CN1141913C - Degradable internal anastomosing casing for operational anastomosis - Google Patents
Degradable internal anastomosing casing for operational anastomosis Download PDFInfo
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- CN1141913C CN1141913C CNB981265162A CN98126516A CN1141913C CN 1141913 C CN1141913 C CN 1141913C CN B981265162 A CNB981265162 A CN B981265162A CN 98126516 A CN98126516 A CN 98126516A CN 1141913 C CN1141913 C CN 1141913C
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- recessed
- surgical stapling
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Abstract
The present invention relates to a degradable internal anastomosing casing for operational anastomosis, which is composed of a convex casing and a concave casing, wherein the concave casing is a tubular concave casing body, and a locking groove is arranged on the concave casing body; the convex casing body of the convex casing is also tubular, and a key is arranged on the head of the convex casing body. A biodegradable composition forming material comprises the components by the following weight percentage: 100 portions of biodegradable macromolecules, 5 to 100 portions of a developer and 0.01 to 2.0 portions of anti-infection and anti-cancer medicine. The anastomosing casing has the advantages of simple structure, convenient arrangement during operations, time saving, noninvasive testing implementation by X-ray fluoroscopy, prevention of the wound surface infection of anastomosing stomas and promotion of wound healing.
Description
Technical field
The present invention relates to a kind of degradable in vivo surgical stapling cover that is used for surgical stapling.Specifically, provide a kind of by having the made degradable in vivo that is used for surgical stapling of the biological degradability compositions cover that coincide.
Background technology
Degradable in vivo surgical stapling cover, claiming operation anastomat to be meant again a kind ofly has been used for the cut organ of temporary transient coincideing (connect or fixing) and itself can be have in vivo been degraded voluntarily to cut the organ desired certain speed that coincide in surgical operation, lose intensity, final cracked back or absorbed or be excluded external surgical operation by health and repair device.As this degradable in vivo surgical stapling cover; at first must make by macromolecular material with good biodegradability properties; after just making the cover that coincide implant during keeping one section solid shape under certain physiological condition; degraded voluntarily gradually; collapse or metabolism, thus can be absorbed by life entity or excrete.Secondly, identical cover also must have suitable structure, uses in operation so that be suitable for.
(M.P.Bulrick, M.L.Corman, C.J.Cahill et al. such as U.S. Bulrick, TheAmerican Journal of Surgery, 1991,161,136.1) and (R.Gullichsen, J.Ovaska, T.Havia et al. such as Gullichsen, Dis Colon Rectum, 1993,36 362.) reported a kind of biofraction type bowel anastomosis device, this kind anastomat is material with the polyglycolic acid, can be cracked voluntarily after degraded, then be excluded external.Utilize so identical sundries to carry out bowel anastomosis, can reach and avoid the anastomotic stoma foreign body residual, thereby reduce the anastomotic stoma complication, and shorten the effect when coincideing.But the performance of polyglycolic acid is more crisp, and mechanical performance is relatively poor, and processing is difficulty.In addition, can't understand anastomat degraded and cracked situation in vivo in the method for external employing noninvasive testing and monitoring after coincideing with such anastomat, and can't prevent the problems such as traumatic infection of anastomotic stoma.
Can not check the degraded of anastomat and cracked shortcoming by not damaged for overcoming in the above-mentioned technology, present inventors once provided a kind of biodegradation rate adjustable, contain anticancer, anti-infectives and the controlled biodegradation high molecular composition (Chinese invention patent application number 97116925.X) of drug releasing rate.
Above-mentioned biological degradability compositions comprises three components, and its component and content (weight portion) are as follows:
Constituent content is preferable
Biodegradation high molecular 100 100
Developing agent 5-100 10-50
Infection and cancer therapy drug 0.01-2.0 0.05-0.5
Wherein, biodegradation high molecular can be polycaprolactone, polycaprolactone-polyether block copolymer, polylactic acid, polycaprolactone-polylactide copolymer, polylactic acid-copolyether, polycaprolactone-polyethers-polylactide copolymer, poly-(Acetic acid, hydroxy-, bimol. cyclic ester-lactide) copolymer, polycaprolactone-poly-glycolide copolymer and other fatty acid polyglycol lactone copolymers, and the blend of natural high molecular substance such as glue protein, chitosan, gelatin, alginate or above various materials;
Developing agent is barium sulfate (BaSO
4);
Infection and cancer therapy drug are that streptomycin, penicillin, gentamycin, silk split chain element, erythromycin, metronidazole, norfloxacin, 5-fluorouracil, and the mixture of above medicine.
The preparation method of above-mentioned composition is that three kinds of components are carried out uniform mixing by solwution method or hot melt.Be prepared as follows:
1, solwution method: biodegradation high molecular solution is made into the solution of 5-20% in acetone, chloroform, oxolane or water, adds developing agent BaSO then
4And medicine, after stirring, slough solvent, make compositions.
2, heat fusion joint: at 55-160 ℃ the softening or alkane of biodegradation high molecular is melted, add developing agent BaSO then
4And medicine, the postcooling molding stirs.
Above-mentioned this biological degradability compositions is because wherein therefore infection, antibiotic, anti-inflammation drugs can play the effect of protecting from infection, accelerate wound healing effectively at the wound site sustained release.By adding developing agent BaSO
4, can in use carry out undamaged vitro examination with X-light at any time.
Summary of the invention
The biodegradation high molecular composition (Chinese patent application 97116925.X) that the objective of the invention is to utilize the inventor to provide in earlier stage provides a kind of degradable in vivo surgical stapling cover that surgical stapling uses that is suitable for of practicality.
Characteristics of separating the identical cover of intestinal of the present invention are made up of protruding cover and recessed cover two parts.These two parts are put into intestines two broken ends of fractured bone that need coincide respectively, as long as after the inclined-plane of just protruding cover head pushes recessed cover, protruding cover just can utilize the inherent elasticity of high molecular polymer and restore to the original state naturally; Simultaneously because the recoverability of intestinal portion can be pressed against the rear end on protruding cover head inclined-plane the inner end of recessed cover.The key of recessed cover enters recessed cover along the groove of recessed cover when being pressed into, thereby guarantees chimeric mutually between concavo-convex two cover each key and grooves.Because concavo-convex two cover joints can guarantee good the coincideing between intestines two broken ends of fractured bone to the modest pressure that intestinal wall produced.In the certain hour after intestines two end-to-end anastomosis and recovery from illness, along with the degraded of the cover material that coincide, the cover nature that coincide is cracked and be excluded external.
Specifically, the identical cover that is used for the degradable in vivo operation of surgical stapling of the present invention is made up of protruding cover and recessed cover two parts.Wherein, recessed cover is the recessed body of a tubulose, has the sealed groove that sees through recessed body tube wall on recessed body; The protruding body of protruding cover also is a tubulose, has key at protruding body head; This key cross section is for slightly being " ∽ " shape, the key inclined-plane that the head band protrudes, and rear portion and protruding body link into an integrated entity and are formed with the spill keyway; Recessed body and protruding body outer, internal diameter is close, the size of the key of protruding body is corresponding with the sealed groove of recessed body, after protruding body head key inclined-plane was pushed recessed cover, the protuberance of rubber-like key put in outside the sealed groove of recessed body, and the spill keyway of protruding body is just in time sealed lives recessed body outer wall.Thereby make concavo-convex two covers chimeric mutually.
Recessed, sealed groove on the protruding body is corresponding one by one with key, there is no particular limitation to the number of sealed groove and key, but for guaranteeing postoperative effect, sealed groove and key should respectively be no less than 2, the quantity that increases sealed groove and key is utilized recessed, protruding body sealed, but cause processing difficulties in the time of too much, generally preferably be respectively 3-10, sealed groove is evenly distributed on the outer tube wall middle part of recessed body, key all is distributed on protruding body head, and be integral with protruding body, after key length made key stretch into recessed body, the protuberance of its key head portion stretched in the sealed groove just and makes the spill keyway of key sealed toward recessed body outer wall.
The preparation method of the identical cover of the invention described above is also very easy.The coincide material (after the biological degradability compositions) of cover of the technology preparation that is at first provided by patent application (97116925.X number), technology and equipment can adopt the method extruded or the method molding of mold pressing routinely.Can adopt high steam, gamma-radiation, formalin, ethanol or oxirane to steam sterilization according to the difference of the medicament categories different and that added of material, obtain product of the present invention.
Description of drawings
Below by drawings and Examples technology of the present invention is further described.
Fig. 1 overlaps the broken section structure chart of recessed cover and the sealed state of protruding cover for the present invention coincide;
Fig. 2 overlaps the structure chart of concave cover for the present invention coincide, and wherein Fig. 2 (a) is a recessed cover cutaway view vertically, and Fig. 2 (b) is recessed cover end face front view;
Fig. 3 overlaps the structure chart of convexity cover for the present invention coincide, and wherein Fig. 2 (a) is a protruding cover cutaway view vertically, and Fig. 2 (b) is recessed front view along the chain survey end.
Among the figure, 1. recessed cover; 11. recessed body; 12. sealed groove; 2. protruding cover; 21. protruding body; 22. key; 23. key inclined-plane; 24. key spill keyway.
The specific embodiment
Embodiment 1 identical nested structure of the present invention
Can be one embodiment of the present of invention by the identical cover shown in Fig. 1-3.It is the identical cover of an example that has equally distributed 4 sealed grooves 12 and key 22 on recessed body 11 of expression and the protruding body 21 respectively.Key 22 becomes the long key of ∽ type for the cross section, when key 22 inserts in the recessed cover 1, the protuberance of elastic key 22 reaches outside the sealed groove 12 of recessed cover 2, and the just sealed outer tube wall of living recessed body 11 of key spill keyway, recessed body 11 is roughly the same with the external diameter of protruding body 21, key is inserted in the pipe of recessed body 11, and key inclined-plane 23 is to design for the insertion that utilizes key.
The preparation of embodiment 2 identical covers of the present invention
With 100 parts of caprolactones/oxygen ethylene unit mol ratio is that 80: 20 molecular weight is that polycaprolactone-polyoxyethylene blocks of 120000 is got thing and 40 parts of BaSO altogether
4Behind 140 ℃ of heating mix homogeneously, compression moulding is again at Co
60Under be used for 0 ℃ the irradiation 2,500,000 rad carry out sterilization.The article shaped that obtains is planted behind rat intestine, and normally to having no side effect in the body, about 2 all aftershaping things disappear activities in rats.
Embodiment 3
100 parts of caprolactone/oxygen ethylene unit mol ratios are polycaprolactone-polyoxyethylene ether block copolymers of 60/40 with 20 parts of chloroform dissolving (15% concentration) after vulcanization acid barium, 0.1 part of metronidazole, elder generation is after the imitative molding of 25 ℃ of following dechlorinations behind the mix homogeneously, subtracting imitative 72 hours of dechlorination down again, sterilization is 24 hours on the formalin steam.
The X-photodevelopment was clear after prepared compositions implanted rat small intestine, begin after the about week cracked, 2 week the back disappear.Do not have and infect and the morbid state generation.
Embodiment 4 usefulness experiments 3 methods but to adopt molecular weight be that 63000 polylactic acid is a biodegradable polymer.Experimental phenomena is similar, and implant disappears after about 10 days.
Embodiment 5
100 parts of caprolactone/oxygen ethylene unit mol ratios are that polycaprolactone-polyoxyethylene ether block copolymers (with embodiment 1) of 60/40 adds 0.05 part of metronidazole and promise fluorine and disappears behind 0.05 part on the star, heating mixing on 65 ℃ of hot plates, sterilized 24 hours on the formalin steam in the cooling back.Do not have infection and ill the generation after implanting rat small intestine, but can not develop under the X-light.Two weeks back dissection implant does not exist.
Embodiment 6
With molecular weight is the thing degraded macromolecular material that 98000 polycaprolactone replaces example 4, and other condition is with embodiment 5, implants not have behind the rat small intestine and infects, and can not develop under the X-light.The back dissection of three weeks, implant does not exist.
Embodiment 7
Polycaprolactone-polyethers-100 parts of polylactide ternary polymers, be mixed with 20% concentration solution, sneak into 10 parts of barium sulfate with chloroform, behind the mix homogeneously, molding or desolventizing 72 hours under reduced pressure.With alcohol-pickled sterilization 12 hours.After implanting Rat Esophagus, can observe by external X-light the back disappearance of two weeks.
Embodiment 8
The Biodegradable high molecular of embodiment 7 continued decompression again and kept 72 hours down with after evenly sneaking into 0.10 part of streptomycin and 0.10 part of 5-fluorouracil mixture desolventizing and molding in the barium sulfate mixed liquor, with stifling 30 minutes of epoxy second ring steam.After implanting Rat Esophagus, can observe by external X-light.Two week backs disappear, during do not have and infect and morbid state is found.
Embodiment 9
4% aqueous solution of 100 parts of sodium alginates adds 0.06 part of gentamycin and 0.06 part of erythromycin again with in 80 portions of barium sulfate mixed liquors, behind 3% calcium chloride water coagulation forming, uses the water wash secondary, however drying under reduced pressure.Behind this constituent implantation rat rectum, the external light of available X-is observed.The back disappears all around, during do not have and infect and morbid state is found.
Embodiment 10
The aqueous gelatin solution of 100 part of 20% concentration mixes 25 ℃ of dryings of back row with 80 parts of barium sulfate, then 150 ℃ of dehydrated crosslinkings 24 hours.With available X-photodevelopment after this constituent implantation Rat Esophagus.Disappear after one month.
Embodiment 11
Implant Rat Esophagus after splashing into 0.1 part of mitomycin in the constituent of embodiment 10, available X-photodevelopment.Disappear after one month.Rat health does not have and infects and the morbid state discovery during this period.
Embodiment 12
25 parts of chitosans place 1500 parts of distilled water, add behind 20 parts of hydrochloric acid 25 ℃ of following stirring and dissolving, add 10 parts of barium sulfate mix homogeneously aftershaping dryings again, and article shaped immersed 0.5% sodium hydroxide solution 30 minutes again, took out fully washing of back.Immersed in the ethanol sterilization then 24 hours.With available X-photodevelopment behind the small intestinal of this constituent implantation rat.Disappear after two months.
Embodiment 13
With the unit ratio of components is the terpolymer that 50/50 polycaprolactone-polylactide copolymer replaces embodiment 6, and other processing method comes to the same thing with experiment 8.
Embodiment 14
With the unit ratio of components is the copolymer that 60/40 polycaprolactone-copolyether replaces embodiment 13, comes to the same thing.
Embodiment 15
With the unit ratio of components is that 60/40 polycaprolactone-poly-acid ester copolymer replaces the copolymer of embodiment 13, comes to the same thing.
Embodiment 16
The women patient who suffers from rectal adenocarcinoma, about 7 centimetres apart from anus of its tumor lower edges are the ulcer type, and area is 2 * 3cm
2The row radical resection of rectal carcinoma, tumor formed excision fully after, adopt the degradable in vivo surgical stapling cover of embodiment 1 structure to coincide.The surgical stapling cover is extruded gained by screw extruder after mixing 20 parts of barium sulfate and 0.1 part of metronidazole by 100 part 60/40 polycaprolactone-copolyether.And adopt the oxirane steam sterilization to sterilize.Each holostrome of rectum fracture two ends is sewed up a purse wire, and " protruding body " that putting the cover that coincide in the near-end enteric cavity, and the purse wire ligation is in groove, and " recessed body " that putting the cover that coincide again in the far-end enteric cavity, and with the purse wire ligation in groove.By stretching into anus with forefinger, withstand recessed cover, recessed cover is stretched in the recessed cover, exert oneself gradually, be drawn onto " click " sound, promptly coincide and finish.Operating time 3 hours 20 minutes, the postoperative Ninth Heaven is taken out stitches, and in the two weeks after stating, can observe the complete existence that coincide and overlap with the X-x ray fluoroscopy x, after this can observe the fragmentation of the cover that coincide, the final elimination.Wound healing is good.Postoperative check half a year, coincideing, it is narrow not see.
Embodiment 17
The dog that suffers from rectal cancer, the state of an illness are with embodiment 16, but the ulcer area is smaller, are 1.5 * 2cm
2, about 7 centimetres of tumor lower edges apart from anus.The polylactic acid system of employing is coincide and is overlapped, and other several operation methods of sterilizing are also with embodiment 16.Postoperative was taken out stitches in 9 days, and wound healing is good.Postoperative check half a year, anastomotic stoma is not seen narrow.
Embodiment 18
With poly-(Acetic acid, hydroxy-, bimol. cyclic ester-lactide) copolymer is the identical cover that raw material is made, and by gamma-radiation irradiation sterilization sterilization back male's adenocarcinoma of colon patient is carried out the postoperative anastomosis operation.About 30 centimetres apart from anus in patient's tumor is the ulcer type, and the ulcer area is 3 * 3cm
2, row colon cancer radical correction.Tumor is formed the excision back be fixed on two edge of a knife broken ends of fractured bone with the embodiment 16 methods cover that will coincide, two broken ends of fractured bone are involutory then, exert oneself gradually in that distortionless situation is following, hear that " click " sound is promptly identical to finish.Operating time 2 hours 50 minutes, postoperative was taken out stitches in 9 days, and wound healing is good, postoperative check half a year, anastomotic stoma is not seen narrow.
Embodiment 19
With embodiment 18 identical operations, make the cover that coincide with the mixture of 100 parts of poly-Acetic acid, hydroxy-, bimol. cyclic ester-polylactides-polycaprolactone terpolymer of being mixed with 0.1 part of 5-fluorouracil, the otch that carries out postoperative coincide.Operating time 2 hours 40 minutes, postoperative was taken out stitches in 9 days, and wound healing is good, postoperative check half a year, anastomotic stoma is not seen narrow.
By the result of the foregoing description as can be known, that degradable in vivo bowel anastomosis cover of the present invention has is simple in structure, settle convenient and time-saving characteristics during operation.This bowel anastomosis can keep not only preventing that the anastomotic stoma foreign body is residual, the effect of reduction anastomotic stoma complication, but also have can carry out noninvasive testing by the X-x ray fluoroscopy x, with the advantage of cracked situation of monitoring anastomat, after when in material, introducing the anti-inflammatory and anticancer medicine, also can have the characteristics that prevent the anastomotic stoma traumatic infection and promote wound healing.
Claims (5)
1, a kind of degradable in vivo surgical stapling cover that is used for surgical stapling is characterized in that, is made up of protruding cover and recessed cover two parts, and wherein: recessed cover is the recessed body of a tubulose, has sealed groove on recessed body; The protruding body of protruding cover also is a tubulose, has key at protruding body head; This key cross section is for slightly being " ∽ " shape, and the key inclined-plane that the head band protrudes, rear portion are connected with protruding body and are formed with the spill keyway; The size of the key of protruding body is corresponding with the sealed groove of recessed body, after protruding body head key inclined-plane is pushed recessed cover, the protuberance of rubber-like key puts in outside the sealed groove of recessed body, and the spill keyway of protruding body is sealed lives recessed body outer wall, makes concavo-convex two covers chimeric mutually.
2, by the described degradable in vivo surgical stapling cover that is used for surgical stapling of claim 1, it is characterized in that the sealed groove on the concave, convex body is corresponding one by one with key, sealed groove and key should respectively be no less than 2; Sealed groove is evenly distributed on the outer tube wall middle part of recessed body, and key is evenly distributed on protruding body head, and is integral with protruding body.
By the described degradable in vivo surgical stapling cover that is used for surgical stapling of claim 1, it is characterized in that 3, sealed groove and key are respectively 3-10.
4, by the described degradable in vivo surgical stapling cover that is used for surgical stapling of claim 1, it is characterized in that the biological degradability compositions of the identical cover material of formation comprises three components, its component and content by weight are as follows:
Constituent content
Biodegradation high molecular: 100;
Developing agent: 5-100;
Infection and cancer therapy drug: 0.01-2.0.
5, by the described degradable in vivo surgical stapling cover that is used for surgical stapling of claim 1, it is characterized in that, biodegradation high molecular can be polycaprolactone, polycaprolactone-polyether block copolymer, polylactic acid, polycaprolactone-polylactide copolymer, polylactic acid-copolyether, polycaprolactone-polyethers-polylactide copolymer, poly-(Acetic acid, hydroxy-, bimol. cyclic ester-polylactide) copolymer, polycaprolactone-poly-glycolide copolymer and other fatty acid polyglycol lactone copolymers, and the blend of glue protein, chitosan, gelatin or alginate natural high molecular substance or above various materials; Developing agent is a barium sulfate; Infection and cancer therapy drug are that streptomycin, penicillin, gentamycin, silk split chain element, erythromycin, metronidazole, norfloxacin or 5-fluorouracil, and the mixture of above medicine.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB981265162A CN1141913C (en) | 1998-12-25 | 1998-12-25 | Degradable internal anastomosing casing for operational anastomosis |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB981265162A CN1141913C (en) | 1998-12-25 | 1998-12-25 | Degradable internal anastomosing casing for operational anastomosis |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1258482A CN1258482A (en) | 2000-07-05 |
| CN1141913C true CN1141913C (en) | 2004-03-17 |
Family
ID=5229714
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB981265162A Expired - Fee Related CN1141913C (en) | 1998-12-25 | 1998-12-25 | Degradable internal anastomosing casing for operational anastomosis |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1141913C (en) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1317998C (en) * | 2003-09-04 | 2007-05-30 | 马剑文 | Degradable medical tissue suture piece |
| CN100548226C (en) * | 2008-02-27 | 2009-10-14 | 刘忠臣 | The invagination type glue ring lock catch fixed intestines fitting ring |
| CN100556377C (en) * | 2008-08-04 | 2009-11-04 | 刘忠臣 | Sleeve type lock fixation intestine anastomosis ring |
| EP2432400B1 (en) * | 2009-03-13 | 2019-08-28 | Surgisense Corporation | Sensing adjunct for surgical staplers |
| CN103239265B (en) * | 2013-05-10 | 2015-05-20 | 杭州铭众生物科技有限公司 | Anastomat for gastrointestinal tract anastomosis surgery and production method thereof |
| CN103230289B (en) * | 2013-05-10 | 2014-04-02 | 杭州铭众生物科技有限公司 | Gastrointestinal tract anastomat and application method thereof |
-
1998
- 1998-12-25 CN CNB981265162A patent/CN1141913C/en not_active Expired - Fee Related
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| Publication number | Publication date |
|---|---|
| CN1258482A (en) | 2000-07-05 |
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