CN112932562A

CN112932562A - Heart atrial septal defect occluder with flat two end surfaces and manufacturing method thereof

Info

Publication number: CN112932562A
Application number: CN202110139678.8A
Authority: CN
Inventors: 张健; 张瑾; 马彩霞; 张永凯; 程海波; 杨晨
Original assignee: Shanghai Jinkui Medical Devices Co ltd
Current assignee: Shanghai Jinkui Medical Devices Co ltd
Priority date: 2021-02-01
Filing date: 2021-02-01
Publication date: 2021-06-11
Anticipated expiration: 2041-02-01
Also published as: CN112932562B

Abstract

The invention discloses a heart atrial septal defect occluder with two smooth end surfaces and a manufacturing method thereof. The heart atrial septal defect occluder comprises a main body component, a flow resisting component and a suture line; the main body component is of a net body structure and comprises a first disc-shaped part, a tubular part and a second disc-shaped part which are sequentially connected, and two ends of the tubular part are respectively connected to the inner net surface of the first disc-shaped part and the inner net surface of the second disc-shaped part; the flow resisting part is at least two layers of degradable films or non-degradable films for resisting the blood flow; after the closing-in line closes up, the outer net surfaces of the first disk-shaped part and the second disk-shaped part are continuous and flat net surfaces; the stopper is made of a special mould; the special mould comprises a core mould; the core mold includes a first cover, a central member, a second cover, a first outer peripheral member, and a second outer peripheral member. The shaping is carried out through a special die, so that the shaping method is simple and quick and has lower cost. The two end surfaces are smooth, so that the endothelialization process on the surface of the occluder is accelerated, and the atrial septal defect of the heart is repaired by self tissues earlier.

Description

Heart atrial septal defect occluder with flat two end surfaces and manufacturing method thereof

Technical Field

The invention relates to the field of occluders, in particular to a cardiac atrial septal defect occluder with two smooth end surfaces and a manufacturing method thereof.

Background

Atrial septal defects are one of the common congenital heart diseases. The human heart is formed by four chambers, i.e., the left atrium, the left ventricle, the right atrium, and the right ventricle, wherein the two chambers located above the left atrium and the right atrium should have a complete interatrial septum, and if there is an opening in the interatrial septum of the heart, it is called an interatrial defect. Atrial septal defects are mainly formed in the growth and development process of fetuses, and are formed because the development of hearts is influenced by certain factors. In the case of a patient with an atrial septal defect, blood will generally flow from the left atrium through the septal defect and into the right atrium, causing an increase in the volume of blood in the right atrium. The long-term presence of atrial septal defects can cause pulmonary artery pressure elevation, congestive heart failure, arrhythmia, stroke, dizziness, fainting, and other diseases.

Atrial septal defects are common congenital heart diseases, and the traditional treatment mode is surgery. The surgical treatment method, in which the patient needs to be surgically opened, has the greatest disadvantages that: (1) extracorporeal circulation is needed during the operation, which may cause complications and death; (2) the surgical operation has large wound and scars are left after the operation; (3) the surgery is expensive.

With the development and improvement of catheter interventional diagnosis and treatment technology in the 80 s of the 20 th century, the minimally invasive interventional technology is gradually introduced to treat congenital heart diseases in China, and the method for treating atrial septal defect through minimally invasive interventional treatment is rapidly developed and is mature at present. Compared with the traditional surgical operation, the minimally invasive interventional therapy is modern high-tech minimally invasive therapy, and the guide steel wire is guided by medical imaging equipment through femoral vein puncture to enter the right atrium along the femoral vein and the inferior vena cava and then enter the left atrium through the atrial septal defect. And then, the conveying catheter is arranged at the atrial septal defect part along the guide steel wire, and finally, the atrial septal defect occluder is pushed to the atrial septal defect part in the conveying catheter to implement occlusion treatment. The minimally invasive interventional therapy has the advantages of no operation, small wound, less complication, quick recovery, good effect, wide range of indication, relatively low operation cost and the like.

The treatment method of implanting the atrial septal defect occluder through minimally invasive intervention surgery has many advantages over traditional surgery. However, the main structure of the patent ductus arteriosus occluder clinically used at present is that two end faces are provided with convex connection points, the end face convex structure is not beneficial to the process of endothelialization of the surface of the disc face, and the endothelialization process at the convex connection points is relatively slow, so that the healing process at the position of the occluder implanted is influenced, and the healing time is prolonged. Meanwhile, the protruding connection points on the two end faces can increase the release length of the occluder, and the occluder may touch nearby heart tissues to cause heart injury.

Disclosure of Invention

The invention aims to solve the technical problems that the atrial septal defect occluder used clinically in the prior art has long-term risk, overcomes the defects that the cost is high, the endothelialization of the surface of the occluder is slow due to the protruding connection points of the two end surfaces of the occluder and the release length of the occluder is long in the prior art, and provides a cardiac atrial septal defect occluder with smooth two end surfaces and a manufacturing method thereof.

The invention solves the technical problems through the following technical scheme:

a heart atrial septal defect occluder with two smooth end surfaces comprises: a main body component, a flow impeding component, and a suture; the main body component is of a net body structure and comprises a first disc-shaped part, a tubular part and a second disc-shaped part which are sequentially connected, the first disc-shaped part and the second disc-shaped part are both double-layer net surfaces, two ends of the tubular part are respectively connected to an inner net surface of the first disc-shaped part and an inner net surface of the second disc-shaped part, the cross-sectional dimension of the outer net surface of the first disc-shaped part is larger than that of the inner net surface of the first disc-shaped part, and a containing cavity for containing at least part of the tubular part is formed on one side where the inner net surface of the first disc-shaped part is located; wherein the flow resisting part is at least two layers of degradable films or non-degradable films for resisting the blood flow; wherein the suture is a degradable suture or a non-degradable suture for sewing the flow resisting part on the main body part and serving as a closing line;

after the opening is closed by the closing line, the outer net surface of the first disc-shaped part and the outer net surface of the second disc-shaped part are continuous and flat net surfaces;

wherein, the heart atrial septal defect stopper is made of a special mould;

the special mold comprises a core mold;

the core mold includes: a first cover, a central member, a second cover, an annular first outer peripheral member, and an annular second outer peripheral member;

the first cover body covers a first opening of the first outer peripheral component in the axial direction, the second outer peripheral component is connected to a second opening of the first outer peripheral component in the axial direction, the second cover body covers a third opening of the second outer peripheral component in the axial direction, the first cover body and the second cover body are positioned on two sides of the second outer peripheral component, the central component is arranged inside the second outer peripheral component, and an intermediate annular gap is formed between the outer peripheral wall of the central component and the inner peripheral wall of the second outer peripheral component and used for forming the tubular part;

a first annular gap is formed among the inner peripheral wall of the first outer peripheral member, the inner side surface of the first cover body and the outer peripheral wall of the second outer peripheral member, and the first annular gap is used for forming the first disc-shaped part;

a second annular gap is formed between the inner peripheral wall of the second outer peripheral part and the inner side surface of the second cover body, and the second annular gap is used for forming the second disc-shaped part;

and vent holes are formed in the first cover body and the second cover body.

In this scheme, the outer wire side of first discoid portion and the outer wire side of second discoid portion are level and smooth in succession, and there is not convex tie point, can increase the quotation holding power and the shape of plugging device and from expanding resilience nature, can reduce the risk of local thrombus formation on plugging device surface simultaneously, is favorable to accelerating the endothelial process on plugging device surface, makes heart atrial septal defect department earlier by self tissue repair, and the healing time is shorter. In addition, the release length of the occluder in the operation process is reduced, the damage to the heart can be greatly reduced, and the operation is more effective and safer.

In addition, in this scheme, the main part both can be woven by degradable silk, also can be woven by non-degradable silk and become. Wherein, the degradable silk is a biodegradable high polymer material, and is selected from polylactide, polyglycolide, polycaprolactone, polydioxanone, polyhydroxybutyrate, polyhydroxyalkanoate, polyanhydride, polyphosphate, polyurethane or polycarbonate, and derivatives thereof, blends of more than two or corresponding monomers. The materials have good biocompatibility, can be completely degraded and absorbed in a human body, and avoid the long-term influence of implanted foreign matters on the human body. The plugging device only provides a temporary bridge for heart repair, is degraded by an organism after the completion of a historical mission, and enables the defect to be completely repaired by self tissue, thereby avoiding long-term complications and potential safety hazards brought by metal remaining in the body. The non-degradable wire is made of metal or alloy materials, including stainless steel, cobalt-based alloy, titanium and titanium alloy, nickel-titanium alloy shape memory material and the like.

In addition, the flow blocking part may be a degradable flow blocking film or an undegradable flow blocking film. Wherein, the degradable flow-resisting film filled in the stopper is a biodegradable material selected from polylactide, polycaprolactone, polyhydroxybutyrate, polydioxanone and the like; the non-degradable choke membrane is a non-biodegradable material selected from polyethylene terephthalate, polytetrafluoroethylene and the like.

Accordingly, the suture may be either a degradable suture or a non-degradable suture. Wherein, the degradable suture is made of biodegradable material selected from poly (ethyl propyl acetate), poly (lactide) and the like; the non-degradable suture line is a biological non-degradable material and is selected from polyethylene terephthalate and the like.

In addition, the first cover body and the second cover body are respectively provided with the vent hole, so that heat conduction inside the special die is facilitated, heat is diffused outwards from the central axis of the die, and meanwhile, heat diffused inwards from the outside of the die exists, so that heat balance inside and outside the die is facilitated, and the mesh body can be heated uniformly and quickly shaped in the shaping process.

The special die adopts a multi-part assembly structure, and is convenient to disassemble and assemble the die in the production process. The atrial septal defect occluder is shaped by the special die, is simple and rapid, has higher manufacturing stability, can effectively control the size of the main body part, reduces the manufacturing tolerance of the main body part, and has better shaping effect, thereby improving the quality and the qualification rate of products and reducing the production cost. Meanwhile, the main body part of the stopper shaped by using the special die has larger supporting force and self-expansion resilience, and can meet the use requirement.

Preferably, one or more vent holes are formed in the second cover body, and the vent holes penetrate through the second cover body and communicate the inside and the outside of the core mold;

preferably, the outer diameter of the second disc portion is smaller than the outer diameter of the inner web surface of the first disc portion.

In this aspect, the outer diameter of the second disk-shaped portion is set smaller than the outer diameter of the inner mesh surface of the first disk-shaped portion. The first disc-shaped part is positioned in the left atrium of the heart, the second disc-shaped part is positioned in the right atrium of the heart, the pressure of the left atrium of the heart is larger than that of the right atrium of the heart, and for a patient with atrial septal defect, blood can generally flow into the right atrium from the left atrium through the atrial septal defect.

Preferably, the first cover body is provided at a center thereof with a first protrusion protruding toward an inside of the core mold;

preferably, the central part is an annular member, and the first projection is inserted into a central hole of the annular member;

preferably, the center member includes a first center piece and a second center piece, the first center piece and the second center piece are stacked and have overlapping axes, an outer peripheral surface of the first center piece is disposed more radially inward than an outer peripheral surface of the second center piece, and the first center piece is closer to the first lid body than the second center piece.

Preferably, a second protruding portion is arranged on the second cover body, the second protruding portion is clamped in a central hole of the second central piece, and the first protruding portion is clamped in a central hole of the first central piece.

Preferably, the centers of the first cover body and the second cover body are both provided with positioning holes, and the positioning holes are used for adjusting the closing-in positions on the corresponding first disk-shaped portion and the second disk-shaped portion.

Preferably, the first outer peripheral member and/or the second cover are/is snap-connected to the second outer peripheral member;

and/or the first peripheral component is detachably connected with the first cover body;

and/or the first peripheral part comprises two half ring portions spliced together.

Preferably, the special mold further comprises a shell, a plurality of heating pipes are inserted into the wall surface of the shell, and a cooling pipeline is further arranged in the wall surface of the shell;

the core die is accommodated in the inner cavity of the shell;

a rest stand is arranged in the inner cavity, and at least four core molds can be placed on the rest stand;

preferably, the housing includes a cover plate and a frame, the cover plate is covered on an upper opening of the frame, the heating pipe is arranged in a wall surface of the frame, and the cooling pipeline is arranged in the wall surface of the frame;

preferably, in the wall surface, the cooling line is provided inside the heating pipe;

preferably, the shell is also provided with an air inlet for introducing inert gas.

The shell is generally made of stainless steel, the temperature of the electric heating pipe is quickly raised, and heat conduction is quickly and stably after the electric heating pipe is heated. The cooling pipeline can rapidly cool the main body part, and is favorable for improving the supporting force and the self-expansion resilience of the product.

The net body of the atrial septal defect occluder is subjected to heat setting through the heating pipe, and can be rapidly cooled after heat setting through the cooling pipeline, so that the molding effect of the atrial septal defect occluder is enhanced.

At least four core moulds can be placed on the rest stand. Therefore, the production efficiency can be improved, and the cost can be reduced.

If the main body part is woven by degradable filaments, the inert gas is added and is input into the shaping mold, so that the water vapor in the air can be discharged, the influence of the water vapor on the performance of the net body in the shaping process of the net body is reduced, and the net body is prevented from being degraded in the shaping process. The inert gas may be helium, neon, argon, krypton, xenon, radon, or the like.

The invention also provides a manufacturing method of the heart atrial septal defect occluder with two smooth end surfaces, which comprises the following steps: a main body component, a flow impeding component, and a suture; the main body component is of a net body structure and comprises a first disc-shaped part, a tubular part and a second disc-shaped part which are sequentially connected, the first disc-shaped part and the second disc-shaped part are both double-layer net surfaces, two ends of the tubular part are respectively connected to an inner net surface of the first disc-shaped part and an inner net surface of the second disc-shaped part, the cross-sectional dimension of the outer net surface of the first disc-shaped part is larger than that of the inner net surface of the first disc-shaped part, and a containing cavity for containing at least part of the tubular part is formed on one side where the inner net surface of the first disc-shaped part is located; wherein the flow resisting part is at least two layers of degradable films or non-degradable films for resisting the blood flow; wherein the suture is a degradable suture or a non-degradable suture for sewing the flow resisting part on the main body part and serving as a closing line;

the manufacturing method comprises the following steps:

calculating the required weaving length of the tubular net body;

weaving the degradable filaments into a tubular mesh body by using a die rod, wherein the number of the woven meshes of the tubular mesh body is 20-144, grooves extending according to the direction of the degradable filaments are formed in the peripheral surface of the die rod so as to standardize the direction of the filaments, and the die rod is provided with a gas through hole extending along the central axis of the die rod;

shaping the tubular net body, wherein the shaping temperature of the tubular net body is 35-200 ℃, the shaping time is 1-60min, and both ends of the tubular net body are open ends capable of being bundled;

placing the tubular net body into a special mould, and heating and shaping to make the net body have a first disc-shaped part, a tubular part and a second disc-shaped part, wherein the shaping temperature is 35-200 ℃, and the shaping time is 1-60 min;

wherein the special mold comprises a core mold;

and vent holes are formed in the first cover body and the second cover body.

The manufacturing method comprises the steps of calculating the required weaving length of the tubular net body. In the scheme, the length of the plugging device needs to be accurately calculated, and the tubular net body after weaving just meets the product requirements. The reason is that the plugging device with the flat two end surfaces does not need to cut nets to be used as connectors, and no modification space is needed.

In the scheme, the number of the braided meshes of the tubular mesh body is 20-144, so that the requirements of the supporting force and the oversheath size of the plugging device can be met. The supporting force of the plugging device can be improved by increasing the number of the woven degradable filaments, but the over-sheath size can be increased, namely the diameter of the matched conveying sheath tube is larger, so that the range of indications is reduced; the support force of the plugging device can be reduced by reducing the number of the woven degradable filaments, but the oversheath size can be reduced, namely the diameter of the matched delivery sheath tube is smaller, so that the range of indications is enlarged.

Weaving the degradable filaments into a tubular net body on the mold rod, selecting a pin at one end of the mold rod as a starting point, knotting the degradable filaments on the pin at the starting point and fixing the pin at the starting point, and then winding and weaving the degradable filaments on the mold rod along the peripheral surface of the mold rod, wherein a groove extending along the direction of the degradable filaments is arranged on the peripheral surface of the mold rod, so that the direction of the filaments is normalized until the weaving of the tubular net body is completed. The weaving method of the net body enables the net body to be more uniform in grid, is easy to operate and reduces the manufacturing cost.

The mold rod is provided with a gas through hole extending along the central axis of the mold rod, so that heat conduction inside and outside the mold rod is facilitated, the gas through hole of the mold rod enables heat to be diffused outwards from the central axis of the mold rod, meanwhile, the heat is also diffused inwards from the outside of the mold rod, so that heat balance inside and outside the mold rod is facilitated, and the mesh body is uniformly heated and rapidly shaped.

And (3) shaping the tubular net body, wherein the shaping temperature of the tubular net body is 35-200 ℃, the shaping time is 1-60min, and both ends of the tubular net body are open ends capable of being bundled. The braided tubular net body needs to be shaped at a certain temperature and time to keep the shape of the braided net body unchanged. During the shaping process, the mould rod can support the net body and keep the shape of the net body unchanged. After the setting is completed, the tubular net body is taken off from the mold rod.

And putting the tubular net body into a special die, and heating and shaping to form the tubular net body with a first disc-shaped part, a tubular part and a second disc-shaped part. The setting temperature is 35-200 ℃, the setting time is 1-60min, and the main body component of the stopper is obtained by removing the special mould after setting.

The net body shaping method is easy to operate, the manufactured occluder is stable in size, and the occluder manufactured by the method has larger supporting force and better shape self-expansion resilience, so that the requirements of operation are met, and the operation is more effective and safer.

the manufacturing method comprises the following steps:

calculating the required weaving length of the tubular net body;

weaving the nondegradable wires into a tubular net body by using a mold rod, wherein the number of the woven nets of the tubular net body is 30-160, grooves extending according to the trend of the nondegradable wires are formed in the peripheral surface of the mold rod so as to standardize the trend of the wires, and the mold rod is provided with a gas through hole extending along the central axis of the mold rod;

setting the tubular net body at the temperature of 350-550 ℃ for 1-60min, wherein both ends of the tubular net body are open ends capable of being bundled;

placing the tubular net body into a special mould, and heating and shaping to ensure that the tubular net body is provided with a first disc-shaped part, a tubular part and a second disc-shaped part, wherein the shaping temperature is 350-550 ℃, and the shaping time is 1-60 min;

wherein the special mold comprises a core mold;

and vent holes are formed in the first cover body and the second cover body.

In the scheme, the number of the braided meshes of the tubular mesh body is 30-160, so that the requirements of the supporting force and the oversheath size of the plugging device can be met. The supporting force of the plugging device can be improved by increasing the number of the braided non-degradable filaments, but the over-sheath size can be increased, namely the diameter of the matched conveying sheath tube is larger, so that the range of indications is reduced; the support force of the plugging device can be reduced by reducing the number of the braided non-degradable filaments, but the oversheath size can be reduced, namely the diameter of the matched delivery sheath tube is smaller, so that the range of indications is widened.

The non-degradable wires are woven into a tubular net body on the mold rod, one pin at one end of the mold rod is selected as a starting point, the non-degradable wires are knotted on the pin at the starting point and are fixed at the starting point, and then the non-degradable wires are wound and woven on the mold rod along the groove which is arranged on the outer peripheral surface of the mold rod and extends along the direction of the non-degradable wires, so that the direction of the wires is regulated until the tubular net body is woven. The weaving method of the net body enables the net body to be more uniform in grid, is easy to operate and reduces the manufacturing cost.

And (3) shaping the tubular net body, wherein the shaping temperature of the tubular net body is 350-550 ℃, the shaping time is 1-60min, and both ends of the tubular net body are opening ends capable of being bundled. The braided tubular net body needs to be shaped at a certain temperature and time to keep the shape of the braided net body unchanged. During the shaping process, the mould rod can support the net body and keep the shape of the net body unchanged. After the setting is completed, the tubular net body is taken off from the mold rod.

Putting the tubular net body into a special mould, and heating and shaping to form the tubular net body with a first disc-shaped part, a tubular part and a second disc-shaped part; the setting temperature is 350-.

Preferably, after the step of "putting the tubular net body into a special mold, and heat-setting to have the first disk portion, the tubular portion, and the second disk portion", the manufacturing method further comprises the steps of:

sewing the choke component to at least one of the first disc, the second disc, and the tubular portion with the suture thread;

and closing the outer net surface of the first disc part and the outer net surface of the second disc part into continuous and flat net surfaces by using the sewing threads.

On the basis of the common knowledge in the field, the above preferred conditions can be combined randomly to obtain the preferred embodiments of the invention.

The positive progress effects of the invention are as follows:

the outer net surface of the first disc-shaped part and the outer net surface of the second disc-shaped part are connected to form a flat net surface without protruding connection points, so that the disc surface supporting force and the shape self-expansion resilience of the occluder can be increased, the risk of local thrombus formation on the surface of the occluder can be reduced, the endothelialization process on the surface of the occluder can be accelerated, and the atrial septal defect of the heart can be repaired by self tissues earlier. In addition, the release length of the occluder in the operation process is reduced, the damage to the heart can be greatly reduced, and the operation is more effective and safer; in addition, the plugging device also has the advantage of low manufacturing cost.

Drawings

Fig. 1 is a schematic perspective view of a cardiac atrial septal defect occluder with two flat end surfaces according to an embodiment of the present invention.

Figure 2 is a schematic side view of a flat-ended atrial septal defect occluder in accordance with an embodiment of the present invention.

Figure 3 is a side view of a flat-ended atrial septal defect occluder in accordance with one embodiment of the present invention.

FIG. 4 is an enlarged partial schematic view of the mouth end of the outer web side of the first disk according to one embodiment of the invention.

Fig. 5 is a schematic structural diagram of a mold rod for weaving a heart atrial septal defect occluder with two flat end surfaces.

Fig. 6 is a circuit diagram of a weaving starting point on a mold rod for weaving a heart atrial septal defect occluder with flat two end surfaces.

Fig. 7 is a circuit diagram of another weaving starting point on a mold rod for weaving a heart atrial septal defect occluder with flat end surfaces.

Fig. 8 is a schematic view of the weaving effect on the mold bar.

Fig. 9 is a schematic perspective view of a dedicated mold according to an embodiment of the present invention.

Fig. 10 is a schematic sectional structure view of a dedicated mold according to an embodiment of the present invention.

Fig. 11 is a sectional structure view of a core mold of a dedicated mold according to an embodiment of the present invention.

Fig. 12 is another sectional structure view of the core mold of the exclusive mold according to one embodiment of the present invention.

Fig. 13 is an exploded view of a core mold of a dedicated mold according to an embodiment of the present invention.

Fig. 14 is an exploded view schematically illustrating a core mold of a dedicated mold according to another embodiment of the present invention.

Fig. 15 is a schematic structural view of a jig according to an embodiment of the present invention.

FIG. 16 is a schematic structural view of a clip according to another embodiment of the present invention

FIG. 17 is a schematic view of the structure of the tubular mesh body with the central member inserted therein after the open end of one end of the tubular mesh body is closed.

Figure 18 is a schematic diagram of sheath outlet of the heart atrial septal defect occluder with two flat end surfaces.

Description of reference numerals:

occluding device 100

First disk portion 10

Inner net surface 11

Outer mesh surface 12

Closing end 13

Ring network cable 14

Closing line 15

Second disk 20

Inner net surface 21

Outer mesh surface 22

Tubular part 30

Special mold 200

Core mold 201

First cover 203

First protrusion 204

Vent 206

Second cover 207

Second projection 208

Positioning hole 209

Center part 211

First centerpiece 212

Second centerpiece 213

First outer peripheral member 214

Semi-ring portion 215

First opening 216

Second opening 217

Intermediate annular space 218

First annular gap 219

Second annular void 220

Clamp 221

Clamping plate 223

Adjustable fastener 224

Outer casing 241

Cover plate 243

Frame 244

Shelf 246

Heating pipe 251

Cooling circuit 252

Air inlet 253

Second outer peripheral member 254

Third opening 255

Mold bar 300

Groove 301

Detailed Description

The present invention is further illustrated by way of example and not by way of limitation in the scope of the embodiments described below in conjunction with the accompanying drawings.

This embodiment discloses a cardiac atrial septal defect occluder with flat two end surfaces, as shown in fig. 1-4, a cardiac atrial septal defect occluder 100 comprises a main body component, the main body component is woven from degradable filaments or non-degradable filaments, the main body component is a net body structure and comprises a first disc-shaped portion 10, a tubular portion 30 and a second disc-shaped portion 20 which are connected in sequence, the first disc-shaped portion 10 and the second disc-shaped portion 20 are both double-layer net surfaces, two ends of the tubular portion 30 are respectively connected to an inner net surface 11 of the first disc-shaped portion 10 and an inner net surface 21 of the second disc-shaped portion 20, and the first disc-shaped portion 10, the tubular portion 30 and the second disc-shaped portion 20 are integrally formed. The outer web surface 12 of the first pan 10 and the outer web surface 22 of the second pan 20 are each a continuous flat web surface. The outer web surface 12 of the first disc portion 10 has a cross-sectional dimension greater than the cross-sectional dimension of the inner web surface 11 of the first disc portion 10, and the inner web surface 11 of the first disc portion 10 is formed on one side with a receiving cavity for receiving at least part of the tubular portion 30. Taking the first disk-shaped portion 10 as an example, as shown in fig. 3-4, the outer mesh surface 12 of the first disk-shaped portion 10 includes a closed end 13, the closed end 13 is a plurality of sequentially adjacent annular mesh wires 14, the first disk-shaped portion 10 is further provided with a closed line 15, the closed line 15 is disposed through all the annular mesh wires 14, and the outer mesh surface 12 of the first disk-shaped portion 10 forms a continuous and flat mesh surface after being closed by the closed line 15.

The outer mesh surface 12 of the first disk portion 10 is a mesh surface of the first disk portion 10 facing away from the tubular portion 30 and the end of the second disk portion 20. Correspondingly, the outer mesh surface 22 of the second disc 20 is the mesh surface of the end of the second disc 20 facing away from the tubular portion 30 and the first disc 10.

In the present embodiment, the main body member including the first disk portion 10, the tubular portion 30 and the second disk portion 20 is made of a high molecular degradable filament. The degradable silk is a biodegradable high molecular material, and is selected from polylactide, polyglycolide, polycaprolactone, polydioxanone, polyhydroxybutyrate, polyhydroxyalkanoate, polyanhydride, polyphosphate, polyurethane or polycarbonate, derivatives thereof, blends of more than two of the polyhydroxybutyrate, the polyhydroxybutyrate and the polyhydroxyalkanoate, or copolymers of corresponding monomers. The materials have good biocompatibility, can be completely degraded and absorbed in a human body, and avoid the long-term influence of implanted foreign matters on the human body. The plugging device only provides a temporary bridge for heart repair, is degraded by an organism after the completion of a historical mission, and enables the defect to be completely repaired by self tissue, thereby avoiding long-term complications and potential safety hazards brought by metal remaining in the body. In an alternative embodiment, the material of the body member comprising the first disk 10, the tubular portion 30 and the second disk 20 may also be a non-degradable wire, such as a metal or alloy material, including stainless steel, cobalt-based alloys, titanium and titanium alloys, nitinol shape memory materials, and the like.

The atrial septal defect occluder 100 further comprises a flow-resisting part and a suture line, wherein the flow-resisting part is at least two layers of degradable films or non-degradable films for resisting blood flow; wherein the suture is degradable suture or non-degradable suture for sewing the flow resisting part on the main body part and serving as a closing line.

Specifically, in the present embodiment, the flow blocking component is a degradable flow blocking film, which is a biodegradable material, such as polylactide, polycaprolactone, polyhydroxybutyrate, polydioxanone, and the like, thereby playing a role in blocking blood flow. In an alternative embodiment, the flow-impeding component may also be a non-degradable flow-impeding membrane, which is a non-biodegradable material, such as polyethylene terephthalate, polytetrafluoroethylene, etc., to act as a blood flow barrier.

In addition, regarding the suture thread, in the present embodiment, a degradable suture thread is selected, which may be a biodegradable material, such as poly-propyl-acetate, poly-lactide, etc., for suturing the flow blocking part to the main body part and closing the mouth as a closing line. In an alternative embodiment, a non-degradable suture thread, which is a non-biodegradable material such as polyethylene terephthalate, may be used to suture the flow-obstructing component to the main component and to act as a setback.

The first disc-shaped part 10 and the second disc-shaped part 20 of the cardiac atrial septal defect occluder are continuous and flat reticular surfaces after being closed by the closing line 15, no protrusion exists, the structure is favorable for shape recovery and disc surface supporting force improvement of the occluder, and is more favorable for accelerating endothelialization process on the surface of the occluder, so that cardiac atrial septal defect is repaired by self tissues earlier.

The present embodiment also provides a method for manufacturing the atrial septal defect occluder 100. Wherein, the main body component of the heart atrial septal defect occluder 100 is woven by degradable filaments.

The manufacturing method comprises the following steps:

and calculating the length of the tubular net body required to be woven according to the setting requirement. For the plugging device, the length needs to be accurately calculated, and the tubular net body after weaving just meets the product requirements. The reason is that the plugging device with the flat two end surfaces does not need to cut nets to be used as connectors, and no modification space is needed.

Weaving a tubular net body on a mold rod 300 by using degradable wires, wherein the mold rod 300 is shown in figure 5, a pin at one end of the mold rod 300 is selected as a starting point, the degradable wires are knotted on the pin at the starting point and fixed at the starting point, then the degradable wires are wound and woven on the mold rod 300 along a groove 301 on the mold rod 300, a first wire is wound along the mold rod for one circle as shown in figure 6, a second wire is wound as shown in figure 7, the mold rod 300 is provided with a groove 301 according to the wire direction so as to standardize the wire direction until the weaving of the tubular net body is completed, and the woven tubular net body is shown in figure 8. The weaving method of the net body enables the net body to be more uniform in grid, is easy to operate and reduces the manufacturing cost. The net weaving number of the net body is 20-144, and the requirements of the supporting force and the oversheath size of the plugging device can be met. The supporting force of the plugging device can be improved by increasing the number of the woven degradable filaments, but the over-sheath size can be increased, namely the diameter of the matched conveying sheath tube is larger, so that the range of indications is reduced; the support force of the plugging device can be reduced by reducing the number of the woven degradable filaments, but the oversheath size can be reduced, namely the diameter of the matched delivery sheath tube is smaller, so that the range of indications is enlarged.

The braided tubular net body needs to be shaped at a certain temperature and time to keep the shape of the braided net body unchanged. The setting temperature of the tubular net body is 35-200 ℃, and the setting time is 1-60 min. In the design process, the mold rod 300 can support the net body and keep the shape of the net body unchanged, and simultaneously, the central axis department of mold rod 300 has the gas through hole, is favorable to the heat conduction inside and outside the mold rod 300, and the gas through hole of mold rod 300 makes the heat outwards diffuse by the central axis of mold rod 300, and the heat is also inwards diffused by the outside of mold rod 300 simultaneously, is favorable to realizing heat balance inside and outside the mold rod 300 so fast to guarantee that the net body is heated evenly and stereotypes fast. After setting is complete, the tubular mesh body is removed from the mandrel 300.

And (3) shaping the net body into a shape with a first disc-shaped part 10, a tubular part 30 and a second disc-shaped part 20 by using a special mould 200, heating and shaping the net body, wherein the shaping temperature is 35-200 ℃, the shaping time is 1-60min, and removing the special mould after shaping to obtain the main body part of the stopper.

As shown in fig. 9-14, the special mold includes a core mold 201 and a shell 241.

The core mold 201 includes: a first cover 203, a center member 211, a second cover 207, an annular first outer peripheral member 214, and an annular second outer peripheral member 254.

The first cover 203 covers the first opening 216 of the first outer circumferential member 214 in the axial direction, the second outer circumferential member 254 is connected to the second opening 217 of the first outer circumferential member 214 in the axial direction, the second cover 207 covers the third opening 255 of the second outer circumferential member 254 in the axial direction, and the first cover 203 and the second cover 207 are located on both sides of the second outer circumferential member 254. The center member 211 is provided inside the second peripheral member 254, and an intermediate annular space 218 is formed between the outer peripheral wall of the center member 211 and the inner peripheral wall of the second peripheral member 254, the intermediate annular space 218 being used to form the tubular portion 30. A first annular space 219 is formed between the inner peripheral wall of the first outer peripheral member 214, the inner side surface of the first cover 203, and the outer peripheral wall of the second outer peripheral member 254, and the first annular space 219 is used to form the first disk portion 10. A second annular gap 220 is formed between the inner peripheral wall of the second peripheral member 254 and the inner side surface of the second cover 207, and the second annular gap 220 is used for forming the second disc portion 20.

The inner peripheral wall of the first outer peripheral member 214 is a wall surface of the first outer peripheral member 214 facing one side of the second outer peripheral member 254, the outer peripheral wall of the second outer peripheral member 254 is a wall surface of the second outer peripheral member 254 facing one side of the first outer peripheral member 214, and the inner peripheral wall of the second outer peripheral member 254 is a wall surface of the second outer peripheral member 254 facing one side of the second cover 207 and the center member 211.

One or more vent holes 206 are provided in the second cover 207, and the vent holes 206 penetrate the second cover 207 and communicate the inside and outside of the core mold 201. One or more vent holes 206 may be provided in the first cover 203, and optionally, a positioning hole 209 described below may be used as the vent hole 206. Note that the wall thickness of the first cover 203 is small, and a small number of vent holes, such as one, are preferably provided. The vent holes 206 are beneficial to the heat conduction in the special die, so that the heat is diffused outwards from the central axis of the die, and the heat diffused inwards from the outside of the die exists at the same time, thereby being beneficial to quickly realizing the heat balance inside and outside the die, and further ensuring that the net body can be heated uniformly and quickly shaped in the shaping process. Fig. 12 shows heat conduction in the mold, where the arrow direction indicates the heat conduction direction.

The first cover 203 is provided at the center thereof with a first projection 204, and the first projection 204 projects toward the inside of the core mold 201. The first projection 204 is used to form a depression in the center of the first disk portion 10. Wherein the depressed portion is located at the closed end 13 of the outer mesh surface 12 of the first disk-shaped portion 10, and the depressed portion has no rivet point.

The central part 211 is an annular member, and the first protrusion 204 is inserted into a central hole of the annular member; the center member 211 includes a first center piece 212 and a second center piece 213, the first center piece 212 and the second center piece 213 are stacked and axially overlapped, an outer peripheral surface of the first center piece 212 is disposed more radially inward than an outer peripheral surface of the second center piece 213, and the first center piece 212 is closer to the first cover 203 than the second center piece 213.

The first protrusion 204 is engaged with the central hole of the first central member 212, the second cover 207 is provided with a second protrusion 208, and the second protrusion 208 can be configured to be engaged with the central hole of the second central member 213. By providing the second protrusion 208, the net surface of the shaped second disc 20 away from the tubular part is slightly recessed inwards, which counteracts the slight springback of the heart atrial septal defect occluder 100 after demolding.

In the present embodiment, the center member 211 includes the first center piece 212 and the second center piece 213 having different cross-sectional dimensions. In other alternative embodiments, the first centerpiece 212 and the second centerpiece 213 may be provided with the same cross-sectional dimensions. In another alternative embodiment, first centerpiece 212 and second centerpiece 213 may also be provided as a unitary structure.

The center of the first cover 203 and the center of the second cover 207 are provided with positioning holes 209, and the positioning holes 209 are used for adjusting the closing positions on the first disk portion 10 and the second disk portion 20, respectively. After the net body is put into the core mold 201 and the core mold 201 is closed, the closing position of the net body can be adjusted by inserting a member such as a pin into the positioning hole 209.

The first outer peripheral member 214 and/or the second cover 207 are/is engaged with the second outer peripheral member 254.

It should be noted that in an alternative embodiment, the first outer peripheral member 214 is a unitary member, as shown in fig. 13. In another alternative embodiment, the first outer circumferential component 214 may be provided to include two half-rings 215 that are spliced together, as shown in fig. 14. This further facilitates assembly of the various components of the core 201. When the first outer circumferential member 214 includes the halved two half ring portions 215, a jig described below preferably also grips the first outer circumferential member 214 from both sides of the two half ring portions 215.

In addition, in the present embodiment, as shown in fig. 11 to 14, the first cover 203 and the first outer circumferential member 214 are two separate parts, and the first cover 203 and the first outer circumferential member 214 are preferably provided to be detachably connected. Set up the first lid 203 of two independent parts and first peripheral component 214 to connecting for dismantling, when putting into special mould with the tubulose dictyosome after the shaping, can install first lid 203 again at last, so set up, when the deviation was placed to the position of tubulose dictyosome, before the first lid 203 of installation, can get into special mould's inside and adjust or finely tune the position of tubulose dictyosome by first opening 216 to be favorable to improving the fashioned reliability of plugging device.

In an alternative embodiment, the first cover 203 and the first outer peripheral member 214 may be provided as a single body.

The dedicated mold 200 further comprises a clamp 221 clamping the first cover 203 and the second cover 207 towards the central part 211. As shown in fig. 15-16, the clamp 221 has two clamping plates 223 and adjustable fasteners 224 attached to the two clamping plates 223, respectively. The fasteners may be at least two, such as 2, 4, etc. The clamping plate can be clamped left and right or up and down.

The special mold 200 further includes a housing 241, a plurality of heating pipes 251 are inserted into a wall surface of the housing 241, and a cooling pipeline 252 is further provided in the wall surface of the housing 241. The core 201 is received in the inner cavity of the housing 241. The heating pipe 251 is generally an electric heating pipe, and can be pulled out from the wall surface to adjust the heating power. The shell 241 is preferably made of a material that conducts heat well so that the mandrel 201 inside it is heated uniformly. Similarly, the core mold 201 is also made of a material having good thermal conductivity.

The net body of the atrial septal defect occluder 100 is heat-set by the heating pipe 251, and can be rapidly cooled after heat-setting through the cooling pipeline 252, so that the molding effect of the atrial septal defect occluder 100 is enhanced.

The casing 241 includes a cover plate 243 and a frame 244, the cover plate 243 covers an upper opening of the frame 244, the heating pipe 251 is provided in a wall surface of the frame 244, and the cooling pipe 252 is provided in a wall surface of the frame 244. The housing 241 is also provided with an inlet 253 for introducing inert gas into the interior of the housing. Through letting in inert gas, be favorable to getting rid of the steam in the inside air of shell, reduce the influence of shutoff ware design in-process steam to the dictyosome performance, prevent that the dictyosome from taking place the degradation when stereotyping. The inert gas may be helium, neon, argon, krypton, xenon, radon, or the like.

In the wall surface, the cooling line 252 is provided inside the heating pipe 251. The cooling line 252 spirally surrounds the inner cavity of the housing 241 in the wall surface to enable rapid cooling of the wall surface.

When the special mold 200 is used to shape the atrial septal defect occluder 100, first, as shown in fig. 17, the open end of one end of the net body which can be contracted is closed by a suture, the central part 211 is arranged in the net body through the open end of the other end of the net body which can be contracted, then, the open end of the net body is closed, the net body with the central part 211 is passed through the second outer circumferential part 254, then, the two half ring portions 215 are joined to form the complete first outer peripheral member 214 (taking the first outer peripheral member shown in fig. 14 as an example), the first outer peripheral member 214 is engaged with the second outer peripheral member 254, next, the adjustment net is positioned on the disk surfaces of the two disk-shaped portions, the first cover 203 is placed on the first opening 216 of the first outer peripheral member 214, the second cover 207 is placed on the third opening 255 of the second outer peripheral member 254, and the closing position of the net is adjusted through the positioning hole 209. By pressing the first cover body 203 and the second cover body 207 inward, the mesh body in the cavity between the inner surface of the first cover body 203 and the inner circumferential wall of the first outer circumferential member 214 and the outer circumferential wall of the second outer circumferential member 254 and the mesh body in the cavity between the inner surface of the second cover body 207 and the inner circumferential wall of the second outer circumferential member 254 are radially expanded to form a disk-like portion.

After the tubular net body is shaped, the opening ends capable of being bunched at the two ends of the net body are closed nets capable of being opened freely, and the opening ends are bunched by utilizing one or more degradable or non-degradable wires to close the net body or released to open the other end of the net body. The net wires at the open ends can be mutually constrained without loosening the net body, the phenomenon that the net body woven by a double-rivet plugging device machine is easy to loosen after being cut off is avoided, and the net body has higher stability in the process of adding a die and removing the die, so that the process and the operation are simplified.

The mandrel 201 is clamped using the clamp 221 and then the clamp 221 is placed into the internal cavity of the housing 241 with the mandrel 201. The housing 241 has a cavity in which a rest 246 is placed, and the jig 221 is placed on the rest 246. The shelf 246 has four platforms for placing core molds, and can heat-set at least four nets at one time, thereby improving the production efficiency and reducing the cost. Of course, the rest 246 can be provided in other shapes to hold more core molds.

The heating pipe 251 is used to perform heating, and after a predetermined heating time, the heating is stopped, and a coolant is introduced into the cooling pipe, so that the core mold 201 is rapidly cooled.

The net body shaping method is easy to operate, and the manufactured occluder 100 is stable in size. The occluder 100 manufactured by the method has larger disc surface supporting force and better shape self-expansion resilience, thereby meeting the requirements of operation and ensuring that the operation is more effective and safer.

The shaped main body part is sewed on the disk-shaped part and/or the tubular part of the main body part by using a sewing thread. Finally, the outer web of the first disk 10 and the outer web of the second disk 20 are closed with sutures to form a continuous flat web.

In an alternative embodiment, another method of manufacturing an atrial septal defect occluder 100 is provided. Wherein, the main body component of the heart atrial septal defect occluder 100 is woven by non-degradable silk. The manufacturing method is basically the same as the manufacturing method that the main body component is woven by degradable filaments, and the difference is mainly that: (1) setting temperature of the tubular net body; (2) the temperature at which the body part is set in the dedicated mold 200. Specifically, when the main body part is formed by weaving non-degradable filaments, the setting temperature of the tubular net body is 350-550 ℃, and the setting time is 1-60 min; the tubular net body is placed into a special mould 200 and heated for shaping, the shaping temperature is 350-550 ℃, and the shaping time is 1-60 min.

The outer mesh surfaces of the two disk-shaped parts (the first disk-shaped part 10 and the second disk-shaped part 20) of the occluder 100 manufactured by the occluder manufacturing method are continuous and flat mesh surfaces without salient points; the supporting force of the occluding device 100 generally refers to the disc surface supporting force of the first disc-shaped part 10, and through the detection of the supporting force, the supporting force value of the occluding device 100 is far larger than the differential pressure value of the defect part, so that enough stable supporting force can be ensured, and the occluding device 100 can be firmly fixed at the atrial septal defect. The process of withdrawing the sheath of the occluder 100 is shown in fig. 18, after the occluder 100 is retracted, pushed and released in the sheath tube, the occluder can return to the original shape, the sheath can be retracted smoothly without obstruction, and the occluder 100 can be ensured not to fall off on the conveying steel cable; the closing line is firmly connected with the conveying system; the plugging device 100 can be stored completely after 4 years under the set storage condition, the mechanical property is met, and the components of the plugging device 100 can still meet the use requirements.

In the description of the present invention, it is to be understood that the terms "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate orientations or positional relationships based on those shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, are not to be construed as limiting the present invention.

While specific embodiments of the invention have been described above, it will be appreciated by those skilled in the art that this is by way of example only, and that the scope of the invention is defined by the appended claims. Various changes and modifications to these embodiments may be made by those skilled in the art without departing from the spirit and scope of the invention, and these changes and modifications are within the scope of the invention.

Claims

1. The utility model provides a heart atrial septal defect occluder that both ends face is smooth, its characterized in that heart atrial septal defect occluder includes: a main body component, a flow impeding component, and a suture; the main body component is of a net body structure and comprises a first disc-shaped part, a tubular part and a second disc-shaped part which are sequentially connected, the first disc-shaped part and the second disc-shaped part are both double-layer net surfaces, two ends of the tubular part are respectively connected to an inner net surface of the first disc-shaped part and an inner net surface of the second disc-shaped part, the cross-sectional dimension of the outer net surface of the first disc-shaped part is larger than that of the inner net surface of the first disc-shaped part, and a containing cavity for containing at least part of the tubular part is formed on one side where the inner net surface of the first disc-shaped part is located; wherein the flow resisting part is at least two layers of degradable films or non-degradable films for resisting the blood flow; wherein the suture is a degradable suture or a non-degradable suture for sewing the flow resisting part on the main body part and serving as a closing line;

wherein, the heart atrial septal defect stopper is made of a special mould;

the special mold comprises a core mold;

and vent holes are formed in the first cover body and the second cover body.

2. The atrial septal defect occluder of claim 1, wherein said second cover has one or more ventilation holes formed therein, said ventilation holes extending through said second cover and communicating between the interior and the exterior of said core mold;

3. The atrial septal defect occluder of claim 1, wherein the first cap has a first protrusion at the center thereof, said first protrusion protruding toward the inside of the core mold;

4. The atrial septal defect occluder of claim 3, wherein the second cover has a second protrusion, the second protrusion is engaged with the central hole of the second central member, and the first protrusion is engaged with the central hole of the first central member.

5. The atrial septal defect occluder of claim 1, wherein the first cap and the second cap each have a positioning hole at the center thereof for adjusting the position of the constriction on the corresponding first disk portion and second disk portion.

6. The atrial septal defect occluder of claim 1, wherein the first peripheral component and/or the second cover is snap-fit to the second peripheral component;

7. The atrial septal defect occluder of claim 1, wherein said mold further comprises a housing, a plurality of heating tubes are inserted into the wall of said housing, and a cooling pipeline is further disposed in the wall of said housing;

the core die is accommodated in the inner cavity of the shell;

8. A manufacturing method of a heart atrial septal defect occluder with two flat end surfaces is characterized by comprising the following steps: a main body component, a flow impeding component, and a suture; the main body component is of a net body structure and comprises a first disc-shaped part, a tubular part and a second disc-shaped part which are sequentially connected, the first disc-shaped part and the second disc-shaped part are both double-layer net surfaces, two ends of the tubular part are respectively connected to an inner net surface of the first disc-shaped part and an inner net surface of the second disc-shaped part, the cross-sectional dimension of the outer net surface of the first disc-shaped part is larger than that of the inner net surface of the first disc-shaped part, and a containing cavity for containing at least part of the tubular part is formed on one side where the inner net surface of the first disc-shaped part is located; wherein the flow resisting part is at least two layers of degradable films or non-degradable films for resisting the blood flow; wherein the suture is a degradable suture or a non-degradable suture for sewing the flow resisting part on the main body part and serving as a closing line;

the manufacturing method comprises the following steps:

calculating the required weaving length of the tubular net body;

wherein the special mold comprises a core mold;

and vent holes are formed in the first cover body and the second cover body.

9. A manufacturing method of a heart atrial septal defect occluder with two flat end surfaces is characterized by comprising the following steps: a main body component, a flow impeding component, and a suture; the main body component is of a net body structure and comprises a first disc-shaped part, a tubular part and a second disc-shaped part which are sequentially connected, the first disc-shaped part and the second disc-shaped part are both double-layer net surfaces, two ends of the tubular part are respectively connected to an inner net surface of the first disc-shaped part and an inner net surface of the second disc-shaped part, the cross-sectional dimension of the outer net surface of the first disc-shaped part is larger than that of the inner net surface of the first disc-shaped part, and a containing cavity for containing at least part of the tubular part is formed on one side where the inner net surface of the first disc-shaped part is located; wherein the flow resisting part is at least two layers of degradable films or non-degradable films for resisting the blood flow; wherein the suture is a degradable suture or a non-degradable suture for sewing the flow resisting part on the main body part and serving as a closing line;

the manufacturing method comprises the following steps:

calculating the required weaving length of the tubular net body;

wherein the special mold comprises a core mold;

and vent holes are formed in the first cover body and the second cover body.

10. The method for manufacturing a cardiac atrial septal defect occluder of claim 8 or 9, wherein after the step of placing the tubular net body in a special mold and heat setting the tubular net body to have a first disk portion, a tubular portion and a second disk portion, the method further comprises the steps of: