Intervention type artificial heart valveTechnical Field
The invention relates to the technical field of medical instruments, in particular to an intervention type artificial heart valve.
Background
The heart is a very important organ of a human body and provides power for blood circulation of the human body, the heart is divided into a left part and a right part, each part comprises a ventricle and an atrium, the ventricle and the atrium are separated by a ventricular septum and an atrial septum, and valves for preventing blood backflow are arranged among the atrium, the ventricle and the artery.
The mitral valve is located between the left atrium and the left ventricle, and acts as a one-way valve to ensure that blood flows from the left atrium to the left ventricle and through a certain flow. The mitral valve complex is a complex set of devices that function and dissect structures, commonly thought of as including the annulus, leaflets, chordae tendinae, and papillary muscles. The function of the mitral valve depends on the integrity of its physiological structure. When the normal mitral valve is closed, the two valve leaflets are in the same plane and closely coapt, so that the backflow of the ventricular blood flow can be completely blocked. To achieve this result, the mitral annulus is required to be of a proper size, the leaflets have a complete structure, the papillary muscle contracts and pulls the chordae tendineae to support the leaflets, the left ventricular muscle contracts and generates a proper closing force, and the ventricles are required to have normal shapes and functions. Abnormalities in any of these factors can lead to Mitral Regurgitation (MR).
The most common cause is rheumatic valvular heart disease, and the most common cause is rheumatic valvular heart disease. Other common causes include mitral valve prolapse, mitral valve degeneration, mitral annulus calcification, papillary muscle failure due to myocardial ischemia, functional mitral insufficiency due to left ventricular enlargement, infectious endocarditis, congenital malformations, and the like. Surgical valve replacement surgery has large trauma and long recovery time of patients, so that the old patients are often contraindicated to surgery due to the old, weak constitution, serious disease or combination of other diseases.
In recent years, with the progress of interventional therapy technology, the interventional artificial heart valve replacement or repair operation carried out by a catheter is rapidly developed and applied to clinic, and a satisfactory effect is achieved. Interventional prosthetic heart valves are implanted into the heart's native mitral valve by minimally invasive interventional procedures to replace or repair the damaged native valve for relevant work. The interventional artificial heart valve mainly comprises a support and valve blades arranged in the support, and does not need to open a chest in the operation process, so that the trauma is small, the postoperative recovery is quick, and a new solution is provided for heart valve stenosis patients who cannot prolong the life or relieve the pain of the patients by the conventional treatment means at present.
But because the intervention treatment technology has short time, the application of the intervention treatment technology also faces more problems. For example, some interventional prosthetic heart valves are prone to breakage during use due to insufficient support; the degree of coincidence between the stent and the physiological structure of the natural valve is not enough, and perivalvular leakage is easy to occur; the stent structure easily compresses the cardiac outflow tract; too long and large a stent structure hurts the heart; the unreasonable design of the developing points influences the operation. In response to the problems with existing interventional prosthetic heart valves, those skilled in the art are constantly searching for solutions.
Disclosure of Invention
The invention aims to provide an interventional artificial heart valve, which aims to solve the problems that in order to meet the working requirement, the degree of coincidence between a stent and a natural valve is not enough, and displacement and paravalvular leakage are easy to occur; the stent structure easily compresses the cardiac outflow tract; too long and large a stent structure hurts the heart; the unreasonable design of the developing point influences the operation of the operation.
In order to solve the above technical problem, the present invention provides an interventional prosthetic heart valve, comprising:
the support comprises a support, valve leaflets arranged on the inner side of the support and a covering film arranged on the wall of the support; wherein,
the support comprises a first sub-support, a second sub-support and a third sub-support which are sequentially connected, wherein the first sub-support is a truncated cone-shaped net pipe, the second sub-support is a cylindrical net pipe, and the third sub-support is a trumpet-shaped net pipe; the biggest pipe diameter of first sub-support with the pipe diameter of second sub-support is the same, the minimum pipe diameter of third sub-support with the pipe diameter of second sub-support is the same, first sub-support and/or be provided with the barb on the body wall of second sub-support, the free end of barb is along deviating from the direction slope of the free end of first sub-support, on the third sub-support and/or be provided with the development point on the tectorial membrane on the third sub-support.
Optionally, in the interventional artificial heart valve, a body wall of the first sub-stent is inclined by 10 to 60 degrees with respect to a body wall of the second sub-stent.
Optionally, in the interventional artificial heart valve, an angle between the free end of the barb and a body wall of the first sub-stent or the second sub-stent is 20 degrees to 80 degrees, and the length of the barb is 3mm to 10 mm.
Optionally, in the interventional artificial heart valve, a delivery connecting part is further included, and the delivery connecting part is disposed at a free end of the first sub-stent.
Optionally, in the interventional prosthetic heart valve, the number of the delivery connecting parts is at least 3.
Optionally, in the interventional prosthetic heart valve, the number of the visualization points is 2.
Optionally, in the interventional artificial heart valve, the number of the valve leaflets is at least two.
Optionally, in the interventional artificial heart valve, the valve leaflet is a valve or a tissue engineering valve made of biological tissue or high polymer material.
Optionally, in the interventional artificial heart valve, a leaflet suture hole is provided on the first sub-stent or the second sub-stent, and the leaflet is sutured to the stent through the leaflet suture hole.
Optionally, in the interventional artificial heart valve, the stent is made of nickel-titanium alloy, and the covering film is made of one or more of PET, e-PTFE and pericardium materials.
In the intervention type artificial heart valve provided by the invention, the intervention type artificial heart valve comprises a support, valve leaflets arranged on the inner side of the support and a covering film arranged on the wall of the support, wherein the support comprises a first sub-support, a second sub-support and a third sub-support which are sequentially connected, the first sub-support is a truncated cone-shaped net pipe, the second sub-support is a cylindrical net pipe, and the third sub-support is a horn-shaped net pipe; 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. Compared with the prior art that the stent in the interventional artificial heart valve is designed into a cylindrical mesh tube, the first sub-stent has the advantages that the length of the stent is shortened due to the structure of the first sub-stent, damage to the heart caused by the fact that the stent is too long and penetrates into surrounding heart tissues is avoided, and the success rate of surgery is improved; on the other hand, as the stent structure is matched with the physiological structure of the natural valve, the body wall of the first sub-stent or the second sub-stent is provided with the barbs, and the barbs can penetrate into tissues around the valve after the heart valve is implanted to a specific position to play a positioning role, so that the intervention type artificial heart valve is not easy to displace and leak around the valve after being released; on the other hand, the position of the developing point is more reasonable based on the invention, which meets the requirement of the operation.
Drawings
FIG. 1 is a schematic structural diagram of an interventional prosthetic heart valve according to an embodiment of the present invention after implantation in an in situ mitral valve of a heart;
FIG. 2 is a front view of a stent of an interventional prosthetic heart valve in accordance with an embodiment of the present invention;
FIG. 2a is a top view of FIG. 2;
FIG. 3 is a front view of an interventional prosthetic heart valve after stent coating in accordance with an embodiment of the present invention;
fig. 3a is a top view of the stent of fig. 3 after leaflets have been sutured inside.
In the figure: a bracket 1; a leaflet 2; coating a film 3; a first sub-mount 10; a second sub-mount 11; a third sub-mount 12; a barb 4; a conveying connecting part 5; a development point 6; the leaflets suture the aperture 110.
Detailed Description
The interventional prosthetic heart valve of the present invention is further described in detail below with reference to the figures and the embodiments. Advantages and features of the present invention will become apparent from the following description and from the claims. It is to be noted that the drawings are in a very simplified form and are not to precise scale, which is merely for the purpose of facilitating and distinctly claiming the embodiments of the present invention.
Before explaining the present invention in detail, the principle and idea of the present invention will be explained. For minimally invasive interventional therapy, the stent of the interventional artificial heart valve can be stretched in the radial direction, the stent is convenient to be tightened and arranged in a conveying device with limited volume during installation and conveying, and the stent can be quickly opened after being released from the conveying device, so that the stent is conveniently and tightly attached to a target tissue to form an adequate blood flow channel; the structure of the third sub-bracket is matched with the physiological structure of the natural valve (especially matched with the natural physiological structure of the tissue around the mitral valve), has a certain self-positioning function, is convenient for quick and accurate positioning and release, is tightly attached to a blood flow channel after release, is not easy to shift, and is matched with the surrounding tissue to facilitate film covering to form a plugging structure, thereby being beneficial to avoiding the leakage around the valve; the barb can pierce the tissue around the valve after the heart valve is implanted to a specific position, so that the positioning effect is achieved, the heart valve is not easy to displace and leak around the valve after being released, the third sub-stent is used as a blood inlet of blood after being implanted to the valve position, and the first sub-stent is used as a blood outlet of the blood. Because the diameter of the third sub-stent structure part is larger than that of the second sub-stent, when the heart is in diastole, the natural plate-ring tissue can block the third sub-stent part to prevent the valve from sliding towards the heart chamber, and when the heart contracts, the barb can prevent the valve from moving, so that the stent with the structure can more effectively prevent the valve from shifting under the pressure of blood flow and scouring after the valve is released, the service life of the valve is longer after the valve is released, and the damage to the surrounding tissue is small.
Fig. 1 is a schematic structural diagram of the interventional prosthetic heart valve of the present invention after being implanted into an in situ mitral valve of a heart. Fig. 2 is a front view of a stent for an interventional prosthetic heart valve of the present invention. Fig. 3 is a front view of an interventional prosthetic heart valve after stent coating in accordance with an embodiment of the present invention. Fig. 3a is a top view of the stent of fig. 3 after leaflets have been sutured inside the stent. As shown in fig. 2, 3-3 a, the interventional prosthetic heart valve of the present invention comprises: the support comprises a support 1, valve leaflets 2 arranged on the inner side of the support 1 and a covering film 3 arranged on the body wall of the support 1; the stent 1 comprises a first sub-stent 10, a second sub-stent 11 and a third sub-stent 12 which are sequentially connected, wherein the first sub-stent 10 is a truncated cone-shaped mesh tube, the second sub-stent 11 is a cylindrical mesh tube, and the third sub-stent 12 is a trumpet-shaped mesh tube; the maximum pipe diameter of the first sub-support 10 is the same as that of the second sub-support 11, and the minimum pipe diameter of the third sub-support 12 is the same as that of the second sub-support 11.
Referring to fig. 2 and 2a, the first sub-mount 10, the second sub-mount 11 and the third sub-mount 12 are coaxial, and the three sub-mounts differ in shape. When the stent is actually prepared, the same original mesh tube is adopted, the original mesh tube is divided into three sections for a shaping process, the second sub-stent 11 has the same tube diameter as the original mesh tube, namely, no deformation treatment is needed, the edge of one end of the original mesh tube is radially contracted along the original mesh tube by the first sub-stent 10 to present the shape of the part marked with the reference number 10 in fig. 2, wherein the inclined angle theta of the body wall of the first sub-stent 10 relative to the body wall of the second sub-stent 11 is 10-60 degrees, and preferably 30 degrees.
Referring to fig. 2 and 3, a barb 4 is disposed on the body wall of the first sub-bracket 10 or the second sub-bracket 11, the free end of the barb 4 is inclined in a direction away from the free end of the first sub-bracket 10, and an angle between the barb 4 and the body wall of the first sub-bracket 10 or the second sub-bracket 11 is 20 degrees to 80 degrees, preferably 60 degrees. The length of the barb is 3 mm-10 mm. When the positioning device is applied, the barbs 4 penetrate into tissues around the valve to play a role in positioning the intervention type artificial heart valve. Here, the number of the barbs 4 is plural, and a plurality of the barbs 4 are uniformly distributed on the outer circumference of the first sub-stent 10 or the second sub-stent 11.
Specifically, the interventional artificial heart valve in this embodiment can be extended and retracted along the radial direction thereof, and when the interventional artificial heart valve is mounted and conveyed, the structure matched with the structures of the second sub-stent and the third sub-stent is designed to be matched with the physiological structure of the natural valve (especially matched with the natural physiological structure of the peripheral tissue of the mitral valve) so as to have a certain self-positioning function, facilitate quick and accurate positioning and release, and after the release, the stent is tightly attached to the blood flow channel and is not easy to shift.
In practical application, the intervention type artificial heart valve is accommodated in a conveying device and implanted in a patient, when the intervention type artificial heart valve reaches a target position, the intervention type artificial heart valve is released, at the moment, the support of the intervention type artificial heart valve is rapidly expanded from a compressed state, as shown in fig. 1, after the intervention type artificial heart valve is released, the first sub-support is positioned in a ventricle, the third sub-support is positioned in an atrium, the third sub-support is used as a blood inlet of blood, the first sub-support is used as a blood outlet of blood, as the pipe diameter of the third sub-support is larger than that of the second sub-support, when the heart is diastole, the natural plate ring tissue can block the third sub-support to prevent the intervention type artificial heart valve from sliding into the ventricle, and when the heart is contracted, the intervention type artificial heart valve can be prevented from displacing due to the barb effect, so based on the support structure of the invention, the method can effectively prevent the displacement of the intervention type artificial heart valve under the pressure and the scouring of blood flow after the intervention type artificial heart valve is released, prolong the service life of the intervention type artificial heart valve after the intervention type artificial heart valve is released, and reduce the damage of the intervention type artificial heart valve to surrounding tissues.
As shown in fig. 3a, the distribution position and shape of the leaflets 2 can be known, and in this embodiment, the number of the leaflets 2 is at least two. The valve leaflet is a valve or a tissue engineering valve prepared from a high molecular material and biological tissue (such as porcine pericardium, bovine pericardium, porcine heart valve, bovine heart valve and the like). Wherein, the valve leaflet includes the rectangle portion and with the arc portion that the rectangle portion is connected, the valve leaflet of adopting this shape is convenient for cooperate the suture, and the hemodynamics of gained valve is effectual. As shown in fig. 2, in order to install the leaflet in the holder, the leaflet sewing hole 110 is provided in the first sub-holder or the second sub-holder, and the leaflet is sewn to the holder through the leaflet sewing hole 110.
Further, referring to fig. 2, fig. 2a and fig. 3, in order to facilitate the engagement of the interventional prosthetic heart valve with the delivery device during the delivery phase, a delivery connection part 5 is disposed at the free end of the first sub-stent, and the number of the delivery connection parts 5 is at least 2.
Referring to fig. 2 and fig. 3a, in order to position and observe the position of the interventional artificial heart valve, 3 visualization points 6 are disposed on the third sub-stent and/or the cover film on the third sub-stent, and the three visualization points 6 are uniformly disposed along the circumferential direction of the stent. Specifically, if the developing points 6 are arranged on the third sub-bracket, developing holes need to be arranged on the outer wall of the third sub-bracket, and developing media are filled in the developing holes; if the development sites 6 are provided in the coating, a developing medium is added to the coating material at the positions where the development sites 6 need to be provided. The developing medium is one or more of platinum-iridium alloy (Pt/Ir), platinum metal (Pt) and tantalum metal (Ta).
Preferably, the stent is made of nickel-titanium alloy, and the covering membrane is made of one or more of PET, e-PTFE and pericardium materials.
Preferably, the grid shape of the cylindrical net tube of the second sub-stent is designed into a diamond shape, so that the supporting force of the interventional artificial heart valve in use is improved, and the problem of fracture of the stent caused by insufficient supporting force is avoided.
In summary, in the interventional artificial heart valve provided by the present invention, the interventional artificial heart valve includes a stent, valve leaflets disposed inside the stent, and a covering film disposed on a wall of the stent, the stent includes a first sub-stent, a second sub-stent, and a third sub-stent connected in sequence, the first sub-stent is a truncated cone-shaped mesh tube, the second sub-stent is a cylindrical mesh tube, and the third sub-stent is a trumpet-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. Compared with the prior art that the stent in the interventional artificial heart valve is designed into a cylindrical mesh tube, the first sub-stent has the advantages that the length of the stent is shortened due to the structure of the first sub-stent, damage to the heart caused by the fact that the stent is too long and penetrates into surrounding heart tissues is avoided, and the success rate of surgery is improved; on the other hand, as the stent structure is matched with the physiological structure of the natural valve, the body wall of the first sub-stent and/or the second sub-stent is provided with the barbs, and the barbs can penetrate into tissues around the valve after the heart valve is implanted to a specific position to play a positioning role, so that the intervention type artificial heart valve is not easy to shift after being released, and meanwhile, the valve is matched with the surrounding tissues to facilitate film covering to form a blocking structure, thereby being beneficial to avoiding the leakage around the valve; on the other hand, the position of the developing point is more reasonable based on the invention, which meets the requirement of the operation.
The above description is only for the purpose of describing the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention, and any variations and modifications made by those skilled in the art based on the above disclosure are within the scope of the appended claims.