CN103239265A - Anastomat for gastrointestinal tract anastomosis surgery and production method thereof - Google Patents
Anastomat for gastrointestinal tract anastomosis surgery and production method thereof Download PDFInfo
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- CN103239265A CN103239265A CN2013101756562A CN201310175656A CN103239265A CN 103239265 A CN103239265 A CN 103239265A CN 2013101756562 A CN2013101756562 A CN 2013101756562A CN 201310175656 A CN201310175656 A CN 201310175656A CN 103239265 A CN103239265 A CN 103239265A
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Abstract
The invention provides an anastomat for gastrointestinal tract anastomosis surgery and a production method thereof. The anastomat comprises an anastomosis nail and a base and is divided into two types, namely a combined type and an independent type. The anastomat is composed of degradable materials and medical barium sulfate and can be finally disintegrated to be powder to be removed from the body after being used up. An envelope is formed on the outer surface of the anastomat through polyacrylic resin and contains medicines such as sulfonamides and quinolones antisepsis and anti-inflammation medicines and adrenobazonum, dicynone and other hemostasis medicines, and the envelope can selectively perform medicine slow release and controlled release according to different pH physiological environments of gastrointestinal tracts.
Description
Technical field
The present invention relates to a kind of medical apparatus and instruments, a kind of gastrointestinal tract anastomat particularly is mainly used in gastral end to end anastomosis, end-to-side anastomosis and the side to side anastomosis operations such as stomach, small intestinal, large intestine of human body.
Background technology
Operation stitching is to cut or tissue, the organ of wound fracture carries out involutory or rebuild its passage, recover its function, guarantee the surgery operating technology commonly used of good healing.1881, Billroth completed successfully first routine manual suture's operation, and the manual suture technology is progressively full-fledged subsequently, is seamed to one of important surgical operation basic operation technology.The histoorgan of different parts needs in different ways or method is sewed up, and simple stitching is usually used in the stitching of skin, subcutaneous tissue, muscle, aponeurosis (aponeuroses); Everting suture keeps the edge of wound inner face level and smooth, is usually used in the stitching of blood vessel, peritoneum, lax skin; Inverting suture keeps the edge of wound outside level and smooth, is usually used in the stitching of intestinal, bladder.1908, Hungary doctor Hultl and Fisher invented stiching instrument.The founder Leon Hirsh of U.S. surgery company (Auto Suture) invention titanium nail anastomat in 1967, and make titanium nail anastomat realize commercially producing, have landmark meaning in mechanical stitch technograph.Present commercial product has: end to end anastomosis device, anastomosis ring applicator, straight line anastomat, line style Endo-GIA, circular arc Endo-GIA, hemorrhoid anastomat, purse-string suture device, skin fascia stiching instrument.1892, Murphy doctor invented identical button (Murphy button).1976, Hardy doctor invented anastomosis ring.(document 1 sees reference).
The identical method of the gastrointestinal tract of clinical use has manual suture, the stitching of metal anastomotic device, anastomosis ring to fasten this three kinds of methods.Manual suture is with a long history, is a kind of suturing skill that uses suture to repair wound.This technical operation is more loaded down with trivial details, and suture time is decided on surgical experience, generally needs 30 minutes, and in addition, the repeated localised puncture of suture is bigger to stomach intestinal tissue's damage, has increased the probability that the generation of postoperative enteritis and granuloma etc. occur.Along with the appearance of Titanium nail anastomat, the no suture anastomosis of a kind of novel utilization operating theater instruments that has been born.This anastomat operates more convenient, and sewing up mouth more can standardization control.Yet after the operation recovery from illness, leaving over of Titanium nail can influence inspections such as postoperative X ray, CT, MRI.Simultaneously, the titanium nail remains in the periphery of suture site, has reduced gastrointestinal elasticity, is unfavorable for the wriggling of intestinal, has increased anastomotic stoma cicatrixization, the narrow probability that blocks of enteric cavity.Anastomosis ring then is at two annulus of utilization that the development of no suture anastomosis is come out anastomat that principle makes that interlocks.
At present show huge application and economic potential with Acetic acid, hydroxy-, bimol. cyclic ester, lactide, caprolactone, trimethylene carbonate, medical treatment consumptive materials or apparatus (stitching thread, hemostatic clamp, bone anchor etc.) that degradable high polymer materials such as the homopolymer of dioxy Ketohexamethylene or copolymer are made.In order to satisfy the specific demand of medical field, the product of various macromolecular material blend or copolymerization development constantly occurs.The medical application of poly-Acetic acid, hydroxy-, bimol. cyclic ester (PGA) or polylactide (PLA) includes but are not limited to these:
(1) for pure PGA or pure PLA.
Solid articles: nail, bone screw, hone lamella, bone substitute are (for example: mandibular prostheses), operation needle, impermanent implantation intrauterine device, interim drainage tube or test conduit, blood vessel implant or support, stitching thread etc.
Fibre: burn dressing, hernia patch, can absorb paster, wound surface gauze or fabric, sthptic sponge, tourniquet bandage, anti thin film, dental care bag etc.
Other: but burn or wound are with thin slice or powder absorbing foams, thin film coatings prosthetic appliance etc.
(2) for the blend goods of PGA, PLA and other material.
Solid articles: the ion exchange resin of slow degraded, reinforced nail, bone rod etc.
Fibre: arterial graft or substitute, skin surface binder, burn dressing (using in conjunction with other thin polymer films).
The present invention has gathered the advantage of stitching method and the method for fastening, designs a kind of novel no suture anastomat, and this anastomat adopts manual or mechanical manner operation, make two parts combinations of anastomat, two parts connect in the mode of anastomosis staple, operate easylier, connect more firm.
The present invention has selected for use widely used medical degradable material to gather Acetic acid, hydroxy-, bimol. cyclic ester, polylactide is raw material, cooperates with the medical development agent again, makes anastomat, is applied to gastrointestinal tract and coincide.The function that this anastomat has frangible solution, can develop.Need to prove that here the size of this anastomat can be improved according to the size of body lumen, is designed to not only be fit to the gastrointestinal anastomosis device of stomach, small intestinal, large intestine, can also be fit to the tube chamber anastomat that esophagus, tremulous pulse, vein etc. coincide, support early stage.
This anastomat loads various anti-inflammation haemostatic medicaments by coating medicine-carried system, in the physiological environment (stomach pH1-3.5, small intestinal pH5-7, large intestine pH8.3-8.4) of the different pH of human body, carry out slow release and the controlled release of medicine, the feasible anastomat that only has gastrointestinal tract anastomosis bracket function, develop into the multi-functional anastomats that is integrated in one such as having postoperative anti-inflammation, hemostasis, give full play to its potential, realize " a tractor serves several purposes, a device multipotency ".
The prior art document
List of references 1: publication number is the United States Patent (USP) of US3974835A.
Summary of the invention
The problem that invention will solve
The invention provides a kind of gastrointestinal tract anastomat of novel structure, this anastomat has been gathered the advantage of multiple anastomosis, comprises anastomosis staple assembly and the base that is the flat ring-type bodily form of hollow.Anastomat is divided into combination type and two kinds of stand alone types.Anastomat can be made by degradation material and medicinal barium sulfate.
The invention provides a kind of gastrointestinal tract anastomat of disintegratable, disintegration time can be controlled in the certain limit, by through the time disintegrate become broken powder, eliminated fragment corner angle damage intestinal and remained in the possibility of intestinal corner.
The invention provides a kind of gastrointestinal tract anastomat with anti-inflammation anastalsis, it can be used in combination medicines such as sulfonamides, quinolones, carbazochrome salicylate, etamsylate.Sulfonamides, quinolones have broad-spectrum antiseptic, weaken or alleviate the effect of gastrointestinal tract post-operation inflammatory.Haemostatic medicament such as carbazochrome salicylate, etamsylate has the effect that reduces platelet counts in capillary permeability and fragility, promotion impaired blood capillary pipe end retraction hemostasis and the increase blood, accelerates blood coagulation.
The invention provides a kind of gastrointestinal tract anastomat with medicine sustained and controlled release function, this anastomat can carry out slow release and the controlled release of medicine in the physiological environment (stomach pH1～3.5, small intestinal pH5～7, large intestine pH8.3～8.4) of the different pH of human body, realize continuing medication.
For the scheme of dealing with problems
The invention provides a kind of gastrointestinal tract anastomat, it is characterized in that, comprising:
The anastomosis staple assembly comprises anastomosis staple;
Base, described base are the flat ring bodies of hollow, have ringwise main part basically, and the main part of described base has a plurality of through holes that run through main part from top to bottom, and described through hole cooperates with described anastomosis staple;
Described anastomosis staple assembly and described base are made by degradation material and medicinal barium sulfate.
According to gastrointestinal tract anastomat of the present invention, it is characterized in that, the cross section of the nail bar part of described anastomosis staple is circle, rhombus, triangle, tetragon, polygon or other regular shapes, and described shape of through holes is consistent with the nail bar shape of cross section of described anastomosis staple.
According to gastrointestinal tract anastomat of the present invention, it is characterized in that described anastomosis staple assembly also comprises at least one ring component, one in described at least one ring component is the anastomosis staple connecting ring, described anastomosis staple connecting ring is connected with many described anastomosis staples.
According to gastrointestinal tract anastomat of the present invention, it is characterized in that described anastomosis staple is corresponding one by one with described lead to the hole site.
According to gastrointestinal tract anastomat of the present invention, it is characterized in that the internal ring of described base body part is provided with intilted annular slope.
According to gastrointestinal tract anastomat of the present invention, it is characterized in that described identical ailing bar is provided with latch, is provided with the draw-in groove that cooperates with described latch in the described through hole.
According to gastrointestinal tract anastomat of the present invention, it is characterized in that described anastomosis staple tip is provided with pawl, described anastomosis staple enters described through hole, and passes described base and fix.
According to gastrointestinal tract anastomat of the present invention, it is characterized in that described through hole is more than the row, each exhausting hole is evenly distributed on the circumference of circle of same diameter that axle center with base is the center of circle.
According to gastrointestinal tract anastomat of the present invention, it is characterized in that described anastomat has freestanding structure, to be formed by anastomosis staple and the head of a nail, anastomosis staple is made up of nail catcher, nail bar, ailhead, and the head of a nail has " inverted gun thorn " structure.
According to gastrointestinal tract anastomat of the present invention, it is characterized in that described degradation material is selected from one or both in poly-Acetic acid, hydroxy-, bimol. cyclic ester, the polylactide.
According to gastrointestinal tract anastomat of the present invention, it is characterized in that described degradation material is 100:0-70:30 with the ingredients by weight ratio of medicinal barium sulfate; The disintegration time of described anastomat is 1-3 week.
According to gastrointestinal tract anastomat of the present invention, it is characterized in that the poly-Acetic acid, hydroxy-, bimol. cyclic ester of described degradation material is 95:5～85:15 with the ingredients by weight ratio of medicinal barium sulfate.
According to gastrointestinal tract anastomat of the present invention, it is characterized in that the poly-Acetic acid, hydroxy-, bimol. cyclic ester of described degradation material is 90:10 with the ingredients by weight ratio of medicinal barium sulfate.
Preparation method according to gastrointestinal tract anastomat of the present invention, it is characterized in that, described anastomat carries out the fusion injection moulding with following condition and is prepared from: mold preheating temperature is 35～65 ℃, injection temperature is 215～235 ℃, the pressure that shoots material is 800～1200 bar, briquetting pressure remains 500～900 bar, and the dwell time is 2～8 seconds.
The present invention also provides a kind of method with gastrointestinal tract anastomat medicine carrying of the present invention, it is characterized in that, adopt art for coating evenly to be coated on gastrointestinal tract anastomat periphery medicine-carried system, drying obtains the gastrointestinal tract anastomat of medicine carrying, described anastomat is packed ethane via epoxyethane or irradiation sterilization.
The method according to this invention is characterized in that, described art for coating condition is: preheating 2-5 minute, and coating 100-130 minute, dry 3-5 minute; Inlet temperature 30-40 ℃; 30-37 ℃ of anastomat temperature; Whiff pressure 0.1-0.5MPa; Hydrojet speed: 3-30g/min.
The method according to this invention is characterized in that, described medicine-carried system comprises polyacrylic resin.
The method according to this invention is characterized in that, described medicine-carried system uses at least a medicine that is selected from sulfonamides, quinolones, carbazochrome salicylate, etamsylate.
The effect of invention
The present invention has following outstanding effect and characteristics:
1, compares with manual suture, reduced the puncture time of needlework, thereby reduce operating difficulty, improved success rate of operation.Postoperative can reduce the occurrence probability of complication such as coelenteron tissue edema, hemorrhage, inflammation.
2, compare with titanium nail formula anastomat, reduced the quantity of anastomosis staple, and do not had the apparatus legacy.
3, with biodegradable anastomosis ring (English name: Biofragmentable anastomosis ring, be called for short BAR) compare, after anastomosis staple and base coincide, with tube chamber broken ends of fractured bone nail between two rings and fix, reduce the purse string suture knotting and reinforced, simplified operating procedure.And the applying of the tube chamber broken ends of fractured bone is more firm, and the locking structure that anastomosis staple ailhead and base " inverted gun thorn " form has stronger " stitching power ".
The advantage that stitching power is big is, can guarantee that the intestinal tube after the stitching bears bigger intestinal pressure, and the good broken ends of fractured bone intestinal tube two ends that prevent from just coincideing disconnect again.Intestinal pressure refers to the food of patients after surgery feed or the pressure that gas flows and forms in bowel lumen.This pressure is fatal for the broken ends of fractured bone intestinal tube two ends that just coincide, and just the intestinal tube of Wen Heing is not also grown intactly, does not live this pressure in case anastomotic stoma is born, the possibility that disconnects is again just arranged, cause intestinal contents to flow out from breach, pollute the abdominal cavity, threaten patient's life.
4, design feature:
(1) annular slope guiding intestinal is arranged on the base ring, and isolate intestinal tissue and intestinal contents, be beneficial to intestinal tissue growth reparation and intestinal contents and pass through anastomat with annular slope.
(2) in the middle of anastomosis staple connecting ring and the base ring slit is arranged, be convenient to intestinal tube and fill.
(3) easy disintegrating becomes broken end.Than fragment, when broken end excretes through intestinal, the intestinal tissue of can not swiping can not remain in the narrow positions of corner, transverse colon and the intestinals such as colon descendens corner, descending colon and Sigmoidocolic corner of ileocecal valve (valve of ileum and caecum), ascending colon and transverse colon.Get rid of the very long absorption process of absorbable material, this process of disintegrate behind the degraded of realization macromolecular material elder generation, the anastomat in enteric cavity is treated the timely discharge in gastrointestinal tract healing back anastomat disintegrate thing, makes the diet normalization of sufferer, rehabilitation as early as possible.
(4) add the medicinal barium sulfate with developing function.In the anastomat disintegrating procedue, barium sulfate discharges gradually with the disintegrate thing, makes the disintegrating procedue of anastomat to obtain by the observation of X image, realizes the visual control that the anastomat disintegrate is discharged.
5, medicine characteristics:
(1) though the medicinal preparation for oral administration absorption is rapid but incomplete usually, is about 30%～40% of dosage; Adopt the anastomat medicine carrying with strong points, medicine directly acts on operative site, reduces medicine in gastral loss.
(2) reduce the quantity of modes such as postoperative is oral, intravenous injection anti-inflammation drugs, haemostatic medicament, simplified therapeutic process, alleviated the treatment cost of sufferer.Reduce postoperative patient wound infection, hemorrhage equivalent risk.Provide better repairing environment for healing the early stage of gastrointestinal tissue.
6, peplos characteristics: at the different pH environment of gastrointestinal tract, discharge ingredient as the polyacrylic resin of coated fertilizer gradually, realize slow release and the controlled release of medicine, play postoperative and continue medication, reach the effect of anti-inflammation hemostasis.
Description of drawings
Fig. 1 is the structural representation of combination type anastomat.The combination type anastomat adopts free-hand firmly closure or apparatus percussion, anastomosis staple (2) puncture is seen through intestinal tissue, by anastomosis staple connecting ring (4) and base (1) the intestinal tissue folder is closed between the two, cause the intestinal tissue placenta percreta to the tissue adhesion of placenta percreta, thereby reach anastomotic healing.
Fig. 2 is the structural representation of free-standing anastomat.The stand alone type anastomat adopts the apparatus percussion, anastomosis staple bar (2.1) and ailhead (2.2) puncture are seen through far-end intestinal tissue (8) and near-end intestinal tissue (9), by nail catcher (2.3) and the head of a nail (7) the intestinal tissue folder is closed between the two, cause the intestinal tissue placenta percreta to the tissue adhesion of placenta percreta, thereby reach anastomotic healing.
Description of reference numerals
1 base, 2 anastomosis staples, 3 nail holes, 4 anastomosis staple connecting rings, 5 base annular slopes.
2.1 the nail bar, 2.2 ailheads, 2.3 nail catchers, 6 inverted gun thorns, 7 contain the head of a nail of " inverted gun thorn ", 8 far-end intestinal tissues, 9 near-end intestinal tissues.
It will be understood to those of skill in the art that anastomat of the present invention presents in clear and simple mode, and needn't draw in proportion.Therefore, dimension of picture amplifies to some extent with respect to true material object, to help the understanding to embodiments of the present invention.
The specific embodiment
As mentioned above, the invention provides a kind of gastrointestinal tract anastomat.
The present invention also provides a kind of gastrointestinal tract method of coincideing, and this method may further comprise the steps: 1. prepare anastomat, 2. anastomat is assemblied in broken ends of fractured bone intestinal tube two ends respectively, and 3. stapled anastomosis device, 4. the closure procedure wound is finished operation.
Under practical situation, when anastomosis finishes, broken ends of fractured bone intestinal tube two ends by anastomosis staple be fixed on two the ring between the slit in, if the tissue that coincide is intestinal tissue, then adopt the intestinal tube inverting suture, anastomat is enclosed within the inside of tube chamber.After the anastomat that the non-degradable material makes treated that the growth of broken ends of fractured bone intestinal tube two ends is intact, the tissue necrosis that is sandwiched in the two circumferential weld cracks came off, and anastomat integral body excretes with feces.The anastomat that degradation material makes loses mechanical property gradually in the growth course of broken ends of fractured bone intestinal tube two ends, about 1～3 all disintegrates become broken end to excrete with feces.
If what carry out is that esophagus, blood vessel etc. coincide, because esophagus, blood vessel are smooth, the general everting suture technology that adopts, anastomat is enclosed within the outside of tube chamber, the anastomat that the non-degradable material makes will forever stay in the body as implanting the class medical apparatus and instruments, and the anastomat that degradation material makes will be degraded into CO gradually
2, H
2Small-molecule substances such as O are absorbed by the body, and degradation cycle guarantees more than 6 months at least according to the size of tube chamber.
And the invention provides a kind of gastrointestinal tract anastomat of disintegratable, and disintegration time can be controlled in the certain limit, and it can disintegrate become broken powder, has eliminated fragment corner angle damage intestinal, remains in the possibility of intestinal corner.And select for use the poly-Acetic acid, hydroxy-, bimol. cyclic ester of medical degradable material as primary raw material, cooperate again with medical development agent barium sulfate.Poly-Acetic acid, hydroxy-, bimol. cyclic ester is 100:0-70:30 with the ingredients by weight ratio of medicinal barium sulfate, is preferably 95:5-85:15, is preferably 90:10.When described weight ratio is 95:5-85:15, the disintegration time of anastomat (1-3 week) and stitching pulling force (30N at least) meet the gastrointestinal physiological environment more, after having guaranteed that gastrointestinal tract heals fully, anastomat just loses mechanical property, disintegrate becomes broken end to excrete with feces, finishes identical mission.
The present invention also provides a kind of preparation method of described anastomat, and be characterised in that described anastomat is carrying out the fusion injection moulding with following condition: mold preheating temperature is 35-65 ℃, and preferred 40-60 ℃, more preferably 45-55 ℃; Injection temperature is 215-235 ℃, preferred 220-230 ℃; The pressure that shoots material is the 800-1200 bar, preferred 900-1100 bar; Briquetting pressure remains the 500-900 bar, preferred 650-800 bar; Dwell time is 2-8 second, preferred 3-6 second.
Gastrointestinal tract anastomat provided by the invention has the anti-inflammation anastalsis, and it is applicable to medicines such as sulfonamides, quinolones, carbazochrome salicylate, etamsylates.Medicine such as sulfonamides, quinolones has broad-spectrum antiseptic, slackens or alleviate the effect of gastrointestinal tract post-operation inflammatory.Haemostatic medicament such as carbazochrome salicylate, etamsylate has the capillary permeability of reduction and fragility, promotes the hemostasis of impaired blood capillary pipe end retraction; And platelet counts in the increase blood, accelerate the effect of blood coagulation.Below these medicines are described further.
Sulfa drugs such as sulfapyridine silver, mafenide, sulfasalazine etc.Sulfapyridine silver, mafenide are used for traumatic infection, escherichia coli, clostridium tetani, bacillus subtilis, staphylococcus aureus, Hemolytic streptococcus, streptococcus pneumoniae etc. all there is antibacterial activity, and sulfapyridine silver also can impel wound surface drying, incrustation and promotion healing except control is infected.Sulfasalazine resolves into 5-aminosalicylic acid and sulfapyridine at distal small bowel and colon under the enteric microorganism effect.The long period rests on and plays anti-inflammation and immunosuppressive action in the intestinal tissue after 5-aminosalicylic acid and the complexation of intestinal wall connective tissue, as reduce escherichia coli and clostridium, suppress synthesizing of prostaglandin and synthesizing of other inflammatory mediator leukotrienes simultaneously.
Quinolones such as enoxacin (fluorine pyridine acid), norfloxacin (norfloxacin), ciprofloxacin, ofloxacin (ofloxacin) etc.Antimicrobial spectrum is big, especially to aerobic gram negative bacilli, comprises that Pseudomonas aeruginosa has powerful bactericidal action, and golden Portugal bacterium and product enzyme gold Portugal bacterium are also had good antibacterial action.To by the gastrointestinal infection due to Shigella, Salmonella, enterotoxigenic escherichia coli, aeromonas hydrophila, the vibrio parahaemolytious etc. the good curing effect being arranged.
Haemostatic medicament such as carbazochrome salicylate, etamsylate, tranamic acid, rutosids etc.Carbazochrome salicylate can reduce the permeability of blood capillary, promotes impaired blood capillary pipe end retraction and stops blooding.Be mainly used in capillary permeability hemorrhage due to increasing,, gastrointestinal hemorrhage hemorrhage as chronic pulmonary, epistaxis, spitting of blood etc.Etamsylate can increase platelet counts in the blood, strengthens its aggregation and adhesiveness, promotes the release of blood coagulation substance, to accelerate blood coagulation.Tranamic acid is antifibrinolytic medicine, can make established blood clot unlikely dissolved and destroy, and reaches to prevent because fibrinolysis hemorrhage due to strengthening, and it is hemorrhage etc. to be used for upper gastrointestinal hemorrhage, oozing of blood, surgical operation.Rutosids is mainly used in treating the capillary hemorrhage disease that fragility increases.
Gastrointestinal tract anastomat provided by the invention has the medicine sustained and controlled release function, and this anastomat can carry out slow release and the controlled release of medicine in the physiological environment (stomach pH1-3.5, small intestinal pH5-7, large intestine pH8.3-8.4) of the different pH of human body, realize continuing medication.Described anastomat selects for use pharmaceutic adjuvant-acrylic resin in the Pharmacopoeia of People's Republic of China (2010 editions) as coated fertilizer.This acrylic resin is divided into polyacrylic resin I type, polyacrylic resin type, three kinds of enteric solubility coating materials of polyacrylic resin type and a kind of stomach dissolution type coating material of polyacrylic resin type.This acrylic resin also has corresponding external product, in now the title of domestic and international corresponding product being listed in the table below.
The domestic and international corresponding product of table 1 acrylic resin
Polyacrylic resin type, this product are that methacrylic acid and methyl methacrylate are with the 50:50(weight ratio) the ratio copolymerization obtain.Polyacrylic resin type, this product are that methacrylic acid and methyl methacrylate are with the 35:65(weight ratio) the ratio copolymerization obtain.Polyacrylic resin type, this product are the copolymer of dimethylaminoethyl methacrylate and methyl acrylic ester.Can be referring to Chinese Pharmacopoeia (2010 editions) text kind second portion 1247-1248 page or leaf.
The invention provides a kind of method with described anastomat medicine carrying, adopt art for coating that medicine-carried system evenly is coated on the periphery of anastomat, described art for coating condition is: preheating 2-5 minute, and coating 100-130 minute, dry 3-5 minute; Inlet temperature 30-40 ℃; 30-37 ℃ of anastomat temperature; Whiff pressure 0.1-0.5Mpa; Hydrojet speed: 3-30g/min.Final drying obtains the medicine carrying anastomat, this anastomat is packed ethane via epoxyethane or irradiation sterilization.
Below, embodiment is shown and comparative example is specifically described embodiments of the present invention.But the present invention is not limited to following embodiment.
Preparation example 1, feedstock production
Poly-Acetic acid, hydroxy-, bimol. cyclic ester preparation: Acetic acid, hydroxy-, bimol. cyclic ester 500g is added in the reactor, in reactor, add the 0.005%(part by weight) stannous octoate catalyst.Sealed reaction system feeds the nitrogen protection reaction.Control response system temperature is 120 ℃, reacts 30 hours.Reactant is shredded the pellet of making the 1-8mm particle diameter, and weighing obtains pellet 491g, yield 98.2%.Above-mentioned pellet is dissolved in the hexafluoroisopropanol solution, and the intrinsic viscosity that records polymer with Ubbelohde viscometer in 25 ℃ of waters bath with thermostatic control is 3.28dL/g.
Injection raw material preparation: will gather Acetic acid, hydroxy-, bimol. cyclic ester 491g and encapsulate stand-by.
Preparation example 2, feedstock production
Poly-Acetic acid, hydroxy-, bimol. cyclic ester preparation: according to the method for preparation example 1, except the response time becomes 25 hours, prepare poly-Acetic acid, hydroxy-, bimol. cyclic ester 495g, yield 99%.The intrinsic viscosity that its method according to preparation example 1 records polymer is 3.15dL/g.
Injection raw material preparation: will gather Acetic acid, hydroxy-, bimol. cyclic ester 495g and mix (ratio 95:5) with medical grade barium sulfate 26g evenly, and encapsulate stand-by.
Preparation example 3, feedstock production
Poly-Acetic acid, hydroxy-, bimol. cyclic ester preparation: according to the method for preparation example 1, except the response time becomes 32 hours, prepare poly-Acetic acid, hydroxy-, bimol. cyclic ester 498g, yield 99.6%.The intrinsic viscosity that its method according to preparation example 1 records polymer is 3.33dL/g.
Injection raw material preparation: will gather Acetic acid, hydroxy-, bimol. cyclic ester 498g and mix (ratio 90:10) with medical grade barium sulfate 55g evenly, and encapsulate stand-by.
Preparation example 4, feedstock production
Poly-Acetic acid, hydroxy-, bimol. cyclic ester preparation: according to the method for preparation example 1, except the response system temperature becomes 125 ℃, the response time becomes 32 hours, prepares poly-Acetic acid, hydroxy-, bimol. cyclic ester 490g, yield 98%.The intrinsic viscosity that its method according to preparation example 1 records polymer is 3.42dL/g.
Injection raw material preparation: will gather Acetic acid, hydroxy-, bimol. cyclic ester 490g and mix (ratio 85:15) with medical grade barium sulfate 86g evenly, and encapsulate stand-by.
Preparation example 5, feedstock production
Poly-Acetic acid, hydroxy-, bimol. cyclic ester preparation: according to the method for preparation example 1, except the response system temperature becomes 118 ℃, prepare poly-Acetic acid, hydroxy-, bimol. cyclic ester 496g, yield 99.2%.The intrinsic viscosity that its method according to preparation example 1 records polymer is 3.21dL/g.
Injection raw material preparation: will gather Acetic acid, hydroxy-, bimol. cyclic ester 496g and mix (ratio 80:20) with medical grade barium sulfate 124g evenly, and encapsulate stand-by.
Preparation example 6, feedstock production
Poly-Acetic acid, hydroxy-, bimol. cyclic ester preparation: according to the method for preparation example 1, except the response system temperature becomes 115 ℃, prepare poly-Acetic acid, hydroxy-, bimol. cyclic ester 495g, yield 99%.The intrinsic viscosity that its method according to preparation example 1 records polymer is 3.17dL/g.
Injection raw material preparation: will gather Acetic acid, hydroxy-, bimol. cyclic ester 495g and mix (ratio 70:30) with medical grade barium sulfate 212g evenly, and encapsulate stand-by.
Preparation example 7, feedstock production
Poly-Acetic acid, hydroxy-, bimol. cyclic ester preparation: according to the method for preparation example 1, except the response time becomes 34 hours, prepare poly-Acetic acid, hydroxy-, bimol. cyclic ester 498g, yield 99.6%.The intrinsic viscosity that its method according to preparation example 1 records polymer is 3.36dL/g.
Injection raw material preparation: will gather Acetic acid, hydroxy-, bimol. cyclic ester 498g and mix (ratio 60:40) with medical grade barium sulfate 332g evenly, and encapsulate stand-by.
Preparation example 8, feedstock production
Poly-Acetic acid, hydroxy-, bimol. cyclic ester preparation: according to the method for preparation example 1, except the response time becomes 28 hours, prepare poly-Acetic acid, hydroxy-, bimol. cyclic ester 490g, yield 98%.The intrinsic viscosity that its method according to preparation example 1 records polymer is 3.22dL/g.
Injection raw material preparation: will gather Acetic acid, hydroxy-, bimol. cyclic ester 490g and mix (ratio 50:50) with medical grade barium sulfate 490g evenly, and encapsulate stand-by.
Below be preparation example 9-16.
Preparation example 9, feedstock production
Polylactide preparation: lactide 500g is added in the reactor, in reactor, add the 0.004%(part by weight) stannous octoate catalyst.Sealed reaction system feeds the argon shield reaction.Control response system temperature is 130 ℃, reacts 24 hours.Reactant is shredded the pellet of making the 1-6mm particle diameter, and weighing obtains pellet 493g, yield 98.4%.Above-mentioned pellet is dissolved in phenol/sym-tetrachloroethane (2:3/V:V) mixed solution, and the intrinsic viscosity that records polymer with Ubbelohde viscometer in 25 ℃ of waters bath with thermostatic control is 3.31dL/g.
Injection raw material preparation: polylactide 493g encapsulation is stand-by.
Preparation example 10, feedstock production
Polylactide preparation: according to the method for preparation example 9, except the response time becomes 20 hours, prepare polylactide 498g, yield 99.6%.The intrinsic viscosity that its method according to preparation example 9 records polymer is 3.26dL/g.
The injection raw material preparation: polylactide 498g is mixed (ratio 95:5) with medical grade barium sulfate 26.2g even, encapsulates stand-by.
Preparation example 11, feedstock production
Polylactide preparation: according to the method for preparation example 9, except the response system temperature becomes 115 ℃, prepare polylactide 496g, yield 99.2%.The intrinsic viscosity that its method according to preparation example 9 records polymer is 3.04dL/g.
The injection raw material preparation: polylactide 496g is mixed (ratio 90:10) with medical grade barium sulfate 55.1g even, encapsulates stand-by.
Preparation example 12, feedstock production
Polylactide preparation: according to the method for preparation example 9, except the response system temperature becomes 120 ℃, prepare polylactide 490g, yield 98%.The intrinsic viscosity that its method according to preparation example 9 records polymer is 3.18dL/g.
The injection raw material preparation: polylactide 490g is mixed (ratio 85:15) with medical grade barium sulfate 86.4g even, encapsulates stand-by.
Preparation example 13, feedstock production
Polylactide preparation: according to the method for preparation example 9, except the response time becomes 36 hours, prepare polylactide 492g, yield 98.4%.The intrinsic viscosity that its method according to preparation example 9 records polymer is 3.42dL/g.
The injection raw material preparation: polylactide 492g is mixed (ratio 80:20) with medical grade barium sulfate 123g even, encapsulates stand-by.
Preparation example 14, feedstock production
Polylactide preparation: according to the method for preparation example 9, except the response time becomes 28 hours, prepare polylactide 495g, yield 99%.The intrinsic viscosity that its method according to preparation example 9 records polymer is 3.37dL/g.
The injection raw material preparation: polylactide 495g is mixed (ratio 70:30) with medical grade barium sulfate 212.1g even, encapsulates stand-by.
Preparation example 15, feedstock production
The polylactide preparation: according to the method for preparation example 9, except the response system temperature becomes 125 ℃, the response time becomes 20 hours, prepares polylactide 491g, yield 98.2%.The intrinsic viscosity that its method according to preparation example 9 records polymer is 3.21dL/g.
The injection raw material preparation: polylactide 491g is mixed (ratio 60:40) with medical grade barium sulfate 327.3g even, encapsulates stand-by.
Preparation example 16, feedstock production
The polylactide preparation: according to the method for preparation example 9, except the response system temperature becomes 115 ℃, the response time becomes 26 hours, prepares polylactide 497g, yield 99.4%.The intrinsic viscosity that its method according to preparation example 9 records polymer is 3.08dL/g.
The injection raw material preparation: polylactide 497g is mixed (ratio 50:50) with medical grade barium sulfate 497g even, encapsulates stand-by.
(injection mo(u)lding of anastomat)
According to fusion Shooting Technique of the present invention the injection raw material of preparation example 1-16 is carried out injection mo(u)lding.Concrete process conditions are listed in the table below among the 2-5.The mould that uses in the injection mo(u)lding meets following requirement: make the structure shown in the anastomosis apparatus drawings attached 1 that injection mo(u)lding obtains.
(the stitching tensile test of anastomat)
Test with ergometer.After the base of anastomat and the anastomosis staple stitching, under the effect of 30N external force, do not get loose.The gained experimental result is listed among the following table 2-5.
(test of anastomat degradation time)
Acid-base value: anastomat is soaked fully the external phosphate buffered solution (pH7.2 ± 0.1) that places 200mL simulation application environment, try one's best little and guarantee safety in glass container inner top space, under 37 ℃ ± 1 ℃ condition of temperature, the pH that glass container is measured solution is taken out in vibration (40 rev/mins) in ZWY-211B type electric heating constant temperature shaking table (Shanghai ZHICHENG Anaiytical Instrument Manufacturing Co., Ltd.) every day.The gained experimental result is listed in the following table 2 to 7.
(anastomat degraded Mechanics Performance Testing)
Compression resistance: after having measured the pH of solution according to the method for " test of anastomat degradation time ", take out anastomat and radially exert pressure, the fragment behind the feel range estimation size degradation.With the piezometer test, exert pressure with the speed of 5mm/min.Anastomat soaked 11 days in the external buffer solution of simulation application environment, took out the back and answered free from flaw radially slowly applying under the 10N pressure, did not have damaged.Anastomat soaked 21 days in the external buffer solution of simulation application environment.Take out the back radially slowly applying palpus disintegrate or inner and outer ring disengaging under the 5N pressure, there is no sharp corner angle.The gained experimental result is listed in the following table 2 to 7.
Table 2 injection mo(u)lding test
An explanation is done in the disintegrate among the his-and-hers watches 2-4 here, and disintegrate refers to be broken, lost by the anastomat overall structure that poly-Acetic acid, hydroxy-, bimol. cyclic ester or these macromolecular compounds of polylactide are made a kind of change procedure of mechanical property.The disintegrate here can be understood as a descending variation of macro object, is different from degraded and changes, and namely poly-Acetic acid, hydroxy-, bimol. cyclic ester or these macromolecular compounds of polylactide resolve into the change procedure of this microcosmic of micromolecular compound.
Table 3 injection mo(u)lding test
Because preparation example 7 and preparation example 8 can not injection moulding prepare the molding anastomat, so just there is not the test data of projects such as stitching pulling force, disintegration time, the corresponding test data in the form is just with " // // // " expression.
From above-described embodiment as can be seen, when the ingredients by weight of poly-Acetic acid, hydroxy-, bimol. cyclic ester (PGA) and medicinal barium sulfate than for 100:0-70:30 the time, can molding make anastomat.The anastomat that makes has higher stitching pulling force (more than the 30N) and the mechanical property of degrading preferably, especially when the ingredients by weight of poly-Acetic acid, hydroxy-, bimol. cyclic ester and medicinal barium sulfate than 95:5-70:30, during preferred 95:5-85:15.And the anastomat that makes can disintegrate in the short period in 1-3 week.
Table 4 injection mo(u)lding test
The fusion Shooting Technique parameter of polylactide (PLA) and barium sulfate mixture: mold preheating temperature is 40-70 ℃, preferred 55-65 ℃; Injection temperature is 220-255 ℃, preferred 230-240 ℃; The pressure that shoots material is the 1000-1400 bar, preferred 1100-1200 bar; Briquetting pressure remains the 700-1000 bar, preferred 800-900 bar; Dwell time is 3-6 second, preferred 4-5 second.
Table 5 injection mo(u)lding test
Because preparation example 14, preparation example 15 and preparation example 16 can not injection moulding prepare the molding anastomat, so just there is not the test data of projects such as stitching pulling force, disintegration time, the corresponding test data in the form is just with " // // // " expression.
When the ingredients by weight of polylactide (PLA) and medicinal barium sulfate than being 100:0-80:20, can molding prepare anastomat.Can select polylactide and compare the anastomat for preparing for 90:10-85:15 with the medicinal barium sulfate ingredients by weight, this anastomat stitching pulling force is greater than 30N, and disintegration time is in 2.5 weeks.But, with select for use poly-Acetic acid, hydroxy-, bimol. cyclic ester to prepare anastomat with the medicinal barium sulfate proportioning to compare, the anastomat disintegration time that the batching of polylactide and medicinal barium sulfate prepares is grown (2-3.5 week), and degraded has all produced a lot of fragments when applying 5N pressure last day, in the time of pressure will being applied to 10N, fragment just might disintegrate become broken end.By contrast, the proportioning of poly-Acetic acid, hydroxy-, bimol. cyclic ester and medicinal barium sulfate becomes preferred prescription.
Table 6 anastomat degradation process acid-base value changes
Table 7 anastomat degradation process acid-base value changes
Anastomat 13 was degraded 14 days in buffer solution, the anastomat overall structure begins disintegrate, loses mechanical property when exerting pressure in the 14th day, whole anastomat has not possessed cradling function, so just there has not been the test of follow-up pH value, the corresponding test data in the form is just with " // // // " expression.Anastomat 12, anastomat 11, anastomat 10 all are based on identical reason, just do not carry out follow-up pH test again.About the pH value of buffer solution is down to 6.0 or 6.0 when above, anastomat 9, anastomat 10, anastomat 11, anastomat 12 degradeds all can be born the pressure of 10N in the time of 11 days, under this pressure the anastomat free from flaw, do not have damaged.Crack, breakage appearred in 11 days in anastomat 13 degradeds.About the pH value of buffer solution is down to 5.0 and when lower, anastomat 9 degradeds still had big fragment in 24 days under 5N even 10N pressure, and fragment has corner angle; Anastomat 10 degradeds still had big fragment in 21 days under 5N even 10N pressure, fragment has corner angle; Anastomat 11 degradeds were broken into fractionlet in 18 days under 5N pressure, be ground into broken end under the 10N pressure; Anastomat 12 degradeds were broken into fractionlet in 18 days under 5N pressure, be ground into broken end under 10N pressure; Anastomat 13 degraded 14 days is ground into broken end at 5N pressure.
Preparation example 17: the preparation of polyacrylic resin I type medicine-carried system
Coat 200g anastomat (4g/ 's) medicine-carried system: in a glass container, adding Eudragit L30-55(polyacrylic resin I type) 166.7g, triethyl citrate 5.0g, Pulvis Talci 12.5g, water 215.8g, amount to 400g, and silver sulfadiazine 1g and carbazochrome salicylate 1g, little heating, fully the dissolving mix homogeneously is put cold.Adopt the ordinary coating pot drug solution evenly to be coated to the anastomat periphery, the room temperature vacuum drying.
Preparation example 18: the preparation of polyacrylic resin I type medicine-carried system
According to the method for preparation example 17, except medicine replaces with mafenide 1g and etamsylate 1g.
Preparation example 19: the preparation of polyacrylic resin I type medicine-carried system
According to the method for preparation example 17, except medicine replaces with mafenide 1g and rutosids 1g.
Preparation example 20: the preparation of polyacrylic resin I type medicine-carried system
According to the method for preparation example 17, except medicine replaces with sulfasalazine 1g and carbazochrome salicylate 1g.
(polyacrylic resin I type coats the anastomat test)
Art for coating parameter: preheating 2 minutes, coating 130 minutes, dry 5 minutes; 32 ℃ of inlet temperature; 30 ℃ of anastomat temperature; Whiff pressure 0.15Mpa; Hydrojet speed: 3g/min.
Final drying: be placed in the tray, placed 30 ℃ of baking ovens 2 hours, obtain the medicine carrying anastomat.
Different pharmaceutical prescription according to preparation example 17, preparation example 18, preparation example 19, preparation example 20, prepare the anastomat (anastomat 17, anastomat 18, anastomat 19, anastomat 20) of different medicine carrying compositions, this anastomat pH greater than the solution system more than 5.5 in the time medicine begin stripping, can realize enterally continuing medication.This anastomat is packed ethane via epoxyethane or irradiation sterilization.
Preparation example 21: the preparation of polyacrylic resin type medicine-carried system
Coat 1000g anastomat (4g/ 's) medicine-carried system: in a glass container, adding EudragitL100(polyacrylic resin type) 94g, triethyl citrate 10g, Pulvis Talci 20g, 95% ethanol 1400g, amount to 1524g, and enoxacin 5g and carbazochrome salicylate 5g, little heating, fully the dissolving mix homogeneously is put cold.Adopt the ordinary coating pot drug solution evenly to be coated to the anastomat periphery, the room temperature vacuum drying.
Preparation example 22: the preparation of polyacrylic resin type medicine-carried system
According to the method for preparation example 21, except medicine replaces with norfloxacin 5g and etamsylate 5g.
Preparation example 23: the preparation of polyacrylic resin type medicine-carried system
According to the method for preparation example 21, except medicine replaces with ciprofloxacin 5g and tranamic acid 5g.
Preparation example 24: the preparation of polyacrylic resin type medicine-carried system
According to the method for preparation example 21, except medicine replaces with ofloxacin 5g and rutosids 5g.
(the polyacrylic resin type coats the anastomat test)
Art for coating parameter: preheating 3 minutes, coating 120 minutes, dry 5 minutes; 40 ℃ of inlet temperature; 30 ℃ of anastomat temperature; Whiff pressure 0.5Mpa; Hydrojet speed: 25g/min.
Final drying: be placed in the tray, placed 30 ℃ of baking ovens 2 hours, obtain the medicine carrying anastomat.
Different pharmaceutical prescription according to preparation example 21, preparation example 22, preparation example 23, preparation example 24, prepare the anastomat (anastomat 21, anastomat 22, anastomat 23, anastomat 24) of different medicine carrying compositions, this anastomat pH greater than the solution system more than 6.0 in the time medicine begin stripping, can realize enterally continuing medication.This anastomat is packed ethane via epoxyethane or irradiation sterilization.
Preparation example 25: the preparation of polyacrylic resin type medicine-carried system
Coat 1000g anastomat (4g/ 's) medicine-carried system: in a glass container, adding EudragitS100(polyacrylic resin type) 34g, dibutyl sebacate 3g, Pulvis Talci 9g, microcrystalline Cellulose 3g, 95% ethanol 571g, amount to 620g, and silver sulfadiazine 5g and tranamic acid 5g, little heating, fully the dissolving mix homogeneously is put cold.Adopt the ordinary coating pot drug solution evenly to be coated to the anastomat periphery, the room temperature vacuum drying.
Preparation example 26: the preparation of polyacrylic resin type medicine-carried system
According to the method for preparation example 25, except medicine replaces with mafenide 5g and etamsylate 5g.
Preparation example 27: the preparation of polyacrylic resin type medicine-carried system
According to the method for preparation example 25, except medicine replaces with mafenide 5g and rutosids 5g.
Preparation example 28: the preparation of polyacrylic resin type medicine-carried system
According to the method for preparation example 25, except medicine replaces with sulfasalazine 5g and carbazochrome salicylate 5g.
(the polyacrylic resin type coats the anastomat test)
Art for coating parameter: preheating 4 minutes, coating 130 minutes, dry 3 minutes; 35 ℃ of inlet temperature; 30 ℃ of anastomat temperature; Whiff pressure 0.25Mpa; Hydrojet speed: 5g/min.
Final drying: be placed in the tray, placed 30 ℃ of baking ovens 2 hours, obtain the medicine carrying anastomat.
Different pharmaceutical prescription according to preparation example 25, preparation example 26, preparation example 27, preparation example 28, prepare the anastomat (anastomat 25, anastomat 26, anastomat 27, anastomat 28) of different medicine carrying compositions, this anastomat pH greater than the solution system more than 7.0 in the time medicine begin stripping, can realize continuing medication of small intestinal, big enteral.This anastomat is packed ethane via epoxyethane or irradiation sterilization.
Preparation example 29: the preparation of polyacrylic resin type medicine-carried system
Coat 1000g anastomat (4g/ 's) medicine-carried system: in a glass container, adding Eudragit E100(polyacrylic resin type) 20g, sodium lauryl sulphate 2g, stearic acid 3g, magnesium stearate 7g, distilled water 168g, amount to 200g, and enoxacin 5g and carbazochrome salicylate 5g, little heating, fully the dissolving mix homogeneously is put cold.Adopt the ordinary coating pot drug solution evenly to be coated to the anastomat periphery, the room temperature vacuum drying.
Preparation example 30: the preparation of polyacrylic resin type medicine-carried system
According to the method for preparation example 29, except medicine replaces with norfloxacin 5g and etamsylate 5g.
Preparation example 31: the preparation of polyacrylic resin type medicine-carried system
According to the method for preparation example 29, except medicine replaces with ciprofloxacin 5g and tranamic acid 5g.
Preparation example 32: the preparation of polyacrylic resin type medicine-carried system
According to the method for preparation example 29, except medicine replaces with ofloxacin 5g and rutosids 5g.
(the polyacrylic resin type coats the anastomat test)
Art for coating parameter: preheating 2 minutes, coating 60 minutes, dry 3 minutes; 35 ℃ of inlet temperature; 30 ℃ of anastomat temperature; Whiff pressure 0.2Mpa; Hydrojet speed: 4g/min.
Final drying: be placed in the tray, placed 30 ℃ of baking ovens 2 hours, obtain the medicine carrying anastomat.
Different pharmaceutical prescription according to preparation example 29, preparation example 30, preparation example 31, preparation example 32, prepare the anastomat (anastomat 29, anastomat 30, anastomat 31, anastomat 32) of different medicine carrying compositions, this anastomat pH less than 5.0 solution system in the time medicine begin stripping, can realize continuing medication of stomach.This anastomat is packed ethane via epoxyethane or irradiation sterilization.
Claims (17)
1. a gastrointestinal tract anastomat is characterized in that, comprising:
The anastomosis staple assembly comprises anastomosis staple;
Base, described base are the flat ring bodies of hollow, have ringwise main part basically, and the main part of described base has a plurality of through holes that run through main part from top to bottom, and described through hole cooperates with described anastomosis staple;
Described anastomosis staple assembly and described base are made by degradation material and medicinal barium sulfate.
2. gastrointestinal tract anastomat according to claim 1, it is characterized in that, the cross section of the nail bar part of described anastomosis staple is circle, rhombus, triangle, tetragon, polygon or other regular shapes, and described shape of through holes is consistent with the nail bar shape of cross section of described anastomosis staple.
3. gastrointestinal tract anastomat according to claim 1 and 2, it is characterized in that, described anastomosis staple assembly also comprises at least one ring component, one in described at least one ring component is the anastomosis staple connecting ring, described anastomosis staple connecting ring is connected with many described anastomosis staples, and described anastomosis staple is corresponding one by one with described lead to the hole site.
4. according to each described gastrointestinal tract anastomat of claim 1～3, it is characterized in that the internal ring of described base body part is provided with intilted annular slope.
5. according to each described gastrointestinal tract anastomat of claim 1～4, it is characterized in that described identical ailing bar is provided with latch, is provided with the draw-in groove that cooperates with described latch in the described through hole.
6. according to each described gastrointestinal tract anastomat of claim 1～5, it is characterized in that described anastomosis staple tip is provided with pawl, described anastomosis staple enters described through hole, and passes described base and fix.
7. according to each described gastrointestinal tract anastomat of claim 1～6, it is characterized in that described through hole is more than the row, each exhausting hole is evenly distributed on the circumference of circle of same diameter that axle center with base is the center of circle.
8. according to each described gastrointestinal tract anastomat of claim 1～7, it is characterized in that described anastomat has freestanding structure, be made up of anastomosis staple and the head of a nail that anastomosis staple is made up of nail catcher, nail bar, ailhead, the head of a nail has " inverted gun thorn " structure.
9. according to each described gastrointestinal tract anastomat of claim 1～8, it is characterized in that described degradation material is selected from one or both in poly-Acetic acid, hydroxy-, bimol. cyclic ester, the polylactide.
10. according to each described gastrointestinal tract anastomat of claim 1～9, it is characterized in that described degradation material is 100:0～70:30 with the ingredients by weight ratio of medicinal barium sulfate, the disintegration time of described anastomat was 1～3 week.
11. gastrointestinal tract anastomat according to claim 10 is characterized in that, the poly-Acetic acid, hydroxy-, bimol. cyclic ester of described degradation material is 95:5～85:15 with the ingredients by weight ratio of medicinal barium sulfate.
12., it is characterized in that the poly-Acetic acid, hydroxy-, bimol. cyclic ester of described degradation material is 90:10 with the ingredients by weight ratio of medicinal barium sulfate according to claim 10 or 11 described gastrointestinal tract anastomats.
13. the preparation method of each described gastrointestinal tract anastomat of claim 1～12, it is characterized in that, described anastomat carries out the fusion injection moulding with following condition and is prepared from: mold preheating temperature is 35～65 ℃, injection temperature is 215～235 ℃, the pressure that shoots material is 800～1200 bar, briquetting pressure remains 500～900 bar, and the dwell time is 2～8 seconds.
14. one kind will be according to the method for each described gastrointestinal tract anastomat medicine carrying of claim 1～12, it is characterized in that, adopt art for coating that medicine-carried system evenly is coated on gastrointestinal tract anastomat periphery, drying obtains the gastrointestinal tract anastomat of medicine carrying, described anastomat is packed ethane via epoxyethane or irradiation sterilization.
15. method according to claim 14 is characterized in that, described art for coating condition is: preheating 2～5 minutes, coating 100～130 minutes, dry 3～5 minutes; 30～40 ℃ of inlet temperature; 30～37 ℃ of anastomat temperature; Whiff pressure 0.1～0.5MPa; Hydrojet speed: 3～30g/ minute.
16. according to claim 14 or 15 described methods, it is characterized in that described medicine-carried system comprises polyacrylic resin.
17., it is characterized in that described medicine-carried system uses at least a medicine that is selected from sulfonamides, quinolones, carbazochrome salicylate, etamsylate according to each described method of claim 14～16.
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