A medical gasket that does not shed fibers and its preparation method

Abstract

The present invention discloses a medical gasket that does not shed fibers and a preparation method thereof. The medical gasket that does not shed fibers consists of a PTFE felt sheet in the middle layer and biodegradable electrospun film layers on the upper and lower surfaces as the main body; a laser drilling process is used to form uniformly distributed through holes on the main body of the medical gasket, and a layer of biodegradable biomaterial coating is covered on the surface of the through holes; the medical gasket is used in vascular surgery to achieve the effects of decompression and hemostasis; among them, the electrospun film layer is made of a biodegradable biomaterial, has good biocompatibility, not only effectively avoids the phenomenon of fluff shedding of the PTFE felt sheet, but also can guide and support cell differentiation and promote tissue regeneration; the through holes coated with the biodegradable biomaterial coating are beneficial to the insertion of the suture needle, improving the convenience of the operation.

Description

Technical Field

[0001] The present invention relates to the field of medical supplies, in particular to a medical gasket that does not shed fibers and a preparation method thereof. Background Art

[0002] Blood vessels in the human body transport blood and nutrients to various tissues of the body to maintain the normal operation of body functions. Therefore, once the blood vessels are damaged or diseased, it will greatly affect human health. During vascular surgery, it is often necessary to suture the blood vessels. However, directly suturing the blood vessels may cause blood leakage at the suture line, and the force of the suture will also directly act on the blood vessels, causing certain damage to the blood vessels.

[0003] In existing vascular surgery, medical gaskets are used to reduce the pressure of the suture on the blood vessel wall and prevent the suture from strangling the outer wall of the blood vessel. Most medical gaskets are polytetrafluoroethylene short fiber felt sheets, and the short fibers on their surfaces are prone to falling off, which may cause additional harm to the human body. For example, the "Surgical Gasket for Microvascular Decompression Surgery" in Chinese Patent Document CN201821408729 discloses a medical gasket with a cotton-like fiber structure composed of polytetrafluoroethylene fibers, without a process for preventing the gasket from shedding fibers. Therefore, it is difficult to avoid the phenomenon of the surgical gasket shedding hair during the operation. Moreover, the unmodified PTFE-type medical gasket is difficult to guide cell differentiation and promote tissue regeneration in the early stage of vascular surgery recovery.

[0004] Therefore, how to solve the above technical problems has become the research direction of those skilled in the art. Summary of the Invention

[0005] The purpose of the present invention is to overcome the deficiencies of the prior art and provide a medical gasket that does not shed fibers and a preparation method thereof to solve the technical problems raised in the above background art.

[0006] The purpose of the present invention is achieved through the following technical solutions:

[0007] A medical gasket that does not shed fibers, the medical gasket includes an intermediate layer and electrospun thin film layers arranged on the upper and lower surfaces of the intermediate layer. The intermediate layer is a PTFE felt sheet with a three-dimensional structure having a multi-microporous structure formed by subjecting polytetrafluoroethylene short fibers to opening, carding, web laying non-woven processes and strengthening treatment in sequence. The electrospun thin film layer is a nanofiber layer with a microporous structure formed by spraying a biodegradable biomaterial solution using electrospinning technology. Through holes are uniformly arranged on the medical gasket, and the inner wall surface of the through holes is covered with a biodegradable biomaterial coating.

[0008] In the above-mentioned invention content, further, the thickness of the intermediate layer is 400 - 2000 microns, and the thickness of the electrospun film layer is 100 - 200 microns.

[0009] In the above-mentioned invention content, further, the aperture of the through-hole is 150 - 550 microns, and the volume ratio of the through-hole in the medical gasket is 10% - 30%.

[0010] In the above-mentioned invention content, further, the thickness of the degradable biomaterial coating is 100 - 350 microns.

[0011] A preparation method of a medical gasket that does not shed fibers, the preparation method includes the following preparation steps:

[0012] S1. A PTFE felt sheet with a three-dimensional structure having a multi-porous structure formed by successively subjecting polytetrafluoroethylene short fibers to opening, carding, cross-laying nonwoven process treatment, and reinforcement treatment;

[0013] S2. Take a degradable biomaterial and dissolve it in an organic acid solution, stir at room temperature until completely dissolved, to obtain a degradable biomaterial solution with a concentration of 5% - 10%;

[0014] S3. Use an electrospinning device to form the obtained degradable biomaterial solution into an electrospun film layer, then dry it using an oven, and laminate the dried electrospun film layer on the upper and lower surfaces of the PTFE felt sheet to obtain a medical gasket body;

[0015] S4. Use a laser drilling process to form uniformly distributed through-holes in the medical gasket body structure, then apply a degradable biomaterial solution to the inner walls of the through-holes, so that the degradable biomaterial solution forms a degradable biomaterial coating on the inner walls of the through-holes, and finally dry it to obtain a medical gasket that does not shed fibers.

[0016] In the above-mentioned invention content, further, in step S1, the polytetrafluoroethylene short fibers are reinforced by needling or hydroentangling.

[0017] In the above-mentioned invention content, further, in step S2, the organic acid is formic acid or acetic acid.

[0018] In the above-mentioned invention content, further, in step S2, the degradable biomaterial is selected from collagen, gelatin, silk fibroin, hyaluronic acid, chitosan, or porcine small intestinal submucosa extract.

[0019] In the above-mentioned invention content, further, in step S3, the spinning voltage of the electrospinning device is set to 10 - 25 kV, the feeding rate is 1 - 3 mL·h -1 , and the receiving distance is 10 - 25 cm.

[0020] The beneficial effects of the present invention are as follows: the medical gasket provided by the present invention includes an intermediate layer and an electrospun film layer arranged on the upper and lower surfaces of the intermediate layer. The intermediate layer is a PTFE felt sheet with a three-dimensional structure having a multi-microporous structure formed by polytetrafluoroethylene short fibers being sequentially processed by opening, carding, laying non-woven processes and reinforcement. The electrospun film layer is a nanofiber layer with a microporous structure formed by spinning degradable biomaterials using an electrospinning process. The electrospun film layers arranged on the upper and lower surfaces of the PTFE felt sheet can effectively prevent the fibers on the upper and lower surfaces of the PTFE felt sheet from falling off. The medical gasket is evenly provided with holes formed by laser punching. The through hole has an inner wall surface covered with a degradable biomaterial coating. During the laser drilling process, holes are formed by the principle of high-temperature melting material. After the polytetrafluoroethylene fiber is melted and cooled, the fibers will bond together, effectively preventing the short fibers from falling off. At the junction of the electrospun film and the PTFE felt sheet, the molten PTFE fiber bonds the two together, playing the role of fixing the PTFE felt sheet and the electrospun film layer. The electrospun film layer is made of degradable biomaterials, which is degradable and biocompatible. It can guide cell growth from the upper and lower surfaces of the gasket and promote wound recovery.

[0021] Secondly, the through holes on the medical gasket of the present invention not only facilitate needle insertion during surgical suturing, but also the inner wall of the through holes is coated with a degradable biomaterial coating. The through holes can guide and promote the growth of cell tissue in the through holes, and can better combine the medical gasket and cell tissue together. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 This is a schematic diagram of the cross-sectional structure of the medical gasket that does not lose fibers according to the present invention;

[0023] Figure 2 It is a schematic diagram of the upper surface or lower surface structure of the medical gasket that does not lose fibers of the present invention.

[0024] In the figure, 1-electrospinning film layer, 2-PTFE felt sheet, 3-through hole, 4-degradable biomaterial coating. DETAILED DESCRIPTION

[0025] The following specific examples illustrate the implementation manners of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific implementation manners. Various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that, without conflict, the following embodiments and the features in the embodiments can be combined with each other.

[0026] It should be noted that the diagrams provided in the following embodiments only illustrate the basic concept of the present invention in a schematic manner. Therefore, only the components related to the present invention are shown in the diagrams, rather than being drawn according to the number, shape, and size of the components in actual implementation. The type, quantity, and ratio of each component in actual implementation can be arbitrarily changed, and the component layout type may also be more complex.

[0027] Embodiment 1:

[0028] A medical gasket that does not shed fibers. Please refer to Attachment Figure 1 and Attachment Figure 2 As shown, the medical gasket includes an intermediate layer and electrospun film layers 1 provided on the upper and lower surfaces of the intermediate layer. The intermediate layer is a PTFE felt sheet 2 with a three-dimensional structure having a multi-porous structure, which is formed by subjecting polytetrafluoroethylene short fibers to opening, carding, web laying non-woven process treatment, and strengthening treatment in sequence. The electrospun film layer 1 is a nanofiber layer with a porous structure formed by spraying a biodegradable biomaterial solution using an electrospinning process. Through holes 3 are uniformly provided on the medical gasket, and a biodegradable biomaterial coating 4 covers the inner wall surface of the through holes 3.

[0029] In the present invention, the electrospun film layers 1 provided on the upper and lower surfaces of the PTFE felt sheet 2 can effectively prevent the fibers on the upper and lower surfaces of the PTFE felt sheet 1 from falling off. The through holes 3 are formed on the medical gasket by using a laser drilling process. During the drilling process, holes are formed based on the principle of melting materials at high temperature. After the polytetrafluoroethylene fibers are melted and cooled, the polytetrafluoroethylene short fibers will bond together, so the phenomenon of polytetrafluoroethylene short fibers falling off can be effectively avoided. Secondly, the electrospun film layer 1 is made of a biodegradable biomaterial, has biodegradability and biocompatibility, can guide cell growth from the upper and lower surfaces of the gasket, promote the recovery of blood vessel wounds, and after the electrospun film layer 1 degrades, it will not cause harm to the body. Finally, the through holes 3 uniformly provided on the medical gasket can not only facilitate the insertion of needles during surgical suturing, but also the inner wall of the through holes 3 is coated with a biodegradable biomaterial coating 4. The through holes 3 can guide and promote the growth of cell tissues in the through holes 4, and can better combine the medical gasket and cell tissues together.

[0030] In the above embodiments, preferably, the thickness of the PTFE felt sheet 2 in the middle layer is 400 - 2000 microns, and the thickness of the electrospun film layer 1 is 100 - 200 microns.

[0031] In the above embodiments, preferably, the aperture of the through hole 3 is 150 - 550 microns, and the volume ratio of the through hole 3 in the medical gasket is 10% - 30%.

[0032] In the above embodiments, preferably, the thickness of the degradable biomaterial coating 4 is 100 - 350 microns.

[0033] A preparation method of a non - fiber - shedding medical gasket is obtained through the following preparation steps:

[0034] S1. The PTFE short fibers are successively subjected to opening, carding, web - laying non - woven process treatment and strengthening treatment to form a three - dimensional PTFE felt sheet 2 with a multi - microporous structure;

[0035] S2. Take a degradable biomaterial and dissolve it in an organic acid solution, stir at room temperature until completely dissolved to obtain a degradable biomaterial solution with a concentration of 5% - 10%;

[0036] S3. Use an electrospinning device to form the obtained degradable biomaterial solution into an electrospun film layer 1, then dry it using an oven, and laminate the dried electrospun film layer 1 on the upper and lower surfaces of the PTFE felt sheet 2 to obtain a medical gasket body;

[0037] S4. Adopt a laser drilling process to form uniformly distributed through holes 3 in the medical gasket body structure, then apply the degradable biomaterial solution on the inner walls of the through holes 3 to form a degradable biomaterial coating 4 on the inner walls of the through holes 3, and finally dry it to obtain a non - fiber - shedding medical gasket.

[0038] In the above embodiments, preferably, the PTFE short fibers can be strengthened by needling or hydroentangling process.

[0039] In the above embodiments, preferably, in step S2, the organic acid is preferably formic acid or acetic acid.

[0040] In the above embodiments, preferably, in step S2, the degradable biomaterial is selected from collagen, gelatin, silk fibroin, hyaluronic acid, chitosan or porcine small intestinal submucosa extract.

[0041] In the above embodiments, preferably, in step S3, the spinning voltage of the electrospinning device is set to 10 - 25 kV, and the feeding rate is 1 - 3 mL·h -1, The receiving distance is 10 - 25 cm.

[0042] Example 2:

[0043] A preparation method of a medical gasket that does not shed fibers is obtained through the following preparation steps:

[0044] S1. The PTFE felt sheet 2 with a three-dimensional structure having a multi-microporous structure formed by successively subjecting polytetrafluoroethylene short fibers to opening, carding, web-forming non-woven process treatment, and strengthening treatment;

[0045] S2. Dissolve chitosan in a 90% acetic acid solution, stir at room temperature until completely dissolved, to obtain a degradable chitosan solution with a concentration of 5%;

[0046] S3. Load the chitosan solution into a 10 ml syringe and fix it on an electrospinning device. Set the spinning voltage of the electrospinning device to 10 kV and the feeding rate to 1 mL·h -1 , The receiving distance is 10 cm. Shape the chitosan solution into an electrospun film layer 1, dry the electrospun film layer 1 in an oven at 37 °C, and then laminate the dried electrospun film layer 1 on the upper and lower surfaces of the PTFE felt sheet 2 to obtain a medical gasket body;

[0047] S4. Use a laser drilling process to form uniformly distributed through-holes 3 with a pore diameter of 400 microns on the medical gasket body structure. Then apply the chitosan solution on the inner wall of the through-holes 3 to form a chitosan coating with a thickness of 100 mm on the inner wall of the through-holes 3. Finally, dry the medical gasket in an oven at 35 °C to obtain a medical gasket that does not shed fibers.

[0048] Example 3:

[0049] A preparation method of a medical gasket that does not shed fibers is obtained through the following preparation steps:

[0050] S1. The PTFE felt sheet 2 with a three-dimensional structure having a multi-microporous structure formed by successively subjecting polytetrafluoroethylene short fibers to opening, carding, web-forming non-woven process treatment, and strengthening treatment;

[0051] S2. Dissolve silk fibroin powder in a 90% acetic acid solution, stir at room temperature until completely dissolved, to obtain a degradable silk fibroin solution with a concentration of 10%;

[0052] S3. Load the silk fibroin solution into a 10 ml syringe and fix it on an electrospinning device. Set the spinning voltage of the electrospinning device to 25 kV and the feeding rate to 3 mL·h -1, The receiving distance is 25 cm. The silk fibroin solution is formed into an electrospun film layer 1, and the electrospun film layer 1 is dried in an oven at 37 °C. Then, the dried electrospun film layer 1 is laminated on the upper and lower surfaces of the PTFE felt sheet 2 to obtain a medical gasket body;

[0053] S4. A laser drilling process is used to form uniformly distributed through holes 3 with a pore diameter of 550 microns in the medical gasket body structure. Subsequently, the inner wall of the through hole 3 is coated with the silk fibroin solution, so that the silk fibroin solution forms a silk fibroin coating with a thickness of 350 millimeters on the inner wall of the through hole 3. Finally, the medical gasket is dried in an oven at 35 °C to obtain a medical gasket that does not shed fibers.

[0054] The above embodiments only represent the specific implementation manners of the present invention. The description is relatively specific and detailed, but it should not be construed as a limitation on the scope of the present invention patent. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can still be made, and these all belong to the protection scope of the present invention.

Claims

1. A medical gasket that does not shed fibers, characterized in that, The medical gasket includes an intermediate layer and electrospun thin film layers disposed on the upper and lower surfaces of the intermediate layer. The intermediate layer is a PTFE felt sheet with a three-dimensional structure having a multi-porous structure, which is formed by subjecting polytetrafluoroethylene short fibers to carding, combing, web laying non-woven process treatment and reinforcement treatment in sequence. The electrospun thin film layer is a nanofiber layer with a porous structure formed by spraying and spinning a biodegradable biomaterial solution using the electrospinning process. Through holes formed by laser drilling are uniformly provided on the medical gasket, and a biodegradable biomaterial coating covers the inner wall surface of the through holes. The through holes are formed by the principle of melting materials at high temperature during the laser drilling process.

2. The medical gasket without fiber shedding according to claim 1, wherein The thickness of the intermediate layer is 400 - 2000 microns, and the thickness of the electrospun thin film layer is 100 - 200 microns.

3. The medical gasket without fiber shedding according to claim 1, wherein The aperture of the through holes is 150 - 550 microns, and the volume ratio of the through holes in the medical gasket is 10% - 30%.

4. The medical gasket without fiber shedding according to claim 1, characterized in that, The thickness of the biodegradable biomaterial coating is 100 - 350 microns.

5. A preparation method of a medical gasket without fiber shedding according to claim 1, characterized in that, The preparation method includes the following preparation steps: S1. Form a PTFE felt sheet with a three-dimensional structure having a multi-porous structure by subjecting polytetrafluoroethylene short fibers to carding, combing, web laying non-woven process treatment and reinforcement treatment in sequence; S2. Dissolve the biodegradable biomaterial in an organic acid solution, stir at room temperature until completely dissolved to obtain a biodegradable biomaterial solution with a concentration of 5% - 10%; S3. Use an electrospinning device to form the obtained biodegradable biomaterial solution into an electrospun thin film layer, then dry it using an oven, and laminate the dried electrospun thin film layer on the upper and lower surfaces of the PTFE felt sheet to obtain the main body of the medical gasket; S4. Adopt a laser drilling process to form uniformly distributed through holes in the main structure of the medical gasket, then apply the biodegradable biomaterial solution on the inner walls of the through holes to form a biodegradable biomaterial coating on the inner walls of the through holes, and finally dry it to obtain a medical gasket that does not shed fibers.

6. The preparation method of a medical gasket without fiber shedding according to claim 5, characterized in that, In step S1, the polytetrafluoroethylene short fibers are subjected to reinforcement treatment by needling or hydroentangling.

7. The preparation method of a medical gasket without fiber shedding according to claim 5, characterized in that, In step S2, the organic acid is formic acid or acetic acid.

8. The preparation method of a medical gasket without fiber shedding according to claim 5, characterized in that, In step S2, the biodegradable biomaterial is selected from collagen, gelatin, silk fibroin, hyaluronic acid, chitosan or porcine small intestinal submucosa extract.

9. The preparation method of a medical gasket without fiber shedding according to claim 5, characterized in that, In step S3, the spinning voltage of the electrospinning device is set to 10 - 25 kV, the advancing rate is 1 - 3 mL·h -1 , and the receiving distance is 10 - 25 cm.

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