In-vitro splicing method of a covered stent and covered stent

Abstract

The application discloses an in-vitro splicing method of a covered stent and the covered stent. The in-vitro splicing method of the covered stent comprises the following steps: constructing a digital model of an aortic vessel segment of a patient's affected part; generating a physical model of the aortic vessel segment of the patient's affected part according to the digital model; selecting a plurality of stent units and placing the plurality of stent units in the physical model; and connecting every two adjacent stent units to connect the plurality of stent units into an integral covered stent. The covered stent is formed by the in-vitro splicing method of the covered stent. The covered stent constructed by the application has higher conformity with the shape of the aorta of the patient's affected part, has better stability, is more in line with the physiological characteristics of human blood flow, and can be sent into the body as a whole when the covered stent is transported into the body, thereby reducing the operation in the body and improving the safety.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of stent graft splicing, in particular to a stent graft splicing method and a stent graft. BACKGROUND

[0002] At present, the stent graft for the aortic arch adopts the design of integrated single-branch stent graft or in-vivo spliced multi-branch stent graft. The above-mentioned stent grafts are pre-assembled in the stent graft delivery device before leaving the factory, and the corresponding stent graft is selected according to the patient's arch anatomical characteristics and implanted into the patient's body. However, due to the strong individuality of the arch anatomy and the great variability of each branch, the current arch stent cannot meet the above-mentioned individual needs. Therefore, more different types of stent grafts need to be prepared during the operation, and it is still difficult to meet the clinical operation needs. The current in-vivo spliced arch multi-branch stent graft design scheme, such as the weflow stent and the concave supra-arch arch branch stent, adopts a non-integrated design of stent body and branch implantation. The above-mentioned non-integrated stent design has the defects of complex branch stent implantation operation, the main body stent and branch design do not conform to the physiological structure characteristics of human blood vessels, the connection between the stents is connected in a unstable way such as friction, and the connection between the stents lacks stability. SUMMARY

[0003] Based on the above, the purpose of the present application is to provide a stent graft splicing method and a stent graft. The stent graft is spliced in-vitro before being implanted in the body, and an integrated stent graft is constructed, which is highly compatible with the shape of the target blood vessel and more consistent with the physiological characteristics of human blood flow, and the connection between the stents is more stable.

[0004] To achieve the above purpose, the present application adopts the following technical scheme:

[0005] A stent graft splicing method, comprising the following steps:

[0006] Constructing a digital model of the aortic vascular segment of the patient's affected area;

[0007] Generating a physical model of the aortic vascular segment of the patient's affected area according to the digital model;

[0008] Selecting a plurality of stent units and placing the plurality of stent units in the physical model;

[0009] Connecting each adjacent two stent units to connect the plurality of stent units to form an integrated stent graft.

[0010] As a preferred solution of the in-vitro splicing method of the covered stent, when the physical model is generated, the physical model having the profiling groove simulating the aortic vessel segment is printed by a 3D printing device according to the digital model.

[0011] When the plurality of stent units are constrained, each of the stent units is transported to a corresponding position in the profiling groove by a transport device.

[0012] As a preferred solution of the in-vitro splicing method of the covered stent, when the physical model is generated, the profiling groove segments simulating the aortic vessel segment are formed on at least two needle plates by a needle plate forming device according to the digital model.

[0013] The physical model is formed by splicing together all the needle plates, and all the profiling groove segments form the profiling groove simulating the aortic vessel segment.

[0014] When the plurality of stent units are constrained, each of the stent units is transported to a corresponding position in the profiling groove by a transport device. As a preferred solution of the in-vitro splicing method of the covered stent, the method further comprises the following steps before the plurality of stent units are spliced:

[0015] The physical model can be divided into a plurality of model blocks, and each two adjacent model blocks can be spliced together.

[0016] The plurality of stent units are transported into the spliced physical model.

[0017] When the stent units are spliced, at least one model block at a corresponding splicing position is removed each time to expose the splicing position.

[0018] As a preferred solution of the in-vitro splicing method of the covered stent, the method further comprises the following steps when the stent units are spliced:

[0019] The stent units constrained in the physical model are observed, and at least one model block is selectively removed to expose the splicing position.

[0020] As a preferred solution of the in-vitro splicing method of the covered stent, when each two adjacent stent units are spliced, the splicing is performed by means of sewing, hot pressing, burning, bonding, nailing, embedding, etc., and is not limited to the above-described means.

[0021] A covered stent formed by the in-vitro splicing method of the covered stent according to any one of the above technical solutions.

[0022] The in-vitro splicing method of the covered stent has the following beneficial effects:

[0023] The present application provides a method for constructing a digital model of an aortic vessel segment of a patient's affected part, and generating a physical structure of the aortic vessel segment of the patient's affected part according to the digital model, which accurately simulates the physical structure of the actual aortic vessel segment of the patient's affected part, so that the constructed covered stent is more stable, and more in line with the physiological characteristics of human blood flow and the pathological characteristics of the lesion; by selecting a plurality of stent units according to the physical model, the stent does not need to be customized according to the physical structure of the aortic vessel segment of the patient's affected part in clinical application, greatly improving the availability of personalized multi-branch covered stents for patients, improving the efficiency of obtaining the covered stent, and reducing the waiting time for surgery due to waiting for individualized stent manufacturing; by placing a plurality of stent units in the physical model, the relative positions between the stent units can be more accurate, and the constructed covered stent is more in line with the shape of the patient's affected aorta; by connecting a plurality of branch stents adjacent to each other in vitro, the connection between the branch stents is more stable, the obtained covered stent is more in line with the physiological characteristics of human blood flow, and is less likely to occur. Stent displacement, internal fistula and other conditions, and the in-vitro splicing method is flexible.

[0024] The present application also provides a covered stent, which is formed into a multi-branch covered stent by an in-vitro splicing method of a covered stent unit, so that the multi-branch covered stent is in high conformity with the shape of the patient's affected aorta, in line with the physiological characteristics of human blood flow, and has good stability, and is less likely to occur. Stent displacement, internal fistula and other conditions. BRIEF DESCRIPTION OF DRAWINGS

[0025] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following will briefly introduce the drawings needed to be used in the description of the embodiments of the present application. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative labor on the basis of the contents of the embodiments of the present application and these drawings.

[0026] Figure 1 is a flow chart of the in-vitro splicing method of the covered stent provided by the embodiments of the present application.

[0027] Figure 2 is a structure diagram of the aortic vessel segment of the patient's affected part provided by the embodiments of the present application;

[0028] Figure 3 is a structure diagram of the physical model obtained by the 3D printing device provided by the embodiments of the present application. Figure 1 (showing the aortic vessel segment of the patient's affected part);

[0029] Figure 4 is a structural schematic diagram of a physical model obtained by a 3D printing device provided by an embodiment of the present application Figure 2 (not showing the aortic vessel segment of the patient's affected part);

[0030] Figure 5 is a structural schematic diagram of a stent unit of different models provided by an embodiment of the present application;

[0031] Figure 6 is a partial structural schematic diagram of a stent unit placed in a physical model (obtained by a 3D printing device) provided by an embodiment of the present application Figure 1 ;

[0032] Figure 7 is a partial structural schematic diagram of a stent unit placed in a physical model (obtained by a 3D printing device) provided by an embodiment of the present application Figure 2 (not showing part of the model block);

[0033] Figure 8 is a structural schematic diagram of a covered stent provided by an embodiment of the present application;

[0034] Figure 9 is a partial structural schematic diagram of a physical model obtained by a needle plate forming device provided by an embodiment of the present application;

[0035] Figure 10 is a structural schematic diagram of a physical model formed by needle plates being spliced together provided by an embodiment of the present application;

[0036] Figure 11 is a schematic diagram of a stent unit placed in a physical model (obtained by a needle plate forming device) provided by an embodiment of the present application Figure 1 ;

[0037] Figure 12 is a structural schematic diagram of a stent unit placed in a physical model (obtained by a needle plate forming device) provided by an embodiment of the present application Figure 2 .

[0038] in the figure:

[0039] 1, aortic vessel segment; 2, physical model; 2001, model block; 201, needle plate; 2011, needle plate block; 3, profiling groove; 4, stent unit; 5, covered stent. DETAILED DESCRIPTION

[0040] The present application will be further described below in conjunction with the drawings and embodiments. It can be understood that the specific embodiments described herein are only used to explain the present application, but not to limit the present application. In addition, it should be noted that, for the convenience of description, only part of the structures related to the present application are shown in the drawings, but not all the structures.

[0041] In the description of the present application, unless otherwise explicitly specified and limited, the terms "connected", "connected", "fixed" should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or it can be integrated; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the internal communication of two elements or the interaction relationship between two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0042] In the present application, unless otherwise explicitly specified and limited, the first feature "on" or "under" the second feature can include that the first and second features are in direct contact, or that the first and second features are not in direct contact but are in contact through another feature between them. Moreover, the first feature "on", "above" and "above" the second feature includes that the first feature is directly above and obliquely above the second feature, or only indicates that the first feature is higher than the second feature in horizontal height. The first feature "under", "below" and "below" the second feature includes that the first feature is directly below and obliquely below the second feature, or only indicates that the first feature is lower than the second feature in horizontal height.

[0043] In the description of the present embodiment, the terms "up", "down", "left", "right" and other orientation or position relationship are based on the orientation or position relationship shown in the drawings, and are only for the convenience of description and simplification of operation, and do not indicate or imply that the device or element referred to 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. In the description of the present application, unless otherwise stated, the meaning of "a plurality of" is two or more. In addition, the terms "first", "second" are only used to distinguish in the description, and have no special meaning.

[0044] Embodiment one

[0045] As shown in Figures 1 to 8 The present embodiment provides an in-vitro splicing method of a covered stent, which comprises the following steps:

[0046] S1: constructing a digital model of the aortic vessel segment 1 of the patient's affected part;

[0047] As shown in Figure 2As shown, CT or nuclear magnetic scanning is performed on the aorta of the patient's affected part to obtain image data with the morphological structure of the aorta of the patient's affected part, and a digital model is constructed according to the above image data. The CT or nuclear magnetic scanning technology is a relatively mature existing technology, and therefore will not be described here. By constructing the digital model of the aorta blood vessel segment 1 of the patient's affected part, the physical characteristics of the aorta blood vessel of the patient's affected part can be accurately obtained, so that the subsequent constructed covered stent 5 has a higher morphological fit degree with the aorta of the patient's affected part and better stability. The digital model can also be appropriately modified according to the lesion condition of the patient's affected part to make it more consistent with the lesion characteristics and mechanical characteristics of the patient's aorta.

[0048] S2: generating a physical model 2 of the aorta blood vessel segment 1 of the patient's affected part according to the digital model;

[0049] In this embodiment, as shown in Figure 3 and Figure 4 When generating the physical model 2, a 3D printing device can be used to print the physical model 2 according to the digital model of the aorta blood vessel segment 1 of the patient's affected part, and the physical model 2 has a profiling groove 3 simulating the aorta blood vessel segment 1. The specific steps include:

[0050] S201: identifying the digital model obtained in step S1 with the physical structural characteristics of the aorta of the patient's affected part, and modifying the obtained digital model to make the aorta structure in the digital model more clear and complete;

[0051] The above processed digital model is converted into a file format that can be recognized by a 3D printing device, such as an STL file, and is imported into a 3D printing device. The 3D printing device prints a physical model 2 of the aorta blood vessel segment 1 of the patient's affected part. The physical model 2 has a profiling groove 3 simulating the aorta blood vessel segment 1 of the patient's affected part, and the profiling groove 3 can accommodate the stent unit 4, so that the stent unit 4 can be fitted with the corresponding segment of the profiling groove 3 after being accommodated in the profiling groove 3.

[0052] By generating a physical model 2 of the aorta blood vessel segment 1 of the patient's affected part according to the digital model, the structure of the actual aorta blood vessel segment 1 of the patient's affected part is accurately simulated, so that the constructed covered stent 5 has a higher morphological fit degree with the aorta of the patient's affected part and better reliability.

[0053] S202: the physical model 2 can be divided into a plurality of model blocks 2001, and each adjacent two model blocks 2001 can be spliced together;

[0054] As shown in Figure 4 and Figure 7As shown, the physical model 2 is divided into a plurality of model blocks 2001, so that after the stent unit 4 is delivered into the physical model 2, the model blocks 2001 can be selectively disassembled to observe the placement of the stent unit 4 inside the physical model 2, so that the stent unit 4 can be adjusted in time to improve the positional accuracy of the stent unit 4, thereby improving the accuracy of the formed covered stent 5. When the physical model 2 is small in structure, the physical model 2 can not be divided. In other embodiments, the disassemblable model blocks 2001 also facilitate manual placement of the stent unit 4, without the need for a stent delivery device. After the stent unit 4 is placed, the model blocks 2001 are assembled to constrain the stent unit 4.

[0055] Exemplarily, the disassemblable structure between adjacent model blocks 2001 is achieved by clamping, for example, at least one side of each model block 2001 is provided with a clamping groove, the clamping groove penetrates the model block 2001 along the thickness direction of the model block 2001, and the side surface of the adjacent model block 2001 is provided with a corresponding clamping strip, the clamping strip is protrudingly arranged on the side surface of the model block 2001, the clamping strip can be slid into the clamping groove from one end of the clamping groove, and the outer peripheral surface of the clamping strip is in frictional contact with the inner wall of the clamping groove. When one of the model blocks 2001 needs to be disassembled, it can be pulled out. When assembling, the model block 2001 can be clamped in. Preferably, the cross section of the clamping strip is in T-shaped structure, and the clamping groove is also in corresponding T-shaped groove, so as to improve the connection stability between the model blocks 2001. More preferably, in order to facilitate the pulling out of the model block 2001, the outer side surface of the model block 2001 is provided with a protruding structure, so as to facilitate the operator to pull out the model block 2001 by the protruding structure; or the model block 2001 is pulled out by sucking the model block 2001 by a suction cup or the like. Of course, in other embodiments, the disassemblable structure between adjacent model blocks 2001 can also be achieved by other structures, for example, the model blocks 2001 are magnetically attracted to achieve disassemblable connection.

[0056] S3: selecting a plurality of stent units 4 and placing the plurality of stent units 4 in the physical model 2;

[0057] Specifically, as shown, Figure 5 the medical staff can directly select a plurality of stent units 4 of appropriate models according to the physical model 2 or data model (measured data) of the aortic vessel segment 1 of the patient's affected part. The stent units 4 are batch-made and include various different models of stent units 4, and the different models of stent units 4 differ in size, shape, etc. By selecting a plurality of stent units 4 according to the physical model 2, the stent does not need to be customized according to the physical structure of the aortic vessel segment 1 of the patient's affected part in clinical application, which greatly improves the availability of personalized multi-branch covered stents for patients, improves the availability of covered stents, and reduces the waiting time for surgery due to waiting for individualized stent manufacturing.

[0058] Further, as shown in the step S2, the physical model 2 of the aortic vessel segment 1 of the patient is generated, and the stent units 4 are constrained in the physical model 2. Figure 6 Further, as shown in the step S2, the physical model 2 of the aortic vessel segment 1 of the patient is generated, and the stent units 4 are constrained in the physical model 2.

[0059] S4: connecting each two adjacent stent units 4 to form an overall covered stent 5.

[0060] Preferably, the physical model 2 is made of transparent material, so that the medical staff can better observe the stent units 4 in the physical model 2. Of course, in other embodiments, the physical model 2 can also be opaque or translucent material.

[0061] As shown in the step S2, the physical model 2 of the aortic vessel segment 1 of the patient is generated, and the stent units 4 are constrained in the physical model 2. Figure 7 As shown in the step S2, the physical model 2 of the aortic vessel segment 1 of the patient is generated, and the stent units 4 are constrained in the physical model 2.

[0062] As shown in the step S2, the physical model 2 of the aortic vessel segment 1 of the patient is generated, and the stent units 4 are constrained in the physical model 2. Figure 8 As shown in the step S2, the physical model 2 of the aortic vessel segment 1 of the patient is generated, and the stent units 4 are constrained in the physical model 2.

[0063] The embodiment also provides a covered stent 5 obtained by the above-mentioned covered stent body splicing method, which can be delivered into the body as a whole during delivery into the body, reduces the splicing operation in the body, and is safer.

[0064] Embodiment two

[0065] As Figures 9 to 12 shown, the embodiment provides a covered stent splicing method, which is basically the same as the method of embodiment one, and only improved on the basis of embodiment one. Therefore, only the differences between the two are described here, and the same parts of the embodiment and embodiment one are not described again.

[0066] S2: generating a physical model 2 of the aortic vessel segment 1 of the patient's affected part according to the digital model;

[0067] In the embodiment, as Figure 9 In generating the physical model 2, a needle plate forming device can be used to form a profiled groove segment simulating part of the aortic vessel segment 1 on each of the at least two needle plates 201 according to the digital model of the aortic vessel segment 1 of the patient's affected part. The needle plate forming device includes a structure as described in the patent document “CN214562961U-Needle plate forming device”, for example. The needle plate forming device includes a workbench, a horizontal multi-joint robot and a needle plate provided on the workbench, a plurality of positioning pins arranged on the array needle plate, a dial head connected to the horizontal multi-joint robot, and the horizontal multi-joint robot can control the dial head to dial the positioning pins to control the movement of the positioning pins.

[0068] The specific steps of forming a profiled groove segment simulating part of the aortic vessel segment 1 on each of the at least two needle plates 201 using the needle plate forming device include:

[0069] The digital model with the physical structure characteristics of the aorta of the patient's affected part obtained in step S1 is processed and converted into an intermediate file format that can be read by three-dimensional model digitizing software;

[0070] A code file of a machining path is generated by using three-dimensional machining software that can read the intermediate file format;

[0071] The code file is imported into the control module of the horizontal multi-joint robot of the needle plate forming device, and the horizontal multi-joint robot performs machining operation according to the code file of the specified machining path, and the dial head pushes the plurality of positioning pins to move to the theoretical position to form a needle plate with a profiled protrusion of the aortic vessel segment 1 of the patient's affected part;

[0072] Take the needle plate;

[0073] As Figure 10As shown, all needle plates 201 are assembled together to form a physical model 2, and all contoured groove segments form contoured grooves 3 that simulate aortic segment 1.

[0074] By using a needle plate forming device to form a contoured groove segment 1 simulating a portion of the aortic vessel segment 1 on two needle plates 201, i.e., physical model 2, the structure of the aortic vessel segment 1 at the actual patient's affected area is accurately simulated, resulting in a higher degree of morphological fit between the constructed covered stent 5 and the aorta at the patient's affected area, and better reliability.

[0075] Among them, such as Figure 11 and 12 As shown, the needle plate 201 can also be divided into multiple needle plates 2011. Each pair of adjacent needle plates 2011 can be spliced ​​together. When splicing the support unit 4 after the support unit 4 is placed in the physical model 2, one needle plate 2011 at the corresponding splicing position can be removed each time to expose the splicing position. This makes it easier to connect each pair of adjacent support units 4 in the future, improves the splicing efficiency of the support unit 4, and saves time.

[0076] Note that the above description is merely a preferred embodiment of the present invention and the technical principles employed. Those skilled in the art will understand that the present invention is not limited to the specific embodiments described herein, and various obvious changes, readjustments, and substitutions can be made without departing from the scope of protection of the present invention. Therefore, although the present invention has been described in detail through the above embodiments, the present invention is not limited to the above embodiments, and may include many other equivalent embodiments without departing from the concept of the present invention, the scope of which is determined by the scope of the appended claims.

Claims

1. An in-vitro method of splicing a covered stent, characterized by, The method comprises the following steps: S1: constructing a digital model of an aorta vessel segment of a patient's affected part; wherein, a CT or nuclear magnetic scan is performed on the aorta of the patient's affected part, image data with the aorta morphological structure of the patient's affected part is obtained by scanning, and the digital model is constructed according to the image data; S2: generating a physical model of the aorta vessel segment of the patient's affected part according to the digital model; wherein, when the physical model is generated, the physical model is printed by a 3D printing device according to the digital model, the physical model has a profiling groove simulating the aorta vessel segment, and the specific steps include: identifying the digital model obtained in step S1 with the physical structural characteristics of the aorta of the patient's affected part, and correcting the obtained digital model so that the aorta structure in the digital model is clearer and more complete; the physical model is divided into a plurality of model blocks in the row and column directions, and each adjacent two model blocks can be spliced together, so that after the stent unit is transported into the physical model, the model blocks can be selectively disassembled to observe the placement of the stent unit inside the physical model, and the stent unit can be adjusted in time; S3: selecting a plurality of stent units and placing the plurality of stent units in the physical model; wherein, a plurality of stent units of appropriate types are directly selected according to the physical model or the digital model of the aorta vessel segment of the patient's affected part, and the stent units are batch-produced and include stent units of various types; when the plurality of stent units of appropriate types are constrained, each stent unit of an appropriate type is transported to a corresponding position in the profiling groove of the physical model by using a stent unit conveying device in vitro; S4: connecting each adjacent two stent units to connect the plurality of stent units to form an integral covered stent; wherein, the stent units constrained in the physical model are observed, and at least one model block at a corresponding splicing position is selectively removed to expose the to-be-spliced position when the stent units are spliced.

2. The method of claim 1, wherein the stent graft is a bifurcated stent graft. when the physical model is generated, a profiling groove segment simulating part of the aorta vessel segment is formed on at least two needle plates by using a needle plate forming device according to the digital model; all needle plates are spliced together to form the physical model, and all profiling groove segments form a profiling groove simulating the aorta vessel segment; when the plurality of stent units are constrained, each stent unit is transported to a corresponding position in the profiling groove by using a conveying device.

3. The method of claim 2, wherein the stent is a covered stent. The specific steps of forming a profiling groove segment simulating part of the aorta vessel segment on at least two needle plates by using a needle plate forming device include: processing the digital model obtained in step S1 with the physical structural characteristics of the aorta of the patient's affected part, and converting it into an intermediate file format that can be read by three-dimensional model digitalization software; using three-dimensional processing software that can read the intermediate file format, a code file of a processing path is generated; Importing the code file into a control module of a horizontal multi-joint robot of a needle plate forming device, the horizontal multi-joint robot performing a machining operation according to the code file of the specified machining path, pushing a plurality of positioning needle columns to a theoretical position by a dial head to form a needle plate with a profiled protrusion of an aortic vessel segment of the patient; Taking the needle plate; Splicing all the needle plates together to form the physical model, and all the profiled grooves form the profiled groove simulating the aortic vessel segment.

4. The method of claim 3, wherein the stent graft is a bifurcated stent graft. The needle plate is divided into a plurality of needle plate blocks, each adjacent two needle plate blocks can be spliced together, and when the stent unit is placed on the physical model and spliced, one needle plate block at the corresponding splicing position is taken out each time to expose the to-be-spliced part.

5. The method of claim 1, wherein the stent graft is a bifurcated stent graft. The physical model is made of transparent or translucent material.

6. The method of claim 1, wherein the stent graft is a bifurcated stent graft. When splicing each adjacent two stent units, splicing is performed in the manner of suturing, hot pressing, burning, bonding, pinning, and embedding.

7. A stent covering, characterized by Formed by the in-vitro splicing method of the stent graft according to any one of claims 1-6.

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