CN203208160U

CN203208160U - Biological amniotic membrane structure

Info

Publication number: CN203208160U
Application number: CN 201320114933
Authority: CN
Inventors: 耿文静; 刘博文; 刘影
Original assignee: SHAANXI RUISHENG BIOLOGICAL SCIENCE AND TECHNOLOGY Co Ltd
Current assignee: SHAANXI RUISHENG BIOLOGICAL SCIENCE AND TECHNOLOGY Co Ltd
Priority date: 2013-03-14
Filing date: 2013-03-14
Publication date: 2013-09-25
Anticipated expiration: 2023-03-14

Abstract

The utility model discloses a biological amniotic membrane structure. The biological amniotic membrane structure is characterized by being formed by closely attaching and overlapping 2-15 layers of single biological amniotic membranes with the same size and consistent membrane layer direction. Compared with the prior art, the biological amniotic membrane structure has the advantages that the stiffness, toughness and mechanical strength are improved, so that the membrane can be always maintained smooth, the phenomenon of static electricity is eliminated, and an operative site can be quickly and conveniently clamped, cut, sewn and wrapped in an operation; as a substrate is not arranged, the possibility of pollution caused by the contact between the substrate and the surface of a wound in the operation is avoided; an adhesive and other ingredients are not added so as to be safe and reliable, and dispersion cannot occur after rehydration; and experiments show that the strength and toughness of the membrane can be improved by increasing the layer number, so that the degradation time of the membrane in a body can be increased, the application range of the biological amniotic membrane structure is expanded, and the biological amniotic membrane structure can be used for preventing adhesion of tissues such as tendon and nerve after the operation, as well as strengthening and repairing various soft tissue defects and the like.

Description

A kind of bioamnion structure

Technical field

This utility model belongs to the bio-medical material technical field, is specifically related to a kind of improvement of bioamnion structure.

Background technology

Amniotic membrane is that one deck does not have the nerveless biomembrane of blood vessel, and primary structure is five layers: epithelial layer, basement membrane, compacted zone, fibroblast layer and spongy layer.Contain a large amount of different collagens in the amniotic membrane, be mainly I type, III type, IV type and V Collagen Type VI etc., and contain the various active factor, and have effects such as the fibrocyte of being suppressed to hyper-proliferative, anti-cicatrization, anti-inflammatory, anti, in the wound healing process, have important regulatory role.Bioamnion is to be raw material with the fresh amnion, goes Processing of Preparation such as antigen to form through a series of cells that take off, and has reduced immunogenicity when keeping the natural performance of amniotic membrane.

Clinically bioamnion is mainly used at present that eye surface diseases treatment, skin burn that reparation, prevention tendon and the nerve etc. of wound are organized in that postoperative sticks together and the reinforcement reparation of soft tissue defects etc.Because dry back monolayer bioamnion is light, thin, crisp, easily produces Electrostatic Absorption in operating theater instruments, and the shrinkage that absorbs water immediately after when operation, contacting transudate or tissue fluid, make troubles to clinical manipulation.In order to overcome these problems, now adopt nitrocellulose filter be material as the substrate of bioamnion, again diaphragm is peeled off from substrate before the clinical use.This method has reduced the operation easier (as cutting out) to bioamnion to a certain extent, but does not fundamentally solve the inconvenience of monofilm in clinical use yet, and because bioamnion is the translucent thin diaphragm, also can bring the problem that is difficult to peel off with substrate.

For example, Chinese patent 200620092212.8 discloses a kind of amniotic membrane material with holder, its amniotic membrane closely attaches with the holder size is consistent, holder is provided with circle, square or erose hole, will inevitably cut off the hole on the holder when before clinical use, cutting out, the amniotic membrane edge is exposed, again film is separated with holder; Though it has solved the problem that diaphragm separates with holder, but still makes troubles to clinical manipulation, also unresolved Electrostatic Absorption, meet the problem of water shrinkage and suture strength.

Summary of the invention

At the existing defective of prior art, the purpose of this utility model provides a kind of bioamnion structure, solve the problem of Electrostatic Absorption, chance water shrinkage and suture strength, has the clinical manipulation advantage that makes things convenient for cutting and sew up easily, can improve operation efficient and operability, guarantee quality and the effect of operation.

The bioamnion structure that this utility model is designed adopts cell free monolayer bioamnion with epithelial layer, basement membrane layer and compacted zone structure; It is characterized in that described bioamnion structure is closely to attach stack by 2 ~ 15 layers of size monolayer bioamnion identical, rete direction unanimity to constitute.

The designed bioamnion structure of this utility model adopts following method to realize, to after taking off PROCESS FOR TREATMENT such as cell, obtain the monolayer bioamnion, by the folded overlay of rete direction unanimity (being that the membrane structure layer is towards unanimity), the shop layer requires smooth, reduce intermembranous bubble, be cut into required specification again behind natural drying, the monolayer bioamnion is combined with each other by dry dehydration; Wherein, when 6 layers of preparations and above this utility model bioamnion structure, layer back, shop adopted to place and finished natural drying between the pressing plate, can guarantee to fit tightly no bubble between the smooth and film of film, and rete can not scatter after the rehydration.

This utility model bioamnion structure increases thickness by the monolayer stack, thereby improves well-pressed degree, toughness and mechanical strength, and it is smooth that film is remained, and eliminated electrostatic phenomenon, conveniently cuts out and the apparatus clamping; Need not rehydration in the operation, can directly be wrapped in around damaged tissues or the nerve, sew up or fix with glue, significantly weakened the shrinkage phenomenon after soaking blood and tissue fluid; Well-pressed curling, can fully fit with wound tissue; Toughness and intensity make stitching stressed easily, the defective of having avoided monofilm to tear easily.

Compared with prior art, this utility model bioamnion structure has the following advantages: clamping quickly and easily, cutting in operation technique, sew up and hold operative site; Owing to the linerless end, avoided substrate in operation, to contact the possibility that wound surface causes pollution; This utility model adopts the physical method of extruding and dry dehydration compound, does not add binding agent and other compositions, and is safe and reliable, and also can not scatter after the rehydration; Experiment showed, the increase number of plies, can improve film strength and toughness, increase film degradation time in vivo, thereby enlarged range of application of the present utility model, sticked together after making it to can be used for preventing tendon and nerve etc. to be organized in operation, and the reinforcement reparation of all kinds of soft tissue defects etc.

Description of drawings

Accompanying drawing 1 is the designed bioamnion structure of this utility model (four layers) structural representation.1 is ground floor monolayer bioamnion diaphragm among the figure, and 2 is second layer diaphragm, and 3 is the trilamellar membrane sheet, and 4 is the 4th tunic sheet; The structure direction unanimity of each tunic sheet, i.e. its epithelial layer towards unanimity.

The specific embodiment

Below in conjunction with example in detail implementation result of the present utility model.

This utility model adopts takes off the cell biological amniotic membrane and can purchase in green hill, Chengdu Li Kang Pharma Inc.; Certainly also can be with reference to " human acellular amniotic membrane preparation and Study on biocompatibility thereof " (Chinese J Reparative Reconstrutive Surgery, 2004, Vol 18 (2)) or China Patent No. 02116305.7(amnion tissue engineering rack and amniotic membrane method for removing cells) in the preparation of cited method for removing cells obtain.

When clinical trial certificate, this utility model bioamnion structure are 2 ~ 4 layers monolayer bioamnion, be applicable to the parcel of hand tendon and thinner neural operative site, Film with Preventing Adhesion; When being 4 ~ 9 layers, be applicable to the thick or bigger tissue of area such as heel string, vertebra, Film with Preventing Adhesion; When being 8 ~ 12 layers, be applicable to that the defect in rotator cuff injury, the rupture of achilles tendon operation is strengthened; When being 10 ~ 15 layers, be applicable to tissue defect thickness and the bigger operations of area such as stomach wall reparation, all kinds of hernia reparations.

Example 1,The bioamnion structure is 2 layers monolayer bioamnion, area 2 * 3 cm ²

Need not rehydration before the operation, in the operation, film does not have electrostatic phenomenon, is difficult for fold, can directly be clamped to operative site with dry operating theater instruments, can directly attach on it after film touches tendon or nerve, film is taken advantage of a situation around thereon again.Because the number of plies is few, comparatively pliable and tough, degradation time is short, can adopt biogum to fix, operation time is short and convenient, is used for the anti of thin tissue site such as hand tendon and nerve, can significantly reduce the probability that postoperative sticks together, and eases the pain.

It is applied to the Film with Preventing Adhesion that the full breaking joint of chicken unguiflexor tendon closes after the reparation and tests 12 examples, and in the observation of drawing materials respectively in 4 weeks of postoperative, 8 weeks, 12 weeks, the tendon suture site of wrapping up does not all stick together with surrounding tissue, and healing process of tendons is good.

Example 2: the bioamnion structure is 6 layers monolayer bioamnion, area 3 * 4cm ²

Need not rehydration before the art, film remains smoothly in the art, directly is clamped to operative site with dry operating theater instruments, can directly attach on it after film touches heel string, and film is taken advantage of a situation is surrounded on the heel string again; When being used for operation on vertebra, being attached at operative site or supporting tissue site after apparatus is removed film is smooth.Because film strength is higher, sew up not to be prone to and tear phenomenon, be fit to adopt suture way to fix; And clamping parcel is convenient in operation, does not occur that static curls or because of suction shrinkage phenomenon; Operation time is short, and is easy to operate, is used for thick or area such as prevention heel string, vertebra than macrolesion position and surrounding tissue generation anti, significantly reduces the adhesion odds, the reduction pain, and the membrane degradation time is longer.

Its Film with Preventing Adhesion that is applied to after the full breakdown wound of rabbit heel string is sewed up is tested 12 examples, in 4 weeks of postoperative, and 8 weeks, the observation of drawing materials respectively in 12 weeks, the amniotic membrane place of wrapping up does not all stick together, and the heel string healing is good.

Example 3:The bioamnion structure is 10 layers monolayer bioamnion, area 4 * 6cm ²

Need not rehydration before the art, film does not have electrostatic phenomenon in the art, remains smoothly, is clamped to operative site with dry operating theater instruments, adopt single or double sutured in rotator cuff injury or tendon injury position, sew up the back and drip the integration that a small amount of normal saline is beneficial to film and tissue.This film improves 3 ~ 6 times than the mechanical strength of 2 tunics and 6 tunic structures, adopts many row's suture ways phenomenon not occur tearing, still keeps good membranaceous form, and phenomenons such as fold do not occur after the infiltration curling.Operation time is short and convenient, is used for the reinforcement of rotator cuff injury, Achilles tendon healing art defect, can significantly strengthen the mechanical strength of operative site tendon, reduces tendon fracture probability again, and can reduce pain; The degradation time of this film is long, experiment in animal body, and segregation phenomenon does not take place between each tunic more than half a year in the multilamellar that is kept perfectly membrane structure.

It is applied to the zoopery of repairing behind the 8 routine Canis familiaris L. rotator cuff injuries, and through 4 weeks, in 8 weeks, the observation of drawing materials in 12 weeks finds that shoulder sleeve healing process of tendons is good, and phenomenon of rupture does not again take place.

Example 4: the bioamnion structure is 15 layers monolayer bioamnion, area 7 * 10cm ²

Film does not have electrostatic phenomenon in operation, remain smooth, be clamped to operative site with dry operating theater instruments, adopt stomach wall reparation or hernia prosthesis sticking patch suturing skill commonly used to be sutured in damage location, sew up the back and drip the integration that a small amount of normal saline is beneficial to film and tissue.In clamping and sewing process, still keep good membranaceous form, the phenomenons such as fold and stitch tear of curling do not appear, the mechanical strength height, be conducive to sew application, operating time is short and convenient, is used for can significantly strengthening the damaged of operative site soft tissue after stomach wall reparation, the hernia reparation as biological sticking patch, reduces relapse rate.

It is applied to the reparation of Canis familiaris L. stomach wall and tests 12 examples, and the observation of drawing materials through March, June is repaired the existing autologous tissue in abdominal-wall defect position and grown into, film and autologous tissue merge gradually, and do not stick together with intra-abdominal organ, June, posterior abdominal wall was repaired substantially, complication such as incisional hernia or abdominal hernia do not occur.

Experiment showed, that this film adopts the normal saline rehydration after 20 minutes, fit between each layer and closely do not separate that do not have bubble, the edge is difficult to peel off.

Claims

1. a bioamnion structure adopts cell free monolayer bioamnion with epithelial layer, basement membrane layer and compacted zone structure; It is characterized in that described bioamnion structure is closely to attach stack by 2 ~ 15 layers of size monolayer bioamnion identical, rete direction unanimity to constitute.

2. bioamnion structure according to claim 1 is characterized in that, is closely to attach stack by 2 ~ 4 layers of size monolayer bioamnion identical, rete direction unanimity to constitute.

3. bioamnion structure according to claim 1 is characterized in that, is closely to attach stack by 4 ~ 9 layers of size monolayer bioamnion identical, rete direction unanimity to constitute.

4. bioamnion structure according to claim 1 is characterized in that, is closely to attach stack by 8 ~ 12 layers of size monolayer bioamnion identical, rete direction unanimity to constitute.

5. bioamnion structure according to claim 1 is characterized in that, is closely to attach stack by 10 ~ 15 layers of size monolayer bioamnion identical, rete direction unanimity to constitute.