Multilayer ultra-light hernia patch

Abstract

The invention relates to the technical field of medical instruments, in particular to a multi-layer ultra-light hernia patch which comprises a large-mesh electrostatic spinning tissue ingrowth layer, a mesh woven base material layer and an anti-adhesion layer which are sequentially connected in a stacked mode. Wherein after the large-mesh electrostatic spinning tissue ingrowth layer is implanted into a human body, a cell microenvironment can be better simulated, cell adhesion, differentiation and migration are facilitated, uniform distribution of newborn cells in the fiber direction of an electrospinning membrane is promoted, granulation tissues uniformly ingrow in a defect part, and the electrospinning fiber membrane and the tissues are cooperatively repaired; secondly, the middle layer can provide supporting performance and mechanical performance of the patch in the early stage for the patch, the defects of the electrospinning fiber membrane in the supporting performance and the mechanical performance are overcome, the long-term implantation amount of the patch after later degradation is greatly reduced, and the foreign body sensation is obviously reduced; the anti-adhesion layer also adopts the electrostatic spinning technology, and the anti-adhesion effect is achieved by selecting materials and regulating and controlling the porosity, the aperture and the fiber diameter of the electrospun fiber membrane.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a multi-layer ultra-lightweight hernia patch. Background Art

[0002] Hernia is a relatively common disease. The current main treatment method is to surgically implant a hernia patch at the site of the hernia to repair the defect.

[0003] Existing hernia patches are usually made of meshes woven from non-absorbable polymer monofilaments or meshes woven from a mixture of non-absorbable and absorbable monofilaments, which can provide long-term mechanical support in the human body and reduce the recurrence rate of hernia. Therefore, such patches generally have a certain degree of rigidity, which can easily lead to a more obvious foreign body sensation in patients after the patch is implanted, and can also easily cause severe inflammatory reactions. If the collagen and other matrix content in the scar tissue is too much, the scar tissue will be too hard, which is not conducive to the activity of the repair site, and will also cause the patch to shrink and cause chronic pain.

[0004] After the hernia patch is implanted in the human body, the human tissue will generally go through the following stages due to damage: First, the inflammatory phase: It starts within 24 hours after the tissue is injured, showing a strong inflammatory response, and at the same time, the temporary extracellular matrix (ECM) is formed, the cell mediator is released and activated, and the inflammatory cells, fibroblasts and endothelial cells migrate to the injured area. Among them, the macrophages are mainly pro-inflammatory macrophages M1 type, which can effectively phagocytize bacteria and damaged tissues; the proliferation phase: It usually starts 3 days after the tissue is injured and lasts for about 15 days. More complex tissue healing can be delayed to 6 weeks. During this period, macrophages are polarized into anti-inflammatory M2 type, which promotes tissue healing by secreting anti-inflammatory factors and cell growth factors, and endothelial cells and fibroblasts proliferate, promoting the synthesis of new extracellular matrix and the formation of new blood vessels, helping tissue healing; the remodeling phase: Usually 6 to 12 weeks after the injury, under the action of fibroblasts, the extracellular matrix is ​​reconstructed, and the fiber network composed of collagen fibers, elastin, network fibers, etc. becomes dense, forming a more stable ECM. ECM is crucial in the process of tissue healing.

[0005] ECM is a complex network structure composed of collagen, proteoglycans, adhesion glycoproteins and other components. It connects cells, maintains the physiological structure and function of cells, provides physical support for cells, connects different cells and structures in tissues, promotes the spreading of cells, and provides conditions for cell proliferation. According to the distribution site, it is mainly divided into basement membrane and interstitial matrix. ECM can also combine with a variety of growth factors and hormones to affect cell morphology, movement and differentiation, thereby affecting the rate and quality of tissue healing. It is also an indispensable part for various cells to complete physiological functions.

[0006] Therefore, in diseases such as hernia caused by tissue defects, ECM is crucial for tissue repair and healing. Tissues have high requirements for the growth of the patch after implantation. It is necessary to ensure the support of the patch and tissue at the repair site to avoid hernia recurrence; it is also necessary to avoid problems such as granulomas and patch shrinkage caused by excessive tissue proliferation. Summary of the invention

[0007] To solve the above problems, the present invention provides a multi-layer ultra-lightweight hernia patch, which can improve the quality of tissue ingrowth after patch implantation, and significantly reduce the long-term implantation amount of the patch, reduce the foreign body sensation and the possibility of hypertrophic scar tissue, granuloma, etc.

[0008] To achieve the above purpose, the technical solution of the present invention is:

[0009] A multi-layer ultra-lightweight hernia patch comprises a large-mesh electrostatic spinning tissue ingrowth layer, a mesh woven substrate layer and an anti-adhesion layer which are sequentially stacked and connected.

[0010] Preferably, the large-mesh electrospinning tissue ingrowth layer is an electrospun fiber membrane composed of non-absorbable material.

[0011] Preferably, the large-mesh electrospun tissue ingrowth layer is an electrospun fiber membrane composed of a blend of absorbable material and non-absorbable material.

[0012] Preferably, the mesh woven substrate layer is woven from absorbable material monofilaments.

[0013] Preferably, the anti-adhesion layer is an electrospun fiber membrane made of absorbable material.

[0014] Preferably, the non-absorbable material is at least one of polypropylene, polyester, polytetrafluoroethylene and polyvinylidene fluoride.

[0015] Preferably, the absorbable material is at least one of polylactide-caprolactone, polyglycolide-lactide, polyglycolide-caprolactone, polyglycolide-trimethylene carbonate, polylactic acid, polyglycolic acid, polyvinyl alcohol and polydioxanone.

[0016] Preferably, the electrospun fiber membrane of the macro-mesh electrospinning tissue growth layer has an average fiber diameter ranging from 0.001 to 10 μm, an average pore size ranging from 1 to 500 μm, and a thickness of 0.1 to 3 mm.

[0017] Preferably, the mesh shape of the mesh woven layer is quadrilateral, hexagonal or elliptical.

[0018] Preferably, the average diameter of the monofilaments of the mesh woven layer is in the range of 0.05-1 mm, the average size of the mesh holes is in the range of 0.1-5 mm, and the thickness of the mesh woven layer is in the range of 0.1-2 mm.

[0019] Preferably, the electrospun fiber membrane of the anti-adhesion layer has an average fiber diameter ranging from 0.001 to 10 μm, an average pore size ranging from 1 to 500 μm, and a thickness ranging from 0.1 to 4 mm.

[0020] Preferably, the large-mesh electrospinning tissue ingrowth layer, the mesh woven substrate layer and the anti-adhesion layer are connected by at least one of spinning, thermal fusion, welding, bonding and suturing.

[0021] The beneficial effects of this technical solution are:

[0022] 1. The multi-layer ultra-lightweight hernia patch of the present invention has a three-layer structure, which provides different functions respectively: first, the large-mesh electrospun tissue ingrowth layer can improve the quality of tissue recovery by introducing a structure similar to ECM. The electrospun fiber membrane with high porosity, high specific surface area, softness and low gram weight prepared by electrospinning technology is similar to the interweaving and superimposed structure of the fiber network of collagen, elastin and the like in ECM. After being implanted into the human body, it can better simulate the cell microenvironment, which is conducive to cell adhesion, differentiation and migration, and avoids the deposition of the extracellular matrix itself. At the same time, the tissue grows along the deposited matrix, so that the tissue defect site is gradually reshaped or regenerated, increasing the toughness of the growing tissue; secondly, the middle layer is a mesh woven base material layer composed of fully absorbable material monofilaments: it can provide support for the patch and the early mechanical properties of the patch, make up for the defects of the electrospun fiber membrane in support and mechanical properties, and after degradation in the later stage, the long-term implantation volume of the patch is greatly reduced, and the foreign body sensation is significantly reduced; finally, the anti-adhesion layer also uses the electrospun fiber membrane made of electrospinning technology, and the anti-adhesion effect is achieved by regulating the porosity, pore size and fiber diameter of the electrospun fiber membrane.

[0023] 2. In the multi-layer ultra-lightweight hernia patch described in the present invention, the proportion of non-absorbable materials is significantly reduced. After implantation into the human body, it is degraded in the body and the residual amount of non-absorbable materials is low, which can significantly reduce the risks of severe foreign body sensation, severe granuloma, obvious shrinkage of the patch and other problems after long-term implantation into the human body. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 It is a schematic diagram of the structure of the multi-layer ultra-lightweight hernia patch of the present invention;

[0025] Figure numerals: 1. Multi-layer ultra-lightweight hernia patch, 2. Large mesh electrospinning tissue ingrowth layer, 3. Mesh woven substrate layer, 4. Anti-adhesion layer. DETAILED DESCRIPTION

[0026] The embodiments of the present invention are described in detail, but no limitation is imposed on the claims of the present invention. The described embodiments are only a part of the embodiments of the present invention. All other embodiments obtained based on the principles of the present invention belong to the protection scope of the present invention.

[0027] A multi-layer ultra-lightweight hernia patch 1 comprises a large-mesh electrostatic spinning tissue ingrowth layer 2, a mesh woven substrate layer 3 and an anti-adhesion layer 4 which are sequentially stacked and connected.

[0028] (1) The large-mesh electrospun tissue ingrowth layer 2 can be selected from electrospun fiber membranes composed of non-absorbable materials or electrospun fiber membranes composed of a blend of absorbable and non-absorbable materials according to needs. The average fiber diameter of the electrospun fiber membrane is in the range of 0.001-10 μm, the average pore size is in the range of 1-500 μm (preferably 200-500 μm), and the thickness of the electrospun fiber membrane is in the range of 0.1-3 mm.

[0029] The electrospun fiber membrane of the large-mesh electrospun tissue ingrowth layer has a network structure of both micron-porous and nanofibers, in which the micron-porous structure facilitates the passage of body fluids and macrophages, helping to reduce the risk of dead cavity formation and infection after implantation. Nano-sized fibers can reduce the amount of patch implanted, while the softness of the patch is greatly increased, which can reduce the foreign body sensation. Nano-sized fibers have a large surface tension, which helps to evenly distribute various cells and promote even tissue ingrowth.

[0030] The non-absorbable material constituting the electrospun fiber membrane can be selected from polypropylene (PP), polyester materials, polytetrafluoroethylene and polyvinylidene fluoride, etc., and one material can be used alone or two or more materials can be mixed.

[0031] The absorbable material constituting the electrospun fiber membrane can be selected from polylactide-caprolactone (PLCL), polyglycolide-lactide (PLGA), polyglycolide-caprolactone (PGCL), polyglycolide-trimethylene carbonate (PGA-TMC), polylactic acid (PLA), polyglycolic acid (PGA), polyvinyl alcohol (PVA) and polydioxanone (PDO), etc. One material can be used alone or two or more can be mixed.

[0032] (2) The mesh woven substrate layer 3 is woven from absorbable material monofilaments. The mesh shape of the mesh woven layer can be quadrilateral, hexagonal or elliptical. The average pore size range is 0.1-5 mm, the average monofilament diameter range is 0.05-1 mm, and the thickness range of the mesh woven layer is 0.1-2 mm.

[0033] The absorbable material can be selected from polylactide-caprolactone (PLCL), polyglycolide-lactide (PLGA), polyglycolide-caprolactone (PGCL), polyglycolide-trimethylene carbonate (PGA-TMC), polylactic acid (PLA), polyglycolic acid (PGA), polyvinyl alcohol (PVA) and polydioxanone (PDO), etc. One material can be used alone or two or more can be mixed.

[0034] (3) The anti-adhesion layer 4 is made of an electrospun fiber membrane made of absorbable material. The average fiber diameter of the electrospun fiber membrane of the anti-adhesion layer is in the range of 0.001-10 μm, the average pore size is in the range of 1-500 μm, and the thickness of the electrospun fiber membrane is in the range of 0.1-4 mm.

[0035] The absorbable material can be selected from polylactide-caprolactone (PLCL), polyglycolide-lactide (PLGA), polyglycolide-caprolactone (PGCL), polyglycolide-trimethylene carbonate (PGA-TMC), polylactic acid (PLA), polyglycolic acid (PGA), polyvinyl alcohol (PVA) and polydioxanone (PDO), etc. One material can be used alone or two or more can be mixed.

[0036] (4) The large-mesh electrospun tissue ingrowth layer, the mesh woven substrate layer and the anti-adhesion layer can be connected by spinning, thermal fusion, welding, bonding and suturing.

[0037] In order to realize the above technical solution, the present invention also provides a method for preparing the above multi-layer ultra-lightweight hernia patch, as exemplified below:

[0038] The first one:

[0039] A method for preparing a multi-layer ultra-lightweight hernia patch, comprising the following steps:

[0040] A woven mesh is prepared by a weaving process, and the mesh is cleaned, stretched, shaped, and cut to obtain a mesh woven substrate layer;

[0041] An electrospun fiber membrane is formed by spinning on one side of the mesh woven substrate layer through an electrospinning process to obtain a large-mesh electrospun tissue growth layer;

[0042] An electrospun fiber membrane is spun on the other side of the mesh woven substrate layer through an electrospinning process to obtain an anti-adhesion layer.

[0043] The beneficial effects of the technical solution are: the preparation steps are simple, easy to implement, and can be industrially promoted and applied.

[0044] Second type:

[0045] A method for preparing a multi-layer ultra-lightweight hernia patch, comprising the following steps:

[0046] A woven mesh is prepared by a weaving process, and the mesh is cleaned, stretched, shaped, and cut to obtain a mesh woven substrate layer;

[0047] Electrospun fiber membranes were prepared by electrospinning process to obtain large-mesh electrospun tissue ingrowth layers;

[0048] The electrospun fiber membrane is prepared by an electrospinning process to obtain an anti-adhesion layer;

[0049] Connecting the large-mesh electrospun tissue ingrowth layer anti-adhesion layer to one side of the mesh woven substrate layer by at least one of thermal fusion, welding, bonding and suturing processes;

[0050] The anti-adhesion layer is connected to the other side of the mesh woven substrate layer by at least one of heat fusion, welding, bonding and sewing processes.

[0051] The method has simple preparation steps, is easy to implement, and can be promoted and applied industrially.

[0052] Several specific embodiments are given below in combination with the above scheme:

[0053] Example 1

[0054] The PP monofilament and the PGCL monofilament are mixed and woven into a mesh, and the mesh is then cleaned, stretched, shaped, and cut to obtain a mesh woven substrate layer;

[0055] The PP fiber membrane was prepared by electrospinning process. Dichloromethane solvent was selected and spun directly on one side of the mesh. A small amount of non-volatile solvent helped to connect the mesh with the electrospun fiber membrane, that is, to obtain a large-mesh electrospun tissue growth layer. The average diameter of the electrospun fiber membrane. The average size of the pore size;

[0056] The other side of the mesh is directly electrospun with PLCL material and hexafluoroisopropanol solvent is used to obtain an anti-adhesion layer;

[0057] Finally, the preparation is completed by drying with circulating air to obtain a multi-layer composite tissue shaping hernia repair patch.

[0058] Example 2

[0059] The PGCL monofilaments are woven into a fully absorbable mesh, and the mesh is then cleaned, stretched, shaped, and cut to obtain a mesh woven substrate layer;

[0060] The PP fiber membrane was prepared by electrospinning process. Dichloromethane solvent was selected and spinning was carried out directly on one side of the mesh to obtain an electrospun fiber membrane with small diameter and high specific surface area, which had excellent adhesion on the mesh, that is, a large mesh electrospun tissue growth layer was obtained.

[0061] On the other side of the mesh, PLCL material is directly used for electrospinning, and hexafluoroisopropanol solvent is used to prepare an electrospun fiber membrane to obtain an anti-adhesion layer;

[0062] Finally, the preparation is completed by drying with circulating air to obtain a multi-layer composite tissue shaping hernia repair patch.

[0063] Example 3

[0064] The PGCL monofilaments are woven into a fully absorbable mesh, which is then cleaned, stretched, shaped, and cut to obtain a mesh woven substrate layer;

[0065] The PP and PGCL fiber membranes were prepared by electrospinning process, and hexafluoroisopropanol solvent was used to prepare the electrospun fiber membrane as the tissue ingrowth layer;

[0066] The PLA fiber membrane was prepared by electrospinning process, and hexafluoroisopropanol solvent was used to prepare the electrospun fiber membrane as the anti-adhesion layer;

[0067] The two electrospun fiber membranes are dried with circulating air, and a dilute PGCL solution is sprayed evenly on both sides of the PGCL woven mesh in small amounts in turn. The two electrospun fiber membranes are then pasted on the two sides respectively, and then subjected to low-temperature and low-intensity hot pressing and secondary cutting to obtain a hernia repair patch.

[0068] In summary, the present invention has the following advantages:

[0069] 1. The multi-layer ultra-lightweight hernia patch described in the present invention has a three-layer structure, combining a fully absorbable woven mesh with an electrospun fiber membrane, with complementary disadvantages and superimposed advantages. The ECM-like structure of the electrospun membrane of the tissue ingrowth layer is used to improve the quality of tissue ingrowth, and the anti-adhesion performance of the patch is improved by adjusting the fiber pore size and degradation time of the anti-adhesion layer.

[0070] 2. In the multi-layer ultra-lightweight hernia patch described in the present invention, the proportion of non-absorbable materials is significantly reduced. After implantation into the human body, it is degraded in the body and the residual amount of non-absorbable materials is low, which can significantly reduce the risks of severe foreign body sensation, severe granuloma, obvious shrinkage of the patch and other problems after long-term implantation into the human body.

[0071] 3. The preparation method provided by the present invention has simple steps, is easy to implement, and can be promoted and applied industrially.

[0072] It is understood that the above specific description of the present invention is only used to illustrate the present invention and is not limited to the technical solutions described in the embodiments of the present invention. Those skilled in the art should understand that the present invention can still be modified or replaced by equivalents to achieve the same technical effects; as long as the use requirements are met, they are within the protection scope of the present invention.

Claims

1. A multi-layer ultra-lightweight hernia patch, characterized in that: The invention comprises a large-mesh electrostatic spinning tissue growth layer, a mesh woven substrate layer and an anti-adhesion layer which are sequentially stacked and connected.

2. The multi-layer ultra-lightweight hernia patch according to claim 1, characterized in that: The large-mesh electrostatic spinning tissue ingrowth layer adopts an electrospun fiber membrane composed of non-absorbable materials.

3. The multi-layer ultra-lightweight hernia patch according to claim 1, characterized in that: The large-mesh electrostatic spinning tissue ingrowth layer adopts an electrospun fiber membrane composed of a blend of absorbable material and non-absorbable material.

4. The multi-layer ultra-lightweight hernia patch according to claim 1, characterized in that: The mesh woven substrate layer is woven from absorbable material monofilaments.

5. The multi-layer ultra-lightweight hernia patch according to claim 1, characterized in that: The anti-adhesion layer adopts an electrospun fiber membrane composed of absorbable material.

6. The multi-layer ultra-lightweight hernia patch according to claim 2 or 3, characterized in that: The non-absorbable material is at least one of polypropylene, polyester, polytetrafluoroethylene and polyvinylidene fluoride.

7. The multi-layer ultra-lightweight hernia patch according to claim 3, 4 or 5, characterized in that: The absorbable material is at least one of polylactide-caprolactone, polyglycolide-lactide, polyglycolide-caprolactone, polyglycolide-trimethylene carbonate, polylactic acid, polyglycolic acid, polyvinyl alcohol and polydioxanone.

8. The multi-layer ultra-lightweight hernia patch according to claim 2 or 3, characterized in that: The electrospun fiber membrane of the large-mesh electrospinning tissue growth layer has an average fiber diameter range of 0.001-10 μm, an average pore size range of 1-500 μm, and a thickness of 0.1-3 mm.

9. The multi-layer ultra-lightweight hernia patch according to claim 4, characterized in that: The average diameter of the monofilaments of the mesh braided layer is in the range of 0.05-1 mm, the average size of the mesh holes is in the range of 0.1-5 mm, and the thickness of the mesh braided layer is in the range of 0.1-2 mm.

10. The multi-layer ultra-lightweight hernia patch according to claim 5, characterized in that: The electrospun fiber membrane of the anti-adhesion layer has an average fiber diameter ranging from 0.001 to 10 μm, an average pore size ranging from 1 to 500 μm, and a thickness ranging from 0.1 to 4 mm.

11. The multi-layer ultra-lightweight hernia patch according to claim 1, characterized in that: The large-mesh electrostatic spinning tissue ingrowth layer, the mesh woven substrate layer and the anti-adhesion layer are connected by at least one of spinning, thermal fusion, welding, bonding and suturing.

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