TWI749395B - Method for fabricating polymer fiber tubular structure with high patency rate - Google Patents

Abstract

A method for fabricating polymer fiber tubular structure is provided, which includes: forming a first pipe element includes an inner surface and an outer surface, forming a second pipe element includes an inner surface and an outer surface to coat the outer surface of the first pipe element, such that the first pipe element and the second pipe element are concentric structures, and forming a coil winding structure on the outer surface of the first pipe element or on the outer surface of the second pipe element, in which the step of forming the first pipe element further includes: providing a silicon-containing polycarbonate type polyurethane solution, spraying the silicon-containing polycarbonate type polyurethane to form a silicon-containing polycarbonate type polyurethane fiber, and collecting the silicon-containing polycarbonate type polyurethane elastomer to form the first pipe element. The step of forming the second pipe element further includes: providing a polycarbonate type polyurethane solution and spraying the polycarbonate type polyurethane solution to coat on the outer surface of the first pipe element to form a polycarbonate type polyurethane elastomer, in which the polycarbonate type polyurethane elastomer is the second pipe element.

Description

Method for preparing polymer fiber tube structure with high unblocking rate

The invention provides an artificial blood vessel, in particular to a polymer fiber tube structure that can prevent the tube from kinking.

According to the 2014 World Health Organization (WHO) report, in recent years, due to factors such as the continued aging of the global population, excessive urbanization, and unhealthy lifestyles, four of them are caused by cancer, diabetes, cardiovascular disease and chronic respiratory disease. The number of deaths from major non-communicable diseases accounted for about 4/5 (82%) of the total deaths. What’s more noteworthy is that the number of patients with cardiovascular diseases and diabetes is increasing year by year. Therefore, the global demand for artificial blood vessels is also increasing year by year. As of 2015, the global consumption of artificial blood vessels has reached 29. Wangen.

The current surgery for peripheral vascular obstruction of the lower extremities is to take the bypass artificial blood vessel treatment, but because the properties of existing products and autologous blood vessels (such as mechanical properties, biocompatibility, etc.) are too different, they are used in lower extremities with narrower diameters. In peripheral blood vessels, patients often have poor postoperative results; other treatment methods, such as balloon dilation, are not very effective, and the probability of re-occlusion within three months after surgery is still as high as 70%. .

Polyurethane (PU) is a polymer material with a wide range of adjustable mechanical properties, and has good biocompatibility and material stability. Many studies have been introduced This material is used in the treatment of small blood vessel bypass in the lower extremities, and has obtained good results in animal experiments. The data shows that polyurethane has considerable potential for the treatment of small blood vessel bypass in the lower extremities.

Clinically, when blood clots or vascular stenosis are generated, autologous veins are usually the first choice for transplantation when surgery is required after evaluation. If no suitable autologous veins are available for use, then autologous veins are used instead. Artificial blood vessels made of synthetic materials are used as substitutes for vascular grafts. However, the main materials currently commercially available as bypass artificial blood vessels are ePTFE and Dacron. These two materials are good for low-resistance large-diameter artificial blood vessels (>6mm). Dimensional stability and patency, but when used in high-resistance small-caliber artificial blood vessels, due to the large difference between the material and the autogenous blood vessel in compliance, elasticity and flexibility, it is easy to produce shear stress at the junction of the blood vessel. , Turbulent flow and intimal hyperplasia, leading to thrombosis, further resulting in unsatisfactory postoperative effects.

Another problem in the use of artificial blood vessels is kink. For example, when an artificial blood vessel is implanted in a patient's body, it is often encountered that the artificial blood vessel is bent and the entire tube is kinked. Therefore, the kinking phenomenon occurs when the artificial blood vessel is implanted, which leads to obstruction of blood flow and thrombosis, which further causes poor postoperative effects.

According to the problems of the prior art, the main purpose of the present invention is to provide a polymer fiber tube structure that prevents the tube from kinking, and reduces the problem of thrombosis caused by obstruction of blood flow.

According to the objective of the present invention, the present invention provides a polymer fiber tube structure, including: a first tube, a second tube, and a coil winding structure, and the first tube has an inner surface and an outer surface, and is made of silicon-containing polycarbonate polyurethane elastic Body composition; the second pipe has an inner surface and an outer surface, composed of polycarbonate polyurethane elastomer, the second pipe is wrapped on the outer surface of the first pipe, Make the first pipe and the second pipe have a concentric structure; and a coil winding structure, which is embedded on the outer surface of the first pipe or on the outer surface of the second pipe.

According to the above, the present invention also provides a method for preparing a polymer fiber tube structure, the steps of which include: forming a first tube having an inner surface and an outer surface to form a second tube having an inner surface and an outer surface, and covering the first tube. The outer surface of the pipe is such that the first pipe and the second pipe are concentric circles and a coil winding structure is formed on the outer surface of the first pipe or on the outer surface of the second pipe, wherein the forming step of forming the first pipe further includes: The silicon-containing polycarbonate polyurethane solution is sprayed out to form the silicon-containing polycarbonate polyurethane fiber, and the silicon-containing polycarbonate polyurethane elastomer is collected to form the first pipe. The step of forming the second pipe further includes: providing a polycarbonate polyurethane solution and spraying the polycarbonate polyurethane solution to coat the outer surface of the first pipe to form a polycarbonate polyurethane elastomer, wherein the polycarbonate polyurethane Polyurethane elastomer is the second pipe.

1: Polymer fiber pipe structure

11: The first pipe fitting

12: The second pipe

20: Coil winding structure

22: Coil winding structure

30: Adhesion layer

L1, L2, L3, L4: separation distance

S1-S6: Step process of preparation method of polymer fiber tube structure

Fig. 1 is a side view showing the structure of a polymer fiber tube according to the disclosed technology of the present invention.

Fig. 2 is a flow chart showing the steps of a method for preparing a polymer fiber tube structure according to the technology disclosed in the present invention.

3a is a schematic cross-sectional view showing a coil winding structure embedded on the outer surface of the first tube in the polymer fiber tube structure according to the technology disclosed in the present invention.

3b is a schematic cross-sectional view showing a coil winding structure embedded on the outer surface of the first tube in the polymer fiber tube structure according to the technology disclosed in the present invention.

Fig. 3c is an SEM image of the inner fiber structure of the first tube in the polymer fiber tube structure according to the technology disclosed in the present invention.

4a is a schematic diagram showing a coil winding structure embedded on the outer surface of the second tube in the polymer fiber tube structure according to the technology disclosed in the present invention.

4b is a schematic cross-sectional view showing a coil winding structure embedded on the outer surface of the second tube in the polymer fiber tube structure according to the technology disclosed in the present invention.

Fig. 4c is an SEM image showing the outer fiber structure of the second tube in the polymer fiber tube structure according to the technology disclosed in the present invention.

FIG. 5 is a schematic cross-sectional view showing the inner surface of the first tube and the outer surface of the second tube in the polymer fiber tube structure according to the technology disclosed in the present invention.

6 is a schematic cross-sectional view showing that an adhesion layer is provided between the inner surface of the first tube and the second tube in the polymer fiber tube structure according to the technology disclosed in the present invention.

FIG. 7 is a schematic diagram showing the SEM/EDS mapping of the double-layer fiber structure of the polymer fiber tube structure according to the technology disclosed in the present invention.

In order to let the judges of the bureau and those skilled in the art have a complete understanding of the effects of the present invention, a preferred embodiment of the present invention is used for further explanation with the help of the figures and figure numbers.

Please refer to Figure 1 first. FIG. 1 is a schematic cross-sectional view showing a two-layer structure of a polymer fiber tube structure according to the disclosed technology of the present invention. In Figure 1, the polymer fiber tube structure 1 is composed of a first tube 11 and a second tube 12. The first tube 11 has an inner surface and an outer surface, and the second tube 12 also has an inner surface and an outer surface. The two pipe pieces 12 are wrapped on the outer surface of the first pipe piece 11 so that the first pipe piece 11 and the second pipe piece 12 have a concentric structure. In the embodiment of the present invention, The material of the first tube 11 is a silicon-containing polycarbonate polyurethane elastomer, and the material of the second tube 12 is a polycarbonate polyurethane elastomer. The manufacturing steps are as described in the step flow chart of FIG. 2.

As shown in Figure 2, step S1: Provide a silicon-containing polycarbonate polyurethane solution. Step S2: spray the silicon-containing polycarbonate polyurethane solution to form a silicon-containing polycarbonate polyurethane elastomer. Step S3: Collect the silicon-containing polycarbonate polyurethane elastomer to obtain a first pipe made of the silicon-containing polycarbonate polyurethane elastomer. Step S4: Provide a polycarbonate polyurethane solution. Step S5: spray the polycarbonate polyurethane solution to coat the outer surface of the first pipe to form a polycarbonate polyurethane elastomer, wherein the polycarbonate polyurethane elastomer is the second pipe. Step S6: forming a coil winding structure on the outer surface of the first pipe or on the outer surface of the second pipe. The further description of step S1-step S6 is as follows.

Firstly, a 10wt%-20wt% silicon-containing polycarbonate polyurethane solution is selected and placed in a syringe of an automatic sampling device. The sampling speed is 0.5 to 5.0 milliliters/hour (mL/h) and passes through 12kV to 28kV. The voltage and the collection distance of 10 cm to 25 cm, the silicon-containing polycarbonate polyurethane solution is sprayed through the electrospinning technology to prepare the silicon-containing polycarbonate polyurethane fiber, where the silicon-containing polycarbonate polyurethane fiber is deposited The electrode (not shown in the figure) is collected. In this embodiment, the deposition electrode is a rotating shaft, and the layered silicon-containing polycarbonate polyurethane elastomer obtained from the deposition electrode is made of polymer fiber tube structure 1. The inner tube is the first tube 11. Immediately afterwards, the same 10wt%-20wt% polycarbonate polyurethane solution was replaced into the syringe of the automatic sampling device, and the sampling speed was 0.5 to 5.0 milliliters/hour (mL/h) through 12kV to 28kV. The voltage and the collection distance of 10 cm to 25 cm, the polycarbonate polyurethane solution is sprayed through the electrospinning technology to prepare polycarbonate polyurethane fiber, and the polycarbonate polyurethane fiber is collected outside the first pipe 11 On the surface, the first tube 11 is covered, so the layered polycarbonate polyurethane elastomer forms The outer tube is the second tube 12. In the embodiment of the present invention, the thickness of the first tube 11 accounts for 30% to 70% of the total thickness of the polymer fiber tube structure 1 and the thickness of the second tube 12 accounts for the total thickness of the polymer fiber tube structure 1 20%~80%.

Then please refer to Figure 3a~Figure 3c. Figure 3a is a schematic diagram showing the coil winding structure embedded in the outer surface of the first tube in the polymer fiber tube structure, and Figure 3b is the coil winding structure embedded in the outer surface of the first tube in the polymer fiber tube structure The cross-sectional schematic diagram and FIG. 3c show the SEM4 image of the inner fiber structure of the first tube in the polymer fiber tube structure.

Please refer to Figures 3a and 3b at the same time, the polymer fiber tube structure 1 is composed of a first tube 11 and a second tube 12, and between the first tube 11 and the second tube 12 also includes a coil winding structure 20 (ie The structure shown by the dashed line in Figure 3a), the coil winding structure 20 is embedded on the outer surface of the first tube 11, and its purpose is to prevent the polymer fiber tube structure 1 from kinking through the coil winding structure 20, and Avoid the problem of blood flow obstruction.

In this embodiment, the method of forming the coil winding structure 20 on the outer surface of the first tube 11 is that after the first tube 11 is formed, the coil winding structure 20 is wound on the outer surface of the first tube 11 and then The second tube 12 is formed to cover the first tube 11 and the coil winding structure 20. In another embodiment of the present invention, in the process of forming the first tube 11 and the second tube 12, the coil winding structure 20 is wound between the first tube 11 and the second tube 12, that is, the first tube 11 The position where the outer surface of the second pipe 12 contacts the inner surface. It should be noted that the spacing distance between the coil winding structure 20 embedded on the outer surface of the first tube 11 can be the same, as shown in Fig. 3a as L1, and the spacing distance ranges from 100 μm to 1000 μm. In another preferred embodiment, the spacing distance between the coil winding structure 20 embedded on the outer surface of the first tube 11 can be L2, L3, or L4, that is, the coil winding structure 20 is embedded in the first tube 11. The spacing distance on the outer surface of the pipe 11 can be set as required, Therefore, the spacing distance of the coil winding structure 20 embedded on the outer surface of the first tube 11 can be equidistant as shown by L1, or can be the separation distance as represented by L2, L3, and/or L4, and are wound at the same time. A tube 11 on the outer surface. Therefore, according to the above, the polymer fiber tube structure 1 of FIGS. 3a and 3b is irradiated by SEM scanning, and the inner layer of the polymer fiber tube structure 1 as shown in FIG. 3c (ie, the outer surface of the first tube 11 and the The SEM image of the fiber structure of the interface between the inner surfaces of the second tube 12, and FIG. 3c can also prove that the inner layer of the polymer fiber tube structure 1 has a specific fiber diameter and holes.

Next, please refer to Figure 4a~Figure 4c. Figure 4a is a schematic diagram showing the coil winding structure embedded on the outer surface of the first tube in the polymer fiber tube structure, and Figure 4b is the coil winding structure embedded on the outer surface of the second tube in the polymer fiber tube structure The cross-sectional schematic diagram of the structure and FIG. 4c are the SEM images showing the outer fiber structure of the second tube in the polymer fiber tube structure.

In Figures 4a and 4b, after the second tube 12 is formed, the coil winding structure 22 is wound on the outer surface of the second tube 12. Similarly, the coil winding structure 22 is embedded in the outer surface of the second tube 12 The separation distance ranges from 100 μm to 1000 μm, and the separation distance of the coil winding structure 22 can be the same or different. In addition, in the embodiment of the present invention, the diameter of the coil winding structure 20 and the coil winding structure 22 ranges from 100 μm to 500 μm. Similarly, the polymer fiber tube structure 1 of FIGS. 4a and 4b is irradiated by SEM scanning, and the fiber structure of the outer layer of the polymer fiber tube structure 1 (that is, the outer surface of the second tube 12) as shown in FIG. 3c can be obtained. The SEM image of Figure 4c can prove that the outer layer of the polymer fiber tube structure 1 has a specific fiber diameter and holes.

In another embodiment of the present invention, it is shown in FIG. 5. 5 is a schematic cross-sectional view showing a coil winding structure embedded in the inner surface of the first tube and the outer surface of the second tube in the polymer fiber tube structure. In Figure 5, the aforementioned Figure 3a~Figure 3b and Figure 4a~Figure 4b are combined, that is It is said that the coil winding structure 20 can be wound around the outer surface of the first pipe 11 after the first pipe 11 is formed; or during the process of forming the first pipe 11 and the second pipe 12, the coil can be wound again The structure 20 is wound between the first pipe 11 and the second pipe 12. Then, after the second tube 12 is formed, the coil winding structure 22 is wound on the outer surface of the second tube 12. In this embodiment, the coil winding structure 20 is wound on the outer surface of the first tube 11 at a distance from the coil The distances at which the winding structure 22 is wound on the outer surface of the second tube 12 may be the same or different.

In addition, in another embodiment of the present invention, the polymer fiber tube structure 1 further includes an adhesion layer 30 disposed between the first tube 11 and the second tube 12, as shown in FIG. 6. For the convenience of description, FIG. 6 uses the structure of FIG. 3b as an example, but in FIG. 3b or FIG. In FIG. 6, the preparation method includes: first coating an adhesive layer 30 in the middle of the first tube 11 or the second tube 12, and then winding the coil winding structure 22 on the adhesive layer 30 or embedding in the adhesive layer 30 Inside, then, the second tube 12 is formed to cover the adhesive layer 30, the coil winding structure 22, and the first tube 11. In an embodiment, the adhesion layer 30 may be alternately inserted between the outer surface of the first tube 11 and the coil winding structure 22. In the embodiment of the present invention, the adhesion layer 30 is dense polyurethane.

According to the above, the polymer fiber tube structure 1 disclosed in the present invention is subjected to scanning electron microscope/energy dispersive X-ray spectrum mapping (SEM/EDS mapping), as shown in FIG. 7, the red dot in FIG. 7 can be obtained Representing the element of silicon, it can also be proved that the first tube 11 is a polycarbonate polyurethane containing silicon, and the second tube 12 is a polycarbonate polyurethane containing no silicon.

S1-S6: Step process of preparation method of polymer fiber tube structure

Claims (9)

A method for preparing a polymer fiber tube structure. The steps include: forming a first tube, and the first tube has an inner surface and an outer surface. The steps include: providing a silicon-containing polycarbonate polyurethane solution with a concentration The range is 10wt%~20wt%; the silicon-containing polycarbonate polyurethane solution is sprayed to form a silicon-containing polycarbonate polyurethane fiber; and the silicon-containing polycarbonate polyurethane fiber is collected to obtain a silicon-containing polycarbonate The first pipe is composed of an ester polyurethane elastomer; a second pipe is formed to coat the outer surface of the first pipe so that the first pipe and the second pipe are concentric circles, and the second pipe has An inner surface and an outer surface, and the steps include: providing a polycarbonate polyurethane solution with a concentration ranging from 10wt% to 20wt%; and spraying the polycarbonate polyurethane solution to coat the outer surface of the first pipe A polycarbonate polyurethane elastomer is formed on the surface, wherein the polycarbonate polyurethane elastomer is the second pipe; and a coil winding structure is formed to be embedded on the outer surface of the first pipe or on the first pipe. The outer surface of the second pipe. The method for preparing a polymer fiber tube structure as described in item 1 of the scope of patent application, wherein a thickness of the first tube occupies a range of 30% to 70% of the total thickness of the polymer fiber tube structure, and the second tube The thickness of the polymer fiber tube structure accounts for 20% to 80% of the total thickness. According to the method for preparing the polymer fiber tube structure described in the first item of the patent application, the silicon-containing polycarbonate polyurethane solution and the polycarbonate polyurethane solution are sprayed out by using an electrospinning step. According to the method for preparing the polymer fiber tube structure described in the first item of the patent application, the collection of the silicon-containing polycarbonate polyurethane fiber is achieved by using a deposition electrode. The method for preparing a polymer fiber tube structure as described in item 1 or item 3 of the scope of patent application, wherein the coil winding structure is embedded in the outer surface of the first tube or a part of the outer surface of the second tube The separation distance range can be the same or different. According to the method for preparing a polymer fiber tube structure as described in item 5 of the scope of patent application, the separation distance ranges from 100 μm to 1000 μm. As described in the first item of the scope of patent application, the method for preparing the polymer fiber tube structure further includes forming an adhesion layer between the outer surface of the first tube and the inner surface of the second tube. As described in the first item of the scope of patent application, the method for preparing the polymer fiber tube structure further includes forming an adhesion layer to be alternately inserted between the outer surface of the first tube and the coil winding structure. The method for preparing the polymer fiber tube structure as described in item 7 or item 8 of the scope of patent application, wherein the adhesion layer is polyurethane.

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