CN106510901A - Integral forming ring design of novel folding patch - Google Patents

Abstract

The invention relates to a new type of folded patch. The folded patch includes a patch part and a forming ring part. The patch part and the forming ring part are connected into one body. The forming ring part is formed by folding one end of the patch part or is connected with Other materials are matched and connected. Its advantages are as follows: in the present invention, the edge of the patch is folded as a forming ring for fixing, and the unfolded part is used as the leaflet used in valve leaflet enlargement, and the structure is designed as a random cut structure, because the elasticity of the patch material is greater than that of the current general The forming ring improves the surgical effect while reducing the use of the surgical forming ring. At the same time, the pericardium treated with anti-calcification treatment and dry preservation technology was selected as the patch material to reduce tissue toxicity caused by free aldehyde groups.

Description

A new type of folded patch integrated into a ring design

technical field

The invention relates to the technical field of medical devices, in particular to a novel patch with the function of a forming ring.

Background technique

The treatment of mitral regurgitation in children has become one of the difficulties in cardiac surgery due to the diversity of disease mechanisms and potential development of children.

At present, valve repair and valve replacement are mainly used in the treatment of mitral regurgitation; however, mechanical valves are often used for valve replacement. Not only is there a lack of mechanical valves suitable for children in the market, but the replaced mechanical valves cannot meet the developmental needs of children. At the same time, mechanical valves require lifelong anticoagulation, which brings additional medication risks. In addition, the rigid structure of the mechanical valve cannot meet the deformation capacity of the valve during the ventricular systolic movement, which will destroy the ventricular function in the later stage. However, valve repair can maintain the natural structure and shape of the valve to the greatest extent, meet the growth and development of children, and does not require lifelong anticoagulation. Therefore, most children with mitral regurgitation are treated with repair.

In the treatment of mitral regurgitation in children, methods such as adjusting the key cord and papillary muscle, increasing the artificial key cord to reduce the length of the key cord are usually used to change the prolapse of the valve leaflet, and at the same time, plastic ring fixation and/or valve leaflet enlargement are used to increase the alignment of the valve leaflet. Reduce reflux by repairing the combined area. Annuloplasty ring fixation uses an annuloplasty ring to tighten the expanded valve annulus and fix the valve annulus, reducing the apposition distance of the front and rear valve leaflets. Because the full ring fixation limits the growth and development of the repaired valve annulus, half-ring reinforcement is often used at present. ring scheme.

The material of the annuloplasty ring is relatively hard, and the operation process cannot be cut according to the required length, and because the fixed annulus of the semi-annuloplasty ring is still too long, it has an impact on the growth of children, and because the use of the annuloplasty ring adds additional instruments cost. Untreated pericardial strips are at risk of later calcification and degeneration. Autologous pericardium or pericardial patch treated with glutaraldehyde is often used for valve leaflet expansion, and autologous pericardium or pericardial patch is preserved with liquid glutaraldehyde and treated with anti-calcification process. Heavy metal residues have potential tissue toxicity, and there are problems of later degeneration and calcification.

Contents of the invention

The object of the present invention is to provide a patch for treating children's mitral valve regurgitation aiming at the deficiencies in the prior art.

Another object of the present invention is to provide the application of the patch for treating children with mitral valve regurgitation.

In order to achieve the above object, the technical solution adopted by the present invention is: a folded patch for treating mitral valve regurgitation in children, the folded patch includes a patch part and a forming ring part, and the patch part and the forming ring part are connected In one piece, the forming ring part is formed by folding one end of the patch part or cooperating with other materials.

The forming ring part is folded into 2-7 layers.

The forming ring part is folded into 3-5 layers.

There is a layer of polymer material between each layer of the forming ring part or the outer layer of the folded patch as a whole.

The polymer material is polyester cloth or polytetrafluoroethylene cloth.

The polyester cloth and polytetrafluoroethylene cloth have certain elasticity.

The material of the folded patch is pericardial material.

The forming ring part is stitched into a whole by sewing different layers, and each stitch is knotted independently to form an independent unit.

In order to achieve the above-mentioned second purpose, the technical solution adopted by the present invention is: the application of the folded patch in the preparation of medical devices for treating children with mitral valve regurgitation.

The present invention has the advantage that:

In the present invention, the edge of the patch is folded as the forming ring for fixing, and the unfolded part is used as the valve leaflet used in the leaflet enlargement operation, and the structure is designed as a random cut structure, because the elasticity of the patch material is greater than that of the current general forming ring, improving Improve the surgical effect, while reducing the use of surgical rings. At the same time, the pericardium treated with anti-calcification treatment and dry preservation technology was selected as the patch material to reduce tissue toxicity caused by free aldehyde groups.

Description of drawings

Accompanying drawing 1 is the structural representation of the novel patch of the present invention.

Accompanying drawing 2 is the schematic diagram that forming ring is fixed.

Accompanying drawing 3 is the schematic diagram of joint repair of valvular dilatation and forming ring fixation.

Accompanying drawing 4 is the schematic diagram of routine steps of valve repair.

detailed description

The specific embodiments provided by the present invention will be described in detail below in conjunction with the accompanying drawings.

The reference signs and components involved in the accompanying drawings are as follows:

1. Patch part

2. Forming ring part

3. Suture

Example 1

The current treatment for mitral regurgitation mainly uses valve repair and valve replacement. Valve replacement often uses a mechanical valve for valve replacement. However, due to the small area of the annulus and the fragility of the tissue in children, it is difficult to find a mechanical valve suitable for children in the market. Even if a mechanical valve that fits the individual size is found at that time, in the face of growing and developing children, the mechanical valve is faced with the problem of valve stenosis, that is, the mechanical valve cannot meet the growth and development needs of children. The rigid structure of the mechanical valve will cause the imbalance of ventricular diastolic and systolic function, resulting in the decline of left ventricular function in the later stage. At the same time, the application of mechanical valves requires life-long anticoagulant therapy, and for a developing child, the dosage of anticoagulant drugs needs to be adjusted continuously. In addition, the cost of mechanical valves is high, and repeated surgical replacements not only increase the risk of surgery, but also bring additional economic burden.

Valve repair, by locally repairing the anatomical causes of mitral regurgitation, maximizes the maintenance of the original natural structure and shape of the valve annulus and valve, ensuring the functionality of the valve; at the same time, the repaired valve can meet the In addition to the needs of children's growth and development, valve repair does not require lifelong anticoagulant therapy. Based on the above considerations, valve repair has gradually become the first choice for surgeons to treat children with mitral valve diseases.

At present, the repair and treatment of mitral regurgitation generally adopts a three-step plan:

1) Repair of subvalvular appendages (chordae, papillary muscles): improve the prolapsed valve leaflets (A, B), and increase the mobility of the valve leaflets (C), as shown in Figure 4.

2) Plastic fixation: tighten the expanded valve annulus, and reduce the apposition distance of the front and rear valve leaflets, as shown in Figure 2.

3) Leaflet enlargement: increase the coaptation area of the front and rear leaflets, as shown in Figure 3.

In the mechanism of mitral valve regurgitation in children, the anterior valve of the mitral valve is lengthy and prolapsed, the posterior valve chord of the mitral valve is short, the area of the leaflet is small, it is difficult to lift, and it is poorly aligned with the anterior valve. Primary mechanism causing reflux. Annuloplasty fixation not only tightens the enlarged annulus and stabilizes it, but also elevates the height of the posterior annulus to increase coaptation with the anterior valve. Therefore, annuloplasty and fixation are considered to be the most critical step in the treatment of children with mitral regurgitation.

At the same time, since the full ring fixation limits the further growth and development of the annulus, at present, the half ring fixation of the posterior annulus is mostly used to allow the continued growth of the anterior annulus; in addition, studies have found that using untreated pericardial strips as As for the fixing material of the valve ring, it was found that the pericardial strip was completely endothelialized within a certain period of time and fused with the valve ring tissue.

The above-mentioned mitral valve repair scheme has been confirmed by many centers to achieve good clinical results, however, the repair also faces the difficulty of reoperation. This is mainly related to the poor long-term effect of the expansion material of the patch and the fixation material of the annulus.

At present, the most commonly used clinical materials for patch expansion include: autologous or allogeneic pericardium and artificial patch materials, and artificial patch materials can be divided into two categories: polyester patch and biological patch. Autologous pericardium has good biocompatibility, but the quantity is limited. At the same time, autologous pericardium is currently used in valvular enlargement surgery and often needs to be fixed with glutaraldehyde solution to meet the surgical requirements. The pericardium fixed with glutaraldehyde not only brings potential tissue toxicity, but also faces problems such as degeneration and calcification in the long-term. Allogeneic pericardial materials come from a wide range of sources, but the immunogenicity between different individuals The specificity limits its further clinical application, and the decellularized allogeneic pericardial material often cannot meet the mechanical requirements of clinical application. At the same time, the application of heterogeneous materials also faces issues such as ethical review. The polyester patch is composed of synthetic polymer materials, and the production technology is mature, and it is widely used in the field of cardiac surgery. However, problems such as bleeding/bleeding are prone to occur, which affects the repair effect. Its biocompatibility is not as good as autologous or allogeneic pericardium and biological patch, and it is prone to inflammatory reactions.

Biological patches are generally derived from the pericardial material of healthy cattle. After special chemical treatment, the tissue can be cross-linked and fixed while reducing its immunogenicity. It is generally considered to be a type of cardiac surgery with good biocompatibility. Repair material. The bovine pericardium is composed of multiple layers of collagen fibers with a dense structure, which not only avoids problems such as bleeding, but also has good biocompatibility and low risk of inflammatory reactions, which is more conducive to the growth of autologous tissue after repair.

For annulus fixation, the material of valvuloplasty rings currently on the market is relatively hard, and the operation process cannot be cut according to the required length, and the fixed annulus is too long, which will affect the growth of children. At the same time, when the ventricle contracts and relaxes, the shape of the valve annulus will change accordingly. If a less flexible forming ring material is used, the original deformation of the valve annulus will be destroyed, causing ventricular diastolic and systolic dysfunction, resulting in later ventricular failure. disfunction. Although the untreated pericardial strip has good flexibility and ensures the deformation ability of the annulus during ventricular systolic movement, it was found that the pericardial strip was completely endothelialized and fused with the annulus tissue within a certain period of time, but it faced potential problems. Risk of later calcification and degeneration.

The invention adopts a novel and simple integrated design of the patch forming ring. The material is composed of special chemically treated biological patch, and the forming ring part is made of the patch material through multiple folds. The multiple folds of the patch strengthen the toughness of the structure while retaining the softness of the material, and play a role equivalent to a forming ring in annuloplasty. The number of folded layers is usually 2-7 layers, and 3-5 layers are the best. After folding, the different layers are connected to form a whole. Each connected unit is independent of each other, and each unit can be cut without destroying the firmness of other connected units. Connections can be made by stitching the different layers into one, with each stitch knotted independently to form a self-contained unit. Doctors can use surgical scissors to cut between each stitch according to the actual required size to obtain the actual required size. Because each stitch is independent of each other, there is no opening behavior of each stitch after cutting, and the overall firmness of the connection between each layer can still be maintained.

Polymer materials can be added between each layer of the folded patch of the forming ring part or the outside of the entire folded part, usually medical polyester cloth and polytetrafluoroethylene cloth are added. When weaving, the two kinds of cloth are woven relatively loosely. Be flexible. The addition of cloth can increase the strength of the folded ring suture of the patch, and at the same time, it is more conducive to the growth of endothelial cells on the cloth and promotes endothelialization.

At the same time, after the treatment, the valve part will become more compact in structure due to the influence of the folded part, which is beneficial to the operation. This integrated annulus valve design can also ensure that the surgeon can cut out the valve and valve leaflet structure that meets the optimal size and shape of the child according to the actual needs, and apply it to different individuals, providing a wide range of methods for mitral valve repair. source of material.

Anti-calcification treatment methods and dry preservation techniques. The treatment process does not contain heavy metals, and is separated from the conventional glutaraldehyde preservation solution, reducing tissue toxicity caused by free aldehyde groups

The invention provides a new type of patch, the edge of the patch is folded as a fixing ring, and the unfolded part is used as the leaflet used in valve leaflet enlargement, which is designed as a random cut structure, because the elasticity of the patch material is greater than The current general-purpose forming ring improves the operation effect while reducing the use of the surgical forming ring. At the same time, the pericardium treated with anti-calcification treatment and dry preservation technology was selected as the patch material to reduce tissue toxicity caused by free aldehyde groups.

Example 2

Please refer to accompanying drawing 1, a kind of folding patch, described folding patch comprises patch part (1) and forming ring part (2), and patch part (1) and forming ring part (2) are connected as a whole, The forming ring part (2) is formed by folding one end of the patch part (1) in 2 to 7 layers, and there is a layer of polyester cloth or polyvinyl fluoride cloth between each layer of the forming ring part (2), and the forming ring part ( 2) The different layers are sewn into a whole by sutures (3), and each stitch is knotted independently to form an independent unit.

Example 3

Please refer to accompanying drawing 1, a kind of folding patch, described folding patch comprises patch part (1) and forming ring part (2), and patch part (1) and forming ring part (2) are connected as a whole, The forming ring part (2) is formed by folding one end of the patch part (1) in 3 to 5 layers, the outer layer of the folded patch is wrapped with a layer of polyester cloth or polyvinyl fluoride cloth, and the forming ring part (2) is passed through the suture (3) Different layers are sewn into a whole, and each stitch is knotted independently to form an independent unit. The material of the patch part (1) is pericardium material, and the material of the patch part (1) has undergone anti-calcification treatment, and the calcification treatment process does not contain heavy metals, and is stored in a dry environment that is not soaked in glutaraldehyde. The shape of the patch part (1) is preset or cut arbitrarily by the doctor.

The above is only a preferred embodiment of the present invention, it should be pointed out that for those of ordinary skill in the art, without departing from the method of the present invention, some improvements and supplements can also be made, and these improvements and supplements should also be considered Be the protection scope of the present invention.

Claims (10)

1. A folded patch for the treatment of mitral valve regurgitation in children, said folded patch comprises a patch part and a forming ring part, it is characterized in that the patch part and the forming ring part are connected as one, and the forming ring part consists of One end of the patch part is folded or connected with other materials. 2. The folded patch according to claim 1, wherein said forming ring part is folded into 2-7 layers. 3. The folded patch according to claim 2, wherein the forming ring portion is folded into 3-5 layers. 4. The folded patch according to claim 1, characterized in that there is a layer of polymer material between each layer of the forming ring part or the outer layer of the folded patch as a whole. 5. The folded patch according to claim 4, wherein the polymer material is polyester cloth or polytetrafluoroethylene cloth. 6. The folded patch according to claim 5, wherein the polyester cloth and the polytetrafluoroethylene cloth have certain elasticity. 7. The folded patch according to claim 1, wherein the material of the folded patch is pericardial material. 8. The folded patch according to claim 7, wherein the material of the patch part is subjected to anti-calcification treatment, the calcification treatment process does not contain heavy metals, and is stored in a dry environment that is not soaked in glutaraldehyde . 9. The folded patch according to claim 1, characterized in that, the forming ring part is stitched into a whole by stitches between different layers, and each stitch is knotted independently to form an independent unit. 10. The application of the folded patch according to claim 1 in the preparation of medical devices for treating children with mitral valve regurgitation.