CN121015991A - A salt-sensitive hernia repair material and its application method - Google Patents

A salt-sensitive hernia repair material and its application method

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Publication number
CN121015991A
CN121015991A CN202511244097.5A CN202511244097A CN121015991A CN 121015991 A CN121015991 A CN 121015991A CN 202511244097 A CN202511244097 A CN 202511244097A CN 121015991 A CN121015991 A CN 121015991A
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sensitive
salt
hernia repair
repair material
hydrogel
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赵娜
刘俊
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Jiangsu University of Technology
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Jiangsu University of Technology
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Priority to CN202511244097.5A priority Critical patent/CN121015991A/en
Publication of CN121015991A publication Critical patent/CN121015991A/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • 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
    • A61L31/04—Macromolecular materials
    • A61L31/048—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • 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
    • A61L31/04—Macromolecular materials
    • A61L31/042—Polysaccharides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • 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
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • 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
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/145—Hydrogels or hydrocolloids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • 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
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148—Materials at least partially resorbable by the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/06—Flowable or injectable implant compositions

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

本发明属于医疗器械技术领域，公开一种盐敏感性疝修补材料及其应用方法；包括作为经线的聚丙烯纤维和作为纬线的盐敏感性水凝胶聚合物纤维；旨在可控调节疝修补材料机械性能，构建一种可在体内维持较强机械性能一段时间，随后通过离子刺激而软化的纤维，并将此纤维与聚丙烯编织为疝修补材料，从而实现组织物理加固又能降低术后异物感。

This invention belongs to the field of medical device technology and discloses a salt-sensitive hernia repair material and its application method; it includes polypropylene fibers as warp and salt-sensitive hydrogel polymer fibers as weft; the aim is to controllably adjust the mechanical properties of the hernia repair material, construct a fiber that can maintain strong mechanical properties in the body for a period of time, and then soften through ion stimulation, and weave this fiber with polypropylene to form a hernia repair material, thereby achieving physical reinforcement of tissue and reducing postoperative foreign body sensation.

Description

Salt-sensitive hernia repair material and application method thereof
Technical Field
The invention belongs to the technical field of medical appliances, and particularly relates to a hernia repair material and an application method thereof, in particular to a salt-sensitive hernia repair material with mechanical properties capable of being regulated and controlled by ion stimulation.
Background
Hernia is a clinically common surgical disorder, and mainly comprises inguinal hernia, incisional hernia, umbilical hernia and other types. Hernia repair materials are medical implant materials used to repair a damaged abdominal cavity or other site, and are typically woven from fibers, intended to strengthen weak tissues and induce tissue regeneration, thereby promoting repair and reducing the risk of recurrence.
The hernia repair materials currently used clinically can be mainly divided into the following categories:
(1) Non-absorbable synthetic materials, represented by polypropylene (PP), polyester (Polyester), polytetrafluoroethylene (PTFE). The material (such as Bard Mesh and Gore-Tex Mesh) has high strength and good stability, is suitable for repairing large-area defects, but is used as a permanent implant, and is easy to cause obvious foreign body reaction and chronic pain and has high infection risk;
(2) The absorbable synthetic material mainly comprises polyglycolic acid (PGA), polylactic acid (PLA) and the like, and is characterized in that the material can be gradually degraded in vivo, and the mechanical strength of the absorbable synthetic material decays too fast to provide durable mechanical support for tissue repair although the problem of long-term stimulation of foreign matters is solved;
(3) The biological derivative materials such as pig skin, bovine pericardium, human dermis and the like which are subjected to cell removal treatment have good biocompatibility and small inflammatory reaction, can be replaced and rebuilt by human cells, but have high cost, insufficient mechanical properties and large batch-to-batch difference, and are difficult to meet the repair requirement of high-tension parts.
The existing hernia repair material has contradiction between mechanical strength and long-term foreign body sensation, and a novel material capable of dynamically adjusting mechanical properties with time is needed.
Disclosure of Invention
The invention aims to solve the defects in the prior art, and provides a salt-sensitive hernia repair material and an application method thereof, and the material is used for constructing a fiber which can maintain strong mechanical properties in vivo for a period of time (time is controllable), is softened by ion stimulation, and is woven with polypropylene into a hernia patch, a hernia mesh plug and the like, so that physical reinforcement of tissues is realized, and foreign body sensation after operation can be reduced.
In order to achieve the above purpose, the invention is realized by the following technical scheme:
In a first aspect, the present invention provides a salt-sensitive hernia repair material comprising polypropylene fibers and salt-sensitive hydrogel polymer fibers, wherein the salt-sensitive hernia repair material forms a network structure by a braiding process, and the mechanical properties of the salt-sensitive hydrogel polymer fibers can be controlled by ionic stimulation.
According to the invention, firstly, the performance of the hernia repair material is synergistically improved by adopting a 'PP+hydrogel' fiber combination, although the hydrogel is a commonly used medical grade polymer, the application in the field of hernia repair is not realized at present, and secondly, salt sensitivity refers to the fact that the hydrogel is sensitive to Hofmeister series (Hofmeister), the principle that the Hofmeister series influences the mechanical performance of the hydrogel is applied to the hernia repair material, and the mechanical performance is adjustable by locally injecting sodium citrate solution of a non-classical sequence in the Hofmeister series, so that the contradiction between retaining the mechanical performance and reducing foreign body sensation in the prior art is solved.
Preferably, polypropylene fibers are used as warp yarns and salt-sensitive hydrogel polymer fibers are used as weft yarns.
Preferably, the salt-sensitive hydrogel polymer is selected from polyvinyl alcohol (PVA), polyacrylic acid (PAA), or a dual network hydrogel combination.
Preferably, the dual-network hydrogel is combined with sodium alginate-polyacrylic acid.
Preferably, the hydrogel polymer is sensitive to ions in the Hofmeister series (Hofmeister series), including citrate, thiocyanate.
Preferably, the knitting process is warp knitting, weft knitting or a weaving process.
Preferably, the hydrogel polymer fibers are loaded with anti-inflammatory drugs or growth factors so as to realize a local sustained release administration function.
In a second aspect, the present invention provides a method for preparing a salt-sensitive hernia repair material, comprising the steps of:
preparing salt-sensitive hydrogel polymer fibers;
and taking the polypropylene fiber and the salt-sensitive hydrogel fiber as warp and weft, and preparing the mesh patch through a braiding process.
Wherein, the fiber diameter is in the micron order and can be 100-300 microns, and the knitting density is 40-80g/m 2.
In a third aspect, the present invention provides a salt-sensitive hernia repair material composition comprising the salt-sensitive hernia repair material and a citrate-containing solution.
Preferably, the solution containing citrate is sodium citrate solution. Sodium citrate is very safe and injectable, is recognized as safe and nontoxic, is commonly used as a buffering agent and an anticoagulant in medicine and is also used as a food additive in food.
In a fourth aspect, the present invention provides a method of using a composition comprising the steps of:
the salt-sensitive hernia repair material is implanted into target tissue, and a solution containing citrate is locally injected into the implantation site, so that hydrogel fibers are softened, and the mechanical strength and foreign body sensation of the patch are reduced. Wherein, the solution containing citrate is injected in a concentration of 40-60mM and 0.2-0.5 mL.
Preferably, the injection is performed during the tissue recovery phase after implantation.
The invention has the following beneficial effects:
(1) The invention skillfully combines the durability of the non-absorbable material with the bio-friendliness of the absorbable material. The material keeps high strength to support tissue repair in the initial stage of implantation, and in the later stage of recovery, the hydrogel is triggered to soften by local injection of specific ion solution, so that rigidity and foreign body sensation are actively reduced, and the on-demand regulation and control of mechanical properties are realized. Solves the limitation of the prior non-absorbable material, and has better mechanical strength compared with the absorbable material.
(2) The synergistic effect is that the 'PP-hydrogel' fiber combination and the Hofmeister special effect are applied to the hernia repair field for the first time, and the physical properties of the implant can be remotely regulated in vivo through simple local injection operation, so that the long-term clinical contradiction is solved.
(3) The function is expanded, the hydrogel fiber can be used as a drug carrier, loads and slowly releases anti-inflammatory drugs or growth factors, promotes tissue regeneration while repairing a mechanical structure, reduces infection risk, and realizes multifunctional integration.
(4) The application range is wide, the patches suitable for different anatomical positions (such as light-weight or weight hernia repair) can be flexibly designed by selecting different types of hydrogels (such as single-network PVA or double-network PAA-SA) or adjusting the knitting parameters, and the application range is stronger.
Drawings
FIG. 1 is a schematic drawing of a braiding process of a salt-sensitive hernia repair material of the present invention;
FIG. 2 is a graph comparing stress-strain curves of PVA hydrogels before and after treatment with 50mM sodium citrate solution;
FIG. 3 is a graph comparing stress-strain curves of PAA-SA dual network hydrogels before and after treatment with 50mM sodium citrate solution;
FIG. 4 is a graph showing the comparison of Young's modulus change before and after treatment with sodium citrate solution for the two hydrogel materials prepared in example 1 and example 2.
Wherein, 1, polypropylene fiber, 2, salt sensitive hydrogel polymer fiber.
Detailed Description
The invention is further illustrated by the following examples, which are not intended to be limiting.
EXAMPLE 1 salt-sensitive hernia Patch based on PVA (polyvinyl alcohol) hydrogel
PVA hydrogel fiber is prepared by dissolving PVA powder (44.05 g/mol) in pure water, vigorously stirring for 2 hours at 95 ℃ to prepare 10 wt% PVA solution, pouring the solution into a mold, drying in a 60 ℃ oven for 4 hours to obtain a PVA film, and preparing the PVA hydrogel fiber by a melt extrusion spinning technology. The melt extrusion spinning is to extrude the polymer through a spinneret orifice after melting, obtain filaments after cooling and drawing, wherein the melting temperature is 200 ℃, and the diameter of the spinneret orifice is 0.5mm.
And (3) knitting the mesh hernia patch by taking polypropylene (PP) fiber and PVA fiber as warp and weft respectively and adopting a warp knitting process. The structure is shown in figure 1, polypropylene is used as warp yarn to provide a core skeleton, the hydrogel polymer forms coils continuously along the longitudinal direction in the knitting process, and the coils are connected transversely to form a net-shaped structure. The chemicals used above were purchased from Shanghai Ala Biochemical technology Co., ltd, and were selected from PVA having a molecular weight of 31000-50000 and a product number of P110853, and PP having a melt index of 0.3g/10 min.
Application and performance test the patch was sutured to the target site and after the tissue had healed initially, a solution of 0.5 mL mM sodium citrate was locally injected into the surface of the target tissue. The hydrogel weft in the patch is softened under the stimulation of ions, so that the whole woven structure becomes loose, the mechanical strength is reduced, and the foreign body sensation of a patient is effectively relieved.
The main physical quantity for measuring the foreign body sensation of the hernia repair material is the Young's modulus of the material, and can be measured by using a stress-strain curve. The Young's modulus is measured by making a cylindrical silica gel mold with a diameter of about 0.5 cm and a height of about 1:1 cm, pouring the hydrogel liquid into the mold, and polymerizing to obtain a cylindrical hydrogel. The hydrogel cylinders were compressed using a universal mechanical tester at a compression rate of 1 mm/min, while the force sensors recorded the test curves of the stress and strain of the hydrogels in real time (as shown in figure 2). According to the calculation of stress divided by strain, after soaking in a 50mM sodium citrate solution for 24 hours, the Young's modulus of PVA hydrogel is obviously reduced from 12.079 MPa to 5.076 MPa, and the excellent salt-sensitive softening property of the PVA hydrogel is proved, so that the sodium citrate can reduce the mechanical strength of the hydrogel, thereby reducing the foreign body sensation of the material.
EXAMPLE 2 salt-sensitive hernia Patch based on PAA-SA (sodium alginate-polyacrylic acid) double-network hydrogel
Preparation of PAA-SA double-network hydrogel fiber:
12.33 mL acrylic acid (AAc) as a monomer is dissolved in deionized water, then 36.96N-Methylene Bisacrylamide (MBAA) cross-linking agent is added, 173.2 mg alpha-ketoglutaric acid (alpha-KGA) photoinitiator is added, and the solution is mixed and stirred uniformly to obtain the stock solution of PAA hydrogel. Then 0.2g of Sodium Alginate (SA) is added into 10mL deionized water, the sodium alginate is heated and stirred on a magnetic stirrer to be dissolved in water, 10mL of PAA hydrogel collagen solution is added into SA solution, and the mixture is uniformly mixed to be used as the stock solution of PAA-SA hydrogel. Finally, pouring part of the stock solution into a mould, and irradiating for 6-10 minutes under an ultraviolet lamp to realize chemical crosslinking, so that the PAA-SA film is obtained, and the fiber is manufactured through melt extrusion spinning. The melt temperature used was 200℃and the orifice diameter was 0.5 mm. The chemicals used above were purchased from Shanghai Ala Latin Biochemical technologies Co., ltd.
And (3) knitting the patch, namely knitting polypropylene (PP) fibers and PAA-SA fibers serving as warp yarns and weft yarns into the hernia patch by adopting a warp knitting process. The structure is shown in figure 1, polypropylene is used as warp yarn, the hydrogel polymer forms loops continuously along the longitudinal direction in the knitting process, and the loops are connected transversely to form a net-shaped structure.
Application and performance test the patch was sutured to the target site and after the tissue had healed initially, a solution of 0.5 mL mM sodium citrate was locally injected into the surface of the target tissue. The hydrogel weft in the patch is softened under the stimulation of ions, so that the whole woven structure becomes loose, the mechanical strength is reduced, and the foreign body sensation of a patient is effectively relieved.
The Young's modulus of PAA-SA hydrogel is measured by making a cylindrical silica gel mold with a diameter of about 0.5 cm and a height of about 1:1 cm, pouring the hydrogel liquid into the mold, and polymerizing to obtain cylindrical PAA-SA. The hydrogel cylinders were compressed using a universal mechanical tester at a compression rate of 1 mm min-1, while the force sensors recorded the test curves of the stress and strain of the hydrogels in real time (as shown in figure 3). According to the calculation of stress divided by strain, after soaking in a 50nM sodium citrate solution for 24 hours, the Young's modulus of the PAA-SA hydrogel is obviously reduced from 79.072 MPa to 19.305 MPa, and the excellent salt-sensitive softening property of the PAA-SA hydrogel is proved, and the sodium citrate solution can reduce the mechanical strength of the PAA-SA hydrogel, so that the foreign body sensation of the material is reduced.
As shown in fig. 4, the two-network structure (PAA-SA) and the single-network structure (PVA) both meet the requirement of high mechanical strength, and one of the characteristics of the hydrogel is that the mechanical strength is adjustable, so that the mechanical strength can be adjusted by adding the network structure in practical application, thereby meeting the requirements of different types of hernia repair materials. For example, for lightweight hernia mesh, a low stiffness hydrogel material may be used. For a weight-type hernia mesh, a high stiffness hydrogel material may be used. The Young's modulus of the same salt-sensitive hydrogel material is obviously reduced after the sodium citrate solution acts, which indicates that the sodium citrate solution can soften the hernia repair material, thereby reducing the foreign body sensation in the human body. The validity and design flexibility of the invention are fully verified.
The foregoing has outlined and described the basic principles, features, and advantages of the present invention. However, the foregoing is merely specific examples of the present invention, and the technical features of the present invention are not limited thereto, and any other embodiments that are derived by those skilled in the art without departing from the technical solution of the present invention are included in the scope of the present invention.

Claims (10)

1.一种盐敏感性疝修补材料，其特征在于，包括聚丙烯纤维和盐敏感性水凝胶聚合物纤维，所述盐敏感性疝修补材料通过编织工艺形成网状结构，并且盐敏感性水凝胶聚合物纤维的机械性能能够通过离子刺激调控。1. A salt-sensitive hernia repair material, characterized in that it comprises polypropylene fibers and salt-sensitive hydrogel polymer fibers, wherein the salt-sensitive hernia repair material is formed into a mesh structure by a weaving process, and the mechanical properties of the salt-sensitive hydrogel polymer fibers can be regulated by ion stimulation. 2.根据权利要求1所述的盐敏感性疝修补材料，其特征在于，聚丙烯纤维作为经线，盐敏感性水凝胶聚合物纤维作为纬线。2. The salt-sensitive hernia repair material according to claim 1, characterized in that polypropylene fiber is used as the warp and salt-sensitive hydrogel polymer fiber is used as the weft. 3.根据权利要求1所述的盐敏感性疝修补材料，其特征在于，所述盐敏感性水凝胶聚合物选自聚乙烯醇、聚丙烯酸或双网络水凝胶组合。3. The salt-sensitive hernia repair material according to claim 1, wherein the salt-sensitive hydrogel polymer is selected from polyvinyl alcohol, polyacrylic acid, or a combination of dual-network hydrogels. 4.根据权利要求3所述的盐敏感性疝修补材料，其特征在于，所述双网络水凝胶组合为海藻酸钠-聚丙烯酸。4. The salt-sensitive hernia repair material according to claim 3, wherein the dual-network hydrogel assembly is sodium alginate-polyacrylic acid. 5.根据权利要求1所述的盐敏感性疝修补材料，其特征在于，所述水凝胶聚合物对霍夫迈斯特序列中的离子敏感，所述离子包括柠檬酸根、硫氰酸根。5. The salt-sensitive hernia repair material according to claim 1, characterized in that the hydrogel polymer is sensitive to ions in the Hofmeister sequence, the ions including citrate and thiocyanate. 6.根据权利要求1所述的盐敏感性疝修补材料，其特征在于，所述水凝胶聚合物纤维中负载有抗炎药物或生长因子。6. The salt-sensitive hernia repair material according to claim 1, characterized in that the hydrogel polymer fiber is loaded with anti-inflammatory drugs or growth factors. 7.一种盐敏感性疝修补材料组合物，其特征在于，包括权利要求1-6任一项所述的盐敏感性疝修补材料和含柠檬酸根的溶液。7. A salt-sensitive hernia repair material composition, characterized in that it comprises the salt-sensitive hernia repair material according to any one of claims 1-6 and a solution containing citrate. 8.根据权利要求7所述的组合物，其特征在于，所述含柠檬酸根的溶液为柠檬酸钠溶液。8. The composition according to claim 7, wherein the citrate-containing solution is a sodium citrate solution. 9.一种如权利要求7或8所述的组合物的应用方法，其特征在于，包括以下步骤：将所述盐敏感性疝修补材料植入目标组织，向植入部位局部注射含柠檬酸根的溶液，使水凝胶纤维软化，降低补片的机械强度和异物感。9. A method of applying the composition as described in claim 7 or 8, characterized in that it comprises the following steps: implanting the salt-sensitive hernia repair material into the target tissue, and locally injecting a solution containing citrate into the implantation site to soften the hydrogel fibers and reduce the mechanical strength and foreign body sensation of the patch. 10.根据权利要求9所述的应用方法，其特征在于，在植入后的组织恢复期进行注射。10. The application method according to claim 9, characterized in that the injection is performed during the tissue recovery period after implantation.
CN202511244097.5A 2025-09-02 2025-09-02 A salt-sensitive hernia repair material and its application method Pending CN121015991A (en)

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