Stent implantation assembly

Abstract

The present application provides a kind of stent implantation assembly, comprising: shaft body, with front end and end;Catheter, with the balloon of the shaft body is set, closer to the front end than the end;And the stent of tubular shape, combined with the balloon, the outer peripheral surface of the balloon is wrapped;The balloon includes the main body provided with first end and second end;The main body includes preferential inflation area, which is arranged at a position deviated from the first end based on the stent, exposed to the outside from the second end and the stent;The main body is formed by extending with the same diameter in the whole interval from the first end to the second end, when the balloon is inflated, the preferential inflation area is preferentially subjected to the action of inflation force, and the part close to the preferential inflation area in the stent occurs inflation and forms tapered shape.

Description

Technical Field

[0001] The invention relates to a component for implanting a stent at a specific position in a blood vessel. Background Art

[0002] Generally speaking, a vascular implant component is a structure in which a stent is curled on an air balloon. After the stent approaches the target lesion location, it is expanded by the air balloon, and the expanded stent expands the narrowed blood vessel again.

[0003] In the case of an ostial lesion at the entrance of a blood vessel or a bifurcation lesion at a branching vessel, the stent must be inserted precisely at the vessel's origin and deformed accordingly. This area is difficult to visually locate during angiography, and the heart's blood vessels move with the heartbeat, making it difficult for the surgeon to accurately align the stent with the vessel's origin during surgery.

[0004] To this end, various stents and stent implantation assemblies have been developed. However, convenient and efficient manufacturing technology has yet to be developed. For example, while conical catheter balloons have been successfully developed, this presents new challenges in manufacturing specialized balloon shapes. Summary of the Invention

[0005] Problem to be solved

[0006] One of the purposes of the present invention is to provide a stent implantation assembly that can not only easily manufacture an airbag, but also accurately guide the airbag to the corresponding position for expansion in response to lesions in the opening of the blood vessel and lesions in the branch tube.

[0007] Means of solving the problem

[0008] In order to solve the above technical problems, the present invention provides a stent implantation assembly, comprising: a shaft having a front end and a rear end; a catheter having an airbag arranged on the shaft, closer to the front end than to the rear end; and a tubular stent, combined with the airbag, wrapping the outer peripheral surface of the airbag; the airbag comprises a main body provided with a first end and a second end; the main body comprises a preferential expansion area, which is exposed to the outside from between the second end and the stent based on the stent being arranged at a position biased towards the first end; the main body is formed in the same straight line in the entire interval from the first end to the second end The diameter of the bracket extends to form a separate internal space, and the entire area from one end to the other end of the bracket is located at a position corresponding to the entire interval formed by extending the same diameter between the first end and the second end of the airbag; the shaft body includes an inner cavity connected to the separate internal space, and in the process of inflating the airbag by the fluid injected into the separate internal space through the inner cavity, the priority expansion area in the airbag is preferentially subjected to the expansion force compared to the delayed expansion area wrapped by the bracket and subjected to resistance during expansion, and the part close to the priority expansion area in the bracket expands to form a conical shape.

[0009] Here, the first end portion may be located closer to the front end of the shaft body than the second end portion.

[0010] Here, the priority expansion area can be set within the range of 3 mm to 7 mm.

[0011] Here, the priority expansion area can be set within the range of 3 mm to 6 mm.

[0012] According to another embodiment of the present invention, a stent implant assembly includes: a shaft having a front end and an end; a catheter having an airbag arranged on the shaft, closer to the front end than the end; and a tubular-shaped stent combined with the airbag to wrap the outer circumference of the airbag; the airbag includes a main body provided with a first end and a second end; the main body includes a preferential expansion area, which is exposed to the outside from between the second end and the stent based on the stent being arranged at a position biased towards the first end; the main body extends from the first end to the second end with the same diameter to form a separate internal space. During the expansion process of the airbag, the preferential expansion area in the airbag is preferentially subjected to the expansion force compared to the delayed expansion area wrapped by the stent and subjected to resistance during expansion, and the part close to the preferential expansion area in the stent expands to form a conical shape.

[0013] Here, the entire region from one end to the other end of the stent may be located at a position corresponding to the entire region extending between the first end and the second end of the airbag with the same diameter.

[0014] Here, the first end portion may be located closer to the front end of the shaft body than the second end portion.

[0015] Here, the priority expansion area is set within the range of 3 mm to 6 mm.

[0016] According to another embodiment of the present invention, a stent implant assembly includes: a shaft having a front end and an end; a catheter having an airbag arranged on the shaft, closer to the front end than to the end; and a tubular-shaped stent combined with the airbag to wrap the outer circumference of the airbag; the airbag includes a main body provided with a first end and a second end; the main body includes a preferential expansion area, which is exposed to the outside from between the second end and the stent based on the stent being set at a position biased towards the first end; the main body is formed by extending the same diameter from the first end to the second end, and during the process of balloon expansion, the preferential expansion area is preferentially subjected to the expansion force, and the part of the stent close to the preferential expansion area expands to form a conical shape.

[0017] Here, the shaft body includes an inner cavity communicating with the separate inner space, and the airbag can be expanded under the action of a fluid injected into the separate inner space through the inner cavity.

[0018] Here, the main body further includes: a delayed expansion region wrapped by the stent; during the expansion of the airbag, the priority expansion region preferentially expands when the delayed expansion region receives the expansion resistance of the stent.

[0019] Effects of the Invention

[0020] According to the stent implantation assembly of the present invention constructed as described above, the catheter includes an airbag, and the stent wraps the airbag. When the airbag is divided into an area wrapped by the stent and a priority expansion area that is not wrapped by the stent and exposed to the outside, the priority expansion area is laterally arranged on one side of the second end of the airbag body, and the body including the priority expansion area extends with the same diameter. Therefore, the processing and manufacturing of the airbag not only becomes very easy, but also when it is expanded, it is subjected to the priority expansion force of the priority expansion area, and the part close to the priority expansion area of ​​the stent can expand into a conical shape. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 FIG. 1 is a conceptual perspective view illustrating a stent implant assembly 100 according to an embodiment of the present invention.

[0022] Figure 2 It is an icon Figure 1 FIG. 1 is a conceptual perspective view showing an enlarged portion of the connection between the airbag 115 and the bracket 150 .

[0023] Figure 3 1 and 2 are diagrams illustrating experimental results when the length of the preferential expansion region 117 is 5 mm.

[0024] Figure 4 yes Figure 3 FIG is an enlarged view with the tapered portion 155 as the center.

[0025] Figure 5 1 and 2 are diagrams showing experimental results when the length of the preferential expansion region 117 is 10 mm.

[0026] Figure 6 Graphs showing experimental results at various lengths of the integrated preferential expansion region 117 . DETAILED DESCRIPTION

[0027] The following is a detailed description of the stent implant assembly of the wired embodiment of the present invention with reference to the accompanying drawings. In the present invention, even if the embodiments are different from each other, the same or similar structures can be given the same or similar reference numerals, and the description thereof will be replaced by the original description.

[0028] Figure 1 FIG. 1 is a conceptual perspective view illustrating a stent implant assembly 100 according to an embodiment of the present invention.

[0029] According to the drawing, the stent implant assembly 100 may include a catheter 110 and a stent 150 .

[0030] First, the catheter 110 is provided with a central body 111 , a shaft 113 and a balloon 115 .

[0031] The central body 111 is a hollow cylindrical structure. The central body 111 is configured to be held in the hand of the operator. In terms of material, the central body 111 can be made of a plastic material.

[0032] The shaft 113 is a structure inserted into a blood vessel and is configured in a tubular shape. As one end of the shaft 113, the front end 114 is a front structural portion for insertion into a blood vessel, while the other end is a fixed end fixed to the central body 111. An inner cavity (lumen) is formed on the shaft 113. The portion close to the front end 114 of the central shaft is a structure inserted into a blood vessel with many tortuous parts such as the heart. It is made of a relatively soft material and can be bent accordingly at the tortuous part of the blood vessel.

[0033] The airbag 115 is positioned near the front end 114 of the shaft 113. Made of an elastic material, the airbag 115 expands in response to the fluid supplied through the lumen. If the fluid supply is interrupted or the fluid is recovered, the airbag 115 can deflate again. The shaft 113 forms a single lumen for the separate internal space of the airbag 115, which is used to supply the separate fluid. Therefore, the stent implant assembly is feasible and suitable for use in cardiovascular applications. Airbags used in cardiovascular applications need to penetrate deep into the lesion site and must possess excellent flexibility. If they need to pass through narrow lesions, a smaller cross-sectional area is advantageous. Furthermore, since cardiovascular systems cannot remain closed for extended periods during surgery, the time required to deflate or inflate the airbag must be very short. The shaft 113 forms a single lumen for the separate internal space of the airbag 115, providing the operator with the advantage of only having to operate a single inflation and deflation device.

[0034] The stent 150 is then inserted into the blood vessel to expand the blood flow cross section in the blood vessel. The stent 150 is formed by connecting the zigzag-shaped struts to each other so that it can expand as a whole to form a tubular shape. (See Figure 4 Finally, the bracket 150 may be formed of a cobalt alloy material.

[0035] When the stent 150 contracts, it forms the outer circumference of the airbag 115 and is combined with the airbag 115 after crimping. The length of the stent 150 can be slightly shorter than that of the airbag 115.

[0036] Now refer to Figure 2 , the connection relationship between the airbag 115 and the bracket 150 is described in detail. Figure 2 It is an icon Figure 1 FIG. 1 is a conceptual perspective view showing an enlarged portion of the connection between the airbag 115 and the bracket 150 .

[0037] Referring to the accompanying drawings, the airbag 115 is arranged to extend along the length of the shaft body 113. The airbag 115 includes a main body 116. One end of the main body 116 is a first end 116a, which is located near the front end 114, and the other end is a second end 116b, which is located closer to the center body 111 than the first end 116a. A single internal space is formed from the first end 116a to the second end 116b. Based on this structure, the injection molding process of the airbag 115 and the manufacturing process of the shaft body 113 that accommodates the inner cavity can be simplified, which has this advantage.

[0038] Main body 116 is completely unenclosed by stent 150. Specifically, stent 150 is positioned toward first end 116a. Consequently, the area of ​​main body 116 of airbag 115 that is unenclosed by stent 150, namely, the area between stent 150 and second end 116b, is exposed. This exposed area is referred to as the preferential expansion region 117.

[0039] The related functions of the priority expansion area 117 will be referred to Figures 3 to 6 The experimental results are explained.

[0040] first, Figure 3 1 and 2 are diagrams illustrating experimental results when the length of the preferential expansion region 117 is 5 mm. Figure 4 yes Figure 3 FIG is an enlarged view with the tapered portion 155 as the center.

[0041] Referring to the figure, fluid is injected into the separate interior space of balloon 115 through the lumen. When balloon 115 is inflated, priority expansion region 117 within balloon 115 expands first. While the portion of balloon 115 encased by stent 150 (the delayed expansion region) experiences resistance from stent 150, priority expansion region 117 is not subject to such restrictions.

[0042] When the priority expansion area 117 expands first, the diameter of the end area adjacent to the priority expansion area 117 in the stent 150 gradually expands toward the end of the stent 150 to form a tapered portion 155. As a result, when the diameter of the central portion of the stent 150 is 1.04 mm, the diameter of the edge area of ​​the tapered portion 155 becomes 1.88 mm. As a result, the initial angle of the tapered portion 155 reaches 42°. Based on this initial angle, the stent 150 will feel stuck at the opening of the blood vessel or the entrance of the branched blood vessel. When the operator is informed, he can insert it a little deeper, so that the stent 150 can be implanted in the corresponding position more easily and accurately.

[0043] after, Figure 5 1 and 2 are diagrams showing experimental results when the length of the preferential expansion region 117 is 10 mm.

[0044] Referring to this figure, when airbag 115 inflates, preferential expansion region 117 is affected first and expands, resulting in the initial angle of tapered portion 155 becoming 21°. Compared to the example above, where preferential expansion region 117 was 5 mm, the initial angle of tapered portion 155 has decreased.

[0045] This is because the length of the preferential expansion region 117 is lengthened, and the force generated by the expansion of the preferential expansion region 117 is slowly applied to the tapered portion 155 of the stent 150.

[0046] Next, referring to Figure 6 The experimental results will be analyzed comprehensively. Figure 5 is a graph illustrating the experimental results for the preferential expansion region 117.

[0047] Referring to the drawing (and Figures 1 to 5 ), the length of the preferential expansion region 117 is from 3 mm, and the experimental results are sampled when the length is increased by 1 mm up to 10 mm. There are a total of 6 experimental objects for each length of the preferential expansion region 117. When the length of the preferential expansion region 117 is less than 3 mm, the tapered portion 155 is not formed in the stent 150 or an intermittent state is generated, so these results are removed from the graph.

[0048] The use length of the stent 150 is set to 18 mm. The use length of the stent 150 can be selected from a range of half to twice the length. Even if a different stent 150 is used, the length of the preferential expansion region 117 can be appropriately changed. The length of the stent 150 is longer than the length of the preferential expansion region 117.

[0049] For the test method, first, the fluid is injected into the balloon 115 to expand it, and the angle of the tapered portion 155 of the stent 150 is measured. When the balloon 115 is expanded, the preferential expansion region 117 is immediately expanded, and the expansion force generated thereby causes the tapered portion 155 to be formed on one end region of the stent 150.

[0050] The experimental results, the angle of the tapered portion 155 based on the length of the preferential expansion region 117 is shown in the following table.

[0051] [Table 1]

[0052]

[0053] As can be seen from the above table, the angle of the tapered portion 155 increases somewhat when the length of the preferential expansion region 117 is increased from 3 mm to 4 mm, but the angle becomes smaller and smaller as the length of the preferential expansion region 117 becomes longer. In particular, when the length of the preferential expansion region 117 is increased from 7 mm to 8 mm, the angle of the tapered portion 155 is reduced by 9°, which is the largest reduction. In other intervals, the angle of the tapered portion 155 is generally reduced by about 2° to 4°, so the largest reduction is about twice the reference value.

[0054] As a second experiment, the probability of sample failure, resulting from the force generated in the preferential expansion area 117 pushing the stent 150 toward the front end 114, was analyzed. Six samples were taken at each length of the preferential expansion area 117. The number of samples that shifted was analyzed and the associated probability of shift was calculated. The following table summarizes the test results.

[0055] [Table 2]

[0056]

[0057] When the length of the preferential expansion region 117 is between 3 mm and 6 mm, the probability of stent 150 moving is a constant 17%. However, at 7 mm, the probability of moving increases by two times, and from 7 mm to 8 mm, the probability of moving increases by two times again. Finally, at 10 mm, the probability of stent 150 moving reaches 100%.

[0058] Attachment Figure 5 The angle of the tapered portion 155 and the movement probability of the bracket 150 are marked and sorted at the same time. Figure 5 It can be seen from the content that it is most appropriate to set the length of the priority expansion area 117 to 3mm to 7mm.

[0059] The preferred length of the preferential expansion region 117 is 3 mm to 6 mm. This is particularly important given the potential for movement of the stent 150, as it avoids the double range from 17% to 33%. When the preferential expansion region 117 is 6 mm long, the angle of the tapered portion 155 can still be maintained at 39°.

[0060] The stent implant assembly described above is not limited to the structures and operating modes of the various embodiments described above. In the above embodiments, various modifications can be made to complete the configuration by selectively combining the entirety or part of each embodiment.

[0061] Industrial application possibilities

[0062] The present invention is industrially applicable in the field of stent implant component manufacturing.

Claims

1. A stent implant assembly, characterized in that: include: The shaft body has a front end and an end; a catheter having a balloon disposed on the shaft body closer to the front end than to the rear end; and a tubular stent, coupled to the airbag and wrapping the outer circumference of the airbag; The airbag includes a main body provided with a first end and a second end, wherein the first end is located closer to the front end of the shaft than the second end; The main body includes a preferential expansion area, which is exposed to the outside from between the second end and the bracket based on the bracket being arranged at a position biased toward the first end; The main body extends from the first end to the second end to form a single internal space with the same diameter, and the entire area of ​​the stent from one end to the other end is located at a position corresponding to the entire area extending from the first end to the second end of the airbag with the same diameter. The shaft body includes a separate inner cavity communicating with the separate inner space. During the process of inflating the airbag with a separate fluid injected into the separate inner space through the separate inner cavity, the priority expansion region in the airbag is preferentially subjected to the expansion force compared to the delayed expansion region wrapped by the stent and receiving resistance during expansion. The portion of the stent adjacent to the priority expansion region expands to form a conical shape. The priority expansion area is set within the range of 3mm to 7mm.

2. The stent implant assembly according to claim 1, characterized in that: The priority expansion area is set within the range of 3mm to 6mm.

3. A stent implant assembly, characterized in that: include: The shaft body has a front end and an end; a catheter having a balloon disposed on the shaft body closer to the front end than to the rear end; and a tubular stent, coupled to the airbag and wrapping the outer circumference of the airbag; The airbag includes a main body provided with a first end and a second end, wherein the first end is located closer to the front end of the shaft than the second end; The main body includes a preferential expansion area, which is exposed to the outside from between the second end and the bracket based on the bracket being arranged at a position biased toward the first end; The main body extends from the first end to the second end with the same diameter to form a single internal space. The shaft body includes a separate inner cavity communicating with the separate inner space. During the process of expanding the airbag by a separate fluid injected into the separate inner space through the separate inner cavity, the priority expansion area in the airbag is preferentially subjected to the expansion force compared to the delayed expansion area wrapped by the stent and receiving resistance during expansion. The portion of the stent adjacent to the priority expansion area expands to form a conical shape. The priority expansion area is set within the range of 3mm to 6mm.

4. The stent implant assembly according to claim 3, characterized in that: The entire region from one end of the stent to the other end is located at a position corresponding to the entire region extending between the first end and the second end of the airbag with the same diameter.

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