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CN105520792B - A kind of D-shaped insertion type artificial cardiac valve - Google Patents

A kind of D-shaped insertion type artificial cardiac valve Download PDF

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Publication number
CN105520792B
CN105520792B CN201610074782.2A CN201610074782A CN105520792B CN 105520792 B CN105520792 B CN 105520792B CN 201610074782 A CN201610074782 A CN 201610074782A CN 105520792 B CN105520792 B CN 105520792B
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China
Prior art keywords
sub
support
stent
shaped
body wall
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CN105520792A (en
Inventor
虞奇峰
秦涛
王海山
梁玉晨
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Shanghai Niu Mai Medical Science And Technology Co Ltd
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Shanghai Niu Mai Medical Science And Technology Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418Scaffolds therefor, e.g. support stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2445Annuloplasty rings in direct contact with the valve annulus
    • A61F2/2448D-shaped rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466Delivery devices therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028Shapes in the form of latin or greek characters
    • A61F2230/0034D-shaped

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

The present invention provides a kind of D-shaped insertion type artificial cardiac valves, including bracket, the leaflet being set on the inside of bracket and the overlay film being set on bracket body wall, bracket includes sequentially connected first submounts, the second submounts and third submounts, first submounts are network management, second submounts are the network management that cross section is D-shaped, and third submounts are in horn-like network management;The maximum caliber of first submounts is identical as the caliber of the second submounts, and the minimum pipe of third submounts is identical as the caliber of the second submounts.By the way that the second submounts are designed as the network management that cross section is D-shaped, with support Design in existing D-shaped insertion type artificial cardiac valve be compared with section is circular tubulose, the shape of second submounts matches with the accommodating space shape that mitral primary body wall in situ surrounds, to avoid the problem that it causes patient other complication occur the compressing of heart efferent tract when in use, the success rate of operation is improved.

Description

D-shaped interventional artificial heart valve
Technical Field
The invention relates to the technical field of medical instruments, in particular to a D-shaped interventional 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, transcatheter heart valve replacement or repair is rapidly developed and applied clinically, 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 a D-shaped interventional artificial heart valve, which aims to solve the problem that the outflow tract of a heart is pressed when the existing interventional artificial heart valve is applied.
In order to solve the above technical problem, the present invention provides a D-shaped 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 net pipe, the second sub-support is a net pipe with a D-shaped cross section, and the third sub-support is a trumpet-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.
Optionally, in the D-shaped interventional prosthetic heart valve, the second sub-stent includes a straight body wall and an arc body wall, the straight body wall and the arc body wall are mutually connected to form a mesh tube with a D-shaped cross section, and an inclination angle of the body wall of the third sub-stent relative to the straight body wall of the second sub-stent is greater than an inclination angle of the body wall of the third sub-stent relative to the arc body wall of the second sub-stent.
Optionally, in the D-shaped interventional prosthetic heart valve, the first sub-stent is a truncated cone-shaped mesh tube, and 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 D-shaped interventional prosthetic heart valve, a barb is disposed on a body wall of the first or second sub-stent, and a free end of the barb is inclined in a direction away from the free end of the first sub-stent.
Optionally, in the D-shaped interventional prosthetic heart valve, a visualization point is further included, and the visualization point is disposed on the third sub-stent and/or on a cover film on the third sub-stent.
Optionally, in the D-shaped interventional prosthetic heart valve, the number of the visualization points is 3, wherein 2 visualization points are disposed on the third sub-stent connected to the straight body wall of the second sub-stent, and the other 1 visualization point is disposed on the cover membrane of the third sub-stent connected to the curved body wall of the second sub-stent.
Optionally, in the D-shaped interventional prosthetic heart valve, the number of the leaflets is at least two.
Optionally, in the D-shaped intervention type artificial heart valve, the leaflet is a valve or a tissue engineering valve made of biological tissue or high polymer material.
Optionally, in the D-shaped interventional artificial heart valve, the first sub-stent or the second sub-stent is provided with a leaflet suture hole, and the leaflet is sutured on the stent through the leaflet suture hole.
Optionally, in the D-shaped interventional prosthetic 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.
The D-shaped interventional artificial heart valve provided by the invention 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 mesh tube, the second sub-support is a mesh tube with a D-shaped cross section, and the third sub-support 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. Compared with the prior D-shaped interventional artificial heart valve in which the stent is designed into a tubular shape with a circular section, the shape of the second sub-stent is matched with the shape of the accommodating space enclosed by the wall of the original body of the in-situ mitral valve, so that the problem that other complications of a patient occur due to the compression of the second sub-stent on the outflow tract of the heart is avoided when the stent is used, and the success rate of the operation is improved.
Drawings
FIG. 1 is a schematic structural diagram of a D-shaped interventional prosthetic heart valve according to an embodiment of the present invention after being implanted in an in situ mitral valve of a heart;
FIG. 2 is a front view of a stent for a D-shaped interventional prosthetic heart valve in accordance with an embodiment of the present invention;
FIG. 3 is a front view of a D-shaped 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; leaflet suture holes 110; a flat body wall 111; an arcuate body wall 112; a third sub-mount 12; a barb 4; a conveying connecting part 5; and a development point 6.
Detailed Description
The D-shaped interventional prosthetic heart valve provided by the invention is further explained in detail in the following by combining the attached drawings and specific 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. Aiming at the problem that the existing interventional artificial heart valve compresses the outflow tract of the heart during application, long-term experimental verification proves that the phenomenon is caused because the support structure of the existing interventional artificial heart valve is tubular, and the cross section of the space for accommodating the interventional artificial heart valve is not circular but D-shaped, so that the straight side wall of the accommodating space can be compressed after the interventional artificial heart valve with the tubular support is arranged in the in-situ mitral valve of the heart, and the outflow tract of the heart becomes narrow. Based on the discovery of the problem, the technical scheme of the invention is provided, and the technical scheme of the invention is mainly carried out from the design of the shape of the bracket.
Fig. 1 is a schematic structural diagram of the D-shaped 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 a D-shaped interventional prosthetic heart valve of the present invention. Fig. 3 is a front view of a D-shaped 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 D-shaped 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 mesh tube, the second sub-stent 11 is a mesh tube with a D-shaped cross section, 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. 3, the second sub-stent includes a straight body wall 111 and an arc body wall 112, and the straight body wall 111 and the arc body wall 112 are connected to each other to form a mesh tube with a D-shaped cross section, so that the structural shape of the prepared D-shaped interventional artificial heart valve conforms to the cross-sectional shape of the space for accommodating the D-shaped interventional artificial heart valve, and the compression on the cardiac outflow tract due to unreasonable stent structure is avoided; the inclination angle of the body wall of the third sub-stent relative to the straight body wall 111 of the second sub-stent is larger than the inclination angle of the body wall of the third sub-stent relative to the arc body wall 112 of the second sub-stent, so that the morphological distribution of native tissues is further conformed, and the damage of the third sub-stent structure to heart tissues is avoided. In practical application, after the D-shaped interventional artificial heart valve is placed in an in-situ mitral valve of a heart, the straight body wall of the second sub-stent is close to one side of a cardiac outflow tract.
Furthermore, the first sub-stent is a cone frustum-shaped net tube, so that the length of the whole stent is reduced, and the injury of the stent to tissues around the heart due to overlong length after the stent is implanted into the heart is avoided.
Referring to fig. 2, the first sub-mount 10, the second sub-mount 11 and the third sub-mount 12 are coaxial, and the three are different 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, when the second sub-stent 11 is prepared, the section of original mesh tube is shaped into a mesh tube with a D-shaped cross section, the edge of one end of the original mesh tube is contracted along the radial direction of the original mesh tube to present the shape of a part marked with 10 in figure 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 10 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 D-shaped interventional 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 D-shaped interventional artificial heart valve in this embodiment can be extended and retracted along the radial direction thereof, and when the D-shaped interventional artificial heart valve is installed 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 that the D-shaped interventional artificial heart valve has a certain self-positioning function, is convenient to quickly and accurately position and release, is not easy to displace after being released, and is matched with the peripheral tissue to facilitate the film covering to form a blocking structure, thereby being beneficial to avoiding the leakage around the valve.
In practical application, the D-shaped interventional artificial heart valve is accommodated in a conveying device and implanted in a patient, when the D-shaped interventional artificial heart valve reaches a target position, the D-shaped interventional artificial heart valve is released, at the moment, a support of the D-shaped interventional artificial heart valve is rapidly expanded from a compressed state, as shown in fig. 1, after the D-shaped interventional 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 serves as a blood inlet of blood, the first sub-support serves as a blood outlet of blood, since the pipe diameter of the third sub-support is larger than that of the second sub-support, when the heart is in diastole, the natural plate ring tissue can block the third sub-support to prevent the D-shaped interventional artificial heart valve from sliding into the ventricle, and when the heart is in systole, due to the effect of the barb, the D-shaped interventional artificial heart valve can be prevented from moving into the ventricle, therefore, based on the support structure, the D-shaped intervention type artificial heart valve can be more effectively prevented from shifting under the pressure of blood flow and under the scouring after being released, the service life of the D-shaped intervention type artificial heart valve after being released is prolonged, and the damage to surrounding tissues is reduced.
As shown in fig. 3a, the distribution position and the shape of the valve leaflets 2 can be known, in this embodiment, the number of the valve leaflets 2 is at least two, and the valve leaflets are biological tissues (such as porcine pericardium, bovine pericardium, porcine heart valve, bovine heart valve, etc.), valves made of polymer materials, or tissue engineering valves. 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 and 3, in order to facilitate the combination of the D-shaped interventional prosthetic heart valve with the delivery device in the delivery stage, a delivery connection part 5 is provided 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 3a, in order to position and observe the position of the D-shaped interventional artificial heart valve, there are 3 visualization points 6 disposed on the third sub-stent and/or on the cover film on the third sub-stent, wherein 2 visualization points are disposed on the third sub-stent connected to the straight body wall of the second sub-stent, and the other 1 visualization point is disposed on the cover film of the third sub-stent connected to the arc body wall of the second sub-stent, and 3 visualization points form a plane, and when the D-shaped interventional artificial heart valve reaches the target position when being placed in the heart, two visualization points disposed on the third sub-stent connected to the straight body wall are on the same straight line, and are observed and displayed as the same point. 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 D-shaped interventional artificial heart valve in use is improved, and the problem of breakage of the stent caused by insufficient supporting force is avoided.
In summary, in the D-shaped interventional artificial heart valve provided by the present invention, the D-shaped 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 mesh tube, the second sub-stent is a mesh tube with a D-shaped cross section, 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 D-shaped interventional artificial heart valve in which the stent is designed into a tubular shape with a circular section, the shape of the second sub-stent is matched with the shape of the accommodating space enclosed by the wall of the original body of the in-situ mitral valve, so that the problem that other complications occur to a patient due to the compression of the second sub-stent on the outflow tract of the heart is avoided when the stent is used; on the other hand, the first sub-stent is designed into a truncated cone-shaped mesh tube, so that the overall length of the stent is shortened, the damage to the heart caused by the fact that the stent is excessively long and penetrates into surrounding heart tissues is avoided, and the success rate of the operation is improved; on the other hand, as the body wall of the first sub-stent or the second sub-stent is provided with the barbs, 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 D-shaped 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.
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.

Claims (7)

1. A D-shaped 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 net pipe with a D-shaped cross section, and the third sub-support is a trumpet-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; the second sub-stent comprises a straight body wall and an arc body wall, and the inclination angle of the body wall of the third sub-stent relative to the straight body wall of the second sub-stent is larger than the inclination angle of the body wall of the third sub-stent relative to the arc body wall of the second sub-stent;
the developing point is arranged on the third sub-bracket and/or the coating on the third sub-bracket;
the quantity of development point is 3, wherein 2 development point set up with the straight body wall of second sub-support is connected on the third sub-support, 1 development point set up in addition with the arc body wall of second sub-support is connected on the tectorial membrane of third sub-support.
2. The D-shaped interventional prosthetic heart valve of claim 1, wherein a body wall of the first sub-stent is inclined at 10-60 degrees relative to a body wall of the second sub-stent.
3. The D-shaped interventional prosthetic heart valve of claim 1, wherein a body wall of the first or second sub-stent is provided with barbs, free ends of the barbs being inclined in a direction away from the free ends of the first sub-stent.
4. The D-shaped interventional prosthetic heart valve of claim 1, wherein the number of leaflets is at least two.
5. The D-shaped interventional prosthetic heart valve of claim 4, wherein the leaflet is a biological tissue, a valve made of a polymeric material, or a tissue engineered valve.
6. The D-shaped interventional prosthetic heart valve of any one of claims 1-5, wherein the first or second sub-stent has leaflet suture holes disposed thereon through which the leaflets are sutured to the stent.
7. The D-shaped interventional prosthetic heart valve of any one of claims 1-5, wherein the stent is a nickel titanium alloy and the cover is one or more of PET, e-PTFE, and pericardial material.
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