement is more stable.

In one embodiment, as shown in fig. 6d and 6e, the leakage preventing ring 411 and the valve sewing section 412 are separately manufactured and then connected into a unitary structure. Holes 4123 are formed in the frame of the valve sewing section 412, and the leak-proof ring 411 is connected to the valve sewing section 412 through the holes 4123 by using sewing threads 4113. The leakage prevention ring 411 has a skeleton made of shape memory alloy, the skeleton is completely covered with a film, and the projection of the atrial tissue adaptation section 4116 is a disk-shaped structure on a longitudinal section parallel to the central axis of the prosthetic valve. Be provided with barb 4114 on the leak protection ring 411, when the fit of leak protection ring 411 patient autologous valve annulus, barb 4114 pierces in the patient autologous tissue.

The fifth concrete embodiment:

in one embodiment, as shown in fig. 7a and 7b, the heart valve prosthesis 500 comprises a plurality of said fixation devices 513, unlike the previous embodiment. One of the fixing devices 513a is an inverted cone-shaped structure and is located at the proximal end of the valve sewing section 512, the large-diameter end of the fixing device 513a is connected with the proximal end of the valve sewing section 512 by a known technology such as sewing, buckling or welding, and the small-diameter end of the fixing device 513a is provided with a connecting rod (not shown). Another of the fixation devices 513b is a wire or rod, one end of the fixation device 513b is connected to the valve sewing section 512, and the other end of the fixation device 513b is fixed to the atrial tissue of the patient. The advantage of design like this lies in adopting the mode of upper and lower spacing to prevent that the implant from shifting or coming off, the anchoring firmness of reinforcing implant.

In another embodiment, as shown in fig. 7c, the fixing device 513b is further provided with a fixing member 514, the fixing member 514 is a bracket with two large ends and a small middle, and is formed by shaping a shape memory alloy, and the fixing device 513b is fixed on the atrium wall 581 by the fixing member 514 in a free state. In another embodiment, as shown in fig. 7d, the fixation member 514 is a cylindrical stent, and the fixation device 513b is fixed in the superior vena cava 582 by the fixation member 514 in a free state. In another embodiment, as shown in fig. 7e, the heart valve prosthesis 500 comprises a plurality of the fixation devices 513(513a, 513b, 513c, 513d), the fixation devices 513 are rod-shaped members with sharp ends and barbs, and the rod-shaped members 513a, 513b, 513c are fixed on the right ventricular muscle tissue respectively.

In another embodiment, as shown in fig. 8a, the outer surface of the sewn valve section 512 is further provided with a filling device 518. In the cross section perpendicular to the central axis of the prosthetic valve 520, as shown in fig. 8b, the projection of the filling device 518 is an annular structure, which includes a circular ring structure or a D-ring structure, so that the design has the advantage of increasing the contact with the native valve leaflets and improving the leakage prevention effect. The filling device 518 has a skeleton made of shape memory alloy, the skeleton is partially or completely covered with a film, and the film material includes a metal material, polytetrafluoroethylene, polyethylene, polypropylene, dacron or an animal-derived material. In another embodiment, as shown in FIG. 8c, the filling device 518 is a unitary structure with the containment ring 511. The proximal frame 5120 of the valve sewing section 512 is partially elongated. The design enables the proximal end of the valve sewing section 512 to be in a compressed state, and the leakage-proof ring 511 expands first, so that the position of the stent can be adjusted, and the vessel wall is prevented from being punctured due to the expansion of the proximal end of the stent in the adjustment process.

In one embodiment, as shown in fig. 9a-9d, the heart valve prosthesis 500 is passed from the right atrium of the patient into the tricuspid region of the heart of the patient via a catheter and released gradually, and finally the heart valve prosthesis 500 is fixed to the ventricular septum 583 and the atrial tissue 581 of the patient via the fixing means 513(513a, 513b), respectively.

In another embodiment, as shown in fig. 10a-10d, the heart valve prosthesis 500 is passed from the apex of the patient's heart into the area of the mitral valve of the patient's heart via a catheter and gradually released, and finally the heart valve prosthesis 500 is fixed at the apex 584 of the patient's heart by the fixing means 513.

The sixth specific embodiment:

in one embodiment, as shown in fig. 11a to 11D, the autologous annulus adaptation section 6115 is provided with a connection section 6117, the cross section of the autologous annulus adaptation section 6115 is a D-shaped structure, the cross section of the connection section 6117 is a circular structure, and the autologous annulus adaptation section 6115 is connected with the valve sewing section 612 through the connection section 6117, so that the design has the advantages of improving the connection strength between the autologous annulus adaptation section 6115 and the valve sewing section 612 on one hand, and enabling the autologous annulus adaptation section 6115 to be designed to be closer to the patient's annulus on the other hand.

In another embodiment, as shown in fig. 11b, the distal end frame of the valve sewing section 612 is provided with an extension section 6121, and the extension section 6121 is detachably connected with the valve sewing section 612. Due to the design, on the premise of ensuring controllable release of the stent, the extension segment 6121 can be withdrawn from the body, so that the number of implants is greatly reduced, the contact and stimulation to atria are reduced, a conveying system is convenient to withdraw from the body, and the implantation limitation to the valve in the future is eliminated. A hole-shaped structure 6125 is arranged at the proximal end of the extension section 6121, the far-end framework of the valve sewing section 612 enters the hole-shaped structure 6125 in a staggered manner, a locking hole 6126 is arranged on the far-end framework of the valve sewing section 612, and a locking rod 6127 is inserted into the locking hole 6126 to realize locking; when the locking rod 6127 is pulled out of the locking hole 6126, the distal end skeleton of the valve sewing section 612 is separated from the hole-shaped structure 6125 of the extension section 6121, so that the extension section 6121 and the valve sewing section 612 are detached.

Finally, it should be understood that the above-mentioned embodiments are merely preferred embodiments of the present invention, and not intended to limit the present invention, and any modifications, equivalents and improvements made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims (10)

1. A self-adaptive heart valve prosthesis comprises a support and a prosthetic valve, and is characterized in that the support comprises a leakage-proof ring and a valve sewing section, the leakage-proof ring is connected with the valve sewing section, the prosthetic valve is fixedly connected on the valve sewing section, the valve sewing section is at least partially positioned between autologous valve leaflets of a patient, the cross section of the valve sewing section is smaller than that of the autologous valve annulus of the patient on the cross section perpendicular to the central axis of the prosthetic valve, so that the valve sewing section cannot directly and radially expand the autologous valve annulus of the patient, the cross section of the leakage-proof ring is larger than that of the autologous valve annulus of the patient in a free state, and the leakage-proof ring can conform to the uneven contour of the atrial chamber wall or the autologous valve annulus of the patient,

the heart valve prosthesis also comprises a fixing device, one end of the fixing device is fixedly connected to the valve sewing section, the other end of the fixing device is fixed on atrial tissue of a patient, or the other end of the fixing device is fixed in a blood vessel of the patient, or the other end of the fixing device is fixed on a ventricular septum of the patient, or the other end of the fixing device is fixed on apical tissue of the heart of the patient,

the fixing device is one of the following structures:

the fixing device is of an inverted cone-shaped structure, one end with a large diameter of the fixing device is connected with the near end of the valve sewing section, one end with a small diameter of the fixing device is connected with a connecting rod, the connecting rod is rigid, a fixing piece is arranged at the proximal part of the connecting rod, and the fixing device is fixed on heart tissue through the fixing piece in a free state;

or the heart valve prosthesis comprises a first fixing device and a second fixing device, the first fixing device is of an inverted cone-shaped structure and is positioned at the near end of the valve sewing section, one end with the large diameter of the first fixing device is connected with the near end of the valve sewing section through sewing, buckling or welding, and one end with the small diameter of the first fixing device is provided with a connecting rod; the second fixing device is a wire or a rod, one end of the second fixing device is connected to the valve sewing section, and the other end of the second fixing device is fixed to atrial tissue of a patient; or the second fixing device is fixed in the superior vena cava by the cylindrical bracket when in a free state;

wherein the connecting rod and the fixing piece are one of the following structures:

the proximal part of the connecting rod is a hollow tube, a hole is arranged on the tube wall, and the farthest end of the fixing piece penetrates out of the hole on the hollow tube and penetrates into the heart tissue in a free state; the distal-most end of the anchor is pointed, the distal portion of the anchor is pre-shaped to one or a combination of the following shapes: a spiral shape, a circular shape, an arc shape, a combination of an arc line and a straight line shape, a bifurcated double hook shape, a 3D bent shape, a multi-section bent shape, wherein the far end of the fixing piece is not provided with a barb or is provided with one or more barbs;

or the fixing piece is a sucker-shaped component which is adaptive to the outline of the apex of the heart, the surface of the proximal part of the connecting rod is provided with threads, the fixing piece is provided with a threaded hole, and the proximal part of the connecting rod is in threaded fit with the fixing piece;

or the fixing piece is a sucker-shaped component adaptive to the contour of the apex of the heart, the fixing piece is provided with a convex column, a fastener and a screw cap, the convex column is hollow, the fastener is positioned in the convex column, the outer surface of the convex column is provided with threads, the fastener is hollow, the outer diameter of the fastener is equivalent to the inner diameter of the convex column, the inner diameter of the fastener is equivalent to the proximal part of the connecting rod, the connecting rod is positioned in the fastener, the top end of the fastener is provided with an inclined plane, the fastener is provided with parallel cutting seams along the axial direction, the screw cap is internally provided with an inclined plane with an angle larger than that of the inclined plane at the top end of the fastener, and when the screw cap is in threaded fit with the convex column, the gap of the cutting seams on;

or the fixing piece is a bracket with two large ends and a small middle and is formed by shaping shape memory alloy;

or the fixing device is of a triangular structure, and a bending section is arranged on the fixing device, so that the proximal end part of the fixing device can be fit with the patient room interval; the fixing device is also provided with an anchoring needle, the distal end part of the anchoring needle is pre-shaped, and the needle tip part of the anchoring needle is pre-shaped into a spiral shape, a circumferential shape or an arc shape; a limiting piece is arranged at the tail of the anchoring needle, and the diameter of the limiting piece is larger than the needle diameter of the anchoring needle; a membrane is covered on the fixing device, and the needle tip part of the anchoring needle penetrates through the membrane and is inserted into the heart tissue of the patient; the fixing device and the valve sewing section are of an integral structure, the fixing device is an extension of a proximal framework of the valve sewing section, and the fixing device is rigid;

or the fixing device is of an arc-shaped structure, a reinforcing rod is arranged in the fixing device, an anchoring needle is arranged on the fixing device, the distal end part of the anchoring needle is pre-shaped, the needle tip part of the anchoring needle is pre-shaped into a combination of an arc line and a straight line or a forked double-hook shape, and the needle tip part of the anchoring needle is provided with a barb; the tail part of the anchoring needle is provided with a limiting piece; the fixing device is provided with a hole, the needle tip part of the anchoring needle penetrates through the hole and is inserted into cardiac tissue of a patient, and the diameter of the limiting piece is larger than the aperture of the hole; the fixing device and the valve sewing section are of an integral structure, the fixing device is an extension of a proximal framework of the valve sewing section, and the fixing device is rigid;

one end of the valve sewing section framework is provided with an extension section which is detachably connected with the valve sewing section,

the leakage-proof ring comprises an autologous valve ring adapting section and an atrial tissue adapting section, the autologous valve ring adapting section is provided with a connecting section, the cross section of the autologous valve ring adapting section is of a D-shaped structure, the cross section of the connecting section is of a circular structure, and the autologous valve ring adapting section is connected with the valve sewing section through the connecting section.

2. The adaptive heart valve prosthesis of claim 1, wherein a center of the leak-proof ring is not coincident with a center of the sewn section of the valve in a cross-section perpendicular to a central axis of the prosthetic valve.

3. The adaptive heart valve prosthesis of claim 1, wherein the native annulus accommodating segment and the atrial tissue accommodating segment are each connected to a distal portion of the sewing segment.

4. The adaptive heart valve prosthesis of claim 1, wherein the atrial tissue accommodating segment is attached to the native annulus accommodating segment, and wherein the native annulus accommodating segment is attached to a distal portion of the sewing segment.

5. The adaptive heart valve prosthesis of claim 4, wherein the native annulus-conforming segment and the atrial tissue-conforming segment are a unitary structure.

6. The adaptive heart valve prosthesis of claim 1, wherein the atrial tissue accommodating segment has an elliptical configuration or a circular configuration or a D-shaped configuration in cross-section.

7. The adaptive heart valve prosthesis of claim 1, wherein the fixation device is a unitary structure with the sewn valve section.

8. The adaptive heart valve prosthesis of claim 1, wherein the fixation device further comprises a fixation element.

9. The adaptive heart valve prosthesis of claim 1, wherein the outer surface of the sewn valve section is further provided with a filling device.

10. The adaptive heart valve prosthesis of claim 1, wherein a clamp is provided on a proximal portion of the sewn valve section.

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