CN101125220A - Preparation for biological packing drainage used for rectocele repairing and its using method - Google Patents
Preparation for biological packing drainage used for rectocele repairing and its using method Download PDFInfo
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- CN101125220A CN101125220A CNA2007101635079A CN200710163507A CN101125220A CN 101125220 A CN101125220 A CN 101125220A CN A2007101635079 A CNA2007101635079 A CN A2007101635079A CN 200710163507 A CN200710163507 A CN 200710163507A CN 101125220 A CN101125220 A CN 101125220A
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Abstract
The present invention relates to a preparation method of drain of biological plugging applied in the operation of repair rectocele and the application. The drain of biological plugging is made with human or animal skin tissue as the material, preparing in the procedures of fixing, cell extraction and coating with antibiotic layer; the drain is placed in the weak area of rectovaginal septa via operation, realizing the unstressing defect repair, eliminating the weak area and rebuilding the anterior wall of rectum. The present invention provides a biological scaffold for concrescence of repaired wound surface, remarkably advances the concrescence of wound surface and greatly shortens the concrescence time of wound surface as well as reduces the hospitalizing time; in addition, the drain of biological plugging of the present invention is coated with an antibiotic layer and has the drain effect, therefore, the infection of the wound surface is remarkably decreased; the efficiency of the drain of biological plugging of the present invention is 100 percent with a low recurrence rate. And the incident ratio of pains, fecal incontinence, stenosis of anal canal and other complicating diseases are reduced after the operation.
Description
Technical field:
The present invention relates to a kind of preparation method and application thereof that is used for the biology filling drain of encysted rectum repairing operation.The skin histology that this biology filling drain is the application human or animal is a raw material, be prepared from by fixing, take off steps such as cell, introducing antibiotic coating, insert the rectum vaginal septa weak area of encysted rectum by modus operandi, can realize not having tension force ground repairs damaged, eliminate weak area, rebuild rectum front wall.For the healing of mend wound surface provides biological support, can obviously promote the healing of wound surface, obviously reduce wound healing time, reduce the hospital stays; In addition, this biology filling drain has antibiotic coating, and, can bring into play the effect of drain, thereby significantly reduce traumatic infection; Use biological filling drain effective percentage provided by the present invention up to 100%, relapse rate is low.And, obviously reduce the incidence rate of complication such as postoperative pain, anal incontinence, stenosis of anal canal.
Background technology
The described encysted rectum of this description, be also referred to as the preceding bulging of rectum, perhaps rectum front wall hernia, perhaps posterior vaginal wall hernia, be because of rectum lower end antetheca, recto-vaginal septum and posterior vaginal wall weakness, elasticity lowers, and rectum front wall changes the defecation line of force to the bulging of vagina direction under the effect of defecation pressure.Mainly cause symptoms such as difficult defecation and anus tenesmus, in being more common in, elderly woman.Encysted rectum is the one of the main reasons that causes the constipation by outlet obstruction, and in intractable defecation cases reported, the encysted rectum sickness rate accounts for the first place, accounts for 30.6%～62.0%.
Primary disease is mainly adopted surgical operation therapy, and traditional surgical approaches is that transvaginal, rectum or perineum are repaired recto-vaginal septum, to strengthen its strength, alleviates the encysted rectum degree of depth and width and improves symptom.Can be divided into per rectum, transvaginal, repair 3 kinds through perineum according to the approach difference, wherein, repairing through perineum is modus operandi the most commonly used clinically at present.
Above-mentioned three kinds of modus operandis are the weak area of direct suture repair rectum lower end antetheca, recto-vaginal septum and posterior vaginal wall, owing to can not avoid mend to have tension force, the recurrence after operation rate is higher, up to 30%.
This description provides the preparation and the using method thereof of the biology filling drain that is used for the encysted rectum repairing.Biological filling drain provided by the invention is that the skin histology with the human or animal is a raw material.The principle that biological filling drain provided by the present invention is used for the encysted rectum repairing operation is: it is damaged to realize not having the repairing of tension force ground, eliminates weak area, rebuilds rectum front wall, recovers rectum normal anatomy form.For the healing of mend wound surface provides biological support, can obviously promote the healing of wound surface, obviously reduce wound healing time, reduce the hospital stays; In addition, this biology filling drain has antibiotic coating, and, can bring into play the effect of drain, thereby significantly reduce traumatic infection; Use biological filling drain provided by the present invention and can significantly reduce postoperative relapse rate.And, the incidence rate of complication such as anal incontinence, stenosis of anal canal after obviously reduction is performed the operation.
Summary of the invention
The invention provides a kind of preparation and using method that is used for the biology filling drain of encysted rectum repairing operation, the preparation method of described biological filling drain may further comprise the steps:
A. the skin histology that obtains the human or animal from human or animal's donor is as raw material,
B. with fixative the skin histology that is obtained is fixed,
C. take off the cell treatment step, described step is that using basic solution is hatched the tissue after fixing,
D. the step of washing and eliminating residual fixative and regulate pH value, described step are to use neutral buffered liquid the tissue that takes off after cell is handled is washed, and use Freamine hatch to pH value be 7.35～7.55,
E. introduce the step of antibiotic coating,
F. before introducing the step of antibiotic coating or forming step afterwards, described step is that the tissue that will prepare is pressed into the square sheet shape body that is fit to be packed in the rectum vaginal septa weak area.
Described animal can be pig, cattle, sheep, rabbit, preferably pig.
According to above-mentioned preparation method, the wide of wherein said square sheet shape body is 2～5cm, and length is 5～10cm, and thickness is 0.3～0.8cm.
Described fixative comprises that commonly used various in present technique field are used for preventing histolysis and corruption, and make various compositions such as intracellular protein, fat, sugar, enzyme change insoluble substance into, the form in the time of can keeping organizing with cell and orthobiosis and the material of structural similarity, can be formaldehyde, paraformaldehyde, picric acid solution, glacial acetic acid, glutaraldehyde, osmic acid, BouinShi fixative, Zenker liquid, Carnoy liquid, the improvement BouinShi fixative etc. of any concentration, preferably 2% formaldehyde and 1.5% glutaraldehyde.
Described alkaline solution is an alkali hydroxide soln, preferably sodium hydroxide solution and potassium hydroxide solution.
Described neutral buffered liquid can be phosphate buffer, borate buffer solution, TRIS buffer (Tris buffer).Proof buffer used in the invention process is a sodium phosphate buffer.
Described buffered with amino acid liquid can be glycine-HCl buffer, glycine-NaOH buffer, glycine-Tris buffer, histidine buffering liquid, Aminoacetamide (glycine amide) buffer, glycylglycine (glycylglycine) buffer.Its effect is to adjust pH value to 7.35～7.55 of taking off the tissue after cell is handled, and it selects to decide according to the pH value that takes off the tissue after cell is handled.Used proof acidic amino acid buffer is glycine-HCl buffer in the invention process.
Described antibiotic coating preparation method is the mode by spraying, soaking or instil, antibiotic homogenizing aqueous solution is incorporated in the tissue after the molding, through evaporation and/or after using desiccant and removing water basically, add at least a amphiphatic molecule solution soluble in water by same method again, obtain antibiotic coating through evaporation and/or after using the desiccant drying again.
Described antibiotic can be an aminoglycoside antibiotics, tetracycline antibiotics, lincosamides, quinolone antibiotic, the nitro glyoxaline antibiotic, the sulfonamides antibiotic, methylfuran class antibiotic, specifically the mixture of itrofurans antibiotic or above-mentioned antibiotic combination in any can be gentamycin, metronidazole, sisomicin, netilmicin, streptomycin, tobramycin, spectinomycin, vancomycin, ciprofloxacin, Moxifloxacin, clindomycin, lincomycin, tetracycline, shuttle chlortetracycline, oxytetracycline and the mixture of enumerating tetracycline or above-mentioned antibiotic combination in any.Proof antibiotic used in the invention process is the compositions of sulmycin and metronidazole.
Described amphiphatic molecule can be alkyl sulfate, alkylsulfonate, alkyl aryl sulfate, di alkylaryl sulfate, alkylaryl sulfonates, di alkylaryl sulfonate, cycloalkyl sulfate, cycloalkyl sulfonate, alkyl-cycloalkyl sulfate.Proof amphiphatic molecule used in the invention process is a sodium lauryl sulphate.
It is a kind of according to the prepared biology filling drain of above-mentioned each preparation method that the present invention also provides, and described biological filling drain is a square sheet shape body.The wide of wherein said square sheet shape body is 2～5cm, and length is 5～10cm, and thickness is 0.3～0.8cm.
The present invention also provides above-mentioned biological filling drain to be used for the application of the medicine and the apparatus of encysted rectum repairing operation in preparation.Described treatment is preferably by the method for operation, and the biology filling drain that the present invention is prepared is inserted the rectum vaginal septa weak area of encysted rectum, and its outer end is drawn through perineal incision.In concrete enforcement, can be according to the size and the shape of rectum vaginal septa weak area, biology filling drain the present invention is prepared with shears is cut into suitable size and dimension in advance.
Embodiment 2 provides the present invention the concrete using method of prepared biology filling drain.
According to embodiment 3, the inventor also provides the prepared biology filling drain of the present invention to be used for effective percentage (100%), relapse rate (0～10%) and the infection rate (0%～10%) of encysted rectum repairing operation, and its therapeutic effect significantly is better than the traditional operation therapy.
The specific embodiment
Describe the present invention in detail below in conjunction with embodiment, described embodiment is used to describe the present invention, rather than restriction the present invention.
The specific embodiment
Embodiment
Embodiment 1: use the biology filling drain that the preparation of fresh pig dermal tissue is used for the encysted rectum repairing operation
Gather the fresh pig dermal tissue, cut into 1～3cm
3Fritter is fixed 2～4 hours with 2% formalin immediately, with distilled water wash for several times.Then, tissue is hatched under 20 ℃ of constant temperature with the sodium hydroxide solution of 1N took off cell processing in 24 hours.Then, use sodium phosphate buffer washing tissue until the tissue shape that is translucent.Being organized in after will washing then hatched in glycine-HCl buffer to eliminate remaining fixative and to reduce pH value, is 7.35～7.55 until pH value.
Tissue after the above-mentioned processing is soaked in the metronidazole homogenizing aqueous solution of the gentamycin sulfate that mixes 50mg/ml and 50mg/ml, take out after 10 minutes, dry, then tissue is soaked in the sodium dodecyl sulfate solution of 50mg/ml, crushed after being dried, and use the mould prepare and be pressed into biological filling drain, this biology filling drain is a square sheet shape body.The wide of wherein said square sheet shape body is 2～5cm, and length is 5～10cm, and thickness is 0.3～0.8cm.
Embodiment 2: operation method is inserted the biological filling of hemorrhoid drain
1. get the about 3cm of the nearly vagina side of perineal position curved incision, cut skin, subcutaneous tissue, passivity reaches from walking around the external anal sphincter leading edge in addition, separates the open texture of recto-vaginal septum, separating ranges reaches 1cm on the weak area, reaches preceding intersection of rectum of isolating perineal body and levator ani m..
2. be cut into suitable size according to the big young pathbreaker embodiment 1 prepared biology filling drain of weak area in advance with shears.
3. the biology filling drain that will cut is clogged in rectum vaginal septa weak area, notes sprawling neat, fixing.
4. biology being clogged the drain outer end draws through the perineal incision place.
5. sew up subcutaneous tissue and skin.
6. remove biological filling drain outer end redundance, make biological filling drain outer end parallel with otch skin.
7. otch covers aseptic dressing and changes dressings until healing every day.
Embodiment 3: curative effect
Case is selected: select in June, 2003～2007 encysted rectum patient in year October totally 15 examples, it is middle and aged women.Application Example 1 prepared biology is clogged drain, and the method that adopts embodiment 2 to provide is treated.Through following up a case by regular visits to, the result is as described below:
15 routine patient's postoperative proctography checks all point out encysted rectum to disappear, and do not have stool and are detained.Follow up a case by regular visits to and do not see recurrence, cure rate 100% in 6 months～4 years.3～6 days postoperative hospital stayss, average 4.8 days.Postoperative main suit pain 2 examples all can tolerate, and need not to handle.It is normal that patient's anus profile is recovered, and no blood stasis is deviate from, and defecation is smooth and easy, and nothing is had blood in stool, anal stenosis, infection, fecal incontinence.
Claims (14)
1. preparation method that is used for the biology filling drain that encysted rectum repairs, described preparation method may further comprise the steps:
A. the skin histology that obtains the human or animal from human or animal's donor is as raw material,
B. with fixative the skin histology that is obtained is fixed,
C. take off the cell treatment step, described step is that using basic solution is hatched the tissue after fixing,
D. the step of washing and eliminating residual fixative and regulate pH value, described step are to use neutral buffered liquid the tissue that takes off after cell is handled is washed, and use Freamine hatch to pH value be 7.35～7.55,
E. introduce the step of antibiotic coating,
F. before introducing the step of antibiotic coating or forming step afterwards, described step is that the tissue that will prepare is pressed into the square sheet shape body that is fit to be packed to rectum vaginal septa weak area.
2. preparation method according to claim 1, it is characterized in that, the step of wherein said introducing antibiotic coating is the mode by spraying, soaking or instil, antibiotic homogenizing aqueous solution is incorporated in the tissue, through evaporation and/or after using desiccant and removing water basically, add at least a amphiphatic molecule solution soluble in water by same method again, obtain antibiotic coating through evaporation and/or after using the desiccant drying again.
3. according to each described preparation method among the claim 1-2, it is characterized in that the wide of wherein said square sheet shape body is 2～5cm, length is 5～10cm, and thickness is 0.3～0.8cm.
4. preparation method according to claim 3, it is characterized in that wherein said fixative is selected from formaldehyde, paraformaldehyde, picric acid solution, glacial acetic acid, glutaraldehyde, osmic acid, BouinShi fixative, Zenker liquid, Carnoy liquid, the improvement BouinShi fixative of suitable concentration etc.
5. preparation method according to claim 3 is characterized in that wherein said alkaline solution is an alkali hydroxide soln.
6. preparation method according to claim 3 is characterized in that, wherein said neutral buffered liquid is selected from phosphate buffer, borate buffer solution, TRIS buffer.
7. preparation method according to claim 3, it is characterized in that wherein said Freamine is selected from glycine-HCl buffer, asparagine acid buffer, glycine-NaOH buffer, glycine-Tris buffer, histidine buffering liquid, Aminoacetamide buffer, glycylglycine buffer.
8. preparation method according to claim 3, it is characterized in that wherein said amphiphatic molecule is selected from alkyl sulfate, alkylsulfonate, alkyl aryl sulfate, di alkylaryl sulfate, alkylaryl sulfonates, di alkylaryl sulfonate, cycloalkyl sulfate, cycloalkyl sulfonate, alkyl-cycloalkyl sulfate.
9. preparation method according to claim 3, it is characterized in that wherein said antibiotics salt is selected from aminoglycoside antibiotics, tetracycline antibiotics, lincosamides, quinolone antibiotic, nitro glyoxaline antibiotic, sulfonamides antibiotic, methylfuran class antibiotic, itrofurans antibiotic or above-mentioned antibiotic compositions.
10. preparation method according to claim 9, it is characterized in that wherein said antibiotic is selected from gentamycin, metronidazole, sisomicin, netilmicin, streptomycin, tobramycin, spectinomycin, vancomycin, ciprofloxacin, Moxifloxacin, clindomycin, lincomycin, tetracycline, shuttle chlortetracycline, oxytetracycline and enumerates tetracycline or above-mentioned antibiotic compositions.
11. preparation method according to claim 10 is characterized in that, wherein said antibiotic is the compositions of sulmycin and metronidazole.
12. according to the prepared biology filling drain of each described preparation method of claim 1-11, it is characterized in that described biological filling drain is a square sheet shape body, the wide of wherein said square sheet shape body is 2～5cm, length is 5～10cm, and thickness is 0.3～0.8cm.
13. biological filling drain according to claim 12 is used for the application of the medicine and the apparatus of encysted rectum repairing operation in preparation.
14. application according to claim 13 is characterized in that, described treatment is by operation method, with described biological filling drain insert encysted rectum rectum vaginal septa weak area.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2007101635079A CN101125220A (en) | 2007-10-12 | 2007-10-12 | Preparation for biological packing drainage used for rectocele repairing and its using method |
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| CNA2007101635079A CN101125220A (en) | 2007-10-12 | 2007-10-12 | Preparation for biological packing drainage used for rectocele repairing and its using method |
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| CN101125220A true CN101125220A (en) | 2008-02-20 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105079880A (en) * | 2015-09-01 | 2015-11-25 | 河北爱能生物科技股份有限公司 | Preparing method of heterogeneous acellular dermal matrix substrate with good biocompatibility |
-
2007
- 2007-10-12 CN CNA2007101635079A patent/CN101125220A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105079880A (en) * | 2015-09-01 | 2015-11-25 | 河北爱能生物科技股份有限公司 | Preparing method of heterogeneous acellular dermal matrix substrate with good biocompatibility |
| CN105079880B (en) * | 2015-09-01 | 2018-06-12 | 河北爱能生物科技股份有限公司 | A kind of preparation method of the good Xenogenic acellular dermal matrix of biocompatibility |
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Open date: 20080220 |