CN112294495A - Skirt edge type artificial mechanical heart valve and using method thereof - Google Patents

Abstract

The invention belongs to the technical field of medical devices implanted into human bodies, and particularly relates to a skirt edge type artificial mechanical heart valve and a using method thereof. The invention redesigns the sewing ring structure, can solve the PPM problem of the patient and implants the artificial mechanical heart valve which is adaptive to the surface area of the patient. The structure of the outer edge of the sewing ring is unchanged from that of the inner ring, the cloth ring is coated on the outer ring of the valve ring to form a skirt edge, the skirt edge connects the inner ring and the outer edge of the sewing ring into a whole, the skirt edge extends out of the lower end face of the valve ring and is about 3mm-5mm higher than the lower end face of the valve ring, when part of patients with small autologous valve rings are found, the sewing ring and autologous tissues cannot be sutured when valves matched with the body surface area are implanted, the problem can be solved by the artificial mechanical heart valve with the skirt edge structure, the skirt edge is higher than the valve rings and can go deep into the lower end of the autologous valve rings, then suturing with the human tissues can. In addition, above-mentioned structure can reduce the operation degree of difficulty in the hand by a wide margin in the operation, effectively reduces the operation risk, and disease postoperative remains and complication compare with traditional equipment and show the promotion.

Description

Skirt edge type artificial mechanical heart valve and using method thereof

Technical Field

The invention belongs to the technical field of medical devices implanted into human bodies, and particularly relates to a skirt edge type artificial mechanical heart valve and a using method thereof.

Background

The heart of a human body is internally provided with four valves, each valve is a one-way valve, blood is controlled to flow along a certain direction, and a certain flow is ensured to pass through. One of the most common heart diseases is mechanical blood flow disorder caused by congenital or acquired malformation or deformation of heart valves. The artificial heart valve is an artificial organ which can be implanted in the heart to replace heart valves (an aortic valve, a pulmonary valve, a tricuspid valve and a mitral valve), can enable blood to flow in a single direction and has the function of a natural heart valve.

With continuous research and clinical feedback on artificial mechanical heart valves, the phenomenon of mismatching between an implanted valve and a patient occurs, which is called PPM phenomenon in clinic. The PPM phenomenon refers to the phenomenon that the Effective Opening Area (EOA) of an artificial mechanical heart valve implanted with the same valve ring diameter is smaller than that of a normal person, and the artificial mechanical heart valve cannot meet the requirements of a patient, so that a series of adverse consequences are caused.

The consequences of PPM following aortic replacement (AVR) are excessive trans-valvular pressure differences, poor post-operative hemodynamic status, slow regression of left ventricular hypertrophy, susceptibility to sudden cardiac death and reduced long-term survival. The consequence of PPM after Mitral Valve Replacement (MVR) is a residual high trans-valvular pressure difference at the mitral valve site, producing pathophysiological changes similar to mitral stenosis, leading to increased rates of hospitalization and mortality.

PPM, induced after Aortic Valve Replacement (AVR), is clinically generally classified into 3 grades: no or only slight PPM, EOAI > 0.85cm²/m²(ii) a Moderate PPM, 0.65cm²/m²＜EOAI≤0.85cm²/m²(ii) a Severe PPM, EOAI less than or equal to 0.65cm²/m². After Mitral Valve Replacement (MVR)Also classified as 3-level: no or only slight PPM, EOAI > 1.2cm²/ m²(ii) a Medium PPM, 0.9cm²/m²＜EOAI≤1.2cm²/m²(ii) a Heavy PPM, EOAI less than or equal to 0.9cm²/m². The normal aortic valve opening area is 3.0cm²～4.5cm²The area of the mitral valve opening is 4cm²-6cm²The artificial mechanical valve or biological valve in clinical application can not meet the standard.

Disclosure of Invention

The invention provides a skirt edge type artificial mechanical heart valve, aiming at solving the PPM problem caused by mismatching of a patient autologous valve ring and an implanted valve and causing unpredictable operation risks without enlarging the autologous valve ring.

The invention aims to provide a skirt edge type artificial mechanical heart valve, which solves the problem that the autologous valve ring of a part of replacement artificial mechanical heart valve patients is not matched with the artificial mechanical heart valve and PPM is caused if the skirt edge type artificial mechanical heart valve is implanted into the artificial mechanical heart valve with the unmatched surface area of the autologous valve, and brings health to the patients with the replacement artificial mechanical heart valve.

A skirt edge type artificial mechanical heart valve comprises a valve ring, a valve sheet and a sewing ring, wherein the valve sheet is arranged in the valve ring; the sewing ring is provided with an outer edge and a skirt edge, the outer edge of the valve ring is attached to the human body self-tissue, and the skirt edge is sewn with the human body self-tissue.

The skirt edge is wrapped on the outer ring of the sewing ring, the skirt edge extends out of the outer ring, and the extending part of the skirt edge is sewed with human tissues. The skirt edge is used for assisting the doctor in the operation, so that better operation treatment can be performed on the patient with the heart defect.

The skirt is made of medical polyester fabric. The suture is convenient to be implemented on the basis of ensuring the fit with human tissues.

An outer edge is arranged at one end of the outer ring of the sewing ring, and a skirt edge is arranged at the other end of the outer ring of the sewing ring. Through two-way laminating from top to bottom and sewing up, improve the steadiness.

The valve plate is semicircular, a pivot boss is arranged on the valve plate, the valve plate is connected with the pit of the valve ring inner ring through the pivot boss, and the pivot boss rotates along the pit. And the long-acting work of the petals is ensured under the matching of the pits.

The two side walls of the concave pit are respectively provided with a limiting block, the concave pit is 8-shaped, and the limiting block limits the rotating limit position of the pivot boss. The opening and closing of the blood supply channel can be conveniently controlled, the opening and closing bidirectional limiting can be realized through the 8-shaped limiting block, and the heart work can be better simulated.

The sewing ring is formed by coating a plurality of layers of cloth rings, and the cloth rings are made of medical polyester fabrics.

The outer edge bulge forms a fitting cavity. Is convenient to be mutually attached to human tissues of the mitral valve, and effectively communicates the new chamber and the ventricle to establish a blood supply channel.

A method of using a skirt-type prosthetic mechanical heart valve, comprising the steps of: the skirt edge type artificial mechanical heart valve is implanted into a human body, intermittent mattress type sewing is carried out on the edge of the skirt edge by adopting a double-thread needle, then the double-thread needle penetrates out of the valve orifice of the human body valve ring from inside to outside, the suture is tightened to fix the skirt edge type artificial mechanical heart valve and the valve orifice of the human body valve ring, and the penetrated suture is knotted.

The invention has the beneficial effects that: the invention redesigns the sewing ring structure, can solve the PPM problem of the patient and implants the artificial mechanical heart valve which is adaptive to the surface area of the patient. The structure of the outer edge of the sewing ring is unchanged from that of the inner ring, the cloth ring is coated on the outer ring of the valve ring to form a skirt edge, the skirt edge connects the inner ring and the outer edge of the sewing ring into a whole, the skirt edge extends out of the lower end face of the valve ring and is about 3mm-5mm higher than the lower end face of the valve ring, when part of patients with small autologous valve rings are found, the sewing ring and autologous tissues cannot be sutured when valves matched with the body surface area are implanted, the problem can be solved by the artificial mechanical heart valve with the skirt edge structure, the skirt edge is higher than the valve rings and can go deep into the lower end of the autologous valve rings, then suturing with the human tissues can. In addition, above-mentioned structure can reduce the operation degree of difficulty in the hand by a wide margin in the operation, effectively reduces the operation risk, and disease postoperative remains and complication compare with traditional equipment and show the promotion.

Drawings

FIG. 1 is a sectional view of a prior art mitral valve human tissue installation;

FIG. 2 is a cross-sectional view of a prior art aortic valve body tissue installation;

FIG. 3 is a schematic view of a prior art mitral valve not being implantable due to a native annulus being small;

FIG. 4 is a schematic view of a prior art aortic valve that is not implantable due to a native annulus being small;

FIG. 5 is a sectional view of a mitral valve in accordance with the present invention in mounted relation to human tissue;

FIG. 6 is a sectional view of an aortic valve body tissue installation of the present invention;

fig. 7 is a schematic view of an annulus structure of the present invention;

FIG. 8 is a schematic view of a flap of the present invention;

fig. 9 is a schematic view of the assembly of the annular flap of the present invention;

FIG. 10 is a schematic view of the open state of the petals of the present invention;

FIG. 11 is a schematic view of the flap of the present invention in a closed position;

FIG. 12 is a schematic view of an aortic valve sewing ring of the present invention;

figure 13 is a schematic view of a mitral valve sewing ring of the present invention.

Labeled as: the device comprises avalve ring 1, avalve plate 2, aslit ring 3, anouter edge 4, askirt edge 5, apivot boss 6, apit 7, alimit block 8 and ablood supply channel 9.

Detailed Description

A skirt edge type artificial mechanical heart valve comprises avalve ring 1, avalve plate 2 and asewing ring 3, wherein thevalve plate 2 is arranged in thevalve ring 1; thesewing ring 3 is provided with anouter edge 4 and askirt edge 5, theouter edge 4 of thevalve ring 1 is attached to the human body self-tissue, and theskirt edge 5 is sewed with the human body self-tissue.

Theskirt edge 5 is wrapped on the outer ring of thesewing ring 3, theskirt edge 5 extends out of the outer ring, and the extending part of theskirt edge 5 is sewed with human tissues. Theskirt edge 5 is made of medical polyester fabric. Anouter edge 4 is arranged at one end of the outer ring of theseam ring 3, and askirt edge 5 is arranged at the other end of the outer ring of theseam ring 3. Thevalve plate 2 is semicircular, thevalve plate 2 is provided with apivot boss 6, thevalve plate 2 is connected with apit 7 of the valve ring inner ring through thepivot boss 6, and thepivot boss 6 rotates along thepit 7. Limiting blockingparts 8 are arranged on two side walls of theconcave pit 7 respectively, theconcave pit 7 is 8-shaped, and the limitingblocking parts 8 limit the rotating limit position of thepivot boss 6. The opening and closing of theblood supply channel 9 can be conveniently controlled, the opening and closing bidirectional limiting can be realized through the 8-shaped limiting block, and the heart work can be better simulated.

Thesewing ring 3 is formed by coating a plurality of layers of cloth rings, and the cloth rings are made of medical polyester fabrics.

A common artificial mechanical heart valve consists of three parts: the valve ring can rotate and fix the valve ring at a fixed position, and the sewing ring is sewed with human tissues. FIG. 1 is a schematic view of a mitral valve human tissue installation and dissection in the prior art, FIG. 2 is a schematic view of a aortic valve human tissue installation and dissection in the prior art, a flap in the prior art is installed in a manner that bosses at two ends of the flap are matched with symmetrical 8-shaped pits in an annulus inner ring, the flap can rotate flexibly, a sewing ring is divided into an inner ring and a sewing outer edge, the inner ring fastens the sewing ring and a valve annulus flap assembly, the outer edge is sewn with the human tissue, the valve position is fixed to prevent the valve from falling off, but under the condition that the valve annulus of a part of a patient is small, the valve structure cannot complete the replacement operation of the valve, because a matched artificial mechanical heart valve cannot be attached to the self tissue under the self valve annulus of the patient, the outer edge of the sewing ring cannot be sewn with the self tissue, the life safety of the patient is enda, fig. 4 is an anatomical diagram illustrating the inability of a conventional aortic valve to be implanted due to the small native annulus. All of these conditions increase the risk of the procedure and are a serious threat to the life and health of the patient.

Fig. 5 and 6 show the artificial mechanical heart valve of the inventor, the valve ring and the two flaps are similar to the traditional structure and the installation mode is the same, the invention redesigns the sewing ring structure, can solve the PPM problem of the patient and implants the artificial mechanical heart valve which is adaptive to the surface area of the patient. The structure of the outer edge of the sewing ring is unchanged from that of the inner ring, the cloth ring is coated on the outer ring of the valve ring to form a skirt edge, the skirt edge connects the inner ring and the outer edge of the sewing ring into a whole, the skirt edge extends out of the lower end face of the valve ring and is about 3mm-5mm higher than the lower end face of the valve ring, when part of patients with small autologous valve rings are found, the sewing ring and autologous tissues cannot be sutured when valves matched with the body surface area are implanted, the problem can be solved by the artificial mechanical heart valve with the skirt edge structure, the skirt edge is higher than the valve rings and can go deep into the lower end of the autologous valve rings, then suturing with the human tissues can.

A method of using a skirt-type prosthetic mechanical heart valve, comprising the steps of: the skirt edge type artificial mechanical heart valve is implanted into a human body, intermittent mattress type sewing is carried out on the edge of the skirt edge by adopting a double-thread needle, then the double-thread needle penetrates out of the valve orifice of the human body valve ring from inside to outside, the suture is tightened to fix the skirt edge type artificial mechanical heart valve and the valve orifice of the human body valve ring, and the penetrated suture is knotted. The skirt edge type artificial mechanical heart valve using method can be firmly connected with human tissues, and the problems that the existing mitral valve cannot be implanted due to small autologous valve ring and the existing aortic valve cannot be implanted due to small autologous valve ring are thoroughly solved. Reduce the risk of the procedure and ensure the life health of the patient.

It will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrative embodiments, and that the present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein. Any reference sign in a claim should not be construed as limiting the claim concerned.

Claims (9)

Translated fromChinese

1.一种裙边型人工机械心脏瓣膜，包括瓣环（1）、瓣片（2）和缝环（3），瓣片（2）安装在瓣环（3）内；其特征在于：缝环（3）上设有外缘（4）和裙边（5），瓣环（1）的外缘（4）与人体自身组织贴合，裙边（5）与人体自身组织缝合。1. a skirt type artificial mechanical heart valve, comprising valve annulus (1), flap (2) and seam ring (3), flap (2) is installed in valve annulus (3); It is characterized in that: seam The ring (3) is provided with an outer edge (4) and a skirt edge (5), the outer edge (4) of the valve annulus (1) is fitted with the human body's own tissue, and the skirt edge (5) is sutured with the human body's own tissue.2.根据权利要求1所述一种裙边型人工机械心脏瓣膜，其特征在于：所述裙边（5）包裹在缝环（3）外环上，裙边（5）延伸出外环，裙边（5）的延伸部与人体组织缝合。2. A skirt-type artificial mechanical heart valve according to claim 1, characterized in that: the skirt (5) is wrapped on the outer ring of the seam ring (3), and the skirt (5) extends out of the outer ring, The extension of the skirt (5) is sutured with the human tissue.3.根据权利要求2所述一种裙边型人工机械心脏瓣膜，其特征在于：所述裙边（5）的材质为医用涤纶布。3 . The skirt-type artificial mechanical heart valve according to claim 2 , wherein the skirt (5) is made of medical polyester cloth. 4 .4.根据权利要求2所述一种裙边型人工机械心脏瓣膜，其特征在于：所述缝环（3）外环一端设有外缘（4），缝环（3）外环另一端设有裙边（5）。4. The skirt type artificial mechanical heart valve according to claim 2, characterized in that: one end of the outer ring of the seam ring (3) is provided with an outer edge (4), and the other end of the outer ring of the seam ring (3) is provided with an outer edge (4). With skirt (5).5.根据权利要求1所述一种裙边型人工机械心脏瓣膜，其特征在于：所述瓣片（2）为半圆形，瓣片（2）设有枢轴凸台（6），瓣片（2）通过枢轴凸台（6）与瓣环内环的凹坑（7）连接，枢轴凸台（6）沿凹坑（7）转动。5 . The skirt-type artificial mechanical heart valve according to claim 1 , wherein the flap ( 2 ) is semicircular, and the flap ( 2 ) is provided with a pivot boss ( 6 ), and the flap ( 2 ) is 5 . The sheet (2) is connected with the pit (7) of the inner ring of the valve ring through the pivot boss (6), and the pivot boss (6) rotates along the pit (7).6.根据权利要求1所述一种裙边型人工机械心脏瓣膜，其特征在于：所述凹坑（7）两侧壁分别设有限位卡挡（8），凹坑（7）呈8字形，限位卡挡（8）限制枢轴凸台（6）转动的极限位置。6 . The skirt-type artificial mechanical heart valve according to claim 1 , wherein the two side walls of the pit ( 7 ) are respectively provided with limit stops ( 8 ), and the pit ( 7 ) is in a figure-eight shape. 7 . , the limit stop (8) limits the pivot boss (6) to the limit position of rotation.7.根据权利要求1所述一种裙边型人工机械心脏瓣膜，其特征在于：所述缝环（3）由多层布环包覆形成，布环的材质为医用涤纶布。7 . The skirt-type artificial mechanical heart valve according to claim 1 , wherein the seam ring ( 3 ) is formed by covering with multiple layers of cloth rings, and the material of the cloth rings is medical polyester cloth. 8 .8.根据权利要求1所述一种裙边型人工机械心脏瓣膜，其特征在于：所述外缘（4）凸起形成贴合空腔。8 . The skirt-type artificial mechanical heart valve according to claim 1 , wherein the outer edge ( 4 ) bulges to form a fitting cavity. 9 .9.根据权利要求1至8任一项所述一种裙边型人工机械心脏瓣膜的使用方法，其特征在于包括如下步骤：裙边型人工机械心脏瓣膜植入人体，采用双线针在裙边边缘进行间断褥式缝合，再将双针线从人体瓣环瓣口处由内向外穿出，拉紧缝线将裙边型人工机械心脏瓣膜与人体瓣环瓣口固定并将穿出的缝线打结。9. according to the using method of a kind of skirt type artificial mechanical heart valve described in any one of claim 1 to 8, it is characterized in that comprising the steps: skirt type artificial mechanical heart valve is implanted in human body, adopts double-thread needle in skirt Intermittent mattress suture is performed on the edge and edge, and then the double needle thread is passed from the inside to the outside from the human valve annulus valve opening, and the suture is tightened to fix the skirt-type artificial mechanical heart valve and the human valve ring valve opening and pass through the suture. The line is knotted.

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