A universal heart valve interventional shaping system

Abstract

The present application relates to the technical field of heart valve, in particular to a universal heart valve interventional forming system, which comprises a heart valve body, an inner support and an outer support, the heart valve body is provided with keel surfaces for supporting the valve at intervals along the axis thereof, the outer support is fixedly installed on the outer side of the heart valve body, the inner support is fixedly installed between the keel surfaces, the inner support and the outer support are coaxial, the outer support and the inner support are staggered, and the side of the keel surface close to the outer support is provided with an installation surface for matching the inner support and the outer support to enhance the installation friction force, so that the stability of the early artificial heart valve installation is ensured while avoiding the damage to the heart valve tissue caused by the use of barb structure for installation, and the blood can be disturbed at the paravalvular leakage to form thrombus for plugging without secondary surgery intervention, thereby solving the problems of the damage to the heart valve tissue caused by the use of barb for installation of the artificial heart valve and the secondary surgery intervention required for the paravalvular leakage.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of heart valve, in particular to a universal heart valve interventional forming system. BACKGROUND

[0002] The existing artificial heart valve is installed initially, and the artificial heart valve has not formed adhesion with the original heart valve tissue of the human body, so that the stability of the initially installed artificial heart valve is not strong. In order to improve the stability during initial installation and avoid movement, a barb structure is usually provided to penetrate into the heart valve tissue, thereby providing immediate stability for the early installation of the artificial heart valve which has not formed adhesion. Although the barb structure can provide initial installation stability, the barb structure is easy to damage the original heart valve tissue of the human body, causing discomfort to the human body.

[0003] In addition, when the artificial heart valve is installed, if the installation position is not accurate, the artificial heart valve cannot completely fit the original heart valve tissue of the human body, which will cause a paravalvular leakage phenomenon, that is, blood will flow back from the gap, causing abnormal blood flow. If the paravalvular leakage phenomenon is serious, it is easy to cause complications such as heart failure and myocardial hypertrophy, so secondary surgical intervention adjustment is needed. However, some patients have poor physical condition, suffer from serious lung diseases, kidney dysfunction, coagulation dysfunction and other diseases, and the patients are difficult to bear the secondary surgery. Or, the artificial heart valve is implanted for too long to produce adhesion, making it difficult to intervene in the secondary surgery.

[0004] Therefore, the present application provides a universal heart valve interventional forming system to solve the above problems. SUMMARY

[0005] The technical problem to be solved by the present application is that the existing artificial heart valve uses a barb for installation, which is easy to damage the heart valve tissue and cause a paravalvular leakage phenomenon requiring secondary surgical intervention.

[0006] The present application provides the following technical scheme: a universal heart valve interventional forming system, comprising a heart valve body, an inner support and an outer support, the heart valve body is provided with keel surfaces for supporting the valve at intervals along the axis thereof, the outer support is fixedly installed on the outer side of the heart valve body, the inner support is fixedly installed between the keel surfaces, the inner support and the outer support are coaxially arranged, the outer support and the inner support are staggered, the side of the keel surface close to the outer support is provided with an installation surface for matching the inner support and the outer support to enhance the installation friction force, and the outer surface of the installation surface, the inner support and the outer support are coplanar.

[0007] At least one curved surface for increasing the contact area is arranged on the outer surface of the installation surface.

[0008] The convex points and the concave points are arranged on the mounting surface respectively and are used for enhancing the mounting stability.

[0009] The bottom of the heart valve body is fixedly provided with an annular body, an annular groove is formed in the annular body, a shielding strip is fixedly installed in the annular groove, and a lagging belt is fixedly installed in the annular groove.

[0010] The inner support is provided with arc bending points which are arranged at intervals and are used for facilitating directional deformation.

[0011] The inner support is provided with a rough surface near the heart valve tissue.

[0012] The beneficial effects of the present application are as follows:

[0013] 1. The mounting surface at the keel surface cooperates with the inner support, the outer support and the annular body, so that the mounting surface, the inner support, the outer support and the shielding strip in the annular body are in contact with the heart valve tissue at the same time, thereby improving the stability during installation under mutual cooperation, and further improving the stability of the early artificial heart valve installation without damaging the heart valve tissue caused by the installation of the barb structure.

[0014] 2. When the installation position is not accurate and the peristalsis occurs, the lagging belt, the shielding strip in the heart valve body, the inner support and the outer support can cooperate with each other to slow down or disturb the blood at the peristalsis, so as to form a thrombus at the peristalsis to block, and further, when the peristalsis occurs, no secondary surgery is needed for intervention. In addition, the uneven surface of the lagging belt can further disturb the blood to form a thrombus to block the peristalsis more quickly and easily. BRIEF DESCRIPTION OF DRAWINGS

[0015] In order to more clearly illustrate the specific embodiments of the present application or the technical solutions in the prior art, the following will briefly introduce the drawings needed to be used in the specific embodiments or the prior art description. Obviously, the drawings in the following description are some embodiments of the present application, and those skilled in the art can also obtain other drawings according to these drawings without creative labor.

[0016] Figure 1 It is a whole schematic diagram of the present application;

[0017] Figure 2 It is a whole cross-sectional structure schematic diagram of the present application;

[0018] Figure 3 It is a structure schematic diagram of the inner support and the outer support of the present application;

[0019] Figure 4 It is a cross-sectional structure schematic diagram of the inner support and the outer support of the present application;

[0020] Figure 5 Structure diagram of the heart valve body of the present application in which the ring body exposes the adhesion zone;

[0021] Figure 6 Structure diagram of the heart valve body of the present application in which the ring body exposes the adhesion zone.

[0022] In the figure: 1, heart valve body; 11, ring body; 12, ring groove; 13, shielding strip; 14, adhesion zone; 141, concave section; 2, inner support; 21, connecting body; 22, circular arc bending point; 3, outer support; 4, keel surface; 41, mounting surface; 411, convex point; 42, curved surface. DETAILED DESCRIPTION

[0023] In order to make the objects, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings. Obviously, the described embodiments are some of the embodiments of the present application, rather than all the embodiments of the present application. Therefore, the following detailed description of the embodiments of the present application is not intended to limit the scope of the claimed application, but merely represents some embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative work fall within the scope of the present application.

[0024] It should be noted that similar reference numerals and letters indicate similar items in the following drawings, and therefore, once an item is defined in one drawing, it need not be further defined and explained in subsequent drawings.

[0025] In the description of the present application, it should be noted that the terms “center”, “upper”, “lower”, “left”, “right”, “vertical”, “horizontal”, “inner”, “outer”, “back” and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the product of the present application is usually placed. Such terms are only for the convenience of describing the present application and simplifying the description, and are not intended to indicate or imply that the indicated device or element must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application.

[0026] It should also be noted that in the description of the present application, unless otherwise explicitly specified and limited, the terms “provided”, “mounted”, “connected”, “linked” should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or integrally connected; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the communication inside two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0027] The embodiments of the present disclosure aim to solve the problems that the existing artificial heart valve is easy to damage heart valve tissue and cause paravalvular leakage phenomenon which requires secondary surgical intervention when the barbs are installed. In view of this, the embodiments of the present disclosure provide a universal heart valve interventional shaping system, which comprises a heart valve body 1, an inner stent 2 and an outer stent 3. The heart valve body 1 is provided with keel surfaces 4 for supporting the valve at intervals along the axis thereof. Three keel surfaces 4 are arranged in a circular array. The outer stent 3 is fixedly stitched and installed on the outside of the bottom of the heart valve body 1. The outer stent 3 is in a diamond mesh structure after being expanded. The inner stent 2 is fixedly stitched and installed between the keel surfaces 4. The inner stent 2 and the outer stent 3 are coaxially arranged. The outer stent 3 and the inner stent 2 are staggered, so that the inner stent 2 is arranged in the diamond mesh structure of the outer stent 3. The side of the keel surface 4 close to the outer stent 3 is provided with an installation surface 41 for cooperating with the inner stent 2 and the outer stent 3 to enhance the installation friction. The installation surface 41 is close to the outer stent 3. The outer surfaces of the inner stent 2 and the outer stent 3 are coplanar, so that the inner stent 2 and the outer stent 3 can contact the heart valve tissue together.

[0028] It should be noted that the installation surface 41 is made of the same material as the biological heart valve, and the material of pig heart valve or cow heart valve is selected, so that during the process of pressing the outer stent 3 after the expansion of the artificial heart valve, the installation surface 41 can slightly deform through the toughness of the pig heart valve or cow heart valve material, so that the outer surface of the installation surface 41 can be coplanar with the outer stent 3, and then the installation surface 41 can contact the heart valve tissue.

[0029] The inner stent 2 is made of nickel-titanium alloy material. The nickel-titanium alloy material has toughness and can slightly deform during the process of pressing the outer stent 3 after the expansion of the inner stent 2, so that the inner stent 2 is coplanar with the outer stent 3 after expansion, and then the inner stent 2 contacts the heart valve tissue after expansion. It should be noted that in order to make the inner stent 2 better fit the heart valve tissue, the surface of the inner stent 2 is wrapped with pig heart valve or cow heart valve material. In this way, during the process of expanding and fitting the outer stent 3, the outer surface of the inner stent 2 can be coplanar with the outer surface of the outer stent 3 through the pig heart valve or cow heart valve material, so as to better fit the heart valve tissue.

[0030] It should be noted that in the case of the inner stent 2 surface with a pig heart valve or a cow heart valve material, the inner stent 2 can also be partially protruding, and the protruding part is just opposite to the diamond mesh of the outer stent 3, so that the outer surface of the inner stent 2 is coplanar with the outer surface of the outer stent 3 during the manufacturing process. In order to ensure that the inner stent 2 can be stably located in the diamond mesh of the outer stent 3, the corresponding positions of the mounting surface 41, the inner stent 2 and the outer stent 3 can be marked, so that the inner stent 2 can be located in the diamond mesh of the outer stent 3 after suture according to the marked position. The marking is any positioning method in the prior art.

[0031] In order to make the inner stent 2 and the outer stent 3 relatively stable, a connecting body 21 is fixedly installed between the inner stent 2 and the outer stent 3, the connecting body 21 is arranged along the axial direction of the inner stent 2 and the outer stent 3, and the connecting body 21 can also be arranged in the horizontal circumferential direction.

[0032] During installation, when the universal heart valve in the embodiment of the present disclosure is input to the lesion site by a guide wire, the balloon expands and drives the heart valve body 1, the inner stent 2 and the outer stent 3 in the embodiment of the present disclosure to expand synchronously and adhere to the heart valve tissue. After the outer stent 3 expands, it presents a diamond mesh structure, and the inner stent 2 is located in the diamond mesh of the outer stent 3 after expansion. The mounting surface 41 can press the outer stent 3 and pass through the diamond mesh of the outer stent 3 after expansion, so that the outer surfaces of the mounting surface 41, the inner stent 2 and the outer stent 3 are coplanar, thereby ensuring that the mounting surface 41, the inner stent 2 and the outer stent 3 adhere to the heart valve tissue at the same time to provide support, thereby effectively improving the stability during installation in the case that the universal heart valve in the embodiment of the present disclosure is installed early and does not set the barb to avoid damaging the heart valve tissue.

[0033] It should be noted again that the mounting surface 41 presses the outer stent 3 after expansion, thereby enhancing the installation stability of the outer stent 3, and at the same time, the mounting surface 41 can be coplanar with the outer surface of the outer stent 3 through slight deformation to contact the heart valve tissue. In addition, during the contact between the heart valve tissue and the heart valve body 1, the inner stent 2 and the outer stent 3, the heart valve tissue can also deform to compensate for the contact with the keel surface 4, the inner stent 2 and the outer stent 3.

[0034] And, it needs to be explained that the inner support 2 and the outer support 3 are staggered and the mounting surface 41, the inner support 2 and the outer support 3 are coplanar, thereby synchronously contacting the heart valve tissue, which is to avoid that the single support skeleton structure is too much or too complex to cause the support force to be too large, thereby being difficult to expand or causing the heart valve tissue to be damaged due to the excessive compression force, the cooperation of the mounting surface 41, the inner support 2 and the outer support 3 can improve the stability of the installation while avoiding the damage to the heart valve tissue due to the excessive pressure at the contact point with the heart valve tissue without using the barb structure.

[0035] The outer surface of the mounting surface 41 is provided with at least one curved surface 42 for increasing the contact area, which can fit the heart valve tissue, thereby increasing the stability of the heart valve body 1 during installation through the curved surface 42 when the mounting surface 41 fits the heart valve tissue. The curved surface 42 can increase the contact area on the one hand, reduce the pressure at the contact point with the heart valve tissue, and avoid damaging the heart valve tissue; on the other hand, it can also improve the stability of the installation.

[0036] The bottom of the heart valve body 1 is fixedly provided with an annular body 11, which can fit the heart valve tissue, and the annular body 11 is provided with an annular groove 12, a plurality of shielding strips 13 are fixedly installed in the annular groove 12 at intervals, the shielding strips 13 are inclined relative to the annular groove 12, and a slow flow belt 14 for slowing down the blood flow is fixedly installed in the annular groove 12, which is woven by fiber material, specifically polypropylene fiber or polyester fiber material.

[0037] After the heart valve body 1 in the embodiment of the present disclosure is installed, if the installation position is accurate and there is no leakage phenomenon, the shielding strips 13 contact the heart valve tissue to close the annular groove 12, if the installation position is not proper and causes incomplete fitting to produce a leakage phenomenon, the shielding strips 13 do not contact the heart valve tissue, so that the shielding strips 13 remain in the inclined state relative to the annular groove 12, and the slow flow belt 14 in the annular groove 12 is exposed, and when the blood flows from the leakage, it contacts the slow flow belt 14, and the slow flow belt 14 slows down the flow speed of part of the blood through its own tension, and the slow flow belt 14 can disturb the stable flow of blood to form a vortex, thereby causing the blood at the leakage to gradually form a thrombus, thereby closing the leakage to prevent the leakage phenomenon when the installation position is not proper.

[0038] It should be noted that the shielding strip 13 in the embodiment of the present disclosure also has the effect of improving the installation stability of the heart valve body 1, the inner support 2 and the outer support 3, that is, after the installation of the heart valve body 1 in the embodiment of the present disclosure is completed, if the installation position is accurate and there is no leakage phenomenon, the shielding strip 13 is in contact with the heart valve tissue and cooperates with the heart valve body 1, the inner support 2 and the outer support 3 to be in contact with the heart valve tissue, thereby improving the stability of the installation without using the barb structure to fix and avoid damaging the heart valve tissue.

[0039] It should be noted that the shielding strip 13 and the heart valve body 1 are both biological materials, which can be selected as any material of the existing biological heart valve, such as pig heart valve or cow heart valve material. In the case that the shielding strip 13 and the heart valve body 1 are both biological materials, the shielding strip 13 can also be selected as an integrated structure. Because the biological material has a certain toughness, when the part of the shielding strip 13 in contact with the heart valve tissue is pressed and closed by the annular groove 12 in the case of leakage, the shielding strip 13 at the leakage position twists by the toughness of the biological material itself, thereby ensuring that the shielding strip 13 at the leakage position maintains an inclined state relative to the annular groove 12, and further enabling the lag belt 14 to be in an open and exposed state.

[0040] The lag belt 14 is provided with a concave section 141 on the circumferential surface, and the lag belt 14 has a plurality of gradients with different heights in the axial direction. In this way, the lag belt 14 is a non-flat surface in both the circumferential direction and the axial direction, thereby more easily disturbing blood and forming a vortex flow, and more easily forming a thrombus at the leakage position. When the installation position is not accurate and leakage occurs, the lag belt 14 can quickly and easily seal the leakage position to avoid leakage.

[0041] The inner support 2 is provided with arc bending points 22 for facilitating directional deformation, which are used for stable deformation of the inner support 2 in the diamond mesh of the outer support 3, thereby further improving the stability between the inner support 2 and the outer support 3. In addition, the arc structure can also avoid damaging the heart valve tissue.

[0042] The inner support 2 is provided with a rough surface near the heart valve tissue on the outer surface, which is a non-flat surface. The setting of the rough surface can improve the stability of the installation of the inner support 2, and also cooperate with the annular body 11 and the lag belt 14 to slow down the blood flow or disturb the blood when leakage occurs, thereby easily forming a thrombus at the leakage position to seal, and further avoiding the leakage in the case of inaccurate installation position.

[0043] The mounting surface 41 is provided with convex points 411 and concave points at intervals, respectively, which are passivated to avoid damaging the heart valve tissue, and which can be attached to the heart valve tissue, thereby making the heart valve body 1 more stable when attached to the heart valve tissue, and further enhancing the stability of the heart valve body 1 when attached. Moreover, the convex points 411 and concave points can improve the installation stability, and can also disturb or slow down the blood flow on the surface of the inner support 2 and the rough surface of the lag belt 14 when the installation position is inaccurate, thereby further facilitating the formation of thrombus at the paravalvular leakage to block it, avoiding the generation of paravalvular leakage.

[0044] The shielding strip 13 is inclined and has the same length as the height of the annular groove 12 when vertically pressed, so that when the shielding strip 13 is in contact with the heart valve tissue and is limited to be vertical, the annular groove 12 can be exactly blocked, and the lag belt 14 is in a sealed state. Therefore, in the embodiment of the present disclosure, if the installation position is accurate, the lag belt 14 is in a sealed and protected state, and only when the installation position deviates to cause paravalvular leakage and the heart valve tissue does not contact the shielding strip 13 to lose the limiting effect, the lag belt 14 comes into effect.

[0045] The annular groove 12, the shielding strip 13 and the lag belt 14 are provided at intervals along the annular body 11, and the plurality of annular grooves 12, shielding strips 13 and lag belts 14 can facilitate bundling and installation, and can also be used to treat a certain paravalvular leakage, improving the flexibility in use.

[0046] In the production process, the mounting surface 41 and the inner support 2 are pre-installed in the diamond mesh of the outer support 3.

[0047] At the beginning of the operation, the doctor delivers the universal heart valve in the embodiment of the present disclosure to the preset installation position of the lesion through the guide wire, and then expands the inner support 2 and the outer support 3 synchronously by the balloon and attaches them to the heart valve tissue. In the expansion process, the inner support 2 expands synchronously in the diamond mesh of the outer support 3 and is attached to the heart valve tissue, and the mounting surface 41 presses the outer support 3 and passes through the diamond mesh of the outer support 3 to contact the heart valve tissue. In this process, the circular arc bending point 22 and the connecting body 21 can ensure that the inner support 2 stably deforms in the outer support 3. After the installation is completed, the curved surface 42 of the mounting surface 41 can be attached to the heart valve tissue.

[0048] Thus, through the cooperation of the mounting surface 41 of the keel surface 4 and the inner support 2 and the outer support 3, the stability of the overall installation is improved without damaging the heart valve tissue by using the barb structure for installation.

[0049] After the installation is completed, if the installation position is accurate and no leakage phenomenon occurs, the shielding strip 13 contacts the heart valve tissue to close the annular groove 12, and the shielding strip 13 can contact the heart valve tissue synchronously with the heart valve body 1, the inner support 2 and the outer support 3, thereby improving the stability of the installation without damaging the heart valve tissue by using the barb structure for fixation.

[0050] If the installation position is improper and causes incomplete adhesion to generate a leakage phenomenon, the shielding strip 13 does not contact the heart valve tissue, so that the shielding strip 13 remains in an inclined state relative to the annular groove 12, and the annular groove 12 is exposed, and when blood flows from the leakage, the blood contacts the slow zone 14, the slow zone 14 slows down the flow speed of part of the blood by its own tension, and the slow zone 14 can disturb the stable flow of blood to form a vortex, thereby causing the blood at the leakage to gradually form a thrombus, thereby closing the leakage to prevent the leakage phenomenon caused by the improper installation position.

[0051] During the contact between the slow zone 14 and the blood, the concave segments 141 spaced on the circumferential surface and the multiple gradients of different heights in the axial direction form an uneven surface, so that the blood is more easily disturbed and forms a vortex, and a thrombus is more easily formed at the leakage, and when the improper installation position causes incomplete adhesion to generate a leakage phenomenon, the leakage is more quickly and easily closed to avoid the leakage.

[0052] Thus, when the installation position is inaccurate to cause a leakage and the patient's physical condition is poor to make it difficult to withstand reoperation, or the implantation time is too long to form adhesion with the heart valve tissue, a thrombus can be formed at the leakage to be closed, so that secondary surgery intervention is not required for adjustment.

[0053] Those skilled in the art should understand that the present application is not limited to the above embodiments, and the above embodiments and descriptions in the specification are only to illustrate the principles of the present application, and various changes and improvements can be made without departing from the spirit and scope of the present application, and these changes and improvements all fall within the scope of the claimed present application. The scope of protection of the present application is defined by the appended claims and their equivalents.

Claims

1. A universal heart valve plasty system comprising a heart valve body (1), an inner stent (2) and an outer stent (3), characterized in that: The heart valve body (1) is provided with keel surfaces (4) for supporting the valve at intervals along its own axis, an outer support (3) is fixedly installed outside the heart valve body (1), an inner support (2) is fixedly installed between the keel surfaces (4), the inner support (2) and the outer support (3) are coaxially arranged, the outer support (3) and the inner support (2) are staggered, the side of the keel surface (4) close to the outer support (3) is provided with an installation surface (41) for matching the inner support (2) and the outer support (3) to enhance the installation friction, the installation surface (41), the outer surface of the inner support (2) and the outer support (3) after expansion are coplanar; The bottom of the heart valve body (1) is fixedly provided with an annular body (11), an annular groove (12) is formed in the annular body (11), a shielding strip (13) is fixedly installed in the annular groove (12), and a delay belt (14) is fixedly installed in the annular groove (12); The shielding strip (13) is obliquely arranged and vertically after being pressed, the length thereof is the same as the height of the annular groove (12). The annular groove (12), the shielding strip (13) and the delay belt (14) are arranged at intervals along the annular body (11).

2. The universal heart valve intervention system of claim 1, wherein: At least one curved surface (42) for increasing the contact area is arranged on the outer surface of the installation surface (41).

3. The universal heart valve intervention system of claim 2, wherein: Convex points (411) for enhancing the installation stability are arranged at intervals on the installation surface (41).

4. The universal heart valve intervention system of claim 3, wherein: Arc bending points (22) for facilitating directional deformation are arranged at intervals on the inner support (2).

5. The universal heart valve intervention shaping system of claim 4, wherein: A rough surface is arranged on the outer surface of the inner support (2) close to the heart valve tissue.

Images