Tricuspid valve prosthesis suitable for transcatheterTechnical Field
The present invention relates to a tricuspid valve prosthesis suitable for transcatheter.
Background
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.
Patent CN102639179B and patent US8449599 describe a prosthetic device for mitral valve replacement 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 anchor coupled to and external to the main body, the anchor coupled to the main body such that when the main body is in the expanded state, the at least one anchor is configured to hook around the native leaflet, the at least one anchor and the main body defining a leaflet-receiving space therebetween; 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 anchoring device is characterized in that the anchoring device is fixed on the main body, the natural leaflet is flatly placed between the outer side surface of a blood channel of the main body of the stent and the inner side surface of the anchoring device, the fixing firmness is completely dependent on the friction force between the anchoring device and the main body, the native valve is always in the leaflet opening position and the unfolding state in the diastole period after being clamped, the blood flow of the left ventricle outflow channel is blocked in a large-area annular mode, part of blood flowing into the aorta from the left ventricle in the period is blocked by one part of the blood and flows back to the left ventricle, and after long-term implantation, the heart failure and other diseases can occur. The clamping force of this method is mainly based on the coincidence area of the inner side surface of the anchoring device and the outer side surface of the blood channel of the stent, and the contact area is not too large due to the limitation of the rod width of the stent, even as the anchoring device is outside the main body, the bending state of the anchoring device can cause the autologous valve to be fixed between the anchoring device and the main body by multi-point contact, so that the fixation of the device has unstable risk.
Jenavalve, patent US8465540, discloses an expandable stent having a plurality of positioning arches located at the sinus of the native valve and on one side of the native valve, and a plurality of retaining arches located on the other side of the native valve, and a plurality of radial supply arches, each positioning arch being radially connected by a single radial arch, each retaining arch comprising several curved edges, each curved edge constituting a bending point between two adjacent rods. The design is not enough, because the support adopts integrative cutting, the cutting space of location hunch form spare and maintenance hunch form spare must be each other non-overlapping, autologous valve is by the centre gripping only the line contact of several shaft-like objects when the arch form spare of location hunch with keep hunch between the form spare, autologous valve still has great range shake in the space between the shaft-like object under the blood flow effect, influence the normal motion of artificial valve prosthesis, reduce effective open area, and the centre gripping of line contact between the arch form spare and the maintenance hunch form spare of location, can lead to the clamping-force not enough, cause artificial valve prosthesis to shift easily.
Patent US20130325110a1 describes a method of treating mitral and tricuspid regurgitation by delivering a leaflet closing prosthesis without beating, the method comprising anchoring a ventricular anchor from the atrium through the native valve to the right ventricle, delivering and adjusting the position of the prosthesis at the tricuspid annulus using a catheter until regurgitation is reduced, securing the catheter relative to the flexible track and to the inferior vena cava. Although the position of the prosthesis can be adjusted by the delivery method to adapt to different reflux positions and have certain pathological adaptability, the position of the prosthesis at the fixed position of the inferior vena cava is far away from the valve ring position, so that the prosthesis is easily unstable to fix and can be displaced after the fixation is finished.
The fixing mode has two defects, one is that the fixing is not stable and firm due to the structural design of the fixing piece; the second drawback is that when these techniques are applied to mitral valve therapy, the expanded state along the circumferential direction of the valve annulus results in a large area of left ventricular outflow tract blocked when the native valve is clamped, which is prone to a series of complications after long-term implantation.
Disclosure of Invention
In order to solve the problems, the invention provides a tricuspid valve prosthesis suitable for transcatheter, which adopts the following technical scheme:
the invention provides a tricuspid valve prosthesis suitable for transcatheter placement on a tricuspid valve of a heart, comprising a stent and a prosthetic valve, wherein the stent comprises: the valve sewing section is in a hollow cylinder shape, and the artificial valve is fixedly connected to the valve sewing section. The anchoring mechanism is in a strip shape, is fixedly connected to the outer side of the valve sewing section and is provided with a main fixing piece and an auxiliary fixing piece which are connected with each other. The atrium section is cylindrical, and the near end of the atrium section is fixedly connected with the far end of the valve sewing section. The primary fixture includes a relief portion and a first arcuate segment. The auxiliary fixing piece comprises a pressing part and a second arched section, and a connecting section is arranged on the outer side of the valve sewing section. One end of the first arch section is connected to the connecting section. One end of the second arch section is connected to the connecting section. The buffer portion is connected to the other end of the first arcuate section. The stitching portion is connected to the other end of the second arcuate segment. The first arch section is in an arch shape bending towards the apex. The second arch section is an arch bent towards the apex of the heart, and the bending radian of the second arch section is larger than that of the first arch section, so that the buffering part and the pressing part can be close to each other for pressing. The surface of the buffer part facing the stitching part is provided with a plurality of micro-thorns.
The invention provides a tricuspid valve prosthesis suitable for transcatheter, which can also have the technical characteristics that the transverse cross-sectional dimension of the main fixing member is larger than that of the auxiliary fixing member.
The invention provides a tricuspid valve prosthesis suitable for transcatheter, and can also have the technical characteristics that the radial dimension of an atrial section is greater than or equal to the radial dimension of a valve sewing section.
The invention provides a tricuspid valve prosthesis suitable for transcatheter, and can also have the technical characteristics that the stent further comprises a reinforcing mechanism. The reinforcing mechanism is D-shaped or saddle-shaped. The proximal end of the stiffening mechanism is fixedly attached to the distal end of the atrial segment.
The invention provides a tricuspid valve prosthesis suitable for transcatheter, and can also have the technical characteristics that the reinforcing mechanism is made of flexible memory metal alloy material.
The invention provides a tricuspid valve prosthesis suitable for transcatheter, and can also have the technical characteristics that the reinforcing mechanism is a wave or a rod or a combination of the two.
Action and Effect of the invention
According to the transcatheter tricuspid valve prosthesis, firstly, the main fixing piece is turned upwards to fold and clamp the autologous valve leaflets in the first arched section, and then the auxiliary fixing piece is turned downwards and matched with the buffer part on the main fixing piece to clamp the autologous valve leaflets, so that the anchoring strength is further enhanced, and meanwhile, the support can be anchored on the autologous valve leaflets by the anchoring mode without radially supporting the autologous valve annulus, and the compression on native tissues is avoided.
Secondly, the projected area of the atrial section in the radial direction of the valve sewing section of the invention is larger than or equal to the projected area of the valve sewing section in the radial direction, the atrial section is provided with a reinforcing structure, the reinforcing structure is a wave or a rod or a combination of the wave and the rod, one end of the reinforcing structure is fixedly connected to the atrial section or fixedly connected to a material which is fixedly connected with the atrial section and used for reducing or preventing blood from flowing through, under the natural state, the other end of the reinforcing structure is opened towards the outside of the valve sewing section, the angle formed by the farthest end of the other end of the reinforcing structure and the far end direction of the axial lead is larger than or equal to the maximum value of the angle formed by the atrial section adjacent to the reinforcing structure and the far end direction of the axial lead, the angle design can enable the reinforcing structure to more tightly press the material which reduces or prevents blood from flowing through, enable the material to be in closer contact with autologous tissues, and prevent the material from generating micro motion along with the flow of blood, the paravalvular leakage phenomenon of the atrium segment of the heart valve prosthesis is reduced, particularly at the position corresponding to the junction area of the autologous valve.
Drawings
FIG. 1 is a schematic view of the overall structure of a transcatheter tricuspid valve prosthesis according to an embodiment of the present invention;
FIG. 2 is a schematic representation of an anchoring mechanism suitable for use in a transcatheter tricuspid valve prosthesis according to an embodiment of the present invention;
FIG. 3 is a schematic view of the primary and secondary fastening elements of an embodiment of the present invention shown in a pre-assembled condition;
FIG. 4 is a schematic view of the primary fasteners shown in a released state in accordance with an embodiment of the present invention;
FIG. 5 is a schematic view of an embodiment of the present invention showing the auxiliary fastener in a released state;
fig. 6 is a schematic view of the tricuspid valve prosthesis in the embodiment of the invention in a state of being installed.
Detailed Description
In order to make the technical means, the creation characteristics, the achievement purposes and the effects of the invention easy to understand, a transcatheter tricuspid valve prosthesis of the invention is specifically described below by combining the embodiment and the attached drawings.
< example >
Proximal in this embodiment refers to the end proximal to the apex of the heart and distal to the end distal to the apex of the heart.
Fig. 1 is a schematic view of the overall structure of a tricuspid valve prosthesis suitable for transcatheter use according to an embodiment of the present invention.
As shown in fig. 1, atricuspid valve prosthesis 01 suitable for transcatheter comprises astent 1 and aprosthetic valve 2.
Wherein, thestent 1 comprises anatrium section 11, avalve sewing section 12, ananchoring mechanism 13 and areinforcing mechanism 14.
Theatrium section 11 is cylindrical, and the near end is fixedly connected with the far end of thevalve sewing section 12. The radial dimension of theatrial section 11 is greater than or equal to the radial dimension of thevalve sewing section 12.
Thevalve sewing section 12 is in a hollow cylinder shape, and theartificial valve 2 is fixedly connected on thevalve sewing section 12. The outer side of thevalve sewing section 12 is provided with a connectingsection 121.
FIG. 2 is a schematic representation of an anchoring mechanism suitable for use in a transcatheter tricuspid valve prosthesis, in accordance with an embodiment of the present invention.
As shown in fig. 2, theanchoring mechanism 13 is in the form of a strip fixedly attached to the outside of thevalve sewing section 12, and has amain fixing member 131 and anauxiliary fixing member 132 connected to each other. The transverse sectional dimension of theprimary mount 131 is larger than that of thesecondary mount 132.
Themain fixture 131 includes abumper 1311 and a firstarched section 1312.
One end of the firstarched section 1312 is connected to the connectingsection 121. Abumper 1311 is attached to the other end of the firstarched section 1312. The firstarched section 1312 has an arch shape curved toward the apex.
Theauxiliary fixture 132 includes apress portion 1321 and a secondarched section 1322.
One end of the secondarched segment 1322 is connected to the connectingsegment 121. Acompression 1321 is attached to the other end of the secondarcuate segment 1322. The secondarched section 1322 is arched in a direction of the apex of the heart, and the curvature of the secondarched section 1322 is greater than that of the firstarched section 1312, so that thebuffer portion 1311 and thepressing portion 1321 can be pressed close to each other. The surface of thebuffer portion 1311 facing thenip portion 1321 is provided with a plurality ofmicro-pricks 13211.
Thepressing portion 1321 cooperates with thebuffer portion 1311 to clamp and press the native valve leaflet between thepressing portion 1321 and thebuffer portion 1311. Themain fixing member 131 in this embodiment is turned upwards to fold and clamp the native valve leaflets in the firstarched section 1312, and then theauxiliary fixing member 132 is turned downwards to cooperate with thebuffer part 1311 on the main fixingmember 131 to clamp the native valve leaflets, so as to further enhance the anchoring strength, and at the same time, the anchoring manner can anchor thestent 1 on the native valve leaflets without radially supporting the native valve annulus, so as to avoid pressing the native tissues.
The reinforcingmechanism 14 is D-shaped or saddle-shaped, and the proximal end of the reinforcingmechanism 14 is fixedly connected with the distal end of theatrial segment 11. The reinforcingmechanism 14 is made of a flexible memory metal alloy material. Thestrengthening mechanism 14 is a wave or a rod or a combination of both.
Theartificial valve 2 is fixedly connected on thevalve sewing section 12.
FIG. 3 is a schematic view of the primary and secondary fastening elements of an embodiment of the present invention shown in a pre-assembled condition; FIG. 4 is a schematic view of the primary fasteners shown in a released state in accordance with an embodiment of the present invention; FIG. 5 is a schematic view of an embodiment of the present invention showing the auxiliary fastener in a released state; fig. 6 is a schematic view of the tricuspid valve prosthesis in the embodiment of the invention in a state of being installed.
The central axis of thevalve sewing section 12 in the blood flow direction in this embodiment is referred to as the axis of thevalve sewing section 12.
As shown in fig. 3, 4, 5 and 6, a method of using the transcathetertricuspid valve prosthesis 01 according to the present embodiment is as follows: the main fixingmember 131 and theauxiliary fixing member 132 have a predetermined shape. As shown in fig. 3, when pre-assembled, the main fixingmember 131 is axially straightened toward the blood outflow end, and theauxiliary fixing member 132 is axially straightened toward the blood inflow section. When released, as shown in fig. 4, the distal end portion of the main fixingmember 131 returns to the preset configuration in the direction of the inflow section of the blood stream along the axial line. As shown in fig. 5, theauxiliary fixing member 132 is returned to the predetermined shape in the direction of the blood flow outflow end along the axial line. As shown in fig. 6, when thetricuspid valve prosthesis 01 is completely installed, thepressing portion 1321 of themain fixture 131 cooperates with thebuffer portion 1311 of theauxiliary fixture 132 to clamp and press the native valve leaflet between thepressing portion 1321 and thebuffer portion 1311.
Examples effects and effects
According to the transcatheter tricuspid valve prosthesis provided by the embodiment, firstly, the main fixing piece is turned upwards to fold and clamp the autologous valve leaflets in the first arched section, and then the auxiliary fixing piece is turned downwards to be matched with the buffer part on the main fixing piece to clamp the autologous valve leaflets, so that the anchoring strength is further enhanced, and meanwhile, the support can be anchored on the autologous valve leaflets by the anchoring mode without radially supporting the autologous valve annulus, and the compression on native tissues is avoided.
Secondly, the projected area of the atrium section of the embodiment in the radial direction of the valve sewing section is larger than or equal to the projected area of the valve sewing section, a reinforcing structure is arranged on the atrium section, the reinforcing structure is a wave or a rod or a combination of the wave and the rod, one end of the reinforcing structure is fixedly connected on the atrium section or fixedly connected on a material which is fixedly connected with the atrium section and used for reducing or preventing blood from flowing through, under the natural state, the other end of the reinforcing structure is opened towards the outside of the valve sewing section, the angle formed by the farthest end of the other end of the reinforcing structure and the far end direction of the axial lead is larger than or equal to the maximum value of the angle formed by the atrium section adjacent to the reinforcing structure and the far end direction of the axial lead, the angle design can enable the reinforcing structure to be more tightly pressed and reduce or prevent the material from flowing through which the blood flows through, so that the material is in closer contact with autologous tissues and can be prevented from generating micro motion along with the flow of the blood, the paravalvular leakage phenomenon of the atrium segment of the heart valve prosthesis is reduced, particularly at the position corresponding to the junction area of the autologous valve.
The above-described embodiments are merely illustrative of specific embodiments of the present invention, and the present invention is not limited to the description of the above-described embodiments.