CN117244106A - Completely absorbable anti-adhesion hernia repair patch - Google Patents
Completely absorbable anti-adhesion hernia repair patch Download PDFInfo
- Publication number
- CN117244106A CN117244106A CN202311355036.7A CN202311355036A CN117244106A CN 117244106 A CN117244106 A CN 117244106A CN 202311355036 A CN202311355036 A CN 202311355036A CN 117244106 A CN117244106 A CN 117244106A
- Authority
- CN
- China
- Prior art keywords
- absorbable
- growth factor
- hernia repair
- metal mesh
- repair patch
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
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Classifications
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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Abstract
The invention provides a completely absorbable anti-adhesion hernia repair patch, which comprises an absorbable metal mesh loaded with a growth factor coating and an absorbable polymer anti-adhesion membrane, wherein the absorbable polymer anti-adhesion membrane carries medicine; the absorbable metal mesh in the hernia repair patch provided by the invention is used as a structural support layer, strong support is provided at the initial stage of implantation, and in addition, the absorbable metal mesh is coated with growth factors, so that cell growth can be promoted, the defect tissue repair speed is improved, the coating can also effectively protect metal from corrosion degradation at the initial stage of implantation, the degradation speed is reduced, the function of structural support is prolonged, and after the repair is finished, the metal mesh is gradually degraded and is absorbed by a body to be excreted, so that the hernia repair patch has good mechanical properties and good application prospects.
Description
Technical Field
The invention relates to the technical field of medical materials, in particular to a completely absorbable anti-adhesion hernia repair patch.
Background
Hernias are the departure of tissues or organs from the original location in a certain part of the human body, the passage of weak spots, defects or pores formed by the birth or the later, into another part, and the dysfunction of some viscera. The most common site of hernias is the abdomen, with mainly intra-and extra-abdominal hernias, which are more common. Hernia may occur in different age groups, and the elderly are highly ill people and cannot repair themselves once suffering from hernia. As hernia causes various diseases, such as abdominal pain and abdominal distention, and gradually causes nausea and vomiting, the quality of life is seriously affected, and the hernia forms a serious threat to the health and life of people.
Surgical treatment is the most effective way to treat hernias, and mainly includes traditional suture repair and tension-free hernia repair patches. The hernia repair patch is a medical instrument in hernia operation and helps patients recover after hernia operation. Although the traditional suture has no implant material, the traditional suture has the defects of easy recurrence, long operation time, postoperative pain and the like. Although the tension-free repair avoids the defects of easy recurrence, postoperative pain and the like of the traditional operation type operation, the new problem is brought, the hernia repair patch material is non-absorbable, inflammation can be caused in the initial stage of implantation, adhesion between the patch material and viscera can be seriously caused, in addition, the material is non-absorbable, long-term adverse effects can be caused on a human body, if the infection is serious, secondary operation is needed, pain of a patient is increased, and the hospitalization time is prolonged. A reported degradable hernia repair patch, however, has not yet repaired the tissue at the defect completely and the patch has been completely degraded.
CN114246980a discloses a partially absorbable hernia repair patch and a method for preparing the same, comprising the steps of: s1, adding a water-soluble polymer solution, a boric acid solution and a polylactic acid-glycolic acid copolymer into an emulsion of polytetrafluoroethylene, and mixing to obtain a part of absorbable component solution; s2, adding non-absorbable materials into part of the absorbable component solution in the step S1, and stirring to obtain spinning solution; s3, carrying out electrostatic spinning treatment on the spinning solution obtained in the step S2 to obtain a composite fiber membrane base membrane; s4, soaking the fiber membrane base membrane in the step S3 in purified water, ultrasonically cleaning, washing and drying at normal pressure to obtain a composite nanofiber membrane; and S5, heating the composite nanofiber membrane in the step S4 to 250 ℃ at a heating rate of 10 ℃/min, and performing heat treatment for 10-30 min to obtain the partially absorbable hernia repair patch. Although this method has some supporting strength at the beginning of implantation, over time, the hernia gap has not healed to form scar tissue, and the absorbable polymer has degraded and cannot withstand the pressure from the abdominal cavity or other organs, resulting in hernia recurrence or other serious complications. In addition, the non-absorbable material of polytetrafluoroethylene has a microporous structure, fibroblasts and macrophages cannot enter the pores, the repairing capability and the anti-infection capability are poor, and once the patients are infected, great pain is brought to the patients.
CN114191607a discloses an anti-adhesion absorbable hernia repair patch and a preparation method thereof, the patch comprises a patch body (1), the patch body (1) is a porous net structure woven by polypropylene filaments, an anti-adhesion absorbable membrane (2) is arranged on the patch body (1), the anti-adhesion absorbable membrane (2) is prepared from a mixed solution of an L-lactide/caprolactone copolymer and a polyethylene glycol copolymer, the solvent is methylene dichloride, and the molar ratio of the L-lactide/caprolactone copolymer to the polyethylene glycol copolymer in the mixed solution is 4:6-10:1. The method adopts polypropylene as a body material, is a non-absorbable material, causes complications for a plurality of patients after implantation, such as chronic inflammation and infection, and under the condition of infection, the repair patch is removed by secondary operation for controlling the infection, thereby bringing great pain to the patients and prolonging the hospitalization time. In addition, although the patch manufactured by the invention comprises the anti-adhesion film, the anti-bacterial and anti-inflammatory capabilities of the patch are insufficient, and the anti-adhesion effect gradually decreases with the passage of time, so that the adhesion between the viscera and the patch is finally caused.
Therefore, to overcome the above drawbacks, there is a need to develop a new hernia repair patch to enhance and exert better performance.
Disclosure of Invention
The invention aims to solve the technical problems that the existing hernia repair patch has low supporting strength, poor degradation effect in a body and poor anti-adhesion effect in the body.
In order to solve the technical problems, the invention provides a completely absorbable anti-adhesion hernia repair patch, which is characterized by comprising an absorbable metal mesh loaded with a growth factor coating and an absorbable polymer anti-adhesion membrane, wherein the absorbable polymer anti-adhesion membrane carries medicine.
The absorbable metal mesh in the hernia repair patch provided by the invention is used as a structural support layer, strong support is provided at the initial stage of implantation, in addition, the absorbable metal mesh is coated with growth factors, so that cell growth can be promoted, the repair speed of defective tissues is improved, the coating can also effectively protect metal from corrosion and degradation at the initial stage of implantation, the degradation speed of the metal mesh is reduced, the function of structural support is prolonged, and after the repair is finished, the metal mesh is gradually degraded and is absorbed by a body to be excreted.
The drug-loaded absorbable polymer anti-adhesion layer can provide an effect of enhancing support at the initial stage of implantation, and the drug-loaded polymer film can control the release of the drug, inhibit the proliferation of an inner film and prevent the hernia repair patch from adhering to an organ for a long time. When the repair of the defective tissue is completed, the anti-adhesion layer is also absorbed by the body or excreted outside the body.
Compared with the prior method and technology, the method mainly has the following 4 different points:
(1) the invention introduces the growth factors on the structural support layer of the absorbable metal net for the first time; (2) the growth factor-soybean phosphatidylcholine compound is encapsulated in the absorbable polymer, so that the release speed of the growth factor is controlled, the activity and concentration of the growth factor can be ensured, and the repair speed of defective tissues is accelerated; (3) the coating solution is simple to prepare and easy to operate; (4) the anti-hyperplasia medicine and the antibacterial anti-inflammatory medicine are introduced on the anti-adhesion layer, so that the antibacterial anti-adhesion effect of the implanted hernia repair patch in the whole life cycle is further ensured.
Preferably, the preparation method of the absorbable metal mesh loaded with the growth factor coating comprises the following steps:
a1: mixing the growth factor solution with the soybean phosphatidylcholine solution, and freeze-drying to obtain a growth factor-soybean phosphatidylcholine compound;
a2: dissolving the growth factor-soybean phosphatidylcholine compound in the step A1 and an absorbable polymer, maleamide-polyethylene glycol-absorbable polymer copolymer in a solvent, and mixing to obtain a growth factor-polymer compound coating solution;
a3: and (3) soaking the absorbable metal mesh in the growth factor-polymer compound coating solution in the step (A2), and drying to obtain the absorbable metal mesh loaded with the growth factor coating.
Preferably, the growth factor in the growth factor solution comprises any one or a combination of at least two of an epidermal growth factor, a fibroblast growth factor or a vascular endothelial growth factor;
preferably, the concentration of the growth factor solution is 0.5-3 mug/mL. In the invention, in the concentration range, the compound of the growth factor and the soybean phosphatidylcholine is stable, the activity of the growth factor is high, and after the concentration is exceeded, the growth speed of the cell is not increased but is slightly reduced.
Preferably, the concentration of the soybean phosphatidylcholine solution is 1-10 mg/mL. In the present invention, in this concentration range, the complex formed by the growth factor and soybean phosphatidylcholine is stable. The solvent of the soybean phosphatidylcholine solution is typically a t-butanol solution.
Preferably, the absorbable polymer in step A2 comprises any one or a combination of at least two of polycaprolactone, glycolide-lactide copolymer, polylactic acid, L-lactide caprolactone copolymer, polydioxanone, polytrimethylene carbonate or chitosan.
In the present invention, the absorbable polymer in step A2 is the same as the absorbable polymer in the maleamide-polyethylene glycol-absorbable polymer copolymer in the selection range.
Preferably, the solvent in step A2 comprises any one or a combination of at least two of dichloromethane, chloroform, tetrahydrofuran, N-methylpyrrolidone, N-dimethylformamide, acetone or hexafluoroisopropanol.
Preferably, the absorbable metal mesh is prepared from any one or a combination of at least two of ferromanganese alloy, ferrocopper alloy, ferrosilver alloy, ferroplatinum alloy, ferrogold alloy, magnesium-zinc alloy, magnesium-lithium alloy, zinc-calcium alloy, zinc-iron alloy, zinc-copper alloy, zinc-silver alloy or zinc-lithium alloy;
preferably, the absorbable metal mesh is a single-layer structure or a multi-layer structure.
Preferably, the thickness of the absorbable metal mesh is 0.2-5 mm. In the thickness range, the manufactured hernia repair patch has good flexibility and mechanical strength, and can give enough supporting strength without abrading organism tissues.
Preferably, the preparation method of the absorbable polymer anti-blocking film comprises the following steps:
b1: dissolving a drug and a polymer in a solvent to obtain a mixed solution;
b2: and B, carrying out electrostatic spinning on the mixed solution obtained in the step B1 to obtain the absorbable polymer anti-adhesion film.
Preferably, the medicament in step B1 comprises an antiproliferative medicament and/or an antibacterial anti-inflammatory medicament;
preferably, the antiproliferative drug comprises any one or a combination of at least two of paclitaxel, rapamycin or dexamethasone;
preferably, the antibacterial and anti-inflammatory drug comprises any one or a combination of at least two of penicillin, cefradine, antibacterial peptide, chitosan, norfloxacin or ciprofloxacin lactate.
Preferably, the growth factor-coated absorbable metal mesh is attached to the absorbable polymer anti-blocking film by means of bonding or stitching.
The polymer in step B1 has the same selection range as the absorbable polymer in step A2 in the present invention.
In the invention, the coating solution can be uniformly coated on the surface of the metal net in a spraying and depositing mode.
The implementation of the invention has the following beneficial effects:
the absorbable metal mesh in the hernia repair patch provided by the invention is used as a structural support layer, strong support is provided at the initial stage of implantation, and in addition, the absorbable metal mesh is coated with growth factors, so that cell growth can be promoted, the defect tissue repair speed is improved, the coating can also effectively protect metal from corrosion degradation at the initial stage of implantation, the degradation speed is reduced, the function of structural support is prolonged, and after the repair is finished, the metal mesh is gradually degraded and is absorbed by a body to be excreted, so that the hernia repair patch has good mechanical properties and good application prospects.
Detailed Description
For the purpose of making the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the technical solutions in the embodiments of the present invention will be clearly and completely described below, and it is apparent that the described embodiments are some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
Example 1
The embodiment provides a completely absorbable anti-adhesion hernia repair patch
The hernia repair patch includes a growth factor coated absorbable metal mesh and an absorbable polymer anti-blocking film loaded with a drug.
The preparation method of the absorbable metal mesh loaded with the growth factor coating comprises the following steps:
a1: mixing an epidermal growth factor aqueous solution with the concentration of 1 mug/mL with a soybean phosphatidylcholine tertiary butanol solution with the concentration of 5mg/mL, and obtaining a growth factor-soybean phosphatidylcholine compound after freeze drying;
a2: dissolving the growth factor-soybean phosphatidylcholine compound in the step A1 and polycaprolactone, maleic amide-polyethylene glycol-polycaprolactone in dichloromethane, and mixing to obtain an epidermal growth factor-polycaprolactone compound solution;
a3: and (3) immersing the absorbable ferromanganese alloy metal net with the thickness of 0.5mm in the epidermal growth factor-polycaprolactone composite solution in the step (A2), and drying dichloromethane to obtain the absorbable ferromanganese alloy net loaded with the epidermal growth factor coating.
The preparation method of the drug-loaded absorbable polymer anti-adhesion film comprises the following steps:
b1: 15mg of paclitaxel, 20mg of penicillin and 15g of polycaprolactone are dissolved in dichloromethane to prepare a polycaprolactone spinning solution;
b2: and carrying out electrostatic spinning on the polycaprolactone solution to obtain the drug-loaded absorbable polycaprolactone anti-blocking film.
And (3) sewing the absorbable ferromanganese alloy net with the coating and the absorbable polycaprolactone anti-adhesion film together by using a degradable polycaprolactone suture line to prepare the completely absorbable anti-adhesion composite hernia repair patch.
Example 2
This example is substantially the same as example 1, except that:
the absorbable metal net is a double-layer magnesium-zinc alloy material with the thickness of 1mm; the surface is loaded with vascular endothelial growth factor, and the concentration of the aqueous solution of the vascular endothelial growth factor is 0.5 mug/mL; the concentration of the soybean phosphatidylcholine is 8mg/mL; the organic solvent is chloroform; the absorbable polymer in the step A2 is polylactic acid.
The anti-proliferation medicine of the drug-loaded absorbable polymer anti-adhesion film is rapamycin, the polymer is polylactic acid, 20mg of rapamycin, 25mg of antibacterial peptide and 10g of polylactic acid are dissolved in N, N-dimethylformamide.
The absorbable metal mesh and the drug-loaded polymer anti-adhesion film are sewn together by using a suture line of polylactic acid.
Example 3
This example is substantially the same as example 1, except that:
the absorbable metal net is made of three layers of iron-copper alloy materials, and the total thickness is 1.5mm; the surface is loaded with fibroblast growth factor, and the concentration of the aqueous solution of the fibroblast growth factor is 3 mug/mL; the concentration of the soybean phosphatidylcholine is 10mg/mL; the absorbable polymer in the step A2 is glycolide-lactide copolymer; the organic solvent is tetrahydrofuran.
The drug carried by the drug-carrying absorbable polymer anti-adhesion film is norfloxacin, the polymer is polydioxanone, 30mg of norfloxacin and 10g of polydioxanone are dissolved in acetone.
The absorbable metal mesh and the drug-loaded polymer anti-adhesion film are adhered together by adopting a degradable chitosan-hyaluronic acid adhesive.
Example 4
This example is substantially the same as example 1, except that:
the absorbable metal net is a double-layer zinc-calcium alloy material, and the total thickness is 0.9mm; the absorbable polymer in the step A2 is poly (trimethylene carbonate); the organic solvent is N, N-dimethylformamide. The coating solution is uniformly coated on the surface of the zinc-calcium alloy net in a spraying mode.
The drug carried by the drug-carrying absorbable polymer anti-adhesion membrane is dexamethasone, the polymer is chitosan, and 10mg of dexamethasone and 5g of chitosan are dissolved in hexafluoroisopropanol.
Comparative example 1
The composite hernia repair patch of this comparative example 1, which is produced by Kang Dina medical technology limited, changzhou, differs from example 1 in that it is made of polypropylene, a polyglycolide-caprolactone copolymer, does not contain an epidermal growth factor-polycaprolactone composite coating in A2, nor does it contain a drug-loaded absorbable polycaprolactone anti-blocking film in B2.
The hernia repair patches prepared in the above examples and comparative examples were subjected to performance tests including mechanical properties, in vitro cell viability, antibacterial properties (colonies on the surface of the patch), and time used in vitro degradation tests.
Wherein, the reference standard of the mechanical related performance is as follows: YY/T1814-2022.
The method for testing the in vitro cell survival rate comprises the following steps: leaching a patch with a size of 1cm x 1cm by adopting a serum-containing culture medium, leaching for 24 hours, pouring the leaching solution into the culture medium with a certain amount of cells for culturing for 24 hours, and observing the survival rate of the cells;
the colony testing method of the patch surface comprises the following steps: a patch of 1cm x 1cm in size was placed on an agar plate coated with 0.1ml of staphylococcus aureus bacteria solution, and after 72 hours the colonies on the surface of the patch were observed.
The results obtained are shown in table 1 below:
TABLE 1
As can be seen from table 1: the mechanical properties of the hernia repair patch manufactured by the invention are slightly larger than those of the hernia repair patch of comparative example 1, and the hernia repair patch can meet the supporting force required after being implanted into a human body; the survival rate of the hernia repair patch manufactured by the embodiment of the invention in an in-vitro cell survival rate test is larger than that of comparative example 1, which shows that the growth factor coating on the surface of the patch can improve the survival rate of cells; in addition, the patch prepared by the invention has certain antibacterial property, but comparative example 1 has no antibacterial property, and in addition, the time required for degradation of the coating in the patch prepared by the invention has no obvious difference from that in comparative example 1.
In addition, the metal mesh of the hernia repair patch prepared in example 1 was immersed in Phosphate Buffer Solution (PBS) to perform an in vitro degradation test, and the mechanical properties and mass loss ratio results are shown in table 2 below. As can be seen from Table 2, after soaking in vitro for 6 months, the tensile strength of the hernia repair patch prepared in example 1 was greater than 16N/cm, indicating that the hernia repair patch still satisfied the mechanical properties required during repair of the defect site during 6 months of implantation.
TABLE 2
| Soaking time (month) | Tensile Strength (N/cm) | Percent mass loss (%) |
| 1 | 40.53 | 2.5 |
| 2 | 37.65 | 9.7 |
| 4 | 35.89 | 15.4 |
| 6 | 24.37 | 26.9 |
Finally, it should be noted that: the above embodiments are only for illustrating the technical solution of the present invention, and are not limiting; although the invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit and scope of the technical solutions of the embodiments of the present invention.
Claims (9)
1. A fully absorbable anti-adhesion hernia repair patch comprising a growth factor coated absorbable metal mesh and an absorbable polymer anti-adhesion membrane, the absorbable polymer anti-adhesion membrane being drug loaded.
2. The hernia repair patch according to claim 1, wherein the growth factor-loaded absorbable metal mesh is prepared by a process comprising:
a1: mixing the growth factor solution with the soybean phosphatidylcholine solution, and freeze-drying to obtain a growth factor-soybean phosphatidylcholine compound;
a2: dissolving the growth factor-soybean phosphatidylcholine compound in the step A1 and an absorbable polymer, maleamide-polyethylene glycol-absorbable polymer copolymer in a solvent, and mixing to obtain a growth factor-polymer compound coating solution;
a3: and (3) soaking the absorbable metal mesh in the growth factor-polymer compound coating solution in the step (A2), and drying to obtain the absorbable metal mesh loaded with the growth factor coating.
3. The hernia repair patch according to claim 2, wherein the growth factor in the growth factor solution comprises any one or a combination of at least two of an epidermal growth factor, a fibroblast growth factor, or a vascular endothelial growth factor;
preferably, the concentration of the growth factor solution is 0.5-3 mug/mL.
4. The hernia repair patch according to claim 2 or 3, wherein the concentration of the soybean phosphatidylcholine solution is 1-10 mg/mL.
5. The hernia repair patch according to any one of claims 2-4, wherein the absorbable polymer in step A2 comprises any one or a combination of at least two of polycaprolactone, glycolide-lactide copolymer, polylactic acid, L-lactide caprolactone copolymer, polydioxanone, polytrimethylene carbonate, or chitosan;
preferably, the solvent in step A2 comprises any one or a combination of at least two of dichloromethane, chloroform, tetrahydrofuran, N-methylpyrrolidone, N-dimethylformamide, acetone or hexafluoroisopropanol.
6. The hernia repair patch according to any one of claims 2-5, wherein the absorbable metal mesh is made of any one or a combination of at least two of a ferro-manganese alloy, a ferro-copper alloy, a ferro-silver alloy, a ferro-platinum alloy, a ferro-gold alloy, a magnesium-zinc alloy, a magnesium-lithium alloy, a zinc-calcium alloy, a zinc-iron alloy, a zinc-copper alloy, a zinc-silver alloy, or a zinc-lithium alloy;
preferably, the absorbable metal mesh is a single-layer structure or a multi-layer structure;
preferably, the thickness of the absorbable metal mesh is 0.2-5 mm.
7. The hernia repair patch according to claim 1, wherein the absorbable polymer anti-blocking film is prepared by a process comprising:
b1: dissolving a drug and a polymer in a solvent to obtain a mixed solution;
b2: and B, carrying out electrostatic spinning on the mixed solution obtained in the step B1 to obtain the absorbable polymer anti-adhesion film.
8. The hernia repair patch according to claim 7, wherein the drug in step B1 comprises an antiproliferative drug and/or an antibacterial anti-inflammatory drug;
preferably, the antiproliferative drug comprises any one or a combination of at least two of paclitaxel, rapamycin or dexamethasone;
preferably, the antibacterial and anti-inflammatory drug comprises any one or a combination of at least two of penicillin, cefradine, antibacterial peptide, chitosan, norfloxacin or ciprofloxacin lactate.
9. The hernia repair patch according to claim 1, wherein the growth factor-coated absorbable metal mesh is attached to the absorbable polymer anti-blocking film by means of bonding or suturing.
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| CN202311355036.7A CN117244106A (en) | 2023-10-19 | 2023-10-19 | Completely absorbable anti-adhesion hernia repair patch |
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| CN202311355036.7A CN117244106A (en) | 2023-10-19 | 2023-10-19 | Completely absorbable anti-adhesion hernia repair patch |
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