A repair patch and its application

Abstract

The present invention provides a repair patch and its application. The repair patch includes a first fixing layer, a first repair layer, and a particle support layer stacked in sequence. The repair patch provided by the present invention can strengthen the support for soft tissue defects, establish a good connection relationship with the damaged end of the host tissue, and reduce the displacement or deformation of the patch caused by changes in soft tissue tension. In addition, the repair patch provided by the present invention has good biocompatibility, can effectively reduce the occurrence of adhesions, and can promote tissue regeneration, improve the effect of regenerated tissue reconstruction, and achieve a better repair effect.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to a repair patch and its application. Background Art

[0002] A hernia refers to any organ or tissue that has left its original position and enters another part through a normal or abnormal congenital or acquired weakness, defect, or pore in the human body. Hernias are classified into direct inguinal hernias, indirect inguinal hernias, femoral hernias, umbilical hernias, linea alba hernias, incisional hernias, diaphragmatic hernias, etc. according to the location, and are classified into reducible hernias, irreducible hernias, incarcerated hernias, strangulated hernias, etc. according to their nature. Hernia repair is a common method for clinically treating hernias. In recent years, with the rapid development of materials science, various hernia repair materials have been widely applied in clinical practice, bringing about fundamental changes in the treatment of hernias. Currently, repair surgery has become a routine procedure adopted by clinicians for treating hernias.

[0003] CN102920528A discloses a hollowed-out membrane used as a hernia patch and its preparation method. The hollowed-out membrane used as a hernia patch is a polymer thin film with holes, and the polymer thin film with holes is used as a hernia patch; the thickness of the polymer thin film is 0.05 - 1.0 mm; the material of the polymer thin film is polyethylene, polypropylene, polyvinylidene fluoride, or polyethylene terephthalate. However, when using a polymer patch for hernia repair surgery, patients often experience chronic pain and a foreign body sensation, and adhesions, large fibrous capsules, and intestinal obstruction may occur.

[0004] CN108261565A discloses a hernia patch, a preparation method, and its application in hernia repair. The hernia patch is made from allogeneic skin raw materials by completely removing all cells that can cause host immune rejection reactions and intactly retaining the extracellular matrix identical to the original tissue structure; the tensile strength of the acellular allogeneic dermal matrix is 3.0 - 7.0 MPa, the suture strength is 18 - 22 N, the tensile elongation rate is 10 - 30%, and the bursting strength is 20 - 30 KPa. However, the patch made of acellular allogeneic dermal matrix used in this invention is prone to displacement and has poor connectivity with host tissues, which is not conducive to the fusion and regeneration of the regenerated tissue and host tissues.

[0005] CN112914785A discloses a hernia patch, including a hernia patch body. The hernia patch body is a sheet material with a reticular structure, and at least one elastic ring is arranged on the hernia patch body. The elastic ring has a greater resilience than the hernia patch body, and the elastic ring is made of a material that can be absorbed by the human body to solve the problems of blood vessel compression and foreign body sensation existing in the reinforcing ring of the existing hernia patch; however, the hernia patch provided by this invention has a risk of elastic ring fracture and does not have sufficient safety.

[0006] Generally, non-absorbable polymer patches are currently widely used in clinical tension-free hernia repair, such as polypropylene patches and expanded polytetrafluoroethylene patches. Their advantages are low price, good flexibility, tight combination with tissues, and a small shrinkage ratio of the patch after surgery. However, their disadvantages are also very obvious, often accompanied by chronic pain, foreign body sensation, adhesions, and the formation of large fibrous capsules and intestinal obstruction.

[0007] In recent years, the developed biological tissue hernia patch materials have, to a certain extent, made up for the disadvantages of polymer patches. The biological materials that have been approved by the US Food and Drug Administration (FDA) for clinical application in repairing adult hernias mainly come from human dermis, porcine small intestinal submucosa, porcine dermis, embryonic bovine dermis, etc. Their characteristics are low hernia recurrence rate, good biocompatibility, and significantly lower incidence of postoperative adverse reactions. However, such biological materials on the current market often lack the strength of synthetic tissues and cannot meet the physiological functions of natural diaphragmatic tissues. Therefore, for diseases such as diaphragmatic hernia, due to the often severe loss or dysfunction of muscle tissues, the repair effect of simply applying a patch is less than satisfactory.

[0008] Therefore, how to provide a repair patch that can not only play a good role in supporting and filling the defect, but also actively induce the regeneration of the patient's own defective tissues and organs, promote the repair of the morphological and functional structure of the defect, and achieve good integration with human tissues to achieve a better repair and treatment effect has become an urgent problem to be solved. Summary of the Invention

[0009] Aiming at the deficiencies of the prior art, the purpose of the present invention is to provide a repair patch and its application.

[0010] The repair patch provided by the present invention has high biocompatibility and biological safety while being able to repair defective tissues, achieve guided regeneration of defective tissues, and ultimately contribute to the repair of the morphological and functional structure of the defect, achieving a better repair effect.

[0011] To achieve the purpose of this invention, the present invention adopts the following technical solutions:

[0012] In the first aspect, the present invention provides a repair patch, which includes a first fixing layer, a first repair layer, and a particle support layer stacked in sequence.

[0013] The repair patch provided by the present invention can strengthen the support of soft tissue defects, reduce the displacement or deformation of the patch caused by changes in soft tissue tension, promote the establishment of a good connection relationship between the patch and the damaged end of the host tissue, promote tissue regeneration, and improve the reconstruction effect of soft tissue defects.

[0014] In the present invention, the first fixing layer covers the first repair layer, the first repair layer covers the particle support layer, and the particle support layer fills the inside of the defective tissue.

[0015] In the present invention, the first fixing layer comprises a biomaterial film.

[0016] Preferably, the biomaterial film comprises a decellularized matrix biomembrane and / or a polymer film, preferably a decellularized matrix biomembrane.

[0017] In the present invention, the decellularized matrix biomembrane refers to a biomembrane prepared from a decellularized matrix; the decellularized matrix refers to a material obtained by subjecting animal tissues to a decellularization process to remove antigenic components that can cause immune rejection reactions, while completely retaining the three-dimensional spatial structure of the extracellular matrix and some growth factors that play an important role in cell differentiation.

[0018] Preferably, the decellularized matrix biomembrane comprises a collagen matrix biomembrane.

[0019] Preferably, the first fixing layer is in a sheet structure.

[0020] Preferably, the cross-sectional shape of the first fixing layer includes any one or a combination of at least two of a rectangle, a square, a circle, an ellipse or a trapezoid, preferably a rectangle.

[0021] In the present invention, the cross-section of the first fixing layer may also be an irregular shape.

[0022] Preferably, the thickness of the first fixing layer is 0.05 - 3 mm, for example, it may be 0.05 mm, 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, etc.

[0023] In the present invention, one side of the first fixing layer is a smooth plane and the other side is a rough plane.

[0024] Preferably, in the first fixing layer, the pore diameter of the smooth plane is 0.05 - 25 μm, for example, it can be 0.05 μm, 0.08 μm, 0.1 μm, 0.2 μm, 0.3 μm, 0.8 μm, 1 μm, 2 μm, 3 μm, 4 μm, 5 μm, 6 μm, 7 μm, 8 μm, 9 μm, 10 μm, 11 μm, 12 μm, 13 μm, 14 μm, 15 μm, 16 μm, 17 μm, 18 μm, 19 μm, 20 μm, 21 μm, 22 μm, 23 μm, 24 μm, 25 μm, etc.; the porosity is 5 - 80%, for example, it can be 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, etc.

[0025] Preferably, in the first fixing layer, the pore diameter of the rough plane is 15 - 650 μm, for example, it can be 15 μm, 20 μm, 50 μm, 70 μm, 90 μm, 110 μm, 130 μm, 150 μm, 170 μm, 200 μm, 230 μm, 250 μm, 280 μm, 300 μm, 320 μm, 350 μm, 370 μm, 400 μm, 430 μm, 450 μm, 470 μm, 500 μm, 550 μm, 600 μm, 650 μm, etc.; the porosity is 30 - 95%, for example, it can be 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, etc.

[0026] Preferably, the rough plane of the first fixing layer faces the first repair layer, and the smooth plane faces the cavity.

[0027] In the present invention, while the first fixing layer plays a role in providing mechanical support for fixation, it can also reduce the interference of soft tissue tension changes on the first repair layer; in addition, the rough plane of the first fixing piece faces the first repair layer, and the smooth plane faces the cavity, which is beneficial to reducing the occurrence of adhesion.

[0028] In the present invention, the first repair layer includes a biomaterial membrane.

[0029] Preferably, the biomaterial membrane includes a decellularized matrix biomembrane and / or a polymer membrane, preferably a decellularized matrix biomembrane.

[0030] Preferably, the decellularized matrix biomembrane includes a collagen matrix biomembrane.

[0031] Preferably, the first repair layer is in a sheet structure.

[0032] Preferably, the cross-sectional shape of the first repair layer includes any one or a combination of at least two of a rectangle, a square, a circle, an ellipse, or a trapezoid, and is preferably a rectangle.

[0033] In the present invention, the cross-sectional shape of the first repair layer may also be an irregular shape.

[0034] Preferably, the thickness of the first repair layer is 0.05 - 3 mm, and may be, for example, 0.05 mm, 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, etc.

[0035] In the present invention, one side of the first repair layer is a smooth plane, and the other side is a rough plane.

[0036] Preferably, in the first repair layer, the pore diameter of the smooth plane is 0.05 - 25 μm, and may be, for example, 0.05 μm, 0.08 μm, 0.1 μm, 0.2 μm, 0.3 μm, 0.8 μm, 1 μm, 2 μm, 3 μm, 4 μm, 5 μm, 6 μm, 7 μm, 8 μm, 9 μm, 10 μm, 11 μm, 12 μm, 13 μm, 14 μm, 15 μm, 16 μm, 17 μm, 18 μm, 19 μm, 20 μm, 21 μm, 22 μm, 23 μm, 24 μm, 25 μm, etc.; the porosity is 5 - 80%, and may be, for example, 5%, 10%, 15%, 20%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, etc.

[0037] Preferably, in the first repair layer, the pore diameter of the rough plane is 15 - 650 μm, and may be, for example, 15 μm, 20 μm, 50 μm, 70 μm, 90 μm, 110 μm, 130 μm, 150 μm, 170 μm, 200 μm, 230 μm, 250 μm, 280 μm, 300 μm, 320 μm, 350 μm, 370 μm, 400 μm, 430 μm, 450 μm, 470 μm, 500 μm, 550 μm, 600 μm, 650 μm, etc., and the porosity is 30 - 95%, and may be, for example, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, etc.

[0038] Preferably, the rough plane of the first repair layer faces the inside of the defect tissue, and the smooth plane faces the first fixing layer.

[0039] In the present invention, the smooth plane of the first repair layer faces the first fixing layer, and the rough plane faces the inside of the defect tissue, which is beneficial for cells to grow into the first repair layer and promote tissue regeneration.

[0040] In the present invention, the particle support layer includes any one or a combination of at least two of acellular matrix particles, gelatin particles, hyaluronic acid particles, alginate particles, chitosan particles, poly(lactic-co-glycolic acid) copolymer particles or polylactic acid particles, preferably acellular matrix particles; the particle support layer can also be other types of medical biological particles.

[0041] Preferably, the acellular matrix particles include collagen matrix particles.

[0042] Preferably, the cross-sectional shape of the particles in the particle support layer includes any one or a combination of at least two of rectangle, square, circle, ellipse or trapezoid, preferably circle. The cross-sectional shape of the particles in the particle support layer can also be an irregular shape.

[0043] Preferably, the particle size of the particles is 10 - 1000 μm, for example, it can be 10 μm, 20 μm, 50 μm, 70 μm, 100 μm, 150 μm, 200 μm, 250 μm, 300 μm, 350 μm, 400 μm, 450 μm, 500 μm, 550 μm, 600 μm, 650 μm, 700 μm, 750 μm, 800 μm, 850 μm, 900 μm, 950 μm, 1000 μm, etc.; the distribution density of the particles is 50 - 10 6 pcs / cm 2 , for example, it can be 50 pcs / cm 2 , 100 pcs / cm 2 , 1000 pcs / cm 2 , 2000 pcs / cm 2 , 3000 pcs / cm 2 , 4000 pcs / cm 2 , 5000 pcs / cm 2 , 6000 pcs / cm 2 , 7000 pcs / cm 2 , 8000 pcs / cm 2 , 9000 pcs / cm 2 , 10000 pcs / cm 2 , 11000 pcs / cm 2 , 12000 pcs / cm 2 , 13000 pcs / cm2 、14,000 pieces / cm 2 、15,000 pieces / cm 2 、16,000 pieces / cm 2 、17,000 pieces / cm 2 、18,000 pieces / cm 2 、19,000 pieces / cm 2 、20,000 pieces / cm 2 、21,000 pieces / cm 2 、22,000 pieces / cm 2 、23,000 pieces / cm 2 、24,000 pieces / cm 2 、25,000 pieces / cm 2 、30,000 pieces / cm 2 、60,000 pieces / cm 2 、80,000 pieces / cm 2 、100,000 pieces / cm 2 、200,000 pieces / cm 2 、300,000 pieces / cm 2 、400,000 pieces / cm 2 、500,000 pieces / cm 2 、600,000 pieces / cm 2 、700,000 pieces / cm 2 、800,000 pieces / cm 2 、900,000 pieces / cm 2 、1,000,000 pieces / cm 2 etc.

[0044] In the present invention, while providing a tissue regeneration scaffold, the particle support layer has appropriate pores to promote the regeneration of damaged tissues.

[0045] In the present invention, the usage method of the biological patch specifically includes the following steps: during the surgical operation, the particle support layer is filled into the defect tissue; a first repair layer is covered at the defect position, and the first repair layer is densely sutured end-to-end with the wound, with the smooth plane facing the first fixation layer and the rough plane facing the inside of the defect tissue; a first fixation layer is covered outside the first repair layer, and the first fixation layer straddles the wound margin and is sutured with the host tissue. The rough plane of the first fixation layer faces the first repair layer, and the smooth plane faces the lumen.

[0046] In the present invention, the repair patch further includes a second repair layer and a second fixation layer.

[0047] Preferably, the repair patch includes a first fixation layer, a first repair layer, a particle support layer, a second repair layer, and a second fixation layer stacked in sequence.

[0048] Preferably, the second repair layer comprises a biomaterial film.

[0049] Preferably, the biomaterial film comprises a decellularized matrix biomembrane and / or a polymer film, preferably a decellularized matrix biomembrane.

[0050] Preferably, the decellularized matrix biomembrane comprises a collagen matrix biomembrane.

[0051] Preferably, the second repair layer is in a sheet structure.

[0052] Preferably, the cross-sectional shape of the second repair layer includes any one or a combination of at least two of a rectangle, a square, a circle, an ellipse, or a trapezoid, preferably a rectangle.

[0053] In the present invention, the cross-section of the second repair layer may also be an irregular shape.

[0054] Preferably, the thickness of the second repair layer is 0.05 - 3 mm, for example, it may be 0.05 mm, 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, etc.

[0055] Preferably, one side of the second repair layer is a smooth plane and the other side is a rough plane.

[0056] Preferably, in the second repair layer, the pore diameter of the smooth plane is 0.05 - 25 μm, for example, it may be 0.05 μm, 0.08 μm, 0.1 μm, 0.2 μm, 0.3 μm, 0.8 μm, 1 μm, 2 μm, 3 μm, 4 μm, 5 μm, 6 μm, 7 μm, 8 μm, 9 μm, 10 μm, 11 μm, 12 μm, 13 μm, 14 μm, 15 μm, 16 μm, 17 μm, 18 μm, 19 μm, 20 μm, 21 μm, 22 μm, 23 μm, 24 μm, 25 μm, etc.; the porosity is 5 - 80%, for example, it may be 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, etc.

[0057] Preferably, in the second repair layer, the pore diameter in the rough plane is 15 - 650 μm, for example, it can be 15 μm, 20 μm, 50 μm, 70 μm, 90 μm, 110 μm, 130 μm, 150 μm, 170 μm, 200 μm, 230 μm, 250 μm, 280 μm, 300 μm, 320 μm, 350 μm, 370 μm, 400 μm, 430 μm, 450 μm, 470 μm, 500 μm, 550 μm, 600 μm, 650 μm, etc.; the porosity is 30 - 95%, for example, it can be 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, etc.

[0058] Preferably, the rough plane of the second repair layer faces the interior of the defective tissue, and the smooth plane faces the second fixing layer.

[0059] Preferably, the second fixing layer includes a biomaterial membrane.

[0060] Preferably, the biomaterial membrane includes a decellularized matrix biomembrane and / or a polymer membrane, preferably a decellularized matrix biomembrane.

[0061] Preferably, the decellularized matrix biomembrane includes a collagen matrix biomembrane.

[0062] Preferably, the second fixing layer is in a sheet structure.

[0063] Preferably, the cross-sectional shape of the second fixing layer includes any one or a combination of at least two of a rectangle, a square, a circle, an ellipse, or a trapezoid, preferably a rectangle.

[0064] In the present invention, the cross-sectional shape of the second fixing layer can also be an irregular shape.

[0065] Preferably, the thickness of the second fixing layer is 0.05 - 3 mm, for example, it can be 0.05 mm, 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, etc.

[0066] In the present invention, one side of the second fixing layer is a smooth plane, and the other side is a rough plane.

[0067] Preferably, in the second fixing layer, the pore diameter of the smooth plane is 0.05 - 25 μm, for example, it can be 0.05 μm, 0.08 μm, 0.1 μm, 0.2 μm, 0.3 μm, 0.8 μm, 1 μm, 2 μm, 3 μm, 4 μm, 5 μm, 6 μm, 7 μm, 8 μm, 9 μm, 10 μm, 11 μm, 12 μm, 13 μm, 14 μm, 15 μm, 16 μm, 17 μm, 18 μm, 19 μm, 20 μm, 21 μm, 22 μm, 23 μm, 24 μm, 25 μm, etc.; the porosity is 5 - 80%, for example, it can be 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, etc.

[0068] Preferably, in the second fixing layer, the pore diameter of the rough plane is 15 - 650 μm, for example, it can be 15 μm, 20 μm, 50 μm, 70 μm, 90 μm, 110 μm, 130 μm, 150 μm, 170 μm, 200 μm, 230 μm, 250 μm, 280 μm, 300 μm, 320 μm, 350 μm, 370 μm, 400 μm, 430 μm, 450 μm, 470 μm, 500 μm, 550 μm, 600 μm, 650 μm, etc.; the porosity is 30 - 95%, for example, it can be 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, etc.

[0069] Preferably, the rough plane of the second fixing layer faces the second repair layer, and the smooth plane faces the cavity.

[0070] The present invention is a multi - part composite design. The first repair layer, the second repair layer, the first fixing layer, and the second fixing layer can all be appropriately cut according to needs, and the particle support layer is filled as required. It has a three - dimensional structure and fits the human anatomy. The repair layers (the first repair layer and the second repair layer) and the fixing layers (the first fixing layer and the second fixing layer) are preferably collagen - matrix biofilms, which have the advantages of good biocompatibility, high biosafety, and biodegradability while playing the roles of isolation and mechanical support.

[0071] In the present invention, the repair patch includes a first fixing layer, a first repair layer, a particle support layer, a second repair layer, and a second fixing layer stacked in sequence.

[0072] Among them, when performing diaphragmatic hernia repair, the first repair layer covers the upper part (thoracic cavity side) of the diaphragmatic defect tissue, and the second repair layer covers the lower part (abdominal cavity side) of the diaphragmatic defect tissue; the smooth plane of the first repair layer faces the first fixing layer, and the rough plane faces the inside of the diaphragmatic defect tissue; the smooth plane of the second repair layer faces the second fixing layer, and the rough plane faces the inside of the diaphragmatic defect tissue; the first fixing layer covers the first repair layer, and the second fixing layer covers the second repair layer; the rough plane of the first fixing layer faces the first repair layer, and the smooth plane faces the thoracic cavity; the rough plane of the second fixing layer faces the second repair layer, and the smooth plane faces the abdominal cavity; the particle support layer is located between the first repair layer and the second repair layer.

[0073] In the present invention, the method of using the biological patch specifically includes the following steps: For example, when performing a diaphragmatic hernia repair operation, first fill the particle support layer into the diaphragmatic hernia defect site; then cover the first repair layer at the defect position on the diaphragm (thoracic cavity side), and cover the second repair layer at the defect position under the diaphragm (abdominal cavity side). The repair layer is tightly sutured end-to-end with the wound. The smooth plane of the first repair layer faces the first fixing layer, and the rough plane faces the inside of the defect tissue. The smooth plane of the second repair layer faces the second fixing layer, and the rough plane faces the inside of the defect tissue. The first fixing layer is covered outside the first repair layer, and the second fixing layer is covered outside the second repair layer. The fixing layer spans the wound margin and is sutured to the host tissue. The rough plane of the first fixing layer faces the first repair layer, and the smooth plane faces the thoracic cavity. The rough plane of the second fixing layer faces the second repair layer, and the smooth plane faces the abdominal cavity.

[0074] In a second aspect, the present invention provides an application of the repair patch as described in the first aspect in the preparation of materials for treating hernias and / or tissue fistulas.

[0075] In the present invention, the repair patch can be used to prepare materials for treating diaphragmatic hernias, umbilical hernias, direct inguinal hernias, indirect inguinal hernias, femoral hernias, etc.

[0076] Among them, the repair patch for preparing materials for treating diaphragmatic hernias includes, in sequence, a first fixing layer, a first repair layer, a particle support layer, a second repair layer, and a second fixing layer.

[0077] Among them, the repair patch for preparing materials for treating umbilical hernias, direct inguinal hernias, indirect inguinal hernias, femoral hernias, etc. includes, in sequence, a first fixing layer, a first repair layer, and a particle support layer.

[0078] In the present invention, the repair patch can be used to prepare tissue fistulas such as rectovaginal fistulas, vesicovaginal fistulas, esophageal fistulas, airway fistulas, etc.

[0079] Among them, the repair patch includes a first fixing layer, a first repair layer, a particle support layer, a second repair layer, and a second fixing layer that are stacked in sequence.

[0080] Compared with the prior art, the present invention has the following beneficial effects:

[0081] (1) The repair patch provided by the present invention can strengthen the support for soft tissue defects, establish a good connection relationship with the damaged end of the host tissue, and reduce the displacement or deformation of the patch caused by changes in soft tissue tension.

[0082] (2) The repair patch provided by the present invention has good biocompatibility, can reduce the occurrence of adhesions, and can promote tissue regeneration, improve the effect of regenerated tissue reconstruction, so as to achieve a better repair effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0083] Figure 1 Schematic diagram of the structure of the repair patch provided in Example 1;

[0084] Among them, 1 is the first fixing layer; 2 is the first repair layer; 3 is the particle support layer; 4 is the second repair layer; 5 is the second fixing layer.

[0085] Figure 2 Schematic diagram of the structure of the repair patch provided in Example 9;

[0086] Among them, 1 is the first fixing layer; 2 is the first repair layer; 3 is the particle support layer.

[0087] Figure 3 Preoperative X-ray film of the short-haired cat in Test Example 2.

[0088] Figure 4 Postoperative X-ray film of the short-haired cat on the 6th day in Test Example 2.

[0089] Figure 5 Postoperative X-ray film of the short-haired cat on the 8th day in Test Example 2.

[0090] Figure 6 Postoperative X-ray film of the short-haired cat on the 16th day in Test Example 2.

[0091] Figure 7 Postoperative X-ray film of the short-haired cat on the 49th day in Test Example 2. DETAILED DESCRIPTION OF THE INVENTION

[0092] The technical solution of the present invention will be further described below through specific embodiments. Those skilled in the art should understand that the embodiments are only for helping to understand the present invention and should not be regarded as specific limitations to the present invention.

[0093] In the following embodiments, the sources of various materials and reagents are as follows:

[0094] The polypropylene mesh uses the Hemei brand;

[0095] The preparation method of the chitosan microspheres includes the following steps:

[0096] It is prepared by the reverse emulsion-crosslinking method. The specific steps include: taking 300 mg of chitosan (molecular weight about 130 kDa, deacetylation degree about 96%), dissolving it in 10 mL of 0.01 wt% acetic acid aqueous solution, standing still, and removing air bubbles; adding 20 mg of polyethylene glycol (molecular weight 4000) and 20 mg of adenosine monophosphate to the above solution, mixing evenly as the aqueous phase; slowly dripping the aqueous phase into 80 mL of the oil phase containing 5% (v / v) surfactant span@80 and 0.5% mass concentration of dispersant liquid paraffin, stirring rapidly, emulsifying completely to form a W / O system; slowly dripping 20 mL of the crosslinking agent (0.1 M NaOH ethanol solution, 2% (v / v) divinyl sulfone solution) into the W / O system, stirring rapidly, crosslinking and curing to form bead-like particles; collecting the precipitate, filtering by suction, dehydrating and washing with organic solvents, and drying to obtain chitosan microspheres.

[0097] Example 1

[0098] This example provides a diaphragmatic hernia repair patch, which includes a first fixing layer, a first repair layer, a particle support layer, a second repair layer and a second fixing layer stacked in sequence.

[0099] Among them, the fixing layer (the first fixing layer and the second fixing layer) is a collagen matrix biomembrane; the cross-section of the fixing layer is rectangular; the thickness of the fixing layer is 0.5 mm; one side of the fixing layer is a smooth plane and the other side is a rough plane; the pore diameter of the smooth plane is 10 μm and the porosity is 20%; the pore diameter of the rough plane is 200 μm and the porosity is 80%;

[0100] Among them, the repair layer (the first repair layer and the second repair layer) is a collagen matrix biomembrane; the cross-section of the repair layer is rectangular; the thickness of the repair layer is 0.5 mm; one side of the repair layer is a smooth plane and the other side is a rough plane; the pore diameter of the smooth plane is 10 μm and the porosity is 20%; the pore diameter of the rough plane is 200 μm and the porosity is 80%;

[0101] Among them, the particle support layer is collagen matrix particles, the cross-section of the particles in the particle support layer is circular, the particle size of the particles is 200 μm, and the distribution density of the particles is 200 pieces / cm 2 。

[0102] Such as Figure 1As shown in the figure, it is a schematic structural diagram of the repair patch provided in Embodiment 1; among them, 1 is the first fixing layer; 2 is the first repair layer; 3 is the particle support layer; 4 is the second repair layer; 5 is the second fixing layer;

[0103] Among them, the first repair layer 2 covers the upper part of the diaphragmatic defect tissue, and the second repair layer 4 covers the lower part of the diaphragmatic defect tissue; the smooth plane of the first repair layer 2 faces the first fixing layer 1, and the rough plane faces the inside of the diaphragmatic defect tissue; the smooth plane of the second repair layer 4 faces the second fixing layer 5, and the rough plane faces the inside of the diaphragmatic defect tissue; the first fixing layer 1 covers the first repair layer 2, and the second fixing layer 5 covers the second repair layer 4; the rough plane of the first fixing layer 1 faces the first repair layer 2, and the smooth plane faces the thoracic cavity; the rough plane of the second fixing layer 5 faces the second repair layer 4, and the smooth plane faces the abdominal cavity; the particle support layer 3 is located between the first repair layer 2 and the second repair layer 4.

[0104] Among them, the collagen matrix biofilm is prepared according to the preparation method provided in Example 1 of CN113368313A.

[0105] Among them, the preparation method of the collagen matrix particles includes the following steps: cut the collagen matrix biofilm into pieces with scissors.

[0106] Embodiment 2

[0107] This embodiment provides a diaphragmatic hernia repair patch, which includes a first fixing layer, a first repair layer, a particle support layer, a second repair layer and a second fixing layer stacked in sequence.

[0108] Among them, the fixing layer (the first fixing layer and the second fixing layer) is a collagen matrix biofilm; the cross-section of the fixing layer is rectangular; the thickness of the fixing layer is 1.5 mm; one side of the fixing layer is a smooth plane and the other side is a rough plane; the pore diameter of the smooth plane is 12 μm and the porosity is 18%; the pore diameter of the rough plane is 210 μm and the porosity is 75%;

[0109] Among them, the repair layer (the first repair layer and the second repair layer) is a collagen matrix biofilm; the cross-section of the repair layer is rectangular; the thickness of the repair layer is 1.0 mm; one side of the repair layer is a smooth plane and the other side is a rough plane; the pore diameter of the smooth plane is 12 μm and the porosity is 18%; the pore diameter of the rough plane is 210 μm and the porosity is 75%;

[0110] Among them, the particle support layer is collagen matrix particles, the cross-section of the particles in the particle support layer is circular, the particle size of the particles is 210 μm, and the distribution density of the particles is 190 per cm2 .

[0111] Among them, the first repair layer covers the upper part of the diaphragmatic defect tissue, and the second repair layer covers the lower part of the diaphragmatic defect tissue; the smooth plane of the first repair layer faces the first fixing layer, and the rough plane faces the inside of the diaphragmatic defect tissue; the smooth plane of the second repair layer faces the second fixing layer, and the rough plane faces the inside of the diaphragmatic defect tissue; the first fixing layer covers the first repair layer, and the second fixing layer covers the second repair layer; the rough plane of the first fixing layer faces the first repair layer, and the smooth plane faces the thoracic cavity; the rough plane of the second fixing layer faces the second repair layer, and the smooth plane faces the abdominal cavity; the particle support layer is located between the first repair layer and the second repair layer.

[0112] The preparation methods of the collagen matrix biomembrane and the collagen matrix particles are the same as those in Example 1.

[0113] Example 3

[0114] This example provides a diaphragmatic hernia repair patch, which includes a first fixing layer, a first repair layer, a particle support layer, a second repair layer and a second fixing layer stacked in sequence.

[0115] Among them, the fixing layer (the first fixing layer and the second fixing layer) is a collagen matrix biomembrane; the cross-section of the fixing layer is rectangular; the thickness of the fixing layer is 0.8 mm; one side of the fixing layer is a smooth plane, and the other side is a rough plane; the pore diameter of the smooth plane is 9 μm, and the porosity is 35%; the pore diameter of the rough plane is 190 μm, and the porosity is 83%;

[0116] Among them, the repair layer (the first repair layer and the second repair layer) is a collagen matrix biomembrane; the cross-section of the repair layer is rectangular; the thickness of the repair layer is 0.9 mm; one side of the repair layer is a smooth plane, and the other side is a rough plane; the pore diameter of the smooth plane is 9 μm, and the porosity is 35%; the pore diameter of the rough plane is 190 μm, and the porosity is 83%;

[0117] Among them, the particle support layer is collagen matrix particles, the cross-section of the particles in the particle support layer is circular, the particle size of the particles is 190 μm, and the distribution density of the particles is 210 pieces / cm 2 .

[0118] Among them, the first repair layer covers the upper part of the diaphragmatic defect tissue, and the second repair layer covers the lower part of the diaphragmatic defect tissue; the smooth plane of the first repair layer faces the first fixing layer, and the rough plane faces the inside of the diaphragmatic defect tissue; the smooth plane of the second repair layer faces the second fixing layer, and the rough plane faces the inside of the diaphragmatic defect tissue; the first fixing layer covers the first repair layer, and the second fixing layer covers the second repair layer; the rough plane of the first fixing layer faces the first repair layer, and the smooth plane faces the thoracic cavity; the rough plane of the second fixing layer faces the second repair layer, and the smooth plane faces the abdominal cavity; the particle support layer is located between the first repair layer and the second repair layer.

[0119] The preparation methods of the collagen matrix biofilm and the collagen matrix particles are the same as those in Example 1.

[0120] Example 4

[0121] This example provides a diaphragmatic hernia repair patch. The difference from Example 1 is only that the fixing layers (the first fixing layer and the second fixing layer) are polypropylene mesh sheets, and other structures are the same as those in Example 1.

[0122] Example 5

[0123] This example provides a diaphragmatic hernia repair patch. The difference from Example 1 is only that the repair layers (the first repair layer and the second repair layer) are polypropylene mesh sheets, and other structures are the same as those in Example 1.

[0124] Example 6

[0125] This example provides a diaphragmatic hernia repair patch. The difference from Example 1 is only that the particle support layer is chitosan microspheres.

[0126] Example 7

[0127] This example provides a diaphragmatic hernia repair patch. The difference from Example 1 is only that both sides of the fixing layers (the first fixing layer and the second fixing layer) are smooth planes.

[0128] Example 8

[0129] This example provides a diaphragmatic hernia repair patch. The difference from Example 1 is only that both sides of the repair layers (the first repair layer and the second repair layer) are smooth planes.

[0130] Example 9

[0131] This example provides an umbilical hernia, direct inguinal hernia, indirect inguinal hernia or femoral hernia repair patch. The repair patch includes a first fixing layer, a first repair layer and a particle support layer stacked in sequence.

[0132] Among them, the first fixing layer is a collagen matrix biofilm; the cross-section of the first fixing layer is rectangular; the thickness of the first fixing layer is 1.1 mm; one side of the first fixing layer is a smooth plane and the other side is a rough plane; the pore diameter of the smooth plane is 10 μm and the porosity is 20%; the pore diameter of the rough plane is 200 μm and the porosity is 80%.

[0133] Among them, the first repair layer is a collagen matrix biofilm; the cross-section of the first repair layer is rectangular; the thickness of the first repair layer is 1.0 mm; one side of the first repair layer is a smooth plane and the other side is a rough plane; the pore diameter of the smooth plane is 10 μm and the porosity is 20%; the pore diameter of the rough plane is 200 μm and the porosity is 80%.

[0134] Among them, the particle support layer is collagen matrix particles. The cross-section of the particles in the particle support layer is circular. The particle size of the particles is 200 μm, and the distribution density of the particles is 200 particles / cm 2 .

[0135] As Figure 2 shown, the schematic structural diagram of the repair patch provided in Example 9; among them, 1 is the first fixing layer; 2 is the first repair layer; 3 is the particle support layer;

[0136] Among them, the smooth plane of the first repair layer 2 faces the first fixing layer 1, and the rough plane faces the inside of the defect tissue; the first fixing layer 1 covers the first repair layer 2. The rough plane of the first fixing layer 1 faces the first repair layer 2, and the smooth plane faces the lumen; the particle support layer 3 is located inside the defect tissue.

[0137] Comparative Example 1

[0138] This comparative example provides a diaphragmatic hernia repair patch. The difference from Example 1 is only that the fixing layer (the first fixing layer and the second fixing layer) is missing, and other structures are the same as those in Example 1.

[0139] Comparative Example 2

[0140] This comparative example provides a diaphragmatic hernia repair patch. The difference from Example 1 is only that the repair layer (the first repair layer and the second repair layer) is missing, and other structures are the same as those in Example 1.

[0141] Comparative Example 3

[0142] This comparative example provides a diaphragmatic hernia repair patch. The difference from Example 1 is only that the particle support layer is missing, and other structures are the same as those in Example 1.

[0143] Test Example 1

[0144] Animal experiment

[0145] Test samples: The repair patches provided in Examples 1-8 and Comparative Examples 1-3

[0146] Test method: Fifty-five New Zealand white rabbits, weighing between 1.5 - 3.0 Kg, were divided into 11 groups with 5 rabbits in each group. They were anesthetized, and after disinfection, a median upper incision was made. The falciform ligament was transected and the liver was pulled down to fully expose the diaphragm. An approximately 1 / 3 area defect region hole was incised on the left diaphragm to understand the area of the rabbit diaphragm and further confirm the size of the defect. A positive pressure ventilation device was used during the operation. Subsequently, the patch was sutured to the diaphragm defect and the wound was sutured. Biochemical tests were performed on the blood of New Zealand rabbits before surgery and 7 days after surgery to observe the impact of the infection on the body; they were sacrificed and dissected for sampling 30 days after surgery to observe the implantation changes of the repair patch, and to evaluate the anti-adhesion performance of the repair patch and its role in promoting tissue regeneration.

[0147] (1) Anti-adhesion test

[0148] The anti-adhesion effect was evaluated 30 days after surgery, including the degree of adhesion, adhesion area, and adhesion incidence rate. The grading standard for the degree of adhesion was: 0 points - no adhesion; 1 point - tissue adhesion can be separated by gravity; 2 points - tissue adhesion requires blunt dissection; 3 points - tissue adhesion requires sharp dissection. The grading standard for the adhesion area was: 0 points - no adhesion; 1 point - ≤25% of the surface had adhesion, with an average of 12.5%; 2 points - 26 - 50% of the surface had adhesion, with an average of 37.5%; 3 points - 51 - 75% of the surface had adhesion, with an average of 63%; 4 points - ≥76% of the surface had adhesion, with an average of 88%. Vertical high-definition cameras were used to photograph the patches with adhesion, and they were processed using Photoshop and SiconImage software to calculate the adhesion area. The adhesion incidence rate was the percentage ratio of the number of animals with adhesion to the total number in the same group (5 in each group);

[0149] The experimental results are shown in Table 1:

[0150] Table 1

[0151] Sample Degree of adhesion Incidence of adhesion (%) Example 1 0 0 Example 2 0 0 Example 3 0 0 Example 4 3 60 Example 5 2 40 Example 6 2 40 Example 7 1 20 Example 8 1 20 Comparative Example 1 1 20 Comparative Example 2 1 20 Comparative Example 3 1 20

[0152] As can be seen from the data in Table 1, the adhesion incidence rate of the repair patches provided by the present invention (Examples 1-8) was 0 - 60%. The repair patches provided by the preferred technical solutions (Examples 1-3) could avoid the occurrence of adhesion.

[0153] By comparing Example 1 with Examples 4-8, it can be seen that using the repair patches provided in Examples 4-8 would cause adhesion in New Zealand white rabbits, indicating that the material selection and the rough condition of the material surface would affect the adhesion condition.

[0154] It can be seen from the comparison between the examples and Comparative Examples 1-3 that when any one of the fixing layer (the first fixing layer and the second fixing layer), the repair layer (the first repair layer and the second repair layer), or the particle support layer is missing, adhesion will occur; and the reason for the adhesion may be related to the slow tissue regeneration speed.

[0155] (2) Evaluation of tissue regeneration and reconstruction effect

[0156] Thirty days after the operation, observe the area of the newly formed tissue around the patch, and use Van-Gieson to calculate the proportion of the newly formed tissue area in the total area of the defective tissue. The experimental results are the average of each group of experiments;

[0157] The experimental results are shown in Table 2:

[0158] Table 2

[0159] Group Percentage of newly formed tissue 30 days after surgery (%) Example 1 15.7 Example 2 14.6 Example 3 13.8 Example 4 4.1 Example 5 4.7 Example 6 5.1 Example 7 9.1 Example 8 9.3 Comparative Example 1 8.2 Comparative Example 2 7.4 Comparative Example 3 5.6

[0160] It can be seen from the data in Table 2 that 30 days after using the repair patch provided by the present invention (Examples 1-8), the proportion of the newly formed tissue is 4.1-15.7%; 30 days after using the repair patch provided by the preferred technical solution (Examples 1-3), the proportion of the newly formed tissue is 13.8-15.7%; it shows that the repair patch provided by the present invention can promote the regeneration of defective tissues.

[0161] A large number of blood vessels and tissues have regenerated around the repair patches provided in Examples 1-3. The repair patches are closely combined with blood vessels and tissues around them, showing good tissue repair effects; while using the repair patches provided in Comparative Examples 1-3, there are few newly formed tissues and blood vessels around the repair patches, and no good effect of promoting tissue regeneration is shown.

[0162] (3) Observe the morphological changes of the repair patch in the animal body

[0163] Observe the morphological changes of the patch 7 days, 14 days, and 30 days after it is implanted into the animal body;

[0164] The repair patches provided in Examples 1-8 have a good morphology in the organism, without any shedding or shrinking.

[0165] Test Example 2

[0166] Clinical case

[0167] A 5-month-old stray Chinese shorthair cat presented with dyspnea. Digital radiography (DR examination) showed that the abdominal viscera occupied the thoracic cavity; an exploratory laparotomy was performed for repair, and a large diaphragmatic defect was found. The liver and intestine in the abdominal cavity occupied the thoracic cavity. The viscera were displaced back into the abdominal cavity, and the repair patch described in Example 1 of the present invention was used to repair the diaphragmatic hernia and guide the regeneration of the diaphragm.

[0168] As Figure 3 shown, a short-haired cat was found to have a diaphragmatic hernia during preoperative X-ray examination, with abdominal organs entering the thoracic cavity and compressing the lungs; as Figure 4 shown, on the 6th day after surgery, the short-haired cat gradually recovered; as Figure 5 shown, on the 8th day after surgery, the short-haired cat was in the recovery period; as Figure 6 shown, on the 16th day after surgery, the organs of the short-haired cat were fixed well and the diaphragm was well protected; as Figure 7 shown, on the 49th day after surgery, the short-haired cat recovered well.

[0169] The applicant declares that the present invention uses the above embodiments to illustrate a repair patch and its application of the present invention, but the present invention is not limited to the above embodiments, that is, it does not mean that the present invention must rely on the above embodiments to be implemented. Those skilled in the art should understand that any improvement of the present invention, the equivalent substitution of each raw material of the product of the present invention, the addition of auxiliary components, the selection of specific methods, etc., all fall within the protection scope and the disclosure scope of the present invention.

Claims

1. A repair patch, characterized in that, The repair patch includes a first fixation layer, a first repair layer, a particle support layer, a second repair layer and a second fixation layer; The first fixation layer, the first repair layer, the second repair layer and the second fixation layer include biomaterial membranes; One side of the first fixation layer, the first repair layer, the second repair layer and the second fixation layer is a smooth plane, and the other side is a rough plane; Wherein, the first repair layer covers the upper part of the defective tissue, and the second repair layer covers the lower part of the defective tissue; the smooth plane of the first repair layer faces the first fixation layer, and the rough plane faces the inside of the defective tissue; the smooth plane of the second repair layer faces the second fixation layer, and the rough plane faces the inside of the defective tissue; the first fixation layer covers the first repair layer, and the second fixation layer covers the second repair layer; the rough plane of the first fixation layer faces the first repair layer, and the smooth plane faces the lumen; the rough plane of the second fixation layer faces the second repair layer, and the smooth plane faces the lumen; the particle support layer is located between the first repair layer and the second repair layer; the particle support layer fills the inside of the defective tissue; The particle support layer is acellular matrix particles; the acellular matrix particles include collagen matrix particles.

2. The repair patch according to claim 1, characterized in that The biomaterial membrane includes an acellular matrix biomembrane and / or a polymer membrane.

3. The repair patch according to claim 2, characterized in that, The biomaterial membrane is an acellular matrix biomembrane.

4. The repair patch according to claim 3, characterized in that, The acellular matrix biomembrane includes a collagen matrix biomembrane.

5. The repair patch according to claim 1, characterized in that, The first fixation layer is a sheet structure.

6. The repair patch according to claim 1, wherein, The cross-sectional shape of the first fixation layer includes any one or a combination of at least two of a rectangle, a square, a circle, an ellipse or a trapezoid.

7. The repair patch according to claim 6, characterized in that, The cross-sectional shape of the first fixation layer is a rectangle.

8. The repair patch according to claim 1, characterized in that, The thickness of the first fixation layer is 0.05 - 3 mm.

9. The repair patch according to claim 1, characterized in that, In the first fixation layer, the pore diameter of the smooth plane is 0.05 - 25 μm, and the porosity is 5 - 80%.

10. The repair patch according to claim 1, characterized in that, In the first fixation layer, the pore diameter of the rough plane is 15 - 650 μm, and the porosity is 30 - 95%.

11. The repair patch according to claim 1, characterized in that, The first repair layer is a sheet structure.

12. The repair patch according to claim 1, characterized in that, The cross-sectional shape of the first repair layer includes any one or a combination of at least two of a rectangle, a square, a circle, an ellipse or a trapezoid.

13. The repair patch according to claim 12, wherein The cross-sectional shape of the first repair layer is a rectangle.

14. The repair patch according to claim 1, characterized in that, The thickness of the first repair layer is 0.05 - 3 mm.

15. The repair patch according to claim 1, wherein, In the first repair layer, the pore diameter of the smooth plane is 0.05 - 25 μm, and the porosity is 5 - 80%.

16. The repair patch according to claim 1, characterized in that, In the first repair layer, the pore diameter of the rough plane is 15 - 650 μm, and the porosity is 30 - 95%.

17. The repair patch according to claim 1, wherein, The cross-sectional shape of the particles in the particle support layer includes any one or a combination of at least two of a rectangle, a square, a circle, an ellipse or a trapezoid.

18. The repair patch according to claim 17, wherein The cross-sectional shape of the particles in the particle support layer is a circle.

19. The repair patch according to claim 1, characterized in that, The particle size of the particles in the particle support layer is 10 - 1000 μm, and the distribution density of the particles in the particle support layer is 50 - 10 6 pieces / cm 2 .

20. The repair patch according to claim 1, characterized in that, The second repair layer is a sheet structure.

21. The repair patch according to claim 1, characterized in that, The cross-sectional shape of the second repair layer includes any one or a combination of at least two of a rectangle, a square, a circle, an ellipse or a trapezoid.

22. The repair patch according to claim 21, characterized in that, The cross-sectional shape of the second repair layer is a rectangle.

23. The repair patch according to claim 1, characterized in that, The thickness of the second repair layer is 0.05 - 3 mm.

24. The repair patch according to claim 1, characterized in that, In the second repair layer, the pore diameter of the smooth plane is 0.05 - 25 μm, and the porosity is 5 - 80%.

25. The repair patch according to claim 1, characterized in that, In the second repair layer, the pore diameter of the rough plane is 15 - 650 μm, and the porosity is 30 - 95%.

26. The repair patch according to claim 1, characterized in that, The second fixing layer is in a sheet structure.

27. The repair patch according to claim 1, characterized in that, The cross-sectional shape of the second fixing layer includes any one or a combination of at least two of rectangle, square, circle, ellipse or trapezoid.

28. The repair patch according to claim 27, characterized in that, The cross-sectional shape of the second fixing layer is a rectangle.

29. The repair patch according to claim 1, characterized in that, The thickness of the second fixing layer is 0.05 - 3 mm.

30. The repair patch according to claim 1, characterized in that, In the second fixing layer, the pore diameter of the smooth plane is 0.05 - 25 μm, and the porosity is 5 - 80%.

31. The repair patch according to claim 1, characterized in that, In the second fixing layer, the pore diameter of the rough plane is 15 - 650 μm, and the porosity is 30 - 95%.

32. Use of a repair patch according to any one of claims 1 - 31 in the preparation of a material for treating hernia and / or tissue fistula.

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