CN1830492B - bioprotein artificial meninges - Google Patents

Abstract

Translated fromChinese

本发明为生物蛋白人工脑膜片，以解决现有人工脑膜容易被吸收而不利于之后的颅骨修补手术等技术问题，属于医疗外科、尤其脑外科的修补材料。它包括有可植入性的医用硅胶片和生物蛋白人工硬脑膜，该硅胶片的厚度不大于1mm，其两面为生物蛋白人工硬脑膜。该人工脑膜片在脑膜缺损修补时，其生物蛋白人工脑膜容易被人体组织吸收，有利脑膜的修补，而其中的医用硅胶片不易吸收，有利于之后的颅骨修补手术等，从而避免了硅胶片直接接触脑组织等所引起的组织刺激和排异反应的发生。

The invention is a biological protein artificial meninges sheet, which solves the technical problems that the existing artificial meninges are easily absorbed and is not conducive to subsequent cranioplasty operations, and belongs to the repair material for medical surgery, especially brain surgery. It includes an implantable medical silica gel sheet and a bioprotein artificial dura mater, the thickness of the silica gel sheet is not greater than 1mm, and both sides of the silica gel sheet are bioprotein artificial dura mater. When the artificial meningeal sheet repairs meningeal defects, its biological protein artificial meninges are easily absorbed by human tissue, which is beneficial to meningeal repair, while the medical silica gel sheet is not easy to absorb, which is beneficial to subsequent skull repair operations, etc., thereby avoiding direct contact with the silicone sheet Occurrence of tissue irritation and rejection reactions caused by contact with brain tissue, etc.

Description

Bioprotein artificial meninges sheet

Technical field

The present invention relates to a kind of medical surgery, especially the patching material of department of cerebral surgery is a kind of bioprotein artificial meninges sheet.

Background technology

Geneogenous defect of meninges, or the defect of meninges that is caused because of wound and neurosurgery postoperative can cause the serious phenomenon of leakage, thereby jeopardize human life.This just needs shutoff, and it is damaged or/and leak.At present, the Clinical Processing mode is mainly the direct damaged place of stitching of using artificial dura mater patching material and using artificial dura mater patching material directly pastes two kinds of forms at damaged place, that can sew up and paste 2 kinds of formulas, corresponding patching material be divided into can sew up and paste two kinds of artificial dura mater patching materials of formula.This dual mode and used patching material all have shortcoming separately.The former is stitched together self meninges, so only be fit to little leak, presses the patient of cerebral hernia decompression hindbrain bulging for acute high cranium, the sew application difficulty, and when sewing up, injure cerebral tissue easily.It is synthetic by bioprotein pasting the artificial meninges of using at damaged place, is pure bioprotein film, though have that pliable and tough shape is good, good springiness and an advantage such as absorption easily; Yet at clinicing aspect, when using this bioprotein film to carry out the defect of meninges reparation, on the one hand, existence pastes not tight, forms the outer hydrops of meninges; On the other hand, owing to can absorb, when making skull repairing in the later stage, artificial meninges is absorbed and lacks protection to meninges, is easy to accidentally injure cerebral tissue, and cerebrospinal fluid spills, and forms the postoperative hypohydrops.Therefore, ideal artificial meninges should be to meet following condition: 1, have reliable intensity and good pliability, elasticity; Can bear certain power when surgical repair and after repairing and produce distortion and not damaged.2, has good biological tissue's compatibility, no foreign body rejection.3, can not be absorbed fully; Can play the effect of protection cerebral tissue, can play a part again to isolate scalp soft tissue and cerebral tissue well, make later cranioplasty surgery safer, reliable.At present, the artificial meninges of Shi Yonging is simple bioprotein clinically, as collagen protein artificial dura mater etc., can be absorbed fully, is unfavorable for post surgery treatment.Also do not possess the preferable artificial meninges that the artificial meninges defect repairing of above-mentioned three conditions is used simultaneously.Disclosed technical data also is the bioprotein meninges that simple material is made in the relevant patent documentation, be to disclose a kind of absorbability artificial dura mater in the Chinese patent literature of CN1155347C as notification number, though be double-decker, but its composition is absorbability, has above-mentioned defective in use equally.

Summary of the invention

The present invention be mainly solve existing when clinically defect of meninges being repaired used artificial meninges be absorbed easily, can't play abundant isolation scalp soft tissue and cerebral tissue effect and be unfavorable for problems such as cranioplasty surgery afterwards, and a kind of bioprotein artificial meninges sheet that not exclusively is absorbed and has good pliability, elasticity and biological tissue's compatibility is provided.

Bioprotein artificial meninges sheet of the present invention, include implantable medical silica-gel sheet and bioprotein artificial dura mater, the thickness of described implantable medical silica-gel sheet is not more than 1mm, plasticity deformation pressure takes place be not more than 20 millimetress of mercury, its deformation ratio minimum is 30%, and tensile strength is no less than 50 millimetress of mercury; The two sides of described implantable medical silica-gel sheet is the bioprotein artificial dura mater, and the above and below that forms implantable medical silica-gel sheet all has the composite construction of bioprotein artificial dura mater.

Have equally distributed through hole on the above-mentioned implantable medical silica-gel sheet, its adjacent holes is apart from being not more than 2 centimetres, and its aperture is 2～3 millimeters.

Be distributed with pit on the above-mentioned implantable medical silica-gel sheet surface, the depth capacity of its pit is less than 0.3 millimeter, and this pit is of a size of 2～3 millimeters.

Above-mentioned implantable medical silica-gel sheet and the contacted surface of bioprotein artificial dura mater stick into one by sending biological fibrin glue forth.

The diaphragm-operated thickness of brain of the present invention is not more than 3 millimeters, preferred 2.4 millimeters.

Above-mentioned silica gel sheet and bioprotein artificial dura mater are existing medical material, or are fit to the artificial meninges of bioprotein of human body through the prepared energy of common processes by prior art.As: get the tendon of animal, adopt biochemical the separation, extractive technique, the preparation biological collagen also forms membranaceous getting final product.

This meninges sheet is when carrying out the defect of meninges repairing, because its bioprotein artificial dura mater is absorbed by tissue easily, the repairing of favourable meninges, and medical silica-gel sheet wherein is difficult for absorbing, cranioplasty surgeries after helping etc., the artificial dura mater of this meninges sheet appearance has avoided the silica gel sheet directly to contact the generation of cerebral tissue and caused tissue stimulation of subcutaneous tissue and rejection.

Hole or select for use and the compact concaveconvex structure of artificial dura mater has distributed on the described medical silica-gel sheet, thereby the artificial dura mater on medical silica-gel sheet two sides is closely sticked together with the medical silica-gel sheet, and the silica gel sheet on two sides is consistent when producing physical change, similar to a monoblock artificial dura mater, has same pliability, elasticity, to alleviate intracranial pressure.This meninges sheet also has following characteristics in addition: 1, the present invention adopts the medical silica-gel sheet to be the bioprotein artificial dura mater outward, making it to have the bioprotein artificial dura mater can absorb, and the medical silica-gel sheet can not absorb double effects, has overcome the shortcoming that can absorb merely and can not absorb artificial meninges.Can directly it be covered on the brain surface when 2, operating, edge reuse bioprotein is gluing stifled, both can avoid leakage, and is simple to operate again.3, this meninges sheet has elasticity, pliability, can be good at alleviating intracranial pressure.4, because medical silica-gel sheet two sides is the bioprotein layer, and histocompatibility is good, can absorb, and merge, form pseudomembrane, avoid the silica gel sheet directly to contact cerebral tissue and caused tissue stimulation of subcutaneous tissue and rejection with when injected organism tissue.5, owing on the silica gel sheet a lot of apertures is arranged, and distribute rationally, the bioprotein artificial dura mater on silica gel sheet two sides is merged, play the effect of reinforcing the silica gel sheet.When 6, carrying out cranioplasty surgery later on, the silica gel sheet plays the boundary effect, can be easy to separate scalp along silica gel sheet outside, is unlikely to hurt cerebral tissue.7, because the silica gel sheet does not absorb,, can be easy to take off the silica gel sheet simultaneously, help post surgery treatment with when injected organism tissue also adhesion.

The alternative cerebral dura mater of this meninges sheet and other body biomembranes can be widely used in the repairing that brain, the heart, gastrointestinal, aponeurosis (aponeuroses), bladder and other have the damaged and hollow organ wall of biomembrane.

The drawing explanation

Accompanying drawing is a structural representation of the present invention.

The specific embodiment

Embodiment 1, selects present hospital implantable medical silica-gel sheet commonly used for use.This silica gel sheet physicochemical property in 0～50 degree temperature range is stable; The human body zest is little, and histocompatibility is good, meets human body implant related standards.The DuraMax collagen protein artificial dura mater of selecting for use the Beijing TianXinFu Medical Treatment equipment Co., Ltd to produce.This collagen protein artificial dura mater has absorbability, and no rejection has characteristics such as good flexibility and attenuation after meeting water, and need not to sew up during operation.But the retrospective deformation pressure of this silica gel sheet is 20 millimetress of mercury; Its deformation ratio is 30%; Tensile strength is 50 millimetress of mercury; Thickness is 0.8 millimeter.

In conjunction with referring to accompanying drawing.On selected silica gel sheet 1, evenly get through hole 3 by 1 * 1 centimetre of square formation with punch device, its aperture is 2～3 millimeters, use two block-shaped identically then, the collagen protein artificial dura mater 2 that area is not less than this silica gel sheet directly is bonded at the two sides of this silica gel sheet 1, gets final product through shearing packing again.

Embodiment 2, and selected implantable medical silica-gel sheet and the characteristic of collagen protein artificial dura mater are with embodiment 1.The plasticity deformation pressure of this silica gel sheet is 15 millimetress of mercury; Its deformation ratio is 35%; Tensile strength is 60 millimetress of mercury; Thickness is 1 millimeter.

Extrude pit with pressing equipment on its two sides on selected silica gel sheet, pit depth is less than 0.3 millimeter, and its size (planar dimension at place, pit top) is 2～3 millimeters; Send biological fibrin glue forth at implantable medical silica-gel sheet and the contacted surface of bioprotein artificial dura mater then, it is sticked together be integral again and can shear packing.

Claims (8)

Translated fromChinese

1.生物蛋白人工脑膜片，包括有可植入性的医用硅胶片和生物蛋白人工硬脑膜，其特征在于所述的可植入性的医用硅胶片的厚度不大于1mm，发生可塑性形变压强不大于20毫米汞柱，形变率大于30％，抗拉强度不少于50毫米汞柱；所述的可植入性的医用硅胶片的两面为生物蛋白人工硬脑膜，形成可植入性的医用硅胶片的上、下面均具有生物蛋白人工硬脑膜的复合结构。1. Bioprotein artificial meninges, including implantable medical silica gel sheet and bioprotein artificial dura mater, is characterized in that the thickness of the implantable medical silica gel sheet is not more than 1mm, and the plastic deformation pressure is less than 1mm. greater than 20 mm Hg, the deformation rate is greater than 30%, and the tensile strength is not less than 50 mm Hg; the two sides of the implantable medical silicone sheet are biological protein artificial dura mater, forming an implantable medical Both the upper and lower sides of the silica gel sheet have a composite structure of biological protein artificial dura mater.2.根据权利要求1所述的脑膜片，其特征在于：上述的可植入性的医用硅胶片上具有均匀分布的通孔，其相邻孔距不大于2厘米，其孔径为2～3毫米。2. The meningeal patch according to claim 1, characterized in that: the above-mentioned implantable medical silicone sheet has uniformly distributed through holes, the distance between adjacent holes is not more than 2 cm, and the hole diameter is 2 to 3 mm. .3.根据权利要求1所述的脑膜片，其特征在于：上述的可植入性的医用硅胶片表面上分布有凹坑，其凹坑的最大深度少于0.3毫米。3 . The meningeal sheet according to claim 1 , wherein pits are distributed on the surface of the implantable medical silicone sheet, and the maximum depth of the pits is less than 0.3 mm. 4 .4.根据权利要求1或2或3所述的脑膜片，其特征在于：通过在所述的可植入性的医用硅胶片与生物蛋白人工硬脑膜相接触的表面喷散生物蛋白胶粘成一体。4. according to claim 1 or 2 or 3 described meninges, it is characterized in that: by spraying biological protein glue on the surface that described implantable medical silica gel sheet contacts with biological protein artificial dura mater One.5.根据权利要求1或2或3所述的脑膜片，其特征在于：该脑膜片的厚度不大于3毫米。5. The meningeal patch according to claim 1, 2 or 3, characterized in that: the thickness of the meningeal patch is not greater than 3 mm.6.根据权利要求4所述的脑膜片，其特征在于：该脑膜片的厚度不大于3毫米。6. The meningeal patch according to claim 4, characterized in that: the thickness of the meningeal patch is not greater than 3 mm.7.根据权利要求5所述的脑膜片，其特征在于：该脑膜片的厚度不大于2.4毫米。7. The meningeal patch according to claim 5, characterized in that: the thickness of the meningeal patch is not greater than 2.4 mm.8.根据权利要求6所述的脑膜片，其特征在于：该脑膜片的厚度不大于2.4毫米。8. The meningeal patch according to claim 6, characterized in that: the thickness of the meningeal patch is not greater than 2.4 mm.