CN111569161B - Decompression material for microvascular decompression and preparation method and application thereof - Google Patents
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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Abstract
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 the microvascular decompression surgery and reducing the surgery risk.
Description
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 microscopic vascular compression is that vascular compression causes reversible demyelination of cranial nerve roots, which causes short circuit among neurons, and finally causes the attack of the 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 vessels pressing the cranial nerve root part are dissociated in the surgery, and decompression pad cotton with proper shape and size is arranged between the responsible blood vessels and the nerve root after the responsible blood vessels are pushed away from the nerve root part, so that the responsible blood vessels are 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 decompression material for microvascular decompression, 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).
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 XXIV collagen and type XXVII 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 15-25 cm3In g, more preferably, 18 to 22 cm3In g, more preferably, 20 to 21 cm3/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 10 mg/mL, preferably, 0.5 to 8 mg/mL, more preferably, 1 to 7 mg/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 decompression cotton wadding.
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 the microvascular decompression surgery and reducing the surgery risk.
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.
Example 1 preparation of decompression Material for microvascular decompression
Firstly, preparing the curled polyester padding cotton:
(1) curling treatment: 20 polyester multifilaments (each having a fineness of 150D and consisting of 48 monofilament fibers) of 150D/48f are braided in a braid-three-strand twist braid manner (fig. 1).
(2) Cleaning: and (3) immersing the braided fabric in the step (1) into an ultrasonic cleaning solution for ultrasonic cleaning for 60 min.
(3) Heat setting: the braid was removed from the ultrasonic cleaning solution and heat set at 185 ℃ for 10 min.
(4) The knitted fabric was released to obtain a crimped polyester wadding having a crimp rate shown in table 1.
II, compounding collagen:
(1) 4 kinds of collagen solutions with different concentrations are prepared, the solute is type I collagen extracted from bovine achilles tendon, the solvent is 0.05M (mol/L) acetic acid solution, and the concentrations of the collagen are 0, 1.5mg/mL, 3.0mg/mL, 4.5mg/mL and 6.0mg/mL respectively.
(2) Mixing the polyester padding cotton curled in the step one with any one of the collagen solutions according to the weight ratio of 0.5 g: 5mL of the mixture was mixed.
(3) And respectively carrying out vacuum freeze drying on the mixed mixture, removing the solvent, and attaching collagen to the surface of the polyester yarn to obtain four types of decompression materials, wherein the state of the decompression material prepared by the collagen concentration of 4.5mg/mL is shown in figure 2, and the collagen attached to the surface of the polyester multifilament can be observed as shown in the scanning electron microscope results (figures 3-5).
The procedure for the vacuum freeze-drying was as follows:
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.
Example 2 Performance testing of the pressure-relief Material for microvascular decompression
First, crimping rate
Three polyester-collagen multifilaments were respectively drawn from the four kinds of reduced-pressure materials prepared in example 1, the length in a curled state was measured, and the crimp rate was calculated:wherein L is1Is the initial length (all equally long, 10 cm), L0The length in the rolled state (unit: cm). The results are shown in Table 1.
TABLE 1 Effect of different collagen concentrations on the crimping rate of decompression Material
The results in table 1 show that the larger the concentration of collagen, the larger the crimping rate, and in addition, the collagen is attached to the polyester yarn, and the material is shrunk due to the volatilization of the solvent in the freeze-drying process, so that the composite material is more crimped, and the crimping rate is increased.
Second, restoring elasticity
0.5g of each of the four reduced-pressure materials prepared in example 1 was put in a 20mL syringe (Kangleda disposable) as shown in FIG. 6Sterile syringe), seal the syringe down and cut the pusher off a little to vent, record the initial height of the material on the scale L1, press the pusher down to 2.5mL on the scale for 30s, release the pusher, record the plunger's rebound scale L2, calculate the resilience:the results are shown in Table 2.
TABLE 2 Effect of different collagen concentrations on the recovery elasticity of pressure relief Material
The results in Table 2 show that the decompression material prepared with the collagen concentration of 4.5mg/mL has the highest recovery elasticity, because the collagen forms a silk-screen structure between the polyester monofilaments, the resilience of the material is increased, but when the collagen concentration is too high, the collagen is seriously adhered to each other, large pieces of collagen are aggregated, and the resilience of the composite material is limited.
Third, fluffy degree
0.5g of each of the four reduced-pressure materials prepared in example 1 was placed in the same 20mL syringe as in step two, a 100mg weight was placed on the top of the pusher, and the height h (in cm) of the sample under this force was recorded. Bulk is defined as the volume of a single mass pad under light pressure, i.e., bulk = V/m = Ah/m, where: a is the cross-sectional area of the syringe (unit cm)2) And m is the mass of the padding cotton. The results are shown in Table 3.
TABLE 3 Effect of different collagen concentrations on loft of pressure reducing Material
The results in Table 3 show that the greater the collagen concentration, the greater the bulk, which is maximal at 4.5-6 mg/mL.
Fourth, flexibility
From each of the four types of pressure-reducing materials prepared in example 1, 5 were randomly sampled as samples 1, 2, 3, 4, and 5, and the hand feeling was compared and classified into 3 grades: 1. soft, no irritation when being kneaded; 2. is soft and slightly stimulates when being kneaded; 3. harder and irritate the skin. The results are shown in Table 4.
TABLE 4 influence of different collagen concentrations on the softness of the decompression Material
The results in Table 4 show that the pure polyester fiber has soft hand feeling, the change is small with the addition of collagen, the softness of 4.5mg/mL is optimal, and when the concentration reaches 6mg/mL, the hand feeling is affected due to serious adhesion caused by large aggregation among collagens.
The comprehensive comparison of the results shows that the prepared decompression material with the collagen concentration of 4.5mg/mL has better performance, and does not generate new compression on cranial nerves during decompression.
Those not described in detail in this specification are within the skill of the art. The above description is only an example of the present application and is not intended to limit the present application. Various modifications and changes may occur to those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application should be included in the scope of the claims of the present application.
Claims (34)
1. A decompression material for microvascular decompression is 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);
the crimp rate of the pressure reducing material is 25-40%, the recovery elasticity of the pressure reducing material is 25-65%, and the bulk density of the pressure reducing material is 15-25 cm3/g;
The preparation method of the decompression material 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 to enable the collagen to be attached to the surface of the polyester yarn, and obtaining the decompression material, wherein the solvent is removed by vacuum freeze drying, and 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.
2. The decompression material according to claim 1, wherein: the mass ratio of the polyester yarns to the collagen is 1000 (5-80).
3. The decompression material according to claim 2, wherein: the mass ratio of the polyester yarns to the collagen is 1000 (10-70).
4. The decompression material according to claim 3, wherein: the mass ratio of the polyester yarns to the collagen is 1000 (15-65).
5. The decompression material of claim 4, wherein: the mass ratio of the polyester yarns to the collagen is 1000 (30-60).
6. The decompression material of claim 5, wherein: the mass ratio of the polyester yarns to the collagen is 1000 (40-55).
7. The decompression material of claim 6, wherein: the mass ratio of the polyester yarns to the collagen is 1000: 45.
8. The reduced-pressure material according to any one of claims 1 to 7, characterized in that: the collagen is any one or mixture of any more of type I collagen, type II collagen, type III collagen, type XI collagen, type XXIV collagen and type XXVII 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.
9. The reduced-pressure material according to claim 8, characterized in that: the collagen is any one or mixture of more of type I collagen, type II collagen and type III collagen,
the collagen is derived from bovine achilles tendon.
10. The reduced-pressure material according to claim 9, characterized in that: the collagen is type I collagen.
11. The decompression material according to claim 1, wherein: the crimping rate of the decompression material is 30-35%;
the recovery elasticity of the pressure reducing material is 35-60%;
the bulk of the pressure reducing material is 18-22 cm3/g;
The single fineness of the polyester yarns in the pressure reducing material is 100-200D, and each polyester yarn is composed of 30-60 monofilament fibers.
12. The reduced-pressure material according to claim 11, characterized in that: the recovery elasticity of the pressure reducing material is 50-60%;
the bulk of the pressure reducing material is 20-21 cm3/g;
The single fineness of the polyester yarns in the pressure reducing material is 140-160D, and each polyester yarn is composed of 45-50 monofilament fibers.
13. A method for producing a decompression material according to any one of claims 1 to 12, 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.
14. The method of manufacturing according to claim 13, wherein: the concentration of the collagen solution is 0.1-10 mg/mL;
the solvent is acetic acid solution, hydrochloric acid solution, sulfuric acid solution or nitric acid solution;
the concentration of the solvent is 0.001-1M;
the mixing ratio of the polyester yarns to the collagen solution is (0.5-1.5) g:10 mL.
15. The method of claim 14, wherein: the concentration of the collagen solution is 0.5-8 mg/mL;
the solvent is acetic acid solution;
the concentration of the solvent is 0.01-0.1M;
the mixing ratio of the polyester yarns to the collagen solution is (0.8-1.2) g:10 mL.
16. The method of claim 15, wherein: the concentration of the collagen solution is 1-7 mg/mL;
the concentration of the solvent is 0.03-0.07M.
17. The method of manufacturing according to claim 16, wherein: the concentration of the collagen solution is 1.5-6.5 mg/mL.
18. The method of claim 17, wherein: the concentration of the collagen solution is 3.0-6.0 mg/mL.
19. The method of claim 18, wherein: the concentration of the collagen solution is 4.0-5.5 mg/mL.
20. The method of claim 19, wherein: the concentration of the collagen solution is 4.5 mg/mL.
21. The production method according to any one of claims 13 to 20, characterized in that: in step S3, the solvent is removed by low-temperature drying.
22. The method of manufacturing according to claim 21, wherein: in step S3, the solvent is removed by vacuum freeze drying.
23. The production method according to any one of claims 13 to 20, 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.
24. The method of claim 23, wherein: the temperature of the heat setting treatment is 170-195 ℃, and the time is 5-15 min.
25. The method of claim 24, wherein: the temperature of the heat setting treatment is 180-190 ℃, and the time is 8-12 min.
26. The method of claim 25, wherein: the temperature of the heat setting treatment is 185 ℃, and the time is 10 min.
27. The method of claim 23, wherein: before the heat setting treatment, the method also comprises the step of cleaning the polyester yarns.
28. The method of manufacturing according to claim 27, wherein: the cleaning is ultrasonic cleaning.
29. The method of claim 28, wherein: the ultrasonic cleaning time is 10-90 min.
30. The method of claim 29, wherein: the ultrasonic cleaning time is 40-80 min.
31. The method of claim 30, wherein: the ultrasonic cleaning time is 60 min.
32. Use of a pressure relief material according to any of claims 1 to 12 or prepared according to any of claims 13 to 31 for the preparation of a medical product.
33. The use of claim 32, wherein the medical product is a microvascular decompression surgical product.
34. The use of claim 33, wherein the microvascular decompression surgical product is a decompression pledget.
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