A method of manufacturing a medical device

Abstract

The application discloses a manufacturing method of a medical device, which comprises the following steps: weaving, weaving a plurality of wires into a grid-shaped base pipe; blanking, shaping the base pipe through a heat setting device, and then cutting the base pipe according to a preset length to form a pipe segment; folding, folding one end of the plurality of wires forming the pipe segment outward or inward, aligning the one end of the wires with the other end of the wires, and forming a plurality of closed loop structures at the upper end of the pipe segment; and setting, the lower end of the pipe segment having a plurality of wire ends, the wire ends being bundled together through a first bundling member, and then being put into the heat setting device for setting. In this way, the upper end of the pipe segment is formed with a plurality of closed loop structures, the wire ends at the lower end are bundled together, a medical device with only one end provided with the first bundling member is formed, endothelial cells are easily adhered to and covered on the closed loop structures at the other end of the medical device, and the endothelialization process of the medical device tends to be ideal.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a manufacturing method of a medical device. BACKGROUND

[0002] Interventional surgery is a kind of treatment by means of percutaneous catheterization of medical devices, and the two ends of the medical devices generally need to be provided with a closed loop structure. Due to the uniqueness of interventional surgery, the medical devices need to have two states, one is a delivery state (cylindrical shape) for being accommodated in a catheter, and the other is a preset state (any shape) after being released. Therefore, the medical devices generally adopt wire knitting and then shaping into various shapes.

[0003] In the prior art, the knitting process by using a knitting machine needs to use multiple wires, and each wire inevitably has two sharp ends. Therefore, the two ends of the medical device need to use a fixing component to accommodate the ends of all wires, and the obtained medical device has a relatively long fixing component end, which makes it difficult for endothelial cells to adhere and cover on the medical device, and finally leads to an unsatisfactory endothelialization process after the medical device is implanted. SUMMARY

[0004] The present application aims to at least solve one of the technical problems existing in the prior art. To this end, the present application proposes a manufacturing method of a medical device, wherein one end of a pipe section is composed of a plurality of closed loop structures, and only the ends of the wires need to be bundled at the other end of the pipe section.

[0005] The manufacturing method of a medical device according to an embodiment of the present application comprises the following steps:

[0006] Knitting: knitting a plurality of wires into a grid-shaped base pipe;

[0007] Cutting: cutting the base pipe into pipe sections according to a preset length by a heat setting device;

[0008] Folding: folding one end of each wire outward or inward to align the one end of the wire with the other end of the wire, so as to form a plurality of closed loop structures at the upper end of the pipe section;

[0009] Setting: the lower end of the pipe section has a plurality of wire ends, and the wire ends are bundled together by a first bundling member, and then the pipe section is put into the heat setting device for setting.

[0010] A method for manufacturing a medical device according to an embodiment of the present invention has at least the following beneficial effects: the plurality of wires on the tube segment after cutting all have two ends, the end of one end of the plurality of wires is folded outward and downward or inward and downward along the circumference of the tube segment, so that the end of one end of the plurality of wires is aligned with the end of the other end, so that the upper end of the tube segment forms a plurality of closed-loop structures, and then the ends of the plurality of wires at the lower end of the tube segment are bundled together by a first bundling member to form a medical device with the first bundling member at only one end, so that endothelial cells can easily adhere to and crawl on the closed-loop structure at the other end of the medical device, making the post-endothelialization process of the medical device ideal.

[0011] According to some embodiments of the present invention, in the shaping step, the first constricting member may include a first fixing member and a first connecting member, and the first fixing member and the first connecting member cooperate to define a gap for accommodating the end head.

[0012] According to some embodiments of the present invention, the first fixing member and the first connecting member are connected by welding or threading.

[0013] According to some embodiments of the present invention, the first connecting member is further provided with an internal thread or a buckle for connecting to a conveying device.

[0014] According to some embodiments of the present invention, in the shaping step, the first bundling members are provided in a plurality of pieces, the ends of the plurality of wires are divided into a plurality of groups, and each group of the ends corresponds to one first bundling member.

[0015] According to some embodiments of the present invention, the first converging member is configured as a sphere having a converging cavity.

[0016] According to some embodiments of the present invention, in the folding step, several of the closed-loop structures are distributed at the center of the tube segment, and in the shaping step, a second converging member is further included to converge the several closed-loop structures.

[0017] According to some embodiments of the present invention, the second constricting member includes a second fixing member and a second connecting member, and the second fixing member and the second connecting member cooperate to define a gap for accommodating the closed-loop structure.

[0018] According to some embodiments of the present invention, the second constricting member is configured as a suture, and the plurality of closed-loop structures are connected and constricted by the suture.

[0019] According to some embodiments of the present invention, in the folding step, a plurality of the closed-loop structures are distributed on the circumference of the tube segment.

[0020] Additional aspects and advantages of the present application will be apparent from the following description of the application, taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS

[0021] The above and / or additional aspects and advantages of the present application will become apparent and be readily appreciated from the following description of the embodiments, taken in conjunction with the accompanying drawings.

[0022] Figure 1 Structure diagram of a tube segment of a first embodiment of the present application;

[0023] Figure 2 Structure diagram of a medical device of a first embodiment of the present application;

[0024] Figure 3 Structure diagram of a medical device of a second embodiment of the present application;

[0025] Figure 4 Structure diagram of a medical device of a third embodiment of the present application;

[0026] Figure 5 Structure diagram of a tube segment of a third embodiment of the present application;

[0027] Figure 6 Structure diagram of a tube segment of a third embodiment of the present application;

[0028] Tube segment 100, wire material 110, closed loop structure 111;

[0029] First constriction member 200, first fixing member 210, first connecting member 220;

[0030] Second constriction member 300. DETAILED DESCRIPTION

[0031] Embodiments of the present application are described in detail below with reference to the attached drawing figures, wherein the same or like reference numerals and characters are used throughout the figures to designate the same components. The embodiments described below are exemplary only and are not intended to be limiting of the present application.

[0032] In the description of the present application, it is to be understood that the orientation description, such as the orientation or position relationship indicated by up, down, front, back, left, right, etc. is based on the orientation or position relationship shown in the drawings, and is only for the convenience of describing the present application and simplifying the description, and therefore cannot be understood as a limitation on the present application 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 a limitation on the present application.

[0033] In the description of the present application, the meaning of one or more is one or more, the meaning of several is more than one, greater than, less than, more than, etc. is not included in the number, above, below, within, etc. is understood to include the number. If it is described as first, second, it is only used to distinguish the technical features for the purpose, and cannot be understood as indicating or implying the relative importance or implicitly indicating the number of indicated technical features or implicitly indicating the sequence of indicated technical features.

[0034] In the description of the present application, unless otherwise expressly limited, the words such as setting, installing, connecting, etc. should be broadly understood, and those skilled in the art can reasonably determine the specific meaning of the above words in the present application in combination with the specific content of the technical scheme.

[0035] Referring to Figures 1 to 6 , a medical device manufacturing method according to an embodiment of the present application comprises the following steps:

[0036] weaving, weaving a plurality of wire materials 110 into a grid-shaped base pipe;

[0037] cutting, shaping the base pipe through a heat setting device, and then cutting off the base pipe according to a preset length to form a pipe segment 100;

[0038] folding, folding one end of the plurality of wire materials 110 forming the pipe segment 100 outward or inward, aligning the one end of the wire material 110 with the other end of the wire material 110, and forming a plurality of closed loop structures 111 at the upper end of the pipe segment 100;

[0039] shaping, the lower end of the pipe segment 100 has a plurality of wire material 110 end heads, the plurality of wire material 110 end heads are bundled together by a first bundling member 200, and then put into a heat setting device for shaping.

[0040] In the above steps, it should be noted that the grid-shaped base pipe refers to a cylindrical woven pipe with a plurality of grids. In the cutting process, a pipe segment 100 is cut from the woven pipe according to the preset length required by different medical devices. The two ends of the pipe segment 100 have a plurality of wire material 110 end heads. Referring to Figure 1 、 Figure 5 or Figure 6 In the folding step, the end head of one end of the plurality of wire materials 110 on the pipe segment 100 is folded outward along the circumferential direction of the pipe segment 100 and downward, or inward and downward, so that the end head of one end of the wire material 110 coincides with the end head of the other end, as shown in Figure 1 、 Figure 5 or Figure 6As shown in the lower end of the tube segment 100 in the figure, a plurality of closed loop structures 111 are formed at the upper end of the tube segment 100, and it is to be noted that when the end of the wire 110 is bent to coincide with the end of the other end, the structure at the U-bend is called a closed loop structure 111, that is, the upper end of the tube segment 100 is composed of a plurality of closed loop structures 111.

[0041] In the above blanking step and shaping step, the heat setting device can be a heating box, and the base pipe and the tube segment are placed in the heating box to shape the base pipe and the tube segment by constant heating.

[0042] According to the manufacturing method of the medical device of the embodiments of the present application, the wire 110 on the tube segment 100 after blanking has two ends, the end of the wire 110 is folded outwardly downward or inwardly downward along the circumference of the tube segment 100, the end of the wire 110 is aligned with the end of the other end, a plurality of closed loop structures 111 are formed at the upper end of the tube segment 100, and then the ends of the wires 110 at the lower end of the tube segment 100 are bundled together by the first bundling member 200 to form a medical device with only one end having the first bundling member 200, so that the endothelial cells are easy to adhere and cover on the closed loop structure 111 at the other end of the medical device, and the process of endothelialization of the medical device tends to be ideal.

[0043] According to some embodiments of the present application, in the shaping step, Figure 4 The first bundling member 200 can include a first fixing member 210 and a first connecting member 220, the first fixing member 210 has a plurality of first recesses or first protrusions, and the first connecting member 220 is provided with a plurality of second protrusions or second recesses corresponding to the first recesses or the first protrusions, the first recesses and the first protrusions are matched, or the first protrusions and the second recesses are matched, to define a gap for clamping the ends of the wires 110, so that the ends of the wires 110 are clamped in the center of the lower end of the tube segment 100, and the step surface formed after the first recesses and the second protrusions or the first protrusions and the second recesses are matched can form greater friction on the wires 110, so that the wires 110 are tightly fixed between the first fixing member 210 and the first connecting member 220 to avoid slipping.

[0044] It is to be noted that the above tube segment 100 refers to Figure 4 The medical device in the figure can be an occluder.

[0045] In the above embodiment, the first fixing member 210 and the first connecting member 220 are connected by welding or screwing, when screwing is adopted, the first fixing member 210 can be processed with inclined protruding tooth structure, and the first connecting member 220 can be processed with several recesses for matching the protruding tooth structure, so that the first fixing member 210 and the first connecting member 220 can be prevented from loosening.

[0046] In the above embodiment, the first connecting member 220 is also provided with internal thread or buckle structure for connecting the conveying device, when the internal thread structure is adopted, the conveying device is provided with corresponding external thread structure, and when the buckle structure is adopted, the conveying device is provided with clamping structure for buckling the buckle structure.

[0047] According to some embodiments of the present application, in the shaping step, referring to Figure 6 , the first collecting member 200 is provided with several, the end of the wire 110 of the lower end of the pipe segment 100 is divided into several groups, and the end of each group is provided with one first collecting member 200, and it should be noted that the medical device of the pipe segment 100 can be an esophageal stent or a heart stent, and the end of the wire 110 of the lower end of the pipe segment 100 is collected and covered by the first collecting member 200, so that the end of the wire 110 can avoid damaging or destroying the pathological tissue.

[0048] In the above embodiment, the first collecting member 200 is provided as Figure 6 a ball with a collecting cavity as shown, the outer wall of the ball is smooth and has no edges, so that the end of the wire 110 or the first collecting member 200 can avoid damaging or destroying the pathological tissue.

[0049] According to some embodiments of the present application, in the folding step, referring to Figures 1 to 4 , the closed loop structure 111 is distributed near the central axis of the pipe segment 100, in the shaping step, referring to Figure 2 and Figure 4 , the second collecting member 300 is also provided, the second collecting member 300 collects and fixes the closed loop structure 111, avoids the closed loop structure 111 in loose state, and prevents the pipe segment 100 from being scattered.

[0050] In the above embodiment, the second collecting member 300 can have the same structure as the first collecting member 200, and the second collecting member 300 also includes a second fixing member and a second connecting member, and the second fixing member and the second connecting member have the same structure as the first fixing member and the first connecting member described above, which will not be described here.

[0051] In the above embodiment, referring to Figure 2The second bundling member 300 can also be a suture, which is used to connect and bundle the plurality of closed loop structures 111, so as to avoid the plurality of closed loop structures 111 from being scattered.

[0052] In the above embodiments, the pipe segment 100 can be a stent, which can be bundled at one end of the wire material 110 as shown in Figure 1 and Figure 2 Alternatively, the wire material 110 can be folded twice, so that the lower end of the pipe segment 100 forms a blocking disc, and the upper end forms an arc-shaped or linear support disc, as shown in Figure 3 or

[0053] According to some embodiments of the present application, in the folding step, the plurality of closed loop structures 111 can be distributed on the circumference of the pipe segment 100, which can be a stent or a heart stent without the need of the second bundling member 300, as shown in Figure 5 and Figure 6

[0054] The above embodiments of the present application are described in detail in combination with the drawings, but the present application 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 spirit of the present application.​

Claims

1. A method for manufacturing a medical device, characterized in that: include: Weaving, weaving several wires into a grid-like base tube; Cutting the base pipe by passing it through a heat setting device to set the shape, and then cutting it from the base pipe according to a preset length to form a pipe segment; Folding: folding one end of a plurality of the wires forming the tube segment outward or inward so that the one end of the wire is aligned with the other end of the wire, so that the upper end of the tube segment forms a plurality of closed loop structures; Shaping: the lower end of the tube section has a plurality of ends of the wires, the ends of the plurality of wires are bundled together by a first bundling member, and then placed in the heat-setting device for shaping; In the folding step, the plurality of closed-loop structures are distributed in the middle position of the length direction of the tube section before folding. In the shaping step, a second constricting member is further included, and the second constricting member constricts the plurality of closed-loop structures. The second constricting member is configured as a suture, and the plurality of closed-loop structures are connected and constricted by the suture; The tube segments are all occluders, and the wire material is folded a second time so that the lower end of the tube segment forms an occluding disk and the upper end forms an arc-shaped or straight-line support disk structure.

2. The method for manufacturing a medical device according to claim 1, wherein: In the shaping step, the first constricting member may include a first fixing member and a first connecting member, and the first fixing member and the first connecting member cooperate to define a gap for accommodating the end head.

3. The method for manufacturing a medical device according to claim 2, wherein: The first fixing member and the first connecting member are connected by welding or threading.

4. The method for manufacturing a medical device according to claim 2, wherein: The first connecting member is also provided with an internal thread or a buckle for connecting to a conveying device.

5. The method for manufacturing a medical device according to claim 1, wherein: In the shaping step, the first bundling members are provided in a plurality of numbers, the end heads of the plurality of wires are divided into a plurality of groups, and each group of the end heads corresponds to one first bundling member.

6. The method for manufacturing a medical device according to claim 5, characterized in that: The first converging member is configured as a sphere having a converging cavity.

7. The method for manufacturing a medical device according to claim 1, wherein: The second constricting member includes a second fixing member and a second connecting member. The second fixing member and the second connecting member cooperate to define a gap for accommodating the closed-loop structure.

8. The method for manufacturing a medical device according to claim 1, wherein: In the folding step, a plurality of the closed-loop structures are distributed on the circumference of the tube section.

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