CN113197601A

CN113197601A - Manufacturing method of plugging device

Info

Publication number: CN113197601A
Application number: CN202110473923.9A
Authority: CN
Inventors: 王梓曼; 李泽明; 向仟元
Original assignee: Zhuhai Yixin Medical Technology Co ltd
Current assignee: Zhuhai Yixin Medical Technology Co ltd
Priority date: 2021-04-29
Filing date: 2021-04-29
Publication date: 2021-08-03

Abstract

The invention discloses a manufacturing method of a plugging device, which comprises the steps of cutting a plurality of rods, deforming the rods to obtain a net-shaped framework, connecting a connecting part at one end of each rod after heat setting, enabling one end of each rod to be occluded in the connecting part, forming an end face of the plugging device at one end of each rod, and enabling the height of the end face of the outer side of each connecting part, which exceeds the end face of the plugging device, to be L which is less than or equal to 0.5 mm. So set up, through cutting and warping raw and other materials, obtain netted skeleton, through adapting unit to a plurality of ends of netted skeleton contract the connection to make adapting unit exceed the height L of the terminal surface of plugging device be less than or equal to 0.5mm, make the arch of the terminal surface of plugging device tend to level and smooth, endothelial cell can carry out good adhesion and climb and cover, make short-term and long-term effect after implanting the plugging device tend to the ideal.

Description

Manufacturing method of plugging device

Technical Field

The invention relates to the technical field of medical instruments, in particular to a manufacturing method of an occluder.

Background

There are a number of corresponding types of heart septal defect occluders that have been minimally invasive to treat heart septal defects, and these occluders are typically delivered to the specific location of the heart septal defect of the patient via the femoral vein or artery via a guidewire and catheter.

At present, a connecting part with a connecting structure is generally welded with a medical instrument, and the connecting part generally protrudes from the disk surface of the instrument, so that endothelial cells are difficult to adhere and cover on the left atrial appendage occluder, and the endothelialization process after the left atrial appendage occluder is finally implanted is not ideal in short term and long term.

Disclosure of Invention

The present invention is directed to solving at least one of the problems of the prior art. Therefore, the invention provides a manufacturing method of the occluder, which limits the height of the connecting part exceeding the end face of the occluder within a certain range, so that the end face of the occluder tends to be flat, and endothelial cells are convenient to adhere and cover.

The manufacturing method of the occluder comprises the following steps:

cutting, namely cutting/carving the raw material to form a plurality of mutually connected rods at one end of the raw material;

deformation, namely stretching a prefabricated mould into the centers of the rods, outwards extruding the prefabricated mould to bend one ends of the rods to form a plurality of petal shapes, continuously driving the prefabricated mould to bend the rods back, and converging one ends of the rods at the centers above the other ends of the rods to form a net-shaped framework;

heat setting, namely putting the prefabricated mould and the reticular framework into heat treatment equipment to heat-set the reticular framework;

and assembling, wherein one end of each of the rods is connected with a connecting part, so that the ends of the rods are all occluded in the connecting part, the ends of the rods form the end surface of the occluder, the height of the end surface of the outer side of the connecting part, which exceeds the end surface of the occluder, is L, and L is less than or equal to 0.5 mm.

The manufacturing method of the occluder provided by the embodiment of the invention at least has the following beneficial effects: the raw materials are cut and deformed to obtain the net-shaped framework, a plurality of ends of the net-shaped framework are bundled and connected through the connecting parts, the height L of the connecting parts, which exceeds the end face of the plugging device, is less than or equal to 0.5mm, the bulges on the end face of the plugging device tend to be flat, endothelial cells can be well adhered and coated, and the short-term and long-term effects after the plugging device is implanted tend to be ideal.

According to some embodiments of the invention, in the cutting step, the other end of the raw material forms a tube end, and the plurality of rods each extend in an axial direction of the tube end.

According to some embodiments of the invention, in the cutting step, the two ends of the raw material are formed into a plurality of rods coupled to each other, and the other ends of the plurality of rods are bundled together by a bundling member.

According to some embodiments of the invention, the constriction may constrict the other ends of the rods by welding or crimping.

According to some embodiments of the invention, the step of assembling includes the step of coupling the connecting member to the rod by a coupling member.

According to some embodiments of the invention, the fixing member and the connecting member are connected by a screw thread, or the fixing member and the connecting member are connected by welding.

According to some embodiments of the invention, the fixed member is provided with a bent tooth, the connecting member is provided with a step surface, and the bent tooth and the step surface define the gap therebetween.

According to some embodiments of the invention, the connecting member is further provided with a connecting portion for connecting a conveying system, and the connecting portion is provided with a thread structure or a buckling structure.

According to some embodiments of the invention, in the cutting step, an anchor is cut/carved on each of the rods and is lifted to an inclination, forming a number of anchors.

According to some embodiments of the invention, in the cutting step, a mounting hole is cut/engraved in each of the bars, and in the assembling step, anchors are attached to the mounting holes by riveting or welding, forming anchors.

Additional aspects and advantages of the invention will be set forth in part in the description which follows and, in part, will be obvious from the description, or may be learned by practice of the invention.

Drawings

The above and/or additional aspects and advantages of the present invention will become apparent and readily appreciated from the following description of the embodiments, taken in conjunction with the accompanying drawings of which:

FIG. 1 is a schematic structural view of an occluding device according to an embodiment of the invention;

FIG. 2 is a schematic structural view of a first connecting member according to an embodiment of the present invention;

FIG. 3 is a cross-sectional view of the first attachment member of FIG. 2;

FIG. 4 is a schematic structural view of a second connecting member according to an embodiment of the present invention;

FIG. 5 is a cross-sectional view of the second attachment member of FIG. 4;

figure 6 is a schematic view of an occluding device of an embodiment of the present invention after implantation;

FIG. 7 is a schematic view showing an assembly process of the mesh skeleton and the connection members according to the embodiment of the present invention;

FIG. 8 is a schematic cut-away view of a mesh skeleton according to an embodiment of the present invention;

fig. 9 is a schematic diagram of a deformation process of the mesh skeleton according to the embodiment of the present invention.

A mesh skeleton 100, a rod 110, an anchor 120, a tube end 130;

the connecting part 200, the fixing part 210, the bent teeth 211, the toothed bar 212, the toothed seam 213, the connecting part 220, the step surface 221, the connecting part 222 and the gap 230;

a delivery system 300.

Detailed Description

Reference will now be made in detail to embodiments of the present invention, examples of which are illustrated in the accompanying drawings, wherein like or similar reference numerals refer to the same or similar elements or elements having the same or similar function throughout. The embodiments described below with reference to the accompanying drawings are illustrative only for the purpose of explaining the present invention, and are not to be construed as limiting the present invention.

In the description of the present invention, it should be understood that the orientation or positional relationship referred to in the description of the orientation, such as the upper, lower, front, rear, left, right, etc., is based on the orientation or positional relationship shown in the drawings, and is only for convenience of description and simplification of description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus, should not be construed as limiting the present invention.

In the description of the present invention, the meaning of a plurality of means is one or more, the meaning of a plurality of means is more than one, and the meaning of more than, less than, more than, etc. is understood as excluding the present number, and the meaning of more than, less than, etc. is understood as including the present number. If the first and second are described for the purpose of distinguishing technical features, they are not to be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated or implicitly indicating the precedence of the technical features indicated.

In the description of the present invention, unless otherwise explicitly limited, terms such as arrangement, installation, connection and the like should be understood in a broad sense, and those skilled in the art can reasonably determine the specific meanings of the above terms in the present invention in combination with the specific contents of the technical solutions.

Referring to fig. 1 and fig. 7 to 9, a method for manufacturing an occluder according to an embodiment of the present invention includes the following steps:

cutting, cutting/carving the raw material to form a plurality of mutually connected rods 110 at one end of the raw material;

deforming, namely extending the prefabricated mold into the centers of the rods 100, outwards extruding to bend one ends of the rods 110 to form a plurality of petal shapes, continuously driving the prefabricated mold to bend the rods 110, and converging one ends of the rods 110 to the center above the other ends of the rods 100 to form a net-shaped framework 100;

heat setting, namely putting the prefabricated mould and the net-shaped framework 100 into heat treatment equipment to heat-set the net-shaped framework 100;

and assembling, wherein one end of each of the rods 110 is connected with a connecting part 200, so that one end of each of the rods 110 is occluded in the connecting part 200, one end of each of the rods 110 forms an end face of the stopper, the height of the end face of the outer side of the connecting part 200 exceeding the end face of the stopper is L, and L is less than or equal to 0.5 mm.

It should be noted that, referring to fig. 8, the raw material is set as a cylindrical tube, the cylindrical tube is cut and engraved, and the cut waste is removed to form the rod 110 with a plurality of pores as shown in fig. 8, the process of bending the plurality of rods 110 into the net-shaped skeleton 100 is schematically shown in fig. 9, the tube end 130 at the upper end is fixed, the plurality of rods 110 are outwardly pressed, in the diagram shown in fig. 9, the rods 110 are pressed towards the left and right sides to be opened and to form a trumpet shape in the second state, in the actual process, the plurality of rods 110 form a plurality of petal shapes when viewed from top to bottom, the rods 110 are continuously bent upwards to form a return bend in the third state as shown in fig. 9, and finally, one end of the rods 110 is converged at the center above the tube end 130, and the net-shaped skeleton 100 is formed.

It is understood that the return bend refers to a C-shaped bend formed by bending one end of the rod 110 from a lower portion to an upper portion. The end surface of the stopper means that, as shown in fig. 7, the ends of the rods 110 at the upper end of the mesh-shaped frame 100 are located on the same horizontal plane, and the ends together form an end surface, and the height L means the distance from the upper surface of the connecting member 200 to the end surface when the connecting member 200 is assembled on the mesh-shaped frame 100, referring to fig. 1.

The manufacturing method of the occluder provided by the embodiment of the invention at least has the following beneficial effects: the raw materials are cut and deformed to obtain the reticular skeleton 100, a plurality of ends of the reticular skeleton 100 are bundled and connected through the connecting parts 200, and the height L of the connecting parts 200, which exceeds the end face of the occluder, is less than or equal to 0.5mm, so that the bulges on the end face of the occluder tend to be flat, endothelial cells can be well adhered and coated, and the short-term and long-term effects after the occluder is implanted tend to be ideal.

The end surface of the occluder is a surface formed by the upper end of the mesh skeleton 100.

According to some embodiments of the present invention, in the cutting step, referring to fig. 8, the lower end of the raw material forms a tube end 130, and the rods 110 are all distributed along the axial extension of the tube end 130, it can be understood that the tube end 130 refers to a portion of the raw material that is not engraved or cut, and is integrally formed with the rods 110, so that the rods 110 are all provided with only one end to be constricted, and the tube end 130 has a constriction function, and no additional constriction member is required, so that the processing is facilitated, the material and production costs are saved, and meanwhile, the other end of the rod 110 can be ensured to be always kept in a constricted state.

In the above embodiment, during actual production, both ends of the raw material may be cut and engraved to form the rods 110 connected to each other, a bundling piece needs to be added to the structure, one ends of the rods 110 are bundled together, the bundling manner may be that the rods 110 are welded in the bundling piece, or one ends of the rods 110 are bundled in a hoop pressing manner, the final structure after bundling is the same as that shown in fig. 7, the bundling piece replaces the pipe end 130, and the structure makes production more flexible, and production and processing can be performed according to actual situations.

According to some embodiments of the present invention, referring to fig. 2 to 5 and fig. 7, in the assembling step, the connection member 200 includes a fixing member 210 and a connection member 220, and after the fixing member 210 and the connection member 220 are assembled together, a gap 230 is formed as shown in fig. 3 or 5, and the gap 230 is used to receive one end of the rod 110.

In the above embodiment, referring to fig. 2 and 3, the bent teeth 211 are disposed on the fixing member 210, the step surface 221 is disposed on the connecting member 220, and after the fixing member 210 and the connecting member 220 are assembled together, the bent teeth 211 and the step surface 221 form the gap 230, as shown in fig. 3, one end of the rod 110 can swing in the gap 230 with a certain amplitude, as shown in the representation of the dotted line portion shown in fig. 3, and the phenomenon that the end of the rod 110 is fixed to be easily broken can be reduced.

Referring to fig. 4 and 5, the fixed member 210 may further include toothed bars 212, a slot 213 is formed between every two toothed bars 212, and after the fixed member 210 and the connecting member 220 are assembled together, a gap 230 is formed between the stepped surface 221 and the slot 213, which has the same intended effect as above and will not be described again.

According to some embodiments of the present invention, the fixing member 210 and the connecting member 220 are connected by a screw, as shown in fig. 4, or by welding, in fig. 2, an end surface of the bent tooth 211 facing the center is welded to a side surface of the fixing member 220, in fig. 4, an upper end surface of the rack bar 212 is welded to an upper end surface of the connecting member, thereby facilitating assembly by the screw, and the welding is used to make the assembly between the fixing member 210 and the connecting member 220 more firm.

According to some embodiments of the present invention, referring to figure 4, a connecting portion 222 for connecting a delivery system is formed on the connecting member 220. referring to figure 6, after the delivery system 300 delivers the occluding device to the implantation site, the occluding device is disconnected from the connecting portion 222 and withdrawn. The connecting portion 222 may be a threaded structure, and is connected to the conveying system 300 through a thread, the connecting portion 222 may also be a snap structure, and the corresponding conveying system 300 is a hook.

According to some embodiments of the present invention, in the cutting step, referring to fig. 1 or 6, a length of the anchoring thorn 120 is cut or engraved in the middle of each of the rods 110, and the anchoring thorn 120 is lifted to be bent obliquely to form an upward barb shape, and after being heat-set, an anchor is formed for allowing the occluding device to be maintained at the implantation site without displacement.

In the above embodiment, a mounting hole may be cut and carved in the middle of each rod 110, and the waste material may be removed, and then the anchor 120 may be fixedly mounted in the mounting hole by riveting or welding to form an anchor.

The embodiments of the present invention have been described in detail with reference to the accompanying drawings, but the present invention is not limited to the above embodiments, and various changes can be made within the knowledge of those skilled in the art without departing from the gist of the present invention.

Claims

1. The manufacturing method of the occluder is characterized by comprising the following steps:

and assembling, wherein one end of each of the plurality of rods is connected with a connecting part, so that the one ends of the plurality of rods are all occluded in the connecting part, the one ends of the plurality of rods form an end face, the height of the end face of the outer side of the connecting part, which exceeds the end face, is L, and L is less than or equal to 0.5 mm.

2. The method of making an occlusion device of claim 1, wherein in said cutting step, said other end of said stock material forms a tube end, and a plurality of said rods each extend axially of said tube end.

3. The method of making an occlusion device of claim 1, wherein said cutting step forms a plurality of said stems connected to each other at each end of said stock material, and a bundling member bundles said other ends of said plurality of said stems together.

4. The method of claim 3, wherein the constriction member is adapted to constrict the other ends of the plurality of rods by welding or crimping.

5. The method of claim 1, wherein in the step of assembling, the connecting member comprises a fastener and a connector, the fastener and the connector cooperating to define a gap for receiving the end of the rod.

6. The method of claim 5, wherein the fastening member is connected to the connecting member by a screw thread or by welding.

7. The method of claim 6, wherein the retaining member includes a curved tooth and the connecting member includes a stepped surface, the curved tooth and the stepped surface defining the gap therebetween.

8. The method for manufacturing the occlusion device according to claim 6, wherein the connecting member is further provided with a connecting portion for connecting a delivery system, and the connecting portion is provided with a thread structure or a snap structure.

9. The method of making an occlusion device of claim 1, wherein in said cutting step, an anchor is cut/carved into each of said stems and said anchor is lifted to a slant to form a plurality of anchors.

10. The method of claim 1, wherein the cutting step includes cutting/carving a mounting hole in each of the rods, and the assembling step includes attaching an anchor spike to the mounting hole by riveting or welding to form a plurality of anchors.