阅读说明：本技术 显微血管减压术用减压材料及其制备方法与应用 (Decompression material for microvascular decompression and preparation method and application thereof ) 是由 陈刚 郭晓霖 栗国贝 孙冰冰 于 2020-05-27 设计创作，主要内容包括：本申请公开了一种显微血管减压术用减压材料及其制备方法与应用。所述减压材料包括涤纶丝和附着于所述涤纶丝表面的胶原蛋白,所述涤纶丝与所述胶原蛋白的质量比为1000:(1-100)。本发明提供的减压材料在涤纶丝表面上复合胶原蛋白,结合了涤纶可永久隔离的优点和胶原蛋白生物相容性好、防粘连的优势,且蓬松的结构避免了像垫片一样对神经或血管造成再次压迫。本发明提供的减压材料在提高微血管减压手术治愈率、降低手术风险方面具有重要意义。(The application discloses a decompression material for microvascular decompression, a preparation method and application thereof. The decompression material comprises polyester yarns and collagen attached to the surfaces of the polyester yarns, and the mass ratio of the polyester yarns to the collagen is 1000 (1-100). The pressure reducing material provided by the invention is compounded with collagen on the surface of the polyester yarn, combines the advantage that polyester can be permanently isolated and the advantages that the biocompatibility of the collagen is good and the collagen is anti-adhesion, and the fluffy structure avoids the repeated compression on nerves or blood vessels like a gasket. The decompression material provided by the invention has important significance in improving the cure rate of microvascular decompression surgery and reducing the risk of surgery.)

1. A decompression material for microvascular decompression surgery, characterized in that: the decompression material comprises polyester yarns and collagen attached to the surfaces of the polyester yarns, and the mass ratio of the polyester yarns to the collagen is 1000 (1-100).

2. The decompression material according to claim 1, wherein: the mass ratio of the polyester silk to the collagen is 1000 (5-80), preferably 1000 (10-70), more preferably 1000 (15-65), more preferably 1000 (30-60), more preferably 1000 (40-55), more preferably 1000: 45.

3. The decompression material according to claim 1 or 2, wherein: the collagen is any one or mixture of any one of type I collagen, type II collagen, type III collagen, type XI collagen, type XXX collagen and type XXX collagen, preferably, any one or mixture of any one of type I collagen, type II collagen and type III collagen, and more preferably, type I collagen;

and/or the collagen is derived from any one or a mixture of bovine achilles tendon, porcine achilles tendon, cow leather, pig skin, fish skin and fish scale, preferably bovine achilles tendon.

4. The decompression material according to any one of claims 1 to 3, wherein: the crimping rate of the decompression material is 25-40%, preferably, 30-35%;

preferably, the decompression material has a recovery elasticity of 25 to 65%, more preferably, 35 to 60%, more preferably, 50 to 60%;

preferably, the bulk of the pressure reducing material is 15-25cm³In g, more preferably, 18 to 22cm³In g, more preferably, 20 to 21cm³/g；

Preferably, the single fineness of the polyester yarns in the pressure reducing material is 100-200D, more preferably 140-160D, and more preferably, each polyester yarn is composed of 30-60 monofilament fibers, more preferably 45-50 monofilament fibers.

5. A method for producing a decompression material according to any one of claims 1 to 4, characterized by: the preparation method comprises the following steps:

s1, dissolving the collagen in a solvent to obtain a solution of the collagen;

s2, mixing the polyester yarns with the collagen solution obtained in the step S1 to obtain a mixture;

s3, removing the solvent in the mixture in the step S2, and enabling the collagen to be attached to the surface of the polyester yarn to obtain the decompression material.

6. The method of claim 5, wherein: the concentration of the collagen solution is 0.1-10mg/mL, preferably, 0.5-8mg/mL, more preferably, 1-7mg/mL, more preferably, 1.5-6.5mg/mL, more preferably, 3.0-6.0mg/mL, more preferably, 4.0-5.5mg/mL, more preferably, 4.5 mg/mL;

the solvent is acetic acid solution, hydrochloric acid solution, sulfuric acid solution or nitric acid solution, preferably, acetic acid solution;

the concentration of the solvent is 0.001-1M, preferably, 0.01-0.1M, more preferably, 0.03-0.07M;

preferably, the mixing ratio of the polyester silk and the collagen solution is (0.5-1.5) g:10mL, more preferably, (0.8-1.2) g:10 mL.

7. The production method according to claim 5 or 6, characterized in that: in step S3, the solvent is removed by low-temperature drying, preferably vacuum freeze drying.

8. The production method according to any one of claims 5 to 7, characterized in that: before mixing the polyester yarn with the collagen solution in the step S1 in the step S2, the polyester yarn is further treated as follows: firstly, curling treatment and then heat setting treatment are carried out,

preferably, the temperature of the heat setting treatment is 170-195 ℃ for 5-15min, more preferably, the temperature of the heat setting treatment is 180-190 ℃ for 8-12min, and more preferably, the temperature of the heat setting treatment is 185 ℃ for 10 min.

9. The production method according to any one of claims 5 to 8, characterized in that: before the heat setting treatment, the method further comprises a step of cleaning the polyester yarns, preferably, the cleaning is ultrasonic cleaning, more preferably, the ultrasonic cleaning time is 10-90min, more preferably, 40-80min, more preferably, 60 min.

10. Use of the decompression material according to any one of claims 1 to 4 or the decompression material produced by the method according to any one of claims 5 to 9 for the production of a medical product, preferably a microvascular decompression surgical product, more preferably a decompression pledget.

Technical Field

The invention relates to the field of medical instruments, in particular to a decompression material for microvascular decompression and a preparation method and application thereof.

Background

The cranial nerve diseases such as trigeminal neuralgia, facial spasm, glossopharyngeal neuralgia and the like bring great pain to patients, and even lose normal living and working abilities when the disease is serious. The theory of microangiocompression is that the vascular compression causes reversible demyelination of cranial nerve roots, which in turn causes short circuit between neurons, and finally causes the onset of the above-mentioned diseases. The first surgical procedure to treat this disease is microvascular decompression.

The key of the microvascular decompression surgery (MVD) is that the responsible blood vessel pressing the cranial nerve root part is dissociated in the surgery, and decompression pad cotton with proper shape and size is arranged between the responsible blood vessel and the nerve root after the responsible blood vessel is pushed away from the nerve root part, so that the responsible blood vessel is prevented from being reset. The specific operation method comprises the following steps: firstly, performing anesthesia, and perforating the back of the lateral ear of a patient, wherein the diameter of the opening is about 2-2.5 cm; then, with the help of a microscope, searching for a compressed nerve, and separating a responsible vessel or other vessels which cause the compression; finally, a suitable pressure reducing pad is placed between the culprit vessel and the compressed nerve, thereby relieving pain. Although a great deal of clinical practice has proved that most patients have pain immediately after operation, normal facial sensation and function are kept, the quality of life is not affected, and the microvascular decompression can effectively treat the dysphoric syndrome, the literature reports that some patients still have symptoms which cannot be relieved after the microvascular decompression. In order to improve the cure rate and reduce the surgical risk, the operator must strictly control the indications and improve the surgical skill. In addition to this, the selection of the padding is also important.

Currently, alternative pressure reducing pad materials include autologous muscle mass, gelatin sponge, collagen sponge, dacron sheet, Teflon cotton, and the like. The muscle mass, the gelatin sponge and the collagen sponge have good biocompatibility, but are easy to absorb, thereby causing postoperative recurrence. The terylene sheet has high strength and may damage nerves or blood vessels.

Disclosure of Invention

Aiming at the defects in the prior art, the invention aims to provide a pressure reducing material for microvascular decompression and a preparation method and application thereof.

In order to achieve the above purposes, the technical scheme adopted by the invention is as follows:

in one aspect, the invention provides a pressure reducing material for a microvascular decompression surgery, the pressure reducing material comprises polyester yarns and collagen attached to the surfaces of the polyester yarns, and the mass ratio of the polyester yarns to the collagen is 1000 (1-100).

In the decompression material, the mass ratio of the polyester yarns to the collagen is 1000 (5-80), preferably 1000 (10-70), more preferably 1000 (15-60), more preferably 1000 (30-55), more preferably 1000 (40-50), more preferably 1000: 45.

In the pressure reducing material, the collagen is any one or a mixture of any more of type I collagen, type II collagen, type III collagen, type XI collagen, type XXX collagen and type XXX collagen, preferably, any one or a mixture of any more of type I collagen, type II collagen and type III collagen, and more preferably, type I collagen;

and/or the collagen is derived from any one or a mixture of bovine achilles tendon, porcine achilles tendon, cow leather, pig skin, fish skin and fish scale, preferably bovine achilles tendon.

In the above-mentioned pressure-reducing material, the crimping rate of the pressure-reducing material is 25 to 40%, preferably 30 to 35%;

preferably, the decompression material has a recovery elasticity of 25 to 65%, more preferably, 35 to 60%, more preferably, 50 to 60%,

preferably, the bulk of the pressure reducing material is 15-25cm³In g, more preferably, 18 to 22cm³In g, more preferably, 20 to 21cm³/g；

Preferably, the hand feeling of the pressure reducing material is not irritating during kneading;

preferably, the single fineness of the polyester yarns in the pressure reducing material is 100-200D, more preferably 140-160D, and more preferably, each polyester yarn is composed of 30-60 monofilament fibers, more preferably 45-50 monofilament fibers.

In another aspect, the present invention provides a method for preparing the decompression material, including the steps of:

s1, dissolving the collagen in a solvent to obtain a solution of the collagen;

s2, mixing the polyester yarns with the collagen solution obtained in the step S1 to obtain a mixture;

s3, removing the solvent in the mixture in the step S2, and enabling the collagen to be attached to the surface of the polyester yarn to obtain the decompression material.

In the above production method, the concentration of the collagen solution is 0.1 to 10mg/mL, preferably, 0.5 to 8mg/mL, more preferably, 1 to 7mg/mL, more preferably, 1.5 to 6.5mg/mL, more preferably, 3.0 to 6.0mg/mL, more preferably, 4.0 to 5.5mg/mL, more preferably, 4.5 mg/mL;

the solvent is acetic acid solution, hydrochloric acid solution, sulfuric acid solution or nitric acid solution, preferably, acetic acid solution;

the concentration of the solvent is 0.001-1M, preferably, 0.01-0.1M, more preferably, 0.03-0.07M, more preferably, 0.05M;

preferably, the mixing ratio of the polyester silk and the collagen solution is (0.5-1.5) g:10mL, more preferably, (0.8-1.2) g:10 mL.

In the above preparation method, in step S3, the solvent is removed by low-temperature drying, preferably, vacuum freeze drying; more preferably, the vacuum freeze-drying comprises the following steps:

freezing stage, temperature: -36 ℃, time: 40 minutes;

evacuation drying stage, temperature: -18 ℃, time: 100 minutes, vacuum degree: 0.2 bar;

first drying stage, temperature: -8 ℃, time: 660 minutes, vacuum degree: 0.2 bar;

second drying stage, temperature: 0 ℃, time: 420 minutes, vacuum degree: 0.2 bar;

third drying stage, temperature: 10 ℃, time: 180 minutes, vacuum degree: 0.2 bar;

fourth drying stage, temperature: 24 ℃, time: 110 minutes, vacuum degree: 0.2 bar.

In the above preparation method, before the polyester yarn is mixed with the collagen solution in step S1 in step S2, the polyester yarn is further treated as follows: firstly, curling treatment and then heat setting treatment are carried out,

preferably, the temperature of the heat setting treatment is 170-195 ℃ for 5-15min, more preferably, the temperature of the heat setting treatment is 180-190 ℃ for 8-12min, and more preferably, the temperature of the heat setting treatment is 185 ℃ for 10 min.

A preferred embodiment of the curling process is: and weaving 20 polyester multifilaments of 150D/48f into a group in a mode of three-strand twisted braid, wherein the fineness, the length and the weaving mode of the polyester yarns and the polyester multifilaments can be selected according to actual needs and production processes.

In the above preparation method, before the heat setting treatment, a step of cleaning the polyester yarn is further included, preferably, the cleaning is ultrasonic cleaning, and more preferably, the ultrasonic cleaning time is 10 to 90min, more preferably, 40 to 80min, and more preferably, 60 min.

In another aspect, the present invention protects the application of any one of the decompression materials described above or the decompression material prepared by any one of the methods described above in the preparation of a medical product, preferably, the medical product is a product for microvascular decompression surgery, and more preferably, the product for microvascular decompression surgery is a decompression cotton pad.

The invention has the following beneficial effects:

the pressure reducing material provided by the invention is compounded with collagen on the surface of the polyester yarn, combines the advantage that polyester can be permanently isolated and the advantages that the biocompatibility of the collagen is good and the collagen is anti-adhesion, and the fluffy structure avoids the repeated compression on nerves or blood vessels like a gasket. The decompression material provided by the invention has important significance in improving the cure rate of microvascular decompression surgery and reducing the risk of surgery.

Drawings

The accompanying drawings, which are included to provide a further understanding of the application and are incorporated in and constitute a part of this application, illustrate embodiment(s) of the application and together with the description serve to explain the application and not to limit the application. In the drawings:

FIG. 1 is a drawing showing a group of 20 150D/48f polyester multifilament yarns braided in a three-strand twist braid manner.

FIG. 2 is a view showing a state of a pressure reducing material.

FIG. 3 is a scanning electron micrograph of the decompression material. Wherein the scale unit is 200 μm.

FIG. 4 is a scanning electron micrograph of the decompression material. Wherein the scale unit is 20 μm.

FIG. 5 is a scanning electron micrograph of the decompression material. Wherein the scale unit is 10 μm.

FIG. 6 is a diagram illustrating a recovery elasticity test of the pressure reducing material.

Detailed Description

The experimental procedures used in the following examples are all conventional procedures unless otherwise specified.

Materials, reagents and the like used in the following examples are commercially available unless otherwise specified.