TW202302164A - Implanted medical device - Google Patents

Abstract

The present disclosure provides an implanted medical device including a weaving network structure formed from warp yarns and weft yarns, in which at least one of the warp yarns and the weft yarns includes a polypropylene fiber, and a radius of the polypropylene fiber is between 0.05 mm and 0.25 mm. A warp density and a weft density of the weaving network structure are respectively between 20 ends per inch and 65 ends per inch and 20 picks per inch and 50 picks per inch.

Description

Implantable Medical Devices

The present disclosure relates to an implantable medical material, and in particular to an implantable medical material with a woven mesh structure.

Implantable medical materials can provide mechanical strength to support tissues, so they can be used to assist implanted subjects to restore their tissue functions. However, various implantable medical materials often produce a rejection reaction between them and biological tissues after implantation, thus causing discomfort to the implanted person. For example, implantable medical materials may have too small or too large pore size, improper fiber size or rough surface, which may cause inflammation or foreign body sensation after implantation. Therefore, how to improve the bio-histocompatibility of implantable medical materials and reduce the inflammatory response of implantable medical materials is an important subject of active research by the industry.

The disclosure provides an implantable medical material, which includes a woven mesh structure with an appropriate weaving density, so as to improve the inflammation caused by the implantable medical material.

According to one embodiment of the present disclosure, an implantable medical material is provided, which includes a woven mesh structure woven by warp yarns and weft yarns, wherein at least one of the warp yarns and weft yarns includes polypropylene fibers and the diameter of the polypropylene fibers is between 0.05 mm to 0.25 mm, the warp yarn density and weft yarn density of the woven mesh structure are respectively between 20 counts/inch and 65 counts/inch and 20 counts/inch to 50 counts/inch.

In an embodiment of the present disclosure, the weight of the base fabric of the implantable medical material is between 20 grams/square meter and 70 grams/square meter.

In one embodiment of the present disclosure, the woven mesh structure has a pore size (D90) ranging from 0.25 mm to 1.2 mm.

In one embodiment of the present disclosure, the woven mesh structure is a 1×1 plain weave.

In one embodiment of the present disclosure, the warp and weft yarns comprise polypropylene fibers of the same diameter.

In an embodiment of the present disclosure, the implantable medical material further includes collagen adhered to the surface of the polypropylene fiber.

In an embodiment of the present disclosure, based on the total weight of the implantable medical material, the content of collagen is between 0.2 wt% and 1.5 wt%.

In one embodiment of the present disclosure, the polypropylene fiber is a single strand polypropylene fiber.

In one embodiment of the present disclosure, the implantable medical material is composed of a single-layer woven mesh structure.

According to the above-mentioned embodiments of the present disclosure, since the woven network structure in the implantable medical material includes warp and weft yarns with appropriate fiber diameter and weaving density, the woven network structure can increase the cell attachment of the implantable medical material , thereby improving the inflammation caused by implantable medical materials in vivo.

To achieve the different features of the mentioned subject matter, the following disclosure presents a number of different implementations. Specific examples of components, values, materials, configurations, etc. are described below to simplify the present disclosure. Of course, these are examples only, not limiting.

The present disclosure provides an implantable medical material comprising a woven mesh structure, wherein the woven mesh structure is woven with warp yarns and weft yarns having appropriate fiber diameters, and the woven mesh structure has appropriate warp yarn density and weft yarns density. Since the woven network structure in the implantable medical material includes warp and weft yarns of appropriate size and weaving density, the woven network structure can increase the cell attachment of the implantable medical material, thereby improving the implantable medical material. Inflammation caused by materials in living organisms.

According to some embodiments of the present disclosure, the implantable medical material includes a woven mesh structure woven by warp yarns and weft yarns. Specifically, the warp density of the woven mesh structure in the implantable medical material is between 20 counts/inch and 65 counts/inch, and the weft density is between 20 counts/inch and 50 counts/inch. between. For example, a woven mesh structure may have a warp and fill density that is also 35 threads per inch, or it may have a warp and fill density of 62 threads per inch and 48 threads per inch, respectively. Since the woven mesh structure of the implantable medical material has an appropriate warp density and weft density, the cell attachment of the implantable medical material is increased, so that the implantable medical material has good bio-histocompatibility and reduces An inflammatory response in an organism. On the other hand, the increase of cell adhesion can improve the tightness between the implantable medical material and the biological tissue, so that the implantable medical material is less prone to displacement in the living body.

More specifically, in the woven mesh structure of the implantable medical material, at least one of the warp and weft includes polypropylene fibers. The warp and weft yarns of the woven network structure use polypropylene fibers as the base material, which makes the woven network structure have strong mechanical properties, heat resistance, and resistance to organic solvents and acid and alkali corrosion. Therefore, the woven mesh structure can improve the supporting strength of the implantable medical material for biological tissues, and make the implantable medical material withstand the sterilization process, thereby increasing the safety of the implantable medical material in use.

Specifically, the polypropylene fiber included in at least one of the warp and weft has a diameter between 0.05 mm and 0.25 mm. In a preferred embodiment, at least one of the warp and weft yarns comprises polypropylene fibers with a diameter ranging from 0.1 mm to 0.15 mm. If the warp and weft yarns include polypropylene fibers with a diameter greater than 0.25 mm, it may reduce the compatibility between the implantable medical material and biological tissue, thereby increasing the foreign body sensation of the implantable medical material in the living body; if the warp yarn and weft yarn include polypropylene fibers with a diameter of less than 0.05 mm polypropylene fibers may reduce the cell attachment of implantable medical materials, which may easily cause inflammation and increase the possibility of displacement of implantable medical materials. In some embodiments, the warp and weft yarns of the woven mesh structure may comprise polypropylene fibers of the same diameter, so that the implantable medical material has a uniform warp and weft structure. By way of example, the warp and weft threads may comprise polypropylene fibers also having a diameter of 0.12 mm. In some embodiments, the warp and weft yarns of the woven mesh structure may include single-strand polypropylene fibers, so that the warp and weft yarns have a smooth surface, thereby further reducing the inflammatory response of the implantable medical material.

In some embodiments, the woven mesh structure of the implantable medical material may have a suitable pore size, thereby providing the implantable medical material with good support strength and compatibility with biological tissues. Specifically, the woven mesh structure may have a pore size (D90) between 0.25 mm and 1.2 mm. If the pore size (D90) of the woven mesh structure is greater than 1.2 mm, it may reduce the support strength of the implantable medical material for biological tissues, thereby reducing the applicability of the implantable medical material; if the pore size of the woven mesh structure (D90) less than 0.25 mm may reduce the flexibility of the implantable medical material and make it difficult for the implantable medical material to adhere to the biological tissue, and the too small pore size may also reduce the cell permeability of the implantable medical material prone to inflammatory reactions.

In some embodiments, the woven network structure of the implantable medical material can reduce nodes between yarns through the woven weaving method, thereby increasing the cell attachment of the implantable medical material. For example, the woven mesh structure of the implantable medical material may be a 1×1 plain weave. Because the woven mesh structure provides good cell attachment of the implantable medical material, it can improve the displacement phenomenon of the implantable medical material in the living body and the resulting inflammation. In some embodiments, the implantable medical material may be composed of a single-layer woven mesh structure, so that the weight of the implantable medical material is reduced, thereby reducing the foreign body sensation of the implantable medical material in the living body. For example, the weight of the base fabric of the implantable medical material can be between 20 grams/square meter and 70 grams/square meter.

In some embodiments, the implantable medical material may further include collagen attached to the woven mesh structure, thereby increasing the biocompatibility of the implantable medical material. Specifically, the implantable medical material with the above-mentioned woven network structure is immersed in a collagen solution, and cultured at a suitable pH value and temperature, so that collagen is precipitated and attached to the polypropylene woven network structure. the surface of the fiber. Then, the solvent on the implantable medical material is removed through a drying process, thereby forming the implantable medical material including collagen. Since collagen is beneficial for cell attachment on the woven mesh structure, implantable medical materials including collagen can have good bio-histocompatibility. In some embodiments, based on the total weight of the implantable medical material, the content of collagen may be between 0.2 wt% and 1.5 wt%. It is worth noting that the polypropylene fiber diameters of the warp and weft yarns of the woven mesh structure may affect the collagen content of implantable medical materials. For example, if the warp and weft yarns have too large diameters of polypropylene fibers, the surface area of the woven network structure may be reduced to reduce the collagen content of the implantable medical material.

In the following description, various measurements and evaluations will be performed on the implantable medical material of the present disclosure. The features of the present disclosure will be described in more detail below with reference to Experimental Example 1 to Experimental Example 3. ＜Experimental example 1: Basic formula and collagen content evaluation of implantable medical materials＞

In this experimental example, the collagen content was evaluated for the implantable medical materials of the comparative example and each example. Specifically, implantable medical materials were prepared according to the weaving structure parameters in Table 1 below, wherein the warp and weft yarns of each implantable medical material were polypropylene fibers with the same diameter. Next, the implantable medical materials of Examples 2, 4, 6, 8, 10, and 12 were respectively immersed in neutral collagen solutions of the same concentration, and were incubated at a temperature of about 36.5°C for 36 hours before being dried. , so that the implantable medical material of the above embodiment includes collagen attached to the polypropylene fiber. The weaving structure parameters and collagen content of the comparative example and each embodiment are shown in Table 1.

Table I Warp and weft fiber diameter (mm) Warp density (count/inch) Weft density (count/inch) Collagen content (wt%) Example 1 0.25 twenty three twenty three 0 Example 2 0.25 twenty three twenty three 0.21 Example 3 0.25 30 30 0 Example 4 0.25 30 30 0.41 Example 5 0.25 36 36 0 Example 6 0.25 36 36 0.34 Example 7 0.12 25 25 0 Example 8 0.12 25 25 0.84 Example 9 0.12 35 35 0 Example 10 0.12 35 35 1.0 Example 11 0.12 62 48 0 Example 12 0.12 62 48 1.2 comparative example 0.15 knitted structure 0 Note 1: The comparative example is a knitted structure without warp density and weft density Note 2: The collagen content is based on the total weight of the implantable medical material

It can be seen from Table 1 that the implantable medical materials of Examples 2, 4, 6, 8, 10 and 12 have high collagen content. In more detail, the warp and weft fiber diameters of Examples 8, 10 and 12 are smaller than those of Examples 2, 4 and 6, so that the woven mesh structures of Examples 8, 10 and 12 have a larger surface area , so that the collagen content of Examples 8, 10 and 12 is higher than that of Examples 2, 4 and 6. Therefore, warp and weft yarns with smaller fiber diameters in various embodiments can provide higher collagen content in the implantable medical device. ＜Experimental Example 2: Evaluation of Cell Adhesion of Implantable Medical Devices＞

In this experimental example, cell attachment was evaluated for the implantable medical materials of the comparative example and each example. Specifically, the implantable medical materials of the comparative example of Experimental Example 1 and each of the examples were cultured for 48 hours in an environment with a temperature of about 37° C. with the same number of cells. Next, each implantable medical material was transferred to a culture solution supplemented with a cell viability assay reagent (MTS detection reagent), and cultured for 2.5 hours in an environment with a temperature of about 37°C. Then, the absorption value of the culture medium for light with a wavelength of 490 nm was measured to determine the cell attachment of each implantable medical material. More specifically, when the absorption value of the culture medium is higher, the result reflects that there is a higher content of living cells in the culture medium, and thus it is determined that the corresponding implantable medical material has higher cell attachment. The measurement results of the comparative example and each embodiment are shown in Table 2.

Table II Absorbance Example 1 0.2638 Example 2 0.2667 Example 3 0.2140 Example 4 0.2734 Example 5 0.2454 Example 6 0.2741 Example 7 0.1909 Example 8 0.2044 Example 9 0.1883 Example 10 0.2150 Example 11 0.2218 Example 12 0.2965 comparative example 0.1814

It can be seen from Table 2 that the implantable medical materials of each embodiment have a greater absorption value for light with a wavelength of 490 nm than the implantable medical materials of the comparative examples. Therefore, the woven mesh structure with appropriate warp yarn density and weft yarn density in each embodiment can provide good cell attachment for implantable medical materials. In more detail, the absorption values of Examples 2, 4, 6, 8, 10, and 12 that include collagen in the implantable medical material for light with a wavelength of 490 nm are respectively greater than those not included in the implantable medical material. Collagen Examples 1, 3, 5, 7, 9 and 11. Therefore, an implantable medical material including collagen in a woven mesh structure may have better cell attachment. ＜Experimental Example 3: Evaluation of Inflammatory Reaction of Implantable Medical Devices＞

In this experimental example, the evaluation of the inflammatory reaction was performed on the implantable medical materials of the comparative example and the example. Specifically, the implantable medical materials of the comparative example of Experimental Example 1 and Examples 2, 7, 8 and 12 were cut into a size of 1 cm × 0.5 cm, and each implantable medical material was implanted into mice of the back. Then, the mice were anesthetized and sacrificed on the 4th day, 14th day and 30th day after implantation, and the skin samples at the implantation site were taken out, and the skin samples of each implantable medical device were tested using the standard method ISO 10993-6. Perform histopathological interpretation. In more detail, when the skin sample gets a higher score in histopathological interpretation, this result reflects that the mouse tissue has a higher rejection reaction to the implanted medical device, thereby determining the inflammatory response caused by the implanted medical device more intense. The test results of the comparative example and each embodiment are shown in Table 3.

Table three Day 4 Score Day 14 Score Day 30 Score total score Example 2 19.5 28.4 26.0 73.9 Example 7 20.5 24.5 25.9 70.9 Example 8 21.4 22.9 21.9 66.2 Example 12 20.5 24.1 25.5 70.1 comparative example 22.0 26.0 25.1 73.1 Note 1: Fractions are pure values without units

It can be seen from Table 3 that on the 4th day after implantation, the scores of the comparative example and other examples are similar, and the score of the comparative example is the highest. In other words, within a short period of time after each implantable medical material is implanted, the inflammatory response caused by each embodiment is slightly lower than that caused by the comparative example. The scores of the three evaluations were summed 30 days after implantation, wherein the scores of Example 2 were comparable to those of the comparative example, while the scores of Examples 7, 8 and 12 were lower than those of the comparative example. Therefore, a woven mesh structure with appropriate warp and weft yarn density and fiber diameter can reduce the inflammatory response of implantable medical materials in vivo.

According to the above-mentioned embodiments of the present disclosure, the implantable medical material of the present disclosure includes a woven network structure woven by warp yarns and weft yarns. Since the woven network structure has an appropriate warp yarn density and weft yarn density, and the warp yarns and weft yarns have an appropriate The diameter of the fiber increases the cell adhesion and biological tissue compatibility of the implantable medical material, thereby improving the inflammation, displacement and foreign body sensation of the implantable medical material in the living body. On the other hand, the appropriate weaving density and fiber diameter of the warp and weft yarns can make a high content of collagen adhere to the woven mesh structure, thereby further increasing the cell attachment of implantable medical materials.

The foregoing outlines features of some embodiments so that those skilled in the art may better understand the aspects of the present disclosure. Those skilled in the art should appreciate that they may readily use the present disclosure as a basis for designing or modifying other processes and structures for carrying out the same purposes and/or achieving the same advantages as the embodiments described herein. Those skilled in the art should also understand that such equivalent constructions do not depart from the spirit and scope of the present disclosure, and that they can make various changes, substitutions and alterations without departing from the spirit and scope of the present disclosure.

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Claims (9)

An implantable medical material, comprising a woven mesh structure woven by warp yarns and weft yarns, wherein at least one of the warp yarns and the weft yarns comprises polypropylene fibers and the diameter of the polypropylene fibers is between 0.05 mm and 0.25 mm mm, the warp yarn density and the weft yarn density of the woven mesh structure are respectively between 20 counts/inch and 65 counts/inch and between 20 counts/inch and 50 counts/inch. The implantable medical material according to claim 1, wherein the weight of the base fabric of the implantable medical material is between 20 grams/square meter and 70 grams/square meter. The implantable medical material according to claim 1, wherein the woven mesh structure has a pore size (D90) between 0.25 mm and 1.2 mm. The implantable medical material according to claim 1, wherein the woven mesh structure is 1×1 plain weave. The implantable medical material according to claim 1, wherein the warp yarn and the weft yarn comprise the same diameter of the polypropylene fiber. The implantable medical material as claimed in claim 1 further includes collagen attached to the surface of the polypropylene fiber. The implantable medical material according to claim 1, wherein the collagen content is between 0.2 wt% and 1.5 wt% based on the total weight of the implantable medical material. The implantable medical material according to claim 1, wherein the polypropylene fiber is a single-strand polypropylene fiber. The implantable medical material according to claim 1, wherein the implantable medical material is composed of a single layer of the woven mesh structure.